Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 04, 2024. 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: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on document review and staff interview during the lab tour, the laboratory failed to document and review inspections of the flush eyewash equipment on a weekly basis in the laboratory to protect against accidental chemical and bioharzard facial contamination as required by CLIA from July 2022 to June 2024. Findings: 1. A review of maintenance records revealed that the laboratory failed to document and review inspections of the eyewash flush equipment, on a weekly basis, to protect against accidental biohazard or chemical facial contaminations from July 2022 to June 2024. 2. Interviews with the General (GS) and Technical Supervisor (TS) staff (TP #2 and #3 CMS 209) at approximately 12:00 PM on 06/04/2024 confirmed the laboratory failed to document and review inspections of the flush eyewash equipment on a weekly basis from July 2024 to June 2024.. 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 --