Summary:
Summary Statement of Deficiencies D0000 Based on an on-site initial certification survey conducted on March 12, 2025, deficiencies were cited for UC Health Heart and Vascular Clinic - Harmony Campus in Fort Collins, Colorado. 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 laboratory's policies and procedures manual, and an interview with technical consultant 1 (TC1), the laboratory failed to establish and follow a written policy or procedure to assess the competency of personnel in the position of technical consultant (TC). The laboratory conducts approximately 450 chemistry tests, and 100 hematology tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to establish and follow a written policy or procedure to assess the competency of two out of two of the TC listed on the CMS-209 Form. 2. Based on an interview with TC1 on March 12, 2025, at approximately 10:00 AM, confirmed that the laboratory failed to assess the competency of or establish a written policy or procedure for assessing the competency of personnel in the position of TC. 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 --