University Of Texas Medical Branch Department

Summary Statement of Deficiencies D0000 An onsite survey performed 06/26/2024 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. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the 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 2 testing personnel. The findings were: 1. Review of CMS 209 form Laboratory Personnel Report (CLIA) revealed the laboratory identified 2 testing personnel performing high complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical supervisor failed to have documentation of initial training records and 6- month competency assessment documentation for 1 of 2 testing personnel performing high complexity testing. Testing personnel #1 Hired: June, 2023 3. In an interview on 06/26/2024 at 12:00 pm in the laboratory, the laboratory supervisor confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services 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 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the