I would like to thank the Committee for extending an invitation to the VA to testify at today’s hearing on the use of message format standards related to PMRI.
The Veterans Health Administration (VHA) is a major user of message format standards for the exchange of patient medical record information. VHA first implemented a message format standard in the early 1990s, namely HL7 version 2.1, and also began participating in standards development organizations at the same time. Today VHA is a participant in virtually all the standards development organizations related to the list of standards for which NCVHS is requesting testimony. VHA has implemented or had experience with almost all the standards except the IEEE medical device standards.
The one high priority area that is not addressed by the standards in the list you provided is the area of vocabularies and code sets. The vocabularies and code sets used to exchange information are an integral part of the message format standards. The assumption we have is that vocabularies and code sets will be addressed at a separate hearing.
Let me address each of the groups of standards more specifically.
VHA participated in and was a co-chair of the ASTM E31.25 Subcommittee. The DTDs that this subcommittee developed are based on the HL7 Clinical Document Architecture (CDA) and implement the Level 1 Header of the HL7 CDA standard. The DTDs are intended to provide detailed healthcare information that would normally be associated with Level 3 of the HL7 CDA. VHA has implemented the Draft Specification for Healthcare XML DTDs as a demonstration project. Not unexpectedly, we encountered a number of issues in implementing the draft specification. We believe all the issues are due to the fact there is a natural disconnect between the currently defined Level 1 Header of the HL7 CDA and a Level 3 implementation because Level 2 of the CDA is not yet fully defined. We believe that once Level 2 of the HL7 CDA is fully defined and the ASTM XML DTDs are revised to accommodate the changes this will introduce, the ASTM XML DTDs will be very useful standards for the exchange of healthcare information.
VHA has participated only peripherally in the ASTM E31.27 Subcommittee and not sufficiently to be able to comment on the Draft Specification for Healthcare Document Formats.
VHA has implemented the DICOM 3.1 standard. We found it relatively easy to implement. We had implemented an earlier version of the standard so our implementation was an upgrade as opposed to a new implementation. We also found the standard relatively easy to use, however, we issued a set of VHA requirements in addition to the standard that further limited optionality allowed by the standard itself. The standard has met our needs quite well. We have no major weaknesses to report. We believe a new section of the standard called Structured Reporting will be very useful for exchanging imaging reports and we are beginning to evaluate implementation of this section.
As I indicated previously, VHA has been a long-time user of HL7 standards starting with version 2.1. We have continued to expand our use of different sections of the HL7 standard to the point where we have now implemented and/or evaluated virtually all of the HL7 standards on the list provided by NCVHS. The 2.x versions of HL7 have continued to improve with each new release. VHA found even the early versions met many of our needs, however they required extra work to implement due to the amount of optionality in the standards. Optionality has been reduced with each subsequent version, but there is still too much even in the latest 2.x version of the standard.
Version 3 of the HL7 standard is expected to significantly reduce the problem of optionality, but it is still too early in the development of version 3 to draw a conclusion. The only part of the version 3 standard VHA has implemented is a demonstration project based on the HL7 Clinical Document Architecture. The main comment that we can make at this time regarding the messaging part of the HL7 version 3 standard is that it holds the promise of being a significant improvement over version 2.x standards.
Our evaluation of the HL7 Clinical Document Architecture Framework standard is that it currently meets only a limited amount of VHA’s needs due to the fact that only Level 1 of the standard has been implemented. We believe that most of VHA’s needs can be met once Level 2 of the CDA is fully defined. We believe this standard has great potential for enhancing the exchange of clinical information.
VHA has not yet evaluated or implemented the IEEE standards for medical devices and therefore we are unable to comment on these standards at this time.
VHA has not yet implemented or evaluated version 4.2 or the prescriber-pharmacist part of the NCPDP standard. We have currently implemented version 3.2 of the NCPDP standard, specifically the part related to claims submissions, and it is meeting our needs. We have also evaluated version 5.1 (the version required by HIPAA) relative to claims submissions and have found it acceptable for our needs.
As part of a project called Government Computer-based Patient Record (GCPR) VHA has evaluated and implemented the OMG Person Identification Service (PIDS) specification and the OMG Clinical Observation Access Service (COAS) specification. These implementations consisted of minimum functionality as opposed to the most robust implementation of the standards. VHA did not have prior experience with these standards; therefore a lot of training was required. Implementation of both standards (including training) took approximately 18 months. The standards were reasonably easy to use once implemented.
There is a need for a scanned document standard that includes file format and annotation capabilities. Some existing document formats include TIFF, PDF, or DICOM. The DICOM standard could be extended to fill this need by enhancing the standard to handle document images, since annotation capabilities are already built into the DICOM standard.
There is also a need for an EKG standard – we believe DICOM is working on this, but are uncertain of the current status.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
ASTM E31.25 Draft Specification for Healthcare DTDs
3. What functions or characteristics caused you to select this standard for implementation?
This standard attempts to define fully encoded clinical documents at a detailed level (Level 3 of the HL7 Clinical Document Architecture)
4. What was your experience implementing this standard?
Not unexpectedly, we encountered a number of issues in implementing the draft standard. We believe all the issues are due to the fact there is a natural disconnect between the currently defined Level 1 Header of the HL7 CDA and a Level 3 implementation because Level 2 of the CDA is not yet fully defined. We believe that once Level 2 of the HL7 CDA is fully defined and the ASTM XML DTDs are revised to accommodate the changes this will introduce, the ASTM XML DTDs will be very useful standards for the exchange of healthcare information.
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Approximately two months.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Approximately $20,000.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
See comments for question 4 above.
a. What could or should be done to improve or strengthen this standard?
See comments for question 4 above.
6. Have you evaluated any more current version(s) of the standards you are using?
No.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
DICOM 3 or 3.1 with updates through now
3. What functions or characteristics caused you to select this standard for implementation?
Its ability to support image data - communication, storage and display. We intend to use the Structured Reporting standard for passing report information including links between images and reports.
4. What was your experience implementing this standard?
a. What aspect of implementing this standard exceeded your expectations?
(1) The broad capabilities supported by the standard; (2) the completeness of the standard in allowing us to implement and communicate with those who we interface with; (3) interoperability is great -- sometimes it takes only 5-15 minutes to have an interface working with a new vendor; (4) the continuing development and expansion of the standard.
b. How long did it take for your organization to implement this standard?
We initially implemented the earlier version and converted. This question is not very useful because the DICOM standard has lots of parts and everyone implements the parts of it that they need.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not known.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes, extremely easy to connect with other devices. The standard is well defined, and the VA issued its own requirements for items that we required and the standard left optional.
5. What are the major weaknesses or limitations of this standard(s)?
None.
a. What could or should be done to improve or strengthen this standard?
6. Have you evaluated any more current version(s) of the standards you are using?
a. If so, what is your evaluation of them?
We want to use the Structured Reporting standard. Capabilities here are extremely useful.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
HL7 Version 2.x Order Entry Transaction Set
3. What functions or characteristics caused you to select this standard for implementation?
Initially it was the only open standard available. Subsequently, it was a widely used standard that was being continually improved through an open process in which VHA could participate.
4. What was your experience implementing this standard?
Initial interfaces required additional work to define the use of optional data elements. Subsequent interfaces continued to require additional work, but less than the initial interfaces.
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Not known.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not known.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
There is too much optionality in the standard.
a. What could or should be done to improve or strengthen this standard?
Improve the definition of data elements as is being done for version 3 of the HL7 standard.
6. Have you evaluated any more current version(s) of the standards you are using?
No.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
HL7 Version 2.x Scheduling Transaction Set
3. What functions or characteristics caused you to select this standard for implementation?
It was the only open standard available for these types of transactions.
4. What was your experience implementing this standard?
VHA has not yet implemented this standard; we have only evaluated it for implementation. Our evaluation indicates that it will meet our needs.
a. What aspect of implementing this standard exceeded your expectations?
Not applicable.
b. How long did it take for your organization to implement this standard?
Not applicable.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not applicable.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Not applicable.
5. What are the major weaknesses or limitations of this standard(s)?
We did not identify any major weaknesses or limitations.
a. What could or should be done to improve or strengthen this standard?
6. Have you evaluated any more current version(s) of the standards you are using?
No.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
HL7 Version 2.x Patient Administration Transaction Set
3. What functions or characteristics caused you to select this standard for implementation?
It was a widely used standard that was being continually improved through an open process in which VHA could participate.
4. What was your experience implementing this standard?
Initial interfaces required additional work to define the use of optional data elements. Subsequent interfaces continued to require additional work, but less than the initial interfaces.
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Not known.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not known.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
There are a number of data elements that VHA uses that the standard does not currently support. VHA created ‘Z’ segments to exchange these data elements, however, VHA is evaluating ways to incorporate these data elements into the standard such that they will be applicable to and supported by other organizations.
a. What could or should be done to improve or strengthen this standard?
See above response.
6. Have you evaluated any more current version(s) of the standards you are using?
No.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
HL7 Version 2.x Observation Reporting Transaction Set
3. What functions or characteristics caused you to select this standard for implementation?
Initially it was the only open standard available. Subsequently, it was a widely used standard that was being continually improved through an open process in which VHA could participate.
4. What was your experience implementing this standard?
Initial interfaces required additional work to define the use of optional data elements. Subsequent interfaces continued to require additional work, but less than the initial interfaces.
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Not known.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not known.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
There is too much optionality in the standard.
a. What could or should be done to improve or strengthen this standard?
Improve the definition of data elements as is being done for version 3 of the HL7 standard.
6. Have you evaluated any more current version(s) of the standards you are using?
No.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
HL7 Version 2.x Patient Administration Financial Management Transaction Set
3. What functions or characteristics caused you to select this standard for implementation?
It was a widely used standard that was being continually improved through an open process in which VHA could participate
4. What was your experience implementing this standard?
Initial interfaces required additional work to define the use of optional data elements. Subsequent interfaces continued to require additional work, but less than the initial interfaces.
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Not known.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not known.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
There is too much optionality in the standard.
a. What could or should be done to improve or strengthen this standard?
Improve the definition of data elements as is being done for version 3 of the HL7 standard.
6. Have you evaluated any more current version(s) of the standards you are using?
No.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
HL7 Version 2.x Patient Care Transaction Set
3. What functions or characteristics caused you to select this standard for implementation?
It was a widely used standard that was being continually improved through an open process in which VHA could participate
4. What was your experience implementing this standard?
Initial interfaces required additional work to define the use of optional data elements. Subsequent interfaces continued to require additional work, but less than the initial interfaces.
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Not known.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not known.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
There is too much optionality in the standard.
a. What could or should be done to improve or strengthen this standard?
Improve the definition of data elements as is being done for version 3 of the HL7 standard.
6. Have you evaluated any more current version(s) of the standards you are using?
No.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
HL7 Version 3 Clinical Document Architecture Framework
3. What functions or characteristics caused you to select this standard for implementation?
It supports the VHA architectural direction, namely to use secure, services oriented, web-based and component-based standards to support the distributed application environment of VHA.
4. What was your experience implementing this standard?
This standard has great potential to support the exchange of clinical and other healthcare documents. Currently the standard is only partially defined and therefore its usefulness is limited.
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Approximately two months.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Approximately $20,000.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
Currently the standard is only partially defined and therefore its usefulness is limited.
a. What could or should be done to improve or strengthen this standard?
Level 2 of the CDA needs to be defined as soon as possible and the work that ASTM has done in developing Level 3 XML DTDs needs to be merged with the work that HL7 is doing on the overall Clinical Document Architecture.
6. Have you evaluated any more current version(s) of the standards you are using?
VHA has sponsored and participated in a work effort to develop a document ontology that is expected to become part of the Level 2 definition of the HL7 CDA standard. We believe this document ontology will be a major contribution to the definition of Level 2 of the HL7 CDA.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
NCPDP SCRIPT version 3.2
3. What functions or characteristics caused you to select this standard for implementation?
It was the most widely accepted version of the standard in use in 1997 when we implemented it.
4. What was your experience implementing this standard?
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Not known.
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Not known.
d. After you completed the implementation of this standard, did it prove to be easy to use?
Yes.
5. What are the major weaknesses or limitations of this standard(s)?
None identified.
a. What could or should be done to improve or strengthen this standard?
6. Have you evaluated any more current version(s) of the standards you are using?
Yes, version 5.1.
a. If so, what is your evaluation of them?
We believe version 5.1 of the standard will meet our needs for claims submissions. We have not yet evaluated it for other purposes.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
OMG Health CORBAmed 2001 -06-04 Clinical Observation Access Service (COAS)
3. What functions or characteristics caused you to select this standard for implementation?
GCPR was looking to explore the use of an object-oriented technology for passing data between disparate systems. The main reason for its selection is the vendor-neutral, standards based, component-based architecture that it provides.
4. What was your experience implementing this standard?
a. What aspect of implementing this standard exceeded your expectations?
None.
b. How long did it take for your organization to implement this standard?
Approximately 18 months to implement only the get_observations_by time method of the standard. (However, this standard was implemented at the same time as the OMG PIDS standard and extensive training and learn-as-you-go efforts were also accomplished during this time.)
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Approximately 1.5 million was expended on support from an outside contractor to assist in implementing the required portions of the COAS and PIDS interfaces from VA to GCPR, and to provide training and guidance to VA team developers participating in the GCPR project.
d. After you completed the implementation of this standard, did it prove to be easy to use?
The implementation of this standard was very different from the environment our VHA staff was previously familiar with. The standard is relatively new and developing/finding experience with it either within our organization or in the private sector was difficult.
5. What are the major weaknesses or limitations of this standard(s)?
a. What could or should be done to improve or strengthen this standard?
The addition of "templates" such as those developed in support of GCPR for use in grouping like sets of data would be helpful. A template is a construct that is capable of representing and transporting healthcare content of relatively fine granularity consistently across disparate systems while maintaining semantic integrity.
i. Have you evaluated any more current version(s) of the standards you are using?
No, we are utilizing the current version.
2. What is the name of the specific standard and version that your comments will address in response to questions 3 through 6?
OMG Health CORBAmed 2001-06-02 Person Identification Service (PIDS)
3. What functions or characteristics caused you to select this standard for implementation?
GCPR was looking to explore the use of an object-oriented technology for passing data between disparate systems. The main reason for its selection is the vendor-neutral, standards based, component-based architecture that it provides.
4. What was your experience implementing this standard?
a. What aspect of implementing this standard exceeded your expectations?
b. How long did it take for your organization to implement this standard?
Approximately 18 months to implement only the register_new_IDs, find_or_register_IDs, and find_candidates methods of the standard. (However, this standard was implemented at the same time as the OMG COAS standard and extensive training and learn-as-you-go efforts were also accomplished during this time.)
c. What was the total implementation cost? (Please include your best estimate for fees, education, interface engines, custom coding, testing, maintenance, etc.)
Approximately 1.5 million was expended on support from an outside contractor to assist in implementing the required portions of the COAS and PIDS interfaces for GCPR, and to provide training and guidance to GCPR team developers.
d. After you completed the implementation of this standard, did it prove to be easy to use?
The implementation of this standard was very different from the environment our staff is familiar with. The standard is relatively new and so finding experience with it either within our organization or in the private sector was difficult.
5. What are the major weaknesses or limitations of this standard(s)?
a. What could or should be done to improve or strengthen this standard?
No areas were found in our limited implementation of this standard.
6. Have you evaluated any more current version(s) of the standards you are using?
No, we are utilizing the current version.