Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 20, 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: 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 the Proficiency Testing(PT) document review and staff interview, the laboratory failed to perform the required correction action for unacceptable/failed evaluations. The Findings include: 1. College of American Pathologists (CAP-PT) document review revealed that the staff and Laboratory Director failed to document a correction for Bacteriology ID for D-A-2022, unacceptable score of 67% for Event 3 of 2021 and Event 1 of 2022. 2. During an interview on May 20, 2022, at 2:20 PM, with the Technical Consultant(TC) and testing personnel #1 on (CMS-209), in a front office of the facility, confirmed that the staff and Laboratory Director did not perform the required correction action for unacceptable/failed evaluations. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved