Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of MLE (Medical Laboratory Evaluation) proficiency testing and interview with the Technical Consultant the laboratory failed to retain proficiency testing records for 1 testing events (1st testing event in 2017) out of 6 testing events reviewed (1st, 2nd, 3rd in 2017 and 2018). Findings Included: Review of MLE proficiency testing records revealed there was no attestation statement or the raw data printouts from the CBC (Complete Blood Count) analyzer. During an interview on 02 /21/19 at 3:22 PM, the Technical Consultant confirmed that the proficiency testing records were missing. 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 and interview with the Technical Consultant the laboratory failed to have