Edward Elmhurst Health Center-Oak Park 3rd

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 proficiency testing records, laboratory policies and procedures, lack of documentation, and interviews with the Technical Consultant (TC), the laboratory failed to follow written policies and procedures to assess the competencies of 1 of 12 testing personnel (TP) performing moderate complexity testing. Findings include: 1. Review of laboratories proficiency testing records revealed one TP not previously listed on CMS-209 (laboratory personnel) Form. TP #12 performed moderate complexity troponin chemistry proficiency testing for College of American Pathologists event 2 in 2025. 2. Review of the laboratory policies and procedures identified the policy titled "Competency Evaluation, V: PER -1.02", which stated, "Only certified competent operators/ analysts may perform testing". 3. The laboratory failed to have completed competency documents for TP # 12. 4. Interviews with the TC on 09/17/2025, at 12:20 pm, confirmed that the laboratory failed to have completed competency documents for TP # 12 prior to testing proficiency testing samples. 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 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 laboratory policies and procedures; Laboratory Personnel Report (Form 209); and personnel records, and interview with the technical consultant, the laboratory failed to establish and follow written policies and procedures to assess employee and consultant competency. Findings: Based on review of laboratory policies and procedures; Laboratory Personnel Report (Form 209); and personnel records, and interview with the technical consultant, the laboratory failed to establish and follow written policies and procedures to assess employee and consultant competency. Findings: 1. There were no policies and procedures to assess competency of personnel, based on the position responsibilities. 2. Review of Form 209 revealed that there are persons listed in the following named positions: a. Laboratory Director b. Clinical Consultant (listed as Laboratory Director) c. Technical Consultant (1 person) e. Moderate Complexity Testing Personnel (X 8 persons) 3. There was no documentation to show that the technical consultant's competency was assessed, based on the position responsibilities. 4. On January 22, 2020 at 3:00 PM, the technical consultant confirmed the surveyor's findings 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 --