Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of an recertification survey completed on April 09, 2026 and recertification is recommended. 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 test menu, laboratory competency assessments, laboratory policy, and interview, the technical consultant failed to ensure two of two testing personnel had annual competency for the moderately complexity testing being performed for 2025. The findings include: 1. Review of the laboratory test menu included the following moderate complexity testing performed in the laboratory being performed by testing personnel (TP) 1 and TP 2: KOH prep Urine Sediment Examination 2. Review of laboratory competency assessments for TP 1 and TP 2 did not include competency assessment for KOH and Urine Sediment examination testing performed in 2025. 3. Review of the laboratory policy titled "Competency of Laboratory Personnel" included the following information: "It is the responsibility of the Laboratory Director in conjunction with the Laboratory Technical Consultant to assess the performance and competency semiannually in the first year and yearly thereafter." 4. In an interview on 4/9/2026 at 11:05 hours, in the laboratory, the Technical Consultant (TC) confirmed the Urine Sediment and KOH was not on the 2025 competency assessments. KEY: KOH - potassium hydroxide 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 --