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, and an interview with Technical Consultant #1, determined the laboratory failed to follow written policies to assess testing personnel competency annually for Potassium Hydroxide (KOH) for Mycology (fungal) and Wet Preps (Vaginal Mount) for Parasitology for 2017 and 2018. The findings include: 1. A review of the QA Plan revealed that testing personnel competencies would be assessed annually by the Laboratory Director or Designee. 2. A review of the personnel records revealed that testing personnel number 6-64 (Medical Doctors and Mid-Level Providers) had no competencies documented for for 2017 and 2018. 3. An interview with the Technical Consultant #1 at approximately 11:30 a.m. December 5, 2018, confirmed the laboratory failed to follow QA Plan for assessing annual competency for testing personnel number 6-64 for KOH for Mycology (fungal) and Wet Preps (Vaginal Mount) for Parasitology for the two year period. 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 --