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 MLE (Medical Laboratory Evaluation) proficiency testing results and interview with the Laboratory Supervisor, the Laboratory failed to score at least 80% for one (3rd testing event 2017) out of six (1st, 2nd, 3rd testing events in 2016 and 2017) testing events reviewed. Findings Included: A review of the 3rd testing event in 2017 revealed a score of 60% for Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, and Platelets with an overall Hematology score of 63%. During an interview on 03/21/18 at 9:30 AM, the Laboratory Supervisor 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 MLE (Medical Laboratory Evaluation) proficiency testing results and interview with the Laboratory Supervisor, the Laboratory failed to have