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 a review of the twice year verification procedure, twice year verification for the histology slides and Wet Mounts, and an interview with the laboratory director, the laboratory failed to verify the accuracy of interpretation of skin biopsies and KOH slides at least twice per year for calendar year 2017. Findings Include: The laboratory director confirmed on October 9, 2018 at approximately 12:30 PM, that the laboratory failed to verify the accuracy of skin biopsies and KOH slides for the calendar year 2017. Approximately 260 patients' slides for Skin Biopsies and KOH were interpreted and reported in calendar year 2017. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of procedures and confirmed in an interview with the laboratory director, the director failed to perform twice annual verification in 2017. Refer to: D5217 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 --