Rprd Diagnostics, Llc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of College of American Pathologists (CAP) proficiency testing (PT) records and interview with the general supervisor, testing personnel and the laboratory director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for three of four pharmacogenetics events in 2023. Findings include: 1. Review of CAP PT pharmacogenetics PT records showed the following: PGX-A: attestation statement not signed by the laboratory director or designee PGX-B: attestation statement not signed by testing personnel or the laboratory director or designee PGX3-A: attestation statement signed by testing personnel or the laboratory director or designee PGX3-B: attestation statement not signed by testing personnel or the laboratory director or designee 2. Interview with the general supervisor on January 16, 2025, at 11:40 AM confirmed testing personnel and the laboratory director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for three of four pharmacogenetics events in 2024. 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 --

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing reports from the College of American Pathologists (CAP) and interview with the general supervisor, the laboratory did not evaluate the accuracy of the results that the proficiency testing provider did not grade in the first PGX event in 2018. Findings include: 1. Review of the proficiency testing reports from CAP for the first PGX event in 2018 showed interpretation and clinical management results were not graded. There is no indication that the laboratory reviewed these results. 2. Interview with the general supervisor on February 13, 2019 at 11:30 AM confirmed the laboratory had not reviewed or verified the accuracy of results that were not graded. 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 --