Transfusion medicine checklist: Record and other requirements updated in new release

Amy Carpenter Aquino

August 2018—One new requirement and several modified requirements in the CAP transfusion medicine checklist are part of the new edition of CAP accreditation program checklists released this month.

In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification.

The 2018 updates address questions that laboratories have had about some requirements since the 2017 transfusion medicine checklist revision, says CAP Checklists Committee member Manish J. Gandhi, MD. “In this version those important items were clarified,” says Dr. Gandhi, a consultant in Mayo Clinic’s Division of Transfusion Medicine and associate director of the component processing and product testing laboratory and director of the histocompatibility laboratory.

The recent changes make the transfusion medicine checklist an “even better, stronger list,” says Yara Park, MD, chair of the CAP Transfusion Medicine Committee, who with other committee members reviewed every requirement and reference for the 2017 checklist revision. The 2018 changes now provide more detail on some of those revisions and better direction in other areas where there were questions, says Dr. Park, associate professor in the Department of Pathology and Laboratory Medicine and director of transfusion medicine services and hematopoietic progenitor stem cell laboratories, University of North Carolina School of Medicine.

The new computer crossmatch requirement, TRM.40665, will serve as an introduction to the checklist’s computer crossmatch section.

“When we were trying to fix all the things that mention computer crossmatch, we felt like we were missing an overarching checklist [requirement] to say, ‘This is what a computer crossmatch is and this is who can have it,’” Dr. Park says.

The FDA allows computer crossmatches in place of serologic methods, Dr. Gandhi says, “if you have enough checks and balances where the patient sample has been screened for preformed antibodies—not ABO but other antibodies—and it’s found to be negative, and if you’re sure about the patient’s type.”

The new requirement calls for written procedures for computer crossmatch methods based on validated decision rules for verifying donor and recipient compatibility. The requirement says a computer crossmatch may not be used if the patient has a current or past history of clinically significant alloantibodies or if there are unexplained typing discrepancies on the current sample. This clarification of when a computer crossmatch is acceptable “keeps everyone”—CAP members and inspectors—“on the same page,” Dr. Gandhi says.

New additions to the record retention requirement, TRM.32250, further align the CAP’s requirements for blood banks with those of other accrediting organizations. “Since CAP has deemed status with other regulatory agencies, we needed to make sure our checklist requirements met all the other requirements, at a minimum,” Dr. Gandhi says, who notes the updated TRM.32250 requirement is “more inclusive.”

Added to the list of donor records that must be retained for 10 years is documentation of the acceptability of returned units into inventory. Under patient records, a new 10-year requirement is documentation of the evaluation of delayed transfusion reactions. New retention requirements also include, among several others, records of the identification of individuals who performed each significant step in collection, processing, compatibility testing, and transportation; container qualification/process validations; the final inspection and verification of blood before issue; and blood supplier agreements.

The change to the historical record requirement, TRM.40300, makes it acceptable for blood banks to use a validated computer system capable of performing historical checks to compare ABO, Rh, and antibody screen test results against results of the same tests recorded previously. The alternative is a manual check performed by qualified personnel.