Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's 2017 hematology/coagulation proficiency testing comparative evaluation reports and interview with the laboratory liaison, the laboratory failed to verify the accuracy of proficiency testing scores for 2017 events two and three when it did not evaluate non-graded scores for blood cell identification and activated partial thomboplastin time (aPTT). The findings include: 1. Review of the laboratory's 2017 hematology/coagulation proficiency testing comparative evaluation reports revealed the following: 2017 Event one: Non-graded results for blood cell identification for sample numbers BCI-06 and BCI-07 Non-graded results for aPTT for sample numbers COA-02, COA-05 2017 Event three: Non-graded results for blood cell identification for sample numbers BCI-20 and BCI-21 Both reports were reviewed by the technical consultant with no evaluation of the results to determine accuracy. 2. Interview with the laboratory liaison on November 14, 2018 at 3:00 pm confirmed the laboratory failed to determine the accuracy of non-graded proficiency testing scores in 2017 for blood cell identification (events one and three) and aPTT (event one). 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 --