TRM.40230 Specimen Labeling for Pretransfusion Testing also was revised. It lists the information with which blood samples must be labeled at the time of collection in the patient’s presence, and now the collection date and the identity of the person who collected the specimen need not be on the label itself if that information is accessible via electronic capture, referred to in the requirement as “a method to identify the date” or “a method to identify the collector.” This same requirement is in the laboratory general checklist as GEN.40493.
“If you have an electronic medical record that you can go into and find out the date and who the collector is without both of those elements being on the sample itself, that is now acceptable practice,” Dr. Roush says.
Among the other revised requirements is TRM.40250 Specimen/Requisition Verification, which says a trained member of the transfusion service must confirm that all identifying data on the paper or electronic requisition is identical to the information on the specimen tube before pretransfusion testing. Laboratories must now have a policy for how to handle names that are too long for the allotted space or are misaligned on labels.
“Labs would reject specimens because the label did not reflect the patient’s full name as it was in the EHR or on their wristband, for example. So now,” Dr. Roush says, “if you have a policy that addresses that situation, a sample could be acceptable even if the name is truncated.”
The transfusionist training requirement, TRM.41025, was revised, too, to ensure that the transfusion service medical director or physician designee approves a training curriculum, or that an appropriate institutional authority, in consult with the transfusion service medical director, approves the training.
Almost all hospitals have such training, Dr. Roush notes, but whether a pathologist or someone else with blood bank oversight approved the curriculum is the question. TRM.41025 also now says that third-party providers of personnel must provide the records of training if that training was not done by the institution. “This revision helps make sure everyone is on the same page,” Dr. Roush says.
TRM.41300 requires donor and recipient information to be verified immediately before transfusion in the recipient’s presence and to include six elements. The first element was revised; it says this verification includes conclusive identification of the recipient with two patient identifiers “and confirmation that patient identifiers on the blood or component unit label match the identity of the recipient” by either two persons or by use of bedside patient identification technology instead of a second person.
“It incorporates an electronic method to suffice as one of the identifiers when you’re about to transfuse a patient,” Dr. Roush says.
Also among the revised transfusion requirements is TRM.45257, which says donor physiologic measurements must meet inclusion requirements and provides the FDA-defined inclusion criteria. This requirement was revised to align with the July 2024 Food and Drug Administration guidance on documenting blood pressure and pulse donor eligibility and says deviations for both require medical evaluation, “performed in person or remotely for donors with values outside the specified criteria.”
In addition, the requirement says: The determination for pulse outside the specified criteria (rate or irregularity) can be evaluated by donor screening personnel when guided by standard operating procedures that include appropriate exceptions such as for a healthy athletic donor.
“It’s just a reflection of how technology is allowing more efficiencies,” Dr. Roush says. “This is part of a broader trend toward remote competency and assessment models across laboratory medicine. It improves efficiency without compromising donor safety.”
Valerie Neff Newitt is a writer in Audubon, Pa.