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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to retain the PT review page documentation for four of six events reviewed in 2022 through 2023. The findings include: 1. A review of the API PT records revealed no documentation of a review from the Laboratory Director, or designee, for the following surveys: a) 2022 Hematology 2nd Event. b) 2022 Hematology 3rd Event. c) 2022 Chemistry Miscellaneous 1st Event. d) 2022 Chemistry Miscellaneous 2nd Event. 2. During an interview on September 14, 2023, at 11:18 AM, Testing Personnel #1 confirmed the above findings. 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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to document