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 laboratory verification of accuracy records and interview with testing personnel (TP) #4 11/10/21, the laboratory failed to verify the accuracy of the Mart I Immunostain at least twice annually in 2019, 2020, and 2021, a period of approximately 3 years in which verification of accuracy was not performed. Findings: Review of laboratory verification of accuracy records revealed no documentation the laboratory had performed a twice annual verification of accuracy for the Mart I Immunostain in 2019, 2020, and 2021. During interview at approximately 2:30 p.m. TP #4 confirmed the laboratory did not perform a twice annual verification of accuracy for the Mart I Immunostain in 2019, 2020 and 2021. He stated when he took over the position in March of 2021 a twice annual verification of accuracy was not being performed for the Mart I Immunostain, so he did not know that it was needed. 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 --