CLIA Forum

A - Refer to Subpart A - General Provisions, 493.2 Definitions. "Facilities only collecting or preparing specimens (or both) and not performing testing are not considered laboratories."

The diagnosis is the test not the preparation. To have a CLIA certificate in cytology it is not necessary for the processing or screening to be performed at that site.

Contact CMS and request that the specialty of cytology be added to your certificate. I have worked in laboratories with the identical situation. A duplicate of the QC/QA manual was prepared for each hospital for the laboratory director to review and sign. All records from the processing and screening lab were available during the inspection. CAP sent a large team for the inspection and surveyed the main lab and all the pathology/cytology labs at each hospital.

Sandra K. Fite, CT(ASCP)

A - According to regulation you must enroll each laboratory for PT and the laboratory must ensure that each individual is enrolled in cytology PT. Yes, that's $1500 each. This regulation does need to be changed as it is greatly increase a laboratory's operating expense. Even small laboratories have pathologists at one or two hospitals that evaluate paps.

CLIA '88 was enacted primarily due to the exposure of Pap mills. This regulation makes it even more difficult for local laboratories to practice cytology. More closures will lead us back to the Pap mills.

Refer to 493.801 that requires that each laboratory to enroll in a PT program for each of the specialties or subspecialties for which it seeks certification. Refer to 493.855 that requires that the laboratory must ensure that each individual engaged in the examination of gynecologic preparations is enrolled in a PT program.

Sandra K. Fite, CT(ASCP)

The corrective action taken would depend on the SOPs utilized within your laboratory and as determined by the Technical Director.

Jana Sullinger, MD