Few but notable— new accreditation checklist changes

Valerie Neff Newitt

August 2023—Climate control, calculation verification, block retention, and histocompatibility section director (technical supervisor) qualifications are among the areas in which laboratories can expect to see revisions in the new edition of the CAP laboratory accreditation checklists, to be released this month.

But the number of revisions in the 2023 edition overall is relatively limited, and the decision to limit them to a handful of priorities was deliberate.

“We wanted to clarify language if there has been confusion, on the part of laboratories or inspectors, about how to interpret a checklist requirement. At the same time, we tried to keep changes to a minimum” because of the labor shortage and other stressors affecting all labs, says Stephen Sarewitz, MD, chair of the CAP Checklists Committee. The focus for the 2023 edition was therefore on what could help to address advancements in technology, ensure regulatory compliance, clarify requirements that are commonly cited as deficiencies, and improve patient care.

One such revision now includes biopsies of pediatric tumors in a requirement (ANP.12350) related to cancer protocols, says Jessica L. Davis, MD, a member of the CAP Cancer Committee. “Previously, pediatric pathology CAP cancer synoptics have not been required for biopsies or resections. They’ve been optional. So historically no cancer synoptic reporting was required in the pediatric pathology space. This requirement change moves them from optional synoptics or templates to required synoptics,” says Dr. Davis, Lawrence M. Roth professor of pathology and laboratory medicine and director of surgical pathology, Indiana University School of Medicine.

One major reason for the move to synoptic reporting for biopsies of pediatric tumors is because the large majority of pediatric neoplasia is treated neoadjuvantly, Dr. Davis explains. “The management and the key data elements are being obtained in that initial biopsy.” She cites neuroblastoma as an example. “The risk stratification of a patient is performed at the time of biopsy, which dictates patient management, and limited new data is gathered at the resection.”

In general, Dr. Davis notes, there is a shortage of pediatric cancer data. “There are large initiatives trying to collect that data, not just for research but for clinical care. There is good evidence showing that patients are better treated when synoptic reports are available.”

Many pathologists at children’s hospitals already use the available synoptic reports, she says, though some do not. “It will require some additional work, but I’ve heard from many pathologists that they’re excited about this [requirement] to help in standardization. And our clinical partners in the oncology space are looking forward to obtaining the data to better treat our patients.” Yes, it’s a change, she says, but a beneficial one. “I’m happy we’re able to do this and move this forward.”

In the laboratory general checklist, the climate control requirement that calls for the room temperature and humidity to be adequately controlled in all seasons (GEN.61300) now has a note that says laboratories must follow the manufacturer’s instructions for temperature and humidity for proper functioning of instruments, equipment, and test systems.

“This one looks like a humble checklist requirement,” Dr. Sarewitz says, “but there have been problems with that, particularly with humidity but also temperature, where they may be outside the range that’s specified in the manufacturer’s instructions for proper operation.” If humidity or temperature are not maintained within range due to extreme weather conditions, he says, a proper step would be for the laboratory to work with its facilities department to adjust environmental conditions or consider the use of portable equipment—a humidifier, for example—to adjust conditions near the instrument.

If the environment cannot be controlled such that variances in humidity or temperature outside the manufacturer’s range are a chronic problem, continued operation of the instrument would be considered a modification to the instrument requiring the laboratory to perform validation studies of analytical accuracy, precision, reportable range, sensitivity, and specificity to ensure proper operation of the instrument.

GEN.43450 Verification of Calculations Producing Patient Results was revised to clarify which computer-based functions are considered calculations that require the lab to verify them every two years or when a system change is made that may affect the calculations. The requirement applies to laboratory information systems, middleware, and analyzer calculations modifiable by the user. The checklist defines calculated test result as a reportable patient test result that is not directly measured but rather calculated from one or more directly measured results.

“If there’s a calculation that is hardwired into the instrument, that is not covered by this,” Dr. Sarewitz says. “But when there is something the laboratory can modify, errors can creep in, and those results should be reviewed. It doesn’t apply to calculations that do not produce patient results or to such things as reference ranges.”