Summary:
Summary Statement of Deficiencies 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 of the service maintenance sticker on the Microscopes and interview with the Laboratory Director (LD) at the time of the survey (10:10 11/19 /2020), the laboratory failed to perform and document service maintenance for 5 of 5 Olympus microscopes. Findings include: 1. On the day of survey, 11/19/2020, the laboratory could not provide service maintenance records for 5 of 5 Olympus microscopes from 03/2019 to 11/19/2020. 2. Service stickers on 5 of 5 microscopes observed at the time of survey, showed that service maintenance was due on 03/2020. 3. Laboratory tested approximately 1356 patients during 03/2020 to 11/19/2020. 4. During the survey (10:10 11/19/2020), the Laboratory Director confirmed the above findings. 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 --