August 2010

Michael R. Henry, MD
Lydia P. Howell, MD

The new checklists for the CAP Laboratory Accreditation Program were released on June 17 and include updates to the cytopathology checklist. All of the checklists have been reformatted with enhancements that are meant to provide laboratories a better means to engage in and meet their accreditation requirements. New to the checklists is the addition of an �Evidence of Compliance� section in some of the questions. In this section are specific examples of acceptable documentation for the question that will assist the laboratory in preparing for an inspection and help the laboratory and the inspector have a consistent understanding of the requirements. In addition, some of the checklist questions themselves have been reformatted as declarative statements to better convey the requirements.

Changes to the cytopathology checklist include the following:

New questions
CYP.00115
Activity Menu Phase 1

The laboratory�s current CAP Activity Menu accurately reflects the testing performed.

This new question instructs the laboratory on the requirements for the activity menu, which is needed to determine which checklist or additional checklist questions to use during the inspection. The laboratory is reminded that the activity menu should at all times reflect the laboratory�s current testing and that all tests the laboratory performs should be listed on the activity menu. Specifically, cytology laboratories that have pathologists examining gynecologic specimens must use one of the following activity codes: (1) Cytology menu activity 2053: Screening by pathologist, gynecologic cytology (this applies to laboratories where pathologists screen any gynecologic specimens without assistance of a cytotechnologist) or (2) Cytology menu activity 2060: Pathologist interpretation, gynecologic cytology (this applies to laboratories where a cytotechnologist initially reviews all of the gynecologic specimens before referring them to a pathologist).

CYP.07653
HR-HPV Records Phase 1

If available, records are maintained for high-risk human papillomavirus (HR-HPV) tests performed on ASC-US including:
1. Total number of HR-HPV tests performed on ASC-US cases.
2. Total number of POSITIVE HR-HPV ASC-US cases.

The note to this question explains that the percentage of ASC-US cases with a positive HR-HPV result may be a helpful quality metric for overall laboratory performance and individual performance of pathologists, especially when combined with an individual�s ASC-SIL ratio. HR-HPV rates closely recapitulate and can complement ASCUS-SIL rate.¹ Though a 2007 CAP Q-Probes study found significant interinstitutional variability in HPV-positive rates, individual performance beyond two standard deviations of the mean should prompt a reassessment of the diagnostic criteria to ensure optimal performance.² While data for other HR-HPV testing results (for example, co-testing with a Pap test in women older than 30 years) do not have to be maintained, it is noted that this information, too, may provide helpful quality metrics, and if records are maintained, they should be kept separately.

Changes to existing questions (changes are bold type; deletions are marked with strikethrough)

CYP.02800
Knowledge of Procedures Phase 2

The laboratory has a system documenting that all personnel are knowledgeable about the contents (including changes) of procedure manuals rele-vant to the scope of their testing activities.

This question was changed to add the requirement that personnel must be knowledgeable about changes to procedure manuals. As the checklist note explains, this does not require annual procedure sign-off by testing personnel, which can become onerous, particularly in large laboratories. The method used to ensure that personnel are knowledgeable is at the discretion of the laboratory director and this allows the laboratory to meet the requirement in a way that best fits its own environment and culture.

CYP.05260
Instrument Maintenance
Evaluation Phase 2

There is documentation of monthly evaluation ongoing monitoring of instrument maintenance and function, including temperatures of refrigerators/freezers in which re-agents or patient specimens are kept for all devices.

This question was changed to be more specific about what is needed in instrument maintenance.

CYP.07400
Statistical Records Phase 2

Statistical records are maintained, and evaluated at least summarized annually, that include the number of cytopathologic specimens and type/sources of specimens.

This question was changed slightly to remind laboratories that it is important to evaluate the statistical data collected as part of the overall QA program rather than just collect and summarize the data.

CYP.07600
Statistical Records Phase 2
For gynecologic cytopathology cases, statistical records are maintained of the number of cases of the following cytopathology results:

1. Diagnostic category (including unsatisfactory cases), by preparation type.
2. Significant cytologic/histologic discrepancies (as defined by laboratory policy).
3. Total number of negative cases rescreened before sign-out (to include but not limited to the 10% rescreen).
4. Cases for which the rescreen resulted in reclassification as premalignant or malignant.
5. Cases for which histopathology results are available to compare with malignant or high-grade squamous intraepithelial lesion (HSIL) cytopathology results.

This question includes benchmark data for cervical cytology for the three types of Pap tests currently performed. The data include laboratory percentile reporting rates for all of the major diagnostic categories with recommendations for comparing a laboratory�s result with the benchmark data. These data have been updated and replaced with more comprehensive numbers obtained by the Laboratory Accreditation Program as part of the accreditation process.

CYP.07655
Screening Performance Phase 2

The laboratory has a documented system to evaluate and document the ongoing performance of individuals who do cervicovaginal cytology screening against the overall annual statistics for the laboratory as a whole.

This question was changed to reflect variability in volume of cases which may make annual evaluation of performance inappropriate. Laboratories with high volumes may want to use a shorter time frame, and laboratories with small volumes may need to collect data over a longer period for accurate evaluation.

CYP.08575
Individual Maximum Workload Phase 2

There is a policy for the establishment of an individual maximum workload for the screening of cytology slides. Note: This checklist requirement applies only to laboratories subject to US regulations. The laboratory director must establish the maximum work-load limit (based on capability/documented performance evaluation) for each individual who screens slides. The workload limit must be reassessed at least every 6 months. Performance must be evaluated using the following: (1) re-evaluation of 10 percent of the cases interpreted to be negative by cyto-technologists; and (2) comparing the cytotechnologist's interpretation in gynecologic specimens with the final cytologic diagnosis on cases of ASC-US, LSIL, HSIL, glandular epithelial cell abnormalities, or other malignant neoplasms; and (3) comparing, in a manner determined by the laboratory, the cytotechnologist�s interpretation in non-gynecologic specimens with the final cytologic diagnosis. These are minimal requirements and the laboratory may use additional methods of evaluating performance such as retrospective reviews, comparison of individual statistics with overall lab statistics, and competency assessment.

The note to this question was updated to more accurately reflect the requirements for establishing maximum individual workload for screening as reflected in CLIA �88. In the CLIA regulations there is a specific requirement to include nongynecologic specimens for those cytotechnologists who screen them as part of their overall evaluation.

References

1. Ko V, Nanji S, Tambouret RH, et al. Testing for HPV as an objective measure for quality assurance in gynecologic cytology: positive rates in equivocal and abnormal specimens and comparison with the ASCUS to SIL ratio. Cancer. 2007;111:67�73.
2. Tworek JA, Jones BA, Raab S, et al. The value of monitoring human papillomavirus DNA results for Papanicolaou tests diagnosed as atypical squamous cells of undeter-mined significance: a College of American Pathologists Q-Probes study of 68 institutions. Arch Pathol Lab Med. 2007;131:1525�1531.