Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 14, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: 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 review of the Personnel Competency documents and staff interview, the laboratory failed to provide Competency Assessment documents for all employees for the past two years. Findings: 1. Review of the Personnel Competency documents showed that the following personnel did not have documentation of a Competency Assessment as required: (Using the CMS 209 Personnel form for identification) #2, had initial training 1-18, there was no 6 month, or 12 month documentation #3, had initial training 4-17, there was no 6 month, or 12 month documentation #6, had initial training 4-17, 6 month 11-17, no 12 month documentation #7, had yearly competency 5-17, but did not have competency 5-18 2. Staff interview with the Practice Manager, and Practice Consultant on 3-14-2019, at approximately 1:45 pm confirmed that the aforementioned competency performance dates were correct. 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 --