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 Training and Competency policy, personnel records, and confirmed by interview with Technical Consultant (TC) #1 at 10:00 am on 07/01/2025, the laboratory failed to follow written policies and procedures for assessing competency for 5 out of 20 new testing personnel hired since the last survey on 07/11/2023. The findings include: 1. The laboratory's Training and Competency policy stated the following under the New Employee heading: "Initially: Perform training checklists, competency & quizzes. 6 months: Perform competency. 1 Year: Perform competency & quizzes." 2. The laboratory hired and documented training for Testing Personnel (TP) #1- #20 since the last survey on 07/11/2023. 3. Review of personnel records did not include documentation of competency assessment performance at 6 months for the following personnel: TP #1, TP #2, TP #3, TP #6, and TP #11. 4. At the time of the survey, TC #1 confirmed the laboratory did not assess and document 6 month competency assessments for TP #1, TP #2, TP #3, TP #6, and TP #11. 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 --