Fetal Blood Group Genotyping (FBGG) Clinical Implementation Working Group - Terms of Reference
Background
Prenatal Screening Ontario (PSO) is funded by the Government of Ontario to coordinate and oversee the operations of prenatal screening services in Ontario, supporting a cohesive and high-quality screening system. PSO is a program of the province’s maternal, newborn and child registry, the Better Outcomes Registry and Network (BORN) Ontario.
PSO currently oversees prenatal screening for fetal aneuploidies (e.g. trisomy 21 and 18). Ontario’s Ministry of Health has tasked PSO with expanding antenatal screening options. The initial expansion, planned for 2025, will introduce screening for fetal Rh and other fetal blood group antigens through fetal DNA circulating in the pregnant individual’s blood.
Provincial Screening for Fetal Blood Group Incompatibility
In 2020, Ontario Health Quality published a health technology assessment (HTA) on noninvasive fetal RhD blood group genotyping and made the recommendation to publicly fund this testing for alloimmunized and non-alloimmunized RhD negative pregnancies conditional on attaining reasonable cost-effectiveness. In response to this recommendation, PSO established a time-limited Task Force to assess implementation considerations for Fetal Blood Group Genotyping (FBGG). In 2021, a business case was developed by PSO advocating for the introduction of Fetal blood group genotyping in Ontario and in 2022, PSO was entrusted with the governance and implementation responsibilities for this new screening service.
This new screening will allow for the continued prevention of hemolytic disease of the fetus and newborn (HDFN) while reducing unnecessary health-care utilization by enabling a) a more effective and efficient approach to Rh Immune Globulin (RhIG) prophylaxis for RhD-negative pregnancies, as well as b) more targeted high-risk follow-up for alloimmunized pregnant individuals.
PSO depends on input from experts in relevant fields, including people with lived experience, to ensure inclusion of all elements of a robust screening program. The FBGG Clinical Implementation Working Group, responsible for advising on essential activities pertaining to implementation, will play a pivotal role in supporting the successful rollout of this new screening service.
Mandate and Scope
PSO is seeking evidence-based, clinical/scientific leadership advice, and insights from individuals with lived experience on the implementation of Fetal Blood Group Genotyping in Ontario.
The FBGG Clinical Implementation Working Group will be tasked with advising on the planning and coordination of the clinical implementation of fetal blood group incompatibility screening in Ontario.
The FBGG Clinical Implementation Working Group will:
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Advise on and review PSO’s proposed implementation plan, including timelines, tasks and resource requirements.
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Advise on and inform the development of an effective knowledge translation strategy.
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Review and provide feedback on educational material development including, but not limited to:
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Content for the PSO website and other online opportunities
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Paper and web-based education tools
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Social media communications
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Provide input on identifying areas for change management and devise strategies to address them effectively.
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Provide input on identifying gaps and barriers to fetal blood group incompatibility care and advise on the development of strategies to ensure equitable access.
While the expertise, advice and recommendations of the Working Group are essential to the process, the final decision on the implementation approach remains that of PSO.
Membership
The membership will be interdisciplinary, representing the following areas of content expertise:
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Screening Systems
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Knowledge Translation
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Primary Care (i.e. Family Medicine, Midwifery, Urgent/Walk-In Medicine)
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Specialty Care (i.e. Maternal Fetal Medicine, Hematology)
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Laboratory Medicine (i.e. FBGG testing lab(s))
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Care for Indigenous Populations and/or Remote Care
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Health Equity
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Lived Experience
The Working Group will be comprised of a maximum of 10-12 members, including a Chair and Vice-Chair(s). Members will be chosen to meet the required area of expertise or will be specific delegates nominated by their organization or region.
Administrative and resource support persons will be provided by PSO.
Accountability and Reporting
The FBGG Clinical Implementation Working Group will report to the FBGG Steering Committee who is accountable to PSO/BORN leadership. The Working Group may interact with other internal and external bodies as required to accomplish its tasks.
Procedures
The advice and recommendations developed by the Working Group should reflect the consensus of the whole group.
The Chair and Vice-Chair(s) will facilitate a consensus decision-making process that is inclusive and provides enough time for evaluation, discussion, proposed options, identification of concerns, and acceptable resolution of the items and/or issues under consideration. Moreover, decisions must be in keeping with PSO’s scope and mandate.
Members will agree to support a consensus decision or course of action. Where members are unable to reach consensus, the Working Group will seek to develop a clear and balanced statement or summary detailing the item or issue of disagreement to outline the differing positions tabled and options considered.
Meetings
Working Group members are expected to actively engage in meetings on average biweekly, each lasting approximately 60 minutes. Meetings will be held by web conference, with other business conducted by email through deliverable completion. Additional meetings will be scheduled as required at the call of the Chair and/or Vice-Chair(s).
Members will be required to review related materials in advance of scheduled meetings which will be shared via email.
Meeting minutes will be taken for each meeting and maintained by PSO. Once reviewed by the Chair and/or Vice-Chair(s), meeting minutes will be circulated to the Working Group for review. Members will have an opportunity to collectively approve the minutes at the next meeting.
At the first meeting, the work plan will be shared with the Working Group.
Term
The FBGG Clinical Implementation Working Group will be active for the duration of the project (anticipated to extend through fall of 2025). Upon successful project implementation, the continuation of this group will be evaluated based on organizational needs.
Members are expected to attend a minimum of 50% of meetings per year to maintain membership. Alternate delegates will not normally be invited to meetings. Members are requested to withdraw membership if unable to attend meetings on a regular basis.
Nominations and Expression of Interest
PSO will issue a call for Expressions of Interest for select areas of expertise. A nominations committee will review all submissions and will nominate individuals based on the aforementioned membership criteria, excluding any individuals with conflicts of interest (as detailed below).
Conflict of Interest
It is recognized that members of the Working Groups are drawn from the perinatal and laboratory sector and as such, there may be relationships that give rise to a potential or actual conflict of interest. It is expected that members shall discharge their duties towards PSO and BORN in a manner that is impartial, ethical and consistent with the best interests of the provincial perinatal screening and laboratory systems. It is recognized that not all relationships will lead to a conflict of interest. The intent is to encourage awareness of existing relationships and manage these relationships effectively vis-à-vis the member’s obligation to carry out their duties with integrity, rather than preventing participation in the Working Groups.
Upon joining, members shall disclose to the Chair and PSO leadership, the nature and details of any personal, business or volunteer relationships that may impact or be perceived to impact the member’s ability to engage in their duties as a member of the Working Group in a manner that is impartial, ethical and consistent with the best interests of the provincial perinatal screening and laboratory system. Each member shall have a duty to inform the governing Chair/Vice-Chair(s) of any changes that may occur with respect to these roles and responsibilities.
Members shall not vote on matters where conflicts of interest could create undue bias in their duties to the Working Group.
The Chair has the right to deny participation or excuse any member with a COI that is perceived to interfere with the deliverable.
Code of Conduct
To foster a productive and inclusive environment, it is essential that all participants adhere to a shared set of principles. This Code of Conduct section outlines the standards of behavior expected of all members to ensure that our work is conducted with mutual respect, integrity, and a commitment to our collective goals.
Respect
Members always treat each other with respect and dignity. We are courteous and considerate in our language and actions. We are compassionate and fair. We are sensitive and responsive to others’ beliefs, cultures, and background.
Anti-discrimination
As a part of their commitment to equity, diversity, and inclusion, PSO and BORN are both committed to preventing and calling out discrimination based on race, colour, gender identity or expression, sexual orientation, disability, creed, age and other grounds articulated in the Ontario Human Rights Code. Discrimination can occur both explicitly and implicitly at the personal and/or structural/systemic level. Any form of discrimination denies people their basic human rights, dignity, and respect. PSO and BORN do not tolerate discrimination and stands in solidarity with those who experience it. We challenge incidents of discrimination as they arise within our organization and in our meetings. We assess all key health policy decisions for their impact on, and their contribution to, positive outcomes for marginalized groups and for those experiencing discrimination of any kind.
Honesty and Integrity
We have a responsibility to each other, the people we serve, and our community to ensure that a concern for what is right forms the basis of our decisions and our conduct. We are truthful in our communications with others. We respect and comply with legislation, and our professional codes and standards. We make judgements, in the course of our work, that are independent of personal interests.
Accountability
We take personal responsibility for our actions and decisions and follow through on our commitments.
Confidentiality
Every member will respect the confidentiality of matters brought before the committee. All PSO/BORN meeting materials, including slides, are all to be considered confidential and may not be used outside the Working Group and may not be disclosed or shared with non-committee members. If such material is no longer confidential and may be circulated externally, Working Group members will be notified by the Chair.
Upon joining, members will be required to sign a Declaration of Code of Conduct, Conflict of Interest, Confidentiality and Consent agreement.
Consent to Receive Electronic Communication
Communication and collaboration are key strategic enablers supporting the dissemination and implementation of work done by the Working Groups. Given the vast geographical distances between members, technology is a key enabler of communication. PSO and/or BORN rely heavily on electronic communication (email) with members for the dissemination of information either generated by PSO, BORN or sent on behalf of other similarly focused organizations. This may include information and announcements, including invitations to meetings, webinars, conferences and other events.
Upon joining, members are consenting to receipt of electronic communication in accordance with Canada’s Anti-spam Legislation. Members may withdraw their consent at any time, by notifying PSO by email at PSO@bornontario.ca.
Compensation
We are thankful for the participation of individuals with lived experiences, and they will be offered remuneration for their valuable contributions.
We are also thankful for the participation of our healthcare partner members. Due to the anticipated intensity of the commitment required for this work, remuneration will be offered to our healthcare delivery partners whose participation is not on behalf of their employing organization.
Upon joining, compensation details and related documents will be sent separately to eligible members.