Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 17, 2021. 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: 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 testing personnel (TP) document review and staff interview, the laboratory failed to establish and follow written policies and procedures to assess TP competency as required. Findings include: 1. TP competency document review revealed the laboratory failed to include the six required CLIA procedures in performance of TP competencies. 2. An interview with the Center Director on 3/17/2021 in the conference room at approximately 12:30 p.m. confirmed TP competency performance did not include the aforementioned CLIA procedures. 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 --