CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Dr. Downes
Informed consent for donation is the subject of TRM.45263, which now contains a bulleted list of exactly what is expected, per FDA guidelines. Namely, the donor must: review the required educational material about relevant transfusion-transmitted diseases; agree not to donate if the donation could result in a potential risk to recipients as defined in the educational material; be informed that a sample of their blood will be tested for relevant transfusion-transmitted diseases; be informed that if the donation is determined to be unsuitable or if the donor is deferred, the record will identify the donor as ineligible and the donor will be notified of the basis for and period of deferral; be provided with information about the risks and hazards of the specific donation procedure; and be given the opportunity to ask questions and withdraw from the donation procedure. Nothing too surprising, but, says Dr. Downes, “This is a concise summary for laboratories, and it’s useful to put it in here as part of the checklist.”
Regarding directed donors, the checklist has become more specific about how often units must be collected from them. This pertains to TRM.47100, “Infectious Disease Testing,” which now says: “For laboratories subject to U.S. regulations, all FDA-required or recommended infectious disease tests are performed on blood samples collected at the time of donation, or collected at least once in the prior 30 days for a directed donor for a single intended recipient. Reagents used are licensed or registered by the FDA and procedures are approved by the FDA.”
The checklist item also now spells out the tests currently required by the FDA, such as for HIV-1, HCV, and the West Nile and Zika viruses. It also now contains an additional note stipulating that autologous donations for the patient-donor’s own use are not required to be tested for infectious disease markers unless the units could be used for allogeneic transfusion or will be transferred to another establishment.
Checklist requirement TRM.42460, “Blood and Blood Component Shipping,” now includes a note to reiterate what was added in 2016: Laboratories must validate containers—portable coolers, for example—to ensure they maintain the appropriate shipping temperature. “Some labs may not have thought of portable coolers as needing to be validated,” Dr. Downes says, “and we want to make sure they understand the importance of validating such items.”
Laboratories that use microwave ovens to quickly thaw plasma or cryoprecipitate are likely to be relieved by a change to TRM.44450, “Plasma and Cryoprecipitate Thawing.” The requirement no longer contains the directive that such ovens be FDA cleared/approved as class III medical devices. That’s because the FDA never provided an effective date for that requirement. The microwave ovens these laboratories use are generally class II devices, and class III microwaves seem to be difficult to locate. The checklist requirement now contains a note saying that if a microwave oven is used, any manufacturer’s claim that the temperature of the contents does not exceed 37°C must be verified by the laboratory. In the absence of such claim, the laboratory must validate the device’s preservation of labile coagulation factors.
Finally, non-U.S. laboratories may be interested in a new clarification that appears in TRM.43950, which pertains to red blood cell freezing method. “There’s been a clarifier placed there for labs outside the United States, letting them know to refer to the applicable accreditation requirements or national or local laws and regulations,” says Dr. Downes. The same stipulation has been added to TRM.45251, which addresses the subject of regulatory documents.
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Anne Ford is a writer in Evanston, Ill. The work to reexamine and revise Laboratory Accreditation Program checklists is led by the CAP Council on Accreditation.