Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 16, 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: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: After a review of the procedure manual, personnel records, and interview with the laboratory supervisor, it was determined that the laboratory did not have a comprehensive competency assessment policy with the CLIA six (6) standards for its testing personnel specific to the specialty of Histopathology. Findings include: 1.) Testing Personnel (TP) records review revealed that competency assessment was performed in 2019 and 2020. The policy did not clearly contain the six (6) CLIA criteria for personnel competency assessment. 2.) The laboratory Supervisor TP # 10 (CMS 209), confirmed during the interview, on 06/16/2021, at approximately 12:20 pm, in the review room, that the laboratory competency assessment policy needs to be in compliance with the six (6) CLIA standard criteria. 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 --