AIRA FEEDBACK ON:

Immunization and Response Management Prototype Use Case

ORGANIZATION CONTACT INFORMATION

American Immunization Registry Association (AIRA)
Cindy Sutliff , Executive Director
212 676 2325
csutliff@health.nyc.gov

AIRA Data Exchange Standards Committee authors:

HLN Consulting, LLC
Noam H. Arzt, President
858-538-2220
arzt@hln.com

Software Partners, LLC
Alean Kirnak, President
760-944-8436 x18
akirnak@swpartners.com
 
EDS
Rob Savage, Senior Business Services Analyst
608-221-4746   ext 3641
savagrb@dhfs.state.wi.us

Introduction and Scope

The American Immunization Registry Association (AIRA) is a membership organization to promote the development and implementation of immunization information systems (IIS) or registries as an important tool in preventing and controlling vaccine preventable diseases. The Association provides a forum through which registry programs, interested organizations and individuals and communities combine efforts and share knowledge that promotes registry activities as a resource for immunization information systems (IIS) and immunization programs. AIRA’s goals are:

• To promote and advocate for universal population-based registry standards.
• To contribute to the development and maintenance of immunization information systems (registries).
• To advocate for immunization information systems (registries) through legislation, policy development and public information.
• To build stronger partnerships with and between public and private registries, vendors, providers and federal agencies.
• To collaborate with agencies and organizations, both domestic and international, on issues of concern to immunization information systems (registries).

IIS originated as childhood immunization registries but have been expanded to lifespan systems, are used for routine immunization administration, outbreak and emergency response tools, are able to link to routine ordering and SNS and have standards-based tools and/or processes for person identification, person and vaccine event deduplication, provision for feedback to and notification of providers, reminder and recall actions and an algorithm which is used to assess immunization  histories to determine coverage status and to identify persons due or overdue for immunizations and HL7 data exchange standards and message transport.

It is not clear from the initial Introduction and Scope whether this use case is describing immunization and response management in the case of an emergency (which might be implied) or in the case of more routine activities. Immunization Information Systems provide the infrastructure to assume roles in both routine immunization administration and tracking and in emergency management and response alone and/or in connection with additional systems and players.

If it is assumed that the use case is addressing emergencies, it needs to acknowledge that the scale of the emergency and the ensuing intervention is an important factor in choosing an appropriate work flow and information flow. For small scale events, existing infrastructure and processes will likely remain in place and function. For large-scale events, alternative infrastructure and processes will likely come into play. For instance,

• During a small-scale emergency, clinicians in the community will likely take care of their own patients within their existing medical homes. In the case of a large-scale emergency, public health agencies will likely step in and set up alternative treatment/care centers or points of dispensing (PODs) using alternative clinical staff (though the staff may be drawn from the talent available in the community, but deployed in a different organizational structure and context).
• During a small-scale emergency, the information systems used routinely (e.g., an ambulatory EHR-S or community/state immunization information system) would likely remain in place and be used to capture clinical treatment information. In a large-scale emergency these systems would likely be replaced or supplemented by other systems (such as the CDC’s Countermeasure Administration Tracking System or local/state equivalent).
• During a small-scale emergency, existing office work flows and processes will likely stay in place as the load of potential patients is manageable within existing resources and facilities. During a large-scale emergency, additional materiel will likely be received through alternative means and processes (such as Strategic National Stockpile). Basic work flow will likely be very different. In some cases, large jurisdictions have already decided (in their response plans) not to collect encounter data electronically at the point of service but to collect it on paper and enter data retrospectively.

A note on the term “registries”: while it is being used generally here, the immunization registry community now refers to these systems as Immunization Information Systems (IIS) and not registries.

3.0 Use Case Stakeholders

It is not clear why the list of stakeholders in this use case does not map more closely to the more thorough list in, say, the Public Health Case Reporting use case. In addition, it is not clear what the difference between some of the stakeholders is across these two use cases: clinician versus provider, commercial sector supply chain versus manufacturers/distributors, on-site care providers versus response management entities. The stakeholder terminology should be consistent across use cases.

More specifically, we propose adding and merging the following stakeholder definitions to this use case:

Clinicians/Providers

Clinicians (Healthcare providers with patient care responsibilities, including physicians, advanced practice nurses, physician assistants, nurses, and other credentialed personnel involved in treating patients.) within healthcare delivery organizations, or the organizations themselves, with patient interaction in the delivery of care including physicians, nurses, and other clinicians. This can also refer to healthcare delivery organizations. Healthcare delivery may also occur in settings such as: schools, correctional institutions, research settings, etc.

Knowledge Providers

Associations of public health individuals/organizations who provide technical advice and assistance to state and local health agencies in a broad range of areas including: occupational health, infectious diseases, immunization, environmental health, chronic diseases, injury control, and maternal and child
health. The American Immunization Registry Association (AIRA) is a key provider of knowledge and expertise on all aspects of immunization information systems and their uses in both routine and emergency settings.

Public and Private Experts on immunology, vaccine response and adverse events (could be a subset of knowledge providers)

Governmental organizations such as the FDA, the CDC National Vaccine Program Office, the National Vaccine Advisory Committee, the Advisory Committee on Immunization Practices, physician associations which license vaccines, establish effective and safe dosages, establish schedules for vaccine administration based on immunology principles defining “take” responses, recommending pre or post exposure prophylactics, proper handling of vaccine, and reporting of adverse events, defining adequate documentation of vaccination events for reporting, coverage assessments and recall of patients or vaccine lots.

Policy Makers/Decision Makers

Persons or organizations that make decisions, based on input from many sources (including public health, citizen groups, etc) that set priorities, fund resources, and make policies that are the foundation that the other stake holders operate on.  An example might be the executive branch of the federal government or state government.

Government Agencies

A department of a local, state, or national government responsible for the oversight and administration of a specific function. Government agencies that could participate in Immunization and Response may include: Food & Drug Administration (FDA), Centers for Disease Control (CDC), Centers for Medicare &Medicaid (CMS), Department of Defense (DoD), Department of Homeland Security (DHS), etc.

Public Health Agencies (local/state/federal)

Local, state, and federal government organizations and personnel that exist to help protect and improve the health of their respective constituents.

Healthcare Payors

Insurers, including health plans, self-insured employer plans, and third party administrators, providing healthcare benefits to enrolled members and reimbursing provider organizations.

Registries

Organized systems for the collection, storage, retrieval, analysis, and dissemination of information on individual persons to support health needs, the government agencies and professional associations which define, develop and support them, specifically the Centers for Disease Control, the Immunization Registry support team, the Public Health Information Network (PHIN) and the National Center for Public Health Informatics.

Health Researchers

Organizations or individuals who use health information to conduct research.  (These folks will be working to evaluate, make sense of and improve responses to events.) Special reference to be made to CDC centers for Public Health Informatics Excellence at Johns Hopkins, Columbia, Harvard, Universities of Washington and Utah Schools of Public Health.

4.0 Issues and Obstacles:

Data exchange obstacles

One area of technical risk is secure connection between systems.  Identification of and implementation of a common transport mechanism is crucial.  (Note: from the public health perspective, the CDC supported PHIN-MS is one approach which is also used in case reporting and health alert network actions.) One current area where this issue is obvious is the link between IIS and EHR-S.

Technical Infrastructure Obstacles

It is worth noting that there is the potential in the case of an emergency, regardless of the planning done ahead of time, that core infrastructure (communications, systems) will simply fail due to the magnitude of the emergency. We saw that in New Orleans, we saw that in NYC on 9/11 with the complete collapse of data and telephone lines for months in Lower Manhattan. This needs to be acknowledged. The identification of a common transport mechanism, mentioned above, should also be explicitly addressed here.

Shortage or emergency obstacles

The final bullet point could benefit from reorganization.  Put the topic sentence first.  The issue is lack of integration between private sector supply chain and government stockpile inventory system.

Unique Person identification

A key problem that should be added is unique person identification and deduplication. Coordination between systems is not possible without unique person identification.

5.0 Use Case Perspectives

Resource manager: This perspective is not clear enough. Are these private parties? Public health officials? Providers? Local? Federal? All of the above? There are specific processes (like Strategic National Stockpile) set up to deal with the management and distribution of materiel during an emergency. Some of the organizational complexity needs to be recognized here.

This section is unsatisfying.  It is hard to tell whether the idea is to further describe stakeholders or to identify the needs of specific stakeholders or if this only mirrors or expands on the definitions in the table in 3.0.

In general, it may be more useful to identify the needs or goals of the stakeholders.  For instance, Consumers have the following needs related to immunization and response management:

• Knowledge of their immunization status and needs
• Knowledge of their risk status
• Tracking of their exposure status
• Tracking of their preventive treatment status
• Knowledge of where to get treatment

6.0 Candidate Workflows

In Figure 6-1

• It is important to separate the workflow for routine vaccine administration and that required for emergency response as additional functions and players are needed for the latter. However, both require some core functions, especially those included in the IIS.
• Identifying the target population is the first task in the workflow summary. In many cases, this will involve determining whether people have already received vaccinations for a disease and whether the date of administration and number of doses is sufficient to confer immunity. A key feature of IIS is the forecast or recommendation algorithm which assesses a person’s age and immunization history against the recommended schedule for administration of that vaccine and automatically determines whether that person is a candidate for vaccination now. The algorithm is also used for reminder/recall functions to for prospectively required vaccinations or ones past due. This function can also be used to recall persons for “take” responses. Some IIS have inventory management and ordering systems integrated with IIS functionality. The detail of lot, manufacturer and expiration date information in this feature facilitates stock rotation and transfer of vaccines as well as recall based on use of expired lots or other problems with the vaccine.
• It is worth noting that the “administer the intervention” may in fact be multiple events as the intervention might involve more than one dose of an immunization or dispensation of a medicine.
• Isolation and Quarantine is shown in parallel to Prevention and Treatment, but that might lead one to conclude that there is no treatment happening when a patient is in isolation or quarantine.
• Post Intervention Follow-up Activities do not appear in the text anywhere, making the reader wonder perhaps why they are suddenly introduced in the table.

Just under Figure 6-1, the use case introduces the notion of notifying public health to initiate follow-up activities. It is important to note that it is also likely that providers/patient medical homes will also need to be notified, through public health or more directly. Follow-up activities may happen there.

ONC has asked whether self-reported immunizations should play a role. The IIS community has struggled with this for some time, and the decisions about how to treat information provided by patients or their guardians differ. In many ways, accepting unverified information from a PHR is no different than accepting unverified information from a child’s “yellow card” (or equivalent childhood immunization record). Most clinicians will not accept an unverified immunization record (that is, a record without a signature from another clinician). In most cases, IISs accept whatever records are entered by authorized users, making a distinction between immunization doses that were administered by the user’s practice and immunization doses being submitted as “history” supplied by the patient/guardian, another provider and/or as administrative data supplied by a health plan.

Most IIS (registries) have standards about the quality of data they will accept.  In general, they will not accept parental reports unless they are supported by documentation (immunization record or card).  They will not accept estimated dates.  In addition, most IIS can capture the “source” of a record, though the accuracy of this varies.

On page 10, it is noted that the “clinician administers the intervention”. Per the notes above under Introduction and Scope, it is ambiguous in this case just who the “clinician” is. It is significant to understanding the work flow whether this is a clinician at a practice or hospital, a public health treatment center, or a temporary treatment center or POD. The fact that in all cases the person administering the treatment is a licensed clinician is not helpful to understanding the organizational and work flow implications of this use case.

The candidate workflows do not include any communication or interaction with resource managers.