What’s new in latest transfusion medicine checklist

This is a requirement about selecting which products go to which patients, Dr. Ramsey says. “So for facilities that are using group O whole blood, we are asking them to have criteria on what they mean by low titer and indications for using those units in particular.” No uniform titer has been identified, nor has a universally accepted titer cutoff been established. “Whoever is supplying the blood has to define what the titer is, and then the transfusion service has to be in agreement and say, ‘Yes, we accept that titer as being a low titer.’”

Similarly, TRM.40720 “Provisions for Special Components” now includes transfusion of low-titer group O whole blood, including the maximum volume/units allowed per event, as one of four listed items for which the laboratory must have written procedures for the provision of appropriate components.

“Some patients have specific antibodies, risk factors, so they need special products. Some places want to limit the numbers of units of low-titer group O whole blood they give per patient because they perceive it as a special product,” Dr. Ramsey says. “So it’s listed here to be sure a lab has a written procedure for how many units they’re giving to a patient.”

Other changes to the 2020 checklist are as follows:
• TRM.45270 “Directed Donation Requirements” says laboratories must have a written procedure to ensure that directed donations between blood relatives are irradiated or treated by a method approved by the FDA to prevent transfusion-associated graft-versus-host disease.

“This is important,” Dr. Park says, explaining it’s not about the directed donation but about using a method to prevent graft-versus-host disease. “In years past the only way to do that was by irradiating the products. But now there is a process called pathogen reduction or pathogen inactivation, which also treats the white cells in a way to prevent transfusion-associated graft-versus-host disease. So if laboratories are using directed donations from a family member, they now have the option to irradiate the product or use pathogen reduction technology for a platelet product. They have a choice. It’s a nice addition.”

The group took into account that FDA-approved pathogen reduction methods that inactivate viruses and bacteria also inactivate the donor’s white cells. “When that is being done,” Dr. Ramsey says, “the product does not need to be irradiated. So that may cut out a step.”

• TRM.47100 “Infectious Disease Testing” says that for labs subject to U.S. regulations, all FDA-required or -recommended infectious disease tests must be performed on blood samples collected at the time of donation, or at least once in the prior 30 days for a directed donor for a single intended recipient. A note listing the required or recommended tests has been revised to include testing for Babesia species in some states.

“With this addition, the CAP is catching up to where the industry is and where the FDA is,” Dr. Park says. “The FDA now requires certain states that have Babesia to do Babesia testing, and those states use nucleic acid testing of donors for Babesia. So we changed our requirement to say that nucleic acid testing for Babesia species may be required in selected states by the FDA.”

Also added is this: “In certain instances, the FDA may approve pathogen reduction methods as an alternative to testing.” Says Dr. Ramsey, “In some cases the FDA is now accepting pathogen reduction in lieu of the testing, and it is important to clarify that.”

• TRM.50150 “Training and Competency for Critical Tasks” is a new requirement that says transfusion service personnel responsible for performing critical tasks must be trained and then assessed at least annually. 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, such as issuing blood components or modifying or manufacturing a blood product.

“This was designed to focus on non-testing issues,” Dr. Ramsey says. “It arose from concern that the laboratory testing requirements might not be covering these areas as well as they should. We have a lot of compliance requirements for testing issues, and we cover those thoroughly. But there are other concerns that are important with regard to patient safety that also need to be addressed. This was created to cover these other areas where it’s not specifically a test but yet it’s important to the patient.”

Laboratories can decide what these non-testing critical tasks are, how competency is assessed, and who will assess that competency, Dr. Park says. “This is recognition of how important it is that we assess competency for the entirety of the transfusion medicine service. Unlike a lot of other laboratories, we in the transfusion medicine service are not only performing testing but also providing a product. When we modify, issue, or label a blood product, we must do it correctly. It is critical.”

• TRM.45254 “Training and Competency for Donor Collection Personnel” has been revised to say that personnel responsible for the donor selection process, pre-donation examination, and phlebotomy must now be assessed for competency at least annually. Previously it required only that they be trained, qualified, and competent.

“For personnel who are not performing a test function per se,” Dr. Ramsey says, “we want to make sure they are properly screening donors and collecting the blood. And we are requiring they be assessed for competency at least once a year.”

• TRM.42750 “Storage Unit Alarms” says all component storage units must be equipped with a monitored alarm system, with alarm checks performed according to the manufacturer’s recommended interval, or at least quarterly if the manufacturer has not specified the intervals. Results must be recorded. The temperature at which the alarm sounds must be compared to the temperature on the recording chart/log. The requirement now lists four examples of recording systems: paper chart records, paper graphs, electronic records, and event logs.

“At one time back in the day,” Dr. Park says, “a lot of places used paper charts and drew on it to record temperature for refrigerators and freezers and such. But now most places have moved to an electronic system. It wasn’t clear in our guidelines and our checklist requirements that it was okay to use an electronic system. So by adding this additional wording to the checklist, we’re saying it is fine to use an electronic recording method as well.”

• TRM.43605 “Component Labeling—Final Inspection” is a new checklist requirement that says the final inspection of the component labeling process must include verification that all information on the label is correct. This verification must be done, it says, 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.

“This explains that one person using a validated process, i.e. the computer, can do this validation, or two members of the transfusion service checking each other can do it. It’s giving an option to do it either way,” Dr. Ramsey says. The requirement was added to comply with an FDA requirement.

Valerie Neff Newitt is a writer in Audubon, Pa.