Summary:
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 record review and an interview with Testing Personnel #1 (TP #1), the laboratory failed to establish and follow written policies and procedures to assess the competency of the Clinical Consultant, (CC) based on the responsibilities of that position for the moderate complexity iStat Arterial Blood Gas (ABG) testing procedures performed in the subspecialty of General Chemistry and the specialty of Hematology. This deficient practice affected one out of one Clinical Consultant. Findings Include: 1. Review of the laboratory's Form CMS-209, approved via signature and date by the Laboratory Director on 12/07/2025 and provided on the date of the inspection, found one qualified individual that performed in the role of the CC from the beginning of patient testing, 04/13/2025. 2. Review of the laboratory's competency records did not find any competency assessment documentation for the CC from the beginning of patient testing, 04/13/2025 through 12/09/2025. 3. Review of laboratory records revealed a total of 14 patients were tested for ABG over seven months, from beginning of patient testing 04/13/2025 through 12/09/2025. 4. An interview with TP #1 conducted on 12/09/2025 at 1:33 PM confirmed that the laboratory failed to conduct CC competency assessment from beginning of patient testing, 04/13/2025 through 12/09/2025. 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 --