Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Cleaver Medical Group Dermatology on August 26, 2025, by a federal surveyor from the CMS DCLIQ Survey Branch. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be compliance with condition-level CLIA requirements. The following standard-level deficiencies were found during the CLIA validation survey. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on observation of the laboratory area and interview with the laboratory manager, the laboratory failed to monitor temperature conditions for storage of Mohs slides to ensure proper preservation for two of two years (August 26, 2023 to August 27, 2025). Findings Include: 1. Observation of the Mohs micrographic surgery area first floor on August 26, 2025 at 10:45 am revealed Mohs slides were stored in a Microscope Slide Storage Cabinet which was in a closest on the first floor. 2. The laboratory could not provide documentation for temperature being monitored in the closest where Mohs micrographic surgery slides have kept since 2017. 3. Per the Clinical laboratory improvement Amendment (CLIA) Application for Certification signed by the laboratory director on August 25, 2025, the laboratory performed an estimated 800 MOHS examinations annually. 4. By interview, the laboratory manager confirmed that the storage conditions where the Mohs micrographic surgery slides were stored where not being monitored on August 26, 2025 at 11:00 am. Key: Mohs = Micrographic Surgery. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: I. Based on the lack of records and interview with the laboratory manager, the laboratory failed to verify at least twice annually the accuracy of KOH preparations performed for two of two years (2023 and 2024). Findings Included: 1. On August 26, 2025 at 10:45 am, the laboratory could not provide documentation for the performance of accuracy of KOH testing on a semi-annual basis in 2023 and 2024. 2. Per the Clinical laboratory improvement Amendment (CLIA) Application for Certification signed by the laboratory director on August 25, 2025, the laboratory performed an estimate of 120 KOH preparations annually. 3. By Interview, the laboratory manager on August 26, 2025 at 11:00 am confirmed the above findings. Key: KOH - Potassium Hydroxide. II. Based on review of laboratory records and interview with the laboratory manager, the laboratory failed to verify at least twice annually the accuracy (peer review) of MOHS examinations performed for two of two years (2023 and 2024). Findings Included: 1. Review of laboratory records on August 26, 2025 at 10:45 am revealed the MOHS peer review performed by laboratory director was not assessed by another physician on a semi-annual basis in 2023 and 2024. 2. Per the Clinical laboratory improvement Amendment (CLIA) Application for Certification signed by the laboratory director on August 25, 2025, the laboratory performed an estimated 800 MOHS examinations annually. 3. By Interview, the laboratory manager on August 26, 2025 at 11:00 am confirmed the above findings. Key: Mohs = Micrographic Surgery. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)