Guiding the Standardization in Acute Leukemia Service Delivery through the Development of Organizational Requirements

Abstract Introduction: In Ontario, Canada, acute leukemia (AL) care is delivered to patients at three levels of specialized service provider sites: 1) Transplant and AL Service Sites, providing all services, including stem cell transplant, chimeric antigen receptor T-cell therapy, and high intensity chemotherapy (e.g., induction); 2) AL Service Sites, providing a subset of services, including high intensity chemotherapy; and 3) AL Shared-Care Partner Centres providing consolidation and less intense chemotherapy, supportive care and follow-up. Sites and healthcare are government funded, through a single-payer system. In 2017, Cancer Care Ontario (now a part of Ontario Health), the government agency managing the delivery of cancer services, released the Acute Leukemia Provincial Plan to provide a vision for the delivery of timely access to high-quality, coordinated services for patients with AL in Ontario. Working with the 14 Regional Cancer Programs in the province, a 10-year plan for expansion to meet the expected demand was developed. Subsequently, provincial stakeholders, including clinical and administrative leaders from across the Province identified a need to develop guidance to ensure all provider sites (existing, new and in development) have the same infrastructure, expertise, quality management, and policies and procedures necessary to deliver high quality care for this specialized, high-need patient population. Methods: The AL Specifications Working Group (WG) was formed to lead the development of organizational guidance. A systematic literature review and jurisdictional scan using key search terms identified existing standards and recommendations. Recommendations were extracted from relevant texts and reviewed. Through informal consensus, the WG endorsed recommendations "as is", adapted recommendations to meet the needs of Ontario, or rejected recommendations deemed not relevant. Where recommendations were lacking, but thought to be needed, new recommendations were written. Results: The literature search identified 2,651 potential texts, of which 17 texts were deemed relevant (Figure 1) and 642 recommendations were extracted. After three rounds of review by the WG members, the Cancer Care Ontario team, and targeted external stakeholders, 229 recommendations were approved (Figure 2). Recommendations were written for each level of service provider using the terminology shall (must be complied with), should (recommended or advised) and may (permissive). Recommendations were grouped into 9 sections: 1) 15 General recommendations related to infrastructure, patient volumes and service provider availability, 2) 25 Clinical Unit recommendations related to inpatient and outpatient structure and services, 3) 99 Personnel recommendations related to roles, responsibilities and training of the multidisciplinary clinical team, 4) 43 Quality Management program and plan recommendations, 5) 22 Policies and Procedures recommendations, 6) 9 Patient Care recommendations, 7) 2 Clinical Research recommendations, 8) 9 Data Management recommendations, and 9) 5 Laboratory Services recommendations related to testing access and turnaround times. In June 2021, the recommendations were shared with impacted stakeholder groups, including health care providers and hospital administration through the release of the Organizational Requirements for Acute Leukemia Service Providers in Ontario: Recommendations Report 2021 (https://www.cancercareontario.ca/en/guidelines-advice/types-of-cancer/69431). The full list of recommendations is available in the Report. Conclusions: The development of these recommendations will serve as a framework for improvement and expansion at existing and new service sites, with the aim of ensuring AL service providers throughout Ontario have the same necessary organizational and operational requirements in place. A gap assessment will inform next steps for focused efforts to provide high quality care which will meet the needs of patients into the future. Figure 1 Figure 1. Disclosures Buckstein: Takeda: Research Funding; TAIHO: Research Funding; Otsuka: Research Funding; Celgene: Research Funding; BMS: Membership on an entity's Board of Directors or advisory committees. Sabloff: BMS: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; TaiHo: Membership on an entity's Board of Directors or advisory committees; Jaxx: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; ROCHE: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees. Yee: Onconova: Research Funding; Astex: Membership on an entity's Board of Directors or advisory committees, Research Funding; Forma Therapeutics: Research Funding; Geron: Research Funding; F. Hoffmann La Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Tolero: Research Funding; Janssen: Research Funding; MedImmune: Research Funding; Jazz: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; TaiHo: Membership on an entity's Board of Directors or advisory committees; Shattuck Labs: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Paladin: Membership on an entity's Board of Directors or advisory committees; Otsuka: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb/Celgene: Membership on an entity's Board of Directors or advisory committees; AbbVie: Honoraria; Genentech: Research Funding.

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