Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 05/27/20 at Elise Chang Hillmann, M.D., a clinical laboratory in Jupiter, Florida. Elise Chang Hillmann, M.D. was not in compliance with 42 Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. 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 record review and interview with the laboratory director, the laboratory did not verify the accuracy of histology slide interpretation twice annually. Findings include: Review of profiiency testing records on over the past two years on 05/27 /2020 revealed that the laboratory did proficiency testing 12/7/2018, 2/26/2019, and 4 /17/2020. The laboratory did not verify accuracy twice annually in 2018 and 2019. The Peer Review Services Agreement in the procedure manual indicated that three regular derm cases would be sent out for review from an outside laboratory every six months. During an interview with the laboratory director at 10:40 a.m. on 05/27/2020, she confirmed that there was one set of cases sent out for proficiency testing in 2018 and 2019. 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 --