Summary:
Summary Statement of Deficiencies D0000 The Riverwood Clinic McGregor laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the validation survey performed on March 12, 2026. The following standard-level deficiency was cited: 493.1235 Personnel Competency Assessment Policies . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure two of two Technical Consultants (TCs) received a competency assessment in 2024 and 2025 which included the specific TC position responsibilities listed in Subpart M. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 12:35 p.m. on 03/12/26. 2. The following items were observed as present and available for use during the tour: MedTOXScan reader and Profile-V drug testing cassette devices Laxco microscope for Urine Sediment examinations 3. TC competency assessments were not found for TC1 and TC2 during review of 2024 and 2025 laboratory personnel records. The laboratory was unable to provide the missing competency assessments upon request. 4. A TC competency assessment procedure was not found in HealthStream, the laboratory's policy management software. 5. In an interview at 1:15 p.m. on 03/12/26, the LD confirmed the above finding. . 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 --