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, review of maintenance records, procedures and interview with the Quality Manager (QM) Manager (not listed on the CMS-209 Testing Personnel form), the laboratory failed to follow its procedures to perform preventative maintenance for two of two microscopes and the Tanner Scientific TN50 cryostat since May 2022. Findings include: 1. Observed during a laboratory tour at 9:00 AM on 01/29/2024 two microscopes available for use had service stickers which expired in 05/2023 and the Tanner Scientific TN50 cryostat lacked maintenance stickers. 2. A review of laboratory maintenance records revealed no maintenance documentation for two of two microscopes and the Tanner Scientific TN50 cryostat since May 2022. 3. A review of the laboratory maintenance procedure manual revealed the laboratory staff failed to follow their procedure that preventative maintenance should be performed at least annually. 4. Interview with QM at 9:45 AM on 01/29/2024 confirmed that the two microscopes had not received preventative maintenance since May 2022 and date of the last cryostat preventative maintenance was unknown. 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 --