Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2021, 2022, and 2023 API (American Proficiency Institute) proficiency testing records, and interview with TP (testing personnel) #2 on 11/30/23, the laboratory failed to test proficiency samples in the same manner as patient specimens are routinely tested for 9 of 17 proficiency testing events reviewed. Findings: Review of the laboratory's "PANIC VALUE POLICY" revealed "When a patient's laboratory result result is in the Alert range or does not fit the clinical picture, you should do the following: 1. Re- run the same patient specimen if available to assure that the first result obtained was correct. ..." Review of 2021, 2022, and 2023 API proficiency testing records revealed that proficiency samples with panic value results were not re-run to verify the accuracy of the results obtained on 9 of 17 proficiency testing events. Examples: 1. 2021 Chemistry Core 1st event - samples NB-02 and NB-04 with panic value results for bilirubin not repeated. 2. 2021 Hematology / Immunohematology 3rd event - sample HSY-11 with panic values for hemoglobin, hematocrit, and platelets not repeated. 3. 2022 Chemistry Core 2nd event - samples NB-06 and NB-10 with panic value results for bilirubin not repeated. 4. 2023 Hematology / Immunohematology 2nd event - sample HSY-07 with panic values for hemoglobin, hematocrit, and platelets Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- not repeated. 5. 2023 Chemistry Core 3rd event - samples NB-13 and NB-14 with panic value results for bilirubin not repeated. During interview at approximately 10:15 a.m., TP #2 stated that patient specimens with panic value results are re-run for confirmation, and she stated that proficiency samples with panic values should be also be re-run. 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 2021, 2022, and 2023 API proficiency testing records and interview with TP #2 on 11/30/23, the laboratory failed to evaluate ungraded proficiency testing results for 3 of 8 hematology test events reviewed. Findings: Review of 2021, 2022, and 2023 API proficiency testing records revealed the laboratory failed to evaluate ungraded proficiency testing results on the following test events to ensure