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 Quality Assurance (QA) Plan, Technical Consultant (TC) and testing personnel (TP) records, and an interview with the Nurse/Laboratory Manager, determined the laboratory failed to follow written policies to assess 2018 annual TC competency and failed to complete annual competency documentation for 4 of 20 TP performing Complete Blood Counts (CBC's) in 2018. The findings include: 1. A review of the QA Plan revealed that TC and TP competencies would be assessed annually. 2. A review of personnel records revealed no annual competency documented for TC for 2018. 3. A review of personnel records revealed incomplete competency documentation for 4 of 20 TP to include TP numbers 11, 12, 14, and 16 in 2018 for CBC testing. 4. An interview with the Nurse/Laboratory Manager at approximately 1:00 p.m. August 15, 2019 confirmed the laboratory failed to follow QA Plan for assessing annual competency for TC in 2018, and for incomplete documentation of annual competencies on TPs 11, 12, 14, and 16 for 2018. ===================================== 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 --