Master
Transfusion Medicine
Checklist
CAP Accreditation Program
College of American Pathologists
325 Waukegan Road
Northfield, IL 60093-2750
www.cap.org 06.04.2020
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Disclaimer and Copyright Notice
On-site inspections are performed with the edition of the Checklists mailed to a facility at the completion
of the application or reapplication process, not necessarily those currently posted on the website. The
checklists undergo regular revision and a new edition may be published after the inspection materials
are sent.
For questions about the use of the Checklists or Checklist interpretation, email [email protected] or call
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The Checklists used for inspection by the College of American Pathologists' Accreditation Programs
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All Checklists are ©2020. College of American Pathologists. All rights reserved.
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Transfusion Medicine
Checklist
TABLE OF CONTENTS
SUMMARY OF CHANGES....................................................................................................................5
INTRODUCTION.................................................................................................................................... 7
QUALITY MANAGEMENT AND QUALITY CONTROL........................................................................7
GENERAL ISSUES..............................................................................................................................................................7
REAGENTS and CRITICAL MATERIALS......................................................................................................................... 11
INSTRUMENTS AND EQUIPMENT..................................................................................................................................13
RECORDS..........................................................................................................................................................................14
PROCEDURES AND TESTS...............................................................................................................18
IMMUNOHEMATOLOGICAL PROCEDURES...................................................................................................................18
COMPATIBILITY TESTING............................................................................................................................................... 21
Computer Crossmatches.............................................................................................................................................25
SELECTION OF BLOOD AND COMPONENTS FOR TRANSFUSION............................................................................27
PERINATAL TESTING.......................................................................................................................................................29
TRANSFUSION PROCEDURES......................................................................................................... 31
ADVERSE REACTION PROCEDURES............................................................................................................................36
APHERESIS......................................................................................................................................... 40
DONOR APHERESIS........................................................................................................................................................ 40
THERAPEUTIC APHERESIS............................................................................................................................................ 43
THERAPEUTIC PHLEBOTOMIES...................................................................................................... 46
COMPONENT PREPARATION, STORAGE AND MODIFICATION...................................................48
RED BLOOD CELLS......................................................................................................................................................... 54
RED BLOOD CELLS WASHED........................................................................................................................................ 55
RED BLOOD CELLS FROZEN......................................................................................................................................... 55
RED BLOOD CELLS DEGLYCEROLIZED....................................................................................................................... 56
RED BLOOD CELLS LEUKOCYTE-REDUCED (LABORATORY-PREPARED)...............................................................57
FRESH FROZEN PLASMA............................................................................................................................................... 57
CRYOPRECIPITATE..........................................................................................................................................................58
PLATELETS....................................................................................................................................................................... 59
PLATELETS LEUKOCYTE-REDUCED............................................................................................................................. 62
IRRADIATED CELLULAR COMPONENTS.......................................................................................................................62
STORAGE AND ISSUE OF TISSUES................................................................................................64
BLOOD/COMPONENT DONOR SELECTION AND COLLECTION...................................................66
ALL DONORS (ALLOGENEIC AND AUTOLOGOUS)......................................................................................................67
ALLOGENEIC DONORS ONLY........................................................................................................................................ 72
DONOR BLOOD TESTING............................................................................................................................................... 73
HEMATOPOIETIC PROGENITOR CELLS......................................................................................... 78
QUALITY MANAGEMENT AND GENERAL ISSUES....................................................................................................... 78
COLLECTION.....................................................................................................................................................................80
REAGENTS, SUPPLIES, AND EQUIPMENT................................................................................................................... 82
PROCESSING....................................................................................................................................................................83
CRYOPRESERVATION AND STORAGE......................................................................................................................... 84
ADMINISTRATION.............................................................................................................................................................85
PERSONNEL........................................................................................................................................86
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PHYSICAL FACILITIES.......................................................................................................................87
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ON-LINE CHECKLIST AVAILABILITY AND RESOURCES
Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org)
by logging into e-LAB Solutions Suite. They are available in different checklist types and formatting options,
including:
●
Master — contains ALL of the requirements and instructions available in PDF, Word/XML or Excel
formats
●
Custom — customized based on the laboratory's activity (test) menu; available in PDF, Word/XML or
Excel formats
●
Changes Only — contains only those requirements with significant changes since the previous checklist
edition in a track changes format to show the differences; in PDF version only. Requirements that have
been moved or merged appear in a table at the end of the file.
A repository of questions and answers and other resources is also available in e-LAB Solutions Suite under
Accreditation Resources, Checklist Requirement Q & A.
SUMMARY OF CHECKLIST EDITION CHANGES
Transfusion Medicine Checklist
06/04/2020 Edition
The information below includes a listing of checklist requirements with significant changes in the current edition
and previous edition of this checklist. The list is separated into three categories:
1. New
2. Revised:
●
Modifications that may require a change in policy, procedure, or process for continued
compliance; or
●
A change to the Phase
3. Deleted/Moved/Merged:
●
Deleted
●
Moved — Relocation of a requirement into a different checklist (requirements that have been
resequenced within the same checklist are not listed)
●
Merged — The combining of similar requirements
NOTE: The requirements listed below are from the Master version of the checklist. The customized checklist
version created for on-site inspections and self-evaluations may not list all of these requirements.
NEW Checklist Requirements
Requirement Effective Date
TRM.40145 09/17/2019
TRM.43605 06/04/2020
TRM.43610 09/17/2019
TRM.48060 06/04/2020
TRM.48070 06/04/2020
TRM.48090 06/04/2020
TRM.50150 06/04/2020
TRM.60710 06/04/2020
REVISED Checklist Requirements
Requirement Effective Date
TRM.30575 06/04/2020
TRM.30700 06/04/2020
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TRM.30800 06/04/2020
TRM.31400 06/04/2020
TRM.31900 06/04/2020
TRM.32250 06/04/2020
TRM.40215 06/04/2020
TRM.40600 09/17/2019
TRM.40650 09/17/2019
TRM.40670 09/17/2019
TRM.40700 06/04/2020
TRM.40720 06/04/2020
TRM.40780 09/17/2019
TRM.42170 09/17/2019
TRM.42212 09/17/2019
TRM.42290 09/17/2019
TRM.42305 06/04/2020
TRM.42470 09/17/2019
TRM.42500 06/04/2020
TRM.42600 06/04/2020
TRM.42750 06/04/2020
TRM.42850 09/17/2019
TRM.44450 09/17/2019
TRM.44977 09/17/2019
TRM.45252 09/17/2019
TRM.45254 06/04/2020
TRM.45259 09/17/2019
TRM.45270 06/04/2020
TRM.47100 06/04/2020
TRM.47725 09/17/2019
TRM.47975 09/17/2019
DELETED/MOVED/MERGED Checklist Requirements
Requirement Effective Date
TRM.31250 06/03/2020
TRM.32216 09/16/2019
TRM.32232 09/16/2019
TRM.32350 06/03/2020
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INTRODUCTION
This checklist is used in conjunction with the All Common and Laboratory General Checklists to inspect a
transfusion medicine laboratory section or department.
NOTE: Many of the requirements in this Checklist reflect United States regulatory requirements, particularly
those of the US Food and Drug Administration (FDA). These requirements may not be applicable in other
countries for purposes of CAP accreditation. Laboratories not subject to US regulations must follow national,
state or provincial, and local laws and regulations at minimum.
The term "transfusion service medical director" is used generically throughout the checklist to refer to the
physician who has oversight responsibility for the different services (eg, transfusion service, donor service,
apheresis service, hematopoietic progenitor cell service) addressed by the checklist requirements. Some
laboratories may have separate directors providing oversight for these services; however, all directors must
meet the required qualifications.
Laboratories not subject to US regulations: Checklist requirements apply to all laboratories unless a specific
disclaimer of exclusion is stated in the checklist. When the phrase "FDA-cleared/approved test (or assay)" is
used within the checklist, it also applies to tests approved by an internationally recognized regulatory authority
(eg, CE-marking).
QUALITY MANAGEMENT AND QUALITY CONTROL
GENERAL ISSUES
Inspector Instructions:
●
Sampling of final disposition
●
Blood/tissue supplier agreement
●
Timely provision of blood agreement
●
CBER notification policy
●
What do you do if QC for components is not acceptable?
●
What is your laboratory's risk-reduction system for mistransfusion? How do you
monitor the system's effectiveness?
●
How has your laboratory validated the LIS for blood banking?
●
Select several occurrences in which component QC is not acceptable and follow
records to determine if the steps taken follow the laboratory procedure for corrective
action
TRM.22000 LIS Transfusion Validation Phase II
The laboratory information systems are validated for blood banking/transfusion medicine
activities.
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NOTE: The LIS must be validated at initial installation, and when a change is made to the
system. All possible anticipated permutations of processes should be checked (eg, electronic
crossmatching and release of group specific products). Most laboratories utilize a series of
screen captures to demonstrate the processes in the LIS. Records of system validation must be
retained for at least two years beyond the service life of the system.
REFERENCES
1)
Department of Health and Human Services, Food and Drug Administration. FDA letter to blood establishments, Mar 21, 1994
2)
Cowan DF, et al. Validation of the laboratory information system. Arch Pathol Lab Med. 1998;122:239-244
3)
Food and Drug Administration. Revisions to the requirements applicable to blood, blood components, and source plasma. Fed
Register. 1999(Aug 19):[42CFR606.15(c]
4)
Food and Drug Administration. Guidance for Industry: Blood Establishment Computer System in the User's Facility. April 2013.
TRM.30000 Monthly QC Review Phase II
Quality control data are reviewed and assessed at least monthly by the laboratory director
or designee.
NOTE: The review of quality control data must be recorded and include follow-up for outliers,
trends, or omissions that were not previously addressed.
The QC data for tests performed less frequently than once per month should be reviewed when
the tests are performed.
Evidence of Compliance:
✓
Records of QC review including follow-up for outliers, trends, or omissions
TRM.30550 Misidentification Risk Phase II
The facility has a written program to ensure that the risk of pretransfusion sample
misidentification and other causes of mistransfusion are monitored and subjected to
continual process improvement.
NOTE: The laboratory must actively monitor the key elements of the transfusion process,
including, as applicable, donor management, unit production and handling, sample identification
and testing, and the transfusion itself including recipient identification.
Evidence of Compliance:
✓
Occurrence records/error logs demonstrating appropriate review and follow-up of significant
errors and patterns of errors in identification and other processes AND
✓
Records of investigation and appropriate corrective action (eg, education of staff, changes
in procedures, etc.) for significant errors, including review of monitoring data for corrective
action and process improvement, when appropriate
REFERENCES
1)
Linden JV, et al. A report of 104 transfusion errors in New York State. Transfusion. 1992;32:601-6
2)
Dzik WH, et al. An international study of the performance of patient sample collection. Vox Sanguinis 2003;85:40-47
3)
Lumadue JA, et al. Adherence to a strict specimen-labeling policy decreases the incidence of erroneous blood grouping of blood
bank specimens. Transfusion 1997;37:1169-72
**REVISED** 06/04/2020
TRM.30575 Misidentification Risk Phase II
The facility has a system to reduce the risk of mistransfusion for non-emergent red cell
transfusions.
NOTE: Mistransfusion occurs from misidentification of the intended recipient at the time of
specimen collection for pretransfusion testing, during laboratory testing and preparation of
units to be issued, and at the time of transfusion. Misidentification at sample collection occurs
approximately once in every 1,000 samples, and in one in every 12,000 transfusions the recipient
receives a unit not intended for or not properly selected for him/her.
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Risk reduction options that might be considered include:
●
Verifying the ABO group of the intended recipient on a second sample collected
at a separate phlebotomy (including the recording of the result in the institution's
historical record)
●
Utilizing a mechanical barrier system
●
Utilizing an electronic identification verification system that ensures that the
patient from whom the pretransfusion specimen was collected is the same
patient who is about to be transfused
●
Other approaches capable of reducing the risk of mistransfusion.
The laboratory is expected to participate in monitoring the effectiveness of the system that it
implements.
The laboratory should also consider improvements in procedures and/or educational efforts as
part of its program to reduce the risk of mistransfusion.
REFERENCES
1)
WH Dzik, MF Murphy, G Andreu, MD et al. An international study of the performance of patient sample collection. Vox Sanguinis
2003;85:40-47
2)
Lumadue JA, Boyd JS, Ness PM. Adherence to a strict specimen-labeling policy decreases the incidence of erroneous blood
grouping of blood bank specimens. Transfusion 1997;37:1169-72
3)
Wenz B, Burns ER. Improvement in transfusion safety using a new blood unit and patient identification system as part of safe
transfusion practice. Transfusion. 1991;31:401-3
4)
Callum JL, Kaplan HS, Merkley LL et al. Reporting of near-miss events for transfusion medicine: improving transfusion safety.
Transfusion 2001;41:1204-11
5)
Bolton-Maggs PHB, Wood EM, Wiersum-Osselton C. Wrong blood in tube - potential for serious outcomes: can it be prevented? Br J
Haematol. 2015;168:3-13. Doi: 10.1111/bjh.13137.
**REVISED** 06/04/2020
TRM.30700 QC Records Phase II
The laboratory has records for components prepared that do not meet the quality control
requirements, including investigation, corrective action taken, and final disposition.
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for finished pharmaceuticals. Washington, DC: US Government
Printing Office, 1999(Apr 1):[21CFR211]
2)
Food and Drug Administration. Additional standards for human blood and blood products. Immune globulin (Human). Washington,
DC: US Government Printing Office, 1999(Apr 1):[21CFR640.100]
**REVISED** 06/04/2020
TRM.30800 Disposition Records Phase II
There is a record of the disposition of all blood components, derivatives, cellular therapy
products, tissues, including the method of destruction, as applicable, or transfer of units
unsuitable for transfusion or transplant.
NOTE: The disposition of each product or tissue obtained by the laboratory, including recovered
plasma where appropriate, is recorded. "Record of disposition" refers to whether the product,
component, derivative, or tissue was transfused, transplanted, discarded or returned. The
method of destruction must be specified in the facility's policies and procedures when applicable.
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Records.
Washington, DC: US Government Printing Office, current edition:[21CFR606.160]
TRM.30850 Adequate Blood/Tissue Supply Phase II
There is a written agreement or letter of understanding between the transfusion service
and its blood/tissue supplier(s) to ensure an adequate and safe blood/tissue supply.
NOTE: This agreement should include the means for maintaining inventory, requirements for
notification when a donor or components are found to be seropositive, and redistribution of
components for disaster or emergency need, which could include obtaining needed components
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by drawing donors or by agreement with another facility. For services provided by an outside
blood center (eg, provision of blood and blood products, referral laboratory support, donor
testing), a hospital must have an agreement approved by the transfusion service medical director
and hospital administration. Information regarding means of immediate communication to the
blood supplier (eg, phone numbers) must be readily available to laboratory staff.
Evidence of Compliance:
✓
Copy of approved agreement (eg, contract) with blood/tissue supplier(s)
REFERENCES
1)
Sazama K. The changing relationships in transfusion medicine. Arch Pathol Lab Med. 1999;123:668-671
TRM.30866 Service Agreement Phase II
There is a written policy or agreement between the transfusion service and the clinical
areas for which it provides transfusion and transplantation support (eg, surgery,
emergency room, patient care units) to ensure timely provision of blood, blood
components and tissue.
NOTE: The policy or agreement should define the expectations for turnaround time, requests for
patients with special transfusion needs (eg, CMV negative, leukoreduced), notifications of delays
in obtaining suitable products, and transportation of components and products.
Evidence of Compliance:
✓
Copy of approved agreement (eg, policy, transfusion committee meeting minutes, written
statement) detailing the transfusion support services that will be provided to the clinical areas
TRM.30882 Supplier Evaluation/Selection Process Phase II
The transfusion service laboratory has a process for evaluating and selecting suppliers of
critical materials and monitoring suppliers' ability to meet the laboratory's needs.
NOTE: The definition of “critical materials” is given in the “Reagents and Critical Materials”
section, below.
Evidence of Compliance:
✓
Written procedure for evaluation, selection and monitoring of suppliers AND
✓
Records of supplier monitoring
TRM.30900 Records of Deviation From SOP Phase II
The transfusion service medical director or designee provides written authorization for
deviations from the standard operating procedures.
NOTE: The standard operating procedures constitute the approved procedures of the laboratory
and are to be followed at all times. Any deviations from these procedures must either be
authorized by the responsible transfusion medicine medical director or designee prior to their
performance or, if detected only after the event, must be investigated through the laboratory's
quality assurance process. A wide variety of routine procedures may, from time to time, require
the transfusion service medical director or designee to authorize an alternative approach
because of specific clinical situations. Among these, for example, might be the need to give Rh
positive red cells to an Rh negative recipient because of inventory shortages, or to provide a
unit of platelets that was not HLA-matched (or “crossmatch compatible” or “antigen-negative,”
depending on the laboratory's routine approach) to an alloimmunized patient in an attempt to
control hemorrhage.
REFERENCES
1)
Lam H-TC, et al. Are retrospective peer-review transfusion monitoring systems effective in reducing red blood cell utilization? Arch
Pathol Lab Med. 1996;120:810-816
2)
Shulman G, et al. Creating useful statistics to audit transfusion services. Lab Med. 1998;29:371-374
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TRM.30950 CBER Notification Phase II
There is a policy requiring notification of the Center for Biologics Evaluation and
Research according to US federal regulations when a biological product deviation occurs.
NOTE: Deviations may include compatibility testing, component preparation, labeling, storage,
and distribution of units for transfusion. A Biologic Product Deviation (BPD) is reportable to
CBER if the transfusion service releases a blood product from its control and the error has the
potential to affect the safety, potency or purity of the product, even if it is not administered to
a patient. A laboratory or transfusion service that performs manufacturing activities is required
to report to the Center for Biologics Evaluation and Research (CBER), Office of Compliance
and Biologics Quality (OCBQ) as soon as possible, but not to exceed 45 calendar days from
the date of discovery of information reasonably suggesting a reportable event has occurred.
In accordance with 21CFR606.171, transfusion facilities that are not licensed or registered
with FDA are required to report to FDA any deviations or unexpected events associated with
manufacturing that may affect the safety, purity or potency of a distributed product.
Evidence of Compliance:
✓
Records of reportable events, as applicable
REFERENCES
1)
US Food and Drug Administration Biologic Product Deviation Reporting https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/biological-product-deviation-reporting-blood-and-plasma-establishments
REAGENTS AND CRITICAL MATERIALS
A “critical material” is a good or supply used in the collection, preservation, storage, preparation, or testing of
blood components that directly affects quality or patient safety (for example, blood collection sets).
Inspector Instructions:
●
Sampling of test procedures for reagent handling
●
Sampling of current reagent/critical material package inserts, for consistency with
written procedures
●
Sampling of records of new reagent and critical material lot inspection and evaluation
●
Inventory log
●
Sampling of typing sera/reagent cell reactivity QC records
●
Sampling of reagents (expiration date, storage)
●
How do you store reagents and controls used in test procedures?
●
How do you evaluate new lots of critical materials?
●
How does your laboratory manage and control reagent inventory?
●
Review a sampling of QC data over the previous two-year period. If there is an
occurrence in which typing sera/reagent cell QC is not acceptable, follow records to
determine if the steps taken follow the laboratory policy for corrective action
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Additional requirements are in the REAGENTS section of the All Common Checklist.
TRM.31227 Package Inserts Phase II
Current package inserts are available for the reagents and other critical materials used by
the laboratory.
NOTE: The laboratory must have a procedure that assures that:
●
The most current package insert is in use
●
The relevant procedures are updated when changes to the package insert occur.
TRM.31234 Reagent Handling Phase II
Typing sera and other critical materials are used according to the manufacturers'
directions, or if alternative procedures are used, validation records confirm that they
perform as intended.
NOTE: Typing sera and other critical materials must be used according to the manufacturers'
instructions. Testing methods used for ABO, Rh and antibody screening that are different
from the manufacturers' instructions, are acceptable provided they are not prohibited by the
manufacturer, and have been demonstrated to be satisfactory, or, for laboratories subject to US
regulations, have been approved by CBER.
For FDA-licensed blood agencies, use of approved reagents in a manner not consistent with
manufacturer's directions may require prior FDA authorization.
REFERENCES
1)
Food and Drug Administration. Guide to inspections of blood banks, 1994(Sep)
2)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1271(a)(1)]
TRM.31241 Reagent QC Phase II
All new lots of reagents and critical materials (eg, blood collection sets) are inspected and
tested, as applicable, before use, with records of acceptance.
TRM.31375 Inventory Control Phase II
An inventory control system tracks the use of all lot numbers of critical materials
received.
NOTE: Records must include dates received and placed into use, and the disposition of
unacceptable materials.
Evidence of Compliance:
✓
Inventory log (paper or electronic)
**REVISED** 06/04/2020
TRM.31400 Antisera/Reagent Red Cell QC Phase II
There are records of acceptable reactivity and specificity of typing sera and reagent red
cells on each day of use, including a check against known positive and negative cells or
antisera, or manufacturer's instructions for daily quality control are followed.
NOTE: Unless manufacturer's instructions state otherwise, the following apply:
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■
Typing reagents, including antisera (eg, anti-D, anti-K, anti-Fy(a)) and reagent red cells
must be checked for reactivity and specificity on each day of use. Typing antisera must
be checked with known positive and negative cells; reagent red cells must be checked
with known positive and negative antisera.
■
Each cell used for antibody screening must be checked each day of use for reactivity of
at least one antigen using antisera of 1+ or greater avidity.
■
Anti-IgG reactivity of antiglobulin reagents may be checked during antibody screening
and crossmatching.
This checklist requirement can be satisfied by testing one vial of each reagent lot each day of
testing.
For red cell antibody panels, manufacturer's instructions and control processes, as outlined in
the facility's written procedures (eg, ruling out antibodies, antigen typing of patient cells for the
corresponding antibody) must be followed.
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7171 [42CFR493.1271(a)]
INSTRUMENTS AND EQUIPMENT
The checklist requirements in this section should be used in conjunction with the requirements in the All
Common Checklist relating to instruments and equipment.
Inspector Instructions:
●
Procedure for evaluating and approving the use of products that were collected or
processed under compromised conditions
●
Sampling of semi-annual serologic centrifuge checks (mechanical timer and speed)
●
Sampling of blood volume regulator QC records
**REVISED** 06/04/2020
TRM.31900 Serologic Centrifuge Checks Phase II
Mechanical timers on serologic centrifuges, and the speed of the centrifuge, are checked:
●
Initially
●
After adjustments and repairs
●
At least every six months
NOTE: The frequency of such checks should be based on the historical stability of the centrifuge.
This requirement does not apply to digital timers.
Evidence of Compliance:
✓
Records of serologic centrifuge checks at defined frequency
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Equipment. Washington, DC:
US Government Printing Office, 2000(Apr 1):[21CFR606.60(b)]
TRM.32200 Blood Volume Standardization Phase II
Equipment used to regulate volume of blood drawn from blood donors or individuals
undergoing therapeutic phlebotomy is standardized with a container of known mass or
volume before initial use and after repairs or adjustments, and checked according to the
manufacturer's recommended intervals, with result recorded.
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NOTE: Devices such as agitators, balances, and scales must be standardized with a container
of known mass or volume. This must be done before initial use and after repairs or adjustments,
and checked as instructed or recommended by the manufacturer to ensure that the correct
volume is drawn. If the manufacturer does not provide or recommend a quality control testing
interval, the facility must specify the frequency of testing.
Evidence of Compliance:
✓
QC records showing standardization checks at defined frequency
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Equipment. Equipment.
Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.60]
2)
ibid. Equipment. Supplies and reagents. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.100]
TRM.32208 Collection/Processing Equipment Phase II
There is a procedure to assess the conformance of blood, components or tissues when
equipment used for collection or processing is found to be out of calibration. Records are
retained.
NOTE: Traditional good manufacturing practices generally do not allow for therapeutic use of
products collected under compromised conditions, but the life-saving and irreplaceable nature
of stem cells and similar components may be a legitimate exception. Although it is impossible
to retroactively correct for potential errors in collection and processing when the system is
later found to be compromised, the laboratory should have a procedure for dealing with such
situations to determine whether the affected component(s) are or can be made to be suitable for
their intended use. Records must include the approval of the potentially compromised product by
both the transfusion service medical director and clinically responsible physician.
Evidence of Compliance:
✓
Written procedure for evaluating and approving the use of products that were collected or
processed under compromised conditions AND
✓
Records of approval for potentially compromised products AND
✓
Records of disposal for unsuitable products
RECORDS
The following routine records must be retained and available as required by applicable national, federal, state
(or provincial), and local law; but, in no instance for fewer than five years after the records for processing have
been completed, or six months after the latest expiration date for an individual component (whichever is later), in
accordance with 21 CFR 606.160 and 42CFR493.1103 through 493.1105.
Inspector Instructions:
●
Record retention policy
●
Applicable FDA registration or license
●
Review a sampling of units (one or more component types) to ensure that all steps
from donor draw or receipt of blood components, through storage and testing to
final disposition, including transfusion, are recorded. Determine if records provide an
adequate audit trail of all activities.
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**REVISED** 06/04/2020
TRM.32250 Record Retention Phase II
Records are retained for an appropriate period.
NOTE: Records must be retained per the current CAP requirements, and in conformity with
national, federal, state (or provincial), and local laws and regulations. At the time of this checklist
edition, the requirements are as listed in the table below.
Extension of the retention periods may be appropriate for optimal patient care in certain
circumstances.
These requirements apply only to donor and transfusion-related testing and activities. Refer to
the general retention requirements in the Laboratory General Checklist (GEN.20377) for testing
not related to transfusion.
TYPE OF RECORD RETENTION PERIOD
Donor Records
●
Blood/component donor information, consent and
collection
●
Donor blood testing
●
Donor notification of significant findings
●
Component production
●
Look back investigation/disease reporting
●
Final unit disposition
●
Irradiation of cellular components
●
Acceptability of returned units into inventory
10 years
●
Indefinitely and permanently deferred donors
●
Donors placed under surveillance (for recipient
protection
Indefinitely
Patient Records
●
Transfusion administration records (TRM.41450)
●
Therapeutic phlebotomy/apheresis records
●
Final unit disposition
10 years
●
Patient pre-transfusion testing results/
interpretation
●
Immediate evaluation/interpretation of transfusion
reactions
●
Evaluation/interpretation of delayed transfusion
reactions
●
Emergency release of blood, including signature
of requesting physician obtained before or after
release
10 years
●
Transfusion problems such as difficulty in
blood typing, transfusion reactions, unexpected
antibodies, and special transfusion requirements.
Indefinitely
Other Records
●
Employee signatures, initials, identification
codes, and inclusive dates of employment
●
Identification of individuals performing each
significant step in collection, processing,
compatibility testing, and transportation of blood
and blood components
10 years
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●
Traceability of blood, blood components, and
critical materials
●
Final inspection and verification of blood before
issue
●
Container (eg, portable coolers) qualification/
process validations
●
Competency records
●
Orders and requests for blood/blood components
●
Blood supplier agreements
●
Review and approval of new and revised policies
and procedures before use
5 years
Quality Control Records
●
Management reviews for the effectiveness of the
quality system
●
Proficiency testing records
●
Irradiation dose delivery
●
Procedure review/procedure discontinued
5 years
●
Control systems for donor testing
●
Retyping of donor units
●
Inspections of blood/critical materials
●
Instrument/equipment quality control and
maintenance
●
Control systems for patient testing
●
Inspection of weld for completeness
●
Temperature monitoring (eg, graphs, logs) of
refrigerators, freezers, and platelet incubators
10 years
Tissue Records (including bone marrow and/or
progenitor cells)
●
Collection, transportation, processing, issuing,
and disposition
10 yrs beyond tissue's disposition or
expiration, whichever is longer
●
Daily temperature monitoring
●
Investigation of adverse events
●
Discontinued policies, procedures and other
controlled documents
10 years
TRM.32275 Component Records Phase II
Records are retained for each component from collection or receipt through processing,
storage, and testing, to final disposition.
TRM.32300 Receipt of Blood Phase II
Records include information about all blood received from outside sources.
Evidence of Compliance:
✓
Written procedure defining the required information as stipulated by the laboratory AND
✓
Invoices, shipping records and/or logs for all incoming blood components
TRM.32900 Bacteriologic Studies Phase II
Records include information about bacteriologic studies (when indicated).
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Evidence of Compliance:
✓
Culture results from transfusion reactions with suspected bacterial contamination AND
✓
Records for in-house bacterial contamination testing of random and apheresis platelets not
tested by the blood supplier
TRM.33200 Personnel Audit Trail Phase II
The laboratory can identify the person performing each significant step in the collection,
processing, testing, storage, and distribution of blood and blood components.
NOTE: Records must be complete and all relevant data available, including results,
interpretation, dates, and identity of persons performing the work. A personnel audit trail must be
maintained for each significant step in the collection, processing, testing, storage, and distribution
of blood and blood components.
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Records.
Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.160]
TRM.33300 License/Registration of Laboratory Phase II
If blood components or cellular therapy products are collected or modified, even if only
for autologous collections, the blood bank or transfusion service is licensed or registered
appropriately.
NOTE: The blood bank or transfusion service must have appropriate registration or license,
as required by the FDA. 21 CFR 607.20 of the Code of Federal Regulations states that all
establishments that engage in the manufacture of blood products are required to register with the
FDA. This includes blood centers or transfusion services that irradiate, wash, or deglycerolize
components. The laboratory must have appropriate FDA registration form(s) available for the
Inspector to examine.
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PROCEDURES AND TESTS
IMMUNOHEMATOLOGICAL PROCEDURES
Inspector Instructions:
●
Sampling of blood type/antibody screen policies and procedures
●
Sampling of QC policies and procedures
●
Sampling of QC records
●
Sampling of critical patient results/log
●
Technologist performing testing (recording results at the time of testing)
●
What is your laboratory's course of action when ABO and Rh typing results are not in
agreement with the patient's historical record?
●
How does your laboratory ensure that the direct antiglobulin test detects RBC-bound
complement as well as IgG?
●
How do you confirm negative antiglobulin tests?
●
How do you determine when quality control is unacceptable and when corrective
actions are needed?
●
How do you document critical results? Who do you contact?
●
Select several occurrences in which QC is out of range and follow records to
determine if the steps taken follow the laboratory policy for corrective action
TRM.40050 Agglutination/Hemolysis Criteria Phase II
Criteria for agglutination and/or hemolysis are defined.
NOTE: Criteria must be defined in the procedure manual to provide uniformity of interpretation of
positive and negative agglutination and hemolysis results.
TRM.40100 Test Result Recording Phase II
Observations of all test results are recorded properly at the time the test is performed.
NOTE: Test results must be recorded at the time the test is performed in order to reduce the risk
of transcription errors from delayed recording.
TRM.40120 QC Handling Phase II
Control specimens are tested in the same manner and by the same personnel as patient/
donor samples.
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NOTE: QC specimens must be analyzed by personnel who routinely perform patient/donor
testing. This does not imply that each operator must perform QC daily, so long as each
instrument and/or test system has QC performed at required frequencies, and all analysts
participate in QC on a regular basis. To the extent possible, all steps of the testing process must
be controlled.
Evidence of Compliance:
✓
Records reflecting that QC is performed by the same personnel performing patient testing at
defined frequency
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7166 [42CFR493.1256(d)(7)(8)] .
TRM.40130 Alternative Control Procedures Phase II
If the laboratory performs test procedures for which control materials are not
commercially available, there are written procedures for an alternative mechanism to
detect immediate errors and monitor test system performance over time. The performance
of alternative control procedures must be recorded.
NOTE: "Performance" includes elements of accuracy, precision, and clinical discriminating
power. Examples of alternative procedures may include split sample testing with another method
or with another laboratory, the testing of previously tested patient specimens in duplicate, testing
of patient specimens in duplicate, or other defined processes approved by the laboratory director.
Evidence of Compliance:
✓
Written procedures for alternative quality control AND
✓
Records of alternative control procedures
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1256(h)].
TRM.40140 QC Confirmation of Acceptability Phase II
The results of controls are reviewed for acceptability before reporting results.
Evidence of Compliance:
✓
Written policy stating that controls are reviewed and acceptable prior to reporting patient
results AND
✓
Records of control result approval
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7166 [42CFR493.1256(f)].
**NEW** 09/17/2019
TRM.40145 QC Corrective Action Phase II
There are records of corrective action when control results exceed defined acceptability
limits.
NOTE: Patient/client test results obtained in an analytically unacceptable test run or since the last
acceptable test run must be re-evaluated to determine if there is a significant clinical difference
in patient/client results. Re-evaluation may or may not include re-testing patient samples,
depending on the circumstances.
Even if patient samples are no longer available, test results can be re-evaluated to search for
evidence of an out-of-control condition that might have affected patient results. For example,
evaluation could include comparison of patient means for the run in question to historical patient
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means, and/or review of selected patient results against previous results to see if there are
consistent biases (all results higher or lower currently than previously) for the test(s) in question.
The corrective action for tests that have an IQCP approved by the laboratory director must
include an assessment of whether further evaluation of the risk assessment and quality control
plan is needed based on the problems identified (eg, trending for repeat failures, etc.).
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003 (Oct 1): 1046 [42CFR493.1282(b)(2)]
2)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003 (Oct 1): 1046 [42CFR493.1282(b)(1)(i)]
TRM.40150 Anti-D Controls Phase II
Appropriate control(s) are used for anti-D testing.
NOTE: If an anti-D reagent contains a potentiating diluent, the appropriate control is the diluent
alone.
Evidence of Compliance:
✓
Written procedure defining controls used for anti-D testing consistent with manufacturer's
instructions AND
✓
Records of anti-D control results
TRM.40200 DAT Controls Phase II
When performing an antiglobulin test with anti-IgG or polyspecific antiglobulin reagents,
IgG-coated red blood cells are used as a control in all negative antiglobulin tests.
NOTE: IgG-coated red blood cells must be used to confirm all negative antiglobulin test results
when the antiglobulin reagent used for testing has anti-IgG reactivity. Tests found negative
by tube methodology must be verified by obtaining a positive test result after adding IgG-
coated (control) red blood cells. If a licensed blood typing system is used that does not require
verification of negative test results using IgG-coated red blood cells, an appropriate quality
control procedure must be followed, as recommended by the manufacturer.
Evidence of Compliance:
✓
Records of testing that include control results confirming negative antiglobulin tests
TRM.40210 DAT Phase II
When performing an antiglobulin test with anti-C3 antiglobulin reagents, C3-coated red
blood cells are used as a control in all negative antiglobulin tests.
NOTE: Complement-coated red blood cells must be used to confirm all negative antiglobulin
test results when the antiglobulin reagent used for testing has anti-C3 reactivity. Tests found
negative by tube methodology must be verified by obtaining a positive test result after adding C3-
coated (control) red blood cells. If a licensed blood typing system is used that does not require
verification of negative test results using C3-coated red blood cells, an appropriate quality control
procedure must be followed, as recommended by the manufacturer. If a polyspecific antiglobulin
reagent is used, refer to checklist item TRM.40200.
Evidence of Compliance:
✓
Records of testing that include control results confirming negative antiglobulin tests
**REVISED** 06/04/2020
TRM.40215 ABO Typing on Solid Organ Donors Phase I
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Laboratories participating in donor evaluation for solid organ transplantation have a
written policy for ABO typing, and A subgroup typing on group A and AB donors.
NOTE: If the organ donor has been transfused with red blood cells in the past three months, ABO
subgroup typing must be performed on a pretransfusion sample. This is due to the possibility of
misinterpretation of ABO typing.
REFERENCES
1)
Organ Procurement and Transplantation Network (OPTN). OPTN Policies. Richmond, VA: OPTN; April 2016. (Accessed at https://
optn.transplant.hrsa.gov/media/1200/optn_policies.pdf).
COMPATIBILITY TESTING
This section applies whenever crossmatching is performed. The Inspector should pay particular attention to the
Laboratory General Checklist - SPECIMEN COLLECTION, DATA HANDLING, AND REPORTING regarding
acquisition of samples for testing.
Inspector Instructions:
●
Sampling of compatibility testing policies and procedures
●
Sampling of historical record checks
●
Sampling of confirmation of donor unit ABO/Rh records
●
Sampling of worksheets/computer records with forward and reverse grouping,
autologous and allogeneic serologic crossmatches
●
Collection of blood specimen used for compatibility testing (patient identification,
specimen labeling)
●
How is the phlebotomist identified who has collected the specimen for compatibility
testing?
●
What do you do if the specimen label does not match the requisition exactly?
●
If applicable, how do you handle neonatal transfusions? What blood groups are
transfused?
●
If there had been an instance when the ABO and Rh typing results were not in
agreement with the patient's historical record, further evaluate the laboratory's
responses, corrective actions and resolutions
TRM.40230 Compatibility Specimen Labeling Phase II
All blood samples used for compatibility testing are labeled in the presence of the patient
with:
1. Patient's first and last name
2. Unique identification number
3. Date of collection
4. A method to identify the phlebotomist.
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NOTE: Blood specimens collected for compatibility testing must be positively and completely
identified and labeled before leaving the patient. Acceptable practices for positive identification
of patient and blood specimen labels must be defined in the procedure manual and may include
visual inspection and/or an electronic system to read the identifying information contained in bar
codes or radio-frequency identification (RFID) microchips or the patient's wristband. Acceptable
practices for generating specimen labels must be defined in the procedure manual (refer to
GEN.40490) and may include electronic devices utilizing information encoded in bar codes or
RFID microchips. There must be a dependable method to identify the phlebotomist who collected
the blood sample, such as initials or another identifier on the tube, or an electronic record.
Evidence of Compliance
✓
Written procedure defining labeling requirements of specimens for compatibility testing
✓
Written procedure defining system identifying the phlebotomist collecting compatibility testing
specimens
REFERENCES
1)
Wenz B, et al. Practical methods to improve transfusion safety by using novel blood unit and patient identification systems. Am J Clin
Pathol. 1997;107(suppl 1):S12-S16
2)
Dale JC, Renner SW. Wristband errors in small hospitals. A College of American Pathologists' Q-Probes study of quality issues in
patient identification. Lab Med. 1997;28:203-207
3)
Sandler SG, Langeberg A, Carty K, Dohnalek LJ. Bar codes and radio-frequency technologies can increase safety and efficiency of
blood transfusions. LabMedicine 2006;37:436-439
4)
Sandler SG, Langeberg A, DeBandi L, Gibble J, Wilson C, Feldman CL. Radio frequency identification technology can standardize
and document blood collections and transfusions. Transfusion 2007;47:763-70
TRM.40250 Specimen/Requisition Verification Phase II
An appropriately trained member of the transfusion service confirms that all identifying
data on the transfusion requisition (paper or electronic) is identical to the information on
the specimen tube before compatibility testing.
NOTE: Laboratories must have a policy on how to handle truncated names on labels, if
applicable.
Evidence of Compliance:
✓
Written procedure for verifying that the requisition/computer order matches the information on
the specimen label
TRM.40300 Historical Record Check Phase II
ABO, Rh, and antibody screen test results are compared against results of the same tests
recorded previously to detect discrepancies and identify patients requiring specially
selected units.
NOTE: Comparison of records of previous ABO and Rh typing are an essential step in
compatibility testing. Available laboratory records for each patient must be routinely searched
whenever compatibility testing is performed. The historical record search can be performed
manually by qualified laboratory personnel or by a validated computer system capable of
performing historical checks. If no record of the patient's blood type is available from previous
determination(s), the transfusion service should be aware that there is an increased probability
of an incorrect blood type assignment and, consequently, of a hemolytic transfusion reaction. If a
laboratory collects an additional sample for the purpose of verification of patient identity, a repeat
antibody screen need not be performed on this specimen.
Evidence of Compliance:
✓
Written procedure for checking ABO/Rh and antibody screening results with historical results
AND
✓
Records of historical checks OR
✓
Records of LIS historical check validations
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TRM.40350 Typing Discrepancies - Investigation/Reconciliation Phase II
There are records of the investigation and reconciliation of all cases in which the ABO and
Rh typing results were not in accord with the patient's historical record.
NOTE: Available laboratory records for each patient must be routinely searched whenever
compatibility testing is performed. Quality management records must include an investigation
of all cases in which the ABO or Rh typing was not in accordance with the patient's laboratory
historical record.
TRM.40450 Donor Unit ABO/Rh Confirmation Phase II
There are records of the confirmation of the ABO group of all red blood cell components
and as appropriate, Rh type, using a sample of red blood cells from an attached segment.
NOTE: All donor red cell units must have the ABO group confirmed, using a sample from an
attached segment. The D negativity of units labeled "Rh-negative" must be similarly confirmed.
Records must show that the result was acceptable before the unit is made available for
transfusion. Tests for weak D are not required for confirmation of Rh-negative units. A transfusion
service may choose to omit the confirmation of the unit's ABO/Rh type if the transfusion service
patient pre-transfusion and/or compatibility testing was performed at another CAP-accredited or
CLIA-certified laboratory, with confirmation of the unit's ABO/Rh type. For laboratories subject
to US regulations, the compatibility testing must have been performed in another CLIA-certified
laboratory.
REFERENCES
1)
Domen RE. Policies and procedures related to weak D phenotype testing and Rh immune globulin administration. Results from
supplementary questions to the comprehensive transfusion medicine survey of the College of American Pathologists. Arch Pathol
Lab Med. 2000;124:1118-1121
TRM.40500 Recipient Sample Phase II
There is a written policy defining the maximum interval during which a sample may be
used before obtaining a new sample.
NOTE: The transfusion service must have a policy defining the maximum interval during which
a recipient sample may be used for crossmatching. This may not exceed 3 days in patients who
have been transfused or pregnant within the past 3 months, or if relevant medical/transfusion
history is unknown or uncertain. The day of sample draw is day 0.
TRM.40550 Forward/Reverse Typing Phase II
For each patient, red blood cells are tested with anti-A, anti-B, and anti-D, and serum/
plasma is tested using A1 and B reagent red cells.
NOTE: The ABO/Rh type of the patient's red blood cells must be determined by an appropriate
test procedure. Tests on each sample must include forward and reverse grouping.
The use of molecular based screening assays alone is not acceptable for ABO and RhD blood
type assignment for the purposes of transfusion or transplantation. ABO and RhD typing by FDA-
cleared or approved serological methods must be used for the purpose of transfusion or donor
and recipient ABO and RhD typing for transplantation.
Laboratories not subject to US regulations must follow national, state or provincial, and local
laws.
Evidence of Compliance:
✓
Written procedure for ABO/Rh typing AND
✓
Logs or computer records with forward and reverse grouping
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REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1271(a)]
**REVISED** 09/17/2019
TRM.40600 Unexpected Antibody Screen Phase II
Prior to transfusing red cell products, a screen to detect unexpected red cell
alloantibodies is performed that includes the following:
●
Incubation at 37°C
●
Use of red cells that are not pooled
●
Interpretation at the antiglobulin phase
Evidence of Compliance:
✓
Written procedure for screening for unexpected red cell alloantibodies AND
✓
Logs or computer records indicating the reactions at the different phases of testing
**REVISED** 09/17/2019
TRM.40650 Serologic Crossmatch Phase II
For allogeneic units, a serologic crossmatch is performed to detect serologic
incompatibility unless the specimen is eligible for computer crossmatch.
NOTE: Under certain circumstances, a transfusion service may elect to omit the antiglobulin
phase of the serologic crossmatch. The antiglobulin test may be omitted if the antibody screen is
negative and there is no history of detection of unexpected antibodies. Nevertheless, a procedure
to detect ABO incompatibility, either a serologic crossmatch or a computer crossmatch using a
system validated for computer crossmatching is required. Typing, screening and crossmatching
of infants less than or equal to four months old can be abbreviated if a specific procedure is
available.
Evidence of Compliance:
✓
Written procedure for serologic crossmatch, including criteria for omitting the antiglobulin
phase AND
✓
Written procedure for crossmatching for infants less than or equal to four months old, if
applicable AND
✓
Logs or computer records of serologic crossmatches
TRM.40651 Autologous Unit Crossmatch Phase I
For autologous units, a crossmatch procedure is performed (either serologic or
electronic) to detect incompatibility.
Evidence of Compliance:
✓
Logs or computer records of autologous crossmatches
TRM.40652 Neonate Transfusion Phase II
For non-group O neonates receiving non-group O red blood cells, there is a written
procedure to screen the neonate's serum/plasma for anti-A or anti-B if the donor unit and
maternal blood ABO blood groups are not compatible.
NOTE: Methods used to detect anti-A or anti-B must include an antiglobulin phase. Neonates
include infants up to four months of age.
Evidence of Compliance:
✓
Written procedure for detection of anti-A or anti-B in non-group O neonates AND
✓
Logs or computer records with screening results
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TRM.40655 DAT Testing Algorithm Phase II
When a direct antiglobulin test is ordered by a patient's physician, the testing algorithm
allows for detection of RBC-bound complement as well as IgG.
NOTE: The testing algorithm is intended to detect patients with complement-mediated hemolysis
which may occur in paroxysmal cold hemoglobinuria, autoimmune hemolytic anemia, or drug-
induced hemolytic anemia. Detection of complement is not required for the purpose of diagnosing
hemolytic disease of the newborn.
The use of anti-IgG alone will fail to detect some cases of complement-mediated hemolysis
because not all cases of complement-mediated hemolysis have detectable IgG coating the red
blood cell. TRM.40200 and TRM.40210 also apply.
Evidence of Compliance:
✓
Written procedure for DAT testing providing for the detection of RBC-bound complement and
IgG AND
✓
Records for DAT consistent with procedure
REFERENCES
1)
Sokol RJ, et al. Autoimmune haemolysis: an 18year study of 865 cases referred to a regional transfusion centre. Brit Med J.
1981;282:2023-2027
2)
Packman CH, Leddy JP, Cryopathic hemolytic syndromes. In: Beutler E, et al, eds. William's Hematology, 5th ed. New York:
McGraw-Hill, 1995:685-691
3)
Vengelen-Tyler V, ed. American Association of Blood Banks Technical Manual, 13th ed. Bethesda, MD: AABB Press, 1999:259-262
COMPUTER CROSSMATCHES
A computer crossmatch is an electronic method that is used to confirm that the unit is appropriate for transfusion
to the intended recipient through the use of validated software logic to determine compatibility, rather than
serologic techniques.
This section does not apply if the laboratory does not perform computer crossmatches.
Inspector Instructions:
●
Sampling of computer crossmatch policies and procedures
●
Sampling of confirmation of donor unit ABO/Rh records
●
Sampling of records of the initial/revalidation of the electronic crossmatch system
●
What method do you use to verify the recipient's ABO blood group?
●
What computer alerts are generated when there are discrepancies?
●
In what instances would an electronic crossmatch not be appropriate?
TRM.40665 Computer Crossmatches Phase II
There are written procedures for computer crossmatch methods based on validated
decision rules for verifying donor/recipient compatibility.
NOTE: The computer crossmatch may not be used if patients have a current or past history of
clinically significant alloantibodies, or if there are unexplained typing discrepancies on the current
sample.
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Evidence of Compliance:
✓
Written procedure for computer crossmatch, including eligibility criteria AND
✓
Records of software validation for computer crossmatching
REFERENCES
1)
Food and Drug Administration. Guidance for Industry. Computer Crossmatch (Computerized Analysis of the Compatibility Between
the Donor's Cell Type and the Recipient's Serum or Plasma Type). Rockville, MD: Food and Drug Administration, April 2011.
**REVISED** 09/17/2019
TRM.40670 ABO Group and Rh(D) Type Verification Phase II
The recipient's ABO group and Rh(D) type has been verified by repeat testing of the same
sample, a different sample, or agreement with a historical type in the laboratory's records.
NOTE: Repeat testing of the same sample is inadequate for computer crossmatching for issuing
non-type O red cells, unless the sample has been drawn using technology or methods for
ensuring positive identification (eg, mechanical barrier system or digital bedside identification
system).
When unexplained ABO typing discrepancies exist on the current sample, serologic crossmatch
techniques must be employed.
Evidence of Compliance:
✓
Written procedure defining method for verification of ABO AND
✓
Work records of test results and/or search of records verifying ABO type
REFERENCES
1)
Food and Drug Administration. Guidance for Industry. "Computer Crossmatch" (Computerized Analysis of the Compatibility Between
the Donor's Cell Type and the Recipient's Serum or Plasma Type). Rockville, MD: Food and Drug Administration, April 2011.
TRM.40680 Donor Unit/Recipient Information Phase II
The laboratory information system contains the donor unit number, component type,
ABO/Rh type of the component, the interpretation of the unit's ABO confirmatory test, and
the patient's (recipient's) ABO/Rh type, when appropriate.
Evidence of Compliance:
✓
Written policy defining information to be stored in the information system
TRM.40690 Data Entry Verification Phase II
If a serologic crossmatch is not performed, there is a procedure to verify correct computer
data entry before issuing blood or blood components, and the computer alerts the user of
any discrepancies.
NOTE: When a serologic crossmatch is not performed, patient safety must be ensured by
requiring verification of proper data entry before issuing blood or blood components. The
computer system must alert the user of any discrepancies of donor unit labeling, blood group
confirmatory test interpretation, and to the existence of any ABO incompatibility.
Evidence of Compliance:
✓
Written procedure for the verification of correct data entry prior to release of blood/blood
components AND
✓
Records of verification of correct data entry AND
✓
Written description of computer system alerts used to prevent issuance of blood components
when discrepancies exist
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SELECTION OF BLOOD AND COMPONENTS FOR TRANSFUSION
Inspector Instructions:
●
Sampling of policies and procedures for selection of blood/components
●
What is your course of action when receiving a request for blood for a patient with
special transfusion requirements (eg, leukoreduced, CMV negative, aliquoting
components for patients at risk of TACO)?
●
What is your procedure for emergency release requests?
●
What is your course of action when an incompatibility has been discovered with an
emergency release?
**REVISED** 06/04/2020
TRM.40700 Selection of Blood Components Phase II
The written procedure for selection of blood components for transfusion requires the
use of ABO group-specific whole blood, low-titer group O whole blood, or ABO group-
specific or compatible red blood cell-containing components and contains criteria used
for selection of plasma or platelet containing components.
NOTE: To avoid potentially life-threatening ABO incompatibility, the laboratory must have written
procedures for the selection of appropriate whole blood, red cells or plasma for recipients.
ABO group-compatible plasma and platelet components should be used. If transfusion of ABO
incompatible plasma is permitted due to blood supply and medical necessity, the laboratory has a
written policy on the use of ABO incompatible plasma and platelet components.
If transfusion of low-titer group O whole blood occurs, the procedure must describe:
●
Definition of "low-titer" group O whole blood as mutually agreed by the
transfusion service and the blood supplier
●
Indications for the use of these units.
TRM.40710 Rh Negative Transfusion Recipients Phase II
The transfusion service has a written procedure for approving the transfusion of Rh-
positive red cell-containing components to Rh-negative patients.
NOTE: Rh-negative transfusion recipients shall receive Rh-negative Red Blood Cells and
Whole Blood except with authorization of the transfusion service physician due to inventory
shortages or other extraordinary circumstances. However, the policy of the laboratory may allow
for transfusion of Rh-positive platelet units to Rh-negative recipients who are not at risk of future
pregnancy. The procedure should include consideration of prophylaxis against Rh immunization
in Rh-negative platelet recipients receiving an Rh-positive platelet unit.
REFERENCES
1)
Heim, MU, et al, Intravenous anti-D gammaglobulin for the prevention of Rhesus isoimmunization caused by platelet transfusions in
patients with malignant diseases, Vox San 62: 165, 1992
2)
Menitove, JE, Immunoprophylaxis for D- patients receiving platelet transfusions from D+ donors. Transfusion 42: 136, 2002
3)
Lichtiger B, Hester JP. Transfusion of Rh-incompatible blood components to cancer patients. Haematologia. 1986;19:81-88
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**REVISED** 06/04/2020
TRM.40720 Provisions for Special Components Phase II
The laboratory has written procedures for providing appropriate components for:
●
Patients with immunohematologic conditions (clinically significant red cell
antibodies, transplantation, etc.)
●
Transfusion of special blood components (red cell antigen-negative, irradiated,
CMV-reduced risk, hemoglobin S-negative, etc.)
●
Aliquoting or volume reduction of blood components for patients identified to be a
risk for transfusion associated circulatory overload (TACO)
●
Transfusion of low-titer group O whole blood, including the maximum volume/
units allowed per event.
NOTE: Exceptions to the procedure may be made only with the approval of the physician
responsible for the transfusion service, or designee.
REFERENCES
1)
AABB, the American Red Cross, America's Blood Centers and the Armed Services Blood Center, Circular of information for the Use
of Human Blood and Blood Components. Bethesda, MD. October 2017.
2)
Alam, A, Lin Y, Lima A, Hansen, M, Callum, JL. The prevention of transfusion-associated circulatory overload. Trans Med Rev. 2013:
27(2):105-12.
TRM.40740 ABO-Incompatible Plasma and Platelet Transfusions in Infants Phase II
There is a written procedure to prevent or limit the administration of ABO-incompatible
plasma in platelet and plasma components for transfusion given to infants.
NOTE: For infant recipients, plasma in platelet components should be ABO-compatible, as
relatively large amounts of ABO-incompatible plasma may cause hemolysis or shortened red
cell survival. If necessary, the plasma volume in platelet units can be reduced shortly before
transfusion by removing plasma from the platelet unit and resuspending the platelets in an
approved alternate solution.
TRM.40760 Granulocytes And/Or Platelets Crossmatch-Compatible Phase II
The red cells in granulocytes and/or platelets are crossmatch-compatible with the
recipient's plasma, except when the component contains less than 2 mL of donor red
cells.
NOTE: If a platelet unit appears abnormally pink or red, the contaminating red cell volume can be
determined to assess whether crossmatching is required.
Evidence of Compliance:
✓
Written procedure for crossmatching red cells in granulocyte or platelet components with
recipient plasma for products with greater than 2 mL of donor cells AND
✓
Records of crossmatches
TRM.40770 Life-Threatening Situations Phase II
Adequate policies and procedures have been established for the investigation and
handling of life-threatening situations (such as the use of uncrossmatched blood or
abbreviation of testing) that include the written authorization of a qualified physician.
NOTE: Written policies and procedures must be available to expedite testing for transfusion in
a life-threatening situation. If an institution's procedure allows abbreviated testing in massive
transfusion situations, records should indicate that the procedure was followed. Records must
include the authorization by a qualified physician. (If approved by the institution and recorded
in the laboratory's procedures, the physician responsible for the transfusion service laboratory
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may accept this responsibility.) If an incompatibility is discovered on completion of an incomplete
crossmatch, the responsible physician must be notified in a timely manner and this notification
recorded.
Red blood cells released before testing has been completed must be conspicuously labeled
as uncrossmatched on the tag or label. Records of completion of compatibility testing for units
released uncrossmatched must be retained.
Evidence of Compliance:
✓
Records of emergency release authorization by a qualified physician
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Laboratory controls.
Compatibility testing. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.151]
2)
ibid. Records and reports. Records. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.160]
PERINATAL TESTING
Inspector Instructions:
●
Rh immune globulin release policy
●
How do you ensure that all Rh-negative women receive protection against Rh
immunization?
●
How do you evaluate for fetomaternal hemorrhage in those candidates for Rh
immune globulin?
●
What procedures are in place to ensure that identified candidates receive Rh immune
globulin within 72 hours?
●
Follow the records of a patient receiving Rh immune globulin. Determine if
procedures for testing, dosing and time interval for administration are adequate.
**REVISED** 09/17/2019
TRM.40780 RhIG Candidates Phase II
There is a written procedure to identify all potential candidates for Rh immune globulin.
NOTE: Information about every pregnant woman's Rh type should be available when the
possibility of alloimmunization and subsequent Rh disease of the newborn may occur. The
institution must ensure that all Rh-negative women receive the maximum protection against Rh
immunization. A test record from any CLIA-licensed or CAP-accredited laboratory is acceptable
for establishing the Rh type (positive or negative). Potential Rh immune globulin candidates
include: pregnancy termination through delivery or abortion, amniocentesis, invasive obstetric
procedures, and abdominal trauma during pregnancy. The procedure should address the RhIG
candidacy of women of childbearing age with weak or discrepant RhD typings.
Maternal RhIG candidacy assessment must include the identification of weak-D phenotype
newborns.
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Evidence of Compliance:
✓
Written procedure defining the method for identification of RhIG candidates
REFERENCES
1)
Clinical and Laboratory Standards Institute. Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline. 2
nd
ed.
CLSI Document H52-A2. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
2)
Sandler SG, Fiegel WA, Westhoff CM, et al. It's time to phase in RHD genotyping for patients with a serologic weak D phenotype.
Transfusion 2015;55:680-9.
TRM.40790 Fetomaternal Hemorrhage Detection Phase II
Identified Rh immune globulin candidates are tested after delivery to detect fetomaternal
hemorrhages greater than 30 mL of whole blood.
NOTE: A post-partum blood sample from identified Rh immune globulin candidates must be
evaluated for fetomaternal hemorrhages. A standard method (Kleihauer-Braun-Betke or flow
cytometry) should be used to calculate the recommended dosage of Rh immune globulin, based
on the estimated volume of fetal whole blood or red blood cells in the maternal circulation. In
the event the laboratory provides RhIG dosage recommendations to physicians, standardized
formulas must be used for translating the mL of fetal blood into vials of RhIG.
Evidence of Compliance:
✓
Written procedures for detection of fetomaternal hemorrhage AND
✓
Written procedures for quantification of fetal bleed, including calculations used to determine
dose of Rh immune globulin AND
✓
Patient reports with screening results, quantification of fetal bleed, and recommended
dosage (if applicable)
REFERENCES
1)
Pollack W, et al. Studies of Rh prophylaxis: relationship between dose of anti-Rh globulin and size of antigen stimulus. Transfusion.
1971;11:333-339
2)
Thein SL, Reittie JE. F cells by immunofluorescent staining of erythrocyte smears. Hemoglobin. 1998;22:427-444
3)
Casey M, et al. Comparison of 2 methods of detecting fetomaternal hemorrhage in Rh-negative women. Am J Clin Pathol.
1999;112:556
4)
Clinical and Laboratory Standards Institute. Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline. 2
nd
ed.
CLSI Document H52-A2. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
5)
Sandrick K. Keep the classic or move to modern? Weighing whether flow cytometry can replace Kleihauer-Braun-Betke. College of
American Pathologists CAP Today. 2000;14(4):76-82
6)
Pourbabak S, Crookston KP. Massive fetomaternal hemorrhage may occur without clinical suspicion. Am J Clin Pathol. 2000;114:313
7)
Ramsey G. Inaccurate doses of Rh immune globulin after Rh-incompatible fetomaternal hemorrhage: survey of laboratory practice.
Arch Pathol Lab Med. 2009;133:465-9.
TRM.40800 RhIG Administration Phase II
There is a written procedure to ensure that an adequate dose of Rh immune globulin is
administered to all identified candidates within 72 hours of an Rh alloimmunizing event,
whenever possible.
NOTE: This requirement does NOT apply if the fetus is Rh-negative or the patient is known to be
alloimmunized to the D antigen.
Evidence of Compliance:
✓
Written procedure for administration of RhIG AND
✓
Patient records confirming administration within the appropriate timeframe
TRM.40820 Historical Record Check Phase II
There is a written procedure to ensure that laboratory records for ABO/Rh testing are
searched for each pregnant patient for at least the preceding 12 months.
NOTE: The purpose of this comparison is to detect sample/patient identification errors or other
errors that might lead to the attribution of an incorrect blood type or antibody screen result to
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a pregnant patient; this might result in a missed opportunity to provide prophylaxis against
or appropriate treatment for perinatal alloimmunization. The historical record search can be
performed manually by qualified laboratory personnel or by a validated computer system capable
of performing historical checks. If the laboratory performing the testing does not maintain records
that would allow this check to be performed, the testing shall be reported with a disclaimer
alerting the ordering physician that the check has not been performed and that verifications of the
sample's identity and the test results are strongly recommended.
Evidence of Compliance:
✓
Written procedure for checking ABO/Rh results with historical results AND
✓
Records of historical checks OR
✓
Records of LIS historical check validations
TRANSFUSION PROCEDURES
Inspector Instructions:
●
Sampling of transfusion policies and procedures
●
Sampling of transfusionist records of initial and annual training
●
Sampling of patient records for recording of the required elements of administration
and monitoring of transfusion of blood components
●
Sampling of blood warming system maintenance records (if applicable)
●
If applicable, sampling of transfusion committee or blood utilization committee
minutes demonstrating transfusion service medical director participation
●
How do you examine blood products just prior to issue?
●
What are the sign/symptoms of a transfusion reaction?
●
What course of action would you take if you suspect a transfusion reaction?
●
Observe a transfusion beginning with bedside patient identification, verification of
label or tag for all required elements listed in TRM.41300, use of additional fluids/
drugs, monitoring by the transfusionist and records of blood administration. If a
patient identification technology system is used, ask the transfusionist to explain what
they are checking when scanning donor and recipient information.
TRM.40875 Transfusion Service Medical Director Responsibility Phase I
There are records of the transfusion service medical director's participation in:
1. Oversight of the development of policies and procedures that pertain to
transfusion service functions
2. Review of processes and documents that support the consent for transfusion
3. Establishing criteria for transfusion
4. Monitoring and auditing transfusion practices
NOTE: The transfusion service medical director must be involved in the policies and patient
safety procedures that pertain to transfusion services (eg, review of transfusion practices to
ensure the appropriate use of blood components and the ability of the transfusion service to
meet patient needs). The monitoring required to do this effectively can be achieved by various
mechanisms. Data from the review and monitoring of transfusion practices should be used
to suggest improvements in policies and procedures, as necessary, as well as educational
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endeavors. The recipient consent procedures should communicate risks and benefits of
transfusion, alternatives to transfusion, and the right of the adult patient to refuse transfusion.
Evidence of Compliance:
✓
Written policy defining responsibilities of transfusion service medical director
REFERENCES
1)
Saxena S, Ramer L, Shulman IA. A comprehensive assessment program to improve blood-administering practices using the
FOCUS-PDCA model. Transfusion. 2004 Sep;44(9):1350-6
2)
Sherman LA. Legal issues in blood banking. Elements of informed consent. Clin Lab Med. 1996 Dec;16(4):931-46
TRM.40900 Blood/Tissue Sign-Out Phase II
The procedure for signing blood and tissue out of the laboratory provides adequate
protection for the potential recipient.
NOTE: A person authorized by the transfusion medicine service must perform a clerical and
visual inspection of each component immediately before it is issued. Transporters of blood
components and tissue must be trained in prompt delivery. Training may consist of instruction at
the time the product is dispensed.
Evidence of Compliance:
✓
Written procedures for the issue of blood components and tissue AND
✓
Written policy for the instruction of transporters on the proper handling of the product
TRM.40925 Blood/Component Compatibility Label or Tag Phase II
A label or tag with at least the following information is securely attached to each blood or
component unit before issuance and remains attached until completion of the transfusion:
●
Identification of the recipient with two patient identifiers
●
Blood (or component) unit identifier
●
Interpretation of crossmatch tests, where applicable
REFERENCES
1)
Wenz B, et al. Practical methods to improve transfusion safety by using novel blood unit and patient identification systems. Am J Clin
Pathol. 1997;107(suppl 1):S12-S16
TRM.40950 Clerical Identification and Transfusion Records Final Check Phase II
There are written procedures for a final check at the time of issuance to verify clerical
identification and transfusion records for the following:
●
Identification of the recipient with two identifiers
●
Donor information number (DIN) or pool number
●
Recipient and donor blood types
●
Interpretation of crossmatch tests, where applicable
●
Donor unit expiration date and time (as applicable)
●
Special transfusion requirements (eg, cytomegalovirus (CMV)-reduced-risk,
irradiated, antigen-negative components)
●
Date and time of issue
Evidence of Compliance:
✓
Written procedures describing the elements checked at the time of issue
REFERENCES
1)
Wenz B, et al. Practical methods to improve transfusion safety by using novel blood unit and patient identification systems. Am J Clin
Pathol. 1997;107(suppl 1):S12-S16
TRM.41000 Blood Administration Procedure Phase II
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There is a written procedure for blood administration, including the positive identification
(ie, two patient identifiers) of transfusion recipients and blood components and
observation of recipients.
NOTE: Blood component misidentification causing incompatibility between the donor and
recipient may cause acute harm. Some blood product defects (eg, bacterial contamination) may
be detected during the process of administration. Patients must be closely observed during and
for a period of time after blood administration.
REFERENCES
1)
Renner SW, et al. Wristband identification error reporting in 712 hospitals. A College of American Pathologists' Q-Probes study of
quality issues in transfusion practice. Arch Pathol Lab Med. 1997;117:573-577
2)
Mancini ME. Performance improvement in transfusion medicine. What do nurses need and want? Arch Pathol Lab Med.
1999;123:496-502
3)
Shulman IA, et al. Assessing blood administering practices. Arch Pathol Lab Med. 1999;123:595-598
TRM.41025 Transfusionist Training Phase II
There are records for initial training and in-service at least annually for personnel involved
in transfusion, in accordance with national, federal, state (or provincial), and local laws
and approved institutional policies and procedures, for the following:
●
Identification of transfusion recipients and blood components
●
Observation of recipients during and after transfusion
●
Recognition and reporting of adverse transfusion events
Evidence of Compliance:
✓
Records of appropriate annual training for all transfusionists
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Condition of Participation: Nursing
Services. 2011(October 1): [42CFR482.23(c)(4)].
TRM.41050 Handling of Blood Products Phase II
There are written procedures for handling blood outside of the laboratory (avoidance of
prolonged warming, need for filter, etc.).
NOTE: Such procedures should be used to train personnel who transport and/or transfuse blood,
whether or not they are members of the transfusion medicine laboratory staff. The transfusion
service should have appropriate procedures for transfusion offsite or at another institution, if
applicable.
TRM.41150 Addition of Fluids/Drugs Phase II
There is a policy regarding the addition of drugs, or fluids other than 0.9% NaCl, through
the same tubing simultaneously with blood or blood components.
NOTE: Fluids routinely added to or infused through the same tubing with blood or blood
components, with the exception of 0.9% NaCl, may be harmful to blood. Drugs or other materials
may be added to blood/blood products only if documentation exists that no harm will result to the
component or patient, or for laboratories subject to US regulations, they are FDA-approved for
that purpose.
REFERENCES
1)
AABB, the American Red Cross, America's Blood Centers and the Armed Services Blood Center. Circular of Information for the Use
of Human Blood and Blood Components. Bethesda, MD. October 2017.
TRM.41300 Donor and Recipient Information Verification Phase II
Donor and recipient information is verified immediately before transfusion in the presence
of the recipient, and includes the following:
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●
Conclusive identification of the recipient in the presence of the recipient
with two patient identifiers by either two persons (eg, by checking the
wristband for name and hospital number), or using bedside patient
identification technology
●
Patient identifiers on the blood or component unit label match the identity
of the recipient
●
Intended recipient's blood type
●
Donor unit identification number and donor blood type
●
Interpretation of crossmatch tests, if performed
●
Donor unit expiration date and time (as applicable)
●
Special transfusion requirements (if warranted)
Evidence of Compliance:
✓
Written procedure for blood administration that defines the information verified in the
presence of the patient prior to transfusion
REFERENCES
1)
Mancini ME. Performance improvement in transfusion medicine. What do nurses need and want? Arch Pathol Lab Med.
1999;123:496-502
2)
Shulman IA, et al. Assessing blood administering practices. Arch Pathol Lab Med. 1999;123:595-598
3)
Wenz B, et al. Practical methods to improve transfusion safety by using novel blood unit and patient identification systems. Am J Clin
Pathol. 1997;107(suppl 1):S12-S16
4)
Dale JC, Renner SW. Wristband errors in small hospitals. A College of American Pathologists' Q-Probes study of quality issues in
patient identification. Lab Med. 1997;28:203-207
TRM.41450 Blood Administration Record Phase II
The blood administration record on the patient chart includes the following:
●
Identity of the transfusionist
●
Name of the blood component
●
Identification number of donor unit transfused
●
Date and time of transfusion
●
Evidence of patient monitoring pretransfusion, during and after transfusion
●
Amount transfused
●
Any transfusion-related adverse effects
REFERENCES
1)
Shulman IA, et al. Assessing blood administering practices. Arch Pathol Lab Med. 1999;123:595-598
TRM.41475 Post-Transfusion Observation Phase II
For patients receiving transfusions that will not be observed by medical personnel post-
transfusion, instructions are provided to the patient regarding adverse reactions to
transfusion.
NOTE: Examples include out-patient transfusions, home transfusions and situations where the
patient is discharged shortly after transfusion. The instructions provided must include information
on possible adverse effects from the transfusion, as well as whom to contact in case of a
reaction.
TRM.41500 Blood Warming System Phase II
If a blood warming system is used during transfusion, it is properly maintained and
equipped with special features to alert the user to improper transfusion conditions.
NOTE: An alert feature (eg, a visible thermometer and audible alarm), must be used so that use
of the system does not result in damage to the blood component being warmed.
For laboratories subject to US regulations, the system must be FDA-cleared/approved.
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Evidence of Compliance:
✓
Records of blood warmer maintenance, including checks of the alert system
TRM.41525 Intraoperative/Perioperative Blood Program Phase II
The authority, responsibility, and accountability of the intraoperative/perioperative blood
recovery and reinfusion program are defined.
Evidence of Compliance:
✓
Memorandum or policy describing the program
REFERENCES
1)
Stowell CP, et al. Guidelines for blood recovery and reinfusion in Surgery and trauma. Committee on Autologous Transfusion.
Bethesda, MD: American Association of Blood Banks, 1997
TRM.41550 Intraoperative/Perioperative Safety and Efficacy Phase II
The procedures for intraoperative and perioperative blood recovery ensure the safety and
efficacy of the recovered blood components.
REFERENCES
1)
Yawn DH. Ensuring quality during intraoperative blood salvage. Lab Med. 1994;25:626-631
TRM.41600 Intraoperative/Perioperative Program Involvement Phase II
The transfusion service medical director is involved in establishing policies and
procedures related to intra- and perioperative collection and reinfusion procedures.
NOTE: The intra- and perioperative collection and reinfusion procedures are part of the
transfusion medicine procedures. The transfusion service medical director must be aware of, and
participate in, the development of policies and procedures to help the institution ensure efficacy
and patient safety.
Evidence of Compliance:
✓
Written policy defining responsibilities of transfusion service medical director
REFERENCES
1)
Yawn DH. Ensuring quality during intraoperative blood salvage. Lab Med. 1994;25:626-631
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ADVERSE REACTION PROCEDURES
Inspector Instructions:
●
Sampling of transfusion reaction policies and procedures
●
Sampling of initial and annual personnel training records for recognition of transfusion
reactions
●
Sampling of records of transfusion reaction work-ups, investigation, interpretation of
findings, and reporting
●
Sampling of records of blood supplier notification
●
Sampling of records of actions taken when notified of quarantine, recall or market
withdrawal
●
Records of provider/recipient notification of a potentially infectious blood product and
counseling as applicable
●
Notification of suspected transfusion related fatality to appropriate governmental or
oversight agency, if applicable
●
Donor/recipient transfusion reaction specimens (seven day retention, refrigerated,
sealed)
●
Are suspected transfusion reactions reported to the laboratory in a timely basis?
●
What action do you take when you have been notified of a quarantine, recall or
market withdrawal by your blood supplier?
●
Review the records of several transfusion reaction work-ups. Determine if the policies
and procedures provide for thorough investigation and reporting. Determine if
transfusion service medical director involvement is sufficient.
TRM.41650 Transfusion Reaction Recognition Phase II
There are written procedures describing the criteria for the recognition of transfusion
reactions, and the clinical actions to be taken in the event of a suspected transfusion
reaction.
NOTE: These procedures must be readily available to clinical personnel in areas where patients
are transfused.
Evidence of Compliance:
✓
Facility transfusion procedure availability to clinical staff administering blood and blood
component products
REFERENCES
1)
Sazama K, et al. Practice parameter for the recognition, management, and prevention of adverse consequences of blood transfusion.
Arch Pathol Lab Med. 2000;124:61-70
TRM.41750 Reporting of Transfusion Reactions and Incidents Phase II
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Policies require that suspected transfusion reactions or incidents are reported
immediately to the laboratory.
NOTE: Investigation by the laboratory must be initiated as soon as possible to facilitate
continuing care of the patient.
TRM.41770 System Failure Phase I
When an incident investigation indicates a system failure (eg, misadministration of a
blood product), the transfusion service medical director is involved in the investigation
and resolution of the issue.
Evidence of Compliance:
✓
Records of transfusion service medical director involvement in investigation and resolution
REFERENCES
1)
AuBuchon JP. The role of transfusion medicine physicians. A vanishing breed. Arch Pathol Lab Med. 1999;123:663-667
TRM.41800 Post Transfusion Specimen Storage Phase II
Donor and recipient blood samples are appropriately stored for at least 7 days after
transfusion for retesting, in the event of a transfusion reaction.
NOTE: Appropriate storage conditions (refrigeration, sealed containers) are necessary to prevent
specimen degradation and contamination.
Evidence of Compliance:
✓
Written procedure defining criteria for storage of donor and recipient samples
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1271(d)]
TRM.41850 Investigation of Suspected Hemolytic Transfusion Reaction Phase II
The immediate investigation of a suspected hemolytic transfusion reaction includes all of
the following.
1. Examination of patient identification, blood unit labels, and all pre-reaction
records for possible errors in patient or blood identification at the bedside and
in the laboratory
2. Visual examination of post-reaction and pre-reaction (if available) serum or
plasma for evidence of hemolysis
3. ABO and direct antiglobulin test on post-reaction patient (recipient) blood
sample
NOTE: RhD typing of the post-reaction patient (recipient) blood sample is not required. However,
it is encouraged to add an additional level of patient verification. The direct antiglobulin test must
allow detection of RBC-bound complement as well as IgG.
Evidence of Compliance:
✓
Records of investigation and interpretation of findings
REFERENCES
1)
Wenz B, et al. Practical methods to improve transfusion safety by using novel blood unit and patient identification systems. Am J Clin
Pathol. 1997;107(suppl 1):S12-S16
2)
Dale JC, Renner SW. Wristband errors in small hospitals. A College of American Pathologists' Q-Probes study of quality issues in
patient identification. Lab Med. 1997;28:203-207
3)
Sazama K, et al. Practice parameter for the recognition, management, and prevention of adverse consequences of blood transfusion.
Arch Pathol Lab Med. 2000;124:61-70
4)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1271(e)]
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TRM.42000 Additional Transfusion Reaction Evaluation Phase II
The transfusion service medical director has established a written procedure indicating
under what circumstances additional testing will be done after a suspected transfusion
reaction (including delayed transfusion reactions), and the nature of that testing.
Evidence of Compliance:
✓
Records of investigation and interpretation of findings
REFERENCES
1)
AuBuchon JP. The role of transfusion medicine physicians. A vanishing breed? Arch Pathol Lab Med. 1999;123:663-667
TRM.42050 Transfusion Reaction Interpretation Phase II
The findings of an adverse reaction investigation are interpreted by the transfusion
service medical director or designee, and reported in a timely and effective manner.
NOTE: The patient's physician must be immediately notified of suspected cases of hemolytic
transfusion reactions, bacterial contamination, or other serious reactions. A prompt and complete
adverse reaction investigation report, including interpretation and evaluation by the transfusion
medicine medical director or designee, must be placed in the patient's chart.
Evidence of Compliance:
✓
Adverse reaction investigation reports in patient charts
REFERENCES
1)
AuBuchon JP. The role of transfusion medicine physicians. A vanishing breed? Arch Pathol Lab Med. 1999;123:663-667
2)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Adverse
reaction file. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.170(b)]
TRM.42060 Transfusion Reaction Monitoring Phase II
The transfusion service tracks the incidence of transfusion reactions and monitors the
rate of transfusion reactions by each reaction type (eg, febrile, hemolytic, TRALI, etc.).
Evidence of Compliance:
✓
Records of transfusion reaction data
REFERENCES
1)
AuBuchon JP. The role of transfusion medicine physicians. A vanishing breed? Arch Pathol Lab Med. 1999;123:663-667.
2)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Adverse
reaction file. Washington, DC: US Government Printing Office, 2015 (Apr 3):[21CFR606.170(b)].
TRM.42100 Blood Supplier/Testing Laboratory Notification Phase II
There is a written procedure to notify the blood supplier or laboratory responsible for the
pretransfusion testing (if performed by another laboratory) when blood components are
a suspected primary cause of an adverse reaction (eg, hemolytic transfusion reaction,
transfusion-related acute lung injury, transfusion-transmitted infection).
Evidence of Compliance:
✓
Records of notifications to the blood supplier or pretransfusion testing laboratory (where
applicable)
REFERENCES
1)
Sazama K. The changing relationships in transfusion medicine. Arch Pathol Lab Med. 1999;123:668-671
2)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Adverse
reaction file. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.170(b)]
TRM.42110 TRALI Phase II
The laboratory has written policies and procedures to recognize, investigate and reduce
the risk of transfusion-related acute lung injury (TRALI).
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Evidence of Compliance:
✓
Written transfusion service procedure to investigate suspected TRALI cases AND
✓
Records from blood supplier regarding TRALI mitigation strategies for plasma, apheresis
platelets and whole blood
REFERENCES
1)
Kleinman S, Caulfield T, Chan P, et al. Toward an understanding of transfusion-related acute lung injury: Statement of a consensus
panel. Transfusion 2004;44:1774-89
2)
Kopko PM, Marshall CS, MacKenzie MR, et al. Transfusion-related acute lung injury: Report of a clinical look-back investigation.
JAMA 2002;287:1968-71
3)
Insunza A , Romon I, Gonzlaes-Ponte ML, et al. Implementation of a strategy to prevent TRALI in a regional blood centre. Transfus
Med 2004;14:157-64
TRM.42120 Blood Component Recall and Quarantine Phase II
There is a procedure to identify and quarantine suspect blood components in the
inventory when notice is received about donors who have tested reactive for an infectious
disease and/or have been recalled by the supplier.
NOTE: Because the FDA requires blood suppliers to notify transfusion facilities when donors
are found to have reactive infectious disease testing or have other reasons for recalling donor
components, there must be a procedure to ensure that all suspect components in current
inventory are quarantined.
Evidence of Compliance:
✓
Records of actions taken for each notification AND
✓
Written procedure for quarantine of blood components
REFERENCES
1)
Food and Drug Administration. General biological products standards. Human immunodeficiency virus (HIV) requirements.
Washington, DC: US Government Printing Office, 2009(Apr 1):[21CFR610.45]
2)
Food and Drug Administration. General biological products standards. "Lookback" requirements. Washington, DC: US Government
Printing Office, 2009(Apr 1):[21CFR610.46 and 610.47]
TRM.42135 Blood Supplier Notifications Phase II
The transfusion service has a procedure for managing quarantines, recalls, and market
withdrawals issued by its blood suppliers.
Evidence of Compliance:
✓
Records of actions taken for each notification
REFERENCES
1)
FDA. Enforcement policy. Recall communications. Washington DC: US Government Printing Office. 1999(Apr 1) [21 CFR 7.49(d)]
2)
Ramsey G. Blood component recalls and market withdrawals: frequency, reasons, and management in the United States. Transfus
Med Rev. 2013; 27:82-90
**REVISED** 09/17/2019
TRM.42170 Notifications for Potentially Infectious Blood and Blood Component Units Phase II
The transfusion service has a written procedure consistent with national, federal, state
(or provincial), and local regulations and guidances for notification and counseling, as
appropriate (eg, components potentially infectious for HCV and HIV), of providers or
recipients (or next of kin or legal representative for HIV when the recipient is deceased) of
a potentially infectious blood or blood component unit.
Evidence of Compliance:
✓
Records of provider or recipient or next of kin or legal representative notifications and
counseling, as applicable AND
✓
Written procedure stating when notification and counseling is warranted to providers and
recipients of infectious blood components
REFERENCES
1)
CMS. Condition of participation: laboratory services Washington, DC: US Government Printing Office, 2011(42CFR482.27(b)
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2)
Food and Drug Administration. General biological products standards. "Lookback" requirements. Washington, DC: US Government
Printing Office, 1999(Apr 1):[21CFR610.46 and 610.47]
3)
Guidance for industry: Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV):
testing, product disposition, and donor deferral and reentry. Rockville, MD, Food and Drug Administration, May 2010
4)
Guidance for Industry: "Lookback" for hepatitis C virus (HCV); product quarantine, consignee notification, further testing, product
disposition, and notification of transfusion recipients based on donor test results indication infection with HCV. Rockville, MD, Food
and Drug Administration, December 2010
5)
Guidance and rules may be found at http://www.fda.gov/BiologicsBloodVaccines/default.htm
TRM.42185 CBER Notification Phase II
There is a policy requiring notification of the appropriate agency when a transfusion-
related fatality occurs following transfusion of any component.
NOTE: For laboratories subject to US regulations, this agency is the Center for Biologics
Evaluation and Research (CBER). CBER requires notification by telephone, facsimile, express
mail, or electronic mail "as soon as possible," with a written report of the investigation within 7
days.
Evidence of Compliance:
✓
Records of reportable events, if applicable
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Adverse
reaction file. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.170(b)]
APHERESIS
DONOR APHERESIS
Please note that the checklist requirements in the Blood/Component Donor Selection and Collection section
also apply to donor apheresis.
Inspector Instructions:
●
Sampling of donor apheresis policies and procedures
●
Sampling of donor apheresis procedure records and test results
●
Sampling of personnel training records
●
Apheresis components (labeling)
**REVISED** 09/17/2019
TRM.42212 Donor Safety and Protection Phase II
The apheresis equipment and procedures are designed to ensure sterility of the donor's
blood and safe return after separation of components.
NOTE: The equipment used must be appropriately maintained and monitored.
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Written procedures must include criteria for the administration and dose of medications
and ancillary agents (eg, calcium supplements, hetastarch, etc.) used during the apheresis
procedures.
TRM.42213 Staff Training Phase II
Persons responsible for apheresis donations are qualified, trained, and competent for
these tasks, including the recognition of procedural complications, adverse reactions, and
donor care.
Evidence of Compliance:
✓
Records of education and training of personnel involved in apheresis
TRM.42214 Donor Eligibility Phase II
A policy defining donor apheresis eligibility criteria is available.
NOTE: Prior to the start of each apheresis procedure, the prospective donor's history and
physical examination findings are evaluated against the eligibility criteria to ensure that the
procedure will be safe for the donor and the blood components safe for the recipient.
Evidence of Compliance:
✓
Donor eligibility criteria for each apheresis procedure performed (eg, RBC apheresis, platelet
apheresis, plasmapheresis) AND
✓
Records of donor evaluation prior to the procedure
REFERENCES
1)
Food and Drug Administration. Guidance for Industry. Implementation of Acceptable Full-Length and Abbreviated Donor History
Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood. May 2016.
TRM.42215 Extended Donor Evaluation Phase II
Additional criteria beyond routine donor screening and testing, appropriate for the type of
apheresis collection, are used to evaluate donors
NOTE: Additional testing may be required to evaluate donors in serial apheresis programs.
Examples of additional measures may include:
●
Total serum protein (no less than 6 g/dL), protein electrophoresis, and serum
immunoglobulin quantification before plasmapheresis
●
Platelet concentration before plateletpheresis and granulocyte collections.
Evidence of Compliance:
✓
Written policy defining criteria for extended testing of donors AND
✓
Donor records with test results
REFERENCES
1)
Department of Health and Human Services, Food and Drug Administration. Additional standards for human blood and blood
products. Code of Federal Regulations. 1999(Apr 1):[21CFR640.63]
2)
FDA Guidance for Industry, February 13, 2001, "Technical Correction: Recommendations for Collecting Red Blood Cells by
Automated Apheresis Methods"
3)
FDA Guidance for Industry, December 17, 2007, "Collection of Platelets by Automated Methods"
4)
FDA Memorandum, March 10, 1995, "Revision of FDA Memorandum of August 27, 1982: Requirements for Infrequent
Plasmapheresis Donors"
5)
FDA Memorandum, November 4, 1992, "Volume Limits for Automated Collection of Source Plasma"
TRM.42220 Plateletpheresis Donor Deferral Phase II
Plateletpheresis donors who have taken medications known to inhibit platelet function are
deferred for an appropriate time based upon the half-life of the medication.
Evidence of Compliance:
✓
Records of deferral AND
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✓
Medication deferral list
TRM.42222 Donor Informed Consent Phase II
An informed consent explaining the risks and benefits of apheresis donation is reviewed
and signed by the donor prior to donation.
NOTE: The donor must have the opportunity to ask questions and sign a document indicating
consent to the procedure.
Evidence of Compliance:
✓
Records of the signed donor consent forms
REFERENCES
1)
FDA. Additional standards for human blood and blood products. Source plasma. Informed consent. Washington, DC: US
Government Printing Office, 1999(Apr 1):[21CFR640.61]
2)
Food and Drug Administration. Guidance for Industry: Informed Consent Recommendations for Source Plasma Participation in
Plasmapheresis and Immunization Program. June 2007.
TRM.42223 Donor Apheresis Records Phase II
Complete records are kept of each apheresis procedure including the following elements:
1. Informed consent
2. Donor identification
3. Pertinent laboratory test results
4. Lot numbers of disposables and replacement fluids used
5. Component(s) collected
6. Volume of components
7. Anticoagulants used
8. Medications administered
9. Reactions and treatment, if any
TRM.42224 Adverse Reaction Phase I
There is a written procedure for the recognition, treatment, tracking, and trending of
adverse donor reactions to apheresis.
Evidence of Compliance:
✓
Records of donor reactions, including data on trending AND
✓
Procedure for recognizing and treating adverse reactions
TRM.42230 Volume Limits Phase II
During apheresis, the total volume deficit is limited to the following criteria:
1. No greater than 15% of the donor's estimated blood volume, including the
total volume of products being collected and the total volume of blood in the
extracorporeal circuit OR
2. No greater than 10.5 mL/kg of blood including the volume of products being
collected and the blood in the extracorporeal circuit OR
3. The laboratory has written procedures in place to compensate for donors with
smaller blood volumes.
NOTE: The laboratory must have policies and procedures that limit the total volume deficit and
prevent hypotension.
TRM.42235 Apheresis Component Labeling Phase II
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The apheresis components are properly labeled and meet all current labeling
requirements.
Evidence of Compliance:
✓
Written procedure defining labeling requirements
TRM.42240 Donation Interval Phase II
For allogeneic apheresis donations, the time interval since prior donations meets current
requirements.
NOTE:
1. Apheresis donors who give a two-unit red cell apheresis must be deferred for 16
weeks.
2. A donor who gave a unit of whole blood may donate by apheresis within eight weeks
only if the anticipated extracorporeal red cell volume of the intended apheresis
procedure is less than 100 mL.
3. If the red cell loss during an apheresis donation is 200 mL, but less than 300 mL, the
donor must be deferred for eight weeks. If the loss is equal to or greater than 300
mL, the donor must be deferred for 16 weeks.
4. Total donor red cell losses during any 16-week period and any 12-month period must
not exceed the loss of red cells permitted for whole blood donations (one per eight
weeks).
5. The interval between each plateletpheresis for a single platelet unit should be at
least two days with no more than two procedures in a seven-day period. The interval
between collection of double or triple platelet units and any subsequent collection
by plateletpheresis should be at least seven days. There must be no more than 24
donations in 12 months.
6. If plateletpheresis is performed more frequently than once every four weeks, the
donor platelet count must be no less than 150 X 10
9
before the procedure or at the
conclusion of the previous procedure.
7. If plasmapheresis is performed more frequently than once every four weeks, the FDA
guidelines must be followed.
Evidence of Compliance:
✓
Written procedure with defined donation intervals for the different products collected AND
✓
Donor records consistent with defined procedure
REFERENCES
1)
Guidance for Industry and FDA Review Staff, Collection of Platelets by Automated Methods, U.S. Department of Health and Human
Services, Food and Drug Administration, Center for Biologics Evaluation and Research, December 2007.
2)
Guidance for Industry, Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods, U.S. Department of
Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), January 2001.
3)
Food and Drug Administration. Additional standards for blood and blood products. Code of Federal Regulations. 2019 (Apr. 1):
[640.65].
THERAPEUTIC APHERESIS
Inspector Instructions:
●
Sampling of therapeutic apheresis policies and procedures
●
Sampling of therapeutic apheresis patient records, including initial device placement
●
Sampling of physician evaluation records and informed consents
●
Sampling of personnel records of education and training
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●
If you use venous access devices, how do you verify the placement?
●
What information is confirmed in a "time-out"?
●
To what degree is the transfusion service medical director involved in the apheresis
procedure?
TRM.42245 Responsibility for Therapeutic Apheresis Phase II
There is a record in the patient's chart that the transfusion service medical director or
a designated, qualified physician has accepted responsibility for the oversight of the
therapeutic apheresis procedures.
NOTE: The oversight responsibility includes quality assurance measures and medical
responsibility relating to patient care, such as consultation to determine whether a patient is
a candidate for therapeutic apheresis, rationale and appropriateness of treatment, patient
assessment and monitoring, treatment plan and endpoint, and care for adverse events.
Evidence of Compliance:
✓
Written policy defining transfusion service medical director/designated physician
responsibility for the apheresis service AND
✓
Patient records/charts showing evidence of transfusion service director/designated physician
oversight
TRM.42246 Therapeutic Apheresis Records Phase II
Complete records are retained of each apheresis procedure, including the following
elements:
1. Physician order to perform apheresis
2. Patient identification (two identifiers required)
3. Patient diagnosis
4. Type of apheresis procedure
5. Results of pertinent laboratory tests
6. Anticoagulant used
7. Blood fraction and volume removed and replacement fluid(s) type and volume
8. Medications administered
9. Lot numbers of disposables and replacement fluids used
10. Patient monitoring
11. Reactions and treatment, if any
12. Informed consent
TRM.42248 Patient Safety and Protection Phase II
The apheresis equipment and procedures are designed to ensure sterility of the patient's
blood, and safe return after separation of component parts.
NOTE: The equipment must be appropriately maintained and monitored.
TRM.42255 Staff Training Phase I
All personnel performing and/or supervising therapeutic apheresis procedures are
qualified by education and training.
NOTE: The personnel involved in provision of therapeutic apheresis, including operators and
supervising physicians, shall be appropriately qualified. This training includes recognition of
complications and patient care. Records of training may include in-house training programs,
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vendor/manufacturer training, education from third parties (eg, professional societies), and
continuing education courses (if applicable).
Evidence of Compliance:
✓
Record of education and training of personnel involved in therapeutic apheresis
TRM.42260 Evaluation and Approval for Therapeutic Apheresis Phase I
There is a policy for timely evaluation and approval of requests for therapeutic apheresis.
NOTE: This policy should address routine, urgent (treatment within 24 hours) and emergency
(treatment as soon as feasible) apheresis.
TRM.42265 Apheresis Patient Evaluation Phase I
A qualified physician is responsible for evaluating apheresis patients, including
indications for the procedure, therapeutic goals, and selection of replacement solutions.
NOTE: Therapeutic apheresis should be performed using an evidence-based approach.
REFERENCES
1)
Padmanabhan A, Connelly-Smith L, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice—evidence-
based approach from the Writing Committee of the American Society for Apheresis. The Eighth Special Issue. J Clin Apher.
2019;34:171-3554.
TRM.42267 Patient Informed Consent Phase II
A qualified physician is responsible for ensuring that an explanation of risks of the
procedure is provided and informed consent is obtained.
NOTE: The patient must have the opportunity to ask questions, and sign a document indicating
consent to the procedure. A process must be in place for obtaining consent from authorized
representatives when a patient is unable to give consent or in emergent situations where consent
cannot be obtained.
Evidence of Compliance:
✓
Copy of the consent form AND
✓
Records of physician evaluation of the patient prior to procedure
REFERENCES
1)
Food and Drug Administration. Additional standards for human blood and blood products. Source plasma. Informed consent.
Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR640.61]
2)
Sazama K. Practical issues in informed consent for transfusion. Am J Clin Pathol. 1997;107(suppl 1):S72-S74
3)
Sherman LA. Legal issues in blood banking. Elements of informed consent. Clin Lab Med. 1996;16:931-946
TRM.42270 Venous Access Verification Phase I
The placement of the venous access device is verified by the operator prior to each use.
NOTE: Verifications of the appropriate placement of central venous access can be achieved by
reviewing radiologic images or reports prior to the first use or after repositioning. Verification of
central venous access and peripheral access prior to each use should also be confirmed through
the examination of the vascular access site, as well as ensuring the free flow of blood when
drawing and returning through the vascular access device prior to connecting the apheresis
device. Inappropriate placements have been reported to be the cause of severe complications
including fatalities.
TRM.42275 Time-Out Phase II
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A "time-out" is called and the following information confirmed prior to initiation of each
therapeutic apheresis procedure.
1. Two patient identifiers to verify patient identity
2. Type of apheresis
3. Informed consent
4. Written physician's order
5. Availability of a qualified physician
Evidence of Compliance:
✓
Written apheresis procedure with steps to verify information AND
✓
Records of time-out verification for each procedure
TRM.42280 Adverse Reaction Phase II
The standard operating procedure(s) describes evaluation of the apheresis patient for
risks, as well as the monitoring and treatment of patients for any adverse reaction to
therapeutic apheresis.
NOTE: Therapeutic apheresis can result in complications necessitating prompt medical
treatment. Procedures should provide information on monitoring for and treatment of potential
complications including the loss of consciousness, hypocalcemia, hypotension, allergic reactions,
air embolus, and hemolysis
THERAPEUTIC PHLEBOTOMIES
Inspector Instructions:
●
Sampling of therapeutic phlebotomy policies and procedures
●
Sampling of therapeutic phlebotomy patient records
●
Sampling of physician orders with required information
●
What patient goals have been established for the therapeutic phlebotomy?
TRM.42285 Therapeutic Phlebotomy Units for Transfusion Phase II
If blood collected by therapeutic phlebotomies is intended for transfusion without specific
labeling, the patient/donor meets all the criteria for allogeneic donation.
NOTE: For laboratories subject to US regulations, as of May 22, 2015, the final rule,
Requirements for blood and blood components intended for transfusion or further manufacturing
use (21CFR630), eliminated the requirement to obtain a variance from the FDA in order to use
blood collected from therapeutic phlebotomies for transfusion.
Evidence of Compliance:
✓
Written procedure for using blood collected for therapeutic phlebotomy for allogeneic
donation including inclusion criteria AND
✓
Records of patient/donors meeting the criteria for allogeneic donations
REFERENCES
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1)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR606.145].
**REVISED** 09/17/2019
TRM.42290 Therapeutic Phlebotomy Responsibility Phase II
If therapeutic phlebotomies are performed by laboratory staff, the transfusion service
medical director or qualified physician designee has accepted medical responsibility for
the procedures.
NOTE: If the laboratory is responsible for therapeutic phlebotomies, the transfusion service
medical director or qualified physician designee must accept medical responsibility for the
patient undergoing this procedure. This involvement is in addition to responsibility for overall
management of the therapeutic phlebotomy program, establishment of eligibility criteria for
therapeutic phlebotomy, provision of medical support for reactions, and oversight of quality
assurance measures.
Evidence of Compliance:
✓
Written policy defining responsibility for therapeutic phlebotomy procedures AND
✓
Patient records/charts showing evidence of transfusion service medical director or qualified
physician designee review
TRM.42295 Patient Protection Phase II
The procedures for therapeutic phlebotomy provide adequate protection for the patient.
NOTE: The procedures should include proper patient identification, adequate training of
laboratory staff, proper sterile technique, and appropriate volume to be removed.
TRM.42300 Record Retention Phase II
Records are retained of all the following elements.
1. Physician order to perform therapeutic phlebotomy
2. Patient identification (two identifiers required)
3. Patient diagnosis
4. Type of procedure performed
5. Lot numbers of disposables and replacement fluids used
6. Nature and volume of blood removed and replaced
7. Patient data and criteria for measuring patient response, as available
8. Reactions and treatment, if any
9. Informed consent
**REVISED** 06/04/2020
TRM.42305 Therapeutic Plan Phase I
A designated physician has developed a therapeutic plan for patients undergoing
therapeutic phlebotomies and the goals for the therapeutic phlebotomy have been clearly
stated.
Evidence of Compliance:
✓
Patient/donor records indicating plan and timeline
REFERENCES
1)
Tavill SA, Diagnosis and Management of Hemochromatosis. Hepatology 2003: 33(5);1321-1328
TRM.42310 Physician Order Phase I
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The physician's order for therapeutic phlebotomy, includes at a minimum, the frequency,
the volume to be removed and the laboratory values to be monitored.
TRM.42315 Indications For Therapeutic Phlebotomy Review Phase II
The indications for therapeutic phlebotomy are reviewed by the physician responsible
for performance of therapeutic phlebotomy prior to initiation and not less frequently than
every 12 months thereafter.
Evidence of Compliance:
✓
Records of approval for therapeutic phlebotomy
COMPONENT PREPARATION,
STORAGE AND MODIFICATION
Checklist requirements relating to blood storage temperature apply to the transfusion service and other
blood storage areas located within the facility (eg, surgery, nursing and dialysis units) for all blood and blood
components.
The following component definitions are offered as a convenience:
Component Definition
Fresh Frozen Plasma (FFP) Plasma frozen within 8 hours of collection after being separated from a unit of
whole blood or frozen within 6 hours after collection by apheresis
Plasma Frozen Within 24
Hours After Phlebotomy
Plasma separated from whole blood and frozen between 8-24 hours after
collection
FFP, Thawed
Fresh Frozen Plasma thawed between 30-37°C, then stored at 1-6°C for up to
24 hours
Plasma Frozen Within 24
Hours After Phlebotomy,
Thawed
Plasma frozen within 24 hours of collection that has been thawed between
30-37°C, then stored at 1-6°C for up to 24 hours
Thawed Plasma
“FFP, Thawed” or “Plasma Frozen Within 24 hours After Phlebotomy, Thawed”
which is stored in a closed system at 1-6°C for 1-5 days after thawing
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Inspector Instructions:
●
Sampling of blood component storage and handling policies and procedures
●
Sampling of storage unit temperature logs (4 weeks of recordings), including
recording charts when high/low alarm testing performed, and remote storage, as
applicable
●
Sampling of records of corrective action when storage unit temperatures fall outside
of the defined range
●
Sampling of blood component records of inspection
●
Records of staff training on alarm response
●
Refrigerator storage unit (organization, sufficient space, placement and number of
temperature probes, separation of units), including remote storage, as applicable
●
Sampling of blood/blood components (labeling with all required elements, assigned
expiration date)
●
Active alarm system(s) in place for all storage units
●
How are blood components received/shipped from the facility?
●
If you receive blood back into inventory, how did you validate your procedure?
●
What back-up options are available in the event of an electrical power outage?
●
At what range do you set your alarms to sound?
●
How is the storage unit alarm system monitored? How was the response time
validated?
TRM.42350 Blood Component Storage Phase II
There is adequate blood component storage space to meet the needs of the facility.
NOTE: Adequate refrigerated, room temperature, and freezer storage space is needed for proper
storage and organization of blood components. Insufficient storage space can compromise the
organization of blood components in the laboratory.
TRM.42400 Issuance/Release Control Phase II
The storage system for blood components minimizes the inadvertent issuance or release
of the wrong unit.
NOTE: The blood in the refrigerator must be arranged to facilitate the location and separation of
units. Examples of such organization include, but are not limited to, different groups and types of
blood, unprocessed blood, blood that is suitable for issue or release, quarantined or rejected or
outdated units, autologous units, and crossmatched and non-crossmatched units. Such a system
is important to minimize the inadvertent transfusion of the wrong unit.
TRM.42450 Blood/Blood Component Inspection Phase II
All blood/blood components and tissues are inspected upon receipt from the supplier and
at the time of issue, and records are retained of these checks.
NOTE: Upon receipt from the supplier, each product must be inspected for proper labeling
and shipping conditions, including an inspection of the shipping container and condition of the
coolant. Temperature measurement is not required unless a problem is suspected. Products
must be checked for expiration date and abnormal appearance, such as color, hemolysis, clots,
and bag integrity, upon receipt from the supplier and at the time of issue. Comparison of bag
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and segment color should be performed for red blood cell units as an aid in detecting bacterially-
contaminated units.
REFERENCES
1)
Kim DM, et al. Visual identification of bacterially contaminated red cells. Transfusion. 1992;32:221-225
TRM.42460 Blood and Blood Component Shipping Phase II
For blood and blood components shipped outside of the facility there are written
procedures for proper packaging to prevent damage and control shipping temperatures.
NOTE: Containers (eg, portable coolers) must be validated by the laboratory to ensure that they
maintain appropriate temperature.
**REVISED** 09/17/2019
TRM.42470 Acceptance Back Into Inventory Phase II
There is a written procedure, validated by the laboratory, for accepting blood/blood
components back into inventory after they have been issued.
NOTE: The procedure must include steps to verify the integrity and appearance of the blood/
blood component and maintenance at appropriate temperatures.
The steps and criteria defined in the procedure for acceptance of units back into inventory, such
as the use of transport containers (eg, portable coolers) must be validated by the laboratory.
TRM.42480 Blood Components Storage Requirements and Expiration Dates Phase II
The expiration dates and storage requirements of all blood components comply
with the most recent edition of the Circular of Information and the manufacturer's
recommendations. For laboratories not subject to US regulations, expiration dates
conform to national, state or provincial, and local laws and regulations for all approved
component storage systems in use.
REFERENCES
1)
Food and Drug Administration. General biological products standards. Dating periods for licensed biological products. Washington,
DC: US Government Printing Office, 1999(Apr 1):[21CFR610.53]
2)
AABB, the American Red Cross, America's Blood Centers and the Armed Services Blood Center. Circular of Information for the Use
of Human Blood and Blood Components. Bethesda, MD. October 2017.
**REVISED** 06/04/2020
TRM.42500 Blood/Component Storage Monitoring Phase II
For blood/blood component storage units (eg, refrigerators, freezers, and platelet
incubators) that lack continuous automated temperature recording, the temperatures are
recorded at least every four hours.
NOTE: This checklist requirement applies to all blood component storage devices in the facility,
including those located outside of the transfusion service (eg, in surgery, nursing and dialysis
units). When platelets are stored outside of a platelet incubator (eg, in ambient temperature), the
temperature of the room must be monitored.
All blood and components must be stored at an appropriate temperature to maintain viability
and function. The storage temperatures must be monitored continuously or at least every four
hours, such that appropriate action can be taken should the temperature in the storage device
reach a temperature that might result in harm to the blood or component. There must be written
procedures for evaluating these systems as well as maintenance of temperature when power
failures and other problems occur.
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Temperatures may be recorded either manually, or using a recording device or system by: 1)
recording the numerical temperature, or 2) placing a mark on a graph that corresponds to a
numerical temperature. If temperatures are recorded manually, the identity of the individual
recording the temperature(s) must be recorded (recording the initials of the individual is
adequate).
If an automated (including remote) temperature monitoring systems is used instead of manual
temperature monitoring, laboratory personnel must have ongoing immediate access to the
temperature data, so that appropriate corrective action can be taken if a temperature is outside of
the acceptable range. System records must demonstrate daily functionality of the system.
Evidence of Compliance:
✓
Written procedure defining criteria and frequency for evaluation of blood/component storage
units to include maintenance of temperature under all conditions AND
✓
QC records for continuous temperature monitoring OR records of checks at defined
frequency
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Equipment. Washington, DC:
US Government Printing Office, 1999(Apr 1):[21CFR606.60]
2)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Records.
Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.160(b)(3)(iii)]
3)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1271(c)]
TRM.42550 Storage Temperature Range Corrective Action Phase II
If the proper storage temperature range is not maintained (inspector will check 4 weeks
of recordings), there is evidence that timely corrective action has been taken, to include
records of the disposition of any affected components.
**REVISED** 06/04/2020
TRM.42600 Consistent Temperature Phase II
There are records that refrigeration unit devices maintain the proper temperature
throughout the unit.
NOTE: On refrigeration units, thermometers must be placed in appropriate areas, or multiple
point readings taken on a periodic basis to ensure that a 1 to 6°C temperature is maintained
throughout. The placement and number of probes needed is based on the size of the
temperature-dependent unit. There must be records that such readings have been taken.
Unrestricted air circulation within the unit reduces the potential for warmer or colder areas that
may have detrimental effects on blood/component units without detection by the monitoring
system.
Data from temperature mapping performed when refrigeration units are placed in service, after
repairs, and when unit devices are relocated can be used to determine the appropriate number
and placement of temperature probes or thermometers.
TRM.42650 Monitored Temperature Phase I
The temperature of refrigerators is monitored in a manner that will mimic the temperature
characteristics of a component stored in the device.
NOTE: For example, placement of the temperature sensor probe in liquid with heat
transfer characteristics similar to blood, and a volume similar to the smallest units stored, is
recommended, but other procedures are also acceptable.
TRM.42700 Emergency Power Supply Phase II
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The blood/blood components and tissue refrigerator(s) and freezer(s) have an emergency
power supply.
**REVISED** 06/04/2020
TRM.42750 Storage Unit Alarms Phase II
All component storage units are equipped with an alarm system that is monitored 24
hours/day (in laboratory or remote), with alarm checks (for both low and high settings)
performed according to the manufacturer's recommended interval, or at least quarterly if
not specified by the manufacturer, with results recorded.
NOTE: The laboratory must demonstrate that all components of the alarm system (including
chart/graph recordings) work as expected and that there is a process to ensure a timely response
to alarms, including remote alarms.
When facilities perform alarm checks, the temperature at which the alarm sounds must be
compared to the temperature on the recording chart/log. Examples of recording systems include:
●
Paper chart records
●
Paper graphs
●
Electronic records
●
Event logs
Evidence of Compliance:
✓
Records of alarm checks at defined frequency
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1271(c)]
**REVISED** 09/17/2019
TRM.42850 Alarm Adjustment Phase II
Alarms are adjusted to be triggered before the temperature falls outside the 1 to 6°C
acceptable temperature range for refrigerators, or outside the acceptable range for
freezers, liquid nitrogen storage units, and platelet incubators.
NOTE: Refrigerators, freezers and platelet incubators must have alarm systems that provide
opportunity to take action before the temperature of blood or components is outside of
acceptable ranges (eg, alarms set to trigger at 1°C or 6°C do not provide adequate time for staff
to respond to the alarm before temperature ranges are exceeded).
Red cell units stored at temperatures higher than 6°C may be subject to accelerated bacterial
growth. Temperatures below the freezing point may induce hemolysis. Freezers need not be
operated at their lowest possible temperature, since some plastic plasma containers held at
temperatures lower than -25°C may exhibit increased breakage rates upon handling.
Evidence of Compliance:
✓
Records of trigger temperatures during alarm checks AND
✓
Records of corrective action, when appropriate
TRM.42900 Power Failure Back-Up Phase II
The alarms will continue to function if the power is interrupted.
NOTE: Alarm systems must continue to function during a power failure. This may be
accomplished by having the alarm on a separate circuit, installing battery power back-up, or
having a power failure alarm.
TRM.42950 Storage Temperature Variances Phase II
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There are written procedures to follow if there are variances outside acceptable storage
temperature limits.
NOTE: Specific procedures must be available and understood by personnel regarding handling
blood and blood components if storage temperature limits cannot be maintained. The primary
concern is the preservation of blood. If there is a power failure, arrangements must be made for
service, and for alternative storage of blood.
TRM.43500 Component Processing/Storage Phase II
There are written procedures for the processing and storage (including expiration,
quarantine criteria, additives, pooling, etc.) of all components prepared and stored in the
laboratory.
TRM.43600 Component Labeling Phase II
For each component, the label specifies all of the required information, and requirements
for proper labeling of components are defined.
NOTE: Required information may be offered separately in an approved "circular of information,"
provided that the component label refers to the circular. All steps of blood component labeling
must be defined in the procedure manual and conform to the International Society of Blood
Transfusion labeling system (ISBT). The laboratory must have a valid system to receive and
manage all blood components that come into inventory, including those labeled with legacy
labeling systems such as the 1985 Uniform Labeling Guideline system (CODABAR).
REFERENCES
1)
Food and Drug Administration: Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule, Fed.
Register (2004;69:9120-9171 4)
**NEW** 06/04/2020
TRM.43605 Component Labeling - Final Inspection Phase II
Final inspection of the component labeling process includes verifying that all the
information is correct on the label by:
●
One appropriately trained member of the transfusion service using a
validated process, such as an electronic system capable of preventing the
release of mislabeled components OR
●
Two appropriately trained members of the transfusion service.
NOTE: When using a validated process where each barcode quadrant of the component label
is scanned and compared to the electronic record of the laboratory computer system, it is
acceptable for one member of the transfusion service to perform this check.
Evidence of Compliance:
✓
Written procedure for verifying the accuracy of the component labeling process
**NEW** 09/17/2019
TRM.43610 Red Blood Cell Unit Labeling With Historical Antigen Typing Phase II
There are written procedures for the labeling of red blood cell units with historical antigen
typing results of non-ABO/Rh antigens.
NOTE: Written procedures must describe the non-ABO/Rh(D) antigen typing process using
manufacturer's instructions. Labeling of red cell units with historical antigen typing results must
follow current FDA guidelines. Units may be labeled as antigen negative, without testing the
current donation, if units from two previous separate donations were found to be concordant in
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the records from the same collection facility. Concordant antigen typing results may be obtained
using serological or approved molecular tests or a combination thereof.
Laboratories not subject to US regulations must follow national, state (or provincial) and local
laws and regulations.
REFERENCES
1)
Food and Drug Administration, Guidance for Industry: Labeling of Red Cell Units with Historical Antigen Typing Results. December,
2018.
TRM.43625 Label Approval Phase II
There is a written procedure to approve the content and use of all new blood product
labels including inspection for acceptable label content.
NOTE: The procedure should include phasing out old labels and implementing new labels.
TRM.43650 Component Handling Phase II
For each component, there are written procedures for maintaining sterility, including
pooling and the use of sterile connecting devices, and there is evidence that these
procedures are followed.
NOTE: If a sterile connecting device is used, the integrity of the weld and maintenance of the
closed system must be assessed and recorded after each weld. If the integrity of the weld is
incomplete, the unit must be considered an open system and the expiration date on the product
label must be modified accordingly.
REFERENCES
1)
Food and Drug Administration. Use of an FDA-cleared or approved sterile connecting device (STCD) in blood bank practice.
Memorandum, 1994(Jul 29)
TRM.43700 Pooled Components Phase II
If components are pooled, records are maintained to include the individual unit
identification numbers contained within the pool.
Evidence of Compliance:
✓
Log or computer records with the identity of each donor unit in a pooled product
RED BLOOD CELLS
Inspector Instructions:
●
RBC processing policy or procedure
●
Sampling of RBC component processing and QC records
TRM.43750 24 Hour Expiration Phase II
If a unit is entered for any reason without appropriate use of a sterile connection device, a
24 hour expiration time is assigned to refrigerated components.
NOTE: Closed systems retain the same expiration date as the original whole blood unit.
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Evidence of Compliance:
✓
Written procedure for changing the expiration date when a unit is entered with an open
system AND
✓
Component processing records showing modified expiration dates when appropriate
TRM.43800 RBC Hematocrit Limit Phase II
The method for preparing Red Blood Cells ensures that the final hematocrit does not
exceed 80% if the component is to be stored for an extended interval. (This item does not
apply if an additive solution is used.)
NOTE: If an insufficient amount of plasma is left on the red cells, the cells may not have enough
nutrients to survive.
Evidence of Compliance:
✓
Records of component QC documented at defined frequency
RED BLOOD CELLS WASHED
Inspector Instructions:
●
RBC washing policy or procedure
TRM.43850 Plasma Removal Phase II
Methods are adequate to ensure removal of almost all of the plasma.
RED BLOOD CELLS FROZEN
Inspector Instructions:
●
Red cell cryopreservation policy or procedure
●
Sampling of temperature records
●
Sampling of inventory records
TRM.43900 RBC Storage Phase II
Storage facilities are adequate to meet the requirements for preserving and retrieving
frozen Red Blood Cells.
NOTE: Frozen Red Blood Cell units must be maintained at temperatures appropriate for the
cryopreservation technique. Inventory records should be retained to permit prompt retrieval.
TRM.43950 RBC Freezing Method Phase II
Red Blood Cells are frozen by an approved method.
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NOTE: RBCs should be frozen within six days of collection if anticoagulated with CPD or CPDA-1
or promptly after rejuvenation. Laboratories subject to US regulations must use methods and
solutions approved by the FDA. Laboratories not subject to US regulations must follow national,
state or provincial, and local laws and regulations.
REFERENCES
1)
AABB, the American Red Cross, America's Blood Centers and the Armed Services Blood Center. Circular of Information for the Use
of Human Blood and Blood Components. Bethesda, MD. October 2017.
TRM.44000 Pre-Transfusion Testing Phase II
Red blood cell samples from the unit are available for pre-transfusion testing.
NOTE: Red blood cells must be available for pre-transfusion testing in a manner that guarantees
linkage with the unit.
RED BLOOD CELLS DEGLYCEROLIZED
Inspector Instructions:
●
RBC deglycerolization policy or procedure
●
Sampling of inventory records
TRM.44100 Open System Preparation Usage Phase II
Reconstituted deglycerolized Red Blood Cells that have been prepared with an open
system are used within 24 hours.
NOTE: Post-thaw storage is also allowed for up to 14 days in a functionally closed, approved
system.
Evidence of Compliance:
✓
Inventory records showing deglycerolization and expiration dates
REFERENCES
1)
Valeri CR et al. A multicenter study of in vitro and in vivo values in human RBCs frozen with 40-percent (wt/vol) glycerol and stored
after deglycerolization for 15 days at 4°C in AS-3: assessment of RBC processing in the ACP 215. Transfusion. 2001;41:933-9
TRM.44150 Deglycerolization Requirements Phase II
The method of deglycerolized Red Blood Cell preparation ensures at least 80% physical
recovery of cells, adequate removal of cryoprotective agent, and minimum hemolysis.
NOTE: The deglycerolization process must ensure the adequate removal of cryoprotective
agents and minimal hemolysis, as failure to return the red cells to an isosmotic state may result in
hemolysis upon transfusion.
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RED BLOOD CELLS LEUKOCYTE-REDUCED (LABORATORY-PREPARED)
Inspector Instructions:
●
Leukoreduced policy or procedure
●
Sampling of leukocyte-reduced RBC component QC records
TRM.44250 Leukocyte-Reduced RBC Criteria Phase II
Records indicate that leukocyte-reduced Red Blood Cells contain less than 5 X 10
6
leukocytes and retain at least 85% of the original red blood cells.
NOTE: The method of preparation of leukocyte-reduced Red Blood Cells must be shown to
retain at least 85% of the original red cells and to reduce the leukocyte concentration to less
than the maximum amount prescribed by the FDA. Units with lower leukocyte concentrations
are associated with decreased febrile transfusion reactions, reduced alloimmunization potential,
reduced cytomegalovirus transmission, and other benefits. For quality control, the FDA requires
95% confidence that 95% of each leukoreduced product meets specifications.
Laboratories not subject to US regulations must follow national, state or provincial, and local laws
and regulations.
REFERENCES
1)
Beckman N et al. Review of quality monitoring methods used by countries using or implementing universal leukoreduction.
Transfusion Med Rev 2004;18:25-35
2)
Dzik S et al. A multicenter study evaluating three methods for counting residual WBCs in WBC-reduced blood components.
Transfusion 2000;40:513-20
3)
Food and Drug Administration. Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components
Intended for Transfusion. Rockville, MD. Food and Drug Administration. September 2012.
FRESH FROZEN PLASMA
Inspector Instructions:
●
FFP policy or procedure
●
Sampling of temperature monitoring records
●
Sampling of thawed FFP components (relabeled)
TRM.44350 Plasma Collection/Storage Phase II
The plasma is separated from the whole blood and placed at -18°C or lower within eight
hours of collection if the anticoagulant is CPD, CP2D, or CPDA-1.
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NOTE: Fresh Frozen Plasma must be separated within eight hours of collection when using
CPD, CP2D, or CPDA-1 as the anticoagulant. Plasma may be separated from whole blood as
long as 24 hours after collection and frozen at -18°C or lower, but it may not be labeled "Fresh
Frozen" Plasma -- it is called "Plasma, Frozen Within 24 Hours of Collection." Freezers need not
be operated at their lowest possible temperature, since some plastic plasma containers held at
temperatures lower than -25°C may exhibit increased breakage rates upon handling.
Evidence of Compliance:
✓
Written procedure for plasma component preparation and storage for the different types of
products prepared AND
✓
Component records
TRM.44400 Plasma Freezer Monitoring Phase II
The temperature required for proper storage in freezers is maintained and recorded.
NOTE: Freezer storage temperatures must be maintained at -18°C or below for preservation of
procoagulants in the plasma.
**REVISED** 09/17/2019
TRM.44450 Plasma and Cryoprecipitate Thawing Phase II
Frozen plasma components and cryoprecipitate are thawed at 30 to 37°C with protection
against water contamination of outlet ports or thawed using an FDA-cleared device.
NOTE: If a microwave oven is used, any manufacturer's claim that the temperature of the
contents does not exceed 37°C must be verified by the laboratory. In the absence of such claim,
the laboratory must validate the device's preservation of labile coagulation factors.
If frozen plasma components are thawed in a waterbath, an overwrap bag or other similar
protection must be used to prevent water from coming in contact with outlet ports and possibly
introducing bacterial contamination.
TRM.44525 Thawed Plasma Label Phase II
If Fresh Frozen Plasma or plasma frozen within 24 hours of collection is thawed at 30 to
37°C and maintained at 1 to 6°C for one to five days, it is relabeled as "Thawed Plasma".
TRM.44537 Thawed Cryoprecipitate-Reduced Plasma Usage Phase II
If cryoprecipitate-reduced plasma is thawed between 30 to 37°C and maintained at 1 to
6°C, it is used within five days.
REFERENCES
1)
Erik A Scott, Kathleen E. Puca, Bradley C. Pietz, Brian K. DuChateau, Kenneth D. Friedman. Analysis of ADAMTS13 Activity in
Plasma Products Using a Modified FRETS-VW73 Assay. Blood Vol. 106, 165a, 2005
CRYOPRECIPITATE
Inspector Instructions:
●
Cryoprecipitate policy or procedure
●
Sampling of records of component processing
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TRM.44600 Cryoprecipitated AHF Preparation Phase II
Cryoprecipitated AHF is prepared to preserve fibrinogen and factor VIII activity:
1. Fresh frozen plasma is thawed at 1 to 6°C
2. The thawed plasma is immediately centrifuged at 1 to 6°C to separate the
cryoprecipitate from the plasma, and
3. The cryoprecipitate is frozen within one hour
Evidence of Compliance:
✓
Written procedure for preparation of cryoprecipitate AND
✓
Records of temperature monitoring for the refrigerated centrifuge AND
✓
Records of component processing
PLATELETS
Inspector Instructions:
●
Platelet component policy or procedure
●
Sampling of records of component processing QC
●
How have you verified your platelet count method for the expected concentration
range?
●
What system are you using to control the risk of bacterial contamination in platelet
components?
●
What actions do you take if a platelet component is suspected of having bacterial
contamination?
TRM.44850 Platelet Preparation Phase II
Platelets are prepared within eight hours of the collection of whole blood that has
NOT been cooled below 20°C or, if prepared by apheresis methods, they are prepared
according to the instrument manufacturer's instructions.
NOTE: Platelets must be separated within eight hours from whole blood that has not been
cooled to below 20°C to allow appropriate refrigerated storage of Red Blood Cells and storage of
platelets at room temperature (20 to 24°C) with agitation. However, whole blood may be held for
a longer period at room temperature prior to separation of components, not to exceed 24 hours,
provided that safety and efficacy of the components are recorded. Storage at lower temperatures
may result in reduced platelet survival. Apheresis platelets must be prepared according to the
instructions of the manufacturer.
REFERENCES
1)
Moroff G, Holme S. Concepts about current conditions for the preparation and storage of platelets. Transf Med Rev. 1991;5:48-59
2)
Food and Drug Administration. Additional standards for human blood and blood products. Platelets. Collection of source material.
Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR640.22(c)]
3)
ibid. Platelets. Processing. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR640.24]
4)
Silberman S. Platelets. Preparations, transfusion, modifications, and substitutes. Arch Pathol Lab Med. 1999;123:889-894
TRM.44900 Platelet Component Acceptability Criteria Phase II
Records indicate that platelet components have acceptable numbers of platelets and that
acceptable pH levels have been maintained during storage.
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NOTE: Platelet concentrates are required to have a minimum of 5.5 X 10
10
platelets/unit and
Apheresis Platelets are to have a minimum of 3 X 10¹¹ platelets/unit in at least 90% of units
tested. Plastics currently approved and commonly used for platelet unit storage permit adequate
gas exchange to maintain pH of at least 6.2.
Laboratories not subject to US regulations must follow national, state or provincial, and local laws
and regulations.
REFERENCES
1)
Food and Drug Administration. Guidance for Industry and FDA review staff. Collection of Platelets by automated methods. Rockville,
MD. FDA: 2007.
2)
Food and Drug Administration. Additional standards for human blood and blood products. Platelets. Washington, DC: US
Government Printing Office, 1999(Apr 1):[21CFR640.25(b)(2) and -640.24(d)]
3)
Silberman S. Platelets. Preparations, transfusion, modifications, and substitutes. Arch Pathol Lab Med. 1999;123:889-894
TRM.44925 Platelet Count Verification Phase I
Platelet counts on platelet components are determined, when required, using a method
that has been verified to be accurate in the expected concentration range.
NOTE: Automated whole blood hematology analyzers may yield inaccurate, non-linear results in
the range of platelet counts encountered in platelet components (generally 1,000,000-2,000,000/
µL). Predilution of samples from components, alone, may not avoid this problem. The entire
method used for determining platelet concentrations in platelet components (including any
manual manipulations in addition to the automated instrument's functions) should be verified
periodically using a preparation of known concentration (such as provided commercially or
determined through a reference method).
Evidence of Compliance:
✓
Written procedure defining criteria and frequency for verification of the instrument for
accuracy of platelet concentrations in the expected range AND
✓
Records of verification at defined frequency
REFERENCES
1)
Dumont LJ, Moroff G. Platelet and residual leukocyte counting in platelet components. In, Seghatchian J, Snyder EL, Krailadsiri P,
eds. Platelet therapy. Current status and future trends. New York: Elsevier, 2000:277-317
2)
Whitbread J, Moroff G, Coker SO, Finch S, Murphy S, Wenz B. Prospective comparisons of platelet counting in automated
hematology analyzers. Transfusion 1998;38:86S
3)
Peoples BG, Moroff G, Friedman LI, Katz AJ. A multi-site study of variables affecting platelet counting for blood component quality
control. Transfusion 1994;34:11S
4)
The influence of various hematology analyzers on component platelet counts. Moroff G, Sowemimo-Coker SO, Finch S, Murphy S,
Brandwein H, Whitbread J, Wenz B for the BEST Collaborative. Transf Med Rev 2005;19:155-66
5)
International Council for Standardization in Hematology Expert Panel on Cytometry and International Society of Laboratory
Hematology Task Force on Platelet Counting. Platelet counting by the RBC/platelet ratio method: a reference method. Am J Clin
Pathol 2001;115:4604
6)
Harrison P, Horton A, Grant D, Briggs C, Machin S. Immunoplatelet counting: a proposed new reference procedure. Br J Haematol
2000;108:228-35
TRM.44950 Platelet Component Storage Phase II
Platelet components are stored at 20 to 24°C with appropriate agitation and transfused
within the approved storage time for the particular container and collection method used.
NOTE: Storage of Platelets above 24°C may result in undesirable metabolic changes. Platelet
storage below 20°C, even for brief periods, may cause irreversible declines in platelet function.
Platelet bags currently approved and used for five-day storage maintain adequate platelet
viability and function for up to seven days. However, concerns that contaminating bacteria may
proliferate to dangerous levels during prolonged storage have reduced the allowable dating
period to five days. Agitation during storage is necessary to ensure optimal gas exchange and
maintenance of pH.
Data in the literature suggest that platelets may be stored up to 24 hours without agitation.
However, platelet bag manufacturer's instructions must be followed if more stringent.
REFERENCES
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1)
Shelton JB, et al. The effects of early agitation on the viability of stored platelets. Am J Clin Pathol. 1997;108:352-353
2)
Silberman S. Platelets. Preparations, transfusion, modifications, and substitutes. Arch Pathol Lab Med. 1999;123:889-894
3)
Moroff G, George VM. The maintenance of platelet properties upon limited discontinuation of agitation during storage. Transfusion.
1190;30:427-430
TRM.44955 Bacterial Contamination in Platelets Phase II
The laboratory (or its blood supplier) must assure that the risk of bacterial contamination
of platelets is adequately controlled using 1) FDA-cleared/approved devices or an
equivalent system for bacterial detection in platelets, or 2) other adequate and appropriate
methods found acceptable by the FDA (eg, pathogen reduction).
NOTE: Equivalent system is defined as a system that has been validated to demonstrate
comparable or improved sensitivity in CFU/mL. If testing is performed by the supplier of platelet
components, the laboratory can satisfy this checklist requirement by having a written agreement
with the supplier to be notified of supply units suspected of containing bacteria.
Evidence of Compliance:
✓
Records of use of individual units of whole blood derived (WBD) platelets or pools of up to six
units of such platelets that have been tested by an FDA-cleared/approved method OR
✓
Records of use of pre-pooled WBD platelets tested with an FDA-cleared/approved culture-
based QC test by the supplier OR
✓
Records of use of apheresis platelets tested with an FDA-cleared/approved culture-based
QC test by the supplier OR
✓
Records of culture of aliquots from individual WBD platelet units destined for pooling OR
✓
Records of testing by methods that are not FDA-cleared/approved but have been validated to
be of equivalent clinical sensitivity to an FDA-cleared/approved assay OR
✓
Records for use of other adequate/appropriate methods found acceptable by the FDA (eg,
pathogen reduction)
REFERENCES
1)
Brecher ME, Means N, Jere CS, Heath D, Rothenberg S, Stutzman LC. Evaluation of an automated culture system for detecting
bacterial contamination of platelets: an analysis with 15 contaminating organisms. Transfusion. 2001 Apr;41(4):477-82
2)
Benjamin RJ, Kline L, Dy BA, Kennedy J, Pisciotto P, Sapatnekar S, Mercado R, Eder AF. Bacterial contamination of whole-blood-
derived platelets: the introduction of sample diversion and prestorage pooling with culture testing in the American Red Cross.
Transfusion. 2008 Nov;48(11):2348-55
3)
Yazer MH, Stapor D, Triulzi DJ. Use of the RQI test for bacterial screening of whole blood platelets. Am J Clin Pathol. 2010
Apr;133(4):564-8
4)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR606.145].
TRM.44957 Bacterial Contamination in Platelets Notification Phase II
If the transfusion service laboratory performs testing to detect bacterial contamination
of platelets, there are written procedures for the handling and investigation of platelet
components that are suspected of having bacterial contamination that prohibit release
of the units for transfusion and include notification to the blood supplier and appropriate
steps to identify the contaminating organism(s).
NOTE: If testing to identify the contaminating organism(s) is not performed by the laboratory,
appropriate steps may include having an agreement with the blood supplier or another laboratory
to identify the organism(s). The notification to the blood supplier must include information about
the species of the contaminating organism, where possible.
Evidence of Compliance:
✓
Records of investigation and interpretation of findings AND
✓
Records of blood supplier notification for contaminated platelet(s) with organism identified
REFERENCES
1)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR606.145].
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PLATELETS LEUKOCYTE-REDUCED
Inspector Instructions:
●
Platelet leukoreduced policy or procedure
●
Sampling of leukocyte-reduced platelet component QC records
TRM.44960 Method of Preparation Phase II
The method of preparation ensures acceptable leukocyte-reduction and platelet
concentration in the final component.
NOTE: The WBC content for leukocyte reduced whole-blood-derived platelets must be less than
8.3 x 10
5
WBCs, and for plateletpheresis units, less than 5 x 10
6
WBCs. After filtration, platelet
recovery must be at least 85% of the original content.
Laboratories not subject to US regulations must follow national, state or provincial, and local laws
and regulations.
REFERENCES
1)
Lutz P, Dzik WH. Large-volume hemocytometer chamber for accurate counting of white cells (WBCs) in WBC-reduced platelets;
validation and application for quality control of WBC-reduced platelets prepared by apheresis and filtration. Transfusion.
1993;33:409-412
2)
Narvios AB, et al. Assessing the efficiency of leukoreduction of cellular blood components. Use of a simplified formalin-fixation and
batch-counting method. Am J Clin Pathol. 1997;107:111-113
3)
Leparc GF. Leukocyte reduction in cellular blood components. Lab Med. 1997;28:328-331
4)
Silberman S. Platelets. Preparations, transfusion, modifications, and substitutes. Arch Pathol Lab Med. 1999;123:889-894
5)
Food and Drug Administration. Guidance for industry. Storage Leukocyte Reduction of Whole Blood and Blood Components
Intended for Transfusion, September 2012
IRRADIATED CELLULAR COMPONENTS
Inspector Instructions:
●
Irradiated component policy or procedure
●
Sampling of records of component processing QC
●
Sampling of indicator system QC records
●
Sampling of maintenance records
●
Certificate or letter of compliance with US NRC
●
How do you ensure that your equipment meets the standards of the US Nuclear
Regulatory Commission?
●
Select a patient who has received an irradiated unit. Follow the handling of the
component including processing and relabeling.
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TRM.44970 Radiation Dose Phase II
If the facility irradiates blood and components, there is a written procedure to ensure that
the procedure delivers the anticipated radiation dose.
NOTE: The radiation dose delivered must be verified by measurement at the time of the
installation of the equipment and after mechanical maintenance, particularly the parts of the
equipment that handle the specimen such as the turntable. There should be verification records
(annually for Cesium-137 and semi-annually for Cobalt-60) that the procedure delivers a
minimum of 2500 cGy targeted to the midplane of the canister if a free-standing irradiator is used,
or to the central midplane of an irradiation field if a radiotherapy instrument is used. The minimum
dose at any point in the canister or irradiation field should be 1500 cGy. The procedure should
define the maximum number of units of blood or blood components that can be irradiated in a
batch. There should be a quality control program for the indicator system in use.
REFERENCES
1)
Przepiorka D, et al. Use of irradiated blood components. Practice parameter. Am J Clin Pathol. 1996; 106:6-11
2)
Moroff G, Leitman SF, Luban N. Principles of blood irradiation, dose validation, and quality control. Transfusion. 1997;37:1084-92
**REVISED** 09/17/2019
TRM.44977 Blood Component Labeling And Expiration Dates Phase II
Irradiated blood and blood components are permanently labeled as irradiated and
expiration dates for irradiated Red Blood Cell products are modified not to exceed 28 days
from the date of irradiation or the original outdate, whichever is sooner.
Evidence of Compliance:
✓
Written procedure for labeling irradiated units
TRM.44984 Blood Irradiator Maintenance Phase II
There is a schedule and records of maintenance and function checks for all blood
irradiation equipment including timer checks, back-up timer checks, turntable inspection,
and radiation leakage testing.
TRM.44987 US NRC Requirements Phase II
The laboratory meets the requirements of the US Nuclear Regulatory Commission for
blood irradiation devices that contain radioactive materials.
NOTE: This checklist element can be satisfied by a certificate or letter stating that the laboratory
is in compliance with the US Nuclear Regulatory Commission for blood irradiation devices
containing radioactive materials.
REFERENCES
1)
Nuclear Regulatory Commission. Policy Statement of the US Nuclear Regulatory Commission on the Protection of Cesium-137
Chloride Sources. Fed Register. Vol. 76, No. 142. 2011(July 25): 44378-83. http://www.gpo.gov/fdsys/pkg/FR-2011-07-25/
pdf/2011-18757.pdf Notice published July 25, 2011.
2)
Security orders. Holders of material licenses authorized to possess radioactive material quantities of concern. Attachment B:
increased controls. Enclosure 2 and Supplemental: guidance with questions and answers. Washington, DC: Nuclear Regulatory
Commission, November 2005 and February 2007. http://www.nrc.gov/reading-rm/doc-collections/enforcement/security/
TRM.44991 Irradiated Blood/Blood Component Records Phase II
Records are maintained for blood and blood component irradiation for at least 10 years, to
include unit numbers, duration of procedure, dose of irradiation for each batch, identity of
the person performing the irradiation, as well as date, time and site of procedure.
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STORAGE AND ISSUE OF TISSUES
This section applies only to the storage and issue of tissues OTHER than blood, bone marrow and progenitor
cells. Please note that other sections of the TRM checklist, such as record retention, donor selection and
testing, quality management, and component preparation/storage, apply as appropriate.
Inspector Instructions:
●
Sampling of tissue storage policies and procedures
●
Source facility registration/license
●
Sampling of tissue storage records
●
How are you informed of an adverse reaction to implanted tissue?
●
Follow the records of receipt of tissue from donor facility through preparation, issuing,
acceptance and disposition. Confirm that procedures and records ensure adequate
tracing of all tissues.
TRM.45050 Tissue Program Phase II
The authority, responsibility and accountability of the tissue-handling program are
defined in a written policy.
NOTE: The authority and responsibility for all aspects of the tissue-handling program should be
adequately defined to ensure compliance. The program should be coordinated on a hospital-wide
basis.
Evidence of Compliance:
✓
Written policy defining the responsibilities for the tissue-handling program AND
✓
QM records documenting hospital-wide involvement
TRM.45075 Source Facility Criteria Phase II
All source facilities are registered or licensed as required by national, federal, state (or
provincial), and local regulations.
TRM.45100 Tissue Records Phase II
There are records of the infectious disease testing and type of processing performed for
each tissue stored.
TRM.45125 Donor Infections/Adverse Events Investigation Phase II
There are procedures for investigating donor infections or adverse events after tissues
are received and implanted.
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NOTE: Possible tissue-transmitted infections and other adverse events must be investigated and
reported to the tissue source facility when appropriate.
If the source facility notifies the user facility about a donor's infection or reactive infectious-
disease test, procedures are required for quarantining tissue or notifying the tissue recipient
when appropriate. There should be look-back and recipient notification for HIV, HTLV-I/II,
Hepatitis B, Hepatitis C, or other tissue-transmissible infectious agents subsequently found in
tissue donors after the tissue has been implanted.
Evidence of Compliance:
✓
Records of investigation of tissue-transmitted infections or adverse events AND
✓
Records indicating action taken following source facility recalls
TRM.45150 Tissue Storage Conditions Phase II
The written policies and procedures define the storage conditions of the different tissues
handled, records retained, and process for return of each tissue type to storage, as
appropriate, after issuance for use.
TRM.45160 Specimen Handling/Storage Phase II
All tissues are transported, handled, stored, and issued or disposed of according to the
source facility's written directions.
TRM.45165 Blood Vessel Storage Phase I
Blood vessels stored by the laboratory from organ donors are managed in accordance
with requirements of the US Organ Procurement and Transplantation Network (OPTN).
NOTE: The OPTN in the US Department of Health and Human Services regulates blood vessels
from organ donors as organs. Stored vessels are sometimes used in recipients different from the
organ recipients, raising the possibility of disease transmission. Laboratories with responsibilities
for storing or managing blood vessels must collaborate with their transplant centers to establish
applicable procedures and records for the laboratory's duties, as required by OPTN Policies. For
example, OPTN requirements include refrigeration monitored at 2 to 8°C, maximum storage time
14 days after recovery, prohibition against storing vessels from donors with hepatitis C antibody
or hepatitis B surface antigen, inventory logs, and disposition records.
Evidence of Compliance:
✓
Policies and procedures for laboratory responsibilities in storing or managing organ-donor
blood vessels AND
✓
Records as required in the laboratory's duties, such as refrigerator temperature records and
alarm checks, inventory logs, and disposition records
REFERENCES
1)
Organ Procurement Transplantation Network (OPTN) Evaluation Plan. Policy 16.7.B. Vessel Recovery, Transplant, and Storage. US
Department of Health and Human Services. March 22, 2016.
TRM.45170 Specimen Tracking Phase II
There are written procedures for the receipt, product identification, preparation, issue, and
disposition of each tissue received.
NOTE: Procedures and records are required for receipt and acceptability (eg, transport
conditions, package integrity); source facility; donor and lot alphanumeric identifiers; expiration
date; the date, time, and staff involved in preparing, issuing, and acceptance; and disposition.
Records must permit tracing of all tissues from source facility to recipient or other disposition.
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TRM.45180 Issue Usage Cards Phase I
There is a written procedure for completing and returning issue usage cards to the source
facility, if applicable.
TRM.45190 Record Retention Phase II
Procedures and records are retained for at least 10 years, or longer if required by national,
federal, state (or provincial), or local regulations.
NOTE: Hospital accreditation may require record retention of tracking information and expiration
dates for at least 10 years after the tissue's disposition or expiration date, whichever is longer.
TRM.45200 Tissue Storage Temperature Phase II
The records show that tissues were stored at the required temperatures.
NOTE: Storage of tissues must be appropriate for the type of tissue and its means of
preservation. Failure to adhere to requirements could result in a unit not being suitable for the
purpose for which it was intended. Good manufacturing practices require a clear statement of
these conditions.
TRM.45250 Donor/Recipient Tracking Records Phase II
Records allow for the identification of the donor and the recipient of each tissue handled,
as well as tracking from donor to recipient and vice-versa.
NOTE: Records must allow association of donor and recipient to allow withdrawals/recalls to be
directed appropriately and to allow problems in transplanted tissues to be tracked to their source.
BLOOD/COMPONENT DONOR
SELECTION AND COLLECTION
This section applies to both autologous (self) donations and donations for others (allogeneic, including
apheresis donations)
Autologous collections should be transfused only to the individual for whom they were collected. If exceptional
circumstances warrant and are adequately documented, the transfusion service medical director can direct that
these units be converted to the allogeneic supply. In that case, the units must meet all criteria for allogeneic
donation.
Autologous units that are reactive or positive for ANY infectious disease marker, including a serologic test for
syphilis, must be labeled with a "BIOHAZARD" label in addition to the usual labeling. Units that are prepared on
site and are not tested must be labeled “DONOR UNTESTED.”
Requirements posed in this section do not imply that a donor must be deferred from donation because of a
positive response, but rather that the information is recorded and that an evaluation of that donor response
ensues.
In addition to the requirements in this section, there immediately follows an additional section entitled
"Allogeneic Donors Only".
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ALL DONORS (ALLOGENEIC AND AUTOLOGOUS)
Inspector Instructions:
●
Sampling of donor policies and procedures
●
Sampling of donor history, physical exam and screening test records
●
Sampling of personnel training and competency records
●
Donor arm preparation, if possible
●
How do you determine if a donor is qualified to donate?
●
What are the signs/symptoms of a donor adverse reaction? What action is taken?
●
What collection process do you follow to reduce bacterial contamination?
●
Follow a donor record through all phases of collection. Further evaluate evidence of
follow up for significant findings in donor history, physical examination or screening
test results.
TRM.45251 Regulatory Documents Phase I
Appropriate regulatory documents for donor collection and selection are readily
available (paper or electronic), and there is evidence of their use in policy and procedure
development.
NOTE: For laboratories subject to US regulations, the following documents must be available and
used:
1. Latest version of applicable sections of 21CFR
2. Current FDA guidelines
3. Latest version of applicable state and local laws
Laboratories not subject to US regulations must follow national, state (or provincial), and local
laws and regulations.
REFERENCES
1)
FDA Guidelines: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=606&showFR=1
**REVISED** 09/17/2019
TRM.45252 Donor Procedures Phase II
There are written procedures in compliance with CAP requirements and FDA regulations
for the following:
●
Donor identification
●
Donor selection
●
Physical examination of the donor
●
Arm preparation
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●
Phlebotomy
●
Handling of collected units
●
Treatment/prevention of donor reactions
TRM.45253 Donor Privacy/Confidentiality Phase II
There are written policies and procedures to ensure privacy of donor interviews and
confidentiality of all donor records.
NOTE: To ensure accurate and truthful answers to the screening questions by donors, the donor
interview must be done in a manner to ensure privacy. Donor records and test results must be
kept confidential.
**REVISED** 06/04/2020
TRM.45254 Training and Competency for Donor Collection Personnel Phase II
Personnel responsible for the donor selection process, predonation examination, and
phlebotomy are assessed for competency at least annually.
NOTE: It is the laboratory director's responsibility to determine:
●
How competency is assessed
●
Qualifications of individual assessing competency.
Evidence of Compliance:
✓
Records of training and annual competency
REFERENCES
1)
Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI document
QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA; 2009.
TRM.45255 Physician Availability Phase II
There is a qualified and licensed physician available to answer donor suitability
questions, and there are procedures to obtain emergency services for treatment of
adverse donation reactions.
REFERENCES
1)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office, 2015 (May 22):[21CFR630.5].
TRM.45256 Donor Demographics Phase II
Donor demographics include date of birth and address.
NOTE: All donor demographics must include a birthdate. In the US, allogeneic donors should
generally be at least 16 years old or conform to applicable state law. Consent from a parent
or guardian must be obtained if a donor is less than 17 years old, unless State law specifies a
different age for donor consent. Furthermore, date of birth is a standard donor identification tool.
The donor's address is required for notification of abnormal test results and deferral.
Evidence of Compliance:
✓
Donor selection records consistent with defined inclusion criteria
REFERENCES
1)
Sherman LA. Legal issues in blood banking. Elements of informed consent. Clin Lab Med. 1996;16:931-946
2)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2006(Jan 1):57 [21CFR606.160(b)(1)(x)]
TRM.45257 Inclusion Requirements Phase II
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Donor physiologic measurements (including temperature, pulse and blood pressure) meet
inclusion requirements.
NOTE: Donor physiologic measurements must meet inclusion criteria. FDA-defined inclusion
criteria include:
1. Body temperature less than or equal to 37.5° C (99.5º F)
2. Pulse between 50-100 beats/minute and regular
3. Diastolic blood pressure less than or equal to 100 mm Hg and greater than or equal
to 50 mm Hg
4. Systolic blood pressure less than or equal to 180 mm Hg and greater than or equal
to 90 mm Hg
Deviations for pulse and blood pressure require medical evaluation. The responsible physician
must perform the examination onsite for donors with blood pressure values outside the specified
range; the determination for pulse outside the specified range can be obtained by telephonic or
other offsite evaluation.
Evidence of Compliance:
✓
Donor screening records
REFERENCES
1)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR630.10], [21CFR630.20].
TRM.45258 Inclusion Requirements Phase II
The laboratory has records indicating that donor weights meet inclusion requirements.
NOTE: The donor must weigh at least 50 kg (110 pounds). Certain apheresis procedures may
require different minimum weights.
REFERENCES
1)
Food and Drug Administration Guidance for Industry, "Technical Correction: Recommendations for Collecting Red Blood Cells by
Automated Apheresis Methods", February 2001.
2)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR630.10], [21CFR630.20].
**REVISED** 09/17/2019
TRM.45259 Inclusion Requirements Phase II
The donor's blood hemoglobin concentration or hematocrit is determined, and meets
inclusion requirements.
NOTE: Donor blood hemoglobin concentration or hematocrit must be measured before donation.
Female allogeneic donors must have a hemoglobin concentration no less than 12.5 g/dL, or a
hematocrit no less than 38%. Male allogeneic donors must have a hemoglobin concentration no
less than 13.0 g/dl or a hematocrit no less than 39%. The facility may collect blood from female
allogeneic donors who have a hemoglobin level between 12.0-12.5 g/dl or a hematocrit value
between 36% and 38% provided the facility uses a procedure that has been found acceptable by
the FDA to ensure the health of the donor will not be adversely affected.
For certain apheresis collections procedures (eg, collection of two units of red blood cells), the
FDA has established a specific algorithm for donor acceptance.
For autologous donors only, the transfusion service medical director may establish less stringent
erythrocyte mass measurement criteria. Autologous donors must have a hemoglobin level no
less than 11.0 g/dl or a hematocrit no less than 33%.
Evidence of Compliance:
✓
Donor screening records AND
✓
Record of FDA acceptance of procedure(s), if applicable
REFERENCES
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1)
Food and Drug Administration Guidance for Industry, "Technical Correction: Recommendations for Collecting Red Blood Cells by
Automated Apheresis Methods", February 2001.
2)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR630.10], [21CFR630.20].
TRM.45260 Instrument QC Phase II
For methods used to determine donor hemoglobin concentration or hematocrit, the
laboratory follows manufacturer's instructions for quality control, reviews results, and
records acceptability prior to use in donor screening.
Evidence of Compliance:
✓
QC records
✓
Written procedure consistent with manufacturer's instructions
TRM.45261 Health Interview Phase II
A general health interview is performed to ensure that donation will not be harmful to the
individual.
NOTE: Allogeneic donors should be healthy, and free of acute or symptomatic significant
disease. Prospective donors with significant disease should be evaluated for risk to themselves
and for risk of disease transmission to the transfusion recipient by the responsible qualified
physician.
Evidence of Compliance:
✓
Donor screening records
TRM.45263 Informed Consent for Donation Phase II
Prior to each donation, informed consent, including the FDA-required elements, is
obtained from the donor with a written signature or other record of acknowledgement.
NOTE: The FDA-required elements of informed consent include the following:
1. The donor has reviewed the required educational material about relevant
transfusion-transmitted diseases.
2. The donor agrees not to donate if the donation could result in a potential risk to
recipients as defined in the educational material.
3. The donor is informed that a sample of their blood will be tested for relevant
transfusion-transmitted diseases.
4. The donor is informed that if the donation is determined to be not suitable or if the
donor is deferred, the record will identify the donor as ineligible and the donor will be
notified of the basis for the deferral and the period of deferral.
5. The donor is provided with information about the risks and hazards of the specific
donation procedure.
6. The donor is given the opportunity to ask questions and withdraw from the donation
procedure.
REFERENCES
1)
Sherman LA. Legal issues in blood banking. Elements of informed consent. Clin Lab Med. 1996;16:931-946
2)
FDA. Additional standards for human blood and blood products. Source plasma. Informed consent. Washington, DC: US
Government Printing Office, 1999(Apr 1):[21CFR640.61]
3)
Shaz BH, Demmons DG, Hillyer CD. Critical evaluation of informed consent forms for adult and minor aged whole blood donation
used by United States blood centers. Transfusion 2009;49:1136-1145
4)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR630.10(g)(2)(ii)].
TRM.45264 Donor Record Phase II
The donor history, physical examination, and screening test results are recorded (paper
or electronic).
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TRM.45265 Follow-Up Phase II
There is evidence of follow-up for significant findings in donor history, physical
examination and screening test results.
TRM.45266 Numeric Identification Agreement Phase II
There is a written procedure to ensure that the numeric identification on pilot tubes, bags
and related donor records are in agreement.
TRM.45267 Donor Arm Preparation Phase II
A written procedure requiring the use of FDA-approved methods for skin disinfection
prior to phlebotomy is followed for donor arm preparation to reduce the risk of bacterial
contamination of the donor unit.
NOTE: The specific procedure used may vary but should include directions for the chemicals to
be used, the time and manner that each is applied and the EXACT sequence of the steps taken.
Donor arm preparation should be monitored to assure that the laboratory's procedure is followed.
Appropriate skin preparation methods must be used, allowing alternative procedures for those
who are allergic to the primary method. For laboratories subject to US regulations, the FDA
recognizes several methods for arm preparation.
REFERENCES
1)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office, 2015 (May 22):[21CFR610.4]
TRM.45268 First Volume Diverted From WB Platelets Phase I
The first volume of the phlebotomy from which a platelet component will be derived is
diverted from the whole blood or component collection.
NOTE: The diverted volume should be at least 10 mL.
Evidence of Compliance:
✓
Written procedures defining the use of collection bags with diversion pouches when platelet
products are to be prepared
TRM.45269 Adverse Reactions Phase II
There is a written procedure for recognition, treatment, tracking, and trending of adverse
donor reactions, and personnel collecting donor units are appropriately trained.
Evidence of Compliance:
✓
Record of training for adverse reactions AND
✓
Records of donor reactions, including data on trending AND
✓
Procedure for recognizing and treating adverse reactions
**REVISED** 06/04/2020
TRM.45270 Directed Donation Requirements Phase II
There is a written procedure to ensure that all directed donations between blood relatives
are irradiated or treated by a method approved by the FDA to prevent transfusion
associated graft-versus-host disease (TA-GVHD).
NOTE: The blood relationship of directed donors to recipients must be determined to ensure that
components are irradiated or treated by the FDA approved method (eg, pathogen reduction) to
minimize the risk of graft versus host disease.
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REFERENCES
1)
Irradiation of units from blood relatives: Recommendations Regarding License Amendments and Procedures for Gamma Irradiation
of Blood Products - 7/22/93 CBER
TRM.45271 Physician Request - Autologous Collection Phase II
For autologous blood collections, there is a written request by the donor/patient's
physician.
TRM.45272 Autologous Donation Guidelines Phase II
The transfusion service medical director has approved a policy to allow for the safe
collection of autologous blood under certain guidelines, and if a patient falls outside
those guidelines, the policy requires consent of the transfusion service medical director
or physician designee.
Evidence of Compliance:
✓
Autologous donation records consistent with suitability criteria or with physician approval
REFERENCES
1)
Yomtovian R. Practical aspects of preoperative autologous transfusion. Arch Pathol Lab Med. 1997;107(Suppl 1):S28-S35
ALLOGENEIC DONORS ONLY
This section applies only for allogeneic whole blood or apheresis donations (ie, not self-donation or autologous),
and is in addition to the requirements in the previous "All Donors (Allogeneic and Autologous)" section. The
presence of certain items does not imply that the donor must be rejected because of a positive response, but
rather that the information is recorded and that an evaluation of that specific problem ensues. If blood is not
collected from allogeneic donors, omit this section.
Inspector Instructions:
●
Sampling of allogeneic donor policies and procedures
●
Educational material provided to donors
●
Sampling of donor history, physical exam and screening test records
●
Follow a donor record through all phases of collection. Further evaluate evidence of
follow up for significant findings in donor history, physical examination or screening
test results.
TRM.45273 Educational Material Phase II
Potential allogeneic donors are given educational material explaining the risks of
infections transmitted by transfusion.
NOTE: Allogeneic donors must be given educational material informing them of the risks of
relevant transfusion-transmitted infections, the activities that may place a person at risk of
acquiring HIV and other infections, and that testing may not detect all infected persons. The
donor screening questions must provide an opportunity to obtain an accurate and truthful history
of possible infectious exposure.
Evidence of Compliance:
✓
Records indicating that donor received educational material
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REFERENCES
1)
Food and Drug Administration. Memorandum for HIV risk screening, 4/23/1992
2)
Food and Drug Administration. Guidelines regarding exclusion of donors with a history of CJD or incarceration, 1995 (Jun)
3)
Food and Drug Administration. General biological products standards. History of hepatitis B surface antigen. Washington, DC: US
Government Printing Office, 1999(Apr 1):[21CFR610.41]
4)
Food and Drug Administration. Guidance for industry. Revised preventive measures to reduce possible risk of transmission of
Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products. January 2002
TRM.45275 Parenteral Drug Use Inspection Phase II
Records indicate that both arms of allogeneic donors are inspected for evidence of
parenteral drug use.
NOTE: Both arms of allogeneic donors must be inspected for evidence of parenteral drug use
and to ensure the venipuncture site is free of any scars, lesions, or needle marks which may be
indicative of self-injected drug use.
TRM.45276 Donation Time Intervals Phase II
For allogeneic donations, the time interval between donations meets current
requirements.
NOTE: Allogeneic donors must be excluded if their last donation has not met the required interval
between donations. Current exclusions include less than eight weeks since last whole blood
donation, less than 16 weeks since two-unit red cell apheresis collection, and less than two days
since last hemapheresis.
Evidence of Compliance:
✓
Written donor collection procedures with minimum collection intervals between donations
defined
REFERENCES
1)
Food and Drug Administration. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing
Use. US Government Printing Office. 2015 (May 22):[21CFR630.15].
TRM.46138 Allogeneic Donor Evaluation Phase II
There are records indicating that allogeneic donors are evaluated in a manner consistent
with FDA regulations and guidances.
NOTE: The Uniform Donor History Questionnaire is one approved approach, but other methods
using procedures approved by the FDA may be used. If the Uniform Donor History Questionnaire
is utilized, blood collectors may append additional questions and/or apply more stringent
requirements in donor selection.
Laboratories not subject to US regulations must follow national, state or provincial, and local laws
and regulations.
REFERENCES
1)
Food and Drug Administration, Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History
Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood. May 2016.
DONOR BLOOD TESTING
This section applies to the primary testing of DONOR blood collected on site. If the laboratory performs
infectious disease testing (eg, HBsAg, anti-HIV, RPR, etc.) in the Transfusion Medicine section of the laboratory,
additional checklists (eg, Chemistry, Immunology, etc.) will be required to inspect this testing.
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Inspector Instructions:
●
Sampling of donor blood testing policies and procedures
●
Sampling of donor blood testing records
●
Sampling of infectious disease testing QC records
●
Sampling of instrument function check records
●
Deferred donation list
●
How do you ensure that quarantined units are not inadvertently released?
●
What is your process for identifying prior donations from donors who now test positive
for infectious diseases? How are recipients of those components notified?
●
Follow a quarantined unit from testing to final disposition. Determine if procedures
ensure safeguards to prevent transfusion.
TRM.47000 Routine Typing Phase II
The routine procedure includes tests with anti-A and anti-B, A
1
and B cells, anti-D, and if
negative for anti-D, a test for weak D.
NOTE: Routine procedures must include at a minimum, forward and reverse A and B grouping,
and a test for the D antigen. Negative-appearing D tests must be confirmed by a test for weak D.
Evidence of Compliance:
✓
Records of donor blood typing for each unit
REFERENCES
1)
Domen RE. Policies and procedures related to weak D phenotype testing and Rh immune globulin administration. Results from
supplementary questions to the comprehensive transfusion medicine survey of the College of American Pathologists. Arch Pathol
Lab Med. 2000;124:1118-1121
TRM.47050 Screen for Unexpected Antibodies - Allogeneic Donors Phase II
Testing includes a screen for unexpected antibodies to red cell antigens on all allogeneic
donors.
Evidence of Compliance:
✓
Written procedure defining criteria for screening for unexpected antibodies AND
✓
Records of antibody screening for blood donations meeting defined criteria
**REVISED** 06/04/2020
TRM.47100 Infectious Disease Testing Phase II
For laboratories subject to US regulations, all FDA-required or recommended infectious
disease tests are performed on blood samples collected at the time of donation, or
collected at least once in the prior 30 days for a directed donor for a single intended
recipient. Reagents used are licensed or registered by the FDA and procedures are
approved by the FDA.
NOTE 1: Tests required or recommended by the FDA are provided in the Code of Federal
Regulations and FDA Guidelines, and are subject to change. In certain instances, the FDA
may approve pathogen reduction methods as an alternative to testing. Current tests include the
following: nucleic acid testing (NAT) for HIV-1, HCV, HBV, WNV and Zika virus; serologic anti-
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HIV-1, anti-HIV-2, anti-HBc, anti-HCV, HBsAg, anti-HTLV-I, anti-HTLV-II and serologic tests for
syphilis and Trypanosoma cruzi antibodies. T. cruzi testing should be done at least once in the
lifetime of each donor. NAT testing for Babesia species may be required in selected states by the
FDA.
NOTE 2: Autologous donations for the patient-donor's own use are not required to be tested for
infectious disease markers unless the units could be used for allogeneic transfusions or will be
transferred to another establishment:
●
If the receiving establishment allows autologous donations to be used for allogeneic
transfusion, all donations must be tested for infectious disease markers.
●
If the receiving establishment does not allow autologous donations to be used for
allogeneic transfusion, the laboratory must at a minimum test the first donation in each
30-day period.
Evidence of Compliance:
✓
Records of infectious disease testing for each unit
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2002(Apr 1):71 [21CFR 610.40]
2)
Food and Drug Administration. Guidance for Industry: Recommendations for Management of Increased Risk for Human
Immunodeficiency Virus Type 1 (HIV) Group O Infection. August 2009.
3)
Food and Drug Administration. Guidance for Industry: Revised Recommendations for Reducing Zika Virus Transmission by Blood
and Blood Components, Rockville, MD. July 2018.
4)
Food and Drug Administration. Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of
Whole Blood and Blood Components, including Source Plasma to Reduce the Risk of Transmission of Hepatitis B Virus. Rockville,
MD. October 2012.
5)
Food and Drug Administration. Guidance for Industry: Recommendation for Reducing the Risk of Transmitted Babesiosis. Silver
Spring, MD. May 2019.
TRM.47105 Infectious Disease Testing Phase II
For laboratories not subject to US regulations, blood donors are tested for human
immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and
syphilis on blood samples taken at the time of donation (or taken in the prior 30 days
for a designated donor to a single recipient), using reagents and procedures that are in
compliance with applicable regulations.
NOTE: Laboratories must also perform all other infectious disease tests required by their
national, federal, state (or provincial), and local laws and regulations.
The World Health Organization (WHO) recommends mandatory blood donor testing for HIV-1,
HIV-2 and HCV (HIV and HCV antibodies or antigen-antibody combinations), HBV (surface
antigen, HBsAg), and syphilis (treponemal antibodies). Nucleic acid testing is not required, but if
feasible should be performed in countries with high incidences of HIV, HCV or HBV.
REFERENCES
1)
World Health Organization. Screening donated blood for transfusion-transmissible infections: recommendations. Geneva: WHO
Press, 2010
2)
Roth WK, et al. International survey on NAT testing of blood donors. Vox Sang 2012;102:82-90
TRM.47112 Off-Site Testing Agreement Phase II
If testing of donated units is performed by another facility, there is a written agreement
for the performance of this testing that specifies adherence to the requirements of
this checklist and a system to assure accurate receipt of test results with appropriate
interpretation.
Evidence of Compliance:
✓
Written agreement with testing site, as applicable
TRM.47125 Supplemental Tests Phase II
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FDA licensed, approved, or cleared supplemental tests, when available, are performed
when a donor screening test is reactive.
NOTE: The FDA requires that a licensed, approved, or cleared supplemental test be performed
whenever available for a reactive screening test. Supplemental tests are currently approved for
syphilis, anti-HIV, Chagas, HTLV, and HBsAg neutralization.
Laboratories not subject to US regulations must follow national, state or provincial, and local laws
and regulations.
REFERENCES
1)
Food and Drug Administration. General Biological Products Standards. US Government Printing Office, 2015 (May 22):
21CFR610.40.
TRM.47150 Infectious Disease Testing QC Phase II
The records of infectious disease testing indicate controls and standards react as
expected and instrument function checks are appropriate.
NOTE: Review of the records must indicate proper function of all the components of the test
before reporting results and releasing units from quarantine.
TRM.47200 Sample Mix-Up Precautions Phase II
There is a written procedure to track and minimize the risk of sample mix-up to ensure
specimen integrity and identification.
NOTE: This can be accomplished in an automated fashion, or by manual procedures, but it must
ensure that positive results are linked to the correct unit.
Evidence of Compliance:
✓
Written procedure defining criteria for tracking samples
TRM.47250 Record Review Phase II
Testing records and records of release from quarantine are reviewed by a supervisory
level individual or other designated individual prior to release of units for transfusion, and
the reviews are recorded.
NOTE: There are records demonstrating compliance with the quarantine policies and assuring
that incompletely tested units, or units that have reactive results, are not released for transfusion.
TRM.47300 Deferred Donor Units Phase II
There is a written procedure to ensure that quarantined units, units from deferred donors
and units on which testing is incomplete are not inappropriately released.
NOTE: Disposition of these units must be controlled and recorded.
Evidence of Compliance:
✓
Written procedure for releasing units from quarantine with processes to prevent inappropriate
release
TRM.47320 Donation Tracking Phase II
There is a written procedure for identifying previous donations from persons who now
test reactive for viral marker screening tests and notifying consignees of components
from those units, when applicable.
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NOTE: In the US, the FDA requires that blood centers identify previous units collected from
donors who are reactive in one or more tests for viral markers and recommends that, under
certain conditions, consignees of components from these units be notified of a potential risk to
recipients.
Evidence of Compliance:
✓
Written procedure for look-back and consignee notification for donors testing positive for viral
marker screening AND
✓
Donor records
REFERENCES
1)
Food and Drug Administration. General biological products standards. Human immunodeficiency virus (HIV) requirements.
Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR610.45]
2)
FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus
(HCV): Testing Product Disposition, and Donor Deferral and Reentry, December 2017.
3)
FDA Guidance for Industry: "Look back" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing,
Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indication Infection with HCV,
December 2010.
4)
Food and Drug Administration. Fed Register. Requirements for Blood and Blood Components Intended for Transfusion or for Further
Manufacturing Use: final rule, May 22, 2015.
TRM.47350 Quarantine/Unit Disposal Procedure Phase II
There are written procedures for unit quarantine and disposal, and records are retained.
NOTE: An effective procedure for unit quarantine and disposal is a necessity to prevent
inappropriate release of units.
Evidence of Compliance:
✓
Written procedure for unit quarantine and disposal AND
✓
Donor records for quarantine and disposal
TRM.47400 Deferred Donor List Phase II
The donor's identity is checked against a list of deferred donors before the blood is
distributed.
NOTE: Records must be retained to allow identification of deferred donors, so that blood and
components from such individuals will not be distributed. When possible, checking this registry
before donation is preferred.
Evidence of Compliance:
✓
Records of checks against deferral list prior to release
REFERENCES
1)
Food and Drug Administration. Current good manufacturing practice for blood and blood components. Records and reports. Records.
Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.160(e)]
TRM.47450 Result Review Phase II
Records indicate that the transfusion service medical director reviews abnormal donor
testing results and ensures donor notification in a timely manner.
NOTE: The transfusion service medical director must review abnormal donor testing results and
ensure donor notification so appropriate counseling and treatment can be obtained. The FDA
requires notification attempts to be completed within eight weeks.
The patient's physician must be notified for autologous donations.
Evidence of Compliance:
✓
Written procedure for result review and donor notification for abnormal donor testing results
AND
✓
Records of director review and notification for abnormal results
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REFERENCES
1)
Food and Drug Administration. Fed Register. 2001(Nov 11):66:31165
TRM.47500 Post-Donation Information Phase II
There is a written procedure for managing post-donation information about the donor's
suitability.
NOTE: Post-donation information from the donor or another source may affect the donor's
eligibility and the safety of past or current products.
HEMATOPOIETIC PROGENITOR CELLS
This section addresses the collection, transport, processing, storage and administration of cellular therapy
products including hematopoietic progenitor cells (bone marrow, peripheral blood stem cells, and cord blood).
Requirements for qualification and management of donors of allogeneic products are as for allogeneic blood
donors. Record retention, quality management and quality control, and other requirements in this checklist, as
well as in the Laboratory General and All Common Checklists, apply to cellular therapy products, as appropriate.
QUALITY MANAGEMENT AND GENERAL ISSUES
Inspector Instructions:
●
Sampling of cellular therapy policies and procedures
●
Sampling of records of unusual events with notification
●
How do you ensure communication with physicians of patient treatment decisions?
●
How do you monitor clinical outcomes?
●
Have you validated your protocols?
●
How do you label cellular therapy products?
●
Select a component/product and track progression through ordering, patient consent,
collection, processing and final disposition. Confirm that the identity of the individual
performing each step is recorded.
TRM.47525 Personnel Responsibilities Phase II
The responsibilities of all parties in the collection, transport, processing, storage and
administration of cellular therapy products are defined.
TRM.47575 Personnel Qualifications Phase II
The collection, processing, storage, and administration of cellular therapy products
is overseen by qualified, licensed physician(s) having appropriate training and/or
experience, who meets the qualifications defined in TRM.50050.
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TRM.47625 System of Communication Phase II
An appropriate communications system is in place between the laboratory and treating
physicians for communicating decisions on patient treatment.
NOTE: The system must address the ordering of procedures, collection protocols to be followed,
end points and objectives of the collection procedures, storage including cryopreservation, and
thawing and administration of cellular therapy products.
TRM.47675 Adverse Reaction Reporting Phase II
There is a written policy for reporting adverse reactions to the person responsible for
investigating the occurrence.
Evidence of Compliance:
✓
Written policy defining criteria for reporting adverse reactions AND
✓
Records of unusual events with notification
**REVISED** 09/17/2019
TRM.47725 Deviations from SOP Phase II
There are records that all deviations (planned and unplanned) from standard operating
procedures have been approved by the transfusion service medical director or, as
appropriate, the recipient's physician.
NOTE: Planned deviations must be approved prior to implementation.
Examples of planned/unplanned deviations:
●
Planned: Collection from a donor with a low hemoglobin or with a relevant travel history
●
Unplanned: Apheresis collection personnel failed to record vital signs for an hour of the
collection or intravenous access is lost and the collection must be aborted
Evidence of Compliance:
✓
Written policy for planned and unplanned deviations AND
✓
Records of deviation notification
TRM.47775 Clinical Outcomes Phase II
The laboratory monitors and reviews the clinical outcomes associated with the cellular
therapy products it provides, such as determining the time to engraftment after infusion of
hematopoietic progenitor cells.
NOTE: The transfusion service medical director responsible for HPC services must be involved
in the review of the data and assessment of outcome to monitor the quality of the laboratory
service. In situations where there is a failure to engraft or a problem relating to product quality,
there are records of investigation and corrective action, as appropriate.
TRM.47825 New/Changed Protocol Validation Phase II
The laboratory has written procedures to validate new protocols, including significant
changes to existing protocols.
TRM.47875 Requisition Phase II
Written orders are obtained from the patient's physician for the collection, processing,
storage and administration of cellular therapy products; or, if appropriate, the processing,
storage and/or administration of the cellular therapy product is conducted according to an
approved investigational study in which the subject/patient is enrolled.
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TRM.47925 Process Tracking Phase II
Records identify the person performing each significant step in the collection, processing
and administration of cellular therapy products.
NOTE: For collections performed at other facilities, there is a process to obtain the identity of the
collection personnel, if requested.
TRM.47975 Product Labeling Phase II
The laboratory assigns a unique alphanumeric identifier to each cellular therapy product
collected, processed and/or stored, including aliquots, and labeled with the International
Society of Blood Transfusion (ISBT) terminology, with maintenance and tracking of this
identifier throughout receipt, storage, issuing of the product, and disposition.
NOTE: All steps of cellular therapy labeling must be defined in the procedure manual and
conform to ISBT labeling. The laboratory must have a valid system to receive and manage all
cellular products that come into inventory, including those labeled with legacy labeling systems
such as the 1985 Uniform Labeling (Codabar) Guidance System.
TRM.47985 Labeling Systems Phase II
Standard operating procedures define appropriate and complete labeling systems for all
cellular products, aliquots and other samples.
NOTE: Units testing positive for infectious disease markers or having an at-risk medical history
must be labeled as a “Biohazard”. Hematopoietic progenitor cell (HPC) products must be
clearly labeled or tagged “Do Not Irradiate” if transported outside the control of cellular therapy
laboratory personnel.
The labeling of products must be consistent with the current Circular of Information for and the
use of cellular therapy products.
COLLECTION
Inspector Instructions:
●
Sampling of cellular therapy collection policies and procedures
●
Sampling of records of pre-collection donor testing
●
Sampling of records of product assessment
●
Sampling of donor eligibility records
TRM.47995 Donor Qualifications Phase II
There are written procedures to evaluate the acceptability of cellular therapy product
donors.
NOTE: The transfusion service medical director responsible for HPC services and transplant
physicians should establish the qualifications for cellular therapy product donation. Approval from
the donor's physician must be obtained prior to donation. Evaluation should include history and
physical examination to protect donors from risks of the collection process, and to assess the
risk of disease transmission. Donors not meeting the established criteria must be approved by
the HPC medical director and transplant physician. For allogeneic donation, there is a written
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procedure to verify that HLA typing for major histocompatibility antigens has been performed on
both the donor and the patient by (for US laboratories) a CLIA-certified laboratory.
REFERENCES
1)
Food and Drug Administration. Human Cells, Tissue and Cellular and Tissue-Based Products. Subpart C. Donor Eligibility.
Washington, DC: US Government Printing Office 2019(April 1): [21CFR1271.47].
TRM.48010 Consent Phase II
Signed consent for collection is obtained prior to the collection procedure.
TRM.48020 Donor Evaluation Phase II
Autologous and allogeneic donors are evaluated prior to the collection procedure by a
qualified individual, as specified by the transfusion service medical director.
Evidence of Compliance:
✓
Records of donor evaluation prior to collection procedures
**NEW** 06/04/2020
TRM.48060 Pre-Collection Testing Phase II
The laboratory performs a complete blood count, including platelet count from each
cellular therapy donor within 24 hours prior to the collection.
Evidence of Compliance:
✓
Records of donor testing prior to collection
**NEW** 06/04/2020
TRM.48070 Assessment of Cellular Product Phase II
The laboratory has a process for assessing the quality of each cellular therapy product
collected to confirm product safety, viability, and integrity, and records are retained.
Evidence of Compliance:
✓
Written process for assessing the quality of the cellular product collected AND
✓
Records of cellular product assessment meeting predetermined specifications
**NEW** 06/04/2020
TRM.48090 Donor Eligibility Status - Allogeneic Donors Phase II
The collection facility provides the records for each allogeneic cellular donor's eligibility
to the processing facility.
NOTE: The eligibility record must accompany the product at all times. Determination of eligibility
is based on screening and testing according to applicable laws and regulations.
Evidence of Compliance:
✓
Policy for communicating cellular therapy donor eligibility AND
✓
Records of cellular therapy donor eligibility status
REFERENCES
1)
Food and Drug Administration. Human Cells, Tissue and Cellular and Tissue-Based Products Donor Eligibility. Washington, DC: US
Government Printing Office 2019 (April 1):[21CFR1271.50] [21CFR1271.55].
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REAGENTS, SUPPLIES, AND EQUIPMENT
Inspector Instructions:
●
Sampling of critical reagent, supply and equipment logs
●
Sampling of records of LN2 monitoring
●
Sampling of alarm checks
●
Sampling of maintenance records
●
Records of staff training on alarm response
●
Sampling of storage unit temperature logs
●
Liquid nitrogen storage unit visual inspection (sweating, cracks, rusting) and process
to monitor LN2 level
●
Active alarm system(s) in place for all liquid nitrogen storage units
●
What is your back-up if your instrument fails?
●
Identify a product that has been issued to a patient. Trace back to all reagents,
supplies and equipment used in collection, processing and storage. Review
associated temperature charts and liquid nitrogen records.
TRM.48120 Record Retention Phase II
Records of all critical reagents, supplies, and equipment used in collection and
processing, including lot numbers and expiration dates, are retained and traceable for
each product.
NOTE: The record retention requirements of TRM.32250 apply, but the time period for retention
begins with final disposition of the cellular therapy product.
Evidence of Compliance:
✓
Written policy defining the tracking of critical reagents, supplies and equipment used for each
product AND
✓
Records such as reagent log, patient record or worksheets allowing for tracking of the
required information
TRM.48130 Approved Reagents Phase II
Reagents and supplies used in the collection, processing, cryopreservation, and
administration of cellular therapy products are approved for human use.
NOTE: The use of reagents or supplies that are not approved must be either approved by the
institution's Institutional Review Board as part of a trial, covered under an investigational new
drug or device exemption, or previously validated in the scientific literature. For laboratories
subject to US regulations, this approval comes from the FDA.
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TRM.48140 Liquid Nitrogen Levels Phase II
The laboratory has a written procedure to monitor and maintain adequate liquid nitrogen
(LN2) levels in frozen storage units.
Evidence of Compliance:
✓
Written procedure defining method for monitoring LN2 levels AND
✓
Records of daily monitoring of LN2 levels
TRM.48180 Liquid Nitrogen Storage Unit Alarms Phase II
All liquid nitrogen storage units are monitored 24 hours/day and are equipped with
an alarm (in laboratory or remote) that is tested according to the manufacturer's
recommended interval, or at least quarterly if not specified by the manufacturer, with
results recorded.
NOTE: The laboratory must be able to demonstrate how the alarm system works and that there
is a process to ensure a timely response to an alarm, including remote alarms.
Evidence of Compliance:
✓
Records of alarm checks at defined frequency
TRM.48190 Critical Equipment Back-Up Phase II
The laboratory has back-up capability for all critical instrumentation and storage devices.
TRM.48210 Laminar Flow Hood Maintenance Phase II
Records show that the laminar flow hood is regularly cleaned, decontaminated and
certified as appropriate.
PROCESSING
Inspector Instructions:
●
Sampling of processing policies and procedures
●
Sampling of processing and QC/culture records
●
Sampling of records of ABO/Rh compatibility
●
What is your course of action when a product is culture positive?
TRM.48220 Aseptic Techniques Phase II
Aseptic techniques are employed in the collection, processing and administration of
cellular therapy products prepared by the laboratory.
NOTE: Products must be handled using aseptic techniques, processed with minimum delay
and maintained at appropriate storage temperatures. Processing of the cellular therapy product
should be performed under appropriate environmental conditions to minimize the risk of microbial
contamination (eg, biosafety cabinets, if not using a closed system).
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TRM.48230 Microbial Content Phase II
All products intended for administration are cultured for microbial content at appropriate
time(s).
NOTE: There are records of review of positive culture results by the transfusion service medical
director, including investigation and corrective action, as required
Evidence of Compliance:
✓
Written procedure defining criteria and timelines for culturing
TRM.48240 Physician Notification Phase II
There is a written procedure to notify the patient's physician of any positive microbial
culture results or other problems with the cellular therapy product that could affect its
suitability for administration.
NOTE: This requirement is not intended to preclude the use of components testing positive for
bacterial contaminants. It is the responsibility of the transfusion service medical director and
patient's physician to determine if the cellular therapy product is suitable for use.
Evidence of Compliance:
✓
Records of physician notification
TRM.48250 Processing Record Review Phase II
For each product processed, detailed records are retained and there is evidence that they
are reviewed by the transfusion service medical director or designee in a timely manner
(at least prior to administration).
TRM.48260 Allogeneic ABO/Rh Mismatch Phase II
For allogeneic donations, there is a written procedure for the processing of products
where there is an ABO/Rh mismatch between the donor and the recipient.
CRYOPRESERVATION AND STORAGE
Inspector Instructions:
●
Sampling of cryopreservation and storage policies and procedures
●
Sampling of cryopreservation records
●
Sampling of consent forms
TRM.48270 Cryopreservation Record Review Phase II
Cellular therapy product cryopreservation records, including freezing charts, when
applicable, are reviewed by the transfusion service medical director or designee.
NOTE: If the laboratory uses a controlled rate freezer, the freezing chart for each
cryopreservation must be reviewed for appropriate heat of fusion, cooling rate and unexpected
peaks in temperature.
TRM.48280 Product Exposure To Cryoprotectant Agents Phase II
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The cryopreservation procedure includes steps to minimize the exposure of the product
to the cryoprotectant agents (eg, DMSO) used during the freezing process.
NOTE: As DMSO is potentially toxic to cells at temperatures above 0° C, the processing and
freezing procedure must involve steps to minimize the exposure of the stem cell component to
DMSO.
TRM.48290 Informed Consent for Disposal Phase II
There is a written policy that addresses informed consent for collection, processing,
length of storage, and conditions to be met for final disposition of the cellular therapy
product.
NOTE: A pre-collection written agreement between the storage facility and the designated
recipient and/or donor defining the length of storage of cellular therapy products and their long
term disposition must be obtained. There must be records of efforts taken to contact the patient
and the patient's physician prior to discarding the components.
TRM.48300 Cord Blood Storage Phase II
Cord blood products are stored with integrally attached segments to allow verification of
their contents.
Evidence of Compliance:
✓
Written procedure defining criteria for cord blood storage and verification of content
TRM.48310 Quarantined Cellular Therapy Products Phase II
All quarantined cellular therapy products, including products untested or testing
positive for infectious disease markers, are stored in a manner to prevent inadvertent
administration of the product and to minimize the risk of cross contamination of other
products.
Evidence of Compliance:
✓
Written procedure defining criteria for storage of quarantined cellular therapy products
ADMINISTRATION
Inspector Instructions:
●
Cellular therapy adverse reaction policy or procedure
●
Sampling of adverse reaction records and evaluation
TRM.48320 Administration Adverse Reactions Phase II
Adverse reactions unique to administration of cellular therapy products are recorded and
evaluated.
NOTE: The transfusion service medical director is responsible for setting criteria for the detection
of adverse reactions to cellular therapy products, as well as the evaluation and reporting of
adverse reactions.
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PERSONNEL
Inspector Instructions:
●
Records of education and experience
●
Sampling of policies/procedures for transfusion service medical director review
TRM.50050 Transfusion Service Medical Director (Technical Supervisor) Qualifications Phase II
The transfusion service medical director (technical supervisor) is qualified.
NOTE: The transfusion service medical director (technical supervisor) must be an MD or DO,
licensed to practice medicine or osteopathy in the State in which the laboratory is located, and
either 1) possess qualifications required for board certification in clinical pathology or 2) have at
least one year training or experience in immunohematology.
In Department of Defense laboratories, technical supervisors for the subspecialty of
immunohematology must meet the qualifications defined in the Clinical Laboratory Improvement
Program (CLIP) Procedures. A qualified medical director must perform duties requiring medical
expertise.
For laboratories not subject to US regulations, the person in charge of technical operations
must: 1) hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory
science from an accredited institution, AND 2) have 4 or more years of fulltime general laboratory
training and experience, of which at least 2 years were spent acquiring proficiency in one of the
laboratory specialties OR be certified by a board approved or recognized in the jurisdiction where
the laboratory is located.
The transfusion service medical director has oversight responsibility for the different services
addressed by the checklist (eg, transfusion, donor, apheresis, hematopoietic progenitor cell).
Some laboratories may have separate directors providing oversight for these services; however,
all directors must meet these qualifications.
Evidence of Compliance:
✓
Records of transfusion service medical director (technical supervisor) qualifications including
diploma, transcript(s), equivalency evaluation, current license (if required) AND
✓
Records of work history in related field
REFERENCES
1)
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2002(Oct 1):1054 [42CFR493.1449(q)(1-2)]
TRM.50100 Director Involvement Phase II
The transfusion service medical director of the transfusion service is involved in
development of all policies and procedures related to transfusion.
Evidence of Compliance:
✓
Records of transfusion service medical director review of transfusion-related policies and
procedures AND/OR meeting minutes of institutional transfusion committee meetings where
policies and procedures are developed/approved
**NEW** 06/04/2020
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TRM.50150 Training and Competency for Critical Tasks Phase II
Transfusion service personnel responsible for performing critical tasks are trained and
assessed at least annually.
NOTE: A critical task is defined as any non-testing function performed in the transfusion
service that can affect patient safety or the quality of the service performed (eg, issuing blood
components, modification/manufacturing of blood products).
It is the laboratory director's responsibility to determine:
●
How competency is assessed
●
Qualifications of the individual's assessing competency.
Requirements for training and competency of personnel performing patient testing are found in
the Laboratory General Checklist, Personnel section. Training of blood transporters is described
in TRM.40900.
Evidence of Compliance:
✓
Records of training and annual competency for critical tasks performed
REFERENCES
1)
Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI document
QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA; 2009.
PHYSICAL FACILITIES
Sufficient space and utilities need to be provided for the overall workload of the transfusion medicine section,
and to meet all safety requirements
Inspector Instructions:
●
Space, storage and collection areas are all sufficient
●
Is the work area sufficient for you to perform your duties safely and accurately?
TRM.60000 Adequate Space - Donor Collections Phase I
There is adequate space for blood collection from donors.
NOTE: There must be sufficient space of appropriate design to provide donors with privacy such
that they will feel comfortable divulging details of their health history. In addition, there must
be sufficient space in the phlebotomy area to accomplish the necessary functions and to allow
access of additional or emergency personnel in case of an untoward event.
TRM.60400 Adequate Space Phase I
There is adequate space for blood storage refrigerators and freezers, reagent
refrigerators, and platelet rotators.
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TRM.60600 Adequate Space - Donor Apheresis Phase I
There is adequate space for donor apheresis.
NOTE: There must be sufficient space in the phlebotomy area to accomplish the necessary
functions and to allow access for additional or emergency personnel in case of an untoward
event.
TRM.60700 Adequate Space - Therapeutic Apheresis Phase I
There is adequate space for therapeutic apheresis.
NOTE: There must be sufficient space in the therapeutic area to accommodate the necessary
functions and to allow access of additional or emergency personnel in case of an untoward
event.
**NEW** 06/04/2020
TRM.60710 Adequate Space - Cellular Therapy Products Phase I
There is adequate space in the cellular therapy area for:
●
Collection of cellular therapy products
●
Storage of equipment supplies, and reagents
●
Access of additional or emergency personnel in the event of an untoward
event
●
Minimization of the risk of airborne microbial contamination, mix-ups and
cross-contamination of products.
