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CLIA Forum Help

Hosted by Sandra Fite, CT(ASCP)

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Question: If a hospital does not have a Cytyc 2000 and sends their vials to another hospital that does have the machine, and if the slides are stained and coverslipped and returned to the first hospital for screening, how can cytotechs be sure of the patient's identifiers (original vial, req form, computer generated history)? Does the final report need to indicate that the "processing" took place at another hospital but the "screening" of slides was done at the first hospital? What kind of Controls are needed. Thanks
Answer  A reply to your question has been posted in the CLIA Forum, which can be accessed at this link, http://cytopathnet.org/tiki-view_forum_thread.php?topics_offset=&topics_sort_mode=&topics_threshold=&topics_find=&forumId=2&comments_parentId=63(external link). Or, click on the Forums folder in the lefthand menu, choose list forums, and choose CLIA Forum.
Question: Our laboratory process gyn cytologies and they are screened on-site. However some of the abnormals are sent to pathologists at various hospital locations for final diagnosis. Each hospital has a CLIA certificate for pathology (tissue examination and frozen sections) but not for cytology. How can these labs be inspected and accredited for cytology when all they do is interpret abnormal paps at that site with no actual performance of primary screening or processing?
Answer 

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)

Question: Q - Our laboratory operates in the same manner as described in the two previous questions. Are we required to enroll each hospital laboratory where we sign out abnormal gyn cytologies in Proficiency Testing (PT) or can the pathologists go to the main laboratory on the PT day? Having PT enrollment for each site would be $1500 for each.
Answer 

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)

Question: If you miss a low grade in 6 months is it mandatory to get your slides rescreened up to 300.
Answer 

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

Jana Sullinger, MD


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