Strong Clinic

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: Review of the CMS 209 form, lack of documentation and interviews with laboratory staff, determined the laboratory failed to assess employee competency as directed in personnel requirements. Survey findings follow: A) Review of the CMS 209 form submitted by the laboratory revealed that the Testing Personnel 1 (TP1) on the CMS 209 form had competency evaluation performed on 2/28/2023 and 3/18/2025. B) Review of personnel records for TP1 on the CMS 209 form, revealed that no competency evaluation for the position of TP was present for 2024. C) Upon request, the laboratory was unable to provide documentation of competency determinations for calendar year 2024 for the position of TP1 for the personnel identified above. D) In an interview at 1:32 p.m. on 5/21/2025, the Laboratory Directory on the form CMS 209, confirmed that competency determinations have not been performed on the personnel designated as TP1. 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 D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on written procedures and interview, laboratory failed to follow written Quality Assurance Plan to monitor, assess and correct problems with Test Tracking via Requisitions. Findings Follow: A). The Quality Assurance Plan states, "2. Test Tracking via Requisitions: 20 requisitions will be randomly pulled and evaluated two times each year for their inclusion of: name and address of healthcare provider ordering the tests, patient name, order date, patient sex, and date of birth. Each requisition will be examined for completeness in the aforementioned categories. Any deviation from 100% will be noted. Since test requisitioned are computer generated, problems will be brought to the attention of the IT department and corrected ASAP". Laboratory could not provide any documentation of the twenty selected records twice per year for year 2022. B) The Technical Consultant on the CMS 209 form confirmed only selecting five random records during interview on July 28, 2023, at 1:25 PM. 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 --