1. Transfusion Medicine: Checklists and Challenges
Ljiljana Petkovic, MT(ASCP)SBB Checklist Technical Content Analyst
March, 2016

2. Transfusion Medicine: Checklists and Challenges
Today’s presentation will review:
Common checklist deficiencies
Lab General
All Common
Transfusion Medicine
Checklist Challenges
Interpretation of requirements
New requirements
© 2016 College of American Pathologists. All rights reserved.

3. Common Deficiencies – Laboratory General Checklist
GEN Document Control System (Revised in 2015)
Policies and procedures are current
Personnel are knowledgeable – including defined process for introduction of new or revised documents (sign-off sheets, electronic, meeting minutes)
Signed by Laboratory Director before implementation
Procedures reviewed per laboratory policy by director or designee (at least biennially)
Discontinued policies/procedures removed
© 2016 College of American Pathologists. All rights reserved.

4. Common Deficiencies – Laboratory General Checklist
GEN Document Control
Management of document control system applies to labs that are subject to CAP accreditation
More examples of documents listed to include: safety, specimen collection, personnel, and information systems
Card files and summary charts added to list of policies and procedures that must be current.
Records for approval, review and discontinuance are available
© 2016 College of American Pathologists. All rights reserved.

5. Common Deficiencies – Laboratory General Checklist
GEN Personnel Records
Personnel files are maintained and current for all testing personnel
Copy of academic, diploma or transcript of highest degree on file
License acceptable (applicable only for laboratory personnel) if required by state
Credential verification allowed in lieu of diploma providing laboratory can obtain copies within seven days of request and process has been validated (New for 2015)
© 2016 College of American Pathologists. All rights reserved.

6. Common Deficiencies – Laboratory General Checklist
GEN Personnel Records Required:
Summary of training and experience
Certification, if required by state or employer
Job Descriptions
Records of continuing education
Work-related incident and/or accident records
Dates of employment
© 2016 College of American Pathologists. All rights reserved.

7. Common Deficiencies – Laboratory General Checklist
GEN Competency Assessment
- Each non-waived test system – to include all 6 required elements
- Waived test systems – elements can be selected
- Semiannually during first year of duties for new employees (not required for waived testing)
- Annually thereafter
- Performed by Technical Supervisor or qualified designee (in writing)
© 2016 College of American Pathologists. All rights reserved.

8. Common Deficiencies – Laboratory General Checklist
GEN Test Systems
Process that includes pre-analytic, analytic, and post-analytic steps to produce a test result or set of results
May be manual, automated or single use
Tests performed on same instrument or device may be defined as a single test system
Tests with unique aspects, problems or procedures within the same testing platform (eg. Eluates) must be assessed as separate test system to ensure staff perform aspects correctly
© 2016 College of American Pathologists. All rights reserved.

9. Common Deficiencies – Laboratory General Checklist
GEN Who Can Assess Competency?
High Complexity testing- Section director or general supervisor
Individual with minimum of associate’s degree in Medical Laboratory Technology with 2 years of training and/or experience in high-complexity
Doctoral/M.S/B.S degree in clinical lab science or chemical, physical or biological science and 1 year training and experience in high-complexity
Must be delegated in writing by the section director
© 2016 College of American Pathologists. All rights reserved.

10. Common Deficiencies – Laboratory General Checklist
GEN Who Can Assess Competency (cont’d)
Moderate Complex testing- Technical Consultant individual with a B.S. degree in clinical laboratory science or chemical, physical or biological science and 2 years experience in non-waived testing in designated specialty
Doctoral/M.S degree in clinical laboratory science or chemical, physical or biological science and 1 year training and/or experience in non-waived testing in designated specialty. Visit FDA website to determine testing complexity level
© 2016 College of American Pathologists. All rights reserved.

11. Common Deficiencies – Laboratory General Checklist
GEN Performance Assessment of Supervisors/Consultants
Laboratory Director must delegate responsibilities in writing
Perform and document the performance assessment
If the individual is performing non-waived testing must document competency assessments including the six elements (GEN.55500)
If state regulations are more strict, follow stricter rules
© 2016 College of American Pathologists. All rights reserved.

12. Common Deficiencies – All Common Checklist
COM PT Attestation Page (Revised in 2015)
Written signature of Lab Director or designee (electronically submitted signature not acceptable)
Designee must be in writing:
For high complexity testing, may be delegated to individual meeting qualifications of technical supervisor or section director
For moderate complexity testing, may be delegated to individual meeting qualifications of technical consultant
© 2016 College of American Pathologists. All rights reserved.

13. Common Deficiencies- All Common Checklist
COM PT Evaluation
Prompt evaluation
All unacceptable results
Includes follow-up/corrective action
Records kept for five years for Transfusion Medicine
© 2016 College of American Pathologists. All rights reserved.

14. Common Deficiencies- All Common Checklist
COM Instrument/Equipment Record Review
All instruments/ equipment maintenance and function checks
Reviewed monthly
COM Comparability of Instrument/Method
Non-waived instruments/methods; eg, Gel vs. tube method, multiple instruments, etc.
Twice/year
Acceptability criteria defined
Documented review
© 2016 College of American Pathologists. All rights reserved.

15. Common Deficiencies – All Common Checklist
COM Procedure Manual
Cited when policy does not match practice
Use of manufacturers’ inserts not acceptable in place of procedure manual.
Extra copies of procedures at workstations subject to document control
Complete manual (electronic or paper) must be available in work area
Current and complete (expired removed)
© 2016 College of American Pathologists. All rights reserved.

16. Common Deficiencies – All Common Checklist
COM There are records of review of all technical policies and procedures by the current laboratory director or designee at least every two years
Laboratory Director or designee (in writing)
New/significantly changed policies and procedures cannot be delegated
Per laboratory policy (at least biennially)
At individual procedure level OR multiple signatures on a list of procedures
Electronic OR written signature acceptable
© 2016 College of American Pathologists. All rights reserved.

17. Common Deficiencies – All Common Checklist
COM Reagent Labeling – revised expiration date must be recorded on container or log
COM Reagent Storage
Per manufacturer requirements
Temperatures recorded daily
COM Reagent Expiration Date – used within expiration date
© 2016 College of American Pathologists. All rights reserved.

18. Common Deficiencies – All Common Checklist
COM New Lot/Shipment – confirmation of acceptability
To confirm that use of new reagent lots and shipments do not affect patient results (i.e. improper storage)
Daily quality control of ABO, Rh and Antibody screen satisfies intent of checklist item
Fetal detection screen kits must be checked when new lots arrive
Does not apply to antibody panels
© 2016 College of American Pathologists. All rights reserved.

19. Common Deficiencies – All Common Checklist
COM Method Validation/Verification Approval Summary statement signed by laboratory director or designee who meets CAP director qualifications
Written assessment of validation/verification study
Problems discovered, corrective action and resolution is documented and included in summary
Approval of validation plan signed prior to use in patient testing
© 2016 College of American Pathologists. All rights reserved.

20. Common Deficiencies – Transfusion Medicine Checklist
TRM Monthly QC Review
QC records
Temperature records – 7 days/week; 52 weeks/year
Alarm checks
TRM Reagent Expiration Date (Revised in 2015)
Reagents used within expiration date
Expired reagents may be used if rare; expectation is for lab to have in-date reagents for routine antibody panel testing
© 2016 College of American Pathologists. All rights reserved.

21. Common Deficiencies – Transfusion Medicine Checklist
TRM Antisera/Reagent Red Cell QC
Records of acceptability performed each day of use
Includes check against known positive and negative cells or manufacturer’s directions for quality control followed
TRM Transfusionist Training
Personnel who transfuse blood are trained in observation of transfusions of recipients and in recognition of transfusion reactions
Training done initially and annually
© 2016 College of American Pathologists. All rights reserved.

22. Common Deficiencies – Transfusion Medicine Checklist
TRM Acceptance Back Into Inventory (Revised for 2015)
Written procedure validated by the laboratory including validation of “30 minute” rule
Records show appropriate temperatures maintained
© 2016 College of American Pathologists. All rights reserved.

23. Common Deficiencies – Transfusion Medicine Checklist
TRM Storage Unit Alarms
Quarterly alarm testing
Alarm checks to include both high and low tests
TRM Alarm Sensors To Trigger Action Needed
Set to alarm prior to falling out of range
Corrective action documented
Review documented
© 2016 College of American Pathologists. All rights reserved.

24. Interpretation “challenges”
GEN.54400/54750 Personnel Records
Personnel license alone acceptable only if required by your state
Copy of diploma or transcript required if state licensure not applicable
Must include course of study, eg, Bachelor of Science in Medical Technology, Biology, etc.
Non-US degrees require foreign equivalency evaluation; eg, NACES, AICE and others
Certification – copy needed only if required by state or employer; eg, ASCP
© 2016 College of American Pathologists. All rights reserved.

25. Interpretation “challenges”
COM New Reagent Lot Verification
Applicable to all test kits
For ABO/Rh/Antibody screen, daily QC can meet this requirement
Requires acceptability criteria, records and review
COM Manufacturer Instructions
Any change to instructions requires validation
Change in waived test instructions makes test high complexity (and changes personnel requirements)
TRM Serologic Centrifuge Checks – RPM and mechanical timer checks required each 6 months
© 2016 College of American Pathologists. All rights reserved.

26. Interpretation “challenges”
TRM.41525/ 41550/ Perioperative/ Intraoperative Blood Programs (Revised)
Defined responsibility of Laboratory Director and laboratory in perioperative and intraoperative programs
Documented Laboratory Director involvement in policies and procedures
TRM CBER Notification (Revised)
FDA biological product deviation reporting requirements (website:
Includes testing, component prep, labeling, storage, and distribution of units
© 2016 College of American Pathologists. All rights reserved.

27. Checklist requirement update
New/Revised requirements – 2015
TRM Adequate Blood/Tissue Supply (Revised)
Requires written agreement OR
Letter of understanding between transfusion service and blood supplier
TRM Misidentification Risk (Revised)
Now requires facilities to have a system to reduce risk of mistransfusion (rather than a plan to reduce risk)
© 2016 College of American Pathologists. All rights reserved.

28. Checklist requirement update
TRM Reagent Expiration Date (Revised)
Lab is expected to use in-date reagents for routine antibody panel testing
TRM Pipette Accuracy (Revised)
Added note that minimally, checks to be performed per manufacturer’s instructions and defined
TRM Selection of Blood Components (Revised)
Formerly titled Whole Blood/Red Cells/Plasma
Allows provision for transfusion of ABO incompatible plasma
© 2016 College of American Pathologists. All rights reserved.

29. Checklist requirement update
TRM Blood Administration Procedure (Revised)
Formerly entitled Transfusion Protocol
Requires written procedure
TRM Transfusionist Training (Revised)
Clarification of annual training to include recognition and reporting of adverse transfusion events
TRM Transfusion Reaction Recognition (Revised)
Written procedures for clinical actions taken
Deleted “Education” from subject header
© 2016 College of American Pathologists. All rights reserved.

30. Checklist requirement update
TRM TRALI (Revised)
Checklist requirement now a Phase II
Laboratory is requirement to have written policies and procedures to recognize, investigate and reduce risk
Sole written record of communication from blood supplier no longer accepted to meet the intent of the requirement
© 2016 College of American Pathologists. All rights reserved.

31. Checklist requirement update
TRM Instrument QC (Revised)
Requires that facility follows manufacturers instructions for quality control prior to use in donor screening
TRM ABO Typing on Solid Organ Donors (New)
Written policy for ABO typing
A1 subgroup not to be performed in patients transfused within last three months
© 2016 College of American Pathologists. All rights reserved.

32. Resources
Phone: Technical Staff in Laboratory Accreditation: , option 1
Lilly Petkovic:
, ext. 7387
THANK YOU!
© 2016 College of American Pathologists. All rights reserved.