1 PROJECT OVERVIEW

This project will work with CSTE and other partners to track federal public health-impacting policy publications for commenting opportunities, develop draft comments, develop policy summaries, perform policy education, and support public health agencies (PHAs) and labs (PHLs) who want to submit personal or organizational comments to policymakers. APHL will work with partners, PHAs, PHLs, and other parties as identified others to perform this work on an ongoing basis, after the initial pilot iteration to establish and test processes.

1.1 Project Goals and Objectives

• Inventory and decision log of policies evaluated.
• Policy summaries, as prioritized and approved by APHL.
• Draft comment letters (for NPRM/RFI responses), as prioritized and approved by APHL.
• Repository of final comments submitted on behalf of APHL and/or in collaboration with partners.
• Confluence project space that fosters information sharing, facilitates collaborative development of comments, and serves as a repository for project documents.

1.2 Background * (optional for small projects)

N/A: Small project, beginning with a pilot

1.3 Business Need

PHA/Ls are under-resourced and PHA/L SME implementers don’t have time to read federal policies that will have large impacts to their work, operations, and critical data quality and availability.

In the past CSTE, APHL, and others (JPHIT1.0) have reviewed various federal policies and have occasionally presented draft comments to PHA/Ls, submitting a comment letter with various signatories as the association. As policy analysis has not previously received dedicated funding, these reviews and information sharing only ever occurred at the last second for PHA?Ls, though national leaders, within-association, and association leaders were aware somewhat sooner. This “scramble” did not allow PHA/Ls to work through agency internal review procedures that would allow them to submit a letter as the organization, and education about the potential to submit comments as an individual was not available. Finally, agencies, associations, and national leaders may not have realized the degree to which numbers of letters are weighted differently from letters with several or many signatories, which still only counts as one letter. These, as well as chronic under-resourcing, have contributed to low awareness of and participation of STLTs PHA/Ls in federal rule-making input procedures.

?may be too much detail about why submitting individual PHA/L letters is needed??

In addition, when there are conflicts in perspective between PHAs, due to the nature of submitting one letter, letters do not reflect full spectrum of impact to different PHA/L operations, and may not reflect differences in different types of public health reporting (immunization, syndromic, and ELR all have different structures and needs). In addition, PHLs and their unique perspectives have not been well reflected in submitted Association (CSTE, APHL) group comment letters. (is that true? I don't' recall any lab participation in CSTE’s discussions…)

The needs the policy education project plans to address, and our resulting goals, are threefold:

1. Efficiently review and identify predicted impacts of high-priority proposed policies and requests for information and identify potential impacts on PHA/Ls.

   1. Share findings and rapidly-developed draft comments our public health community, especially PHA/Ls themselves in a way that allows them to contribute directly to the draft comments to allow all to see the variety of impacts depending on the agency, lab, public health reporting standard and other environmental (or is operational a better word?) differences.

   2. With these draft comments, PHA/Ls and agency staff will be empowered to submit their own comment letters as well as meeting their agency’s internal review processes so that their letters will reflect their priority concerns, and include specific impacts, especially if those are unique (for example; AK v NYC, unique challenges faced by territories and the differences in operations among different tribal nations. With timely drafts to work from, these letters will be easier and faster for time-constrained SMEs to write.

   3. This efficient method of developing and sharing draft comments will empower PHA/Ls to comment on federal policies that will impact their work intimately as well as meeting agency and laboratory review procedures in a timely manner. They will be empowered to voice the diversity of their STLTs PHA/L needs directly, rather than being spoken for.

   4. Federal partners will receive a greater number of letters from STLTs PHAs including staff and agencies who have not otherwise been able or comfortable to comment previously.

2. Provide education about federal policy-making processes, timelines, comment review procedures, including understanding what makes more and less useful comment letters from the perspective of policy-writers and reviewers. This education will assist PHA/L staff in understanding of policy-making, and develop their confidence and skillsets in this area, ideally contributing their perspectives and input to leaders directly, though submission of their own letters. If we are lucky, they’ll share with colleagues and friends, and we will begin to develop a robust policy-contributing core of STLTs practitioners, with critical operational and implementation knowledge to share with policymakers and leadership.

3. To increase ambient awareness of PHA/Ls staff of the various proposed policies and published rules federal partners are working on, develop clear and readable summaries of policies for those federal publications that are not of large enough impact to develop comments, but may still interest PHAs, PHLs, or our partners. These summaries will increase awareness among PHA/Ls about policies relevant to their work and contribute to their engagement.

   1. Encourage PHAs to share impacts they identify from summaries or comments they were inspired to develop and submit, encourage conversation and other interactions.

   2. Develop and grow member knowledge and confidence with the goal of growing the (nascent?) STLTs policy community and increasing the space that STLTs perspectives take up in national discussions and policy-making. Encourage relationship-building that will improve awareness of STLTs perspectives and that could move STLTs towards putting their needs and goals on the federal agenda.

   3. To encourage interaction, we will remove barriers, lower the stakes of interaction and discussion, facilitate and encourage to provide a supportive and responsive space for discussion and learning.

      1. This is what I’m imagining, and yes, I realize it’s pretty pie in the sky (for example, perhaps a rule only affects STLTS STI data collection in some way, is not high-priority for APHL resources to develop draft comments and gather input, but for staff working in STIs, it may be important enough to develop their own comments. We hope PHA/Ls will feel comfortable enough sharing those too, so others can benefit and are inspired to take opportunities to practice and grow their policy analysis and commenting skillsets.) However, if we get three people who do this in a year, we’ve just identified STLTs policy leaders - and can start introducing them to feds and leaders who will benefit from talking to them. This is like identifying a future Nancy, Karla, or Annie - I’d consider that an incredible win, even if it’s only one person, because they will set direction and become a pillar of the community.

2 SCOPE

2.1 Scope of Work

Items in Scope:

• Review of federal Notice of Proposed Rule-making (NPRMs), Requests for Information (RFIs), and federal policy priorities for relevance to public health.

• Development of policy summaries, as prioritized and approved by APHL.

• Development of draft comment letters to be submitted under the APHL organizational banner, as prioritized and approved by APHL. As applicable, draft comments letters will be developed in joint collaboration with partners.

• Engaging with and collecting input from PHAs, PHLs and partners on policy implications.

• Development of materials, tools, templates, or educational products of various sorts to assist PHAs and PHLs in writing agency or lab-specific comments.

• For released policies (past the stage for providing comments), sharing of information and updates as identified to PHAs and PHLs.

• Collaboration with others in the public health policy space to streamline efforts and expedite development of draft comments by implementing a strategic and coordinated approach.

• Convening forums in which “on the ground” staff at PHAs and PHLs can communicate about their needs to inform national policy making.

• Initial project scope will be focused policies that impact public health informatics, information systems, and data exchange. However, this scope may expand in the future (as approved by APHL Project Owner) depending on evolving needs and priorities of PHAs, PHLs, and partners.

2.2 Out of Scope

Items out of Scope

• Writing jurisdiction-specific responses to policies for PHAs and PHLs. Instead, the project will provide education, templates, draft language (as applicable), and opportunities for discussion that enable PHAs and PHLs to write and submit their own feedback to national policy making.

• Lobbying.

• Submitting comments claiming to speak on behalf of all PHAs and PHLs.

2.3 Critical Success Factors  

1. Subject matter expertise covering broad public health scope that can provide the project team with reasonable insight into jurisdiction’s interest in engaging with NPRMs, RFIs, and other policy opportunities.

2. Timely identification of priority policies for engagement and allowance of ample time to develop materials and comments by the submission deadline.

3. Efficient, transparent, and simultaneous development of draft comments (likely in a centralized location) that allows for timely incorporation and reconciliation of proposed content.

4. Partner support of and agreement to policy project parameters, especially access to and use of a collaborative space for developing draft comments.

5. Availability and interest of PHAs, PHLs, and partners to engage with the APHL project team on policy initiatives. The project is well socialized in relevant forums.

6. Policymakers and other regulators welcome and value submitted comments and feedback from PHAs and PHLs.

7. Buy-in from APHL and partner leadership to approve and provide signature on comments letters, as necessary.

8. The project team can accurately assess and deliver the type of engagement that is most valuable to PHAs, PHLs, and partners.

9. PHAs, PHLs, and partners perceive there is value and progress stemming from the comments/feedback submitted in response to policy making.

2.4 High-Level Requirements (* optional for small projects)

N/A: small project beginning with a pilot that will finalize deliverables and processes using stakeholder engagement

2.5 Major Deliverables  

2.5.1 Work Breakdown Structure

See initial plan image: (TBD)

2.6 Approach (* optional for small projects)

• 1) Identification, 2) prioritization, and 3) approval of opportunities for comment to policies that have not yet been released

  • Identification:

    • PM or BA reviews Fed Reg and curates list for PH Policy Engagement Workgroup review (known as Workgroup)

    • Regular meetings of Workgroup to review short-list of flagged policies (short 7-10 sentence description)

    • APHL Leadership identification and priority (source of decision to comment)

  • Prioritization:

  • Approval:

• Development summary materials of Workgroup-approved policies (~3 per quarter) and post on External Engagement Confluence page

  • Identifying most helpful level of detail

• Socialization of information

• Collection of feedback and comments, for the purpose of APHL Comment submission

  • Internally Comment Letter development on Internal Confluence Space

• Finalization of APHL Comment Letter

• Posting APHL Comment Letter on External Confluence Space

• **Note about focus of policy engagement to develop feedback on policies that have not yet been officially published. Future efforts may expand scope to developing summaries for policies that have already been published for increasing awareness in PHAs and PHLs.

2.7 Relationship to Other Systems / Projects

• TBD - Brooke, I’m unsure what goes here, but could imagine listing federal partners who develop policy, partner organizations working on policy (all of them…), AIMS (b/c data exchange affected by policy, especially TEFCA), etc.

• Should this include resourcing, PHA/L availability and competing priorities, other items in that vein?

3 ASSUMPTIONS, CONSTRAINTS, AND RISKS

3.1 Assumptions

1. Dedicated availability of APHL resources and project team. Without resourcing, the policy summaries will be uninteresting and generic (rather than tightly relevant to PHA/L operations and impacts) and review and comment development timelines will be lengthy, discouraging PHA/L involvement and participation in federal commenting processes.

2. The project team consists of the relevant policy expertise, skills, and experience.

3. PHA and PHL staff (notably those with the relevant expertise and experience) have sustained availability and interest in engaging with the project team.

4. Partners have dedicated staff, and sustained availability and interest in engaging with the project team.

5. Barriers to PHA and PHL access, participation, interest, are identified and removed.

6. The relevant subject matter expertise breadth is identified, recruited, and retained.

7. The project team can demonstrate sustained project value to APHL Management and the project is adequately funded to support necessary resources.

8. In the case of resource changes: project knowledge, processes, and relationships can be readily transferred and maintained.

9. The project team can socialize and emphasize the importance of project engagement with partners in the relevant arenas (e.g., Joint Public Health Informatics Task Force (JPHIT 2.0).

10. The project team and partners agree on the process and tools to collaboratively develop and review comments.

11. Federal policy makers appreciate or benefit from this work.

3.2 Constraints  

• The project team inadvertently makes or maintains barriers to participation, or does not execute on the value that PHAs and PHLs hoped to receive from the project. If this occurs, engagement in the project – and therefore project success - will falter.
• PHAs and PHLs do not feel informed enough about policy content to participate meaningfully in the project.
• Political nuances and sensitivities may arise when providing public comment, which may deter the perceived ability and willingness of PHAs, PHLs, and partners to contribute.
• Disagreement on an approach, tools, and expectations to collaboratively develop comments.
• Opportunities to provide feedback to NPRMs, RFIs, and other policy initiatives may be identified “late in the game,” significantly reducing the time available to convene and collaborate with PHAs, PHLs, and partners.

3.3 Risks

(This is an initial list only; to be maintained in a Risk Log at <URL>)

4 SCHEDULE

4.1 Major External Dependencies

• CSTE agreement on approach, trial, location of draft comments

• PHA/L advisors (resources)

• Sufficient resources with wide SME brought to post-pilot project ??

4.2 Timeline / Gantt Chart / Schedule

(This is an initial timeline only; to be maintained at <URL>)

Flagging for development - my suspicion is that we’ll need to do the pilot to develop a Gantt, but I’d like feedback on that if I’m wrong! @Brooke Beaulieu

4.3 Executive Milestones (* optional for small projects)

5 PROJECT ORGANIZATION

5.1 Interested Parties, Roles, and Responsibilities

5.2 Reporting Structure  

(This is an initial reporting chart; to be maintained at <URL>)

TBD post-resourcing (?)

6 QUALITY MANAGEMENT

6.1 Risk Management Approach

Flagging as TBD

The project team will follow the APHL Informatics Risk Management Plan to plan for and address areas of uncertainties and develop contingency plans.  The RMP documents our iterative Process for identifying, analyzing, response planning, monitoring, and reporting risks.  The APHL TA project team will work with Client staff throughout the engagement to monitor and resolve these risks and any others that may arise during the engagement.  Risks will be reported in all Status Reports to the Client.  APHL TA project management staff will use a Risk Register or Log for ongoing tracking and reporting.

All risks will be analyzed for the probability of occurring and impact to project objectives of scope, cost, schedule, and quality.  A grid will determine their red, yellow, and green priority.  All risks will be tracked by a Project Risk Log.

Open

6.2 Issue Management Approach (* optional for small projects)

N/A: size of project, large scope of potential issues with new work. May be able to narrow potential issues once pilot is completed and project is resourced/begins.

Issues will be categorized into four levels of importance (Urgent, High, Medium, and Low) based on their impact on the project goals, objectives, scope, schedule, and budget. The following guidelines will be used to prioritize the issue:

Issues will be tracked in the Issue Log and are defined within the status categories listed below.  The Project Manager, in consultation with project personnel, should update the issue status.

Issues will be monitored weekly, and the project manager will update the issue log as needed.  The Issue Log will be stored in a document repository located at <URL>.

6.3 Change Management Approach

@Brooke Beaulieu Flagging as TBD.

@Tom Brinks Could this be developed post-pilot? I think it’s incredibly important, but there’s so many unknowns here that a log is the wrong level of response in my mind - it might be more like ‘re-architect the approach!’

During implementation, changes to a project usually occur.  To accommodate the inevitable need for change, APHL TA project management will create a Change Management Plan (CMP) early in the engagement, which documents the process for submitting, tracking, analyzing (for impact to cost, schedule, staffing, risk), and approving (by the Client and APHL) each change.

Some large scope changes may require a re-scoping of the entire project.  Some scope changes are small and can be incorporated within the existing effort.

Some key project documents (like Message Mapping Guides and associated artifacts) must be placed under Change Control once they have been published or are pilot-ready.  Changes to related vocabulary or data elements must be carefully managed through a formalized change request process to minimize disruption to systems in production while enabling improvements or maintenance.  This process will facilitate communication regarding requested changes to the standardized vocabulary or messaging rules among the stakeholders.  This process will also provide a common practice for resolving requested changes and reported problems, resulting in accurate and up-to-date common MMGs.

APHL TA project management staff will use a Change Management log for ongoing tracking and reporting.  The Change Management Plan will identify the following:

• How change requests are communicated to the project team

• Who can submit a Change Request (CR)

• Tips for writing change requests so that their intent is communicated clearly and immediately to the project team

• How change requests are processed

• Definition of and how the Change Control Board (CCB) operates

• Who the CCB members are that can approve a change request

6.4 Acceptance Criteria  

• Creation of policy review tracking (i.e. SS)

• Creation of policy summaries for some policies (i.e. summaries requested on Confluence)

• Creation of draft comment letters for some policies (i.e. draft comment letters req on Confl)

7 COMMUNICATIONS MANAGEMENT

7.1 Communications Matrix

7.2 Project Documentation (* optional for small projects)

7.3 Project Meetings (* optional for small projects)

N/A: Policy tracking, especially pilot, is a small project and we do not yet require project meetings or this kind of documentation, though I’d expect a mature and resourced project to benefit from some written documentation of decisions/prioritization (though more pragmatically documented in smartsheet conversation on priority policies in policy tracker, rather than meeting notes).

Meeting minutes will be distributed within one business day following each meeting.  Minutes will include a summary of the meeting, status updates, progress updates, and new action items.  All meetings will have a set agenda to be distributed one business day before the meeting.  The following chart describes the type of meetings for this project.  Internal means just within the APHL organization and APHL TAs; external would be any other organization.

8 APPLICATION DEPLOYMENT PLAN (* optional for small projects)

• N/A?

• Potentially could describe pilot project then resourcing and modifying and then executing vs plan then launch, which I’m guessing is more typical for APHL?