Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 04, 2026. 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: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on personnel records review and interview with laboratory staff, the laboratory director failed to ensure that annual competencies for testing personnel (TP) including mid level practitioners performing laboratory tasks were performed according to CLIA criteria in May 2024 thru June 2026. Findings: 1. A review of competency assessment records revealed that TPs (#2 thru #6) (CMS-209 ) had no annual competency assessments records from May 2024 thru June 2026. 2. There were no peer review records for KOH preps available for TPs (#2 thru #6) (CMS 209) twice annually from May 2024 thru June 2026. 3. An interview, with the laboratory staff, in the review room, at approximately 12:10 PM, on 06/04/2026, confirmed there were no annual competencies for TPs (#2 tthru #6) (CMS -209 ) from May 2024 thru June 2026. 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