Nova Southeastern University -

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/24/2023 found the NOVA SOUTHEASTERN UNIVERSITY - ORAL PATHOLOGY SERVICES clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on patient report, slides review and interview, the laboratory failed to have and record the negative control reactivity verification for the immunohistochemical (IHC) stain interpretation that the laboratory performed at least since 01/01/2022 to present for six out of six patients reviewed. Findings included: - The laboratory performed only the microscopic examination of the slides. -Review of the Form CLINICAL LABORATORY IMPROVEMENT AMMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION Form CMS-116 signed by the Laboratory Director on 08/19 /2023 revealed the following test menu for IHC: CD45 (Cluster of Differentiation 45 leukocyte IHC stain), CD3, CD20, Actin-HHF-35(Muscle Specific IHC stain), AE1 /AE3 (Epithelial IHC stain), Calponin, CD1a, CD4, CD8, CD68, Desmin, EMA (Epithelial Membrane Antigen IHC stain), Epstein-Barr virus latent membrane protein, Factor XIIIa, HMB45 (Anti-Human Melanosome IHC stain), Ki-67 (Nuclear Non-histone Protein IHC stain), MART-1/Melan-A (Melanocytic Marker IHC stain), Pan Keratin (Epithelial IHC stain), S100 (Neural Tissue/Lesion and Melanoma IHC Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- stain), SOX-10 (Melanoma IHC stain), Synaptophysin (Neuroendocrine cell IHC Marker), Vimentin (Mesenchymal Cells IHC stain). - Review of six final reports and slides for the following cases revealed: a) Patient #1 (dated 06/03/2022). The report listed the use of IHC stain Epstein-Barr virus latent membrane protein, slide review revealed no negative control found. b) Patient #2 (dated 09/06/2023): The report listed the use of IHC stains Desmin, AE1/AE3 and Pan Keratin, slides review revealed no negative control. c) Patient #3 (dated 05/22/2023): The report listed the use of IHC stains EMA, Vimentin and Pan Keratin; slides review revealed no negative control used. d) Patient #4 (dated 06/09/2023): The report listed the use of IHC stains AE1 /AE3 and SMA, slides review revealed no negative control used. e) Patient #5 (dated 06/28/2023): The report listed the use of IHC stains SOX-10 and EMA, slides review revealed no negative control used. f) Patient #6 (dated 08/09/2023): The report listed the use of IHC stains SOX-10, mart-1 and hmb-45, slides review revealed no negative control used. During an interview on 08/24/2023 at 10:30 AM, the laboratory director confirmed that the laboratory failed to have and record negative control reactivity for the immunohistochemistry stains for the cases of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/04/2019 found that Nova Southeastern University clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 staff interview, the laboratory failed to perform annual competency assessment for 1 out of 2 testing personnel (TP) for 2 out of 2 years reviewed. Findings include: 1) Review of CMS form 209 Laboratory Personnel Report dated and signed by the Laboratory Director on 12/04/2019 revealed that: -The Laboratory Director, Clinical Consultant (A), Technical Supervisor, General Supervisor (B) and Testing person (TP) B, was the same person. -Clinical Consultant (B), General Supervisor (A), Testing person (TP) # A was same individual. 2) Review of personnel files revealed that there was no documentation of the annual competency assessment for TP # A for 2018 and 2019. During an interview on 12/04/2019 at 1:00 PM, with Laboratory Director, she confirmed that there was no documentation of the competency assessment for TP A for the period of reference. 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 --