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 Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on six out of six testing personnel for the calendar years 2016 and 2017. The TP #1 listed on CMS form 209 confirmed on 3/29/18 at 10:00 am that the CA was not performed. 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 Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director failed to have education records for one out of six Testing Personnel from 11/13/15 to the date of the survey. The TP #1 listed on 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 -- CMS form 209 confirmed on 3/29/18 at 10:30 am that there were no education records for one out of six TP. -- 2 of 2 --