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 competency assessment records review and interview with Testing Personnel (TP) #1, the laboratory failed to perform and complete competency assessment on 13 of 13 testing personnel who performed Blood Gas analyzes tests in 2017. Findings Include: A. 1. The laboratory's Competency Assessment Program Policy, under Principles states, "The employee will not be scheduled to work independently on any procedure or instrument method until that item has been signed off on the training checklist by the department supervisor, or designee. Sign off indicates that the employee has demonstrated competency and can perform testing ....". 2. On the day of survey, 12/13/2018, the laboratory was unable to provide documentation of 2017 competency assessment records for 8 out of 13 (TP# 1, 3, 5, 6, 7, 8, 9, and 13) testing personnel who ran patient specimens on the Gem 4000 Blood Gas analyzer. 3. TP #1 confirmed the finding above on 12/13/2018 around 9:30 am. B. 1. On the day of survey, 12/13/2018, review of testing personnel competency assessment records revealed, in 2017 TP #1 (laboratory supervisor) signed off on 5 of 13 (TP# 2, 4, 10, 11, 12) TP competency assessment records. TP#1 holds an Associate of Science in Respiratory Therapy, which does not meet the minimum qualifications to perform the regulatory responsibly of a technical consultant. 2. TP #1 confirmed the findings above on 12/13/2018 around 9:15 am. 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 --