Summary:
Summary Statement of Deficiencies D0000 An onsite survey conducted 05/02/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's personnel competency records, and confirmed in an interview, the laboratory failed to have documentation of competency assessment for 1 of 1 technical supervisor. The findings were: 1. Review of the laboratory's CMS 209 Laboratory Personnel Report, signed by the laboratory director on 05/02/2024, revealed the laboratory identified 1 technical supervisor. 2. Review of the laboratory's personnel competency records revealed the laboratory failed to have documentation of competency assessment for 1 of 1 technical supervisor. Technical Supervisor #1 Hired date: 8/23/2023 3. In an interview on 05/02/2024 at 10:28 am in the laboratory, the mohs tech confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services CMS 209 form=Laboratory Personnel Report (CLIA) D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the 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 -- performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209 Laboratory Personnel Report, the laboratory's personnel competency records, and confirmed in an interview, the Technical Supervisor failed to have documentation of testing personnel initial training records and 6-month competency assessment for 1 of 1 testing personnel. The findings were: 1. Review of CMS 209 form, signed by the laboratory director on 05/02 /2024, revealed the laboratory identified 1 testing personnel performing high complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical supervisor failed to have initial training records and 6-month competency assessment documentation for 1 of 1 testing personnel performing high complexity testing. Testing personnel #1 Hired date: 08/28/2023 3. In an interview on 05/02/2024 at 10:28 am in the laboratory, the mohs tech confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services CMS 209 form=Laboratory Personnel Report (CLIA) -- 2 of 2 --