Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 25, 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 the Proficiency Testing (PT) attestation statements and staff interview, the laboratory failed to rotate PT testing among all testing personnel (TP). Findings include: 1. Review of the 2017- 2018 (to date) PT documents revealed TP #1 (CMS 209 form) performed all the PT testing. 2. Interview with TP #1 (CMS 209 form) on 7/25/18 at approximately 2:30 PM in the side office confirmed the same TP had performed all the 2017-2018 (to date) PT. 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 --