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 laboratory policy, review of testing personnel (TP) competency assessment records and interview with technical consultant (TC) 5/1/23, the laboratory failed to ensure the competency assessment policy was followed for performing direct observation assessments of TP competency. Findings: Review of laboratory policy "Personnel Competency Assessment" revealed "V. Procedure 1. Team Member Competency Assessment Plan...a. Non-Waived Testing: ...Competency assessments for each individual non-waived test must include all of the following elements that are applicable to the individual's duties: 1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen collection/handling, and the processing of each test...4. Direct observations of performance of instrument maintenance and function checks....". Review of random TP competency assessment records revealed "Subtask 1 Direct Observation - Observe patient or quality control testing, OR Personnel able to correctly verbalize testing procedure...Subtask 5 Maintenance- Record date of maintenance performed, OR Observe maintenance, OR Personnel able to correctly verbalize maintenance procedure, including frequency". The competency assessment records include an option to "correctly verbalize testing procedure" and "correctly verbalize maintenance procedure" instead of performing direct observations as required. Interview with TC at approximately 2:30 p.m. confirmed the laboratories competency assessments included the option to verbalize testing and maintenance procedures instead of performing direct observations. She stated that verbalizing is used occasionally when direct observations are unable to be performed. 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 --