Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on 04/13/2022. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate 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 testing personnel(TP) documents and and staff interview, the technical consultant (TC) failed to perform semiannual competency on all testing personnel. Findings include: 1. Review of testing personnel training and competency records reveals the TC failed to perform the semiannual competency on staff # 6 (CMS 209 form). Document was not available to review. 2. Interview with staff #6 (CMS 209 form) and the assistant manager of quality on 4/13/22 in the conference room at approximately 1130 am, confirmed the missing semiannual competency on staff # 6 (CMS 209 form). 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 --