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 laboratory records and patients records and reports for biosies and Mohs procedures, the lack of laboratory documents, and interview with a laboratory administrative person, it was determined that the laboratory failed to at least twice annually verify the accuracy of test reports from 2 out of 3 testing persons in 2017 and 2018. Findings included: a. Review of Mohs log books for 2017 and 2018 revealed Testing Persons 1 and 2 both performed procedures. Review of pathology reports revealed a third testing person provided diagnoses for Biopsies in 2017 and 2018. b. The laboratory provided for review documents verifying the accuracy of testing in 2017 and 2018 for Testing Person-1. The laboratory failed to provide documents for Testing Person-2 and the third testing person. c. An administrative person affirmed (2 /21/19 at 3:00 pm) that there were no documents for "peer review" of histopathology slides reported by Testing Person-2 and the third testing person; and thus, the laboratory failed to at least twice annually in 2017 and 2018, verify the accuracy of testing for these two testing persons. d. The reliability and quality of biopsy reports and Mohs procedures by two testing persons in 2017 and 2018 could not be assured in the absence of slide reviews to verify the accuracy of testing. A few examples are as follows: Year Slide # ---------------------------------- 2017 DL-0126 " DL-0127 " DL- 0721 " C17-0429 " C17-0598 2018 DL18-002 " DL18-003 " DL18-023 e. Based on the stated annual histopathology test volumes including biopsies and Mohs procedures, the laboratory reported between 450 - 2610 reports 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 --