Donation Rates in Manitoba Presentation to the Organ and Tissue Donation Special Committee Manitoba Legislature February 28, 2018 By Christopher Snow, BPT MSc CTBS Director, Tissue Bank Manitoba Kimberly Dodds, P.Eng MBA CTBS Quality Assurance and Regulatory Affairs Officer, Tissue Bank Manitoba

The Human Tissue Gift Act Human Tissue Gift Agencies (HTGAs) Transplant Manitoba (TrMB) Tissue Bank Manitoba (TBM) Misericordia Eye Bank (MEB) The Human Tissue Gift Act has been in force since 2004. It identifies 3 Human Tissue Gift Agencies currently called Transplant Manitoba, Tissue Bank Manitoba and Misericordia Eye Bank. The Act gives the three agencies the authority to determine eligibility for donation, and if appropriate, seek a direction and if acquired, follow that direction for the purpose transplantation, medical education and/or scientific research. To facilitate the agencies‘ abilities to do this, The Act also requires all designated facilities to report all deaths or imminent deaths to them, or if they receive a dead body. The Act also allows for the Human Tissue Gift Agencies to jointly establish how and under what circumstances this notification should be done . It also allows the Human Tissue Gift Agencies to determine the circumstances in which notification is not required. In 2012, the online donor registry SignUpForLife.ca was established by the government to further facilitate the increase in donor numbers. Online donor registries are common in North America and laws are typically framed to state that a person registered as a donor on a registry can be considered by a Human Tissue Gift Agency as an authorization to proceed with donation and no other direction or consent is necessary. In 2016, the previous government moved to introduce the Personal Identification Card (PIC) and the 3 Human Tissue Gift Agencies worked to persuade the government, MPI and Manitoba Health to make donor registration part of the package as most other jurisdictions have done. However the new government cancelled the project.

The Human Tissue Gift Act (2004) Instituted required referral to the HTGAs from designated facilities (i.e. hospitals). Authorized HTGA personnel to determine donor eligibility and to seek a direction. Authorized HTGA personnel to access information, including personal information and personal health information of the deceased in order to determine eligibility. Defined the forms of how a direction can be made. These requirements were enacted to ensure that as many Manitobans as possible could be offered the option of donation and in doing so, maximize donation rates in the Province.

~4,500 Death Notifications/yr. MEB TBM TrMB Screen Annually, many deaths are reported to the Human Tissue Gift Agencies. Tissue Bank Manitoba, contracts a call centre to receive death notifications and receipt of dead bodies from the designated facilities for both TBM and MEB. Transplant Manitoba has established a separate reporting system for patients who may be suitable for organ donation. About 4,500 are received each year by the call centre. Based on certain criteria established by TBM and MED, most calls are directed to MEB (60%) in 2017 and the other 40% to TBM. Death notification ( or imminent death) volume to TrMB is not available. However, all 3 agencies combine their actual donor numbers each year and from that data, in 2016 there were 127 Manitobans who donated organs, tissue , and or eyes. Approach Consent Donors

127 Deceased Manitoba Donors in 2016 9 Organ Donors Organ Donors 16 2* 3* 2* Tissue Donors Tissue Donors Eye Donors Eye Donors 17 43 101 72 The distribution of the 127 donors in 2016 show most were eye donors (101), followed by tissue donors (43) and organ donors (16). Some Manitoba donors were both eye and tissue donors (22) and two donated organs, tissues and eyes. 22* *Shared Donors (17+72+9+2+22+3+2) = 127

Deceased Manitoba Donors 5 yr. Trend This is the annual number of Manitoba deceased donors over the last 5 years.

Donations from Deceased Manitobans This is the number of Manitoba donors who donated organs, tissues and/or eyes. Work on PIC Human Tissue Gift Act Donor Registry Launched

Plans Regarding Organ & Tissue Donation N=1000 Manitobans for each survey TB1. “We are going to spend another minute or so talking about organ and tissue donation. Before I ask you any questions, I want to remind you that any answers you provide will be used only for research on what Manitobans think about this issue, and will not be used for any other purpose. Which of the following statements best describes your own situation with regard to organ and tissue donation? Would you say…  You have decided to donate your organs or tissues at the time of your death? You have decided not to donate your organs or tissues at the time of your death? Or, you have not made a decision about this issue?” (n=1,000) Between 2005 and 2016, about half of Manitobans have consistently said that they have made a decision to donate and only 10% stating they have decided not to donate. This suggests that there is significant potential for increasing donation rates in Manitoba. However, barely 2% have registered as a donor. Another 40% of the population have not yet decided which provides and excellent opportunity for the right kind of persuasion at the right time could provide even larger numbers of registrants. So why is Manitoba’s registration rate so low?

Registered Donor Rates by State/Province as a % of the Eligible Population The Manitoba online Donor Registry was launched in April 2012 and replaced the “blue” donor cards that had been available at local Autopac outlets and the Manitoba Health Card registration form. Online registries are now operated in every US State and most Canadian Provinces. Online registration can have several advantages over a paper card system such as: The ability of Donation Coordinators to quickly determine whether or not a deceased person is a registered donor or not. The number of registered donors could be monitored and the impact of various donation awareness strategies could be measured. More sophisticated registries can also help target particular groups or geographical areas for donation awareness promotion and have even generated donation drive challenges and competitions between municipalities. In most jurisdictions across North America, registration takes place at Department of Motor Vehicle Offices. Customers are asked if they want to be registered and if they say yes, they can be put on the registry immediately. Most jurisdictions report at least 80% of their registrations occur this way. This process is not in place in Manitoba. Consequently, we have the lowest registration rates in North America. Sources: Donate Life America, 2017; provincial agencies, news reports, SignUpForLife donor registry, 2018

A Comparison of Public Attitudes Towards Organ and Tissue Donation (June 2017) N=1000 Manitobans Q.1. If you had a close family member who had registered to donate their organs and tissues for transplant, would you be willing or unwilling to provide additional medical and family history information at the time of death to assist with the donation process. Q.2 If you had a close family member who had not registered to donate their organs and tissues for transplant, would you be likely or unlikely to provide consent for the donation to occur on their behalf if you were asked to do so by hospital staff at the time of death? (n=1,000) Registered Donor Non-Registered Donor

Donor Registry Performance (TBM) Last 5 years Registered Donors Eligible to Donate Tissue Recovered Nearest Relative Declined to Complete DRAI Tissue Not Recovered Donor Register 32 5 3 1 Donor Cards 8 4 Health Care Directive 2   42 10 This is TBM data of all death notifications of Manitobans who were found to have made a direction to donate since the online donor registry was launched in 2012. Of the 10 who were eligible to donate only 1 nearest relative refused to cooperate with completing the DRAI. In other words, 90% of nearest relatives were willing to cooperate in the donation process, a proportion consistent with the TBM 2017 survey of Manitobans which indicated 86% of Manitobans would be willing to cooperate in competing the DRAI if their loved one was a registered donor.

Why is Opt-In is Not Working? Why is the Current System Not Working Well? Why is Opt-In is Not Working? A significant proportion of Manitobans have made a decision to donate but very few have actually registered to donate. A significant proportion of Manitobans have not yet made a decision on donation. The current registration process and registry set-up is not suitable to produce the registration rates that are required for an effective donor registry. Donation policy is not clearly aligned with the law. The registry is not linked to large government –public points of service. The registration process takes too long (at least 2-3minutes vs 30 secs for Donate Life America). The registry does not collect information such as postal codes that could be useful to target geographic areas for donation promotion. Can leverage this capability to encourage regions to compete in registration drives.

Why is Opt-In is Not Working? Why is the Current System Not Working Well? Why is Opt-In is Not Working? The HTGAs organizational structures are not aligned to produce optimal results for deceased donation. Significant numbers of eligible donors must be deferred because we are: Unable to contact the nearest relative The nearest relative is not eligible to make a direction There is are no nearest relatives and others such as close friends are not eligible to make a direction. The death notification to the HTGA came too late. The registry is not set-up to produce the registration rates that are required for an effective donor registry. Not linked to large government –public points of service Takes too long to register (at least 2-3minutes vs 30 secs for Donate Life America) Registry does not collect information such as postal codes that could be used to target geographic areas for donation promotion. Can leverage this capability to encourage regions to compete in registration drives.

Primary Solutions Specifically identify in The Act a person registered as a donor on the online Donor Registry is a valid Direction. Require MPI and Manitoba Health to offer to all customers at point of contact, the option of registering as an organ and tissue donor. Expand the definition of “Nearest Relative” to include more eligible categories including close friends. Expand the required notification provisions of The Act to include: -Office of the Chief Medical Examiner -Police and paramedic services These are the main initiative that are likely to have the most impact on donation rates under the current opt-in system.

Additional Solutions Lower the age for donor registration eligibility to 16 years of age. Require all middle and high schools to provide education on organ and tissue donation. Expand donation services to more regions of Manitoba. Organize the 3 Human Tissue Gift Agencies under a common administrative structure outside of the Regional Health System. Change the system entirely to an Opt-Out System (presumed Consent). Many US states have lowered the eligibility to donate to 16. One state is currently about to lower it further to 15 based on input from their teenage population. Providing information to students on organ and tissue donation can be made part of the health curriculum and can facilitate family conversations about the topic. A common administrative structure would help to align goals and objectives of the agencies, improve communication, realize more efficient and effective operations and present a unified single pubic image for donation in Manitoba.

The Donation Process Recovery Death Transplant Autopsy Medical Physical Assessment Medical Screen Blood Testing Donor Risk Assessment Interview Autopsy & other reports Donor Registry These are the key steps in the donation process. The circles in the box are steps required to be completed to comply with Health Canada regulations. The red circles are the steps that involve the nearest relative and often include other family members. The DRAI must be competed by a person knowledgeable about deceased’s medical and social history and that person is usually the nearest relative or close family member. The first 5 steps come under Provincial jurisdiction and can be addressed by the Manitoba Legislature. The Donation Process Approach Consent

Direction from nearest relative Death Direction from nearest relative Medical Screen Donor Risk Assessment Interview Donor Registry Since very few Manitobans are registered donors (or their registration cannot be found), this is the typical process that is followed by HTGAs. The chart shows the results of our 2017 randomized survey of 1000 Manitobans conducted by Probe Research. To the question: If you had a close family member who had not registered to donate their organs and tissues for transplant, would you be likely or unlikely to provide consent for the donation to occur on their behalf if you were asked to do so by hospital staff at the time of death? 59% said they would or likely would be willing to consent and 27% would not, or not likely give consent. These proportions are consistent with actual TBM consent rates. Approach Consent

Direction from registered donor Death Direction from registered donor Medical Screen Donor Risk Assessment Interview Donor Registry When a registered donor is found on the online registry (or a donor card or Health Care Directive concerning donation) is found and they are eligible to donate, this is the typical process that is followed by TBM. The chart shows the results of our 2017 randomized survey of 1000 Manitobans conducted by Probe Research. To the question: If you had a close family member who had registered to donate their organs and tissues for transplant, would you be willing or unwilling to provide additional medical and family history information at the time of death to assist with the donation process. 86% said they would be willing to consent and 7% would not be willing to provide the information required to complete the DRAI. These proportions are consistent with actual TBM experience (90% willing to provide DRAI information) for registered donors. Approach Consent

? Presumed Consent Death Medical Screen Opt out Registry ? Donor Risk Assessment Interview Opt out Registry Maybe/Unsure ? This is the likely process that would have to be followed for Presumed Consent. While a consent would not be required from a nearest relative (the same as a registered donor), the federal regulatory requirement of the DRAI would still need to be completed. This interview must be conducted with a person knowledgeable with the medical and social history of the deceased which is usually the nearest relative. In contrast to knowing Manitoban’s attitudes towards willingness to participate in the current donation process, we do not have any data on their willingness to cooperate under an Opt-out (presumed consent) system. ? Approach Consent Yes, willing

Public Opinion on Proposed Change in Law In order to determine how Manitobans would likely support such a system, TBM used Probe Research to conduct a randomized survey of 1000 Manitobans and asked the following question: “In some countries, when a person dies they automatically become potential organ and tissue donors unless that person specifically indicates that he or she does not want this. This does not occur in Manitoba where people must voluntarily indicate their willingness to donate and close family members are approached for consent. Do you support or oppose changing the law in Manitoba so that anyone who dies would be automatically considered an organ and tissue donor unless they had specifically indicated otherwise? Is it strongly or somewhat?” In 2005 20% of Manitobans strongly supported the change with 44% strongly opposed. In 2016, support for the change increased to 40% strongly supporting the change with 29% strongly opposing the change. Base: Manitoba adults aged 18 years and over.

Presumed Consent Death Medical Screen Opt out Registry Donor Risk Assessment Interview Opt out Registry This is the likely process that would have to be followed for Presumed Consent. While a consent would not be required from a nearest relative (the same as a registered donor), the federal regulatory requirement of the DRAI would still need to be completed. This interview must be conducted with a person knowledgeable with the medical and social history of the deceased which is usually the nearest relative. In order to determine how Manitobans would likely support such a system, TBM used Probe Research to conduct a randomized survey of 1000 Manitobans and asked the following question: “In some countries, when a person dies they automatically become potential organ and tissue donors unless that person specifically indicates that he or she does not want this. This does not occur in Manitoba where people must voluntarily indicate their willingness to donate and close family members are approached for consent. Do you support or oppose changing the law in Manitoba so that anyone who dies would be automatically considered an organ and tissue donor unless they had specifically indicated otherwise? Is it strongly or somewhat?” In 2005 20% of Manitobans strongly supported the change with 44% strongly opposed. In 2016, support for the change increased to 40% strongly supporting the change with 29% strongly opposing the change. Approach Consent

Issues to be considered with Opt-out (Presumed Consent) The Opt-out option for Manitobans has become a polarizing issue. Based on our survey data, a properly structured and administered Opt-In system should increase donations by up to 30%. It is unclear at this time how an Opt-out system would affect donation rates in Manitoba. By adopting an Opt-out system, could donation still be considered a gift? While a significant proportion of Manitobans support presumed consent (40% strongly support), a significant number (29%) strongly oppose it.

Thank-you