Summary:
Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the Laboratory Director or designee failed to review and evaluate proficiency testing (PT) results for 1 of 1 PT events with Unacceptable results in 2017. Findings are as follows: 1. The laboratory performed Chemistry, Hematology, Microbiology, Urinalysis and Parasitology / Mycology testing as confirmed by Testing Personnel 1 (TP-1) during a tour of the laboratory on 4/5/18 at 10:05 a.m. 2. The laboratory performed Proficiency Testing (PT) using American Proficiency Institute (API) as the provider. 3. Review of API PT documents revealed the following result was graded as unacceptable: Year: 2017 Survey: Microbiology Event: 3rd Sample: VIR-14 Test: Influenza A 4. Documentation of review, internal evaluation and