title: The potential for failure in gynecologic regulatory proficiency testing with current slide validation criteria: results from the College of American Pathologists Interlaboratory Comparison in Gynecologic Cytology Program.
abstract: BACKGROUND
  Current regulatory proficiency testing scoring results in an automatic failure for identifying high-grade squamous intraepithelial lesion (HSIL) as negative.
  
  
  OBJECTIVE
  The College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology data from January 2004 to April 2005 were analyzed to estimate the percentage of failure based on negative responses for HSIL and validation criteria.
  
  
  METHODS
  More than 15,000 participants received field-validated and educational slide sets for conventional, ThinPrep, and SurePath modules. Educational sets fulfilled the validation criteria of the Center for Medicare and Medicaid Services, which required the consensus diagnosis of biopsy-proven HSIL (not field-validated) after review by 3 pathologists. The College of American Pathologists field validation required at least 20 responses to the HSIL+ series, with 70% matched to HSIL+ (standard error < or = 0.05). Minimum regulatory proficiency testing failure estimates were based on incorrect negative responses for the reference category of HSIL.
  
  
  RESULTS
  For both cytotechnologists and pathologists, there was a statistically significant higher failure rate for slides that were not field-validated versus those that were field-validated. In conventional modules, 5.3% of the slides that were not field-validated were called negative, versus 1.2% of the field-validated slides. In all liquid-based preparations, 4.0% of the non-field-validated versus 2.2% field-validated slides were called negative. Pathologists would have failed more often than cytotechnologists for the slides that were not field-validated, whereas there was no statistical difference in failure performance with field-validated slides.
  
  
  CONCLUSIONS
  Failures were significantly greater with the slides that were not field-validated for both conventional and liquid-based preparations (ThinPrep only) and have implications for both regulatory proficiency testing and expert legal review. Poor performance of pathologists relative to that of cytotechnologists may reflect a lack of prescreening of slides or scope of practice issues.
authors.affiliation: Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pa 19111, USA. na_young@fccc.edu
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Young
authors.forename: Ann T
authors.initials: AT
authors.lastname: Moriarty
authors.forename: Molly K
authors.initials: MK
authors.lastname: Walsh
authors.forename: Edward
authors.initials: E
authors.lastname: Wang
authors.forename: David C
authors.initials: DC
authors.lastname: Wilbur
mesh_terms: D002983:Clinical Competence / Q000706:statistics & numerical data*; D003951:Diagnostic Errors / Q000706:statistics & numerical data*; D005104:Expert Testimony; D005260:Female; D006801:Humans; D009656:North America; D010338:Pathology, Clinical / Q000379:methods / Q000592:standards*; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D012955:Societies, Medical; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis; D014626:Vaginal Smears / Q000145:classification / Q000379:methods / Q000592:standards*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis