Members of the CAP Cytopathology Committee reviewed and updated the cytopathology checklist requirements to clarify how they apply to digital cytology and to provide further guidance where needed.
“We are dedicated to maintaining patient safety and laboratory quality without creating a burden for laboratories that want to implement new systems,” says Christopher VandenBussche, MD, PhD, chair of the Cytopathology Committee and professor of pathology and oncology and associate director of cytopathology, Johns Hopkins Medicine.
As an aside, he notes the March 23 deadline this year on which the Centers for Medicare and Medicaid Services will no longer allow remote review of cytology digital slides at locations separate from the primary CLIA-certified cytology lab (QSO-23-15-CLIA Revised). Personnel who access and review cytology diagnostic images and data remotely will not be permitted to do so; alternatively, the lab can obtain a separate CLIA certificate for the location in which the digital cytology remote reviews continue to be performed.
Among the several updated cytopathology checklist requirements in the new edition is CYP.08550, which requires workload data to be recorded for the automated or digital screening of cytology slides, if applicable. The following information on calculating workload is included:
- All slides with full manual review count as one slide equivalent.
- All slides with field of view (FOV or AI-generated gallery of images) only review count as 0.5 or 1/2 slide equivalents.
- Slides with both FOV or AI-generated gallery of images and full manual review count as 1.5 or 1-1/2 slide equivalents.
“The checklist update is basically saying that a gallery of images is the equivalent of a field of view for how you would count a slide, which is one half slide equivalent,” Dr. VandenBussche explains. Hologic’s Genius Digital Diagnostics System provides a gallery of cells instead of a field of view, and Hologic said the gallery of images should count for one half slide equivalent. “The committee agrees that a gallery is somewhat equivalent to a field of view,” Dr. VandenBussche says.
Related to workload is CYP.08575, which requires individual maximum workloads to be established for cytology slide screening and/or digital review. But this revision is largely one of terminology. Prior to the revision, slide screening was the focus, “but a gallery of images is not technically a slide,” Dr. VandenBussche notes, “so to generalize the language, we added digital review to be inclusive of the gallery.”
CYP.07600 requires statistical records for gynecologic cytopathology cases to be maintained and evaluated at least annually. It says separate gynecological statistics should be maintained for each preparation method, including digital. The revision “stipulates that if a laboratory is using a digital method for some of its tests and using a different method for a different subset, it should maintain different statistics for the digital versus nondigital specimens,” Dr. VandenBussche says.
Most laboratories are likely to be using one type of system—digital or nondigital, he notes, and thus the revised requirement won’t necessitate their having “to break up their statistics.” It will be useful for the committee to determine at a later time “if laboratories that are using a particular digital method may become an outlier for some reason unknown,” he says.
Similarly, other requirements were revised to include, in addition to glass slides, the possible use of digital images, among them CYP.07200, which requires the circulation, referral, transfer, and receipt of original slides and now also whole slide/digital images used for diagnosis to follow a consistent process that includes records of the location of the slides to ensure availability for consultation and legal proceedings. “A laboratory must know where those images are and be able to produce them,” Dr. VandenBussche says. “If they are transferred, there must be a record of that transfer and return.”
CYP.05350 details the required elements of a cytopathology report, and one of those elements is a designation of an automated screening device, now also including digital platforms, when applicable.
The revisions to the cytopathology requirements, as with the laboratory general requirements, contemporized the checklist, Dr. VandenBussche says, and the work will be ongoing. “The CAP Cytopathology Committee will continue to review the requirements, as well as publications and studies about these technologies, to ensure the checklist is up to date to support these emerging technologies,” he says.
Valerie Neff Newitt is a writer in Audubon, Pa.