Summary:
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 review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and staff interview, the laboratory failed to evaluate non-graded PT scores for minimal residual disease markers in 2022 (3 of 8 PT results). The findings include: 1. Review of the laboratory's CAP PT records for minimal residual disease (MRD-B 2022) revealed PT samples MRD1-04 and MRD1- 06 had 3 ungraded results for the "BCR::ABL 1 p190 Log Red" tests. 2. Interview with the general supervisor on 07/10/23 at approximately 1:30 p.m. confirmed the laboratory failed to evaluate non-graded PT scores for accuracy in 2022 for 3 of the 8 minimal residual disease PT results reviewed. 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 --