The role of monitoring interpretive rates, concordance between cytotechnologist and pathologist interpretations before sign-out, and turnaround time in gynecologic cytology quality assurance: findings from the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference working group 1.

CONTEXT: The College of American Pathologists (CAP) conducted a national survey of gynecologic cytology quality assurance (QA) practices. Experts in gynecologic cytology were asked to join 5 working groups that studied the survey data on different aspects of QA. Evaluating the survey data and follow-up questions online, together with a review of pertinent literature, the working groups developed a series of preliminary statements on good laboratory practices in cytology QA. These were presented at a consensus conference and electronic voting occurred. OBJECTIVE: To evaluate a set of QA monitors in gynecologic cytology. Working group 1 evaluated (1) monitoring interpretive rate categories for Papanicolaou tests (Pap tests), (2) concordance of cytotechnologist and pathologist interpretations before sign-out, and (3) turnaround time for Pap tests. DATA SOURCES: The statements are based on a survey of gynecologic cytology QA practice patterns and of opinions from working group members and consensus conference attendees. CONCLUSIONS: The outcomes of this process demonstrate the current state of practice patterns in gynecologic cytology QA. Monitoring interpretive rates for all Bethesda System categories is potentially useful, and it is most useful to monitor interpretive rates for cytotechnologists individually and in comparison to the entire laboratory. Laboratories need to determine what level of discrepancy between cytotechnologist and pathologist interpretations of Pap tests is important to track. Laboratories should consider formalizing procedures and policies to adjudicate such discrepant interpretations. Turnaround time should be monitored in gynecologic cytology, but individual laboratories should determine how to measure and use turnaround time internally.

Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening.

OBJECTIVE: To increase awareness of the limitations of high-risk human papillomavirus (hrHPV) laboratory-developed testing (LDT) widely used in US cervical cancer screening. METHODS AND RESULTS: A young woman in her 30s was diagnosed and treated for stage 1B1 cervical squamous cell carcinoma in which HPV 16 DNA was detected using polymerase chain reaction testing. Both 1 month before and 42 months before cervical cancer diagnosis, the patient had highly abnormal cytology findings; however, residual SurePath™ (Becton, Dickson and Company, Franklin Lakes, NJ) vial fluid yielded negative Hybrid Capture 2 (HC2; Qiagen NV, Hilden, Germany) hrHPV LDT results from each of the two specimens. This prompted questions to be asked concerning the performance characteristics of hrHPV LDT. A review of the available data indicates that (1) purification of DNA from SurePath specimens requires complex sample preparation due to formaldehyde crosslinking of proteins and nucleic acids, (2) HC2-SurePath hrHPV testing had not been Food and Drug Administration-approved after multiple premarket approval submissions, (3) detectible hrHPV DNA in the SurePath vial decreases over time, and (4) US laboratories performing HC2-SurePath hrHPV LDT testing are not using a standardized manufacturer-endorsed procedure. CONCLUSION: Recently updated cervical screening guidelines in the US recommend against the use of hrHPV LDT in cervical screening, including widely used HC2 testing from the SurePath vial. The manufacturer recently issued a technical bulletin specifically warning that use of SurePath samples with the HC2 hrHPV test may provide false negative results and potentially compromise patient safety. Co-collection using a Food and Drug Administration-approved hrHPV test medium is recommended for HPV testing of patients undergoing cervical screening using SurePath samples.

Assessment of quality of data provided on Pap test requisitions: implications for quality of care and patient safety.

BACKGROUND: The reliability of patient history and clinical information on Pap test requisitions has been questioned but not previously objectively determined. The effect of incomplete/inaccurate information on quality of patient care has not been previously quantified. Our objectives were (1) to find out how clinicians and their assistants viewed the requisition slip, and whether they understood the reasons for supplying the information requested, (2) to measure the completeness and accuracy of information on the requisition slips, and (3) to determine whether the clinical information and patient history provided on Pap test requisitions could be relied upon to accurately assign a Pap test to the laboratory's "high-risk rescreen" pool. METHODS: Clinicians and their assistants were surveyed. A total of 899 consecutive Pap test requisition slips were reviewed. Patient history and clinical information from the slips were compared to data from our laboratory information system and/or electronic patient medical records. RESULTS: Most survey respondents felt that proper completion of requisitions was important, but only 17% of clinicians and less staff realized that negative high-risk Pap tests underwent a quality assurance rescreen. Clinicians and/or staff recorded the last menstrual period, specimen source, and clinical information on the requisition slips 96%, 97%, and 88% of the time, respectively. Of 695 Pap tests with applicable computerized records, 171 (25%) qualified for high-risk rescreen based upon information provided on the requisition slip alone. An additional 52 Pap tests (7%), or 23% of the total high-risk Pap tests were discovered to be of high risk only after review of the electronic records. CONCLUSIONS: Clinicians and staff were receptive to discussions concerning the completion of requisition slips, but laboratory expectations could be better communicated. Requisition slips were properly completed with a high frequency, but the check boxes did not elicit all the information expected, so revision was necessary. The high accuracy of the completion of requisition slips permitted 77% of high-risk Pap tests to be identified via the requisition slip alone. Our findings challenge the conventional anecdotal impressions of "notoriously unreliable" information on Pap test requisition slips, but our experience may not be applicable to other settings.

The dysfunctional federally mandated proficiency test in cytopathology: a statistical analysis.

Proficiency testing in cytopathology and in other disciplines should be based on firm statistical and scientific foundations, because test theory in general is a heavily statistical subject. Statistical considerations have demonstrated that the design of "short" proficiency tests in cytopathology, including the current federally mandated test, fundamentally is unsound because of the lack of sufficient validity and reliability. Examinees too frequently are misclassified by such short-format tests: Competent examinees fail the test in surprisingly high numbers, whereas most of the examinees who have insufficient cytologic skills eventually pass the test after the allowed retakes. Only dichotomous tests are suitable for accurate computation of the effects of test design on reliability, but the statistical conclusions also are generalizable to nondichotomous tests. In conclusion, the current federally mandated proficiency test cannot reliably measure the level of expertise of cytologists and, thus, cannot assure that only adequately skilled individuals evaluate Papanicolaou test samples. To render the test suitable for its intended purpose, the authors believe that complete redesign of the test, with the participation of experts in modern test theory, would be advisable.