Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at South Shore Hospital on 08 /06/2024 - 08/12/2024. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 College of American Pathology (CAP) proficiency testing records, review of laboratory policy, and interview, the laboratory failed to run proficiency testing in the same manner as patient specimens for 2 (1st testing event in 2022 and 2nd testing event in 2023) out of 7 (1st, 2nd, 3rd testing event in 2022 and 2023, and 1st testing event in 2024) testing events reviewed in Critical Care Blood Gas with Chemistry. Findings Included: Review of CAP proficiency testing for 1st testing event in 2022 (AQ-A 2022) revealed that 5 Testing people each ran 1 CAP specimen on Blood Gas Machine #45873 starting at 2:26 PM on 03/15/2022 (these 5 samples were the results submitted to CAP), and 5 different Testing people each ran 1 CAP specimen on Blood Gas Machine #45866 starting at 2:55 PM on 03/15/2022. The CAP proficiency testing was due 03/16/2022. Review of CAP proficiency testing for 2nd testing event in 2023 (AQ-B 2023) revealed that 5 Testing people each ran 1 CAP specimen on Blood Gas Machine #56000 starting at 12:37 PM on 07/05/2023 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 -- (these 5 samples were the results submitted to CAP) and 5 different Testing people each ran 1 CAP specimen on Blood Gas Machine #55957 starting at 1:15 PM on 07/05 /2023. The CAP proficiency testing was due 07/18/2023. Review of "ABG-CAP Proficiency Surveys and Testing" last reviewed 11/2022 showed "Second instrument CANNOT be used for any CAP samples until after the deadline for submission." Interview on 08/08/2024 at 11:00 AM with the Respiratory Manager confirmed that patient specimens are not ran on both Blood Gas instruments and confirmed the proficiency testing was not being run as patient samples. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require