Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 24, 2021. 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: 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 review of laboratory records and interviews with the clinic's CEO and TP # 5 (CMS 209) the laboratory failed to enroll in a CMS approved Proficiency Testing (PT) Program for Virology and diagnostic Immunology testing as required by Clinical Laboratory Improvement Amendments. The findings include: 1.) A review of College of American Pathology (CAP) PT and testing records revealed Validation for the Luminex Aries for SARS -COV - 2 was completed in July 2020 and patient testing began around December 2020. The laboratory should have enrolled in Proficiency Testing by the 3rd quarter of 2020 and 1st quarter of 2021, but failed to do so. 2.) An interview with the clinic's CEO and lab staff (PT # 5 CMS 209) at approximately 1:00 p.m on March 24, 2021 in the break room confirmed the clinic is not yet enrolled in proficiency testing (PT) for Virology and diagnostic Immunology as of 03/24/2021. 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 --