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 American Proficiency Institute's (API) proficiency testing (PT) records and interview with Testing Personnel (TP) #2 (CMS 209), the laboratory failed to verify the accuracy of analytes that were not evaluated or scored for 2 of 3 API hematology/coagulation PT events in 2023. Findings include: 1. On the day of survey, 10/10/2023 at 12:15 PM, review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following hematology /coagulation API events that were not graded in 2023: -API 1st Event 2023: Blood Cell ID- Blast, Neutrophil band, Dacrocyte, Neutrophil hyposegmented. -API 2nd Event 2023: Blood Cell ID- Lymph Reactive, Neutrophil segmented, Red blood cell normal, Platelet normal. 2. The TP #2 confirmed the findings above on 10/10/2023 at 16:15 PM 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 --