Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was performed on April 18, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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 observation during the laboratory tour and interviews with testing personnel (TP) and the laboratory consultant , the lab failed to maintain the microscope as required.. Findings include: 1. Observation during the lab tour revealed the lack of evidence for the microscope preventive maintenance (PM). 2. Interview with TP #2 (CMS 209 form) and the laboratory consultant on 04/17/24 in the lab at approximately 11:00 AM, confirmed the microscope has not had a PM performed . 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 --