Arming labs with biopreparedness tools: disease trends--analyzing, tracking and being prepared in local communities--has never been a more important topic. The roles of laboratorians and lab managers will be paramount to the nation's success.

The threat of an epidemic, regardless of whether it is naturally occurring or is the result of a chemical or biological agent, has always been greatly alarming for the healthcare industry. Several incidents in past decades have proven that chemical and biological agents can be major hazards.

The Centers for Disease Control and Prevention (CDC) was founded in 1946 as a means of preventing malaria and other tropical diseases. Since its inception, the CDC has had to deal with many situations that could potentially cause epidemics, including the anthrax scare of 2001 and the likely spread of infectious diseases in the aftermath of Hurricane Katrina. The prospect for outbreaks of epidemic proportions has become an area of increasing concern.

President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act into law June 12, 2002 to prepare for and prevent future incidents. In response to this act, the CDC introduced the National Electronic Disease Surveillance System (NEDSS). NEDSS is part of a nationwide effort to fulfill the preparedness goals, provide real-time disease reporting and automate a process that typically involves a significant amount of time and labor.

The risk of outbreaks due to terrorist attacks and natural disasters, such as Hurricane Katrina, bring to light the importance of networked systems. Such systems are invaluable for monitoring infectious diseases that occur when disasters compromise sanitation and hygiene.

The NEDSS initiative provides a foundation for better managing current surveillance systems and for providing a rapid response to public health threats by providing a standardized system. The goals of this initiative are to monitor and assess disease trends, guide prevention and intervention programs, provide information to policy makers and the public, identify issues needing public health research, and reduce provider burden in the provision of information. NEDSS is not a federal mandate. However, for the CDC to fund future surveillance activities through the Emerging Infections Cooperative Agreement, facilities must convert to the NEDSS Base System (NBS) or to another NEDSS-compliant system.

The Birth of NEDSS

Many of the CDC surveillance systems previously utilized, such as the National Electronic Telecommunications System for Surveillance, known as NETSS, were unable to communicate with each other. This resulted in thousands of heterogeneous, largely disconnected systems operated by counties and state agencies. Outbreaks recorded by one system were not necessarily seen by another; thus limiting accurate reporting. In addition, older systems were only designed to detect simple disease and disability conditions.

The communication barrier between these systems resulted in an inability to construct a national disease surveillance system, thus making the identification of a national bioterrorism attack, infectious outbreak or other public health event hard to identify. The presence of these nonintegrated systems also created a high error rate in records with the potential for over- or under-reporting and misuse of time and labor.

These inefficiencies, coupled with the fact that HIPAA requirements called for electronic data standardization, produced the need for a nationally integrated system of record keeping that would provide a near real-time view of national health. Such a system would need to be centralized, involve common reporting mechanisms and provide rapid access to records for statistical analysis and occurrence tracking.

Implementing NEDSS

Realization of NEDSS begins with a central data repository hosted by the CDC. This repository is to be populated with data reported from each state department of health (DOH) in a common format. In turn, each DOH must gather and store reports from all testing sites throughout the state. The CDC has backed the NBS system as a tool commonly available to meet states' project needs.

The NBS is comprised of many rules, working together as an integrated package. There are core modules (e.g., Core Demographics and Nationally Notifiable Disease) and Program Area Modules, both of which handle information relevant to a particular disease or program.

States' departments of health have the option of utilizing NBS, developing new software locally or utilizing parts of the NBS and "plug-in" modules. NEDSS does not define which surveillance systems or NBS modules should be included, which enables state departments to make the decision regarding what information should be under surveillance based on the needs and resources available.

For example, MeritCare Health Systems, a 600-bed multisite hospital located in North Dakota, reports all communicable diseases and conditions as defined by the North Dakota Department of Health. Because MeritCare's services span into Minnesota, MeritCare's data is sent to the North Dakota DOH, which then forwards relevant data to the Minnesota DOH.

As the largest hospital in North Dakota, MeritCare was asked by the state DOH to go on board with NEDSS. MeritCare has been working with SCC Soft Computer's ELR interface and with the North Dakota Department of Health's Disease Reporting Epidemiological Assessment and Monitoring System in setting up the facility's NEDSS-compliant system.

Because the NEDSS initiative involves many parties (e.g., separate state agencies, individual healthcare facilities, different software vendors), NEDSS-compliant systems follow a loose architecture based on the concept of a multilayer system. There are eight clearly defined components required with NEDSS, which enable information to pass through many platforms using different database formats.

Complying With NEDSS

To be NEDSS-compliant, the CDC requires states to:

* Conduct and support Web browser-based data entry and data management;

* Accept, route, and process electronic HL7 messages containing laboratory and clinical content;

* Implement an integrated data repository;

* Develop active data translation and exchange functionality (integration broker);

* Develop transportable business logic capability;

* Develop data reporting and visualization capability;

* Implement a shareable directory of public health personnel;

* Implement a security system and appropriate security policies.

Although NEDSS has a structured architecture, its flexibility can lead to some implementation issues. There are several options states can offer labs, including the implementation of a fully integrated system, the implementation of separate systems with common tools that are shared, or the use of a Web browser.

Fully-integrated systems involve a common interface, common validation rules, and database. This model easily provides information from different programs, enabling comparisons of diagnoses. It also provides for easier system upgrades since the system interface is shared. However, full integration requires a considerable amount of planning and is costly.

This mechanism is most efficient for facilities that have a high frequency of disease and condition reporting. Because this tool automates the process, either in real-time or scheduled periodic sends, the interface option proves useful. The interface uses HL7 protocols and may be based on the CDC's published specifications.

Through NEDSS, the CDC promotes the use of LOINC and SNOMED, which are supported by HL7. Codes for tests and other clinical activity can differ between systems; the migration of facilities toward industry standards improves healthcare communication.

Alternatively, Web browser user interfaces enable effective communication between sources and do not require proprietary software. Because the programming language for Web browsers has been more standardized, the Web format is inexpensive and easy to use. This may be best suited for facilities that have a small degree of disease detection. This mechanism also provides the necessary standardization, although it requires manual entry and can be time consuming.

Benefits of NEDSS

Currently, MeritCare runs weekly SQL reports, which state representatives physically pick up from each of MeritCare's two main facilities. This procedure prolongs data capture, as follow-up information not included on the original report must be researched by the facility and the state.

Ruth Johnson, LIS administrator at MeritCare, points out that the NEDSS-compliant system will also provide the ability to detect, track and monitor orders, such as ER orders for trends. Tracking order occurrence patterns can aid in earlier detection of diseases. "Past systems were not timely," Johnson says, "They provided statistical information, but were not preventative."

MeritCare is in the final stages of creating their HL7 transmission files. Once MeritCare's NEDSS-compliant system is running, all disease reporting from both of their sites may be compiled into one report. With the use of automated interfaces through an NBS system, MeritCare can all but eliminate the healthcare professional's involvement in daily reporting activities.

Biopreparedness: The Real Costs

Depending on the type of architecture chosen, large costs can be incurred when implementing the NBS or NEDSS-compliant systems. Special interfaces and system setup may be required; testing and validation will be necessary. However, not implementing NEDSS can be much more costly.

The reporting process entails many intricacies and can involve various problems. Cases are reported from different areas within the healthcare sector such as private physicians, hospitals and clinical laboratories. It often rests in the hands of these healthcare providers to determine if a case meets public health surveillance case definitions, as well as deciphering the array of forms that the CDC and health departments employ.

Without the NEDSS system, healthcare professionals spend valuable time locating patient records and completing forms. Although these directives seem outside the scope of daily life, these actions directly impact the lives of everyone. For example, in the wake of Hurricane Katrina, 22 new cases of Vibrio were identified. Since hurricane victims were relocated to different states, this stresses the importance of surveillance through networked systems, as communication between states and the CDC is critical.

Although it has not been determined that an outbreak will occur in direct relation to the cases isolated from the hurricane, networked surveillance systems provide awareness and expedite warnings that could prevent such an event. Homeland security and surveillance systems should cover any breaches to our national infrastructure, whether caused by natural disasters or events related to terrorism.

"After 9/11, it really brought to mind that we didn't have systems in place in emerging disease trends," says Johnson. "We have a commitment to improve disease management reporting capabilities. Otherwise, we put ourselves and our loved ones at risk."

For more information about products and services from SCC Soft Computer, www.rsleads.com512ht-204

Ray Harms is interface product manager at SCC Soft Computer, Palm Harbor, Fla.