Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 19, 2025. 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: D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on Peer Review document review and staff interview, the laboratory failed to verify at least twice annually the accuracy of any test or procedure performed Findings: 1. Peer Review document review revealed twice annually peer reviews were not performed for MOHS Micrographic Surgery/ Histology testing in 2024 to 2025 thus far. 2. Interview with the laboratory coordinator on 03/19/25 at 14:25 p.m. in the breakroom confirmed the lack of peer reviews for the dates indicated above. 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