§170.205 Content exchange standards and implementation specifications for exchanging electronic health information. The Secretary adopts the following content exchange standards and associated implementation specifications:
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(d) Electronic submission to public health agencies for surveillance or reporting.
(1) Standard. HL7 2.3.1(incorporated by reference in §170.299).
(2) Standard. HL7 2.5.1(incorporated by reference in §170.299).
Implementation specifications. Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting Final Version 1.0 and Errata and Clarifications National Notification Message Structural Specification (incorporated by reference in §170.299).
§170.302 General certification criteria for Complete EHRs or EHR Modules. The Secretary adopts the following general certification criteria for Complete EHRs or EHR Modules. Complete EHRs or EHR Modules must include the capability to perform the following functions electronically, unless designated as optional, and in accordance with all applicable standards and implementation specifications adopted in this part:
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(l) Public health surveillance. Electronically record, modify, retrieve, and submit syndrome-based public health surveillance information in accordance with the standard (and applicable implementation specifications) specified in §170.205(d)(1) or §170.205(d)(2).One of the teams that was looking to implement this internally discovered a number of issues with this selection. In reviewing the PHIN specification, we found this [emphasis mine]:
1.1 SCOPE
This document specifies the structure and methodology for the use of the Health Level 7 (HL7) Version 2.5 Unsolicited Result Message (ORU^R01) to support electronic interchange of any de-identified Nationally Notifiable Condition message from public health entities to the CDC. The message structure is the same for the individual Case Notification, the Summary Notification, the Environmental Investigation Notification, and the notification of Laboratory report results to meet national reporting requirements to CDC.
On followup with experts from a state public health agency, we heard that this was wrong on several counts:
- This specification describes a framework for public health reporting from states to the CDC, not for reporting to state public health.
- It's an old version (Version 2.0 is out).
- It describes a framework for communication but doesn't describe what goes into the message. One observer reported: "It specifies what the picture frame should look like, but not what the picture should be that goes in it."
So what is an implementor to do while we wait for CDC and the rest to find the right solution, and for ONC to announce that there really is a problem and that it will be fixed?
Well, here's my advice:
1. Use HL7 Version 2.3.1, because there is no implementation guide specified, and you can do something reasonable with it.
2. Use the message formats defined in HITSP C39 Encounter Message Component, which is designed (in 2006 I might add) for the purpose of "sending patient encounter data (excluding laboratory, radiology) from a Biosurveillance Message Sender to a Biosurveillance Message Receiver.", but change the version from 2.5 to 2.3.1
This should be compliant with §170.205 (d)(2) (it will be an HL7 Version 2.3.1 message) and §170.302 (l) (by compliance with §170.205 (d)(2)).
Now, what should CDC and ONC do?
- Fess up. Everyone makes mistakes. Please correct this one swiftly, and with as much transparency as you possibly can. We don't need heads to roll. Meaningful Use has amazingly crazy schedules that we are all trying to meet. Make it possible for us to meet them by giving us the information we need, when you know it, not after you've had a change to make it all better. Cause by then, it will already be too late.
- Give us a schedule for when you think the correction will be made.
- Consider seriously using the HITPS C39 specification which was purpose designed for this specifc use case for the replacement. I'll point out that the HITSP C39 guide had the input of experts from the CDC and Federal Advisory Committees conveigned on this topic, and State Public Health agencies.
HITSP developed use cases around Syndromic Surveillance and laid out the basics in what they call the “HITSP Biosurveillance Interoperability Specification” (HBIS). The most recent version is 3.2 and can be found here: http://hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=1&PrefixNumeric=2
ReplyDeleteData requirements 3 and 4 together make up the core Syndromic Surveillance visit message. These have been at the core of most Syndromic Surveillance work in the past years.
WA Department of Health has mapped these into an HL7 v2.5 ADT message. It should be quite simple to map it to a HL7 v2.3.1 ADT message.
ISDS is quite involved in syndromic surveillance and they are working towards a proposal to validate with CDC and CSTE by December.
I don't buy their arguments that this is soon enough and have been trying to push the HBIS document within Public Health because most of the work is already done - and doesn't need to be done again!
It is good to have your rant to help me push Public Health to get this done quickly!
Well,Dr.John Halamka presented at a HIMSS event on "MU" today [Aug 25, 2010], and in response to a question on this issue, he clearly stated that an "erratum" will be issued by ONC soon.
ReplyDeleteI've heard an announcement is in the works, possibly early next week.
ReplyDeleteConfirmation of this issues comes from the transcript of the HIT Standards FACA meeting held on Monday, August 31st, and also appears on John Halamka's blog:
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Another public comment, Keith Richard.
I was told by Dr. -- last week that the public surveillance test procedure is being reworked. Is this correct and it is being reworked, does someone have, the documentation for that?
Dr. John Halamka: Let me get this one back to Doug. As we talked about this morning, I have gone through every question and. Talk to ONC and CMS and the consistencies did not exist except for one, it appears the syndrome and surveillance implementation guide is the wrong document. And, if you can make it,?
Dr. Doug Fridsma: Yes, we are currently, we have identified this as an issue and a problem but part of what happens when you do rulemaking is the standards are the documents that describe the standards are incorporated in the final rule by reference and so the documents that were incorporated by reference in the documents we received from the CDC were not reflective of the standards that we wanted to include an we are currently working on trying to figure out the best strategy for fixing that particular problem. I don't have a time frame for you just yet or a particular approach we would need to make sure that we work very closely with the office of General Counsel to do things correctly but I guess, the best I can say, stay tuned. We realize there is an issue that needs to be addressed and we are actively trying to figure out what options we have.
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1. So, they "fessed up" and did a pretty decent job of it.
2. There's still no schedule, although I hear that something is in the works through an organization working with the CDC, but that could take some time, and I haven't really been able to confirm that yet (maybe I'll know more this week).
3. I've also heard that C39 is possibly on the table, or something built from it, but don't have any confirmation of that either.
Thanks Keith! You're a great resource for all of out here feeling our way in the dark.
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