Unitypoint Health Finley Hospital

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 the POCQM002 Quality Management, POCT; Competency Assessment procedure and laboratory personnel records and confirmed by technical consultant (TC) identifier #1 at approximately 10:00 am on 1/15/2025, the laboratory failed to follow the competency procedures for four out of four new employees hired since the last survey performed on 6/21/2023. The findings include: 1. The POCQM002 Quality Management, POCT; Competency Assessment procedure states, "For Non-waived testing: During the first year of an individuals duties, competency must be assessed semi-annually." 2. Testing personnel identifier #2 had initial training for non-waived testing documented on 4/22/2023. 3. Testing personnel identifier #3 had initial training for non-waived testing documented on 4/12/2023. 4. Testing personnel identifier #4 had initial training for non-waived testing documented on 2/2 /2024. 5. Testing personnel identifier #5 had initial training for non-waived testing documented on 4/23/2024. 6. The TC identifier #1 confirmed at the time of the survey, the laboratory did not have semi-annual competencies documented for the above testing personnel. 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 D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume form, lack of comparison activity records, observation during the survey, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 06/21/2023, the laboratory failed to perform and document comparison activities twice annually between three out of three i-STAT analyzers for the analytes: partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), and pH for five out of five time periods from 01/01/2021 - 06/21 /2023. The findings include: 1. The Laboratory Test List & Annual Volume form listed the laboratory as performing PO2, PCO2, and pH testing on the i-STAT analyzer. 2. During an interview with personnel identifier #2 and observations made during the survey, the laboratory revealed that it had one i-STAT analyzer in the Respiratory Care Department, one i-STAT analyzer in the Emergency Department, and one i-STAT analyzer in the Cardiac Catheterization Laboratory. 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not perform and document comparison studies between the three i-STAT analyzers from 01/01/2021 - 06/21/2023. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9:45 am on 06/21/2023, the technical consultant failed to assess and document the competency of individuals performing moderate complexity testing in the cardiac catheterization laboratory at least annually for one out of one testing personnel (identifier #17) in 2021 and 2022. -- 2 of 2 --