Thank you for giving me this opportunity to testify. Some of you know me in my role as co-chair of the HIPAA Implementation Team on Unique Identifiers. However, today I will report to you some recent standards implementation activities in the work of the CDC's National Immunization Program (NIP). One of our tasks is to help States and local communities overcome barriers to implementing immunization registries. I will start by giving you some background on immunization registries, then describe where we are now, and finally discuss possibilities for the future.
Immunization registries are confidential, computerized information systems that contain information about immunizations and children. Most people believe that registries must be tailored to local needs; therefore, the concept of a national immunization registry is not one that our program supports. Instead, our approach to universal coverage is to encourage community and state population-based registries that are capable of exchanging information through a nationwide network. Typically, registries are established at the State Health Department level, then connect county health departments to their system. Today, all but 4 of the 64 CDC-funded immunization projects (50 States, District of Columbia, 5 cities, and 8 U.S. territories) have current or planned immunization registries. Thirty-six of these are currently operational in one or more public sites, and 11 of the 36 are currently operational in all public sites in their areas. With the progress made in public sites, many operational registries now are ready to exchange information with each other and to exchange with private providers. To be fully successful, all immunization providers, both public and private, must participate actively in the registry.
When all immunization providers participate, registries can:
Other functions can be added to compute HEDIS coverage rates, to link provider vaccine usage with the practice inventory system, and to generate records for school, camp, and day care.
Children typically are entered into a registry either at birth through a linkage with electronic birth records or at their first contact with the health care system. As the child is immunized at whatever source, a report of the immunization is sent to the registry. When a child goes to a different provider, and often the parent does not have the immunization history with them, the provider can query the registry and obtain a complete history. This allows the provider to give any vaccine needed during the visit and reduces the chance of missed opportunities to immunize while at the same time decreasing "extra" immunizations due to an incomplete record. However, this system depends on registries having the ability to receive and process information from many different kinds of systems. Providers are generally supportive of immunization registries, but do not want to have to purchase special equipment or devote additional staff time in order to participate. This situation presents quite a technical challenge. In 1995, we started working with HL7, an ANSI-accredited Standards Development Organization, to develop standardized messages, or transactions, that would transmit our core data set. With the help of many people within HL7, including Dr. Clement McDonald, the effort resulted in the successful inclusion of these messages in Version 2.3, which was issued in April 1997. We published an implementation guide to help immunization registry developers use the standard and made it available on our web site at www.cdc.gov/nip/registry. Several of the more advanced registries began development of tools to exchange records using this standard.
In a ceremony on July 23, 1997, President Clinton stated his support for efforts to raise the immunization levels of children under the age of two and announced steps to lend additional Federal support for this work. One of these steps was to direct Secretary Shalala to start working with the States on an integrated immunization registry system. Since that announcement, a great deal of work involving our partner organizations, parent focus groups, and provider associations has been done. You will hear more about these efforts when the activities are announced nationally in a few months, but one area of focus is overcoming the technological challenges.
One of the efforts directed toward the technical solutions is relevant to today's discussion. In August 1998, NIP convened a meeting of informatics experts, healthcare system vendors, immunization registry developers, and technical experts to plan next steps that would increase participation in registries, particularly among private providers. The group concluded that NIP's approach should be to develop standards and benchmarks, rather than attempt to develop the software itself for registries. The vendors who were present, including Dr. Eisenberg, encouraged the different immunization registries to work together to develop one common exchange protocol, rather than having each registry have a slightly different requirement from the others. This would make it easier for interested vendors to incorporate this functionality into the systems they sell to providers.
The registries that were present agreed to attempt to remove optionality from the messages so that they could approach vendors with one standard solution that would allow unambiguous record exchange among a large number of private providers and State and local registries. The group met on September 10 last year. The registries represented were Georgia, New York State, Illinois, Michigan, California, and San Bernardino, which has its own registry within California. These registries had described how they planned to use the HL7 standard in their own written document. These written guides allowed a field by field comparison of how the transactions would be formatted. By comparing these, we could see differences and discuss ways to eliminate them, reduce optionality in the messages, and work toward one common implementation. HL7's broad framework provides vendors with flexible solutions for their customers, but our kind of project with so many different participants requires some agreement on how to use the options available. Several examples of the kinds of options that resulted in the need to reach agreement are attached. The participants agreed to give up user-defined segments, called z-segments, and to work with CDC's coordination to agree on specific codes for the user-defined code options and to add needed codes to the HL7-defined code tables or additional fields to the segments within the HL7 standard.
Since this cooperative effort has begun, we have also attracted the interest of the Indian Health Service, the Department of Veteran's Affairs, the Department of Defense, and Kaiser Permanente's National Clinical Information System. Collaboration with Kaiser on this is natural, because they helped to develop the original messages. We believe this project will teach some lessons that can be applied to the exchange of a more complex longitudinal computerized patient record. We will continue to work with HL7 to incorporate the needed fields and codes for immunization registries. We have now sent our first draft of the new implementation guide to the participants for their review. When it is final, we will make it available to everyone on our web site. We plan to provide this single implementation standard to vendors and to enlist their support by building it into the systems they create for physicians to use in reporting to immunization registries. Other activities within NIP will be directed toward educating providers about these systems so that they begin to request them when purchasing upgrades to their systems.
We appreciate the efforts of your committee to promote standardization in the healthcare industry. We support the use of computer-based patient records as the source of immunization data and look forward to your recommendations in this area.
As the standard itself explains in Version 2.3, Section 1.7.1, HL7 currently is not a complete systems integration solution. Because there is little conformity within healthcare delivery environments, HL7 offers a broad framework within which vendors can develop flexible systems to provide solutions to users. Vendors typically develop site-specific solutions to their customers' needs without regard for inter-enterprise solutions. Future versions of HL7 will use a different approach and become more prescriptive with a smaller set of choices for implementers.
The following descriptions provide a very simplistic description of some basic formatting methods that the current standard employs:
The registries in this activity had differences in their planned HL7 messages, even though they were all following NIP's original implementation guide. Several examples of the differences in implementation of immunization registries follow.