Summary:
Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and staff interview reveals that the laboratory failed to evaluate its proficiency testing results that were not scored by the PT program. Findings: 2019 1st event Hematology/Coagulation PT performance evaluation included three ungraded results. 1. Ungraded samples included: Urine Sediment US-02, Vaginal Wet Preparation (KOH) VKP-01 and Urobilinogen UA-01. 2. No evidence of lab investigation and evaluation was available for all three results at the time of survey. 3. Interview with Testing Personnel #1 at 9:50 am 7/29/19 confirmed ungraded results for all three samples were not evaluated or investigated. 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 --