Cytopathology in focus: Inspection pitfalls: Common cytology lab-related deficiencies

Create PDF

Another inspection “flag” that consistently rises to the top is competency assessment. Competency assessment (GEN.55500), a phase two deficiency, is one of the top three commonly cited deficiencies laboratorywide, based on the inspection data in years 2018–2020. More than 20 percent of laboratories are cited annually for deficiencies in this area. Its relevance to the cytopathology laboratory cannot be overemphasized, given that it is one of the most regulated areas in the laboratory overall. Competency assessments confirm that laboratory personnel are performing their routine laboratory duties adequately. While proficiency testing can be used as one of the assessment methods, PT performance alone is not sufficient to meet all competency assessment criteria. In the cytology laboratory, the technical supervisor is responsible for performing and documenting competency assessments; however, the laboratory director is held ultimately responsible for ensuring the implementation and supervision of laboratory staff competency assessments. Personnel competency assessment is required at least semiannually during the first year a new employee tests patient specimens and must be performed at least annually thereafter.

Although each laboratory can establish its own competency checklist, assessments need to reflect all areas of routine duties—for example, routine patient test performance; specimen handling, processing, and testing; instrument maintenance; and test reporting. Another criterion for competence is communication and problem-solving, an area of particular importance owing to cytology’s unique role in clinical encounters including ROSE.^4,5

Another phase two deficiency that finds its place in the top 10 of laboratorywide citations addresses the disparity between the performance of daily duties and the procedures laid out in the procedure manual in cytology (COM.10000 and COM.10100). Although listed under the all common checklist, it applies equally to all laboratory areas. These two checklist requirements tie into the competency assessments that are performed periodically with regular updates of the policies and procedures, such that they accurately reflect the current laboratory practices and daily routines in the lab. This also includes annual and biennial procedure manual review and signoff by the laboratory director and/or the director’s designee, something that can slip from the minds of the most diligent of laboratory teams.

To conclude, cytology-laboratory–specific deficiencies remain low overall, representing no more than five percent of the cited deficiencies. Laboratorywide phase two deficiencies that reflect on cytology are more frequent and typically involve personnel oversight, competency assessments, and procedure manual reviews. In these areas, clear delineation of oversight responsibilities within the laboratory and continued periodic communication with cytology personnel might help reduce the frequency of citations or deficiencies during an inspection.

1. 1. Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html. Modified April 9, 2013.
   2. Nakhleh RE, Fitzgibbons PL, eds. Quality Improvement Manual in Anatomic Pathology. 2nd ed. College of American Pathologists; 2005.
   3. Centers for Medicare and Medicaid Services. Clarification Regarding Fine Needle Aspiration (FNA) Specimen Adequacy Assessment, Rapid On-Site Evaluation (ROSE) and Workload Limits. March 16, 2018. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO-18-14-CLIA.pdf.
   4. Centers for Medicare and Medicaid Services. What Do I Need to Do to Assess Personnel Competency? November 2012. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf.
   5. Clinical and Laboratory Standards Institute. QMS02-A6: Quality Management System: Development and Management of Laboratory Documents; Approved Guideline, 6th ed.; 2013.

Dr. Sharma, a member of the CAP Cytopathology Committee, is associate professor, University of Pittsburgh School of Medicine, and director of the cytopathology laboratory, VA Pittsburgh Healthcare System.