Download APPENDIX H - Canadian Blood Services

APPENDIX H: GLOSSARY OF ACRONYMS USED IN THIS REPORT
Anti-HBc
Antibody to Hepatitis B Core
AABB
American Association of Blood Banks
International organization of blood banks, transfusion services, and
individuals engaged in blood banking and transfusion standards
determination. Standards do not carry force of law.
ABO
Blood Group Types (can be A, O ,B, or AB)
The blood group of an individual is dependant on the presence or absence
of proteins and sugars called antigens on the surface of blood cells as well
as the proteins called antibodies in the watery part of the blood.
There are four major blood groups: A, O, B, and AB divided into Rh Positive
and Rh Negative types. The most common type in Canada is O Rh Positive.
People with O Rh Negative blood are considered universal blood donors
because patients of all blood types can receive O Rh Negative blood.
A test for Hepatitis B that detects the presence of circulating antibodies
made by the host in response to the Hepatitis B “core” antigen. At this time,
this test is not performed by CBS though discussions are underway with
Health Canada regarding the core test. Core testing is being performed in
the United States. CBS currently tests for Hepatitis B using the HBsAg
(Hepatitis B Surface Antigen) test that detects the outer envelope of the
Hepatitis B virus.
BCIS
Blood Component Issuing System
Computer system used to distribute blood components from blood centres to
hospitals.
BERD
Blood Establishment Regulatory Division
The division of Health Canada that regulates Canada’s blood supply system.
ADMS
Alarm/Data Monitoring System
Computer software system used to monitor ambient conditions in
manufacturing environment (e.g. fridges and freezers, areas where medical
supply inventories are used or stored).
AFFP
Apheresis Fresh Frozen Plasma
Apheresis Fresh Frozen Plasma is collected by apheresis and frozen within
eight hours. Trisodium Citrate anticoagulant is added during the apheresis
process.
Apheresis Fresh Frozen Plasma contains plasma proteins
including all coagulation factors. Apheresis Fresh Frozen Plasma is
indicated for massive transfusion (replacement of patient’s blood volume in
less than 24 hours) with demonstrated deficiency of Factor VIII and V,
otherwise Plasma is adequate. Apheresis Fresh Frozen Plasma is also
indicated in exchange transfusion in neonates.
BERG
Blood Education Resource Group
Group commissioned by CBS that was tasked to review the current
availability of educational resources and identify the needs for specific
additional resources for physicians, technologists, nurses, patients/families,
and public at large.
BLIS/BLIS 2000
Blood Information System
Computer software system used to manage the CBS donor base and
donation information. BLIS 2000 is the year 2000 revision (i.e. Y2K
compliant) of the former BLIS program. To be replaced by the MAK system.
CBA
Canadian Blood Agency
cGMP/GMP
Current Good Manufacturing Practices/Good Manufacturing Practices
Formed in 1991 as a federal, not for profit corporation through which the
provinces and territories would fund and direct the blood system.
Regulations that prescribe the materials, personnel, methods, equipment,
facilities, and controls required for the safe and effective production of
human and veterinary products, medical devices, and processed food. They
define a quality system that manufacturers must use as they build quality in
to their products. For example, approved blood products and components
developed and produced according to GMPs are deemed to be effective,
safe, properly identified, of the correct strength, pure, of high quality, and
suitably labeled.
CBC
Canadian Blood Committee
During the 1980s, the CBC administered provincial and territorial funding for
the Red Cross.
CBS
Canadian Blood Services
A not-for-profit charitable organization whose mandate is to manage the
blood supply in all provinces and territories (excluding Quebec).
CBSI
Canadian Blood Services Insurance, Inc.
The wholly owned subsidiary of CBS, and captive insurance company, which
provides comprehensive insurance coverage for all blood related liabilities.
CEO
Chief Executive Officer
The most senior manager in an organization.
CFO
Chief Financial Officer
The most senior manager in an organization with responsibility for the
finance function.
Good Manufacturing Practices is the terminology used in Canada, while
Current Good Manufacturing Practices is the terminology used in the United
States.
CIHI
Canadian Institute for Health Information
CIHI is the national, not-for-profit organization responsible for coordinating
the development and maintenance of Canadian integrated health information
system. Created in 1996 by Canada’s Health Ministers.
CIHR
Canadian Institutes of Health Research
Canada’s major federal funding agency for health research. Its objective is
to excel, according to internationally accepted standards of scientific
excellence, in the creation of new knowledge and its translation into
improved health for Canadians, more effective health services and products
and a strengthened Canadian health care system. Formerly known as the
Medical Research Council.
CIO
Chief Information Officer
The most senior person in an organization with responsibility for information
management and information technology.
CJD
Creutzfeldt Jakob Disease
Known as Classical CJD, a neurodegenerative disease with sporadic
occurrence in people with a mean age of 60 and incidence rate of one-inone million worldwide for which there is no evidence of transmissibility
through blood. Variant Creutzfeldt Jakob Disease (vCJD) differs from CJD
and represents theoretical risk of being transmissible through blood. Also
see vCJD.
CMV
Cytomegalovirus
Virus related to the herpes virus that can be transmitted through blood. In
immune competent individuals, causes flu like symptoms while it can cause
potentially fatal disease in immuno-compromised patients. CBS tests a
portion of blood donations for CMV to be able to provide hospitals with a
supply of CMV negative blood. Risk of transmission greatly reduced by
leukoreduction.
customer segments, fostering customer-satisfying behaviors and
implementing customer-centric processes. CRM technologies should
enable greater customer insight, increased customer access, more
effective customer interactions, and integration throughout all
customer channels and back-office enterprise functions. (Source:
The Gartner Group)
CUE
Confidential Unit Exclusion
Process by which an individual donor notifies CBS in confidence at time of
donation that his/her unit is/is not to be used for transfusion.
DOP
Departmental Operating Procedure
Department (usually Head Office) specific work instruction.
COP
Centre Operating Procedure
A Centre specific work instruction for manufacturing related process.
CPM
Clinic Performance Monitoring
A tool to monitor performance of blood donor clinics by measuring labour
hours expended at clinics against the clinic’s output; and cost per unit.
CRCS
Canadian Red Cross Society
Charitable organization and former operator of the blood supply system.
CRM
Customer Relationship Management
CRM is a business strategy the outcomes of which optimize
profitability, revenue and customer satisfaction by organizing around
EMT
Executive Management Team
The CBS Senior Management Team comprised of the Chief Executive
Officer; Executive Vice-President, Medical, Scientific and Clinical
Management; Executive Vice-President, Operations; Executive VicePresident, Safety and Performance Management; Vice-President, Human
Resources and Organizational Development; Vice-President, Corporate
Services & Chief Financial Officer; Vice-President and General Counsel;
Director, Corporate Planning and Executive Assistant to the Chief Executive
Officer.
ESS
Event Scheduling System
Automated system for the scheduling and planning of blood donor clinics as
well as staff scheduling for blood donor clinics.
FFP
Fresh Frozen Plasma
Fresh Frozen Plasma is separated from Whole blood, and frozen within eight
hours of collection. Fresh Frozen Plasma contains proteins including all
clotting factors. Plasma also has volume expansion properties. Fresh
Frozen Plasma is indicated for massive transfusion (replacement of patient’s
blood volume in less than 24 hours) with demonstrated deficiency of Factor
VIII and V, otherwise plasma is adequate for transfusion.
FDA
Food and Drug Administration
Agency of the United States’ Department of Health and Human Services that
regulates blood and blood products.
FPMS
Fractionated Products Management System
The computer system used by CBS to manage the inventory and distribution
of fractionated products.
F/P/T
Federal/Provincial/Territorial
Federal, Provincial and Territorial Governments.
FTE’s
Full-Time Equivalents
developed and produced according to GMPs are deemed to be effective,
safe, properly identified, of the correct strength, pure, of high quality, and
suitably labeled.
Good Manufacturing Practices is the terminology used in Canada, while
Current Good Manufacturing Practices is the terminology used in the United
States.
HBV
Hepatitis B Virus
The virus that causes Hepatitis B. CBS currently tests for Hepatitis B using
the HBsAg (Hepatitis B Surface Antigen) test that detects the outer envelope
of the Hepatitis B virus.
HCV
Hepatitis C Virus
The virus that causes Hepatitis C. CBS performs an antibody test for
Hepatitis C that detects antibodies to the Hepatitis C virus which are
developed by the host in response to the presence of the virus. CBS also
performs NAT testing for HCV which is a test that directly tests for genetic
material of the virus itself.
HIV-1/HIV-2
Human Immunodeficiency Viruses 1 and 2
Staffing measure expressed as the number of full-time staff where full-time is
defined as 1,950 working hours per year.
The viruses that cause AIDS (Acquired Immune Deficiency Syndrome).
CBS performs an antibody test for the HIV-1 and HIV-2 viruses that detects
antibodies to these viruses. CBS also performs an antigen test (HIV-1 p24)
for the HIV-1 antigen and performs NAT (Nucleic Acid Amplification Testing)
that tests directly for the genetic material of the HIV-1 virus.
GMP/cGMP
Good Manufacturing Practices/Current Good Manufacturing Practices
H.Q.
Hema-Quebec
Regulations that prescribe the materials, methods, equipment, facilities, and
controls required for the safe and effective production of human and
veterinary products, medical devices, and processed food. They define a
quality system that manufacturers must use as they build quality into their
products.
For example, approved blood products and components
The agency responsible for the blood program in the province of Quebec.
HTLV – I/II
Human T-Cell Lymphotropic I and II Viruses
IVIG/IGIV
Intravenous Immune Globulin
Viruses that can cause a rare form of leukemia in adults. Transmission in
blood greatly reduced by leukoreduction. CBS uses a test to detect
antibodies to HTLV – I and II viruses which are produced by the host in
response to the presence of the virus.
Proteins (antibodies) extracted from human plasma that are primarily used to
treat patients with immune disorders, either immune (antibody) deficiency
disorders or autoimmune disorders.
NB: Acronyms are used interchangeably.
HVAC
Heating, Ventilation, Air Conditioning System
Heating, ventilation, air conditioning systems, or those facility systems which
are among the manufacturing critical systems and therefore require system
validation.
IGIV/IVIG
Intravenous Immune Globulin
Proteins (antibodies) extracted from human plasma that are primarily used to
treat patients with immune disorders, either immune (antibody) deficiency
disorders or autoimmune disorders.
NB: Acronyms are used interchangeably.
Components of the validation process in which:
ISO
International Organization for Standardization
Global federation of national standards bodies from some 130 countries that
work towards creating consistent international quality standards.
IS/IT
Information Services/Information Technology
LB/TB
Lookback/Traceback
Lookback begins with a donor who has tested positive for a transmissible
disease. CBS conducts a targeted search to identify the patients who may
have received earlier donations from that donor, to have these recipients
tested for the infection in question.
Traceback begins with a patient who may have a transfusion-related
infection. CBS conducts a targeted search to identify the donors who gave
that person blood and who may have been the cause of the infection.
LHU
Labour Hours Per Unit
Performance indicator that measures labour hours expended per unit of
whole blood collected.
LIS
Laboratory Information System
Computer system used to integrate donor testing results from testing
equipment with appropriate donor and clinic data in BLIS 2000 (Blood
Information System).
Also referred to as LDMS (Laboratory Data
Management System).
LRF
Leukocytes reduced by filtration
Acronyms and terms used interchangeably.
A filtration process to remove white blood cells from whole blood.
MAK
MAK System
NTL
National Testing Laboratory
Vendors of the “Progesa” software that will be used by CBS to manage
blood collection, processing and distribution to hospitals. It will replace
existing systems such as BLIS 2000 (Blood Information System) and BCIS
(Blood Component Issuing System). MAK also handles “Traceline” software
that manages the tracking of blood from hospital blood banks to recipient.
Head Office Laboratory which provides testing support to blood centres;
performs confirmatory transmissible disease testing for all blood centres;
and houses one of CBS’ four NAT laboratories.
MOU
Memorandum of Understanding
Usually refers to the document signed in 1997 by the
Federal/Provincial/Territorial Ministers of Health to establish a “National
Blood Authority”, later to be named Canadian Blood Services.
NAT
Nucleic Acid Amplification Testing
A new screening test for Hepatitis C and HIV relying on the detection of viral
genetic materials, rather than the host’s immune response to the infection.
CBS has implemented NAT testing for both viruses. NAT is not a Health
Canada licensed test (unlike other testing performed by CBS) but is being
undertaken as an investigational new drug test.
NBSC
National Blood Safety Council
Council responsible for providing advice to the Minister of Health on public
health, ethical, public policy, and other issues pertaining to blood safety,
within the responsibility of the Federal government.
NLC
National Liaison Committee
A one-year pilot, consisting of two meetings, started on October 22, 2001.
The NLC is co-chaired by the two CBS Board of Director’s Consumer
Representatives and is comprised of CLC delegates, representatives from
national organizations such as consumer groups, patient/recipient groups,
health care professionals, hospitals, and national sponsors. Created in
response to the recommendations of the public participation task force.
OH&S
Occupational Health and Safety
A division of Human Resources and Organizational Development that is
responsible for the management of Canadian Blood Services’ Health and
Safety System and Disability Management Programs.
p24
HIV-1 p24 Antigen
A test used by CBS to test for the HIV-1 virus. The test screens for antigens
of the HIV-1 virus. CBS also performs an antibody test for the HIV-1 and
HIV-2 viruses that detects antibodies to these viruses and performs NAT
(Nucleic Acid Amplification Testing) that tests directly for the genetic material
of the HIV-1 virus.
PBCO
Provincial Blood Coordinating Office
An office of the British Columbia Ministry of Health Services established to
integrate and coordinate management of the provincial blood system
including inter-hospital transfer of blood and blood products.
PDSI
Principle Decision Systems International
Automated system used for the scheduling of blood donors.
PO/PMO
Project Office/Project Management Office
The department within CBS that coordinates projects within the organization
and advocates best practices in project management.
P/T
Provincial/Territorial
RBC
Red Blood Cell
Provincial and Territorial Governments
Red Blood Cells are the cellular component of whole blood that carry oxygen
(bound to hemoglobin) to the tissues.
QC
Quality Control
Testing of random samples of blood products manufactured by CBS; other
products manufactured by CBS (e.g. HLA test kits); and medical supply
inventories used by CBS (e.g. blood bags), to ensure that they meet predefined quality standards.
QIR
Quality Improvement Report
Alternative term for NCR (Non-Conformance Report) which is a report that
provides details on a deviation from a manufacturing process including
description, contributing factors, root cause analysis, corrective action, and
measures to minimize potential for recurrence. Depending on the nature of
the non-conformance, reporting to the BGTD (Biologics and Genetic
Therapies Directorate) might be required.
QSA
Quality Systems Associate
CBS, professionally trained quality systems personnel who are responsible
for performing: a quality assurance overview of manufacturing processes;
internal audits; incoming supplies and materials qualifications; document and
data control; change control; non-conformance management; and training
and competency evaluation.
QSM
Quality System Manager
CBS, professionally trained quality systems management personnel who are
responsible for ensuring: a quality assurance overview of manufacturing
processes; internal audits; incoming supplies and materials qualifications;
documents and data control; change control; non-conformance
management; and training and competency evaluation.
Red Blood Cells are the primary product manufactured by CBS from a whole
blood donation.
RFP
Request for Proposal
Request for Proposal is a formal tender document used for purchases over
$30,000 and does not meet the criteria of an RFQ.
RP
Recovered Plasma
Recovered plasma is the plasma that is removed from a whole blood unit
during the processing of packed red cells (+/- platelet concentrate). It is
differentiated from Source Plasma, which is plasma collected from the donor
as an isolated product using a plasmapheresis procedure in which the cells
are returned to the donor and only the plasma is donated.
S&PM
Safety and Performance Management
Division within Canadian Blood Services responsible for maximizing the
quality and safety of CBS’ manufacturing related processes and subsequent
products.
SAP
Systems Applications and Products
Off-the-shelf computer software used by CBS to manage financial
transactions.
SIRP
Service Interruption Recovery Plan
vCJD
Variant Creutzfeldt-Jakob Disease
Emergency, contingency plans to guide operations during times of service
interruption (e.g. power failure, major snow storm, etc).
A neurodegenerative disease that occurs in people thought to be caused by
exposure to contaminated beef products from cattle with BSE. To date,
cases have only been diagnosed in the United Kingdom (>100) and France
(3). The human equivalent of “mad-cow” disease.
SOP
Standard Operating Procedure
System wide work instruction for a manufacturing related process.
WB
Whole Blood
TB/LB
Traceback/Lookback
The unit collected directly from a donor before separation into components.
Comprised of red blood cells; white blood cells; platelets; and plasma.
Lookback begins with a donor who has tested positive for a transmissible
disease. CBS conducts a targeted search to identify the patients who may
have received earlier donations from that donor, to have these recipients
tested for the infection in question.
WBC
White Blood Cell
Cellular component of the blood that is responsible for protecting the body
from invasion by foreign substances such as bacteria, fungi, and viruses.
Traceback begins with a patient who may have a transfusion-related
infection. CBS conducts a targeted search to identify the donors who gave
that person blood and who may have been the cause of the infection.
TD
Transmissible Disease
Disease that can be transmitted from one person to another.
UBMDR
Unrelated Bone Marrow Donor Registry
The function within CBS that locates compatible, committed, healthy
unrelated donors for Canadian bone marrow transplant patients and for
patients around the world.
UK
United Kingdom
US
United States
Acknowledgement: Many of the definitions above were provided by CBS.