Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on October 04, 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: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the laboratory tour and staff interview, the laboratory failed to have professional maintenance on the Microscope as required. Findings include: 1. Observation during the laboratory tour revealed that the Accu-Scope Microscope from Infinity 1 Lumenera was NOT calibrated annually as required. The last calibration was performed on 08/17/2017. 2. An interview with testing personnel #2 (CMS 209) and Lab director on 10/04/2022 in the laboratory at approximately 10:15 AM, confirmed the lack of the aforementioned professional maintenance on the main Microscope. 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 --