Summary:
Summary Statement of Deficiencies D0000 At the time of the announced onsite initial survey, Advanced Dermatology and Cosmetic Surgery, was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document annual competency assessment for Testing Person A in 2021. Findings include: The review of competency records for Testing Person A, who performs KOH (Potassium Hydroxide) and Scabies testing ,showed no annual assessment was performed in 2021. The interview with the Office Manager on 10/28/22 at 11:23am confirmed the competency assessment was not completed in 2021. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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: Based on a review of the quality assurance records and staff interview, the laboratory failed to verify the accuracy of the KOH (Potassium hydroxide) and Scabies testing twice annually for 2021. The findings include: 1. Review of the laboratory's quality Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- assurance records for 2021 indicated the laboratory had not verified accuracy of test results for KOH and Scabies testing on a twice annual basis. The interview with the Office Manager at 11:23am on 10/28.22 confirmed the accuracy of the KOH and Scabies testing had not been verified at least twice a year. -- 2 of 2 --