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 lack of the Competency Assessment (CA) records, review of the personnel files and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on eighteen out of eighteen in the calendar year 2018. The TP #4 listed on CMS form 209 confirmed on 3/19/19 at 12:45 pm that CA was not performed on TP. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Personnel (TP), the Laboratory Director failed to have education documented for twelve out of eighteen TP on the date of survey. The TP #4 listed on CMS form 209 confirmed on 3/19/19 at 1:10 pm that all TP did not have education documented. -- 2 of 2 --