Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 24, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 testing personnel (TP) competency document review and staff interview, the laboratory director/technical supervisor (LD/TS) failed to perform a semi-annual competency for TP during their first year of testing as required. Findings include: 1. TP competency document review revealed a semi-annual competency was not performed in 2019 for Staff #1 (CMS 209). 2. An interview with the laboratory manager in the laboratory on 9/24/2019 at approximately 3:30 p.m. confirmed the aforementioned lack of TP competency. 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 --