American Health Information Community

Population Health and Clinical Care Connections Workgroup Meeting #17

Wednesday, May 16, 2007

**Disclaimer**

*The views expressed in written conference materials or publications and
by speakers and moderators at HHS-sponsored conferences do not
necessarily reflect the official policies of HHS; nor does mention of
trade names, commercial practices, or organizations imply endorsement by
the U.S. Government.*

**[\>\> Judy Sparrow:]{.underline}**

Thank you, and welcome, everybody, to the fifteenth meeting of the
Population Health and Clinical Care Connections Workgroup. We are
designed to meet the requirements of FACA, which means we\'re operating
in the public domain. The notice of the meeting was registered in the
Federal Register. We will be Webcast, and a transcript will be made
available. And also at the end of the meeting there will be an
opportunity for the public to make comment.

Let me just remind the members for those of you on the phone to please
speak clearly and distinctly and state your name before you speak. Let
me just ask Matt to introduce those on the phone and then we\'ll
introduce the members here at ONC.

**[\>\> Matt McCoy:]{.underline}**

On the phone today, LuAnn Whittenberg from DoD. Theresa Cullen from the
Indian Health Service. Michael Barr from the American College of
Physicians. Laura Conn from ONC. James Pearsol from the Association of
State and Territorial Health Officials. Scott Becker from the
Association of Public Health Labs. Marty LaVenture from the Minnesota
Department of Health. Lisa Rovin from the FDA. Michelle Meigs from the
Association of Public Health Laboratories. Steve Solomon from CDC. John
Lumpkin from The Robert Wood Johnson Foundation. Shu McGarvey from ONC.
Maria Rudolph from the American College of Physicians. Brian Keaton from
American College of Emergency Physicians. And I believe that\'s it. Is
there anybody that got left out?

**[\>\> Judy Sparrow:]{.underline}**

Thank you, Matt. Let me just mention, Chip Kahn is not on the telephone
phone today. Chip is stepping down as co‑chair. As most of you probably
know we\'re in the middle of planning for the AHIC successor which will
take a number of months, and Chip is going to be devoting a lot of
effort to that, to the successor planning. Meanwhile we are working with
the Federation of American Hospitals to locate a provider to substitute
for Chip, American Hospital Association, sorry, to locate someone to
take his place on the Workgroup.

With that I\'ll have the people in the room introduce themselves here.

[**\>\> Kelly Cronin:**]{.underline}

Kelly Cronin from ONC.

[**\>\> John Loonsk:**]{.underline}

John Loonsk from ONC.

**[\>\> Amy Helwig:]{.underline}**

Amy Helwig with AHRQ.

[**\>\> Angela Fix:**]{.underline}

Angela Fix with ASTHO.

[**\>\> Judy Sparrow:**]{.underline}

I\'ll turn it over now to Steve Solomon and John Lumpkin.

[**\>\> Steve Solomon:**]{.underline}

Thank you very much. John, did you want to make some opening comments?

**[\>\> John Lumpkin:]{.underline}**

I think I just wanted to start off and welcome everyone for attending,
that we are actively engaged in two components of our work plan. The
first is the adverse events activities which the Workgroup will report
on first, followed by our response management, and we\'re going to be
talking about this for the next steps but I wanted to remind everyone
that we do have a hearing where we will have presentations in person, so
I just wanted to remind people that on June the 15th \-- isn't that
correct?

[**\>\> Judy Sparrow:**]{.underline}

Yes.

[**\>\> John Lumpkin:**]{.underline}

In Washington, so we\'ll encourage representatives to make their plans
to be able to attend that session. Steve?

[**\>\> Steve Solomon:**]{.underline}

Okay. Are we moving to the adverse events recommendations?

[**\>\> John Lumpkin:**]{.underline}

Unless you have opening comments.

[**\>\> Steve Solomon:**]{.underline}

No, just echo what you said. I wanted to report out on the work of the
ad hoc group on adverse events recommendations. We took the testimony,
you recall back in February, the group has met several times by
conference call, and I just wanted to make a few points. Those are on
the slides.

First let me say that we recognize, particularly in light of the
Secretary\'s comments at the last full AHIC meeting, the importance of
truly focusing on developing recommendations that can demonstrate some
forward progress within a reasonable period of time and that really do
have an impact on demonstrating the effectiveness of electronic health
records in the detection and reporting of adverse events. With that in
mind, I then want to talk a little bit about the scope of the work as
the committee has discussed it, make a couple of discussion points, and
then go over the timeline for delivering a successful product.

As was discussed in the testimony \-- talking about scope \-- as was
discussed in the testimony, adverse events is a term that is used very,
very broadly to discuss a great many things that are adverse
consequences of the receipt of healthcare or healthcare services. In the
interest of defining a scope that is most effective for leading us to a
successful conclusion with these recommendations, we have clearly
included adverse drug events as part of the scope. Devices including
biologics, drugs and biologics devices and tissues and organs that would
almost certainly be within the scope of these recommendations. The
committee is still discussing whether or not healthcare-associated
infections should in fact be part of the scope of these recommendations.
There is a strong argument to be made for including
healthcare-associated infections and that argument is that they are
complementary in many ways to a focus on drugs and devices. But again we
do want to come up with recommendations that are focused and measurable
and the narrower the focus obviously the more successful we\'re going to
be in delivering very specific actionable recommendations. The committee
is still debating that and we will, by the time we come to you with a
first draft then, we will have made that decision for your review.
However, if anyone, any member of the committee would like to weigh in
on that either today or subsequent, I\'ll be happy to hear from you on
that.

Clearly out of scope are things which are often referred to perhaps as
medical errors. These are process‑related events that occur in
healthcare settings that were the subject, obviously, of a number of
reports and is very much in everyone\'s consciousness. It is one element
of what is called patient safety. But the process‑related issues which
are being addressed in many different venues, we have chosen to put out
of scope for this set of recommendations. So we\'ve come to those
conclusions.

Moving on to issues related to adverse events detection. During the
testimony we had really superb testimony offered from the folks at
Regenstrief and superb input from David Bates and John Einbinder. One
area that the committee has discussed extensively is to come to the
conclusion that again within the scope of these recommendations what
we\'re talking about is not adverse event detection. That would include
identifying previously unsuspected or unexpected adverse events,
particularly as we\'re talking about drugs and devices or related
activities. The complexity of doing that and the level of detail that is
needed to do that, we have taken out of scope. So that when we\'re
talking about adverse event detection, we\'re talking about, for
example, what FDA will be moving ahead with with post-marketing
surveillance. Not limited to that, but really an identification on
things that may be expected or suspected adverse events as well as being
able to respond to signals, for example, if someone brings up an issue
and says we are suspicious that we are seeing a consequence of
administration of this drug, we can then query that or assess that in a
very targeted fashion. But simply casting a very wide net and saying
we\'re going to do what is essentially data mining for unsuspected
events would not be in scope. So we would then be looking for specific
outcomes and using the adverse event data to look for specific results.

Second issue on adverse event detection is to really promote and
especially to get best practices and learning from existing pilot
projects, demonstration projects, and work that is going on in this
area. We heard some testimony about that. The VA, we heard, has a
developing system which really is extremely promising in this regard and
we certainly want to use these best practices and the learning from the
work that has already come and leverage that through the NHIN pilots
that we\'re expecting to come on line later this year. So again take
advantage of work that has already been done, continue to promote those,
and especially to take those that have been already learned and
disseminate those as best practices and adapt that for wider use.

A third issue that came up is what is meant by the term data‑driven
triggers. That term is used and the committee has talked a little bit
about what that may mean. I think the sense as we\'re discussing it now
is the use of data in a way that has in the past sometimes been called
substitute data or looking for a constellation of findings in the
biosurveillance domain that\'s called syndromic surveillance, but
looking for particular constellations of findings in the data that would
suggest an adverse event, and how to make a specific recommendation
around that is something that we\'re working on language very
specifically for.

Let me move on to the question of adverse event reporting.

[**\>\> John Loonsk:**]{.underline}

Steve, it's John Loonsk. Just to add to your point, in some contexts
that term is used to refer to some data that may exist in the electronic
health record that indicate a need to accumulate more data or report on
something but may not be the reported data themselves. So the trigger is
the data that would occur as a normal part of clinical care that exists
in a record that sponsors, if you will, or initiates, triggers a
subsequent activity, whether that be the reporting of those data or at
times the reporting of, augmenting with additional data, developing a
case report form or whatever that may be, or investigation.

[**\>\> Steve Solomon:**]{.underline}

Thank you John. That is right on the point. And as I was saying in the
healthcare-associated infection world, those are sometimes referred to
as surrogate data. May not apply here but that\'s the term that\'s used
in the infection control world. So your point is right on. Thank you.

Moving on to adverse event reporting, obviously this is a major issue in
moving data and is the focus of a lot of our work. Moving data out of
the clinical sphere into the public health sphere, recognizing
absolutely the need for standardization and harmonization of standards
for data, messaging, and the reporting of adverse events. There\'s a
tremendous amount of work going on. We have some superb testimony about
the development of the ICSR and the VAERS and the fact that those are
already harmonized. I think we\'re looking at a recommendation that
would really support and promote the continued use and dissemination of
the standards so that these can be brought online for movement of these
data into the appropriate public health sphere at the earliest possible
opportunity. Again, following up on John\'s point we do need to achieve
this balance between active surveillance, that is, the push of data out
into the public health sphere, and the need for some kind of a
query‑based system as needed, including a look‑back capacity, which I
know has always been a source of a real need to ensure that we do have
the capacity to look back to individual cases where that is necessitated
by the public health need.

A second area is in fact to specify the roles of public health. We did
have discussion about the fact that drug and device monitoring is a
well-established federal role. States and local governments in general,
although there are some exceptions, in general do not have heavy
emphasis in their public health sphere on drug and device monitoring.
That is a federal role. There obviously are other state and federal
roles as we had testimony back in February around other aspects of
adverse events and so the recommendations here will in fact be dictated
by the final determination on scope. We will, of course, take into full
account the needs of state and local health agencies and we will want to
ensure that we are absolutely defining the varying roles with as much
precision and care as needs to be done.

We also talked about the pros and cons of a distributed versus a
centralized model. The difficulty of maintaining large datasets in a
centralized way, but in fact the need to have access to a broad range of
data to fulfill certainly the federal role in drug and device monitoring
at the very least, and we would need to have recommendations that ensure
that that capacity exists and that the federal government has access to
the data that is demanded by current and proposed regulatory authority
on behalf of the federal government.

I\'ve already mentioned the importance of the look-back capability in
the database and again to reiterate the point made about, the point made
about detection is that we really do want to not just promote pilot
projects, which is certainly something that we do want to encourage, but
to take the best practices, the learning, the experience of work that
has already been done, and be fairly vigorous in promoting the
dissemination of those.

[**\>\> Kelly Cronin:**]{.underline}

Steve, this is Kelly. Can I make just a couple of comments?

**[\>\> Steve Solomon:]{.underline}**

Sure.

**[\>\> Kelly Cronin:]{.underline}**

I think it would be helpful getting back to the centralized versus
decentralized approach to know what the public health needs are and sort
of almost like what are the requirements if we want to be able to access
data for improved medical product surveillance and adverse detection and
reporting, given everything else you said. Not necessarily interested in
data mining but interested in following up on serious adverse events
that have been perhaps reported into MedWatch or something that\'s been
noted in phase two or three of clinical trials and isperhaps under
consideration under a new drug application review process, where
there\'s a known or suspected safety problem and there\'s an interest
for public health to really have a much better understanding of the
magnitude of the risk, what are the requirements for public health? Is
there a need to only have access on a regional or local level, or is
there an interest in having multiple regions or multiple states perhaps
to really understand perhaps what both the numerator and the denominator
might be to get a real incidence rate for some of these events. I think
it would be very helpful for us in our subsequent conversations to sort
of continue those discussions because I think, well, we mentioned a
couple of times how valuable the two‑day Sentinel public meeting was and
I think FDA is really rapidly moving forward in their thinking in that
area. I don\'t think that in terms of health information exchange we
clearly articulated what the needs are for public health when it comes
to medical product surveillance and it\'s an opportunity to do that so
that when we do actually get down to specifying what kind of pilots
would most advance this area and we get down to considerations even in
the next year or so around certification of network services and
relevant certification criteria from a public health perspective, that
we have more of an understanding of what\'s really needed. And hopefully
if pilots were, would be funded over the next couple of years we\'ll
have real empirical evidence to base some of our judgments on. Just
getting back to the how do you manage data and where do you access it.
We really should try to drill down more on what really are the needs of
public health and how do we best address those through our process.

[**\>\> John Lumpkin:**]{.underline}

Superb point, thank you.

[**\>\> Kelly Cronin:**]{.underline}

Lisa, I don\'t know if you\'re on the phone, but you may have some
opinions on where we are now or what more we need to do vis-à-vis both
the moving legislation and where the thinking is so far on Sentinel.

[**\>\>** **Lisa Rovin: **]{.underline}

This is Lisa Rovin, FDA. Going back to the question of public health
needs, I think needs vary with the purpose. So it\'s a question that\'s
going to be very difficult to answer in the abstract. If there\'s a way
the question could be posed with more particulars, either with respect
to a particular NHIN pilot once you get those up and see what the
parameters are going to be, because you can imagine, I mean just taking
the small piece that you threw up about do you need something regional
or local, it completely depends on what you are looking at. You may need
national if you\'re talking about a drug that\'s in widespread use and
you may need extremely local if you\'re talking about an adulterated
food product that hasn't crossed state lines. So that's going to be a
question where the answer is going to be, like, all of the above,
depending. But if we can narrow down the question that would be great.

And then with respect to legislation, it\'s good to get this on the
table. Kelly is making an excellent point. For those of you who don\'t
know, there\'s legislation now moving on the Hill which would completely
change the way the FDA does post-market surveillance. And I\'m following
that so we\'re going to have to be very careful to make sure that
whatever recommendations come out of our subgroup to you guys and then
to the AHIC doesn\'t ‑‑ works with the legislation and I\'m not sure
what, how the timing is going to work on that. The Senate has passed its
bill, but the House is now just beginning its process. So as the
committee, as the subcommittee, our adverse events group moves forward
we\'ll also keep our eyes on that.

[**\>\> Kelly Cronin:**]{.underline}

Lisa, does the Senate bill have any provisions now that are relevant,
that we should be considering just as background information?

[**\>\>** **Lisa Rovin: **]{.underline}

Certainly. In fact, this is just really long, but the Senate bill has an
enigmatic \-- is that a kind way to put it? \-- has a section about
post-marketing surveillance, a public-private partnership. It\'s very
difficult to tell what they\'re talking about. The drafting is hard to
follow. The current version of the House bill does not have a
counterpart. But we\'ll have to see ‑‑ it will clearly be down the road
or even conferenced before we know if the final bill will have something
like that in it.

[**\>\> Kelly Cronin:**]{.underline}

That\'s helpful to know. There\'s probably no conference report
available yet either.

[**\>\>** **Lisa Rovin: **]{.underline}

The House is just starting its work.

**[\>\> Kelly Cronin:]{.underline}**

Right. Right. No, I meant a report-out from the Senate bill.

[**\>\>** **Lisa Rovin: **]{.underline}

Just the bill language.

**[\>\> Kelly Cronin:]{.underline}**

That's really helpful.

**[\>\> Lisa Rovin:]{.underline}**

So that\'s going to be a little bit of a dance. But we can dance that
dance.

[**\>\> Kelly Cronin:**]{.underline}

I think maybe before our next subgroup call it might be helpful just to
know what FDA\'s priorities are so that we might be able to structure
some of the questions around what you think is most important. And I
think some of that was identified in the Sentinel meeting and perhaps in
the white paper that\'s being drafted. So if we can be clear on what you
think is most important, that might shape some of our thinking.

[**\>\> John Lumpkin:**]{.underline}

This is John Lumpkin, I\'m back on.

**[\>\> Steve Solomon:]{.underline}**

Okay. Thank you. Let me finish up quickly if we can have more discussion
on the question of reporting again just to reiterate the importance, as
we always do, of standardization and the need for harmonization of those
standards through HITSP with regard to reporting of adverse events. I
want to then take you through the timeline quickly in the final slide.
We are giving you the update today, May 16th. Scheduled three more
meetings to resolve the issues that you\'ve heard discussed in the last
few minutes and present you with a draft set of recommendations no later
than June 15th. We would then take your comments and your input back,
turn that around and give you a final draft of the letter, of the actual
letter that we would prepare to present to the AHIC at our July 19th
meeting as we have done with previous letters, get any last comments on
that and then hope to present that to the full AHIC on July 31st as you
see on that slide. I\'ll be happy to take any other questions or any
comments or any input or recommendations that you have to offer on this
process. Thank you.

[**\>\> John Lumpkin:**]{.underline}

Any comments on the issues that were raised related to nosocomial
infections?

Well Steve, I think people are pretty comfortable, based upon the
discussion we just had, with where the Workgroup is coming and we\'re
looking forward to that final report.

[**\>\> Kelly Cronin:**]{.underline}

Actually, John, this is Kelly. I think the only thing that might be
worth noting, and I\'m sure we\'ll address this in our next subgroup
meeting, is that the testimony we had from the VA that showed a really
progressive, almost it seemed like a futuristic program in terms of
automating the surveillance of nosocomial infections, if we can engage
that program manager more in our deliberations in terms of what
standardization could be done in the near-term, what EHR functionality
is feasible and not difficult to consider to automate the detection and
reporting of these types of events, I think it would just be helpful to
drill down with somebody who has really spent the last couple of years
trying to develop a program with an electronic health record to really
understand more of what is possible with EHRs. So I think when we
consider it both from a standards perspective and a certification of
electronic health records perspective, we might know some of the more
tangible opportunities.

**[\>\> John Lumpkin:]{.underline}**

This will be some place where having someone like Chip and his
organization or someone from the AHA helping out \-- I\'ve got to
believe that large hospital chains like the VA and others are thinking
about some sort of centralized reporting, and given the fact that the
hospitals aren\'t static and sometimes they go from one chain to
another, having standardization has a business case in regards to that
kind of reporting. And I also think we want to be careful that we
coordinate the work with the Quality Workgroup also.

[**\>\> Kelly Cronin:**]{.underline}

I can reach out to Nancy Foster at AHA, she's a Quality Workgroup member
and has already noted very clearly there\'s some overlap here in terms
of they already have some measures around nosocomial infections that are
commonly used and adopted. So there\'s definitely a need to coordinate
there.

[**\>\> John Lumpkin:**]{.underline}

Great. Any other comments?

**[\>\> Steve Solomon:]{.underline}**

If anyone thinks of anything later, or has anything that you want to
talk about, please feel free to contact me. I would love to get your
calls and talk this over with you. Thank you.

**[\>\> Sunanda McGarvey:]{.underline}**

And this is Shu, I want to point out that the presentation that was
actually shown, unfortunately Steve it did not include your slides but
we will circulate that to the Workgroup and make sure that that updated
version is what\'s posted online as well. I apologize for that.

[**\>\> John Lumpkin:**]{.underline}

Okay. I also note that we neglected to approve the meeting notes and
testimony summary from March 2nd and 29th.

[**\>\> Shu McGarvey:**]{.underline}

Correct. That does need to be done.

[**\>\> John Lumpkin:**]{.underline}

Chip was supposed to do that but then he had other things.

**[\>\>]{.underline}**

\[inaudible\]

[**\>\> John Lumpkin:**]{.underline}

Do I hear a motion from Brian?

[**\>\>** **Brian Keaton: **]{.underline}

So moved.

[**\>\> John Lumpkin:**]{.underline}

Is there a second?

[**\>\>**]{.underline}

Second.

**[\>\> John Lumpkin:]{.underline}**

Moved and seconded. All those in favor say aye.

**[\>\>]{.underline}**

Aye.

**[\>\>]{.underline}**

Aye.

**[\>\> John Lumpkin:]{.underline}**

Any opposition?

Okay. Next item on our list is to ‑‑ I\'m sorry, were we going to do the
ASTHO update? That seems to have dropped off my agenda.

**[\>\> Shu McGarvey:]{.underline}**

It did drop off your agenda. You\'re correct. They were still getting in
information from various RHIOs as of Monday and Tuesday. So they
couldn\'t pull it all together for today. We\'re going to do that on the
next go-around. I think we're ready to go ahead and move forward to
response management.

**[\>\> John Lumpkin:]{.underline}**

Great. Scott?

[**\>\>** **Scott Becker: **]{.underline}

Thanks very much. Well, we also heard some excellent testimony last
month or the end of the month before on outbreak and event management
and also laboratory response. There were five individuals who presented
and we had a great cross-section of state, local, and federal issues
that were addressed. And some of the items that were discussed you\'ll
hear some consistency from the previous, the adverse events group, some
of the same types of issues are again here. Specifically consistency,
consistent implementation of standards, the use of common terminology,
usage and definitions, that is definitely a need. We heard that clinical
data was insufficient for outbreak management, that more information was
needed. And then we heard, and we went a little bit deeper than we
usually do, we heard a lot about a particular issue, the CDC\'s outbreak
management system, and the need for continued support to improve that
tool. We heard that consistently from state and local levels. Also the
need to manage and track various exposures within the healthcare setting
so that we could continue to track where those were going in terms of
patient and staff movements, for example.

Tim Morris also presented on shared infrastructure and we talked I think
in particular across both of the different tests of the various
components of testimony about the need for work force development, that
that was a critical need that spanned laboratory, it spanned
surveillance, it spanned just the general health informatics workforce
was a need and we\'ll get to that in a little bit.

On the laboratory testimony, we heard from the state level and from CDC,
from various components of CDC, about that. And again some of the same
kinds of needs exist, standardization in terms of refining and
implementing lab standards. There\'s work that\'s going on now but it
needs to continue and it needs to really be beefed up. The notion of
integrating lab data with epi case data was also a need. I think
oftentimes the public certainly thinks that that happens and we know
that there\'s some barriers to that at this point. The need to track
sentinel laboratory capacity and capability, and by sentinel, the group
discussed that that really meant clinical hospital laboratories not
necessarily in the public health side but within the community and
making certain that that data was captured, as well as considering the
full breadth of all of the kinds of laboratory data that might be
necessary for response. So it crosses sectors, which I think is an issue
on how, for example, HHS might collaborate and manage with various
agencies where they don\'t have the, or we don\'t have the control, if
you will, of that data. So environmental, for example. It may be
environmental testing of a microbiologic nature which of course will
affect human health but it\'s testing the matrices from the environment
as opposed to a clinical kind of thing. We talked about the need to
evaluate how uniform reporting across agencies would happen, so that
again the need to harmonize those requirements for reporting purposes,
because there\'s different requirements at different places. And we also
talked about funding for sustained support of IT and infomatics.

And I guess I want to comment here that although we heard the Secretary
talk about the need to have fewer yet actionable items that will come
out of those various working groups where they may not necessarily have
a high dollar value or we don\'t want them to have a high dollar value,
I think we\'re going to have to at some point come to terms with the
cost of this. It may not be in our scope right now but that was
definitely something discussed. It\'s not inexpensive.

In terms of additional needs, recommending the uniform minimum data
elements within the states for affordable conditions, because these are
different in different states and then the need for continued research
in different areas here. And then something that I think was mentioned
in the lab testimony, which seems like a minor thing, but the need for
supporting national OID solutions for lab service providers and medical
service providers, public health labs, for example, won\'t be able to
connect in unless there is a unique OID. It\'s pretty deep into the
issue but it\'s pretty critical as well.

We talked about laboratory, the challenges to lab response. And one is
the pretty broad one, which is the challenge of how large commercial
labs have to report across states and that have, of course, states have
the specific reporting requirements but there\'s no central place ‑‑
router comes to mind but the concept of a central repository which could
then send out the reporting requirements. It\'s very challenging for
largest commercial labs and I think we should take a look at what work
the Electronic Health Records Workgroup has done, because I know
there\'s a laboratory component. I don\'t have the details of that but
it would be good to understand more of that.

Also the FDA approval of assays to be used in public health is a
challenge right now, because of the lack of capacity, frankly, within
CDC to be able to develop those assays to 510(k) standards. I know
there\'s some discussion between the agencies on that. But it\'s a
challenge and it will be a barrier for rapid response. It doesn\'t
necessarily have the data element attached to it, but there\'s
certainly, certainly a challenge. Work force development cut across the
surveillance and laboratory response and then just again the integration
issue which we\'ve talked about. Those were the needs and the challenges
of the groups.

Moving on to the key issues. Infrastructure is something that we believe
as a subgroup, if you will, needs to be addressed but better defined.
It\'s something we\'ll be taking on in the next couple of months. I\'ll
get to that point when we talk about the proposed schedule. But again
the need for consistent implementation of the data standards, and a
common vocabulary. Again, these are the sort of highest level issues
that we felt we needed to pull out. And then the disparate business
requirements that the federal agencies have and the agencies at
different levels of government, state, local, and federal, that will of
course need to be harmonized to make this work. So those were the
highest level key issues. We talked a little bit about whether work
force is a subcomponent of infrastructure and we\'ll continue to address
that particular issue.

So the recommendations included the various categories we talked about.
So harmonization and implementation of the standards and how to adopt
them or how they should be adopted, and then capacity issues and from
the lab perspective an example we used was the interagency coordination
that\'s necessary and trying to get more information from the, I think
it\'s the data standards working group of the interagency consortium of
laboratory networks, which is led by DHS. And I know that CDC and other
agencies have a role there.

The current outline for the recommendations, it breaks out into four
areas. Outbreak and event management, which Steve talked about. I\'m
sorry, for this group it\'s outbreak and event management, which was our
first panel, lab response, and then the upcoming testimony that we\'ll
hear next month will deal with the other issues that are listed there.
That was a lot. Any comments by other members?

Hearing none, then, the timeline that we\'re projecting, it\'s pretty
aggressive. Our endpoint is September 18th, the recommendations for
response management to be presented to the AHIC. So we work backwards.
We held an organizational call I\'d call it last week to talk about
basically the scope of our work and the schedule and we have a very
aggressive schedule, where on the 22nd we\'ll be dealing with outbreak
and event management recommendations. And then begin to focus on the
laboratory recommendations. We\'ll suspend a little bit while we hear
the testimony from the next two areas and then we\'ll get to work
immediately on those. Then we\'ll have a fair amount of time to complete
the draft letter, to work on integrating additional comments. And I
guess the one thing I\'d like to say is I think we\'ll probably need for
this ad hoc workgroup some more involvement from members from the field.
So we\'ll need to reach out a little bit more, beginning with the call
on the 22nd.

So actually I was wondering if Laura or John you wanted to talk about
the plans for the day two for the response management testimony.

[**\>\> John Lumpkin:**]{.underline}

Sure. As you can see, we\'re shooting for the, for June 15th, looking
at, as you can see from the next steps, time scheduled to be about from
10 until 2:30 or 3:00. I think people shouldn\'t plan on leaving before
that. This will be an in‑person event. We will be having speakers coming
in. I think it\'s as important for as many of the Workgroups as possible
to come.

We\'ll look at three areas. First is the counter measure allocation,
distribution, administration, which is once we\'ve identified a threat
or a problem, how does the public health writ large, the much larger
public health system as opposed to public health agencies, respond to
that, looking at integration with registries which will be where we have
another area of testimony. And then to do some overview of scope and
requirements. One of the areas that we had originally talked about
having a discussion which was the bidirectional communications, we\'re
going to propose that we hold that off until we complete this work. One
of the reasons is that we\'ve already made some recommendations for
those to AHIC. They\'re still processing them. And it really emphasizes
the importance of us in these recommendations of narrowing the number of
recommendations that we make to AHIC so that we certainly get the key
and most important recommendations as part of what they have on their
agenda. Any questions about the direction that the subworkgroup is going
on or the day two of the testimony?

Quiet group today.

[**\>\>**]{.underline}

I think we\'ve overwhelmed them with information.

[**\>\>** **Laura Conn: **]{.underline}

This is Laura. I\'ll pose another question to see if we can get some
other input. We have been talking with ASTHO and NACCHO and CDC and
others about testifiers in these areas. But I\'m wondering if there are
others outside of our usual comfort space that we should be reaching out
to, we\'ve made some initial contact with DHS, but others that we should
be talking with in this area.

[**\>\> John Lumpkin:**]{.underline}

There\'s an ASTHO affiliate on state EMS directors and I think it would
be important to reach out to them, particularly since about half of them
are not part of a state public health agency.

**[\>\> Laura Conn:]{.underline}**

Thank you.

[**\>\> Kelly Cronin:**]{.underline}

John, do you know what the name of the organization is?

[**\>\> John Lumpkin:**]{.underline}

National Association of State and Territorial EMS Directors, or
something like that.

**[\>\> Kelly Cronin:]{.underline}**

We can look into it.

**[\>\> Jim Pearsol:]{.underline}**

This is Jim from ASTHO. We can assist with that.

[**\>\> Laura Conn:**]{.underline}

Thank you.

[**\>\> John Lumpkin:**]{.underline}

Any other thoughts on folks who should be engaged? What about state
emergency management agency directors? Not a group we usually talk to.

[**\>\>**]{.underline}

They\'re also an ASTHO affiliate.

[**\>\> John Lumpkin:**]{.underline}

No.

[**\>\>**]{.underline}

Which one the emergency ‑‑ the emergency medical ‑‑

[**\>\> John Lumpkin:**]{.underline}

They usually are aligned ‑‑

[**\>\>**]{.underline}

Preparedness directors, I\'m sorry.

[**\>\> John Lumpkin:**]{.underline}

They\'re usually aligned with Homeland Security. And FEMA.

[**\>\> Kelly Cronin:**]{.underline}

It wouldn\'t hurt to reach out to them.

**[\>\>]{.underline}**

I\'m just thinking they don\'t do a whole lot in this area that we\'re
getting a particular testimony on, though. It\'s more the purview of
public health.

[**\>\> John Lumpkin:**]{.underline}

Yes, it is which is a good reason why to ask them. Because my guess is
something, when it hits the fan this group believes they\'re in charge.

**[\>\>]{.underline}**

Oh. Good point.

**[\>\> Kelly Cronin:]{.underline}**

They're all one happy family.

**[\>\>]{.underline}**

Dysfunctional.

\[laughter\]

**[\>\> John Lumpkin:]{.underline}**

And under most state laws, they actually are, sort of.

**[\>\> James Pearsol:]{.underline}**

This is Jim here. I also think \[inaudible\].

**[\>\> John Lumpkin:]{.underline}**

Yes.

**[\>\> James Pearsol:]{.underline}**

With the sequencing, and availability of information.

**[\>\> Laura Conn:]{.underline}**

John, do you have a contact name for them?

**[\>\> John Lumpkin:]{.underline}**

No, but I could probably scare one up if you remind me. I have, I talk
fairly frequently to one of the past presidents of the State EMS
Directors, and she's in contact with these folks.

**[\>\> James Pearsol:]{.underline}**

And they do have a national group, so they would be ready to pitch in.

**[\>\> Laura Conn:]{.underline}**

What's the national group name?

**[\>\> James Pearsol:]{.underline}**

I don't know the name, but we can track that down for you as well.

**[\>\> Laura Conn:]{.underline}**

Okay. Great. Thanks.

**[\>\> John Lumpkin:]{.underline}**

Okay. Any other suggestions?

Okay. I think we're on to next steps. As mentioned we, the testimony on
response on June 15th, more information, actual times on that. The 19th,
the final review of the adverse events recommendation letter, we'll do
that by conference call, correct?

**[\>\>]{.underline}**

Correct.

**[\>\> John Lumpkin:]{.underline}**

Okay, and then we will be going for the July 31st AHIC meeting, for the
adverse events recommendations, and the September 18th meeting on the
response management. Any other comments or questions from the Workgroup?

**[\>\> Kelly Cronin:]{.underline}**

John, this is Kelly. I just have a couple other quick updates.

**[\>\> John Lumpkin:]{.underline}**

Thank you.

**[\>\> Kelly Cronin:]{.underline}**

We are likely going to have to revisit our priorities in the next six
weeks. The ones that we initially defined starting last summer were
fairly high level, and I think we have a better understanding of sort of
the areas within some of the priorities, like adverse event reporting.
So we\'re working on sort of our next phase of priority setting and when
we have our process well‑defined, we\'ll be coming back to the Workgroup
and most likely asking for your input again on how best to advance our
priorities so that the full AHIC can then consider again across all the
different Workgroups and different perspectives. As you probably
remember, we ended up presenting a population health perspective with
options where our top priority was advanced as an option. And then we
had a consumer perspective and a provider perspective. So I think it\'s
likely we\'re going to keep that high level sort of orientation of those
perspectives, but we\'ll need to think within our priorities identified
to date, or perhaps even new priorities, what we want to advance and
perhaps refine.

The other thing that, John Lumpkin you were invited to attend and I
think had a conflict, was a planning session on clinical decision
support that was really across Workgroups, because we have at least
four, almost five Workgroups that are very interested in clinical
decision support with the Quality Workgroup really taking the lead
because they have it as a big part of their broad charge. But there\'s
also a real strong interest in the Personalized medicine or Healthcare
Workgroup. There\'s also an interest in the Electronic Health Records
Workgroup. And Consumer Empowerment is also interested in shared
decision-making, too. So we had a planning session with many of the
co-chairs and some of the subject matter experts across Workgroups to
figure out not only a conceptual framework for us all to follow in
taking on these issues but also sort of how do we organize our work
across all of AHIC and even perhaps how do we act as ‑‑ this is a
mechanism to do more public/private coordination around this issue
because it\'s so important to where we all want to go. And we had a lot
of discussion at the Workgroup around bidirectional communication and
there\'s a lot of different aspects we've touched on in the last year or
so having to do with decision support, but yet we haven\'t really
identified what would our key target areas be? What do we think would be
particularly important from a population health perspective for us to
focus on? And just a side conversation we were just having here, it
could be something like immunizations where reminders around
immunizations could really improve the overall compliance with CDC
recommendations or general immunization schedules. And that\'s something
where the standards are probably ripe enough that we could really see
some real progress over the next couple years if we were to advance
that. So it would be helpful if as a Workgroup, we could maybe, I don\'t
know if folks are ready to talk about it right now, but if we could,
over the next couple of weeks, share some ideas with each other and
identify one or two target areas that we think really could advance this
field from a population health perspective.

[**\>\> John Lumpkin:**]{.underline}

I think in both those processes, the priorities as well as the decision
support, it might be helpful if we use our e-mail chain as sort of a way
to prompt ideas that could then be discussed at the next call.

[**\>\>**]{.underline}

What would the ultimate follow‑through on that be? Sorry, maybe I missed
it, advancing these as recommendations to AHIC? Or would these be
projects?

[**\>\> Kelly Cronin:**]{.underline}

Probably it would be first the recommendations that would then lead the
project. I think there\'s a lot of interest. As you may know, the
American Medical Informatics Association was contracted by ONC and with
support from AHRQ, too, to develop a road map for CDS. And it had more
of a clinical orientation, but it did touch on some population health
issues, and really laid out a conceptual framework for everybody to
follow. And they\'ve been working on trying to implement that ever
since. But they\'ve been looking for sort of the coordination mechanisms
across the federal government and across the public/private sector.
They've called for a steering committee and a series of pilots. And
there hasn\'t really been consensus or definition around what those
pilots or priorities should be. So I think we\'re looking at AHIC as a
potential venue to really flesh out what we should be doing as the
critical next steps in this area, recognizing that it\'s not just
infrastructure. We\'re really potentially talking about a lot of very
complicated issues having to do with workflow and liability and
standards of care and translating from practice guidelines or
e-guidelines, understanding the latest computer science and determining
how best to do that and even trying to, at least the Quality Workgroup
is really focusing on how do you integrate the health IT and quality
community even such that you start to develop measures that make sense
and that are executable. So, there\'s a variety of things that we could
be exploring through recommendations, but it\'s intended, really, to
result in recommendations either within or across our Workgroups that
could show some sort of cohesive progress and result in some, you know,
perhaps funded activities that would really move things along.

[***\>\>* Brian Keaton:**]{.underline}

Kelly, this is Brian Keaton. We go back to one of the original issues
that I brought to this group when we first started and that is at some
point in time we need to deal with the ability to link the communication
from emergency department to emergency department. From one to one, one
to many, many to many, to local, state, and federal public health, and
across to an incident command structure. We kind of pigeon-holed that
underneath response management and then said we won\'t deal with that
for a while because it\'s too big. My question is when does that awhile
timeframe let up? We have a specific pilot project that has gone through
a whole process at CDC and has been languishing for eight months because
of the freeze on BioSense funding. Those type of things that are out
there are examples of issues that have become very, very important
should we have to deal with a high consequence issue in the real world.

[**\>\> Kelly Cronin:**]{.underline}

John, I don\'t know if you have any thoughts, or Steve, about how best
to address that in the future. Or in the near-term.

[**\>\> Steve Solomon:**]{.underline}

There is nothing specific for that at the moment, although there\'s a
lot of work on the whole issue of communication. And we have a whole
organization here in terms of emergency communication. One of the
questions that I would ask, perhaps our state colleagues, wasn\'t some
of that capacity included as at least part of the guidance in the
BT grants that have gone out to the states? Wasn\'t communication issues
among facilities part of that? Do you happen to know?

[**\>\> Brian Keaton:**]{.underline}

I know there\'s a lot of communication issues between fire‑related
agencies and police‑related agencies. But as somebody who works in a
tertiary care hospital, I haven\'t seen or heard or been involved in any
even discussions of involving the actual people that take care of
patients.

[**\>\> John Lumpkin:**]{.underline}

I think that much of the work has been done more looking more towards
regionalization and building upon those communication modes that exist
under EMS regions and trauma regions. And I think it\'s probably
significantly high degree of variation from state to state. Most of the
communication that I think was done with the BT grant tended to be along
the lines of establishing Internet‑based modes of communication.

**[\>\> James Pearsol:]{.underline}**

Well, some of those, though, can trigger other kinds of connections \--
this is Jim from ASTHO \-- including cell phone, voice mail, other kinds
of connections, by providing notices of alert.

[**\>\>**]{.underline}

And so the actual people who would be communicating among the ERs would
be the providers, Brian?

[**\>\> Brian Keaton:**]{.underline}

That was the intent. The specific project that we\'ve worked with CDC to
the point of funding but is now sitting on a desk because of the
BioSense issues that exist are focused on bed availability tied to the
system that now does 40 percent of the nation\'s emergency departments
and emergency department visits looking at ambulance diversion and
boarding type issues as well as hospital capacity issues. So we were
going to multi‑purpose that into dealing with specific bed availability
region by region.

**[\>\> John Loonsk:]{.underline}**

This is John Loonsk. Some of the utilization data were actually part of
the first round of the biosurveillance activity. And the Health
Information Technology Standards Panel has just approved the version 2
of their interoperability specification. As an example, I believe that
the standard identified for some of the utilization data was the HAV
standard, which has not been balloted yet, so it\'s still outstanding.
But that is in the scope of some of those ‑‑ that part is in the scope
of some of those activities. There was, in the previous CDC cooperative
agreements, preparedness cooperative agreements, there was a fair amount
of discussion around communications technologies in the context of radio
communications and such. And I think Steve is right in that regard, in
terms of alerting and collaborative communications, in other words,
Internet‑based technologies, push e-mail alerts, Web‑accessible
information, collaborations among participants in a given ‑‑ whether
they be epidemiologists or others. I think that\'s in scope for some of
our ongoing discussions, though, in the response management domain if
I\'m not mistaken.

**[\>\>]{.underline}**

The example that we\'ve used from an emergency management standpoint is
I start seeing people in my emergency management department with purple
spots on their face. To be able to message surrounding emergency
departments, are you seeing purple spots? For me to be able to
communicate with local public health, we\'re seeing people with purple
spots, here\'s what they look like, help. Public health to be able to
come back and escalate that up whatever chain they need to, meaning
we\'re not talking real complex‑type activities. Just to be able to
start that communication and that bidirectional communication so that
instead of simply sending a report out that I\'ve seen a patient with
ABC disease, to be able to make it part of the ongoing clinical care
alerting, response, assessing, and on and on down the public health
chain.

**[\>\> John Loonsk:]{.underline}**

Right.

[**\>\>**]{.underline}

But there are class A and other reporting requirements that aren\'t just
simply electronic that are already in place.

[**\>\>**]{.underline}

Right. We\'re talking about more of a true bidirectional, more closer to
real-time communication that would be the type of communication that
needs to take place in the event of the acute management of a
high consequence event.

[**\>\> John Loonsk:**]{.underline}

I\'m not familiar with the purple spots case report.

\[laughter\]

[**\>\>**]{.underline}

That\'s what they come in looking like.

[**\>\> John Loonsk:**]{.underline}

But there is a fair amount of discussion I think that is still cued up
to talk about alerting and the sort of cascade approach that has been
described in the past for getting alerts out to ‑‑ from public health to
public health and to clinical care providers. Part of that issue there
is some of the directory issues in having e-mail addresses, for example,
for providers to be able to communicate. And there\'s a fair amount of
complexity under those covers.

The other issue in that domain is that as it\'s been described in the ‑‑
such an alert is actually a slowly or rapidly progressing press release
in some context. And that\'s one of the reasons that some of the secure
collaborative technologies like FEX were developed so that communities
of practice who were working together on an issue could raise something
for the attention of others without alarming people that indeed the
purple spot epidemic has finally occurred.

[**\>\>**]{.underline}

That\'s why we were using the existing EM system on network, which has
40 percent emergency departments in the country on it, as our tool to do
that.

[**\>\> John Loonsk:**]{.underline}

Right. I think there are a host of issues under there. I don\'t know.
Laura, is that ‑‑ it\'s still part of the future agenda for
discussioning in response management?

**[\>\> Laura Conn:]{.underline}**

Well I think it\'s open for discussion. What we had talked about in
light of the message to get to real specific priorities was the fear
that since we had already addressed at least a piece of this, that going
deeper might not be the best thing to do. But if it is now, we can
certainly add it on. I don\'t know that we\'re at a point where we think
we can add it on by the June 15th testimony. But what our plan was to
sort of push it to as we address the broader communication priority,
which is one of our five domains for the Workgroup, to tackle it then.
But it sounds like there\'s some, could potentially be some pressing
issues that we might want to talk about in this Workgroup before that.

[**\>\> Brian Keaton:**]{.underline}

My point for bringing it up now was to make sure that ‑‑ not that the
issue doesn\'t necessarily have to push to the front of the line, but I
just wanted to make sure it didn\'t get pushed off the table in the
course of the discussion. I mean, I\'m a firm believer that when you eat
an elephant, you take bite-sized pieces to try to accomplish that.

[**\>\> Laura Conn:**]{.underline}

It\'s not off the table, but it\'s not necessarily on our calendar yet,
either, Brian. So it\'s one of those as our next step at figuring out
how we\'re going to start tackling the broader domain of the population
health picture that we talked about, it would be in there. But like I
said, if there\'s key issues or bite-sized pieces that we should address
now, I mean if you want we can have a separate conference call to think
about what those might be.

**[\>\> Brian Keaton:]{.underline}**

Assuming that we eventually move forward through this CDC program, it\'s
going to be dealt with through a separate channel at least for the first
bite-sized piece. But I bring it up here to make sure that it doesn\'t
leave the radar screen.

**[\>\> Teresa Cullen:]{.underline}**

This is Terry Cullen with Indian Health. I would really like to ensure
this doesn\'t leave the radar screen, but I\'d also like people to
realize that the PAHPA Pandemic and All-Hazards Preparedness Act
implementation plan that was given to the Assistant Secretary for
Preparedness and Response also has a lot of recommendations that may
overlap where this is going. So I think for the Population Health
Workgroup, we just need to be aware of them. And I don\'t know if you
guys have seen those final. I don\'t know if they\'re out from draft or
not.

**[\>\> Laura Conn:]{.underline}**

Terry, this is Laura. And I actually have been sitting on the
surveillance and information systems group and trying to bring this up.
So we do recognize the overlap and we\'re working closely with the folks
in the Office of the Secretary to figure out how these two activities
can come together and inform one another.

[**\>\> Theresa Cullen:**]{.underline}

Okay. Because I think that this most recent conversation is really fits
right in there, develop use cases to clarify situational awareness needs
including biosurveillance, emergency responders, and electronic health
records. So there\'s just tremendous overlap here.

**[\>\>]{.underline}**

Would it be possible for us as a Workgroup to get an update on where
PAHPA stands once that becomes clear?

**[\>\> Teresa Cullen:]{.underline}**

Laura, I have the draft from May 7th. I don\'t know if it\'s been
released or not.

**[\>\> Laura Conn:]{.underline}**

I don\'t think it has. But, Brian, as soon as we can share it, we
certainly will. And if we want to put this on the next agenda for a
conference call, we can do a quick update and have discussions of those
overlap because we do want to make sure that that group and those
activities moving forward take advantage of the things that we\'ve
thought about in this group and are informed by this.

[**\>\> Shu McGarvey:**]{.underline}

Laura, are you thinking about the July timeframe for that? Or to try to
fit it into the June on site meeting?

**[\>\> Laura Conn:]{.underline}**

We\'ll have to see, Shu. We will have to determine how quickly the
Department\'s going to move on something that we can share broadly.

[**\>\> John Lumpkin:**]{.underline}

So we\'re going to not include this in what we\'re doing for June and
focusing in October. But this is an area that we ‑‑ Brian\'s raised a
couple of times. I think it\'s one that merits some full discussion. I
think that there are pluses and minuses to ‑‑ there are configuration
issues to assure that the kinds of communications that occur are going
to be those that are going to be helpful and not necessarily
problematic. So I think that we really need to look and think about a
time that we can have that discussion and invite some outside speakers
to give their input to it also. So let\'s keep that on the agenda.
Anything else for today before we go to public comment?

[**\>\> Judy Sparrow:**]{.underline}

Are we ready for public comment?

**[\>\> Matt McCoy:]{.underline}**

Yeah, for people who are following along on the Webcast, you\'ll see
there\'s a slide up there now that has the information that you need to
call in and make a public comment. If any members of the public have
been listening to this meeting and are already on the phone, just press
star 1 to alert the operator. And, Judy, I will check back with you in
one minute to let you know if anybody\'s dialed in.

It doesn\'t look like anybody\'s calling in today, Judy.

[**\>\> Judy Sparrow:**]{.underline}

Okay, great. Back to you Dr. Lumpkin.

[**\>\> John Lumpkin:**]{.underline}

Thanks. Thanks for all of you participating in the call. Again we have
the in‑person hearing on the 15th of June. And some active aggressive
schedules for the two subworkgroups. So thank you so much. And we\'ll be
talking to all of you soon.

**[\>\> Judy Sparrow:]{.underline}**

Great, thank you.

[**\>\>**]{.underline}

Thank you.