Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 6, 2023. 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 review of the Standard Operating Procedure (SOP) and staff interview, the laboratory failed to establish a safety procedure for the Eyewash. The Findings include: 1. SOP document review revealed that the laboratory failed to establish a safety procedure for the sink eyewash in the laboratory. 2. During an interview with the Center Director, Center Quality Manager, and the Center Quality Assurance Director (CMS-209) on January 6, 2023, at approximately 1:45 PM, in the conference room upstairs, in the facility and also in the processing area of the donor center, confirmed that the laboratory failed to establish a safety procedure for the Eyewash. 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 --