Illegitimi Non Carborundum

Illegitimi Non Carborundum
<RANT>
I'm afraid they are, though.  Perhaps it's just my exhaustion, what between meaningful use posts, and HL7 balloting, and basically doing all the rest of the stuff I do in standards as a professional "volunteer".

Closed Standards
Vested Interests
Members only Club

These are the politically loaded phrases people are throwing around in recent discussions on the #ABBI project.  Most of the time I can just ignore them, even though I find them alienating, but tonight for some reason, I just cracked.  I bust my ass doing this work, because I love what I do, and because I really do believe I'm doing the right thing.  It's always been about me, my family, my tribe, and my community, first, before I ever get to considerations of my employment, or the organization that I'm doing stuff for. And that's because if it isn't right for them, it isn't right.  Period.  I get tired and cranky, and right now, I'm probably right at the peak of cranky.

Let's start with closed standards.  Define please, what you mean by open standards.  You might have even mentioned some organizations like W3C, or IETF.  Well, here's what W3C, IETF, IEEE, the Internet Society and others think it means:  http://open-stand.org/principles/

Note that free is NOT part of the definition.  This stuff has to be paid for.  Someone has to build the web site, answer the phones and t-con lines, schedule meetings, and all the rest of that stuff.  That costs real money.  Many SDOs charge for standards.  Some charge for membership.  Others charge for testing services.  There has to be a business model.  It's just like HIE.  You cannot just build it for free and expect someone to fund it.

Reasonable is part of the definition, and some would argue that HL7's prices aren't reasonable, or aren't affordable for the little guy, or ... well, they can go on for quite some time about this.  Fair enough.  Have you looked at the costs to join W3C?  More on that below.

If all you ever do is complain from the outside, YOU will never change the organization.  Change comes from within.  I've been working on change from within in every single one of the organizations that I've been working with from almost the very beginning (including every employer I'v ever worked for).  None of them are perfect.  All of them make mistakes.

If you want to stand on your soap-box and preach, fine, your audience is in the church, you might consider moving your soap-box inside it.  Meanwhile, mine's already been there long enough to get on the board, and whispering into the ears of the people in charge.  Which of us do you think will be more effective?

Vested interests?  That's laughable.  A vested interest is "a personal stake or involvement", especially with respect to financial gain.  Few of us are in a position to give away our time and effort, and so ALL of us have vested interests.  Go ahead.  Declare my vested interests.  But declare yours first.

Here are mine:  I have vested interests in being able to use CCDA, and IHE XCA standards which I've already invested a great deal of time and effort in. And neither of those are going away anytime soon.  One of my interests in the ABBI project is to be able to use the same work I ALREADY HAVE TO DO, for Meaningful Use, and reuse it again to support what I think patients want (and remember, I am one).  In this, it would be awful nice to kill two birds with one stone.

At the same time, I ALSO want these content standards to be easier to use.  I've worked on two separate projects Documents for Mobile Health in IHE (MHD), and FHIR in HL7, to simplify things.  I think MHD is ready for use in the pull situation.  HL7 is still working on FHIR, and so am I.  I don't want to deal with yet another content standard that nobody can describe in real terms of anything other than what it isn't (HL7 CDA).

If you want to change something, it is much better to offer a suggestion of what to change it to, rather than to just say "I don't like that one".  And, BTW a list of requirements for a new standard IS NOT a standard.  It won't meet the project deadlines.  If you want to work on the next generation XML or JSON content standards, I suggest you go work on the FHIR project with Grahame, Lloyd and others (including me).  Because that's where it's happening.  There will even be some testing going on in a couple of weeks (and I'll be tweeting out from that event).

Members only club.  Well, I have to agree, every organization I've ever known is about its members, and I really don't think there's a reason any of them should ever apologize for it.  This particular attack was basically against the principle that you should pay for a product.  Frankly, I want all standards to be free, but I also want free gas, food and a house too.  It is never free.

People cite W3C and OASIS as ideal models of free standards.  But they aren't golden models for me.  I cannot afford to be a member of either W3C or OASIS. I cannot vote on their standards, nor can I participate in governance.  It would cost my employer more than three times what it spends on HL7 to become of member of W3C.  If I personally were to join, it would be thrice what a consultant would paid to HL7.  This is how they can manage to make their standards free, by charging big fees to to members.  So, I cannot vote on those standards, nominate something to become a standard, or participate much in the development process, vote for committee chairs, or board members.  All I get to do is use their standards for free.  How's that for members-only?

Do me a favor, show some respect and save politically loaded vocabulary for some other meeting.  We've got a ton work to do, and my daughters are counting on us, to make their data available.

</RANT>

Thanks. If you've gotten this far, thanks for listening. That's off my chest now.  I can at least go back to address the issue of being tired.  Cranky?   We'll see what surprises tomorrow holds for me.

    Keith

On Ballot Quality

HL7 Structured Documents is presently developing a scope statement for a new project that is, in my estimation, long overdue.  The focus of this project is to improve the quality of ballot documents that create CDA implementation guides.  I suspect that the scope of the project could grow, as ballot quality is an issue that currently impacts a number of different workgroups within HL7.

Here are some specific things I'd to see in a quality initiative:

1. Readability:  In one recent ballot, a balloter ran the content through a reading ease score (probably Flesch-Kincaid) and came out with a result of negative 5 on a scale of 0 - 100 (it is possible, according to Wikipedia, a passage in Moby Dick has a score < -145).  Every ballot should report a readability score, even if nothing else is done with it.
2. Full content: A recent HL7 ballot was missing the diagrams and hierarchical descriptor.  The latter is normative content.  Other ballots are routinely missing the change log.  This is also required for normative content.  This one is in part the fault of myself (and other committee members), because we failed to review the content when it was placed on the ballot preview site.  There needs to be a checklist for V3 XML Publications to ensure that all necessary resources are included.
3. For CDA Guides, there's some boilerplate text that SDWG has been using repeatedly in its ballots.  This text should become reusable a resource that can be used in any CDA Implementation Guide, and we should stop seeing variations in it.  These sorts of variations are usually just minor distractions, but can become major from time to time.
4. No implementation guide should ever go out to ballot without at least one sample content that is valid.  Meaningful variations should also be expressed (e.g., "patient reports no allergies" vs. a list of allergies being reported).  The sample also needs to be valid according to the ballot.
5. Conformance tools -- We've been creating conformance tools at the end of some ballots, and this should almost certainly be a final publication requirement.  Ideally, we'd have preliminary tools (e.g., schematron) upon completion of the ballot.

Some of this is making sure that we dot the i's and cross the T's in following the usual ballot process.  In other cases, there are improvements to existing processes that we need to be executing upon.

I complained that when we started this cycle, there didn't seem to be enough time to get all of our work done.  I wish I had been more vocal on this point, because it appears that we've gone and shot ourselves in the foot.  Rather than getting HQMF out late, it seems like we need to go through another complete ballot cycle, because the current content is missing critical components.

I'm glad SDWG is taking on this project, and I hope it improves the quality of our existing work.  

One other thing will have to change for this to work.  We have to be willing to say NO to balloting new work on a schedule where we cannot meet our quality goals.  I can understand why, when a stakeholder has critical deadlines, that we would want to try to meet them.  We have to remember that HL7 is PRINCIPALLY a volunteer organization, and that commitments made by others to their stakeholders DO NOT represent commitments from HL7 itself, or its members.

I don't think it is realistic to initiate a normative project at WGM N, ballot it at WGM N+1, and publish the content before WGM N+2 on our current cycle.  It basically means that the project scope, requirements, and content have to be developed in an 8-10 week period, followed by a 3-4 week publication period, and  30-day ballot cycle.  Unfortunately, there seems to be a great demand for these short cycles, although I can think of few projects that have really succeeded in anything significantly less than a year.

At some point, we may want to consider moving to two ballots a year as a way to improve quality.  But that will ONLY work if we do fewer ballots annually.

Are we Final yet for MeaningfulUse Stage2? Perhaps Not

Apparently not.  I missed something pretty important in my review of the Standards rules with respect to quality reporting.  All I can say was that it was late...

These are two standards cited for quality reporting:

(h) Clinical quality measure data import, export, and electronic submission. Standard. HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture, (incorporated by reference in § 170.299).

-- AND --

(k) Clinical quality measure aggregate electronic submission. Standard. Quality Reporting Document Architecture Category III, Implementation Guide for CDA Release 2 (incorporated by reference in § 170.299).

These are the references in 170.299:

(12) HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture, DTSU Release 2 (Universal Realm), Draft Standard for Trial Use, July 2012, IBR approved for § 170.205.

(14) Quality Reporting Document Architecture Category III, Release 1, Implementation Guide for CDA Release 2 (US Realm) Based on HL7 CDA Release 2.0, August 2012, IBR

approved for § 170.205.

Note that Number 14 is different from number 12, and that document that is still in ballot, in HL7.  So, ONC apparently cited a standard that hasn't gone through the consensus process for Meaningful Use Stage 2.  

I was saddened originally by the selection of QRDA III because I'd though what they had selected was still the early DRAFT in the Release 2 DSTU content, and we'd have to make a muddle of it to coordinate the two.  Now that it's the later draft, I'm actually happier.

I'm currently reviewing that standard now, which is why I bring this up.  So far, I have a few negatives that would require changes [following the consensus process].  I'm rather concerned that some would oppose changes because the DRAFT has been named in US Federal Regulation.  I hope that isn't the case, because the US Federal government has a process to fix a broken rule (they used it last time around for the misnamed PHIN Guide).

So, are we really final yet?  Perhaps not.  This does give me hope that we can address the language problem at the same time, but that might just be wishful thinking.

-- Keith

On Standards for Human Language and MeaningfulUse

There's quite a few standards for Human Language:

ISO 639-1 creates a bunch of 2 character codes for active languages.
ISO 639-2 creates 3-character codes for major languages, active or not.
ISO 639-3 creates 3-character codes for all languages.

These codes are incomplete, because while they describe language, they do not address dialect, which can be critically important to interpretation.  Just ask anyone from the country where English originated ;-)

RFC 4646 is the coding system that is commonly used to encode languages on the web, and the first part of the code is the shortest ISO-639 code for the language.  That means a 2-character code if it's in 639-1, or a 3-character code from 639-2 or -3 if not.  It also happens to support dialect.  Just about everyone uses these in web applications to identify languages, and there's quite a bit of software that knows how to deal with it.

In CDA (including Consolidated CDA and QRDA), the patient's preferred language is recorded in the languageCommuncation structure:

That structure uses HumanLanguage, which is defined as IETF RFC-4646 (that being the successor to RFC 1766).


It just happened that ISO 639-1 is a legal subset of RFC 4646, and so it was not really a problem when they specified that in Meaningful Use.  But now they've gone and changed it to 639-2, and it does create an interesting kerfuffle.


Here are the relevant comments in the Final Rule as to why they changed it:

Comments. Some commenters expressed support for the ISO 639-1 standard. One commenter recommended the ISO 639-3 standard as being more comprehensive. Another commenter suggested adopting the 2009 IOM recommendations on how to ask for language data. Multiple commenters suggested that we should use ISO 639-2. The HITSC clarified in their comments that their recommendation to ONC was that preferred language should be expressed by constraining 639-2 to those that are in ISO 639-1, noting that 639-1 includes only active languages, while 639-2 includes languages no longer in use. A few commenters asked for clarification as to whether all languages listed in the standard must be visible for a customer to select. 

Response. We agree with the clarification provided by the HITSC. Accordingly, we are adopting ISO 639-2 constrained by ISO 639-1. This will constrain ISO 639-2 to only the active languages in ISO 639-1, but will permit the use of the alpha-3 codes of ISO 639-2. As such it is a better approach than adopting solely ISO 639-2 or 639-1. We believe that ISO-639-3 exceeds the baseline we seek to specify for certification and have not adopted it. Last, in response to the commenters request for clarification, EHR technology is not required to display all the languages of the standard to meet the certification criteria. But, it must be capable of recording a patient’s language according to any of the languages in the standard.

Note the underlined text:  This will constrain 639-2 to ONLY the active languages of 639-1, but will permit the use of the alpha-3 codes of 639-2.

I'm not sure the use of these 3-character codes is an improvement.  The final rule broke (modestly, and arguably in a way that won't matter much, and is certainly still implementable) one of the standards, in order to make a change in another that has the ONLY effect of changing the code values, not the semantics.

Why change it at all?  They really aren't clear as to the value of 639-2, especially given that they've limited it to those codes found in 639-1.  And in fact, RFC 4646 is more widely used, and has greater value, in that it allows reporting of a particular dialect.

This is something that can be fixed, but something has to change.  Either the final rule, or the HL7 CDA Standard as used in the US.  I'd rather the final rule was fixed, but could be convinced it's easier to adapt HL7 CDA as it is used in the US.  That latter part is going to be a wee challenge, because right now, we don't have a US Affiliate with the capability to do so, but I'm sure HL7 could find a way to adapt to this.  It's really a shame we have to do either. 

Even so, I'm still pretty please with the Final Standards rule.  It's hard to get nearly 500 pages of text right all the time.

-- Keith

HL7 Standards and IHE Profiles in the MeaningfulUse Stage2 Final Rule

The following HL7 Standards and IHE Profiles are required in some way the Final Rule on Standards and Certification criteria.  They are either named directly, or are required via one or more references within the named standards and/or implementation guides:

Summary Records

• HL7 Clinical Document Architecture, Release 2.0, Normative Edition: Referenced by HITSP C32, Cancer Registry Guide, and HL7 IHE/Health Story Consolidation Guides
• HL7 IHE/Health Story Consolidation Guide, version 1.1 Summary Records
• Health Level Seven Implementation Guide: Clinical Document Architecture (CDA) Release 2—Continuity of Care Document (CCD) View only for historical content in Stage 2
• HL7 V3 Vocabulary: Referenced by IHE/Health Story Guides (you can find that content in the CDA R2 Normative Edition)

Family History

• HL7 Version 3 Standard: Clinical Genomics; Pedigree, Release 1, Edition 2011

Public Health Reporting

• HL7 Version 2.5.1
• HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1
• HL7 v2.5.1 IG: Electronic Laboratory Reporting to Public Health (US Realm), Release 1 Errata and Clarifications

Laboratory Reporting

• HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US Realm

Quality Reporting

• HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture, DTSU Release 2 (Universal Realm)

Patient Education and Referential Clinical Decision Support Content Access

• HL7 Version 3 Standard: Context-Aware Retrieval Application (Infobutton); Release 1
• HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain, Release 3
• HL7 Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton) Service-Oriented Architecture Implementation Guide, Release 1

Transport
Both of the following can be found in the ITI Technical Framework

• IHE Cross Document Sharing via Reliable Messaging: Referenced by XDR and XDM for Direct Messaging
• IHE Cross Document Sharing via Media: Referenced by XDR and XDM for Direct Messaging

Other Helpful Content

In addition, the following two IHE profiles will be very helpful as I mentioned here:

Patient Education and Referential Clinical Decision Support Content Access

• IHE Retrieve Clinical Knowledge (RCK)

Problem, Medication and Allergy Reconciliation

• IHE Reconciliation of Problems, Medications and Allergies (RECON)

The IHE XDR and XDM profiles, RCK, RECON, and the HL7 IHE/Health Story Guides will be tested at the 2013 North American IHE Connectathon in January, which I suggest you attend.

Changes to the MeaningfulUse Incentives Stage2 Rule

As for the Standards Rule, I've gone through the Incentives rule and tried to highlight the major changes.  This time, I put the executive summary up front.

Executive Summary

• 3-month/90-day reporting period (Medicare/Medicaid) added in 2014 for Stage 1 or Stage 2 Meaningful Users to allow time for implementation.
• Hospital-based EPs can be designated non-hospital if they pay for their own EHR.
• Menu-sets objectives have to be meaningful to you, you cannot pick one just because it offers you an exclusion.
• There are hardship exceptions allowed.
• EPs in an HPSA can receive a 10% bonus payment.
• CPOE is reduced to 30% for lab and radiology (remains at 60% for meds).
• Many exceptions now include "fewer than 100 events" 
• View/Download/Transmit and Secure Messaging reduced to 5% from 10%, and exceptions given for < 3Mbs Broadband availability.
• Public Health reporting exceptions granted for lack of availability, not using the MU Standards, or not able to enroll at the start of the reporting period.
• Added Progress Note Menu objective for EPs and Hospitals.
• Added Lab Reporting Menu objective for Hospitals
• Changed EMAR to be applicable for 10% of med orders.
• Changed CDS to be 5 interventions for 4 CQMs, and allows for use of high priority conditions if those CQMs are not available.

General

They've added a 3-Month/90-day reporting period for Medicare/Medicaid providers who attest in 2014 to either Stage 1 or Stage 2.  If Medicare, the 3-month period must be aligned to a quality reporting quarter.  If Medicaid, any 90-day period will do.  Essentially, this give providers an extra 9 months to become compliant.  This change avoids creating a funnel problem according to CMS's Rob Anthony.  I agree.  It will make transitioning given the MU Stage 2 deadlines much easier for providers and for vendors trying to meet the requirements.

CMS also added a provision for a hospital-based EP (one who furnishes more than 90% of his services in an inpatient or emergency room setting), the option to request (through an administrative process) to be identified as a non-hospital-based EP if they fund the acquisition, implementation, and maintenance of their own EHR (including software, hardware and interfaces).  The HITECH Act limits who is eligible for MU under the law, and the regulations cannot change that, but this is one area where CMS has some leeway.

Beginning in 2014, an excluded menu set objective cannot be used to meet the meaningful use requirements, unless all other menu set objective can also be excluded.  You have to pick the ones you can meet, unless you cannot pick enough.

CMS added provisions and a process for hardship exceptions for certain cases.

They added a 10% incentive bonus for EPs who furnish 50% or more of there services in a Health Professional Shortage Area (HPSA) (see §495.102)

Objectives for EPs

Core Objectives for EPs

CPOE: Instead of 60% of medication, laboratory or radiology orders, it is now only 30% for lab and radiology orders (still at 60% for meds).

Formulary:  Reduced from 65% of orders to 50%.

CDS: Implement five CDS Interventions for 54 CQMs.  If 4 CQMs aren't available to the provider, then CDS must be related to high priority conditions.

Drug/Drug&Allergy Checks: Exclusion added for providers writing < 100 prescriptions.

Generate Patient Lists:  Denominator changed to patients who have had two (rather than one) or more visits in a 24 month period.

View/Download/Transmit: Changed from 10% to 5% of patients seen in the period.  Exclusion criteria changed bandwidth requirement from 4Mbps to 3Mbps.

Provide Clinical Summaries: Change 24 hours to 1 business day, and added "patient authorized representative".

Medication Reconciliation: Reduced from 65% to 50%.

Transitions of Care: Summary record provided to 50% (was 65%) of patients for transfers of care, where more than 10% are either: 1) electronically transmitted by the EHR, or 2) transmitted via an NwHIN exchange participant under NwHIN Governance rules  AND where at least one exchange is either with a different vendor, or tested using a CMS designated test EHR. Changed the exclusion to include providers to transition or refer fewer than 100 times.

Transmission of Immunization Data to Public Health:  Clarified exclusions:  Provider does not immunize, or No Immunization registry exists, or it does not use certified EHR standards, or provider cannot be enrolled at the start of the provider's reporting period.

Secure Messaging: Changed the numerator from 10% to 5%.  Added an exclusion for the case where less than 50% of patient encounters are in a county without at least 3Mbs broadband service.

Menu Objectives (Choose 3)

(Note, this isn't a complete list of menu objectives, just changes to them)

Imaging: The image and report on it are available from the EHR for more than 10% (was 40%) of tests whose results are images.  Exclusions: Now includes (A) Orders fewer than 100 tests, or (B) has no access to images at the start of the reporting period.

Submission of Syndromic Surveillance Data: Added exclusion for no agency with capability to accept the data.

Cancer Registry: Added exclusions for No agency has a registry, or they do not support the standards.

Other Registry: Added exclusions for No agency or national specialty society has a registry, or they do not support the standards.

Progress Notes:  Added a new objective for EPs:

(6)(i)  Objective.  Record electronic notes in patient records. (ii) Measure.  Enter at least one electronic progress note created, edited, and signed by an EP for more than 30 percent of unique patients with at least one office visit during the EHR reporting period. The text of the electronic note must be text-searchable and may contain drawings and other content.

Objectives for Hospitals

In general, the changes for hospitals mirror similar changes for EPs.

Core Objectives

CPOE: Instead of 60% of medication, laboratory or radiology orders, it is now only 30% for lab and radiology orders (still at 60% for meds).

CDS: Implement five CDS Interventions for 54 CQMs.  If 4 CQMs aren't available to the provider, then CDS must be related to high priority conditions.

View/Download/Transmit: Changed from 10% to 5% of patients seen in the period.  Exclusion criteria changed bandwidth requirement from 4Mbps to 3Mbps.

Transitions of Care: Summary record provided to 50% (was 65%) of patients for transfers of care, where more than 10% are either: 1) electronically transmitted by the EHR, or 2) transmitted via an NwHIN exchange participant under NwHIN Governance rules  AND where at least one exchange is either with a different vendor, or tested using a CMS designated test EHR. Changed the exclusion to include providers to transition or refer fewer than 100 times.

EMAR: Changed from EMAR is used in at least one ward during the period to EMAR is in use for more than 10% of medication orders produced.  Added an exclusion for hospitals with fewer than 10 patients per day.

Menu Objectives (choose 3)

(Note, this isn't a complete list of menu objectives, just changes to them)

Imaging: The image and report on it are available from the EHR for more than 10% (was 40%) of tests whose results are images. 

ePrescribe electronically for Discharge Rx: Added refills as well as new or changed Rx to the numerator.

Progress Notes:  Added a new objective for Hospitals:

(5)(i)  Objective. Record electronic notes in patient records. (ii) Measure. Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH’s inpatient or emergency department during the EHR reporting period.  The text of the electronic note must be text-searchable and may contain drawings and other content.   

Lab Reports: Added a new objective for Hospitals:

(6)(i) Objective. Provide structured electronic lab results to ambulatory providers. 

(ii) Measure. Hospital labs send structured electronic clinical lab results to the ordering provider for more than 20 percent of electronic lab orders received.  

Bookmarked MeaningfulUse Stage2

More Meaningful Use Resources via Corey Spears ...

---

I took the liberty to create bookmarked versions of the Final Rule Documents.  They are provided as is and with no warranties, but hopefully they will prove useful. Feel free to share.  In fact I encourage it.  Send out the links.

The bookmarked and cross linked versions of:

• The CMS EHR Incentive Program Stage 2 Final Rule
• And ONC Certification Criteria Program 2014 Edition

If both files are saved to the same folder and with the original names, the cross-links from the Certification Criteria back to the Objective Discussion should work.