Checklists now made to fit for next-gen sequencing labs

Some requirements are common to all areas of NGS testing, and it was the committee members, working in subgroups, who scrutinized the checklist notes to determine what was common and what wasn’t, says Manish Gandhi, MD, Checklists Committee member and vice chair of the Histocompatibility and Identity Testing Committee and professor of laboratory medicine and pathology, Mayo Clinic. “When content is not relevant, an inspector might incorrectly interpret a requirement and tell a lab it should be doing something it’s not doing, which puts the lab in jeopardy of noncompliance. The new customization gives much more clarity,” Dr. Gandhi says. The subgroups also drafted new application-specific requirements and notes to ensure each NGS application was addressed appropriately. For HLA testing, MOL.35855 Discrepancy Resolution—NGS HLA Typing is a new requirement that calls for the lab to follow a written procedure to resolve typing discrepancies within and between labs.

Customization also means shorter notes. “We received feedback about the checklist notes being long, and it was because of the generic nature of these requirements that tackled everything within the notes. We knew something had to be done,” Dr. Gandhi says.

Now that it has, Dr. Voelkerding stresses the importance of the link with the activity menu. “I can imagine undergoing a year or two of transition to fine-tune this,” he says.

“If now a lab receives just that which is pertinent to inherited diseases, if that is what it’s doing, and then it takes on molecular oncology, it is critical, prudent, for the lab to immediately reach out to the CAP and say, ‘We’re adding this new area and the checklist requirements you sent to us for our last inspection don’t cover this area.’” Laboratories need to be aware of that, he says, so they receive the most current set of checklist requirements relevant to their testing. “Even as they’re onboarding and developing a new area, they would be well served to have the pertinent checklist notes section.”

Dr. Mahmoud, too, emphasizes the importance of the activity menu being correct and up to date. “When everything was lumped together in one big, redundant, less efficient set of requirements, there was more tolerance, if you will, to mistakes made by a lab when it picked its activity menu. Regardless of the tests you picked, you probably would have ended up with the same requirements because it was so big and overreaching.

“However, the new checklist is going to be less tolerant when you make errors defining your activity menu because of the customization,” he continues. “So if you have questions and are not sure what test you need to pick, call the CAP for clarification.”

The customization of the checklists will not end with the 2022 checklist edition. The plan is to produce a standalone NGS checklist consisting of generic requirements that apply to all NGS and sections tailored to each type, possibly for 2023.

Despite the multiple layers of review and feedback provided before the 2022 edition was released, Dr. Mahmoud says it’s possible that further tweaking will be needed and that the checklist remains an evolving document. “So feedback is always welcome.” The CAP doesn’t release a checklist until it’s fully vetted and user-friendly, he notes, but “if you point out something that doesn’t make sense or to which you object, the CAP is responsive, and at an impressive speed.”

Dr. Voelkerding says this of the customization in the 2022 edition: “For a decade we worked with generation one and continued to refine it. Now, this is second generation, first version.”

Valerie Neff Newitt is a writer in Audubon, Pa.