Summary:
Summary Statement of Deficiencies D5653 CYTOLOGY CFR(s): 493.1274(e)(3) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(3) All nongynecologic preparations are reviewed by a technical supervisor. The report must be signed to reflect technical supervisory review or, if a computer report is generated with signature, it must reflect an electronic signature authorized by the technical supervisor who performed the review. This STANDARD is not met as evidenced by: Based on the review of written laboratory procedures, review of annual test counts and interview of facility personnel, the laboratory failed to establish written policies and procedures to ensure that all nongynecological slides were reviewed by the technical supervisor for two of two testing personnel performing nongynecological cytology slide interpretations in 2022, until the date of the inspection in 2023. The findings included: 1. Review of the procedure manual found no written policy to ensure that the technical supervisor reviewed all nongynecological preparations. 2. Review of the annual test counts found the laboratory reported performing 233 nongynecological cytology slide interpretations. 3. During interview of technical supervisor one on the CMS report 209 Laboratory Personnel Report conducted September 13, 2023 at 1:28 PM he confirmed that final reports for nongynecological slide preparations were not reviewed by the technical supervisors. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --