Summary:
Summary Statement of Deficiencies 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 review of the twice per year verification procedures and an interview with the general manager, the laboratory failed to verify the accuracy for Free Erythrocyte Porphyries (FEP) at least twice per year in calendar years 2020 and 2021. FINDINGS: The general manager confirmed on July 7, 2022 at approximately 2:30 PM, the surveyor's findings that the laboratory failed to verify the accuracy for Free Erythrocyte Porphyries (FEP) at least twice per year in calendar years 2020 and 2021. a. Approximately 12 patient samples were tested for FEP for the calendar years 2020 and 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 --