Quietly, on Friday afternoon, I published a blog on HL7 V3.0 reporting on the views of some who are concerned with some of the directions being taken by HL7.
The blog is found here:
By late Sunday there had been lots of comments - with an especially interesting part of the thread being initiated by Dr Eric Browne.
Here is the thread from that comment on (the rest is on the blog directly)
Eric Browne said...
"My understanding is that there are two private consortia doing e-prescribing and that NEHTA is working - at a glacial pace - on developing a standards package for the domain - and a few others - referrals etc."
Well NEHTA have produced an HL7 V3 CDA specification for electronic transfer of prescriptions (eTP) and have submitted it to Standards Australia to fast track it into an "Australian Technical Specification". I understand that this is to be used as the basis for eTP in Australia, and presumably will be adopted by the two existing private consortia and any newcomers.
However, although this CDA specification introduces a lot of new complex codes, it is actually less prescriptive than the existing HL7 v2 based AS4700.3 standard for exchanging medication information, particularly for supporting safe clinical practice. Let me give one example. I could give many others.
Quality Use of Medicine programs continually push the mantra "Right person, right drug, route dose, right route, right time". I'm not a clinician, but as a patient, I would like to know that the route and dose have been supplied on the prescription. The existing Australian Standard has a whole HL7 segment devoted to recording route of administration. NEHTA's proposed standard has NO specific field to record Route of Administration, and NO terminology to support it. Instead, it has a single free text field that conflates route with dose. Thus, no compliance checking to ensure that route has been supplied would be possible. No compliance checking to ensure that any dose information has been supplied would be possible.
I'm perturbed that from a clinical safety perspective that we might be going backwards in some areas of clinical data standards. This is not a criticism of HL7 v3 per se in this case, but yet again, illustrates the lack of proper governance in e-health in Australia.
Dr David More MB, PhD, FACHI said...
Eric, thanks for the detailed comment.
It is my understanding that one of the present providers is committed to implement what Standards Australia comes up with and that the other has said they will look at it when the Standard is finalised.
I should say I am aware of others besides Eric with very considerable concerns about just where the HL7 vs CDA situation currently sits - many of who are on the relevant IT-14 Sub Group.
Eric Browne (Saturday, March 12, 2011 3:45:00 PM) said “NEHTA's proposed standard has NO specific field to record Route of Administration, and NO terminology to support it. Instead, it has a single free text field that conflates route with dose.”
That is amazing, indeed quite incredible. It simply is not good enough. I had to check conflate – which means melds or brings together.
From quality control, accreditation, and safety perspectives NeHTA would fail dismally if, what Eric says, is true.
From a medico-legal perspective any doctor, nurse, dentist or anyone else authorised to write prescriptions would be totally liable if a medication error (adverse event) occurred as a consequence of a medication being taken which did not specify precisely the ‘route’ and the ‘dose’.
Much of the rationale behind introducing electronic prescribing and transmission of scripts is to cut down on medication errors. As a doctor I can categorically state that I would never ever prescribe a medication without stating exactly the DOSE (‘n’ mgm, microgram, ml, or whatever) and the ROUTE (Intramuscular, orally, per vagina, in the eye, on the skin, on the affected area, up the nose, in the ear up the rectum, whatever).
It beggars belief to think that NeHTA could even contemplate creating standards which do not include ROUTE and DOSE. So much so that I have to think, despite Eric’s acknowledged expertise in this area, he has to be wrong in his claim that NEHTA has “NO specific field to record Route of Administration, and NO terminology to support it” and simply has a “free text field that conflates route with dose”.
I suggest someone very quickly asks a Medical Defense Organization to provide an opinion on this pronto.
And I suggest too that NeHTA be asked urgently to very clearly clarify its position on this matter.
I think HL7 V2 is a very under-appreciated standard and I would in general agree with the original comments.
V3 messaging appears dead, even from Graham says and CDA is mentioned as "working", but CDA is a Document format and not a messaging specification.
We do require a messaging specification and V2 is rich and flexible in this arena and there are a lot of existing implementations out there, although most are quite flawed however. CDA on its own just cannot do ePrescribing in anything but a token document transfer. HL7V2 medication messaging has all the behaviours needed to actually enable ePrescribing. By definition CDA has no behaviours as it’s a document.
The advantages of CDA are that it is xml and people can use an off the shelf parser and it allows richer structure in the body of the document.
Good HL7V2 parsers are available and V2 can be encoded in xml and the parsing side of the problem is a tiny percentage of the task.
The structuring of the clinical data in HL7V2 is an area that needs improvement, but there are several projects active working on that and in any case you could embed CDA documents in HL7V2 to get the messaging and the structured payload. Either or both approaches are appropriate, but standalone CDA will not solve our problems.
Enhancing V2 structure is a path that could be backward compatible and could be incremental but it seems that very few people have a deep understanding of both V2 and V3 and just choose the most recent technology thinking that V2 is on the way out when in fact, its expanding. Taking the lessons learn in over 12 years of V3 development and applying them to enhancing V2 is a path that is doable, but I fear that it appears to much like a failure for people to support it.
In Australia we really only have V2, so enhancing what we have with compliance testing and actually using the V2 Medication standards we have would seem a very sound choice, but Nehta appear to have a complete block when it comes to looking at working standards and enhancing them. Everything has to be done from the ground up and we end up with over complex V0.9 "standards", that would need years of trials to perfect, time they do not have.
In fact Nehta appear to show no interest in looking at what is working, it’s an arrogance that the country cannot afford. Nothing Nehta have produced so far is out there and working now so the track record is pretty poor and there is high level pressure on Standards Committees to approve the Nehta work, bypassing the normal processes which are there in an attempt to allow proposals to be critically examined. The proposals are all flawed and the new policy is to ignore Nehta work until its proven, which at this stage means ignoring everything they have done.
This Dinosaur has escaped Jurassic Park and it’s time to hit the kill switch before it eats all the people trying to do real work.
Saturday, March 12, 2011 9:03:00 PM thank you for a very lucid account of the HL7 issues and your comments on eprescribing.
Your comments serve to reconfirm the rationale and absolute imperative of funding an industry led eprescribing initiative in parallel with NeHTAs work. It is clear, from what you say, that is the only way we will see any progress in the foreseeable future in this vitally important application.
Saturday, March 12, 2011 9:03:00 PM said "there is high level pressure on Standards Committees to approve the Nehta work, bypassing the normal processes which are there in an attempt to allow proposals to be critically examined."
The Standards Committees should resist such pressures, remain true to their raison d'etre and under no circumstances bypass their normal checking processes. If they did bypass and take short cuts for political expediency or because they are being paid by NeHTA to deliver to an unrealistic timeline they would be doing the nation as a whole a gross disservice and undermining the credibility of Standards Australia.
We have standards for a very good reason. No one should be permitted to corrupt the process under any circumstances.
As the CDA Schema contains specific elements for both Route of Administration Codes and Dose Quantity, it would be very surprising if the NHETA specification (presumably an application layer Data Model) does not map directly to these elements. Whether all of the systems that will use the NEHTA specification currently store these elements in an atomised and (in the case of Routes) coded form is another question.
Grahame Grieve said...
You asked for my opinion on how this will play out. It's too early to say - the outcomes will be driven by external events and not by the quality of the underlying standards. (A familiar story in IT)
Some of the comments on this thread are profoundly ignorant. NEHTA has an extensive consultation process. If ETP does conflate route and dose (which sounds like a bad idea to me), then the decision sure didn't come out of NEHTA, but from the consultation process. (The discharge summary does conflate the two, but I don't think ETP does). Nor is the decision driven by the standards. It's based on requirements analysis.
And I hope that all the anonymous commenters on this blog are also contributing to the NEHTA CMK (http://dcm.nehta.org.au/ckm/). Of course, you have to stand behind your comments with your name there. But the DCM models matter, particularly with regard to things like route/dose conflation.
It's true that there is tension between the consensus based standards process, and project based deadlines. That's true in all contexts, and it's a problem that IT-14 (which met this week) is well aware of. While the standards process shouldn't be compromised, committees do need to figure out how to assist meeting politically set deadlines.
The first thing to be said is that is far as I can tell Dr Browne is spot on:
From Page 36 of 92 of the ETP Structured Document Template Version 3.1 of 8/12/2010
----- Begin Extract
4.9 Dose Instruction
Name Dose Instruction
Metadata Type Data Element
A description of the dose quantity, frequency, route instruction and cautionary advice that determines how the prescribed therapeutic substance is administered to, or taken by, the subject of care.
Definition Source NEHTA
Data Type Text
This SHOULD include the dose quantity, frequency, route, administration schedule and any additional instructions required to safely describe the appropriate dosage. If appropriate, this MAY also include the site of administration.
Conditions of Use
Conditions of NEHTA
1. One tablet twice a day every 12 hours, before or with the first mouthful of food.
2. Apply thin layer to affected area 3-4 times daily; reassess after 7 days if no response.
----- End Extract
Note both this element and the following Quantity of Medication are simple uncoded text.
Just what would drive going down the uncoded path for this information really eludes me.
Using uncoded text for prescribing seems odd given all the work that has been invested in the Australian Medicines Terminology - or am I missing something?
As a clinician I certainly share the concerns raised in the comments above!
Grahame Grieve mentioned the IT-14 group met last week. I wonder what their views are? I suspect we will know soon enough.
I note, in passing, that the US has moved in the drug naming / terminology area:
March 10, 2011 — 11:15am ET | By Janice Simmons - Contributing Editor
The RxNorm standard clinical drug vocabulary produced by the National Library of Medicine (NLM) has added more accurate and complete connections between national drug codes (NDCs)--the product identifiers assigned by American manufacturers and packagers of drugs--and standard nonproprietary names of medications recommended for use in electronic health records (EHRs).
Providing new connections between NDC product codes and RxNorm standard names and identifiers will have many potential uses within an individual patient's EHR, according to the NLM. These include the use of NDCs on medicine bottles to speed up standard data entry or to trigger an alert written in the RxNorm standard to prevent a medication error.
No single source currently contains all the NDCs for all medications marketed nationwide. RxNorm, though, has included NDCs provided by the Food and Drug Administration, the Department of Veterans Affairs, and the Multum and Gold Standard drug information sources for several years.
It is also worth pointing out this has all been going a long time and really should have been sorted long since. The first version of the ETP documents appeared in late 2009 - now near to 18 months ago.
I look forward to further news on all this. Eric’s comments about the lack of appropriate leadership and governance in all this sure ring true to me!