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Countermeasure Response Administration System
CRA Background
The Need for the Countermeasure Response Administration
Events including the threat of pandemic influenza, SARS outbreaks, smallpox preparedness, and the anthrax attacks have demonstrated that information systems are critical to managing the response and to tracking the countermeasures administered for containing and preventing further outbreaks. Public Health must be ready at all times to respond to public health emergencies. During a public health emergency, there is a need to manage information about the event, check availability of countermeasures, and know who has received them. Countermeasures may include pharmaceuticals such as vaccines and antivirals, medical materials such as masks and ventilators, and interventions such as quarantine. Once countermeasures are received, there is a need to monitor their effectiveness or identify resulting adverse events. Post event, there is a need to analyze the information to help better prepare for future emergencies.What is the CRA system?
The CRA system is one tool public health partners may choose to manage countermeasure and response administration activities within their jurisdictions. In addition, for selected events such as the National Smallpox Vaccination Program and the National Pandemic Influenza Plan, CRA supports CDC’s cross-jurisdictional reporting needs by providing flexible methods for accepting data from other systems or by extracting summarized data. CRA has its origins in the Pre-event Vaccination System (PVS) that was implemented nationwide to track and monitor the administration of smallpox vaccines as part of the National Smallpox Preparedness Program. Building from this success and with local, state, and CDC input, CRA has been expanded for national, state, and local use. CRA’s advanced functionality helps ensure that individuals receive recommended countermeasures, and it then tracks and manages information on vaccinations, prophylaxes, treatments, and quarantine. Key system capabilities include:- Custom event creation and configuration
- Collection of information on individual patient or aggregate treatment information
- Streamlined data entry capabilities
- Management of multiple simultaneous events and countermeasures including:
- Vaccine dispensing
- Pharmaceutical dispensing
- Single and multiple dose tracking
- Quarantine of patients
- Data extracts for jurisdictional reporting
- Off-line deployment at points of dispensing (POD)
The CRA system is a Web-based application deployed centrally at CDC via the Secure Data Network (SDN). It is Internet accessible, using any standard Web browser in conjunction with a CDC issued digital certificate. In situations where the Internet is down or inaccessible, CRA may be deployed offline on a stand-alone basis.
Current CRA Functionality
Version 1.7
CRA version 1.7 was released in May 2008. This version included a number of system enhancements and additions including:
• Offline Capability
• Rapid Data Entry for Multiple Countermeasures
• User Configurable Screens
• Simplified Event Setup
• Improved User Navigation
• Context-sensitive Help
Version 1.8 Development
CRA version 1.8 is in development and scheduled for release in September 2008. This version will include the following enhancements:
• Aggregate Group & Reporting Enhancements (with data exchange and synchronization)
• Patient Registration (with import and search)
• Adverse Event Support
•
Patient Follow-up Support•
Sub-Jurisdiction Support•
Event Reports/Data Extracts Enhancements•
User-Defined Fields Support
Future Status of CRA
Future plans for CRA include delivering preconfigured individual-level data collection screens based on accepted practice and CDC guidance for priority events involving the national planning scenarios. In addition, expanded data exchange capabilities with a range of CDC and public health partner systems will be added to identify, track and manage a full range of countermeasure and response activities using PHIN messaging standards. Point of dispensing (POD) deployment will continue to be simplified for easy local installation and automatic synchronization with the central database.
CRA FAQ
Background
What is the CRA system and what does it do?
The
CRA system is a CDC-developed application designed to support the intervention component of PHIN. The system allows custom event creation and configuration, management of multiple simultaneous events, and tracking of single and multiple-dose countermeasure dispensing. Future versions will include links with other CDC applications to support the tracking of products through the delivery chain to patient dispensing.
Implementation
What if I have my own CRA system; how does it relate to CDC’s CRA application?
CDC is extremely supportive of partner’s using their own systems. During a national event, such as pandemic influenza, the need to provide information to CDC is likely to arise. To help provide such information, the CRA system offers ways for project areas to send data to CDC. The methods include file transfer (XML, pipe delimited) for the aggregate reporting anticipated for pandemic influenza and smallpox uploads. HL7 messaging for data exchange will be included in future versions.
How do I get started with CRA?
For those interested in adopting CDC’s CRA application, the CRA team is available to work with you to develop a plan. For additional assistance, contact the help desk at 800-532-9929 or e-mail PHINTech@cdc.gov.
Because of security requirements based on the sensitive nature of
the information accessed, users are required to apply for digital
certificates to use CRA. Digital certificates are assigned to
individual people and reside on each machine that the individual
uses to access CRA. However, certificates can be exported and moved to other machines as necessary. Administrator rights are required to install the digital certificates.
If users currently have a digital certificate for accessing another CDC application, they do not need to reapply for a digital certificate. They can apply for the CRA activity by visiting the SDN home page at
https://sdn.cdc.gov, and by clicking on the "Request Additional Activities" link in the left pane of the Web page. A request for the Countermeasure and Response Administration Activity can be selected from a drop down menu on that page.
How does CRA help me meet my organization’s preparedness needs for events such as pandemic influenza or anthrax?
CRA offers several ways for users to meet their preparedness needs:
- For any event—CRA will allow partners to create their own events and add related countermeasures. The system will allow partners to track different countermeasures including vaccinations, treatments, and quarantine activities. In addition, CRA flexible treatment screens will be able to support a range of data collection requirements based on event-specific or local user needs.
- For pandemic influenza—An aggregate reporting has been added to report vaccine doses administered during a pandemic. An aggregate reporting capability has also been added for partners and project areas to report vaccine doses administered during an actual pandemic. Aggregate reporting can be accomplished either with the CRA application or via upload for those using their own state-based systems.
- Centralized versus decentralized deployment—CRA is a Web-based application deployed centrally at CDC via the Secure Data Network (SDN). It is Internet accessible using any standard Web browser and a CDC-issued digital certificate. CRA may be deployed offline on a standalone basis within a point of dispensing (POD) or during situations where the Internet is inaccessible. This capability will continue to be improved with simplified installation, automatic application updates, and the ability to synchronize collected data with the central database.
Legislation
How do you account for the Health Insurance Portability and Accountability Act of 1996 (HIPAA) policy requirements for personal information privacy and ensure compliance?
The HIPAA privacy rule permits disclosure to public health authorities without further authorization. Covered entities are permitted to disclose Protected Health Information to public health authorities without patients’ authorization as defined at 45 C.F.R § 164.501 and as used in 45 C.F.R. § 164.512(b), Standards for Privacy of Individuality Identifiable Health Information, promulgated under HIPAA.
However, access to identifying data is tightly controlled within the CRA application. The level of access is determined by the requirements of the specific event. For instance, with the National Smallpox Preparedness Program and the monkeypox outbreaks, patient-identifying information was captured in the CRA application,
then referred to as PVS and made available only to jurisdictional users. Identifying data were not shared for national reporting. Data are transported, maintained, and stored using federal security methods which are consistent with the HIPAA security rule. Refer to
www.cdc.gov/phin for more detail.
How is CRA meeting the requirements for PAHPA and HSPD-21?
In December 2006, Congress passed and the President signed the Pandemic and All-Hazards Preparedness Act (PAHPA). This Act provided new authorities for a number of programs, including the advanced development and acquisition of medical countermeasures; and called for the establishment of a quadrennial National Health Security Strategy. On October 18, 2007, the White House released Homeland Security Presidential Directive 21 (HSPD-21) establishing a “National Strategy for Public Health and Medical Preparedness.” This directive is an important and commendable development in national bio-defense policy. It offers clear strategic direction and is in keeping with the best professional judgments of many medical, public health, disaster response and community engagement experts in and out of government. HSPD 21 establishes a Public Health and Medical Preparedness Task Force that comprises: The Secretaries of HHS, Homeland Security, Defense, State, Agriculture, Commerce, Labor, Transportation, and Veterans Affairs; the Directors of the Office of Management and Budget and National Intelligence; and the Attorney General. CRA is working on meeting the requirements set forth in both PAHPA and HSPD-21 by creating the framework and policies for sharing information on best practices and mechanisms for state and local governments to meet countermeasure dispensing time requirements. Additionally, the CRA application can be leveraged by non-federal stakeholders to increase their own capabilities for countermeasure administration. CRA is currently working with multiple state and local jurisdictions on countermeasure administration exercises, as well as conducting a 2008 Pandemic Influenza exercise.