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  PAP/NGC Q and A

 

 

 

August 2008

Question Q. I am unable to take the gynecologic cytology profi­ciency test at my laboratory this year because I will be out of town on our scheduled testing date. What are my options for taking a makeup exam?

A. The ruling from the Centers for Medicare and Medicaid Services says that an individual may take the gynecological proficiency test only at a laboratory with which he or she has an employment affiliation. He or she may take the exam with a PT provider if designated as a locum tenens practitioner. The most common solution is for your laboratory to call the CAP and order an “extra test,” which can then be scheduled when you will be at the laboratory (an additional fee is required). If you are employed (or have sign-out privileges) at multiple institutions and those laboratories have not yet taken their PT, you may test with one of those laboratories provided you notify the laboratory director and an order is placed by the lab for an additional participant. There is no option to take the exam at a colleague’s lab where you are not employed.

Lisa Fatheree, SCT(ASCP)
CAP Cytology Technical Specialist Staff,
CAP Cytopathology Committee
Northfield, Ill.

Joel S. Bentz, MD
Professor and Head of Cytopathology
University of Utah
Salt Lake City
Member, Cytopathology Committee

Question Q. Can you clarify CLIA regulation 493.801(4)? Does this apply to referral of gynecologic cytology PT material? With our practice, pathologists outside of our regional lab sign out our atypical gyn slides. The slides are sent via courier (about 60 miles) from our main core lab. What are our options for taking PT this year?

A. This was addressed recently in a memorandum from the Centers for Medicare and Medicaid Services. The ruling is that cytotechnologists from an affiliated ­institution (with a separate CLIA number) cannot prescreen proficiency testing slides for pathologists located at another institution (with a separate CLIA number) and have them shipped to that location. Pathologists must either screen their own PT slides without prescreening from an “affiliated cytotechnologist” at their location or pathologists must choose to take the test at the main laboratory with the affiliated cytotechnologists. Failure to implement this policy will result in enforcement actions as specified at §493.801(4), which says: “...Any laboratory that CMS determines intentionally referred its proficiency testing samples to another laboratory for analysis will have its certi­fication revoked for at least one year.”

Lisa Fatheree, SCT(ASCP)
CAP Cytology
Technical Specialist
Staff,
CAP Cytopathology Committee
Northfield, Ill.

Joel S. Bentz, MD
Professor and Head of Cytopathology
University of Utah
Salt Lake City
Member, Cytopathology Committee

Question Q. Two of the checklist standards for cytopathology include references to a required time interval for reviewing information: 1) CYP.02500—“Is there documentation of at least annual review of all policies and procedures in the cytopathology la­boratory section by the current laboratory director or desig­nee?” and 2) CYP.08500—“Is there a documented workload policy with evidence of data re­cording?” The latter includes the note: “The laboratory director must establish the maximum workload (based on capability/documented performance evaluation) for each individual examining slides and the limit must be reassessed at least every six months.” We currently use an automated document-management system in our laboratory that begins sending reminders for procedure review three months before the last annual review date. These remind­ers serve to ensure that annual review takes place in a timely manner, but it also has the effect of constantly moving the calendar date back if that review occurs before the previously re­corded date. Is it acceptable to maintain a set review date even if review takes place significantly before that previously documented date? In other words, how inflexible are the review date requirements in these two standards?

A. Many people have misunderstood these two standards when considering the definition of “annual review” and “every six months.” These two time periods arise from CLIA ’88 standards, which are generally inflexible in their interpretation. “Annual review” and “every six months” mean these activities must occur within these time intervals. Thus, if a laboratory procedure has been reviewed a month before its previous review date, the new deadline for review of that procedure is now a month earlier in the next year. It is not acceptable to maintain a “fixed” annual review date if review actually takes place before that previously established review date. Review occurring after the 12-month interval is out of compliance. Similarly, the six-month review referenced in CYP .08500 must occur within six months of the previous review; thus, this review date may also constantly move backward in the annual calendar.

The review date of a procedure may also be reset as a result of any significant revision in that procedure. The laboratory director must define what constitutes a “significant” revision; however, any revision that alters the general way a specimen is processed would be considered significant. For example, changing from a cytospin meth­od of processing a fluid to a filtration method would be considered significant; minor alterations in staining times probably would not.

Ann T. Moriarity, MD
Department of Pathology
AmeriPath Indiana
Indianapolis
Vice Chair, Cytopathology Committee

Sue Zaleski, MA, HT(ASCP), SCT
Laboratory Manager
Department of Pathology
University of Iowa Health Care
Iowa City
Consultant,
Cytopathology Committee

Question Q. Should the pathologist order HPV DNA testing on a six-month followup cytology that is ASC-US if the initial Pap test (six months previous­­ly) was a low-grade squamous intraepithelial lesion and the ASC-US diagnosis now is the first ASC-US diagnosis of the patient?

A. The question is a complex one. The new guidelines of the American Society for Colposcopy and Cervical Pathology that involve HPV testing were recently updated and are age dependent. It is important to know whether the previous LSIL was confirmed at col­po­scopic examination and whether the patient had a prior HPV test or not. For a detailed review of the most recent ASCCP guidelines, go to the following Web site: www. ­asccp. org/ pdfs/ con sen sus/ algo rithms _ cyto _ 07 . pdf.

According to the algorithms, if the patient is an adolescent (age 20 or younger) and has ASC-US, she should have a repeat cytology in 12 months only (regardless of an ASC-US or LGSIL diagnosis). If the repeat cytologic examination is less than HSIL, she should have a repeat cytology in another 12 months. HPV DNA testing should not be performed in adolescents, and if inadvertently obtained, the results should be ignored in planning the patient’s management.

If the patient is older than 20 and underwent colposcopy (as recommended) and no CIN 2 or CIN 3 was detected, the clinical management is repeat cytology at six to 12 months or HPV testing at 12 months. If CIN 1 was detected at colposcopy, repeat cytology every six months or HPV DNA testing every 12 months is also the clinical management. If the clinician is following the patient with cytology, an HPV test should not be ordered. (In general, HPV tests should not be performed for followup of CIN before 12 months.) According to management guidelines, if the repeat cytology is ASC-US or greater, or oncogenic HPV is positive at 12 months, colposcopy should again be performed.

The short answer is that HPV testing should not be ordered too soon in the followup management of LSIL because the virus needs time to clear before future clinical interventions occur.

Ann T. Moriarity, MD
Department of Pathology
AmeriPath Indiana
Indianapolis
Vice Chair, Cytopathology Committee

Sue Zaleski, MA, HT(ASCP), SCT
Laboratory Manager
Department of Pathology
University of Iowa Health Care
Iowa City
Consultant,
Cytopathology Committee