Those are concerns that she and her subgroup colleagues felt could be addressed by revising the accreditation checklists. “Once we started digging in, we knew we were going to need additional expertise from across laboratory subspecialties, and we felt that the CAP, as a leader in proficiency testing and laboratory accreditation, had the experience to help us look at the total testing process and how the quality would need to be addressed in the preanalytic, analytic, and postanalytic phases of testing.” There was another reason to revisit the checklists: the FDA’s approval of the p16/Ki-67 dual stain. “We also wanted to look at the dual stain and what implications that would have, both on CLIA requirements and accreditation standards,” Dr. Booth says.
Dr. Booth’s subgroup approached the CAP Council on Scientific Affairs in May 2022. Shortly after, reviewing the CAP accreditation requirements and CLIA regulations became a joint effort of various CAP groups in addition to the Council on Scientific Affairs: the Microbiology, Molecular Oncology, Quality Practices, and Cytopathology committees and the Council on Accreditation. There were 12 representatives in all, known as the CAP cross-council quality measures workgroup. They wrapped up their process in 2024, with the changes for the most part limited to new notes or line items added to existing requirements. Only two requirements are entirely new.
Stephen Sarewitz, MD, advisor to and immediate past chair of the CAP Checklists Committee and member of the cross-council workgroup, calls the changes straightforward. “But all the T’s have to be crossed and the I’s dotted.”
Cross-contamination is the subject of the revised COM.06250, now titled “Specimen Aliquoting and Shared/Residual Samples.” The prior version applied to the process used for aliquoting specimens to prevent cross-contamination and mixup of specimens and aliquots; now it also calls out the use of shared or residual specimen for additional or reflex testing. A note says the requirement applies to both in-house shared specimens and specimens referred to another laboratory.
The requirement is being “beefed up,” as Dr. Sarewitz puts it. “It was revised because in the past, specimen aliquoting was more within the lab. Now there are a lot of tests that may be sent to another lab, and this is an example, where you may do the HPV testing and then send out an aliquot for dual stain or cytology testing.” It also specifies that aliquots must not be returned to the original specimen container. “That used to not be a requirement for all types of testing; it was just for certain types,” he says. “Now it’s for everything because that’s better practice.”
Says Dr. Rauch: “Molecular testing raises the risks of contamination. And the more steps you have,” the greater the “chance for missteps or mishandling. I’m happy that attention to preanalytical process is being beefed up, and it’s never enough in my opinion. That goes for lab tests of every kind, but especially molecular.” (Dr. Rauch also is a member of the cross-council workgroup.)