Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed April 12, 2023 through April 13, 2023 at Family Doctor Clinic of Thibodaux, CLIA ID # 19D0459641. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level 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 proficiency testing records and interview with personnel, the laboratory failed to ensure the Laboratory Director and Testing Personnel signed the proficiency attestation statements for one (1) of seven (7) proficiency testing (PT) events. Findings: 1. Review of the College of American Pathologists (CAP) proficiency testing records for 2021, 2022, and 2023 revealed the following one (1) attestation statement did not include the signature of the Laboratory Director or Testing Personnel: ID3-A 2022 Nucleic Acid Amplification, Respiratory Limited Survey 2. Interview on April 12, 2023 at 3:35 PM, the Technical Consultant confirmed the attestation was not signed. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This STANDARD is not met as evidenced by: I. Based on review of policies and procedures, personnel records, and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a policy addressing competency assessment to include, but not limited to,