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 proficiency evaluation documentation for 2016, 2017 and 2018, the laboratory failed to verifiy the accuracy of urine sediment analysis at least twice annually. Findings: 1. Proficiency evaluation documentation was reviewed. Accuracy verification through examination of urine sediment photomicrographs was found for the following dates: Testing person 1 (CMS form 209) 26 April 2016 18 August 2017 02 March 2018 Testing person 2 18 August 2017 02 March 2018 Testing person 3 18 August 2017 02 March 2018 2. Review of the laboratory policy and procedure manual showed, in the section marked Competency Testing, the following: "B. Microscopic exam of urine sediment The Laboratory Medical Director or his/her designee will be responsible for personnel competency testing through evaluation of patient testing, CAP Urinalysis slide unknowns and/or direct observation which will be obtained, demonstrated and documented at least annually for all testing personnel." 3. In an interview at the site on 04-13-2018, the laboratory director stated that he was not aware accuracy verification for urine sedimen examination must be performed twice annually. . 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 --