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 Office Manager, the laboratory failed to follow a written policy and procedure to assess competency of Testing Personnel (TP) #1 and TP #2 in the year 2022 as specified in the personnel requirements in subpart M. This deficient practice had the potential to affect 8448 patients tested at the laboratory by two out of two TP in the subspecialty of histopathology in the year 2022. Findings Include: 1. A review of the laboratory's CMS-209 form, approved and signed by the Lab Director on 02/15/2023, found two individuals listed as TP. 2. A review of the laboratory's "Competency Assessment for Histology Technicians" policy and procedure found the following statement:"...They will have biannual competency reviews on or before their anniversary date of hire.." 3. A review of the laboratory's competency assessment data for the year 2021 found the following: TP #1 2021 competency assessment: "5-14-21" TP #2 2021 competency assessment: "5-14-21" 4. The surveyor requested competency assessment documentation for the year 2022. 5. An interview with the Office Manager, on 02/21 /2023 at 1:34 PM, confirmed that the laboratory failed to perform a competency assessment for TP #1 and TP #2 in the year 2022. 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 --