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 laboratory personnel interview with the Laboratory Manager and review of the competency records, the laboratory failed to assess employee competency for 1of 1 Testing Personnel, from (03/19/2018) through the date of the survey (06/15/2020). Findings: 1. Review of the competency records revealed forms used to document competency, did not indicate platforms used for patient testing, from (03/06/2018) through the date of the survey (08/11/2020). 2. On the date of the survey (08/11 /2020), the Roche e411 for chemistry & the Roche Lightcycler 480 II for molecular testing, were available for patient testing. 3. During the survey (08/11/2020), the Laboratory Manager confirmed, the above findings. 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 --