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 personnel competency assessments, review of laboratory policies and procedures, and interview with the Lab Director (LD) on 6/3/26, the laboratory failed to establish and follow written policies to assess Technical Consultant (TC) competency. 1. Review of 2025 and 2026 personnel competencies revealed 5 of 5 testing personnel (TP) received appropriate competency assessments for testing responsibilities. There was no documentation of competency assessment for the TC's duties. 2. Review of the laboratory's policies and procedures revealed the absence of competency assessment procedures for the TC's duties. 3. During an interview at approximately 2:30 p.m., the LD confirmed there was no written competency assessment available for the role of TC. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of Testing Personnel (TP) competency assessments, absence of written Technical Consultant (TC) delegation of duties, and interview with the Lab Director (LD) on 6/3/26, the Lab Director failed to specify the duties of the TC in writing. 1. Review of 2025 and 2026 personnel records revealed that 4 of 5 testing personnel competency assessments were evaluated by TP1 in 2025 and 2026. There were no written documents delegating TC duties to TP1. 2. During an interview at approximately 2:30 p.m., the LD confirmed the TC had competently performed the duties of the role but there was no written list of TC duties available for review. -- 2 of 2 --