Strategy 3: Strategic Alignment
Strategic alignment between the many government and non-governmental stakeholders of SHIELD and is critical to the transformation needed to bring about laboratory data interoperability. The steps proposed in this Strategic Plan must happen at many points in the clinical laboratory starting with manufacturing, ordering of tests, laboratory processing, and the many down stream uses of the data from clinical reporting, billing, surveillance, and research.
Table x below lists SHIELD stakeholders and the alignment that this strategic plan recommends. These range from policy changes, to investment and programmatic action. Both government agencies (federal and state) and non-government stakeholders (manufacturers, coding organizations, laboratories, and professional society) need to act to move the national laboratory system towards interoperable, efficiency and improved patient safety.
Strategic alignment of stakeholders is proposed in three phases. The first phase will work to engage the leadership of the many stakeholders and develop more specific analysis of barriers to reform. The second phase will be to develop and implement a plan to help the partner stakeholders to update and develop their procedures and process to support interoperability. The third phase is to evaluate the efforts. This would take place over a three-year period.
The strategic alignment works with each stakeholder organization separately but also works to build a body that will provide governance and authority for interoperability in the future. This body will coordinate across the many government agencies and private sector organizations that play a role in interoperability.
Phase one – Engagement and assessment
· Develop a case and value proposition for each stakeholder
· Propose that ONC director meet with agency and organization heads meet with stakeholder leaders with a plan for collaboration
· Form collaborative committee (SHIELD and agency members) for each stakeholder
· Develop work plan for committee to continue work and implement as planned
· Publication
· First develop a draft plan for interagency governance of interoperability and hold first meeting of all agencies consider structure, functions and agents that would do this work. An possible convener could be ONC or ASPE/
· Publication
Phase 2- Implementation
· Agency/organization specific committees begin work to move forward policy and process reform
· Second meeting of all stakeholder leadership to review reports of Phase one and develop terms of reference of a coordination body,
· Development of a Governance Proposal between partners at leadership level to coordinate policy regarding interoperability
· Publications
Phase 3 – Evaluation
· Evaluate implementation including potential pilots to be able to view data flow for each part of process
· Establishment of interoperability governance body for ongoing and authority to coordinate interoperability into future
· Evaluate movement of governance body towards alignment of policies to support SHIELD implementation
· Publications
Table X. Strategic Alignment Map
Agency (public and private | Current policy/barrier | Aligned policy | Steps |
Public |
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ONC |
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CMS |
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FDA |
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NIH |
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CDC |
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ASPE |
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Private |
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Cerner |
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Epic |
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IVD manufacturers |
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others |
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