Unsatisfactory specimens in gynecologic cytopathology are the subject of CYP.07452, which requires the laboratory to have written criteria for identifying and reporting unsatisfactory specimens and slide preparations, now including p16/Ki-67. As before, the criteria for categorizing a specimen and/or slide preparation as unsatisfactory are left to the laboratory. To a list of examples of possible criteria, however, such as scant cellularity, has been added a new example: quantity insufficient for reflex testing from primary HPV screening. How exactly to ensure a sufficient HPV specimen is another story, Dr. Tabbara says. Volume isn’t the issue. “It has to do with cellularity,” she says. “This is a question for us to keep an eye on and attempt to establish objective criteria for in the future.”
As always, gynecologic specimens with atypical cells should be considered satisfactory, and a note says any p16/Ki-67 dual stain with positive cells, too, should be reported as adequate.
Interpreting the p16/Ki-67 dual stain can be tricky, Dr. Rauch says, which is why gynecologic slides with dual stain are now one of the categories requiring a pathologist’s interpretation listed in CYP.07465 Pathologist Interpretation. Reporting a positive dual stain is much like reporting malignancy, Dr. Rauch says. “You’re saying we recognized something that indicates features of cell dysregulation and transformation, which is what cervical cancer and precancer is about. To sign something out as a final interpretation of this test should require a pathologist.”
Checklist requirement CYP.07478 10% Rescreen now says that the 10 percent of each cytotechnologist’s gynecologic cases that are rescreened after having been interpreted as negative should include cases reflexed from primary HPV cases. “A Pap that has a high-risk HPV-positive cotest is a case usually included in that population designated for rescreening,” Dr. Tabbara says. “Similarly, Pap tests reflexed from HPV-positive screening tests should be included for rescreening” when the reflex cytology testing is negative. “Another thing to consider is best practices have some laboratories rescreening all negative Paps that have a positive HPV cotest. This follows the same rules and criteria,” she says.
Previously titled “Pap Test—False-Negative Notification,” CYP.07582 is now “Cervical Cancer Screening Test—False-Negative Notification,” a broader name that encompasses primary HPV screening in the requirement for a mechanism to educate providers that cervical cancer screening tests are screening tests with inherent false-negative results. The preferred mechanism, the requirement says, is an educational note on all negative Pap test reports and all primary HPV screening tests. Not everyone will buy into the comment, Dr. Rauch says. “They might think it’s cluttering their report, but a well-worded brief statement, which could even be ‘Refer to our test menu,’ would be fine too,” she says. “You have to consider that the audience of those receiving this test result can include primary care clinicians and patients reading their own results.”
CYP.07600 Statistical Records—Gynecologic Cytopathology is a requirement about maintaining and evaluating records at least annually. “That’s been around for years,” Dr. Sarewitz says. “It’s partly CLIA required, so it’s not anything exotic. But what’s been added to the stem of the requirement is that it’s for screening gynecologic cytopathology cases, but not for those reflexed from primary HPV screening.”
Also added to this requirement is that the laboratory must include in its records the number of positive and negative p16/Ki-67 dual stains performed. If a p16/Ki-67 dual stain is used as a follow-up to an HPV-positive cotest with a negative Pap test, it says, statistics should be maintained separate from p16/Ki-67 dual stain results derived from a positive primary HPV screening test. A dual stain following a primary screening test is different from a dual stain that follows a cotest, where a Pap slide has been prepared and an HPV test has been performed, Dr. Tabbara explains. The steps and procedures differ, as do the populations, she says, with one high risk and the other screening. “Therefore, the results should be kept separately.”
A note that accompanies the benchmarking data (based on 2021 case volumes) provided with this requirement warns that the data may not be applicable for laboratories that use primary HPV screening for a significant portion of cervical cancer screening. A survey the CAP Cytopathology Committee conducted in 2021 found that only 9.6 percent of laboratories reported screening Pap test slides reflexed from primary HPV screening, and of those, only two laboratories reported that more than 25 percent of their slides were derived from positive primary HPV screening. Those two laboratories were not included in the data, Dr. Tabbara says, because the current benchmarking data is based on a screening population, whereas the cytology data derived from positive primary HPV screening tests would belong to a diagnostic population. “There may be a higher percentage of lesions, SIL or others, in the reflexed Pap tests and that will skew the lab’s statistics. It will not be equivalent to the statistics that have been published by the CAP in the checklist, and it will skew the ASC/SIL ratio,” she says. “That’s the reason to separate them.”