Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 27, 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: D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) document review and staff interview, the laboratory failed to perform and submit results to the Medical Laboratory Evaluation Proficiency program. Findings include: 1. PT document review revealed that there were no results for the Immunology subspecialty testing for all events in 2020 and 2021. 2. During an interview with the Laboratory Manager and the Laboratory Director(CMS 209), in the conference room on January 27, 2022 at approximately 2: 15 PM, confirmed that there were no PT testing or results for Immunology in 2020 and 2021. 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