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 review of 2020, 2021, and 2022 API (American Proficiency Institute) proficiency testing records and interview with TP (testing personnel) #1 on 11/29/22, the laboratory failed to evaluate all ungraded and unacceptable proficiency testing results for 2 of 6 test events in 2021 and 2022. Findings: 1. 2021 Hematology 3rd event a. no evaluation of ungraded wet prep/KOH (potassium hydroxide) sample VKP-03; b. no evaluation of 0% for failure to participate for fern test. 2. 2022 Hematology 2nd event a. no evaluation of ungraded wet prep sample VA-02. During interview at approximately 12:25 p.m., TP #1 stated she was unaware they needed to evaluate the ungraded results. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with TP (testing personnel) #1 on 11/29/22, the laboratory director failed to perform and document competency evaluation for 1 of 1 TP (TP #1) during 2020 and 2021. Review of personnel records for TP #1 revealed that her competency was evaluated in 2022 by an off-site technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consultant. There were no records available to indicate that TP #1 had a competency evaluation in 2020 or 2021. During interview at approximately 10:00 a.m., TP #1 confirmed that she did not have a competency evaluation in 2020 or 2021. -- 2 of 2 --