Summary:
Summary Statement of Deficiencies D0000 At the time of the announced on-site recertification, the facility was found to be in non-compliance with the CLIA laboratory requirements of 42 CFR 493. . 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 staff interview, the laboratory failed to document annual competency assessment in 2020 on two out of two testing personnel. The findings include: Review of the competency records showed that the laboratory failed to have documentation of annual competency assessments for two out of two testing personnel for 2020. Testing Persons #A, & #B had a competency assessment on 2/9 /21. During an interview with Testing Person A on 3/22/21 at 10:15 AM, it was confirmed that personal competency had not been performed in 2020 for the two testing personnel. 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 --