Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 22, 2018. 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) documents and staff interview, the laboratory failed to rotate the PT samples among all testing staff. Findings include: 1. Review of PT testing events 2016 #3; 2017 #1, #2, #3; and 2018 #1, #2 revealed staff #2 (CMS 209 form) had ran 5 of 6 PT events. 2. Interview with staff #2 (CMS 209 form) on 8/22/18 in the conference room at approximately 11:45 AM, confirmed she had ran 5 of 6 PT events. 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 lab failed to calibrate the Quest Horizon Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Mini E centrifuge per the manufacturer. Findings include: 1. Observation during the lab tour revealed the Quest Horizon Mini E centrifuge was last calibrated on 11/12/07. 2. Interview with staff #2 (CMS 209 form) on 8/22/18 in the lab at approximately 1130 AM, confirmed the centrifuge had not been calibrated since /12/07. -- 2 of 2 --