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, Obstetrics, Nurse Practitioner, 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), community/hospital labs, transfusion medicine, hematology, NIPT expertise)
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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 12-15 members, including a Chair and Co-Chair. 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 Co-Chair 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 60-90 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 Co-Chair.
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 Co-Chairs, 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
Members whose personal or professional activities constitute a conflict of interest (COI) must disclose the nature and details of their conflict of interest to the Chair and PSO leadership prior to participating on the committee. Activities considered to be in conflict of interest include, but are not limited to, direct ties to private industry and personal interests in developing related technologies, including patents and patents pending. Incumbent and existing members will disclose to the Chair, without delay, any actual or potential situations that arise which might be reasonably interpreted as either a conflict of interest or a potential conflict of interest. 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
Members are expected to conduct themselves in an appropriate and professional manner. This means engaging with others in the group with:
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mutual respect
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kindness
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humility
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honesty
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trust
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integrity
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.
Compensation
We are thankful for the participation of individuals with lived experiences, and they will receive remuneration for their valuable contributions.
We are also thankful for the participation of our health-care partner members. Due to the anticipated intensity of the commitment required for this work, compensation will be offered to our health-care delivery partners whose participation is not on behalf of their employing organization.