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Cell Salvage using an intra-operative cell salvage machine Version 4.1 Name of responsible (ratifying) committee Hospital Transfusion Committee Date ratified 26/10/2012 Document Manager (job title) Transfusion Practitioner Date issued 27/11/2012 Review date 01/10/2017 Electronic location Clinical Policies Related Procedural Documents Blood Transfusion Policy Key Words (to aid with searching) Cell Salvage Blood Transfusion Reinfusion Version Tracking Version Date Ratified Brief Summary of Changes Author 4.1 14/10/2016 Extension to review date agreed HTC Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 1 of 8 CONTENTS 1. 2. 3. 4. 5. 6. 7. 8. 9. QUICK REFERENCE GUIDE ...................................................................................................... 3 INTRODUCTION ......................................................................................................................... 5 PURPOSE ................................................................................................................................... 6 SCOPE ........................................................................................................................................ 6 DEFINITIONS .............................................................................................................................. 6 DUTIES AND RESPONSIBILITIES.............................................................................................. 7 PROCESS ................................................................................................................................... 7 TRAINING REQUIREMENTS ...................................................................................................... 8 REFERENCES AND ASSOCIATED DOCUMENTATION ............................................................ 8 MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL DOCUMENTS.............................................................................................................................. 8 Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 2 of 8 QUICK REFERENCE GUIDE For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy 1. Set up and operation of the equipment Plug in equipment and allow time for self test Disposables needed for collect only include: a 4 litre reservoir, an aspiration and anticoagulation line, ACDA citrate and a yankeur sucker Disposables needed for processing and reinfusion include: a suitably sized bowl processing pack 2. Collect only Hang anticoagulant solution on equipment stand Place the reservoir in the holder, ensuring the clamp is closed Hand the sterile aspiration line to the scrub nurse and receive the end with the spike back Insert spike into anticoagulant bag (with the roller clamp off) and attach to the suction port of the reservoir Connect external suction to the reservoir and turn on. Vacuum should be set at 100mmHg to start but could be increased to between 120 – 140mmHg if brisk blood flow Open the roller clamp on the aspiration line and put 150mls approx into the reservoir, set the drip rate following this at approximately 1 drip per second 3. Setting up the processing pack Open the processing pack and load the bowl into the centrifuge and close the centrifuge support arm. Spin the bowl to ensure it moves freely Fix the tubing into the manifold and sensor lines and ensure locking gates and covers are closed NB the machine will not operate unless all of the above has been completed Color connect the lines accordingly The wash solution is 1000mls Normal Saline (NaCl 0.9%) Ensure that the clamp to the reinfusion bag is open and the retransfusion port clamps are shut The clamp from the reservoir is open The wash solution clamps are open The waste bag is hung on the hooks The equipment is set to automatic, press start at anytime to override this or at the end of the operation to ensure all cells that are available can be processed 4. Processing the salvaged blood for reinfusion Cell washing is automatic when the centrifuge detects a full bowl Once wash cycle is completed the centrifuge will stop, re-suspending the red cells. The pump will reverse and pass the cells to the reinfusion bag along the blue colored line Once complete further blood can be processed 5. Reinfusion of processed blood The reinfusion bag must be labeled with the full patient details e.g. surname, first name, date of birth and hospital number The time and date of collection must be put onto the bag DO NOT USE A PRESSURE CUFF! The bags are not designed for pressure infusion Be aware there will be some residual air in the bags from the system, this air can be removed prior to reinfusion by inverting the bag and opening the clamps to expel the air There is no need to disconnect the bag from the equipment once reinfusion starts, processing can continue Once the operation is completed and no further blood will be salvaged, disconnect the large blue line from the processing pack and use the blue stopper to plug the hole (to avoid drips) Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 3 of 8 The blood can continue with the patient to recovery and/or clinical area Autologous blood must NOT, UNDER ANY CIRCUMSTANCES, be removed from the patient, stored in a clinical area, ward fridge or blood fridge 6. Decontamination of the equipment Once the procedure is completed the disposables can be removed Ensure all clamps are closed and end caps are replaced Disposal of the waste products can be directly into the sluice, taking care to avoid ‘splashing’ All disposables must be placed inside 2 yellow disposal bags and sealed Damp cloth the outside of the equipment to ensure any dirt, dust or spilt blood are removed in between each use 7. Setting up the equipment for Jehovah Witness patients See appendix 1 NB – please note that consultation with patient prior to procedure will establish if complete set up is needed. Most Witnesses will accept cell salvage but do not need to see equipment set up 8. Recording of blood loss and reinfusion totals The approximate blood loss can be calculated using the total processed figure minus the amount of ACDA The amount of unprocessed blood in the reservoir can be worked out by the deducting the approximate amount of ACDA that has been used These 2 figures added together will give you the approximate blood loss 9. Prescriber Role and Responsibilities The prescription of the blood is the responsibility of the Clinician Prescribe on designated prescription sheets using 4 points of patient identification Duration and infusion rate The blood must be identified as ‘AUTOLOGOUS’ blood 10. Identity band All patients, including unconscious patients, must have surname, first name, date of birth, a patient identification number and the gender of the patient recorded on the identity band 11. Observations and administration Cell salvaged blood can be given immediately the processing is finished and can be given stat. Completion of the transfusion must be within 4 hours as per hospital policy for administration Observations should be recorded in line with current hospital policy 12. Documentation (All patients) The patient notes must contain the volume re-transfused and any adverse effects. A follow up note to record the clinical response should also be recorded Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 4 of 8 INTRODUCTION Since the publication of the NHS Executive, Health Service Circular entitled Better Blood Transfusion, published in 1998; attention has focused on blood transfusion for many reasons: Increased demand for blood compared to the decrease in donations Recommendations from the Serious Hazards of Transfusion (SHOT) enquiry, on how the safety of patients receiving blood could be improved Theoretical risk of new-variant CJD Autologous blood transfusion (transfusion of a patient’s own blood) is seen as a valuable advance in improving clinical practice (Department of Health, 2005). There are systems available to collect and re-infuse post-operative patients’ own blood, these are called cell salvage machines In addition to the general benefits of autologous transfusion, cell salvage: Is generally accepted by Jehovah’s Witnesses Allows rapid return of the patient’s own washed red blood cells Can be used in obstetrics Can be used in malignancies Practice in autologous blood transfusion has increased in response to several initiatives and reports; Recommendations from the Serious Hazards of Transfusion (SHOT 2005) enquiry, regarding safety of patients receiving transfusion Department of Health (2002) Better Blood Transfusion 2 circular, which identifies those alternatives to donor blood, and the appropriate use of autologous blood transfusion, should be pursued. This includes intra-operative cell salvage Department of Health (1998) White Paper, The New NHS – Modern and Dependable, which suggests that autologous blood transfusion is seen as a valuable advance in improving clinical practice Potentially lower risks of infection or febrile episodes following autologous blood transfusion in comparison to bank blood (Newman et al, 1997, Gleason and Leone, 1997, Murphy et al, 1991, Tartter, 1988) European Blood Directive 2005, suggests alternative strategies must be considered for effective use of blood Indications for use Any surgery where a blood loss is expected which may result in a post-operative homologous transfusion Any patient who refuses a blood product transfusion for religious or personal beliefs Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 5 of 8 Contraindications for use Surgery involving contamination from bowel contents – although this is contraindicated due to the integrity of the cells, in life threatening situations for people with religious or personal beliefs, cell salvage must continue with care being taken to avoid contamination of the cells Infected wound Bacteraemia or Septic contamination of the autologous blood Presence in collected blood of a substance not suitable for reinfusion e.g. adrenaline or peroxide 1. PURPOSE The purpose of this policy is to: Reduce the risk associated with homologous product transfusion by utilising patients own cells Provide a clear framework and guidance for safe collection and reinfusion of intra-operative cell salvaged blood using a cell salvage machine, throughout Portsmouth Hospitals NHS Trust To ensure a consistent approach to the collection, processing, storage, prescribing, handling and administration of the patient’s own blood throughout the Trust To ensure that all members of staff involved in any stage of the process of transfusing patient’s own blood are aware of their role and the Legal aspects of this Practice To ensure staff competencies are maintained 2. SCOPE Unregistered practitioners can be responsible for assembling the equipment needed but are not allowed to process or administer the shed blood Only Registered Nurses (RN) or Registered Operating Department Practitioners (RODP) who have been trained in the use of the Intra-operative cell salvage machine and have completed the Trust competency, will be allowed to collect, process and reinfuse blood using this system Department managers must satisfy themselves that the RNs/RODP’s who undertake this practice have achieved the level of education and competence required The appropriate manager should keep a record of staff achieving competence and provide copies to the Transfusion Practitioner All staff involved in the administration of autologous blood transfusion must be familiar with the Trusts Blood Transfusion Guidelines and have completed the administration of blood products competency This policy should be read and applied in conjunction with the Trust Blood Transfusion Policy, which is located on the Trust Intranet ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’ 3. DEFINITIONS Homologous – Donated blood from an unknown donor Autologous – The patients own blood Reinfusion – Giving back a patients own shed blood using an intra-operative cell salvage machine Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 6 of 8 RODP – Registered Operating Department Practitioner RN – Registered Nurse Unregistered Practitioner – staff member who does not hold a professional qualification Autotransfusion – reinfusion of patient shed cells 4. DUTIES AND RESPONSIBILITIES The Operational Manager & Professional Lead for Theatres is responsible for all staff; ensuring training is completed in a timely and logical manner The Theatre Training Manager is responsible for providing the training ensuring staff complete their competency prior to carrying out intra-operative cell salvage unsupervised The Transfusion Practitioner is responsible for supporting the Training Manager, assisting where possible with the development of the cell salvage programme. Maintaining records of trained staff, policy updates, quality control and incident reporting Registered Nurses/RODP’s are responsible for identifying their own training needs and operating the machine in accordance to Trust policy 5. PROCESS Rationale This document has been written as a direct result of increased focus on the transfusion process by the publication of the NHS Executive, Health Service Circular entitled Better Blood Transfusion, republished in 2005 and is due to an: Increased demand for blood compared to the decrease in donations Recommendations from the Serious Hazards of Transfusion (SHOT) enquiry, on how the safety of patients receiving blood could be improved Theoretical risk of new-variant CJD Autologous blood transfusion (transfusion of a patient’s own blood) is seen as a valuable advance in improving clinical practice (Department of Health, 2005). There are systems available to collect and re-infuse post-operative patients’ own blood, these are called cell salvage machines A review of the available documentation, has provided a baseline for the policy and resources used include: NPSA Safer Practice Notice 14 – Right Patient Right Blood BCSH Guidelines for Transfusion Handbook of Transfusion Medicine Clinical Networks Department of Health Stakeholders PHT Hospital Transfusion Committee PHT Theatre Departments Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 7 of 8 6. TRAINING REQUIREMENTS Qualified Staff The training will consist of three levels. Level One involves an out of theatre demonstration and principles of cell salvage, allowing time to demonstrate patient selection, assembly of the machine, collection and subsequent re-infusion of bled blood and the safe disposal of and cleaning of the machine and parts therein, according to hospital infection control policy. This will allow for questions and practical demonstration of the running of the machine All members of staff will receive training manual and a training record form supplied by PHT and must complete the competency prior to undertaking any unsupervised cell salvage. No one will be allowed to operate the machine unsupervised in any way unless they have first attended a training session and completed the competencies Level Two will allow time for the operator to develop their own skills whilst undergoing supervision Level 3 will be an established practitioner with additional training responsibilities Unregistered Practitioners Unregistered Practitioners must be aware of their responsibilities and limitations of their role in the assembly and dismantling of the equipment. Under no circumstances must an Unregistered Practitioner operate the cell salvage machine or reinfuse blood to a patient 7. REFERENCES AND ASSOCIATED DOCUMENTATION NHS Executive (2002) Better Blood Transfusion. Health service Circular, DoH Contreras, M (2002) 3rd Edition, ABC of Blood Transfusion. BMI, Rugby National Blood Service (2005) Serious Hazards of Transfusion. SHOT Office, Manchester Farmer, S. Webb, D (2000) Your Body, Your Choice. Media Masters Pte Ltd, Singapore Tawes, R.L (1997) Autotransfusion – Therapeutic Principles and Trends. Gregory Appleton, Detroit Murphy, M. Pamphilon, D. (2001) Practical Transfusion Medicine. Blackwell Science Ltd, London Gleason, D.H, Leone, B.J (1997) Cost effectiveness of blood transfusions; the risks and the benefits Guidelines for the Clinical Use of Red Cell Transfusions, British Committee for Standards in Haematology, Blood Transfusion Task Force in collaboration with the Royal College of Nursing and the Royal College of Surgeons of England. British Journal of Haematology 2001; 113, 24-31 Statutory Instrument 2005 No. 50, The Blood Safety and Quality Regulations 2005 Handbook of Transfusion Medicine (2007), D.B.L. McClelland, 4th Edition. The Stationery Office Norwich European Blood Directive 2005 8. MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL DOCUMENTS Compliance with this policy will be monitored through several key performance indicators: Annual staff updates to ensure compliance with the policy through the APDR Monitoring responses to incidents whilst using the intra-operative system Success / failure to use the system and incidents where the system was not used due to lack of competent staff The results of these indicators will also be reported to the Hospital Transfusion Committee, where any recommendations / required actions will be discussed. These reports will enable the effectiveness of the Policy to be evaluated and presented to the Theatre Training Manager, Theatre Operational Manager and the Hospital Transfusion Committee Policy for the Development and Management of Procedural Documents: Template for Procedural Documents Version 4. Issued: 26th October 2012 (review date October 2017) Page 8 of 8