Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) from the College of American Pathologists (CAP) and an interview with the General Supervisor (GS) on 9/3/2021, the laboratory failed to enroll in proficiency testing to verify the accuracy of testing for the SARS-CoV-2-qRT-PCR assay in accordance with 493.1236(c)(1). The findings include: 1. A review of proficiency testing records from CAP identified that the laboratory failed to verify the accuracy of testing for the SARS-CoV-2-qRT-PCR saliva assay for 2021. 2. An interview with the GS on 9/3/2021 at 12:54 pm confirmed that the laboratory failed to verify the accuracy of testing for the SARS-CoV-2-qRT- PCR saliva assay for 2021. 3. The laboratory reports performing 400 SARS-CoV-2- qRT-PCR saliva tests annually. 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 --