College of American Pathologists
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In transfusion medicine, 7 deficiencies to dodge

December 2001
Feature Story

When inspectors knock, know what’s new

Kathleen Furore

Seven questions on the Laboratory Accreditation Program transfusion medicine checklist tend to trap labs into phase II deficiencies more frequently than other questions, says Ira A. Shulman, MD, chair of the CAPTransfusion Medicine Resource Committee.

Though "a great majority of labs inspected answer checklist questions in a way that suggests that they’re proceeding with good practices," a select group of questions are "answered in a way that raises an eyebrow," says Dr. Shulman, director of transfusion medicine at the Keck School of Medicine of the University of Southern California in Los Angeles. "They suggest some improvement is needed."

For these questions, the noncompliance rate ranges from two percent to 6.8 percent. "The good news," Dr. Shulman says, "is that most labs do comply with these questions." But other labs "wrestle with them," he says.

Here, as tallied by Dr. Shulman and LAPstaff, are the most frequently cited phase II deficiencies in transfusion medicine.

1. TRM.10350: For analytes where graded proficiency testing is not available, are other procedures used to validate performance at least

"Splitting samples with reference laboratories, splitting samples using established in-house methods, and performing clinical validation by chart review are all potential compliance solutions to 10350," Dr. Shulman says.

"There is quite a nice list of transfusion service and donor laboratory analytes for which the CAP provides PT, and hopefully labs are participating with one or more of these," Dr. Shulman says. Those analytes are ABO, Rh, Ab screen, Ab ID, and crossmatch; direct antiglobulin testing; platelet serology; fetal RBC detection; viral markers; viral marker chemistry; and transfusion-related cell counts.

2. TRM.31150: Is there documentation of at least annual review of all policies and procedures by the current laboratory director or designee?

"What works well for me in my own transfusion medicine practice is to approve all new policies and technical protocols but to have them reviewed and signed off on an annual basis by a knowledgeable person whom I designate in writing," Dr. Shulman says. "If any policy or technical protocol requires revision, that would be approved by me."

The CAP recommends setting a schedule to review 1/12 of all standard operating procedures monthly, and it cautions that one signature on a title page or index of SOPs is not sufficient documentation that each SOP has been carefully reviewed.

3. TRM: 31220: Are reagents and solutions properly labeled, as applicable and appropriate, with the following elements: content and quantity, concentration or titer; storage requirements; date prepared or reconstituted by laboratory; expiration date?

Materials such as separate boxes or vials shipped in a single, primary container don’t have to be individually labeled with all elements listed in the checklist question if the original primary container is fully labeled and the vials are maintained in the primary container until they are removed.

"In addition, reagent or solution log files may be used to track materials put into use if it is not practical to fully label small containers, so long as unique identifiers are applied to the small containers," Dr. Shulman says.

There are no requirements to label with "date received" or to routinely label individual containers with "date opened." New expiration dates, however, should be recorded on the container "if opening the container does, in fact, change the expiration date or storage requirements of the open container," Dr. Shulman says.

4. TRM.30000 (previously 05.3000, 05.3010, 05.3020, 05.3030): Is there documentation of ongoing evaluation by the laboratory director or designee of all of the following: control results of routine procedures (05.3000); reactivity of reagents (05.3010); instrument function checks (05.3020); and temperature records (05.3030)?

"Quality control data should be judged acceptable by lab personnel doing the testing prior to reporting any patient results," Dr. Shulman says. However, a director or written designee must review these QC data periodically, perhaps monthly. "The lab may optionally perform more frequent reviews at intervals that it determines appropriate for its own setting and for the assays involved," he adds.

5. TRM.20000: Is there a document for the design and evaluation of the laboratory QC/QI programs?

"This issue gets at the heart of quality—it is an important issue," Dr. Shulman says. The labs cited for this deficiency have inadequate documentation or don’t have a document at all.

The quality control/quality improvement program must detail how the following will be designed and evaluated: specimen collection, identification, and transport; specimen processing, storing, and testing; results reporting; recipient identification at phlebotomy and at transfusion; blood product identification; blood product storage, preservation, and dispensing; and blood product transportation.

"The system design for the QC/QI program must ensure optimum patient specimen and result integrity throughout the preanalytical, analytical, and postanalytical processes," Dr. Shulman says. "The laboratory should evaluate each element of its QC/QI program systematically." Corrective plans must be developed and implemented as the need for improvements
is identified.

6. TRM.42170: Does the transfusion service have a detailed procedure consistent with HCFA and FDA regulations/guidelines for notification and counseling of recipients who have been transfused with a potentially infectious blood component?

"The FDA and CMS [formerly HCFA] require that recipients of units from donors subsequently confirmed positive for certain infectious disease with potential for transmission to the recipient are notified and counseled about their potential risk," Dr. Shulman says.

He cites the following references to help labs comply with 42170:

  • Food and Drug Administration. General Biological Products Standards. History of Hepatitis B Surface Antigen. Washington, DC: US Government Printing Office; April 1, 1999. 21CFR610.41.
  • Food and Drug Administration. General Biological Products Standards. Human Immunodeficiency Virus (HIV) Requirements. Washington, DC:US Government Printing Office; April 1, 1999. 21CFR610.45.
  • Food and Drug Administration. General Biological Products Standards. "Lookback" Requirements. Washington, DC: US Government Printing Office; April 1, 1999. 21CFR610.46.
  • Food and Drug Administration. Additional Standards for Human Blood and Blood Products. Platelets. Collection of Source Material. Washington, DC: US Government Printing Office; April 1, 1999. 21CFR640.22(c).

7. TRM: 41650: Are criteria for the recognition of transfusion reactions documented, and is there documentation of periodic in-service education on the recognition of such reactions?

In-service education is not provided in some labs, but the more common problem is that it’s simply not documented. Labs seeking ways to comply with this question should refer to the Practice Parameter for the Recognition, Management, and Prevention of Adverse Consequences of Blood Transfusion (Sazama K, DeChristopher PJ, Dodd R, et al. Arch Pathol Lab Med. 2000;124:61-70). View the parameter online.

Kathleen Furore is a writer in Oak Park, IL.