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 review of the Quality Assurance (QA) Plan, testing personnel records for providers performing KOH and Wet Prep Analysis, and upon interview with the Site and Clinical Supervisor, it was determined the laboratory failed to have a written policy to document training and assess testing personnel competency for performing KOH (Potassium Hydroxide) and Wet Prep Analysis for 2018 and 2019. The findings include: 1. A review of the QA Plan revealed no documentation of policy for KOH/Wet Prep Analysis training (prior to testing), semi-annual competencies during the first year and annually thereafter. 2. A review of personnel records for testing personnel revealed no initial training, semi- annual or annual competencies documented for KOH/Wet Prep Analysis for all testing personnel for 2018 or 2019. 3. An interview at approximately 3:00 p.m. February 12, 2020, with the Site and Clinical Supervisor confirmed the laboratory failed to have a documented policy for training, semi-annual and annual competencies, training documentation, semi-annual and annual competencies for all testing personnel for performing KOH and Wet Prep Analysis. ==================================== 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 --