Reply to Dr. Cramer

✍ Scribed by Janet F. Stastny; Sherry Woodhouse; Michael Schulte

• Publisher: John Wiley and Sons
• Year: 2000
• Tongue: English
• Weight: 7 KB
• Volume: 22
• Category: Article
• ISSN: 8755-1039
• DOI: 10.1002/(sici)1097-0339(20000301)22:3<202::aid-dc16>3.0.co;2-r

✦ Synopsis

Our editorial was written to alert and remind the cytology community of the provisions of the Clinical Laboratory Improvement Act of 1988 (CLIA '88) as it pertains to proficiency testing in gynecologic cytology. Any proposed test that could impact a physician's or cytotechnologist's ability to practice must be based on valid data with consistently reproducible results. As Dr. Cramer states, an important pitfall may be flaws in test design and/or ambiguity of the classification system. For proficiency testing, the Health Care Finance Administration has proposed four diagnostic categories of unsatisfactory, normal/reactive, low grade squamous intraepithelial lesion (LSIL), and high grade squamous intraepithelial lesion (HSIL)/carcinoma, with point penalties for wrong classification of a slide. The College of American Pathologists' Pap program has repeatedly shown a discrepancy rate of from approximately 10-15% in distinguishing between LSIL and HSIL. This may be a best case scenario! Dr. Cramer is absolutely correct in stating that ''proficiency tests that do not meet these standards may unjustly impeach the credibility of competent pathologists.'' The stakes are high, and validity must be critically evaluated.