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

“Most blood banks now use a pretty sophisticated computer system of some sort that can do that logic and that check for us,” Dr. Park says. “We have added it to make it an acceptable practice. It is a nice change for blood banks because it removes a manual step that they had to somehow, somewhere document on paper.”

Dr. Park predicts blood banks will welcome this time saver. “Although it looks like a minor change, I think it will be very much appreciated.”

Also clarified in the 2018 checklist is that the use of molecular-based screening assays alone for ABO and Rh(D) blood type assignment is unacceptable for transfusion or transplantation. “We still do not know completely everything about ABO and Rh molecular typing,” Dr. Gandhi says, which is why TRM.40550, “Forward/Reverse Typing,” now says an FDA-cleared or -approved serological method must be used. ABO/Rh typing for transplant or transfusion has to be done “by an FDA-approved method, and right now that’s only serology,” Dr. Gandhi says.

“We use molecular-based testing for a lot of blood bank phenotyping now,” Dr. Park says, “but it is not acceptable and it’s just not the right testing and methodology for ABO and Rh.” ABO and Rh typing by molecular methods is complicated and not without risk, she says, adding, “Serology is very simple, so go with the simple one that works well.”

TRM.40650, “Serologic Crossmatch,” has two changes. One is to define neonate as it applies to transfusion. “Neonate in the blood banking world means an infant less than four months, because after four months, infants can start to make their own antibodies, so they need to be treated like anyone else,” Dr. Park says. In infants under four months, less can be done. Only one antibody screen is required, for example, on infants from birth to four months.

The second is to clarify that if a specimen is eligible for computer crossmatch, a serologic crossmatch need not be done. “This is just to say we understand that if it’s eligible for a computer crossmatch, you can do a computer crossmatch,” Dr. Park says.

The addition of the word “unexplained” provides much-needed clarity to TRM.40670, “ABO Group and Rh(D) Type Verification,” which addresses the need for serologic crossmatch in the event of ABO typing discrepancies.

For the most part, the causes of ABO typing discrepancies are known. “When a patient gets a bone marrow transplant, their blood type can change. That’s an expected ABO discrepancy,” Dr. Park says. Most blood banks would prefer to rely on a computer crossmatch in those cases, but the previous version of the requirement did not permit them to opt out of the serologic crossmatch in the presence of any discrepancy. “It was making more work for people.”

The requirement now says serologic techniques must be employed “when unexplained ABO typing discrepancies exist on the current sample.” Says Dr. Park, “We allow laboratories to not have to do the serologic crossmatch if they can explain the discrepancy.”

Other changes in this year’s checklist include the following:

• TRM.41025, “Transfusionist Training,” says there must be rec­ords of initial training and in-service at least annually for personnel involved in transfusion. Language was also added to clarify that it must be in accordance with federal, state, and local laws and institutional policies and procedures for alignment with the Centers for Medicare and Medicaid Services requirements for nursing services. The elements of what needs to be covered in the annual training are listed.
• TRM.40790, “Fetomaternal Hemorrhage Detection,” requires the use of standardized formulas for translating the milliliters of fetal blood into vials of RhIG for laboratories that provide RhIG dosage recommendations to physicians. “We just want to make sure that if a laboratory is doing it, they’re doing it in a standardized fashion” and can document it, Dr. Park says.
• TRM.40925, “Blood/Component Compatibility Label or Tag” is the former TRM.41350 and lists the minimum elements required on the label or tag: identification of the recipient with two patient identifiers, blood (or component) unit identifier, and interpretation of crossmatch tests, where applicable. Some of the elements previously in this requirement (for example, recipient and donor blood types) are already covered in TRM.40950, “Clerical Identification and Transfusion Records Final Check,” which has also been reformatted to list the elements that need to be verified at time of issue.

These changes clarify which elements need to be checked at the time of issue and which need to be attached to the bags. “There are overlaps,” Dr. Park says, “but they’re also different.”

Amy Carpenter Aquino is CAP TODAY senior editor.