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 review of the laboratory's policies and procedures manual, and an interview with the laboratory's technical consultant #2 (TC #2), the laboratory failed to assess the competency of testing personnel (TP) after their initial competency but within their first 6 months of employment; assess or establish a written policy or procedure for assessing the competency of personnel in the positions of Clinical Consultant (CC), and Technical Consultant (TC). The laboratory conducts approximately 500 tests annually. Findings include: 1. A review of the laboratory's personnel files, and policies and procedures manual, revealed the laboratory was assessing initial and annual competency for TP, but not assessing competency at least 6 months after initial competency was assessed, nor had established a policy or procedure to assess competency of TP at least 6 months after their initial competency was assessed. 2. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency for one out of one of the CC, and two out of two of the TC listed on the CMS-209 Form. The laboratory conducts approximately 500 tests annually. 3. Based on an interview with TC #2, on July 30, 2024, at approximately 11: 30 AM, confirmed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency of TP within 6 months of completing their initial competencies, and failed to assess the competency of, or establish a written policy or procedure to assess the competency of personnel in the positions of CC, and 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 --