Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 4/26/21 at Circulogene Theranostics, a clinical laboratory in West Palm Beach, Florida. Circulogene Theranostics is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, and interview with the Laboratory Director, the laboratory failed to verify the accuracy of the result interpretation of Genomic Sequencing and Molecular Pathology PCR at least twice a year since testing began 8/29/19. The findings included: Review of quality assurance documents revealed that there was no twice a year review to verify the accuracy of testing. There was no policy for the twice a year review. Interview on 4/26/21 at 1:00 p.m., the Laboratory Director confirmed that the twice a year verification of accuracy was not performed. 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 --