Summary:
Summary Statement of Deficiencies D0000 Based on an on-site complaint survey conducted on March 30, 2026, deficiencies were cited for Quality Urgent Care, PC laboratory located in Boulder, 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 a review of the laboratory policies, personnel files, and an interview with the technical consultant (TC) 1 and technical consultant (TC) 2 during the survey, the laboratory failed to assess Medonic Complete Blood Count (CBC) annual competency for testing personnel (TP) 1-4 and semiannual competency in the first year of employment of testing personnel 5-7. The laboratory also failed to develop a written policy for assessing technical consultant competency. The laboratory performs approximately 2000 CBC tests annually. Findings include: 1. A review of the laboratory personnel files and laboratory policies revealed that the laboratory assessed CBC competency for TP 1-4 in 2024 but did not assess annual CBC competency for 2025. Additionally, a review of the personnel files revealed that TP 5-7 was hired in 2025. There were no initial and semiannual competency assessments for TP 5-7. 2. A review of the personnel files and laboratory policy revealed that the laboratory failed to assess the competency of or establish a written policy for assessing the competency for technical consultants. 3. An interview with TC 1 and TC 2 on March 30, 2026, at 12:00 PM confirmed that the laboratory failed to assess Medonic Complete Blood Count (CBC) annual competency for TP 1-4 and semiannual competency in the first year of employment of TP 5-7. The laboratory also failed to establish a written policy for assessing TC competency. 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 --