Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 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 proficiency testing (PT) document review and an interview with the lab director (LD) , the lab failed to rotate PT testing among all testing personnel (TP). Findings include: 1. Review of the American Proficiency Institute (API) attestation documents revealed TP #2 (CMS 209 form) performed all testing events reviewed (2016 #2, & #3; 2017 events #1, #2, & #3). 2. An interview with the LD on March 22, 2018 at approximately 11 AM in the business office meeting area, confirmed the same TP ran all the reviewed PT and the PT was not rotated among all TP. 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 --