University Of Miami Immunology And

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 9/9/2024 to 9/12/2024. University of Miami Immunology and Histocompatibility clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to have a uni- directional workflow for Polymerase chain reaction (PCR) testing. Findings Included: During a tour of the laboratory on 09/12/2024 at 11:00 AM , it was a revealed that the laboratoy did not have uni-directional work flow for PCR reageants. The fridges and freezers are located in a corner of the laboratory so reagents and specimen cross through an open space by PCR Elite instrument, Bench top and a acessioning table. Review of ELITe InGenius manual read," The ELITe InGenius system operates in CLOSED or OPEN mode. The CLOSED mode enables the user to run only IVD assay protocols. The CLOSED mode is also considered as a depository including all the IVD validated assay protocol according to the IFUs of the ELITe MGB assays in use. Modification of assay protocols or creation of a new assay protocol are not allowed in the CLOSED mode. The OPEN mode enables the user to run also additional non-IVD user-defined assay protocols developed by the laboratory to fit their specific needs. Review of HISTO MOL 5 VIR BK, CMV & EBV PCR Testing on the EliTech ELITe InGenius System signed by laboratory director on 6/2/2024 read, " Login when prompted (in OPEN mode). Review of HISTO MOL 10 VIR Zika PCR Testing on the EliTech InGenius System signed by laboratory director on 4/13 /2024 read,"Thaw at room temperature the tubes containing the Positive and Negative Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Controls, 20X Zika PreMix, PCR MasterMix and MS2 RNA Internal Control. Mix by vortexing and centrifuge the tubes to bring the contents to the bottom.Prepare the Zika ELITe MGB Monoreagent sufficient for the required number of reactions, including the positive and negative controls according to Table 1 (seebelow)8.7.1 Prepare and label a 2.0 mL Sarstedt tube for the Zika ELITe MGB Monoreagent 8.7.2 Mix by vortexing, centrifuge the tube to bring the content to the bottom, and then keep in orange cooler until ready to transfer to the ELITe InGenius (Trademark) instrument. Prepare the Ready-to-Use MS2 RNA Internal Control Mix sufficient for therequired number of reactions, including the positive and negative controls,8.8.1 Prepare and label a 0.5 mL Sarstedt tube for the Ready-to-Use MS2 RNA Internal Control Mix8. 8.2 First add the nuclease-free water (not included) and then the MS2 RNA Internal Control template. After transferring the MS2 RNA Internal Controlmix the solution several times to ensure complete transfer. Mix by vortexing, centrifuge the tube to bring the contents to the bottom, and then keep the Ready-to-Use MS2 RNA Internal Control mix in the orange cooler until ready to transfer to the ELITe InGenius (Trademark) instrument. Interview on 09/12/2024 at 11:00 PM the Technical Supervisor confirmed PCR testing did not have a uni-directional workflow. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to run quality controls the same day of Zika Virus polymerase chain reaction (PCR) testing for one day out of three months reviewed (September 2022, June 2023 and February 2024). Findings include: 1-Review of policy" HISTO MOL10 VIR Zika PCR Testing on the EliTech InGenius System." Last approval by Laboratory Director on 04/13/2024 revealed that it stated on page 3: "7. QUALITY CONTROL 7.1 Positive and Negative control from kit must be used daily, with expected results. 7.2 Daily, weekly, and monthly maintenance must be performed on the InGenius." 2- Review of Zika quality controls records for September 2022, June 2023 and February 2024 revealed that on 09 /15/2022 there was no quality control records, review of a instrument printout of 09/15 /2022 at 10:28 PM, revealed that the laboratory tested four samples without a quality control. During an interview on 09/11/2024 at 04:30 PM, the Virology Supervisor confirmed that the laboratory did not ran controls on the same testing date of the samples of reference. D5781

Summary Statement of Deficiencies D0000 A recertification survey conducted on 07/8-9/2020 found that University Of Miami Immunology and Histocompatibility 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 follow their employee competency testing policy for testing personnel (TP) for 1 (TP 2) out of 2 (TP1 and TP2) pathologists, acting as TP in the histology specialty. Findings include: 1)Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 07/07/2020 revealed that: -There are 2 pathologist, pathologist 1 (TP 1) is the laboratory director and the second pathologist in the laboratory is TP 2. 2) Record review revealed that the competency assessment provided by the laboratory for TP 2 failed to follow the laboratory employee competency testing policy. During an interview on 07/09/2020 with Laboratory Director at 3:00 pm, he confirmed that the competency for the new pathologist failed to follow the laboratory policy. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure twice a year accuracy verification for Epstein Barr Virus (EBV) Heterophile Antibody detection during 2019 and for the Citrulline quantification in 2018. Findings include: - Review of EBV heterophile antibody detection validation revealed that the completion date was 12/2018. Testing started in January 2019. No record of twice a year accuracy verification was found for 2019. -Review of Citrulline quantification records proficiency testing in the CDC Newborn program, revealed no enrollment in 2018. - During an interview on 07/09/20 at 2:30 p.m., General Supervisor A confirmed that the laboratory failed to perform twice a year accuracy verification for the methods listed above in the years of reference. 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 record review and staff interview, the laboratory failed to document the positive and negative control reactivity verification for the immunohistochemical (IHC) stain that the laboratory performed for 3 out of 3 patients reviewed. The findings include: -Test menu for Immunohistochemical revealed that the laboratory performed the following immunohistochemical stains: Single stain: Adenovirus, Fibrinogen, Simian Virus 40 (SV40), BCL-2 gene, B7, Carbonic Anhydrase IX (CAL IX), CD 1 a glycoprotein, Cluster Differentiation 3 (CD3) protein , CD4, CD8, CD15, CD20, CD138, CD68, CD34, CD79a, C4d, C3d, Chromogranin A, Cytokeratin 7 (CK7), Cytomegalovirus (CMV), Epstein Barr Virus (EBV), Glucagon, Hepatitis Surface antigen (HBs), Hepatitis B Core Antigen (HBc), Human Leukocyte Antigen (HLA-Class II) , Helicobacter Pylori, Herpes Simplex Virus (HSV1), Insulin, Ki-67 protein, Multy-Cytokeratine, Myoglobin, Parvovirus B19, S100, SMPDL3B, S100, Synaptophysin, Uromodulin, Renal Cell Carcinoma (RCC), Inhibin Alpha).Double stain (CD4-CD8, CD3-CD68 CM, CD3-CD20). Immunofluorescence Stain: Immunoglobulin IgG, IgA, IgM; Complement C3, C4, C1q, C4d; Albumin, Immunoglobulin chain Kappa, Lambda; Fibrinogen). -Review of patient report 1, 2 and 3, revealed that 3 out of 3 reports had immunohistochemical stains, however, no documentation of the evaluation of the reactivity of the positive and negative control was founded in laboratory logs or patient reports. During an Interview on 07/09/2020 at 11.30 am, the Histology General Supervisor confirmed that the laboratory failed to document the positive and negative control reactivity for the immunohistochemistry stains for the cases of reference. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the College of American Pathologists (CAP) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on May 7, 2018 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, lactate dehydrogenase, LDH, for two out of three testing events in 2017 and 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the subspecialty of routine chemistry. Findings include: On May 7, 2018 on or about 10:00 AM the College of American Pathologists CAP proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, lactate dehydrogenase, LDH, as shown below. Event #3, 2017 LDH-0% Event #1, 2018 LDH-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On May 7, 2018, on or about 10:00 AM, the College of American Pathologists (CAP) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, lactate dehydrogenase, LDH, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of routine chemistry. Findings Include: The review of the College of American Pathologists (CAP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on May 7, 2018 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency -- 2 of 3 -- testing scores as shown below. Event #3, 2017 Lactate dehydrogenase, LDH-0% Event #1, 2018 Lactate dehydrogenase, LDH-0% -- 3 of 3 --