Summary:
Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and interview with the Technical Consultant, the laboratory had 1 out of 4 testing events that had analytes that received less than 80% in the specialty of Hematology. Findings Included: Review of API proficiency testing results found the 2nd testing event in 2018 had a 73% White Blood Differential. Interview on 02/20/2018 at 10:45 AM with the Technical Consultant, confirmed the proficiency testing failure. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing records and interview with the Technical Consultant, the laboratory failed to have