Ghc-Scw Sauk Trails Laboratory

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of IQCP (Individualized Quality Control Plan) records and interview with the Technical Consultant, the laboratory did not complete the required annual quality reviews of three of three reviewed test systems with IQCP in 2023. Findings include: 1. Review of the IQCP Quality Assurance Plans (QAP) for testing on the Phoenix, Triage, and MedTox analyzers showed the QAP required an annual quality review of the IQCP for each test system. Further review showed the Laboratory Director last documented review of each of the IQCP on September 8, 2022, and the Technical Consultant documented review on May 24, 2024. The records showed no review in 2023 for the three reviewed systems. 2. Interview with the Technical Consultant on June 4, 2024, at 10:20 AM confirmed the laboratory had not completed the annual review and approval of each IQCP in 2023 as required in the laboratory's QAP. 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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with a technical supervisor, staff A, the laboratory director, or a qualified designee, did not attest to the routine integration of the immunohematology PT samples into the patient workload using the laboratory's routine methods for four of four immunohematology events in 2021 and 2022. Findings include: 1. Review of the API immunohematology PT records showed staff A signed the immunohematology attestation statements as the designee. Further review showed the laboratory director, who is the immunohematology technical supervisor, did not sign four of four immunohematology attestation statements in 2021 and 2022. 2. Interview with staff A on August 24, 2022 at 10:20 AM confirmed the laboratory director, or a qualified designee, did not attest to the routine integration of the immunohematology PT samples into the patient workload using the laboratory's routine methods for four of four immunohematology events in 2021 and 2022. 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 --