Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on November 04, 2022. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on Proficiency Testing (PT) records review and staff interview, the laboratory failed to enroll in a CMS approved PT program or Peer Review program at least twice a year to verify accuracy of its testing. Findings include: 1. Proficiency Testing (PT) records review revealed no registration with a CMS approved (PT) Agency or a peer review program with a Pathology group or peers at least twice annually in 2021 and 2022. 2. An interview with the Histotech (TP #6 CMS 209) and the laboratory coordinator on 11/04/2022 at approximately 11:30 AM confirmed failure of the laboratory to enroll in a CMS approved (PT) or peer review program in 2021 and 2022. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) 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 -- (b) The general laboratory systems quality assessment must include a review of the effectiveness of