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When inspectors knock, know what’s new

December 2001
Kathleen Furore

The requirements your laboratory will have to meet to maintain its CAPaccreditation changed recently with the revision of the transfusion medicine checklist.

No laboratory is held to the new checklist, however, until it gets the new checklist as part of the routine accreditation cycle.

"If a new checklist goes into effect between the time you’ve received your upcoming inspection checklist and the actual, scheduled inspection, you will not be held to the new checklist. You’ll be held to the checklist you were sent," says Ira A. Shulman, MD, chair of the CAP Transfusion Medicine Resource Committee and director of transfusion medicine at the Keck School of Medicine of the University of Southern California in Los Angeles.

But don’t ignore the most updated version. "It’s important to realize that when a new checklist is approved, it gives you the future of what you need to comply with," Dr. Shulman says. "I encourage all labs to not only be up-to-date with the checklist they’re going to be inspected against, but to at least be familiar with and work toward complying with the new checklist."

When revising the transfusion medicine checklist, the CAP modified several questions, added seven new ones, and removed two. Here is what’s new in the checklist.

1. TRM.40655 phase I: When a direct antiglobulin test is ordered by a patient’s physician, does the test system allow detection of red blood cell-bound IgG and complement?

"’And complement’ is a key new phrase," says Dr. Shulman, noting that the recommendation to detect RBC-bound complement should improve the evaluation of patients with cold hemagglutinin disease, warm autoimmune hemolytic anemia, and drug-induced immune hemolytic anemia.

"The committee believes using only anti-IgG AHG reagent when performing a direct antiglobulin test does not allow for detection of all patients with autoimmune hemolytic disease or immune complex-mediated hemolytic states," he says.

2. TRM.41525 phase I: Is the authority, responsibility, and accountability of the perioperative blood recovery and reinfusion program defined?

This question relates to TRM.41600 phase I, which asks, ’Is the transfusion service medical director involved in establishing policies and procedures related to intra- and perioperative collection and reinfusion procedures?

"It boils down to this bottom line: Neither the authority nor the responsibility need to be assigned to the transfusion service medical director," Dr. Shulman says. "However, the medical director should be aware of and participate in the development of such policies and procedures."

TRM.41600 was the second most common phase I deficiency, he says.

3. TRM.44525 phase I: For replacement therapy of stable clotting factors, is frozen plasma thawed at 30-37°C, and maintained at 1-6°C for more than 24 hours but less than five days, relabeled as "thawed plasma?"

"What this question is really getting at is that we can now store thawed plasma for up to five days so long as it is labeled ’thawed plasma’ and maintained at the proper refrigerated temperature after the first 24 hours of storage," Dr. Shulman says. Compliance with this question will make it possible to reduce the outdating of thawed plasma products.

4. TRM.40760 phase II: Are the red cells in granulocytes and/or platelets crossmatch-compatible with the recipient’s plasma, except when the method of procurement results in a component with less than 2 mL of donor red cells?

The old requirement dictated crossmatch-compatibility if the products contained more than 5 mL of donor red cells, Dr. Shulman says. The new question requires that if granulocytes or platelets contain more than 2 mL of donor cells, the products must be crossmatch-compatible with the recipient’s plasma. So how does a lab know if there is more than 2 mL of donor cells without spinning it down and measuring it? "From a very practical blood bank standpoint," suggests Dr. Shulman, "if it looks pink or red, it probably has too many red cells in it."

5. TRM.31155 phase II: Does the director or designee review and approve all new policies and procedures, as well as substantial changes to existing documents, before implementation?

"Before implementation" is a key phrase, Dr. Shulman says. "It is important that only approved procedures be followed, and that all procedures be approved before they’re implemented."

6. TRM.43070 phase I: Has the laboratory information system been validated for blood banking/ transfusion medicine activities?

"This is a new question just released into the field," Dr. Shulman says. It will be upgraded to a phase II deficiency as soon as all 6,000 labs inspected have cycled through at least one inspection that employs this question.

7. TRM.42185 phase II: Is there a policy requiring notification of the Centers for Biologics Evaluation and Research according to U.S. federal regulations when a transfusion-related fatality occurs following transfusion of any component?

For the most current information and official instructions on how and when to make such a report, Dr. Shulman suggests logging on to www.fda.gov/cber/transfusion.htm. "That will help in making sure you have a policy if you do not already have one for that phase II deficiency," he says.

The following two questions no longer appear in the checklist.

1. TRM.31100 phase II: Is a copy of NCCLS GP2-A3 available to the author(s) of the procedure manual?

"Currently only one copy of NCCLS GP2-A3 is needed for the entire accredited laboratory, so to have a separate one just for the blood bank inspection is unnecessary," Dr. Shulman says. The requirement to have at least one for the entire accredited laboratory appears in the Laboratory General checklist.

2. TRM.40750 phase II: Are the red cells in granulocyte transfusions ABO-compatible with the recipient’s plasma?

New question TRM. 40760 (No. 4) replaces this question.

For more information about the transfusion medicine checklist and inspection process, email the CAP at accred@cap.org or call 800-323-4040 ext. 6065.