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 record review and an interview with the Laboratory Director (LD), the laboratory failed to follow their written policies and procedures for annual competency assessment for one out of one Testing Personnel (TP) performing high complexity hematology procedures. This deficient practice had the potential to affect all patients tested in the specialty of hematology. Findings include: 1. Review of the laboratory's 'Continuing Education and Employee Reviews' policy and procedure found the following statement: "Employees will be reviewed annually..." 2. Review of the laboratory's competency assessment documentation found the lab failed to complete a 2018 annual competency assessment for TP #1, as stated in the approved policy. 3. An interview with the LD, on 11/19/19 at 12:28 pm, confirmed that the lab failed to ensure a 2018 annual competency assessment was completed for TP #1. 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 --