What’s new in latest transfusion medicine checklist

Valerie Neff Newitt

September 2020—Strong quality management, patient safety, and conformity with regulations are at the heart of the new and revised requirements in the 2020 CAP accreditation program transfusion medicine checklist, released in June.

“Our biggest focus this year was the strengthening of our cellular therapy checklist requirements,” says Yara A. Park, MD, advisor to and former chair of the CAP Transfusion, Apheresis, and Cellular Therapy (TACT) Committee and associate professor of pathology and laboratory medicine, University of North Carolina School of Medicine. “Other important revisions reflect changes in the transfusion medicine industry itself, such as the use of low-titer group O whole blood, pathogen reduction, and Babesia testing.”

Glenn E. Ramsey, MD, TACT Committee chair and professor of pathology at Northwestern Medicine’s Feinberg School of Medicine, says, “Sometimes it was because the standards and the customary procedures have evolved, sometimes it was a new requirement from a regulatory body, and sometimes it was a matter of strengthening and improving what we already had.” The changes followed an extensive review process, he says, “and consultations with our labs, inspectors, and within the committee itself.”

The section of the checklist devoted to hematopoietic progenitor cells contains four new requirements. “We already had checklist requirements related to cellular therapy,” Dr. Park says, “but we wanted to beef it up, strengthen it, so we added four new requirements. Three of them align with the Foundation for the Accreditation of Cellular Therapy [FACT] standards.”

TRM.48060 “Pre-Collection Testing” requires labs to perform a complete blood count, including a platelet count, from each cellular therapy donor no more than 24 hours before collection.

“This one has a focus on donor safety. It makes sure that it is safe for a donor to be put on a machine and have their cells removed by apheresis for this collection,” Dr. Park says. And it does so immediately before the collection instead of days earlier, Dr. Ramsey points out. In prior checklist editions, the CAP did not specify a time frame for this testing.

TRM.48070 “Assessment of Cellular Product” says laboratories must have a process for assessing the quality of each cellular therapy product collected, to confirm its safety, viability, and integrity. A written process for assessing the product and records of cellular product assessment meeting predetermined specifications are the evidence of compliance.

“This is something we hadn’t had before in the cellular product section, although it was in the component prep­aration, storage, and modification section,” Dr. Ramsey says. “We wanted to make sure that facilities that were not necessarily collecting blood also were aware of this. Now it is required for inspectors to check.” The requirement is generally worded; it’s up to each lab to decide how to do the assessments. “But they must have a written process and maintain records of the assessments,” he says.

TRM.48090 “Donor Eligibility Status—Allogeneic Donors” says the collection facility must provide to the processing facility records of each allogeneic cellular donor’s eligibility, and the record must accompany the product at all times. Evidence of compliance requires a policy for the communication of donor eligibility and records of cellular therapy donor eligibility status. Says Dr. Ramsey: “This requires that whoever collects the product provides records to the processing facility. It is an important distinction because regular blood products usually don’t get sent from one lab to another in the same way that cellular products do. This makes sure everybody is aware the donor was eligible.”

The requirement ensures the donor is free of risk factors for transfusion-transmitted infections, Dr. Park notes. “And because eligibility records must accompany the product at all times,” she says, “the processing facility can correctly label the product before it distributes it to the recipient. The eligibility records will accompany the product through all steps of the product’s life.”

TRM.60710 “Adequate Space—Cellular Therapy Products” requires that the cellular therapy area have adequate space for collection; storage of equipment, supplies, and reagents; additional emergency personnel when needed; and “minimization of the risk of airborne microbial contamination, mix-ups, and cross-contamination of products.”

That means, Dr. Park says, it must make sure that each donor has his or her own space and processes are in place to prevent mix-ups. “This helps avoid taking a product from one donor and putting it in the transport cooler for another donor.”

In the laboratory general checklist are space requirements that apply to all laboratories. “But we realized,” Dr. Ramsey says, “there are probably facilities that are only handling cell therapy products, so we made sure they have this space stipulation as well, and that inspectors review the adequacy of space.”

It has been a goal of the CAP committee to strengthen the cellular therapy portion of the transfusion medicine checklist, he says. “And I think these are nice yet simple ways to increase the safety for our donors and the quality of our products.” The TACT Committee will update this section further for the 2021 edition.

The TRM.40700 “Selection of Blood Components” requirement was revised to say that the selection procedure must be a written one and include, now for the first time, low-titer group O whole blood in addition to ABO group-specific whole blood and components. The requirement says if transfusion of low-titer group O whole blood occurs, the procedure must describe the definition of “low-titer” group O whole blood as mutually agreed upon by the transfusion service and the blood supplier and the indications for the use of these units.

“This was a big one for me,” Dr. Park says. “The transfusion community used to use whole blood decades ago, then we moved to component therapy where we’d get a red blood cell or a platelet or plasma. In the past decade we’ve moved back toward the use of whole blood for massively bleeding patients, the idea being if someone is massively bleeding out whole blood, why give them all these components that have additional preservatives in them, and additive solutions that are just adding volume but not blood? If they’re bleeding whole blood, why not give them whole blood? It’s a hot topic in transfusion medicine, and people have strong feelings one way or the other.” Trauma surgeons, she says, usually favor whole blood. “They don’t want the burden of balancing the components.”

“This checklist requirement used to say that you had to give ABO group-specific whole blood, or ABO group-specific or compatible red-cell–containing components. That meant if a patient were group A, we would have to get group A whole blood. We always think of O as the universal donor, but group O donors have antibodies to A and B red blood cells in their plasma, so that can be dangerous to non-group O recipients. However, we often do not know trauma patients’ blood types. So there has been a move to use group O whole blood and to require it be low titer, meaning a low level of antibodies to the A and B red blood cells so that it could be a more universal blood product.” Now that option has been added, permitting the use of low-titer group O whole blood providing that the transfusion service and the blood center have come to an agreement as to what low titer means.