Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 24, 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of profiency test (PT) records and interview with the laboratory tecnical supervisor, the laboratory testing personnel (TP) failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of 2020 American Academy of Family Physicians (AAFP) PT records reveals the TP failed to sign the attestation statement for 2020 events A & B in the subspecialty of Mycology. 2. Interview with the Technical Supervisor (CMS 209) on February 24, 2021 at 11 am in the breakroom, confirmed the TP failed to attest that PT samples were tested in the same manner as patient specimens. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require