University Of Miami Hepatology Diagnostic

Summary Statement of Deficiencies D0000 A recertification survey was completed on 5/17/2021 at UNIVERSITY OF MIAMI HEPATOLOGY DIAGNOSTIC LABORATORY. The clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to receive a passing score of at least 80% in General Immunology, for the 3rd event of 2020 with the College of American Pathologist Proficiency (CAP). Findings Included : Review of CAP 2020 Proficiency Testing revealed 0% for Hepatitis B surface (HBsAg), 0% for Hepatitis B core antibody (Anti-Hbc) and 33% for General Immunology overall during the 3rd proficiency testing event in 2020. During an interview on 5/17/2021 at 3:51 pm, the office supervisor confirmed that the laboratory received a score of 33% for general Immunology, for the 3rd event in 2020. 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 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted at University of Miami Hepatology Diagnostic on 6/18/2019. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with technical supervisor (TS), the laboratory failed to document the annual competency assessment on 1 out of 1 TS and 1 out of 1 general supervisor (GS) for 2 out of 2 years reviewed. Findings include: Review of CMS 209, Laboratory Personnel Report, dated and signed by the Laboratory Director 6/6/2019 revealed that the TS and GS was the same person. Review of employee documentation showed that the laboratory failed to have documentation of annual competency assessment on TS and GS during 2017 and 2018. During an interview on 06/18/2019 at 11:30 AM, with the TS, she confirmed that there was no competency assessment documented for the period of reference for her as TS and GS. 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 --