2014 Quality & Donor Suitability Workshop

Agenda

  • Sunday, March 9, 2014
  • Registration Opens at 4:00 PM
  • Monday, March 10, 2014
  • Registration Opens at 7:30 AM
    7:30 AM  -  8:45 AM
    Breakfast
    8:45 AM  -  9:00 AM
    Welcome and APP Instruction
    9:00 AM  -  10:00 AM
    Med-Soc Discrepancies and Interview Recordings Documentation
    This panel discussion will address different perspectives and elements to resolving discrepancies that occur after a Medical Social Questionnaire or Donor Risk Assessment Interview is completed. Regulatory requirements, industry interpretations, and sensitivity to the donor family will be some perspectives considered. Compliance fundamentals, multiple organization variances, and best practice policies will be some elements reviewed.

    Allyson May (Quality Systems Coordinator, CTS Portland); Alan Taylor, BS (Director, Tissue Services, Donor Network of Arizona); and Martha Wells, MPH, RAC (Vice President, Regulatory Affairs for Tissue and Biologics, Reglera)
    10:00 AM  -  11:00 AM
    Medical Examiners: Critical Partnerships in Tissue Donation
    While understanding there is no National , or universal accepted system across the Unites States, Forensic Death Investigations should be performed according to set standards, and performed in accredited facilities when possible. There are 2 main agencies who accredit Forensic offices - NAME and IAC&ME. This presentation will focus on the requirements and standards of death investigation with direct bearing on tissue donation. Understanding, and then building cooperative practices based on known requirements, and facilitating performance of the expected standards for death investigation should enhance the relationships between the agencies when combining efforts to maintain forensic standards, and accreditation requirements while maximizing tissue donation.

    Samantha Wetzler, MD (Assistant Medical Director, Life Net Health) and Louis Jares, CTBS, CEBT, D-ABMDI (Education Director, MTF)
    11:00 AM  -  11:15 AM
    Break
    11:15 AM  -  12:00 PM
    The Impact of Non-Transplantable Tissue on Donor Families
    Tissue donation and transplantation allows an individual the opportunity to potentially help others at the time of their death, offers solace and comfort to families and provides the hope of renewed health to those who wait. When gifted tissues cannot be recovered or placed for transplantation, the meaning making and comfort that donation can provide may appear to be no longer available resulting in a secondary loss and renewed grief may follow.  In this session we will explore the impact of non-transplantable tissue(s) on donor families by identifying:
    a. family perceptions of the donation and transplant process.
    b. the importance of framing for families during the donation conversation what we can and cannot control in the tissue donation process.
    c. family sensitive language that can be used to explain why tissue donation and/or transplantation may not be able to move forward.
    d. the importance of protocols to identify how to share this information with families in a timely, sensitive and compassionate manner.

    Pam Albert (NEOB)
    12:00 PM  -  1:00 PM
    Lunch
    1:00 PM  -  1:45 PM
    Part A: Audits - Internal and External Approaches
    Can your organization's audit process use some improvement? Of course it can! This two part presentation will explain the key components of the internal and external audit processes, explore the roles and responsibilities of the auditor, and elaborate on how to ensure that all aspects of the audit are effective. You will leave with a better understanding of how an audit can be of benefit to all parties involved.

    Sue Brewster, BSN, CQA, CTBS (Regulatory Compliance Manager, LifeNet Health); Andrew Maple (Donor Network of Arizona); and Michelle Timmins, BA, CTBS (QA Auditor - Analyst, AlloSource)
    1:45 PM  -  2:30 PM
    Part B: Successful Audits and Appropriate Responses, Including CAPA
    Can your organization's audit process use some improvement? Of course it can! This two part presentation will explain the key components of the internal and external audit processes, explore the roles and responsibilities of the auditor, and elaborate on how to ensure that all aspects of the audit are effective. You will leave with a better understanding of how an audit can be of benefit to all parties involved.

    Sue Brewster, BSN, CQA, CTBS (Regulatory Compliance Manager, LifeNet Health); Andrew Maple (Donor Network of Arizona); and Michelle Timmins, BA, CTBS (QA Auditor - Analyst, AlloSource)
    2:30 PM  -  3:00 PM
    Break
    3:00 PM  -  3:45 PM
    Root Cause Analysis Methods
    Root cause analysis (RCA) can be used to effectively resolve problems. When applied correctly, it ensures underlying issues are identified, so that effective corrective actions are taken. In this presentation we will discuss various methods to use, when to use them, and we will apply them in some typical tissue bank scenarios.

    Tim Maye, BSMT, CTBS (Director, Quality Systems, LifeNet Health)
    3:45 PM  -  4:15 PM
    Liver Disease - What's the Scope?
    Donor eligibility determination requires that prospective cell and tissue donors be screened by reviewing relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. One such relevant disease is hepatitis. Hepatitis infection may manifest as: (a) a positive or reactive screening test for hepatitis B virus or hepatitis C virus; (b) unexplained jaundice (icterus); and (c) unexplained hepatomegaly. The latter two conditions are not specific for viral hepatitis. Hepatitis is defined as inflammation of the liver. Liver-specific viruses including hepatitis A, B, C, D, and E may cause acute and/or chronic liver disease, although frequently these are asymptomatic. Viral infections that commonly present with other signs and symptoms can also result in inflammation of the liver, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV). The causes of liver inflammation and injury also include many conditions that are not caused by infectious agents. These include drug and toxin induced injury, ischemic injury, metabolic conditions, gall bladder and biliary diseases, and liver involvement in systemic diseases. This presentation will present an overview of liver disease and discuss etiologies, both infectious and non-infectious.

    Hannis Thompson, MD (Medical Director, AlloSource)
    4:15 PM  -  5:00 PM
    AATB Accreditation and Re-Accreditation Application Process
    This presentation will give a step-by-step description of the AATB accreditation process, including the application , inspection and post-inspection processes. There will be discussion of the new paperwork and expectations along with upcoming changes to Accreditation Policies. Top nonconformities and observations from the last three years will be presented in order to discuss potential trends. There will also be a long question and answer/discussion period.

    Jason LoVerdi, MHA, CTBS (Accreditation Manager, AATB)
  • Tuesday, March 11, 2014
  • 8:00 AM  -  8:30 AM
    Breakfast
    8:30 AM  -  9:30 AM
    Physical Assessment Findings- What Do We Do with Them?
    Presentation will support the basic information required by AATB Standards and the FDA regarding the donor physical assessment and how work through discovering abnormal findings & conflicting information when comparing the Medical-Social Health History with a donor physical exam. In addition, information and findings that promote critical thinking in evaluating the donoros physical assessment when Medical Examiners and Funeral Homes have maintained custody of the donor prior to recovery.

    Ed Ferreol, MD (Senior Manager, National Trainers, LifeNet Health); Josiah Anaya, MPH (National Trainer, CTS) and Darrel Lewis, MBA, CTB, CEBT (Education Director, Procurement, MTF)
    9:30 AM  -  10:30 AM
    Determining Staff Competency: Documenting and Tracking Training and Assessments
    Matt Graves (Manager of Tissue Services, Nevada Donor Network); Jami Otis, CTBS (Training Manager, AlloSource) and Alan Taylor, BS (Director, Tissue Services, Donor Network of Arizona)
    10:30 AM  -  10:45 AM
    Break
    10:45 AM  -  11:30 AM
    Cancer and Donor Suitability
    Donor eligibility in individuals with current or past malignancies is a topic not specifically addressed by current FDA regulations. The AATB does have a section on the topic. Section D4.240 states: Donors with current or prior diagnosis of malignancy shall be evaluated bt the Medical Director (or designee) for suitability in accordance with the tissue bank's SOPM. Evaluation shall include: the type of malignancy, clinical course, and treatment prior to acceptance of the donor. Evaluation and reasons for acceptance must be documented in the donor's record. Each facility is required to address the issue in the SOPM but guidelines do not list specific conditions that would automatically rule out a prospective donor, leaving that determination to the individual facility. Acceptability criteria vary widely among different facilities. This session will present an overview the some of the available literature regarding transplantation and malignancies.

    Gregory Ray, MD (Medical Director, CryoLife) and Hannis Thompson, MD (Medical Director, AlloSource)
    11:30 AM  -  12:15 PM
    A Closer Look at Lyme Disease
    Ocular and skin tissue recovered from a donor in 2013 - Post recovery, post-eligibility determination and post-transplant we received a report from a state public health department that the Center for Disease Control had determined this decedent had expired from myocarditis associated with Borrelia burgdorferi (Lyme). This case study will review: 1. Brief patient history 2. Tissue recovery and donor elegibility 3. The role of the state public health department 4. The role of CDC in confirming results 5. Field safety actions - process and outcomes 6. Roles of risk management, health hazard evaluation and medical director review 7. FDA's current view of Lyme Disease - potential transmission & required (if any) filed safety actions 8. Voluntary field safet actions and outcomes 9. Additional skin and cornea tissue from decedant submitted to CDC for confirmatory testing & results 10. Discussion - Review ideas for improvement in protecting public health

    This presentation will also include a brief overview of the clinical characterisitics and epidemiology of Lyme Disease. Case studies will be presented detailing two potential tissue donors from the Northeastern United Satates who experienced sudden death due to unsuspected Lyme carditis. Details describing current testing methods for the diagnosis of Lyme Disease will also be provided.

    Greg Ray, MD (Medical Director, CryoLife) and Don Fletcher (Vice President, Quality Assurance & Regulatory Affairs, Tissue Banks International)
    12:15 PM  -  1:15 PM
    Lunch
    1:15 PM  -  2:15 PM
    Microbiologic Surveillance Program and Process Validation - A Sneak Peak at the Guidance Document
    The guidance document on Microbiologic Surveillance and Process Validation has been in preparation for some time. A final draft was submitted to FDA, who provided many comments. A task force has been reviewing the FDA comments, editing the document accordingly and providing responses to the FDA. This presentation will cover the primary FDA comments and the resulting changes to the document (Martell Winters) as well as the key points from the document (Alyce Lindhurst-Jones).

    Alyce Linthurst Jones, PhD (Director, Cardiovascular Product Development, LifeNet Health) and Martell Winters, BS, RM/SM(NRCM) (Senior Scientist, Nelson Laboratories)
    2:15 PM  -  2:30 PM
    Break
    2:30 PM  -  5:15 PM
    ROUND TABLE DISCUSSIONS
    You may select one topic to attend during each time slot. You will have the opportunity to attend up to three sessions total.

    Interactive sessions returning by popular demand! These discussions are intended to promote open dialogue on topics relevant to eye and tissue banking. Participants are encouraged to share their ideas and/or potential solutions concerning challenges they face in their workplace. You may select one topic to attend during each time slot. You will have the opportunity to attend up to three sessions total. Assigned facilitators will lead each discussion.

    Roundtable Discussions Timeframes
    2:30 PM - 3:15 PM - Round One
    3:30 PM - 4:15 PM - Round Two
    4:30 PM - 5:15 PM - Round Three

    1. Med-Soc Discrepancies and Interview Recordings Documentation
    2. Physical Assessment Findings – What Do We Do With Them?
    3. Microbiologic Surveillance Program and Process Validation – A Sneak Peek at the Guidance Document
    4. Internal and External Audits – Approaches and Responses
    5. Determining Staff Competency
    6. Recovery and Processing Deviations Which Make the Donated Tissue Not Suitable for Donation
    7. Root Cause Analysis
    8. Moving Forward on Recovery Without a Med/Soc or First Person Designation Only
    9. Ask the Doc
    10. "Chartomegaly"
    5:30 PM  -  6:30 PM
    Wine & Cheese Reception
  • Wednesday, March 12, 2014
  • 8:30 AM  -  9:00 AM
    Breakfast
    9:00 AM  -  9:45 AM
    Correlation of Risk Behaviors with Viral Markers in Tissue Donors
    Reliability of the Med-Soc Hx and the Historian

    Evaluation of the medical and social history of potential tissue donors is used to determine suitability of their tissue for transplantation. This kind of information will be compared with serologic and nucleic acid based tests of the donors blood to ascertain predictive value of historical information.

    David Gocke, MD (Medical Director, MTF)
    9:45 AM  -  10:45 AM
    Tissue Recovery Honoring First Person Authorization Prior to Family Contact
    Review experiences of a 10-case pilot project in which tissue was recovered in accordance with the documented wishes of the decedent in a donor registry, but prior to any contact with legal next of kin. We will describe the criteria for case selection; recovery logistics (e.g., whether or not to transfer to recovery site or remain at donor hospital); contact with next of kin post recovery; and a description of the families' feelings about the process and their loved ones decision. We will also explore the risks associated with recovery prior to family contact (e.g., procurement fees, testing, shipping, and storing tissue) and the necessity to secure a tissue bank partner for this endeavor.

    Matt Graves (Manager of Tissue Services, Nevada Donor Networks) and Bruce Nicely, RN, MSN, CPTC (CCO, Gift of Life Michigan)
    10:45 AM  -  11:00 AM
    Break
    11:00 AM  -  12:00 PM
    Donor Screening Laboratory Updates
    The aim of this presentation is to discuss the nature and impact of proposed changes in laboratory testing requirements for determining the eligibility of prospective HCT/P donors. The Food and Drug Administration recently issues two draft guidances that would change the testing requirements for syphilis and for West Nile Virus (WNV), respectively. If implemented, these new guidances would eliminate the utilization of certain diagnostic tests for syphilis, and would require the performance of nucleic-acid amplification testing for WNV. The presenters will explain the proposed guidance changes, and discuss the foundational regulatory and scientific rationale for the modifications under consideration. In addition, the testing options available if these changes are implemented will be reviewed, and the potential impact of these changes on the tissue industry and the laboratories that provide testing services for the industry analyzed.

    Michael Bauer, MD (Laboratory Director, MJB and Associates) and Charles Cartwright, PhD (Vice President, Technical Director, ViroMed Labs)
    12:00 PM  -  1:00 PM
    Lunch
    1:00 PM  -  2:30 PM
    INTERACTIVE SESSIONS
    Aseptic Technique Training Guide
    This presentation will be dedicated to teaching the principles and practices for properly prepping and draping a cadaveric donor for tissue recovery. The recommended practices contained in this presentation are guidelines for how to best apply the recommended practices, set forth by AORN and AST for the preparation for the surgical patient, to the cadaveric donor recovery process. Participants should dressed in appropriate surgical attire and ready to perform return demonstration if called upon to do so.

    Module 4: Gowning & Gloving Technique
    Module 5: Donor Prep and Draping

    Ed Ferreol, MD, CTBS (Senior Manager, National Trainers, LifeNet Health) and Walter Recker, CST, CTBS (Regional Field Manager, Life Cell Corporation) 

    *Capacity limited to 40 attendees. If the session is full, you will be placed on a wait list.


    Jeopardy! The Game of Champions!
    An interactive educational contest based on the popular TV game show Jeopardy. Randomly selected teams will compete for prizes by stating the correct response to answers drawn from 6 categories of current AATB/EBAA Standards and FDA Regulations.

    Chris Agle, RN, MS, CTBS (Director, Medical Business Development, University of Miami Tissue Bank); Pamela Beeman, CTBS (Hospital and Clinical Services Manager); Carol Rapp, MLT(ASCP), CTBS (QA Senior Manager, LifeNet Health); and Larry Sussman, CTBS, CQA(ASQ) (Director, Quality Systems, NEOB)

    *Capacity limited to 50 attendees. If the session is full, you will be placed on a wait list.
    2:30 PM  -  3:00 PM
    Break
    3:00 PM  -  3:45 PM
    "Chartomegaly" - How to Handle Extensive Medical Records
    This presentation will delve into the topic of dealing effectively with extensive medical records for eye, organ, and tissue donors. The discussion will follow the process of screening a donor through examination of medical records from the time of request, to the time of determination. Effective and efficient methods of requesting medical records will be discussed. Attention will be given to the intracacies of navigating through the increasing number of electronic medical records for critical donor information, including where to locate specific information used in determining donor eligibility. The purpose and intent of each section of medical records will be discussed in the context of what information can be located in each, and how to interpret each section so that a cohesive picture of the donor condition can be garnered from the review of such. Finally, what records to retain and discard for the permanent donor record will also be discussed.

    James Alexander, MD (Medical Director, CTS); Greg Ray, MD (Medical Director, CryoLife) and Emily Buckthorpe (Quality Improvement Manager, Saving Sight)
    3:45 PM  -  5:00 PM
    Case Studies
  • Thursday, March 13, 2014
  • 8:30 AM  -  9:00 AM
    Breakfast
    9:00 AM  -  10:00 AM
    Case Studies
    10:00 AM  -  10:45 AM
    Break
    10:45 AM  -  11:30 AM
    Unique Device Identification (UDI) System - Final Rule
    The FDA's UDI Systems Final Rule is new and applies specifically to device manufacturers, it is considered a solution to adequately address the importance of: traceability of products (from origination to end use and back); adequate identification of products through distribution and use; identification of products involved in adverse events; the potential of a reduction in medical errors; and the capture of data on products. There are institutional members of the American Association of Tissue Banks (AATB) who are not only manufacturers of tissue allografts that fall under the FDA designation as an HCT/P (human cell, tissue, and cellular and tissue-based products), but who are also considered manufacturers of medical devices (that contain a human tissue component). Due to the UDI Systems Final Rule, a number of tissue establishments will be implementing a device identification solution over the next few years. Tissue processors in the United States currently employ their own coding systems to identify and track allografts within their possession/facility, however, very few use coding that can be interpreted and used by all distributors and end users.. This practice was once the norm in the traceability and labeling of pharmaceutical products and medical devices but the FDA – guided by the U.S. Congress - has developed coding and labeling policies over the past several years that would seem to suggest the possibility that conventional HCT/Ps could be held to similar expectations. AATB is considering its position on the topic. The development of new standards and implementation of global identifier solutions in the tissue-processing realm is complex. The reality is that the community as a whole has the opportunity to be proactive in the development of new policies and to be part of the greater discussion whether or not governmentally mandated requirements become a reality.

    Shana Christrup, MPH (Hart Health Associates)
    11:30 AM  -  12:30 PM
    DRAI Cognitive Interview Testing Update
    This presentation will provide an overview of the cognitive testing project of the DRAI. The methodology used to evaluate the questionnaire will be reviewed first, followed by a summary of findings from the study.

    Stephanie Willson, PhD (Survey Methodologist, National Center for Health Statistics)
    Workshop Adjourned at 12:30 PM
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