New requirement MIC.65610 Primary HPV Screening/Reflex Testing says that for laboratories performing primary HPV screening, the laboratory must follow established professional recommendations or guidelines and have a defined process for notifying providers when appropriate reflex testing or clinical follow-up is advised. If additional testing after a primary screening test is needed, the laboratory must provide guidance to providers on submission of additional specimens.
It’s up to the laboratory to decide how to notify the provider, Dr. Sarewitz says. “The obvious thing is to have a statement in the report saying that follow-up is appropriate in this case because of a positive HPV test. Some labs may want to contact the clinician directly, but I would imagine in many cases the volume of tests would be too great to allow that to occur on a routine basis.”
Primary HPV screening is an unusual scenario for the microbiology laboratory, he says, where follow-up is typically more straightforward. “Typically it’s a question of the diagnosis and treatment of infection, which the clinician is looking for. But in this case, it’s a screening test for cancer or precancer, and that’s not the usual kind of test performed in the micro laboratory.” A standalone microbiology laboratory is vulnerable, he says. “Clearly, it would be a bad thing if a patient were HPV positive and got lost to follow-up at that point.”
In the cytopathology checklist, 10 requirements have been revised and one is entirely new.
The existing requirement CYP.05000 On-Site Slide Review has a new note, which says that if p16/Ki-67 dual stain is performed, slides should be included in the on-site slide review. CYP.05300 Cytopathology Report Elements also has a new note. It says that for institutions using integrated cytology reports (including primary HPV screening, reflex HPV, cotesting, and p16/Ki-67 dual stain), the names and addresses of each performing laboratory with a different CLIA number must be on the report.
This was added to aid the investigation of an individual specimen or systemic issue, Dr. Rauch says. “It’s always important to be able to attribute testing to a specific laboratory, especially when you’re troubleshooting a problem,” she says. “The results themselves are the tip of the iceberg and the visible part of something much larger. They sit above a lot of things that occur behind the scenes—knowing which lot of reagents, who performed the test, what day, and other variables useful for investigating a problem.”
CYP.06900 Slide Retention—Cytopathology, an existing requirement, says laboratories must retain all glass slides for an appropriate period. The sole change is to a note that specifies that p16/Ki-67 slides, like other gynecologic glass slides, must be retained for five years—the standard CLIA requirement for any gynecologic preparation, says Sana O. Tabbara, MD, advisor to and immediate past chair of the CAP Cytopathology Committee and co-leader with Dr. Nayar of the cross-council workgroup. She is director of cytopathology at Moffitt Cancer Center and professor of oncologic sciences at USF Health Morsani College of Medicine in Tampa.