Summary:
Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Scott D Warren Md Pa was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 and staff interview, the laboratory failed to perform preventative maintenance on the microscope annually. The findings include: The 5/30/24 observation of the maintenance sticker on the Accu-Scope microscope showed maintenance was performed on 2/17/2023, and next maintenance was due 2/2024. No documentation of yearly preventative maintenance for the microscope was provided. The 5/30/24 interview with Testing Person C at 11:30am confirmed the annual preventative maintenance of the microscope was not 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 --