As more laboratories take on primary HPV screening, Dr. Booth says, new benchmarks and statistics will have to be offered. “We don’t have a large enough cohort reporting statistics on this yet.”
Adds Dr. Tabbara, “It’s going to have to wait until we have a statistically relevant number of tests being performed.” But it’s important to get that data, she says, “because it is going to allow us to create benchmarks and statistics for that high-risk population.”
How to get it? CYP.07620 Statistical Records—Reflexed Gynecological Cytopathology, a new requirement, should help. It says that for gynecologic cytopathology cases reflexed from primary HPV screening, statistical records must be maintained and evaluated at least annually and include the following: number of primary HPV screening tests performed, if available; number of Paps reflexed from primary HPV screening; number of reflexed Paps reported by diagnosis for each specimen type (including the number reported as unsatisfactory for diagnostic interpretation); number of cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; number of cases where cytology and histology are discrepant; number of cases where any rescreen of a normal or negative specimen results in reclassification as LSIL, HSIL, adenocarcinoma, or other malignant neoplasms; and number of positive and negative p16/Ki-67 dual stains performed.
The purpose of the new checklist requirement is a separate accounting of the cases reflexed from primary HPV screening, Dr. Sarewitz says. “The point is, these two sets of data need to be separate because the characteristics of the cytology that’s reflexed from primary HPV-positive tests is going to be very different from screening with cytology alone or cotesting.”
Complying with the new requirement may mean having to create new test codes or test names in the laboratory information system, Dr. Tabbara says. For the cytology lab, these would include reflex Pap, cotest Pap, reflex dual stain, and add-on dual stain. “That way, labs are eventually able to pull those statistics from the LIS,” she says, noting that it’s best to do this work before primary HPV screening goes live. Some of the laboratory information systems may already have or will be able to include these test codes as options as the screening becomes more common.
The existing CYP.07655 Screening Performance requirement now includes that the laboratory must evaluate and record the performance of individuals who screen dual stain gynecologic slides. “It takes a fair amount of cognitive work to determine that the stains worked well, how intense they are, and what the distribution is,” Dr. Rauch says. Tracking performance down to the level of the individual “immediately points to something you might want to take action on.”
Dr. Tabbara agrees. “The results are going to affect clinical management,” she says, “so we have to make sure the performance of individuals is appropriate and adequate.”
Finally, CYP. 08500, the CLIA requirement that limits the number of previously unscreened gynecologic and nongynecologic slides that can be evaluated over a 24-hour period, has undergone a minor change: It now also applies to p16/Ki-67 dual stain gynecologic cytology. Previously screened p16/Ki-67 slides are not subject to the workload limit for pathologists.
“It’s a ThinPrep slide similar to the thin-layer prep we currently use for Pap and other tests in the lab,” Dr. Tabbara says. “Therefore, it needs to be included in the workload.”
Dr. Rauch describes cervical cancer screening as a dynamic area, with evolving best practices.
“There’s new data in the literature, new tests coming to market, there’s evaluation of test performance individually and also how it fits into multistep” algorithms. What works best to sensitively detect cervical cancer as early as possible, for better intervention, undergoes constant critical evaluation, she says. “It’s always a balancing act.”
Case in point: Self-collection for HPV testing, which was approved in 2024, is the next area of focus, Dr. Booth says. Digital review of cytology cases, too, was approved last year. “Our work is not done,” Dr. Booth says. “This is just the beginning.”
Charna Albert is CAP TODAY associate contributing editor.