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 reviews, and an interview with the General Supervisor (GS) #1, the laboratory failed to follow a written policy and procedure to assess the competency of Testing Personnel (TP) #34 as specified in the personnel requirements in subpart M. This deficient practice had the potential to affect all patients tested by TP #34 in the specialties of Chemistry, Hematology and Immunohematology from 10/01/2020 through 04/01/2022. Findings Include: 1. A review of the laboratory's form CMS-209 Personnel Report, approved and signed by the Lab Director on 12/13/2022, found 63 individuals listed as TP. 2. A review of the laboratory's "Competency Assessment - Laboratory, WI No. LG-05" found the following statement: "Competency assessment is performed periodically during the year of the employees performance appraisal cycle. Competency must be assessed at least semiannually during an individual's first year of employment, and assessed at least annually thereafter." 3. A review of six out of 63 TP "staff folders" found a hire date of 04/2020 for TP#34. Further review found the initial competency assessment dates for TP#34 of 04/2020, 05/2020 and 06/2020, and an annual review date of 04/2022, however no semiannual competency assessment records were found. 4. The inspector requested the semiannual competency assessment documentation for TP #34 from the GS #1. The GS #1 confirmed the laboratory failed to perform a semiannual competency assessment as stated in the policy and procedure for TP #34 and was unable to provide the requested documentation. The interview occurred on 12/13/2022 at 11:35 AM. 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 --