Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of competency records and interview with the interim Lab Quality and Compliance Manager, the laboratory failed to ensure testing personnel (TP) performing wet mounts underwent biannual verification competencies. Findings include: 1. During survey 12/07/2020, a request was made by surveyor to review record of biannual verification for TP performing potassium hydroxide (KOH) preparations and vaginal wet mount preparations for seven (7) TP. None could be produced for 2019 or 2020. 2. The Lab Quality and Compliance Manager and the Point of Care Testing Manager confirmed during interview 12/7/2020 at approximately 2:30 pm that it was not currently the policy of Kaiser to require biannual verification for TP performing KOH and vaginal wet mounts. 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 --