Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. 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 review of competency evaluations, pre-survey paperwork, and interview, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing in cytogenetics at least semiannually during the first year for 2 of 2 new employees. Findings follow. A. Review of competency evaluations showed General Supervisors #1, 2 & 3 performed the semiannual competency evaluations for testing personnel #4 & 12, as listed on the CMS form 209, during the first year of testing. B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #4 was hired 03/08/2021, and testing personnel #12 was hired 03/21/2022. C. Review of the semiannual competency evaluations for testing personnel #4 showed they were performed on 09/14/2021 and 12/16/2021 by general supervisor #1, and review of the first semiannual competency evaluation for testing personnel #12 showed it was performed on 10/31/2022 by general supervisors #2 & 3. D. Interview with General Supervisor #1, as listed on the CMS form 209, on April 4, 2023 at 1310 confirmed the findings. 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 --