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 on interview with the Technical Consultant and Laboratory Supervisor, it was determined the laboratory failed to follow written policy to document training and assess testing personnel competency for performing Vaginal KOH (Potassium Hydroxide) and Wet Prep Analysis for 2018 and 2019. The findings include: 1. A review of the QA Plan revealed the following policy: "New personnel are to be adequately trained prior to testing, semi-annual competencies to be documented during first year, then annually, thereafter". 2. A review of personnel records for testing personnel number one and number two revealed no annual competencies documented for 2018 or 2019. 3. A review of personnel records for testing personnel number three (hire date in April 2019) revealed no training or semi- annual competency documentation and testing personnel number four (hire date in August 2019) revealed no training documentation. 4. On interview at approximately 1: 00 p.m. January 14, 2020, the Technical Consultant and Laboratory Supervisor confirmed the laboratory failed to have documented competencies for testing personnel number one and two for 2018 and 2019 and documented training and semi- annual competency for testing personnel number three and documented training for testing personnel number four 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 --