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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on two out of two TP in the calendar year 2017. The findings include: 1. Direct observation of instrument maintenance was not assessed. 2. The laboratory did not document how CA was assessed. 3. The TP #1 listed on CMS form 209 confirmed on 6/18/18 at 10: 00 am that CA was not performed correctly. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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 Records (PR) and interview with the Testing Personnel (TP), The Laboratory Director failed to ensure that one of one new 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 -- TP had appropriate education and training documented prior to patient testing from January 2018 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 6 /18/18 at 10:20 am that education and training were not documented. -- 2 of 2 --