Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 23, 2022. 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: 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 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) document review and staff interview, the Laboratory Director(LD) and Testing Personnel(TP) failed to attest to the routine integration of the samples into the patient workload as required. The Findings include: 1. American Proficiency Institute (API) PT document review revealed that the LD and TP failed to sign the attestation statements for Microbiology for Events 2 and 3 of 2020. 2. API PT document review revealed that the LD and TP failed to sign the attestation statements for Microbiology for Microbiology for Events 2 and 3 of 2021. 3. During an interview with the Lead Medical Assistant and TP#3(CMS-209) on February 23, 2022 at approximately 12:40 PM, in the breakroom, confirmed that the attestation documents for PT was not signed by the LD and TP. 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 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on Proficiency Testing(PT) document review and staff interview, the laboratory failed to evaluate and verify that all unsatisfactory scores were documented with a correction active. The Findings include: 1. American Proficiency Institute (API) PT document review revealed the