Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 15, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was 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 observation by the surveyor during a tour of the laboratory and staff interview, the laboratory failed to perform maintenance and function checks on the LabCorp Horizon Mini E centrifuge used to prepare specimens for testing. Findings include: 1. Observation by the surveyor during a tour of the laboratory revealed a sticker on the centrifuge showing rotations per minute (RPM) check on the centrifuge was last performed on 5/10/2012.. 2. Interview with testing personnel (see CMS 209) on October 15,, 2018 at 12 pm in the laboratory confirmed there is no documentation of centrifuge maintenance and RPM check after 5/10/12 and maintenance is not performed every two years as recommended. 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 --