Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 2, 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 proficiency test (PT) records and interview with the Laboratory Coordinator, the Laboratory Director(LD) failed to attest the routine incorporation of the proficiency test samples into the patient workload as required. The findings include: 1. American Associate of Bioanalysts(AAB) PT document review revealed that the LD failed to sign the attestation statement for Richmond County (Laney- Walker) for the following PT event: Chemistry 2020 Event 3-- KOH(potassium hydroxide) and wet preparation. 2. An interview with the laboratory coordinator on March 2, 2021 at approximately 6:35 PM in the conference room confirmed the aforementioned lack of LD signature on the attestation statement. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency test (PT) record review and staff interview, the laboratory failed to maintain a copy of all PT records as required. Findings include: 1. American Associate of Bioanalysts(AAB) PT document review revealed the lack of an attestation statement for Richmond County, for the following PT event: Chemistry 2020 Event 2-- KOH(potassium hydroxide) and wet preparation. 2. An interview with the laboratory coordinator on March 2, 2021 at approximately 6:30 PM in the conference room confirmed the aforementioned lack of attestation statement. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of