Summary:
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. This STANDARD is not met as evidenced by: Based on policy, lack of documentation and an interview, the laboratory failed to follow established written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in analytic systems. Findings include: A. Policy titled "Policy for Quality Oversight of Rapid Response Laboratories" (SOP ID:KS_QDMOQ757, Version#2) states "RRL Laboratory Director (RRL Certificate Holder) Oversight. Oversight Activities include: Perform Quarterly... Complete an RRL General Oversight Report." B. Upon request, no documentation showing an RRL General Oversight Report from September 2024 to August 2025 was available. C. At 10:32am on 10/29/25 the labroatory director confirmed that RRL General Oversight Reports were not availabel for the last quarter of 2024 and the first two quarters of 2025. 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 --