Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Standards of Transfusion Medicine
Transcript
Società Italiana di Medicina Trasfusionale e Immunoematologia iz i SIMTI M TI Se rv Standards of Transfusion Medicine 2nd Edition SI June 2010 © Editorial board P. Bonomo, G. Alfano, G. Gandini, G. Garozzo, I. Menichini, I. Tomasini, G. Grazzini Edizioni SIMTI 1 1 © M TI SI Se rv iz i © SI M TI Se rv iz i Standards of Transfusion Medicine I II © M TI SI Se rv iz i Società Italiana di Medicina Trasfusionale e Immunoematologia Se rv iz i SIMTI M TI Standards of Transfusion Medicine 2nd Edition SI June 2010 © Editorial board P. Bonomo, G. Alfano, G. Gandini, G. Garozzo, I. Menichini, I. Tomasini, G. Grazzini Edizioni SIMTI III iz i Se rv M TI SI © © Copyright SIMTI Servizi Srl - Via Desiderio, 21 - 20131 Milano (Italy) All right reserved. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or by any information storage and retrieval system, without permission in writing from the Publisher. 1st Edition November 2010 IV Editorial group iz i Pietro Bonomo (Coordinator) Generoso Alfano Giorgio Gandini Giovanni Garozzo Ivana Tomasini Ivana Menichini (Necstep Srl) Giuliano Grazzini Reviewers Se rv Giuseppe Aprili, Vincenzo De Angelis, Gabriella Girelli, Mauro Girotto, Michela Macrì, Anna Lucia Massaro, Mario Piani, Paolo Rebulla, Claudio Velati. Regional SIMTI Delegate Reviewers M TI Giuseppe Curciarello, Alba Giovanna D’Agosta, Augusto D’Angiolino, Luigi Dell’Orso, Giuseppina Facco, Francesco Fiorin, Ivo Gentilini, Maria Antonietta Lupi, Francesco Paolo Maccarione, Antonio Minerva, Maria Pafundi, Eugenio Peres, Mirella Perluzzo, Anna Reina, Gina Rossetti, Gianpaolo Russi, Augusto Scaccetti, Luca Sciariada, Sebastiano Sofi, Vivianna Totis, Franca Tousco. Reviewers for the Coordinamento Interassociativo Volontari Italiani Sangue (Joint Committee for the Italian Associations of Blood Donors, CIVIS) SI Vincenzo Saturni (AVIS National President) Aldo Ozino Caligaris (FIDAS National President) Luigi Cardini (FRATRES National President) Maria Vittoria Torresi (Italian Red Cross Blood Donors National Inspector) Validation © SIMTI Board of Directors President: Giuseppe Aprili Validation coordinators: Giuseppe Aprili, Pietro Bonomo Organisational support SIMTI National Secretariat Manager: Roberta Frisenda Via Principe Amedeo, 149/d 00185 Roma www.simti.it V VI © M TI SI Se rv iz i PREFACE The publication of the Transfusion Medicine Standards marks one of the most important steps in the cultural, ethical and professional advancement of the Italian Society for Transfusion Medicine and Immunohaematology (Società Italiana di Medicina Trasfusionale e di Immunoematologia; SIMTI) and of the Italian blood system as a whole. Se rv iz i The work of preparing and revising this document involved not only the scientific society, but also the other components of the blood system, especially the institutions and voluntary associations. This enabled the scientific community to provide professionals operating in this sector with explicit reference material for the professional, organizational and management requirements that they need to meet in order to fulfil their mission. The cultural and professional growth of a discipline such as Transfusion Medicine - characterised by an ongoing, lively expansion and a constant need to improve its products and services - demands the capacity to analyse and reconsider one’s actions continuously and critically, comparing them with the various other ways in which the same principles are applied elsewhere around the world. M TI This was the premise behind SIMTI’s commitment to this translation project, which benefited from a great deal of support from Immucor (which took care of the organizational issues): the purpose of creating an English version of the Standards is to enable this document to become known internationally, and consequently be submitted to expert comparison and constructive criticism. Given the particular way in which the transfusion system works in Italy, it seems a good idea to provide a brief account of the organizational and institutional model on which it is based. © SI In Italy, the blood system is run under an entirely public governance scheme. Blood collection, testing, processing, storage and distribution, as well as transfusion medicine services, are recognized as “essential healthcare services” (LEA - “Livelli Essenziali di Assistenza”), to be homogeneously delivered nationwide - equitably, impartially and free of charge to any citizen needing them. Blood establishments (BEs) are exclusively public and hospital-based. Most of them are organized in large blood departments and are locally coordinated by Regional Blood Centres (RBCs) operating in the 21 Regions whose health authorities are appointed by law to deliver healthcare services with a considerable degree of autonomy within the comprehensive national framework of welfare and healthcare governance. The National Blood Centre – designated as the competent authority operating on behalf of the Ministry of Health - coordinates and supervises the 21 RBCs, with the goal of guaranteeing blood and blood product self-sufficiency and a homogeneous and standardized application of national and European blood regulations throughout the blood supply and transfusion chain, particularly as concerns quality and safety. Voluntary, anonymous, non-remunerated blood donation is recognized as a strategic issue of the National Health Service and the social value and strategic role of qualified associations and federations of voluntary blood donors are institutionally recognized. The promotion and development of blood and blood component donation is recognized as an “essential healthcare service” (LEA) and the associations and federations of voluntary blood donors participate by law in the institutional framework of the national and regional blood network. Blood VII and blood component collection can be outsourced to specifically licensed and accredited, qualified blood donor associations under the technical supervision and responsibility of BEs. In Italy, blood and blood components may not generate any financial gains, in accordance with the national transposition of the European principles and conventions on human rights and biomedicine. Claudio Velati Presidente SIMTI © SI M TI Se rv Giuliano Grazzini Direttore Centro Nazionale Sangue iz i The English text coincides with the second edition of the Standards, published in Italian in 2010. The next revision of the Standards will hopefully also draw inspiration from constructive exchanges with experts in other countries, who are sure to be able to enrich the Italian experience in this field. VIII PRINCIPAL CHANGES IN THE SECOND EDITION INTRODUCTION The “Definitions” and “References” have been revised. SECTION A - GENERAL ORGANISATIONAL REQUIREMENTS M TI Se rv iz i Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Addition of a Standard Changes to the title of the paragraph and related introduction Changes to the Standard and related Application guidelines Changes to the title of the paragraph and related introduction Addition of a Standard and related Application guidelines Changes to the Standard Addition of a Standard and related Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the title of the paragraph Changes to the Standard and related Application guidelines Changes to the title of the paragraph Changes to the Standard and related Application guidelines Addition of a Standard and related Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Addition of a paragraph and the related Standard and Application guidelines Changes to the Foreword and text, Tables of professional skills SI A.1.1.1.1 A.1.2.2 A.2.1.1 A.2.2.1.3 A.4.2 A.4.2.1 A.4.3 A.4.3.1 A.4.3.2 A.4.3.5 A.5.1.1 A.5.1.2.1 A.5.1.4 A.6.3 A.6.3.1 A.6.4 A.6.4.1 A.6.4.1.2 A.6.4.2 A.6.6.1 A.8 Annex 1 SECTION B - COLLECTION OF BLOOD AND BLOOD COMPONENTS © / B.1.2 B.2.2.1 B.2.2.1.3 B.2.2.1.5 B.3.3.1.6 B.4.3 B.4.5 B.5 B.6.3 B.7.1 B.8.6 B.8.7 B.9 B.9 Addition of an introduction to the Section Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Standard and related Application guidelines Addition of a paragraph and the related Standard and Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Omission of Indicator n. 3 in the previous Edition Changes to Indicator n. 10 in the current Edition IX SECTION C - PRODUCTION, QUALIFICATION AND BIOLOGICAL VALIDATION OF BLOOD COMPONENTS Se rv iz i Changes to the Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Addition of a Standard and related Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Standard and related Application guidelines Changes to the Standard and related Application guidelines Changes to the Standard and related Application guidelines Changes to the Standard and related Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Omission of Indicator n. 3 in the previous Edition M TI C.1.1.1 C.1.1.3 C.1.1.3.1 C.1.1.3.2 C.1.1.3.6 C.1.1.3.7 C.1.2.2 C.1.2.2.1 C.1.2.2.3 C.1.2.2.4 C.1.2.2.5 C.2.1 C.2.1.1 C.2.2 C.2.2.1 C.3.1 C.4.1 C.5.1 C.6.1 C.6.2.1 C.6.2.6 C.7 SECTION D - ALLOCATION AND DISTRIBUTION OF ALLOGENEIC BLOOD COMPONENTS Changes Changes Changes Changes Changes Changes Changes Changes Changes Changes Changes Changes Changes Changes to to to to to to to to to to to to to to the the the the the the the the the the the the the the Application guidelines Application guidelines Application guidelines Application guidelines Standard and related Application Application guidelines Application guidelines Application guidelines Standard and related Application title of the paragraph Standard and related Application Application guidelines Standard and related Application Standard and related Application © SI D.1.1.1 D.1.2.6 D.1.2.7 D.3.1.1 D.4.1 D.4.1.2 D.4.1.7 D.4.2.5 D.5.1 D.6 D.6.1 D.7.1 D.8.1.2.2 D.8.2.1 X guidelines guidelines guidelines guidelines guidelines SECTION E - LABORATORY DIAGNOSTIC ACTIVITIES iz i Changes to the Application guidelines Changes to the Standard and related Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Changes to the Application guidelines Addition of Process control indicators n. 4 and n. 5 in the current Edition Changes to the Process control indicator n. 9 in the current Edition Se rv E.1.1 E.2.1.1 E.2.2.2.2 E.2.4.1 E.2.5.1 E.2.6.1 E.3.1.1 E.3.2.2 E.3.3.2 E.4.1 E.6.1 E.7 E.7 SECTION F - AUTOTRANSFUSION Changes Changes Changes Changes Changes Changes Changes to to to to to to to the the the the the the the Application guidelines Application guidelines Application guidelines Application guidelines Application guidelines Standard and related Application guidelines Standard and related Application guidelines M TI F.2.1 F.2.1.1 F.2.2.3 F.2.2.4 F.2.2.5 F.2.2.7 F.2.3 SECTION G - COLLECTION OF HAEMOPOIETIC STEM CELLS AND OTHER CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE Changes to the title of the Section Changes to the Application guidelines Changes to the Application guidelines Addition of a chapter and the related Standard and Application guidelines Changes to the title of the paragraph Changes to the Application guidelines Addition of Process control indicators n. 5 and n. 6 in the current Edition © SI / G.2.1.2 G.2.1.6 G.3 G.4 G.4.3 G.5 XI CONTENTS INTRODUCTION APPLICABILITY OF THE STANDARDS ............................................................................................. XVII ................................................ XVII DEFINITIONS ..................................................................................................................................................... XVIII REFERENCES ...................................................................................................................................................... XXV TECHNICAL-SCIENTIFIC REFERENCES iz i GUIDE TO THE INTERPRETATION OF THE STANDARDS ......................................................................... Se rv TRANSFUSION MEDICINE STANDARDS XXV SECTION A - GENERAL ORGANISATIONAL REQUIREMENTS A.1 ..................................................................... 3 ................................................................................. 3 ............................................................................................................... 6 ELEMENTS OF MANAGEMENT STRATEGY A.1.1 POLICIES AND OBJECTIVES A.1.2 ORGANISATION A.2 MANAGEMENT OF DOCUMENTS AND DATA ............................................................... M TI A.2.1 MANAGEMENT OF PRESCRIPTIVE DOCUMENTS .................................. MANAGEMENT OF HUMAN RESOURCES 9 ........................................................................ 12 A.3.1 MAINTENANCE, DEVELOPMENT AND ASSESSMENT OF THE PERSONNEL’S SKILLS A.3.2 OPERATOR SAFETY ............................ 12 ....................................................................................................... 14 MANAGEMENT OF TECHNOLOGIES ................................................................................... 15 A.4.1 MANAGEMENT OF SYSTEMS, EQUIPMENT AND INSTRUMENTS ..................................................................................................... 15 A.4.2 MANAGEMENT OF EQUIPMENT USED FOR THE STORAGE OF BLOOD, BLOOD COMPONENTS AND HAEMATOPOIETIC STEM CELLS ............................................................ 18 A.4.3 MANAGEMENT OF INFORMATION TECHNOLOGY (IT) SYSTEMS ......................................... 19 ............................................... 21 ............................................................................................... 22 © SI A.4 A.4.4 RECONDITIONING OF MEDICAL DEVICES A.5 MANAGEMENT OF MATERIALS A.5.1 QUALIFICATION, CONTROL AND STORAGE OF MATERIALS XII 7 ............................ A.2.2 MANAGEMENT OF QUALITY DATA AND RECORDS A.3 6 ..... 22 PROCESS MANAGEMENT ............................................................................................................ ................................................................................................... 25 26 A.6.3 STORAGE OF BLOOD, BLOOD COMPONENTS AND HAEMATOPOIETIC STEM CELLS ............................................................ 28 A.6.4 PACKAGING AND TRANSPORTATION OF BLOOD, BLOOD COMPONENTS AND HAEMATOPOIETIC STEM CELLS ....................... 29 A.6.5 IDENTIFICATION AND TRACEABILITY ......................................................... 31 A.6.6 MANAGEMENT OF ORGANISATIONAL AND TECHNOLOGICAL EMERGENCIES .................................................................................................................. 32 QUALITY MONITORING, ANALYSIS AND IMPROVEMENT ................................ 33 ............................................................................................. 33 iz i A.7 25 A.6.2 QUALITY CONTROL ON THE PROCESSES, PRODUCTS AND SERVICES, AND MANAGEMENT OF NON CONFORMITIES ..... A.6.1 PROCESS PLANNING Se rv A.6 A.7.1 QUALITY MONITORING A.7.2 CORRECTIVE AND PREVENTIVE ACTIONS ............................................... 36 A.8 INFORMATION REPORTING ...................................................................................................... 37 A.9 PARTICIPATION AS PARTNERS IN RESEARCH AND DEVELOPMENT SCHEMES ............................................................................................. 38 A.9.1 RESEARCH AND DEVELOPMENT PARTNERSHIPS 38 ............................... M TI ANNEX 1 - PROFESSIONAL SKILLS OF HEALTH-CARE PERSONNEL .................... 39 SECTION B - COLLECTION OF BLOOD AND BLOOD COMPONENTS PROGRAMMING THE COLLECTION OF BLOOD AND BLOOD COMPONENTS ..................................................................................................... 50 B.2 MANAGEMENT OF DONORS OF BLOOD AND BLOOD COMPONENTS ..................................................................................................................................... 52 B.2.1 AWARENESS, INFORMATION AND EDUCATION OF DONORS OF BLOOD AND BLOOD COMPONENTS ....................................................... 52 B.2.2 SELECTION OF DONORS OF BLOOD AND BLOOD COMPONENTS ................................................................................... 54 B.2.3 MANAGEMENT OF DEFERRED DONORS ...................................................... 60 WHOLE BLOOD COLLECTION AND APHERESIS ...................................................... 63 © SI B.1 B.3 B.3.1 PREPARATION AND CONTROL OF MATERIALS AND INSTRUMENTS FOR COLLECTING WHOLE BLOOD ............... 63 B.3.2 PREPARATION AND CONTROL OF MATERIALS AND INSTRUMENTS USED FOR APHERESIS ......................................... 64 B.3.3 WHOLE BLOOD COLLECTION AND APHERESIS PROCEDURES 66 ..... XIII B.4 DONOR CARE DURING WHOLE BLOOD COLLECTION AND APHERESIS PROCEDURES ........................................................................................... 70 B.5 DONOR HAEMOVIGILANCE 72 B.6 DIAGNOSTIC INVESTIGATIONS CONDUCTED FOR EVERY DONATION, AT REGULAR INTERVALS, AND IN PARTICULAR SITUATIONS ................... 73 B.7 MANAGEMENT OF DONORS’ DATA 75 B.8 REGULATION AND CONTROL OF ACTIVITIES AT BLOOD COLLECTION SITES ............................................................................................. 77 B.9 PROCESS CONTROL INDICATORS 82 ...................................................................................................... iz i ..................................................................................... Se rv ...................................................................................... SECTION C - PRODUCTION, BIOLOGICAL QUALIFICATION AND VALIDATION OF BLOOD COMPONENTS C.1 PRODUCTION OF ALLOGENEIC BLOOD COMPONENTS FROM WHOLE BLOOD AND BY APHERESIS ................................................................ 86 C.1.1 PRODUCTION OF “1 -LEVEL” BLOOD COMPONENTS ........................ 86 C.1.2 PRODUCTION OF “2nd-LEVEL” BLOOD COMPONENTS ....................... 91 ............................................................................... 96 C.3 PRODUCTION OF BLOOD COMPONENTS FOR USES OTHER THAN TRANSFUSION ..................................................................................................................... 98 C.4 IDENTIFICATION AND TRACEABILITY OF BLOOD AND BLOOD COMPONENTS ..................................................................................................... 99 st M TI FREEZING AND THAWING OF RBC AND PLATELETS FOR TRANSFUSION SI C.2 QUALITY CONTROL ON BLOOD COMPONENTS C.6 BIOLOGICAL QUALIFICATION AND VALIDATION OF ALLOGENEIC BLOOD COMPONENTS ........................................................................ 102 © C.5 C.7 PROCESS CONTROL INDICATORS ....................................................... ...................................................................................... 100 107 SECTION D - ALLOCATION AND DISTRIBUTION OF ALLOGENEIC BLOOD COMPONENTS 110 D.1 INFORMATION FOR USERS D.2 ACCEPTING TRANSFUSION REQUESTS D.3 ASSESSING THE APPROPRIATENESS OF TRANSFUSION REQUESTS AND PROVIDING SPECIALIST ADVICE ............................................ 117 XIV ...................................................................................................... ......................................................................... 116 D.4 SELECTION AND ALLOCATION OF BLOOD COMPONENTS D.5 ISSUING BLOOD COMPONENTS D.6 HAEMOVIGILANCE ON RECIPIENTS D.7 MANAGEMENT OF BLOOD COMPONENT STOCKS D.8 DISTRIBUTION OF BLOOD COMPONENTS ............................. 120 .......................................................................................... 129 ................................................................................. ................................................. 132 .................................................................. 134 ...................................................................... ....... 137 .................................................................................... 138 D.8.2 DELIVERY OF PLASMA TO PHARMACEUTICAL COMPANIES PROCESS CONTROL INDICATORS Se rv D.9 134 iz i D.8.1 BLOOD COMPONENT EXCHANGE 131 SECTION E - LABORATORY DIAGNOSTIC ACTIVITIES E.1 LIST OF LABORATORY DIAGNOSTIC SERVICES AND INFORMATION FOR USERS .......................................................................................... 145 E.2 GENERAL CRITERIA FOR THE MANAGEMENT OF LABORATORY DIAGNOSTIC ACTIVITIES .............................................................. 146 E.2.1 VALIDATION OF ANALYTICAL PROCESSES ............................................. 146 M TI E.2.2 MANAGEMENT OF ACTIVITIES IN THE PRE-ANALYTICAL STAGE....................................................................... 147 E.2.3 MANAGEMENT OF ACTIVITIES IN THE ANALYTICAL PHASE ..... 149 E.2.4 MANAGEMENT OF ACTIVITIES IN THE POST-ANALYTICAL PHASE.................................................................... 152 E.2.5 EXTERNAL QUALITY ASSESSMENT ................................................................. SI E.2.6 OUTSOURCING LABORATORY DIAGNOSTIC ACTIVITIES SPECIFIC STANDARDS FOR ERYTHROCYTE IMMUNOHAEMATOLOGY TESTS .......................................... 154 155 E.3.1 MANAGEMENT OF ERYTHROCYTE IMMUNOHAEMATOLOGY TESTS ........................................................................ 155 E.3.2 ABO AND RhD TYPING: DONORS 156 © E.3 ........... 153 .................................................................... E.3.3 ABO AND RhD TYPING: PATIENTS ................................................................. 158 E.3.4 SCREENING FOR IRREGULAR ERYTHROCYTE ANTIBODIES AND CROSSMATCHING ............................................................................................ 159 E.3.5 IDENTIFICATION OF IRREGULAR ERYTHROCYTE ANTIBODIES ................................................. E.3.6 IMMUNOHAEMATOLOGICAL INVESTIGATIONS ON THE HAEMOLYTIC DISEASE OF THE NEWBORN ......................... E.3.7 STUDY OF AUTOIMMUNE HAEMOLYTIC DISORDERS ..................... 160 161 162 XV E.4 SPECIFIC STANDARDS FOR MICROBIOLOGICAL TESTS PERFORMED FOR THE QUALIFICATION OF ALLOGENEIC BLOOD COMPONENTS ....... 163 E.5 SPECIFIC STANDARDS FOR LEUKOCYTE AND PLATELET IMMUNOHAEMATOLOGY TESTS ............................................................................................ 164 E.6 SPECIFIC STANDARDS FOR EXTEMPORANEOUS PREDONATION DIAGNOSTIC TESTS ................................................................................ 165 E.7 PROCESS CONTROL INDICATORS SECTION F - AUTOLOGOUS BLOOD TRANSFUSION 165 iz i ...................................................................................... 170 INFORMATION FOR USERS F.2 MANAGEMENT OF PRE-OPERATIVE AUTOLOGOUS BLOOD DONATION PROGRAMMES ..................................................................................... 171 F.3 MANAGEMENT OF OTHER AUTOLOGOUS BLOOD TRANSFUSION ACTIVITIES .................................................................................. 178 F.4 PROCESS CONTROL INDICATORS Se rv F.1 ...................................................................................................... ...................................................................................... 179 M TI SECTION G - HAEMOPOIETIC STEM CELL COLLECTION AND OTHER CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE ........................................... 182 G.2 GENERAL CRITERIA FOR MANAGING CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE ........................................... 183 SI G.1 LIST OF SERVICES AND INFORMATION FOR USERS G.3 SPECIFIC STANDARDS FOR HAEMOPOIETIC STEM CELL (HSC) COLLECTION ACTIVITIES ........................................................................................................... 188 G.3.1 SPECIFIC STANDARDS FOR COLLECTING BONE MARROW AND PERIPHERAL HAEMOPOIETIC STEM CELLS ................................... 188 © G.3.2 SPECIFIC STANDARDS FOR UMBILICAL CORD BLOOD DONATION ............................................... 191 G.4 SPECIFIC STANDARDS FOR OTHER CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE ................................................................................................... 193 G.5 PROCESS CONTROL INDICATORS XVI ........................................................................................ 196 INTRODUCTION APPLICABILITY OF THE STANDARDS This Manual applies to blood establishments (including any related branches) authorised/accredited in the light of the national and regional legislation applicable to the sector. Se rv iz i The Manual is arranged in Sections, each of which applies to a specific type of organisation, as a function of the products/services it provides: ● Section A - General organisational requirements; ● Section B - Collection of blood and blood components; ● Section C - Production, qualification and biological validation of blood components; ● Section D - Allocation and distribution of allogeneic blood components; ● Section E - Laboratory diagnostic activities; ● Section F - Autotransfusion; ● Section G - Collection of haemopoietic stem cells and other clinical activities in transfusion medicine; Section A establishes the General standards of an organisational and managerial nature applicable to all blood establishments, irrespective of the type of product/service they provide. M TI Sections B, C, D, E, F, G establish Specific organisational-managerial and technical/professional standards applicable to blood establishments depending on the type of product/service they provide. GUIDE TO THE INTERPRETATION OF THE STANDARDS SI The Standards in each Section of the Manual are organised into chapters and are identified by means of alphanumerical codes. © Each Standard is generally complete with Application guidelines, which explain the criteria to adopt for the purposes of a proper interpretation and application of the standard, defining: ● the guarantees that must necessarily be provided and/or the activities that must necessarily be conducted to ensure alignment with the standard concerned (identified by means of the term “shall” - or equivalent expressions - in bold type). Where the Guidelines provide explicit indications in this sense, they have the same prescriptive value as the standards to which they refer; ● recommendations relating to certain aspects of the organisation, i.e. guarantees that should preferably be provided and/or the related instruments/methods, even though compliance is not compulsory (identified by means of the term “should” - or equivalent expressions - in italics and bold type); ● any applicable alternative approaches to the performance of the activities that are considered equivalent to the content described in the two previous items (identified by means of the term “may” - or its equivalent expressions - in italics). XVII DEFINITIONS An unexpected event relating to the donation or transfusion process that can cause unintentional and unwanted harm to the donor/patient. Adverse reaction An undesirable effect seen in an individual relating to a donation, a transfusion or a diagnostic or therapeutic procedure. Analyte A substance identified/measured by a laboratory test. Back-up A procedure for duplicating information (data or software) saved in a workstation or production server on different support media, normally done according to an established schedule. Benchmarking A method for comparing the characteristics of an organisation, activity or institution with those of other, similar organisations, activities or institutions to establish which performs best and to identify the most appropriate management methods and strategies. It is used as an improvement tool. Biological validation Final assessment of the set of elements needed for the biological qualification of a donation and the related products, with a view to declaring it suitable for transfusion purposes (subject to verification of immunological compatibility) and allowing its definitive labelling. The elements that biologically qualify a donation and the related products include: - the results of microbiological and immunohaematological tests required by current legislation; - the treatment of the available details relating to the donation and the donor, particularly concerning any specific findings in their medical history or emerging from their clinical examination during the selection phase, and any post-donation findings/information; - any biological qualification tests not required by law, conducted to satisfy particular blood component safety demands and/or specific clinical requirements. © SI M TI Se rv iz i Adverse event XVIII A permanent or mobile site for collecting blood and blood components, managed by associations and federations of blood donors operating in connection with the blood establishment and under its technical responsibility in accordance with the applicable national and regional standards. Any collection sites managed directly by the blood establishment as branches of its own organisation (at separate units or hospital or inter-hospital departments) are considered for all intents and purposes as an integral part of the blood establishment. Blood establishment In the formulation of the Standards and the related Application guidelines, the term “blood establishment” implicitly refers to different levels of responsibility defined therein (from the BE management to the various levels of responsibility attributed thereby). Blood establishment manager (BE manager) The person responsible for the BE. In Italy, according to a more stringent transposition of Directive 2002/98/EC, a BE manager can only be a physician officially qualified in transfusion medicine having successfully completed a university specialty course and gained at least five years of experience in the field of blood and blood component collection, testing, processing, storage, issuing and distribution. Clinical guidelines A set of clinical behavioural recommendations developed by adopting a formal methodological procedure involving a systematic review of the available scientific information and its multidisciplinary and multi-professional interpretation. They are designed to orient clinical decisions so as to facilitate the adoption of measures of documented efficacy in appropriate clinical circumstances and organisational settings. M TI Se rv iz i Blood collection site A sign, symptom, syndrome, anomaly or unfavourable condition observed in a donor or patient, temporarily associated with an action taken, which may or may not have a causal relationship with the action concerned. Corrective action An action designed to prevent any repetition of a nonconformity to a given standard by eliminating its cause. © SI Complication Cut-off In a laboratory quality test, the value that discriminates between a reactive and a non-reactive test result, depending on the method being used. Donor’s file A set of all the details relating to a given donor, recorded on printed paper and/or in electronic form. External quality audit Periodic monitoring activity on a cooperative basis to assess the precision and accuracy of the analytical methods employed at a test laboratory. XIX A standardised document (on printed paper or in electronic format) for recording details or activities, adopted to ensure homogeneity in data collection by the personnel involved. Grey zone In biological qualification tests, a set of values - defined as a percentage below and/or above the cut-off - coinciding with which the test result cannot be considered non-reactive. Haemovigilance A set of procedures for identifying and monitoring unwanted or unexpected severe adverse reactions and severe incidents relating to the transfusion process and to surveillance of transfusion-transmitted infectious diseases. Haemovigilance systems are governed by specific EC requirements as transposed in national legislation; see Decree of 21 December 2007 on the creation of the Italian transfusion services’ IT system (SISTRA), with the following objectives: - to constitute a European network of basic epidemiological information for orienting strategies and programmes for the continual improvement of transfusion process and product quality and safety, and to support evidence-based decision-making processes; - to establish a system for monitoring severe incidents potentially influencing the quality and safety of blood and blood components, and the safety of recipients and donors, to enable undertake corrective and preventive actions, also with a view to developing early warning models. M TI Se rv iz i Form An individual’s expression of consent to undergo a specific healthcare treatment after they have been suitably informed about its purposes and any risks involved. Internal quality control (laboratory) A set of activities designed to minimise analytical errors and promote the reliability of laboratory data. A set of procedures adopted by a laboratory to continuously monitor whether the results obtained in a set of analyses are sufficiently reliable, and whether there are any trends associated with a given variation are identifiable before the established quality limits are exceeded. © SI Informed consent to treatment XX A retrospective investigation and assessment relating to a given donor’s risk of transfusion-transmitted diseases if one or more donations made by said donor are found to be at risk, or potentially at risk of transmitting disease, based on diagnostic and clinical examinations and the donor’s medical history, or if said donation(s) are implicated in cases of suspected transfusion-transmitted disease. The investigation is also designed to guarantee the performance of any action associated with the involvement of donations being made in situations at risk of transmitting disease via the resulting blood components or plasma-derived medicinal products, to be taken in relation to third parties affected (e.g. pharmaceutical industries with agreements for handling the conversion of plasma, organisations responsible for the regulations governing compensation for personal injury attributable to transfusions). Medical device See the definitions in the specific Community Directives on the matter, transposed by the Italian Legislative Decree (D. Lgs.) n. 46 of 24/02/1997. Near miss A hazardous situation that narrowly avoided developing into an adverse event. Any situation that could have generated an adverse event, but did not due to chance or capable management. M TI Se rv iz i Look back A deviation from a specified standard. Objective evidence Information that is demonstrably reliable on the grounds of observations, measurements, test or other links. Organisation chart A method for representing the hierarchy in an organisation, showing the various levels of responsibility. SI Nonconformity © Organisational emergency, technological emergency An unexpected “critical” organisational or technological situation that the organisation has to cope with, adopting prompt and effective solutions to guarantee user and operator safety, and the continuity of the service at the established quality levels. Outsourcing A strategy consisting in contracting out certain activities, allocating them to other organisations (for reasons of cost, technology, etc.). Post-transfusion follow-up Period of observation based on an established protocol of clinical investigations to monitor some of a recipient’s biological and/or clinical variables to obtain information on the effects of the transfusion. XXI All documents, on printed paper or electronic support media, defining the rules and standards to apply within an organisation. Preventive action An action designed to prevent the occurrence of a potential nonconformity to a specified standard or other critical situation by removing its cause. Procedure A document defining the sequence of activities, responsibilities and methods involved in regulating a process or activity in the light of the established objectives. A procedure’s scope and level of detail differ according to the complexity of the processes/activities it governs and the competence of the personnel responsible its application. Process A structured sequence of activities designed to produce a result that has value for the (internal or external) end user. Process control An activity for auditing certain process variables considered crucial to the proper performance of the related activities and consequently to the quality of the outputs of said process. Process control indicator A tool for measuring the characteristics of a process, product or service. M TI Se rv iz i Prescriptive documents Inter-laboratory tests are conducted according to established programmes and used as a means for ensuring a laboratory’s quality, documenting the referability of its measurements, validating its test methods, certifying its reference materials, and evaluating its personnel’s technical expertise. Protocol A locally agreed, predefined optimal set of actions to take as a starting point in clinical (or operational) activities. It gives an account of the reasons, constraints and objectives of the activities involved. SI Proficiency test (laboratory) © Qualification As a part of validation, the action of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results. (European Commission Directive 2005/62/CE). Quality Conformity of a product, process or parts thereof to established standards. Quality audit An independent, documented, systematic assessment to establish whether quality-related activities and their outcomes comply with the planned requirements and whether any provisions are effectively implemented and appropriate for achieving the objectives. XXII Activity designed to ascertain the conformity of the characteristics of products (or parts of a product), documents, equipment, materials or other elements of a process to established standards. Quality data and records All data and records, on printed paper or electronic and magnetic support media, needed to provide evidence of the systematic performance of an organisation’s programmed activities and/or the satisfaction of its management and working standards. Quality monitoring system A chart for assessing the relevant aspects of a product, service or process, consisting of a set of indicators that are measured to provide useful elements for monitoring activities and results, and consequently for identifying any critical areas and enabling improvements. Recipient The person allocated to receive one or more blood components, or who has received the blood components allocated thereto. Reconditioning of medical devices A set of activities for cleaning, washing, drying, lubricating, decontaminating and sterilising instruments, equipment and systems used in the process for providing the service with a view to preventing contamination. Se rv A biological sample containing a known concentration or activity level of a given analyte, that is processed in the same analytical session and under the same conditions as the biological samples from donors/patients being tested. A representative fraction of an entity or population. SI Sample M TI Run control iz i Quality control The action of collecting or constituting a sample. Test validation Confirmation of the validity and representative value of an analytical finding based on a study of the values identified and a comparison between different parameters. © Sampling Traceability The capacity to retrace the history, usage or location of a given element. Applied to a blood unit or a blood component derived therefrom, traceability refers to the ability to retrace the steps from the donor to the final destination, or vice versa. Transfusion emergency Situation where a patient’s clinical conditions are such that deferring the transfusion may put the patient’s life at risk, making it impossible to follow the normal pre-transfusion blood unit selection and compatibility procedures. XXIII A situation where a patient’s clinical conditions allow for the short-lived postponement of a transfusion. Validation The establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled (European Commission Directive 2005/62/CE). Certification of the efficacy of a process/activity (method, resources used, times, etc) in satisfying the established aims, achieved as a result of planned activities including: - the definition of the results to achieve; - the definition of the acceptance criteria; - the identification of the critical variables in the process/ activity; - the planning and performance of tests designed to produce statistically significant evidence, where applicable; - the consequent production of documentary evidence providing assurance of the capacity of the process/ activity to achieve the established results. © SI M TI Se rv iz i Transfusion emergency XXIV REFERENCES The standards contained in this Manual are defined in accordance with current Italian and European legislation and recommendations. Technical-scientific references College of American Pathologists. Standards for Laboratory Accreditation. 2000 Edition. 2) Schreiber GB, Glynn SA, Busch MP, Sharma UK, Wright DJ, Kleinman SH; Retrovirus Epidemiology Donor Study. Incidence rates of viral infections among repeat donors: are frequent donors safer? Transfusion. 2001 Jun; 41(6):730-5. 3) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI), in collaborazione con GITMO, IBMDR, SIdE, SIE. Linee guida per la raccolta delle cellule staminali ai fini di un trapianto allogenico di midollo osseo. Edizioni SIMTI, 2001. 4) Dodd RY, Notari EP 4th, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion. 2002 Aug; 42(8):975-9. 5) Schreiber GB, Glynn SA, Damesyn MA, Wright DJ, Tu Y, Dodd RY, Murphy EL; Retrovirus Epidemiology Donor Study. Lapsed donors: an untapped resource. Transfusion. 2003 Jan; 43(1):17-24. 6) Glynn SA, Busch MP, Schreiber GB, Murphy EL, Wright DJ, Tu Y, Kleinman SH; National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study. Effect of a national disaster on blood supply and safety: the September 11 experience. JAMA 2003 May 7; 289(17):2246-53. 7) Bocker W, Clark M, Desaint C et al. ISBT. Guidelines for Validation and Maintaining the Validation State of Automated Systems in Blood Banking. Vox Sang. 2003; 85 Suppl 1:S1-14. Se rv M TI SI Stramer SL, Glynn SA, Kleinman SH, Strong DM, Caglioti S, Wright DJ, Dodd RY, Busch MP; National Heart, Lung, and Blood Institute Nucleic Acid Test Study Group. Detection of HIV-1 and HCV Infections among AntibodyNegative Blood Donors by Nucleic Acid-Amplification Testing. N Engl J Med. 2004 Aug 19; 351(8):760-8. © 8) iz i 1) 9) World Health Organization. External Quality Assessment of Transfusion Laboratory Practice. Guidelines on Establishing an EQA Scheme in Blood Group Serology. Geneva, 2004. Available at: http://www.who.int/bloodsafety/ EQA_in_Blood_Group_Serology.pdf. Last visited on: 15.05.2010. 10) Zou S, Musavi F, Notari EP 4th, Fujii KE, Dodd RY; ARCNET Study Group. Prevalence of selected viral infections among temporarily deferred donors who returned to donate blood: American Red Cross blood donor study. Transfusion 2005 Oct; 45(10):1593-600. XXV 11) UK Blood Transfusion & Tissue Transplantation Services. Guidelines for the Blood Transfusion Services in the United Kingdom. 7th Edition, 2005. Available at: http://www.transfusionguidelines.org.uk. Last visited on: 15.05.2010. 12) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI) e Società Italiana di Ginecologia e Ostetricia (SIGO). Raccomandazioni per la gestione della Malattia Emolitica del Neonato. Edizioni SIMTI, 2006. iz i 13) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI) e Società Italiana di Neonatologia (SIN). Recommendations on transfusion therapy in Neonatology. Blood Transfusion 2006; 4:158-180. Se rv 14) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI) e Società Italiana di Ginecologia e Ostetricia (SIGO). Recommendations for the management of Haemolytic disease of the newborn. Blood Transfusion 2006; 4: 237-250. 15) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI), in collaborazione con CIVIS - Coordinamento Interassociativo Volontari Italiani Sangue. Linee guida per la selezione del donatore di sangue e di emocomponenti. II Edizione. Edizioni SIMTI, 2006. 16) UK Blood Transfusion & Tissue Transplantation Services. Handbook of Transfusion Medicine. 4th Edition, 2007. Available at: http://www. transfusionguidelines.org.uk. Last visited on: 15.05.2010. M TI 17) Australian & New Zealand Society of Blood Transfusion inc. Guidelines for Pretransfusion Testing. 5th edition, 2007. Available at: http://www.anzsbt. org.au/publications/index.cfm. Last visited on: 15.05.2010. 18) Canadian Society for Transfusion Medicine (CSTM). Standards for Hospital Transfusion Services. Version 2, 2007. SI 19) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI). Raccomandazioni SIMTI sul corretto utilizzo degli emocomponenti e dei plasmaderivati. Edizioni SIMTI, 1a edizione, settembre 2008. © 20) FACT (Foundation for the Accreditation of Cellular Therapy) and JACIE (Joint Accreditation Committee of the ISCT & EBMT). International standards for cellular therapy product collection, processing, and administration. 4th Edition, October 2008. Available at: http://www.factwebsite.org/main.aspx?id=526. Last visited on 15.05.2010. 21) NetCord-FACT. International standard for cord blood collection, processing, testing, banking, selection and release. 3th edition, version 3.1, December 2008. Available at: http://www.factwebsite.org/main.aspx?id=526. Last visited on 15.05.2010. 22) Joint Accreditation Committee of the ISCT & EBMT (JACIE), Foundation for the Accreditation of Cellular Therapy (FACT). International Standards for cellular therapy product collection, processing and administration. 4th Edition, 2009. Available at: http://www.jacie.org. Last visited on: 15.05.2010. 23) American Association of Blood Banks (AABB). Standards for Blood Banks and Transfusion Services. 26th edition, 2009. XXVI 24) European Federation for Immunogenetics (EFI). Standards for Histocompatibility Testing. Version 5.6.1, 2009. Available at: www.efiweb. eu/fileadmin/user_upload/pdf/Accreditation/version_5_6_1_Revision_ April_2010.pdf. Last visited on 15.05.2010. 25) Canadian Standards Association (CSA). Blood and blood components: a national standard of Canada, CAN/CSA-Z902-F04 (R2009). 2009. 26) Raccomandazioni su terapia con emocomponenti e plasmaderivati nella preeclampsia. Proposta a AIPE il 30 giugno 2009, bozza. Se rv iz i 27) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI). Raccomandazioni SIMTI sulla gestione delle scorte di emocomponenti durante la pandemia influenzale. Il Servizio Trasfusionale, Bollettino di informazione sulle attività trasfusionale italiane, settembre-ottobre 2009, anno XXXVIII n. 5, pagg. 48-50. 28) International Society of Blood Transfusion (ISBT). ISBT Guidelines for Validation of Automated Systems in Blood Establishments. Vox Sanguinis, vol. 98, supplement 1, February 2010. 29) Etablissement Français du Sang (EFS). Principes de bonne pratique. Available at: http://www.afssaps.fr/Afssaps-media/Publications/Recommandationsde-bonne-pratique. Last visited on: 15.05.2010. © SI M TI 30) Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI): Raccomandazioni SIMTI sul corretto utilizzo della Trasfusione Perioperatoria. Edizioni SIMTI, 1a edizione, giugno 2010. XXVII © M SI TI zi Se rv i Standards of Transfusion Medicine Section A - General organisational requirements Società Italiana di Medicina Trasfusionale e Immunoematologia 2nd Edition SECTION A GENERAL ORGANISATIONAL REQUIREMENTS A.1 ELEMENTS OF MANAGEMENT STRATEGY iz i CONTENTS ........................................................... 3 ................................................................................. 3 ............................................................................................................... 6 A.2 MANAGEMENT OF DOCUMENTS AND DATA ..................................................... A.2.1 MANAGEMENT OF PRESCRIPTIVE DOCUMENTS .................................. 6 7 A.1.2 ORGANISATION Se rv A.1.1 POLICIES AND OBJECTIVES ............................. 9 ............................................................... 12 A.2.2 MANAGEMENT OF QUALITY DATA AND RECORDS A.3 MANAGEMENT OF HUMAN RESOURCES A.3.1 MAINTENANCE, DEVELOPMENT ............................ 12 ....................................................................................................... 14 M TI AND ASSESSMENT OF THE PERSONNEL’S SKILLS A.3.2 OPERATOR SAFETY A.4 MANAGEMENT OF TECHNOLOGIES ......................................................................... 15 A.4.1 MANAGEMENT OF SYSTEMS, EQUIPMENT AND INSTRUMENTS ..................................................................................................... 15 A.4.2 MANAGEMENT OF EQUIPMENT USED SI FOR THE STORAGE OF BLOOD, BLOOD COMPONENTS AND HAEMATOPOIETIC STEM CELLS ............................................................ 18 A.4.3 MANAGEMENT OF .......................................... 19 ................................................ 21 ....................................................................................... 22 INFORMATION TECHNOLOGY (IT) SYSTEMS © A.4.4 RECONDITIONING OF MEDICAL DEVICES A.5 MANAGEMENT OF MATERIALS A.5.1 QUALIFICATION, CONTROL AND STORAGE OF MATERIALS ...... 22 1 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements A.6 PROCESS MANAGEMENT 2nd Edition ....................................................................................................... A.6.1 PROCESS PLANNING .................................................................................................... 25 25 A.6.2 QUALITY CONTROL ON THE PROCESSES, PRODUCTS AND SERVICES, AND MANAGEMENT OF NON CONFORMITIES ...... 26 A.6.3 STORAGE OF BLOOD, BLOOD COMPONENTS AND HAEMATOPOIETIC STEM CELLS ............................................................ 28 iz i A.6.4 PACKAGING AND TRANSPORTATION OF BLOOD, BLOOD COMPONENTS AND HAEMATOPOIETIC STEM CELLS ....................... 29 .......................................................... 31 A.6.6 MANAGEMENT OF ORGANISATIONAL AND TECHNOLOGICAL EMERGENCIES .................................................................................................................. 32 Se rv A.6.5 IDENTIFICATION AND TRACEABILITY A.7 QUALITY MONITORING, ANALYSIS AND IMPROVEMENT A.7.1 QUALITY MONITORING ................ 33 .............................................................................................. 33 ................................................ 36 .............................................................................................. 37 A.7.2 CORRECTIVE AND PREVENTIVE ACTIONS A.8 INFORMATION REPORTING A.9 PARTICIPATION AS PARTNERS IN RESEARCH AND DEVELOPMENT SCHEMES ....................................................................................... 38 M TI A.9.1 RESEARCH AND DEVELOPMENT PARTNERSHIPS ................................ 38 © SI ANNEX 1 - PROFESSIONAL SKILLS OF HEALTH-CARE PERSONNEL ................................................................................................. 39 2 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.1 ELEMENTS OF MANAGEMENT STRATEGY The Blood Establishment (BE) management shall guarantee its commitment to establishing, implementing, maintaining and developing the BE’s quality standards, and to adopting mechanisms capable of ensuring its proper management, by providing clear guidelines that must be shared with all personnel operating within the BE. A.1.1 POLICIES AND OBJECTIVES iz i A.1.1.1 The BE management shall develop and formalise the strategies, the general objectives and the policies to pursue at the blood establishment. Se rv A.1.1.1.1 The strategies, general objectives and policies to pursue at the BE shall be circulated to all personnel operating therein. A.1.1.1.2 The strategies, general objectives and policies to pursue at the BE shall be systematically audited at least once a year to ascertain their ongoing adequacy. M TI A.1.1.2 Consistently with the established strategies, general objectives and policies, and also in the light of any critical issues emerging as a result of systematic quality monitoring activities, the BE management shall define specific quality improvement objectives that the establishment undertakes to pursue. A.1.1.2.1 The specific quality improvement objectives shall be circulated to all personnel operating at the BE. SI A.1.1.2.2 The specific quality improvement objectives shall be audited at least once a year. APPLICATION GUIDELINES © A.1.1.1 The BE management shall develop and formalise the strategies, the general objectives and the policies to pursue at the blood establishment. The BE management shall be responsible for developing and formalising the strategic guidelines, the general objectives and the policies to pursue at the establishment, which shall be: a) appropriate for the establishment’s mission; b) consistent with the strategies and policies established at higher hospital/health trust management and institutional levels; c) designed for the purpose of safeguarding and continually improving the safety of the blood transfusion process inasmuch as concerns the donors, the patients and the operators involved; 3 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition Se rv iz i d) designed for the purpose of satisfying the demand for blood components and blood products in the healthcare areas served by the BE (particularly for the needs relating to urgent and emergency situations), as well as in the settings identified in the regional and national self-sufficiency programmes; e) focusing on ensuring the appropriate clinical use of blood components and blood products and an appropriate organisation of the related management processes; f) focusing on furthering and emphasising the role of transfusion medicine as a strategic activity supporting many of the most important healthcare activities, promoting and contributing to the definition of diagnostic-therapeutic processes, also in the context of Hospital Transfusion Committees; g) focusing on making the best use of the personnel and ensuring their continuing professional development; h) focusing on compliance with the SIMTI Transfusion Medicine Standards and on improving the BE’s performance. A.1.1.1.1 The strategies, general objectives and policies to pursue at the BE shall be circulated to all personnel operating therein. The strategies, general objectives and policies to pursue at the establishment shall be decided in co-operation with the responsible persons at the BE (e.g. sector managers, coordinating technicians and nurses). M TI They shall also be circulated to all personnel operating at the establishment, and the action taken to circulate them shall be documented (by means of the minutes of meetings designed for this purpose or equivalent methods). SI A.1.1.1.2 The strategies, general objectives and policies to pursue at the BE shall be systematically audited at least once a year to ascertain their ongoing adequacy. Activities conducted to assess the ongoing adequacy of the strategies, general objectives and policies to pursue at the BE, and any revision thereof, shall be documented. © A.1.1.2 Consistently with the established strategies, general objectives and policies, the BE management defines specific quality improvement objectives that the establishment undertakes to pursue, also in the light of any critical issues emerging as a result of systematic quality monitoring activities. The specific objectives defined by the management shall be: a) consistent with the established strategies, general objectives and policies; b) designed to improve the quality of the processes/activities and/or the corresponding results achieved by the BE, also in relation to the outcome of the periodic monitoring activities and data analyses relating to the quality of the processes, products and clinical outcomes (see Ch. A.7.1 Quality monitoring); 4 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition c) designed to improve the technical/professional quality, according to the SIMTI Transfusion Medicine Standards, and the progress of transfusion medicine and the related disciplines; d) suited to the resources actually available; e) formally recorded in appropriate documents; f) expressed in measurable or otherwise verifiable form, particularly as concerns the results of processes for the development and continual improvement of the BE’s technical/professional performance. iz i For each objective, the corresponding responsible persons, the resources, the timing, and the methods to use to pursue it shall be clearly defined, as well as appropriate measurement indicators for assessing its achievement. Se rv A.1.1.2.1 The specific quality improvement objectives shall be circulated to all personnel operating at the BE. The quality improvement objectives shall be defined in co-operation with the persons responsible for the BE’s sectors and shall be assigned and circulated at all pertinent levels of the BE. M TI The activities conducted to circulate these objectives shall be documented (by means of the minutes of meetings designed for this purpose or equivalent methods). The BE management is responsible for ensuring a thorough understanding of the established improvement objectives at all levels of the BE. A.1.1.2.2 The specific quality improvement objectives shall be audited at least once a year. SI The BE management shall periodically audit, at least once a year, the degree to which the specific quality improvement objectives have been achieved. © The objectives shall be systematically monitored, revised and, where necessary, updated. 5 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.1.2 ORGANISATION A.1.2.1 The BE management shall guarantee that responsibilities and authority are clearly defined and communicated within the establishment. A.1.2.2 The BE management shall appoint a Quality Assurance manager iz i APPLICATION GUIDELINES Se rv A.1.2.1 The BE management shall guarantee that responsibilities and authority are clearly defined and communicated within the establishment. The BE management shall formally define and approve the organisation chart for the establishment and specify the main responsibilities of the various responsible persons within the BE. The responsibilities attributed to the designated individuals shall also be clearly defined in the procedures adopted by the BE. M TI The above-mentioned documents shall be made known to all personnel operating at the BE. A.1.2.2 The BE management shall appoint a Quality Assurance manager. SI The BE management shall identify a person responsible for Quality Assurance who, irrespective of any other responsibilities, is made responsible for supervising all the processes and activities that have a an influence on the quality and safety of blood and blood components and on the services delivered by the BE. The BE management shall formally define the specific responsibilities of the Quality Assurance manager. © A.2 MANAGEMENT OF DOCUMENTS AND DATA The BE management shall adopt and manage a document system designed to ensure: a) the availability to all operators of appropriate and up-to-date references for the proper conduction of the activities for which they are responsible; b) the identification and traceability of all elements needed to provide evidence of the systematic performance of the activities required and/or of compliance with the organisational, managerial, technical/professional requirements and working standards established by the BE in accordance with the present Manual. 6 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.2.1 MANAGEMENT OF PRESCRIPTIVE DOCUMENTS A.2.1.1 The BE shall adopt systems designed to guarantee the effective management of all prescriptive documents used for reference in the proper conduction of processes and activities at the BE. iz i A.2.1.2 The BE shall prepare a specific list of the prescriptive documents issued and applied by the establishment, and keep this list up-to-date. A.2.1.3 The BE shall adopt systems designed to ensure the identification and the constant retrieval and revision of documents of external origin applicable at the BE. APPLICATION GUIDELINES Se rv A.2.1.4 The BE shall develop, make available and systematically use appropriate forms, on printed paper or electronic support, for recording data and activities in accordance with the requirements of the procedures adopted at the BE. M TI A.2.1.1 The BE shall adopt systems designed to guarantee the effective management of all prescriptive documents used for reference in the proper conduction of processes and activities at the BE. Prescriptive documents define the rules and standards to apply within a BE. Examples of prescriptive documents include: procedures, work instructions, diagnostic-therapeutic protocols, behavioural norms, documents outlining the organisation of the establishment. SI The prescriptive documents adopted at the BE shall be controlled in order to ensure the availability of appropriate, clear and up-to-date references for operators involved in conducting the various activities. © The systems adopted to manage prescriptive documents shall guarantee that the following are clearly stated: a) the criteria for identifying the documents; b) the responsibilities for the preparation, review and approval of the documents; c) the methods for managing revisions (changes shall always be dated and signed by expressly authorised parties and should be highlighted); d) the responsibilities and the tools used to circulate the documents to the interested parties (identified in specific lists) every time they are revised; e) the responsibilities and methods for preserving the originals; f) the methods for managing obsolete documents (mechanisms for removing copies from the places where they were in use, preservation times, methods for eliminating documents after the established preservation times have expired). 7 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition Where specified in the present Manual, or deemed advisable by the BE management, the prescriptive documents (and particularly the procedures and work instructions) may be approved only after adequate validation studies have been performed. Prescriptive documents should be prepared using standardised formats. Se rv iz i They should always indicate: a) the scope, or purpose for which they were prepared; b) the field of application; c) the sources used in their preparation (particularly the reference scientific literature in the case of documents of a technical/professional nature); d) the related forms to be used. A.2.1.2 The BE shall prepare a specific list of the prescriptive documents issued and applied by the establishment, and keep this list up-todate. The lists containing the prescriptive documents issued and applied by the establishment shall always indicate the revision level of the documents concerned. M TI The BE shall identify and define the responsibilities for preparing and revising these lists. A.2.1.3 The BE shall adopt systems designed to ensure the identification and the constant retrieval and revision of documents of external origin applicable at the BE. © SI In some cases, the requirements applicable to the proper performance of processes and activities at the BE are stated in documents of external origin, e.g. a) normative requirements (be they regional, national and international) currently in force; b) directives and provisions issued by the body governing the BE (e.g. the hospital management); c) guidelines and other technical-scientific reference documents; d) conventions or memoranda of understanding signed with other bodies/ establishments/associations with which the BE interfaces; e) technical documentation issued by suppliers (use and maintenance manuals and subsequent revisions thereof, technical datasheets on materials, safety data sheets on material, etc.); f) all other documents considered pertinent and useful for the proper performance of the activities. The methods and responsibilities for the retrieval of up-to-date versions of documents of external origin applicable at the BE shall be clearly defined. 8 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.2.1.4 The BE shall develop, make available and systematically use appropriate forms, on printed paper or electronic support, for recording data and activities in accordance with the requirements of the procedures adopted at the BE. For a definition of the term “Form”, see the Introduction to the Transfusion Medicine Standards, Definitions. Se rv iz i The BE shall adopt controlled methods for managing currently-used forms, designed to guarantee that: a) the forms are unequivocally identified; b) they have been approved by the responsible persons at the BE and included in specific lists that are systematically revised by the persons responsible, as identified by the management of the establishment; c) the level of their revision is always clearly identifiable; d) obsolete copies are promptly removed and up-to-date versions are always available to operators at the BE. The labels adopted by the BE for product identification purposes shall be intended as forms requiring a controlled management. M TI The BE shall also guarantee the retrieval and distribution to the operators of up-to-date versions of forms of external origin (originating from the hospital or elsewhere), the use of which is functional to the proper completion and control of the processes and activities. A.2.2 MANAGEMENT OF QUALITY DATA AND RECORDS A.2.2.1 The BE shall adopt systems designed to guarantee the proper management of the quality data and records generated at the BE. SI A.2.2.1.1 The BE shall guarantee that the quality data and records are always legible, identifiable and readily traceable. A.2.2.1.2 The BE shall ensure the traceability of the operators responsible for generating quality data and records. © A.2.2.1.3 The BE shall guarantee the protection of all information and data collected. A.2.2.1.4 The BE shall define and implement emergency procedures designed to ensure the proper and effective performance of its activities even in the event of data on electronic support being momentarily unavailable. A.2.2.2 The BE shall prepare specific lists indicating the quality records that it undertakes to generate and to preserve for established periods of time, and it shall keep these lists upto-date. 9 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition APPLICATION GUIDELINES A.2.2.1 The BE shall adopt systems designed to guarantee the proper management of the quality data and records generated at the BE. For a definition of the term “Quality data and records “, see the Introduction to the Transfusion Medicine Standards, Definitions. iz i Quality data and records may be generated both on printed paper and on IT media. Se rv Either way, their management shall be controlled to guarantee the traceability of the activities involved and of the results achieved for established periods of time. M TI The BE management is responsible for identifying the types of quality data and records to be generated in the light of the following criteria: a) requirements dictated by current legislation and voluntary reference standards; b) the need to provide the BE manager, the hospital management to which the BE responds, and auditors sent by competent external organisations/institutions/ bodies for their established auditing activities, with objective evidence of the activities conducted; c) the need to process and analyse statistical data for the purposes of quality improvement; d) the opportunity to keep a historical record of the activities conducted, or of certain results achieved. © SI The quality data and records shall always include the following: a) those prescribed by current legislation or voluntary reference standards; b) those demonstrating the performance of activities that the BE management considers crucial for ensuring the quality of the products and services it delivers; c) those demonstrating the conduction of auditing/control/monitoring activities and quality analyses on products, services or processes/activities; d) those testifying to decisions reached by personnel appointed to do so on matters crucial to the quality of the service (e.g. process validation activities, decisions relating to the treatment of nonconformities, decisions relating to the implementation of preventive or corrective actions, and to the assessment of their efficacy). A.2.2.1.1 The BE shall guarantee that the quality data and records are always legible, identifiable and readily traceable. The operators responsible for producing quality data and records shall guarantee that they are legible. The BE shall adopt criteria designed to guarantee that the quality data and records are identifiable and readily traceable. 10 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.2.2.1.2 The BE shall ensure the traceability of the operators responsible for generating the quality data and records. The BE shall adopt systems designed to systematically ensure the traceability of the operators responsible for producing quality data and records, as well as an indication of the dates when they were produced, irrespective of the type of support used. iz i A.2.2.1.3 The BE shall guarantee the protection of all information and data collected. Se rv The BE shall ensure the protection of all information and data collected by adopting measures designed to prevent: a) additions; b) cancellations; c) unauthorised changes (if corrections are necessary, the original record shall not be cancelled and the traceability of the party making the change shall be guaranteed); d) the unauthorised circulation of information. M TI A.2.2.1.4 The BE shall define and implement emergency procedures designed to ensure the proper and effective performance of its activities even in the event of data on electronic support being momentarily unavailable. The BE shall adopt specific procedures that define the responsibilities and the working methods to adopt in the event of any data/records on electronic support being momentarily unavailable. SI A.2.2.2 The BE shall prepare specific lists indicating the quality records that it undertakes to generate and to preserve for established periods of time, and it shall keep these lists up-to-date. © The BE management shall identify the quality data and records that the establishment undertakes to generate and preserve for established periods of time, also taking action to have them included in specific lists. 11 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.3 MANAGEMENT OF HUMAN RESOURCES The BE management shall guarantee that the personnel involved in the processes and activities conducted at the establishment have and develop the necessary skills according to the level of responsibility and the tasks assigned to them. A.3.1 MAINTENANCE, DEVELOPMENT PERSONNEL’S SKILLS AND ASSESSMENT OF THE iz i A.3.1.1 The BE management shall identify the skills needed for the personnel performing activities crucial to the quality of the processes, products and services it delivers. Se rv A.3.1.2 The BE shall define and implement plans for the induction of newly-acquired personnel, or when a change of role is planned at the BE, in order to guarantee their adequate training before they start work. A.3.1.2.1 The BE shall document any training activities conducted for the induction of newly-acquired personnel as well as the assessment of their efficacy. M TI A.3.1.3 The BE management shall systematically identify the training needs of personnel operating at the establishment and plan training activities designed to guarantee that their skills are constantly updated and developed. A.3.1.3.1 The BE shall document any training activities conducted in relation to each individual operating at the BE. SI A.3.1.4 The BE shall guarantee the systematic training of operators on the application of any pertinent procedures, the proper management of products/materials, the proper use and maintenance of systems/equipment/instruments, and the proper use of the computer system. © A.3.1.5 The BE shall implement systems for the periodic assessment of the personnel’s skills in order to ensure that all operators can adequately perform the tasks assigned to them. APPLICATION GUIDELINES A.3.1.1 The BE management shall identify the skills needed for the personnel performing activities crucial to the quality of the processes, products and services it delivers. The BE management shall establish the minimum skills that each professional category operating at the establishment must possess, with reference to the contents of Annex 1 of this Section, Professional skills of health-care personnel. 12 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.3.1.2 The BE shall define and implement plans for the induction of newlyacquired personnel, or when a change of role is planned at the BE, in order to guarantee their adequate training before they start work. Se rv iz i The plans for the induction of newly-acquired personnel, or when a change of role is planned for personnel already operating at the BE, shall define at least: a) the skills that the new employee must acquire; b) how long the induction is expected to take; c) the training methods, where applicable; d) the persons responsible for the induction process; e) the criteria and methods for assessing the acquisition of skills by the individual undergoing induction, and the persons responsible for said assessment; f) any reference documents needed for the induction process. A.3.1.2.1 The BE shall document any training activities conducted for the induction of newly-acquired personnel as well as the assessment of their efficacy. The training activities conducted for induction purpose and the assessment of their efficacy shall be documented and they constitute a part of the personal files of each operator at the BE. M TI A.3.1.3 The BE management shall systematically identify the training needs of personnel operating at the establishment and plan training activities designed to guarantee that their skills are constantly updated and developed. © SI The BE management is responsible for identifying the training needs of all personnel in the light of: a) strategies for the evolution of the BE’s activities; b) the establishment’s improvement and management strategies and objectives; c) the introduction of new standards or their evolution; d) the acquisition of new technologies; e) the need to bring operators’ technical/professional skills up to date, or to develop specific abilities; f) the assessment of critical issues identified by the quality monitoring activities. The training plans shall define at least the following elements: a) the content of the training activities; b) the training objectives to pursue; c) the method for conducting the activities; d) the criteria/methods for assessing the activities conducted; e) the personnel to receive training; f) the timing. 13 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.3.1.3.1 The BE shall document any training activities conducted in relation to each individual operating at the BE. iz i For all individuals operating at the BE, the training and updating activities in which they have participated shall be traceable by means of the production and/or preservation of the corresponding documentation (e.g. individual training files, certificates of attendance at training events, attendance registers, teaching material). Se rv A.3.1.4 The BE shall guarantee the systematic training of operators on the application of any pertinent procedures, the proper management of products/materials, the proper use and maintenance of systems/ equipment/instruments, and the proper use of the computer system. Operator training activities focusing on the application of standard operating procedures, the proper use of products/materials, the proper use and maintenance of systems, equipment and instruments, and the proper use of the computer system shall be planned and documented. M TI A.3.1.5 The BE shall implement systems for the periodic assessment of the personnel’s skills in order to ensure that all operators can adequately perform the tasks assigned to them. SI The BE shall implement systems for the periodic assessment of its operators’ management and technical/professional skills in relation to the principal activities/ processes characterising the BE in order to: a) ensure the establishment’s capacity to manage the workload optimally and consequently ensure the continuity of the service; b) to make the best use of the contributions of individual operators to the achievement of the BE’s objectives and purposes; c) to identify any critical areas and consequently decide effective training and updating strategies. © For each activity, the BE management shall define the criteria adopted in the assessment of the skills required, and it shall document their outcome. A.3.2 OPERATOR SAFETY A.3.2.1 The BE management shall guarantee the circulation of the hospital management’s provisions for ensuring the safety of personnel operating at the establishment. 14 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition APPLICATION GUIDELINES A.3.2.1 The BE management shall guarantee the circulation of the hospital management’s provisions for ensuring the safety of personnel operating at the establishment. Se rv iz i The BE management shall identify and make known to the personnel operating at the establishment all the hospital management’s provisions for minimising the risks to the health and safety of operators, e.g. a) regulations on the use of personal protective equipment; b) emergency plans; c) procedures to implement in the event of accidents occurring in the workplace; d) procedures for waste management and disposal. A.4 MANAGEMENT OF TECHNOLOGIES The BE management takes responsibility for identifying and making available systems, equipment and instruments quantitatively and qualitatively appropriate for ensuring the delivery of products and services compliant with the established standards, and for ensuring their proper operation and continuous suitability for use. A.4.1 MANAGEMENT OF SYSTEMS, EQUIPMENT AND INSTRUMENTS M TI The BE shall guarantee that all systems, equipment and support instruments that have a bearing on the quality of its products and the services it delivers: A.4.1.1 Have been qualified prior to their use in order to ascertain their suitability for their intended purpose. A.4.1.2 Have been unequivocally identified. SI A.4.1.3 Have been indicated in specific lists. A.4.1.4 Have been connected, where necessary, to a power supply system designed to guarantee their operation even in the event of a mains power failure. © A.4.1.5 Undergo routine servicing and inspection according to their level of criticality, based on specific schedules. A.4.1.5.1 The maintenance and inspection systematically documented. activities are A.4.1.6 They are not used, and they are suitably identified, if they are found outside their calibration/setting range and/or in the event of faults or malfunctions. A.4.1.7 They are accompanied by appropriate user instructions. 15 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition APPLICATION GUIDELINES The BE shall guarantee that all systems, equipment and support instruments that have a bearing on the quality of its products and the service it delivers: A.4.1.1 Have been qualified prior to their use in order to ascertain their suitability for their intended purpose. iz i The systems, equipment and support instruments that have a bearing on the quality of the product and the service shall have been qualified by the BE prior to their use in order to ascertain their suitability for their intended purpose. Se rv For a definition of the term “Qualification”, see the Introduction to the Transfusion Medicine Standards, Definitions. The equipment may be qualified by relying on analytical data provided by the manufacturer, in which case the BE shall preserve the documentation providing evidence of the capacity of the system/equipment/instrument to effectively satisfy the established requirements. A.4.1.2 Have been unequivocally identified. M TI Every system, item of equipment or support instrument shall be unequivocally identified according to previously-established criteria. Identification codes shall be attributed to them in order to guarantee the traceability of the scheduled measures and of the action taken on the systems/ equipment/instruments in use at the BE. SI The BE may maintain the coding/classification of the systems, equipment and instruments decided by the parties appointed by the hospital management to which the BE responds. A.4.1.3 Have been indicated in specific lists. © The systems, equipment and support instruments used by the BE shall be indicated in specific lists that are kept up-to-date by personnel specifically appointed to do so by the BE management. For each type of the equipment/instrument the lists should indicate at least: a) the identification code b) the name; c) the location; d) the date of purchase. 16 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.4.1.4 Have been connected, where necessary, to a power supply system designed to guarantee their operation even in the event of a mains power failure. iz i The BE shall identify the equipment that has to be guaranteed to continue to function even in the event of a mains power failure, which depends on the level of criticality of the activities for which they are used, with particular reference to product quality and the safety of donors, patients and operators. A.4.1.5 Undergo routine servicing and inspection according to their level of criticality, based on specific schedules. Se rv The maintenance and inspection activities relating to systems, equipment and support instruments used at the BE shall be scheduled in the light of the following criteria: a) the level of criticality in relation to the quality of the product obtained and the service delivered; b) current legislation on the matter of safety for users of the service, operators and the environment; c) the need for periodic adjustments or settings; d) the estimated volumes of activity; e) the working conditions. SI M TI The maintenance and inspection plans shall establish at least: a) the type of action to take and its frequency; b) the internal/external personnel appointed to take action; c) the methods for taking action (where applicable) and the technical reference documents (manufacturers’ use and maintenance manuals, specific working procedures, applicable standards or guidelines, etc.); d) the records required for any action taken. A.4.1.5.1 The maintenance and inspection activities are systematically documented. © The BE shall guarantee the traceability of maintenance and inspection activities conducted by personnel at the establishment or external qualified parties by means of the production and/or preservation of appropriate records. A.4.1.6 Are not used, and are suitably identified, if they are found outside their calibration/settings range and/or in the event of faults or malfunctions. The BE shall take all necessary precautions to prevent the unwitting use of systems, equipment and support instruments found outside their calibration/ setting range and/or faulty or malfunctioning, through the use of appropriate methods for their identification and/or segregation. 17 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.4.1.7 Are accompanied by appropriate user instructions. The BE shall provide personnel using the equipment with the manufacturer’s user manuals and/or specific work instructions. iz i The manuals shall be written in the Italian language or in at least one of the languages attributed equal status in bilingual Italian regions. A.4.2 MANAGEMENT OF EQUIPMENT USED FOR THE STORAGE OF BLOOD, BLOOD COMPONENTS AND HAEMATOPOIETIC STEM CELLS Se rv For equipment used for the storage of blood, blood components and haematopoietic stem cells (HSC) in the various stages of their processing up until their distribution, in addition to the contents of Ch. A.4.1, the BE shall also guarantee that: A.4.2.1 they are equipped with a system for monitoring and recording temperatures or nitrogen levels, and with an acoustic and visual alarm. M TI A.4.2.2 appropriate instructions have been defined for the controlled management of the equipment used for the storage of blood and blood components by other centres in the area that refer to the BE on the basis of specific conventions/contracts. APPLICATION GUIDELINES SI For equipment used for the storage of blood, blood components and haematopoietic stem cells (HSC) in the various stages of their processing up until their distribution, in addition to the contents of Ch. A.4.1, the BE also guarantees that: A.4.2.1 They are equipped with a system for monitoring and recording temperatures or nitrogen levels, and with an acoustic and visual alarm. © The BE shall guarantee: a) the use of equipment for the storage of blood and blood components that comprises an appropriate system for monitoring and recording temperatures, as well as an acoustic and visual alarm; b) the use of equipment for the storage of HSC that comprises an appropriate system for monitoring and recording nitrogen levels, as well as an acoustic and visual alarm. The BE shall ensure the adoption of specific plans for monitoring the functional efficiency of these control systems and the systematic auditing of the calibration status of the devices used to measure temperatures and nitrogen levels, guaranteeing that the measurements are consistent with samples available at Italian Calibration Service Centres. 18 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition The BE management shall identify the personnel responsible for periodically controlling the functional efficiency of the equipment for the storage of blood, blood components and HSC, and the related records. These control activities shall be documented. iz i Equipment located in rooms or areas that are not constantly supervised by BE personnel or other personnel appointed to do so shall be equipped with remote alarms. These remote alarm devices shall be both acoustic and visual, or equipped with equivalent alerting means. Se rv The BE shall define and apply specific procedures for managing alarms and detailed plans for the evacuation of blood, blood components and HSC from faulty or malfunctioning equipment. These procedures shall indicate the methods for managing alarm situations, the records to produce in order to guarantee the traceability of the event, and the responsibilities, criteria and methods for restoring the systems to operation. A.4.2.2 Appropriate instructions have been defined for the controlled management of the equipment used for the storage of blood and blood components by other centres in the area that refer to the BE on the basis of specific conventions/contracts. M TI The BE shall establish and transmit to the other centres in the area that refer to the BE on the basis of specific conventions/contracts appropriate instructions concerning the proper management of the equipment used for the storage of blood and blood components (maintenance and inspection activities, temperature monitoring, management of alarm situations and evacuation of blood components, etc.). A.4.3 MANAGEMENT OF INFORMATION TECHNOLOGY (IT) SYSTEMS SI For the IT systems, the BE shall guarantee that: © A.4.3.1 the hardware, software and backup procedures have been validated prior to their use, their reliability is periodically verified, and they periodically undergo servicing to maintain their established requirements and performance. A.4.3.2 they are accompanied by appropriate user instructions. A.4.3.3 the hardware and software are protected unauthorised uses or unallowable changes. against A.4.3.4 periodic backups are performed to prevent any loss of data or changes thereto in the event of planned or unplanned periods of inactivity or malfunctions. A.4.3.5 written procedures to apply in order to guarantee the continuity of the activities in the event of the IT systems being out of use are in place. 19 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition APPLICATION GUIDELINES For the IT systems, the BE shall guarantee that: iz i A.4.3.1 The hardware, software and backup procedures have been validated prior to their use, their reliability is periodically verified, and they periodically undergo servicing to maintain their established requirements and performance. Se rv The IT systems (hardware, software, back-up procedures) used to deliver the service shall have been validated prior to their use, their reliability shall be periodically verified and they shall periodically undergo servicing in order to maintain their established requirements and performance. The IT systems may be validated on the basis of analytical data provided by the supplier, in which case the BE shall preserve the documentation providing evidence of the capacity of the system/equipment/instrument to satisfy the established requirements effectively. A.4.3.2 They are accompanied by appropriate user instructions. M TI The BE shall provide the personnel using the IT system with the manufacturer’s user manuals and/or specific work instructions. The manuals shall be written in the Italian language or in at least one of the languages attributed equal status in bilingual Italian regions. SI A.4.3.3 The hardware and software are protected against unauthorised uses or unallowable changes. © The BE shall adopt a method designed to prevent any unauthorised use of, or unallowable changes to the hardware and software used to deliver the service, also in compliance with the requirements of current legislation for safeguarding the privacy of personal data with which the establishment comes into contact in its dealings with users of the service. A.4.3.4 Pperiodic backups are performed to prevent any loss of data or changes thereto in the event of planned or unplanned periods of inactivity or malfunctions. The BE shall back up its data at regular intervals, clearly defining the related responsibilities, in order to prevent any loss of data or changes thereto in the event of periods of planned or unplanned inactivity or malfunctions of the computer system in use. 20 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.4.3.5 Written procedures to apply in order to guarantee the continuity of the activities in the event of the IT systems being out of use are in place. The BE shall establish and adopt specific procedures to apply in order to ensure the continuity of activities in the event of the IT systems being out of use. A.4.4 RECONDITIONING OF MEDICAL DEVICES iz i These procedures shall include the recording and the complete realignment of the data in the computer systems once they have been restored to use. APPLICATION GUIDELINES Se rv A.4.4.1 The BE shall apply specific methods to the reconditioning of medical devices to prevent the risk of product contamination and to guarantee the safety of users and operators. A.4.4.1 The BE shall apply specific methods to the reconditioning of medical devices to prevent the risk of product contamination and to guarantee the safety of users and operators. M TI The term “Reconditioning of medical devices” is used to refer to the cleaning, washing, drying, lubrication, decontamination and sterilisation of instruments, equipment and systems in order to prevent the occurrence of contaminations. © SI The methods used to recondition medical devices shall be formally stated in dedicated procedures/work instructions, where specified by the specific Standards defined in the present Manual, and in accordance with the instructions of the manufacturers of medical devices. 21 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.5 MANAGEMENT OF MATERIALS A.5.1 QUALIFICATION, CONTROL AND STORAGE OF MATERIALS A.5.1.1 The BE shall ensure that the materials it uses that have a particular bearing on the quality of its products/services comply with current legislation and are qualified before they are introduced at the establishment in order to assess their suitability for their intended use. iz i A.5.1.2 The materials used by the BE shall be inspected before their use in order to ascertain the absence of defects or nonconformities vis-à-vis the established standards. Se rv A.5.1.2.1 The BE shall ensure the systematic recording of nonconformities encountered at the time of the inspection or use of materials that have a bearing on the quality of the products/services, in order to identify any critical issues and prompt the relevant corrective actions. A.5.1.3 The materials available at the BE shall be unequivocally and clearly identified. M TI A.5.1.4 The materials used by the BE shall be stored under controlled conditions designed to prevent any change in their qualitative characteristics. No materials shall be used beyond their shelf life. A.5.1.4.1 The BE shall guarantee the performance of systematic inspections on the integrity and shelf life of stored materials. SI APPLICATION GUIDELINES © A.5.1.1 The BE shall ensure that the materials it uses that have a particular bearing on the quality of its products/services comply with current legislation and are qualified before they are introduced at the establishment in order to assess their suitability for their intended use. Within the context of the BE, responsibilities shall be clearly defined relating to the qualification of materials considered crucial to the quality of the products and/or service, e.g.: a) reagents; b) devices for collecting and processing whole blood or blood components; c) labels; d) systems for packaging and transporting blood components; e) transfusion sets and filters; f) detergents and disinfectants; g) control materials (for intra-laboratory quality control, calibrators). 22 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition The BE management is responsible for identifying the materials to submit to qualification activities in order to ensure their suitability for their intended use before their release. The qualification activities shall be documented. iz i The materials may be qualified on the basis of data provided by the manufacturers, in which case the BE shall preserve the documentation providing evidence of the capacity of the products to satisfy the established requirements effectively. For a definition of the term “Qualification”, see the Introduction to the Transfusion Medicine Standards, Definitions. Se rv A.5.1.2 The materials used by the BE shall be inspected before their use in order to ascertain the absence of defects or nonconformities vis-àvis the established standards. The BE shall ensure that the materials it uses, depending on their level of criticality in relation to the quality of the product/service, are inspected on arrival at the establishment, or in any case prior to their use, in order to ascertain the absence of defects or nonconformities vis-à-vis the established standards. M TI For these materials, the BE shall define in particular the inspection parameters, the acceptance criteria, the responsibilities for controls and the records to produce. The material inspection activities shall be documented. SI A.5.1.2.1 The BE shall ensure the systematic recording of nonconformities encountered at the time of the inspection or use of materials that have a bearing on the quality of the product and service, in order to identify any critical issues and prompt the relevant corrective actions. For a definition of the term “Nonconformity”, see the Introduction to the Transfusion Medicine Standards, Definitions. © The BE shall guarantee the proper management of any nonconformities identified in critical materials following inspections conducted at the time of their use, defining: a) the methods for recording nonconformities; b) the methods for identifying/segregating nonconforming materials to prevent their unwitting use; c) the decision-making responsibilities relating to the solution of nonconformities and the related records; d) responsibilities for implementing the preventive actions needed to avoid any repetition of nonconformities encountered; e) the notification of the episode to the competent authorities, where applicable. 23 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.5.1.3 The materials available at the BE shall be unequivocally and clearly identified. The materials available at the BE, including those stored in equipment under controlled temperature conditions, shall be unequivocally and clearly identified by means of labels or equivalent means. iz i In the case of reagents that need preparation, the containers used shall be identified with a label indicating the type of preparation, the date of preparation and the date of expiry. Se rv The BE shall also ensure that the following are unequivocally identified: a) any materials produced in-house at the BE (e.g. plated culture media, reagents, calibrators, control sera); b) aliquotted calibrators and controls; c) washing solutions; d) buffer solutions. A.5.1.4 The materials used by the BE shall be stored under controlled conditions designed to prevent any change in their qualitative characteristics. No materials shall be used beyond their shelf life. M TI The BE shall guarantee that perishable materials are stored in appropriate conditions so as to prevent any alteration of their qualitative characteristics. A system shall be in place for monitoring and recording the temperature of the equipment used to store drugs, reagents and materials. SI The BE shall guarantee the recording of the batch numbers and the shelf life of critical materials and reagents. No materials may be used beyond their shelf life. © A.5.1.4.1 The BE shall guarantee the performance of systematic inspections on the integrity and shelf life of stored materials. The BE shall plan and implement systematic inspections in order to ascertain the integrity and shelf life of the materials as applicable, defining the frequency of inspections, the related responsibilities and the records to produce. These inspection activities shall be documented. Any materials beyond their shelf life shall be managed according to established procedures. 24 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.6 PROCESS MANAGEMENT The BE management is responsible for planning the processes carried out at the establishment and their interrelations, as well as for identifying and implementing mechanisms designed to ensure their constant monitoring over time in order to guarantee their efficacy/efficiency and the systematic achievement of outputs consistent with the established quality standards. iz i The requirements relating to the various processes are indicated as specific Standards in the context of the single sections of the present Manual. The Standards that all blood establishments must adopt, irrespective of the specific type of product/service they provide, are defined below. Se rv A.6.1 PROCESS PLANNING A.6.1.1 For each process, the BE shall define specific procedures, the sequence of activities involved, the parties responsible for them, the standard working procedures adopted, the prescriptive reference documents and the records to produce. APPLICATION GUIDELINES M TI A.6.1.1 For each process, the BE shall define specific procedures, the sequence of activities involved, the parties responsible for them, the standard working procedures adopted, the prescriptive reference documents and the records to produce. The processes shall be planned by the BE in specific written procedures. any case, the following shall be clearly stated for each process: the sequence of activities composing it; the parties responsible for the single activities; the working procedures adopted; the prescriptive reference document(s) for the performance of the activity; the records to produce at the various stages; © In a) b) c) d) e) SI The BE may formalise its processes by means of whatever method it considers most appropriate (e.g. a detailed description of the process, process charts, flowcharts, matrices, grids, tables). in accordance with the contents of the specific Standards defined in the present Manual. 25 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.6.2 QUALITY CONTROL ON THE PROCESSES, PRODUCTS SERVICES, AND MANAGEMENT OF NONCONFORMITIES AND A.6.2.1 The BE shall identify the critical variables in the main processes and related support processes, and consequently plan the related control measures to perform, establishing the corresponding responsibilities, test parameters and acceptance criteria, and the records to produce. the the the and iz i The BE shall identify the critical characteristics of products being processed, and consequently plan related control measures to perform, establishing corresponding responsibilities, test parameters acceptance criteria, as well as the records to produce. Se rv A.6.2.2 A.6.2.3 The BE shall adopt systems designed to guarantee that the control status of products and any critical elements identified in the context of the processes are clearly identifiable. M TI A.6.2.4 The BE shall ensure that any nonconformities identified in the context of the processes, or pertaining to the products, are clearly identified, documented and dealt with under the responsibility of the competent personnel. APPLICATION GUIDELINES SI A.6.2.1 The BE shall identify the critical variables in the main processes and related support processes, and consequently plan the related control measures to perform, establishing the corresponding responsibilities, test parameters and acceptance criteria, and the records to produce. © The term “Process control” is used to refer to auditing activities on several variables of a process, or the processes supporting it, that are considered crucial to the proper performance of the activities and consequently to the quality of the output of said processes. Process control may concern: a) the accuracy and the systematic performance of certain activities at the BE (e.g. the accurate preparation of health-care documentation under the responsibility of the appointed personnel); b) the accuracy and the systematic performance of certain activities handled by other parties with which the BE interfaces (e.g. the proper compiling of requests for services, the proper identification and the conformity of samples of biological material received, the proper performance of outsourced activities); c) the conformity of the materials and instruments in use (e.g. the absence of defects in the blood collection devices before the collection process is started, the absence of defects in apheresis kits); 26 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition d) the conformity of the outputs from certain stages in the process to the standards established by the BE (e.g. the adequacy of blood collection in terms of the quantity of blood drawn and the time taken, the conformity of units of fractionated blood, the validity of analytical results, the clinical appropriateness of transfusion requests). Process control activities shall always be conducted whenever required by the specific Standards defined by the present Manual. Se rv iz i Following an analysis of the processes and the identification of any critical variables, the BE shall formally define: a) the tests to perform and the corresponding parameters; b) the correlated responsibilities; c) the methods to use to perform the tests; d) the acceptance criteria; e) the records to produce. All required process control activities shall always be documented. M TI A.6.2.2 The BE shall identify the critical characteristics of the products being processed, and consequently plan the related control measures to perform, establishing the corresponding responsibilities, test parameters and acceptance criteria, as well as the records to produce. The BE shall conduct appropriate tests on the critical qualitative and quantitative characteristics of its products and of the services it delivers in accordance with the content of the specific Standards defined in the present Manual. particular, the BE shall formally define: the tests to conduct and the corresponding parameters; the correlated responsibilities; the methods to use for the tests; the acceptance criteria; the records to produce. SI In a) b) c) d) e) © Tests conducted on the products and service shall always be documented. A.6.2.3 The BE shall adopt systems designed to guarantee that the control status of products and any critical elements identified in the context of the processes are clearly identifiable. The BE shall guarantee that the control status and conformity/nonconformity of products or other critical elements identified in the context of the processes are identifiable thanks to the use of appropriate markings (labels, signs, etc.) or their placement in specific locations (the transfer of a product from one site to another, the segregation of nonconforming products/materials in specific areas/ containers, etc.). 27 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.6.2.4 The BE shall ensure that any nonconformities identified in the context of the processes, or pertaining to the products or services are clearly identified, documented and dealt with under the responsibility of the competent personnel. For a definition of the term “Nonconformity”, see the Introduction to the Transfusion Medicine Standards, Definitions. Se rv iz i The BE management shall identify any nonconformities found in relation to the products, the services or critical elements of the processes, and plan their proper management in terms of: a) recording methods; b) identification/segregation methods; c) decision-making responsibilities to deal with nonconformities and the related records; d) responsibilities for implementing corrective action needed to prevent any repetition of the nonconformities encountered. A.6.3 STORAGE OF BLOOD, BLOOD HAEMATOPOIETIC STEM CELLS COMPONENTS AND M TI A.6.3.1 The BE shall adopt previously-validated, specific procedures for the storage of blood, blood components and haematopoietic stem cells (HSC) to guarantee the preservation of their biological and qualitative characteristics throughout the storage period. SI A.6.3.2 The BE shall adopt specific procedures for managing units beyond their shelf life and units with anomalies identified during their storage that can negatively influence their suitability for use. APPLICATION GUIDELINES © A.6.3.1 The BE shall adopt previously-validated, specific procedures for the storage of blood, blood components and haematopoietic stem cells (HSC) to guarantee the preservation of their biological and qualitative characteristics throughout the storage period. The BE shall define and validate specific procedures relating to the methods for storing blood, blood components and HSC (temperatures, storage times, instruments used, etc.), in accordance with the requirements of current legislation. These procedures shall be revalidated at regular intervals and following any major revisions. For a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. 28 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.6.3.2 The BE shall adopt specific procedures for managing units beyond their shelf life and units with anomalies identified during their storage that can negatively influence their suitability for use. iz i The BE shall define and adopt specific procedures for managing units beyond their shelf life and units with anomalies identified during their storage that can negatively influence their suitability for use, specifying: a) the methods for segregating and disposing of the units; b) the records to produce. A.6.4 PACKAGING AND TRANSPORTATION OF BLOOD, COMPONENTS AND HAEMATOPOIETIC STEM CELLS BLOOD Se rv A.6.4.1 The BE shall define and apply previously-validated, specific procedures for packaging and transporting blood, blood components and haematopoietic stem cells (HSC) in accordance with the requirements of current legislation on the proper storage of these products and the safeguarding of operators and the environment. M TI A.6.4.1.1 The BE shall define specific procedures for packaging and transporting units of blood and blood components collected at the blood collection units (BCUs) referring to the BE. A.6.4.1.2 The BE shall regulate outsourced activities for the transportation of whole blood, blood components and HSC on the basis of specific agreements. SI A.6.4.2 The BE shall prepare instructions on the proper use of the systems for the transportation of blood, blood components and HSC, and circulate these instructions to the healthcare organisations that refer to the BE for their transfusion needs. © A.6.4.3 The BE shall define specific instructions relating to the methods for transporting and storing blood components and the disposal of the devices used, applicable in the case of home blood transfusions. 29 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition APPLICATION GUIDELINES A.6.4.1 The BE shall define and apply previously-validated, specific procedures for packaging and transporting blood, blood components and haematopoietic stem cells (HSC) in accordance with the requirements of current legislation on the proper storage of these products and the safeguarding of operators and the environment. Se rv iz i Both for its own organisation and for other health-care organisations that it serves, the BE shall define and adopt previously-validated procedures and systems for packaging and transporting blood and blood components, particularly as concerns the logistics, the transfer times and the methods for storing products being transported, taking into account the requirements of current legislation for safeguarding operators and the environment. These procedures and systems shall be revalidated at regular intervals and following any major changes. For a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. M TI A.6.4.1.1 The BE shall define specific procedures for packaging and transporting units of blood and blood components collected at the blood collection units (BCUs) referring to the BE. The procedures shall be defined by agreement with the BCUs that refer to the BE, and the BE shall guarantee the timely notification of any revisions to the BCUs. SI A.6.4.1.2 The BE shall regulate outsourced activities for the transportation of whole blood, blood components and HSC on the basis of specific agreements. © Where the activities for transporting whole blood, blood components and HSC are wholly or partly entrusted to outside contractors, their appointment shall be governed by specific agreements and always in compliance with current legislation. A.6.4.2 The BE shall prepare instructions on the proper use of the systems for the transportation of blood, blood components and HSC, and circulate these instructions to the health-care organisations that refer to the BE for their transfusion needs. The BE shall define specific instructions for the proper use of all the systems for transporting blood, blood components and HSC, and circulate these instructions to the health-care facilities that it serves. 30 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition These instructions shall indicate at least: a) the types of container to use; b) the packaging methods; c) the methods adopted to guarantee the proper storage of blood and blood components being transported. iz i A.6.4.3 The BE shall prepare specific instructions relating to the methods for transporting and storing blood components and the disposal of the devices used, applicable in the case of home blood transfusions. The BE shall define specific instructions to adopt in the case of home blood transfusions. Se rv These instructions shall indicate at least: a) the types of container to use; b) the packaging methods; c) the methods adopted to guarantee the proper storage of blood and blood components in transit; d) the methods for disposing of the devices used. A.6.5 IDENTIFICATION AND TRACEABILITY M TI A.6.5.1 The BE shall guarantee the traceability of all the information needed to reconstruct the transfusion process, from donation to transfusion and viceversa. APPLICATION GUIDELINES SI A.6.5.1 The BE shall guarantee the traceability of all the information needed to reconstruct the transfusion process, from donation to transfusion and viceversa. © In accordance with the Standards specified in the single sections of the present Manual and with current legislation, the BE shall guarantee the unequivocal identification: a) of patients and donors; b) of the products and of their status at all stages of the process, from collection to individual attribution and distribution of blood and blood components; c) of the samples of biological material; d) of the systems/equipment/instruments used to deliver the service (see Ch. A.4.1); e) of the materials used to deliver the service (see Ch. A.5). 31 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition iz i By producing and/or preserving appropriate records for an established period of time (see Ch. A.2.2), the BE shall also guarantee the traceability of all the elements needed to reconstruct the activities relating to: a) donor management; b) blood and blood component collection; c) blood component treatment, control and validation; d) blood component handling and transportation; e) the management of individual attribution and distribution of blood components; f) transfused patient management. The records shall be produced so as to guarantee that it is always possible to trace the individuals responsible for performing the above-mentioned activities. Se rv The BE shall also guarantee the traceability of all the data and records needed to provide evidence of the application of the Standards defined in the present Manual, where applicable. A.6.6 MANAGEMENT OF ORGANISATIONAL AND TECHNOLOGICAL EMERGENCIES M TI A.6.6.1 The BE shall identify the main organisational and technological emergencies that might occur at the establishment and adopt practices designed to guarantee the continuity of the service nonetheless. APPLICATION GUIDELINES SI A.6.6.1 The BE shall identify the main organisational and technological emergencies that might occur at the establishment and adopt practices designed to guarantee the continuity of the service nonetheless. © The term “Emergencies” is used here to mean all “critical” unexpected situations with which the BE must cope by implementing prompt and effective responses and solutions in order to guarantee the safety of the users and operators, as well as the continuity of the service in accordance with the established quality levels, also in compliance with provisions issued by the Regional Blood Coordinating Centres, the National Blood Centre, and the Ministry of Health. Examples of “organisational emergencies” may include: the unprogrammed absence of personnel; the blood component stock dropping below a defined threshold; difficulties in meeting programmed blood collection demands due to particular contingencies (e.g. in the case of pandemics or other particular epidemiological situations, or earthquakes); depletion of the stocks of therapeutic apheresis kits; depletion of stocks of reagents and materials for crucial laboratory tests; inability to contact personnel on call, or the latter’s inability to reach the establishment. 32 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition “Technological emergencies” include, for instance: sudden breakdowns of “critical” systems/equipment/instruments that interfere with ordinary activities or that have a significant impact on the quality of products/services (e.g. a telecommunications network outage lasting beyond a certain period of time, a computer system crash, the breakdown of an apparatus used for critical laboratory tests or for therapeutic apheresis). iz i The BE shall identify the principal organisational and technological emergencies that might occur at the establishment and plan the procedures to implement in order to guarantee the continuity of the service. A.7 QUALITY MONITORING, ANALYSIS AND IMPROVEMENT Se rv The BE management is responsible for constantly controlling the quality level of the processes, the products and the services being delivered by implementing a monitoring system designed to identify and correct any nonconformities, as well as identifying the need for improvements in the quality standards and consequently implementing adequate organisational and technical changes. A.7.1 QUALITY MONITORING M TI A.7.1.1 The BE shall implement a systematic monitoring and data analysis activity on the processes and on the quality of the products and services in order to identify any nonconformities that demand the adoption of corrective actions, or to identify any unfavourable trends that demand the adoption of preventive actions. SI A.7.1.2 The BE shall guarantee the conduction of regular quality audits on the main processes and on the related support processes/activities, conducted by independent, qualified and competent individuals on the basis of specific procedures, in order to assess their systematic compliance with the applicable prescriptive documentation. A.7.1.3 The BE shall adopt specific procedures to manage complaints arriving from users. © A.7.1.4 The BE management shall guarantee the analysis and overall assessment, at least once a year, of the BE’s quality-related data in order to measure the level of the establishment’s adequacy and efficiency and to ensure the adoption of adequate corrective and preventive actions, as well as the definition of quality improvement objectives to pursue. 33 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition APPLICATION GUIDELINES A.7.1.1 The BE shall implement a systematic monitoring and data analysis activity on the processes and on the quality of the products and services in order to identify any nonconformities that demand the adoption of corrective actions, or to identify any unfavourable trends that demand the adoption of preventive actions. iz i The BE shall conduct a systematic monitoring and data analysis activity on the processes and the quality of the products and services in order to identify any critical issues. M TI Se rv In particular, the monitoring plan implemented shall indicate: a) the characteristics monitored for the various types of products or services and for the critical process variables; b) the control indicators adopted; c) the reference standards (expected values, where applicable, particularly relating to the products, with reference to available guidelines or the consolidated experience of the BE); d) the data needed for monitoring purposes and the corresponding sources; e) the responsibility for data collection; f) the methods and instruments to use for data collection; g) the responsibility for, and frequency of data-processing; h) the responsibility for analysing the indexes obtained and for taking any corrective actions. The monitoring and analytical activities shall be documented. SI A.7.1.2 The BE shall guarantee the conduction of regular quality audits on the main processes and on the related support processes/activities, conducted by independent, qualified and competent individuals on the basis of specific procedures, in order to assess their systematic compliance with the applicable prescriptive documentation. © To ascertain the systematic compliance of all operators with the applicable prescriptive documentation, the BE shall define and apply specific procedures envisaging the performance of regular audits, which shall specify: a) the management of procedures for qualifying the personnel responsible for conducting the audits; b) the criteria for programming audits to be conducted at the establishment (responsibility for the approval of these programmes lies with the BE management); c) the criteria and responsibilities for organising, preparing and performing single audits and for documenting their outcome; d) the responsibilities and methods for implementing corrective and preventive actions to deal with any nonconformities emerging during the course of audits. 34 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition The personnel responsible for conducting the audits shall have been previously qualified to conduct this activity as a result of specific training (provided on courses conducted by qualified personnel, gained by working alongside expert auditors, etc.) and they shall not have any responsibility for the areas/activities being audited in order to guarantee the utmost objectivity in the outcome of the audits. iz i The BE shall systematically document the outcome of audits and implement appropriate corrective and preventive actions in the event of nonconformities being identified, or any situations interfering with the quality of the products and services. A.7.1.3 The BE shall adopt specific procedures to manage complaints from users. Se rv The BE shall guarantee all users (patients, donors, hospital physicians, general practitioners/specialists, other services) the proper management of any complaints it receives. M TI For this purpose, the BE shall define and apply specific procedures designed to govern: a) the methods and instruments for recording complaints; b) the responsibilities for managing/dealing with complaints; c) the responsibilities and criteria for processing and analysing data relating to complaints; in order to identify any critical issues relating to the quality of products/services and to take adequate corrective actions to deal with them. SI A.7.1.4 The BE management shall guarantee the analysis and overall assessment, at least once a year, of the BE’s quality-related data in order to measure the level of the establishment’s adequacy and efficiency and to ensure the adoption of adequate corrective and preventive actions, as well as the definition of quality improvement objectives to pursue. © The BE management shall conduct an analysis and global assessment of the BE’s quality-related data, involving all the responsible persons at the establishment, and paying particular attention to technical/professional issues, in order to measure: a) the adequacy of the establishment’s strategies, general objectives and policies (see Ch. A.1.1); b) the degree to which the planned specific improvement objectives have been achieved (see Ch. A.1.1); c) the adequacy and the level of process control, based on previously-defined indicators (see Standard A.7.1.1); d) the quality level of the products/services being delivered, based on previouslydefined indicators (see Standard A.7.1.1); e) the degree to which the prescriptive documentation applicable to the BE is applied, based on the outcome of the quality auditing activities (see Standard A.7.1.2); 35 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition iz i f) the level of satisfaction of users of the BE’s products/services (see Standard A.7.1.3); g) the adequacy of the personnel’s skills and the need to provide training (see Ch. A.3.1); h) the adequacy of the human, technological, structural and material resources available; i) the adequacy of the BE in relation to advances in the reference setting (changes in the reference legislation, changes in the demand and the needs of users, advances in technology and in the offer of resources, etc.). M TI Se rv In the light of the results of this assessment, the BE management shall: a) redefine the strategies, general objectives and policies to pursue at the establishment, where necessary; b) redefine the establishment’s specific quality improvement objectives, where necessary; c) revise the plan for monitoring the quality of products and processes, where applicable, in the light of critical issues emerging during the course of the analysis; d) revise the methods for managing the establishment’s processes, where advisable; e) assess the adequacy of the resources in place; ; f) plan any necessary personnel training and updating courses; g) programme the quality auditing activities at the BE; h) plan any corrective or preventive actions with a view to eliminating or preventing any critical issues encountered or potentially emerging. The results of the assessment and the actions planned as a consequence shall be documented. In addition, the findings shall be notified to all personnel operating at the BE and the action taken to circulate the results shall be documented (by means of the minutes of meetings held for said purpose or equivalent methods). SI A.7.2 CORRECTIVE AND PREVENTIVE ACTIONS © A.7.2.1 The BE shall plan and implement preventive and corrective actions designed to prevent the occurrence or repetition of nonconformities. APPLICATION GUIDELINES A.7.2.1 The BE shall plan and implement preventive and corrective actions designed to prevent the occurrence or repetition of nonconformities. For a definition of the terms “Nonconformity”, “Corrective action”, and “Preventive action”, see the Introduction to the Transfusion Medicine Standards, Definitions. 36 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition iz i To deal with severe or systematic nonconformities, or to deal with situations “at risk” of generating nonconformities, the BE shall: a) identify situations necessitating corrective and preventive actions; b) identify the causes of any shortcomings identified, by means of appropriate analyses where necessary; c) identify the corrective or preventive actions to undertake, tailoring them to the existing risks; d) plan and implement the required action; e) assess the efficacy of the action in relation to the established objectives. Se rv Any corrective and preventive actions implemented, together with the related planning and auditing details, shall be documented. A.8 INFORMATION REPORTING A.8.1 The BE shall guarantee the collection of all data and information required by the National Blood IT System (SISTRA), in accordance with current legislation and the recommendations of the Regional Blood Coordinating Centre and the National Blood Centre. A.8.1 M TI APPLICATION GUIDELINES The BE shall guarantee the collection of all data and information required by the National Blood IT System (SISTRA), in accordance with current legislation and the recommendations of the Regional Blood Coordinating Centre and the National Blood Centre. SI The BE shall guarantee the collection of the data and information required by the National Blood IT System (SISTRA) in accordance with current legislation and with the recommendations of the Regional Blood Coordinating Centres and the National Blood Centre. © The BE management shall appoint a reference person for the SISTRA IT system. 37 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition A.9 PARTICIPATION AS PARTNERS IN RESEARCH AND DEVELOPMENT SCHEMES A.9.1 RESEARCH AND DEVELOPMENT PARTNERSHIPS iz i SIMTI periodically promotes research and development projects and schemes in the area of transfusion medicine with a view to providing scientific contributions on the main aspects of the discipline. In some cases, significant results can be obtained by undertaking data collection and/or experimentation by means of multicentre studies, particularly for epidemiological reporting projects and schemes demanding the qualitative and quantitative evaluation and broad-based comparison of activities or segments of the activities of organisational, managerial and technical-scientific interest. © SI M TI Se rv It is recommended that the BE assures its participation in research and development schemes and projects promoted by SIMTI, also in cooperation with other scientific associations, public institutions or other bodies, and particularly when its involvement is specifically requested by SIMTI. 38 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition ANNEX 1 PROFESSIONAL SKILLS OF HEALTH-CARE PERSONNEL Foreword Se rv iz i The personnel belonging to all the professional categories (physicians, biologists, nurses, biomedical laboratory technicians, social health operators, administrative staff, and any others) who work at the BE, and at the related organisations and blood collection units managed by accredited associations and federations of blood donors (BCUs) referring to the BE, may: a) be employed under permanent or temporary employment contracts; b) operate on the basis of an independent contract (e.g. as freelance professionals or in other forms of cooperation); c) work on a voluntary basis, particularly at BCUs. In addition to the professional requirements pertinent to their qualifications and established by current legislation, all the health-care personnel must possess adequate professional skills, intended as the know-how and expertise needed to ensure the quality of the products and services provided by the BE, each in relation to his/her job description and responsibilities. M TI 1. Physician expert in transfusion medicine (TM) The physician expert in TM shall guarantee the necessary professional skills at least in the following areas: Skills References Chapter Information, education and promotion of awareness of blood donors B B.2.1 Clinical selection and counselling of blood donors B B.2.2 B.6 Management of blood donor deferral B B.2.3 Retrospective investigations and assessments on the risk of transfusion-transmissible diseases associated with clinical and diagnostic elements relating to donors and donations B B.2.3 Criteria and procedures for collecting whole blood B B.3.1 B.3.3 Criteria and procedures for collecting blood components and HSC using apheretic methods B B.3.2 B.3.3 © SI Section 39 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements Skills 2nd Edition References Chapter Clinical care of donors and diagnosis and treatment of adverse reactions and adverse events potentially associated with whole blood donations and apheresis procedures B B.4 Procedures and methods for producing “1st-level” blood components C C.1.1 Procedures and methods for producing “2nd-level” blood components C C.1.2 C A.6.5 C.4 Quality requirements for blood components and criteria for processing and assessing the results of quality control on blood components C C.5 Assessment criteria for the biological qualification of blood components that contribute to determining their suitability for transfusion (biological validation) C C.6 Criteria for assessing the appropriateness of transfusion requests D D.2 D.3 Immunohaematological and clinical criteria for the selection and individual attribution of blood components D D.4 Selection/ definition of guidelines for the appropriate clinical use of blood components D D.4 G.2.1.2 Clinical and diagnostic management of reports of adverse reactions to transfusion D D.5 Epidemiology, clinical management and supervision of transfusion-transmissible diseases D D.5 Management of activities for blood component delivery, intraand inter-regional compensation, and delivery of plasma to fractionation industries D D.5 D.8.1 D.8.2 Criteria and methods for managing stocks of blood components D D.7 General elements of clinical pathology and laboratory diagnostics, with particular reference to the significance of, and methods for internal quality control and external quality auditing E E.2 E.4 Immunohaematological serology: diagnostic applications, analytical methods and clinical implications E E.3 Prevention, diagnosis and treatment of the haemolytic disease of the newborn, with particular reference to clinical, immunohaematological and transfusion issues E E.3.6 Diagnosis and treatment of autoimmune haemolytic diseases, with particular reference to clinical, immunohaematological and transfusion issues E E.3.7 © SI M TI Se rv Procedures and reference standards for the identification and traceability of units of blood and blood components iz i Section 40 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements Skills 2nd Edition References Section Chapter E E.5 Clinical and organisational management of autologous transfusion procedures, with particular reference to the pre-operative autologous blood donation for elective surgery F F.1 F.2 iz i Elements of platelet and leucocyte immunohaematology, with particular reference to the diagnostic and clinical implications of interest in transfusion medicine G Se rv Criteria for the selection/definition of diagnostic-therapeutic guidelines for the most common and/or critical diseases treated as part of the clinical care for outpatients and hospitalised patients provided by the BE G.2 Clinical and organisational management of clinical care for outpatients and hospitalised patients provided by the BE G G.2 Diagnosis and treatment of adverse reactions and adverse events associated with therapeutic treatments provided at the BE G G.2 Criteria for assessing the efficacy of administered therapeutic treatments G G.2 Current applicable legislation on transfusion activities / / In relation to the person’s job description and responsibilities A A.1 Management of human resources, technologies, materials, prescriptive documents and quality data and records, main processes and support processes A A.2 A.3 A.4 A.5 A.6 Regulations relating to the management of health-care documentation A A.2 A A.7 SI M TI Elements of the BE’s managerial strategy © Quality monitoring, analysis and improvement 41 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition 2. Physician responsible for selecting donors of whole blood and blood components The physician responsible for selecting blood donors shall guarantee the necessary professional skills at least in the following areas: Skills References Chapter B B.2.1 B B.2.2 B.6 B B.2.3 Criteria, procedures and technologies for collecting whole blood B B.3.1 B.3.3 Criteria, procedures and technologies for collecting blood components using apheretic methods, where applicable B B.3.2 B.3.3 Information, education and promotion of awareness of blood donors Management of blood donor deferral Se rv Clinical selection and counselling of blood donors iz i Section Clinical care of donors and diagnosis and treatment of adverse reactions and adverse events potentially associated with whole blood donations and, where applicable, with apheresis procedures B.4 C A.6.5 C.4 Essential elements relating to blood component quality requirements and quality control C C.5 Essential elements relating to the assessment criteria for the biological qualification of blood components that concur to determining their suitability for transfusion C C.6 Elements of epidemiology and prevention of transfusiontransmissible diseases D D.5 Current applicable legislation on transfusion activities / / SI M TI Procedures and reference standards for the identification and traceability of units of blood and blood components In relation to the person’s job description and responsibilities A A.1 Management of technologies, materials used to deliver the service, prescriptive documents and quality data and records, and main processes of specific interest A A.2 A.3 A.4 A.5 A.6 Regulations relating to the management of health-care documentation A A.2 Quality monitoring, analysis and improvement as applicable to the job description A A.7 © Elements of the BE’s management strategy 42 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition 3. Biologist The biologist shall guarantee the necessary professional skills at least in the following areas: Skills References Section Chapter B B.3.1 B.3.3 Procedures and technologies for collecting blood components and HSC using apheretic methods, excluding the aspects relating to donor care B B.3.2 B.3.3 Procedures and methods for producing “1st-level” blood components C C.1.1 Procedures and methods for producing “2nd-level” blood components C C.1.2 Procedures and reference standards for the identification and traceability of units of blood and blood components C A.6.5 C.4 Quality requirements for blood components and criteria for processing and assessing the results of quality control on blood components C C.5 Assessment criteria for the biological qualification of blood components that contribute to determining their suitability for transfusion (biological validation) C C.6 Criteria for assessing transfusion requests D D.2 D.3 Immunohaematological criteria and basic elements for the selection of blood components to be individually attributed to patients D D.4 Immunohaematological diagnostic methods relating to the reporting of adverse reactions to blood component transfusion D D.5 Epidemiology and surveillance of transfusion-transmissible diseases D D.5 Management of activities for blood component delivery, intraand inter-regional compensation, and delivery of plasma to fractionation industries D D.5 D.8.1 D.8.2 Criteria and methods for managing stocks of blood components D D.7 General elements of clinical pathology and laboratory diagnostics, with particular reference to the significance of, and methods for internal quality control and external quality auditing E E.2 E.4 Genetics and systematics of erythrocyte blood groups: diagnostic and technical applications, and clinical implications in blood transfusions E E.3 © SI M TI Se rv iz i Procedures and technologies for collecting whole blood, excluding the aspects relating to donor care 43 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements Skills 2nd Edition References Chapter Immunohaematological serology: assessment, application and auditing of diagnostic methods E E.3 Elements of the prevention, diagnosis and treatment of the haemolytic diseases of the newborn, with reference to immunohaematological diagnostic methods E E.3.6 Elements of the diagnosis and treatment of autoimmune haemolytic diseases, with reference to immunohaematological diagnostic methods E E.3.7 Elements of platelet and leucocyte immunohaematology, with reference to the diagnostic and clinical implications of interest in transfusion medicine E E.5 Current applicable legislation on transfusion activities / Se rv iz i Section / In relation to the person’s job description and responsibilities A A.1 Management of human resources, technologies, materials used to deliver the service, prescriptive documents and quality data and records, main processes and support processes A A.2 A.3 A.4 A.5 A.6 Regulations relating to the management of health-care documentation A A.2 Quality monitoring, analysis and improvement A A.7 © SI M TI Elements of the BE’s management strategy 44 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition 4. Nurse The nurse shall guarantee the necessary professional skills at least in the following areas: Skills References Section Chapter B B.2.1 iz i Information, education and promotion of awareness of blood donors Support to the clinical selection and counselling of blood donors B B.2.2 B.6 Support to the management of deferred blood donors B B.2.3 B B.3.1 B.3.3 B B.3.2 B.3.3 Se rv Procedures and technologies for collecting whole blood and for submitting collected units to subsequent processing stages Procedures and technologies for collecting blood components and HSC using apheretic methods and for submitting collected units to subsequent processing stages Care of the donor and treatment of any adverse reactions and adverse events potentially associated with whole blood donations and apheresis procedures C C.1.1 Procedures and reference standards for the identification and traceability of units of blood and blood components C A.6.5 C.4 Basic elements relating to blood component quality requirements and quality control C C.5 Essential elements relating to the assessment criteria for the biological qualification of blood components that contribute to determining their suitability for transfusion C C.6 Essential elements relating to the appropriate clinical use of blood components D D.4 G.2.1.2 Essential elements of the management of activities for blood component delivery, intra- and inter-regional compensation, and delivery of plasma to fractionation industries D D.5 D.8.1 D.8.2 Essential elements relating to the criteria and methods for managing stocks of blood components D D.7 Essential elements of systematics of erythrocyte blood groups and immunohaematological serology, and clinical implications of immunological compatibility in blood transfusions E E.3 Organisation, technologies and patient care needs related to autologous transfusion procedures, with particular reference to pre-operative autologous blood donation for elective surgery F F.1 F.2 Selection/ definition of patient care protocols for the most common and/or critical diseases treated as part of the clinical activities for outpatients and hospitalised patients at the BE G G.2 © SI M TI Basic knowledge of the procedures and methods for producing blood components B.4 45 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements Skills 2nd Edition References Chapter Organisation, technologies and patient care needs related to the clinical activities for outpatients and hospitalised patients at the BE G G.2 Prompt identification and treatment of adverse reactions and adverse events associated with the therapeutic treatments provided at the BE G G.2 Identification of diagnostic and clinical elements for assessing the efficacy of administered therapeutic treatments G G.2 Current applicable legislation on transfusion activities / / iz i Section Se rv In relation to the person’s job description and responsibilities A A.1 Management of human resources, technologies, materials used to deliver the service, prescriptive documents and quality data and records, and main processes and support processes A A.2 A.3 A.4 A.5 A.6 Regulations relating to the management of health-care documentation A A.2 Quality monitoring, analysis and improvement A A.7 © SI M TI Elements of the BE’s management strategy 46 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements 2nd Edition 5. Biomedical laboratory technician The biomedical laboratory technician shall guarantee the necessary professional skills at least in the following areas: Skills References Chapter Procedures and technologies for collecting whole blood, excluding the aspects relating to donor care B B.3.1 B.3.3 Procedures and technologies for collecting blood components and HSC using apheretic methods, excluding the aspects relating to donor care B B.3.2 B.3.3 Procedures and methods for producing “1st-level” blood components C C.1.1 Procedures and methods for producing “2nd-level” blood components C C.1.2 Procedures and methods for freezing and thawing blood components C c.2.1 Procedures and reference standards for the identification and traceability of units of blood and blood components C A.6.5 C.4 Quality requirements for blood components, and processing and assessing the results of quality control on blood components C C.5 Essential elements relating to the assessment criteria for the biological qualification of blood components that contribute to determining their suitability for transfusion C C.6 Criteria for assessing transfusion requests D D.2 D.3 Immunohaematological criteria and essential elements for the selection of blood components to be individually attributed to patients D D.4 Essential elements relating to the appropriate clinical use of blood components D D.4 G.2.1.2 Immunohaematological diagnostic methods relating to the reporting of adverse reactions to transfusions D D.5 Essential elements of the epidemiology and surveillance of transfusion-transmissible diseases D D.5 Management of activities for blood component delivery, intraand inter-regional compensation, and delivery of plasma to fractionation industries D D.5 D.8.1 D.8.2 Criteria and methods for managing stocks of blood components D D.7 General elements of laboratory diagnostics, with particular reference to the significance of, and methods for internal quality control and external quality auditing E E.2 E.4 © SI M TI Se rv iz i Section 47 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section A - General organisational requirements Skills 2nd Edition References Chapter Elements of systematics and genetics of erythrocyte blood groups: diagnostic and technical applications, and clinical implications in blood transfusions E E.3 Immunohaematological serology: assessment, application and auditing of diagnostic methods E E.3 Elements of the prevention, diagnosis and treatment of the haemolytic diseases of the newborn, with specific reference to the immunohaematological diagnostic methods E E.3.6 E E.3.7 Se rv Elements of the diagnosis and treatment of autoimmune haemolytic diseases, with specific reference to the immunohaematological diagnostic methods iz i Section Elements of platelet and leucocyte immunohaematology, with particular reference to the technical implications of interest in transfusion medicine E E.5 Elements of the management of autologous units F F.2 Current applicable legislation on transfusion activities / / In relation to the person’s job description and responsibilities A A.1 Management of human resources, technologies, materials used to deliver the service, prescriptive documents and quality data and records, and main processes and support processes A A.2 A.3 A.4 A.5 A.6 Regulations relating to the management of health-care documentation A A.2 Quality monitoring, analysis and improvement A A.7 © SI M TI Elements of the BE’s management strategy 48 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition SECTION B COLLECTION OF BLOOD AND BLOOD COMPONENTS iz i CONTENTS Se rv B.1 PROGRAMMING THE COLLECTION OF BLOOD AND BLOOD COMPONENTS ................................................................................................................................. 50 B.2 MANAGEMENT OF DONORS OF BLOOD AND BLOOD COMPONENTS ................................................................................................................................. 52 B.2.1 AWARENESS, INFORMATION AND EDUCATION OF DONORS OF BLOOD AND BLOOD COMPONENTS ....................................................... 52 B.2.2 SELECTION OF DONORS OF BLOOD AND BLOOD COMPONENTS ................................................................................... 54 B.2.3 MANAGEMENT OF DEFERRED DONORS 60 ....................................................... M TI B.3 WHOLE BLOOD COLLECTION AND APHERESIS .......................................... B.3.1 PREPARATION AND CONTROL OF MATERIALS AND INSTRUMENTS FOR COLLECTING WHOLE BLOOD .............. 63 63 B.3.2 PREPARATION AND CONTROL OF MATERIALS AND INSTRUMENTS USED FOR APHERESIS .......................................... 64 SI B.3.3 WHOLE BLOOD COLLECTION AND APHERESIS PROCEDURES ..... 66 B.4 DONOR CARE DURING WHOLE BLOOD COLLECTION AND APHERESIS PROCEDURES ................................................................................................. 70 B.5 DONOR HAEMOVIGILANCE .............................................................................................. 72 © B.6 DIAGNOSTIC INVESTIGATIONS CONDUCTED FOR EVERY DONATION, AT REGULAR INTERVALS, AND IN PARTICULAR SITUATIONS ......................................................................... 73 B.7 MANAGEMENT OF DONORS’ DATA ........................................................................... 75 B.8 REGULATION AND CONTROL OF ACTIVITIES AT BLOOD COLLECTION SITES .................................................................................................................. 77 B.9 PROCESS CONTROL INDICATORS 82 ............................................................................ 49 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition For the Standards on the collection of haematopoietic stem cells, see Section G - Collection of haematopoietic stem cells and other clinical activities in transfusion medicine. B.1 PROGRAMMING THE COLLECTION OF BLOOD AND BLOOD COMPONENTS iz i B.1.1 The BE shall guarantee the planning of its blood component needs on at least an annual basis, with periodic infra-annual reviews. Se rv B.1.2 The collection of blood and blood components shall be programmed on at least an annual basis, with periodic infraannual reviews, in cooperation with the associations and federations of blood donors. B.1.2.1 Donors belonging to associations and federations of blood donors shall be invited to donate on the basis of dedicated agreements between their associations and federations and the BE. APPLICATION GUIDELINES The BE shall guarantee the planning of its blood component needs on at least an annual basis, with periodic infra-annual reviews. M TI B.1.1 SI The definition of the blood component needs shall take into account: a) the needs of the health care areas served by the BE; b) any need to obtain blood components from other BEs if the BE is not self-sufficient; c) any commitment to supply blood components to other BEs (inside or outside the region) if the BE has a production capacity that exceeds its own needs. © This planning shall also be consistent with regional and national programmes/plans designed to achieve self-sufficiency for blood components and plasma-derived medicinal products. Infra-annual reviews of blood component needs should be conducted on at least a three-monthly basis. The BE shall provide documented evidence of the planning of its needs and of its corresponding infra-annual reviews. The commitments or agreements for planning supplies to, or acquisitions from other bodies shall be managed by arrangement with the Regional Blood Coordinating Centre. 50 Società Italiana di Medicina Trasfusionale e Immunoematologia B.1.2 Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition The collection of blood and blood components shall be programmed on at least an annual basis, with periodic infra-annual reviews, in cooperation with the associations and federations of blood donors. The programming of the collection of blood and blood components shall be consistent with the BE’s planned blood component needs (see Standard B.1.1). Se rv iz i The annual programming of the collection of blood and blood components, and the related periodic infra-annual reviews shall be done in cooperation with the associations and federations of donors referring to the BE and to the connected blood collection sites (BCS). The collection programme shall be periodically reviewed in parallel with the infraannual reviews of the planned needs for blood components and the production of plasma to submit to pharmaceutical processing (see Standard B.1.1). The BE shall provide documented evidence of its programming activities and all related reviews thereof. Relations between the BE and the associations and federations of donors shall be governed by specific agreements stipulated by the hospital management to which the BE responds and by the associations and federations involved1. M TI Up-to-date copies of these agreements governing the activities of the associations and federations of donors operating within the area served by the BE should be available at the BE. SI Permanent consulting and/or coordinating bodies shall be created with the associations and federations of donors referring to the BE for the purpose of identifying and implementing synergies and the levels of cooperation needed for an effective and efficient programming and periodic review of the collection activities with a view to tending towards an optimal, flexible alignment of said activities with the blood component needs for clinical purposes (including the needs for compensatory supply/acquisition activities) and for plasma to submit to pharmaceutical processing. © The creation of said bodies shall be specified in the agreements signed by the hospital management to which the BE responds and by the associations and federations of donors. These bodies should have tasks and functions in the following areas: a) guidance on, and control of blood collection activities; b) management of information flows between the BE and the associations and federations of donors; c) monitoring and assessment of specific objectives; 1 Facsimiles of these agreements are generally prepared by the Regional Authorities and Autonomous Provinces, with specific documents based on models defined at national level. 51 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition iz i d) assessment of the adequacy of the BE’s structural and technological equipment and human resources vis-à-vis the planned activities, and consequent proposals for the hospital management to make any necessary adjustments; e) assessment of the adequacy of the structural and technological equipment and human resources at the BCS connected to the BE; f) the promotion of blood donation; g) action to educate blood donors on health issues and preventive medicine; h) other areas where synergies with the associations and federations of donors can generate added value. Se rv B.1.2.1 Donors belonging to associations and federations of blood donors shall be invited to donate on the basis of dedicated agreements between their associations and federations and the BE. In accordance with current legislation, associations and federations of donors are responsible for inviting their members to give blood on the basis of programmes defined by agreement with the BE to which they refer. M TI The methods and plans for inviting donors shall be agreed and implemented on the basis of arrangements made, at the time of programming the collection activities, between the permanent consultation and/or coordination body and the associations and federations of donors referring to the BE and the related BCS (see Standard B.1.2). Methods shall be arranged for inviting donors in the event of a reduction of the blood stock, in emergency situations (e.g. epidemiological contingencies, earthquakes), and for particular clinical requirements (e.g. the need for blood components with specific cell phenotypes). SI B.2 MANAGEMENT OF DONORS OF BLOOD AND BLOOD COMPONENTS B.2.1 AWARENESS, INFORMATION AND EDUCATION OF DONORS OF BLOOD AND BLOOD COMPONENTS © B.2.1.1 In co-operation with the associations and federations of blood donors, the BE shall guarantee that donors receive proper information and education on all aspects relating to the donation of blood and blood components. B.2.1.2 The BE shall guarantee its co-operation on health care education schemes relating to the donation of blood and blood components promoted by associations and federations of blood donors and by health care institutions. 52 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition APPLICATION GUIDELINES B.2.1.1 In co-operation with the associations and federations of blood donors, the BE shall guarantee that donors receive proper information and education on all aspects relating to the donation of blood and blood components. iz i The activities for promoting blood donations and improving the blood donor’s awareness, loyalty, information and education are strategic to the achievement and maintenance of local, regional and national self-sufficiency for blood, blood components and plasma derivatives, as well as for transfusion safety. Se rv In these activities, the BE shall guarantee the necessary co-operation with the associations and federations of donors inasmuch as concerns the health care and technical-scientific aspects. In particular, the BE shall guarantee its contribution to information and education activities so as to provide donors with all the necessary details, as established by current legislation, in a scientifically correct, up-to-date and suitably understandable form, so that they can make an informed and responsible donation, in terms of safeguarding the health of recipients and donors. M TI The explanatory material shall also contain essential, understandable details relating to the characteristics of blood, blood components and plasma derivatives, and the strategic value of transfusion therapy in health care. © SI Said material shall provide: a) the reasons why donors complete a medical history questionnaire and undergo an assessment of their general state of health and physical conditions, and laboratory tests are conducted for the biological validation of their donations; b) information on the risk of transmitting infectious diseases via blood and blood products, as well as the reasons and types of behaviour that make people ineligible as donors because they could pose a health risk to recipients; c) the meaning of the terms “informed consent”, “self-deferral”, “temporary deferral”, “permanent deferral”; d) the reasons why people must not donate blood because the donation could have a negative effect on their own health; e) specific details on the different donation procedures; f) the opportunity to ask for further information at any time during the procedure; g) the opportunity to withdraw or postpone a donation at the donor’s discretion at any time during the procedure; h) the assurance that donors will be informed if tests performed identify any diseases and, if necessary, their donations will not be used; i) the reasons why donors must promptly notify the health care personnel at the BE of any diseases or symptoms they develop after making a donation, and especially in the first few days afterwards. Steps shall be taken to ensure that potential donors who are blind, or whose sight is severely impaired, can be informed and are able to understand the contents of the explanatory documents. 53 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.2.1.2 The BE shall guarantee its co-operation on health care education schemes relating to the donation of blood and blood components promoted by associations and federations of blood donors and by health care institutions. Se rv iz i Health care education schemes and investigations conducted to safeguard the donor’s health and the safety of recipients are a significant resource in preventive medicine and epidemiology for achieving some of the main goals of the national health care programmes, such as promoting healthy behaviour and lifestyles designed to prevent the most common diseases. For this purpose, the associations and federations of donors and the health care institutions may promote disease prevention and health education schemes also based on analyses and epidemiological assessments of data recorded on donors and donations. The BE shall guarantee its cooperation on such schemes, inasmuch as concerns the health care and technical-scientific aspects, possibly also by conducting surveys, analyses and assessments on epidemiological data obtained on donors and donations. B.2.2 SELECTION OF DONORS OF BLOOD AND BLOOD COMPONENTS M TI B.2.2.1 The BE shall prepare and adopt specific procedures that define the responsibilities and the working methods to use for donor selection. B.2.2.1.1 The donor selection procedures shall implement the documents/guidelines to which the BE refers as concerns the medical history and clinical criteria for allowing donors to donate and the diagnostic tests to perform prior to the donation. SI B.2.2.1.2 The donor selection procedures shall define specific criteria for selecting candidate donors and returning donors (i.e. donors who have not donated in the last 24 months). © B.2.2.1.3 The donor selection procedures shall define specific criteria for selecting donors for apheresis donations. B.2.2.1.4 The decision on a donor’s eligibility to donate shall be made at every donation and recorded in the donor’s file. B.2.2.1.5 To obtain their informed consent to the donation, the BE shall provide donors with all the information they need in a clear and comprehensible manner. 54 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition APPLICATION GUIDELINES B.2.2.1 The BE shall prepare and adopt specific procedures that define the responsibilities and the working methods to use for donor selection. iz i The physician responsible for donor selection and the transfusion medicine physician are entrusted with donor selection and the resulting decision on a donor’s eligibility to donate (for a definition of the corresponding job descriptions, see Section A - General organisational requirements, Annex 1 - Professional skills of health care personnel). M TI Se rv The donor selection procedures shall define the responsibilities and working methods to adopt in completing the following activities: a) checking the donor’s identity by means of an ID document that includes a photograph of the donor; b) collecting details of the donor’s medical history; c) assessing the donor’s general state of health; d) ascertaining the donor’s physical condition; e) performing the pre-donation diagnostic tests; f) declaring the donor eligible to donate; g) obtaining the donor’s informed consent to the donation and to the processing of his/her personal data. The BE shall guarantee that the whole donor selection process takes place in a manner that safeguards the donor’s privacy in accordance with current legislation. SI “Dedicated” donations, or those provided by minors, shall be exceptional practices reserved for very particular cases (e.g. to collect haematopoietic progenitor cells or lymphocytes for DLI - Donor Lymphocyte Infusions); in such cases, the applicable acceptance criteria and working methods shall be defined and documented, particularly as concerns obtaining informed consent. © The following steps should also be taken: a) criteria and methods should be defined and documented for the “customisation” of the donation depending on the particular physical, biohumoral and clinical characteristics of the donor; b) working methods should be designed to facilitate disabled donors judged eligible to donate. For donors coming from geographical areas at higher risk of transfusiontransmissible diseases than in the country of the BE, approval of the donation shall be governed as part of specific programmes/procedures, particularly if the donors concerned are likely to travel periodically to and from their geographical areas of origin. The same shall apply to donors who are likely to travel occasionally or regularly to and from geographical areas where the epidemiological situation is at higher risk of transmissible diseases than in the country of the BE. 55 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition iz i The same safety levels shall be guaranteed for blood and blood components collected from such donors as for those collected from donors unaffected by such situations, in accordance with the requirements of current legislation. Homogeneous safety levels can be achieved by: a) adopting adequate explanatory, training and cultural mediation tools, also in cooperation with the associations and federations of donors, to promote the acquisition of the necessary awareness and responsibility relating to the act of donation, where necessary in the light of the donor’s ethnic and cultural characteristics; b) any ad hoc extension of the screening tests to perform for transfusiontransmissible diseases. Se rv The application of such programmes/procedures shall be documented. The BE should assess the feasibility of conducting screening tests for particular congenital blood diseases in relation to specific epidemiological situations. For the purposes of decisions on a donor’s eligibility to donate, the physician responsible for donor selection may, where necessary, prescribe additional diagnostic tests, or consult specialists (in cardiology, infectious diseases, etc.), or ask donors to produce any health-related documents in their possession. M TI B.2.2.1.1 The donor selection procedures shall implement the documents/guidelines to which the BE refers as concerns the medical history and clinical criteria for allowing donors to donate and the diagnostic tests to perform prior to the donation. The reference documents/guidelines shall be formally approved by the BE manager and be circulated to all operators involved. SI In the context of the documents/guidelines adopted, the BE shall refer to the Donor selection guidelines developed and periodically reviewed by the SIMTI in cooperation with the national representatives of the associations and federations of donors. © For the purposes of decisions on their eligibility to donate, donors’ haemoglobin concentrations or haematocrit shall be measured before each donation. The BE may substitute haemoglobin or haematocrit screening with a complete blood count, in which case additional donor acceptance criteria shall be defined. The BE may decide to conduct other pre-donation tests, in which case, here again, additional donor acceptance criteria shall be defined. 56 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.2.2.1.2 The donor selection procedures shall define specific criteria for selecting candidate donors and returning donors (i.e. donors who have not donated in the last two years). iz i Currently-available scientific evidence demonstrates that confirmed positivity of markers of HBV, HCV and HIV1-2 infections is higher in candidate donors than in regular donors, and this may influence the residual transfusion-related risk of transmission of the above-mentioned infections. SI M TI Se rv For the proper interpretation of the present Standard, the following definitions apply: a) candidate donor: a person expressing his/her will to make a donation who has never donated blood or blood components before, who undergoes a preliminary assessment of his/her medical history and physical conditions, and diagnostic laboratory tests to establish his/her eligibility to donate. For the infectious diseases potentially transmitted by transfusions, the laboratory tests include at least immunometric screening for HBV, HCV, HIV1-2 infections, and syphilis serology. If declared eligible, donors are kept waiting for an established period of time before they can make a donation. Returning donors who wish to donate again but made their last donation more than 24 months earlier are considered for all intents and purposes in the same way as candidate donors; b) donor at his/her first deferred donation: a candidate donor declared eligible who makes his/her first donation some time after his/her first visit; c) donor at his/her first non-deferred donation: a person wishing to donate who has never donated blood or blood components before, or who made his/her last donation more than 24 months earlier, and who - subject to the decision that he/she is eligible in accordance with current legislation - makes a donation immediately, instead of going through the preliminary diagnostic procedure and the waiting time established for candidate donors; d) regular donor: a donor who donates regularly and who has made a donation at least once in the last 24 months. © The donor selection procedures shall define specific criteria for selecting candidate donors and returning donors, and for allowing them to make a donation. By gradually introducing agreements with the associations and federations of blood donors, the BE should adopt the following procedure for selecting candidate donors and allowing them to make a donation: a) checking the donors’ identity; b) collecting details of the donors’ medical history; c) assessing the donors’ general state of health; d) ascertaining the donors’ physical condition; e) performing the diagnostic tests needed to assess their eligibility to donate in relation to the established criteria for protecting the donors’ health; 57 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition f) performing immunometric screening for HBV, HCV and HIV 1-2 infections, and syphilis serology; g) performing any further tests prescribed by the physician responsible for donor selection; h) declaring the donors’ temporary eligibility to donate; i) keeping the donors waiting for a defined period of time before they make a donation. iz i The same behaviour should be adopted when accepting donors returning to donate more than 24 months after their previous donation. Se rv The temporary deferment of candidate donations mentioned in item (i) should strike a reasonable balance between the need to keep candidate donors motivated to donate blood and the need to contain the biological risk associated with the “window periods” for potentially transmissible infections. If the BE accepts candidate donors for a donation without following the preliminary temporary deferment procedure outlined above, then the procedures it adopts shall emphasize the need for a very strict compliance with the criteria for donor selection and acceptance for a donation. M TI B.2.2.1.3 The donor selection procedures shall define specific criteria for selecting donors for apheresis donations. The selection procedures shall define specific criteria for selecting donors to accept for apheresis donations, who shall meet the requirements of current legislation. © SI The physician responsible for donor selection shall pay particular attention to the following conditions: a) any abnormal bleeding episodes; b) any coagulation test anomalies; c) any marked reductions or declining trends in total blood protein levels and/or serum protein electrophoresis abnormalities, particularly for donors involved in intensive plasmapheresis programmes; in such cases, donors shall be referred for assessment by the transfusion medicine physician (for the definition of the job description for the transfusion medicine physician, see Section A General organisational requirements, Annex 1 - Professional skills of health care personnel); d) any medical history suggestive of water retention (particularly if steroids and/ or plasma volume expanders have to be used); e) any use of medicinal products in relation to product quality and safeguarding the donor’s health; f) any gastric disorders, if steroids have to be used; g) any adverse reactions during previous donations; h) sickle-cell trait carriers; i) any other conditions, other than those listed above, of relevance to donor and recipient safety and product quality. 58 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition In agreement with the associations and federations of donors, the BE may take part in programmes designed to produce hyperimmune plasma by apheresis to send for industrial processing and the production of particular plasma-derived medicinal products, based on contracts stipulated between the pharmaceutical companies involved in the sector and the regional authorities. Se rv iz i In such cases, the BE shall prepare and adopt specific procedures designed to govern the related activities for collecting plasma by apheresis, defining the clinical and organisational criteria and the working methods for: a) selecting donors in relation to the goals of the programmes; b) obtaining the donors’ specific informed consent; c) including and retaining donors in the programmes; d) planning and implementing any additional diagnostic tests for quality control on the collected plasma and any additional clinical and diagnostic measures to safeguard the donor’s health. B.2.2.1.4 The decision on a donor’s eligibility to donate shall be made at every donation and recorded in the donor’s file. M TI Having checked the donors’ identity, obtained and assessed their medical history in accordance with the permanent and temporary deferral criteria, evaluated the donors’ general state of health and ascertained that their physical conditions are acceptable, and taking into account any available laboratory findings relating to previous donations, the physician responsible for donor selection shall formally declare the donors’ eligibility to donate in accordance with current legislation. For the management of donors’ personal data and donor files, see Ch. B.6 in this Section, Managing the donor’s data. SI B.2.2.1.5 To obtain their informed consent to the donation, the BE shall provide donors with all the information they need in a clear and comprehensible manner. © To obtain the donors’ consent to the donation, donors shall be provided with all the information they need relating to: a) the purpose of the donation; b) the procedure and how long it is likely to take; c) the chance to withdraw their consent to the donation at any time during the procedure; d) common risks and discomfort associated with donations; e) how to behave after the donation, particularly in the first 12-24 hours afterwards; f) the importance of providing truthful details of their medical history and behaviour by means of the questionnaire and interview to ensure that the blood or blood components they donate are safe and their own health is safeguarded; g) the chance to opt for self-deferral at any time during the procedure, should donors believe their blood may not be suitable for transfusion; 59 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition h) the importance of donors reporting to the physician responsible for donor selection at any time (even after making a donation) about any medical issues, diseases or behaviour that might negatively affect the safety of their donated blood and blood components; i) the fact that physicians at the BE can be contacted with any information (even after making a donation), also by means of ad hoc telephone number(s), and they guarantee that it will remain fully confidential. B.2.3 MANAGEMENT OF DEFERRED DONORS iz i The above information shall be contained in the explanatory material given to the donor before the selection procedure. Se rv B.2.3.1 The BE shall prepare and adopt specific procedures for managing deferred donors. B.2.3.1.1 The procedures for managing deferred donors shall implement the documents and/or guidelines to which the BE refers inasmuch as concerns the medical and diagnostic criteria for donor deferral. M TI B.2.3.2 The BE shall prepare and adopt specific procedures for conducting retrospective investigations and assessments on the risk of transfusion-transmissible diseases. APPLICATION GUIDELINES B.2.3.1 The BE shall prepare and adopt specific procedures for managing deferred donors. SI The procedures for managing deferred donors shall explain the criteria to adopt in relation to the past and present medical conditions, and the outcome of diagnostic tests performed with a view to donation or for other purposes; they shall also define the criteria for permanent and temporary donor deferral and the criteria for reinstating donors, in order to safeguard the health of donors and recipients. © The BE shall guarantee: a) documentation of the essential donor deferral issues, including any reporting by donors themselves (even after making a donation) on their medical history, diseases or behaviour that might negatively affect the safety of donated blood or blood components; b) notification to donors of any significant clinical issues identified during the selection process or the performance of diagnostic laboratory tests associated with the donation and any follow-up diagnostic assessments; c) adequate donor counselling; d) definition of the areas of expertise for deferred donor management, attributed to the physicians responsible for donor selection (particularly those operating at BCS connected to the BE), and of the methods for assigning particular 60 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components assessment and decision-making functions physician (e.g. retrospective assessments diseases - see Standard B.2.3.2). 2nd Edition to the transfusion medicine on transfusion-transmissible iz i The BE should also guarantee: a) a preliminary outline of deferred donors’ clinical situations, also by means of additional diagnostic tests and/or referral to a specialist for advice; b) any subsequent referral of donors to their general practitioners for follow-up2 . Se rv B.2.3.1.1 The procedures for managing deferred donors shall implement the documents and/or guidelines to which the BE refers inasmuch as concerns the medical and diagnostic criteria for donor deferral. The reference documents/guidelines shall be formally approved by the BE manager and circulated to all operators involved. In the context of the documents/guidelines adopted, the BE shall refer to the Guidelines for donor selection developed and periodically reviewed by the SIMTI in cooperation with the national representatives of the associations and federations of donors. M TI B.2.3.2 The BE shall prepare and adopt specific procedures for conducting retrospective investigations and assessments on the risk of transfusion-transmissible diseases. The BE shall prepare and adopt specific procedures for conducting retrospective (look back) investigations and assessments relating to the risk of transfusiontransmissible diseases. SI Look back procedures are designed to define the responsibilities and working methods for the retrospective assessment of donors in the event of one or more of their donations being found at risk, or potentially at risk of transmitting disease as a result of past or present medical conditions and/or diagnostic findings, or if they are implicated in cases of suspected transfusion- transmissible disease. © These procedures are also designed to guarantee the fulfilment of any requirements associated with the potential implication of one or more donations where there is a risk of blood components or plasma-derived medicinal products transmitting disease, in relation to third parties affected (e.g. pharmaceutical companies contracted to process plasma and bodies governing the regulations for issuing compensation for personal damages attributable to transfusion). 2 It is worth emphasising the fundamental importance and priority of the general practitioner (GP) for taking the patient into care as part of the basic health care service, and the usefulness for the BE of establishing an effective link for co-operation and communications with donors’ GPs, where necessary and/or advisable. 61 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition The BE shall refer to specific documents/guidelines to identify cases in which the past and present medical conditions and/or diagnostic findings considered to decide a person’s eligibility to donate, or other donor-related information, contain elements to arouse the suspicion that one or more donations provided by a given donor are at risk, or potentially at risk of transmitting disease. iz i These documents/guidelines shall be made available to the transfusion medicine physicians and the physicians responsible for donor selection, and particularly to those operating at BCS connected to the BE. Se rv The retrospective clinical assessment for look-back activities shall be entrusted exclusively to a transfusion medicine physician, and the methods to use shall be defined. The look-back procedures shall also specify the responsibilities of physicians responsible for donor selection inasmuch as concerns reporting to the BE, particularly for those operating at BCS connected to the BE. SI M TI The BE shall implement look-back procedures: a) in cases where donors are found ineligible to donate during the selection process due to past and/or present medical conditions that have a significant influence on the safety of previous donations in terms of the risk of transfusiontransmissible diseases; b) in cases of donor self-deferral if the information provided by the donors and/ or any investigations conducted as a consequence of their self-deferral, have a significant influence on the safety of previous donations; c) in cases of donors ineligible to donate because they are found positive to markers of transfusion-transmitted infectious diseases after testing in accordance with current legislation, for the purposes of donation or at the time of other medical assessments; d) where one or more blood components are potentially implicated in a case of suspected transfusion- transmissible disease, including cases in which the competent authorities request the information they can legitimately access to decide compensation for the personal injury attributable to the transfusion of blood and blood products. The BE shall guarantee the systematic documentation of all look-back activities conducted. © If the BE has supplied another hospital’s BE with blood components for which a potential disease transmission risk has been identified during look back assessments on the donors involved and their donations, the BE shall send a formal report to the other BE involved, together with all necessary clinical and/or laboratory data. The same report shall also be sent to physicians responsible for the health care areas served by the BE, where blood components have been transfused for which look back assessments on the donors involved and their donations have identified a potential disease transmission risk; the BE management and the above-mentioned physicians can then jointly assess the need to conduct any retrospective assessments on the recipients involved. 62 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.3 WHOLE BLOOD COLLECTION AND APHERESIS B.3.1 PREPARATION AND CONTROL OF MATERIALS INSTRUMENTS FOR COLLECTING WHOLE BLOOD AND B.3.1.1 Before and after collection, the BE shall rely on specific procedures to guarantee the accurate inspection of the devices used to collect whole blood in order to ensure the absence of defects and/or alterations. APPLICATION GUIDELINES Se rv iz i B.3.1.2 The BE shall use weighing scales for whole blood collection with performance characteristics designed to ensure compliance with the requirements of current legislation for whole blood collection and the production of blood components with a view to ensuring end product quality. M TI B.3.1.1 Before and after collection, the BE shall rely on specific procedures to guarantee the accurate inspection of the devices used to collect whole blood in order to ensure the absence of defects and/or alterations. If a blood collection unit that is about to be used shows abnormal signs of moisture, or the liquid it contains is cloudy, or the unit is damaged or shows signs of any alterations that may contraindicate its safe use, then the device shall not be used. SI For the activities for inspecting the medical devices and the management of any nonconformities identified, see Section A - General organisational requirements, Ch. A.5 Management of materials. © B.3.1.2 The BE shall use weighing scales for whole blood collection with performance characteristics designed to ensure compliance with the requirements of current legislation for whole blood collection and the production of blood components with a view to ensuring end product quality. The scales for whole blood collection shall comply with the following minimum requirements: a) they shall guarantee the necessary mixing of the blood with the anticoagulants; b) they shall enable the programming of the volume of blood to collect; c) they shall guarantee the proper measurement of the programmed volume with a defined and acceptable variability; d) they shall signal any slowing or interruption of the blood flow; e) they shall be fitted with clamps that close automatically at the end of the blood collection; f) they shall indicate the time taken to complete the collection. 63 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition Se rv iz i Given the need to guarantee the traceability of data relating to whole blood collection activities and to increase their global safety, in addition to the abovelisted minimum requirements, the scales for whole blood collection should also meet the following further requirements: a) suitability for connecting to a computer-based system for managing traceability, also after a given time lag; b) the capacity to save data on a significant number of donations; c) the means to identify and record the blood units and the operator performing the collection with an optical reader or other objective means; d) the capacity to record a significant set of other details relating to the donation (programmed and actual weights, etc.); e) suitability for connecting to computer-based fractionation systems, also after a given time lag. The BE shall guarantee the regular preventive maintenance and control of the calibration status of the scales used for whole blood collection (see Section A - General organisational requirements, Ch. A.4.1 Management of systems, equipment and instruments). B.3.2 PREPARATION AND CONTROL OF MATERIALS AND INSTRUMENTS USED FOR APHERESIS M TI B.3.2.1 Before and after collection, the BE shall rely on specific procedures to guarantee the accurate inspection of the devices and infusion solutions used to collect blood components by apheresis in order to ensure the absence of defects and/or alterations. SI B.3.2.2 The BE shall use cell separators with performance characteristics designed to meet the requirements of current legislation for the collection of blood components by apheresis with a view to ensuring end product quality and the utmost degree of donor safety. APPLICATION GUIDELINES © B.3.2.1 Before and after collection, the BE shall rely on specific procedures to guarantee the accurate inspection of the devices and infusion solutions used to collect blood components by apheresis in order to ensure the absence of defects and/or alterations. When the packaging of a device used for apheresis is opened, or when the device is assembled on the cell separator, or during the preliminary check normally conducted automatically by cell separators, if the device does not appear to be intact, or shows any sign of changes that might interfere with its safe use, it shall not be used. In such cases, all the devices in the same batch shall be carefully examined to check for any repetition of the defects identified; all faulty kits shall be segregated to prevent their use and subsequently disposed of. 64 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition iz i Particular attention shall be paid to the visual inspection of the anticoagulants and infusion solutions used, especially as concerns any clouding of the liquid, presence of visible precipitated or suspended particles, or any other alterations that may contraindicate their safe use. Nonconforming solutions shall be treated in the same way as explained above for the devices. For the activities for inspecting medical devices and for managing any nonconformities identified, see Section A - General organisational requirements, Ch. A.5 Management of materials. Se rv B.3.2.2 The BE shall use cell separators with performance characteristics designed to meet the requirements of current legislation for the collection of blood components by apheresis with a view to ensuring end product quality and the utmost degree of donor safety. M TI The cell separators shall comply with at least the following minimum requirements: a) they shall guarantee a high degree of donor safety, also as regards the use of compensatory reinfusion solutions; b) they shall guarantee anticoagulant flow control and the proper mixing of the blood with the anticoagulant; c) they shall enable the programming of the volume(s) of blood component(s) to collect, also in relation to the donor’s physical conditions and blood count; d) they shall guarantee the proper measurement of the programmed volume(s), with a defined and acceptable variability; e) they shall signal any slowing or interruption of the blood flow; f) they shall enable a rapid reinfusion in the donor of the blood being processed; g) they shall provide essential procedural data (timing, volumes, etc.). © SI Given the need to guarantee the traceability of data relating to blood component collection activities, and to increase their global safety, in addition to the abovelisted minimum requirements, the cell separators should also meet the following further requirements: a) suitability for connecting to a computer-based system for managing traceability, also at a later date; b) the means to identify and record the operator handling the procedure and the blood component unit(s) with an optical reader or other objective means; c) the capacity to record a significant set of other details relating to the donation (programmed and actual weights, timing, batches, etc.). The BE shall guarantee the regular preventive maintenance and control of the calibration status of the cell separators (see Section A - General organisational requirements, Ch. A.4.1 Management of systems, equipment and instruments). The cell separators shall be cleaned and decontaminated by referring to specific working procedures (see Section A - General organisational requirements, Ch. A.4.4 Reconditioning of medical devices). The BE shall document the decontamination activities conducted. 65 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.3.3 WHOLE BLOOD COLLECTION AND APHERESIS PROCEDURES B.3.3.1 The BE shall prepare and adopt specific procedures designed to guarantee the proper performance of whole blood collection and apheresis procedures in accordance with current legislation. iz i B.3.3.1.1 The BE shall guarantee that personnel responsible for performing whole blood collection and apheresis are given specific training in relation to the skills needed for each professional category. Se rv B.3.3.1.2 For each donation, the documented and traceable identification of the personnel performing the collection procedures shall be guaranteed. B.3.3.1.3 Immediately before starting the collection procedure, a check shall be conducted on the donor’s identity and the correlation between the donor, the data relating to the donation, the blood units inserted in the collection device and the test tubes for the laboratory tests associated with the donation. M TI B.3.3.1.4 The BE shall adopt specific working procedures for preparing and disinfecting the skin and for venepuncture. SI B.3.3.1.5 The BE shall guarantee that venepunctures for the purpose of donating blood and blood components are handled exclusively by adequately-trained health care operators with the professional skills that entitle them to perform these procedures in accordance with current legislation. B.3.3.1.6 The BE shall guarantee the recording and traceability of data relating to each whole blood collection and apheresis procedure in accordance with current legislation. © B.3.3.1.7 If whole blood collection and apheresis procedures are interrupted, the BE shall decide on the basis of established criteria whether the whole blood and blood components may or may not be used. 66 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition APPLICATION GUIDELINES B.3.3.1 The BE shall prepare and adopt specific procedures designed to guarantee the proper performance of whole blood collection and apheresis procedures in accordance with current legislation. iz i The BE shall prepare and adopt procedures in accordance with current legislation that define the activities, the responsibilities and the working methods to adopt for the proper performance of procedures for whole blood collection and apheresis. Se rv B.3.3.1.1 The BE shall guarantee that personnel responsible for performing whole blood collection and apheresis are given specific training in relation to the skills needed for each professional category. As part of the procedures for training newly-employed personnel, the BE shall plan and implement specific training on whole blood collection and apheresis in relation to the skills required of the single professional categories (see Section A - General organisational requirements, Annex 1 - Professional skills of health care personnel). M TI These training activities shall be documented (see Section A - General organisational requirements, Ch. A.3.1 Maintenance, development and assessment of the personnel’s skills). B.3.3.1.2 For each donation, the documented and traceable identification of the personnel performing the collection procedures shall be guaranteed. SI The BE shall guarantee the documented and traceable identification of the operators handling the collection procedures for each donation (see Section A General organisational requirements, Ch. A.6.5 Identification and traceability). © B.3.3.1.3 Immediately before starting the collection procedure, a check shall be conducted on the donor’s identity and the correlation between the donor, the data relating to the donation, the blood units inserted in the collection device and the test tubes for the laboratory tests associated with the donation. For each donor judged eligible, specific documents shall be generated for use in the collection procedure, including: a) the document(s) containing the donor’s personal details and identification code, a number for identifying the donation, the certification of the donor’s eligibility for donating, the type of donation and the quantity(ies) to collect; b) labels to be attached to units included in the blood collection device and to the test tubes to submit for laboratory tests associated with the donation, providing the essential information for ensuring consistency with the details 67 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition of the donor and the donation, and also for the purposes of the unequivocal identification and traceability of the blood units and test tubes. Further documentation (which may also be produced subsequent to the donation) may include the following: a) donation certificates, where requested by the donor; b) a voucher for obtaining food and drink after the donation, where applicable; c) others. iz i The units included in the blood collection device and the test tubes to send for laboratory tests associated with the donation shall be labelled before collection begins. Se rv Immediately before the collection, the following shall be guaranteed: a) the “positive” identification of the donor by asking donors to state their personal details (surname, name and date of birth); b) a check on the consistency of the donor’s details with the labels attached to the units included in the blood collection device and the test tubes to submit for laboratory tests associated with the donation. Each collection station shall be logistically organised so as to facilitate the procedures for unequivocally associating the donor with the relevant blood units and test tubes. M TI Computer-based systems should be adopted to unequivocally associate the operator with the unit(s) collected and the cell separator (for apheresis procedures) by means of optical readers or other objective means, as well as tracing other essential data relating to the procedure, such as the collection time, the programmed quantity and the quantity actually collected and the quantity of anticoagulant used (in apheresis procedures) (see Standards B.3.1.2 and B.3.2.2). SI The methods for labelling blood units and test tubes associated with the donation that are collected at BCS connected to the BE shall guarantee the unequivocal consistency of the data provided on the labels with the data relating to the donor and the donation, as well as the unequivocal identification and traceability of the blood units and the corresponding test tubes to submit for laboratory tests. © B.3.3.1.4 The BE shall adopt specific working procedures for preparing and disinfecting the skin and for venepuncture. The working procedures for preparing and disinfecting the skin and for performing the venepuncture are designed to minimise the risk of contamination of the whole blood or blood components being collected. They shall specify: a) the cleansing/antiseptic solutions to use; b) the time it takes for these solutions to achieve an optimal antiseptic action; c) the need to choose an area of skin free of lesions; d) the recommendation to give priority to a vein in the antecubital fossa; e) the importance of keeping the needle covered until it is needed and of checking in advance that the needle cover is not damaged; f) the importance of performing the venepuncture only after the antiseptic applied to the skin has dried completely (the time it takes for the skin to dry depends 68 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition on the product used, but must never be less than 30-40 seconds); g) the importance of never touching the area treated after applying the antiseptic; h) the recommendation that the venepuncture be completed at the first attempt, making any second attempt in a different area from the one originally chosen; i) the need to use a new needle and blood collection device to perform a second venepuncture. iz i To further reduce the risk of bacterial contamination, the BE shall adopt systems that enable to collect blood samples to be obtained for the laboratory tests by means of a small pouch connected in line with the device, that is filled before starting the whole blood collection and apheresis procedures. Se rv B.3.3.1.5 The BE shall guarantee that venepunctures for the purpose of donating blood and blood components are handled exclusively by adequately-trained health care operators with the professional skills that entitle them to perform these procedures in accordance with current legislation. As part of the training procedures for newly-employed personnel, the BE shall guarantee the planning and provision of training on the performance of venepuncture for whole blood collection and apheresis procedures, specifically for the health care operators who can be qualified to perform this procedure. M TI These training activities shall be documented (see MA - General organisational requirements, Ch. A.3.1 maintenance, development and assessment of the personnel’s skills). SI B.3.3.1.6 The BE shall guarantee the recording and traceability of data relating to each whole blood collection and apheresis procedure in accordance with current legislation. In accordance with current legislation, the BE shall guarantee the recording and traceability of the data relating to each whole blood collection and apheresis procedure (see Section A - General organisational requirements, Ch. A.6.5 Identification and traceability). © All donations shall be recorded, including any donations that were not completed. B.3.3.1.7 If whole blood collection and apheresis procedures are interrupted, the BE shall decide on the basis of established criteria whether the whole blood and blood components may or may not be used. The criteria for using whole blood and blood components deriving from donation procedures that are not completed shall comply with current legislation and also, in the case of plasma for fractionation, with the requirements established in the agreements stipulated with pharmaceutical companies. 69 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.4 DONOR CARE DURING WHOLE BLOOD COLLECTION AND APHERESIS PROCEDURES B.4.1 The presence of at least one nurse shall be guaranteed at all times when whole blood collection and apheresis procedures are taking place. iz i B.4.2 The presence of at least one physician responsible for donor selection shall be guaranteed at all times when whole blood collection and apheresis procedures are taking place in order to deal with any complications or adverse reactions. B.4.3 The BE shall guarantee donors adequate post-donation care. Se rv B.4.4 Donors shall be adequately informed about the proper behaviour to adopt in the post-donation period. B.4.5 The BE shall prepare and adopt specific procedures to guarantee the proper and timely management of any adverse reactions or adverse events occurring in donors during and after whole blood collection and apheresis procedures also guaranteeing their timely recording. B.4.1 M TI APPLICATION GUIDELINES The presence of at least one nurse shall be guaranteed at all times when whole blood collection and apheresis procedures are taking place. SI The nurse is the professional primarily involved in providing donor care relating to whole blood collection and apheresis procedures. The presence of at least one physician responsible for donor selection shall be guaranteed at all times when whole blood collection and apheresis procedures are taking place in order to deal with any complications or adverse reactions. © B.4.2 The physician responsible for donor selection shall supervise the collection activities, take prompt action in the event of adverse reactions in the donor and generally deal with problems that may interfere with the efficient and safe performance of the activities. B.4.3 The BE shall guarantee donors adequate post-donation care. Donors shall be guaranteed a period of rest immediately after the donation and an adequate post-donation availability of refreshments, giving priority to the ingestion of a congruent quantity of liquids. 70 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition In the resting and refreshment areas, there shall always be personnel capable of promptly identifying any signs of malaise and, where necessary, requesting the intervention of the nursing and/or medical personnel. B.4.4 Donors shall be adequately informed about the proper behaviour to adopt in the post-donation period. B.4.5 Se rv iz i By means of the explanatory material provided before the donation, donors shall be given clear and understandable information on how they should behave after making a donation, particularly as concerns the need to avoid occupational, sporting or recreational activities that entail a risk in the first 12-24 hours after the donation. The BE shall prepare and adopt specific procedures to guarantee the proper and timely management of any adverse reactions or adverse events occurring in donors during and after whole blood collection and apheresis procedures, also guaranteeing their timely recording. M TI Any adverse reactions or adverse events occurring in donors during and after whole blood collection and apheresis procedures shall be promptly managed according to specific procedures developed by the BE and they shall be promptly recorded. Materials and means for dealing with any clinical emergencies shall be available and ready for use at the premises used for the blood collection activities. SI The health care personnel responsible for collection shall be adequately trained and periodically brought up to date on how to manage specific clinical emergencies that can occur in the setting of whole blood collection and apheresis activities (see Section A - General organisational requirements, Ch. A.3.1 Maintenance, development and assessment of the personnel’s skills). © These operators shall be qualified to provide BLS (Basic Life Support). 71 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.5 DONOR HEAMOVIGILANCE B.5.1 The BE shall adopt specific procedures to manage its donor haemovigilance activities. APPLICATION GUIDELINES The BE shall adopt specific procedures to manage its donor haemovigilance activities. iz i B.5.1 Se rv The BE shall prepare and adopt specific procedures that identify the responsibilities and the working methods for managing donor haemovigilance activities in the light of current legislation and local, regional and national programmes for haemovigilance and clinical risk management. A reference person for donor haemovigilance shall be formally appointed. M TI The BE shall define working methods designed to guarantee the proper and complete management of: a) epidemiological surveys relating to infectious diseases potentially transmitted by transfusions; b) reports on severe adverse or unexpected reactions and severe incidents relating to the donation process, as well as processing errors and near misses. © SI Procedures shall be prepared and made available for notifying the Regional Blood Coordinating Centres and the National Blood Centre of all serious adverse reactions and severe incidents relating to blood collection based on the applicable national and regional directives and using the dedicated Italian transfusion services’ IT system (SISTRA), see Section A - General organisational requirements, Ch. A.8 Information flows. 72 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.6 DIAGNOSTIC INVESTIGATIONS CONDUCTED AT EVERY DONATION, AT REGULAR INTERVALS, AND IN PARTICULAR SITUATIONS B.6.1 The BE shall adopt specific protocols that define the diagnostic investigations to perform at the time of each donation and other tests to perform to safeguard the donor’s health. iz i B.6.1.1 Where the laboratory tests to perform at every donation or at regular intervals, or in particular situations, are entirely or partially conducted by another organisation, these activities shall be governed by specific agreements and/or provisions issued in relation to the organisational setting in which the BE operates. Se rv B.6.2 The BE shall guarantee that donors are notified of the outcome of diagnostic investigations performed at every donation or at regular intervals to safeguard the donor’s health, and of the results of any further diagnostic tests performed. M TI B.6.3 If the BE conducts research or epidemiological studies entailing [envisaging - people envisage, establishments don’t...] the performance of diagnostic investigations in addition to those required by law and/or defined in the routine profiles, then donors’ informed consent to these investigations and the use of the related results shall be obtained. APPLICATION GUIDELINES The BE shall adopt specific protocols that define the diagnostic investigations to perform at the time of each donation and other tests to perform to safeguard the donor’s health. SI B.6.1 The BE shall adopt specific protocols that define the diagnostic investigations to conduct at the time of each donation and the routine tests performed to safeguard the donor’s health. © These protocols shall define: a) the laboratory tests to perform at the time of each donation for the biological validation of blood components and to safeguard the donor; b) the laboratory tests to perform periodically to safeguard the donor’s health, where these tests differ from those conducted at the time of the donation; c) any further diagnostic investigations to perform systematically (e.g. ECG for donors at their first donation) or routinely (e.g. ECG for selected categories of donors, additional laboratory tests for donors with recurrent lipid metabolism alterations); d) the essential working methods for ensuring the performance of these diagnostic investigations. 73 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.6.1.1 Where the laboratory tests to perform at every donation or at regular intervals, or in particular situations, are wholly or partially conducted by another organisation, these activities shall be governed by specific agreements and/or provisions issued in relation to the organisational setting in which the BE operates. iz i If the laboratory tests to perform for each donation and the other routine or occasional tests are wholly or partially entrusted to another organisation, these activities shall be governed by specific agreements and/or provisions issued in relation to the organisational setting in which the BE operates, and always in accordance with current legislation. Se rv If such arrangements concern the immunometric and/or molecular tests performed for the biological qualification of the blood components, the organisation entrusted to perform these tests shall be an accredited transfusion service; the BE shall provide documented evidence of the relevant agreements or provisions. Said agreements/provisions shall guarantee that the diagnostic systems and analytical procedures adopted comply with current legislation on blood and blood components. M TI In addition, to guarantee the characteristics required for the diagnostic systems, analytical procedures and reagents in relation to the particular safety needs of blood transfusions, specific requirements shall be defined in relation to: a) the sensitivity and specificity levels of the tests; b) the validation criteria for the analytical sessions; c) the definition of grey zones; d) the internal quality control methods and the external quality assessment programmes adopted; e) the adoption of algorithms for managing the results, as established by current legislation. SI B.6.2 The BE shall guarantee that donors are notified of the outcome of diagnostic investigations performed at every donation or at regular intervals to safeguard the donor’s health, and of the results of any further diagnostic tests performed. © The methods used to notify donors of the outcome of their diagnostic investigations shall guarantee absolute compliance with current legislation on privacy. The BE shall promptly notify donors of any pathological findings of particular clinical relevance. Even though this is done at a later date, the routine communication of the outcome of the diagnostic investigations conducted for every donation should be in the form of a letter sent to the donor containing a brief and adequately clear summary of the findings and assessments related to the judgement on his/her eligibility to donate. The communication of the outcome of other routine tests or of further investigations conducted for specific reasons should include a brief but adequately clear summary 74 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition of the meaning of the findings with clear recommendations on the matter and any further action to take or behaviour to adopt. If pathological situations of significant clinical relevance are identified or suspected, donors should be referred to their general practitioners for follow-up (see Standard B.2.3.1). If the BE conducts research or epidemiological studies involving the performance of diagnostic investigations in addition to those required by law and/or defined in the routine profiles, then donors’ informed consent to these investigations and the use of the related results shall be obtained. iz i B.6.3 Se rv The BE may conduct research or epidemiological studies, subject to agreements with the associations and federations of donors involved. Where such research or studies involve performing tests in addition to those established by law and/or defined in the routine profiles, donors’ informed consent shall be required for the performance of the tests and the use of the results. M TI It is not necessary to obtain additional informed consent if the tests are already specified in the routine profiles (even if they are conducted using different methods) providing the quantity of blood normally collected for the biological validation associated with the donation is not exceeded. B.7 MANAGEMENT OF DONORS’ DATA SI B.7.1 For each donor, the BE shall prepare and use a donor’s file, which shall be managed in compliance with specific procedures. APPLICATION GUIDELINES For each donor, the BE shall prepare and use a donor’s file, which shall be managed in compliance with specific procedures. © B.7.1 A donor’s file consists of a set of all the records relating to a given donor, obtained on printed paper and/or in electronic format. The donor’s file shall be designed to contain the elements specified in the format indicated by current legislation and include all the information needed for the proper, complete and unequivocal management of a donor’s personal and medical details, as well as the donor’s visits to the BE and donations and the results of diagnostic tests associated with the donation and other routine and particular diagnostic investigations. 75 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition M TI Se rv iz i The minimum elements to record in the donor’s file include: a) the donor’s personal details and identification code; b) the place of residence, full address, telephone numbers and other contact details; c) the association or federation of donors to which the donor belongs, where applicable; d) the ABO phenotype, Rh, Kell and any other red cell, leukocyte and platelet phenotype details; e) a summary of the donor’s medical history and clinical findings relevant to the physical conditions required in order to be eligible to donate and an assessment of the donor’s general clinical conditions; f) the outcome of screening tests immediately prior to donation; g) the outcome of any additional diagnostic tests or consulting of specialists for the purpose of judging the donor’s eligibility to donate; h) the judgement of the donor’s eligibility to donate; i) any temporary deferrals with the related causes and the planning of tests and reinstatements; j) any permanent deferrals and the related causes; k) the donations made (identification numbers, types and quantities collected); l) any adverse reactions and/or adverse effects identified at the time of donations and the related treatments; m) the results of laboratory tests associated with the donation; n) any other diagnostic tests or investigations conducted independently of the donations and the corresponding outcomes. Unless there is a need to produce and preserve printed documentation relating to the donation signed by the donor and the physician responsible for donor selection, the remainder of the donors’ files should be managed wholly in electronic format. © SI The BE shall adopt procedures that define the responsibilities and the working methods to guarantee the systematic and accurate compilation, revision and assessment of the completeness of the data and the preservation of donors’ files, as well as the relevant criteria for accessing the data. 76 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.8 REGULATION AND CONTROL OF ACTIVITIES AT BLOOD COLLECTION SITES In the context of this Chapter, the term “blood collection site” (BCS) refers to fixed or mobile sites where blood and blood components are collected, managed by the associations and federations of blood donors that operate, based on the relevant national and regional legislation, in connection with the BE and under the technical responsibility of the latter. iz i Any blood collection sites managed directly by the BE as branches of their own organisation are considered for all intents and purposes as an integral part of the BE, so the Standards contained in the present Manual also apply to them for the activities coinciding with those conducted at the BE’s central site. Se rv The purpose of this Chapter is to introduce the elements required so that the BE can effectively take technical responsibility for the BCS managed by associations connected to the BE, as established by current legislation. This role covers relational activities, programming and planning blood collections, managing information flows, preparing the applicable prescriptive documents and assessing the skills of the health care personnel, as well as conducting systematic inspections and monitoring the activities of the BCS and the products it sends to the BE. M TI B.8.1 The activities for collecting whole blood and blood components at the BCS connected to the BE shall be under the technical responsibility of the BE. B.8.2 The BE shall prepare and adopt specific procedures to guarantee the necessary information flows between the BE and the BCS connected thereto. SI B.8.3 The collection of whole blood and blood components at the BCS connected to the BE shall be programmed in accordance with the requirements of Standard B.1.2 in this Section. © B.8.4 The BE shall guarantee that the personnel operating at the BCS have the skills and professional expertise needed to perform whole blood and blood component collection activities. B.8.5 The BE shall guarantee that donors at the BCS are given adequate information and instructions on all aspects relating to the donation of blood and blood components. B.8.6 The BE shall prepare specific procedures governing the donor management and selection activities and the collection of whole blood and blood components at the BCS in compliance with the content of the Standards B.2, B.3 and B.4 in this Section. 77 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.8.7 The BE shall prepare specific procedures governing the activities relating to the storage and transfer to the BE of the whole blood and blood components collected at the BCS. B.8.8 The BE shall prepare and adopt specific procedures to guarantee the systematic control and monitoring of the activities conducted at the BCS and of the whole blood and blood components that they collect. Se rv iz i B.8.8.1 The BE shall guarantee the systematic recording and management of nonconformities relating to crucial activities conducted at the BCS and to the units of whole blood and blood components that they collect, according to the applicable requirements. B.8.8.2 The BE shall guarantee the planning and adoption of adequate corrective actions in response to reiterated or single nonconformities, or serious events identified in relation to the activities conducted at the BCS and/or to the units of whole blood or blood components that they collect. M TI B.8.9 In the light of the results of its control and monitoring activities, the BE shall guarantee the planning and conduction of audits at the BCS to prompt quality improvement activities relating to the latter’s products/services and professional performance. APPLICATION GUIDELINES The activities for collecting whole blood and blood components at the BCS connected to the BE shall be under the technical responsibility of the BE. SI B.8.1 In accordance with current legislation, the whole blood collection and apheresis activities at the BCS connected to the BE shall be conducted under the technical responsibility of the BE concerned. © The agreements/contracts governing the relationship between the BE and the BCS shall specifically state that technical responsibility for the BCS lies with the BE. 78 Società Italiana di Medicina Trasfusionale e Immunoematologia B.8.2 Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition The BE shall prepare and adopt specific procedures to guarantee the necessary information flows between the BE and the BCS connected thereto. B.8.3 Se rv iz i The BE shall specify the types of information flow between the BE and the BCS, as well as the related management methods, particularly as concerns: a) guaranteeing the systematic availability and traceability of all the information relating to donor management and the collection of blood and blood components at the BCS (see Section A - General organisational requirements, Ch. A.6.5 Identification and traceability); b) the procedures for ensuring the systematic control and monitoring of the activities at the BCS and the products they send to the BE (see Standard B.8.8). The collection of whole blood and blood components at the BCS connected to the BE shall be programmed in accordance with the requirements of Standard B.1.2 in this Section. The collection of blood and blood components at the BCS connected to the BE shall be programmed in accordance with the contents of the Standard B.1.2 in this Section. The BE shall guarantee that the personnel operating at the BCS have the skills and professional expertise needed to perform whole blood and blood component collection activities. M TI B.8.4 Only health care personnel whose qualifications and professional skills have been approved by the BE manager may operate at the BSC. © SI The health care personnel operating at the BCS shall be trained under the supervision of a transfusion medicine physician. By agreement with the associations and federations of donors, the BE manager shall guarantee that the professional skills of the health care personnel operating at the BCS are constantly kept up-to-date regarding the activities for collecting blood and blood components (see Section A - General organisational requirements, Ch. A.3.1 Maintenance, development and assessment of the personnel’s skills). B.8.5 The BE shall guarantee that donors at the BCS are given adequate information and instructions on all aspects relating to the donation of blood and blood components. For the activities to ensure donor awareness, information and education, the BE shall guarantee that the BCS can provide donors with explanatory material containing all the information they need, as established by current legislation, to make well-informed and responsible donations with a view to safeguarding the health of recipients and of the donors themselves. 79 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition The explanatory material shall also contain essential, understandable information on the characteristics of blood, blood components and plasma-derivatives, and the strategic value of transfusion therapy in patient care. The elements described in the Application guidelines of Standard B.2.1.1. shall emerge clearly from this material. The BE shall prepare specific procedures governing the donor management and selection activities and the collection of whole blood and blood components at the BCS in compliance with the content of the Standards B.2, B.3 and B.4 in this Section. iz i B.8.6 Se rv The procedures shall guarantee proper and complete compliance with the requirements of current legislation and define the activities, responsibilities and working methods for donor management and selection and the collection of whole blood and blood components at the BCS, as in the contents of the procedures applicable at the BE (see Standards B.2, B.3 and B.4 of this Section), in order to guarantee the necessary homogeneity of the quality levels of their activities and products. B.8.7 M TI The BE shall guarantee that these procedures are circulated to the personnel operating at the BCS and ensure the timely availability of any revisions thereof. The BE shall prepare specific procedures governing the activities relating to the storage and transfer to the BE of the whole blood and blood components collected at the BCS. © SI The procedures shall define the responsibilities and the working methods designed to guarantee that the temporary storage, packaging and transfer to the BE of the units of blood and blood components collected at the BCS are handled in accordance with current legislation and with the requirements established by the BE as regards the need to guarantee the preservation of the biological properties of whole blood and blood components up until the time of their delivery (see Section A - General organisational requirements, Ch. A.6.3 Storage of blood, blood components and haematopoietic stem cells (HSC) and Ch. A.6.4 Packaging and transportation of blood, blood components and haematopoietic stem cells). The BE shall guarantee that these procedures are circulated to the personnel operating at the BCS and ensure the timely availability of any revisions thereof. B.8.8 The BE shall prepare and adopt specific procedures to guarantee the systematic control and monitoring of the activities conducted at the BCS and of the whole blood and blood components that they collect. The BE shall prepare and adopt specific procedures designed to guarantee the systematic control and monitoring of the activities conducted at the BCS and of the units of whole blood and blood components that they collect. 80 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.8.8.1 The BE shall guarantee the systematic recording and management of nonconformities relating to crucial activities conducted at the BCS and to the units of whole blood and blood components that they collect, according to the applicable requirements. iz i By agreement with the associations and federations of donors concerned, the BE shall prepare and adopt specific procedures designed to guarantee the systematic control and monitoring of the activities conducted at the BCS and of the blood and blood components that they collect. M TI Se rv These procedures shall define: a) the potentially critical stages of the collection procedures that the BCS have to control systematically and the nonconformities that they must identify and record during the course of said processes, as well as the corresponding responsibilities and methods for their management; b) the product standards that the BCS are obliged to guarantee for the units of blood and blood components that they collect; c) the control procedures that the BE must perform on the products and documents received from the BCS and the related responsibilities and methods for their management; d) the management of any nonconformities identified by said control procedures; e) the information flows that the BCS must guarantee to the BE regarding the controls they have performed and the nonconformities identified. The procedures shall also define the methods for the control and management of any nonconformities relating to donor selection and control activities at the BCS, focusing particularly on the appropriateness of their clinical selection and its compliance with current legislation and the established guidelines. SI The procedures shall also concern the systematic reporting to the BE of nonconformities relating to the collection procedures and the products identified and recorded by the personnel responsible for the blood and blood component collection activities at the BCS. © In particular, such reports should include: a) collections that were not completed due to the procedure being interrupted; b) the duration of whole blood collections taking longer than the limits set by current legislation; c) the weight of whole blood or blood components found below or above the requirements established by current legislation; d) significantly slow collection flows during apheresis procedures. The BE shall guarantee that these procedures are circulated to the personnel operating at the BCS and ensure the timely availability of any revision thereof. 81 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition B.8.8.2 The BE shall guarantee the planning and adoption of adequate corrective actions in response to reiterated or single nonconformities, or serious events related to the activities conducted at the BCS and/or to the units of whole blood or blood components that they collect. In the light of the results of its control and monitoring activities, the BE shall guarantee the planning and conduction of audits at the BCS to prompt quality improvement activities relating to the latter’s products/ services and professional performance. Se rv B.8.9 iz i The BE shall guarantee the systematic analysis and assessment of nonconformities identified relating to the BCS and take adequate corrective action to deal with them (see Section A - General organisational requirements, Ch. A.7.2 Corrective and preventive actions). M TI Audits shall be planned and conducted particularly following the detection of reiterated or single nonconformities or serious events not solved by any previously-taken corrective action, in order to evaluate the level of application and adequacy of the established procedures and, where applicable, to review the level of professional competence of the personnel operating at the BCS (see Section A - General organisational requirements, Ch. A.7 Quality monitoring, analysis and improvement). Based on the results of such audits, the BE shall implement adequate improvement plans/actions and/or personnel requalification plans, as necessary. B.9 PROCESS CONTROL INDICATORS SI To constantly monitor the quality of the products-services provided and the compliance of the processes implemented with the established standards, the BE shall guarantee the monitoring of at least the indicators listed in the following table. © The indicators relating to the collection of whole blood and blood components apply to the activities conducted both at the BE and at other blood collection sites managed directly by the BE, and at the BCS managed by the associations and federations of donors connected to the BE. For the general criteria for planning quality monitoring activities, see Section A - General organisational requirements, Ch. A.7.1 Quality monitoring. 82 Reference chapter: Section B B.1 B.1 B.2.1 B.2.2 B.2.2 B.2.2 B.2.3 N° 1 2 3 4 5 6 7 © / / / / B.2.1.1 / / Reference standard: Section B Donor selection Donor selection at BCS Donor selection Donor selection Donor awareness, information and education Number of revisions of explanatory material for donors Discrepancy between number of donations per infra-annual period (e.g. per month) vis-à-vis the mean number of donations (monthly) in the previous year(s) Number of donations recorded out of Number of donations programmed (data stratified by type of donation) Process control indicator Sensitivity and specificity of judgement on eligibility to donate Sensitivity and specificity of judgement on eligibility to donate Sensitivity of judgement on eligibility to donate Proportion of deferred donors iz i Number of look back investigations for transfusion-transmissible diseases out of Number of donations Number of cases judged eligible to donate not subsequently confirmed on systematic auditing or random sampling out of Donors selected Number of donations rejected due to positive biological validation test results out of Number of donations collected Number of candidate donors Number of deferred donors out of Total number of candidate donors Se rv Availability of up-to-date explanatory material Infra-annual variability of blood and blood component collection Effectiveness of programming blood and blood component collection Characteristic to monitor M TI SI Programming blood and blood component collection Programming blood and blood component collection Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section B - Collection of blood and blood components 2nd Edition 83 84 B.3.1 B.3.2 B.3.1 B.3.2 B.3.3 B.3.3 B.4 B.8 B.8 B.8 8 9 10 11 12 13 14 15 © B.8.9 B.8.8.2 B.8.8.1 B.8.6 B.4.3 B.3.3.1.5 B.3.3.1.4 / B.3.3.1 B.3.2.1 Reference standard: Section B Control and monitoring of activities conducted at BCS Control and monitoring of activities conducted at BCS Control and monitoring of activities conducted at BCS Donor care Performance of venepuncture Preparation and disinfection for venepuncture Se rv Number of multiple venepunctures out of Number of donations Number of blood units found positive on sterility check out of Number of blood units tests (data stratified by type of blood component) Number of weighing scale and cell separator stoppages Number of devices rejected due to defects Process control indicator iz i Number of corrective/preventive actions implemented by the BE Number of nonconformities identified in critical activities and products sent by the BCS to the BE Application of the control and Number of audits conducted by the monitoring system to activities BE at BCS conducted at the BCS Correction/prevention of reiterated or single nonconformities or serious events Conformity to established standards of activities conducted at the BCS and of their products sent to the BE Adequacy of established donor Number of adverse events affecting care procedures donors out of Number of donations Adequacy of training for personnel responsible for venepuncture Adequacy of established working procedures Efficiency of collection equipment Conformity of collection devices to established standards Characteristic to monitor M TI SI Controlled management of collection equipment Inspection of devices for whole blood collection and apheresis Activity Standards of Transfusion Medicine Section B - Collection of blood and blood components BE = blood establishments BCS = blood collection sites connected to the BE Reference chapter: Section B N° Società Italiana di Medicina Trasfusionale e Immunoematologia 2nd Edition Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition SECTION C CONTENTS iz i PRODUCTION, BIOLOGICAL QUALIFICATION AND VALIDATION OF BLOOD COMPONENTS Se rv C.1 PRODUCTION OF ALLOGENEIC BLOOD COMPONENTS FROM WHOLE BLOOD AND BY APHERESIS ...................................................................... 86 C.1.1 PRODUCTION OF “1st-LEVEL” BLOOD COMPONENTS C.1.2 PRODUCTION OF “2nd-LEVEL” BLOOD COMPONENTS ....................... 86 ....................... 91 C.2 FREEZING AND THAWING OF RBC AND PLATELETS FOR TRANSFUSION ............................................................................................................................... 96 M TI C.3 PRODUCTION OF BLOOD COMPONENTS FOR USES OTHER THAN TRANSFUSION .............................................................................................................. 98 C.4 IDENTIFICATION AND TRACEABILITY OF BLOOD AND BLOOD COMPONENTS .............................................................................................. 99 C.5 QUALITY CONTROL ON BLOOD COMPONENTS ........................................... 100 SI C.6 BIOLOGICAL QUALIFICATION AND VALIDATION OF ALLOGENEIC BLOOD COMPONENTS ............................................................. 102 ............................................................................ 107 © C.7 PROCESS CONTROL INDICATORS 85 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.1 PRODUCTION OF ALLOGENEIC BLOOD COMPONENTS FROM WHOLE BLOOD AND BY APHERESIS C.1.1 PRODUCTION OF “1st-LEVEL” BLOOD COMPONENTS C.1.1.1 All the allogeneic whole blood (WB) collected shall be separated into “1st-level” blood components. iz i C.1.1.2 The BE shall define the types of “1st-level” blood components to produce, specifying the related requirements with reference to current legislation. Se rv C.1.1.3 The BE shall define and adopt specific procedures governing the “1st-level” blood component production process, which shall undergo preliminary validation and be revalidated periodically, and following any major changes to the process. The procedures shall define in particular: C.1.1.3.1 The reference quality standards and working methods to adopt in the production of blood components. M TI C.1.1.3.2 The working methods for the processing, production and treatment of blood components, and the automated systems used to separate whole blood, their characteristics and the working methods for their use. C.1.1.3.3 The process control criteria for WB and for the “1st-level” blood components produced, and the methods for recording, segregating and disposing of units that do not meet the established requirements. SI C.1.1.3.4 The types of collection devices to use for pre-storage leukocyte depletion, and the working methods for the relevant in-line filtering process. © C.1.1.3.5 The methods for preparing sample segments of red blood cell components. C.1.1.3.6 The equipment and working methods to adopt for freezing and subsequently storing the plasma produced. C.1.1.3.7 The methods for storing blood and blood components. 86 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition APPLICATION GUIDELINES C.1.1.1 All the allogeneic whole blood (WB) collected shall be separated into “1st-level” blood components. Se rv iz i The “1st-level” blood components obtained by separating whole blood (WB) are as follows: a) untreated red blood cell components; b) plasma; c) buffy coat; d) platelets obtained from platelet-rich plasma or single buffy coats; e) pre-storage leukocyte-depleted blood components obtained by in-line filtering; f) blood components obtained directly by means of apheretic procedures, including pre-storage leukocyte-depleted blood components obtained by inline filtering. Whole blood transfusions may be acceptable only for demonstrated specific indications in paediatric medicine, e.g. in exchange transfusion. In such cases, the BE shall adopt specific working procedures for resuspending the red blood cells in fresh frozen plasma. M TI For the processing, control, and release of haemopoietic stem cells (HSC) - beyond referring to blood and blood component regulatory provisions - reference shall be made to current regulatory requirements on human cells and tissues. C.1.1.2 The BE shall define the types of “1st-level” blood components to produce, specifying the related requirements with reference to current legislation. SI The BE shall define which types of “1st-level” blood component to produce and specify the related requirements with reference to current legislation. © C.1.1.3 The BE shall define and adopt specific procedures governing the “1st-level” blood component production process, which shall undergo preliminary validation and be revalidated periodically , and following any major changes to the process. The BE shall establish rules governing the “1st-level” blood component production process in the form of specific procedures, which shall undergo preliminary validation and shall be revalidated periodically and after any major changes are made to the process. For a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. 87 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition In addition to ensuring compliance with current legislation, the procedures for the production of blood components should comply with the principles and standards defined in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). The procedures shall define in particular: iz i C.1.1.3.1 The reference quality standards and working methods to adopt in the production of blood components. Se rv The BE shall define the centrifugation parameters it adopts and the characteristics and requirements of the instruments used to separate the WB, as well as the criteria and parameters for the control of said instruments. SI M TI In addition to ensuring compliance with current legislation, the product specifications and the criteria and parameters for the control of the instruments used to separate the WB should comply with the principles and standards defined in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). The blood and blood components shall be processed in a closed system in an area used exclusively for said purpose; this area shall only be accessible to authorised personnel. A plan shall be defined for the daily and periodic cleaning of premises, surfaces and equipment. In addition, the microbial contamination load on equipment and surfaces, and in the environment shall be monitored periodically with reference to defined acceptance criteria. The corrective actions to take in the event of unacceptable departures from the established parameters shall be defined in advance. C.1.1.3.2 The working methods for the processing, production and treatment of blood components, and the automated systems used to separate whole blood, their characteristics and the working methods for their use. © To guarantee a good level of standardisation of blood components, and the objective recording and traceability of the essential information relating to their production, the separation of whole blood without the aid of automated systems shall not be considered acceptable, with the exception of occasional, isolated needs related to particular motivated demands. The WB separation systems shall guarantee the recording of at least the weights/ volumes of the blood components produced, with a defined and acceptable variability. A periodic check on the calibration status of these systems shall consequently be guaranteed. 88 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition Said systems should be part of an in-house computer network connecting them with the WB collection devices and the computer-based BE management system, in order to ensure the unequivocal objective identification of the blood units and the monitoring, automatic transfer and total traceability of all the essential information relating to the production of blood components (blood component weights/volumes, operators involved, times, etc.). Se rv iz i For the processing of whole blood and blood components, the BE shall have adequate quantities of the following types of equipment available: a) refrigerated centrifuge for blood units with functions for managing and monitoring initial acceleration and centrifugation rate; b) automated system for separating whole blood designed to ensure the recording of at least the volumes of the single blood components produced; c) sealing devices designed to prevent the risk of microbial contamination during blood collection and blood component production; d) plasma freezing apparatus suitable for ensuring complete freezing to a temperature of –30°C or lower within 1 hour; e) refrigerators for storing whole blood and red blood cell components; f) freezer for storing plasma at temperatures of –25°C or lower; g) equipment for storing platelets under controlled-temperature conditions; h) sterile connecting devices for assembling blood components; i) plasma thawing equipment. M TI Sterile connection procedures shall be validated, and periodically revalidated, as concerns the system’s capacity to guarantee the proper alignment of the sealed segments, the tightness of the seals and the sterility of the assembled blood components. SI C.1.1.3.3 The process control criteria for WB and for the “1st-level” blood components produced, and the methods for recording, segregating and disposing of units that do not meet the established requirements. © Criteria shall be established for the in-production control of WB and “1st-level” blood components, particularly concerning the simple visual inspections that can be conducted at this stage and the methods for recording, segregating and disposing of units that fail to comply with the established requirements. C.1.1.3.4 The types of collection devices to use for pre-storage leukocyte depletion, and the working methods for the relevant in-line filtering process. For the pre-storage leukocyte depletion with in-line filtering of WB or red blood cell concentrates, the BE shall define the types of collection device to use in relation to the clinical needs of the healthcare areas it serves. Pre-filtering waiting times and temperatures shall be defined with a view to facilitating the reduction of any bacterial contamination in the collection stage, as well as optimising the performance of the filters. 89 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition With reference to advances in the technological features and performance of prestorage leukocyte depletion systems, the use of collection devices with in-line filters capable of ensuring a residual leukocyte content of < 0.5 x 106/unit in at least 90% of randomly-selected samples should be used and the use of in-line filters with an even higher leukocyte-depleting capacity should be considered in relation to specific clinical needs. iz i C.1.1.3.5 The methods for preparing sample segments of red blood cell components. Se rv The sample segments of the units of red blood cell components shall be prepared so as to guarantee that the blood they contain is duly anticoagulated and that every segment is correctly identifiable by means of a corresponding code. C.1.1.3.6 The equipment and working methods to adopt for freezing and subsequently storing the plasma produced. The BE shall define working methods for the freezing and subsequent cryopreservation of the plasma produced, particularly concerning the related times and temperatures. M TI The plasma for clinical uses shall be cryopreserved within time limits and at temperatures designed to adequately preserve labile coagulation factor activity. On random quality control, in no less than 90% of the samples tested, after thawing the product shall contain at least 70% of the original Factor VIIIc content measured on a sample of fresh plasma taking into account the time interval adopted between collection and freezing (preferably within 6 hours of collection; in the case of plasma separated from WB, no more than 18 hours after collection). SI In addition to guaranteeing compliance with current legislation, the methods and frequency of tests should comply with the principles and standards defined in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). © The plasma to submit for pharmaceutical processing shall be produced in compliance with the pertinent European pharmacopoeia monographs, as well as the specifications and quality requirements established in the agreements stipulated with the industries contracted to process the plasma and supply the corresponding plasma-derived medicinal products. To optimise the yield of the transformation processes crucially depending on the proper preservation of the labile plasma proteins, as much as possible of the plasma produced should start to be frozen within 6 hours of collection, using rapid cooling systems that guarantee complete freezing within one hour to a temperature of –30°C or less. After thawing, the plasma shall not be refrozen. 90 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.1.1.3.7 the methods for storing blood and blood components. The BE shall store the blood and blood components in clearly identified areas, separated by type (e.g. RBC, platelets, plasma), status (units awaiting validation, validated units, units in quarantine), and specific collection criteria (e.g. autologous blood units, dedicated blood units). C.1.2 PRODUCTION OF 2nd-LEVEL BLOOD COMPONENTS Se rv iz i C.1.2.1 According to the healthcare needs of the hospital organisation in which it operates, the BE shall define the types of 2nd-level blood component to produce, specifying the related requirements with reference to current legislation. C.1.2.2 The BE shall define and apply specific procedures governing the 2nd-level blood component production processes, which shall undergo preliminary validation and be revalidated periodically , and following any major changes being made to the process. C.1.2.2.1 For post-storage leukocyte-depleted blood components produced in the BE or at the bedside, the BE shall define the types of leukocyte depleting filters to use and the working methods for the filtering process. M TI C.1.2.2.2 For irradiated blood components, the BE shall define the related protocol to apply, the methods for certifying the irradiation treatment and the responsibilities for the management and control of the equipment involved. SI C.1.2.2.3 For washed blood components, the BE shall define the type and volumes of the washing fluids, the number of washing cycles, the characteristics of the equipment involved and the methods for its use. © C.1.2.2.4 For the in-house production of pathogen-inactivated blood components, the BE shall guarantee systematic compliance with the documented procedures recommended by the relevant systems’ suppliers. C.1.2.2.5 Any reliance on outside contractors for pathogen inactivation of blood components shall be governed by specific agreements. C.1.2.2.6 The BE shall define methods for the pooling of blood components. C.1.2.2.7 The BE shall define methods for the fractionation of single units of blood components into subunits. 91 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition APPLICATION GUIDELINES C.1.2.1 According to the healthcare needs of the hospital organisation in which it operates, the BE shall define the types of 2nd-level blood component to produce, specifying the related requirements with reference to current legislation. iz i Depending on the healthcare needs of the hospital organisation in which it operates, the BE shall define the types of 2nd-level blood component to produce and specify their characteristics in accordance with current legislation. Se rv The following are considered 2nd-level blood components: a) blood components leukocyte depleted after storage in the BE; b) blood components leukocyte depleted after storage at the bedside; c) irradiated blood components; d) washed blood components; e) pathogen-inactivated blood components; f) blood components deriving from the pooling of other single blood components; g) blood components deriving from the fractionation of other single blood components. M TI C.1.2.2 The BE shall define and apply specific procedures governing the 2nd-level blood component production processes, which shall undergo preliminary validation and be revalidated periodically, and following any major changes being made to the process. The BE shall regulate the 2nd-level blood component production process by means of specific procedures, that undergo preliminary validation and are revalidated periodically and following any major changes made to the process. SI For a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. © The procedures shall define the reference quality standards and the working methods to adopt in the production of 2nd-level blood components, the in-process control criteria and the methods for recording, segregating and disposing of units that do not meet the established requirements. In addition to guaranteeing compliance with current legislation, the procedures for the production of 2nd-level blood components and the related product specifications should comply with the principles and standards defined in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). 92 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.1.2.2.1 For post-storage leukocyte depleted blood components produced in the BE or at the bedside, the BE shall define the types of leukocyte depleting filters to use and the working methods for the filtering process. iz i For the post-storage leukocyte depletion of blood components performed at the BE or the patient’s bedside, the BE shall define the type of the leukocyte depleting system to use, in relation to the clinical needs of the healthcare areas it serves, and the working methods to adopt in the filtering process. To facilitate a standardised application of the procedure, filtering at the BE should be considered preferable to filtering at the bedside. Se rv Where applicable, the filtering temperatures shall be defined in order to optimise the performance of the leukocyte depleting filters. With reference to advances in the technological features and performance of prestorage leukocyte depletion systems, the use of collection devices with in-line filters capable of ensuring a residual leukocyte content of < 0.5 x 106/unit in at least 90% of randomly-selected samples should be used and the use of in-line filters with an even higher leukocyte-depleting capacity should be considered in relation to specific clinical needs. M TI The post-storage leukocyte depletion of blood components shall be completed as rapidly as possible. SI C.1.2.2.2 For irradiated blood components, the BE shall define the related protocol to apply, the methods for certifying the irradiation treatment and the responsibilities for the management and control of the equipment involved. The fundamental purpose of irradiating blood components is to prevent GVHD associated with transfusion. © The blood component irradiation activity may be handled directly by the BE, or it may be entrusted to specialist structures coming under the same hospital management as the BE (Health physics or Radiotherapy departments) or outside organisations. The BE shall provide evidence that each irradiated batch has received the established irradiation dose, which shall be in the range of 25 Gy (2,500 cGy) to 50 Gy (5,000 cGy) released at the centre of the container. The proper functioning of the irradiation system and the irradiation dose administered shall be tested periodically using a sample with a volume representative of the mean volumes of blood components routinely irradiated. The BE shall adopt methods designed to verify the systematic performance of the tests required on the radiation source by qualified personnel. 93 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.1.2.2.3 For washed blood components, the BE shall define the type and volumes of the washing fluids, the number of washing cycles, the characteristics of the equipment involved and the methods for its use. iz i For the preparation of washed RBC concentrates, the BE shall adopt a method designed to ensure that the products are treated with a quantity of isotonic solution at 4°C sufficient to remove the plasma so that the residual protein content is below 0.3 g/unit. For this purpose, specific random quality control methods shall be planned, adopted and documented. Se rv Also in the case of methods being used to wash platelet concentrates, the BE shall guarantee that the products are treated with a quantity of isotonic solution at 2024°C sufficient to remove the plasma so that the residual protein content is below 0.3 g/unit, and the platelets are resuspended in an appropriate additive solution. M TI A sterile connecting device should be used systematically for the transfer of blood components and washing fluids. The transfusion shall take place within 24 hours of the treatment. If the product is not intended to be transfused within 24 hours, the treatment shall be conducted in a closed system (sterile connections) and an appropriate preserving solution shall be added. C.1.2.2.4 For the in-house production of pathogen-inactivated blood components, the BE shall guarantee systematic compliance with the documented procedures recommended by the relevant systems’ suppliers. © SI For the in-house production of pathogen-inactivated blood components, the BE shall systematically apply the documented procedures recommended by the suppliers of the inactivation systems. In particular: a) a sterile connecting device shall be used systematically and at all stages in which the circuits are to be discontinued; b) where applicable, it shall be guaranteed that the weight of the blood component being treated comes within the range indicated by the supplier of the inactivation system; c) in the case of inactivating treatments on fresh-frozen plasma, the Factor VIIIc content of the inactivated plasma after thawing should be at least 70% of the Factor VIIIc content of the plasma prior to the treatment in at least 90% of random test samples; specific quality control methods shall be planned, adopted and documented to meet this requirement. 94 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.1.2.2.5 Any reliance on outside contractors for pathogen inactivation of blood components shall be governed by specific agreements. Any outsourcing of pathogen inactivation activities on single or pooled blood components to companies authorised to provide said services shall be governed by specific agreements. iz i C.1.2.2.6 The BE shall define methods for the pooling of blood components. Se rv A sterile connecting device, or equivalent method (e.g. working in an environment with a stringent control of particle contamination) shall be used systematically for the pooling of blood components. Only blood components of the same ABO group shall be pooled. This requirement also applies to the pooling of buffy coats for the production of platelet concentrates, and to the pooling of platelet concentrates from single donors. The pooling of blood components for exchange transfusions may be an exception. Platelet concentrates consisting of RhD-negative and RhD-positive units shall be labelled as RhD-positive. M TI In pooling activities, traceability from the pool to the single units comprising the pool and to the corresponding donors shall be guaranteed. Red blood cells without any additive solutions should be used in the case of pooling activities for replacement transfusions. SI C.1.2.2.7 The BE shall define methods for the fractionation of single units of blood components into subunits. A sterile connector, or equivalent method, shall be used systematically for the fractionation of single units of blood components into subunits. © In the fractionation of single blood components into subunits, the identification and traceability of the single subunits shall be guaranteed, systematically enabling the original blood component to be retraced. 95 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.2 FREEZING AND THAWING OF RBC AND PLATELETS FOR TRANSFUSION C.2.1 The BE shall define and adopt specific procedures governing the freezing, thawing and washing of RBC, which shall undergo preliminary validation and be revalidated periodically, and following any major changes to the process. iz i C.2.1.1 For each unit of frozen RBC, the BE shall guarantee the simultaneous preservation of samples of RBC and serum/plasma. Se rv C.2.2 The BE shall define and adopt specific procedures governing the freezing, thawing and washing of platelets, which shall undergo preliminary validation and be revalidated periodically, and following any major changes to the process. C.2.2.1 For each unit of frozen platelets, the BE shall guarantee the simultaneous preservation of samples of serum/plasma. APPLICATION GUIDELINES The BE shall define and adopt specific procedures governing the freezing, thawing and washing of RBC, which shall undergo preliminary validation and be revalidated periodically, and following any major changes to the process. M TI C.2.1 The BE shall regulate the freezing, thawing and washing of RBC by means of specific procedures, which undergo preliminary validation and are revalidated periodically and following any major changes made to the process. SI For the definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. © The procedures shall specify that freezing and thawing operations be systematically documented, particularly concerning the devices and solutions used, the storage temperatures and shelf life, the biological qualification tests, and the haemoglobin content after thawing and glycerol removal. Frozen RBC shall be prepared within 7 days of collection using a method capable of minimising haemolysis after thawing. The BE shall guarantee that frozen RBC are stored at a temperature in the range of –60°C to –80°C and for no longer than 10 years. After thawing, removal of the cryoprotective agent and washing, the RBC shall be resuspended in isotonic solution or additive solution, and shall be used as soon as possible. 96 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition After thawing, the unit of RBC shall meet the following requirements: a) volume > 185 mL; b) haemoglobin content > 36 g/unit. After thawing, the RBC shall be stored at 4°C ± 2°C for no more than 24 hours. iz i Where methods are used to guarantee the integrity of the closed circuit, the BE may consider longer storage times, depending on the features of the thawing and washing system it uses. C.2.1.1 For each unit of frozen RBC, the BE shall guarantee the simultaneous preservation of samples of RBC and serum/plasma. Se rv For each unit of frozen RBC, the BE shall guarantee the simultaneous preservation of samples of RBC and serum or plasma for compatibility tests and for any biological qualification tests introduced after the units were frozen. Subject to physicians using the units being informed and giving their approval, the BE may, on the basis of established criteria, decide to waiver said requirements if a given unit is particularly rare and/or the clinical situation demanding its use is particularly critical. The BE shall define and adopt specific procedures governing the freezing, thawing and washing of platelets, which shall undergo preliminary validation and be revalidated periodically, and following any major changes to the process. M TI C.2.2 SI The BE shall regulate the platelet freezing, thawing and washing activities by means of specific procedures, which undergo preliminary validation and are revalidated periodically and following any major changes made to the process. For a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. © The procedures shall require that freezing and thawing operations be documented systematically, particularly concerning the devices and solutions used, the storage temperatures and shelf life, the biological validation tests and the platelet counts conducted before freezing and after thawing. Cryopreserved platelets shall be prepared by freezing platelet concentrates (preferably obtained by apheresis and collected no more than 24 hours earlier) to –80°C or lower temperatures, using an appropriate cryoprotective agent. The BE shall define the storage temperature and shelf life for cryopreserved platelets. 97 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition After thawing, removing the cryoprotective agent and washing, the platelets shall be resuspended in an appropriate additive solution and used immediately; if a brief period of storage is foreseen, which shall in any case be less than 6 hours, the platelets shall be kept adequately agitated at 22°C ± 2°C. iz i After thawing, the unit of platelets shall meet the following requirements: a) volume in the range of 50 to 200 mL; b) platelet content exceeding 40% of the content determined before freezing; c) residual leukocyte content below 1 x 106. C.2.2.1 For each unit of frozen platelets, the BE shall guarantee the simultaneous preservation of samples of serum/plasma. Se rv For each unit of frozen platelets, the BE shall guarantee the simultaneous preservation of samples of serum or plasma for any biological validation tests introduced after the unit was frozen. C.3 PRODUCTION OF BLOOD COMPONENTS FOR USES OTHER THAN TRANSFUSION M TI C.3.1 The BE shall define and adopt specific procedures governing the production of blood components not intended for transfusion, which shall undergo preliminary validation and be revalidated periodically, and following any major changes to the process. APPLICATION GUIDELINES The BE shall define and adopt specific procedures governing the production of blood components not intended for transfusion, which shall undergo preliminary validation and be revalidated periodically, and following any major changes to the process. SI C.3.1 © The production of blood components for uses other than transfusion, i.e. for topical use, has yet to be adequately standardised in the light of the available technicalscientific evidence. The BE shall consequently define and adopt specific procedures, which shall undergo preliminary validation and be revalidated periodically and following any major changes made to the process, in order to testify to the consistency of the products with the established quality and safety requirements relating to the clinical use of the products. For a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. 98 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.4 IDENTIFICATION AND TRACEABILITY OF BLOOD AND BLOOD COMPONENTS C.4.1 The BE shall guarantee the unequivocal identification and traceability of all units of blood and blood components at every stage of the production process in compliance with current legislation. The BE shall guarantee the unequivocal identification and traceability of all units of blood and blood components at every stage of the production process in compliance with current legislation. Se rv C.4.1 iz i APPLICATION GUIDELINES © SI M TI The identification and traceability of blood components shall be guaranteed by complying with the following requirements: a) an unequivocal code for identifying each donation shall correlate the donation with the donor and with the blood components produced, also in the case of the blood components being fractionated into subunits; b) the units included in the collection devices used for the production of blood components as well as the documents relating to the donation shall be identified by the donation code; c) the blood components shall be identified by printed adhesive labels indicating the identification code, both in plain text and in the form of a barcode; d) the layout and content of the labels used to identify the blood components shall comply with current legislation and the relevant UNI (National Italian Association for Standardization) standards specifically defined for the transfusion setting; e) the labelling used during the in-house production stage at the BE may not necessarily comply with the UNI standards, but shall in any case guarantee the unequivocal identification and traceability of the units; f) the quality of the paper, adhesiveness and printing of the labels used to identify the blood components shall be suitable to guarantee that they are non-toxic and remain legible, intact and adhesive even in a damp environment and at low and very low temperatures for the maximum foreseeable storage times; g) for allogeneic blood components, it shall be guaranteed that none of the donor’s personal details that might enable the donor to be identified shall be indicated, except for specific needs relating to particular dedicated donations (e.g. apheresis of haemopoietic progenitor cells, lymphocyte apheresis); h) where blood components are transferred from their original containers, labelled at the time of collection, to another unlabelled container, the continuity of their identification and traceability shall be ensured by generating and attaching a new label; i) in the case of pooled blood components, methods shall be adopted to ensure that the label on the unit containing the pool indicates a single code for identifying the pool, both as a barcode and in plain text, starting from which the single pooled components can be retraced. For the general criteria relating to identification and traceability, see Section A - General organisational requirements, Ch. A.6.5 Identification and traceability. 99 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.5 QUALITY CONTROL ON BLOOD COMPONENTS C.5.1 The BE shall prepare and adopt specific procedures for defining, planning and performing quality control measures on the blood components it produces. iz i C.5.2 The BE shall conduct a systematic monitoring and data analysis activity on the quality of the blood components in order to identify any critical issues and undertake adequate corrective or preventive actions. C.5.1 Se rv APPLICATION GUIDELINES The BE shall prepare and adopt specific procedures for defining, planning and performing quality control measures on the blood components it produces. M TI The BE shall guarantee that the blood components it produces comply with the quality requirements established by current legislation, as well as any additional specifications adopted by the BE. For this purpose, the BE shall prepare and adopt specific procedures designed to govern the definition, planning and performance of quality control measures on the blood components it produces. Any additional product standards adopted, in addition to the requirements of current legislation, should comply with the principles and standards established in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe), (see Standard C.1.1.3.1). SI The BE shall prepare written procedures on the performance of visual inspections on the blood components throughout the production process with a view to examining their integrity, labelling and appearance. © The BE shall define and plan quality control measures on the blood components in relation to: a) the volumes of blood components produced; b) the levels of criticality of the products and production processes; c) the results of periodic monitoring activities (e.g. following the repeated identification of deviations from the established standards that exceed the acceptability limits). The quality control measures on the blood components shall be planned in order to guarantee statistically significant results in relation to the volumes of blood components produced. For each type of blood component produced, the BE shall define: a) the quality control parameters; b) the reference quality standards; 100 Società Italiana di Medicina Trasfusionale e Immunoematologia c) d) e) f) g) the the the the the Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition frequency of the quality control measures; sampling methods; quality control methods; criteria for analysing the results; records to produce. iz i In addition to guaranteeing compliance with current legislation, the BE should define the parameters to control, the reference quality standards and the frequency of the quality control measures in accordance with the requirements of the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). Se rv The sampling methods used for the purpose of conducting quality control measures on blood components shall: a) include the adoption of randomisation criteria that are significantly representative of the products being tested, also in relation to different operating or logistic conditions pertaining to the collection and production processes; b) take into account the production variables related to the various products; c) guarantee that every single sample is actually representative of the content of the unit being tested. M TI In the case of blood components obtained using procedures that have not undergone preliminary validation (e.g. blood components with a low production rate), the BE shall systematically test each blood component produced. If samples for quality control measures are collected from blood components that are subsequently used for transfusion, the sampling method shall guarantee that the sterility of the blood components and their biological properties are preserved. The BE shall conduct a systematic monitoring and data analysis activity on the quality of the blood components in order to identify any critical issues and undertake adequate corrective or preventive actions. SI C.5.2 © The BE shall prepare specific report forms for monitoring the data relating to quality control measures on blood components and shall plan and document the regular analysis of said data, frequently enough to ensure the early identification of any significant deviations, or tendencies to deviate from the established standards, as well as any critical issues that may negatively affect the efficacy and safety of the products. In the light of said monitoring activities, the BE shall take appropriate corrective or preventive actions (see Section A - General organisational requirements, Ch. A.7.2 Corrective and preventive actions); in the event of one-off or reiterated nonconformities, or major shortcomings that are not solved by any previously undertaken corrective/preventive action, the BE shall guarantee an in-depth assessment of the adequacy of the procedures for the production of blood components, revalidating said procedures where necessary. 101 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.6 BIOLOGICAL QUALIFICATION AND VALIDATION OF ALLOGENEIC BLOOD COMPONENTS For the purposes of the present Manual, the term “biological validation” is used to mean the final assessment of the set of elements needed for the “biological qualification” of donations and related products so that they can be declared suitable for transfusion (subject to verification of their immunological compatibility) and definitively labelled. Se rv iz i The elements for the biological qualification of donations and related products include: a) the results of microbiological and immunohaematological tests required by current legislation; b) the treatment of the available information on the donation and the donor, particularly concerning any specific medical history and clinical issues emerging during donor selection, and any findings/information recorded after the donation; c) any biological qualification tests not required by current legislation, performed to satisfy particular blood component safety requirements and/or specific clinical needs. C.6.1 The BE shall prepare specific procedures defining the diagnostic tests to perform at the time of each donation for the biological qualification of allogeneic blood components. M TI C.6.2 The BE shall prepare specific procedures defining the related responsibilities and working methods to adopt for the biological validation of allogeneic blood components. These procedures shall guarantee in particular: C.6.2.1 The definition of the methods used in the final assessment of the set of elements necessary for the biological qualification of donations and related products so that they can be declared suitable for transfusion. SI C.6.2.2 The unequivocal association of the biological qualification details with the units of blood components being validated and their traceability, as well as the traceability of every single operator involved in the process in any way. © C.6.2.3 That responsibility for biological validation is entrusted exclusively to personnel in specific managerial positions C.6.2.4 Where biological validation is handled by automated computer procedures, that the related configurations and the automatic validation criteria are managed exclusively by individuals authorised by the BE manager to access said specific functions in the BE’s computer-based system. C.6.2.5 The definition of methods for treating blood components that fail the biological validation stage, or that are awaiting validation. C.6.2.6 The definition of methods for labelling validated blood components. 102 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition APPLICATION GUIDELINES C.6.1 The BE shall prepare specific procedures defining the diagnostic tests to perform at the time of each donation for the biological qualification of allogeneic blood components. iz i The BE shall prepare specific procedures defining the diagnostic tests to perform for the biological qualification of allogeneic blood components at the time of each donation in accordance with current legislation. The BE shall guarantee that every donation undergoes the immunohaematological and microbiological qualification tests defined by current national regulations. Se rv For the specific methods relating to the immunohaematological tests on RBC, see Section E - Laboratory testing activities, Ch. E.3 Specific standards for RBC immunohaematological tests. For the specific methods relating to the microbiological qualification tests, see Section E - Laboratory testing activities, Ch. E.4 Specific standards for microbiological tests for qualifying allogeneic blood components. © SI M TI For the immunohaematological tests for biological qualification, the BE shall prepare written procedures in order to guarantee: a) RBC ABO and RhD typing at every donation for donors who are already ABO, Rh and Kell typed at the BE; the BE shall also guarantee the definition and application of appropriate methods for comparing the findings for ABO and RhD typing with those of previous tests, and the prompt clarification of any inconsistencies between them, prior to biological validation; this test should be managed entirely by means of computer-based procedures; b) for donors who have not already been ABO, Rh and Kell typed: - determination of their ABO blood group; - RhD typing, including weak D testing in cases found RhD-negative; - determination of the C, c, E, e antigens; - determination of the Kell antigen, and of the Cellano antigen in individuals found Kell-positive; c) donors at their first typing/donation and all those exposed to potentially immunising events are also tested for clinically significant irregular red cell antibodies; the BE shall also define methods for managing blood components deriving from donors with irregular red cell antibodies, particularly concerning blood components containing plasma. In the case of donors who have not already been typed, the BE shall: a) conduct two RBC tests to establish their ABO blood group, one on a sample collected at the time of the donation and one on a segment of the unit sampling tube (for donations containing no RBC, the second test shall be conducted by repeating the test on the natural isoagglutinins); ABO blood group typing in duplicate may be omitted if a first test was conducted when the donor first attended the BE, prior to making a donation, and said first test can be unequivocally associated with the same donor; 103 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition b) conduct two RBC tests to establish the RhD type with two different anti-D reagents, one on a sample collected at the time of the donation and one on a segment of the unit sampling tube (for donations containing no RBC, the second test shall be conducted by repeating the test on the sample collected at the time of the donation); RhD typing in duplicate may be omitted if a first test was conducted when the donor first attended the BE, prior to making a donation, and said first test can be unequivocally associated with the same donor. iz i The complete Rh and Kell phenotype should be confirmed at the time of a second donation/attendance. Se rv If typing is occasionally done for other RBC blood group systems, and/or leukocyte and platelet systems, the corresponding results shall be systematically recorded and managed in the computer system. M TI The BE shall guarantee that ALT assay and a complete blood count are obtained at the time of each donation, defining the methods for managing the results in relation to the biological qualification of the blood components deriving from the donation, as well as to safeguarding the donor’s health. It should be noted that, although ALT assays and complete blood counts are not mandatory for the purposes of the biological validation of blood components, some alterations in the results of these tests may be indicative of clinically silent pathological conditions that are irrelevant to the donor’s health but may pose a potential risk to the recipient (e.g. a neutrophil leukocytosis can underlie a bacteraemia). A complete blood count can also identify any shortcomings (e.g. a significantly lower than normal platelet count) needed to meet the quality requirements of the blood components obtained from the donation. © SI Where the BE has to extend the microbiological qualification test profile for blood components due to a) particular (even transient) obligations imposed by the competent authorities; b) particular local epidemiological situations; c) programs/procedures for donors from geographical areas at higher risk of transfusion-transmissible diseases than in the country where the BE operates; d) additional screening programs for particular categories of blood components; e) other reasons; the BE shall prepare written procedures to define the criteria for managing these profiles and the acceptability of the results, as well as the related working methods, taking action as soon as possible to adapt and revalidate the computer system to manage said test(s) suitably for the biological qualification and validation of the blood components. 104 Società Italiana di Medicina Trasfusionale e Immunoematologia C.6.2 Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition The BE shall prepare specific procedures defining the related responsibilities and working methods to adopt for the biological validation of allogeneic blood components. The BE shall prepare specific procedures for defining the related responsibilities and the working methods for the biological validation of allogeneic blood components. These procedures shall guarantee in particular: iz i Up until their validation, units of blood and blood components shall be operatively withheld and they shall be stored in separate spaces from validated units. Se rv C.6.2.1 the definition of the methods used in the final assessment of the set of elements necessary for the biological qualification of donations and related products so that they can be declared suitable for transfusion. The BE shall define the methods used in the final assessment of the set of elements necessary for the biological qualification of donations and related products. This assessment enables the blood components to be biologically validated, i.e. declared suitable for transfusion (subject to verification of their immunological compatibility) and definitively labelled. SI M TI For the purposes of biological validation, the BE shall guarantee the preliminary assessment of: a) the results of microbiological and immunohaematological tests required by current legislation; b) the available information on the donation and the donor, particularly concerning any specific medical history and clinical issues emerging during donor selection, and any findings/information recorded after the donation; c) any biological qualification tests not required by current legislation, performed to satisfy particular blood component safety requirements and/or specific clinical needs. © The analytical data relating to the above-mentioned tests shall be transferred from the diagnostic systems to the computer-based management systems using procedures that rule out any manual transcription steps. When it is temporarily impossible to transfer these data via computer, the subsequent transfer and validation of the data in the computer system shall be handled by two different operators, and their traceability shall be guaranteed. For blood component validation purposes, the results of the microbiological tests shall be unequivocal and shall consequently be restricted to the expressions: reactive/non-reactive or positive/negative. 105 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition C.6.2.2 the unequivocal association of the biological qualification details with the units of blood components being validated and their traceability, as well as the traceability of every single operator involved in the process in any way. iz i The BE shall guarantee the unequivocal association of the biological qualification details with the units of blood component being validated and their traceability, as well as the traceability of every single operator involved in the process in any way, particularly concerning the person ultimately responsible for biological validation. Se rv C.6.2.3 that responsibility for biological validation is entrusted exclusively to personnel in specific managerial positions It shall be guaranteed that only personnel in managerial positions are responsible for biological validation. C.6.2.4 Where biological validation is handled by automated computer procedures, that the related configurations and the automatic validation criteria are managed exclusively by individuals authorised by the BE manager to access said specific functions in the BE’s computer-based system. M TI If the biological validation process is handled using automated computer-based procedures, the related configurations and the automatic validation criteria shall be managed exclusively by individuals authorised by the BE manager to access said specific functions in the BE’s computer-based system. SI C.6.2.5 The definition of methods for treating blood components that fail the biological validation stage, or that are awaiting validation. © The BE shall define the methods for treating blood components that fail the validation process, as concerns their identification, segregation, registration, dispatch from stores and disposal in order to prevent any clinical use or transfer to pharmaceutical contracting companies of segregated products awaiting validation or destined for disposal. The BE should systematically monitor and analyse the information relating to blood components that fail the validation process in order to identify any critical issues and consequently undertake any necessary corrective/preventive actions. C.6.2.6 The definition of methods for labelling validated blood components. Labels shall be generated by the computer-based management systems to guarantee the unequivocal connection between the donor, the blood unit and the analytical results. 106 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition iz i The BE shall define methods for the definitive labelling of validated allogeneic blood components, including control measures to guarantee: a) compliance of the information provided on the validation label with the UNI standards for the transfusion sector, as well as with current legislation (data relating to the collection device, i.e. the batch number, the type and composition of the anticoagulant, the additive solutions, may also be provided on the manufacturing labels alone, and not repeated on the validation labels); b) the unequivocal consistency between the information provided on the blood collection label and the corresponding information on the validation label. Se rv Objective, computer-based methods shall be adopted systematically to guarantee the unequivocal consistency between the information provided on the blood collection label and the corresponding information on the validation label to prevent any erroneous definitive labelling of the units. These computer-based procedures shall be designed so that any omission of said objective control shall prevent any allocation and distribution of the corresponding units. M TI Where blood components undergo further treatment after their biological validation, and need to be labelled accordingly, it shall be guaranteed that any label replacing or integrating the original label shall retain all the information required for the validation label as well as providing details of the further treatment and the type and characteristics of the end-product (s) obtained, as applicable. Any labelling added after the definitive biological validation label shall comply with UNI standards for the transfusion sector, whenever applicable. C.7 PROCESS CONTROL INDICATORS SI To constantly monitor the quality of the products-services provided and the compliance of the processes implemented with the established standards, the BE shall guarantee the monitoring of at least the indicators listed in the following table. © For the general criteria for planning quality monitoring activities, see Section A - General organisational requirements, Ch. A.7.1 Quality monitoring. 107 Reference chapter: Section C C.1 C.1 C.5 C.5 C.6 N° 1 2 3 4 5 © 108 C.6.2.6 C.5.2 / C.1.2.2.4 C.1.1.3 Reference standard: Section C Biological validation of blood components Blood component production monitoring and control iz i No. of validation labels inconsistent with collection labels out of No. of units validated No. of corrective/preventive actions undertaken No. of nonconforming products out of No. of products tested [data stratified by type of blood component and by established product specifications] No. of units of fresh-frozen plasma with residual FVIIIc activity < 70% of the activity prior to treatment out of No. of units randomly tested No. of units disposed of for processing-related reasons out of No. of units processed [data stratified by type of cause, whole blood, blood components] Process control indicator Se rv Accuracy of labelling on units of blood and blood components Correction of one-off or reiterated nonconformities, or major shortcomings Blood component quality Conformity of blood control components to established standards M TI Conformity to established standards of in-house pathogen-inactivated fresh-frozen plasma Production of “2nd-level” blood components SI Adequacy and application of defined procedures for processing whole blood and blood components Characteristic to monitor Basic blood component production Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section C - Production, biological qualification and validation of blood components 2nd Edition Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition SECTION D ALLOCATION AND DISTRIBUTION OF ALLOGENEIC BLOOD COMPONENTS .............................................................................................. Se rv D.1 INFORMATION FOR USERS iz i CONTENTS D.2 ACCEPTING TRANSFUSION REQUESTS .............................................................. 110 116 D.3 ASSESSING THE APPROPRIATENESS OF TRANSFUSION REQUESTS AND PROVIDING SPECIALIST ADVICE .............................. 117 .............. 120 ................................................................................. 129 D.4 SELECTION AND ALLOCATION OF BLOOD COMPONENTS D.5 ISSUING BLOOD COMPONENTS M TI D.6 HAEMOVIGILANCE ON RECIPIENTS ...................................................................... ..................................... 132 ...................................................... 134 ...................................................................... 134 D.7 MANAGEMENT OF BLOOD COMPONENT STOCKS D.8 DISTRIBUTION OF BLOOD COMPONENTS D.8.1 BLOOD COMPONENT EXCHANGE ........ 137 ........................................................................... 138 SI D.8.2 DELIVERY OF PLASMA TO PHARMACEUTICAL COMPANIES © D.9 PROCESS CONTROL INDICATORS 131 109 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.1 INFORMATION FOR USERS D.1.1 The BE shall adopt specific procedures designed to provide the information needed to ensure the proper and safe management of the transfusion process to the structures/parties referring to the BE for the care of patients needing transfusion treatments. The procedures shall define the methods and the operational flows for the following activities: iz i D.1.1.1 Unequivocal identification of patients and biological samples for pre-transfusion compatibility testing, and matching of requests with patients and samples. D.1.1.3 Collection and components. Se rv D.1.1.2 Submission of transfusion requests and of the related biological samples for pre-transfusion compatibility tests. transportation of units of blood D.1.1.4 Access to remote blood bank services, where applicable. D.1.1.5 Management of blood components procedures at the patient’s bedside. and transfusion M TI D.1.1.6 Management of untransfused blood components returned to the BE. D.1.1.7 Management of certificates of the final destination of units of blood components not returned to the BE. D.1.1.8 Reporting of adverse events, errors and near misses relating to the transfusion process. SI D.1.2 The BE shall prepare the forms to use when requesting transfusions. The forms to use for requesting transfusions shall contain at least the following details: © D.1.2.1 Identification of the health care structure formulating the request. D.1.2.2 Identification of the patient. D.1.2.3 Degree of urgency. D.1.2.4 Clinical and biological information needed to assess the appropriateness of the request. D.1.2.5 Type and quantity of blood components requested. D.1.2.6 Date of the request. D.1.2.7 Name and signature of the physician formulating the request. 110 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition APPLICATION GUIDELINES D.1.1 The BE shall adopt specific procedures designed to provide the information needed to ensure the proper and safe management of the transfusion process to the structures/parties referring to the BE for the care of patients needing transfusion treatments. Se rv iz i In accordance with current legislation, hospital transfusion committees shall be created and fully operational at healthcare organisations with one or more BE(s). These committees should be constantly committed to promoting the ongoing professional development and training of all individuals involved in the transfusion process and to systematically auditing the effective application of the procedures adopted to ensure the safety of the process and the appropriateness of transfusion. These procedures should be shared and adopted by the one or more committees on which the BE is institutionally required to serve. The procedures should be circulated by means of specific provisions issued by the hospital managements. M TI Depending on the qualitative and quantitative dimensions of the organisation to which the BE belongs and the areas it serves, the BE should provide its technicalscientific expertise in the context of the committee(s), playing a strategic part in its principal design and planning activities. “Practical guidelines” should be produced and made available to users; they should be easy to consult and concise, illustrating the procedures particularly relevant to transfusion safety, also with the aid of flowcharts or other graphic methods. SI The procedures shall define the methods and operational flows for the following activities: © D.1.1.1 Unequivocal identification of patients and biological samples for pre-transfusion compatibility testing, and matching of requests with patients and samples. Specific methods shall be defined for unequivocally identifying patients and biological samples for pretransfusion compatibility tests, and for matching requests with patients and samples, paying particular attention to urgent and emergency situations. Specific methods shall also be defined for identifying patients for whom it is impossible to acquire the routinely required identification details. If the basic immunohaematological tests (blood group and irregular antibody screening) are conducted prior to admission (in the outpatient setting or before hospitalisation) and the need for transfusions is predicted, adequate and reliable 111 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition methods should be in place to identify the patient and the related biological samples, and to verify the correlation between the request for tests and the patient. Computer-based methods should be progressively introduced for the unequivocal identification of patients and the related biological samples, relying on the use of objective identification methods. iz i D.1.1.2 Submission of transfusion requests and of the related biological samples for pre-transfusion compatibility tests. Se rv The BE shall define: a) the methods for compiling requests for scheduled, urgent and emergency transfusions, and for submitting these requests to the BE along with the corresponding biological samples for the pre-transfusion compatibility tests; b) the qualitative and quantitative type of the biological samples to accompany the requests; c) the rules and requirements of interest to users relating to the fulfilment of their requests, particularly concerning the timing and methods for meeting requests, the management of urgent and emergency transfusions, and the organisational and logistic aspects relating to the issuing and collection of blood units. M TI A transfusion is defined as “urgent” in cases where the patient’s clinical conditions demand a prompt transfusion treatment, within a time span that allows for the blood component to be selected and for pre-transfusion compatibility tests to be performed. An “emergency” transfusion is needed for patients in life-threatening conditions so there is no time to complete the selection and compatibility testing procedures as adopted for urgent or scheduled transfusions. SI The defined working methods shall be consistent with the needs of the hospital(s) to which the BE refers and the areas it serves, as well as with any other needs correlating with specific organisational and logistic conditions (e.g. accredited private hospitals, separate branches of the hospital, patients treated at home). © D.1.1.3 Collection and transportation of units of blood components. The BE shall define the methods for managing and handling the collection and transportation of units of blood components, particularly concerning any requirements relating to the logistic issues of the areas it serves. For the general criteria relating to the transportation of units of blood components, see Section A -General organisational requirements, Ch. A.6.4 Packaging and transportation of blood, blood components and haemopoietic stem cells (HSC). 112 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.1.1.4 Access to remote blood bank services, where applicable. Access to remote blood bank services provided by the BE within structures not belonging to the hospital management to which the BE refers (e.g. accredited private hospitals) shall be governed by specific contracts/agreements. iz i In particular, these contracts/agreements shall define the methods for accessing the remote blood bank services as concerns urgent and emergency transfusions, including the methods for restoring the established stock levels (see Standard D.7.1.1). Se rv D.1.1.5 Management of blood components, and transfusion procedures at the patient’s bedside. The working methods for managing blood components at the hospital ward (or anywhere else the patient is treated), and for administering transfusions at the patient’s bedside shall be defined with a view to ensuring the preservation of the biological properties of the blood components, the patient’s safety and the efficacy of the treatment. M TI For the general criteria relating to the storage of blood components, see Section A - General organisational requirements, Ch. A.6.3 Storage of blood, blood components and haemopoietic stem cells (HSC). D.1.1.6 Management of untransfused blood components returned to the BE. The BE shall define working methods to guarantee the timely return to the BE of untransfused blood component units, as well as the transmission of the certificates testifying to their proper preservation. SI For the general criteria relating to the storage of blood components, see Section A - General organisational requirements, Ch. A.6.3 Storage of blood, blood components and haemopoietic stem cells (HSC). © D.1.1.7 Management of certificates of the final destination of units of blood components not returned to the BE. Working methods shall be defined to guarantee the transmission to the BE of certificates testifying to the final destination of units of blood components not returned to the BE. D.1.1.8 Reporting of adverse events, errors and near misses relating to the transfusion process. Working methods shall be defined to ensure the reporting of any adverse events, errors and near misses relating to the transfusion process (see also Standard D.6.1). 113 Società Italiana di Medicina Trasfusionale e Immunoematologia D.1.2 Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition The BE shall prepare the forms to use for transfusion requests. iz i The BE should: a) share the content of the forms to use for transfusion requests within the hospital transfusion committees on which the BE is institutionally required to serve, and/or with the hospital management, prior to their adoption; b) apply the forms only after their documented approval by the hospital management and after their formal distribution by said management to the interested parties. Se rv The forms to use for transfusion requests shall contain at least the following items: D.1.2.1 Identification of the health care structure formulating the request. The forms shall provide a space for the identification of the health care structure issuing the request (e.g. hospital ward, outpatient service, private clinic). D.1.2.2 Identification of the patient. M TI Patients shall be identified by means of their surname, name and date of birth, or using other, specifically-stated methods in the case of patients for whom it is impossible to collect the usual personal identification details. Space may be provided for the physician requesting the transfusion to indicate the ABO blood group and RhD type, if they are already known. SI Where applicable, the patient’s identification code should be used, preferably acquired from barcode labels or the hospital’s intranet, or by equivalent objective means. D.1.2.3 Degree of urgency. © The forms shall contain a specific space for indicating the degree of urgency of the transfusion request. D.1.2.4 Clinical and biological information appropriateness of the request. needed to assess the The clinical and biological information shall include at least: the main diagnosis, the indication(s) for transfusion, the essential blood count and coagulation data related to the blood components requested and the indication(s) (haemoglobin concentration, platelet count, PT/INR, aPTT), and the patient’s body weight. 114 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition The type of surgery should be indicated for requests relating to elective surgical procedures. Space may be provided for indicating other biological parameters or clinical details, depending on the BE’s organisation and functions (e.g. if the BE manages the allocation of plasma-derived medicinal products). Se rv iz i It is advisable to reserve a space for physicians at the BE to briefly provide evidence of their assessment of the appropriateness of the request for transfusion, and of any arrangements to waiver the usual requirements in the light of an exchange with the physician making the request; alternatively, requests may be recorded in the computer system so as to unequivocally associate the patient concerned with the physician formulating the request. Abbreviations may be used for the clinical and biological information, providing the request refers to an indication listed in specifically prepared protocols (e.g. preoperative request forms for elective surgery). D.1.2.5 Type and quantity of blood components requested. The forms shall provide a space for explaining the type and quantity of blood components requested. M TI The BE may use separate forms for different types of blood component, as well as forms for requesting plasma derivatives, if the BE is also responsible for allocating the latter. D.1.2.6 Date of the request. SI The forms shall provide a space for indicating the date on which the request is submitted. It is advisable to reserve a space for recording the date and time when the BE receives the request. © D.1.2.7 Name and signature of the physician formulating the request. The forms shall provide a space for identifying the physician making the request, and for the physician’s signature. It is advisable to reserve a space for identifying the health care professional responsible for collecting the biological samples for pre-transfusion compatibility tests, and for said professionals to sign to the effect that they have unequivocally identified the patient and correlated the patient with the request and the samples. 115 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.2 ACCEPTING TRANSFUSION REQUESTS D.2.1 The BE shall systematically check transfusion requests and the corresponding biological samples Before satisfying transfusion requests, the BE shall check patients’ historical details in its traceability management system. iz i D2.2 APPLICATION GUIDELINES Se rv D.2.1 The BE shall systematically check transfusion requests and the corresponding biological samples. The BE shall systematically record the time of arrival of transfusion requests. The BE shall systematically check transfusion requests and the corresponding biological samples to ensure: a) that requests have been completed properly; b) that the biological samples conform to the established requirements; c) that requests and samples correspond, particularly as regards patients’ demographic details. M TI It shall be guaranteed that any missing information is obtained if it is relevant to the safe, proper and complete satisfaction of the request. SI Without prejudice to the priority of assuring patients the transfusion treatments they need, particularly in cases of urgency or emergency, the BE shall: a) systematically check the identity of the physician making the request and have them sign the request if they have not already done so; b) check that operators responsible for blood sampling for pre-transfusion compatibility tests have added their signatures, or ensure that they do so. A prompt solution shall be guaranteed for any inconsistencies identified, and shall in any case be found before satisfying the request. Before satisfying transfusion requests, the BE shall check patients’ historical details in its traceability management system © D.2.2 Before satisfying any transfusion requests, the BE shall check the patient’s historical details available in its traceability management system to ascertain the essential elements needed to guarantee a safe and appropriate handling of the transfusion request. 116 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition iz i The essential elements that shall be checked, if available in the traceability management system, are as follows: a) previous blood group typing; b) difficulties previously encountered in blood group typing; c) previous searches for irregular antibodies, with particular reference to the detection/identification of clinically significant irregular antibodies; d) previous adverse reactions to transfusions or adverse events; e) specific transfusion requirements (e.g. leuko-depleted or irradiated blood components). D.3 ASSESSING THE APPROPRIATENESS OF TRANSFUSION REQUESTS AND PROVIDING SPECIALIST ADVICE Se rv D.3.1 The BE shall adopt guidelines on the appropriate use of blood components, which are shared with the major users of transfusion treatments. D.3.1.1 The guidelines shall be formally circulated to all interested parties. D.3.1.2 The guidelines shall be periodically reviewed. M TI D.3.2 The BE shall prepare and adopt specific procedures for assessing the appropriateness of transfusion requests. D.3.2.1 The BE shall guarantee the systematic assessment of the appropriateness of transfusion requests by a transfusion medicine physician. SI D.3.2.2 The BE shall guarantee the periodic statistical processing of data on the outcome of the assessment of appropriateness, to be conducted at least once a year. APPLICATION GUIDELINES The BE shall adopt guidelines on the appropriate use of blood components, which are shared with the major users of transfusion treatments. © D.3.1 Guidelines on the appropriate use of blood components should be shared and adopted within the context of the one or more hospital transfusion committees on which the BE is institutionally required to serve. The adoption of guidelines is a prerequisite, given the need to have shared, formally approved and properly circulated references on which to base the BE’s assessment of the appropriateness of transfusion requests, as required by current legislation. 117 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition On this issue, it should be emphasised that the authority with which the BE operates in this role depends largely on the level of technical-scientific competence that it succeeds in expressing, as well as its capacity to establish and maintain effective and efficient interfunctional relationships. Se rv iz i The guidelines on the appropriate use of blood components shall: a) provide recommendations on the appropriate clinical use of blood components, at least inasmuch as concerns the transfusion of RBC, fresh frozen plasma and platelets; b) provide recommendations on the main treatments for 2nd-level blood components, such as leukocyte depletion, washing and irradiation, in relation to the needs of the health care services served by the BE; c) be formulated on the strength of evidence-based criteria and with reference to authoritative bibliographical sources; d) be formulated with an adequate multidisciplinary contribution; e) indicate the year of their adoption; f) be easy to consult and genuinely applicable. The guidelines should also contain recommendations on the appropriate clinical use of the main plasma-derived medicinal products (albumin, intravenous immunoglobulin, antithrombin). M TI D.3.1.1 The guidelines shall be formally circulated to all interested parties. The guidelines should be circulated to all interested stakeholders under the responsibility of the hospital management. D.3.1.2 The guidelines shall be periodically reviewed. SI The BE shall take an active part in the periodic review of the guidelines, also in the light of any introduction of new types of blood components and important needs for technical-scientific update. The BE shall prepare and adopt specific procedures for assessing the appropriateness of transfusion requests. © D.3.2 The BE shall prepare and adopt specific procedures for assessing the appropriateness of transfusion requests. The procedures shall refer to the guidelines contained in the Standard D.3.1. D.3.2.1 The BE shall guarantee the systematic assessment of the appropriateness of transfusion requests by a transfusion medicine physician. The BE shall guarantee the systematic assessment of the appropriateness of transfusion requests by a transfusion medicine physician. 118 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition The assessment of transfusion requests shall apply to all scheduled and urgent requests, where the patient’s clinical conditions permit. Urgent and emergency requests that it may be impossible to assess immediately shall nonetheless undergo systematic retrospective assessment. Activities for assessing the appropriateness of transfusion requests shall be documented. Se rv iz i Transfusion requests are considered inappropriate in cases where the proposed treatment needs to be qualitatively and/or quantitatively integrated or modified in the light of clinical and biological information given in the request, and/or any additional information acquired. In such cases, the transfusion medicine physician shall tend to make the request appropriate by contacting the physician issuing the request providing the latter with specialist advice. The appropriateness of a request shall be assessed giving priority to the content of the guidelines contained in the Standard D.3.1. The BE shall also provide specialist advice when specifically asked to do so, preliminary to or irrespective of any submission of transfusion requests, in relation to clinical cases demanding particular, complex or critical transfusion treatments. M TI The BE should document any requests for advice it receives and any arrangements made, as well as any advice it provides. SI Where it proves impossible to come to an agreement with the physician making the request, irrespective of whether the requested blood components are actually attributed to the patient or not, the outcome of the assessment by the physician at the BE should be formally notified to the structure requesting the transfusion and to the hospital transfusion committee, and a copy of said notification should be preserved at the BE. D.3.2.2 The BE shall guarantee the periodic statistical processing of data on the outcome of the assessment of appropriateness, to be conducted at least once a year. © The BE shall adopt data processing criteria with a view to obtaining a representative picture of the global level of appropriateness of transfusion requests it receives in relation to the type and volume of the transfusion activities performed in the areas it serves, and to any criteria and objectives established by the hospital transfusion committee. These data-processing criteria should include stratifying the data at least by: a) type of blood component; b) areas served that have the highest consumption; c) medical and surgical treatments entailing the highest consumption. The results of such statistical data analyses should be periodically presented and discussed at meetings of the hospital transfusion committee, to enable the latter to use them as a tool for monitoring, auditing and improvement activities. 119 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.4 SELECTION AND ALLOCATION OF BLOOD COMPONENTS D.4.1 The BE shall prepare and adopt specific procedures for selecting the units of blood components to allocate, which undergo preliminary validation and are revalidated periodically, and following any major changes to the process. The procedures for selecting the units of blood components to allocate shall guarantee: iz i D.4.1.1 For RBC transfusions: ABO and RhD immunological compatibility. D.4.1.2 For platelet transfusions: ABO immunological compatibility. Se rv D.4.1.3 For plasma and cryoprecipitate transfusions: ABO immunological compatibility and the absence of clinically significant irregular erythrocyte antibodies in the donor. D.4.1.4 For leukocyte transfusions: ABO and RhD immunological compatibility, and the preparation and adoption of specific selection criteria. D.4.1.5 For neonatal and paediatric transfusions: the preparation and adoption of specific blood component selection criteria. M TI D.4.1.6 For transfusions of leuko-depleted blood components: the systematic assessment of cases in which their selection is indicated, based on the applicable guidelines. SI D.4.1.7 For the transfusion of all blood components: the systematic application of defined criteria and methods for the selection and clinical use of irradiated blood components and of blood components that are serologically tested and/or leuko-depleted to reduce the risk of transmission of CMV. © D.4.2 The BE shall prepare and adopt specific procedures for conducting pretransfusion diagnostic investigations to guarantee that the immunological compatibility between the donor and recipient is ascertained. D.4.2.1 For the allocation of blood components containing RBC, the BE shall guarantee the recipient’s ABO blood group testing and RhD typing in duplicate, on two different samples collected at different times. D.4.2.2 For the allocation of blood components containing RBC, the BE shall guarantee screening for clinically significant irregular erythrocyte antibodies in the recipient. 120 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.4.2.3 For the allocation of blood components containing RBC, the BE shall define the cases in which compatibility testing is required. D.4.2.4 For the allocation of blood components containing RBC for which crossmatch compatibility tests are omitted, the BE shall adopt measures designed to guarantee the safety of the allocation. Se rv iz i D.4.2.5 Where the BE provides blood components for newborn and paediatric patients, the procedures shall define the criteria and working methods to perform the pretransfusion investigations and allocate blood components to these categories of patients. D.4.3 The BE shall prepare and adopt specific procedures for selecting and allocating blood components in urgent and emergency situations. APPLICATION GUIDELINES The BE shall prepare and adopt specific procedures for selecting the units of blood components to allocate, which undergo preliminary validation and are revalidated periodically , and following any major changes to the process. M TI D.4.1 The BE shall prepare and adopt specific procedures for selecting the units of blood components to allocate. SI These procedures shall undergo preliminary validation and be revalidated periodically, and following any major changes made to the process. The procedures for selecting blood components to allocate shall guarantee: © D.4.1.1 For RBC transfusions: ABO and RhD immunological compatibility. The procedures shall define the criteria for guiding the selection of units of RBC, particularly concerning any highly specific clinical situations being treated where applicable (e.g. post-transplant chimerism). They shall also include a definition of the criteria for allocating RhD-positive RBC to RhD-negative patients, should the need arise (see also Standard D.4.3). For women of child-bearing age, paediatric and newborn patients, multi-transfused patients and other particular patient categories, transfusions should be as compatible as possible for the Rh phenotype and the Kell antigen, depending on the urgency and/or deferability of the request. 121 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.4.1.2 For platelet transfusions: ABO immunological compatibility. Se rv iz i The BE shall guarantee the selection of platelets from donors with the same ABO phenotype as the patient whenever possible. The need for compatibility with the RhD type may be waived providing there is no “visible” erythrocyte contamination inside the units of platelets. If they are properly implemented, current methods for preparing platelet concentrates enable erythrocyte contamination to be restricted to approximately 0.03 mL/pool of platelets from whole blood, and approximately 0.005-0.007 mL/unit obtained by apheresis; these levels make the risk of anti-D allo-immunisation virtually negligible. In particular categories of patients (e.g. women of child-bearing age and patients receiving haematopoietic progenitor cell transplants), it may nonetheless be necessary to consider the need for compatibility with the RhD type as well as with the ABO blood group. If units of group O platelets are selected for non-O patients, only products with a minimal plasma residue should be used, such as “dry” platelets from apheresis or from pooled buffy coat resuspended in additive solution, or platelets obtained by pooling or apheresis which have undergone plasma removal and resuspension in additive solution. M TI Where units of group O platelets obtained from pools or apheresis resuspended in plasma are selected for non-O patients, a low titre of anti-A and/or anti-B iso-haemoagglutinins shall be guaranteed (≤ 1:64). Even if the titre of isohaemoagglutinins is low, the selection of platelet units from group O donors resuspended in plasma for non-O patients is generally not to be recommended for newborn and paediatric patients. SI The use of platelets with a major donor-recipient ABO incompatibility is discouraged, except in specific clinical cases, such as the need to transfuse HLA/ HPA-compatible platelets. In making such a choice, operators should bear in mind the potential association of the ABO-incompatible platelet transfusion with a higher frequency of refractory responses. Units of platelets of different ABO blood groups shall not be mixed. © For platelet products containing significant quantities of plasma, a negative result of screening for clinically significant irregular erythrocyte antibodies in the donor(s) shall be guaranteed. This requirement may be waived in relation to specific clinical conditions, such as the need to transfuse HLA/HPA-compatible platelets, providing the patient does not have the antigen(s) corresponding to the antibody(ies) potentially contained in the donor’s plasma, and/or providing the plasma has been removed from the platelet product and the latter has been resuspended in additive solution. 122 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.4.1.3 For plasma and cryoprecipitate transfusions: ABO immunological compatibility and the absence of clinically significant irregular erythrocyte antibodies in the donor. The ABO phenotype of the donor’s plasma should be compatible with that of the recipient. iz i Compatibility with the RhD type may be waived providing there is no visible haemoglobin contamination inside the unit of plasma/cryoprecipitate. Se rv A negative response to screening for clinically significant irregular erythrocyte antibodies in the donor shall be guaranteed. D.4.1.4 For leukocyte transfusions: ABO and RhD immunological compatibility, and the preparation and adoption of specific selection criteria. If the BE produces leukocyte-based blood components for the purposes of particular activities underway in the areas it serves, specific criteria shall be defined and adopted for their selection. M TI D.4.1.5 For neonatal and paediatric transfusions: the preparation and adoption of specific blood component selection criteria. If the BE provides blood components for newborn and paediatric patients, specific criteria shall be defined and adopted for the selection of blood components to allocate to such patients. SI The BE should refer to the “Raccomandazioni per la trasfusione in neonatologia” [Recommendations on transfusion in neonatology] issued by the SIMTI in co-operation with the Italian Neonatology Society (SIN) and the Study Group on neonatal haematology. © D.4.1.6 For transfusions of leuko-depleted blood components: the systematic assessment of cases in which their use is indicated, based on the applicable guidelines. This Standard does not apply to a BE that systematically conducts the leukocyte depletion of blood components in relation to specific policies. 123 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.4.1.7 For the transfusion of all blood components: the systematic application of defined criteria and methods for the selection and clinical use of irradiated blood components and of blood components that are serologically tested and/or leuko-depleted to reduce the risk of transmission of CMV. iz i As concerns blood components that have been irradiated and blood components that are serologically tested and/or leuko-depleted to reduce the risk of transmitting CMV, the present Standard is applicable to BEs that handle said specific treatments. Se rv For the purposes of preventing transfusion-associated GVHD, irradiated blood components should be selected mainly in the following cases: a) selected cases of immunocompromised adult recipients; b) transfusions from closely related donors; c) patients undergoing haemopoietic progenitor cell transplants; d) recipients of units of HLA-compatible platelets; e) selected newborn and paediatric recipients; f) intrauterine transfusion. M TI If clinical and/or organisational reasons prevent irradiated blood components from being transfused into the patients for whom they were specifically selected, said blood components may not be used for other patients for whom said treatment is not indicated. SI To reduce the risk of transfusion-associated CMV infection, serologically tested and/or leuko-depleted blood components should be used mainly in the following cases: a) selected cases of immunocompromised adult recipients; b) selected newborn and paediatric recipients; c) selected cases of patients receiving solid organ or haemopoietic progenitor cell transplants; d) CMV-negative pregnant women. The BE shall prepare and adopt specific procedures for conducting pretransfusion diagnostic investigations to guarantee that the immunological compatibility between the donor and recipient is ascertained. © D.4.2 The BE shall prepare and adopt specific procedures for the pretransfusion diagnostic tests needed to ascertain immunological compatibility between donors and recipients. 124 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.4.2.1 For the allocation of blood components containing RBC, the BE shall guarantee the recipient’s ABO blood group testing and RhD typing in duplicate, on two different samples collected at different times. iz i For the allocation of blood components containing RBC, the BE shall guarantee the availability of the results of tests to establish the recipient’s ABO blood group and RhD type, conducted in duplicate on two different samples obtained at different times, for all scheduled requests and for urgent requests whenever the patient’s clinical conditions allow for the performance of said duplicate test. Se rv In addition to the contents of the Standard D.2.2, a check shall be guaranteed on the consistency of any available prior typing test results with the outcome of tests conducted on the samples received together with the request for transfusion. When consistent prior typing results are available, the second test becomes unnecessary, providing the patient’s identification is guaranteed by means of the exact consistency of the patient’s personal details (surname, name and date of birth). Duplicate blood group tests should also be used for all scheduled and urgent requests for fresh frozen plasma and platelets. SI M TI Where it is impossible to obtain a second blood group test result (a situation allowable exclusively for reasons relating to the patient’s clinical conditions, and therefore only in the case of urgent or emergency requests), the following should be allocated: a) O blood group RBC of the same RhD type as the patient’s, , in the case of allocating blood components containing RBC; b) AB blood group fresh frozen plasma in the case of allocating plasma; c) ABO compatible platelets with a low plasma residue resuspended in additive solution or, as a second choice, O blood group platelets resuspended in the donor’s own plasma, in which a low titre of anti-A and Anti-B isohaemoagglutinins has been ascertained (see Standard D.4.1.2). © Urgent requests relating to patients whose clinical conditions were too severe to allow for duplicate blood group tests should be systematically documented. D.4.2.2 For the allocation of blood components containing RBC, the BE shall guarantee screening for clinically significant irregular erythrocyte antibodies in the recipient. For the allocation of blood components containing RBC, the BE shall guarantee screening for clinically significant irregular erythrocyte antibodies in the recipient, for both scheduled and urgent transfusion requests. 125 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition A negative outcome of screening for irregular erythrocyte antibodies may be used as a pretransfusion compatibility test for up to 7 days after its performance in the following cases: a) if the patient has never received a transfusion before; b) if the patient has received a transfusion no less than 4 weeks previously; c) if the patient is not pregnant and has not delivered/miscarried in the last 4 weeks; d) if the patient’s clinical history of transfusions is not dubious or impossible to ascertain. Se rv iz i Apart from the above-mentioned cases, a negative result of screening for irregular erythrocyte antibodies may be used as a pretransfusion compatibility test for no more than 72 hours after its performance, particularly in cases involving the allocation of blood component containing RBC without any prior major crossmatch compatibility testing (the so-called Type & Screen procedure), as established in Standard D.4.2.4. In patients receiving transfusions routinely for chronic diseases, screening for irregular erythrocyte antibodies should be guaranteed for every new transfusion cycle, or at least according to an established schedule depending on the likelihood of the patient developing a transfusion-related immunisation, even if these patients systematically undergo crossmatch compatibility testing. In patients repeatedly receiving RBC transfusions with a short interval between them, screening for irregular erythrocyte antibodies should be guaranteed every 72 hours. M TI For the specific methods to use in screening for irregular erythrocyte antibodies, see Section E - Diagnostic laboratory activities, Standard E.3.4. Screening for irregular erythrocyte antibodies should be conducted as rapidly as possible after receiving the blood sample concerned. SI If the efficacy of the RBC transfusion is reportedly or found to be inadequate despite negative results emerging from screening for irregular erythrocyte antibodies and/or crossmatch compatibility testing, the tests should be repeated using nonanticoagulated blood samples, which should be tested as soon as possible after their collection, and never more than 2 hours later, particularly to identify any presence of complement-dependent anti-erythrocyte antibodies. © In such situations, the BE should prepare and adopt specific investigation algorithms/protocols to include obtaining detailed clinical information and the further tests required to deal with the reported/identified cases. D.4.2.3 For the allocation of blood components containing RBC, the BE shall define the cases in which crossmatch compatibility tests are required. For the allocation of blood components containing RBC, the BE shall define the cases in which crossmatch compatibility tests have to be conducted and the cases in which other procedures can be adopted in lieu of said tests (see standard D.4.2.4). For the allocation of blood components containing RBC, the BE shall guarantee the performance of crossmatching tests in all cases where screening for irregular 126 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition iz i erythrocyte antibodies in the recipient proves positive or the patient has a clinical history of positivity. Negative crossmatching results may be acceptable as a pretransfusion compatibility test for up to 7 days after the test’s performance in the following cases: a) if the patient has never received a transfusion before; b) if the patient has received a transfusion no less than 4 weeks previously; c) if the patient is not pregnant and has not delivered/miscarried in the last 4 weeks; d) if the patient’s clinical history of transfusions is not dubious or impossible to ascertain. Apart from the above-mentioned cases, a negative crossmatching result may be acceptable as a pretransfusion compatibility test for up to 72 hours after the test’s performance. Se rv For the specific methods to use in crossmatching tests, see Section E - Diagnostic laboratory activities, Standard E.3.4. D.4.2.4 For the allocation of blood components containing RBC for which crossmatch compatibility tests are omitted, the BE shall adopt measures designed to guarantee the safety of the allocation. M TI When implementing the so-called Type & Screen procedure, which involves allocating blood components containing RBC without any crossmatching tests, the BE shall adopt measures designed to guarantee the safety of such allocations. © SI When adopting the Type & Screen procedure, the following safety criteria shall therefore be met: a) acceptance checks shall be conducted systematically on the request and on the associated biological samples in accordance with Standards D.2.1 and D.2.2.; b) the duplicate determination of the patient’s ABO blood group and RhD type shall be systematically guaranteed, in accordance with Standard D.4.2.1; c) screening for irregular erythrocyte antibodies in the recipient shall comply with the requirements established in Standard D.4.2.2, particularly concerning the period during which its use as a pretransfusion test is acceptable, and the technical requirements for the analytical procedure; d) the outcome of screening for irregular erythrocyte antibodies in the recipient shall be negative and the patient’s immunohaematological history shall be negative for any prior, clinically significant irregular erythrocyte antibody positivity; e) unless this has already been done, the ABO blood group and RhD type of the blood units shall be verified (and said verification shall be documented), always using a segment of the blood unit sampling tube to prepare the erythrocytes to test; f) alternatively, an abbreviated crossmatch in saline solution may be done at room temperature (the so-called immediate spinning procedure), here again always using a segment of the blood unit sampling tube to prepare the RBC suspensions to test; g) a validated computer-based management system shall be used to guarantee the systematic reporting of any discrepancies between the donor’s and the recipient’s blood groups, relating to the ABO system at least; the system shall provide the suspension of the procedure for allocating and releasing blood component units that prove to be ABO-incompatible. 127 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.4.2.5 Where the BE provides blood components for newborn and paediatric patients, the procedures shall define the criteria and working methods to perform the pretransfusion investigations and allocate blood components to these categories of patients. iz i If a BE also provides blood components for newborn and paediatric patients, specific criteria shall be defined and adopted for the pretransfusion investigations and for allocating blood components to this category of patients. D.4.3 Se rv These criteria shall refer to the Raccomandazioni per la trasfusione in neonatologia [Recommendations on transfusion in neonatology] developed by the SIMTI in cooperation with the Italian Neonatology Society (SIN) and to the Raccomandazioni per la gestione della Malattia Emolitica del Neonato [Recommendations for the management of Haemolytic Diseases of the Newborn] developed by the SIMTI in co-operation with the Italian Society of Gynaecology & Obstetrics (SIGO). The BE shall prepare and adopt specific procedures for selecting and allocating blood components in urgent and emergency situations. For the definitions of “urgency” and “emergency” relating to transfusions, see Standard D.1.1.2. M TI The BE shall prepare and adopt specific procedures for selecting and allocating blood components in urgent and emergency situations. © SI These procedures shall define: a) the criteria for selecting and allocating blood components in urgent and emergency conditions particularly as concerns: - any allocation of RhD-positive red blood cells to RhD-negative patients; - urgent requests in which it is impossible to obtain the results of a duplicate determination of the ABO blood group and RhD type (see Standard D.4.2.1); - the criteria for allocating fresh frozen plasma and platelets; b) the pretransfusion compatibility test methods; c) the time taken to fulfil requests, which shall be consistent with the time defined in the procedures contained in Standard D.1.1.2; d) the working methods to adopt to guarantee an adequate interaction with any connected structures/organisations (e.g. remote blood bank services, accredited private hospitals, etc.), also in relation to the contracts/agreements mentioned in Standard D.1.1.4. The time technically needed in-house to fulfil requests for urgent transfusions should be kept to no more than a mean 60 minutes, except in cases of: a) particular immunohaematological problems relating to the patient’s typing and compatibility testing; b) any nonconformities emerging from the correlation between the request, the patient and the samples that might negatively influence the safety of the transfusion; c) any unusually high number of simultaneous urgent requests imposing the need to establish an order of clinical priority for fulfilling the requests. 128 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition Blood components containing RBC allocated in emergency conditions shall be systematically submitted to an additional assessment of the ABO blood group and RhD type always using a segment of the blood unit sampling tube; this test may also be conducted prior to the allocation; in any case, its performance shall always be documented. D.5 ISSUING BLOOD COMPONENTS iz i The basic immunohaematological study of patients receiving emergency transfusions (ABO blood group and RhD type, and screening for irregular erythrocyte antibodies) should preferably be conducted on a sample drawn before the patient is transfused in view of the possible need for further transfusions. APPLICATION GUIDELINES The BE shall prepare and adopt specific procedures for the issuing of allocated units of blood components, and of any related returns; these procedures shall be preliminarily validated, and revalidated periodically and following any major changes to the process. M TI D.5.1 Se rv D.5.1 The BE shall prepare and adopt specific procedures for issuing allocated units of blood components, and of any related returns; these procedures shall be preliminarily validated, revalidated periodically and following any major changes to the process. The procedures concerning the issue of allocated units of blood components, and any related returns, shall be preliminarily validated, then revalidated periodically and following any major changes to the process. SI These procedures shall define the methods and working means for conducting the activities described below. © a) Assessment of the correlation between the request, the patient and the blood unit. Prior to the issue of blood units, a check on the unequivocal correlation between the request, the patient and the allocated blood units shall be guaranteed. Computer-based objective functions should be in place and systematically used with a view to preventing the release of blood units for which the unequivocal correlation between the request, the patient and the allocated blood units has not been confirmed. b) Visual inspection of blood units. Prior to the issue of blood units, a check on the integrity of the blood units and their labelling shall be guaranteed, including an inspection to ensure there are no visually detectable anomalies (clotting, haemolysis, flocculation, platelet aggregates, etc.). Blood units that are not intact and/or that reveal other irreparable anomalies shall not be issued. 129 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition © SI M TI Se rv iz i c) Issuing the blood units and related records. The records for issuing blood units shall include at least: - the type, identification code, ABO blood group and RhD type of the blood component; - any treatments; - the surname, name, date of birth, ABO blood group and RhD type of the intended recipient; - the unit/place where the patient is in care; - the date and time of delivery; - identification of the operators issuing and receiving the blood component (by means of a computer-based identification method or signature on paper). d) Management of the issue of documents accompanying blood units. The documentation accompanying the blood units generally comprises: - allocation labels attached to the blood units, bearing witness to donorrecipient compatibility; - forms containing the patient’s personal and immunohaematological details, the unit/place where the patient is treated, certification of donor-recipient compatibility, the date and time of issue of the blood unit(s), spaces for the signatures of the operators involved in issue and receipt; - forms (or spaces/cells provided in the compatibility certificate) for certifying the completion of the transfusion, the proper preservation of untransfused blood units returned to the BE, and for reporting any adverse events, processing errors, or near misses. e) Packaging and transportation of blood units. For the packaging and transportation of blood units, see Section A - General organisational requirements, Ch. A.6.4 Packaging and transportation of blood, blood components and haemopoietic stem cells. Management of untransfused blood units returned to the BE and of the certificates testifying to their proper preservation while away from the BE, and management of the certificates testifying to the final destination of blood units not returned to the BE. g) Management of reports on transfusion-related adverse reactions and adverse events, processing errors and near misses. Said reports shall comply with local/national haemovigilance and clinical risk management programmes. (see Standard D.6.1). h) Management of the issue in the event of a computer system outage or malfunction. The BE shall prepare appropriate alternative procedures to adopt in the event of computer system failures or malfunctions in order to ensure the continuing issue of allocated blood component units, guaranteeing their safety and traceability. i) Management of the issue of plasma derivatives, in cases where the BE handles this activity. The records, documentation and control measures relating to the issue of allocated blood components and any related returns should be managed entirely by computer. 130 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.6 HAEMOVIGILANCE ON RECIPIENTS D.6.1 The BE shall adopt specific haemovigilance on recipients. procedures for managing APPLICATION GUIDELINES The BE shall adopt specific procedures for managing haemovigilance on recipients. iz i D.6.1 Se rv The BE shall prepare and adopt specific procedures defining the responsibilities and working methods for managing the haemovigilance measures for which they are responsible, in the light of current legislation and the local, regional and national haemovigilance and clinical risk management programmes. A reference person for recipient haemovigilance shall be formally appointed. M TI The BE shall define working methods designed to guarantee the proper and thorough management of: a) epidemiological records relating to potentially transfusion-transmitted infectious diseases; b) reports of severe unexpected reactions and severe incidents relating to the transfusion process, as well as processing errors and near misses. SI Procedures shall be prepared and made available for notifying the Regional Blood Coordinating Centre and the National Blood Centre about all undesirable reactions and all severe transfusion-related incidents with reference to the applicable national and regional directives, using the national information system for transfusion services (SISTRA, see Section A - General organisational requirements, Ch. A.8 Reporting). © By arrangement with the one or more hospital transfusion committees on which it is institutionally required to serve, the BE should promote the use of the abovementioned reports as a means for monitoring and auditing transfusion practices in the areas it serves and the BE’s ability to guarantee adequate transfusion quality and safety, in order to enable the identification of any specific critical issues and areas needing improvement. 131 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.7 MANAGEMENT OF BLOOD COMPONENT STOCKS D.7.1 The BE shall establish the necessary qualitative and quantitative levels of its blood component stocks in the light of its predicted needs. iz i D.7.1.1 The BE shall define the blood component stocks relating to other structures/organisations referring to the BE. APPLICATION GUIDELINES The BE shall establish the necessary qualitative and quantitative levels of its blood component stocks in the light of its predicted needs. Se rv D.7.1 The stocks of blood components are defined with a view to efficiently and effectively ensuring that the qualitative and quantitative transfusion needs in the areas served by the BE are met, as well as any commitment to supply blood components to other BEs, or any plan to obtain supplies from other BEs. M TI Proper planning of the blood component stocks also enables an efficient turnover of the blood components to be guaranteed, which is essential to ensuring the systematic availability of blood units that have been stored for the shortest possible time, and to preventing the excessive ageing and expiry of the blood units. The BE shall guarantee qualitatively and quantitatively defined stocks of red blood cells, fresh frozen plasma and platelets in relation to its predicted average needs. SI In order to plan the qualitative and quantitative characteristics of its stocks of blood components, the BE shall establish threshold values, for each ABO and RhD type, based on the global average needs relating to one or more defined periods of time (e.g. daily, weekly) consisting of the sum of the predicted needs for routine purposes and for urgent and emergency requests and, where applicable, to meet any previously arranged commitment to supply other BEs. © It should be noted that the definition of the thresholds for the stocks of blood components shall be objectively consistent with the average predicted needs, particularly concerning red blood cells with the O RhD negative phenotype and fresh frozen plasma with the AB phenotype. If the BE is not self-sufficient, it shall systematically make agreements and establish plans for acquiring blood components from other BEs so as to guarantee the necessary qualitative and quantitative levels of its stocks. For example, threshold values may be identified for the following situations: a) equilibrium; b) excess; c) shortage; d) emergency. 132 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition Based on the established threshold values, the BE shall constantly monitor the qualitative and quantitative levels of its stocks so as to take timely action to deal with any reductions in its stocks attributable to extraordinary demands or rising trend in consumption, as well as any stocks exceeding the predicted levels (due to contingencies or changing trends) and, wherever possible, take action to realign the stocks with the equilibrium threshold values. Se rv iz i To adequately manage potential critical reductions in stocks of labile blood components for transfusions after extraordinary events (e.g. pandemics or other epidemiological crises, earthquakes), the BE shall be proactive in ensuring that the hospital transfusion committees define the specific clinical situations in which transfusion treatments shall nonetheless be guaranteed and those in which they may be postponed. For this purpose, the BE should refer to the guidelines issued by the SIMTI and possibly also by the pertinent Regional Blood Coordinating Centre. The BE should take specific organisational steps to avoid stocking blood components that have been allocated but not issued. D.7.1.1 The BE shall define the blood component stocks relating to other structures/organisations referring to the BE. M TI The BE shall define the stocks of blood components relating to the structures/ organisations (peripheral organisations, remote blood bank services, accredited private hospitals, etc.) referring to the BE. © SI For the needs of these associated structures/organisations, the BE shall guarantee: a) the qualitative and quantitative stocks required to meet routine needs and for urgent and emergency transfusions, based on the predicted average needs at each location; b) an efficient turnover and timely topping up of stocks, particularly concerning the stocks for urgent and emergency transfusions. 133 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.8 DISTRIBUTION OF BLOOD COMPONENTS D.8.1 BLOOD COMPONENT EXCHANGE D.8.1.1 The BE shall participate in blood component exchange activities for the supply/acquisition of blood components according to the instructions of the Regional Blood Coordinating Centre. iz i D.8.1.2 The BE shall prepare and adopt specific procedures for managing blood component exchange activities. Se rv D.8.1.2.1 The BE shall define specific working methods to adopt in the case of acquiring blood components from other structures. D.8.1.2.2 The BE shall define specific working methods to adopt in the case of supplying blood components to other structures; said methods shall undergo preliminary validation and be revalidated periodically and following any major changes to the process. M TI APPLICATION GUIDELINES D.8.1.1 The BE shall participate in blood component exchange activities for the supply/acquisition of blood components according to the instructions of the Regional Blood Coordinating Centre. SI The efficient and effective functioning of blood component exchange flows is one of the fundamental prerequisites for self-sufficiency at local, regional and national level. The BE shall take part in blood component exchange activities to meet regional needs in accordance with the indications of the Regional Blood Coordinating Centre. © D.8.1.2 The BE shall prepare and adopt specific procedures for managing blood component exchange activities. The BE shall prepare and adopt specific procedures that define the responsibilities and working methods for managing blood component exchange activities. The procedures shall particularly define the methods and tools to use in performing the activities described below. a) Identification of the availability/shortage of blood components. The availability/shortage of blood components shall be identified consistently with the planning and management of stocks as specified in Standard D.7.1. 134 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition iz i b) Management of relations and communications. Methods and tools shall be defined for managing relations and communications with the Regional Blood Coordinating Centre, the client/supplier BE(s), the persons responsible for transportation, and any other parties involved. c) Management of blood component packaging and transportation. For the general criteria relating to the packaging and transportation of blood units, see Section A - General organisational requirements, Ch. A.6.4 Packaging and transportation of blood, blood components and haemopoietic stem cells. d) Management of administrative aspects at the BE. The management of administrative aspects consequent to the blood component exchange activities shall be established in relation to the organisational setting in which the BE operates, and to the relevant regional and national provisions. Se rv D.8.1.2.1 The BE shall define specific working methods to adopt in the case of acquiring blood components from other structures. © SI M TI If blood components are acquired from other structures, the BE shall define appropriate working methods to ensure the proper and thorough performance of all the activities relating to the acceptance, control and stocking of the blood components received. In particular, the BE shall guarantee: a) an inspection on the integrity of the containers for transporting blood units; b) an assessment of the state of preservation of the blood units: - by checking any temperature monitoring devices associated with the container; - by recording the temperature with its own instruments; - by obtaining the relevant transport system validation certificates; c) a check on the physical state and integrity of the blood units, including the availability of a sufficient number of sampling tube segments for each blood unit; d) a check on the consistency of the information on the labels on the blood units (sender BE, identification code, blood group, date of collection, date of expiry, any treatments) with the information recorded on the delivery documents; e) a check on the biological validation certificate for the blood units; f) a check on the conformity of the blood units to the quantitative and quantitative specifications as agreed with the sender BE; g) the complete traceability of single blood units in the same way as for blood units produced in-house at the BE; h) the definition of administrative methods for managing any blood units that are unusable due to irreparable nonconformities; i) the systematic documentation of all control activities; j) the systematic recording and management of any nonconformities in blood units received and the related documentation. The BE should guarantee that the process for managing blood units acquired from other BE is supported entirely by adequate computer-based means. 135 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.8.1.2.2 The BE shall define specific working methods to adopt in the case of supplying blood components to other structures; said methods shall undergo preliminary validation and be revalidated periodically and following any major changes to the process. iz i If blood units are supplied to other structures, the BE shall define working methods to guarantee the proper and thorough performance of the activities involved in the selection, control, packaging and delivery/dispatching of the blood components supplied. Se rv These methods shall undergo preliminary validation and shall be revalidated periodically and following any major changes made to the process. SI M TI In particular, the BE shall guarantee: a) the qualitative and quantitative selection of the blood components according to the agreements made with the BE due to receive them, and/or with the specifications established in any previous agreements stipulated with the latter; b) an inspection of the physical state and integrity of the blood units, including the availability of a sufficient number of segments of sampling tube for each blood unit; c) an assessment of the accuracy and integrity of the labels on the blood units; d) the production of the necessary accompanying documents, including biological validation certificates for the blood units, and details of the tests performed for said purpose; e) the operations for releasing the blood units; f) any packaging of the blood units according to the arrangements made with the BE due to receive them, and in any case designed to ensure conditions in transit that preserve the biological properties of the products; g) the delivery or dispatch of the blood units according to the arrangements made with the BE due to receive them; h) notification to the BE due to receive the blood units of any changes to the arrangements concerning the qualitative or quantitative consistency of the blood components supplied, the methods for their packaging and/or dispatch, which must in any case be done before the blood components are distributed. © The BE should guarantee that the process for managing blood units supplied to other BEs is supported entirely by adequate computer-based means. 136 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition D.8.2 DELIVERY OF PLASMA TO PHARMACEUTICAL COMPANIES iz i D.8.2.1 The BE shall adopt specific procedures, which undergo preliminary validation and are periodically revalidated and following any major changes to the process, to guarantee the proper management of deliveries of frozen plasma to pharmaceutical companies under contract for processing plasma and supplying the corresponding plasma-derived medicinal products. APPLICATION GUIDELINES Se rv D.8.2.1 The BE shall adopt specific procedures, which undergo preliminary validation and are periodically revalidated and following any major changes to the process, to guarantee the proper management of deliveries of frozen plasma to pharmaceutical companies under contract for processing plasma and supplying the corresponding plasma-derived medicinal products. M TI Contracts/agreements governing relations with pharmaceutical companies specialising in processing human plasma in accordance with national and European legislation are stipulated between such contracting companies and the regional authorities, which may take action individually or in association with others. The BE shall prepare and adopt specific procedures defining the responsibilities and working methods for managing activities relating to the delivery of frozen plasma to pharmaceutical companies under contract to process the plasma. SI These procedures shall undergo preliminary validation and shall periodically be revalidated and following any major changes being made to the process. They shall be formulated in accordance with the relevant regional provisions and with the rules and requirements established in the agreements stipulated between the regional authorities and the pharmaceutical companies under contract, and/or in documents forming an integral and substantial part of said agreements. © They shall also be formulated so as to guarantee: a) that the process for the production, selection, storage and distribution of the plasma destined for pharmaceutical processing is handled so that the products delivered comply with the established qualitative and quantitative requirements, particularly concerning the need to guarantee that no blood units failing biological validation according to current legislation can be passed on to the industry for any reason whatsoever; b) that the selection, storage and distribution stages are supported by computerbased means sufficient to ensure high product safety levels and the traceability of all the essential operations; 137 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition c) the management of any feedback from pharmaceutical companies under contract relating to nonconformities identified in the units of plasma and/or the documentation associated with each delivery, as established in the reference agreements. iz i The BE may take part in programmes for the production of hyperimmune plasma to submit for industrial processing for the production of particular plasma-derived medicinal products (e.g. anti-hepatitis B immunoglobulin) based on specific agreements stipulated between pharmaceutical companies and the regional authorities, or supplementary documents integrating agreements already in place. Se rv In such cases, the BE shall prepare and adopt specific procedures to govern not only the related activities for collecting plasma, but also the activities for the production, control, storage, packaging and distribution to the industry of the hyperimmune plasma in compliance with the qualitative and quantitative requirements established in the above-mentioned agreements and/or supplementary documents forming an integral part thereof. D.9 PROCESS CONTROL INDICATORS M TI To constantly monitor the quality of the products-services provided and the compliance of the processes implemented with the established standards, the BE shall guarantee the monitoring of at least the indicators listed in the following table. © SI For the general criteria for planning quality monitoring activities, see Section AGeneral organisational requirements, Ch. A.7.1 Quality monitoring. 138 Reference chapter: Section D D.2 D.3 D.3 D.3 D.4 N° 1 2 3 4 5 © D.4.2.1 D.3.2.2 D.3.2.2 D.3.2.2 D.2.1 Reference standard: Section D Selection and allocation of blood components Assessment of the appropriateness of requests Assessment of the appropriateness of transfusion requests Assessment of the appropriateness of transfusion requests No. of requests for biological samples Nonconforming out of No. of requests received Process control indicator Check of patient’s blood group: consistency with previous test results iz i No. of patient blood group assessments inconsistent with previous test results out of No. of assessments performed No. of inappropriate transfusion requests out of No. of transfusion requests received [data stratifiable by type of blood component, areas served, reasons for inappropriateness, etc] Se rv Clinical appropriateness of transfusion requests Appropriateness of transfusion No. of transfused blood components requests (general) out of No. of blood units allocated [data stratifiable by type of blood component, areas served, medical and surgical treatment with the greatest consumption, etc] Appropriateness of transfusion No. of transfused blood components requests (general) out of No. of units requested [data stratifiable by type of blood component, areas served, medical and surgical treatments with the greatest consumption, etc) Conformity of transfusion requests (correctness and completeness of data) and associated biological samples to established requirements Characteristic to monitor M TI SI Acceptance of transfusion requests Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition 139 Reference chapter: Section D D.4 D.5 D.6 D.6 D.6 N° 6 7 8 9 10 © 140 D.6.1 D.6.1 D.6.1 D.5.1 D.4.3 Reference standard: Section D Haemovigilance Haemovigilance Haemovigilance Issuing blood components Errors and near misses relating to the selection and allocation of blood components (by the BE) No. of errors and near misses reported by requesting structures/parties + those identified by the BE out of No. of transfusion requests [data stratifiable by type of error/near miss] No. of errors and near misses identified by the BE out of No. of blood components transfused [data stratifiable by type of error/near miss] iz i No. of reports of adverse events/near misses received out of No. of blood components transfused [data stratifiable by type of event/ near miss] No. of feedback documents received out of No. of blood component units delivered No. of requests for urgent or emergency transfusions out of Total No. of transfusion requests [data stratifiable by type of blood component, urgency/emergency, areas served, etc] Process control indicator Se rv Transfusion-related errors and near misses (involving requesting structures/ subjects) Transfusion-related adverse events and near misses (involving requesting structures/parties) Feedback on blood components (usage of unit, return of untransfused units, reports of adverse reactions and near misses) Requests for urgent and emergency transfusions Characteristic to monitor M TI SI Selection and allocation of blood components Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition Reference chapter: Section D D.7 D.7 D.9 N° 11 12 13 © D.9.1 D.7.1.1 D.7.1.1 Reference standard: Section D SI Stock management efficiency Characteristic to monitor Delivery of plasma to pharmaceutical companies Management of blood component stocks iz i No. of nonconformities identified by pharmaceutical companies out of No. of units of plasma delivered Conformity to agreed product specifications and procedures in deliveries of plasma to pharmaceutical companies under contract Se rv No. of transfusions postponed due to shortage of blood components out of No. of transfusions requested No. of RBC units disposed of due to expiry out of No. of RBC units produced and validated Process control indicator Stock management efficiency M TI Management of blood component stocks Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section D - Allocation and distribution of allogeneic blood components 2nd Edition 141 Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition © SI M TI Se rv iz i Società Italiana di Medicina Trasfusionale e Immunoematologia 142 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition SECTION E LABORATORY DIAGNOSTIC ACTIVITIES iz i CONTENTS Se rv E.1 LIST OF LABORATORY DIAGNOSTIC SERVICES AND INFORMATION FOR USERS ............................................................................... 145 E.2 GENERAL CRITERIA FOR THE MANAGEMENT OF LABORATORY DIAGNOSTIC ACTIVITIES ............................................... 146 E.2.1 VALIDATION OF ANALYTICAL PROCESSES ............................................. 146 E.2.2 MANAGEMENT OF ACTIVITIES IN THE PRE-ANALYTICAL STAGE....................................................................... 147 E.2.3 MANAGEMENT OF ACTIVITIES IN THE ANALYTICAL PHASE .... 149 E.2.4 MANAGEMENT OF ACTIVITIES M TI IN THE POST-ANALYTICAL PHASE................................................................... 152 E.2.5 EXTERNAL QUALITY ASSESSMENT ................................................................ E.2.6 OUTSOURCING LABORATORY DIAGNOSTIC ACTIVITIES ........... 153 154 E.3 SPECIFIC STANDARDS FOR ERYTHROCYTE IMMUNOHAEMATOLOGY TESTS ................................................................................. 155 E.3.1 MANAGEMENT OF ERYTHROCYTE SI IMMUNOHAEMATOLOGY TESTS ........................................................................ E.3.2 ABO AND RhD TYPING: DONORS .................................................................... E.3.3 ABO AND RhD TYPING: PATIENTS ................................................................. 155 156 158 E.3.4 SCREENING FOR IRREGULAR ERYTHROCYTE ANTIBODIES © AND CROSSMATCHING ............................................................................................ E.3.5 IDENTIFICATION OF IRREGULAR ERYTHROCYTE ANTIBODIES ................................................. 159 160 E.3.6 IMMUNOHAEMATOLOGICAL INVESTIGATIONS ON THE HAEMOLYTIC DISEASE OF THE NEWBORN ............................................. 161 E.3.7 STUDY OF AUTOIMMUNE HAEMOLYTIC DISORDERS ..................... 162 E.4 SPECIFIC STANDARDS FOR MICROBIOLOGICAL TESTS PERFORMED FOR THE QUALIFICATION OF ALLOGENEIC BLOOD COMPONENTS ............................................................ 163 143 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition E.5 SPECIFIC STANDARDS FOR LEUKOCYTE AND PLATELET IMMUNOHAEMATOLOGY TESTS .................................................................................. 164 E.6 SPECIFIC STANDARDS FOR EXTEMPORANEOUS PREDONATION DIAGNOSTIC TESTS ...................................................................... 165 ............................................................................ 165 © SI M TI Se rv iz i E.7 PROCESS CONTROL INDICATORS 144 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition E.1 LIST OF LABORATORY DIAGNOSTIC SERVICES AND INFORMATION FOR USERS E.1.1 The BE shall define and formalise a list of the laboratory diagnostic services it offers and provide all interested parties with adequate information on how to access its services and the related reporting times. The BE shall define and formalise a list of the laboratory diagnostic services it offers and provide all interested parties with adequate information on how to access its services and the related reporting times. Se rv E.1.1 iz i APPLICATION GUIDELINES The BE shall define and formalise a comprehensive list of all the laboratory tests it performs. M TI This list of tests shall indicate: a) tests performed for hospital inpatients and outpatients; b) tests performed for donors, based on the established protocols for the biological qualification of blood components and the routine and non-routine testing of donors. © SI The BE shall provide the healthcare structures requiring its laboratory diagnostic services, and any NHS blood collection services for outpatients with a list of the services it provides, indicating the following for each test: a) the forms to use when requesting tests and the methods for managing the forms; b) the methods for collecting biological samples, including: - the types and quantities of test-tubes/other containers to use; - any particular sample collection methods; - methods for identifying patients and sample and for unequivocally correlating patients with their samples; - any particular methods for handling, storing and transporting samples from collection centres to the place where the BE receives them; c) tests that can be requested urgently and methods for submitting urgent requests; d) normal reference values or ranges for the test results; e) reporting times; f) how to collect/send test reports; g) how to ask the medical personnel at the BE to provide counselling on the test results. The diagnostic methods used to perform the tests shall be stated. 145 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition The BE shall provide outpatients and general practitioners with a list of the laboratory diagnostic services it offers, indicating the following for each test: a) methods for accessing the service and the single services provided; b) normal reference values and ranges for the test results; c) reporting times; d) how to collect test reports; e) how to ask the medical personnel at the BE to provide counselling on the test results iz i The documents containing the above-described information may be part of general informative material for users (Service Charters, etc.) issued by the organisation to which the BE refers. Se rv The essential information on the laboratory tests performed for the biological qualification of blood components, and for donor routine and non-routine tests should be made available to donors as part of the informative and educational material placed at their disposal when they make a donation. E.2 GENERAL CRITERIA FOR THE MANAGEMENT OF LABORATORY DIAGNOSTIC ACTIVITIES E.2.1 VALIDATION OF ANALYTICAL PROCESSES M TI E.2.1.1 The BE shall guarantee that the analytical processes it manages are validated and revalidated both periodically and after any major changes have been introduced. APPLICATION GUIDELINES SI E.2.1.1 The BE shall guarantee that the analytical processes it manages are validated and revalidated both periodically and after any major changes have been introduced. © The analytical processes managed by the BE shall be validated to guarantee their efficacy in relation to the established purposes, following planned activities that comprise the clear definition of the results to pursue and the related acceptance criteria, the identification of critical process variables, the performance of tests and the production of documented evidence in accordance with current legislation and with the principles and standards contained in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). Validation of analytical processes shall be conducted prospectively, but may also be performed retrospectively in the case of processes defined and implemented before the present Standards were enforced. 146 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition The analytical processes shall be periodically revalidated according to an established schedule and shall undergo a new validation after any introduction of changes to significant process parameters (e.g. replacement of equipment or reagents, software updates). For a definition of the term “Validation, see the Introduction to the Transfusion Medicine Standards, Definitions. iz i E.2.2 MANAGEMENT OF ACTIVITIES IN THE PRE-ANALYTICAL STAGE E.2.2.1 The BE shall define and adopt specific procedures for managing the pre-analytical stage for all the laboratory tests that it conducts. The BE shall guarantee the systematic assessment of requests for laboratory tests and the related biological samples, and the management of any nonconformities identified. Se rv E.2.2.1.1 E.2.2.2 The BE shall define and adopt procedures to guarantee the systematic assessment of the analytical systems it uses. The BE shall define, plan and implement the calibration of the analytical systems it uses, as applicable. E.2.2.2.2 The BE shall define, plan and implement specific internal quality control activities. M TI E.2.2.2.1 APPLICATION GUIDELINES SI E.2.2.1 The BE shall define and adopt specific procedures for managing the pre-analytical stage for all the laboratory tests that it conducts. © The BE shall prepare and adopt specific procedures for managing the preanalytical stage for all the laboratory tests that it conducts in-house, defining the related stages, responsibilities, working methods and control points. E.2.2.1.1 The BE shall guarantee the systematic assessment of requests for laboratory tests and the related biological samples, and the management of any nonconformities identified. The BE shall adopt specific procedures for assessing the requests for tests that it receives to ascertain: a) the completeness of the details provided and the correctness of the stated indications in the light of the established standards; b) the consistency between the request and the biological samples; 147 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition c) where applicable, the appropriateness of the request in relation to: - other tests requested at the same time; - diagnostic profiles defined in shared protocols; - clinical information on the patient, where available. The BE shall plan the action to take in the event of nonconformities being found in the requests. Se rv iz i The BE shall adopt adequate procedures for checking the biological samples it receives. These control measures shall concern at least: a) the type of test-tube and anticoagulant used for the collection; b) the identification of the sample; c) the quantity of biological material collected; d) any detectable alterations (e.g. clots in the case of blood collected with an anticoagulant, haemolysis); e) the signature of the person responsible for the collection, where applicable. The BE shall plan the action to take if sample nonconformities are identified, such as: a) the use of alternative samples; b) the request for a repeat sample collection; c) sample segregation until they can be made suitable for use. M TI E.2.2.2 The BE shall define and adopt procedures to guarantee the systematic assessment of the analytical systems it uses. SI Before undertaking the analytical activities, the BE shall define and adopt procedures defining the responsibilities and methods for assessing the analytical systems used to perform tests in terms of: a) the proper operation of the analytical systems; b) the checking and preparation of reagents; c) the calibration activities (see Standard E.2.2.2.1); d) internal quality control activities. The BE shall define, plan and implement the calibration of the analytical systems it uses, as applicable. © E.2.2.2.1 For each test requiring calibration, the BE shall define the methods for calibrating the analytical systems and their frequency, and the materials to use in their calibration, so as to guarantee the metrological referability of test results. Calibration activities shall be documented. 148 Società Italiana di Medicina Trasfusionale e Immunoematologia E.2.2.2.2 Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition The BE shall define, plan and implement specific internal quality control activities. The BE shall guarantee the systematic performance and auditing of internal quality control (IQC) activities for all tests conducted so as to assess and document the precision and accuracy of the analytical processes. Se rv iz i The IQC shall be formally planned in terms of: a) the frequency of their performance and auditing; b) the control materials to use; c) the concentrations of control samples, where applicable; d) the rules adopted and acceptance criteria; e) the records to produce and related preservation times; f) the processing of control charts, where applicable; g) further data processing using appropriate statistical methods; h) responsibilities and methods for implementing corrective and preventive actions in the light of assessments of the ICQ outcomes. The IQC performance and auditing activities shall be documented; the related documents shall be preserved for at least a year. E.2.3 MANAGEMENT OF ACTIVITIES IN THE ANALYTICAL PHASE M TI E.2.3.1 The BE shall prepare and adopt specific procedures for managing the analytical phase of all laboratory tests performed. The BE shall adopt specific methods for performing laboratory tests and establishes the characteristics of each test it performs. E.2.3.1.2 For tests performed using different methods and/or instruments, and/or at different locations, the BE shall adopt specific methods for ensuring their correlation and any necessary alignment. SI E.2.3.1.1 © E.2.3.1.3 The BE shall ensure the traceability of the reagents used in laboratory tests. E.2.3.1.4 The BE shall guarantee that test results are validated according to established procedures and by personnel appointed by the management. E.2.3.1.5 The BE shall preserve test results for established periods of time in accordance with current legislation. 149 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition APPLICATION GUIDELINES E.2.3.1 The BE shall prepare and adopt specific procedures for managing the analytical phase of all laboratory tests performed. The BE shall adopt specific methods for performing laboratory tests and establish the characteristics of each test it performs. Se rv E.2.3.1.1 iz i The BE shall prepare and adopt specific procedures for managing the analytical phase of all laboratory tests performed in-house, defining the phases, responsibilities, working methods and control points. The BE shall define and formalise the methods to adopt for performing the laboratory test it conducts. In particular, the characteristics of the methods and the requirements they must meet in relation to the specific demands of transfusion safety shall be defined in terms of sensitivity and specificity. M TI The methods shall guarantee systematic compliance with the manufacturer’s recommendations accompanying the diagnostic systems and kits. Any substantial deviations from said recommendations shall undergo preliminary validation (for a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions). © SI The BE shall formalise the requirements and specifications relating to each test, defining at least: a) for all tests: - the characteristics of the biological sample to test (type of test-tube, quantity of sample, any anticoagulant, etc.); - the test schedule; - the method used; - the type, mode and frequency of IQCs and their auditing; - acceptance criteria for the results of IQCs; - response times (in routine and urgent situations). b) depending on applicability: - the type, mode and frequency of calibration of the analytical systems; - the types of run control to use in addition to the controls provided by the commercial kits; - the types of control charts to produce after IQC activities; - reference ranges for the results; - grey zones; - “clinical panic” findings/values imposing the need to promptly inform users; - sensitivity/specificity levels. 150 Società Italiana di Medicina Trasfusionale e Immunoematologia E.2.3.1.2 Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition For tests performed using different methods and/or instruments, and/or at different locations, the BE shall adopt specific methods for ensuring their correlation and any necessary alignment. iz i For tests conducted using different methods and/or instruments, and/or at different sites, the BE shall adopt specific methods to ensure the correlations between the results, identifying any discrepancies and providing any necessary alignments. Se rv E.2.3.1.3 The BE shall ensure the traceability of the reagents used in laboratory tests. The BE shall guarantee the traceability of the batches of reagents used to perform tests, particularly for microbiological tests for blood component biological qualification and RBC immunohaematology. E.2.3.1.4 The BE shall guarantee that test results are validated according to established procedures and by personnel appointed by the management. M TI The BE shall guarantee that test results are validated according to established procedures and by personnel appointed by the management in the light of their specific professional expertise/responsibilities. For a definition of the term “Test validation”, see the Introduction to the Transfusion Medicine Standards, Definitions © SI The activities for validating test results should always include: a) preliminary validation, normally conducted under the responsibility of a medical technician, involving the following steps: - assessment of any calibrations; - auditing of IQCs; - repetition of any inconsistent tests with results in the grey zone or that prompt a lab instrument alarm; b) secondary validation by a biologist/physician, which may involve (as necessary): - evaluating the consistency of the results, also by consulting online archives (if any), ensuring that any inconsistencies are solved before the results are released (e.g. by comparing a patient’s or donor’s immunohaematological and biological qualification test results with their previous results); - ordering a repeat test on the same sample; - ordering a repeat test using another method; - requesting a new sample on which to repeat the test; - ordering and assessing further tests; - consulting the physician requesting the test. 151 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition The BE shall provide evidence of all the primary and secondary validation procedures that it implements. The BE shall formalise and apply specific procedures for validating the results of urgently performed tests. E.2.3.1.5 The BE shall preserve test results for established periods of time in accordance with current legislation. iz i The BE shall preserve test results for established periods of time in accordance with the requirements of current legislation. Se rv E.2.4 MANAGEMENT OF ACTIVITIES IN THE POST-ANALYTICAL PHASE E.2.4.1 The BE shall adopt specific procedures for preparing, checking and releasing of test reports. E.2.4.2 The BE shall adopt specific methods for managing biological samples after completing the analytical phase. APPLICATION GUIDELINES M TI E.2.4.1 The BE shall adopt specific procedures for preparing, checking and issuing test reports. The BE shall prepare and adopt specific procedures for the preparation, checking and issue of test reports, defining the related responsibilities, working methods and control points. SI Test reports shall be prepared so that they are clearly understandable. © They shall contain all the information needed for their proper interpretation, i.e.: a) the name of the structure issuing the report; b) patient/donor identification details; c) the date of sample collection and the date of the report; d) the name of the test; e) the test result(s); f) reference values/ranges, and corresponding units of measure, as applicable; g) evidence of any pathological findings; h) details of significant events potentially affecting the test result(s) and/or the reference indices; i) any explanatory notes. The report shall not contain corrections or non-standard signs. Any corrections shall be accompanied by the legible signature of the person making the change and the original version shall nonetheless remain visible. 152 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition Wherever feasible, the BE shall handle the transfer of test results from the laboratory equipment to the computer system by electronic means, at least for blood unit validation tests. Where this is unfeasible, the transfer of data shall be validated by two different operators and said validation procedure shall remain traceable. iz i E.2.4.2 The BE shall adopt specific methods for managing biological samples after completing the analytical phase. Se rv The BE shall define and formalise methods for managing biological samples after the analytical phase has been completed, which may involve: a) preserving samples for a given period of time to enable any repeat or further tests, or their use if other samples prove inadequate; b) preserving samples for the period of time established by current legislation for any tests needed in the event of adverse reactions associated with the transfusion process. E.2.5 EXTERNAL QUALITY ASSESSMENT M TI E.2.5.1 The BE shall guarantee its participation in external quality assessment programmes on its laboratory diagnostic activities. APPLICATION GUIDELINES E.2.5.1 The BE shall guarantee its participation in external quality assessment programmes on its laboratory diagnostic activities. SI The BE shall guarantee its systematic participation in external quality assessment (EQA) programmes for assessing the performance of its analytical systems and processes by means of comparisons of its results with a significant number of other structures conducting the same tests and using the same or similar diagnostic systems. © The samples submitted by the EQA programme managers shall be tested in the conditions in which everyday samples are routinely tested. The BE shall guarantee its participation in all EQA programmes managed by regional and national competent authorities. It shall anyway guarantee its participation in EQA/proficiency programmes at least for the tests mainly characterising its laboratory diagnostic activities, i.e. a) basic immunohaematological tests (for RBC phenotyping, irregular antibody screening and identification, crossmatching, direct antiglobulin test); b) immunometric serological assays for the biological qualification of blood components (HBsAg, anti-HIV1-2, anti-HCV, Lue serology); c) molecular tests for the biological qualification of blood components (HBV DNA, HIV RNA, HCV RNA); 153 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition d) serological and molecular tissue typing tests; e) cytofluorometric tests. iz i Participation in EQA programmes shall be formally planned in terms of: a) the diagnostic tests and systems involved; b) the types of programmes and the frequency of their performance; c) responsibilities; d) criteria and methods for assessing results; e) records to produce; f) responsibilities and methods for implementing corrective and preventive actions for significant deviations from the expected results. Se rv The outcome of EQA activities shall be preserved for at least three years. E.2.6 OUTSOURCING LABORATORY DIAGNOSTIC ACTIVITIES E.2.6.1 The outsourcing of one or more test(s) shall be governed by specific agreements and/or provisions established according to the organisational context in which the BE operates. M TI APPLICATION GUIDELINES E.2.6.1 The outsourcing of one or more test(s) shall be governed by specific agreements and/or provisions established according to the organisational context in which the BE operates. © SI Specific formalised agreements and/or provisions shall govern the outsourcing of laboratory diagnostic tests, according to the organisational setting in which the BE operates. Said agreements/provisions shall define: a) the list of tests to perform and the methods for providing said service; b) the methods for collecting, storing/handling and transporting the biological samples; c) the times and methods for delivering test reports or transmitting test results; d) the methods for communicating any changes to the agreements/provisions. Serological and molecular tests for the biological qualification of blood components shall be outsourced exclusively to another BE. For biological qualification tests, the agreements established to perform the tests shall also define the technical specifications for the tests being performed and the guarantee of the quality of the test results in relation to the specific needs relating to transfusion safety and the relevant current legislation, i.e.: a) test sensitivity and specificity levels; b) grey zones; c) internal quality control measures; d) EQA programmes adopted; 154 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition e) criteria for validating test sessions; f) algorithms adopted to manage results as established by current legislation; g) methods for documenting and reporting the results of IQC and EQA activities. The BE shall define its own methods for ensuring the traceability of the essential reporting relating to outsourced tests. iz i E.3 SPECIFIC STANDARDS FOR ERYTHROCYTE IMMUNOHAEMATOLOGY TESTS E.3.1 MANAGEMENT OF ERYTHROCYTE IMMUNOHAEMATOLOGY TESTS APPLICATION GUIDELINES Se rv E.3.1.1 The BE shall define and adopt specific working methods, control procedures and decision algorithms for managing erythrocyte immunohaematology tests. E.3.1.1 The BE shall define and adopt specific working methods, control procedures and decision algorithms for managing erythrocyte immunohaematology tests. M TI The BE shall define and adopt specific working methods, control procedures and decision algorithms for managing erythrocyte immunohaematology tests. SI The methods for handling the biological samples to test, performing the test sessions and related control measures, and managing the results of erythrocyte immunohaematology tests - including the management of anomalies and discrepancies in the test results vis-à-vis the expected values - shall be defined with reference to the particular need to ensure immunological transfusion safety and prevention of the haemolytic disease of the newborn (HDN). Reagents and diagnostic systems bearing the CE-mark for specific diagnostic purposes - whenever available - shall be used and the tests shall have a documented sensitivity and specificity. © In addition to ensuring compliance with current legislation, the procedures, control measures and decision algorithms should conform to the principles and standards defined in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). The essential requirements and recommendations applicable to the main erythrocyte immunohaematology tests are defined below. 155 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition E.3.2 ABO AND RhD TYPING: DONORS E.3.2.1 For unequivocally identified donors who have already been typed for the ABO and RhD blood group systems at the BE, RBCs shall be tested to ascertain ABO blood group and RhD type at the time of donations using at least the anti-A, anti-B and anti-D reagents. APPLICATION GUIDELINES Se rv iz i E.3.2.2 For donors who have not already been typed for the ABO, RhD and Kell blood groups systems: - the ABO blood group shall be determined on RBCs using the anti-A, anti-B and anti-A,B reagents; - the ABO blood group shall be determined in serum/ plasma using at least A1 and B erythrocytes; - RhD typing shall be performed using two different anti-D reagents of documented sensitivity, deriving from different clones in the case of both being monoclonal; - RhD-negative erythrocytes shall be tested for weak D (Du). M TI E.3.2.1 For unequivocally identified donors who have already been typed for the ABO and RhD blood group systems at the BE, RBCs shall be tested to ascertain ABO blood group and RhD type at the time of donations using at least the anti-A, anti-B and anti-D reagents. SI RhD typing shall be conducted using an anti-D reagent of documented sensitivity, preferably capable of identifying partial DVI (see also Section C - Production, qualification and biological validation of blood components, Standard C.6.1). © E.3.2.2 For donors who have not already been typed for the ABO, RhD and Kell blood groups systems: - the ABO blood group shall be determined on RBCs using the anti-A, anti-B and anti-A,B reagents; - the ABO blood group shall be determined in serum/plasma using at least A1 and B erythrocytes; - RhD typing shall be performed using two different anti-D reagents of documented sensitivity, deriving from different clones in the case of both being monoclonal; - RhD-negative erythrocytes shall be tested for weak D (Du). For ABO blood group determination in serum/plasma, it may also be advisable to use A2 and/or O erythrocytes, in order to identify weak phenotypes or antibodies against ABH specificities. 156 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition RhD typing shall be done using two different anti-D reagents of documented sensitivity (deriving from different clones in the case of both being monoclonal), at least one of which should identify partial DVI in order to avoid erroneously attributing the RhD-negative type to donors carrying the partial DVI variant. The search for weak D (Du) shall be conducted using the indirect antiglobulin test, with an anti-D reagent capable of identifying the partial DVI variant. iz i If the search for weak D conducted using the indirect antiglobulin test is positive, the negativity of the direct antiglobulin test shall be systematically tested in parallel. M TI Se rv The following criteria should also be adopted for RhD typing: a) positivity to both the two anti-D reagents: RhD-positive; b) negativity to both the two anti-D reagents and negativity in the search for weak D: RhD-negative; c) negativity to both the two anti-D reagents and positivity in the search for weak D: RhD-positive; d) positivity to only one anti-D reagent and negativity/positivity in the search for weak D: the RhD-positive type is assumed as a “precautionary” measure; such cases of inconsistency should be further analysed, preferably also by searching for the RhD partial variants and/or by determining the RhD type using genome amplification methods, relying on a reference immunohaematology laboratory if necessary; e) identification of partial D: RhD-positive (in which case the donor should be clearly notified of this phenotypic particularity). SI For the search for partial D and weak D, it may be useful to use specific kits containing mixtures of IgG and IgM monoclonal antibodies directed against the different epitopes of the D antigen, which enable most known partial D to be identified and weak D to be confirmed. © Any partial D phenotype established using serological methods should be confirmed by molecular tests. 157 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition E.3.3 ABO AND RhD TYPING: PATIENTS E.3.3.1 For unequivocally identified patients who have already been typed for the ABO and RhD blood group systems at the BE, RBCs shall be tested to ascertain their ABO blood group using at least the anti-A, anti-B and anti-D reagents. APPLICATION GUIDELINES Se rv iz i E.3.3.2 For patients who have not already been typed at the BE: - the ABO blood group shall be determined on RBCs using the anti-A, anti-B and anti-A,B reagents; - the ABO blood group shall be determined in serum/ plasma using at least A1 and B erythrocytes - RhD typing shall be performed using two different anti-D reagents of documented sensitivity, deriving from different clones in the case of both being monoclonal. E.3.3.1 For unequivocally identified patients who have already been typed for the ABO and RhD blood group systems at the BE, RBCs shall be tested to ascertain their ABO blood group using at least the anti-A, anti-B and anti-D reagents. M TI RhD typing shall be conducted using an anti-D reagent of documented sensitivity, that preferably does not identify partial DVI. © SI E.3.3.2 For patients who have not already been typed at the BE: - the ABO blood group shall be determined on RBCs using the anti-A, anti-B and anti-A,B reagents; - the ABO blood group shall be determined in serum/plasma using at least A1 and B erythrocytes; - RhD typing shall be performed using two different anti-D reagents of documented sensitivity, deriving from different clones in the case of both being monoclonal. For ABO blood group determination in serum/plasma, it may also be advisable to use A2 and/or O erythrocytes, in order to identify weak phenotypes or antibodies against ABH specificities. RhD typing shall be done using two different anti-D reagents of documented sensitivity (deriving from different clones in the case of both being monoclonal), at least one of which should not identify partial DVI, in order to avoid erroneously attributing the RhD-positive type to patients carrying the DVI partial variant, who risk developing anti-D immunisation if they are transfused with RhD-positive red blood cells. 158 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition For the purposes related to HDN prophylaxis, the search for weak D shall be conducted in RhD-negative newborn with the indirect antiglobulin test, using an anti-D reagent capable of identifying the partial DVI variant. If the search for weak D conducted using the indirect antiglobulin test is positive, the negativity of the direct antiglobulin test shall be systematically tested in parallel. M TI Se rv iz i The following criteria should also be adopted for RHD typing: a) positivity to both the two anti-D reagents: RhD-positive; b) negativity to both the two anti-D reagents: RhD-negative; c) negativity to both the two anti-D reagents and negativity in the search for weak D: RhD-negative; d) negativity to both the two anti-D reagents and positivity in any search for weak D: weak D (in which case the patient should be clearly notified of this phenotypic particularity); e) positivity to only one anti-D reagent and negativity/positivity in any search for weak D: the RhD-positive type is assumed as a “precautionary” measure; such cases of inconsistency should be further analysed, preferably also by searching for the RhD partial variants and/or by determining the RhD type using genome amplification methods, relying on a reference immunohaematology laboratory if necessary; f) identification of partial D: RhD-negative (in which case the patient should be clearly notified of this phenotypic particularity). For the search for partial D and weak D, it may be useful to use specific kits containing mixtures of IgG and IgM monoclonal antibodies directed against the different epitopes of the D antigen, which enable most known partial D to be identified and weak D to be confirmed. SI Any partial D phenotype established using serological methods should be confirmed by molecular tests. E.3.4 SCREENING FOR IRREGULAR ERYTHROCYTE ANTIBODIES AND CROSSMATCHING © E.3.4.1 Irregular antibody screening (IAS) shall be done using an analytical procedure validated in terms of its capacity to identify an anti-D control serum with a low antibody titre as unequivocally positive. APPLICATION GUIDELINES E.3.4.1 Irregular antibody screening (IAS) shall be done using an analytical procedure validated in terms of its capacity to identify an anti-D control serum with a low antibody titre as unequivocally positive. 159 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition The concentration of the anti-D control serum used to validate the analytical procedure should be ≤ 0.5 IU/ml for the tests to conduct on donors and ≤ 0.1 IU/ml for the tests to conduct on patients. The concentrations of anti-D control serums should be checked against D-heterozygotic RBCs (R1r, R2r). Se rv iz i For IQC purposes, an anti-D control serum with a concentration of ≤ 0.1 IU/ml should be used systematically to verify the sensitivity of the test conducted on patients, and an anti-D control serum with a concentration of ≤ 0.5 IU/ml should be used to verify the sensitivity of the test performed on donors. In addition, to further confirm tests’ sensitivity and the integrity of test erythrocytes’ antigen expression during storage, it may be useful to periodically check erythrocyte panels by means of control sera containing a low titres of clinically significant antibodies against different D antigen specificities. As a basic test, irregular antibody screening (IAS) shall be conducted using the indirect antiglobulin method, using panels of test erythrocytes consisting of RBCs from at least two individuals representing at least the following antigens: C, c, D, E, e, K, k, Fya, Fyb, Jka, Jkb, S, s, M, N, P1, Lea, Leb, preferably with “double dose” expression of antigens Fya, Fyb, Jka, Jkb, S, s, M. For investigations on all types of patients, panels of erythrocytes composed of at least three cells should be used, including a broader array of antigens and as many antigens expressed in “double dose” as possible. M TI Similarly, crossmatching tests shall be conducted using an analytical procedure validated in terms of its capacity to identify an anti-D control serum with an antibody titre ≤ 0.1 IU/ml as unequivocally positive. SI As a basic test, crossmatching shall be performed by the indirect antiglobulin test method, using suitable dilutions for the donor’s RBCs, obtained exclusively from a segment of the sampling tube on the blood unit concerned, and preferably conducted using low ionic strength solutions. E.3.5 IDENTIFICATION OF IRREGULAR ERYTHROCYTE ANTIBODIES © E.3.5.1 Irregular erythrocyte antibodies shall be identified using a validated analytical procedure. APPLICATION GUIDELINES E.3.5.1 Irregular erythrocyte antibodies shall be identified using a validated analytical procedure. Irregular erythrocyte antibodies shall be identified by means of a validated analytical procedure. For a definition of the term “Validation”, see the Introduction to the Transfusion Medicine Standards, Definitions. 160 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition iz i The panels of test erythrocytes should consist of RBCs from at least eight individuals and guarantee the following characteristics: a) they represent at least the following antigens: C, Cw, c, D, E, e, K, k, Kpa, Fya, Fyb, Jka, Jkb, S, s, Lea, Leb, M, N, P1, Lua; b) they contain at least one R1R1 cell and one R1WR1 cell that, in combination, express the following antigens: K, k, Fya, Fyb, Jka, Jkb, S, s; c) they contain at least one R2R2, one r3r and one r2r cell; d) they contain at least three cells with no C, E, or D antigens, one of which is K-positive and, taken together, they express a “double dose” of the antigens: k, Fya, Fyb, Jka, Jkb, S, s, M. Se rv As a baseline test, the irregular erythrocyte antibodies should be identified by means of the same method as was used to screen for their presence. M TI The following recommendations should also be adopted: a) the use of panels of RBCs treated with enzymes if antibodies are found weakly expressed, or there are mixtures of antibodies; b) serum/plasma tests against autologous RBCs; c) typing the patient’s RBCs to ensure that they do not contain any of the antigens against which antibody specificities have been identified; d) tests in saline solution at room temperature, where useful/advisable; e) an anti-D control serum with a concentration of ≤ 0.1 IU/ml should be used systematically to verify the tests’ sensitivity. In addition, to further confirm the tests’ sensitivity and the integrity of the test erythrocytes’ antigen expression during storage, it may be useful to periodically check erythrocyte panels by means of control sera containing low titres of clinically significant antibodies against different D antigen specificities. E.3.6 IMMUNOHAEMATOLOGICAL INVESTIGATIONS HAEMOLYTIC DISEASE OF THE NEWBORN ON THE © SI E.3.6.1 The BE shall adopt specific procedures for the immunohaematological investigations aimed at the diagnosis and prevention of the haemolytic disease of the newborn (HDN), according to the case series observed and the specialisation of the mother and infant services referring to the BE. APPLICATION GUIDELINES E.3.6.1 The BE shall adopt specific procedures for the immunohaematological investigations aimed at the diagnosis and prevention of the haemolytic disease of the newborn (HDN), according to the case series observed and the specialisation of the mother and infant services referring to the BE. 161 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition Se rv iz i For immunohaematological investigations designed to diagnose and prevent HDN, depending on the case series observed and the specialisation of the referring mother and infant services, the BE shall prepare and adopt specific procedures designed to define and govern: a) screening investigations and further diagnostic tests required; b) the diagnostic methods to use; c) the behaviour to adopt if patients suffering from HDN need transfusions; d) methods for interacting with physicians caring for patients involved, particularly in an advisory role; e) any reliance on other immunohaematology laboratories for investigations not conducted at the BE, and/or for cases difficult to solve; f) the recording of anti-D immunoprophylaxis in accordance with current legislation. The Raccomandazioni per la gestione della Malattia Emolitica del Neonato [Recommendations for the management of the haemolytic disease of the newborn] prepared by the SIMTI in co-operation with the Italian society of gynaecology and obstetrics (SIGO) should be adopted. E.3.7 STUDY OF AUTOIMMUNE HAEMOLYTIC DISORDERS M TI E.3.7.1 The BE shall adopt specific procedures for immunohaematological investigations aimed at the study of autoimmune haemolytic disorders (AHD), according to the frequency and complexity of the cases observed. APPLICATION GUIDELINES SI E.3.7.1 The BE shall adopt specific procedures for immunohaematological investigations aimed at the studying of autoimmune haemolytic disorders (AHD), according to the frequency and complexity of the cases observed. © Immunohaematological investigations in patients with autoimmune haemolytic disorders (AHD) shall focus on correctly determining their ABO and Rh phenotype, and ascertaining any concomitant presence of erythrocyte allo-antibodies and autoantibodies. According to the frequency and complexity of the cases observed, for immunohaematological investigations aimed at the study of AHD, the BE shall prepare and adopt specific procedures designed to govern: a) the necessary screening investigations and further diagnostic tests (particularly relating to the absorption-elution techniques for identifying the concomitant presence of erythrocyte allo-antibodies and autoantibodies); b) the diagnostic methods used; c) the behaviour to adopt for patients suffering from AHD who need transfusions, particularly concerning emergency situations; d) the methods for interacting with physicians taking care of AHD patients, 162 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition particularly in an advisory role; e) any reliance on other immunohaematology laboratories for investigations not conducted at the BE, and/or for cases difficult to solve. E.4 SPECIFIC STANDARDS FOR MICROBIOLOGICAL TESTS PERFORMED FOR THE QUALIFICATION OF ALLOGENEIC BLOOD COMPONENTS iz i E.4.1 The BE shall define and adopt specific working methods, control measures and decision algorithms for managing microbiological tests performed for the qualification of allogeneic blood components. APPLICATION GUIDELINES The BE shall define and adopt specific working methods, control measures and decision algorithms for managing microbiological tests performed for the qualification of allogeneic blood components. M TI E.4.1 Se rv E.4.1.1 The BE shall define methods for the analytical sessions and for managing the results of microbiological tests performed for the qualification of allogeneic blood components designed to guarantee blood component safety. The BE shall define and adopt specific working methods, control measures and decision algorithms for managing microbiological tests performed for the qualification of allogeneic blood components. SI In addition to ensuring compliance with current legislation, these working methods, control measures and decision algorithms should comply with the standards for the biological qualification of blood components defined in the latest edition of the Guide to the preparation, use and quality assurance of blood components (EDQM - European Directorate for the Quality of Medicines & Healthcare, Council of Europe). © E.4.1.1 The BE shall define methods for the analytical sessions and for managing the results of microbiological tests performed for the qualification of allogeneic blood components designed to guarantee blood component safety. The methods used in the analytical sessions and for managing the results of microbiological tests for the qualification of allogeneic blood components shall be defined so as to guarantee the safety of blood components. For this purpose, highly sensitive CE-marked tests shall be adopted that are specifically intended for the diagnostic objectives envisaged. 163 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition For immunometric/serological HBV, HCV and HIV1-2 screening tests, grey zones below the cut-off should be defined so as to intercept signals of reactivity potentially associated with very low concentrations of the analyte. The results coming within these grey zones shall be considered reactive for the purposes of biological qualification. iz i For immunometric and molecular HBV, HCV and HIV1-2 screening tests, in addition to the control measures established for the methods, at least one positive control sample (run control) not included in the kit and not coming from the same manufacturer, provided by authorised bodies/regulators or validated against their certified standards, should be used for each test to confirm the diagnostic systems’ capacity to reproducibly identify weak analytic signals. Se rv Run controls should be used as additional elements for validating single analytical series/runs. The BE shall adopt algorithms for managing initially reactive, repeatedly reactive and confirmed positive samples in relation both to the donation and to the donor, in accordance with current legislation. M TI Where the BE decides to extend the set of microbiological tests for biological qualification purposes in the light of specific local epidemiological situations, programs/procedures for donors from geographical areas at higher risk of transmissible diseases, additional screening programs for particular categories of blood components, etc., specific criteria shall be defined for managing the test profiles and the acceptability of results. E.5 S P E C I F I C S T A N D A R D S F O R L E U K O C Y T E A N D P L A T E L E T IMMUNOHAEMATOLOGY TESTS SI For the immunogenetic, serological and molecular tests for HLA typing of donors and patients, reference should be made to the International Standards of the European Federation for Immunogenetics (EFI). © E.5.1 The BE shall define and adopt specific working methods, control measures and decision algorithms for managing leukocyte and platelet immunohaematology tests. APPLICATION GUIDELINES E.5.1 The BE shall define and adopt specific working methods, control measures and decision algorithms for managing leukocyte and platelet immunohaematology tests. The BE shall define and adopt specific working methods, control measures and decision algorithms for managing leukocyte and platelet immunohaematology tests. 164 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition Se rv iz i The following recommendations should be followed: a) systems/reagents CE-marked for the specific diagnostic purposes should be adopted, if available; b) for antigen typing, positive and negative control samples should be used at every analytical session; c) in antibody screening/identification: - cells or cell panels suitable for identifying the fullest possible quota of clinically significant antibodies should be used; - positive and negative control sera should be systematically used at every analytical session; d) the nomenclature internationally accepted or defined at specific consensus conferences should be adopted (HPA for platelets, HNA for neutrophil granulocytes); e) differentiated diagnostic procedures should be defined for donors and patients, where necessary and applicable. Control samples prepared using international reference standards should be used, where available, to certify to the sensitivity of the antibody screening/ identification methods. E.6 SPECIFIC STANDARDS FOR EXTEMPORANEOUS PREDONATION DIAGNOSTIC TESTS M TI E.6.1 The BE shall define and adopt specific working methods for managing any extemporaneous diagnostic tests conducted prior to a donation. APPLICATION GUIDELINES The BE shall define and adopt specific working methods for managing any extemporaneous diagnostic tests conducted prior to a donation. SI E.6.1 © The BE shall prepare and adopt specific working methods for managing extemporaneous diagnostic tests conducted prior to a donation (either at the BE or at blood collection units referring thereto) as regards the analytical instrumentation available, the methods for guaranteeing the availability of backup equipment and the reagents to use, the control measures to implement and the management of the results. E.7 PROCESS CONTROL INDICATORS To constantly monitor the quality of the products-services provided and the compliance of the processes implemented with the established standards, the BE shall guarantee the monitoring of at least the indicators listed in the following table. For the general criteria for planning quality monitoring activities, see Section AGeneral organisational requirements, Ch. A.7.1 Quality monitoring. 165 Reference chapter: Section E E.2.2 E.2.5 E.2.5 E.3 E.3 E.4 E.4 N° 1 2 3 4 5 6 7 © 166 E.4.1.1 E.4.1.1 E.3.3 E.3.2 E.2.5.1 E.2.5.1 E.2.2.1.1 Reference standard: Section E No. of nonconformities in requests or samples out of No. of requests [data stratified at least by requesting department and type of nonconformity] Conformity of requests for laboratory tests and samples to established specifications Performance of microbiological tests for the qualification of allogeneic blood components Performance of microbiological tests for the qualification of allogeneic blood components Irregular antibody screening Blood group typing External quality assessment (EQA) External quality assessment (EQA) Se rv No. of run controls found in compliance with established specifications out of No. of run controls tested [data stratified by type of test] No. of initially reactive tests not confirmed in 2 subsequent determinations out of No. of initially reactive tests [data stratified by type of test] Capacity of diagnostic systems to identify weak analytical signals reproducibly Specificity of immunometric serological screening tests for HbsAg, Anti-HCV, AntiHIV1-2, Lue serology iz i No. of antibodies identified out of No. of screening tests found positive No. of discrepancies in serum/cell tests out of No. of ABO typing tests conducted No. of errors-discrepancies in EQA exercises out of No. of EQA exercises conducted [data stratified by test(s) submitted to EQA] Performance of analytical systems and processes used for screening Performance of analytical systems and processes used for ABO blood group typing Performance of analytical systems and processes Level of participation in EQA programs Number of EQA programs activated/No. of tests managed [data stratified by: immunohaematological tests, immunometric/molecular tests for biological qualification, serological/molecular tissue typing tests] Process control indicator Characteristic to monitor M TI SI Assessing requests for laboratory tests and related biological samples Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition Reference chapter: Section E E.4 E.4 N° 8 9 © E.4.1.1 E.4.1.1 Reference standard: Section E Performance of microbiological tests for the qualification of allogeneic blood components No. of invalid analytical sessions/runs out of No. of analytical sessions/runs conducted Performance of analytical systems and processes used in molecular HCV, HIV, HBV screening tests iz i No. of repeatedly reactive tests found negative on confirmation tests out of No. of repeatedly reactive tests [data stratified by type of test] Specificity of immunometric serological screening tests for HbsAg, Anti-HCV, Anti-HIV1-2, Lue serology Se rv Process control indicator Characteristic to monitor M TI SI Performance of microbiological tests for the qualification of allogeneic blood components Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section E - Laboratory diagnostic activities 2nd Edition 167 Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition © SI M TI Se rv iz i Società Italiana di Medicina Trasfusionale e Immunoematologia 168 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition SECTION F AUTOLOGOUS BLOOD TRANSFUSION .............................................................................................. Se rv F.1 INFORMATION FOR USERS iz i CONTENTS 170 F.2 MANAGEMENT OF PRE-OPERATIVE AUTOLOGOUS BLOOD DONATION PROGRAMMES ........................................................................... 171 F.3 MANAGEMENT OF OTHER AUTOLOGOUS BLOOD TRANSFUSION ACTIVITIES ........................................................................ 178 ............................................................................. 179 © SI M TI F.4 PROCESS CONTROL INDICATORS 169 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition F.1 INFORMATION FOR USERS F.1.1 The BE shall define and formalise its autologous blood transfusion services and provide interested parties with adequate information on the methods and timing for accessing said services. The BE shall define and formalise its autologous blood transfusion services, and provide interested parties with adequate information on the methods and timing for accessing said services. Se rv F.1.1 iz i APPLICATION GUIDELINES The BE shall define, formalise and make available to users (specialist physicians, general practitioners, patients) a list of the autologous blood transfusion services it provides for inpatients and outpatients, indicating: a) the methods and timing for accessing the services and the single services provided; b) any waiting times; c) the clinician responsible for the activities. M TI Documents containing the above-described information may be part of general informative material for users (e.g. a Hospital or NHS Service Charter) issued by the organisation to which the BE refers. It may be useful to provide informative documents (prepared in cooperation with the clinicians involved) in hospital wards and outpatient clinics to inform patients about the opportunity, where appropriate, to have autologous blood transfusion treatments to avoid/reduce the need for homologous blood transfusions. © SI The BE shall serve in a clinical advisory role in response to specific requests for autologous blood transfusion services for inpatients and outpatients, establishing the necessary cooperative relations with the physicians requesting said services. 170 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition F.2 MANAGEMENT OF PRE-OPERATIVE AUTOLOGOUS BLOOD DONATION PROGRAMMES F.2.1 The BE shall prepare specific procedures for defining and implementing pre-operative autologous blood donations by arrangement with the managers of the healthcare services involved. These procedures shall define: iz i F.2.1.1 The indications for autologous transfusion and the clinical suitability and patient eligibility criteria for pre-operative autologous blood donation programmes. Se rv F.2.1.2 The responsibilities, prerequisites and working methods for submitting requests to the BE. F.2.2 The BE shall prepare specific procedures for managing its activities relating to pre-operative autologous blood donation programmes. These procedures shall define: F.2.2.1 The methods and criteria for assessing the appropriateness of requests. M TI F.2.2.2 The type of information required and the methods for obtaining it in order to judge a patient’s clinical suitability and eligibility for a pre-operative autologous blood donation programme. F.2.2.3 Criteria for assessing a patient’s clinical suitability for the treatment. SI F.2.2.4 Specific working methods for receiving patients and providing them with information on the pre-operative autologous blood donation programme. F.2.2.5 Specific working methods for providing patient care and for completing the autologous blood collection. © F.2.2.6 Laboratory tests to conduct for each autologous blood unit and methods for managing blood units found positive at one or more of the screening tests required by law. F.2.2.7 Methods for recording information on patients and the activities conducted, as well as any adverse reactions or events. F.2.2.8 Working methods to adopt for the labelling, storage, delivery and transportation of autologous blood units. 171 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition F.2.2.9 Specific working methods for transferring autologous blood units to other BEs and for acquiring autologous blood units from other BE. F.2.3 The BE shall guarantee the periodic assessment of its preoperative autologous blood donation activities. The BE shall prepare specific procedures for defining and implementing pre-operative autologous blood donations by arrangement with the managers of the healthcare services involved. Se rv F.2.1 iz i APPLICATION GUIDELINES The BE shall prepare specific procedures for defining and implementing preoperative autologous blood donation programmes by arrangement with the managers of the healthcare areas involved, in relation to the latter’s clinical needs and with reference to the Raccomandazioni SIMTI sulla trasfusione perioperatoria [SIMTI Recommendations on Peri-operative Transfusions]. SI M TI In accordance with current legislation, hospital transfusion committees shall be created and made fully operational at health care organisations with one or more BE(s). These committees shall create the institutional opportunity for sharing and adopting procedures, guidelines and programmes relating to the transfusion process, promoting the ongoing professional development and training of all individuals involved in the transfusion process, and systematically auditing the effective application of the procedures adopted to ensure the safety of the process and the appropriateness of the transfusion therapies administered. The procedures for defining and implementing pre-operative autologous blood donation programmes should therefore be shared and adopted within the context of the one or more committees on which the BE is institutionally required to serve. The procedures should be circulated by means of specific provisions issued by the hospital management. © Where “practical guidelines” for users are adopted (see Standard D.1.1), they should contain a brief summary of the procedures for defining and implementing autologous transfusion programmes based on pre-operative autologous blood donations. The procedures shall define: F.2.1.1 172 The indications for autologous transfusion and the clinical suitability and patient eligibility criteria for pre-operative autologous blood donation programmes. Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition With reference to the Raccomandazioni SIMTI sulla trasfusione perioperatoria, the BE shall define the indications for autologous transfusion and the clinical suitability and eligibility criteria for including patients in pre-operative autologous blood donation programmes related to the elective surgery activities conducted in the areas served by the BE. M TI Se rv iz i After ensuring that patients have no clinical contraindications to the treatment, the definition of pre-operative autologous blood donation programmes shall take into account: a) the type of surgery and predicted corresponding peri-operative blood loss, also in relation to the surgical technique used and the performance of the various surgical teams; b) the need to assess the real eligibility of patients with basal Hb values tending towards the upper limit of normal, bearing in mind that it is unnecessary to perform transfusions (and autologous blood collections are consequently not indicated) if a patient’s Hb has basal values that, despite peri-operative blood losses, will predictably maintain a stable postoperative value higher than 10-11 g/dL; c) the need to have sufficient time intervals between the programmed collections, and between the last collection and the surgical procedure to enable a satisfactory recovery of the RBC mass bled; d) the possible need to support the patient’s erythropoietic compensation by administering iron preparations and, where appropriate, accelerating the process by administering erythropoietin. SI Without prejudice to the specific needs of selected cases, criteria based on evidence of a significant added benefit shall be defined for cases where: a) autologous whole blood units are fractionated to produce red blood cells and fresh frozen plasma (a treatment that is not recommended due to the related risk of technical incidents and because it is impossible to obtain therapeutic doses of autologous fresh frozen plasma); b) autologous blood collections are performed using apheretic methods. F.2.1.2 The responsibilities, prerequisites and working methods for submitting requests to the BE. © Responsibilities, prerequisites and working methods shall be established for requests that the BE define and implement a pre-operative autologous blood donation programme, including the forms to be used for this purpose. Requests for a pre-operative autologous blood donation programme shall be formulated by a physician belonging to the healthcare area of the patient due to undergo surgery. It shall be clearly stated that the final decision regarding the patient’s clinical suitability and eligibility, the quantity of blood to collect and the details of the programme, lies with the transfusion medicine physician. 173 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition To make the process as efficient as possible and avoid requests being inadequately documented, the following prerequisites shall be defined: a) information that the physician requesting the programme must give to the patient; b) clinical documentation and diagnostic test results needed to assess the patient’s clinical suitability and eligibility for the treatment; c) responsibilities and methods for collecting the patient’s informed consent. iz i Specific forms should be prepared for submitting requests for pre-operative autologous blood donation programmes, where the physician requesting the service provides the information needed to assess the appropriateness of the request and the patient’s clinical suitability and eligibility. F.2.2 Se rv For the management of requests from structures outside the hospital or NHS management to which the BE refers, see Standard F.2.2.9. The BE shall prepare specific procedures for managing its activities relating to pre-operative autologous blood donation programmes. Specific procedures shall be prepared for managing activities involved in preoperative autologous blood donation programmes conducted at the BE. F.2.2.1 M TI These procedures shall define: The methods and criteria for assessing the appropriateness of requests. SI The BE shall guarantee the systematic assessment of the appropriateness of requests for pre-operative autologous blood donation programmes (also in the light of the contents of Standard F.2.1.1), establishing the necessary cooperative relations with the physicians making said requests. The physician at the BE responsible for assessing the request shall notify the requesting physician of any inappropriate aspects of the request, clearly explaining and justifying the reasons for said opinion. © Activities for evaluating the appropriateness of requests shall be documented. F.2.2.2 The type of information required and the methods for obtaining it in order to judge a patient’s clinical suitability and eligibility for a pre-operative autologous blood donation programme. The BE shall define the information it needs to judge a patient’s clinical suitability and eligibility for a pre-operative autologous blood donation programme and the corresponding methods for presenting said information (e.g. by means of a specific form, a review of clinical records collected in the hospital ward or prior to admission, or a review of the anaesthesiologist’s risk assessment sheet for a given surgical procedure). 174 Società Italiana di Medicina Trasfusionale e Immunoematologia F.2.2.3 Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition Criteria for assessing a patient’s clinical suitability for the treatment. The BE shall define the criteria for assessing a patient’s clinical suitability, particularly concerning diseases of the cardiovascular apparatus that may contraindicate the treatment, as well as criteria for the clinical assessment of the bleeding risk relating to the type of surgery and any prior haemorrhagic diathesis. Specific working methods for receiving patients and providing them with information on the pre-operative autologous blood donation programme. iz i F.2.2.4 Specific working methods for providing patient care and for completing the autologous blood collection. SI F.2.2.5 M TI Se rv The BE shall define and adopt specific working methods relating to: a) patient acceptance; b) information for patients about the pre-operative autologous blood donation programme, particularly as regards: - the meaning of the informed consent required; - the meaning of the medical examination; - the meaning of the clinical history; - the meaning of the laboratory tests conducted, including screening for HIV, HCV and HBsAg; - the autologous blood donation procedure and the related risks and benefits; - the possibility of being denied said procedure if any risk factors are identified; - the possible use, where necessary, of allogeneic transfusions if the autologous blood units prove insufficient; - the risk of the blood units being lost due to technical incidents or for clinical reasons (e.g. the presence of cold agglutinins); - the elimination of unused autologous blood units when they expire, since they cannot be used for other patients. © The BE shall define and adopt specific working methods for providing patient care and performing autologous blood collections, particularly as concerns: a) methods for performing the collection (see Section B - Collection of blood and blood components, Ch. B.3 Whole blood collection and apheresis); b) the treatment of any low-volume collections (e.g. in adult patients of low body weight and in paediatric patients), in which the volume of anticoagulant has to be adjusted; c) the identification of blood units at the time of their collection, including the patient’s and physician’s signatures on the corresponding label; d) patient care measures; e) the identification and treatment of any adverse reactions. 175 Società Italiana di Medicina Trasfusionale e Immunoematologia F.2.2.6 Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition Laboratory tests to conduct for each autologous blood unit and methods for managing blood units found positive at one or more of the screening tests required by law. For each autologous blood unit, the BE shall guarantee the performance of the laboratory tests required by current legislation. iz i For the Standards to guarantee relating to the management of the tests, see Section E - Laboratory diagnostic activities. F.2.2.7 Se rv The BE shall also guarantee the definition of specific working methods for handling autologous blood units found positive at one of or more screening tests. Methods for recording information on patients and the activities conducted, as well as any adverse reactions or events. The BE shall define methods and tools for recording information relating to the patient and the activities conducted, also as concerns the records to include in the patient’s clinical files. For this purpose, the BE may prepare a specific file/datasheet in which to include the necessary records. SI M TI In particular, the following minimum details shall be recorded, or associated with the records: a) the patient’s demographic and nosological data; b) the diagnosis and the type and date of the planned surgical procedure; c) essential medical history and clinical signs; d) informed consent to the pre-operative autologous blood donation programme; e) judgement of the patient’s clinical suitability/unsuitability for the treatment and eligibility for the programme; f) the pre-operative autologous blood donation programme; g) the blood units collected, with the related quantities and identification codes; h) any infusion/pharmacological support treatments administered; i) any adverse reactions that occurred and their treatment. © The records should enable: a) a global synopsis of the programme implemented and of the tests performed each time the patient attended; b) the information needed to enable an assessment of the appropriateness of the programme implemented. The records shall be preserved in accordance with current legislation. Without prejudice to the need to obtain and preserve the documentation relating to the programmes implemented on printed paper if it cannot be managed otherwise, the records should be managed in electronic format. 176 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition Procedures shall be prepared and circulated for notifying the Regional Blood Coordinating Centres and the National Blood Centre of all severe adverse reactions and incidents relating to the blood collections with reference to the applicable national and regional directives and using the national blood IT system - SISTRA (see Section A - General organisational requirements, Ch. A.8 Reporting). Working methods to adopt for the labelling, storage, delivery and transportation of autologous blood units. iz i F.2.2.8 Se rv The BE shall guarantee that the activities for the labelling (particularly concerning the specific recommendations to include on the final labels), storage, delivery and transportation of autologous blood units are conducted in accordance with current legislation. As in the case of allogeneic blood units, the BE shall systematically receive certificates testifying to the final destination of blood units not returned to the BE or, in the case of returns, of their storage in accordance with the established procedures. Specific working methods for transferring autologous blood units to other BEs and for acquiring autologous blood units from other BE. M TI F.2.2.9 SI In cases where: a) the BE receives written requests for pre-operative autologous blood donation programmes for patients due to undergo surgery at structures outside the organisation to which the BE refers (including accredited private hospitals that have agreements with the BE); b) the BE has to receive autologous blood units collected at a BE outside the organisation to which the BE refers, and destined for patients due to undergo surgery in the healthcare area served by the BE, © methods and means shall be defined for transferring/receiving and documenting the information needed to guarantee the appropriateness and safety of the preoperative autologous blood donation programmes, the product specifications established by current legislation and the safety of the modes of delivery and transportation of the autologous blood units collected. F.2.3 The BE shall guarantee the periodic assessment of its pre-operative autologous blood donation activities. The BE shall guarantee the periodic assessment of its pre-operative autologous blood donation activities in order to monitor its compliance with the established appropriateness criteria (see Standard F.2.1.1 and Ch. F.4 in this Section, Process control indicators). 177 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition F.3 MANAGEMENT OF OTHER ACTIVITIES F.3.1 The BE shall ensure the coordination and organisation of pre-operative acute normovolemic haemodilution and intraand post-operative autologous blood salvage. The BE shall ensure the coordination and organisation of pre-operative acute normovolemic haemodilution and intra- and post-operative autologous blood salvage. Se rv F.3.1 iz i APPLICATION GUIDELINES With reference to current standards and the Raccomandazioni SIMTI sulla trasfusione perioperatoria, the BE shall be responsible for coordinating and organising pre-operative acute normovolemic haemodilution and intra- and post-operative retrieval activities. The responsibility for managing these activities generally lies with anaesthetists for pre-operative normovolemic haemodilution and intra-operative blood salvage, and with surgeons and/or anaesthetists for post-operative blood salvage. © SI M TI The coordination and organisation of autologous blood transfusion activities (other than the pre-operative autologous blood donation procedure) that are conducted at by the BE by arrangement with the managers of the healthcare areas concerned, should mainly consist of the following: a) the definition of indications for the appropriate and safe use of these methods; b) the definition and organisation of integrated autologous blood transfusion programmes (e.g. pre-operative autologous blood donation and intra-and/or post-operative blood salvage); c) procedures for assessing the quality and safety of blood products deriving from peri-operative blood salvage procedures (e.g. excessive coagulation factor activation, excessive haemolysis, contamination from the surgical field); d) technical contributions with a view to the controlled management of the peri-operative blood salvage equipment and systems and the qualification of the related suppliers; e) the collection of essential data relating to the completed procedures, also relying on reference persons from the patient care areas concerned; f) the assessment of the appropriateness and, wherever possible, of the cost-benefit ratio of the programmes implemented and treatments provided, to report to the hospital transfusion committee(s) with a view to continuously improving the quality and safety of these particular transfusion activities. Concerning its coordination and organisation functions, attributed by current legislation, the BE should periodically monitor the types and quantities of its preoperative autologous blood donation, pre-operative normovolemic haemodilution and peri-operative blood salvage activities in the healthcare areas it serves in order to contribute data for any national and/or regional scale investigations designed to monitor the qualitative and quantitative dimensions of these activities. 178 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition F.4 PROCESS CONTROL INDICATORS To constantly monitor the quality of the products-services provided and the compliance of the processes implemented with the established standards, the BE shall guarantee the monitoring of at least the indicators listed in the following table. © SI M TI Se rv iz i For the general criteria for planning quality monitoring activities, see Section AGeneral organisational requirements, Ch. A.7.1 Quality monitoring. 179 Reference chapter: Section F F.2 F.2 F.2 F.2 N° 1 2 3 4 © 180 F.2.3 F.2.3 F.2.3 F.2.2.3 Reference standard: Section F No. of patients on pre-operative autologous blood donation programmes also given homologous blood out of No. of patients only given autologous blood Efficacy of pre-operative Assessment of pre-operative autologous autologous blood donation blood donation programmes programmes iz i No. of patients whose donated autologous blood units are entirely or partially unused out of No. of patients on pre-operative autologous blood donation programmes [data stratified by type of surgical procedure] Appropriateness of preAssessment of pre-operative autologous operative autologous blood donation programmes blood donation programmes Se rv No. of autologous blood units disposed of due to expiry out of No. of autologous blood units collected [data stratified by type of surgical procedure] No. of adverse reactions associated with autologous blood unit collection out of No. of autologous blood units collected Process control indicator Appropriateness of preAssessment of pre-operative autologous operative autologous blood donation programmes blood donation programmes a) Safety of autologous blood collection b) Adequacy of patients’ clinical selection c) Adequacy of established patient care procedures Characteristic to monitor M TI SI Performance of autologous blood collections Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section F - Autologous blood transfusion 2nd Edition Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition SECTION G Se rv CONTENTS iz i HAEMOPOIETIC STEM CELL COLLECTION AND OTHER CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE G.1 LIST OF SERVICES AND INFORMATION FOR USERS ........................... G.2 GENERAL CRITERIA FOR MANAGING CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE ......................... 182 183 G.3 SPECIFIC STANDARDS FOR HAEMOPOIETIC STEM CELL (HSC) COLLECTION ACTIVITIES .................................................................................................. 188 M TI G.3.1 SPECIFIC STANDARDS FOR COLLECTING BONE MARROW AND PERIPHERAL HAEMOPOIETIC STEM CELLS .................................. 188 G.3.2 SPECIFIC STANDARDS FOR UMBILICAL CORD BLOOD DONATION .............................................. 191 G.4 SPECIFIC STANDARDS FOR OTHER CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE ........................................................................................ 193 ............................................................................ 196 © SI G.5 PROCESS CONTROL INDICATORS 181 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition G.1 LIST OF SERVICES AND INFORMATION FOR USERS G.1.1 The BE shall define and formalise the list of its clinical transfusion medicine (TM) services, and provide interested parties with adequate information on the methods and timing for accessing said services. iz i G.1.2 The BE shall guarantee its services in an advisory role on clinical TM, in relation to the type of patient care services it provides for inpatients and outpatients. G.1.1 Se rv APPLICATION GUIDELINES The BE shall define and formalise the list of its clinical transfusion medicine (TM) services and provide interested parties with adequate information on the methods and timing for accessing said services. M TI The BE shall define, formalise and make available to users (specialist physicians, general practitioners, patients) a comprehensive list of all the clinical patient care services it provides for inpatients and outpatients, indicating: a) the methods for accessing the services and the single services available; b) the methods for submitting requests for services; c) any waiting times; d) the services that can be requested urgently and the methods for making such requests; e) the TM specialist(s) responsible for the activities. SI Documents containing the above-described information may be part of general informative material for users (e.g. a Hospital Service Charter) issued by the organisation to which the BE refers. The BE shall guarantee its services in an advisory role on clinical TM, in relation to the type of patient care services it provides for inpatients and outpatients. © G.1.2 The BE shall serve in a clinical advisory role in response to specific requests for the patient care services it provides for inpatients and outpatients, establishing the necessary cooperative relations with the physicians requesting said services. 182 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition G.2 GENERAL CRITERIA FOR MANAGING CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE G.2.1 The BE shall prepare and adopt specific procedures for managing its TM-related clinical activities. G.2.1.1 The BE shall guarantee the systematic recording of information relating to its TM-related clinical services. iz i G.2.1.2 The BE shall apply specific clinical guidelines for the most common and/or critical diseases treated in the context of its TM-related clinical activities. Se rv G.2.1.3 The BE shall guarantee the systematic assessment of the appropriateness of requests it receives for TM-related clinical services. G.2.1.4 The BE shall define and adopt specific working methods for patient care and for providing TM-related therapeutic treatments. G.2.1.5 The BE shall guarantee the systematic assessment of the efficacy of the treatments it provides. M TI G.2.1.6 The BE shall prepare and adopt procedures and clinical protocols to guarantee the proper and timely management of any adverse reactions or adverse events in patients receiving therapeutic treatments. SI G.2.1.6.1 The BE shall guarantee the systematic availability of the devices and medicinal products needed to deal with any adverse reactions or adverse events relating to the therapeutic treatments it provides. APPLICATION GUIDELINES The BE shall prepare and adopt specific procedures for managing its TM-related clinical activities. © G.2.1 The BE shall prepare and adopt specific procedures for managing its TM-related clinical activities, particularly relating to: a) the forms to use for requesting its services and the type of information needed to assess said requests; b) methods for booking the services and administrative issues for accessing the services; c) methods for managing the list of appointments; d) methods for managing urgent requests; e) methods for communicating with the physicians requesting these services; f) the related clinical responsibilities. 183 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition Depending on the structural features of the environment available, the equipment, the ability to provide patient care in the event of adverse reactions, and the availability of medical, nursing and auxiliary personnel, the BE should define a maximum daily number of appointments and the allowable clinical conditions for admitting patients. iz i G.2.1.1 The BE shall guarantee the systematic recording of information relating to its TM-related clinical services. Se rv The BE shall guarantee the systematic recording of information on the TM-related clinical services it provides. For this purpose, also in the light of any instructions received from the hospital or other NHS management to which the BE refers, the BE shall prepare one or more clinical record forms to use in all cases of repetitive services/treatment and for the taking into care of patients with particular specialist needs. In the case of occasional services not followed by monitoring, repetitive treatments and/or the patient’s taking into care, it is sufficient to record the essential elements relating to the service provided, including its outcome, instead of creating a clinical file. Clinical files may consist of a set of all the patient’s records, on printed paper and/ or in electronic format. SI M TI The minimum elements that shall be recorded in, or associated with, the clinical file are as follows: a) the patient’s demographic and nosological details; b) the diagnosis and related essential documentation; c) informed consent to the therapeutic treatments; d) informed consent to the treatment of personal details; e) essential medical history and clinical findings; f) clinical and diagnostic tests performed; g) treatments provided; h) any adverse reactions and their treatment. © The clinical file should enable: a) a global synopsis of the procedures for each patient to enable an assessment of the global clinical trend and any trends of specific parameters; b) the recording of information to enable an assessment of the efficacy of the treatments, where applicable. The BE shall define responsibilities and working methods to guarantee that clinical files are systematically and accurately compiled, kept up-to-date, assessed for the completeness of the data and preserved; the BE shall also define the criteria for accessing the clinical files. Clinical files shall be preserved indefinitely. Unless there is a need to obtain and preserve otherwise unavailable documentation relating to the patient care services on printed paper, the clinical file should be managed entirely in electronic format. 184 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition G.2.1.2 The BE shall apply specific clinical guidelines for the most common and/or critical diseases treated in the context of its TM-related clinical activities. To define the clinical guidelines to adopt, the BE shall identify the most common and/or most critical diseases treated in its clinical activities, and particularly the most frequently implemented procedures/treatments. iz i As an example, these may include particular diseases for which transfusion treatments, infusion treatment with plasma-derived or recombinant medicinal products, or iron-based preparations are indicated, and/or cell depletion and plasma exchange treatments. Se rv The guidelines shall: a) be formulated on the strength of evidence-based criteria, referring to authoritative and up-to-date bibliographical sources; b) be shared within the BE; c) be shared, where necessary, with the healthcare structures referring to the BE; d) be easy to consult and effectively applicable. The guidelines shall be circulated to all personnel involved. M TI They shall also be reviewed periodically and whenever new scientific evidence capable of significantly improving the diagnosis and treatment processes becomes available. G.2.1.3 The BE shall guarantee the systematic assessment of the appropriateness of requests it receives for TM-related clinical services. SI The BE shall guarantee the systematic assessment of the appropriateness of requests for its services, establishing the necessary cooperative relations with the physician making said requests. © The physicians at the BE responsible for assessing the request shall notify the physicians making the request of any inappropriate aspects of the request, clearly explaining and justifying the reasons for said opinion. Activities for evaluating the appropriateness of requests shall be documented. 185 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition G.2.1.4 The BE shall define and adopt specific working methods for patient care and for providing TM-related therapeutic treatments. Se rv iz i The BE shall define and adopt specific working methods for providing patient care and completing TM-related therapeutic treatments, particularly relating to: a) patient acceptance; b) patient care measures preliminary to providing treatments; c) patient care measures needed during the treatment; d) patient care measures needed after the treatment; e) recognition and treatment of any adverse reactions; f) management of blood components and transfusions; g) the controlled, safe and appropriate management of equipment used to provide treatments (e.g. equipment for therapeutic apheresis, infusion pumps) and equipment used in the event of emergencies (e.g. defibrillator, vital signs monitor, aspirator). See also Section A of the present Manual -General organisational requirements, Ch. A.4.1 - Management of systems, equipment and instruments; h) procedures for therapeutic apheresis and for managing the related exchange fluids; i) management of medicinal products used for infusions, complementary or adjuvant treatments and emergencies. M TI G.2.1.5 The BE shall guarantee the systematic assessment of the efficacy of the treatments it provides. The BE shall guarantee the systematic assessment of the efficacy of its therapeutic treatments, and provide evidence of said assessments. SI The efficacy of the treatments can be assessed during and after the treatment, for the purpose of supporting decisions relating to: a) changes to the treatment plan; b) termination of the treatment plan; c) the planning of alternative treatments. © The assessment criteria may vary, depending on the disease being treated, but they are based substantially on: a) monitoring objective parameters, e.g. laboratory and/or instrumental test results recorded both after each treatment cycle and as retrospective/ prospective trends in the case of patients receiving long-term treatments; b) focused clinical evaluations to identify improvements in the patient’s general clinical conditions, any disappearance/reduction of specific signs and symptoms, and any interrupted/delayed progression of the disease. Where justified by the number of cases treated, the records on the efficacy of therapeutic treatments should be the object of specific statistical analyses to facilitate continuous improvements in the patient care processes and their outcome. 186 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition G.2.1.6 The BE shall prepare and adopt procedures and clinical protocols to guarantee the proper and timely management of any adverse reactions or adverse events in patients receiving therapeutic treatments. iz i The BE shall define and adopt procedures and clinical protocols for the prevention, prompt recognition and treatment of adverse reactions or adverse events occurring in relation to the therapeutic treatments it provides, particularly focusing on the most severe and most common. These procedures and clinical protocols shall be circulated to all the personnel involved. Se rv The protocols shall also be revised periodically and whenever any new scientific evidence capable of significantly improving the diagnosis and treatment processes becomes available. If it provides treatments carrying a significant risk of severe adverse reactions or adverse events, the BE shall be in a condition to promptly provide a resuscitation service. M TI Activities for the identification and treatment of adverse reactions and adverse events relating to therapeutic treatments involving the transfusion of blood components shall be systematically recorded and notified, where applicable, to the competent regional and national authorities (see Section D - Allocation and distribution of allogeneic blood components, Ch. D.6 Haemovigilance for recipients). SI Information on adverse reactions and adverse events should be the object of specific statistical analyses designed to facilitate continuous improvements in patient care processes and the safety of patients involved in TM-related clinical activities. © G.2.1.6.1 The BE shall guarantee the systematic availability of the devices and medicinal products needed to deal with any adverse reactions or adverse events relating to the therapeutic treatments it provides. Depending on the types of service provided, on current legislation and on the provisions issued by the organisation to which the BE refers, medicinal products and devices for coping with any adverse reactions in patients or adverse events shall be available and ready for use in the rooms used to administer therapeutic treatments. The equipment available shall be defined bearing in mind that some adverse reactions or adverse events potentially associated with therapeutic treatments routinely provided at BEs may develop into clinical emergencies. 187 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition The healthcare personnel involved shall be adequately trained and periodically brought up to date on the management of specific adverse reactions, adverse events and clinical emergencies that can occur in relation to the treatments being provided (see Section A. General organisational requirements, Ch. A.3.1 Maintenance, development and assessment of the personnel’s skills). Said personnel shall be qualified to provide basic life support (BLS). iz i G.3 SPECIFIC STANDARDS FOR HAEMOPOIETIC STEM CELL (HSC) COLLECTION ACTIVITIES G.3.1 SPECIFIC STANDARDS FOR COLLECTING BONE MARROW AND PERIPHERAL HAEMOPOIETIC STEM CELLS Se rv G.3.1.1 The BE shall define and adopt specific procedures for the recruitment and subsequent management of potential unrelated allogeneic donors of peripheral and bone marrow HSC. G.3.1.2 By arrangement with the reference HSC transplant centre(s), the BE shall define and adopt specific procedures for the assessment and subsequent management of potential related allogeneic donors of peripheral and bone marrow HSC. M TI G.3.1.3 The BE shall define and adopt specific procedures for collecting HSC and lymphocytes from peripheral blood by apheresis. APPLICATION GUIDELINES SI G.3.1.1 The BE shall define and adopt specific procedures for the recruitment and subsequent management of potential unrelated allogeneic donors of peripheral and bone marrow HSC. © The activities for the recruitment and subsequent management of potential allogeneic unrelated donors of bone marrow and peripheral HSC shall be handled exclusively in connection with the regional and national bodies responsible for managing the corresponding registries. For these activities, the BE with a HSC donor recruitment centre accredited by the pertinent national authority (the IBMDR - Italian Bone Marrow Donors Registry) shall define and adopt specific procedures complying with the criteria established by said authority, as well as complying with the pertinent provisions of current national and regional legislation. 188 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition Se rv iz i In particular, based on the role of the BE in the regional and national network referring to the IBMDR, and the BE’s consequent connections with the structure hierarchically immediately above and below it, organisational and working methods shall be defined for the following activities: a) information for potential donors; b) assessment and enrolment of potential donors, and collection of their informed consent to listing in the IBMDR’s national register; c) management of donors enrolled in the IBMDR’s national register; d) invitations and interviews for further assessments after enrolment; e) immunogenetic selection of donors for the purposes of HSC donations; f) assessment of the product specifications required by the HSC transplant centre in relation to the donor’s specific characteristics; g) clinical assessment of suitability for bone marrow or peripheral HSC donations; h) obtainment of the donor’s specific informed consent to the donation; i) collection of peripheral and bone marrow HSC. The BE shall prepare and adopt specific procedures to define the responsibilities and working methods for managing the follow-up of unrelated allogeneic HSC donors, tailored to the type of donation involved, including the management of any adverse reactions and adverse events in the short, medium and long term after the donation, in accordance with the provisions of the IBMDR standards and with reference to the contents of Section B, Ch. B.5 Haemovigilance for donors. M TI G.3.1.2 By arrangement with the reference HSC transplant centre(s), the BE shall define and adopt specific procedures for the assessment and subsequent management of potential related allogeneic donors of peripheral and bone marrow HSC. SI For the management of potential related peripheral and bone marrow HSC donors, the BE shall prepare specific procedures, shared with the reference HSC transplant centre(s) and compliant with the SIMTI guidelines as well as the IBMDR standards, to define the global clinical procedure for assessing the donors’ suitability for donation and for obtaining their informed consent. © The related allogeneic donors’ suitability for bone marrow and peripheral HSC donation procedures shall be assessed jointly by the physician at the BE and the physician at the transplant centre, with reference to the criteria defined in the above-mentioned procedures. In agreement with the reference HSC transplant centre(s), the BE shall prepare and adopt specific procedures that define the responsibilities and working methods for managing the follow-up of related allogeneic HSC donors, depending on the type of donation concerned, including the management of any adverse reactions or adverse events in the short, medium and long term after the donation, preferably in accordance with the provisions of the IBMDR standards and with reference to the contents of Section B, Ch. B.5 Haemovigilance for donors. 189 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition G.3.1.3 The BE shall define and adopt specific procedures for collecting HSC and lymphocytes from peripheral blood by apheresis. The activities involved in the allogeneic or autologous collection of HSC and lymphocytes from peripheral blood should be part of regional programmes for supporting highly specialised onco-haematological activities. iz i In agreement with the healthcare areas they serve, the BEs involved in collecting allogeneic or autologous HSC and lymphocytes from peripheral blood shall define specific procedures governing the organisational methods for managing these activities as well as the reference clinical protocols for cell collection and storage. Se rv The protocols for the collection of allogeneic HSC and lymphocytes from peripheral blood shall comply with: a) the IBMDR standards, where applicable, as concerns both the clinical aspects and the organisational, logistic and documentation issues; b) the guidelines for selecting donors of HSC and lymphocytes from peripheral blood prepared by the SIMTI in co-operation with the principal scientific organisations involved in the sector. M TI Where hospital managements run accreditation schemes implemented in accordance with international standards (e.g. JACIE), the organisational and working procedures, the corresponding documentation and the clinical protocols shall be aligned with said standards. The final assessment of a donor’s suitability for allogeneic or autologous HSC and lymphocyte collection from peripheral blood is up to the TM physician responsible for apheretic activities at the BE. SI The predonation diagnostic investigations and final judgement of suitability for the collection shall be documented and recorded in the donor’s clinical file. The donor’s informed consent to the donation of HSC or lymphocytes from peripheral blood shall be obtained prior to the collection, in compliance with current legislation. © Informed consent shall be obtained for: a) the destination of the peripheral HSC or lymphocytes from peripheral blood (allogeneic or autologous therapeutic use, use in clinical experiments, elimination if they are not used for the intended purpose); b) if the donor’s identity is known to the recipient (siblings/parents), permission to notify the recipient of any abnormal outcome of the scheduled tests; c) administration of growth factors stimulating proliferation and mobilisation of peripheral HSC. The BE shall notify donors of the outcome of tests performed at the time of the HSC and lymphocyte donation from peripheral blood, particularly concerning any anomalous results emerging from the diagnostic investigations. 190 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition The BE shall prepare and adopt specific procedures defining the responsibilities and working methods for managing any adverse reactions and adverse events occurring during the procedures for collecting HSC and lymphocytes from peripheral blood, in the light of the contents of Section B, Ch. B.5 Haemovigilance for donors, and Section F, Ch. F.2 Management of pre-operative autologous blood donation programmes, Standard F.2.2.7. iz i The personnel collecting HSC and lymphocytes from peripheral blood shall guarantee that a report containing the information on the collection required by current legislation is sent to the processing/freezing laboratory and/or to the recipient HSC transplant centre. G.3.2 SPECIFIC STANDARDS FOR UMBILICAL CORD BLOOD DONATION Se rv G.3.2.1 The BE shall guarantee an adequate level of information on all aspects relating to the donation of cord blood. G.3.2.2 The BE identified by a cord blood bank (CBB) as the support structure operating within a healthcare organisation that has a birth centre shall guarantee the systematic application of the procedures issued by the CBB. M TI G.3.2.3 The BE running a CBB within its organization shall define, adopt and ensures the application of global management procedures for the process of HSC donation from umbilical cord blood. APPLICATION GUIDELINES SI G.3.2.1 The BE shall guarantee an adequate level of information on all aspects relating to the donation of cord blood. © Even if it operates within a healthcare organisation that does not have a birth centre connected to a CBB, the BE shall guarantee citizens, and particularly women who are potential donors, an adequate level of information on all aspects of the donation of cord blood, also providing users with adequate explanatory and promotional material. The proposed messages and related explanatory material should be shared with the reference CBB(s), and with the obstetrics departments and clinics operating in the area that the BE serves. 191 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition G.3.2.2 The BE identified by a cord blood bank (CBB) as the support structure operating within a healthcare organisation that has a birth centre shall guarantee the systematic application of the procedures issued by the CBB. iz i The BE identified by a CBB as the support structure operating within a healthcare organisation that has a birth centre connected to the CBB, shall guarantee the formal acceptance and systematic adoption of the procedures issued by the CBB for the cord blood donation activities at birth centres. Se rv With reference to clinical, organisational and logistic criteria defined by the reference CBB, and in accordance with the relevant regional and national recommendations, said BE shall guarantee the following activities: a) action to actively provide information on and promote the donation of cord blood; b) enrolment of potential cord blood donors; c) coordination and organisation of logistic matters relating to the donation of cord blood; d) transmission to the reference CBB of all documentation relating to donations, including paediatric assessments prior to the newborn’s discharge; e) co-operation with the CBB in the follow-up of mother and child at 6-12 months after birth for final validation of donated cord HSC. M TI G.3.2.3 The BE running a CBB within its organization shall define, adopt and ensure the application of global management procedures for the process of HSC donation from umbilical cord blood. © SI The BE running a CBB within its organization on the basis of regional and national plans shall define procedures for the activities of the bank, of other corresponding BEs and birth centres. These procedures shall comply with national legislation, with the recommendations and guidelines of the National Blood Centre and National Transplant Centre, and with the IBMDR reference standards, and they shall at least describe the following: a) method for providing information, promoting donations and enrolling potential donors; b) methods for collecting cord blood and blood samples for biological qualification tests; c) criteria and methods for the identification and traceability of cord blood units and the corresponding samples for the purposes of biological qualification and quality control activities; d) methods for the processing, identification, cryopreservation, validation and storage of cord blood units; e) criteria and methods for the follow-up of mother and child at 6-12 months for the definitive validation of the donated cord blood unit; f) methods for requesting and allocating, delivering and transporting cord blood units, focusing particularly on reporting with the IBMDR, which is the sole national centre for dealing with requests for cord blood units and for peripheral and bone marrow HSC from unrelated donors. 192 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition The CBB shall adopt the established procedures and circulate them to the subordinate structures (i.e. birth centres, other BEs at hospitals with birth centres involved in the activities), ensuring their effective acceptance and timely application. G.4 SPECIFIC STANDARDS FOR OTHER CLINICAL ACTIVITIES IN TRANSFUSION MEDICINE iz i G.4.1 For transfusion and infusion treatments, the BE shall guarantee the systematic application of its hospital management’s guidelines, where available and applicable. Se rv G.4.2 The BE shall define and adopt specific procedures for managing therapeutic apheresis activities. G.4.3 The BE shall define and adopt specific procedures for managing its clinical and advisory activities relating to the prevention, diagnosis and treatment of haemolytic disease of the newborn (HDN). G.4.4 The BE shall prepare specific informative documents and procedures governing home transfusions. G.4.1 M TI APPLICATION GUIDELINES For transfusion and infusion treatments, the BE shall guarantee the systematic application of its hospital management’s guidelines, where available and applicable. © SI For transfusions and infusions of medicinal products (plasma derivatives, recombinant coagulation factors, growth factors, etc), in addition to the guidelines in Standard G.2.1.2, the BE shall guarantee the adoption of any available and applicable guidelines issued by its hospital management, particularly relating to the appropriate use of blood components and plasma derivatives as defined by the hospital transfusion committees on which the BE is institutionally required to serve. 193 Società Italiana di Medicina Trasfusionale e Immunoematologia G.4.2 Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition The BE shall define and adopt specific procedures for managing therapeutic apheresis activities. Se rv iz i The BE shall guarantee the adoption of specific procedures defining the organisational and working methods for managing therapeutic apheresis activities in the area it serves, which shall be shared with other interested healthcare areas, and which shall take into account: a) the needs of the healthcare areas served by the BE; b) the availability of staff at the BE, particularly concerning the feasibility of implementing procedures 7 days a week; c) the technological equipment available at the BE; d) the structural and logistic conditions at the BE, particularly concerning the feasibility of ensuring any necessary emergency treatment during the procedure. The clinical conditions of patients requiring apheretic treatments sometimes imply that the treatment has to be started without delay, particularly for certain diseases for which this is considered the elective treatment (e.g. acute polyradiculoneuritis and thrombotic microangiopathies). The BE shall consequently guarantee that therapeutic apheresis procedures are implemented within a period of time judged appropriate, case by case, to avoid any delays having a negative fallout on the efficacy of the treatment. M TI For said purpose, the BE shall define the amount of time allowable between receiving a request and completing the assessment of its clinical appropriateness/ feasibility, and between receiving a request and implementing the therapeutic apheresis procedure, in agreement with the healthcare areas it serves. This time interval shall be defined in relation to the disease to treat, its state of progression and the patient’s clinical conditions at the time. SI Where organisational and/or logistic conditions prevent the systematic performance of therapeutic apheresis procedures within an acceptable period of time, the BE should adopt appropriate alternative organisational methods with the cooperation of other BE(s). © All therapeutic apheresis procedures shall be conducted under the responsibility and supervision of a TM physician at the BE, who shall be on hand and ready to take timely action at the request of the nursing personnel. The practical performance of therapeutic apheresis procedures and patient care before, during and after said procedures shall be entrusted to adequately trained nurses, particularly concerning the handling of the equipment, the procedural methods and the clinical emergencies potentially associated with said treatments. 194 Società Italiana di Medicina Trasfusionale e Immunoematologia G.4.3 Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition The BE shall define and adopt specific procedures for managing its clinical and advisory activities relating to the prevention, diagnosis and treatment of haemolytic disease of the newborn (HDN). The patient care and diagnostic-therapeutic activities for the prevention, diagnosis and treatment of HDN should be defined by a multidisciplinary team representing the parties involved (obstetricians, paediatricians, TM specialists, and any others). iz i Where these activities are not defined or need revision or updating, the BE should be proactive in ensuring that they are defined, revised or updated and effectively implemented. Se rv The BE shall define and adopt specific procedures for managing its clinical and advisory activities relating to the prevention, diagnosis and treatment of HDN, in addition to the content of Section E - Laboratory diagnostic activities in this manual, as regards the diagnostic activities. In compliance with current legislation, the BE shall guarantee the maintenance of a register of the women requiring prophylactic treatment with anti-D immunoglobulins within 72 hours of delivery. Postnatal prophylaxis and/or any antenatal prophylaxis should be documented in the same register. M TI Patients given prophylactic treatment with anti-D immunoglobulins should be followed up for 6 months, preferably recording their outcome in the same register. SI The patient care and diagnostic-therapeutic activities, and the BE’s organisational and working methods should be defined and/or revised in the light of the Raccomandazioni per la gestione della Malattia Emolitica del Neonato developed by the SIMTI in co-operation with the Italian Gynaecology and Obstetrics Society (SIGO), which include the essential technical and clinical recommendations on the topic. G.4.4 The BE shall prepare specific informative documents and procedures governing home transfusions. © For some years there has been a growing tendency to provide patient care at home as an alternative to hospitalisation, particularly for patients suffering from malignancies; these patients are known to frequently need transfusions. Transfusions at home are at potentially higher risk than transfusions in hospital, because the therapeutic resources available (i.e. the services and technologies for dealing with emergencies) are necessarily limited if any severe adverse events occur. For home transfusions, it is therefore particularly important to define specific transfusion procedures capable of minimising the likelihood of clinically relevant adverse events that, judging from available epidemiological evidence, are attributable to human error in most cases. 195 Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition For physicians and nurses performing home transfusions, the BE shall prepare and provide explanatory documents and practical procedures designed to guarantee the proper performance of all stages of the process and its adequate control. M TI Se rv iz i In particular, detailed information and work instructions shall be provided on the topics of: a) the appropriate clinical use of blood components; b) obtaining informed consent to transfusion treatments; c) methods for compiling requests and identifying patients, and for the collection, control and identification of biological samples; d) methods for the collection, transportation and treatment of blood components; e) the management of documents accompanying blood units and the unequivocal association of a patient with a blood unit; f) responsibilities for transfusion (which always lie with a physician); g) methods for handling blood units and the related accessories; in the light of current legislation on matters of personal safety; h) working methods for performing the transfusion and providing patient care during and after the procedure; i) possible adverse events and their management, including the use of medicinal products needed to deal with clinical emergencies; j) disposal of empty containers and the related accessories in the light of current legislation on matters of personal and environmental safety; k) methods for notifying the BE of the performance of transfusions or for returning blood unit(s) if a transfusion has not been administered. G.5 PROCESS CONTROL INDICATORS SI To constantly monitor the quality of the products-services provided and the compliance of the processes implemented with the established standards, the BE shall guarantee the monitoring of at least the indicators listed in the following table. © For the general criteria for planning quality monitoring activities, see Section AGeneral organisational requirements, Ch. A.7.1 Quality monitoring. 196 Reference chapter: Section G / G.2 G.2 G.2 G.3 G.3 G.4 N° 1 2 3 4 5 6 7 © G.4.2 G.3.2.3 G.3.2.3. G.2.1.4 G.2.1.6 G.2.1.3 G.2.1.2 / Reference standard: Section G Therapeutic apheresis Collection and management of cord blood Collection of cord blood No. of adverse events out of No. of treatments provided [data stratified by type of treatment and adverse event] Treatments started within established time limits Adequacy of the cord blood management process at the BE iz i No. of treatments started within the established time limits out of No. of treatments with an established time limit [data stratified by type of disorder and/or type of treatment] No. of cord blood units validated at 6-12 month follow-up out of No. of cord blood units stocked Quality of cord blood collection No. of cord blood units collected with at birth centres an adequate cellularity out of No. of cord blood units collected Se rv Adverse events associated with therapeutic treatments Appropriateness of requests for services M TI Management of adverse events associated with therapeutic treatments Assessment of appropriateness of requests for services No. of inappropriate requests out of No. of requests received No. of guidelines adopted out of No. of different disorders treated SI Application Management of diagnostic-therapeutic of clinical guidelines activities Process control indicator No. of services provided a year [data stratified by type of service] Characteristic to monitor Types and volumes of activities Clinical activities in TM Activity Società Italiana di Medicina Trasfusionale e Immunoematologia Standards of Transfusion Medicine Section G - Haemopoietic stem cell collection and other clinical activities in Transfusion Medicine 2nd Edition 197 1 © M TI SI Se rv iz i iz i Se rv M TI SI © Printed in November 2012 Editor: SIMTI Servizi Srl, Via Desiderio 21, 20131 Milano - Italy Printing: Grafica Briantea Srl, Usmate Velate (MI) - Italy 199 1 © M TI SI Se rv iz i
