CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Valerie Neff Newitt
August 2018—The CAP and the Centers for Medicare and Medicaid Services reached an understanding earlier this year on how adequacy assessments and rapid on-site evaluations in cytology can be accounted for without causing undue impact on workload limits. The agreement, communicated to state survey agency directors in a March 16 CMS memorandum, is reflected in the updated CAP accreditation program cytopathology checklist released this month.
“I would not even call it a compromise, but rather an excellent conclusion to a situation that had become problematic,” Diane Davis Davey, MD, a member of the CAP Cytopathology Committee and a professor of pathology at the University of Central Florida, Orlando, says of the agreement.
Dr. Davey
The problem arose in 2017 when the CMS, in its concern about manageable workloads for pathologists, said adequacy assessments and rapid on-site evaluations, or ROSE, must be counted toward the primary screening workload limit for each individual of 100 slides per 24 hours. (That limit is capped at 80 in California.)
“The stress associated with finding a few abnormal cells buried in a sea of normal cells on a Pap smear—the reason workloads were established in the first place—is quite different from assessing if there are adequate cells [for diagnosis] on a slide resulting from a fine needle aspiration. It is like comparing apples and oranges,” Dr. Davey says.
Bharati Jhaveri, MD, chair of the CAP Council on Accreditation and past medical director of laboratory and staff pathologist at St. John’s Hospital, Springfield, Ill., agrees the two procedures are entirely different. “Adequacy assessment has no diagnostic purpose. It is simply a way of telling whoever is doing the biopsy—pathologist, radiologist, ENT surgeon, interventional gastroenterologist, etc.—that, ‘Yes, you have enough material,’ or ‘No, you need more.’ It is a very rapid check to make sure material is retrieved from the correct area or lesion.”
Dr. Jhaveri
The CAP’s cytopathology checklist, prior to 2017, permitted adequacy assessments and ROSEs to be excluded from the total number of slides counted toward an individual’s primary screening workload. But when the CMS insisted during its review of, and just before the release of, the CAP’s 2017 accreditation program checklists that they must be counted, the language that excluded rapid assessments from the workload count had to be removed.
“Just imagine if all those slides had to be counted,” Dr. Jhaveri says, adding that counting the quick checks toward a total count would leave individuals without enough workload balance to do primary screening. “We would not be able to do the rest of our work. After all, we do need time to screen Pap smears and all the rest,” she says. “We could have faced a situation where we simply would have to stop doing the adequacy assessments. That would send health care backward to a time when patients faced multiple operations, multiple rounds of anesthesia, etc., just to get adequate biopsy tissue for a diagnosis. That is not an acceptable option.” But there was insufficient time before the 2017 checklists were released, she says, to iron out the differences between the CAP and the CMS interpretations and opinions.
The result was “concern and confusion,” says Harris S. Goodman, MD, vice chair of the CAP Checklists Committee and medical director of the clinical laboratory at Saint Francis Memorial Hospital, San Francisco. “CMS threw a monkey wrench into the works at the last minute. Some of our lab professionals were angry, thinking the CAP had not stood up for them. But that wasn’t the case. Lack of time was the immediate problem.”
The CMS originally missed the point that rapid assessments are exactly that, Dr. Goodman says. “We don’t have the luxury of time when doing these evaluations. A patient may be under anesthesia while the operator is waiting to find out if more specimen is required. Furthermore, some tumors are very bloody and can generate a lot of slides—10, 20, or more. You may see blood, normal cells, or abnormal cells, but you don’t take the time to characterize them.”