Weston County Health Services

Summary Statement of Deficiencies 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 review of personnel files, review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, policy and procedure review, and staff interview, the laboratory failed to ensure an annual competency assessment had been completed for 1 of 6 testing personnel (TP #1) for 2 of 2 years (2022, 2023) and failed to ensure a competency assessment for the responsibilities of the general supervisor and technical supervisor (TS/GS #1) were completed for 1 of 2 years (2023) reviewed. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed the laboratory employed one staff member (TS/GS #1) which performed the duties of both the general supervisor and the technical supervisor. TS /GS #1 also acted as testing personnel. Review of the personnel file for TS/GS/TP #1 showed no evidence a competency assessment had been completed in 2023 for his TS /GS responsibilities and no competency assessments and been completed to evaluate his testing personnel responsibilities in 2022 or 2023. 2. Interview with TS/GS/TP #1 on 8/6/24 at 1:52 PM confirmed the competency assessments for his testing personnel responsibilities had not been completed and was unable to locate the 2023 TS/GS competency assessment. 3. Review of the Competency Assessment policy and procedure, last approved by the laboratory director 11/2023, showed "...Established employees are to have competency evaluated on an annual basis...The Laboratory Manager that performs non-waived testing must also display proficiency and competency annually. A staff technologist with a minimum of 6 years of experience can observe the managers techniques in all non-waived testing duties. This observation will be documented. The Laboratory Director, Technical Supervisor, or 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 -- Technical Consultant can then review the observation documentation, proficiency testing, quality control results, worksheets, educational supplements or problem solving exemplars to determine competency of testing. The Laboratory Director or Technical Supervisor will also evaluate competency in managerial duties..." -- 2 of 2 --

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 proficiency testing records review, lack of documentation and interview with staff, the laboratory director failed to attest to the routine integration of proficiency test (PT) samples into the patient workload using the laboratory's routine methods for 9 of 17 testing events reviewed. Findings include: 1. Proficiency testing attestation statements reviewed from: a. The 1st, and 3rd of 2019, and the 1st and 2nd core chemistry events of 2020 reviewed failed to include the director's signature attesting to the routine integration of PT samples. b. The 1st miscellaneous chemistry event of 2020 failed to include the director's signature attesting to the routine integration of PT samples. c. The 2nd and 3rd Hematology events of 2019 and the 1st event of 2020 failed to include the director's signature attesting to the routine integration of PT samples. d. The 3rd immunohematology events of 2019 failed to include the director's signature attesting to the routine integration of PT samples. 2. In an interview with the laboratory director on 09/03/2020 at approximately 5:30 P.M., the laboratory manager confirmed the 9 attestation statements did not include the signature of the laboratory director D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on lack of documentation and confirmation by staff, the laboratory failed to document the date microbiology testing was discontinued for organism identification, susceptibility testing, blood culture testing, and Methicillin Resistant Staphylococcus A testing. Findings include: 1. The laboratory procedure manuals failed to include the date testing was discontinued for bacteriology tests. 2. In an interview conducted on 09 /03/2020 at approximately 4:45 P.M., the laboratory manager stated bacteriology culture testing was discontinued in April 2019 and confirmed the laboratory failed to document the date the bacteriology procedure was no longer in use. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of