HL7 MeaningfulUse Webinar Answers to Questions

Yesterday I gave another webinar on HL7 Standards and Meaningful Use Stage 2.  The presentation and recording links will be posted here and on the HL7 Web site as soon as they are available.  As promised, here are the answers to questions I didn't get to during the call.

Finding the blog and other Resources:

• Can you show the bit.ly address again? Could you go back to the link to the blog again?
  If you found these answers, then you've found the right blog.  The link/bit.ly address was to this post.  I e-mailed and/or tweeted these two querants so that they could find it.
• This is a little overwhelming, especially since there is so much competing "noise" in this domain -- can you recommend a book or other resource that helps communicate the big picture and component parts?
  Do you work for my publisher?  See The CDA Book for one.  Fred Trotter also has a great book called Hacking Healthcare, A guide to Standards, Workflows and Meaningful Use
• Where can one get the Consolidated CDA Guide and is there a fee?
  The Consolidated CDA Guide is available to HL7 Members from the DSTU Web Site [member login required] or from the HL7 Store for $50.  Eventually, this will be freely available to all once HL7 implements the new IP policy.  Stay tuned here for more information on that when it becomes available.
• Does there exist a Consolidated-CDA validation tool?
  For Meaningful Use Stage 2, you want:  http://hit-testing.nist.gov:9100/ttt/
• It's a great presentation. Thanks!
  Thanks for attending.

HL7 2.5.1

• How are you looking MU 2 implementation of HL7 will be? (a) mandatory to upgrade to 2.5.1 for basic few events(transferring to other audiences like Immunizations, labs, cancer registries, surveillance  (b) Compatible to 2.3.1 and 2.5.1. (c) Complete transition to 2.5.1 for all. Here we are considering Outpatient professionals who wont be willing to shift to higher version.
  My expectation is that meaningful users must use the certified EHR technology to qualify, and that technology must use HL7 2.5.1, so (a) or (c) is the answer you are looking for.  You've covered all of the activities for which MU requires use of HL7 2.5.1, anything outside those isn't covered.

Clincial Decision Support

• Do you see a trend to have Clinical Decision Support Modules to be ONC Certified or perhaps under FDA?
  The Certified EHR must enable the provider to enable a clinical decision intervention.  I don't see any more "certification" than that from ONC.  With regard to FDA, I hesitate to predict what they will do.  They have certainly been looking.  There is ongoing work in ONC to develop standards for exchanging clinical decision support artifacts in the Health eDecisions Project, but I suspect they won't be certifying specific artifacts, but rather the use of those standards in the future.

Programming Languages

• Which programming language you recommend for Desktop application programming for implementing HL7
  I've used C, C++, Java, Javascript, HTML, XSLT, PERL, SQL and numerous other programming languages for working with HL7 standards.  You can also use C#/.Net, and just about any other language you like.  What's your preference?

C-CDA

• Any recommendations for someone rendering C-CDA entry elements to add Infobutton links that do not have a clinical background? i.e. any resources for understanding the content in the entry elements.
  Great minds think alike.  I've already implemented this in one of my stylesheets. 

• MU requires to send/receive C-CDA and 'incorporate'. What does incorporate mean? Incorporate means to include the information in the EHR.  It's deliberately vague, because there are a lot of different ways that could be done.  Usually, it means adding the discrete data in the C-CDA to the tables in the EHR's database.
• Can more than one document be included in a single Consolidated CDA "envelope", Clarification - for one patient but more than one type of document
  Each C-CDA document is just that, 1 document.  You can package multiple documents via the various transport methods specified via meaningful use.  In general, you should only need one document to meet the requirements to generate a patient summary and/or transfer of care document.  It's mostly a matter of picking the right one.  See my second ever post.

• All the summaries mentioned in MU2 can be built on top of a CCD given we add the required sections to CCD as required by each summary. Is this understanding correct?
  Not quite, but you have the right idea.  Any of the summaries mentioned in the C-CDA (except the unstructured document), can be used to support Meaningful Use Stage 2.  You can add any section in the C-CDA specification to any document in the C-CDA specification to achieve the MU 2 requirements.
• So is a Transition of Care Document a construct of MU2 that hasn''t been addressed by HL7?
  See above.  Basically, the transition of care is a set of data requirements in MU 2 that can be met by any of the document types in C-CDA (with the exception of the unstructured document), by simply adding the necessary sections to capture the additional data.
• Of all the data elements that are required for MU stage2 which of them are Encounter based and which are entire chart based?
  When generating content for Data Portability, the expectation is that the C-CDA produced would be "chart-based."  For Patient Summaries/Transfers of Care, the document would likely be "encounter-based", but could include data from prior encounters if relevant.  See here.
• CCD document type seems to have everything needed for MU Stage 2 EXCEPT for Reason for Referral section. How do we add Reason for Referral to CCD document type? Other option for Transitions of Care is a Discharge Summary but it is missing Medications (and possibly others)
  You can add any section to the CCD document type that has been specified elsewhere in the C-CDA specification.  There is intentionally no rule that says this cannot be done, for exactly this kind of reason. 
• When you are reviewing the CMU data elements, does it mean these are data elements that customary for healthcare institutions to share with one another as patient summarys?
  Yes.

LOINC and Lab Tests

• Are clinical lab tests still included in the C-CDA list of clinical documents?|
  I covered this during the call, but I'll repeat here.  There is no CDA based document used for reporting of laboratory test results from a lab to a provider specified in Meaningful Use.  IHE developed the XD-LAB profile that could support this use, but it isn't called out in meaningful use.
• It's not feasible for small providers to map lab to LOINC codes
  Arguably, it's easier for everybody to use a single national standard, than it it for everyone to use different vocabularies.  The latter is far more expensive.  Yes, there is a burden, but it impacts everyone.  Talk to your lab vendor.  It may well be that they can generate LOINC codes (since they must already use those codes for electronic laboratory reporting to public health).
• For the LAB reporting do all the Labs have to be reported or only specific ones?  The provider should be able to choose the pertinent and relevant lab results (and any other data exchanged).  See here.
• Is the use of LOINC codes a requirement for the laboratory sending the results, or the EHR, or both?
  Meaningful Use covers eligible providers and hospitals (including to some degree, hospital lab functions, such as transmission of lab results to ambulatory providers).  But it does not cover independent laboratories.  So, the use of LOINC codes is a requirement of the EHR (including the Hospital EHR which has a requirement to be able to send using LOINC codes).  Many labs have the ability to use LOINC, but need to be asked to turn it on, according to several of my standards colleagues in the laboratory space.
• What about lab results we receive from labs that do not have LOINC codes?
  I expect you will need to map thos.
• For Lab reporting if the Lab codes are changed from Local to LOINC codes on the inbound interface as mentioned by Keith, is the message sent by the hospital/provider still MU complaint
  If inbound to the hospital, and sent by an independent lab, it isn't relevant to meaningful use.  The outbound message from the hospital uses LOINC codes (and the HL7 2.5.1 LRI guide), then it can be MU 2 compliant.  Outbound communications from an EP or Hospital, in general, must use LOINC.  Exceptions can be used when there wasn't a LOINC code for a test, but the excuse that you don't have a LOINC code is one that I'd question.
• Having worked with HL7v3 Lab Results and now CCD there seem to be significant differences in the approach to refinement and conformance. In HL7v3 there was much more focused on refinement of the RIM whereas CCD seems to be focusing on refinement and restriction through templates / schematron. can you please explain the reason for the difference in approach?
  Yep.  CDA has a fixed schema.  V3 does not.  So, we use templates to constrain CDA, rather than modeling and schema generation.  Templates are simply another way to apply restriction.

Modular Certification

• I have heard some interface engine vendors are being certified for MU2. What is this certification? Is it required that an engine be certified or just meet certan criteria? Thanks.
  Products that providers use to obtain MU incentive payments must be certified to meet the functionality and standards.  So, if an interface engine is being used to send an HL7 V2 lab message to public health, it can be certified, and that has benefit to providers using it to meet MU requirements.  If some other certified component is being used to generate the message, and it goes through the interface engine, providers don't need the engine to be certified.

QRDA

• Where is CMS Certification reported in qrda file? Is it is the custodian section?
  According to the ballot, it appears in documentationOf/serviceEvent/performer/assignedEntity/representatedOrganization.
  This representedOrganization id/@root coupled with the id/@extension represents the organization's Facility CMS Certification Number (CCN).  Find CONF:16595 in the specification, and that should be what you are looking for.

Vocabulary

• Are the vocabulary mandates strictly enforced - i.e. are nullFlavor/translations still allowed?
  You have to make a distinction between functional testing (e.g., certification), and real world use.  In the real world, there are cases when a code isn't available, and C-CDA allows for that.  Having said that, don't use that as an excuse not to send the required vocabulary codes.  That could get you into trouble.
• What is the vocabulary for allergies? not only RxNorm, right? (RxNorm, NDF-RT, ingredients vocab (name escapes me))
  UNII is the name of  the vocabulary for ingredients.  As far as Meaningful Use goes, only RxNORM has been specified and only for Drug Allergies.  The C-CDA specifies those other vocabularies for Drug Classes, and ingredients and environmental allergies, and those are the vocabularies that should be used for reporting other kinds of allergies.
• We are updating our systems to accept new vocabularies. However, old information has old vocabularies (e.g., existing prescription have NDC instead of RxNorm). Can we send old data using old vocabularies?
  As far as Meaningful Use goes, you should be using the new vocabularies (as part of the new product capabilities) in order for providers to qualify for the incentives.
• How does RxNorm compare with product information that conforms to the IDMP (identification of medicinal products) standards?
  

Miscellaneous

• S&I LCC is working on a comprehensive care plan. It is hoped to be included in stage 3.
  Thanks, yes, see the Longitudinal Coordination of Care Workgroup in the S&I Framework site.
• XDM and XDR are listed as optional. If we support these methods, but we choose not to demontrate them during certification, can our clients meet the attestation requirements if they must use XDR or XDM rather than Direct?
  XDM is used WITH Direct, rather than "instead of".  XDR gateways THROUGH Direct, and is an alternative way to connect to a HISP.  If you work with someone providing an XDR to Direct gateway, and their product is certified, then I'd say, likely yes, but you haven't eliminated Direct.  The key to exchange with Direct is that you have to be able to get the message on the wire at some point via Secure e-mail (S/MIME and SMTP). CMS also changed one thing with respect to transitions of care.  Unlike anywhere else, where they require the certified EHR capabilities to be used, they do not so require them for exchange of Transfer of Care Summaries.
• When do you see HL7 version 3.0 implemented?
  V3 is implemented, as CCD and CDA are HL7 V3 standards.  That's probably not what you meant.  Some HL7 V3 standards (e.g., the Clinical Genomics Pedigree, and the HL7 InfoButton standard) are listed as Stage 2 requirements.  Other V3 standards have been implemented in the NwHIN Exchange (e.g., XCPD uses HL7 V3 Patient Administration Messages).