Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 22, 2020. The laboratory was not in compliance with 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 documents review, laboratory tour and an interview with the Technical Consultant(TC) (TP#27 CMS 209), the laboratory failed to perform and document annual maintenance on the PPM Microscope as required in 2019. Findings include: 1.) Laboratory tour and maintenance documents review revealed the last annual maintenance performed on the PPM (M15 LW Scientific Microscope) was done September 2018. The next due date was September 2019 and there were no records it was done. 2.) An interview with the Technical Consultant (TC) (TP#27 CMS 209) at approximately 02:35 pm on 01/22/2020 in the conference room confirmed there was no annual maintenance for the Microscope in 2019. 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 --