Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 01/30/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of laboratory's test log, personnel records and staff interview, the laboratory's Technical Consultant failed to document annual competency assessment for one of two testing personnel employed by the facility in 2023 and 2024, Testing Person number two (TP2). Findings included: 1. Review of laboratory's test log revealed TP2 performed mineral oil and KOH (potassium hydroxide) microscopic examinations in 2023 and 2024. 2. Review of laboratory's personnel records revealed TP2 did not have documentation of competency assessment for either of the above tests in 2023 or 2024. 3. In an interview on 01/30/2025 at 1115 hours in the breakroom, the laboratory's office manager (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --