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HL7 CIC – Joint Session with CIC, CQI and EHR Work Group to discuss EHR Usability ProjectLocation: Cambridge, MA

Date: 2013-09-24 Tuesday Q2Time: 11:00 AM - 12:30 PM

Facilitator EHR Note taker(s)Attendee Name Affiliation

Quorum Requirements Met:

Attendees:

Official Minutes distributed by EHR Work Group

NOTES From: Dianne ReevesWorking with usability experts to gather information and this group will come up with functional requirements.

Dr. Constance Johnson – usability expert. Develop tools to test usability in electronic systems.

Clinicians said:

1. Make sure usability increases patient safety2. The user interface design3. And a 3rd could be performance

Dr. Ross Koppel from Univ. of Pennsylvania offered a slide deck, examples given for storing BP.

Without a single standard the entry of data like BP could be entered differently at every institution.

Formatting of BP results as two separate fields, or 125/75? Should the user be able to enter it as 125/75 and have the system parse it into separate fields as needed?

Entries should be done in UIs to allow users to see everything they are doing. Entries that are truncated and require manual clicking and scrolling are not good usability examples.

***NIST report on usability of electronic health records – includes functional profile requirements.

Question: Are these usability requirements evidence-based or built on something else?

We need experts in usability, vendors with usability labs.

The more descriptive we get, the more we impinge on the territory of the vendors – like bassinette identification in the newborn nursery.

In the Netherlands they have ‘Citizen Service Number’ – personal identifier.

We need a framework when we review articles to give guidance on levels of specificity and which things to include.

Does the scope of this include mobile devices?

Questions about process were raised, and if testing of criteria will be included.

Usability should include things like capability, expected down time, stability, and other factors. The systems should also be able to measure how well they are performing, collect metrics about their operations.

***ISO 31000 – usability standard

Users are included in the project as stakeholders.

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Outcomes of the usability initiative – are we expected to produce a good analysis of the functional areas and some good guidance for usability recommendations.

NOTES From: Mitra RoccaDon Mon provided an overview of the EHR usability WG and ongoing phase I work.

Strategic HealthIT Advanced Research Project (SHARP) –C is developing a tool, on usability. The SHARP C team has tools; HL7 has standards but no tools. If we could develop a set of Functional requirements, the first set of recommendations can be tested in their tool.

Q: With SHARP-C, there are various tools (ex: TURF model) the tool is developed to test EHR usability or was it to test problems found with the EHR usability?A: (UTH: University of Texas in Houston): We have multiple tools that are being developed, there are 4 SHARP grants and the SHARP-C has been focusing on the cognitive support of EHRs not just usability but also Clinical Decision Support (CDS). One of the projects is representation on the screen and also the workflow. We have tools that can be used to assess the usability of a specific EHR. We can do heuristic testing and we also have guidelines for design under development.

Satisfaction, efficiency and effectiveness are 3 aspects of usability identified by NIST.Make sure that usability increases patient safety, since sometimes usability issues cause patient safety issues such as design issues on screensThe EHR usability WG has done an environmental scan and we are planning to prioritize the work, in order to come up with the functional requirements. Dr. Ross Koppel came up with some aspects of usability; he talks a lot with unintended consequences

Example 1: for displaying Blood Pressure (BP), there are 40 different ways to store BP in EHRs. If you get 125/75 as the BP, it does not mean that the BP has been improved since yesterday. Comment: For BP we have the attributes defined in Detailed Clinical Models (DCM). How it measured, what is measured.

UTH: Ross is right, there are multitude of ways to store the data in EHRs. Don: From one example, the various facets it generates, we talked about patient safety issue. A doctor has to treat in 2 or 3 hospitals, in every hospital he has to learn how to enter data in an EHR system. If we take something entered at the point of care and get it into a quality report, the system is not usable, now I have to take this and make it quantifiable.

Comment: It is not a question of an extra step, non-compliant means different things to many people. Some of these things are interpretation to the data.

Don: Usability means to enter as 2 discrete values for BP. MU test scripts realized that “/ “ or “–“ is also a number.

Example 2: Results review screen in an EHR system, what it shows vitals signs, health rhythms, 2 dosages in the same cell, second dosage should never be hidden. Is this quantitative field or textual field?

Don: this is the example I have been explaining on the usability phone calls. How do we look at patient safety issues, and also look at User Centered Design (UCD). Currently the EHR usability workgroup members have been assigned to conduct literature review. Example of an article to review is NISTIR 7804 which focuses on technical evaluation, testing and validation of the usability of EHRs. We are also talking to experts in usability. One of them is Dr. Zhang who is the lead investigator at UTH on SHARP-C. The EHR usability WG has designed a tool/database to catalogue what we are reviewing, implications of the literature we have to review.

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Janet: There are some public commentaries on the NIST paper (NISTIR 7804)

Don: when you look at articles like the NISTIR 7804, this is a rich set and talks about kinds of errors you can find, accuracy error, etc. In appendix there are some recommendations.

Ex: An EHR screen should include at least 2 patient identifiers. Will be translated to: “The system SHALL display a header with 2 patient identifiers”

Steve: Will there be evidence on what to use? 2 identifiers or 3 Q: why 2 patient identifiers and not 3?

A: Not sure, part of this was not to over burn the Healthcare Provider (HCP), likely referencing Joint commissioner guidelines

Don: what we are searching for, we need experts like UTH; we need technical people; we need EHR vendors here, because vendors have usability labs, where they can present their real-world implementations.Every time you flip the screen, for patient safety reasons, you are working with patient A and Date of Birth (DoB).

Lori: what I would add, looking at what specific they need to be? We should designate which 2 patient identifiers should be displayed on each screen.

Janet: For neonatal unit, in that case, is which bassinet a baby is in (that might be the Patient ID). You need a range of patient identifiers and flexibility,

Richard (National healthcare System (NHS): In UK’s NHS, every display needs at least 2 forms of pat. Identifiers, 2 are absolute minimum, the more prescriptive we get the better, at least 2 with the range of identifiers.

Don: These are recommendations from NIST, we are reading the experts view and change them to Conformance Criteria (CC). The EHR usability Task: identify things that we can translate to function, CC

Anneke: Because of the care setting, it is an international standard. Every citizen in Netherlands has a number. This example is used for medical record linkage. For linking pregnant woman and child; and for neonatal registry. We want this (usability) to be an international standard.

Steve: As we review these publications, we need a framework, I heard from this example above more specificity, a number of features we need to consider. It will help us to read all from the same page, is usability more important than specificity.

Walter: We are putting together some excel, that relates to usability. This article references this, if there are some not on the matrix, you can add it.

Lori: We are talking about 2 levels of usability; there are more global standards for usability. What usability issues are common across institutions and countries and what are unique for each care setting.

What EHR are having problems with is that they have not looked at usability in a particular setting. There needs to be a balance. Patient ID, it will not always be name and DoB but something else, depending on the care setting. Should we perhaps limit the usability to desktop and not include mobile devices?I will be concerned about one size fits all, how to display on a mobile device. We cannot make the same design on a mobile vs. desktop.

A: For scoping purposes, this is for both (desktop and mobile), maybe we can do it in a tiered manner

Lori: for each usability aspect, you can select for what devices.

Gary: Notion to identify, cause and effect and consequence.Three key parameters: Cause, Effect and Consequence.

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For example:Cause: Two individual patients selectedEffect: Both displayed on same screenConsequence: Possible misidentification or entries/updates to wrong patient record

Q: Are we testing this, Child Health FP? Will we be testing this with Houston?

A: This is our second conversation with UTH. We did not get that far, on how far to go with our collaboration.

UTH: We recognize, dif. Types of care setting, like pediatrics, and their needs on usability, there are not many differences for usability issues.

Q: Has Child Health WG be involved in this project?

A: No, will reach out to Pele.

Add HCPs in this project.

Mitra showed the Access Database developed to capture the findings from the literature review.

Access DB suggestions: 1. Be able to add all author’s names not just the primary author.

2. Add consequence for each usability problem/issue.

Other issues to consider:- Implement eCQMs, it does not fit into the HCPs workflow, the same with CDS. - Long term FP and international EHRs?

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HL7 CIC – Joint Session with CIC, CQI and EHR Work Group to discuss EHR Usability ProjectLocation: Cambridge, MA

Date: 2013-09-24 Tuesday Q3Time: 1:45 PM – 3:00 PM

Facilitator EHR Note taker(s)

Attendee Name Affiliation


Official Minutes distributed by EHR Work GroupNOTES From: Dianne Reeves

PSS Review approved by the WG, and moving to TSC approval this week.Plan to reverse engineer the functional profile. Record, change and access – focus of certification test cases; 50 test cases to perform analysis on. On 10/8/2013 the WG will do a demo of walk-through of a test case.

Go to ‘electronic HR functional profile wiki, documents.

Road Show – examine humans’ experience.What is the problem and what is the intensity of their comments?Pilot this discussion in a small group, about 30 people. Solutions like how busy a screen is or scrolling one way or another.

Frequency and severity of the problem?System should also help downstream users get the data and use it. Data can support clinical decision support mechanisms and also surveillance/investigation aspects.

The real challenge with healthcare providers relates to workflow, because they will figure out work-around or ways to get the job done. More concern about people who cannot figure out how to use the system and could create errors and problems.

A big difference between usability and usefulness/utility.

NOTES From: Mitra Rocca

HL7 Meaningful Use Functional Profile (FP)We have resubmitted the Project Scope Statement (PSS). CMS has agreed to join as an external collaborative. Develop an EHR-S FP based on EHR-S FM R2 and focusing on MU Stage I and II, later will focus on Stage III. We are looking at analysis and look at NIST.

EHR Usability Breakout in Q3For the usability to add Functions, Conformance Criteria (CC) in order to beef up the Functional Model (FM). We want to create a road-show, fit for purpose

Structure of a road show for HIMSS, once the one or 2 succeed, come up with an instrument, HIMSS to come up with a mechanism and send it to Becky.

Survey to be designed or a focus group.

Usability: review the literature, We are examining human’s acceptance

A survey to the providers and others to ask questions on usability, we will go to dif. cities, and audience.

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We need to: 1. Educate the attendees2. Place a survey on line

Q: What is the production value? A: This is a hot topic in the US, have it tested by vendors,

20 questions on the survey.

Idea: Record a 4 min. backgrounder on usability and what the goals and outcomes are, when the survey is being done, set the back drop.

Focus group in a particular site,

HIMSS desires socialization. Each of the group needs to meet in person. Virtual meetings, but also a meeting in person

Janet: What is the best way to talk to developers? What are usability issues at system level? HL7 and SDOs to best envision usability.

Dianne: if you teach them, you might skew their objectives.

Walter: decouple it from EHR vendors names. What are usability issues with respect to things?Medical Specialties, dif. Users have dif. Needs.

John: We are interested in things that are not in the literature.

Walter: we know 90% of usability issues and what we need are: details of 90% and 10% missing.

Becky: there is a benefit to a focus group, get them in local chapters of HIMSS, not only the elements of usability, can they share their challenges.

One survey where people can complain to us. Report the level of frustrations.

We need user story.

ONC: Will notice it and place it in MU. Stage IV the systems shall not do a, b, and c.

Get some prioritization and rate them.

Send in advance to the in person meeting, send the background materials. We want more information.

There can be something on survey responses that we did not think of. We need help to find a solution

To sign into 6 EHR systems with 6 user systems.

The EHR system have been developed for HCP with many years of education, but some of the unrealized problem, it might be good idea, to measure them in terms of accessibility.

HCPs, who are much less experienced with EHRs might have more usability issues. A work product that allows differentiating people with various degrees of standards, for example NIST testing requirements, how quickly can people in various groups in healthcare can sit in front of a computer and use it.

Ex: Widget on the bottom of the screen vs. top.

They need to use EHRs without endangering the patients.

Usability of the system; need to enable what the primary and secondary users can use.

There is a need for structured data and use of controlled terminologies for secondary users (public health agencies, the quality of data is important as well as lack of data/missing data (FDA, CDC) and AHRQ).

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Comment from CDC: worked on LIMS for infectious disease labs and CDC, what they share and do not share. Better understand the workflow. We had usability experts come in, things that developers might not have thought about.

Best usability is when observed in a clinician’s workflow.

If we were designers of EHR tools, we need to see how the doctors use the EHRs, but the intent is to capture higher level issues.

We are looking at human-machine interface.

If you prototype it, they can correct it. What would the best way be? Everything you do needs a prototype.

Least challenged, make sure, to include good sampling of users and downstream users.

Data should be sub-set by training, user types, …

Learnability of a system

Usability and usefulness (utility), a patient with PHR or HCP with EHR. In the case of PHR, is the PHR the recipient of data coming from an EHR.

We are concentrating on the usability of EHRs.

Within the EHRs there are various types of users (age, …)

UK: IsabelleIn the UK context, you will not get a good feedback. One thought to add to the mix:

1. Increase quality and safety

2. Getting complete usage, by everyone, downstream users (primary and secondary users)

3. In the UK, we piloted the General Practitioner (GPs) could send electronic dispensing record to hospitals. Setup an ongoing, many virtual tools

By Jan 2014, we will get what we need, and ballot it and get it into Stage III; Scan the literature; conduct a virtual survey

Q: the usability, what is the tangible work of this?A: we all know and provide recommendations to HealthIT Standards Committee (HITSC).

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Presentations of Duke Therapeutic Area ProjectsLocation: Cambridge, MA

Date: 2013-09-24 Tuesday Q4Time: 3:30PM – 5:00PM

Facilitator Mitra Rocca Note taker(s) Anita WaldenAttendee Name Affiliation


Attendees:Anita Walden Clem McDonaldDianne Reeves Norman DaoustMitra Rocca Robert ZozusMeredith Nahm

Minutes/Conclusions Reached:

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Therapeutic Area Data Standards Development ProcessOverview of discussion (see slides)

Lack of semantic specificity in SDTM Redundant data collection process at sites Challenges using healthcare data for research

There is not scientific consensus across remission and relapse and there has been collaboration with the senior reviewer at the FDA, Phillip KronsteinDefinition of Therapeutic Area Data StandardsIdentifies concepts about which data are collected concepts necessary for unambiguous interpretation of the collected data. A broader definition than the FDA.Endpoint for the FDA is the therapeutic area user guide. FDA is dedicated in using the CDISC SDTM model.Anatomy of a Data Element is the concept and the valid valueThe Snomed codes are not linked to the PV list. Clem recommended using Snomed Codes. Who has the final authority? OMB has it.FDA is primarily interested in Outcomes or Endpoints. Clem stated that it is important to collect the individual concepts not just the final endpoint in case the definition and criteria changes over time and they have the raw data for future assessment.The development process used in Mental Health development was explained.

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Review the forms from NDAs since 2006 for the indication. Then other knowledge sources were reviewed using student interns. NIMH provided all of their forms to Duke to extract data elements for submission into the ballot.The Data Element Disposition was discussed- The number of data elements initially identified, the number of unique data elements, # of what is not part of a survey, what was in the final list after clinical expert review.Questionnaires have a copy right so the question prompt should not be displayed. NCI doesn’t display the entire prompt. Mental Health may use the method and tools that NINDS has used for their questionnaires. LOINC can take the questionnaires except the ones that have a copyright that restrict use. Students have extracted the data elements. ACTION: Need a call with CDISC to discuss how they handle the questionnaires in their standards. Include FDA on the call, Margaret Haber and Dianne Reeves.The HL7 comments led to more thought about the data elements and the approach to think about the details of certain mental health issues. This increased the number of data elements.Duke held up the Schizophrenia to harmonize with MDD which changed 30+ data element. This promoted harmonization between two therapeutic areas. The HL7 feedback led to very important changes that improved the standards.In reviewing the data elements extracted from the clinical forms it was identified that there was semantic variability among the various trials using the same compound. Feedback from the previous ballot mentioned that it was hard to determine what was missing on the Class Model because CDISC type items were not included. The current model includes CDISC data elements. Why work through HL7

Required harmonization with other domains Authority Conferred by ANSI accreditation Infrastructure for maintenance of the standards Existing pathway for healthcare standards.

What should we do differently?Shouldn’t have a different model if you start with healthcareWorry about the data element enthusiasm across the world. There is a challenge…ISO requires you to have object than the attribute within the objectMeaning of data elements is spread across concepts. The definition is not just in the one data element concept.Clem stated:Don’t call it common data elements because the answer list will change or their will be variability. Data is something that is measure and obtain the patient along with operational data.Collecting the raw data is more important than the definition of the disease.MOHI –short survey that measure different dimension to obtain data to shorten the visit.The class diagram doesn’t reflect the categories of a healthcare encounter example there will not be a Mental Health Hospitalization there will just be a hospitalization.Want to model the drugs similar to what comes in from the pharmacy There are 185 scales so far used in Schizophrenia. Clem- are they used in published studies. Those who charge for use discourage consistency across the domain.Books

Wicked problems and righteous solutions Dangerous enthusiasm

NLM Widget –works off of LOINC panels; JSON structure; has a couple of standard formats; can’t do all questionnaires.One group wants to do the ISO forms.NCI wants to align their value sets with UMLS

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NOTES From: Mitra RoccaOur experience and process Developing TA data standardsData quality issues and then the quality assessmentProblem statements

1. Current submission to FDA is CDISC SDTM2. Separate and redundant data collection3. Challenges using HC data for research

TA DS, reviewers have a hard time to find data in SDTM and also semantic interoperabilityEx: in Schiz. The number of episode is important. Some sponsors use start date as when the symptom started and some the first day of hospitalization. It is semantic issue. Clem: cardiology surgeon, value and severity, (severity might be dif. Scales). It is more common. One of the senior reviewers from division for pysch is data standards guy. We would like to support remission, …. There is no definition of a TA data standardSubset of what FDA is working at is outcome. We believe that Des should be used for healthcare and clinical research. For FDA clinical research use case End point of TA data standards development for the CR: secondary user SDTM TA specific user guide (UG)You need to add SNOMED CT codes to the ethnic groups. Do not Use VM Public ID and use SNOMED CTTop 5 and trees below. CDC has a good representation for ethnicity.

Data elements are atoms of informationend point: cerebrovascular caused mortality at 30 days post PCI Data elements: death indicator, death cause, death date, procedure dateHave indicators for each. Have all Des to support National cholesterol is 300, you cannot compare stuff if they cannot capture DEs. Later cholesterol level moved to 250. FDA might have their own definitions, use the flag on this. Whether raw data is being collected realiable in HC. We would like to support multiple level of abstraction. ISO 11179, Duke looked at clinical guidelines in EHRs. (clinical formulation)Measures are conclusions, not much raw data. Ex: breast feeding excempted. If the patient TB, .. time of breast feeding is negative. Look at Rx list, and see if fits or not. DSMV: a large symptomology stuff, and dif. to add them to FDA. We might take them out, they are additional 38 extra DE. Psychology and Psychiatry came last. They had 200 measures, and weeded down to 110. We handle questionnaire dif. Than DE. We use it dif. Than NINDS. We have been focusing on Des done. The data could be loaded, CDISC takes the question prompts and place them in CDISC terminology. EVS takes our content, we do not annotate the prompt but portion of the prompt. Best to split the questions in questionnaire. How many items?SKITs, LOINC is not taking copy righted questionnaire, CDISC is mapping to SDTM. IQ test, there are some for cognition, make the prompt Anita: before we give them the questionnaire (validated tools)

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Questionnaires are excluded. Suicidal ideation, historic stuff72 Des are dif. Than MDD>, 38 in common with MDDTB DAM had mock ups. Some have secondary use and suggestions for SDTM For sch. We have 8 clinical narratives. We have activity diagrams. A class is a group of data. We got comments from FDA and clinical professional societies, found it dif. To look at class diagram and see what is missing.

Starting with these TAs, use the HC model. Look at forms, etc. DE enthusiasm, DE is defined by ISO, Object.DE (attribute)In clinical trial you have visit encounter. HbA1C, CBS, ….Units of measure. If you take the ISO definition, it does not allow you. If you look at clinical record

You see a field called observation, and HbA1C is just one attribute.Excel spreadsheet or SAS data sets, DE * The answer list, we cannot lock them down. Color of urine, whether it is cloudy yellow, …We need to standardize, AMI and we want to standardize this. Troponin Q, what do you do with these definitions. They should store, EKG, …. AMI is a judgment not data. AMI is a diagnosis. You need to define the Des. Troponents, cardiology and renal are numbers. FDA credit, no. of zits in AcneOperational data, there is the same issue there. Medicare is taking PHQ9MOHR: group to find questionnaire and 20 questions. Describe variations, do not do a, b or C. Pick one. Getting the data raw. That is permanent. Cardiorenal: Most things people collect for research are observations and Rx historyRecord episode - when was the last time you did x?I would not change encounter vs. visit.Mental health hospitalization will not be in health care record. But just hospitalization. Get a Hx and what Rx you are on.What symptoms do you have. What can you model the Rx, model them as they come from pharmacy. Depressions in 40 classifications for depression. PHQ9 and NINDS has a bunch of specialized survey. PhenX.

ProvidenceNINDS has 8000 variables. NLMCDEs

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ISO definition, Weight of a baby: gramsWeight of a baby: LBSIf you read the specs. They have dif. Objects. If you use the object nameScope is the galaxy. Xforms has not been a hitShip the dataQuery the medical recordThere is not Branch and loopsSurgeon general formLoop under youLoop for relativesLoop for each disease for each relativeLoop and the loop has branches.The kind of things SF36 at each visitClinical data are typically narrative, BP, etc. you can get. If someone is registered in a study, then answer these questionsQ: get this into HC?Wicked problems righteous solution (about SW)

Javascript that works off the loinc panels. If someone JSON, structure in. Common well defined Anything in NINDS and ISO formsCDE, 10 institutes NLM is working on value sets. VSAC, realign the NCI with NLM. Some of these value sets are coming from quality measures.

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BRIDG DiscussionLocation: Cambridge, MA

Date: 2013-09-25 Wednesday Q1Time: 9:00 AM – 10:30 AM

Facilitator PC Note taker(s) Dianne Reeves

Attendee Name AffiliationDianne Reeves NIH

Ed HeltonMitra Rocca

Ed Tripp


BRIDG history, changed in 2009 with Randy Levin, Jason Locke activity. This made CDISC very upset, and they have pulled out of HL7 activities. As a result, Pharma representations in HL7 and RCRIM have halted.

Clinical Trials Repository (CTR) link for the past 4 years, so every change in SDTM is linked to the CTR.

SDC content – Therapeutic Area development, can be wrapped into BRIDG. LSDAM has been harmonized to BRIDG, which is changing the scope of BRIDG.

If the scope of BRIDG is changing, does RCRIM need to revisit it as the model to fit their needs?Should NCI reharmonize BRIDG with the RIM? Is there a path to bring data in for comparative analysis using BRIDG using HL7 messages?

Do we need some education? Is there information about the repositories built on BRIDG both in the government and pharma levels?

BRIDG ties together CDISC concepts and is a conceptual domain for clinical research. Perhaps this is an opportunity to highlight the successes of BRIDG and help them illustrate the value of using BRIDG. BRIDG IP was owned by CDISC – Mead Walker suggested that the Advisory Panel craft their own explanation of BRIDG ownership and IP, focusing on the use of BRIDG.

Ed suggested that the RCRIM meetings for the next few months focus on BRIDG. How has the scope of BRIDG changed and why? What are the instances of actual use of BRIDG?

PSS deadline – October 6thAction Items:

1. Update the BRIDG website and wiki2. Ask people to join the BRIDG listserv3. Consider the balloting of BRIDG in May – October 6th

4. HL7 has its own BAM – so the version of BRIDG that HL7 ballots in FY14 should be constrained to take out BAM

5. By January WGM we should have a constrained version of the new BRIDG model that can be balloted. 6. The biggest hurdle is explaining to folks why BRIDG is important, because there has been a lot of

rhetoric and hype about it. Step back and show value added first as the first step. ‘Cloud of hype’

From a messaging standpoint, the biggest value was the ability to create messages faster and easier.

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Ed Tripp – looking on the horizon of RCRIM he doesn’t see a lot of new messaging development activity. So we’re not sure what the value proposition for using BRIDG really is.

If we are going to ballot BRIDG and constrain it, that’s a lot of work. We need to debate the value of it to HL7 first.

CDA is basically its own model, and the WG is creating little structures of content. BRIDG is more a companion to the HL7 RIM. It is a more spelled-out RIM with additions.

The value of BRIDG is taking your domain experts, have them explain what they are trying to exchange, document them in terms they can understand. Have that expressed, have the interactions and interactions expressed, and come out at the other end with nearly RIM-compliant xml. That should reduce the time from concept to usable message.

We need to lower the barrier to getting content harmonized. We also need to know what we got when we mapped the content to BRIDG.

We need a guidance document to help folks navigate BRIDG. We need to start realizing ROI for BRIDG.

We need to revisit the need to create a view of the content harmonized to BRIDG based on metadata tags added to the content.

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Joint Meeting with EHR/PC and PHERLocation: Cambridge, MA

Date: 2013-09-25 Wednesday Q2Time: 11:00 AM – 12:30 PM

Facilitator PC Note taker(s) Dianne Reeves

Attendee Name AffiliationDianne Reeves NIH

Ed HeltonMitra Rocca

Ed Tripp


Official Minutes distributed by PC Work GroupNotes from Dianne ReevesCIC report: Questions about terminology and adding content to SNOMED-CT. In the past terms for SNOMED-CT had a que for content to be added, and it went into LOINC instead.

CIC will continue to collaborate with Electronic Health Records group and follow their work.

The functional model release 2 is being balloted. Five other organizations balloting it by end of this year. Release 3 of the functional model will be discussed later today. Many other groups have done profiles now. ADA has a US-realm dental profile. Release 2 increased the content by 3 times, so the WG is in phase 2 of a tooling effort to develop profiles. Release 2 of Electronic HR and release 1 of the PHR will have tooling within a year to make the review of content much more efficient. Discussion now of a Public Health functional model to develop. Should all these functional models fit into some sort of framework from which the profiles can fit into?

Anita: Are vendors actually using these profiles now? People are using pieces from it for the development of outreach RFPs.

Public Health items coming to ballot: the OASIS project will be coming. Discussion of the data elements coming from various registries, but PHER is not going to focus on the elements and their curation. Included reference to ISO 11179, registries from NCI, CDASH, etc. (Ken Pool)

Data coming to us not looking ‘HL7ish’ is being addressed at the Board level.

Presentation – Care plans. Chronic Care and care Coordination highlighted as needing a higher % of the healthcare resources. **Larry Garber presentation at Plenary – 14% of patients require a huge amount of resources, and that % is increasing as people live longer.

Created a set of functional profiles with the SOA group to implement the PC Care plan. Care plan has objectives and goals for the patient to meet. Barriers to patient reaching goals – financial, social, othersRisks also affect ability to meet goals, or require modification of goalsPatient preference can affect goals.

Using mind maps and storyboards for the Dynamic modelWorking with CQI to look at CQI quality requirements and implications for quality care

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Getting ready to start the Health Concern topic – not sure when so far. Awareness of the clinical decision support piece in all of these projects.

Sometimes the care plan is from an external source – like Public Health – and includes information from that facility.

Notes from Mitra Rocca

CIC Update: we are integrating these standards into clinical research using CDISC. But how to get it into EHRs. Some are interested in integrating this into EHR. We are paying attention to EHR-S FM and also to ONC SDC. Where ever we place our efforts, it needs to get into the vendors hands.

Q: Challenge of contents, so it can be re-used for clinical research, what resources are you drawing on for resources?A: Look at literature, guidelines, we go to FDA and NIH to get them from Case Report Forms (CRFs), we also contact clinical experts like WHO, Pharma and clinical society groups. We start to harmonize those with experts from professional societies.

Q: Do you harmonize with standard controlled terminologies?A: for anesthesiology we looked at SNOMED CT and found out that some concepts were missing.

Q: Are vendors using the EHR-S FM in EHRs?A: people are pulling pieces out of this. Don Mon is working on a complete list on who is using it.

Q: Does the list include internationally?A: it is part of an article

PHER update:We had issues on vital record, PH reporting, and ready for balloting Death and birth V2 messages are nearing publication

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Schizophrenia/MDD – Joint Meeting with RCRIMLocation: Cambridge, MA


Facilitator Anita Walden Note taker(s) Dianne Reeves



Meredith Nahm presented the reconciliation of Schizophrenia ballot. This is the second ballot for this model and it passed in September.Collecting a large set of forms/550 elements per form, which is nearly a total of 11K elements. I,081 unique elements, and 212 schizophrenia specific and NOT from a validated instrument.From the 212 CDEs – 86 core elements, 118 data elements as part of the SKID (excluded by the clinical expert except for 1)First ballot was 67 elements – not passedSecond ballot started with 69 to a total of 72 CDEs, 38 in common with MDD modelThese 38 common ones may work across mental health.Clinical trials is only one source of clinical data elements, the other is the GSM. GSMV review has been completed and is with the FDA. Collected CRFs from the NIMH from a set of clinical trials. The data elements have been collected and will next be harmonized. Compared clinical practice guidelines for Schizophrenia to data elements – very difficult to compare the elements because the practice guidelines are extremely high level. Plan to instead compare with specialty HER screens (in process).Federal forms, measures and guidelines are not part of the grant – a companion activity.The next step because of FDA interest is to pass them along to CDISC for TA user guide and create a domain in SDTM for this content. Keen on getting the elements put into the Electronic HR functional profile.Schizophrenia72 Schizophrenia specific38 common to mental health core140 for rating scales and questionnairesMDD91 MDD specific38 common83 rating scales and questionnaires

24 total comments- 9 major negative

Major negative comments include the following:*Negative – add data elements to support DSM-V diagnoses

- Change in SCZ categories from DSM-VI to DSM-V

Mead Walker: comment reflects changes in DSM-V. What’s beyond DSM-V? In the next version if there are changes you will need to pull out the appropriate elements and make changes.Diagnosis – changes in DSM-IV to DSM-V. Mead suggested qualifiers like the coding dictionary be added to the model. You would like to model that in a way you don’t have to remodel when the coding dictionary changes.

Action:

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1. Have one Dx data element and another to hold the coding source.

*Negative – data elements need to be added to support definitions of partial response for adjunctive trials in schizophrenia.Clinical expert review committee for SCZ and MDD had a lot of overlap between the two groups. The group was asked to define responder, partial responder, relapse and remission. There is generally no consensus on definitions of response in psychiatric conditions. The responses were decomposed into data elements and compared to the existing set. New data elements reviewed. The responses are derived based on a protocol that is study-specific. Response to negative comment is citation of two data elements added to model with ability for FDA to impose their own definitions as needed. *Negative – data elements need to be added to support definition of open-label concernsResolved*Negative – add data elements to define relapseResolved with 8 elements added*Negative – add data elements to define remissionResolved with 2 elements added*Negative – have a data element to capture different schizophrenia typesNo action needed – captured already*Negative – for QoL and suicidal symptoms two different scales cited as betterResolved – two scales added, no scales removed*Negative – the place of study conduct needs to be collectedResolved – the place of the study is captured in core SDTMWording changes recommended – defer to the clinical expert review committee as the deciders of the definitions.Suggestion to add neuroimaging element from Kaiser – take it back to expert review committee.Final Disposition: Vote to accept this reconciliation. When comments come back from the clinical expert review committee with definitions, that content will come back to CIC, realizing that changes may be needed. People may want to see the final definitions before they withdraw their negatives. That means the disposition will need to be updated with the final definitions.Move to accept - Mead Walker, move that the dispositions be accepted as outlined by M. Nahm. Second – John KiserNo negative, no abstainTotal of 9 votes affirmative

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Notes from Mitra Rocca

Project backgroundSchizophrenia and MDD were funded as grants by FDA as part of TA standardization project, we choose to develop our stuff thru HL7. Single secondary use is not helpful but it is helpful to use these for HealthcareFunded by FDA primarily for Clinical Research (CR) use case.Seven compounds and 1000 total Data Elements were all reviewed. 86 core Data Elements, and 118 on SCID. Worked with specialty Behavioral Health EHR.Schizophrenia Ballot commentsChanges in DSM-IV and V, make sure for any diagnostic criterion we have a DE. Keep in mind what is after DSM-V. SCID is questionnaire. There is specific Data Element (DE) for DSM-IV diagnostics. DSM-IV include semantics in them. Because that changes between DSM-IV and V, we keep DSM, because they carry. Diagnosis categories, and you can use it, one would be coding dictionary, first episode indicator. Since the meaning is in DSM-IV or V, you can embed it in this. DSM-V they are getting complaints. Recommendation: The class on the model is the diagnosis not DSM-IV diagnosis. You do not have to remodel it every time they use another version of DSM or ICD-9 or SNOMED CT. Response: Run it by the review division. Check with them.Change the diagnosis to be a generic diagnosis and add coding source. Make that not a derived DE. Worked with review division to come up with Relapse. Q: for relapse there was a lot of variability. Did review divisions come up with standard definitions?A: sponsors discuss with review divisions what to use. In DSM-V there is no type anymore. We need guides that reference other guides

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Schizophrenia/MDD – Joint Meeting with RCRIMLocation: Cambridge, MA


Facilitator Anita Walden Note taker(s) Mitra Rocca



Attendees: Anita Walden Norman DaoustMitra Rocca Don JaccardMeredith Nahm Jennifer SistoDianne Reeves Vijay ShahMead Walker Evelyn GallegoBob Zozus

Minutes/Conclusions Reached:ONC Structured Data Capture project Purpose: Why we are here today, talk thru solution plan, based on standard

We work with grantees, national and international. And other SDOs like HL7 and CDISC. S&I framework is not about re-inventing the wheel. Why we are here today?

Q: Do you expect to define the standards of form library?A: No, other parties will define the form library. Standardization of the form will be what is on the screen.A: Representation on the screen and how the DE are represented on the form. SDC was kicked off at

the beginning of this year. We are kicking off the content team. PH tiger team is leveraging the PHRI, take the SDC based standard and pilot that within their community.

They have identified 3 use cases. Kicking off on Patient safety and one on AE reporting and one workgroup focusing on researchWhat vocabulary and value set is needed.

Q: You will have one workgroup focusing on PH reporting?A: yes

SDC solution plan:Vijay explained II01 to 05. II01: request for an empty formII02: EHR send request with some dataEHR requesting for a blank form.

Q: requirements for empty form and requirements for form with some data, is this different?A: I will address those.

What standards to figure out for this transaction. SOAP and REST. I want a form and complianceFor transport we use the same mechanism, and the form repository sends the form back, along with some mapping file.

Q: mapping file?A: In general in this form, it gives us enough information, map it to what EHRs have. And where it is

located in the form. Q: More limited cases like SF3500/SF3500a, if the data elements are standardized, they can be standardized.

This shows only the interaction to interact with EHR and form repository.

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Request has the patient information in it. IHE DEX, to prepopulate and map the data within the form for the information that is being sent.II05: where the EHR system can pre-populate the form and send it to the external data repository. We keep the structure open, gives it flexibility.The form and the DEs, we are going with the assumption, the form repository knows how to create the forms, but the standard how the form will be created.Sectional structure will be standardized by SDC. Meta data file (ISO 11176)FDA SF3500, has specific data elementsEHRs will not maintain the forms. It is the agencies who will maintain the form.I will get a form and I will populate it. There are Some sections are mandatory and some are not.

Q: Who will consume the completed form? A: we do not want to mandate how to consume the form. We stop at the last transaction.

Q: what is useful here, agreed some forms, how to place the data in the forms?A: have you seen the Meta data (form) abstract definition on what the form looks like.

Denise (NCI) is working on this.Q: What are the DEs we collect?

A: we provide a framework to define and design a form in a structured manner as well as DEs within a form in a structured manner.

Figure out how to map it. Consume this form and how to use it. Evelyn: when the receiver gets this forms, you will have multiple EHR systems that could use

themQ: in the form standard, is there a way to take a form ID? If someone making a form they can attach?

A: Yes. Q: multiple levels of abstraction, Ex: question on CRF:

1. Schizophrenia: Yes/No2. Diagnosis: yes/noA: ISO standard is very robust.

Slide 13: we are working on phase I, developing SOAP, SAML IG. The goal for phase II is have REST/Oath

SDC base standard Outline for each of this, with or without patient data, what are mandatory Des, sections 2.6 and 2.7 are being defined.

2.7 is how the form will be defined. Q: are you referring to ISO 11179?

A: YesQ: In the standard DE, we took a dimensional approach, instead of cm, we used Length?

A: you can use the same CDE, like name, and provide instructions in the form. Q: how are you handling the prompt? Ex: what is patient’s gender?

A: left to the agency. You might have some prompt list. Q: With this I was hoping they will use this for MU quality measure. NLM will use with MU and quality measures

and Value setsA: we are focusing on pipeline, there is a work being talked about in clinical quality Information (CQI) workgroup and Structured Document (SD), focusing on quality measures. In terms of semantic harmonization and binding we will leverage their work. USHIK has all the MU quality measures. They are in NLM as well. It is not useful to an EHR vendor and we need a single point of truth. Slide 15: Improve the workflow, as we move to a higher adoption in the country, also collect additional information, Slide 16: we are going to finalize the IG. Launch SDC pilot phase - focusing on content work stream, but also the work of CMS and CDC.

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Some are interested in PH, some on research. We would like to include more.Q: What are your timelines for pilot?

A: The pilots will start end of this year or early 2014. The pilots will last 6 months up to one year.

Q: Have any picked out the PCOR coordinating center?A: Yes. Mini-Sentinel Coordinating Center (Harvard Pilgrim). National minority Forum and CDISC will

apply for the pilot. Within ONC there is a PCOR infrastructure project, so we are not duplicating efforts. Thru the ONC lead on that, they will issue a new RFP. As you get grantee and conduct pilots. CIC presented at the summer concert series. We will work with federal agencies and as we move forward, so EHRs can read them. A lot of these forms are used in different ways. For manual data capture in the receiving side. If a data element is on a federal form. take the federal form and make it representative as a form.

Mead: Go to CDC and ask you to NEDSS project history. The problem is if everyone is going to do the same thing, it will not be useful. If you need something clean, let’s do it incrementally, something useful.

Mead: We want to have a vote on SOAP standard. Each one will be on a dif. Timeline.

MDD Ballot reconciliation: SKID is the questionnaire. EHR in mental Health reviewed by the team is “ Mind link”. All new DEs will go as common data elements.

Q: What is the open label responder?A: Definitions are specific for types of clinical trials they are using.

We changed the word” institutionalized” to “already residing.”Q: where does it say in CDISC, in the narrative, that everything in CDISC is included. Point people to that section. Q: Where do suggestions from duke go?

A: This needs to be fixed. This is not the final wording we will use. Make yes/no a Boolean? A: No, we have done them as yes/no throughout the document.

Norman: here is the term in use by NIEM (national Information Exchange Model): “Justice, public safety and other communities”

Norman made the motion that we accept the disposition for MDD. Affirmative: 8Abstain: 0Negative: 0

NOTES from: Dianne Reeves

Evelyn Gallego and Jennifer and Vijay Shah present and gave overview of SDC initiative

This is not about reinventing the wheel. Present at HL7 to educate.

Key area of focus is patient outcomes and quality indicators. Electronic CRF are within scope for the activity.

Structure of common date elementsStandard for the container/formStandard for how electronic interact with form or templateStandard for auto-population of a CRF

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Recognize there are multiple CDE and form libraries. The electronic HR will interact with these registries to bring up a form, fills it with data and through the encounter it is extended and submitted.

Standards for a form library is out of scope.The representation on a screen and how the elements populate a form are within scope.

Now they are ending harmonization phase and preparing for Pilots.A tiger team is formed to pilot use cases – Cancer, hearing, and case reporting (a single surveillance form incidence)PCOR is focused on research semantics

Workflow:The ERH system asks for an empty formThe ERH system asks for a populated formThe ERH system sends an empty form in xml or html or a URI that refers to a form along with a mapping file that will give a logical description of the data needed and where the data is found in the form so the vendor can figures out what data to put in the form.The ERH system sends a populated formThe ERH sends a populated form to the data repository

Assumption: The form repository is responsible for creating the forms and storing them. There will be a standard for how the metadata will be arranged.

ERH is not the one keeping the form. Agencies are creating the form and everyone will have a similar structure. Will the structures change based on the Therapeutic area.

The actual work will happen at the data element level. For the transactions, details are given for how the data elements are defined. Another structure description will be housed for the form structure.The content is up to the user and ISO 11179 elements will be used.

Long term outcomes:Use cases - doneIdentification of national standards - doneBase Standard or Standard created - doneNext step is pilots

Intent is to ballot this standard through HL7Launch pilot phaseIntegrate CDC and CMS work

Want to start some pilots in safety by end of year. Pilots will last for 6-12 months. Would like to be complete with all pilots in one year.

***CDC project NETSS – review

MDD Ballot Reconciliation done.

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Project UpdateLocation: Cambridge, MA

Date: 2013-09-26 Thursday Q1Time: 9:00 AM – 10:30 PM

Facilitator Anita Walden Note taker(s) Dianne Reeves



Attendees: Anita Walden Mitra RoccaDianne Reeves Mead WalkerSteven Daviss Bob ZozusJean Duteau Maria IslerMeredith Nahm


Steve Davis from APA attended – updated on the MDD and Schizophrenia ballots

Two co-Chair slots are open in JanuaryMeredith Nahm will fill in for Anita in January WGM due to Anita’s climb up the mountain.

Facilitator – Project Manager is Mitra RoccaVocabulary Facilitator – Sarah Ryan cannot attend the meetings. Dianne can take the role if needed.

Four Projects Balloted in SeptemberTrauma CDA - PassedSchizophrenia model - PassedMDD model - PassedEMS CDA - Did not pass by one vote

Schizophrenia model comments will also be submitted by Jean Duteau

New project – Co-sponsor with ERH Usability Project** Literature review headed by Dr. Constance Johnson is Phase 1 Reaching out to clinicians is in Phase 2

Road show for ERH will be a focus group or survey with clinicians to gather information about their frustrations with the ERH products they are using. Steve Davis: Physicians would be willing to spend up to 15 minutes on this topic because they feel people have not listened to them. Suggest both a focus group and survey can be used to gather info. Some of the big issues are already knownFrustration – when a physician finds a problem there is no good way to do a screen shot and send a message to the vendor to address. Categorizing problems may be important – annoying vs. critical for patient safety. ERH wants to have all the comments back by January 2014

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Cardiology Imaging ACTION for Becky: Can you place the 250 on the wiki – when finalized they can be published. The funding for the work has closed August 31st. The rest of the original set will need to be addressed at a later date so they can be resourced.

The challenge is there is no funding to go back and collect the comments from professional societies and work them back into the data elements.

CDISC has repurposed their funding to focus on endpoints. The endpoint project was supposed to end before the imaging project. It has not totally transitioned to CDISC, but in progress.

Reconciliation spreadsheet needs to be forwarded and whatever the subset is identified. ACC and CDISC are groups who can move them forward. The dispositions need to be voted on during a monthly CIC call.

AnesthesiologyGaps found that will be taken up with SNOMED. They have international SNOMED experts in their Group.

Schizophrenia - recap for Steve Davis by Meredith. Major negatives came from FDA. The DSM-V change from DSM-IV was source of some negatives. Steve Davis needs to take changes through the committees before the ballot is published. Meredith needs changes by November in order to publish.

MDD – all DSM-IV elements are in now. But based on the decision with V they may not be adding a lot of those in. Kaiser voted positive on the ballot. Steve Davis will move it through APA, a group that did not comment due to DSM-V changes.

Meredith – both ballots hope to be published by January, but dependent on comments from the professional societies to the ballot disposition.

We need first Quarter for January meeting. Steve Davis will attend in January but May cannot attend.

BRIDGConstrained modules of BRIDG would Next ballot we need to show the projects derived from BRIDG

Balloting – now you must sign up for a ballot before it opens.

Training – training portal content needed for clinicians. They have webinars and we could create a PSS to do a webinar. We need to talk with the 4 stakeholders about the revenue created from BRIDG.

NOTES from: Mitra Rocca

EHR usability1. Directly from clinicians on EHR usability2. Hand-held survey at clinical professional societies3. APA: We are frustrated with EHR usability. 13% of physicians are AMA members4. Some of the usability issues depends on the care setting5. Physicians from large hospitals complain.

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6. It should go thru professional societies. They have committees for survey. For example ACC we have informatics committee.

7. Size of survey. (15 minutes) 8. 2 stepper, overview and drill down.

Focus group and survey Survey:Rich story and the clinical workflow (human story) then user story is the way to go. Steven Davies (APA): Inability to encounter an usability issue and circle it and send it back to EHR vendor (no way to provide feedback to the vendor)Would you take 2 minutes to the vendor.Last 50 minutes stroke and send it to the EHR vendor. Whether to focus on errors related to patient safety or just annoying errors. A: categorize the usability errors (patient safety)Duke did observations and there were issues with questions on the form.Schizophrenia and MDDBug APA from his end. We went to 19 members of professional societies which vary on what scale to use. So, at FDA they use sponsor-based protocol-based dimensions. We used all the sponsor and Data elements refined, are they or not responder. Sponsor will negotiate with review division. We added 10 new raw Des. The DSM-V are associated with ICD-9 codes. They have to go thru 3 committees. Mental Health IT group. DSM-V committee. Need it by November In DSM-V is symptom type category. BRIDGJean-Henri: Organizations will be bring back. What will be balloting? The whole thing, or just the DAM

Create Ontology for FDA on TA and it is based on BRIDG. Smita came to Duke and there was a desire to use-case based of BRIDGCTMS comes to Duke, Use case driven breaking up. Many people want to align with BRIDG and only a small group of people know BRIDG. We have to have more intake. We just added stem cell … and it took too longBecause BIRDG is huge and stuff for FDA is about performed activity , etc. but most people do not know that. It would be nice to have study setup., (constrained version of BRIDG)BRIDG is not published. Ballot in JIC RCRIM calls, also on BRIDG listServ. BRIDG’s utility to HL7 and ROI?A: why have BRIDG if you have RIM. Schizophrenia DAM (some way) from BRIDG or maps to BRIDG. How can Schizophrenia . Maps to BRIDG. Because it serves multiple contents. Problem is this DAM, that HL7 will use. We have to show these products we are using based on RBIDG. Actual use cases, on how BRIDG is beingDes for Information model.If I am building DAM, ONC (that are not using RIM or BRIDG)Things that been derived from BRIDG. Webinars for BRIDG.

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NOTES From: Anita Walden

BRIDG Has expanded to include the life science DAM. Need to revisit on the RCRIM calls the scope and the awareness of BRIDG. Why the scope has changed and how it lines up to RCRIM needs.Need to discuss the actual cased of BRIDG use.NCI would like to reballot BRIDG –FDA, NCI, CDISC and HL7 because the scope has been expanded. 3.2 has been loaded into the NCI systems.What will be balloted- just the DAM or the Ontology, transforms, other models? Not sure it will be discussed.Vendors can’t tell what is necessary for a CTMS Use case what is not. Request for Use Cases and how it aligns with the Use Cases. There is a need to lower the barrier to allow individuals to update to BRIDG because only a few people can complete this task.Nice to have study set up constrained version of the BRIDG, even the common items to constrain down based on specific use cases to collapse the BRIDG to what is needed.Hope to ballot BRIDG in May.JIC process is taking a long time to facilitate the ballot process it is much faster to go through the individual organizations.There will be BRIDG calls within RCRIM. What is the return on investment of BRIDG on HL7? There are several RCRIM specifications that are referencing the BRIDG.

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EMS MeetingLocation: Cambridge, MA

Date: 2013-09-26 Thursday Q2Time: 11:00 AM – 12:30 PM

Facilitator Mitra Rocca Note taker(s) Dianne Reeves



Attendees: Mitra Rocca Anita WaldenDianne Reeves Maria IslerSteven Daviss Danielle CoteJean DuteauMeredith Nahm

Minutes/Conclusions Reached

Jay Lyle presenting this Quarter. FHIR presentation by Jean DuteauPatient Care discussion

TSC update – 1. FHIR balloted without a lot of clinician comments. No comments from the ERH group. Some of the resources

had clinical input, others did not. Will be published in January 2014. 2. US Realm task force formed from ONC. It was not a DAM, but they managed to ballot informative. TSC told

them it was not a DAM, and the group wants to reballot as a logical model. (Model was virtual medical record)3. TSC now wants to have a tighter set of criteria for DAMs. CIC has a style guide that can be used for internal and

external groups asking to ballot in HL7. TSC will probably ask the CIC to tighten up what it means to have a DAM in HL7. Use the BRIDG as an example. **This is still being balloted –

4. Take the ARB DAM definition and the CIC style guide can be used to extend the guide. So it will morph from a style guide to a list of criteria. Perhaps all DAMs need to come to CIC as a review group at some point. This will take a tremendous amount of resourcing and assignment of roles.

5. CIC needs more discussion of DAM criteria and potential review of all DAMs.

If a group is cosponsoring a project, there needs to be much more cross-group activity. Patient Care has come up with a list of items that are suggested for cross-group discussions, and the process for involving professional societies.

Main concern was the need to harmonize with other existing standards.

Jay Lyle – for emergency care, the door of the ED is the boundary. Is there overlap in the content between our project and 2 other projects from Emergency care? DEEDS had a very specific version of elements, and another version with more general elements. If the DEEDS ballot in May used the more general elements, the CIC Emergency Care project is in synchronization.

Source of some anxiety in Patient Care – HL7 is used to building up content for standards from within HL7. They are not used to taking content from external groups developed by outside expertise and moving it along.

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This is what happened with NEMSIS – it is an ongoing standard that the clinical folks are happy with. But HL7 seems to be unhappy with external content.

Does this need to go to the TSC? The concern of Patient Care is almost like ‘if the content was not developed by experts within HL7 we don’t value it’. Is there sufficient opportunity to vet or evaluate it through HL7? ONC has thrown a wrench into the process. Now that standards are being put into legislation for Meaningful Use, it has put more scrutiny on the publication of standards.

Projects need some infrastructure to make sure meetings take place and meeting minutes be posted to keep them involved. Tracking of interactions needs to be facilitated by the co-Chairs. Due diligence needs to be done and documented.

Back to the EMS project – if we could have some statement that these artifacts were reviewed by the team and were harmonized. That could be added to the documentation as an addendum. So this addendum should include:

How the project was harmonized with other HL7 artifacts; How the professional societies that were involved and how they gave clinical input into

the work

Emergency Medical Services Care Ballot Reconciliation:Generate CDA compliant patient care report based on the NEMSIS set of data elementsBallot results met 73% affirmative, not approved by 1 vote. Can probably make changes and resolve with publication.

Emergency Medical Service DSTUNext steps:Plan for remainder of NEMSIS (500 elements) data set elements. Current set is about 125 elements.

There is so much variability in the way states and organizations implement this content. Probably need to recommend various document types ***Healthcare Associated Infection – standard form

PSS – need a new statement or extend the current one? IF it’s an extension it doesn’t need to go back through TSC.

Some of the interactions are not really documents – more transactional? The transactions between the vehicle and the hospital are actually outside the NEMSIS scope. Assess FHIR vs. CDA superset. Build NEMSIS superset as next step. Recirculation ballot November 2013

Item by item review of negative comments Disposition comments entered in spreadsheet LOINC codes may be issued in advance of official release, so the reviewer may not be able to find it in

published versions. Move to vote – Jay Lyles Second – Jean Duteau Passed with 9,0,0 votes Disposition accepted by the group.

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**For all major/minor negatives

Other comments reviewed by group.Vote to accept dispositionMove – ClaySecond –Jean DuteauTotal – 8,0,0Passed the approvalNeed the item #s to reference the voting. **Other comments are: 7, 4, 24, 25, 42, 44, 46, 5, 19, 23, 50, 51, 67, 3, 4, 18, 22, 41, and 52

NOTES from: Anita Walden

Q2 FIRHARB has a definition of what a DAM is. The ARB may require a Style Guide and may come to CIC for input of what should be part of a DAM. TSC –CIC project to come up with criteria for balloting a DAM. There will be a task force to look at DAMs.

DAM has an escalation process for involving clinical working groups in developing standards

EMSRecirculation for November – Ask Don the process for the Recirculation process.


FHIR updateUS REALM VMRVMR balloted a DAM that was not a DAM. They managed to ballot successfully, now it is being balloted as a logical model. ARB has a definition of what a DAM is. There is a lot of differences in style, we would like to have a tighter naming. To be a HL7 DAM, you must follow this style guide. If you look at DAMs being balloted here, CIC is the right spot for this. CIC to jump on board and what is a DAM. When the ONC or anyone else comes, here is what HL7 does with a DAMBringing BRIDG to us, make our criteria so The DAM fits. VMR was not a real DAM. They do not have data elements. VMR is now called a logical data model not a DAM.It is a CIC and TSC, these are the criteria we need to meet to be a DAM. CIC becomes the blessing group for DAMs. Harmonize clinical Des and outreach to clinical professional societies, but if CIC does not know about them. Jean-Henri has developed 2 DAMS, one for allergy & Intolerance and one for Pharmacy. There is a group that is gateway for DAMs. IG, ONC has done a lot to us, task force to look at IG, there will be a task force to look at DAMs.

Patient care on Wednesday:If people are co-sponsoring a project, there is a need to have joint meetings. A lot of us tried to do this. List of things that should take place, take it to TSC. Cosponsor a project and what it looks like. They brought up EMS as an example. What does harmonization look like? Harmonization with EMS and DEEDs,

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Jay: for EMS, our discussions have led to consequence, the door to ED is problem. There was not interest on this. Q: Overlap on the content? Only where the Emergency care data will capture pre-hospital data, in DEEDs that is the approach. DEEDS had a version where they used some general LOINC codes and then another version with more specific LOINC codes. If they use more general code, for EMS DAM to look at DEEDS?

A: we asked for specific reasons for anxiety and that is DEEDs. Q: does EMS capture text data?

A: yes, this captures narratives from medics. It was about clinical content and professional societies. The issue is that the clinical content coming to HL7 is being balloted without a lot of input from the HL7 community. What happened to NEMSIS, it is an ongoing standard that clinicians are happy with. Is the solution is that people from my area need to work more with HL7?A: there are a lot of projects that come in with funding. HL7 is an interoperability SDO not a clinical association.

BRIDG and ROI for balloting BRIDG That can be asked for each DAM. If they are not bringing any interoperability issues, then we need to look at DAMs. The concern of external materials is, it comes in and is balloted on and has HL7 stamp on it, we vetted with these people, and calming effect on the organization. HL7 stamp means, we agree with this, this project is happening a lot with HL7. And MUNow that standards are in legistration, what does it mean for HL7?

Jay: one of the criteria in the process is to have the information from clinical professional societies, to include the right working group and provide structure to support the team. We might be 2 additional things in the DAM guides:

1. Clinical professional societies will sign off on the content of the DAM. VMR was developed without input from pharmacy. Maybe the DAM style guide needs to review the other standards. What is the expectation to have a hand-off.

EMS: If we can have statements and we have reviewed the DEEDs and Emergency care DAM. A document, and post it on the Web site. Ammendum to the DAM. Clay: If you harmonized with DEEDS, what is the overlap and where the clinical Des came up?Anita: Harmonization with HL7, how do you harmonize C-CDAThey are planning to TSC. What professional organizations were involved in. for ACS we have a list of 20 or 30 organizations. One of the comments is substantiveNEMSIS has 500 elements, and put the rest of them in. we want to stay in synch with DEEDS and C-CDA. Context diagram: What we have is no. 1in the context diagram. There is so much variability in the way states, hospitals implement this. One spec with all Des and we want to include Data types. Develop the EMS similar to CDC HAI, one big document Extend this one to have more specifications in 2014In cardiovascular we can extend it. Identify other use cases. These are CDA. Some of those interactions might not be document and transactions. The only transaction is between truck and hospitalIf you are building CDA it is better to vendorClay: lots of prioperrory stuff, FHIR is DSTU and it might change. It will be march or April that it might change.

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Extension for SNOMED CT will not be added.EMS Ballot (Rx taking)If prescribed but not taking is not on the list. In C-CDA you are in control of a HCP but for EMS you are in medics’s care in a field. YouIV for a duration of an hour. Is too much information, we only care about time of the Rx administered. LOINC:Show full LOINC name, make sure that LOINC original names are present.

Motion to accept the ballot reconciliation (EMS) for major and minor negativesJay: 2nd: Jean-HenriAffirmative 9Negative 0Abstain 0

Motion to accept the ballot reconciliation (EMS) for affirmativesJean-HenriClay (2nd vote)Affirmative: 8Abstain: 0Negative: 0

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Trauma ProjectLocation: Cambridge, MA

Date: 2013-09-26 Thursday Q3Time: 1:45 PM – 3:00 PM

Facilitator Mitra Rocca Note taker(s) Anita Walden



Attendees: Mitra Rocca Rene NelsonAnita Walden Chrystal PriceGrant Dittmer Dianne ReevesJay Lyle Abdul-Malik ShakirClay Mann Salimah Shakir

Danielle Cote


Trauma Passed the September ballot.The CDA requires who is an author and who is a custodian. This can be a substantive change. The structure changes but it was a relationship that is incorrect it is consider a Technical Question. Major concern is if it needs to be balloted again. TSC stated it doesn’t have to go back to ballot for a change during DSTU. Publish the DAM that passed as dot 1 DSTU. The team will be making changes.

There are a total of 59 comments. There were themes around some of the comments: One was related to missing concepts. Failure to use templates from the CCDA

Made the templates closed. Didn’t want to be different from CCDA but didn’t want to use templates that are not related to the uses. They will review the templates to ensure it is consistent with the CCDA.

The group reviewed the negative comments first.ICD9 –Diagnosis – DG02Some individuals requested in person resolution – They will invite this individual to the next call to address the comment.VoteJay Lyle moves to accept the disposition on the negative votesClay Mann 2nd Motion

0-abstains 0-negatives9-affirmatives

Mitra Rocca will add the votes into the ballot reconciliation spreadsheet.Review of the affirmative comments took place.Recommended to add Beats Per Minute for the vital signs item. It was commented that UCOM doesn’t have BPM. You can extend UCOM to accept BPM (beats per minute) to capture the heart rate. It needs to be stated how the units should be captured.

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Occupational terms the request was to use SNOMED but the codes are not in SNOMED but have been submitted to LOINC. There was discussion submitting the codes to SNOMED but is it up to the project team or the coding system to submit them to SNOMED.The Trauma team would like to reserve Tuesday VoteJay Lyle Moves to accept the affirmative dispositionsCrystal 2nd the motion0-abstains 0-negatives8-affirmatives

ACTION- Clay Mann will provide the list of professional Societies who provided the clinical contentAbdul-Malik Shakir will harmonize the DSTU with the EMS DAMIndicate the harmonization between the Trauma


AMS: We passed the DSTU. Even though the ballot passed, we need to address the negative major. Some are substantive change by ArB, we are dealing with the hospital, is not the HCP. CDA requires that always will be author and custodian and that is a substantive change. Jay: Because there are new structure of the model, if the relationship is incorrect, it might not be a substantive change. AMS: If we ballot again, it will not become DSTU till jan. Austin was clarifying the rules of DSTU, the need to change the specification, and they have been going back to ballot, we do not have to go back to ballot, you need to publish the change as a dot. (version 1.1, etc.)Q: What if you have not got to DSTU and you want to make the change?

A: we need to publish it as a Version 1.0 and still publish it with changes. Spent the past 4 hours to address the comments. These dispositions are the opinion of the committee.

Balloting:Persuasive: the submitter has made a point and you agree and will adjust the standardPersuasive with mod: you found the problem persuasive but you will find another solutionNot persuasive: you do not agree Not Persuasive: we will clarify it somewhere else. Not related: something that has been doing with the ballot at all. Considered for future use: you are not going to make the change now but will do it in the future.Considered – no action taken: they gave you something, but no need to do anythingConsidered – questions answered: answer their questionsReferred and tracked: ex: get some input from Vocab. Nothing to do with CICTotal of 59 comments. Two things keep repeating, we are missing concepts, why we have systolic and not DiastolicC-CDA are not closed but open, but we tried to make our closed templates in alignment with C-CDA. We will look at harmonizing our differences. Row 4: we have a template ID, why do you want multiple identifiers for the same template. Need to add the LOINC codes. IMP: Act code for inpatient encounter. Talk to Trifolia tool vendor to fix the text constraint. Organizers: we call Nervous system observations, but they are organizers. Look up the reference to PQ. time in HL7 V3. Need Guidance to express prehospitalencountersection and prehospitalEncounter

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And there are 4 options, but one needs to be present. (look at DJ-02)Negatives Minor/Major were acceptedAffimative 9Abstain 0Negative 0

AffirmativesWe have UB4 codesIn the introduction to the guide, be explicit on where these comments came fromIdentified opportunity with other standardsQ; have you harmonized with Emergency care DAM?Are there overlap in their re


Trauma Ballot reconciliation

Only 7 abstain, 38 affirmative, 4 negative. We need to resolve all negatives and address all comments before publishing the document. DSTU changes can be published as a minor change without going back to ballot. You’re going to be balloting after DSTU again.

Possible dispositions – 59 comments Patterns of missing concepts or failure to reuse CCDA templates

Value sets are dynamic – meaning they can be versioned separately from the guide. If you want to change the values, you publish the new set but you don’t have to publish the full guide.

Add into the content professional groups that were involved in the content development, and if the project has been harmonized with other HL7 work.

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Trauma ProjectLocation: Cambridge, MA

Date: 2013-09-26 Thursday Q3Time: 1:45 PM – 3:00 PM

Facilitator Dianne Reeves Note taker(s) Anita Walden



Attendees:Dianne Reeves Michael VanderzdAnita Walden Mead WalkerClay Mann Clement McDonaldMitra Rocca

Minutes/Conclusions Reached:Solicit and receive comments and assembled into a spreadsheet. A total of 24 comments that were specified. The spreadsheet were sent to the Developers (Hugh and Mike) for them to look at each requirement to assess if the solution meets the requirements, will be future requirement or there is a limitation that can’t be fulfilled or more clarification that is needed.

Review of each of the requirements was conducted.How do we proceed from here?There are plans to make the MAX tool available for download along with a user guide to explain.Items can be identified and selected to be exported. The units of selection is a class.Text that is removed will be corrected in EA but deletion of and data element is not doable yet. Blank and Replace is not the same.The attribute has to be unique within a class. Attributes can not be present in multiple classes.Tool will work in designated versions can’t meet the needs of any type of version of EAEA had discussion functionalityMAX uses XML and doesn’t export into Word.ACTION: Shakir will email the list to Anita to add as part of the meeting minutes.Shakir will contact Becky Wilgus for clarification on requirement suggestions.Dianne reviewed the agenda for next meetingAnita will talk with RCRIM about Wed Q4 Schedule Joint meeting.Max Tool will present in San Antonio.

Form Generator widget was presented by Clem McDonald that is generating screens from a metadata repository.The Widget will be open source to generate a standard using standard fields.


MAX tool demo How do we go forward from the demonstrated work?Have plans to make MAX available on the website and have it be installed.

The unit to move around is always a class.

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You put content into a diagram, and then export the diagram. So one way to remove a permissible value or entry is to remove it.

Right now there is no good way to remove content. You can add in standardly formatted instructions to remove a value.

- Not an elegant approach, but it works. And we want to get this tool out there for people to start using it.

Demonstration shown – comments on the remarks, primarily from Becky Wilgus.

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