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 Technical Consultant (TC) #1, the laboratory failed to follow a written policy and procedure to assess competency of Testing Personnel (TP) #6 and TP #7 as required in the personnel requirements in subpart M. This deficient practice had the potential to affect two out of 33 TP in the specialties of Hematology, Chemistry and Microbiology. Findings Include: 1. A review of the laboratory's CMS-209 form, approved and signed by the Lab Director on 11/26/2024, found 33 individuals listed as TP. 2. A review of the laboratory's "Competency Assessment Instructions" policy and procedure found the following statement: "...Competency assessment is required for all employees and must be performed semiannually (six months after deemed competent and again in six months) during the first year the individuals test patient specimens..." 3. A review of the laboratory's competency assessment data for TP #6 and TP #7 found the following: TP # Initial 6 Month 6 2-26-24 [none] 7 8-30-23 8-12-24 4. The surveyor requested the 6 Month competency assessment documentation for TP #6 and TP #7 from TC #1. An interview with TC #1, on 12/02/2024 at 2:14 PM, confirmed that the laboratory failed to perform a 6 Month competency assessment for TP #6 and TP #7 and was unable to provide the requested documentation on the date of the survey. 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 --