[This Transcript is Unedited]



Meeting of:

The Subcommittee on Standards and Security

December 9, 2003

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, DC 20201

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 160
Fairfax, Virginia 22030
(703) 352-0091


P R O C E E D I N G S [9:13 a.m.]

Agenda Item: Call to Order – Dr. Cohn

DR. COHN: Good morning, I want to call the meeting to order if everyone’s
seated. This is the first day of two days of hearings of the Subcommittee on
Standards and Security of the National Committee on Vital and Health
Statistics. The NCVHS as you all know is the main public advisory committee to
HHS on health information policy. I’m Simon Cohn, chairman of the subcommittee,
and the national director for health information policy for Kaiser Permanente.

I want to welcome fellow subcommittee members, HHS staffers, and others
here in person. I want to also especially welcome those calling in on the
internet, and I really want to remind everyone today at the hearings to speak
clearly and into the microphone so those on the internet can hear.

We obviously have a lot to cover over the next two days. Today we’re really
going to be devoting the full day to discussions with the Consolidated
Healthcare Informatics Initiative. They are coming forward with final standards
recommendations on nine health care domain areas, and then preliminary reports
on addition three domain areas. These are for use within the federal health
care enterprise.

As part of the federal internal adoption process the NCVHS holds open public
hearings on these recommendations. The purpose is to provide input into the
federal decision making process in this very important work. For everyone’s
information we will be hearing additional CHI reports and recommendations at
our next scheduled hearings also, which will be January 27th and
28th, 2004.

Tomorrow just to remind everyone we start early at 8:30, we’ll begin with a
HIPAA update and then follow with some discussions around the claims attachment
standards, first an update and then a discussion. Finally for tomorrow, as many
of you know the recently approved Medicare Reform legislation, which was passed
I guess two weeks ago and signed by President Bush yesterday, calls on the
Secretary to adopt standards for E-Prescribing, and the NCVHS has been directed
to develop such standards recommendations. We will be discussing a draft
project plan for the effort late Wednesday morning, and Jeff, thank you for
your work putting that together. And obviously we will refine that I’m sure
significantly from where we are now as we begin to mobilize around it.

Now I want to emphasize that this is an open session. Now those in
attendance are willing to make brief remarks if you have information pertinent
to the subject being discussed, we will also have time at the end of each
session for public comments if necessary. And of course those listening in on
the internet we welcome emails and other communications on any issues coming
before the subcommittee.

With that, let’s have introductions around the table and then around the
room. For those on the national committee as always we would ask as part of
your introduction if there are issues coming before us today for which you need
to recuse yourselves would you please so publicly state. Jeff, would you like
to start with the introductions?

MR. BLAIR: Jeff Blair, Medical Records Institute, vice chair of the
subcommittee, member of ASTM, AMIA, HL7, and HIMSS, and there’s nothing that I
can think of that I need to recuse myself about.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
staff to the subcommittee and liaison to the full committee.

DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the
committee and the subcommittee.

DR. HUFF: Stan Huff with University of Utah and Intermountain Health Care in
Salt Lake City, member of the committee. I don’t think there’s anything that’s
coming before us that I need to, but I do have potential conflicts as a
co-chair of the LOINC committee and as a vocabulary co-chair within the HL7
standards committee, and potentially as a conflict if there are any business
about 3M that comes forward, I’ve been a sometimes consultant for 3M.

DR. FITZMAURICE: Michael Fitzmaurice senior science advisor for information
technology to the director of the Agency for Healthcare Research and Quality.
I’m staff to the subcommittee and liaison to the national committee.

MS. BEBEE: Suzie Bebee, ASPE, staff to the subcommittee.

MS. GRAHAM: Gail Graham, VA, staff to the subcommittee.

MS. BRADFORD: Alicia Bradford, Consolidated Health Informatics Initiative
project management team.

MS. WARK: Cynthia Wark, Consolidated Health Informatics project management

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and executive secretary to the committee.

MS. FRIEDMAN: Maria Friedman, CMS, staff to the subcommittee.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services,
program manager for the CHI Initiative.

MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.

MS. GUILFOY(?): Elaine Guilfoy, president, Guilfoy Consulting.

MR. RENDIANACK(?): Mark Rendianack, Consolidated Health Informatics staff.

MS. LESH: Kathy Lesh, the Kever Company.

DR. COHN: And I need to publicly disclose I’m a member of the CPT editorial
panel, therefore I will be recusing myself from any of the discussions related
to that issue.

Now before we start I think that we were expecting Dr. McDonald, another
subcommittee member, to be calling in, I guess that is, where is Dr. McDonald
going to call in this morning? Okay, fine, I guess we’ll welcome him when he
does call in.

Anyway with that, Cynthia and Alicia, thank you very much for being here and
we’ll hand the floor over to you.

Agenda Item: CHI Final Reports – Ms. Wark

MS. WARK: Thank you. This is a rather full agenda today, the Consolidated
Health Informatics Initiative has been busy, working hard all year and we’ve
come to the subcommittee on several previous occasions and today we come in
with nine final reports and three preliminary reports. There are several
handouts on the table and I’d like to draw everyone’s attention to the fact
that the handouts are grouped. So there are only five handouts but there are
several reports in each of the handouts, so there a total of 12 reports in the
five clipped together packages.

Today we’ll review the CHI schedule and the progress that we’re making and
give presentations on each of the nine final recommendations and the three
preliminary recommendations as well. Here’s the schedule that the subcommittee
has seen on many prior occasions and it has remained the same throughout the
year. It has been a very aggressive schedule and our teams have worked hard,
our team leads are here today to deliver the recommendations from their
workgroups and as you can see we are nearing the finish line, have all of our
24 domains covered by the end of December.

Again, this is the slide on the standards adoption process and the arrows on
the bottom of the slide indicate when we come to the subcommittee with
preliminary reports following initial analysis and feedback of the workgroup
and the final reports come following technical presentations to the CHI
Council, department agency review and feedback, and CHI Council establishes
consensus, and it is at that point that we come back with our final
recommendations to the subcommittee to obtain any additional feedback and input
that we should consider before we move ahead with final adoption.

This is a somewhat modified slide from what the subcommittee has seen on our
previous presentations and the reason that this is modified is that as we have
moved forward with our work and come forward with recommendations it has been
clear to us that it hasn’t been as simple as saying there is an acceptable
terminology that needs only ever greening to maintain and there may be an
imperfect terminology with gaps, or no solution.

What we have now found is that there are many intermediate types of
recommendations coming forward based on work that is going on in the standard
development organizations and so we are trying to be much clearer with our
definitions and our terminology so that when we say there is a gap to be
addressed that means that the standard can be used and that we’re recommending
improvements to the standard through the gaps that we identify being addressed.
And when we have a condition placed on the recommendation that means that the
standard cannot be used until the conditions are addressed. There are also
temporal issues we identify when there is work in progress within an SDO and we
are aware of actions that are pending with a defined timeframe, such as
ballots, or work that is ongoing to make a production version available and so
we identify specifically those issues along with the recommendations so that it
is clear when something is adopted what it means that there is a condition or a
temporal issue.

And then we also continue to have domains where we may have no solution at
this time and we may also make a recommendation that appropriate actions be
taken with groups to develop a vocabulary to fill that need.

DR. COHN: Cynthia, could we just spend a minute on that slide because you’re
obviously changing things a little bit, I just want to make sure that everyone
understands this. I guess in your reports you still have conditions, by that
you mean these are things that relate to imperfect terminologies as opposed to
conditional approvals, or if they’re conditional approvals are they one of the
three addressing gaps, conditional approval, or temporal issues? Maybe you
could you just clarify that a little bit.

MS. WARK: The use of the word condition is associated with the need to have
an action take place so that the standard can be ready for use. And when we
identify gaps that does not mean that the standard is not ready for
implementation in the federal enterprise, it simply means we have identified
improvements that we believe will make the standard better.

DR. COHN: I see, so when you put a condition in a report it relates to a
condition or a temporal issue?

MS. WARK: No, the use of the word condition is now being used to indicate
that the standard is not ready for use, so while we may be making a
recommendation that a standard be adopted there are certain conditions that
would need to be met in order for the standard to be available and mature
enough to use and to implement in the federal enterprise.

DR. ZUBELDIA: So it’s more conditional disapproval, right? Instead of a
conditional approval it’s a conditional disapproval of the standard. It’s
disapproval until the conditions are met.

MR. BLAIR: And Cynthia, this is a change in definition for how you use
conditional approval when we were doing message format standards, because in
that case you used the word conditional approval, is that correct?

MS. WARK: That is correct, and I think that there has been a lot of
questions about what does it mean for something to be conditionally approved.
For example, if we go back to the DICOM standard, at the time that that was
approved for us it was approved for use within certain parameters within an
institution, for example, and so yes, the term condition has taken on a new
meaning as we begin to understand some of the work that needs to take place on
the standards in order for them to be successfully implemented in the federal

DR. COHN: I think Karen has a comment.

MS. TRUDEL: I think another way to look at it is that an acceptable solution
is one that is ready for use now and we couldn’t think of any way to make it
better at the moment. A gap is there’s a solution available, it can be used
now, but we can find ways to make it better and we’ve made those suggestions
but you can put it into effect even if those improvements were not made. The
temporal issues are ones where we know that there is a specific action with a
specific timeline that is happening and that therefore we can approve, for
instance saying we expect that an HL7 ballot will take place in January or
something like that. Those are the kind of temporal approvals that we’re
making. The conditional really means that we found something that could work
but it’s not quite there and until it’s there it’s not usable. I don’t view it
as a disapproval because a disapproval means that we couldn’t find anything out
there at all, not even anything that was close to work with. So basically those
are the distinctions we’re trying to make.

MS. BEBEE: Does this change the previous conditional approvals of the
previous recommendations? Or how does that fit now that it’s flipped?

MS. WARK: We’ll go back and revisit when we get everything, the first round
finished, there may need to be some notes added to some of the previous reports
to clarify how it fits but I think most of them were issues where the standard
couldn’t be used without the changes being made.

MS. BEBEE: Well, Steve’s here, Steve, you had led a group, was it LOINC? And
there was a condition? So does that, from your practical application does that

DR. STEINDEL: I’ve been involved with the discussions concerning the, what I
view as somewhat subtle changes in conditional and I think one of the problems
that we’ve been having in the past is not so much with conditional approval,
where people have put in conditional approvals based on something changing in
the terminology, like for instance the conditional approval on LOINC concerned
them developing hierarchies, which they’re doing and released, so in a sense
that condition has already been met. And in other conditional approvals we are
looking at something that needs to occur within the terminology and in some
cases that has occurred and in some cases it has, or it’s starting to occur
directly because of our recommendations.

I think the biggest problem we’ve had in the past with workgroups coming in
using conditional approval was the problem of temporal where workgroups would
be coming in and saying yes, we can approve this terminology, however, it’s not
going to be released until, or the version that we want is not going to be
released until, or this terminology is planning to make the change we’re
requesting but it won’t be done until, and I think that is where the major
change has occurred with regard to temporal. And what in a sense we’re doing
here is when we put a temporal recommendation on it it’s sort of a check-mark
for the federal government to look at this terminology on or around that date,
ask has this occurred, and if it has occurred the terminology then moves from
something that really is not ready for use today but can be used today without
requiring any other action.

MS. BEBEE: I guess what confused me was the part that says that the standard
can’t be used until the conditions are addressed, and so using LOINC as an
example there would still be the use of LOINC except for the need for the
hierarchy to be addressed. Is that correct? So again, would LOINC in your
example be used and still be conditional?

DR. STEINDEL: Looking specifically at LOINC I would say LOINC has already
addressed the conditions that we have placed on it.

MS. BEBEE: Okay.

DR. COHN: Okay, I’m sure we’ll come back and revisit this one as we go
forward. I apologize for focusing in on this one but this obviously is a change
and we just need to make sure everybody understands it.

MS. WARK: The CHI outcomes remain the same as they have been, the domains
with a clear strong candidate we will adopt or acquire. The domains with
standards that need gaps and weaknesses addressed we will nudge. The domains
lacking in standards we will stimulate new development through the standard
development organizations. And the domains with terminologies used by other
processes, for example HIPAA, we will validate those.

Further coordination with the subcommittee will take place on January
27th and at that time we will have our remaining five presentations
and that will complete all of the recommendations for the CHI portfolio to the

Okay, with that we will move to the first final report, Anatomy &
Physiology, and the team lead is Steve Steindel.

DR. COHN: And Steve before we start let’s just talk about process for a
second. I am presuming as in previous occasions you’ll take notes on comments
and modifications and I think what we’ll try to do is we’ll have the committee
vote to accept each of them as we go from one to another rather then holding
them to some later dates. Is that okay with the subcommittee? I should actually
ask at this point has Dr. McDonald called in?

DR. MCDONALD: Yep. Simon I can hardly hear anything.

DR. COHN: Can you hear me now?

DR. MCDONALD: Not too well but better then the previous discussion.

DR. COHN: Steve, do you want to try speaking into the microphone and seeing
if Dr. McDonald can hear you?

DR. STEINDEL: Dr. McDonald, is this clear? Do you hear me clearly?

DR. MCDONALD: I can hear you, I wouldn’t say it blows my ears off.

DR. COHN: Well, we’re thankful for that since you have to travel to Europe
later today.

DR. MCDONALD: It’s much less loud then it has been on past meetings.

DR. COHN: Dr. McDonald, do you want to try calling back in again and see if
the connection is better? We apologize for the technical delay.

Steve, I don’t think I expected it was going to take five minutes to get him
back on the line.

Dr. McDonald, are you back on?

DR. MCDONALD: Yeah, it’s not substantially different but I can hear you.

DR. COHN: Well, Dr. McDonald, since you’re on the line and actually going to
be a voting member for this discussion —

Dr. McDonald are you still there?

DR. MCDONALD: I didn’t hear much in between there.

DR. COHN: Well, that’s probably just as well. Anyway, we just wanted you to
take a minute and have you introduce yourself as well as if there’s any things
that you need to recuse yourself for for this conversation.

DR. MCDONALD: This is Clem McDonald from Regenstrief Institute and Indiana
University, and I will recuse myself from any votes or discussion about LOINC,
I don’t know what’s really on, if that’s on the agenda today.

DR. COHN: Okay, thank you. Steve, would you like to start off?

Agenda Item: CHI Final Reports – Anatomy &
Physiology – Dr. Steindel

DR. STEINDEL: Yes, thank you, I’d like to present the report from the
Anatomy & Physiology CHI domain to you. This team was a mixed group, we had
a member from NASA, a member from VA, a member from the Department of Defense,
a member from NHI, in particular at NCI, and I asked a colleague of mine at
CDC, Dan Pollack, to join the workgroup except I was very specific when I asked
him, I asked him to join as a clinician and not as an epidemiologist because I
thought we needed some direct clinical input on the Anatomy & Physiology
team. And Dan was very gracious and actually wore that hat throughout the whole
discussions and it was very helpful.

The first thing we did was to define the scope of the domains and we
developed an extensive scope for the anatomy domain, used to describe
anatomical locations for the following purposes. One was clinical, the site a
procedure, and the location of an observation. Another was surgical, then it
was pathology, and finally research. And that we felt that the anatomy
terminology to be useful had to have certain characteristics from an
informatics point of view. It had contained and is a hierarchy, a partonomy(?),
or a part of hierarchy, had to be able to indicate laterality, anatomy uses a
lot of synonyms so synonyms had to be accommodated, and we also felt that
lacking a standard term we used the term virtual locators to describe features
of anatomy.

Anatomy terminologies tend, anatomy themselves tend to describe lots of
subparts and a lot of times they use a concept that may not actually physically
exist to describe the collection of those subparts and SNOMED actually is one
terminology that does use virtual locators where they have a liver structure
and they define parts of the liver with respect to that liver structure, and
they also have another concept, which is the entire liver, but it does not have

We also felt that the anatomy terminology must accommodate modifiers because
anatomists tend to use those a lot, and it must have compatibility with animal
models, not necessarily as a decision factor but because we do reach out into
the non-human world. So that was our definition, our scope, for the anatomy

For physiology we looked at that first from the narrow concept and we found
that we couldn’t really accommodate that with standard terminologies that are
used in the medical care profession. So we defined physiology as being used to
describe or infer human physiology, at least at the organ system, cellular and
biochemical levels. Physiology terminology includes tests that are used to
infer physiological states at any level noted, so this is an extension of the
standard way people think about physiology in that we decided to include in our
definition tests to infer that and we did that primarily because when
clinicians talk about physiology they generally don’t talk about physiology
from a scientific viewpoint, they talk about it from the tests that they have
run. If they want to talk about lung function they don’t talk about how the
cells in the lung are behaving, but they talk about the test that was used to
infer that the cells and the lungs may not be behaving properly.

So that was our definition and one thing, because we do feel that is an
extension of the definition and as we’ll note later we do not make a
recommendation in this area, this may be something for the committee to make a
comment on. We then defined the domains and the sub-domains and that’s pretty
much an abstraction of the discussion that I just made.

We looked at as alternative terminology the Medical Subject Headings, or
MESH, the National Cancer Institute Anatomical Terminology, which at the point
the study was done which was the summer was in early stages of development,
SNOMED CT, Clinical LOINC, the Fundamental Model of Anatomy from the University
of Washington, the HL7 Site Table, and the Veterans Administration NDF-RT
Physiological Effects Hierarchy.

I would like to point out at this point that we actually have approved the
NDF-RT Physiological Effects Hierarchy as a CHI recommendation for the Medical
Domain. It doesn’t have any bearing on what we’re going to be talking about
here, but it is an approved CHI terminology.

For anatomy our prime recommendation was a set of hierarchies that are found
in SNOMED CT and those hierarchies are noted. They are primarily found in the
body structure area of SNOMED as one might expect. We also noted that SNOMED
does have a good set of modifier terms and we noted where those are found and
which hierarchies. So our specific recommendations for SNOMED CT and our
primary recommendation is a series of hierarchies found in SNOMED.

One important contribution that came from Dan Pollack from a clinical point
of view was that as a clinician where he has to do things in the emergency
department and note what’s going on he felt that he would be greatly inhibited
if he had to select terms from an anatomy terminology that contained somewhere
between 3,000 and 5,000 terms, which is what these terminologies usually have.
And he felt that it would be very useful to have an abbreviated form of the
anatomy terminology for clinical purposes.

Our conditional recommendation for that was the HL7 Site Table. The HL7 Site
Table could be a subset of SNOMED, it could be independently developed. It
exists at this point in time but it is too weak to rise up to the level of a
full recommendation, but what it is in essence can be viewed as as a subset of
maybe 100 to 200 anatomical terms that would be useful for clinicians to use on
a day to day basis.

Our third recommendation delved into the area of research. As you noted that
was one of the areas we felt was in scope for the anatomy domain. Research
SNOMED is a clinical terminology and usually does not have terms at the
subcellular level where the research people actually work and we felt it was
important to recommend a terminology to use there. If you recall a similar type
of recommendation was made for laboratory result reports, where we said that
for research purposes we would recommend the NCBI terminology as an extension
to the SNOMED terminology. And in this particular case we recommend the NCI
Thesaurus for research purposes. We also note that this has been developed into
a fairly good and well ordered complete terminology.

The NCI Thesaurus at the time that this was written was not complete, it was
still in development stage, I have checked with NCI recently, the terminology
is anticipated to be certified as complete somewhere around the end of this
month, first of January, it’s going into internal test at NCI the
January/February timeframe and is expected to be released as a production
product in the March version of the NCI Thesaurus. So we feel that temporally
this terminology is well on the pathway to be put into use.

We also note that NCI has developed and will make available a map between
their anatomy terminology and the others. We also noted that mapping is very
important in anatomy terminology —

DR. FITZMAURICE: Steve, by the others do you mean both SNOMED and the HL7
Site Table?

DR. STEINDEL: HL7 and in general for any anatomy terminology, because
anatomy terms tend to be synonymous and it’s fairly easy to do one to one

One terminology we did not recommend was the Fundamental Model of Anatomy
from the University of Washington, one reason we did not recommend it was we
felt it was not a clinically related terminology, it was more developed for
views of anatomy and primarily for imaging. But it is still an extremely good
model of anatomy and mapping could make it very useful.

DR. FITZMAURICE: Just a little bit aside but if you’re looking at an x-ray
and you want to describe say where a tumor is located in the lung, is that an
example of where an anatomy could be helpful in showing the dimensions and
where it’s physically located on that picture? Or is that out of the scope of
the anatomy?

DR. STEINDEL: I’m hesitating in answering that for several reasons, one is
because DICOM has released specifications on how to locate spots in an x-ray.
Also I believe the Multimedia group maybe making some recommendations in that
report. But having said that what DICOM does is DICOM provides a structure to
give the coordinate location of the spot in the x-ray that they’re talking
about and then tends to use SNOMED as the anatomical term to describe the
features that they are seeing. So the answer to your question is most likely
yes. But it wasn’t not considered in scope.

Are there any other questions on anatomy?


DR. STEINDEL: Yes, Clem?

DR. MCDONALD: Could I ask a question? The digital anatomous one, did you
look at that hard, or how did that compare? What was its issues/problems?

DR. STEINDEL: That was the Fundamental Model of Anatomy —

DR. MCDONALD: The model was what the problem?

DR. STEINDEL: That’s the Fundamental Model of Anatomy that I mentioned just
a moment ago. The reason why we didn’t, we excluded that was we felt that the
model itself, the way it was put together was more aligned towards people who
were looking at anatomical structures and images and not aligned to clinicians.
But we did feel the model itself was an extremely good model of anatomy, we
just didn’t feel that it was useful for the specific aspect that we were making
the recommendation for. We did note very strongly that the model is usable from
a mapping point of view because we can map terms in the fundamental model for
virtually all cases, one to one, to SNOMED terms. And of the terms that we
looked at the ones that we couldn’t locate, couldn’t map one to one, had to
deal with the concept that we referred to as virtual locators, where SNOMED
would create an anatomical type structure that didn’t exist that would differ
from what the digital anatomous, the Fundamental Model of Anatomy, would create
as their same type of virtual locator. They both used that concept.

MS. GREENBERG: The Fundamental or Foundational?

DR. STEINDEL: Foundational, I always use, I did it in our workgroup
discussions as well, thank you for correcting me, Marjorie.

DR. COHN: Steven, are you done with your presentation and the floor is open
for —

DR. STEINDEL: Physiology just very quickly. For physiology we actually found
that while there were a number of individually developed research level
terminologies for specific projects in the area of cellular physiology, outside
of the NDF-RT physiological axis we found no nationally proposed terminology
for physiology. We also found that the NDF-RT physiology axis was highly
specific for drug physiology and was not suitable, hence we made no
recommendation for a physiology terminology at the cellular level, which is the
traditional view of physiology. And we do not know if we want to recommend that
that be created because I do not know how well that’s used in clinical
medicine. I suspect outside of research it’s not really used at all.

Going to our extended definition where we talked about the tests that are
used to infer physiology we found that there were two terminologies that do
explore that area in different ways and we found problems with both
terminologies and could not make a recommendation. Those two terminologies were
SNOMED CT and the clinical axis of LOINC. We have approved the laboratory axis
of LOINC but we haven’t looked at the clinical axis. The reasons for
disapproval in both cases differ, they both would require extensive work to
clear the condition and we can explore that further if we wish. But my
recommendation, and it’s not noted in the report that we’re passing on to you,
is that if we do wish to explore the expansion of the physiology axis into
tests it’s probably more worthwhile to do it on a more detailed level that can
be accommodated at this time.

Now I’m open to questions.

DR. COHN: Now you’re open for questions on both anatomy and physiology.
Well, first of all I want to thank Marjorie for clarifying the name of the
model from the University of Washington since somebody might be actually
listening in from Washington.

Actually I had a couple of questions here, and I think I want to start with
anatomy. And I guess I’m getting a little confused here and I think it gets
down to the issue is I think about at the end of the day of simplicity versus
how much redundancy we seem to be willing to accept. And I actually do
understand that mapping is the solution to all problems but I also worry to
that certain point maybe people have to make a decision or there has to be some
things that are sort of in and out of scope, and so I guess I’m wondering first
of all, I mean it seems to me that you are recommending sort of unequivocally
the SNOMED CT terminology for at least the intended purpose here. I guess I’m
trying, in my own mind, trying to figure out the HL7 Site Map.

Now once again being also an emergency physician who talks about femurs and
elbows and arms and all that stuff, the last time I looked that seemed to be
accommodated in SNOMED though it was mixed in with very much more granular
concepts at the same time. So I was trying to decide about the independent
utility of the HL7 Site Map as opposed to it being some sort of a subset of
SNOMED CT, which being used as an interface terminology would seem to me to be
more where you were going with that. So that was question number one.

And question number two is the NCI Thesaurus, which I’m actually not as
familiar with as probably should be, but I’m certainly supportive of the idea
of extensions into areas where a currently existing terminology doesn’t have
strength, which I think was what we accepted in your previous recommendations.
But I’m getting an unsettled feeling that the NCI Thesaurus as you’re
describing it here seems, there’s not just extension but there’s significant

Now once again I’m obviously talking about two different issues but maybe
you can address both and why we don’t change this recommendation, or recommend
changing the recommendation.

DR. STEINDEL: To address the first point the HL7 Site Table. In either case,
whether we changed the wording and we say that a subset of SNOMED be created,
or that we leave it as the HL7 Site Table, the main purpose of this
recommendation was that a subset of a large anatomy terminology be made
available to clinicians. Now from a practical point of view our recommendation
for the HL7 Site Table clearly states that that table needs to be redone, it is
inadequate at this point in time. The discussion came up at the CHI Council
meeting regarding the creation of a new HL7 Site Table and Betsy Humphreys from
the National Library of Medicine raised exactly the same question as you did.

And the comment from a subcommittee point of view, a workgroup point of view
on this, was very simple that if we need to create a new HL7 Site Table the HL7
Site Table could be created as that subset of the SNOMED terminologies.

DR. MCDONALD: Steve? HL7 may have some problems with its international
constituency if they can’t have the codes that would be distributed without
special licensing.

DR. STEINDEL: Well, it’s my understanding that Betsey Humphreys is planning
to discuss this with the HL7 vocabulary group to see how we can accommodate
this. It may be perfectly reasonable that SNOMED would be willing to place
those 100 odd terms free for use. But Betsy is well aware and that is the
approach that she would like to take on this so in essence we are merging the
needs of using SNOMED and SNOMED having the terms and isolating those terms in
a separate fashion to make it readily available for everybody. And I’m
encouraged that that approach would be happy in either a change in the
recommendations from this subcommittee or in the letter that we transmit to the
Secretary to specifically note the use of SNOMED to form that new version, a
subset of SNOMED, so I agree in essence with what you’re saying.

Now with regard to the second issue with regard to the NCI Thesaurus, we do
actually have the same problem with respect to our approval for the NCBI
terminology for organisms where SNOMED contains approximately 18,000 living
organisms and the NCBI Thesaurus contains over 100,000. There is this need in
the research community, which does do federal exchange of information, to have
terminologies that do meet their needs, and just by the nature there’s going to
be overlap. What I basically feel in this particular case, we are meeting the
needs of the research community and if we exclude the NCI Thesaurus we are not
meeting their needs and the specific recommendation is for the use of that
terminology for research purposes. So I do feel we are covered.

I think we have a little bit of a practical problem in that within NCI
itself and their clinical trials which routinely use the NCI Thesaurus,
starting in March the anatomy terminology they will be using is the NCI
Thesaurus Anatomy Terminology. And it is mapped within SNOMED CT.

DR. COHN: Okay, so basically one question and then I’ll let Susie have a
question. So basically I guess what I’m hearing is that we probably ought to
accept the NCI Thesaurus though it is noted here that it is anticipated that
the anatomy terminology will be included in the NCI Thesaurus by Fall, 2003,
this is in your recommendation and conditions, and I guess you’re now stating
that it will be there in March 2004.

DR. STEINDEL: It will be in production in March 2004.

DR. COHN: So that would be the revised condition. Susie?

MS. BEBEE: I support the idea of a subset from a practical standpoint, my
question, I wonder how the anatomy perspective is different from a subset of
anything else, supplies, diagnosis, any other type of vocabulary that the
anatomy would need to have a subset versus other types of domains.

DR. STEINDEL: Well, I think you’re statement is quite correct, I mean most
domains are going to be developing smaller subsets of work terminologies that
they would be using. I think the major difference in this particular case is
we’re really looking at kind of an inverse terminology use then in a lot of the
other domains. There is a specific generally used clinical subset of anatomy
that clinicians tend to use. As Simon pointed out they’re major body parts.
When people, the people who actually use the finer levels of anatomy
terminologies, it’s a very small subset of the clinical specialties, like
pathology would use them, radiology might, surgeons might, but in those
particular cases like for surgery or radiology they might create their own
subset of a more extensive use of anatomy terms but in general the full anatomy
terminology really is not used by most of the clinical community and therefore
we felt it was very important to note the need for a specific agreed upon
clinical subset since the main terminology is not used extensively.

DR. COHN: Jeff then Stan then Kepa.

MR. BLAIR: Steve, as I listened to you step through the anatomy and
physiology CHI recommendations one thing that I observed was that the
priorities that CHI is using in this case are a little bit different then the
priorities NCVHS has been looking at as we’ve gone through the PMRI terminology
selections in that, well, actually the PMRI standards and terminologies, in
that we came, we began with the perspective, NCVHS began with the perspective
of identifying clinical data standards and terminologies with a vision that we
would be capturing information once at the point of care, clinically specific
information once at the point of care, and using derivatives of that
information for all other purposes. And here as you’ve gone through anatomy and
physiology it appeared as if you were focusing on it from a research and public
health standpoint and then recognizing the need for its use in patient care and
therefore recognizing that there needed to be a subset, the HL7 Site Map or a
subset of SNOMED. It appeared to me as if what you did accommodated the fact
that you’re coming from a different perspective but I wanted to bring up this
point in case you wanted to make any other observations about it or whether
this difference in perspective does create a problem that we need to consider.

DR. STEINDEL: Jeff, I think the only reason that you sense a difference in
perspective was primarily because of the unique way anatomy and physiology is
used in the clinical community. That as I noted in answer to Susie’s question
it’s not really widely used in the clinical community, the broad terminology,
and that when we were charged with this we looked at the broad terminologies
and focused the clinical need as a subset and I think it’s just unique to this
terminology domain.

DR. COHN: Kepa?

DR. ZUBELDIA: Steve, help me understand what’s the advantage of having HL7
Site Table as a separate new creation to accommodate the subset rather then
having a recommendation to SNOMED to identify the subset and keeping it within
the SNOMED domain.

DR. STEINDEL: I think the answer to that was at the time this was written is
basically availability. As I noted this was done over the summer timeframe, it
was actually started before the federal license was put into effect and we are
still not sure of the distribution mechanism for SNOMED and the ability to
create subsets within SNOMED, but we are sure of the ability to create subsets
within HL7 so we focused it on something that we felt comfortable in it

DR. ZUBELDIA: And the HL7 recommendation is a conditional recommendation?

DR. STEINDEL: Yes, because it’s not there yet. Those on the internet, Kepa
and I are sharing a microphone.

DR. COHN: Stan, do you have any comments?

DR. HUFF: Well, I had a new question. Could you say more Steve about what
needs to be done in physiology? In a sense I guess I would be looking for input
that would allow LOINC or SNOMED or somebody else to correct, it’s not clear
what needs to be done there based on what you said, so could you say more?

DR. STEINDEL: I actually, the basic answer to your question is yes, the
report that was transmitted to NCVHS did not go into specific details of what
we found were the problems with Clinical LOINC and SNOMED, but I could go back
to the report and look at the exact recommendations and wording, but as a first
approximation the problem that we found in Clinical LOINC was basically that it
was not complete. The areas that it did define the tests it was very good but
it was omitting a lot of clinical areas like neurology, etc., so our feeling
about Clinical LOINC was one of lack of completeness.

Our feeling about SNOMED was one of confusion. We found that when we looked
a the EKG area of SNOMED what they had done was brought in what they had
before, merged it with the read terms, and it appeared that several of the
same, what we would consider to be physiological tests appeared in several
locations. Some of it was not cleaned up, for instance EKG and ECG were used
interchangeably. We looked for items that are very important like an
electrocardiogram, like results from various leads, and while they’re clearly
defined in Clinical LOINC they are not clearly defined in SNOMED. So what we
found was there was a tremendous amount of lack of clarity in SNOMED. What we
were saying were both terminologies before they could be looked at from a
recommendation point of view needed extensive work.

DR. COHN: Karen and then Carol Bickford.

MS. TRUDEL: I’d like to clarify that the first phase of CHI, which is what
we are in, is to roll through the first set of 24 domains and do what we can in
terms of making recommendations and adopting standards. Our second phase will
involve developing work plans for each of the areas where we’ve identified gaps
or conditions or where there are, there was no recommendation because there
wasn’t anything that was ready, set up teams to go back to the SDOs to work on
those areas and address them as we can. So phase two will actually have teams
going back to each of the organizations saying this is what we would like to
work with you on.

DR. COHN: Carol Bickford?

DR. BICKFORD: Carol Bickford, American Nurses Association. I have two
questions. The first one is when you were looking at anatomy and physiology has
there been consideration of the complementary and alternative approach to
health care? Or is it strictly the Western medical model?

DR. STEINDEL: It was strictly the Western medical model but I can say that I
think that might have a bearing for consideration for physiology, where we did
not make a recommendation, but I’m not sure it has a bearing with anatomy.

DR. BICKFORD: There may be an approach from the anatomical perspective that
there is a different structuring, for example energy zones or, and I’m just
picking this off the top of my head, from the standpoint of how the system is
structured vice the way we look at it form the Western model.

The second question —

DR. STEINDEL: So that would be a difference in the hierarchical arrangement?

DR. BICKFORD: Correct, and labeling and different concepts that may not be

DR. STEINDEL: Before you ask your second question I would like to comment on
that. This was one thing we did observe as we went through the multiple anatomy
models that we looked at is anatomy, the person who develops an anatomy model
tends to take a different approach to hierarchical arrangements and it’s very,
very common to see anatomy models using a different hierarchical approach, and
an anatomy model can easily accommodate alternative medicine approaches and we
would still be able to map them to the actual anatomical structures.

One comment that I would like to make just as an aside on this is one
comment I made throughout these discussions is that when I look at an anatomy
model is I like to be able to produce the body, walk up the tree and finally
get a body, and SNOMED you actually cannot do that because of the way they’ve
arranged their hierarchies and we’re still recommending it so you can see we
can accommodate multiple approaches. Second question.

DR. BICKFORD: The second question is in relation to the definition of the
tables, who are going to be the experts that are going to be helping make those
decisions? And I raise that as a question from the standpoint perhaps of those
who, physical therapists or occupational therapists who may have an entirely
different view of the physiology or the anatomy tables, the subsets that we’re
talking about. Or are we going to allow that to be an information system
solution, which is a personal view, rather then being reliant on sub-tables?

DR. STEINDEL: I’m assuming you’re asking that question in relation to the
HL7 Site Table and whether the subcommittee feels this should be an HL7 Site
Table or a subset of SNOMED, the wording would be that the charge to the SDO
considers the inclusion in the process that they used to develop the subset

DR. COHN: Let me try to move things back around here, I actually hadn’t
realized you were going to move us off into the physiology area because I was
trying to get closure on the anatomy, that’s no problem, there’s no way to know
what the questions are going to come up. We’ve talked about a lot of things but
haven’t made any decisions on anything, or reached any conclusions on anything.
I think what I’m hearing, and let’s go back to the anatomy and talk about what
we just discussed and see where we are.

Now first of all I’ve just looked through these recommendations, I find them
a little confusing because it appears that we have recommendations excepting
SNOMED CT, HL7, Site Table, and NCI Thesaurus, and then at the very end there’s
the conditions relating to two of the three, so it’s probably, I don’t know
what the rest of them look like but probably conditions that relate to
recommendations probably ought to be a little closer to the actual
recommendations themselves lest someone such as myself think that we’re
actually recommending these three as opposed to really giving temporal
conditions on two and then recommending one other. That’s just an
organizational issue.

Now having said that I think what we seem to be sort of basically agreeing
to accept SNOMED CT, I didn’t hear many objections to that. Now I am hearing,
or at least maybe I brought up and never received a resolution on, this issue
of what we’re doing with the HL7 Site Table or is it the SNOMED micro glossary,
and I think what I’m hearing is a general view that there needs to be some sort
of a micro glossary, smaller set of clinically useful anatomic terms developed,
and I think that we’re trying to say is that this ought to be done in
collaboration potentially with HL7, that there ought to be a discussion that
occurs with them, that this should be used to populate the HL7 Site Table. I
think that’s what I’m hearing, or it would certainly be very convenient if that
happened. And that we should encourage discussions between the CHI group,
SNOMED, and HL7 to try to make that a possibility, I mean given that we don’t,
I mean we actually have two representatives from HL7 at the table but they both
were recused from discussing this I believe, and Stan’s nodding his head so I
think that’s probably right. So I guess the question is what do we want to
specifically do about the HL7 Site Table. Cynthia, sounds like you have a
suggestion? No, I saw some body language —

MS. WARK: No, I was just listening to your proposal about possibilities of
the organizations working together and it sounds like —

DR. COHN: Well, it sounds like a phase two recommendation that as Karen was
sort of talking about it. Steve and Kepa.

DR. STEINDEL: Simon, I would like to point out that the wording on the
condition on the recommendation for the HL7 Site Table, if you look at the last
sentence, it is further recommended that the present and added terms to the
Site Table be closely coordinated with the corresponding SNOMED CT terms. So
the subcommittee is already thinking, the workgroup that put this together is
already thinking in the mode that you are thinking and it could be an NCVHS
recommendation to make that sentence stronger, and I think that would —

DR. COHN: Okay, are we generally, Kepa, did you have further on this
particular point?

DR. ZUBELDIA: Yes, and I would like to make that sentence not just stronger
but more specific, and instead of closely coordinated I would say based on, and
the added terms to the Site Table be based on the corresponding SNOMED CT
terms, assuming or presuming that they will be able to manage some licensing
arrangement where those terms can be distributed for free.

MR. BLAIR: Kepa, would you consider Clem’s observation that it could be
based on that, but it also would need to come up with some mechanism to
accommodate the international community?

DR. ZUBELDIA: Clem, what’s the concern from the international community, is
it the cost or the licensing terms of SNOMED?

DR. COHN: Did we lose Dr. McDonald?

MR. BLAIR: Maybe you’re on hold, or maybe on mute.

DR. COHN: I think we’ve heard his concern before, I don’t know that he needs
to restate it, and I guess I would be concerned us being too pejorative but —

DR. ZUBELDIA: The concern that I have is that we may end up with a close
coordination that ends up being different, and I like to avoid redundancy that
is not redundant, that is just different.

DR. MCDONALD: Kepa, I couldn’t hear that.

DR. ZUBELDIA: Clem, a concern that I have, can you hear me now? A concern
that I have is that with the HL7 Site Table being closely coordinated with
SNOMED, that close coordination could end up resulting in a different set of
terms that are close but not based on SNOMED and the proposal that I have is
that instead of just saying close coordination is that the HL7 Site Table be
based on the SNOMED terms and be a subset of SNOMED. And this of course
presumes the ability to license those terms out into the public domain or
something where the international community could use them freely.

DR. MCDONALD: Well, the question is if you set it up so that HL7 can’t do
international and you don’t already have an agreement, that seems like a really
tough statement. I think you either have to say if they can make the
arrangement they wouldn’t, because otherwise you basically break their
international policies.

DR. COHN: I think we need to come up with wording here that gives people
some flexibility, I mean we’re, considering that we really don’t have an HL7
representative here that’s able to speak freely I think we’re in sort of an
awkward position beginning to, I don’t think we’re in a situation where we want
to tell a standards development organization what to do, I think we want to
basically get them working together to sort of solve this problem.

DR. ZUBELDIA: So how if we recommend that SNOMED and HL7 work together in
achieving one common set.

DR. COHN: Karen?

MS. TRUDEL: I think the recommendation that was already put on the table
does that, it suggests to the Secretary, recommends to the Secretary, that the
CHI project approach both HL7 and SNOMED to do just that to the extent that
it’s feasible.

DR. COHN: And so this is additional wording to what we have in the
recommendation or a suggestion from the subcommittee. Steve, were you able to
capture that? Have you —

DR. STEINDEL: I’m not totally certain.

MS. TRUDEL: I’ve got it.

DR. ZUBELDIA: It may be that some of SNOMED terms have to change based on
the HL7 international recommendations.

DR. MCDONALD: But what you’re saying is the international countries then
have to buy a SNOMED license unless something changes, so I just think it’s
dangerous to set something that can’t maybe be done unless both parties agree.
Plus you also have the problem, these are balloted things that may be very
difficult to create a ballot if there isn’t already a SNOMED term. So I think
there has to be some flippage in the process to allow it to happen right.

MR. BLAIR: Would it be possible to finesse this by indicating that it is the
objective, that the coordination between SNOMED and HL7 and the international
community be done with an attempt to reach certain objectives, one is that the
HL7 Site Tables be based on the SNOMED terms, that’s an objective, not a
requirement but an objective or a target. And the same thing is that the
objective is also that it accommodate international requirements.

DR. MCDONALD: Well, it’s more clear then that, I think if you’re going to
make it an objective it would have to be that they would be free for use
internationally under the HL7 arrangements, otherwise you’re really putting an
independent organization in a bad situation with its members.

DR. COHN: I want to bring this back in on this one, actually I thought
Karen’s suggestion actually meets all the needs I’ve heard so far. Steve, do
you have a question of clarification about that?

DR. STEINDEL: Can I hear Karen’s wording one more —

DR. COHN: Why don’t you restate because it sounds like —

MS. TRUDEL: The recommendation was that the CHI group approach HL7 and
SNOMED to encourage discussions between the two to develop a micro glossary.

DR. FITZMAURICE: To the extent possible.

DR. COHN: To the extent possible. Steve?

DR. STEINDEL: Simon, the way the wording is right now in that area, it’s the
second sentence starts, this is after it says the table is not complete, HL7
has a mechanism to facilitate the addition of these terms through their
vocabulary technical committee, so we’re already saying that HL7 has the
mechanism and that mechanism should be used, which addresses Carol Bickford’s
question and Clem’s point about balloting, etc., that the HL7 mechanism would
be the one that was used. As Kepa brought out and as Clem brought out, I’m
suggesting that the next sentence be modified, it is further recommended that
the present and added terms to the Site Table be based on the corresponding
SNOMED CT terms and be freely available for international use.

DR. MCDONALD: For international use.

MS. TRUDEL: That’s outside the scope of CHI, international. It’s outside our

MR. BLAIR: Is it really?

MS. TRUDEL: Yes. This is an electronic government initiative for the federal

MR. BLAIR: I understand, but don’t we have to, individuals travel
internationally right now, they get care internationally, our troops are
international, so I think that some consideration for international agreements
needs to be at least considered.

DR. STEINDEL: Jeff, with regard to the comment about troops, etc., the
federal SNOMED license actually covers our use in those situations and I can
understand Karen’s point and we can actually make the comment of international
use, not in the change to the CHI recommendation but in the note that we put to
the letter to the Secretary. That could be an NCVHS comment.

DR. COHN: I think similarly maybe, I think what we’ve gotten so far on the
conditions, what we’re actually now talking about is also an additional action,
that we’re encouraging CHI to work with HL7 and SNOMED to help make this
happen, I don’t know whether that’s part of here or whether that’s in the cover
letter. Or do you not want to do that?

DR. STEINDEL: Well, I agree with Karen’s, we have actually in a lot of CHI
recommendations put steps that CHI needs to coordinate in phase two but we’ve
never specifically used the words CHI should coordinate. What I’m hesitant
about doing is just actually introducing those specific words in that we
haven’t done it in the past.

DR. COHN: Why don’t we, isn’t this part of the cover letter? Of our letter
to —

DR. STEINDEL: Actually what I was making the changes was in the
recommendation itself and we could add the statement that you were saying in
the cover letter.

DR. COHN: Well, maybe that’s really where it should be so we don’t introduce
it —

MS. TRUDEL: We can’t change these recommendations without going back to the
CHI Council and through our whole process again, so I would very strongly
suggest that what we focus on today is what the NCVHS wants to tell the
Secretary because if the NCVHS recommendation and whatever suggestions are
made, that will need to be discussed back through the groups to work them into
the reports.

DR. STEINDEL: Karen, it’s been our process in the last set of
recommendations to word the transmission over to the Secretary where there were
felt that there were changes that should be made to word it that we agree with
the CHI recommendation except as noted in the modifications.

DR. COHN: Well, we concur but we also have further suggestions sometimes in
the cover letter.

DR. STEINDEL: Yes, in the cover letter, and then items that we felt were
outside of the CHI scope we have added in that paragraph and the international
use might be something that we feel is outside the CHI scope, and we would add

DR. COHN: And I think this next step issue is also probably in that note.
Now so coming back and before we spend all day talking about anatomy and
physiology, where are we with this? I think what I’m hearing is that we made
some modifications to the conditions for the HL7 Site Table, I think we’re
recommending in the cover letter basically concurrence of the anatomy
recommendations with a statement that we want CHI as a next step to begin
discussions with HL7 and SNOMED about creating this really micro glossary to be
utilized in the Site Table I think is what we’re sort of saying here. And I
think we’re saying that we should further recognize that, do we want to say
something about international in this cover letter at all or do we want to just
leave that alone thinking that they will be talking and deal with it as they
deal with it? I’m not sure there’s really a terrible value to go there in this
letter. Stan?

DR. HUFF: So, I mean yell at me if I’m getting into the area where I
shouldn’t. I think the process is in place that are going to take care of the
concerns that the committee has, so a couple of things. We’re aware of the
SNOMED contract, the SNOMED content into the ULMS meta-thesaurus. HL7, the
co-chairs of the vocabulary committee have met with Betsy Humphreys and members
of the National Library of Medicine for the purpose of placing HL7 terminology
into the meta-thesaurus as well. And what that would mean is that for a
particular use in a message those set of concepts would be a subset of the
concepts in the meta-thesaurus and because of SNOMED being there as well you
have the cross mapping of those terms to the SNOMED concepts. So I think in the
end we’re going to end up with a unified set of things that are a known subset
of SNOMED so I think the process is in place that the goals as stated in CHI
are going to be achieved by that process anyway.

And so I guess I’m not so worried about the particular wording because I
think all of the people are motivated to do what you’re trying to have
expressed here anyway. We do have to work through some of the international
issues but again I think that will happen because of the central coordinating
activity that’s going on within the National Library of Medicine.

DR. COHN: Well, Stan, I think it’s fine for you to say that and the question
is is are we okay with this comment in the letter or are you speaking against
comment in the letter because you think —

DR. HUFF: What I was saying, I’d be happy with any wording because I think
this is going to get taken care of anyway, so whatever’s most appealing to
people I’d be in favor of.

DR. COHN: Well, I’m going to suggest we maybe not include the international
issue in the letter unless, I don’t know, Steve, what do you think?

DR. STEINDEL: I was just expressing the wishes that I thought I was hearing
from the HL7 community and I also agree with Stan, I think it’s redundant, it
would be approached during the discussions. I do have a bit of a problem as
Stan has pointed out in specifically, and this is putting on my NCVHS hat, as
Stan has pointed out about including an actual statement that CHI should work
with HL7 and SNOMED to coordinate the development of a new Site Table because
as Stan has already noted the National Library has already started these
discussions. And introducing CHI into this process —


DR. STEINDEL: Well CHI is, I would just, I personally would just leave it as
it says in the recommendation where it is open as to who is doing it because
the National Library has been recommended by the NCVHS in the PMRI terminology
letter as our point of contact for SNOMED and for this type of work. And CHI
actually extends beyond HHS.

DR. FITZMAURICE: So then should the committee recommend that NLM do this? Do
the coordinating part?

DR. STEINDEL: I just think we should, if we are already saying that it needs
to be done in the recommendations and CHI as a body as their punch list from
the first set of recommendations will note that this is something that they
should follow up on and will talk with the appropriate members of CHI to see
that it gets done. So I think they will coordinate it without being
specifically told in this letter to coordinate it.

DR. FITZMAURICE: I’m more comfortable with that.

DR. COHN: So you just want a concurrence?

DR. STEINDEL: Actually it’s concurred as modified because we have had, I
think I’ve heard two modifications to the recommendation itself, the first
modification was to the NCI Thesaurus, it will be released in March instead of
Fall, the second was Kepa’s modification that it should be based on and not
coordinated with, he wanted to see stronger language there for the Site Table.

DR. COHN: What is the wishes of the subcommittee on this one? I think the
question is how inferential we are versus how direct and I’m not sure I have a
strong feeling one way or another. I see Kepa sort of agreeing.

DR. ZUBELDIA: After all I’ve heard I think that based on, or in conjunction
with, is going to end up with exactly the same result. At some point I’d like
to concur with some recommendation without any changes.

DR. STEINDEL: In that case Kepa since it was your recommendation the change
in date is real, so that would occur, but that’s basically a trivial
modification and if you’re happy if being close and coordinated with then we
have —

MR. BLAIR: I would move, make a motion, that we would concur with the CHI
recommendations with the one modification that Steve has mentioned with respect
to the availability date for the NCI terms.

DR. COHN: Okay, and I think this applies to the anatomy, we’ll move to
physiology in just a second.

MR. BLAIR: Physiology, I’m sorry.

DR. COHN: No, this is just anatomy, I think I want to handle, I think
there’s an issue about physiology we need to discuss. But all in favor, I mean
any further discussion on the anatomy piece? All in favor?


DR. HUFF: In favor but abstaining.

DR. COHN: In favor and abstain. And I guess Clem, do you need to abstain or

MR. BLAIR: Clem, are you on mute?


DR. COHN: Are you in favor or did you abstain?

DR. MCDONALD: Me? Oh, I guess I didn’t hear the request for a vote.

DR. COHN: We were trying to bring the anatomy to a close.

DR. MCDONALD: I missed some of the wording but I think I was agreeing with,
it came out as what Steve was saying, we’d leave it kind of like it was and as
Stan was saying?

MR. BLAIR: we have a motion that we concur with the CHI recommendations.

DR. MCDONALD: I support that.

DR. COHN: So passed then. Okay, now let’s talk about physiology for just a
second since that really is a separate domain. Currently the recommendation is,
I think no recommendation with, I see on our slide here it says reevaluate in
12 to 18 months, I’m not sure that I even see that in the recommendation, I
just see no recommendation as the recommendation on this. I guess to me the
only question on the physiology is as part of any sort of reevaluation does
there need to be a reevaluation of the definition of the domain? I mean it’s
really unclear to me even despite all the conversation whether we’re talking
really about physiology or physiologic effects or what here. And I think that
part of the problem here is that there seems to me to be a certain fuzziness
about what it is we’re really talking about.

DR. STEINDEL: I think Simon you are quite correct in your observation and
this was a problem that the CHI workgroup had in defining the domain. And I
think you’re also correct in your observation that this is not something that
we really can decide in a few minutes, which is one reason why it is no
recommendation. We did not see a clear area, we do not know if the extension
that we placed on the physiology definition is acceptable to the community, and
we should find that out.

DR. COHN: Well, I guess then what I would do is to move a, that we concur
with the recommendation to further, and this is a cover letter issues is that
we recommend that it be reevaluated in 12 to 18 months and that that work begin
with a reevaluation of the definition of the domain.

MR. BLAIR: I’ll second that.

DR. COHN: Does anybody else have any other comments?

DR. HUFF: Well, I would just concur with that as well, I mean I think the
more explicit the roadmap of what needs to be done is the better we could
address it, so I mean if there were a list that said we think pulmonary
function tests are the most important, next thing are EKG potentials, the next
thing are visual evoked potentials, etc., if we had a list like that’s
something that could be targeted by SNOMED or LOINC to address those areas and
fill the gaps that are seen. So we would welcome I think that kind of
refocusing of the work.

DR. COHN: Steve, are you comfortable with what we just came to?


DR. COHN: Okay, any further discussion, comments? All in favor? Concur?


DR. COHN: Kepa? Stan, do you need to abstain?

DR. HUFF: In favor but abstaining.

DR. COHN: Okay, Clem? Dr. McDonald? I guess he’s not answering. Well, I
think we have a majority of people here so we move forward.

Well, we’ve made it through the first two domains.

DR. STEINDEL: No, that was one domain.

DR. COHN: It counts two to me.

MS. WARK: The next one will be quick.

DR. COHN: Okay, the next one is billing?

MS. WARK: I think we’re running a bit behind schedule, should we take a
break now or should I go on with the billing one?

DR. COHN: Should we take a ten minute break then?

DR. STEINDEL: Why don’t we do it?

MS. WARK: Okay, we go ahead with billing before the break?

DR. COHN: I’m hearing no objection, we’ll go through billing and then we’ll
take a break after that.

Agenda Item: CHI Final Reports – Billing – Ms.

MS. WARK: The billing team composition, as you can see we had very wide
representation across the federal government with several representatives from
CMS, we had two representatives from the Social Security Administration, we had
four representatives from the Veterans Administration, and two from the
Department of Defense.

The description of the billing domain is that these standards are used to
implement electronic exchange of health related information needed to perform
administrative functions in the federal health care enterprise. This was a
validation effort assuming that the HIPAA transaction and code sets would serve
as the basis for the standards.

The scope of the billing domain was defined as those areas already addressed
under HIPAA and in addition the workgroup felt that it would be beneficial to
look at appeals and certificate of medical necessity, and other areas that were
out of scope were claims attachments, report of injury, non-claim payment
electronic funds transfer, purchasing, such as medical supplies purchases,
provider identifiers, unique patient identifiers, advanced beneficiary
notification, and electronic signatures, all of those items that I just
mentioned were out of scope. Employer identifiers was defined to be in scope
because that is already covered under HIPAA.

The alternatives for billing were all of those already approved under HIPAA
and in addition we added ICD-10-CM and ICD-10-PCS.

The recommendation is that the HIPAA approved transaction and code sets,
both those currently approved as well as future updates are recommended for
adoption, so essentially the aim here was to keep the federal enterprise in
sync with HIPAA and that we not need to revisit any future updates, that we
simply say that those are adopted as they are enacted.

In the area of claims attachments, those were considered out of scope due to
the scheduled publication of the attachment, NPRM by HHS in 2004, work is
underway between the HL7 attachments special interest group and the CHI staff
to map and align the clinical standards with the proposed HL7 claims attachment
standard, therefore until this work is evolved further the workgroup considers
this out of scope and suggests the area be revisited in 12 months.

In the two additional areas that the workgroup looked at, appeals and
certificate of medical necessity, there were no additional standards that are
being recommended now for adoption, however it’s worth noting that the X-12 837
transaction could be used for certificates of medical necessity, however, it is
not a HIPAA approved transaction code set and it would need some work in order
to be used by the federal enterprise. Currently there are no federal agencies
using an electronic standard for data or structure related to certificates of
medical necessity, therefore no standard for this function is being

And that concludes the billing workgroup recommendations.

DR. COHN: Questions or comments from the subcommittee? Kepa?

DR. ZUBELDIA: I concur with the recommendations but I would like to see in
our letter to the Secretary to expand the domain and so the domain scope to
include all of those parts of HIPAA that are currently not in scope, and you’ve
already recommended to review the claims attachment in 12 months but
potentially under HIPAA there’s a requirement to adopt the transaction for
report of injury and there will be provider identifiers, patient identifiers,
and payer ID’s that will also at some point, except perhaps the patient ID,
become HIPAA standards. And at that point I think the recommendation will be
that CHI should consider those also as CHI standards and that be revised as
HIPAA adopts new standards.

MS. WARK: I believe that is consistent with our recommendation that for
example the, initially we did not have employer identifiers as in scope because
it’s not been implemented yet, however we changed that because we do have the
compliance date noted. It is the intent of the workgroup and the CHI Council
that any future updates to HIPAA would be reflected in the CHI standards
therefore we would simply need to update our standards list and our
documentation to reflect that.

DR. ZUBELDIA: So my recommendation is to recommend to the Secretary that
those future HIPAA standards be brought into scope for this initiative.

DR. COHN: Well, I think I’m reading this as the HIPAA approved transaction
and code sets, both those currently approved as well as future updates are
recommended for adoption. Is that sort of what you’re saying?


DR. COHN: So that’s already in here. I guess the one question I would have,
which I think is sort of along the lines of Kepa, that I think identifiers are
sort of implicitly included but are not mentioned and I tend to think of them
as something different then transactions or code sets, so I would expect that
you would probably, I mean I think that’s what you’re doing though it’s sort of
hard for me to tell. I think that you’re talking about including
recommendations for HIPAA approved transactions, identifiers and code sets.

MS. WARK: Yes, that’s correct.

DR. ZUBELDIA: Then I would add to that list, the plan ID is not on the list.

DR. COHN: That’s an identifier.


DR. COHN: So I’m just sort of saying that maybe this first sentence ought to
be modified where we would suggest the modification, it says HIPAA approved
transactions, identifiers, and code sets as the first sentence, we should just
add identifiers. Kepa, are you okay with that?


DR. COHN: I think that handles that, Steve, are you, I think that’s really
editorial because I think you intended that.

Now one question, actually I have two sort of questions here and these are
just more clarification. Obviously you single out certificate of medical
necessity recognizing that we will in some point 2004 probably in January be
hearing from DSMOs about updates and changes to transactions. Did this turn out
to be the high priority item that you did not have currently for, in terms of
HIPAA requirements? Is this in your view a sort of a very high next level item
or is it just happens, just sort of mentioned?

MS. WARK: I think the workgroup felt an obligation to at least address areas
that weren’t covered under HIPAA and to see if there was an opportunity to
standardize anything beyond the HIPAA approved standards, to take advantage of
the fact that we had the workgroup together and we were doing the assessment.
There was quite a bit of discussion around it, I wouldn’t say that anyone, any
organization felt that we needed to put this on the agenda, it was merely
capturing what’s being done in that area and essentially all reporting federal
agencies said there really isn’t anything in use. We did make an attempt to
look at X-12 to see if there were something there that could be considered,
there is something, it would need some modification and it was left at that. I
wouldn’t say it was on anyone’s agenda.

DR. COHN: Okay, so I think we’ll leave it then without change.

Now a final question and this is actually, I’m almost afraid to go here but
just in terms of your, of how the, your comment about the HIPAA medical code
sets and the recommendations, it says ABC codes for registered users, which I
presume you mean ABC for registered users during the pilot testing period.

MS. WARK: Yes.

DR. COHN: Okay.

MS. WARK: And the full report is more specific about that, yes.

DR. COHN: Is there another full report that’s, okay.

MS. WARK: When the standards are adopted under CHI we take all of the
information that we gather and we post a report on the web, and so I was just
merely commenting that yes, we had had a significant amount of discussion about
what that meant, the ABC codes and it is under the pilot period for those
voluntarily registered users.

DR. COHN: You might just want to wordsmith that bullet.

DR. STEINDEL: Simon, is that a recommendation that it be a modification in
the —

DR. COHN: Yeah, I actually was going to suggest that maybe it’s just, once
again, I think it’s editorial but it’s just a, so we’re concurring with —

DR. MCDONALD: Simon, I can’t hear what you were just saying.

DR. COHN: Okay, Clem, I’m sorry, I think I’m speaking right into the
microphone and I do apologize. What we’re doing is recommending this domain
with the two following modifications, one was that in the recommendation in the
first sentence it would be changed to HIPAA approved transactions, identifiers,
and code sets, so that’s in the first sentence, which we think is just an
editorial modification. The other is in the, there’s a table where it says
HIPAA medical codes sets and there’s a bullet that says ABC codes for
registered users, and we were basically just further clarifying that by saying
ABC codes for registered users during the pilot period, is that —

MS. WARK: That’s correct.

DR. COHN: That is correct, just to further clarify the meaning —

DR. MCDONALD: Sounds fine.

MS. GREENBERG: I think this should say and code sets, this recommendation,
plural —

DR. COHN: That first sentence, code sets rather then codes set —

MS. GREENBERG: In one place it says codes sets, another place it said code
sets, and this third place it says codes set, I think the terminology is code

DR. COHN: Thank you, okay. I figure that’s typographical. Okay, any other
changes to this one?

DR. ZUBELDIA: I would like to add to this domain/sub-domain table that lists
the domains that are in and out of scope the health plan identifier, I think
that it’s probably an oversight because it’s one of the HIPAA identifiers and
is not on the table in the front. Health plan identifier.

MS. WARK: I believe that is an oversight. When we changed the line to
indicate that employer identifiers was in scope we originally had plan/ and I
think it just got dropped off. Thank you.

DR. COHN: So are we, anything else or are we ready to vote on this? Jeff, do
you want to make a motion?

MR. BLAIR: I’d like to make a motion that we concur with the CHI
recommendations with the noted editorial corrections.

MS. GREENBERG: Can I just ask, in light of this language then where it says
no for these identifiers it should say yes, is that a conclusion? They are in
scope and to the extent that they’re —

MS. TRUDEL: They’re not in scope for phase one because the standards have
not been adopted, and in phase one what the group did was to go back and do a
validation process for the standards that had been adopted to date. So they
would be in scope in future.

DR. COHN: Any further comment or discussion? Okay, in favor?


DR. COHN: And Stan your hand up was yes?

DR. HUFF: Yes.

DR. COHN: Any opposed? Any abstentions? Okay, so that domain is passed. I
think now it is time for a break, let’s take a 15 minute break and we’ll come
back, I think we’re one domain behind but we will make up time.

[Brief break.]

DR. COHN: Okay, our next session with a discussion on the supply domains, is
that correct Brock? We’re going to supply now.

Agenda Item: CHI Final Reports – Supplies – Mr.

MR. HEFFLIN: So here we see the composition of the medical supply team, I’d
like to thank —

DR. COHN: Brock, you need to get closer to the microphone.

MR. HEFFLIN: Here we see the composition of the medical supply team, I’d
like to thank its members for their participation.

The subset of the medical supplies domain is any instrument, apparatus,
appliance, material, or other article intended to be used by human beings to
diagnose, prevent, monitor, treat, or alleviate the disease, injury, or
handicap, or to replace and/or modify the anatomy or a physiological process.

The supplies domains includes all medical devices and supplies, and
currently that’s nearly 7,000 generic groups. The names for these products are
used primarily to inventory and document their utilization by health services
establishments, and to regulate their availability and utilization in the
community by public health agencies, specifically the FDA.

The group believed that the terminology for medical supplies should be high
comprehensive and sufficiently specific that as to the generic device for
supplied group level to accommodate regulatory and inventory activities. We
also believe that the terminology should provide definitions for the terms.

Here we see the alternatives considered, HCPCS, otherwise known as HICPICS,
ICD-9, UNSPC or UNSPEC, and SNOMED CT were eliminated as candidates because
they were either not sufficiently comprehensive or robust or specific or they
lacked definitions. The FDA Medical Device Classification is comprehensive and
has definitions, however it’s structure is flawed, there are problems with its
structure. So that left the Global Medical Device Nomenclature and the
Universal Medical Device Nomenclature System.

Now the GMDN and the UMDNS are very similar in scope, that is each supplies
names, definitions and codes for essentially all medical devices and supplies.
The GMDN was recently created through the harmonization of six established
medical device terminologies, it is including a previous version of the UMDNS
and the terminology used by the FDA. It is an ISO and a CEN standard, so
therefore it’s being adopted by many countries.

The UMDNS is owned and operated by ECRI, a U.S. based health services
research agency, it’s been used internationally for a few decades. The UMDNS is
available through the NLM UMLS and is supported by an established business

The GMDNs business plan is still in formation, however as I mentioned
previously it is an international standard and is strongly supported by the FDA
for global communication and as an eventual replacement for its terminology.

Efforts are now underway to start to merge the terminologies, ECRI is being
invited to participate in the GMDN maintenance agency, and in addition the FDA
and ECRI are involved in a CRADA, Cooperative Research and Development
Agreement, and the purpose of that is to, one of the purposes of that is to map
the GMDN and the UMDNS to each other.

So the recommendation is to wait for the GMDN and the UMDNS to merge and to
adopt the resulting terminology. Hopefully this will occur within three years
time and its progress should be monitored. The terminology resulting from a
merge of the GMDN and the UMDNS will enable the U.S. federal system components
to utilize one set of medical device and/or supply names, definitions, and
codes, and to use these same product identifiers to communicate with foreign

In addition I was recently asked to address device type identifiers for
medical devices, device type meaning make and/or model, and I have a few points
here. There’s been primarily discussions surrounding this issue to date, there
hasn’t been a whole lot of action, it’s been primarily discussion. Some
manufacturers have produced device type identifiers as part of bar codes, it’s
been at their discretion, it’s been voluntary, and the purpose has been
primarily for ease of tracking of their devices.

Historically device regulators have had problems with inconsistencies in
device type identifies due to identifiers not provided by all manufacturers,
different identifiers reported on the same product, identifiers reported not
reflecting final identifiers used to market the product, a large number of
manufacturers involved with significant turnover or companies going in and out
of business or merging, a high diversity of medical devices and the lack of a
unifying set of data elements, for example for drugs you have drug formulation
and dose in the NDC, you don’t have that for medical devices.

Internationally many in the device arena recognize the benefits of more
specific device identifiers, those being accurate and consistent device
reporting, cross referencing, tracking, and improved ease of reporting. A
consideration is to place the device nomenclature category code and device type
on the device label, barcode or other industry led identification scheme that
is used to mark devices to limit manufacturer burden. However, it’s felt that
this practice will require regulating to become universal.

The GMDN/UMDNS merge does not address device type identifiers, again without
a unifying set of device, data elements for devices it would be difficult to
make this information part of a device nomenclature. However, we can propose
that this issue be addressed as a new project by involved parties.

DR. COHN: Well, Brock, thank you. I mean obviously the first piece I think
we had heard when you came and testified to us in September and I’m not sure
that I have any great comments to make other then it sounds like you’re
increasingly optimistic that there will be a merging of the two, is that

MR. HEFFLIN: Right, we’re headed in that direction.

DR. COHN: Obviously the second piece that is actually not anywhere listed
here is actually I think in some ways the most interesting of the comments that
you’ve made. I guess I’m looking to see what the full committee, subcommittee
thinks about how we should handle this because I’m certainly willing to accept
your recommendation without further, or concur with your recommendation but I
really, when I heard the earlier testimony on the various nomenclatures it
didn’t seem like it really solved the problem, and obviously your discussions
about the device type ID really begins to get down to knowing what machine
we’re talking about or what device we’re talking about and the issues related
to that device, which has been something that’s been sort of lacking in the
work in this area. But of course as I said it’s not really listed in any of
these recommendations. What does the subcommittee think? I mean I’m sort of
thinking that we sort of concur with the recommendation and that we strongly
encourage further work in this area around device type ID and that that be
really the recommendation.

MR. BLAIR: I would second it.

DR. COHN: How do others feel? Kepa?

DR. ZUBELDIA: I’m a little bit confused on this one. Is the recommendation a
contingent recommendation or is it just no recommendation because there’s
nothing to adopt at this time and then you’ll review the recommendation later?

MR. BLAIR: This is no recommendation I think is what he’s saying at this

DR. ZUBELDIA: Well, that’s not what it says.

MR. HEFFLIN: Well, the actual recommendation, I think what I’ve written
there is that we wait for the merge and to adopt the resulting terminology.

DR. COHN: I guess what I’m hearing actually is probably technically no
recommendation, to be reviewed in some number of months or whatever, though it
doesn’t say it, they’re right, I mean we’re just looking for some commonality
between these and other recommendations are the same.

DR. ZUBELDIA: Under conditions it says the recommendation is contingent upon
the success of the merger, so it looks like it is a contingent recommendation
rather then no recommendation, that’s why I’m a little confused about it.

MS. WARK: Can I add something there that might be helpful? I think the
intent was that we put this on our phase two work plan as something to monitor
and it is contingent on the success of the merger and the continued work in
that area. At this time there is no standard ready to adopt but that we would
continue to monitor the work toward what we expect will be the outcome as long
as things continue on the plan that we envision for the merged terminology.

DR. COHN: Marjorie?

MS. GREENBERG: Did Jeff want to say something?

DR. COHN: Jeff, I’m sorry, did you have a comment?

MR. BLAIR: Well, that’s okay, let me pass for now. Go ahead, Marjorie.

MS. GREENBERG: I just wondered if you had looked at ISO 9999 and what its
relationship is to —

MR. HEFFLIN: GMDN, ISO 9999 technical devices for disabled persons, it was
one of the candidate nomenclatures that comprises the GMDN.

MS. GREENBERG: So it’s included in it, okay, because it has recently been
adopted as a related member of the WHO family of international classifications.

MR. BLAIR: My comment is purely a procedural one and it echoes I think what
Kepa was trying to say is your recommendation is that you wait for the merger,
and that’s fine, and actually you could really do this any way you want to but
the explanation earlier about what conditional meant was usually it was
conditional upon a recommendation going forward, so it just appears a little
confusing because the condition sounds like you are making a recommendation
where in fact you’re winding up saying you’re going to defer the recommendation
for a period of time. Maybe it’s just an observation rather then asking for a

PARTICIPANT: We can clarify that.

DR. STEINDEL: I actually have a wording question and generally speaking what
we have said in the transmission letter is the NCVHS concurs with the CHI
recommendation for, in this case are we concurring with the recommendation for
a conditional recommendation or should I word this to the effect of the NCVHS
concurs with the CHI conditional recommendation?

MS. TRUDEL: The recommendation is not to adopt a standard at this time. So
you can concur with that recommendation.

DR. STEINDEL: I could either add the wording or just leave it as concur.

DR. ZUBELDIA: My recommendation would be to remove the condition.

MR. BLAIR: — for us to wind up saying we concur with the recommendation.
And I don’t think it changes anything in terms of your intent or what you’re
trying to do.

MR. HEFFLIN: Right, so the recommendation you’re recommending to be removed

MR. BLAIR: No, not the recommendation being removed, no, it’s the
conditional statement.

MR. HEFFLIN: The conditional statement, you’re getting that off the final
recommendation information sheet, is that what you’re looking at?

DR. COHN: Well, that’s what we would —

DR. ZUBELDIA: The bottom of the back page, it says conditions.

MS. TRUDEL: We can move that statement out of the condition section and into
one of the other sections.

DR. ZUBELDIA: Or into the recommendation section.

DR. COHN: Well, it would be hard to move into the recommendation section
since it is opposite of what you’re recommending.

MS. TRUDEL: We can fix this easily, this is easy.

DR. COHN: This is easy, this is wordsmithing, so we can concur with the
final recommendation as stated —

DR. ZUBELDIA: We can concur with the recommendation to not adopt a
terminology at this time.

DR. COHN: Why don’t we say that? And I think we’re further, assuming that
everyone is in agreement, further recommend that the federal government further
explore the device type ID as an essential next step. How are we on that, does
that sort of meet everybody’s —

Okay, comments? Are we ready to vote on this one? Steve, do you feel
comfortable with the wording?

DR. STEINDEL: [Inaudible.]

DR. COHN: I was afraid you were going to ask me about that one. I guess we
recommend that HHS further investigate device type ID as an essential, I’m not
sure the term is essential, maybe it’s critical, item —

MR. BLAIR: Do you want to say HHS or CHI?

DR. COHN: I think it’s HHS actually.

DR. STEINDEL: If I may, we recommend HHS further investigate device type ID
as a component of device nomenclature.

DR. COHN: Is that okay? Brock, are you —

MR. HEFFLIN: Or some method of device ID, as I mentioned earlier it might be
difficult to integrate that into the nomenclature but that it be utilized in
some fashion. We can explore the nomenclature option but there are other
options as well, for example, device type ID that’s part of a barcode, separate
from the nomenclature.

DR. COHN: So how should we wordsmith this one? Read what you have again

DR. STEINDEL: We recommend HHS further investigate device type ID as a
component of device nomenclature. Would it be okay to just change device
nomenclature to a device identification?

MR. HEFFLIN: That’d be fine.

DR. COHN: Great. Okay, so are we comfortable with this?

MR. BLAIR: I’m assuming that preceding that we’re saying that NCVHS concurs
with the CHI recommendation to not recommend a supply standard at this time, or
you want to say supply or device standard.

DR. COHN: Medical device.

MR. BLAIR: Medical device.

DR. COHN: And supply.

DR. STEINDEL: Jeff, the way that’s worded right now is the NCVHS concurs
with the CHI recommendation to not adopt a terminology for the supplies domain
at this time, just simply because supplies is what they have called it.

MR. BLAIR: That’s fine.

MR. HEFFLIN: Right, and we tend to, in my neck of the woods we tend to refer
to devices and supplies just as devices, and I know here we’re using the word
supplies but just so we understand each other.

DR. COHN: Let’s call this medical devices and supplies.

DR. STEINDEL: Is that okay with CHI?


DR. ZUBELDIA: I have a question, perhaps out of scope but maybe more for my
own information. How does this interface with the adoption of HCPCS under HIPAA
for supplies? Or does this have anything to do with it?

DR. COHN: I think under billing we just accepted HCPCS.

DR. ZUBELDIA: That’s right, we did, but HCPCS is outside of the scope of
this one and they both talk about supplies, is there going to be confusion

MR. BLAIR: That’s a very good point.

MS. TRUDEL: This is something that we’re going to have to tackle in a number
of places and it has to do with the fact that the standards that are
appropriate for billing and administrative transactions under HIPAA are not
necessarily appropriate for clinical settings, especially with regard to
nomenclature and we need to begin to talk about, well, we have begun to talk
about how mapping would help us step from one to the other.

DR. COHN: Okay, further comments, questions? Steve, what do you have?

DR. STEINDEL: Just as an aside, during the PMRI terminology sessions we did
have some discussion on the difference between the identification of devices
for billing purposes and devices for other purposes, so we’ve already
recognized the difference between the two and the need for mapping between the

DR. COHN: Great. Any further comments? Can we vote? All in favor?


DR. COHN: Opposed? Abstentions? Okay, it’s passed.

Okay, now are we back to nursing or are we, okay, Alicia, please.

Agenda Item: CHI Final Reports – Nursing – Ms.

MS. BRADFORD: I’m Alicia Bradford, team leader for the nursing workgroup,
and we had representation from CMS, DOD, VA, and the Indian Health Service.

Our domain, the scope of our domain is terminology that is used to identify,
classify, and name the delivery of nursing care. Sub-domains were derived from
the Nursing Process and the American Nurses Association approved Nursing
Minimum Data Set, emphasizing nursing assessment, diagnosis, interventions, and
outcomes of nursing care.

So I just listed our sub-domains, assessment or observations, plan or goals,
diagnosis, intervention, evaluation and outcomes. Intensity of nursing care and
patient demographics were determined to be out of scope. Intensity of nursing
care, although part of the Nursing Minimum Data Set, has —

DR. COHN: Alicia you need to get closer to the microphone.

MS. BRADFORD: The intensity of nursing care, part of the Nursing Minimum
Data Set, out of scope, as no rating or vocabulary standard exists, or is
currently widely implemented. Patient demographic data is out of scope because
it has been covered by the demographics workgroup.

So went to the AMA to determine what nursing, what vocabulary support
nursing practiced, there’s 14 that they’ve approved, three are primarily
administrative and were excluded at that point, leaving these alternatives,
SNOMED CT, ABC Codes, NANDA, NIC, NOC, Omaha, the Patient Care Data Set, the
Home Health Care Classification, Perioperative Nursing Data Set, International
Classification for Nursing Practice and Clinical LOINC.

MR. BLAIR: I’m assuming that when you said SNOMED CT you were including the
nursing terminologies that are part of SNOMED CT.

MS. BRADFORD: Yes. The final recommendation is for SNOMED CT, which contains
nearly all of the source nursing terminologies that were listed there. It
contains over 1,000 nursing intervention concepts, modeled from the Georgetown
Home Health Care Classification, Omaha System, Nursing Interventions
Classification. It has intervention concepts from the Perioperative Nursing
Data Set, Nursing Diagnosis and Problem Concepts from NANDA, Perioperative
Nursing Data Set, Home Health Care Classification and Omaha.

The convergent terminology working group with SNOMED continually works with
the source nursing terminology owners to update the nursing content and model
that according to ISO standards. NOC is going to, the Nursing Observations
Classification will be integrated in the January 2004 release and additional
from the Home Health Care Classification and the Omaha Systems will be in the
July 2004 release.

So as attached to the back of my report I did a little table to kind of
illustrate what nursing terminologies are for one, free to the public, the
intent of them, and the ones that are mapped or the concepts are integrated
into SNOMED CT. And all of which are other then the International
Classification for Nursing Practice and the Patient Care Data Set, which is
currently only used at Vanderbilt University. I spoke with the terminology
owner and developer and she says that she has plans to have it coded according
to Clinical LOINC and mapped soon to SNOMED CT. The discussions continue with
the National Classification for Nursing Practice.

Obviously the workgroup could not examine the entirety of SNOMED CT so we
examined it as it pertained to nursing concepts listed in our sub-domains.
Essentially the nursing concepts fall in the SNOMED CT hierarchies of findings
and procedures and I’ve illustrated an example of that hierarchy in my report.

So there’s no conditions with this recommendation. The workgroup would like
to see mappings between the source nursing terminology owners and SNOMED CT and
for those mappings to be maintained, validated and distributed through the
UMLS. The workgroup recognizes the importance of a collaboration of the source
nursing terminology owners and the SNOMED CT convergent terminology working
group for the appropriate inclusion and representation of nursing terms within

That ends the report.

DR. COHN: Okay, comments or questions. Jeff were you going to ask a

MR. BLAIR: Forgive me, this is the blind guy and I did get a chance to look
at some of this but I just don’t remember. I think you mentioned alternative
billing, not, the ABC Codes, and I just don’t remember how you indicated they
would or would not be reflected. Could you remind me?

MS. BRADFORD: Actually the alternative billing codes, the nursing content of
them are built upon NIC, the Nursing Interventions Classification and NOC, and
also NANDA, and I took several of the terms and mapped them directly into the
SNOMED CT using the clue browser. I discussed with the owners of the ABC Codes
whether discussions are underway with SNOMED CT regarding mapping or
integration and that currently according to them is not underway. But primarily
the ABC Codes represent more of a billing and administrative then the
documentation of nursing care.

DR. COHN: Comments? Michael?

DR. FITZMAURICE: So as I understand the recommendation it’s SNOMED CT
because it contains all of the nursing terminologies that you just went
through, and you would adopt the January ’04 release but you then would adopt
the July ’04 release when it comes out.

MS. BRADFORD: Well, part of the licensing agreement, I’m not sure if that
includes the continued upgrades of SNOMED, so if it does, yes. We adopt SNOMED
CT because it brings together all of the source nursing terminologies that have
not converged to date but their inclusion in SNOMED CT is what makes it
appropriate for the nursing work. So as they’re updated we would continue to
adopt that.

DR. FITZMAURICE: Okay, good. I just wondered if you wanted to put that in
your final recommendation, which version that you’re really adopting. Thank

DR. COHN: Other questions or comments? Does anybody want to move concurrence
of this recommendation?

DR. HUFF: I would move concurrent.

DR. COHN: Oh, Stan is. Second?

MR. BLAIR: I’d be happy to second it.

DR. COHN: Okay, further discussion, comments? All in favor?


DR. COHN: Opposed? Abstentions? Okay, passed.

MS. BRADFORD: We’re scheduled for lunch but I have like a five minute
history and physical one, if you want to get back on track with that I think.

Agenda Item: CHI Final Reports – History &
Physical – Ms. Bradford

MS. BRADFORD: The team leads for this workgroup are not present, it’s Dr.
Viet Nguyen and Linda Nugent with the VA.

This workgroup came to you guys I believe in October and it was suggested
just to throw the domain out but instead of that we have determined that
there’s considerable variability in the format and content of the history and
physical and it’s presently not standardized and is typically dependent on the
clinical judgment of the practitioner, so the recommendations to defer work on
standardizing history and physical format to align efforts that are going on
with the standards development organizations and also with the other domains
within CHI.

DR. COHN: And I guess you’re also trying to wind up with the text based —

MS. BRADFORD: This is the same workgroup as the text based reports —

DR. COHN: Oh, so this includes that.

MS. BRADFORD: No, the same people are working on both workgroups, it became
evident when they struck out that they needed to settle text based reports and
then in the next phase look at history and physical and align with what’s going
on currently with HL7, delaying their —

DR. COHN: And by struck out you mean went out to evaluate the area.


DR. COHN: I just want to make sure we didn’t have both history and physical
striking out part of the expression and text based reports striking out, thank

Kepa, did you have a question.

DR. ZUBELDIA: I move that we concur with this recommendation.

DR. COHN: Okay, second?

MR. BLAIR: I’ll second.

DR. COHN: Jeff second. Okay, any comments or questions? Okay, all in favor?


DR. COHN: Opposed? Abstentions? Okay, I think we’re concurring with that.

DR. STEINDEL: Should I word that as we concur with the recommendation or we
concur with the recommendation to defer?

DR. COHN: Okay, that sounds fine. Okay, well I think we’re roughly back on
schedule at this point, I think it’s like 11:45 as I check. I’m going to
suggest we maybe take a 45 minute lunch break rather then an hour, and that
puts us complete back on schedule, so we’ll start back at 12:30. Okay, thank

[Whereupon at 11:45 a.m. the meeting was recessed, to reconvene at 12:30
p.m., the same afternoon, December 9, 2003.]

N S E S S I O N [12:30

DR. COHN: Okay, well why don’t we get started with our afternoon sessions.
Now first of all I think we want to check to see if there’s anybody who is on
our call in line. Sir, would you please introduce yourself?

DR. ANDERSON: This is Bill Anderson and Dr. Lawrence Desi(?) as SSA.

DR. COHN: Well, welcome. Anybody else on the call in line? Is Dr. McDonald
on the line? No, okay.

DR. HUFF: I had contact from him at lunch, I know he was planning to join
back. I guess he was, had to take care of something, he came back and nobody
was on the line so he wondered where we were. Anyway, so I expect him to join

MS. GREENBERG: Does he know we’re reconvening?

DR. COHN: Why don’t we start with the discussion on disability? Jennie?

Agenda Item: CHI Final Reports – Disability – Ms.

MS. HARVELL: Hi, I’m Jennie Harvell and Stan Shipley and I were co-chairs
for the disability domain workgroup that was convened as part of the CHI.

The disability domain workgroup consisted of representatives from the
National Library of Medicine, Vivian Auld was extremely helpful in our efforts
and you’ll see as we go through our report Vivian’s contribution to our effort.
We also had representatives from the SSA, the CDC, and CHS, the VA, CMS, and
DOD monitored our activities and we had other ASPE staff participating as well.

DR. COHN: And Jennie you need to make sure to get really close to the
microphone because I’m sure that people from the Social Security Administration
won’t be able to hear you otherwise.

MS. HARVELL: When our workgroup first convened —

MR. BLAIR: Could we just ask for those folks that are listening in if you
don’t have comments to make and somebody is presenting if you put the mute
switch on your telephone then we won’t hear your rustling papers and coughing
and making other little comments.

Participant: What’s the mute switch?

MR. BLAIR: Don’t you have on your phone, most phones have a little button
that you could press that you could mute —

DR. MCDONALD: It’s a key I think on most of these services, but I don’t know
what key it is.

MR. BLAIR: That’s Clem, we didn’t want you to mute —

DR. MCDONALD: Actually I’m on the phone, I’m not on a, never mind.

DR. COHN: Anyway, Jennie, please.

MS. HARVELL: When our workgroup first started meeting the first thing the
considered was how to proceed with our work and the first thing we thought we
needed to understand were how does the federal government use disability
information in its current health care practices. And we identified several use
cases, CMS uses disability data in its patient assessments and its various
payment methods, as its internal quality assurance process, in its public
reporting process for quality indicators, it uses disability data in its home
health programs, in its skilled nursing facility and nursing facility programs,
and in its inpatient rehabilitation facility programs.

CDC, the NCHS, uses disability data in several surveys that it sponsors and
conducts and it uses the information it gathers from these surveys to guide
policy development.

SSA uses disability data in eligibility determinations for both children
and adults.

The VA uses disability information for internal quality monitoring
purposes, for its service delivery, and it also uses disability information in
eligibility determinations.

DOD uses disability information in various administrative activities, and
it’s used in the course of service delivery within the department.

The workgroup decided that it would sample some of the disability data that
is used across the federal health care agencies that were participating on the
workgroup. We sampled terms and concepts from the Nursing Home Minimum Data
Set, the Home Health Oasis Assessment Instrument, the Functional Independence
Measures used by the VA in its service delivery program. The FIM is also a core
component of the CMS inpatient rehabilitation facility patient assessment
instrument. We also sampled terms from the residual functional capacity form
used by SSA in its eligibility determinations and we also sampled concepts from
various surveys sponsored by the NCHS.

The workgroup initially decided that it would consider the coverage
provided by SNOMED CT, the ICF, and other sources in the UMLS meta-thesaurus in
examining the disability data needs that the workgroup had sampled.

As I mentioned Ms. Auld was extremely helpful and critical to our work. She
used the meta-map transfer program in helping us identify sample terms that,
coverage of sample terms that we provided to her and the coverage in the UMLS
meta-thesaurus. The meta-map was able to parse the terms into noun phrases that
she then mapped back to the meta-thesaurus and she used those noun phrases to
run against the SNOMED CT clue browser and the ICF browser.

The workgroup applied its expertise with respect to federal disability data
needs to Ms. Auld’s findings of SNOMED CT and ICF coverage. We used the ICF
manual as needed to review and modify Ms. Auld’s determination of coverage
provided by the ICF. We did not use a similar method with respect to SNOMED so
therefore we did not use a SNOMED manual to review and modify if needed Ms.
Auld’s SNOMED coverage determinations. We also reviewed and modified as needed
Ms. Auld’s determination of full, partial or no coverage being found in SNOMED
CT and the ICD for our sample terms.

The workgroup constructed several spreadsheets throughout our efforts and
the spreadsheets reflected one term or concept per row, and across the columns
we reflected for SNOMED and ICF and the UMLS in our initial analyses, whether
or not there was full, partial, or no match found in either the SNOMED CT, ICF,
or other sources in the UMLS meta-thesaurus.

Our initial findings based upon the work Vivian initially produced for us
was that the UMLS meta-thesaurus could identify numerous vocabularies, and
given that conclusion the workgroup thought that given the purpose of the CHI
which was to identify largely a single vocabulary or a couple of single
vocabularies if it were possible to slice the disability domain into bitable
chunks, that further review of the UMLS meta-thesaurus as possible sources for
disability coverage would not be productive at this time. We thought the UMLS
meta-thesaurus could be useful in the future once a single vocabulary or
terminology is identified to fill gaps that are found in that identified single
source vocabulary or terminology. Thus the workgroup limited its further
analyses to SNOMED CT or ICF.

We selected SNOMED CT because it is widely recognized as being the most
robust clinical terminology and of course the recent license between the
National Library of Medicine and CAP(?) to make SNOMED freely available in the
United States. We selected the ICF because it is the only internationally
recognized disability classification and there’s been considerable development
work towards that classification over many years.

In additional work, and let me just back up, in our first round of analyses
the first spreadsheets that the workgroup produced, we sampled over 900 terms
and concepts and Vivian ran many of those against the UMLS meta-thesaurus to
identify these noun phrases. In our subsequent analyses given the fact that we
were not going to continue focusing on the UMLS we also reduced our sampled
terms from the MDS, the NCHS survey items, and the Oasis items. Our reduced
sampled terms exceeded 300, I think there were about 312 final sampled items
that were subsequently included in the additional analyses. And as I said we
limited our analyses to only the coverage provided at that point for those 300
plus items to SNOMED CT, coverage provided by SNOMED CT and ICF.

So in our report the final analyses, and we have appendices in our reports
that will eventually be part of a public document, our final spreadsheets
include the 300 plus terms, a summary of coverage provided by ICF and by
SNOMED, a description of whether that coverage provided by either SNOMED or ICF
is full, partial, or complete coverage, and it tallies those coverage levels.

The general findings by the workgroup was that SNOMED CT and ICF do not
include many of the disability data needs that the federal government uses in
its current programs. Further, when coverage is available often it’s only
partial coverage. I should note that levels of partial coverage, there are
shades of gray in partiality. In addition the workgroup observed that ICF
bundles concepts, it is a classification system, and that the federal
government often needs these concepts unbundled and needs discreet terms.

In addition neither SNOMED CT nor ICF adequately covers the disability
scaling needs and the ability to crosswalk across —

MR. BLAIR: Excuse me, Jennie? That is a phrase that I don’t understand and
maybe there’s others that don’t either. What are the scale, disability scaling?
Could you explain that?

MS. HARVELL: For example, on the Nursing Home Minimum Data Set, for every
item a person is to complete an assessment of a nursing home resident’s ability
to perform a certain task. So for example, in the ability to ambulate, there is
a skill included on the Nursing Home Minimum Data Set form that I believe
includes five or six items and it rates, goes from either independent to needs
a level of supervision, needs physical assistance, minimal physical assistance,
needs moderate physical assistance, requires total assistance, or not
applicable. That’s one example of a scale on one of the federal use cases.

MR. BLAIR: Now in your recommendation you refer to the scaling requirements
of SSA and is that different, is that the thing we have to relate scaling to?

MS. HARVELL: I’m trying to remember in our reports the scaling
requirements, I think what you might be referring to with respect to SSA is
that on our first round of analyses that we got back from Vivian she looked at
the SSA sampled items and as we were going through and looking at Vivian’s
results with respect to the SSA sampled items we quickly realized that one of
the places where we were either getting no coverage or often partial coverage
was with respect to SSA scaling items. We then took into account scaling issues
in other federal use cases, for example the Nursing Home Minimum Data Set, the
Home Health Patient Assessment Instrument, the Functional Independence Measure
used by the VA, etc., and we saw the types of concepts, the types of words that
were showing up with respect to these scales are similar, but applied
differently, across these federal use cases. And so we saw that these similar
terms are not showing up or not showing up completely in either ICF or SNOMED.

DR. COHN: Jennie, since we’re talking about scaling, I guess what I’m
thinking of this as is basically permitted values in a data element. What we’re
talking about is basically permitted values for a data element is really what
you were describing and I guess there’s the issue, which I’m sure you’re
probably going to talk about, is one is, I mean we could talk about this one
plus to five plus or whatever way you want to scale, but there’s a question of
exactly that terminology, exactly those words, and then there’s a second piece
of are there other substitute concepts that really mean the same thing but
aren’t said the same way. And I presume that was part of the evaluation also?

MS. HARVELL: In part. What we typically found, for example on SNOMED,
SNOMED allowed observations, findings, so it was possible in SNOMED to capture
a person was observed to talk independently one time, two times, three times,
whatever, an algorithm would need to have been constructed to equate those
SNOMED findings, the observations that could have been recorded using SNOMED,
to the scaling use case in any particular instance. So if, and I just want to
be clear, the workgroup was not at all recommending consistency across scaling,
across the difference federal use cases.

What we were trying to do, trying to find if it’s possible to have a robust
enough terminology that would allow the various scales that are used to be
captured is one thing, and then secondly assuming that that could happen, then
to crosswalk across those different scales within an agency, for example CMS in
its Home Health Nursing Home and Rehab Patient Assessment instruments uses
different scales for similar functional activities or similar functional
domains. Right now it is not possible to crosswalk or equate those different
scales. So if there were an agreed upon terminology that was robust enough to
capture observations it could be possible to equate or crosswalk across these
different scales.

DR. COHN: If you could equate the questions.

MS. HARVELL: Correct.

DR. COHN: I’m sorry to break into your presentation.

DR. STEINDEL: I’d just like to comment that this question of scaling is not
unique to the disability domain, it’s universal in any assessment instrument
that’s using any type of scale or questions that determine assessment or
observations that determine assessment, not just in disability but virtually
any clinical area. I know one example where SNOMED actually did include the
terms is for like the Glasco(?) Coma(?) scores, and they put explicit that but
that’s another type of scale. So it is a problem in terminology in general.

MS. HARVELL: Right. On the other hand, and this goes back to this concept
of varying levels of partiality, so on SNOMED, SNOMED you could capture
observations and we considered that only to provide partial coverage because
somebody would still need to take that observation and create an algorithm,
create a statement, that would link it back to whatever federal use case we
were looking at.

On the other hand ICF was also in terms of scaling considered to provide
only partial coverage because ICF had its own scaling concepts and I don’t have
the ICF right in front of me but they would say no impairment, mild impairment,
moderate impairment, etc., providing their own definitions of what that meant
so they had their own concepts of disability functioning that sometimes equated
with some federal use cases and oftentimes did not equate with federal use
cases so ICF was also rated as providing some partial coverage but for
different reasons then SNOMED was rated as providing partial coverage.

DR. MCDONALD: Could I just make a comment? Can you hear me? It’s Clem. I
think there’s getting to be confusion between questions and answers in the
sense that you have to construct a bunch of answers to make a question. The
attachment structure deals with many of these things using a question and an
answer, the field and the value in the field, but you need two different things
to deal with these survey instruments, that’s what these are.

DR. COHN: Clem, I don’t know that you created great understanding, it looks
like people are looking at you quizzically. I’m presuming you’re reflecting
back on LOINC, which is that I guess the —

DR. MCDONALD: Whether we call it LOINC or BOINC, it’s something different,
I just conceptually we can’t take a vocabulary and make a survey question out
of it and make it right, you got to have two different things, you got to have
one thing as a survey question and often it actually has to have a sentence
that’s exactly the way it’s asked to get it to be a standardized survey and
this is true of some of the nursing issues, it’s true of some of the attachment
issues, it’s true the Hamilton Pain score, it’s true of the Glasco Coma score.
You have a series of questions and you have sort of standardized answers.

The answers might be actually codes that look like SNOMED codes or ICD-9
codes or any other vocabulary, discreet atomic elements, but what the confusion
I think in the discussion is yes, you could construct the syntax and all this
to make something that looked like it but in real life these things are all two
different dimensions, you’ve got a field and a value, you’ve got a question and
an answer, you have something and usually when you have them being asked about
patient symptoms or scores in a formal way it’s done with a formal question,
like within the last two weeks have you ever, etc., etc., and how much, there’s
like hurts scores you get in there sometimes, sometimes it’s just yes/no,
sometimes it’s exactly what the symptom is.

But I just want to clarify that I think the thinking should be developed a
little more about this, that’s all.

MS. HARVELL: Right, and just making sure I understand your comment, one of
the things that the workgroup, particularly with Vivian’s help, was able to do,
as I said we sampled terms and sometimes we sampled concepts, and when we were
looking at a sampled term it was a discreet unambiguous word, and Vivian’s task
was to go back to SNOMED, ICF, UMLS meta-thesaurus and see if she could find
that exact word someplace. Alternatively, if it was a concept that included
multiple words, Vivian would look to see if she could either parse it out into
discreet words or somehow a concept was otherwise captures and you would see
this on our spreadsheet attachments, she would include all the discreet covered
terms that composed that concept and then the workgroup looked at the listing
of discreet covered terms that Vivian told us were, for example included in
SNOMED or ICF, and looked at whether or not those words when strong together
equated the concept that we had sampled.

Just the last point on the slide that’s up there before we change was that
the workgroup also realized that given the lack of scaling, the lack of terms
included in vocabulary or the ICF classification, that not only would that
content need to be added to make a terminology or a vocabulary more robust, but
once it is there then work would be needed to create the, to translate the
scaling needs of the federal government within an agency as I said and across

DR. COHN: Actually can I ask a question back about that? Can you go back
for just one slide? I guess I was just curious about that, we’re obviously
asking questions about your findings. You consider that the algorithms that
you’re talking about are those within scope of a domain or a CHI domain
discussion? Or is that something different? Normally when I hear about things
like this, and I’m thinking for example of the patient safety work going on in
the federal government where they’re trying to commingle or standardize across
various databases, that typically is not so much a terminology discussion as in
like standardized concepts. And not standardized on the terminology, it’s like
let’s first standardize concepts. Is that what you’re seeing here? It sounds to
me like you’re saying let’s keep the concepts the same but let’s figure out
some wonderful mapping algorithm that will map everybody’s unique way of doing

MS. HARVELL: Right. I think that’s exactly right and you’re right, this was

DR. COHN: There’s no reengineering going on here at all that you’re

MS. HARVELL: Right, but it was just a reflection of well, once we get the
terminology straight, work is still going to be needed to map across —

DR. COHN: Well, or some would say that you need to get that done before you
can get the terminology straight, some people would make that comment also. I’m
not saying that as a statement of fact but some might observe that.

MS. HARVELL: Right. We did not because our premise was that the federal use
cases are the federal use cases and the Nursing Home Minimum Data Set, the Home
Health Oasis instrument, the NCHS survey forms, the SSA eligibility forms, the
FIM items used by the VA, are those items and they are using those scales in
their programs. And we did not —

DR. MCDONALD: Could you explain code scales?

DR. COHN: Clem, a code scale is a question with a range of answers.

DR. MCDONALD: And I think goals are like that, too, and I think probably
outcomes are. If the outcome is to get the patient’s diabetes in control it’s a
number at some threshold, so this is mixing apples and elephants I think.

DR. COHN: Okay.

DR. MCDONALD: I mean I think if we’re talking about things that have,
especially if they have numeric values but even if they have categorical values
in their survey instruments, it’s a different critter and I don’t want to make
the LOINC versus something else distinction but it’s just a different creature.
And if you look at how people send those around in HL7 how it’s modeled, any
kind of, they’re observations, they’re not discreet concepts, and the
observation can have numeric, I’m being redundant but —

DR. COHN: Clem, hold the thought and when we get into the recommendations

DR. MCDONALD: I mean some of these things are discreet concepts like
diagnoses and interventions, but some are these structures that have two parts
to them.

DR. COHN: Well, as I’m saying hold that thought and when we get into the
recommendations we can reflect back on some of this stuff. Okay?


MS. HARVELL: So the next slide you’ll see a table that reflects the
percentage of coverage, complete, partial, or no coverage provided by SNOMED CT
and the ICF for the final 312 sampled items. You’ll see that SNOMED provided
complete coverage for 56 percent of the sampled items, partial coverage 39
percent, compared to the ICF that provided 35 percent complete coverage and 52
percent partial coverage.

Generally those findings are consistent just in terms of the trends with
previous research that was conducted by the Mayo Clinic that found that SNOMED
CT provided a complete match on 46 percent of the MDS sampled terms for three
selected clinical domains and the ICF provided a complete match for two percent
of the MDS terms that the Mayo study looked at.

The workgroup recommendations were as follows. The ICF is a classification
scheme that’s used in conjunction with or complementary to the ICD, but it is
not a terminology. SNOMED CT was found to have significant gaps and would need
to be mapped to classification systems as well as federal patient assessment
instruments, therefore the workgroup did not recommend SNOMED CT.

The workgroup recommended that work would be needed to enhance a core
terminology to include the needed disability content that is used by and needed
by the various federal health agencies and following up on your comment, work
would be needed to produce algorithms to crosswalk and equate these scaling
concepts within and across federal agencies and maybe this is beyond the CHI
scope comment.

So that was the work that the workgroup had completed by the time it had
written its report. Following the submission of our report to the CHI the
workgroup had a follow-up conversation with CAP to address an issue that came
up during our workgroup discussions and the question was to what extent will
SNOMED hierarchies support the disability content. And that was a useful
conversation to have, the folks from CAP helped us understand some of the
hierarchies and how some of those hierarchies would support at least some of
the needed disability content. During that discussion CAP indicated that
Denmark, Netherlands, and Wales had asked CAP to incorporate the ICF into
SNOMED and CAP expressed an interest in receiving advice on refining their
hierarchies to better capture needed disability content and also expressed an
interest in working with the World Health Organization in incorporating the ICF
into SNOMED.

Subsequent to the conversation with CAP some of the workgroup expressed
concerns that CAP had organized its work so that the nursing workgroup would be
used to identify gaps with respect to disability terminology, and I think the
concern was that these were nurses and not persons with expertise in

The workgroup report was presented the HHS CAHIT and during that
presentation the CAHIT requested NCVHS input on the pros and cons of the items
listed up on the screen, which are that while SNOMED looks the most promising
it does have significant gaps and therefore do not recommend SNOMED CT as the
endorsed disability terminology at this time. However, that future efforts
should be targeted at enhancing or improving the disability content of SNOMED
CT and further that when NLM and CAP are negotiating the scope of work to
refine SNOMED CT that the disability domain be included as a part of those

And before we get your input on that page —

DR. STEINDEL: I’d like to point out that the NLM contract with CAP does not
indicate any grounds for NLM to demands or even negotiate future work in

DR. MCDONALD: I’m sorry, I couldn’t hear that.

DR. STEINDEL: The NLM contract with CAP concerning SNOMED does not provide
for any way for the NLM to do anything but request CAP to do anything with
SNOMED, there are no terms and conditions for future work with regard to the
development of SNOMED. That needs to be required by the government in the
contract, so that the last condition of asking I don’t believe we can do under
the contract.

MS. HARVELL: It’s been a while since I’ve looked at the license agreement
and maybe I am recalling some earlier version of it, but there were processes
in place, either through participation on the editorial review board, to
highlight areas for enhancement of SNOMED.

DR. STEINDEL: It is just the standard process that occurs within the
development of SNOMED.

DR. COHN: Well, Steve, But CAHIT can make whatever comments it wants to, so
I think this is not a statement of reality necessarily, this is a statement of
what their comments were. I mean this is not their comments, this is CAHIT’s
comments, and the next time you see any of them tell them, please tell them —

DR. STEINDEL: I know about it because Betsy and I have spent a lot of time
talking about that.

MS. HARVELL: Okay, so just before we actually get your comments on that
slide I just wanted to let you know what the workgroup’s next, or what our next
steps will be. As I said the workgroup report was written prior to the
conversation that we had with CAP so we will be modifying the workgroup report
with an addendum to reflect the discussion with CAP, to reflect the CAHIT
comments, to reflect whatever input we receive from you all today. If necessary
we’ll revisit the report recommendations and we’ll present a revised report at
least to CHI and if necessary I guess to CAHIT.

So that’s where we’re at.

DR. COHN: And maybe to us again, you never know. Any other, is this? Okay.
Well I have some comments, I’m sure that others may have some comments also but
maybe I’ll, Stan, do you want to start out and then maybe I’ll chime in and
maybe comment a little bit along the lines that Clem was commenting.

DR. HUFF: This is a comment not just to you but I guess a comment in many
ways to a lot of the work that’s gone on here. It seems to me sometimes we
focus so much on the terminology we forget about the grander scheme of things.
That is if I understand what we’re trying to enable, we’re trying to enable
unambiguous sharing of data, and that sharing of data is more then terminology,
it’s the structure in which you put the terminology, and this is a kind of a
constant refrain, and that I think in a way this is reiterating what Clem said,
that if what you’re trying to achieve is an unambiguous representation of data
you need to consider more then just the terms, you need to consider how you’re
going to combine those terms into a message.

And knowing that HL7 has already been accepted part of what you could do as
your activity is say if we were to send this data from one agency to another
what does the data look like in our databases, but what would it look like in a
message that was sent between there that was an HL7 message or some other kind
of message, and that would help clarify the issues of the relationships between
the questions and the answers and would get you closer to the goal of
unambiguous data representation.

The second thing I think, again, I think following on what Simon was
mentioning earlier, and having dealt with this in my own institution I guess in
a lot of ways, if you don’t do, if I understand again the approach it was to
let people have total independence in the instruments they’re using to evaluate
what they evaluate and that somehow magic would happen that would allow
agencies to share data. And I guess the kind of questions that come to mind and
the kind of problems that we’ve had, the similar kind of problem that we’ve had
for instance is when we collect data in our institution and then we want to
participate in one of the national studies that aggregate data, so for instance
we participate in the National Myocardial Infarction Database and try, we
collect data that says when did the person have chest pain, when did they have
their surgery, what was the complication from surgery, and the NERMI(?) thing
asks things like did the patient have any contraindication to surgery within
one week before the surgery. Did the patient have shortness of breath two hours
before, I mean these very, and if you don’t think about what —

I guess what I’m saying is that even though the questions look very similar
if you don’t worry about justifying the concepts and the content ahead of time
then you can’t answer the questions you’re interested in based on what the data
asks. Or alternatively, you’re going to ask the patient or whoever is filling
in this data to answer 20 questions that are very similar and they’re going to
get really tired of did you have depression in the last two weeks, did you have
depression in the last three weeks, have you ever felt depressed, and you get
so many variations somebody says this is not rational for us to participate in
this. But I may be misunderstanding but that’s kind of some feelings I was
getting relative to this activity.

DR. COHN: And Stan maybe I will sort of jump on what you’re saying a little
bit. I guess as I’m looking here, and I’m not even going to address the CAHIT
comments or questions for the moment, but it sort of struck me that there’s
sort of two very different activities. And I’ve looked at others to see if I’m
mistaking this because some of it is based on what Jeff was reminding us about
earlier today.

The work that the NCVHS has done has been trying to create a vision where in
the course of regular clinical practice clinicians are addressing issues about
a patient, are describing them, are making comments, are dealing with the world
of health care. And then that data can be pulled back and used and
conglomerated and structured and whatever in various ways. Now that’s the world
of clinical care.

Now then there’s the world of questions and answers and questionnaires, and
clearly the way that you’ve embarked on this has not been to look back and say
well geez, a nurse looks at a patient or a physician looks at a patient, geez,
they have a colostomy, they have some disability with that colostomy, what
might they say about it, what concepts they would use. You’ve been really going
directly into the questionnaires and have been trying to replicate them. And
that’s really sort of a different set of activities.

Now you can standardize that set of activities but I think as Stan was sort
of commenting that probably there needs to be discussion at some point between
all the various agencies about geez, do you want to one, do you want to ask
about shortness of breath in one block or two blocks or three blocks or every
five minutes or what do want to ask of them before everybody goes nuts in terms
of asking questions, even before you come up with something more.

Now there are ways to standardize the representation and answers, and I
think that’s been work for example Clem has done around claims attachments with
some aspects of LOINC as I understand, where you ask a question and you have a
range of answers and you codify them. Now you don’t get cross organizational
reliability and, I mean everybody has to ask the same question for you to
figure out what to do with the answer, so there are limitations with that
approach. But if you’re trying to analyze it from that direction it becomes
very hard to figure out what terminology to use I think, or even what makes
sense. Clem am I making bad comments here?

DR. MCDONALD: No, no, you’re addressing, you’re saying what everybody says.
But I think that the key thing is if you’re going to, terminology is useless by
itself. That’s maybe to take an extreme position. And the goal isn’t to find
one terminology, the goal is to find a way to convey. So if you were going to a
history and physical, you’re just using terminology, you’re just talking. And
if we do narrative text we might want to have a terminology for automatic, then
you just think about a flat terminology that would just automatically sort of

But if you’re trying to quantify something, if it’s done with a lab test and
I’m not talking about the terminology, you want to define how hot the beaker
is, what the re-agent, you have to do a lot of standardizing of the process to
make it work. And when it gets to clinical questions we as clinicians we
typically just do narrative and that’s fine, that’s good, I like it.

But if you’re going to do something like how much shortness of breath do you
have and try to use it widely, to quantify it you want to say some kind of
context, after climbing stairs or when you do a treadmill, you really do
quantify the hell out of it. So what we’re aiming toward is those questions
that are kind of discreet things that we use for purposes, the Hamilton
Depression score, some of the nursing scores, you want to have it standardized
so that it will have general meaning I think. You need to have, maybe it’s a
long question, a lot of words to it.

DR. COHN: Clem, are you, I guess I want to find out whether you’re agreeing
with me or disagreeing with me. Do you think that the issue of having
questionnaires and having questions and answers is the same or different then
the general terminology question?

DR. MCDONALD: They’re connected because sometimes forget that just having a
whole bunch of general terminology doesn’t get you all the way there without
the thing you just mentioned first. Because people think that’s all there is
and the reason why you have to bring up the other one is because it’s not all
there is.

DR. HUFF: I think my view is that they’re two ends of the same spectrum, one
is just an extreme end, so at one end of the spectrum you have serum sodium and
nobody cares how you ask the question, they want to know what was the
milliequivalent for milliliter. Somewhere as you get closer and closer to very
important things about disability and social functioning the representation of
the question becomes much, much more important. So a term that’s in SNOMED or
in LOINC or any other terminology, the nuances of human language become
important in the interpretation and so the social scientists work and they say
the meaning of this, they validate the question and the questions’ validity is
dependent upon the context of the questionnaire that its asked in and all that
sort of stuff.

So we want standardized codes for those questions but their representation
is substantially different then the usual kinds of quantitative data or just
asking did somebody vomit or not vomit or something like that. Are you
depressed, which might be the simplest question that was implied by a diagnosis
code of depression is wholly insufficient if you’re trying to elicit the
different shades of whether they’re ready to commit suicide, all that sort of

So anyway, it’s a spectrum and we want coded codes and well understood
meanings for all of those things but I don’t think it’s, it’s just sort of goes
from white to black with a huge gray middle area and it’s just different ends
of the same spectrum whether you’re talking about answers to questions or
whether you’re talking about specific findings in the patient I think.

This is a very philosophical discussion but I don’t know that we’re going to
change anything they do so much, maybe just a suggestion how they focus the
activities that you’re —

MS. HARVELL: Stan, your first comment about the thing that we really need to
focus on is the sharing of data and how are you going to send message, I mean
not as part of this workgroup but as separate work we are working on in a
relatively small project looking at is it possible and if so how is it possible
to send messages about disability content related to quality measures and
quality indicators and care panning information in the nursing home world using
the minimum data set, which is the CMS required instrument. So we’re beginning
to go down this path of looking at the feasibility, the ability to share
information using HL7 —

DR. HUFF: I guess the impression I was getting, and correct me if I’m wrong,
is that you took those as immovable boundaries, that because it was adopted by
the state and this one was a standard and this other one was a standard you
couldn’t change that. I guess what I’m saying is if you take that as an
assumption then there are lots of kind of data sharing you’ll never be able to
accomplish. We may have to go back and examine the assumption and say is it
really rational that we ask this kind of question in a nursing home or this
other kind of question in the Social Security Administration on different,
because there’s certain kind of data correlation you will not be able to
accomplish if you take those things as immutable requirements.

MS. HARVELL: I think in part that’s true and so maybe this is Pollyannaish,
but I think one at least my hope of having a, if there were a robust enough
terminology that could be used in electronic health records, and then there
were electronic health records that spanned a continuum of care, the fact that
CMS slices and dices that clinical content in one way and nursing homes in a
different way and home health, that I think minimizes the provider burden but
gives CMS the flexibility that historically it has wanted and used in slicing
information in different ways for different purposes.

DR. COHN: Gail, maybe you can help us with this.

MS. GRAHAM: I doubt that very much but I’m just trying to reflect on,
because we do of course the FIMs and we do the MDS, but I think if I’m getting
Stan’s point and others is if you would ask those, if there would just be an
agreement that the outcome you’re looking for is X and you’re going to ask it
the same way, then I could pull from the same question on the nursing admission
form or whatever, I could pull the same data for multi purposes but you would
have to make, there would have to be an effort to standardize the instruments
and have an agreement. I really don’t think that much of this can be done after
the fact, no matter how robust the terminology is, without going through that
up front to say when we ask about X and we’re trying to find out we will all
agree to ask it in the same manner. I think that exercise has to preface the
terminologies as it relates to all the data set scaling.

DR. COHN: Other Comments? I guess I’m, Marjorie, please.

MS. GREENBERG: Well, just I think an example in the survey in the
international world is that there has been an effort to sort of back code or
survey disability surveys that ask questions different ways, etc., to some kind
of common terminology but, and it gives you, it’s informative but it doesn’t
provide really true comparative data and there now is an international effort
to try to agree on one or more general questions to be asked on surveys or in
censuses and then more detailed questions because unless, I think there’s been
a conclusion, unless they really ask the same questions, and even asking the
same questions as Stan said won’t get you identical either because of course,
well, international you get into cultural issues, language issues, but you also
get into the setting in which the question was asked and whether you allow
proxies, so I mean this is an evolving area but I think you can only go so far
with back coding to the terminology or using the terminology.

DR. COHN: Other comments? I guess, I apologize, I’m sitting here thinking of
what we can advise you and obviously you’d like comments from us as well as
pros and cons. I’m sort of, I was recently on the IOM committee that dealt with
patient safety recommendations, patient safety data, in some ways it seems like
sort of similar problems that you have many currently existing databases, many
maintained by the federal government, asking similar but not exactly the same
bits of information and all this stuff and what do you do to begin to move
towards increased standardization. And I think we’ll be hearing some of this
coming at a future NCVHS, hopefully response from that.

But on one hand you throw your hands up and you say well, we can’t do
anything until we completely reengineer the entire situation, and then of
course we look at how many more years any of us have until retirement and
knowing how quickly these activities occur, and yet you don’t want to do
nothing before perfection. So we’re dealing with this funny situation which I’m
sure you’re finding yourself in where different agencies for many very, very
good reasons are all asking either different questions or very similar
questions in slightly different ways with slightly different scales and
obviously what you’d like to do is to be able to behind the scenes normalize

And I think what we’re all sort of saying is that that may be a little
unrealistic. Plus on top of everything else what you’d like to do is to have
physicians in the routine care make notations using terminologies that could be
easily abstracted without additional effort that would immediately also be the
same as the questionnaires that you ask and that would be really where you’d
like to go.

Now I don’t think we’re quite there today and I don’t think Stan, who I
think is a lot younger then I am, I don’t even think he has that long in this
career to wait for this to happen.

Now I guess the question I have for the subcommittee is what sort of, I mean
given that we’re not dealing with perfection but we’re trying to help deal with
next steps, what is it that we can advise CHI in terms of this and the other
questions is what else do we need to do? This is a little unusual in the sense
that typically the disability areas have been a lot held by our Subcommittee on
Populations and obviously they aren’t at the table for this discussion right
now. So we may very well, I mean the question is are there things that we just
want to say today, are there things that we want to have them come back in a
month, do we need to get the Subcommittee on Population involved in this
discussion knowing that I’m sure we’ll be hearing a lot of this at the end of
January. What do people want —

DR. HUFF: To summarize after all those other comments I would just say that
in doing the things that you’ve listed here and it sounds like you’re already
doing this so it may just be, but if you focused on saying what the data and
information were that you were hoping to be able to communicate and say how
that would look in a message and let that be the guide to how you ask for
terminologies and codes to represent that I think that would help, that would
help focus the activity in a manageable way.

MS. HARVELL: Can I ask a clarifying question about that? Because I’m still
learning this whole area, so if we undertake some activities to understand the
information, the terminology that we need to send messages so we can identify
where we are sending messages, but now it’s identifying the terminologies, the
content of what those messages are going to be, and just looking at it only
with respect to disability because for example in the nursing home world we
send messages beyond disability. But where do we go to look for the content for
disability that will be the content of these messages that we want to send? I
think that’s the question that the CHI workgroup has been struggling with.

DR. HUFF: Well, there might be different answers, I mean you look where you
can find them but ultimately you need everything that you need, so your need is
not circumscribed by whether it’s present or not present in a given
terminology. What your goal is to make what you need available someplace where
everybody can use it and so I would say that your goal is to either get it into
one of the core terminologies, you’ll get it into the UMLS meta-thesaurus, so I
think part of your job is in fact to expand the universe, I mean again, use
everything that exists, whether it’s in SNOMED CT or in ICF, but if it’s not
there then the goal should be a plan of how to get those things into either
SNOMED or ICF and both of them into the meta-thesaurus so it can be managed as
a common resource.

DR. COHN: Jeff and then Steve and then I have another comment.

MR. BLAIR: I agree with Stan that it is very important to think of this
information within the context of messages, but maybe I disagree with Stan that
it’s also broader then just thinking of it within the context of messages. And
I’m not a clinician so I always feel uncomfortable when I start to step into
these areas but in my mind the use for these codes is multiple. The codes for
disabilities have to be useful for a caregiver, for a therapist, for somebody
in rehabilitation that is endeavoring to either improve or help someone recover
from a disability, and I think the needs for a terminology or some way of
representing disabilities in that context is probably rather different then
someone who’s trying to get an overall view from the CMS or a federal
government or a public health standpoint as to the disability status of a
certain population. And while you might want to be able to do some cross checks
or mappings between the two I think the information requirements of both is
very, very different, so I think you have to consider that the different uses
may require different answers.

DR. STEINDEL: What I’ve been taken about looking at the disability domain is
a lot of the analogous nature of it to the laboratory domain, which of course
in some laboratory and everything relates to the laboratory domain. But what I
actually mean by that is in many cases we’re looking at question/answer as Clem
brought out at the very beginning of this discussion, and the disability
domain, like the laboratory domain, is defined by the question you ask and the
type of answer you need, and it varies. And we noted that when we wrote up the
laboratory result content report.

There were some very specific questions that you can ask and since I don’t
know the disability area there may be some like this that have an extremely
specific answer. Can the patient do, yes/no, so there are those types of
questions. There’s other types of questions that as you point out require a
scale, an ordinal answer, a, b, c, d, or 1, 2, 3, 4, 5. And then there’s the
third type where you ask a question where you’re describing something and you
want a little bit more textual type content and I assume those three types of
questions exist within the disability domain as well. And those are the types
of questions that exist in the laboratory domain.

And in that area we very carefully crafted, and this is not something that
we did today, there’s been over ten years worth of work in crafting the way the
laboratory domain question and answer area goes in that we’ve developed this
set of question to ask for laboratory tests that exist in the laboratory area
of LOINC and then we’ve developed a set of answers to go to those laboratory
tests. Some of those are very straightforward, they’re like as Stan mention the
milliequivalents per liter of sodium where we just put down a number and a unit
and others where we have textual information where we’ve called for SNOMED as
the way to describe that textual information in messages.

And what I might suggest is that the disability domain look at this type of
question and answer, structure, and right now the questions don’t exist in any
form of terminology but the ability to add the questions to a terminology
exists very easily because you have as a minimum all these questionnaires that
you’re currently using that could form the basis to put those questions in some
type of terminology very, I would say very quickly.

And one area, while we have two people that have to recuse themselves, one
area where this is built for is the area of Clinical LOINC, where the questions
can go in there and LOINC has the ability of having the specific numerical
answers, the ordinal answers, your scale values, and the textual answers, and
then we can look at SNOMED and make sure it provides the types of textual
answers we want. And this gets to the point that Simon and Jeff were mentioning
of can we use this at the point of care because we can build those questions
into the various devices at the point of care and we can also address the
granularity that Jeff was pointing to in the continuum of care.

MS. HARVELL: One of the issues that has come up with respect to for example
some of the patient assessment instruments, which in many instances were
developed 20 years ago in a totally different environment then today, for
different purposes then what these forms are presently being used for today,
that as we hopefully move forward into an electronic health record world, do we
want to imbed these forms in the electronic health record world, or conversely,
do we want to have the electronic health record world, do we want clinical
information that’s being collected electronically at the point of care be able
to be used by for example the federal government in various uses. Which may
mean that the forms that we use will change over time to be consistent, more
consistent, with clinical data capture. So this is something that we are, we
don’t want to codify in an electronic world forms that may be, capture
information that’s not recorded at the point of care, and instead we’d like to
be able to change our forms over time to better reflect what’s happening at the
point of care.

MR. BLAIR: There’s another consideration that you may want to explore if you
feel it’s within your scope and your resources and your time. If an individual
is blind it isn’t just their acuity, it could be their field of vision, and the
way you represent field of vision is totally different then you represent their
acuity, and the cause could be different, and that effects how you deal with
the disability. The other piece is if somebody has a broken leg you could wind
up using video films to measure progress in rehabilitation in terms of
measuring the degree of functionality on how people walk, the degree of their
limb, or their gait. So I don’t know if you consider that within your scope but
I guess I’m making it more complex for you because I’m winding up saying, and
part of this is coming out of the fact that one of the things that has been
extremely detrimental to the disability community has been trying to lump all
these things together.

I was on the State Commission for the Blind in New Mexico for a couple of
years and fortunately we were able to remain independent. Many other states
combined disability services for the deaf with disability services for the
blind. Not only are the needs completely different, the problems, the
psychological problems, the coping skills, everything is so completely
different. So if you have the ability, the time, the resources to be able to
look at the disabilities independently I would encourage you to try to do so in
terms of your coming up with a measurement system that could be more valuable,
more useful, for helping persons with functional disabilities.

DR. COHN: Thanks, Jeff. Steve, I’m going to let you talk but I do want to
begin to, we need to come to a resolution on this one. I want to remind, other
then for Steve and Marjorie we are actually not part of the workgroup, I just
want to remind you all. It is not our job to solve our problem but more to
reflect on what they have to come to us with.

DR. STEINDEL: My comment was with respect to the last comments Jennie made,
if you do decide to embark, if the disability community decides to embark on a
question and answer type approach, number one it gives a chance as Gail brought
out earlier to harmonize the questions because the community would come
together to work on what types of questions to submit to the various, whatever
body you choose to submit the questions to so that gives a chance to explore
the harmonization question. And in areas where we’re well aware that there are
regulatory reasons where some antiquated questions need to remain for whatever
reason they need to remain, in those cases they might remain but they might
remain in such a fashion that a hierarchy that you design of the questions can
make roll-up of those questions to a more modern one easier, I mean that’s one

The second approach is as we get to the point where the world is more
comfortable working in a unified environment, which we have to admit we’re not
today, but as we can now go back and look at those older questions and retire
them, say they’re no longer usable in the community and use the modern ones. So
an approach like this would give you a way to build something that could exist
today and transition into the world that we’re looking at tomorrow. And into
the world that you’re conceiving of where we do have a continuum of care and
different types of questions can be used throughout the continuum, but we can
move through the continuum in the same fashion.

DR. COHN: Marjorie?

MS. GREENBERG: Well, I think everyone has made some excellent points to
reflect on and I agree with a lot of what was said but I just wanted to make a
few additional points. One is that whereas I definitely agree with Jennie,
which has been the goal has been all along to try to capture the information
that’s collected or that’s recorded, that’s recorded at the site of care and
then in a granular enough form that it can then be used for multiple purposes,
that’s been the whole PMRI mantra.

But I think one of the things in this area that we have to be cognizant of
and then see how we can influence that was found by the committee in its report
and in a number of articles as well in the literature that not that much and
certainly not much standardized is being collected routinely, or being recorded
routinely, on functional status and on some of these aspects of disability, as
it is being captured on diagnoses and labs and procedures and all that. But
often when you look in acute records or whatever, and probably you’ll find it
more in rehabilitation or therapy records, but it isn’t being captured now so
it’s not even having the terminology that people can use, it’s you’ve got to,
there’s work that has to be done on even getting this information recorded
that’s relevant.

And I think that relates to the second point, which is actually the first
point I wanted to make, that I think Stan has alluded to it when he mentioned
social participation, Jeff has alluded to some of this as well, but in the
disability and functioning area you do go beyond what might be considered the
medical model, you’re looking at social participation, you’re looking at
environmental factors, you’re looking at not just what can they do in the rehab
facility but what can they do, can they get back to work, can they be in school
and all of that. So I think this is also an underdeveloped area for the
concepts and terminologies so there’s clearly work that’s been done. So I think
those are important distinctions to be made here.

DR. COHN: I’m just trying to think of, we’re sort of sitting here with a, I
mean just to sort of try to figure out what we’re going to do with this. We
have CAHIT comments, we have disability workgroup recommendations actually on a
page here that include the need for more research and certain I’m, I guess
given where we are it’s hard for me to imagine that we have an answer today,
but maybe somebody does. I know Kepa was going —

DR. ZUBELDIA: Simon, I think that we have given a lot of feedback to CAHIT
on how to address this and it’s not just for disability, the same problem
applies in other areas where you have a request/response and I think at this
point what we need to do is say okay, there’s the recommendation is not to
adopt any of the existing standards because they don’t satisfy the need and
keep looking, and maybe bring this need to LOINC or to somebody that can set up
a request/response type of standard.

DR. COHN: Okay, well I guess I’m wondering, maybe I’m maybe mishearing but
it seems to me that there’s sort of two issues, and I absolutely agree that
there’s a need for that response, question and response type issue. I’m
actually sitting here wondering whether or not there’s also a need for further
work to improve the disability content in SNOMED because I’m not sure that
there’s, it seems to me that’s sort of like you need to hit it from both sides,
I mean Stan talked about it as a continuum but in reality we’re sort of, a
single terminology approach doesn’t really equally handle both sides of the
continuum —

DR. ZUBELDIA: It’s a two dimensional problem, depending on the question you
ask you’re going to get a different continuum of responses, and I don’t think
that has been addressed with SNOMED or with ICF. And at this point I think our
only recommendation is to say okay well let’s wait for something like that to
happen, the discussion is the feedback we’re giving them, and I think that’s
probably all we can do today.

DR. COHN: Well, do we need to write anything down or do we want to wait
until they come back to us in January?

DR. STEINDEL: I’m putting on my crafter hat. When we drafted the original
template letter that we’re using for the CHI letter itself we did note, and
it’s something that we haven’t used before that we may want to modify and use
in this case, and just to read the way it was in the original draft letter as
an example, we note that the CHI Council has done extensive investigation into
domain area blah, however we still feel that the area is immature and we
recommend either a delay in implementation or implementation only on a limited
experimental basis. We might want to use that as something to craft the actual,
we did foresee something like this occurring.

DR. COHN: What wisdom, please, Jeff.

MR. BLAIR: One of the things is, Steve, if we use that wording —

DR. STEINDEL: No, we have to use different wording.

DR. ZUBELDIA: We don’t have anything to implement.

MR. BLAIR: My thought is why don’t we give credit to the work that’s been
done and the way they articulated their words in their recommendation section,
which I think was that we are in a position to concur with the CHI position at
this stage, which is that, and I don’t have the words right in front of me, is
that they are, no terminology will be recommended at this point and additional
research is needed, I’m paraphrasing it but I think it says something like that
and I think we can concur with that conclusion. No, yes?

DR. COHN: I think we are, the question is whether we agree with a through f
of the additional research or whether we want to even deal with that at this

DR. STEINDEL: I think the problem is we may not agree with a through f.

DR. COHN: I guess the question is, this one is, I mean I think we all knew
walking in today this one was going to be a little more problematic then many
others and I’m wondering if maybe what we need to do is to sort of leave it
potentially at this point, that this being the sense of the subcommittee, I
know the workgroup is going to presume have other sessions between now and the
end of January, is that, no? The workgroup doesn’t exist anymore?

MS. HARVELL: We will modify the report to add the addendum, the subsequent
information that happened since the report was initially written —

DR. COHN: You aren’t going to review the recommendations?

MS. HARVELL: Feedback from you all? Yes, if you all give us feedback we will
take that under consideration and meet to discuss that. If there is no feedback
coming back from you all then we’ll just, we have an addendum, review that
report, and then pass it along.

DR. COHN: Gosh, I thought we were just providing a lot of feedback. Just be
aware of the process, Jennie, our process is we’re obviously hearing your
domain recommendation, we would take a recommendation from the full committee
in late January for final approval. And I guess what I’m trying to say is it
seems to me that there’s an additional cycle that needs to occur here where I
think you’ve heard a fair amount of feedback from us. I think it does impact
these recommendations, I don’t know how it impacts the CAHIT comments or
otherwise, but I think it may cause you to come up with a revised set of
recommendations that I was going to suggest that you bring back to us in
January on probably the 27th or 28th for us to review and
have further discussion on was really my, what I was suggesting. Karen?

MS. TRUDEL: I heard an awful lot of discussion but I’m not sure I heard
specific recommendations, and I want to ask Jennie and Sam whether they feel
that they’re hearing enough of a consensus from the subcommittee in terms of
recommendations, that you know what to go back and talk to your workgroup

MS. HARVELL: Well, one thing that I heard is work on algorithms to equate
within scope or out of scope, that’s a question, and certainly part of our
recommendations dealt with that. So we can go back to our workgroup and talk
about that and communicate the sentiments that we heard form NCVHS about that.

One thing I haven’t heard, and I think this is the kind of core difference
between the workgroup recommendation and the CAHIT request for feedback, which
is the workgroup was agnostic, was silent on suggesting where further work in
terms of enhancing a terminology or a vocabulary should be directed, we just
said further work is needed to build, to identify and build in needed
disability content. The CAHIT recommendation, which is now not up there, was to
direct future work at enhancing the disability content of SNOMED. So the CAHIT
was a much more specific direction in terms of research efforts, work that will
be done.

DR. COHN: I see, I’m sorry, and the current recommendations you had before
us in writing sort of said you wanted to do an evaluation before you made that

MS. HARVELL: The workgroup’s recommendations that you have in writing, the a
through f, said first let us explore the adequacy of the SNOMED hierarchy
because by the time this report was written we were uncertain whether the
SNOMED CT hierarchies would support the needed disability content. We had one
conversation with the folks from CAP, and some offline conversations with
others, that suggest at least in part the SNOMED hierarchies will support the
disability data needs of the federal government. I think additional work is
probably needed in the review of those hierarchies, and perhaps, I don’t know
if additional hierarchies would actually even be needed. With respect to social
context and family issues, the representations by the people from CAP is that
they in fact can capture that. I’m not sure how completely or adequate that
capture is so that’s a refinement or actually an expansion, that’s something I
think that should be explored.

The second recommendation from the workgroup was that a more complete
content coverage analysis be conducted, with more time basically to identify
whether or not SNOMED, ICF, and sources in the UMLS meta-thesaurus actually
cover needed disability terms and concepts.

And then to enhance core terminologies I believe is what we said and my
impression from the workgroup was that if SNOMED was found to provide the
structure to support disability content that the work would go forward in
enhancing SNOMED, to more completely cover disability terms. However, if SNOMED
structure would not support the inclusion of needed disability terms then some
other work would have to be done on some other terminology to make that other
terminology or vocabulary more robust.

MR. BLAIR: Jennie? I think there was several other things that the committee
thought you might consider as you go forward, one was Stan Huff’s comments that
you look upon the role that these things will play in terms of messages and
that looking at it within that context is important.

An additional thing is that the information requirements for disability may
differ significantly if you’re looking at it from a patient care or therapy
vantage point versus a public health standpoint, that probably needs to be

And then a third area that I was suggesting is that if you’re looking at it
from patient care or therapy standpoint the needs of different disability areas
can have very different measurement scales, even if you just pick one example
within one area, just within the blind community the example I was giving is
that a measurement scale for acuity is totally different then a measurement
scale for field of vision.

So I think, I’m not saying you have to do this, I’m simply saying that
consider the differences that the different disabilities have in terms of the
measurement or information representation requirements. That grouping these all
into one area and saying SNOMED could take care of it or International
Classification of Dysfunctions and Disorders can take care of it, maybe that’s
from a public health standpoint but from a patient care standpoint I’m not sure
that that’s going to meet the needs.

DR. COHN: Steve, Kepa, Steve and Kepa.

DR. STEINDEL: Jeff, a clarification question for you. When you say consider
the messaging needs do you mean the question and answer type format?

MR. BLAIR: I was really trying to make sure that Stan’s comments and
guidance was not lost, although I expanded on them it isn’t just, from my
viewpoint it isn’t only messaging but I felt, and maybe Stan rather then my
answering for you, maybe you could restate the gist —

DR. HUFF: Well, I think, messaging is an example. What I said is you need to
focus on the fact that your goal is to unambiguously communicate data and
information and that communicating that information is more then just a stack
of codes, you have to consider the structure, and the message is one structure
that allows you to focus that. But I think that goes hand in hand with some
things that Steve was saying and what I mean by that is that will force you in
fact to consider the question/answer paradigm because that’s the most flexible
and capable way to transmit this information. And then I think to just, to say,
there are two different sort of spaces here, the question space and the answer
space, and SNOMED may be entirely appropriate for representing sort of the
answer space and what was seen in the textual descriptions. Unless there’s a
philosophical change I don’t think for instance SNOMED is set up to handle
survey questions per se, and so you might need to talk to LOINC or talk, and
again, I’m in an area now where I need to recuse myself and not propose that
solution but I think you might have to go someplace else if you really want to
accurately represent survey questions and just as a factual case, I mean we’re
working with, LOINC is working with CDC and others because we have an interest
in that and I’d be glad to share further information —

DR. COHN: Kepa, and then let’s see how we come around to how we deal with

DR. ZUBELDIA: Since I don’t need to recuse myself I would like to be very
direct about it and say that in addition to looking at SNOMED and ICF, which
are single dimensional, even though they’re hierarchical but still single
dimensional nomenclatures, that the recommendation would be to also look at
LOINC, even though it may not have the terminology that you want in it already,
that it provides the infrastructure that you need to develop a terminology that
will meet the questionnaire type of environment that you need. So the
recommendation is specifically to look at LOINC in addition to what you’ve
looked at to provide the environment to support that question/answer —

DR. COHN: Kepa, I guess I would ask, I’m obviously looking at the
recommendations here and I guess I’m wondering whether or not we want to be
that specific as opposed to introducing, and I’m just looking at the
recommendations on page four of the sheet we have here and under 2D they talk
about algorithms, and maybe we really mean that they need to really be focused
on the specific issues of sort of these question and answers and how it fits
in, how the questionnaires can be specifically dealt with and leave it a little
more open ended as a research component for them to figure out. Now I bring
that as an option, I don’t know how you feel about that. The question is what
role does the question versus the answer, what terminologies, how does that all
play out?

DR. ZUBELDIA: The fact that they’ve identified that none of these two
terminologies that they have looked at have met their needs, and they’re at the
point they can’t recommend either one because they don’t meet their needs, and
in the discussion it has become very clear that they have this question/answer
bi-dimensional problem that needs to be addressed with bi-dimensional
terminology. So one that provides that sort of infrastructure is LOINC, and
there may be others and they look at other possibilities, but I think they need
to look outside the box because they’ve only looked at three, SNOMED, ICF, and
UMLS, and perhaps it’s time to look at more then those three.

DR. COHN: Well, the reason I guess I’m asking is that even in one of the
frameworks, you use one terminology for the question and another terminology
for the answers, and that was really what I was trying to get to.

DR. MCDONALD: That’s hardly ever the case, actually Simon. That’s hardly
ever the case and it should be avoided. It’s not a question if you have, I mean
you could say that I guess no answer could always be applied to a single
concept but if you have anything more complicated then that there’s other
qualifications that go on the concept name that make it not be any confusion.

DR. COHN: Marjorie you had a question?

DR. MCDONALD: So you could take a whole bunch of SNOMED codes, or a whole
bunch of IDX codes, and you could just declare by convention that these are
questions whose answers are yes or no, and that’s the one place you can get
this confusion. But for practical purposes that’s hardly ever, I mean I guess
that is something, that’s the one you have to worry about. But beyond that if
you get to a survey instrument with a Lichert(?) scale one through five you’ve
got other qualifiers on that symptom you’re talking about that makes there be
no confusion. They never say headache, ever, in any official survey. They’ll
say have you had headache within the last two weeks that was bothersome, or it
will be qualified by a much longer thing. Is that making sense? It’s only in
sort of the simple case there is this issue you could take a single yes/no,
like an ICD-9 code or any kind of code and say the question is present or

DR. HUFF: But I don’t think that’s what Simon was saying. I think what
you’re saying is true, Clem, but I don’t think, Simon was saying something
different then that.

DR. MCDONALD: I thought he said there’s the problem of the same code
becoming the question or the answer.

DR. HUFF: No, I think he was saying that the solution may be to have the
question come from one terminology and the answer come from a different

DR. MCDONALD: Never mind.

DR. COHN: Thank you Clem, I was beginning to wonder if I was completely
missing it here. Marjorie?

DR. MCDONALD: I guess I’m like that Saturday Night Live thing with the bald
eagle and eagle rights.

MS. GREENBERG: Am I correct that if you, if the LOINC approach, and I think
someone put it well, it may provide the infrastructure, does provide
infrastructure for this question/answer type of framework, but you still need
terms, still need terminology. LOINC doesn’t independently have the
terminology, does it? Is there also the LOINC disability terminology or

DR. HUFF: The thing that’s happening within LOINC, and you guys just yell at
me if I’m being inappropriate, in the usual case LOINC provides only the
questions and so if you’re talking in a usual clinical domain, for instance it
might say something like heart rate or type of abnormal heartbeat. And then you
would expect to find within SNOMED, PBT, atrial fib, all of that sort of stuff.
And so it’s this combination but when you get into survey questions then we’re
putting into place an infrastructure so that in fact the answers themselves are
part of LOINC also. And so it’s, but usually now it’s not, LOINC is still not
trying to incorporate the situation where it would say what is the reason for
disability. The reason for disability would be a question in LOINC but the
answer would be ICD-9, ideology codes or SNOMED codes or some other code
system. The kind of codes related to this are usually the ones that are Lichert
scale like or some other part, so those answers are but the other parts you
would expect to find in some other terminology, in SNOMED or the meta-thesaurus
or somewhere else, so I think that’s —

MS. GREENBERG: I guess as a member of the workgroup though I’d defer to the
chairs, but I think it’s reasonable to ask the workgroup to go back and sort of
absorb for the conversation here and I think we’ll get, well, we’ll get the
transcript in ten working days I guess of this discussion and also the things
that Jennie said she was planning to do also. But obviously it’s not reasonable
to ask the workgroup to come up with a solution by the end of January or
whatever so it’s a question of what you think is reasonable to recommend or to
ask of the workgroup, or of the CHI process between now and the end of January
and maybe in what we’ve referred to as the next phase.

DR. COHN: Sure, and I’ll let Karen address that, I thought that maybe a
revision to the recommendations as opposed, I didn’t think we had a solution to
give you that you could handle in four weeks. Karen?

MS. TRUDEL: I think it’s reasonable for the subcommittee to say yes, we
agree that, either you shouldn’t be making a recommendation at this point,
which is essentially agreement, and you may want to come back and say and we
think that in addition to the points of study that you’ve already talked about
you should add some more, and here there are, and the main one is the notion of
the fact that SNOMED CT may not be well suited to the question and answer issue
and that in phase two or whatever the group needs to cast the net wider on
that, and also some of the notions about in looking at this in the future, at
least addressing the possibility of disability specific consideration is again
something that the workgroup might want to look at in a subsequent phase. And I
think that’s a really good recommendation and it gives the group something to
work with and it does validate the main recommendation which is nothing at this
time. And we can go back to the CAHIT and say that perhaps they were going a
little bit too far in terms of SNOMED because we have this additional notion of
the question and answer and that need to look for something else. I think
that’s, I would feel as if I had adequate feedback with that.

MS. HARVELL: I think one thing that would be helpful, and I don’t know if
this is something you would write down or an offline conversation, is to get
more information about LOINC and the suitability of that because that’s
something that the workgroup did not consider, it’s not something that this
workgroup is pretty, is versed in at all in terms of what it can handle and
what it can’t, and where we could go to find out even more information about
that would be useful.

MS. TRUDEL: We can help with that, too.

DR. COHN: I think we’ll point you at Karen or maybe other people after they
return home or whatever. Well, Steve, so what’s happened with the wordsmithing
as we’ve gone along here?

DR. STEINDEL: I’m not finished yet but basically the way I have it worded
now is it starts off the same way with supplies, the NCVHS concurs with the
recommendation to not adopt the terminology for the disability domain. I’m
going to add a sentence, which I haven’t constructed yet, which will say
something to the effect of we advise CHI to consider adding the question and
answer type format to the list of research areas they had in their

DR. COHN: We might want to say we agree with the list, that there needs to
be a future research agenda and we further recommend that it also include x, y,
and z.

MR. BLAIR: Is it the sense of the subcommittee that we would not indicate
you should also wind up considering the terminology specific to patient care
and within the patient care area that disability specific areas might be
different? Audiology different then blindness and different then physical
therapy, and that ought to be looked at? Or did you decide that you don’t want
to take them in that direction?

MS. GREENBERG: You’re absolutely right, they are different, but I’m not
quite sure what the implications, and it certainly has implications for policy
and the questions you want to ask and all of that but —

MR. BLAIR: Well, maybe it gets to whether or not —

MS. HARVELL: Well, it certainly raises the issue and that we ought to think
about it, whatever the implications might be.

MR. BLAIR: Maybe it gets to whether or not how you define the scope of your
disability terminologies, if the scope is expanded to including patient care
and therapy then I think this would be appropriate.

MS. HARVELL: Again, one of the other things and I think this is on point
with what you were talking about is that we’ve just begun thinking about is
trying to define in the long term care arena the information needs and the
information management needs in that area. Because right now what we have are
these forms that the federal government said we need these bits of data for
payment or quality monitoring for whatever reason we need these forms. As
opposed to starting kind of from a blank slate and saying what is the
information need in the clinical setting in long term care. And we’ve just
begun thinking about that question and how to go about identifying those
information requirements but if we actually sponsor some work in that area I
think we could identify what our information needs are, we could identify what
they are by disability domain condition, and that could inform the federal
government how on point or not on point our disability data requirements are
and whether we should be perpetuating those requirements or changing them and
if so changing them how, and how to make these comparable across these
different, or at least consider comparability across these different agencies.

DR. COHN: Okay, I think we need to begin to wrap this up. Now where are we?

DR. STEINDEL: I’ll read what I have right now for the second sentence, the
first sentence we agree with the recommendation not to recommend remains the
same. We agree with the need for a future research agenda, concur with the
basic list present, and also recommend addition of investigating the question
and answer style format for this domain.

DR. COHN: Well, for aspects of this domain.

PARTICIPANT: [Inaudible.]

DR. STEINDEL: I was just going to ask that question, I’ve gotten to this
point and now I wanted to see if we wanted to include the comments that Jeff
was making and the comments that Jennie was just making about harmonization.
I’m asking the subcommittee.

DR. COHN: I’m not sure I have a strong feeling on this one, Jeff, I guess I
have to ask, while I agree that clearly different disabilities are very
different, I also think that diabetes is a different disease then an acute MI
and I don’t necessarily think we need a different terminology now. The question
is is what you’re asking for is that the, that additional research be done to
assure that the domain, the coverage is expansive enough to cover people with
different types of disabilities? Is that really what we’re talking about here?

MR. BLAIR: Close, and I’m not trying to be prescriptive, this is why I used
the word consider in your research, because if you just check with
ophthalmology and audiology and physical therapy groups, and if they happen to
have measurement scales and they are there then that may meet needs, and if so
maybe they’d be appropriate for adoption. I guess all I’m asking is that you
consider and include that in your research and whatever you wind up deciding is
what you decide.

DR. COHN: Jeff, just to restate this, so you’re basically recommending that
as part of the next phase of research that the workgroup activity survey a
larger group of professionals and others for additional disability questions
scales, etc.

MR. BLAIR: And I wasn’t sure whether it’s the next phase or whether it’s
this phase, if you can’t do it in the timeframe for January then it’s the next

DR. COHN: Well, I don’t think we’ll have it for January.

MR. BLAIR: Okay, fine.

DR. COHN: Jennie, you guys think you can have it for January?

MR. BLAIR: Then your wording is appropriate.

DR. COHN: Steve, I think you’re asking a question.

DR. STEINDEL: Yeah, I would like to just make an observation on Jeff’s
comments. While I totally agree with Jeff’s comments I think what we’re
basically recommending is that we feel that there isn’t a terminology that’s
ready for prime time at this stage and that even with your basic
recommendations we realize that the terminology, whatever terminology that’s
out there needs to be further developed. And in the aspects of terminology
development it behooves, for us to accept a good terminology is to involve all
the people that are going to be using that terminology, so I think just in the
course of developing the terminology Jeff’s needs would be met, and I don’t
think we have to spell it out. At least right now, we might in the future but
right now I think we should just assume that it’s good practice in terminology

DR. COHN: Well, Jeff, I’m looking to you to see what you think of that.

MR. BLAIR: I’ve offered my suggestion and I’ll accept whatever the
subcommittee decides to do.

DR. COHN: Marjorie?

MS. GREENBERG: I hear what Jeff is saying and I think in this disability
area it is somewhat different because it involves not just different medical
specialties but as I said before a broad range of users and domains that
actually go beyond the health domain but are treated in the health domain, such
as transportation needs, accessibility issues, benefits, all sorts of stuff, so
that maybe just, which is a little different then what he’s saying but I think
is reflective of the fact that this is a very multidimensional domain that
involves a lot of different perspectives and a lot of different users and
needs. So maybe just saying that in further terminology development as well as
the question/answer development the broad range of aspects of disability and
people who deal with disabilities should be consulted.

DR. COHN: It’s just a recommendation, I think that’s fine. Is that okay with
you Jeff, that sort of, okay.

MS. GREENBERG: I think that sends a message, too, to terminology developers,
which is good.

DR. COHN: Now let me just ask, is everybody comfortable with this? Stan’s
nodding his head, Kepa, you’re okay? Jeff? Okay, I’m okay, Clem, are you okay
with this? I heard him say yes —

Now I think we’re seriously behind schedule but we will forge ahead anyway.
I’m actually going to suggest that maybe we take a ten minute stretch break at
this point.

[Brief break.]

MS. GREENBERG: Did you vote on that by the way? Did you actually vote on
that or that you had consensus.

DR. COHN: I think I heard, all in favor say aye.


DR. COHN: Opposed say nay. And I guess I’m hearing from one person that we
ought to probably forge ahead because I think, I’ve been reminded we do lose a
quorum in about 40 minutes.

DR. STEINDEL: Can I request that I make certain what we just approved?

DR. COHN: Sure, please, do you want to read it?


DR. COHN: Please.

DR. STEINDEL: The NCVHS concurs with the recommendation to not adopt a
terminology for the disability domain. We agree with the need for future
research agenda, concur with the basic list presented, and also recommend
addition of investigating the question and answer style format for aspects of
this domain. Request that the future research be inclusive of all domain

DR. COHN: Sounds good. Let’s move on to Gene and Protein.

Agenda Item: CHI Final Reports – Genes & Proteins –
Mr. Sorace

MR. SORACE: I’m here for the gene and protein group. Basically we had a
pretty good representation and we had a lot of very fun and spirited
contributions from people and both the CHI, NCBI, FDA, VA, and CDC. And
basically our main goal was to allow the federal health care sector to exchange
information regarding the roles of gene and proteins in biomedical research and
health care.

It was an interesting thing just to even try to scope out because it’s a
very broad field and we really broke it down into five domains, and actually
the top three here are the more interrelated domains. That is we were thinking
more in terms from the medical perspective, again looking back into a basic
science background and that health care professionals would like to know
inherited genetic variations that may contribute to diseases, and this is your
classic gene susceptibility traits, known genomic diseases, or genes that are
associated with responses to pharmacological agents like the mutations that are
found in cancers that may break cancers down diagnostically or prognostically.
Another one I think which has actually turned out to be one of the most
interesting was infectious diseases, and that is it’s not just human genes that
are important but it’s the genomes of those things that like to give us
diseases, and that includes issues such as genes involved in bacterial or viral
pathogenesis, drug resistance or actually just pathogen identification, so
figuring out what the patient has.

And then we had two really narrow domains and actually they’re more just
what do you name these things so we were looking in protein nomenclature and
gene nomenclature —

DR. HUFF: Question. Are you considering the names of laboratory tests that
determine the presence or absence of the gene, is that in scope or out of scope
or was that part of laboratory considerations or how —

MR. SORACE: Well, I’ll answer that two separate ways, it was definitely in
scope in terms of gene names. In other words not so much laboratory tests but
that you can link laboratory tests to the gene that it identified somehow, so
at a minimum we wanted a genomic nomenclature that allowed you, that could then
be linked to like LOINC codes, for example.

We had some debate and we actually think that it may actually fall more into
a gap in terms of how you expand these concepts in various other areas. But I
think that our way of looking at it was not necessarily that we’d want a code
that filled both the test function and the gene identification function in one
code, but rather you’d want something that would allow you to unambiguously
specify a gene that could then be linked to say LOINC codes for laboratory

And we looked at several alternatives, the Human Gene Nomenclatures, which
is supported by HUGO(?) and the Gene Ontology Nomenclature and SNOMED CT. And
basically we recommend, at least for human genes, that we adopt the Human Gene
Nomenclature, sponsored by the Human Genome Organization, which is directly
funded by NIH and the UK. But we’re aware that when you look at the rest of the
things which we said that we’d really like to be able to do with genes and
proteins we couldn’t find an adequate protein nomenclature, the field’s just to
young and everything is very developmental. We couldn’t find a good
nomenclature for non-human genes that was somehow comprehensive and would allow
you to put all the non-human pathogen genes that you may need to express. And
then in these more integrative questions we felt that there was a lot that
needed to be done in phase two and for example the field of infectious disease
actually represented a very important area where a lot of work needs to be
done. There needs to be more work in not only the nomenclature for pathogen
genes but also just in terms of nomenclatures for annotating pathogen genes
functionally, so like which gene confers ampicillin resistance say, or this
gene confers adherence factor that’s important to urinary tract colonization,
that those basic vocabularies, it was very hard to find something that was
satisfactory in all those roles.

But it wasn’t clear, and it’s something that we need to look into more
later, whether or not something like SNOMED or some other nomenclature could in
fact actually be expanded to fill some of those issues. Or whether LOINC could.
So I think the main view of the committee was that in many cases the current
vocabularies that are already adopted by the CHI effort could actually fill
these gaps, or could be tasked to, and that it might not be wise to go and try
to recommend one now because it’s too early.

Another thing we noted was that just more active coordination to cover known
agencies would be very useful for translational research, and also for disease
surveillance in bio defense. And that in terms of infectious disease CDC input
and in coordination with NIAID would also be very, very useful.

The National Cancer Institute is trying to adopt and develop nomenclatures
for a lot of the acquired genomic tests that you can find in a cancer example
and they think they may have something ready in about six, seven months, but
they didn’t feel that their efforts were ready for recommendation at this time.
And I think in terms of genomic diseases a very useful exercise would be to go
back and take some of these well known genomic databases like OMIN(?), say or
Gene Tests and go back and see to what extent they could be SNOMED coded and
see to what extent we could fill in with existing vocabularies and then
consider in what areas those may need to be rounded to meet the effort, versus
going back and starting to try to find if there’s a new vocabulary de

So we came up with I think some useful recommendations in terms of human
genomic nomenclature, fairly narrowly focused recommendation, I hope we’ve sort
of provided a framework for future analysis in this area.

Any questions?

DR. COHN: Jim, thank you. Comments, questions? After the last one, simply
silence, Michael.

DR. FITZMAURICE: It says that the HUGN(?) contains names for approximately
one half of the expected number, oh that’s right, this is for protein, not for

MR. SORACE: Well, the issue is what’s a gene and it’s known that you,
there’s about 35,000 expected protein coding genes but they keep finding all
these other sequences that have physiological significance.

DR. FITZMAURICE: So I guess the question is HUGN still a work in progress?


DR. FITZMAURICE: And you’re saying it’s good enough to be adopted for the
uses for which the government would use it today?

MR. SORACE: It currently is, I mean it’s basically being used by NCBI and
Locus(?) Link, and they all use HUGN notation almost exclusively. If they do
assign a name outside of that nomenclature they only do it temporarily until
they get a name assigned.

DR. COHN: Jim, just to make sure I understand, I mean basically HUGN is
state of the art, it’s that the other half hasn’t been discovered yet. And
people are basically, if you discover them it’s hard to assign a number to

MR. SORACE: And there’s nobody that I’m aware of who’s done one percent.

DR. COHN: That’s fine, that was what I understood from the reading. Kepa?

DR. ZUBELDIA: You say here that it’s usually is free for non-profit uses,
does the government have to pay to use it or is it considered commercial use,
non-profit, and what’s the license for commercial use?

MR. SORACE: It’s free to the government. Somebody like Solera(?) or somebody
who wants to do it commercially might have to go them for a license.

DR. ZUBELDIA: Do you know what the terms of the license are?

MR. SORACE: We haven’t been able to get that information, we’re still trying

DR. STEINDEL: Is a for-profit hospital considered commercial?

MS. WARK: I think probably the best way to answer the question is that we’re
trying to get information from the organization and we have some preliminary
information that basically indicates attribution to the organization but
essentially free for use, I mean that’s what we’re hearing, we’re trying to
clarify a few issues because we don’t want to ultimately put something out in
the report that isn’t accurate but we’re still working on it.

DR. STEINDEL: And of course my question does not pertain to federal to
federal exchange but the idea of CHI being a tipping point.

MR. SORACE: I don’t think there’d be a problem for a non-profit hospital —

DR. COHN: Well, what do we want to do, Steve?

DR. STEINDEL: I do notice that in, I think the report is excellent and agree
with the conclusion but it’s very targeted as you noted to the human genome and
the domain was genes and proteins and I don’t think it really specifically
notes the other areas as either gaps or no recommendation or something like
that and maybe we should specifically close the loop on non-human genomes and

DR. COHN: So you’re recommending no recommendation for those areas.

DR. STEINDEL: I think there’s no recommendation at this time and maybe a
note for research or development.

MR. SORACE: I think we’re in agreement, we didn’t really find anything out
there, it will have to be created.

DR. STEINDEL: I’m just wondering if the report should note that —

MS. TRUDEL: We can make a specific statement to that effect, I mean the lack
of a recommendation essentially gets you there by the back door but we can make
a specific statement that says we are not making any recommendation for
anything other then human genes.

DR. COHN: And maybe what our recommendation says is that we recommend, we
concur with the recommendation for HUGO for human gene nomenclature and with
the lack of a recommendation for terminologies for, and I think what is it,
acquired gene, inherited genetic variation, acquired gene changes, infectious
disease, gene proteins, and protein nomenclature, that would basically just
sort of, and oh yes, the remaining four, exactly.

I guess the only other question I had, which Kepa was bringing up, is there
a condition that we need to note having to do with clarifications of licensure?
It’s hard to imagine it’s going to be too much since it’s, well, actually you
never know, I would say it’s jointly funded by the UK and the NIH but do we,
our letter need to recommend that or did you want to, what are thoughts? Kepa?

DR. ZUBELDIA: Perhaps we need to recommend that the license, a low cost
non-discriminatory license be secured, or be provided or something.

MS. WARK: This would be for outside CHI, is that correct?

DR. ZUBELDIA: Well, interfacing CHI with hospital chains or for-profit
hospitals, for instance.

DR. FITZMAURICE: For example, suppose VA or DOD sends some of their patients
to a for-profit hospital because they have the expertise and they have the
genetic information coming back. If they don’t have it coded in the same way as
their own genetic information —

DR. ZUBELDIA: Or you need to run a generic test somewhere else, you need to
contract, farm it out somewhere.

DR. COHN: Well, what are the thoughts of the subcommittee on this one? How
exactly do we want to frame it? Do we want to not approve it if there’s not a
low cost license negotiated or we’re asking more for clarification of the
commercial license fees?

DR. FITZMAURICE: With a recommendation that they get the specific
information that they’ve described already about the licensing, that way the
recommendation goes up to the Secretary that yes, we find it suitable, but
there is a concern. Doesn’t seem to be anything in second place.

DR. COHN: Well, that’s true.

DR. ZUBELDIA: It’s not a big concern because HUGO is a non-profit and it’s
partly funded by NIH, so they’re not going to be having a huge license fee,
it’s not that big a concern but there could be some discriminatory terms that
you cannot use it for certain things or whatever the terms are.

DR. COHN: Karen?

MS. TRUDEL: Could I make a suggestion? It may just be appropriate to say
that we recognize that there’s still work being done on the terms of the
licensing agreements and the subcommittee does have concerns about how
licensing fees could impact the use of this in the private sector, period. I
mean that doesn’t direct us to do anything, it just suggest that we continue to
look into the concerns as we have already said that we are doing.

DR. COHN: Does that address everyone’s needs? Kepa?

DR. ZUBELDIA: How about, a concern that I have is that you haven’t been able
to find out what the license terms are.

MS. WARK: We have some initial response from the organization but it is not
clear to us that all of the questions about the licensure and any fees
associated with it for commercial use is clear to us, so we have referred the
matter to NIH as the co-funder of the organization to seek clarification on
that and its just pending.

DR. ZUBELDIA: What if that’s a requirement? That whatever the license terms
are that they be explicit? I mean it’s a little scary —

MS. TRUDEL: The suggestion you’re making is that we not adopt this even
though there is nothing else there for the federal health enterprise because we
don’t understand the consequences on the commercial market. I’m not sure I
agree with that.

DR. ZUBELDIA: No, that’s not what I’m suggesting, I’m suggesting that HUGO,
I’m suggesting that it be adopted but that HUGO explicitly state what the
license terms are.

MS. TRUDEL: And we’re working on that. I’m not getting it.

DR. COHN: I’m not sure what the issue is here. What do you have at this

DR. STEINDEL: I actually have to agree, what I have so far is as the first
sentence, the NCVHS concurs with the recommendation for the genes and protein
domain as noted for the human genome, and note the need for explicit comment on
the lack of terminology for the remaining sub-domains. The second sentence,
which is pertaining to the discussion that we have, what I’ve gathered so far
is that we recognize that work is still underway on clarification of licensure
terms for use outside of the federal government. And I don’t really even see
the need for that sentence.

MS. GRAHAM: Is it that this committee wants to be apprised if there is a
cost so they can readdress this if there is a cost associated?

DR. FITZMAURICE: For all the others we’ve known the cost. This is the first
one we haven’t really known the cost, right?

MS. TRUDEL: But we know the cost to the federal health enterprise.

DR. STEINDEL: We do know the cost to the federal health —

MS. TRUDEL: We do know the cost to the federal health enterprise, it’s zero.

DR. FITZMAURICE: But if the federal enterprise uses the private sector to do
its testing, to send patients out there, there is a cost bourn by it —

DR. STEINDEL: Maybe, maybe not.

DR. FITZMAURICE: Maybe, maybe not, so we just don’t know until we see the

DR. COHN: So our question is is do we leave it like that or do we say, do we
want to encourage the Secretary to consider negotiating the low cost license
for use by the private sector to encourage more widespread implementation? Or
do we want to hold that end since they don’t know, I mean we’re in a situation
where they don’t know, they will know next month I presume. Will you know by
late January? Okay, can we make a note on this one to based on what we hear
back from them we can decide whether to put a sentence in there or not?

DR. STEINDEL: Simon, that brings me up with just a basic question I was
going to ask later, are we going to send two letters or just one letter in

DR. COHN: We’re sending one letter at the full committee —

DR. STEINDEL: At the end of January. Then I think what we should just do is
for me to bold the sentence so we know to go back and revisit it in January.

DR. ZUBELDIA: And then in January remove it, remove that sentence

DR. STEINDEL: Hopefully yes.

DR. COHN: Or some other action. Okay, it is now 2:38, people want to keep, I
think it would be nice to take a break. I’m sorry, you can tell I need a break.
Are we, Kepa, do you move acceptance?

DR. ZUBELDIA: Yes, I move that we accept this recommendation with a sentence
that Steve —

DR. COHN: Jeff, are you seconding that?

MR. BLAIR: I’ll second it.

DR. COHN: Any further questions, comments? All in favor?


DR. COHN: Opposed? Abstentions? Okay, this one passes. Now should we take
about a ten minute break and reconvene at ten minutes to 3:00. Is that okay?

[Brief break.]

MR. BLAIR: Just so that you’re aware, we have five more of them to go
through, two of them are going to be final recommendations with votes and we
wanted to make sure we got through that while we still had, before Kepa had to
leave, and we have three more preliminary ones, which are informative. So at
this stage let me ask the testifiers who would be from CHI who were going to be
discussing the diagnosis and problem lists, to introduce themselves and to take
us through.

Agenda Item: CHI Final Reports – Diagnosis/Problem List –
Ms. Acker

MS. ACKER: My name is Beth Acker and Karla Porter is also here with me, we
are the co-chairs of the diagnosis problem lists CHI group.

Our group was composed of members from HHS, DOD, VA, and basically what we
did is we had a really tough time narrowing down our scope for this and so what
we did was we described the diagnosis and problem list as a series of brief
statements that catalog a patient’s medical, nursing, dental, social,
preventative, and psychiatric events and issues that are relevant to that
patient’s health care, for example, signs, symptoms, and other defined

From that we took our scope and we decided what was going to be in scope and
out of scope. We considered clinical diagnosis and problems, subjective
symptoms, observed findings, and synonyms to be within scope. We considered
nursing diagnoses, modifiers and descriptions, dental, and alternative medicine
to be out of scope for this particular realm.

Now that we had narrowed down our scope we identified alternatives, those

Now I’m going to read an excerpt of our summary for the basis of our
recommendation. The team used as a starting point the criteria for PMRI put
forth by the Subcommittee on Standards and Security of the NCVHS, that being
concept orientation, concept permanence, non-ambiguity, and explicit version
IDs. The CHI workgroup then collected information on additional items, which
are content coverage, scope, settings, ownership, cost and availability, usage,
mappings, and other relevant considerations to evaluate all candidate
terminologies. The main distinction between the analysis conducted by the CHI
workgroup is that the NCVHS Subcommittee on Standards and Security used the
criteria to identify terminologies that would be considered further for
recommendation as a core PMRI terminology and CHI considered all criteria and
information gathered for additional items to make our recommendations. This
resulted in identification of what we identified as the best solution for the

The next slide shows that our recommendation is SNOMED CT —

MR. BLAIR: Could I just get that clarified? When you say best solution for
the government, what are the uses that you’re thinking of when you say best
solutions for the government? Are you thinking reimbursement, public health and
research but not patient care? Or does that include patient care because of DOD
and VA?

MS. ACKER: It includes everything, patient care also.

MR. BLAIR: Thank you.

MS. ACKER: The diagnosis and problem list code sets that were evaluated by
NCVHS, Subcommittee on Standards and Security, did not meet all of the
essential criteria for patient medical record terminologies, whereas SNOMED CT
and MEDCIN referenced terminologies met all of the essential criteria. Content
coverage in MEDCIN and ICD-10-CM is limited to diagnoses used by physicians for
the purpose of generating bills. SNOMED CT has the most comprehensive content
coverage including diagnoses and problems identified by nurses and allied
health care providers, therapists, social workers, dieticians, etc. The MEDCIN
referenced terminology is available for a small fee whereas the SNOMED CT is
now available to all U.S. users without additional charge.

Therefore the overall analysis of available alternatives resulted in SNOMED
CT being selected as the best choice for use in federal government as a PMRI
terminology. This will need to be used in conjunction with administrative code
sets to be used for billing purposes under HIPAA and with interface
terminologies developed by a host of other parties such as vendors, government
agencies, and so forth.

The workgroup anticipates that the SNOMED CT concept groups of disorders and
findings will be the primary source for the diagnosis and problem list entries,
although it also anticipates that most, if not all of the other concept
groupings, such as body structure, organism, social context, will also be used
instead or coordinated with the former to accurately express a diagnosis or
problem list entry. The entirety of SNOMED CT is not being recommended, only
the content that contains the diagnosis and problem list concepts as modeled as
integrated from the source PMRI terminologies.

Therefore what we did was we recommended that there needs to be mapping done
for ICD-9-CM, ICD-10-CM, MedDRA, and DSM-IV, and those are examples, they
aren’t exclusive to just those, and we said that these needs are being referred
to the NLM to be handled.

And basically in the interest of time we condensed our presentation to that
so if you have any questions for us —

MR. BLAIR: Are there questions from the subcommittee?

DR. STEINDEL: There is being raised, not necessarily on CHI but in general,
about primary care classifications and you had ICPC as one of the terminologies
you were considering. I was just asking if you would consider expanding your
mappings to add ICPC.

MS. ACKER: That’s certainly fine, again what we had named were just an
example thereof, not exclusive to, so we can certainly add that one in there.

MR. BLAIR: Any other comments? Carol?

DR. BICKFORD: Carol Bickford, American Nurses Association. The group that
was taking a look at the diagnoses and problem list excluded alternative
medicine, complementary therapies environment, what is the intent about making
sure that those practitioners using that frame of reference are supported in
their care delivery process? And the second question that I have is if we’re
looking at health promotion and wellness how are those concepts integrated to
make sure that some of those similar to complementary alternative medicine
concepts are incorporated? So it’s a two pronged question.

MS. ACKER: You might want to stay at the microphone for a second, I may need
to ask for further clarification if we can’t respond adequately to your

Basically what we consider those types of things is to be very specialty
oriented, and that would be where the mappings would come in, that if there is
something that is specifically needed to describe say alternative medicine, the
ABC so forth, something of that nature, then that be referred as a mapping type
category. And it’s not a core terminology, again, what we tried to do or focus
on what’s got the basic overall where can we start from concepts, and that was
how we made our recommendation is that this is what we feel has our overall
basic concepts covered for all of these things.

MR. BLAIR: The only observation that I would have is you did recognize the
ABC codes for billing but not in nursing and not in diagnosis and problem
lists. And if the data isn’t captured in that form during the patient care
nursing activities, then it becomes pretty difficult to use it for billing. How
do you wind up accommodating that?

MS. ACKER: I don’t think that we meant to intimate that we exclude that,
exclude anything, as far as a mapping type situation, again, we saw that as
something that was specialty related that could be referred to as a mapping
issue. We were trying to sort out, say this is what we feel is our core base
and we feel that there are many other specialty type segments that need to be
identified and mapped to and as those are identified and brought to the
forefront those would be referred to NLM for mapping purposes.

MR. BLAIR: Is there any problem with including a phrase that you exactly,
what you just said, that you are assuming that there will be other specialty
related diagnosis and problem areas that would be mapped including alternative

MS. ACKER: I don’t think we would have any problem with that, we just said
for example and we named a few, again, it wasn’t an exclusive list.

MS. TRUDEL: Right, and we did in the write-up specifically define both
dental and alternative medicine as out of scope for phase one.

MS. ACKER: Correct.

MR. BLAIR: Any other comments? Carole Bickford? Marjorie?

MS. GREENBERG: I just want to clarify that when you said they would be
candidates for mapping you’re suggesting that the mapping would be done and
then if gaps were found they could be added.

MS. ACKER: Correct, exactly, because as we, we recognized that the timeline
that we had to do these investigations, and it’s not possible to identify
everything. We wanted to identify their base and leave it open that if
additional gaps were identified they could be addressed.

MR. BLAIR: No more comments? Anyone from the audience? If there are no
comments is there a motion that would reflect the subcommittee’s —

DR. STEINDEL: Jeff, if I can read what I captured. The NCVHS concurs with
the recommendation for the diagnosis and problem list domain and requests the
addition of ICPC to the recommended terminologies for early mapping efforts.

DR. ZUBELDIA: I move that we rule that wording.

MR. BLAIR: Is there a second?

DR. HUFF: I’ll second that.

MR. BLAIR: Okay, any other discussion? Okay, shall we vote? Concur? Okay,
the NCVHS concurs with the wording as Steve described it and thank you very
much for your testimony to us, and Jorge Ferrer you’re our next testifier.

Agenda Item: CHI Final Reports – Non-Laboratory
Intervention and Procedure – Ms. Wark

MS. WARK: I am going to be presenting the recommendations for the
non-laboratory intervention and procedure workgroup on behalf of Dr. Jorge
Ferrer from CMS who was the lead for this workgroup and the team composition
included representatives from NCHS, VA, DOD, and Indian Health Service. And as
the subcommittee may recall Dr. Ferrer came in May and presented the
preliminary report so this workgroup was convened in the spring time and the
report was actually finished some time ago.

The domain description is that the standard will be used to describe
specific non-laboratory interventions and procedures performed or delivered in
the provision of health care.

The scope includes procedures by site, method, intent, focus, device, and
regimen therapy. It excludes again, very similar to the diagnosis and problem
list workgroup, dental, alternative medicine, and the laboratory procedures
were addressed workgroup for laboratory test order names and administrative and
management procedures were also excluded.

The alternatives were SNOMED CT, MEDCIN, ICD-10-PCS, and CPT-IV.

The final recommendation is that SNOMED CT be adopted and that the specific
location in the SNOMED CT hierarchy that forms the basis of the recommendation
is the procedure access, and that is excluding the administrative and
laboratory procedure areas.

The content coverage was assessed across all of the alternatives and it was
found, again, a very similar analysis was done on both the diagnosis and
problem list workgroup and the non-lab intervention and procedures looking at
first the PMRI criteria of concept orientation, concept permanence,
non-ambiguity, and explicit version IDs, and then the workgroup went on to look
at additional factors, content coverage, settings, scope, ownership,
availability cost, use, mapping, and considerations.

And after taking into consideration the information gathered in all of these
areas the workgroup came to the conclusion that SNOMED CT would best meet the
needs of the government due to its extensive content coverage compared with the
other alternatives, and the fact that the scope includes content for multiple
disciplines involved in health care, it can be used in multiple settings,
again, due to the free availability to U.S. users through the UMLS, and in
terms of gaps there was noted a lag in the timeliness of emerging procedures
incorporated in SNOMED CT.

The workgroup did look at some specific procedures that are relatively new
and did not find those to be present in SNOMED CT and so is making a
recommendation that every attempt be made on the part of SNOMED and NLM to
address the need to incorporate those terms as quickly as possible. Also noted
was that mappings are needed to be maintained between SNOMED CT and CPT-IV and
ICD-10-PCS via the UMLS.

And that concludes the workgroup’s report.

MR. BLAIR: Okay, questions, comments from subcommittee and staff?

DR. STEINDEL: Cynthia, the workgroup is making a point about the lag time,
is that just an incidental comment? Because it’s actually, it’s a bit worse
then they may let on because there’s a lag time between when SNOMED includes
the term, and then there is a further lag time as to when it might appear in
the UMLS and there’s a great deal of concern about shortening that lag time to
as much as possible but it can never be reduced to zero. I think I, I agree
with the emphasis but I would just like to make sure that it’s just an
incidental comment, that it’s something they would like to see improved, and
doesn’t have any real bearing on the recommendation.

MS. WARK: It’s not a condition in the sense that the terminology could not
be used, however, the workgroup felt it was important to stress the need for
timely incorporation of concepts associated with newer interventions and they
did discuss the fact that it takes some time for CAP to respond by
incorporating into SNOMED and then into the UMLS version and then the release
of that version. I don’t know that the workgroup had any direct involvement in
the discussions that were taking place between CAP and NLM in terms of how they
can improve the timeliness, I’m not sure that the workgroup didn’t have any
specific ideas about how that could be done quicker but they did feel it
important to note it in the report.

MR. BLAIR: Other comments?

DR. ZUBELDIA: Yes, I have a question. With all this piecemeal adoption of
SNOMED where specific access is adopted by one of the workgroups and a
different access by another workgroup and there is some exception, has anybody
looked at what’s left? Is there something SNOMED that has not been recommended
for adoption?

MS. WARK: Well, specifically in the case of this domain we are excluding
laboratory test order names because LOINC was recommended for adoption in that
area. It’s probably like you say, as we proceed with each of the domains and we
begin to knit together the totality of what is being adopted in SNOMED it will
probably be more the exception that something isn’t included then the rule. But
because we haven’t completed the entire portfolio yet, no, that work hasn’t
been done, it seems like we could take that back as a recommendation for phase
two and the harmonization efforts that we begin to do that and specifically
look at all of the components that have been adopted and those that haven’t.

DR. ZUBELDIA: I would like to see the identification of those things that
are excluded, not necessarily for this specific workgroup, at some point CHI I
think ought to take that —

DR. STEINDEL: Kepa, just looking at the axis structure of SNOMED we have
probably recommended maybe a third but less then half of the axis of SNOMED for
adoption. In terms of actual concepts my off-hand guess, though I haven’t
really counted them, is there’s about 300,000 terms in SNOMED, we’ve probably
recommended about, concepts in SNOMED, there’s more terms, we’ve probably have
recommended about half for CHI purpose. And the things that we’ve excluded are
things like physical force, physical object, the special concepts, social
context axis, items like that is what’s been excluded. I would say in terms of
the actual clinical axis we probably have touched all of them.

MR. BLAIR: Any other comments, questions? Anybody from the audience. Carol?

DR. BICKFORD: Carol Bickford, American Nurses Association. In light of the
federal government’s significant initiatives in the tele-health arena how is
that going to be encompassed in the interventions coding world? The focus has
traditionally been on one to one interaction between clinician and the patient,
so I’m raising that as a question in the discussion as we’ve moved forward,
particularly to support the federal government, with their great diversity in
their tele-health initiatives. Is that part of the intervention component, is
it just an incident, how is that being accommodated?

And secondly, in relation to the interventions, are we going to be, the
non-laboratory ones, was there a look at the public health component, the
significance of that work in relation to the emergency preparedness and some of
those initiatives? Looking at the patient as being the population not the

MS. WARK: If I understood those questions correctly the first one being how
are we addressing tele-health, and the one specific area where that has come up
and is not being reported on today but there was a preliminary presentation in
October is clinical encounters. And there has been some effort to look at
terminologies for clinical encounter information that can be applied across all
settings including tele-medicine.

On the second question, in terms of population health, there is, Steve
Steindel will be offering a report, a preliminary report, from the population
health workgroup later this afternoon and that may offer some insight into your

MR. BLAIR: Other comments? Okay, if there’s no other ones, before I indicate
whether or not, or call for a motion on this particular one I failed to mention
in our last vote that in addition to the members that are here, Stan Huff, Kepa
Zubeldia, and myself on the Subcommittee on Standards and Security, Simon Cohn
instructed me to also add his vote on diagnosis and problem lists as concurring
so for the record there were four committee votes, subcommittee members voting
for it the last time, and he also instructed me to add his concurrence on
non-lab interventions as well. So is there a motion for non-lab interventions?

DR. STEINDEL: Jeff, if I may read what I’ve captured because I haven’t heard
any other comments, is the NCVHS concurs with the recommendation for the
non-laboratory intervention and procedures as presented.

MR. BLAIR: Any second?

DR. ZUBELDIA: I second it.

MR. BLAIR: Okay. Any discussion? Questions?

MS. GREENBERG: I’ll have to check into it, as the executive secretary I
should know the answer but I’m not quite sure whether we permit proxy votes but
on the other hand given that, if they’re given in advance and then there’s
discussion etc., but given that there’s unanimity it’s okay but I’ll check into
whether that, that’s a little atypical.

MR. BLAIR: The only thing I’d add then to add to your examination of that is
that Simon did read through the information before he rendered his assessment.

MS. GREENBERG: I’m sure. As long as you don’t change it he’d agree with it.

DR. STEINDEL: And we didn’t.

MR. BLAIR: Okay, then I think —

DR. ZUBELDIA: Let’s take a vote on this one.

MR. BLAIR: I think we’re prepared to take a vote, and can I hear the votes?
I concur as well and Simon instructed me to give his concurrence, and so the
motion is passed.

We have concluded all of the CHI recommendations, I’d like to thank everyone
from CHI who has done the work to prepare and present that to us. I hope that
the NCVHS comments and review and suggestions has been constructive and

MS. TRUDEL: We’d like to thank the subcommittee for giving us all of its
time and for plowing through reports at very short notice and providing us with
very useful feedback, so thank you also.

MR. BLAIR: We have three additional preliminary CHI recommendations and let
me just discuss before we head into those. Karen, you had made the suggestion
that those three be presented all together, however, we’ve gone through more
expeditiously with our time, very good. So who will be our first presenter of
the three?

PARTICIPANT: We have NIBIB, which correct me, National Institute of
Biomedical Imaging and Bioengineering?


PARTICIPANT: And it’s Dr. William Heetderks and Dr. Richard Swaja.

MR. BLAIR: And this is the media —

PARTICIPANT: Multimedia workgroup.

Agenda Item: CHI Preliminary Reports – Multimedia –
Dr. Heetderks

DR. HEETDERKS: I will just walk you through briefly the preliminary work
that we’ve done on this, first focusing on the scope and in particular domains
and sub-domains. Our overall domain is the incorporation of a broad variety of
multimedia information into patient records and the sub-domains that we
identified were images, audio, critical care patient monitoring data, validated
instruments, and by that we meant things like neuropsychological tests where
one gets a collection of data, which taken together represents a validated
measure of some patient information, and video information.

In terms of the alternatives that we’re looking at, and we’re actually here
hopefully to get some additional suggestions if you have any, the ones that we
identified early on were SNOMED, which was the required one, DIG35, I’m
revealing my level of sophistication in this one, I’m not sure, I think it’s
actually DIG35, but that’s actually a set of standards that’s metadata
standards being developed by the International Imaging Industry Association,
I3A, and that’s multimedia format that we’re looking at. DICOM, which is
probably best known as sort of the emerging standard for medical image
information, especially among radiologists. And IEEE 1073, which is IEEE, the
Institute of Electrical and Electronics Engineers, they are developing a set of
standards which is really focused on data streams, in particular coming from
various instruments and intensive care monitoring.

So those were the standards that we were looking at and additionally we’re
talking with a couple of organizations, NIST, and in fact we went to one of
their workshops earlier in November on biomedical data integration, and RSNA,
the Radiological Society of North America. They in addition to having a strong
interest in DICOM also have this activity called, let me get it straight, the
IHE, the Integrated Healthcare Environment, which is not really a set of
standards but is looking at how standards if you will interact with a variety
of other systems, so to be integrated into a health care system, so we’ve been
talking to them initially.

And in terms of our initial thoughts, I don’t think I need to go through
those, but we just have some initial thoughts on those topics and I think I’ll
quit there and leave this open for questions at this time.

MR. BLAIR: Other questions, first?

DR. HUFF: From the description I’m not sure I understand the scope, in other
words could you say just a few names of things that you would expect to see in
terminology to cover this area? I mean is it the names of x-ray modalities or
is it the names of the image series itself as you would find in DICOM? It’s
just not clear.

PARTICIPANT: [Inaudible.]

DR. HUFF: Oh, this is the standard.

DR. ZUBELDIA: This is not just terminology, right?

DR. HUFF: Maybe I’m more confused then I thought.

DR. HEETDERKS: Well, or it’s also possible that we are, but I think that
what we were taking as this was if you will a vocabulary that was agreed upon
to incorporate this kind of information into patient records, so in a sense
we’re sort of interpreting this as a broader use of the word vocabulary if you
will. So we were sort of picturing DICOM as a standard vocabulary for
exchanging image information between records between different sources, so it’s
a vocabulary in the sense that, and obviously in the case of images so that in
some sense one machine can understand another machine as well as one human
understanding another human, so I think that that’s a significant part of how
we were interpreting vocabulary here. Now if that’s not what’s being looked for
then —

DR. HUFF: No, I’m just trying, CHI is standardization in all kinds of things
and so I guess DICOM was previously accepted as a standard right?

MS. WARK: As a messaging standard.

DR. HUFF: As a messaging standard, and so this is specifically looking at
terminology that would be used in DICOM or in, I’m not sure I understand the
context, or you’ve mentioned that it’s in the patient electronic record but for
instance, there are, Dean Bitgood(?) who helped create the DICOM standard also
worked with LOINC to create 5,000 names for specific radiology procedures. Is
that the scope of this work or is that something different?

DR. HEETDERKS: Dick may want to add to this, too, but my understanding was
that the scope of this was if you will a vocabulary to actually incorporate the
images, that is to incorporate multimedia information into the system as
opposed to incorporating if you will vocabulary. So that’s how we have been
interpreting our scope is actually not integrating the words but integrating
the information itself into —

MR. BLAIR: I struggled with the same difficulty that Stan is struggling with
and I sort of feel like CHI can organize its standardization effort any way
that it wants, but it looks to me as if most of your standard work activities
were focused on medical domains and information content, this one seems to be
multimedia, which is a technology, and it’s a different paradigm or

I would just simply say that it’s a way to do it that I feel uncomfortable
with and the reason that I feel uncomfortable with it partially reflects on
some of my comments earlier when I talked about disabilities as well, but I
think Stan’s example of radiological image is also applies. If you’re going to
look at radiology there could be vocabularies, there could be imaging
specifications, I wound up trying to indicate that if you take a look at a
particular medical domain in some cases you need a nomenclature, in some cases
you need a message format standard, in some cases you need some way to
represent questions and answers, in some cases you may need a standard for
video, such as with physical disabilities. In some cases you may need a
standard for images, such as fields of vision, and I certainly would feel much
more comfortable if the terminologies and the standards were grouped according
to the medical area rather then the technology.

So I’ve kind of said my opinion and I really don’t know whether the rest of
the subcommittee would agree with me, to make that into a recommendation or
not, but I’m voicing that because to me there’s a consistency and you avoid,
you could avoid a lot of problems at least if you’re consistent in the way that
you define the groups. Do you have a comment or thought on that? Is there other
reasons why you thought of what I said and you felt that it just didn’t work
somehow? Other considerations?

DR. SWAJA: We think the sub-domain is based on technologies because the
variety of the technologies that have to be combined. We didn’t focus, we
didn’t even consider the fact that within imaging domains, within imaging
capabilities that there would be a variety of types of images that would have
to be combined, but the point is put them all into one record that would be
accessible throughout the patient’s lifetime or maybe even available for
purposes, access purposes and maybe possibly population research purposes in
the future. That was why we approached it from the technology standpoint as
opposed from the sub-domains of images, sub-domains of video, sub-domains of
audio —

MR. BLAIR: Since this is preliminary what if you pursue just exactly the
perspective you have but when you look at imaging, for example, you include
both the needs of imaging from a radiological standpoint, maybe from a
documentation standpoint, maybe from a visual field standpoint. If you made the
effort to consider all of the different medical domains that require imaging so
that you don’t let things fall through the cracks when you do this then you get
the best of both worlds.

DR. HEETDERKS: Can you expand on that because I’m trying to picture, and it
may be —

MR. BLAIR: Well, I saw the value of what you’re saying, you looked upon it
from a technological standpoint and you said if I have a single imaging
standard for use in a patient record, and that makes sense, so I was simply
accepting the basic premise for why you’re attacking this from a technological
standpoint and then I was trying to marry it as well to saying okay, let’s try
to look at a particular standard, technology standard for imaging, and then
wind up saying given that then let’s make sure that we’re also trying to see
that all of the different medical domains that have imaging requirements are
over time migrating or evolving to that standard, whether it be an
ophthalmology field of vision, whether it be, and I don’t have a clinical
background to mention all of them, whether radiological images, whatever. So I
was thinking if you do that then you’d have the best of both worlds and you
wouldn’t have things fall through the gaps, or at least you’d be able to
identify what gaps there are.

DR. HEETDERKS: I think I see where you’re going, I’m sorry I’m sort of slow
on picking up on that. I think that yes, I would very much agree that that’s
certainly where we were thinking also, that in essence all of these, and in
fact we were just coming back from the radiology meeting and it’s certainly
true that a field like radiology cuts across all of the other traditional areas
of medicine and —

MR. BLAIR: Back up, the field of imaging. Imaging does, radiology is one
example, representing from an ophthalmologist standpoint, field of vision is
another image, and I’m sure there’s many other areas where you have images,
probably dermatology as well, so, yeah. Marjorie?

MS. GREENBERG: I was a little mislead when I saw validated instruments but
that’s only if they include several media, questionnaires wouldn’t fit in
there, they have to include images or photos or something of that type.

DR. SWAJA: Once again, addressing your comment, the point of the initiative
is combining the data from several media, not standards specific to the media
that has generated the data to be combined, so we’re addressing the standard of
how to combine all the information as opposed to the standards within the
various domains.

MR. BLAIR: — all domains correspond to the standard that you feel should be
the overall technical standard for imaging or for video or for sound, if you
don’t look at those you may wind up selecting a technical standard that only
addresses the minority of the clinical domains instead of something that is a
good sound basis for commonalty because it addresses most of them.

DR. ZUBELDIA: I’m still concerned about, I’m confused, sorry, about the
scope of the team. Is the scope the electronic exchange of images that can be
stored and exchanged among the different domains? Or is the scope a terminology
that will be supporting that electronic exchange that would happen in parallel
with the terminology?

DR. SWAJA: I would say the second.

MR. BLAIR: Carol?

DR. BICKFORD: Carol Bickford, American Nurses Association. I have two
questions, one is is the imaging associated with the genomics component of our
health care delivery system encompassed in this? Particularly in light as we’re
looking at the construction of biomedical and genetic medications or
interventions or whatever. And the second item I ask about is in my specialty
for nursing as we’re looking at our patient care delivery process there’s a new
approach in defining our care delivery initiatives called concept mapping,
which includes imaging as well as some of our traditional care delivery
thinking of a diagnosis intervention and looking at outcome sorts of things,
and so it includes an image content. Does this fit in this area and would you
be looking at that?

DR. SWAJA: Well, the overall scope is patient records. We haven’t, beyond
the scope of this is, or outside the scope of it is anything that would have to
do with research, research data for example, and so as far as you have data and
images at the genomic level that would be classified as patient data, yes, this
would encompass that. And the second question, I don’t really remember what
that was.

DR. BICKFORD: I was asking about, in nursing we have our care plan, are care
therapies for the scenario, like critical staff would be another example for
physicians. And some of that now includes concept mapping which has an imaging
component where you’re actually representing a graphic as well as —

The second portion was in relation to what we’re doing in nursing as we’re
looking at new ways to represent our care delivery process and our diagnosis
and our interventions and our outcomes looking at concept mapping, which
includes a graphic representation of those thoughts, those strategies, and
that’s an important part of our patient care documentation. In the past we’ve
had outlines and text based, now we’re looking at images and graphics to
support that. It might hold true in the critical pathways as you’re looking at
representations of that in a graphic format, so I was asking if that’s included
in this work. It is related to patient care, it is included in patient records,
it’s serves as documentation of your decision making process, it represents the
patient’s input in some of these settings.

DR. HEETDERKS: I’m going to struggle with an answer to that question a
little bit because I would guess that that could be incorporated but I don’t
quite, I’m not sure that I necessarily see how that would fit as multimedia
data, because I don’t quite, and perhaps it’s because I’m not quite following
how the images are represented but I think certainly if there is graphical
information that would need to be represented in the chart I think that
absolutely would be incorporated. And if there’s icon kind of information, and
that’s where I’m confused a little bit about what you’re referring to, I think
that might or might not fit within this domain.

MR. BLAIR: I was going to kind of come back to you because I felt like I
kind of interrupted you when you were winding up indicating how you were
initially confused and I wondered if you wanted to follow-up or expand upon
your comment and question.

DR. HUFF: Yes. So from the discussion that we’ve had, you’re looking at
standards that would allow you to incorporate multimedia data and information
into an electronic health record. Is that correct?

DR. HEETDERKS: That’s right. So if that’s not what we’re supposed to be
doing we need to be hearing about it.

DR. HUFF: Oh, no, you can do anything you want, I’m just trying to
understand what it is. So in that, given that use case then the question that
I, so related to that activity there are lots of things that jump into my mind
and I don’t know how to relate it based on how you’ve laid it out here, so let
me just explain and then you tell me what you’re doing.

If I incorporate that image there are things that I want to know about it in
terms of its format of storage, whether it’s JPEG(?) or TIF(?) or that sort of
stuff. There are things that I want to know, I mean in some sense that’s a very
limited but standard terminology. There are all of the things that are related
to mime representation as to whether this, there’s essentially the mime type
and the mime sub-types, which correspond to whether this is an image of sound
byte, and then for each of those whether, if it is an image whether it’s TIF,
so there’s terminology related to just the physical representation of that.

Then I can imagine that there’s terminology related to what is this thing,
what was ordered in order for this to be created, is this a CT scan of the
abdomen, is this four views of an ankle, what is this. There would also be
terminology related to what was seen in the image, that is terminology related
to what I can see in this image is a fracture or I can see a lesion in the left
bronchi or I can see a maculopapular rash where I can see, so there’s
terminology related to the content and then there’s all of the complexity of
course that comes from DICOM about regions of interest and what, which are
essentially overlays on the image that you might want to represent in here and
the region of image is not terminology related but has more to do with
coordinates. But within that region of image then you have all of the sorts of
things that essentially within this region of image there is a particular
lesion or thing that you’re trying to focus on.

And so I guess what I’m, at the heart of my question is are all of those
things within your scope? Is there a particular one of those that are in your
scope? And if they’re all in your scope then it would be useful I think to
break this out and say these are the candidate terminologies for this use, for
describing the physical format of these, these are the terminologies that would
be useful describing the lesions that are seen by these images, this is the
terminology that would be useful for ordering these things. There are even more
complicated things that would have to do with collections, this might be a
collection of things related to, because part of this for instance would seem
to me would get close to claims attachment because you might request in fact
that this, an image be sent as part of adjudication of a claim because you
wanted to see the x-ray that showed the fracture or the lesion, that sort of

Could you clarify using sort of my own paradigm about this, can you clarify
what you see as the scope of your work here?

DR. SWAJA: Well, you just said a lot.

DR. HEETDERKS: Let me take a stab at it at least. I think that we saw as the
scope essentially what you have just described with the possible, or with the
probable exception of the, if you will, the domain of diagnoses or identified

[Phone interruption.]

DR. HEETDERKS: So in terms of vocabularies, I mean I think that there would
be, if you will, fields where that information would be contained within the
multimedia record that is getting into incorporated but I don’t think that we
had necessarily been thinking about the specific vocabularies for the content
of that field. I think in terms of the domain that we were looking at I think
that it was more focused on how do you represent this information, so to try
and say this a little differently, I think where we were looking was everything
up to the final point that you got to which is okay, let’s just take an
example, for example, of an x-ray of a bone as a simple example —

MR. BLAIR: Could I interrupt for a sec? What you’re doing is fine and you’re
going down the path of trying to resolve the issue, and I think Karen has a
comment and an observation which might be appropriate given the direction of
our conversation and questions so far.

MS. TRUDEL: It seems as though very many of the comments and questions have
to do with the scope and what’s in and what’s out, and rather then maybe try to
grapple with some of that on the spot perhaps if you could take that back to
your workgroup and possibly if there is any assistance that the CHI Council can
provide to you in terms of things that we’ve already addressed in other
domains, where we could kind of help you work that out, we’d be glad to do
that. But I think most of the input that we’re getting from this process has to
do with the fact that there’s some uncertainty about the scope and what’s in
and what’s out.

DR. HUFF: And that’s a good comment but I’d still like to hear you complete
what you saw as the scope of what’s in and what’s out.

DR. HEETDERKS: So we were approaching this more from the point of view of
what is in is the multimedia and going back to the earlier discussion,
especially the vocabulary to exchange the multimedia information, we were
conceiving as part of multimedia there being if you will descriptors of what is
represented in this multimedia be it related to the eye, related to the skin,
related to the x-rays, but we were not focusing on what that vocabulary would
be. We were I think presuming that the vocabulary that would be represented
within that domain would be represented by another group.

DR. HUFF: So just see if I understood what you said then, what you’re really
focused on is the terminology that would all you to know what this multimedia
thing is in terms of whether it’s an image and that it’s a JPEG image and that
part of it and not focus so much on whether this is a CT of the abdomen, or
both of those, or neither of those.

DR. HEETDERKS: Both of those and —

DR. HUFF: But not necessarily the diagnostic part.

DR. HEETDERKS: Right, and would have a way of associating with that image,
the radiologist report of that image, and if you will that there would be a way
of putting all of those pieces together in an agreed upon fashion that could be
communicated widely. But I think what would not, what I would say is not part
of it would be, if you will, a description of what are the vocabularies of all
of the —

DR. HUFF: What you could see inside there.

DR. HEETDERKS: All the things that you could see.

MR. BLAIR: Other comments or questions?

DR. FITZMAURICE: In looking through the technologies and looking through the
domains of faxes and material that could be incorporated in electronic health
record, I notice that you don’t have an example of imaging software such as
Adobe Acrobat and PDF files, yet as I search through there if you have
something come up you’ll need to describe what is in such a file. Is that not
medical, not clinical, or outside the scope of your work?

DR. SWAJA: No, the things that you just mentioned, PDF, for example, HTML,
XML, those kinds of things, yes, they are part of this and they would be
considered. We’ve concentrated here, the comments are focused on images, but
those types of information, the computer generated data, the digital data, is
all part of this also.

MR. BLAIR: Steve, have you begun to craft a phrase?

DR. STEINDEL: There’s nothing that’s required for it. We don’t comment on —

MR. BLAIR: Well, if there are no other comments or questions then I think we
could go on to our next category of preliminary, I can’t even say it’s
preliminary recommendations, it’s preliminary information about our next topic,
population health.

Agenda Item: CHI Preliminary Reports – Population
Health – Dr. Steindel

DR. STEINDEL: Thank you, Jeff. I’d like to start my comments on the
population health domain by repeating the comment I just made, we don’t report
anything on preliminary reports. That’s putting on my NCVHS hat and taking off
my CHI hat.

The population health domain is a domain that started back last spring but
was put off several times, basically because we thought we could get other
people to do the work in front of us. Unfortunately late this fall we found out
that we probably couldn’t, so the workgroup has met, it’s looked at the scope
of its domain, it’s decided to crawl into a rabbit hole and hide. So that is
our recommendation.

Now to be a little bit more serious, we’ve looked at our domain as public
health reporting, population health statistics, administrative data statistics,
and institutional health statistics. Of those they are the first two, public
health reporting and population health statistics, we’ve preliminarily reviewed
as being in scope. We’ve viewed administrative data statistics as being out of
scope. We have noted that institutional health statistics are both in and out
of scope, we consider them to be out of scope in the sense that we’re not going
to make recommendations on what an institution should do but we note that it’s
probably a good idea for them to do what we’re doing outside of the institution
as well, but that’s not a firm recommendation.

The approach that we have taken to this domain is that we have identified
those standard terminologies that are currently being used for population
health reporting, we did this by asking the members of the workgroup, which
constitute I’d say about a third of the HHS agencies, which are the major
agencies that are involved in population health reporting, we do have a
representative from DOD on it, Nancy Orvis(?), as a commenter. But we’ve asked
those agencies to just give us a list of the types of population health reports
they produce and within that list the standard terminologies that are used in
those reports. We note that that list is extremely non-exclusive, we made no
attempt to find every population health report that’s being used in HHS and
definitely not in terms of the country, or even all federal agencies. But in
that list we have given in the preliminary worksheet the standard terminologies
we have found that are being used. They include ICD-10, ICD-9, ICD-9-CM,
Classification-Medical Model, HL7 Terminologies, HL7 Vaccine List, ICD-10
E-Codes, ILD Classification, the NAACCR terminologies, NDC, RxNorm, Units of
various types and the VAERS codes for Vaccine Adverse Event Reporting. So you
can see this is an extremely diverse set of terminologies and we do not feel
that we’ve hit every one of them.

Our preliminary thoughts on this is the diversity of terminology needs found
in the workgroup’s investigation of population health reporting is leading to
the conclusion that a specific CHI recommendation is inappropriate at this

I’m opening the floor to questions and comments.

DR. FITZMAURICE: A question, Steve, is there something that has to happen
before a recommendation would be appropriate? Or is the scope so large that you
think maybe it ought to be cut into segments and bitten off like you’d eat an
elephant, a bite at a time?

DR. STEINDEL: I don’t know how we can approach it because actually we do not
know the scope of the domain, and one of the thoughts that the workgroup is
proposing is that a study be done, that we find out the scope of the domain,
and then maybe we can answer the question that you just asked. And if we can’t
recommend specific terminologies perhaps an investigation into how to do some
type of mapping or similar type of relationship between clinical terminologies
and the present population health reporting terminologies. And also when we
look at this from a population health point of view we’ve also identified a
need that has not been previously discussed with respect to mapping and that is
the requirement to relate new data to old data, and that’s a new aspect.

DR. FITZMAURICE: I can see the problem and I can see why you’d want to know
the whole scope because in a lot of the standards that have been proposed in
the other domains you probably have a lot of overlap, it’s just that it’s hard
to define the overlap until you can get a handle on the domain.

MR. BLAIR: Carol?

DR. BICKFORD: Carol Bickford, American Nurses Association. In light of the
previous presentation on imaging has the population health group talked about
the GIF representation of data or are you strictly looking at alphanumeric

DR. STEINDEL: I do believe that when we do a complete list we will find
needs for GIF. In the preliminary list we did it did not come up, but that does
not mean it’s non-existent.

MS. LESH: Kathy Lesh, the Kever Company. Steve, I know you’re aware of this
study out of CDC that looked at a concept coverage study of your website at CDC
and found out that there was a 50 percent gap in public health concepts in the
standardized vocabularies in the UMLS, so I think that would support that you
really need to go back to the drawing board and find out what the scope is and
where, the vocabulary doesn’t exist at this point in time in public health and
most of that would be encompassed in the population.

MR. BLAIR: Marjorie, do you have any suggestions or thoughts on terminology
standards for this area?

MS. GREENBERG: Well, I’m actually on this workgroup —

DR. STEINDEL: That will allow you to remain on the workgroup.

MR. BLAIR: Oh, I’m sorry, I didn’t really know.

MS. GREENBERG: And I guess this is preliminary because we’re taking
something back to —

MR. BLAIR: I’m sorry, this is conflict of interest and you’ll have to recuse
yourself? That was intended to be a joke, please Marjorie.

MS. GREENBERG: I think we are going to have some recommendations on next
steps and studies or investigations that need to be done, so I think that’s,
we’re not just throwing up our hands but as Steve said this is a very broad
area and as was suggested by the other speaker, too, that we know that there
are a lot of gaps in the vocabulary and the terminologies that cover this area.

I wanted to ask Steve something because I guess hadn’t, sometimes when you
see a whole report and then you see the condensed version something strikes you
but didn’t before, and that was that administrative data and statistics are
shown as out of scope, I think billing data obviously is out of scope, for
example, some ways like vital registration data are seen as administrative data
and I don’t think they’re really out of scope.

DR. STEINDEL: I totally agree with you, they’re not out of scope, it’s just
that we were, I think we were thinking about administrative data in the sense
of billing data, and we consider obviously vital statistics one of the most
important parts of population health statistics.

MS. GREENBERG: Because there are a number of populations statistics that are

DR. STEINDEL: Are derived from administrative systems —

MS. GREENBERG: — administrative systems that aren’t necessarily billing.


MS. GREENBERG: So we might want to kind of clarify that.

DR. HUFF: I mean at the level I’m just sort of thinking again about my day
job at IHC and sending this kind of information, exchanging this kind of
information, it would seem like one area that would be very useful would be
standardization of the names of population, so I mean I know the name, people
are working on the names of codes for all the diagnoses that can be in all of
the serum sodiums and measurements and findings and stuff like that. And in all
that you’re doing those names are going to be similar and I guess what I would
see as being very useful is to now if I were going to report that information
on a population how do I do that? One way to do it is you take all of the
things that exist in ICD-9, you say this the sum of people who had that in my
population, and so you would end up basically replicating all of the ICD-9
codes with a code that said this is the count of people with that diagnosis or
something like that.

But I suspect what, I mean the focus that would be very useful is to say how
do you do this population data, and it might be that what you’re really doing
is deciding the structure that will allow you to say what was the, you’re
making a small information model that says what was it I found and how many
people had it or whatever the descriptive characteristics are that need to be
taken together to describe what it is you’re reporting. But I don’t know if
that’s something you want to do or not. Again, at a very superficial level not
being an expert at all in these population things I would have said oh, well,
HEDIS should be here because HEDIS is reporting population statistics about how
many people had mammography, how many people had something, and those HEDIS
codes to me would have been something that were not being covered in a
comprehensive sense by SNOMED or LOINC or by ICD-9 codes because it’s the count
of people who had a particular thing, not the name of the particular thing that
this patient had. Is any of that relevant to what you’re, to the scope of what

MS. GREENBERG: It this a question and answer issue again?

DR. HUFF: No, I don’t think so, it’s just what, it is a domain question
again. I assume that the goal of this was to be able to transmit in an
unambiguous way population data so there are two people aggregating data and
one agency wanted to know the population statistics, and is very similar to
reporting on clinical trial data, I mean that’s one of the things that’s
different about clinical trials then regular patient data, is that what I’m
communicating actually how many people had this complication that were taking
this drug, how many people had, and it seems that is a bounded problem where
you could make, you could form a strategy about how you wanted to do that or
whether it’s too early and we just can’t do that yet.

DR. STEINDEL: I think, Stan, the workgroup is looking at this as more as how
do we derive population health data from clinical data.

DR. HUFF: So it’s more process oriented.

DR. STEINDEL: Yes, is there a terminology and that was one reason why we put
this off for a while was because we wanted to see what the recommendations from
the other workgroups would be so for instance for diagnosis we could point to
the diagnosis recommendation, and I was going to be sneaky as the population
workgroup chair and just say ah, for diagnosis we can just use theirs. It turns
out as we looked at it and we looked at the problem more and more we realized
that was very naïve.

MS. GREENBERG: In some cases we can do that.

DR. STEINDEL: In some cases, and we do note that there are cases in
reporting that it is specific, it’s a one to one relationship and usually
that’s fairly clear. But in a lot of other cases like for instance the
relationship between ICD-10 codes and clinical codes. In some cases it’s a one
to one relationship, in some cases it’s a relatively simple map two codes
combined, in other cases it can be quite convoluted.

MS. GREENBERG: Another issue, too, that I guess is in the report, but I mean
it definitely requires some thought is there are cases where clinical data
could be reported but you might have some people then reporting using say
SNOMED, but other people because they are using SNOMED, but then other people
like on causes of death or something, but other people are just reporting the
terms that they use, not these standardized terms, but terms. And then do you
end up, and then do you put both of them into the automated system to then
create the ICD-10 codes, which is how we do most of it now? If they’re
different, data is coming from a different way, like coming at the term level
or coming at a standardized term level or at a non-standardized term level, or
maybe just at the classification level, and then do you have comparable data. I
mean there are questions here so these are all ones that need to be explored.

MR. BLAIR: Any other questions or comments? Okay, we could go to the last
document and get a chemical reaction from this, Steve, maybe you could take us
to our next one.

DR. STEINDEL: I was just noting, why did we leave chemicals for last? I’m
wondering if that’s what we need at this time, at least caffeine.

Agenda Item: CHI Preliminary Reports – Chemicals –
Dr. Steindel

DR. STEINDEL: The preliminary report is on the chemicals workgroup. The
chemicals workgroup was assigned to identify a terminology that can be used for
chemicals other then drugs. If you’ll recall the FDA terminology is being used
to identify those chemicals that are being used for drugs, so we have the world
of chemicals that are non-drug that as the workgroup discussed this really do
not appear that often in medical records, but they occasionally do, mostly
associated with environmental conditions or poisoning, toxic events, but
generally do not appear that much in medical reports. But this was a domain
that we were charged to look at, we did look at this domain, we have made two
conclusions with respect to it.

The first is the chemical abstract service number is essentially the number
used in the United States and perhaps the world to identify a chemical. There
are approximately 22 million CAS numbers assigned. The problem with the CAS
number is that they have restrictions on its use for non-regulatory purposes.
The CAS number can be freely used for regulatory purposes, we are viewing
medical exchange of information as non-regulatory, and consequently the CAS
number is ruled out. The intellectual property considerations are vast and the
National Library a number of years ago tried to negotiate an agreement to use
CAS numbers more freely and have advised us that it was very difficult to get
that negotiation going, so we have excluded the CAS number from consideration.

There are two other terminologies we are required to look at SNOMED and the
other terminology that commonly has chemicals is MESH, they both have
approximately just under 20,000 chemicals listed, a large number of them are
drugs, but they still have a large number that are not drugs. You have noted
that I said there’s 22 million chemicals identified by CAS so you can see that
there’s a large number that are not identified in SNOMED and in MESH, and our
reaction to the chemicals that are listed in both SNOMED and MESH is that both
of those terminologies tend to be reactionary, and by that I mean when a
chemical has been shown to have importance in medicine it appears in one of
those terminologies and we felt it was important to select a terminology that
was proactive, that the chemical would already be listed so that if the person
was doing messaging they would not have to have it added, and there are
numerous terminologies that do have a more exhaustive list. As I note there are
numerous federal and private lists that do have chemicals.

The workgroup is focusing on a list that’s provided by the Environmental
Protection Agency that’s used in the regulatory realm and has about 80,000
chemicals in it, we are investigating its potential use for medical purposes.

And that is where we’re standing right now, I’ll take any questions.

DR. BICKFORD: Carol Bickford, American Nurses Association. Does chemicals
include some of the complementary and alternative therapies? For example herbs
and botanicals and some of those concoctions?

DR. STEINDEL: To a certain extent, the only thing I can say to that is it’s
a definite maybe. We’re looking at chemicals as the actual chemical and in many
cases these herbs and botanicals are associated with specific chemicals and in
that case they would be listed. But if it’s basically a preparation or
something like that mostly likely it would not appear in the list.

I have to note that there might be in phase two of CHI kind of a bit of a
creep in this domain because some of those do start appearing for medical
purposes when they are found to have toxic events associated with them. So in
that case they might need to appear.

MR. BLAIR: Other comments or questions?

MS. LESH: Kathy Lesh, the Kever Company, I have a question about the MESH,
were you looking at the supplemented chemical list or just the straight MESH

DR. STEINDEL: The straight MESH list.

MS. LESH: You’re aware of the supplemental chemical list?


MS. LESH: Because any time it shows up even once in the literature —

DR. STEINDEL: But that gets to the point what we feel it is reactive and not

MR. BLAIR: Other comments or questions? Well, I’m not going to belabor or
linger on. WE have completed all of these, is there any comments that anybody
would like to make before we adjourn?

DR. STEINDEL: No, we don’t have adjournment, we’re an hour early for the
next part of the agenda, which is supposedly the draft CHI letter.

MR. BLAIR: In which case we could wind up probably taking a break before we
do that I would think and wait for Simon to return.

DR. STEINDEL: Simon is supposed to be back at 4:30.

MR. BLAIR: I think that’s what, ten or 15 minutes from now? Okay, any other
comments on what we’ve gone through before we break?

DR. STEINDEL: The next meeting site.

MR. BLAIR: Okay, well thank you every one and let’s go ahead and break until
4:30 and this has been a marathon, I can’t believe we ate the whole thing.

[Brief break.]

Agenda Item: Draft CHI Letter – Subcommittee

DR. COHN: — probably just as well that we handle them, actually do we have
one, two —

MR. BLAIR: We did our voting.

DR. COHN: Just the wordsmithing —

DR. STEINDEL: And I gather we’re going to not submit it until after the
January session, so this is just very preliminary wordsmithing.

DR. COHN: Exactly. I think we’ll probably want to sort of see where we are
and it’s probably something we’ll want to send out to the full committee as we
prepare for our full committee meeting, so at least I’ll have this as

MR. BLAIR: Steve, are you aware that there were two finals that Simon was
not here for?

DR. COHN: I voted. I think we sort of need to look through and see where we
are here. Steve, do you want to read?

DR. STEINDEL: The first paragraph is our standard paragraph, do I need to
read that?


DR. STEINDEL: Thank you. Now I do have a problem with the second, the next
paragraph, the NCVHS has the following comments on the attached set of CHI
domain area recommendations. The problem that I had with that was we actually
only modified two of the recommendations and I thought I could get away with
only attaching two, but the way I read it is I needed to attach them all. But I
think we actually have to.

DR. COHN: I think we need to, and I also think it will be important —

DR. STEINDEL: I agree with that —

MS. GREENBERG: — then people have access —

DR. STEINDEL: This was basically my laziness, but it didn’t work, so they
are all attached.

DR. FITZMAURICE: I noticed that all of them start with NCVHS concurs with
the —

DR. STEINDEL: That was the style we used before and it really worked when we
had like two or three but now we have close to, it will be about 12 —

DR. COHN: Actually, just wordsmithing if you basically put a period at the
end of the sentence where the NCVHS has the following comments on the attached
set of CHI domain area recommendations, period. And then it say the NCVHS: —


DR. COHN: Do we all, are we concurring with all of them? If we’re concurring
with all of them —

DR. STEINDEL: We do concur with each one of them but I agree with the style.
The first one is with the anatomy and physiology domain as modified, and then
we note the need to revisit the physiology domain in 12 to 18 months and begin
with an evaluation of the domain definition.

DR. COHN: And actually and that begin I think.

DR. FITZMAURICE: How about instead of we note that just say we also concur?

MR. BLAIR: It’s there, isn’t it? Oh, you’re saying in the next sentence, we
also concur with. I see.

PARTICIPANT: And that this process begins, or this examination —

DR. COHN: Oh, you mean that process begins —

PARTICIPANT: Examination, I have —

MS. GREENBERG: When you say as modified then you will attach the —

DR. STEINDEL: Yeah, there’s an attached report with the modifications.

MS. GREENBERG: Which is the CHI report —

DR. STEINDEL: In mark-up format.

MS. GREENBERG: Marked up. And then does it go back to the CHI Council? How
does that work? Does the report get modified —

DR. STEINDEL: I actually think that’s probably in the domain of the CHI
people, in this particular case the modification was simply change of the date.

MS. TRUDEL: I think if they’re minor changes we can at least let the council
know what the changes were and find out whether they feel the need to
re-ballot, which for the most part I don’t think they will.

DR. STEINDEL: So we have this, do people agree now with the wording of the
second sentence as its up there? We also concur with the need to revisit the
physiology domain in 12 to 18 months and this process begin with an evaluation
of the domain definition.

DR. FITZMAURICE: How about and that this process begins —

MS. GREENBERG: Beginning with an evaluation, that’s good.

DR. COHN: And maybe it’s beginning with a reevaluation of the domain
definition is really what we’re talking about.

MS. GREENBERG: I don’t think you need that and that, if you just put a comma
after months and then say beginning with a reevaluation of the domain

DR. STEINDEL: Is everybody happy with that? We also concur with the need to
revisit the physiology domain in 12 to 18 months beginning with a reevaluation
of the domain definition.

Okay, the next bullet is concurs with the CHI recommendation for the billing
domain as modified and there are a couple of modifications in there, mostly
having to do with identifiers. I can go to the report and specifically show

DR. FITZMAURICE: I’m thinking if the Secretary is specifically receiving
this letter he’s not going to know what those modifications are, might they be
modified by the end of January so that the full committee can agree with it
without the as modified?

MR. BLAIR: I think at the level of the Secretary my thought is that just the
fact that there’s concurrence is about all he cares about, I don’t think he’s
concerned about the detail.

DR. FITZMAURICE: Or if he hands it to somebody they’re going to say alright,
what were the modifications.

MR. BLAIR: But there’s an attachment there that shows the modifications.

DR. FITZMAURICE: Okay. Otherwise it’s like it’s hanging out there.

DR. STEINDEL: The first sentence says has the following comments on the
attached set of CHI domain recommendations, and we’re referring to the
modification as appearing in the attachment.

DR. FITZMAURICE: So they will see the original modification and they’ll see,
they’ll see the original and the modification of it?

DR. STEINDEL: It’s done in mark-up format, word document.

DR. FITZMAURICE: I’ve never seen something go to the Secretary in mark-up

DR. STEINDEL: The last one did. Okay, the next one, concurs with the CHI
recommendation to not adopt a terminology for the medical devices and supplies
domain at this time. We recommend HHS further investigate device type as a
component of device identification.

DR. COHN: I agree, I’m just trying to think of whether we need to say
additionally we recommend, just to somehow distinguish it from the fact that it
isn’t really a CHI recommendation.

DR. FITZMAURICE: We independently recommend.

MR. BLAIR: We did something by ourselves.

DR. STEINDEL: Do we use HHS or DHHS?

In the next one, concurs with the CHI recommendation for the nursing domain
as presented.

Concurs with the recommendation to defer the history and physical domain
until the next phase of CHI.

Concurs with the recommendation to not adopt a terminology for the
disability domain. We agree with the need for a future research agenda, concur
with the basic list presented, and also recommend addition of investigating the
question and answer style format for aspects of this domain. We request that
future research be inclusive of all domain stakeholders.

MR. BLAIR: Two pieces, where you said to not adopt, I think you have to say
not adopt it at this time, that’s number, you see what I’m saying because
otherwise it’s almost as if cancel the domain and that’s not what we’re saying.

DR. FITZMAURICE: Maria, what about split infinitives? Are they acceptable
these days? I’m thinking about not to adopt versus to not adopt.

MS. FRIEDMAN: I can live with it.

MR. BLAIR: To not adopt —

DR. STEINDEL: Or not to adopt, we’ll make Mike happy.

MR. BLAIR: Could you read again where it said inclusive of?

DR. STEINDEL: We request that the future research be inclusive of all domain

MR. BLAIR: Is it a problem if we say inclusive of the differences among?

MS. GREENBERG: Well, if you include them all, all the stakeholders and their
various —

PARTICIPANT: Does that mean you only want them to look at the difference or
do you want to look at all of them and consider the difference?

MR. BLAIR: It’s the latter, I want to look at all and consider the
differences, and consider the differences.

DR. FITZMAURICE: Do you mean instead of investing you mean investigating?

DR. COHN: Somehow we need to say that a little better, that particular

DR. STEINDEL: Which one? The second sentence?

DR. COHN: Investing the question and answer style format for aspects of this
domain, doesn’t sound quite right.

DR. FITZMAURICE: I would take away addition and say we recommend
investigation the question and answer style format, question style format used
by such systems as SNOMED, I mean such systems as LOINC? That may be too

DR. COHN: I’m just trying to think of what, the question and answer style
format —

DR. FITZMAURICE: The use of, investigating the use of the question and
answer style format.

DR. COHN: Okay. I guess I, I mean it’s question and answer style format,
should that be in parentheses? I mean that’s not a usually way that, I’ve not
seen —

DR. FITZMAURICE: I think that would be good in quotes.

DR. COHN: Good in quotes.

DR. FITZMAURICE: It exists, it’s not just something we’re saying off the
cuff, it exists.

DR. COHN: I guess I’m just wondering, we could describe this as aspects of
this domain, for parts of this domain, to solve —

DR. FITZMAURICE: For appropriate parts of this domain? Kind of weasel word
the question away? Investigate the appropriate use of the question and answer
style for this domain.

DR. COHN: — aspects of this domain. Well, I guess we were primarily talking
about the questionnaires, but we really didn’t want to start tying their hands
in terms of how they might apply it.

PARTICIPANT: [Inaudible.]

DR. COHN: No, actually I don’t think it is in the modifications, I don’t
think we made modifications to this report.


MS. GREENBERG: I think we need two sentences here.

DR. STEINDEL: We did not make modifications to this report.

MR. BLAIR: I think Marjorie is going down the right track, she’s saying we
need two sentences.

MS. GREENBERG: Say we agree with the need for a future research agenda and
concur with the basic list presented, period. We also recommend that the
workgroup, or CHI, investigate how —

MS. TRUDEL: And it’s not the use, it’s really the appropriate application.

DR. FITZMAURICE: That’s a good word.

MS. GREENBERG: Or investigate how a question and answer style format could
facilitate, could be used, to facilitate the capturing of information for this
domain, something like that.

PARTICIPANT: I think that’s good because that gives the flavor —

MS. GREENBERG: They’re somewhere else over there, but definitely we need a
second stand alone sentence about —

MS. TRUDEL: And then I think it ought to be in addition we request —

MS. GREENBERG: You could say investigating how the question, I wouldn’t say
style —

DR. FITZMAURICE: — add specificity to this domain?

MS. TRUDEL: Because we’re not saying that we’re looking at whether questions
and answers are good or not, we’re saying that they’re inevitable, we have to
figure out how to make it work.

MS. GREENBERG: That was not actually something that was explicitly explored
by the workgroup, now the committee is telling the workgroup to think about

MR. BLAIR: For my benefit when you are finished Steve could you read it?

DR. STEINDEL: I’m not finished because I haven’t heard what to put down.

MS. GREENBERG: I think and facilitate capturing information for this domain,
or something like that.

DR. FITZMAURICE: Facilitate exchanging information. They can facilitate
exchanging information.

MS. GREENBERG: Well, it’s even the capture, let alone the exchanging. Maybe
the representation of information for this domain.

DR. COHN: [Inaudible.]

MS. GREENBERG: That leave it open as to whether it’s the exchange of
information, the collecting of it, the representation —

DR. STEINDEL: Okay, let me read it for Jeff then. We also recommend
investigating how the question and answer style format can facilitate
representation of information in this domain.

MR. BLAIR: And then the rest of it?

DR. STEINDEL: Is still we request that the future research be inclusive of
all domain stakeholders, Marie just added that —

MS. FRIEDMAN: And consider their differences?

MR. BLAIR: Yes, thank you.

MS. FRIEDMAN: Or while considering their differences or —

MS. GREENBERG: — different needs and perspectives?

MR. BLAIR: Yes. Thank you, very much.

MS. GREENBERG: I would say, how about the word request? It almost sounds
like CHI resisted and they didn’t. I would say recommend, we recommend that the
future research and is it clear that that’s also the investigation? Because now
we’ve got research in one sentence and investigation in the other. Just say
that the future work, research and investigation, I wouldn’t want that to only
refer back to the second sentence and not the third.

DR. COHN: Actually this isn’t too bad.

DR. STEINDEL: Future studies?

MS. TRUDEL: I think we liked activities better then studies.

PARTICIPANT: It’s still not clear to me coming from a research environment
whether you mean research like you normally think of it in that sense or
whether CHI —

DR. COHN: I guess, I’m looking at this one, I guess I’m just trying to think
in my own mind what does, I mean I understand what the last part of the
sentence means I just don’t know what the first part means. What does be
inclusive of all domain stakeholders mean exactly in this context?

DR. FITZMAURICE: — federal stakeholders, those who use the terminology? The
federal programs?

PARTICIPANT: Wasn’t that only to include the ones that we don’t normally
think about like the environmental and the —

MR. BLAIR: Well, I think that when I was saying all stakeholders, the point
I was trying to make when we added that was that it be the health care
providers and therapists in addition to the needs of public health and

MS. GREENBERG: Well, it always was though, that’s where I think it wasn’t
clear, we were never just focused on public health, in fact probably the
primary focus is on —

DR. COHN: I guess I’m misunderstanding because I’m reading this almost as
being, since it has to do with their different needs and perspectives I was
presuming that we were talking about different people with different types of
disabilities —


DR. COHN: And so I was thinking well geez, we’d want, I mean are we —

MR. BLAIR: That’s correct.

MS. GREENBERG: As well as people who are involved, who work with people with
different types of disabilities.

MR. BLAIR: And different uses of that information as well.

MS. GREENBERG: So it’s the whole range of stakeholders for disability data.

DR. COHN: Okay, so what does inclusive mean then? I apologize, I don’t mean
to bang on this one, I’m just, I can just imagine a large auditorium filled
with representatives of every sort of whatever and I’m just wondering do we
really want that be inclusive of all domain stakeholders? Or —

MR. BLAIR: Do you want to say consider the needs of all stakeholders?

DR. COHN: Consider the needs of all domains?

PARTICIPANT: There are a lot of different stakeholders —

DR. COHN: Or do we want to talk about consider the needs of all domain
stakeholders? I mean that makes a lot more sense to me then having to have 100
people on this committee, which I could imagine.

PARTICIPANT: [Inaudible.]

DR. COHN: Do you agree with that, Jeff?

MR. BLAIR: Yeah, the only piece I don’t want to lose with that is the tack
on phrase including their differences, so I don’t want to lose that.

DR. COHN: Let’s see what we’ve got here.

MS. GREENBERG: Well, you’ve already got inclusive, consider the different
needs and perspectives of all domain stakeholders.

MR. BLAIR: Okay, when you say it that way, there you go, you’ve got it in
there, consider the different needs and perspectives, that’s, you’ve got it.

DR. STEINDEL: Okay, the way I have this worded right now is we further
recommend that future activities consider the different needs and perspectives
of all domain stakeholders.

MR. BLAIR: Excellent, thank you.

MS. GREENBERG: I think that’s good.

DR. STEINDEL: Okay, should I reread the whole section or should we just move
on to the next one?

DR. COHN: I think we can go on to the next one.

DR. STEINDEL: Concurs with the recommendation for the genes and protein
domain as noted for the human genome, and note the need for explicit comment on
the lack of terminology for the remaining sub-domains.

The next sentence is just in bold for me more or less that we’ve got to come
back to it, we recognize that work is still underway on clarification of
licensure terms for use outside of the federal government, and the notation to
revisit in January for clarification.

DR. COHN: And I presume that first sentence is going to get cleaned up also.

DR. STEINDEL: I’m ready to clean it up. The first sentence I believe is the
one that we should focus on.

MS. FRIEDMAN: You can take out that second noted, as noted for the human
genome as well as the need for —

DR. COHN: That’s actually a placeholder, we’re not wordsmithing that
sentence. I mean basically we need to list the other domains that are not, I
mean basically we basically concur with the recommendation for the human genome
and we basically also need to concur separately that there is no terminology
for the other sub-domains I think is what —

DR. STEINDEL: No, actually what we’re referring to here, and I don’t agree
with the way I just reworded it, what we were commenting on was that the
document that we were presented with didn’t really make an explicit statement
that we are lacking terminology in the other sub-domains. And we were requested
that an explicit statement to that effect appear.

What I’ve said as a separate sentence, we recommend that an explicit comment
on the lack of terminology for the remaining sub-domains be added. And I would
prefer that we don’t try to do any crafting on the sentence in bold at this

DR. COHN: Okay, that sounds, we don’t have the information.

DR. STEINDEL: What they may do is they may actually add the information to
the report in January and we’ll delete the sentence entirely. Cynthia noted
that they were investigating it.

Concurs with the recommendation for the diagnosis and problem list domain
and request the addition of ICPC to the recommended terminology for early
mapping efforts.

DR. COHN: I think it’s actually a period after domain. We further recommend
the addition of ICPC to the recommended terminologies for early mapping, is
there a list of —

DR. STEINDEL: Yeah, there was.

DR. COHN: Where?

PARTICIPANT: It wasn’t meant, it was just an example of a list but they
brought that up several times, it was just for example and then Steve asked
that they specifically name it in that list.

DR. COHN: Well, how about if maybe we further recommend that ICPC be
considered for early mapping or priority mapping to, I’m not sure, what is it
being mapped to?


DR. COHN: To SNOMED, okay. Further recommend —

MS. GREENBERG: I mean if there is a map between SNOMED and ICD-10, although
it’s not an international map, it’s a UK map, and there’s also ICPC has been
mapped completed to ICD-10 as well. You’ve got some foundational work done

DR. STEINDEL: The last one is concurs with the recommendation with the
non-laboratory interventions and procedure domain as presented.

And that’s it.

DR. COHN: That’s it. Okay. Are we comfortable with that?

MR. BLAIR: The dirty deed is done.

DR. COHN: A lot more before it’s done. Okay, well Steve I want to thank you.
So basically we are on time here, it’s actually we’re 15 minutes early, so
tomorrow morning we start off at 8:30 and Maria I think you’re on board and
we’ll hopefully be read to adjourn by 12:30.

[Whereupon the meeting was recessed at 5:15 p.m., to reconvene the following
day, December 10, 2003.]