Beacon Health Alliance, Pc

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of validation records for the Beckman Coulter DxH 520 hematology instrument, and staff interview, the lab director failed to review and approve the validation records for the Beckman Coulter DxH 520 hematology instrument with patient testing being performed since 01.23.2024. The findings include: 1. Observation of the laboratory on 08.08.2024 at 09:30 a.m. revealed the Beckman Coulter DxH 520 (serial# 83626980) in use for Complete Blood Count patient testing. 2. A review of the validation records performed for the Beckman Coulter DxH 520 revealed that the laboratory director did not review or approve the validation records. 3. An interview with the technical consultant on 08.08.2024 at 2:30 p.m. confirmed that the laboratory director had not reviewed or approved validation records for the Beckman Coulter DxH 520 instrument prior to patient testing, which began on 01.23.2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: =================================== Based on record review and interview the laboratory failed to report SARS-Co-V-2 negative test results for 203 of 211 days reviewed from November 2020 through May 2021. The findings include: 1. SARS-CoV-2 test result reporting documentation was reviewed from November 2, 2020 through May 31, 2021. 2. Documentation revealed that SARS-CoV-2 negative test results were not reported as required for 28 days in November 2020, 30 days in December 2020, 29 days in January 2021, 28 days in February 2021, 28 days in March 2021, 30 days in April 2021, and 30 days in May 2021. 3. 1,616 negative test results were not reported as required during the period of review. 4. The laboratory performed 1,787 SARS-CoV-2 tests during the period of review. 5. The laboratory's lead Medical Technologist confirmed the findings on 06.15.2021 at approximately 1: 00 pm. =================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: =================================== Based on review of 2020 and 2021 Proficiency Testing (PT) attestation sheets and upon interview with the Lead Medical Technologist (MT), it was determined the laboratory director failed to sign the attestation sheets for Hematology and Microbiology during the two year period. The findings include: 1. Review of PT reports for 2020 and 2021. 2. The laboratory director failed to sign the PT attestation sheets for the 2nd and 3rd events of 2020 and the 1st event of 2021 for Hematology and Microbiology. 3. An interview at approximately 1:00 p.m. on 06/15/2021 with the Lead MT confirmed the laboratory director had not signed the attestation sheets for the 2nd and 3rd events of 2020 and the 1st event of 2021 for Hematology and Microbiology. =================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --