Summary:
Summary Statement of Deficiencies D2025 BACTERIOLOGY CFR(s): 493.823(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of API proficiency testing (PT) summary reports and interview with the testing person (TP), the laboratory failed to submit PT results before the required deadline. Findings: 1. PT third event of 2023 was completed, however results were not submitted by the deadline. 2. It was noted that the laboratory's PT results were compared to consensus PT findings and results were acceptable. 3. Confirmed findings by interview with the TP on November 7, 2023, at 11:00 A.M. Refer to 6017. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of API PT summary reports and interview with the TP, the laboratory failed to evaluate, perform, and document