Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on June 28, 2022. The laboratory was not in compliance with all 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 observation during the laboratory tour and staff interview, the laboratory failed to implement and establish proper safety procedures to ensure protection from physical, biochemical and biohazardous materials in the lab area. Findings include: 1. During the laboratory tour it was observed there was no hand wash sink with running water and a flush eyewash equipment (for emergency use) in the laboratory testing and processing area. 2. An interview with staff and facility manager, during the laboratory tour, on 06/28/2022, at approximately 10:30 A.M, confirmed the absence of a hand wash sink with running water or eyewash equipment. 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