American Health Information Community
Population Health and Clinical Care Connections Workgroup #22
Thursday, January 3, 2008
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:
Thank you. Good afternoon. Happy New Year, everybody, and welcome to the 22nd meeting of the Population Health and Clinical Care Connections Workgroup meeting. Just a reminder that we are operating under the auspices of the Federal Advisory Committee Act, the meeting is being broadcast over the Internet, and the public will be invited to make comment at the close of the meeting. Workgroup members, if you could please remember to identify yourself before speaking and mute when you’re not making a comment to reduce background noise. Alison, could you let us know who is on the telephone, please?
>> Alison Gary:
Sure. We have John Lumpkin from RWJF, Laura Conn from ONC, Marty Cicchinelli from Centers for Disease Control, Lisa Rovin from Food and Drug Administration, Angela Fix from ASTHO, Scott Becker from APHL, Jennifer Ward from CDC, Theresa Cullen from Indian Health Service, Shu McGarvey from ONC, Brian Keaton from American College of Emergency Physicians, Jim Craver from CDC, Irene Stevens from Association of State and Territorial Health Officials, Amy Helwig from Agency for Health Care Research and Quality.
>> Judy Sparrow:
Thank you. And here in the room, we have Kelly Cronin from ONC. So with that, I’ll turn it over to Dr. Lumpkin for opening remarks.
>> Alison Gary:
Did I miss anybody else?
>> Leslie Lenert:
Yes. This is Leslie Lenert. I just joined. I’m from the CDC.
>> LuAnn Whittenburg:
Yes, this is LuAnn Whittenburg from the Department of Defense Health Affairs.
>> John Lumpkin:
Great. I’d like to thank you all and wish all of you a Happy New Year. It’s been a little bit of a time since our last meeting. (Background noise) I’m sorry. They’re cutting the lawn or blowing the leaves. And in that time, we’ve been moving rapidly toward the next meeting of the AHIC, when we’ve been requested to present our revised letter, as well as CDC has been directed to give a roadmap that was based upon our presentation two meetings of the AHIC ago. We think that this is a very important opportunity for the issues related to our specifically to our Workgroup, to have prominence before AHIC.
This will be a very exciting year. Not only is today the first step on the presidential elections and no matter who gets elected, we know that there’s going to be a change in the administration but the work that we’re doing is of, I think, such high significance that no matter who gets elected that we will be able to help set the agenda for the new administration as well as continue to develop what we’ve been working on in the coming year.
So I look forward to an important year working with all of you and to get on with our agenda. Les?
>> Leslie Lenert:
All right, John, and hi, folks. So that I certainly second what John is saying here about this being an important time and that our need to be able to move forward with the implementing the recommendations of the letter and, you know, continuing on with this process, even as there are changes in the AHIC. So should I think that the first let’s go on with the agenda as written. Kelly?
>> John Lumpkin:
Well, the first item that we have on our agenda is to approve the draft meeting notes from November 30. Any problems with that, other than adding Angela Fix from ASTHO and removing Paula Soper from NACCHO? Sorry for the mix-up.
>> :
That’s okay. No other changes.
>> John Lumpkin:
Okay.
>> :
We approve.
>> John Lumpkin:
Great. I think we don’t need to vote on that. I will take the lack of dissent as being an approval. So we’ll move on to the first item, which is the revisions, the final revisions to the letter to be issued to AHIC, and then some discussion of from Les on just sort of where we are CDC is on the roadmap. Les, I think were you leading this discussion?
>> Leslie Lenert:
Sure, I can, but happy. Are there any further comments on the letter? I think you’ve all been distributed the final version. I believe we’ve gotten all the typographical errors out of it and the other issues that have perhaps limited what we were trying to do, and that I think now it would be time to formally move for approval of this letter. Is there any objection to people approving the letter?
>> Sunanda McGarvey:
Les, this is Shu. We actually had some comments from Theri Cullen that are in the spreadsheet that was distributed with the letter that we need to go through in disposition, because they were provided after we were able to disposition them by email.
>> Theresa Cullen:
Les, this is Theri. I apologize for that. And Shu, I think most of them are on the spreadsheet, right? Well, it’s not just me. There are some other ones, right?
>> Sunanda McGarvey:
They’re all on the spreadsheet, Theri, and thank you for providing them. I know during the holidays, this was really challenging, and we appreciate everyone’s input both the letter and the priorities. But yes, they are all on that spreadsheet.
>> Theresa Cullen:
And Les, mine are if you look at the spreadsheet, I think Shu did a great job with initials. Obviously, I’m the TC person here on these, and I did have lots of comments, and I really apologize: They came in late. I was working at a remote clinical site and lost access for a couple days.
So the reality is, I can endorse the letter if you don’t want to go through these, because Shu picked up a lot of them I was concerned about (inaudible) I did have some concerns. For instance, if we look at #3, I’m not really clear why we’re just calling out Microsoft products, and I thought maybe we should switch it to cost products. Some of this was to try to be sensitive to interpretation to some of this by the public. But I realize it came in late, so I’m willing to just go ahead.
>> Leslie Lenert:
I’m looking for I’m trying to find the spreadsheet myself right now, but so I apologize for that, that the what other comment so you had a problem with Section 3. That was
>> Theresa Cullen:
But I had a ton of comments. Well, Section 3 I just thought that maybe you might want to switch it to cost products as opposed to naming Microsoft Microsoft Access and our Microsoft Excel just seemed there’s other tools that people use. They’re not just Microsoft products. I just didn’t know how that would be interpreted.
>> Leslie Lenert:
The idea was is that to make sure it’s compatible with what people are commonly using. But did you have anything more substantive than that, outside of the what other comments did you have that I’m trying to again, I apologize. I’m trying to find the copy that I have of the spreadsheet, which was quite extensive, and we think
>> John Lumpkin:
Yeah, and actually, I have the spreadsheet in front of me, and I think it may be more helpful if you could just identify those that you think are substantive.
>> Theresa Cullen:
Okay. So if we go to page 3, I didn’t really I was concerned about an annual survey, whether you really wanted to put that in there. But I didn’t know the benefit of doing annual versus biannual, and I was concerned about the impacts of that. And the one right under that, 22 and 23 I was concerned about the dates. So they are CDC dates, and if CDC’s okay with that, I think it’s fine. I was concerned about some of what perceived to be aggressive time frames from my perspective.
>> Sunanda McGarvey:
And Les and John, the presentation the notes on the presentation do point to the specific comments that were still open for discussion. So if we go through that presentation, we should be able to track to Theri’s comments fairly quickly. I don’t know how you want to go through it, but that may be an option.
>> John Lumpkin:
Okay, it’s my bad for not logging onto the slides and just using my paper ones. What do we have on the screen now?
>> Kelly Cronin:
It’s just the title slide, but we can proceed however you’d like.
>> John Lumpkin:
Yeah, well, Les, I don’t know if you have access, but maybe we can just go beginning to walk through the slides.
>> Lisa Rovin:
Am I the only pers this is Lisa at FDA. Am I the only person who’s getting an error message when I click on the “hsrnet” link?
>> Scott Becker:
No, this is Scott Becker. I can’t. I’ve been trying for 10 minutes as well.
>> Leslie Lenert:
I apologize. I’m on leave right now still, so I don’t have access to slides.
>> Lisa Rovin:
Well, you sent the document around. It shouldn’t be any problem. Just make sure you let us know what document and what page you’re on.
>> John Lumpkin:
Yeah, let’s walk through the document, then. And Shu, since it seems like we’re having a little bit of problem with the slides, the first one looks like it’s in
>> Sunanda McGarvey:
I’m now just now able to see the slides. I’m not sure about everybody else.
>> Brian Keaton:
This is Brian. I’ve been on for a while.
>> John Lumpkin:
Yeah, I just tried to get on, and I get an error message.
>> :
And I just tried again and got the error message.
>> Judy Sparrow:
We’re looking into that on this end, so why don’t we just walk through the slides paper slides.
>> :
I figured it out. It’s there’s an extra space after the HTM at the end that you can’t see.
>> :
Great. Thank you.
>> :
Yeah.
>> John Lumpkin:
Okay. So there’s an extra period in there that okay, why don’t we then go to is everybody on that can get on?
>> :
That seems to have worked for me.
>> John Lumpkin:
Okay. I’m just logging in. So Shu, if you could help me with the...
>> Sunanda McGarvey:
The spreadsheet line numbers?
>> John Lumpkin:
Well, they don’t seem to be in order. Now, the first one is updated recommendations?
>> Sunanda McGarvey:
The first set of spreadsheet line numbers that we would be looking at are in the preamble. They’re in the key issues section. And they correspond to spreadsheet numbers 4, 8, 12, 15, and 16, #4 being the first one. It’s the first key issue bullet in the first paragraph. And there’s a change in wording that was suggested by Theri to “robust, scalable solutions that integrate local and state detection and response while also accomplishing notification. The national authorities are required for a strong cross-jurisdictional public health infrastructure. This public health infrastructure, available across all jurisdictions and levels of public health, strongly coupled to a robust private-sector health care information network, will reduce the wide variation and deployment of information technology that exists in public health today.”
And the only question was that the previous text that’s in the letter was came as a result of testimony. We want to make sure that the message that we heard during testimony is still retained. So what I read to you from Theri’s is in the spreadsheet, and then the letter language is in the letter. And again, that’s the key issue, first bullet, first paragraph.
>> Theresa Cullen:
And I was just trying to make it more readable.
>> John Lumpkin:
Okay, so given that and how far we went through on that, Theri, is it okay if we just leave it the way it is?
>> Theresa Cullen:
Fine.
>> John Lumpkin:
Okay. The next item, I think, is #8.
>> Sunanda McGarvey:
Correct.
>> John Lumpkin:
Is that the same rationale for that one, Theri, which is “Delete the text, ‘large municipal health departments’”?
>> Theresa Cullen:
Yes. I do, in fact, think we probably need to edit part of this, but this is all to make it more readable.
>> Leslie Lenert:
I think that we probably should not be debating comments to make it more readable.
>> Theresa Cullen:
That’s fine with me.
>> John Lumpkin:
Okay.
>> Leslie Lenert:
Do you have substantive comments about the (inaudible) which we may have not gotten correctly?
>> Theresa Cullen:
I do Shu, I do have them, but I’m not really clear how to go through these. So if we look at 14, I just thought perhaps we should 14 and 15 make sure that the word “bidirectional” is clear in there. I think it was implied.
>> John Lumpkin:
That would be
>> Sunanda McGarvey:
That’s the fourth bullet, first paragraph.
>> John Lumpkin:
Fourth bullet...
>> Sunanda McGarvey:
And we did make that change, Theri.
>> Theresa Cullen:
Okay.
>> John Lumpkin:
Okay. Next one, Theri, for substantive
>> Theresa Cullen:
was really the annual survey.
>> John Lumpkin:
Okay. So that is page 3. Is that correct? No, page sorry page 5, Recommendation 1.0 first bullet under Recommendation 1.0 on page 5. And if you print it out in color, the word “annual” is in red. And then the second bullet, you raise the issue of the June 2008 time frame. And Les, those are all things that are putting an onus on CDC, and you’ve seen this before. Are you comfortable with those time frames?
>> Leslie Lenert:
Yeah, I’m comfortable with the time frame for June 2008, because I think that that’s a requirement, because I think that the program from the RW date’s perspective (inaudible) though you might know more about the dates of when it’s ending than I, and that we felt we needed to make some progress as to what would be going on to continue this program.
I’m not sure the word the addition of “and undergraduate-level training” should be if we’re going to discuss this bullet, I think it’s (inaudible) needed, because the NLM program doesn’t address undergraduate training and the cooperative agreement with the Robert Wood Johnson and the NLM to do this doesn’t address undergraduate training. Though if we could just put it back the way it was, I think it would be accurate. But I’m happy with the time frame.
>> Kelly Cronin:
And Les, are you comfortable with the annual assessment of informatic educational needs?
>> Leslie Lenert:
I think that we probably should do it annually for a couple of years to see how much progress we’re making. Maybe that’s a little bit much, but I mean that this is a recommendation that if we need to temper it later on, then that’ll be fine, but I’m not unhappy with that.
>> Sunanda McGarvey:
So under Recommendation 1.0, the fifth bullet, are we removing “and undergraduate training”?
>> Leslie Lenert:
I would like to request that, unless people have a strong objection, because the NLM’s program doesn’t deal with undergraduate training. It just deals with people getting PhD’s and master’s-level training. So that’s all graduate training.
>> John Lumpkin:
Yes, and that’s also true with our program.
>> Leslie Lenert:
Yeah.
>> Sunanda McGarvey:
Well, we’ll strike that, then.
>> John Lumpkin:
Okay. Theri, anything else?
>> Theresa Cullen:
Yeah, if you go to Recommendation 2, the second bullet, about the executive order, I think
>> Sunanda McGarvey:
Can we hold up 1 second, Theri?
>> John Lumpkin:
Yeah.
>> Sunanda McGarvey:
Also, under Recommendation 1.0, we need to confirm what the three prongs were. I think it was the transcript was a little bit confusing here. And the three prongs, as we have them now, are professionals who will not be informaticians but would like to increase their understanding of informatics, professionals who will be informaticians or scientists, and then a practicum or field experience. And the transcript actually has a practicum or field experience as something we needed to add in the bullet. And I think it had the three prongs as professionals who will be informaticians, professionals who would not be informaticians but would like to increase their understanding of informatics, and then continuing education in informatics for existing public health practitioners. And we need to determine how that should actually be, because I’m not sure we have it quite the way it
>> John Lumpkin:
Can you help us where we’re looking at that language at?
>> Leslie Lenert:
That’s the first paragraph of Recommendation 1.
>> John Lumpkin:
Okay.
>> Sunanda McGarvey:
It’s in the recommendation itself.
>> Leslie Lenert:
And I didn’t understand what the three prongs were either, but that’s okay.
>> Sunanda McGarvey:
It wasn’t very clear in the transcript, so...
>> Leslie Lenert:
Perhaps it was referring to students who hadn’t completed their training.
>> Sunanda McGarvey:
And how I thought it was, was professionals who will be informaticians, professionals who won’t but want informatics training, and then the continuing education component.
>> John Lumpkin:
I think that I like the second language better than the first, because there are those professionals who the point is that there are people who need to know about this, whether they want to or not. And that’s why I like the third bullet.
Any other preferences? (Pause) Okay, so we’ll stick with the second language. Anything else in 1.0 before we move on? (Pause) Okay, 2.0, Theri.
>> Theresa Cullen:
I’m just unclear, and I must have missed this discussion 2.0, the second bullet, about the executive order for quality and efficient health care I guess I’m not clear what this is talking about, because there isn’t ongoing system maintenance. There’s no system, unless there’s some system I don’t know about. So we’re under this executive order, and we’re working it, and there’s no system that I know of.
>> Leslie Lenert:
The intent on this item was to allow people to read, to combine fronts across various programs, to support ongoing maintenance systems and meeting of federal requirements....
>> Kelly Cronin:
And Theri, the system, as we’re referring to it, at least in the first bullet, is infrastructure that supports public health labs, registry, surveillance systems, outbreak management, and response systems. So it’s not necessarily I mean, it’s mostly pertinent to the public health agencies that would procure these type systems.
>> Theresa Cullen:
Yeah, I guess I’m just unclear on the reason for the bullet, though.
>> Sunanda McGarvey:
So your question was why
>> Leslie Lenert:
I’m sorry John’s not on the call, because this is definitely an ONC I mean, does anybody from ONC want to comment? Because this is an ONC item.
>> Theresa Cullen:
Well, the only thing I would say is, I just don’t think there’s limits on those funds right now. There’s no funds. The funds are optive funds.
>> :
Right.
>> Kelly Cronin:
Yeah, but that’s I mean, we are implementing the executive order in a consistent way. We all have common contract language and even you know, we’re also working on common language for grants and cooperative agreements. So this is consistent with that thinking, but the executive order doesn’t call out public health information systems. It really was more oriented towards health care. So this is really taking it to the level of making sure that across all funding mechanisms that are pertinent to these public health information systems that we have a consistent way of more coordinated way of trying to drive interoperability standards.
>> Theresa Cullen:
Okay, I mean, it
>> Kelly Cronin:
(Inaudible) common interfaces.
>> Theresa Cullen:
Yeah. Okay.
>> John Lumpkin:
Okay, anything else under 2.0? (Pause) Okay, under 3.0?
>> Theresa Cullen:
The only comment I had is that, you know, in many of these, you guys are calling out local, state, and vendor or local, state, and regional. And when you did that I tried to insert the word “tribal,” because there’s as you know, there are many tribal health departments that are not under the jurisdiction of the local or the state. And in this case, I my question was, I didn’t know whether it should include tribal programs, because I didn’t know whether they had the infrastructure to support this. This is related to the OEMS. And I didn’t know whether somebody at CDC might know the answer to that.
>> John Lumpkin:
Okay, I’m again, I’m having trouble finding that in the
>> Theresa Cullen:
Page 7.
>> John Lumpkin:
Yeah, page 7 under...
>> Theresa Cullen:
It would be you would add “tribal” under that second bullet
>> John Lumpkin:
Second bullet, okay.
>> Theresa Cullen:
where it says “local, state, and (inaudible).”
>> Sunanda McGarvey:
That’s a good question, and we can try to find the answer to that, but I think that’s a really good point.
>> Leslie Lenert:
We can add a “tribal.” I don’t think why that would be a bad idea.
>> Sunanda McGarvey:
I think it’s appropriate. Thank you.
>> John Lumpkin:
Okay. Good. Anything else under 3.0? (Pause) Okay, let’s move on to 3.1. Anything under that?
>> Theresa Cullen:
My comment was addressed already.
>> John Lumpkin:
Good. 4.0? There are a couple comments there. Substantive comments, Theri?
>> Theresa Cullen:
Well, I guess I was just architecturally confused a little about NHIN and the linking of labs, which NHIN isn’t actually going to do. So “Develop an incompatible reference data model for public health labs” so I think it’s apparently okay as written. I think it will be a little confusing to the reader, but...
>> Leslie Lenert:
Okay, so
>> Theresa Cullen:
It’s probably fine.
>> Leslie Lenert:
We can move on, then?
>> Theresa Cullen:
Yes.
>> Leslie Lenert:
To 5, countermeasures?
>> John Lumpkin:
Yeah.
>> Leslie Lenert:
On 5, was there any did we get any comments on the language?
>> Theresa Cullen:
My comments were all addressed.
>> Leslie Lenert:
Okay, and 5.1? (Pause) 5.2? (Pause) And then 6.0, then?
>> Amy Helwig:
This is Amy Helwig with AHRQ, and I just have a very, very slight addition if you could take it. In the minutes from the last meeting, there was some comment I had to step out of the meeting at that time for about a half-hour, and it was a comment in the minutes regarding Recommendation 6.2 that in addition to having CMS listed under that second bullet by August 2008 that you also would like to have AHRQ with its consent. And I’d like to give you that consent, because we are very interested and we have a lot that we can bring to the table. So that’s second bullet point by August 2008, the last section with input from ASTHO, NACCHO, CMS and if you could add, comma, “AHRQ”?
>> John Lumpkin:
Done.
>> Leslie Lenert:
Great.
>> John Lumpkin:
Great. Theri, did you have anything under 6.0?
>> Theresa Cullen:
No.
>> John Lumpkin:
Okay.
>> Leslie Lenert:
Okay, and 6.1, then?
>> Sunanda McGarvey:
Theri, were you comfortable with the comments you made? I had you down as having comments under numbers 50, 51, 52, 53, and 101 on the spreadsheet.
>> Theresa Cullen:
I’m fine at this point, because most of this is just to make it clearer language and...
>> Sunanda McGarvey:
52, you were asking about the work already being done under
>> Theresa Cullen:
Yeah, I think 52 is which is related to 6.1 I think they’re it’s probably fine the way it’s written.
>> Sunanda McGarvey:
And then your comments for 50 and 51 on
>> Theresa Cullen:
Yeah, but and once again, Shu, that was just related to make it clear, because it seems pretty vague to me. But I think that’s it’s an edited it’s an editing issue.
>> Sunanda McGarvey:
If it seems vague to you, it may seem vague to others (laugh) is what we’ve learned in the past. But if you’re comfortable with it, we can move on.
>> John Lumpkin:
Right, I don’t think we want to, at this point, try to wordsmith on this at all.
>> Leslie Lenert:
Okay, so (inaudible) get it to the point, the three 6.1 also and are we done, then?
>> Theresa Cullen:
I think so.
>> Leslie Lenert:
Okay. Then I think we should call for a question to approve the letter as written with the amendments.
>> John Lumpkin:
So moved.
>> :
Second.
>> Leslie Lenert:
There any dissent? (Pause) Looks like it’s a maybe unanimous approval of the letter as written. And we thank everyone for their outstanding efforts on this. Now, John, do you should we go on next to the CDC’s response to the letter and our sort of roadmap?
>> John Lumpkin:
Yes, please.
>> Leslie Lenert:
Okay, (inaudible) thank you. Wow. I think this is a difficult task, because of our need to come up with budgeting requirements for each one of these things. So this is still a work in progress for us right now. We’ve inverted these recommendations, and we’ll be you know, have produced a brief list of high-level activities, but they don’t really add a lot I’ve been over what my staff has given me, and they don’t really add a lot to just the actual letter’s content now. So until we actually come up with some budgeting recommendations, I’m going to ask that we defer too much discussion of this. The activities really follow, though, from each one of these. For example, with the recommendations Recommendation 1, 2008, we’ll be trying to do this educational assessment and also working with the NLM and Robert Wood Johnson to try and to figure out what to do with their programs. And we’ll also be working to expand our Informatics Fellowship Program as appropriate. These types of activities will go on one at a time as we based on the levels in this letter. But until I can get actually get the data on budget, I don’t really have too much to share with you. And that’s still in progress this week, given the holiday. So I’m going to suggest, beyond that, that we table it.
>> John Lumpkin:
Okay, as I think the only thing to add to that, Les, is that there will be a pres I think the AHIC meeting is the 22nd.
>> Leslie Lenert:
Yeah, so we should be able to have something next week, if we want, that we could circulate and get some comments by email.
>> John Lumpkin:
Okay. So CDC is working to do the presentation on the 22nd at the AHIC meeting. For those of you who haven’t been on the email, it has been postponed, so it will be held on the 22nd. And so, as any of us who have been prepping for that particular time, we appreciate the fact, Les, that with the holidays, it’s a little bit hard to share something that’s a work in progress at this particular point.
>> Leslie Lenert:
Yeah, I think the real problem is, the budget issues are taking a bit more time than we hoped over the holidays. And so, you know, I can start a program doing this, we’ll do that, but I don’t know what that means unless I tie it to some specifics. And I’d rather tie things to specifics than just parrot the intent of the committee, here.
>> John Lumpkin:
And that’s fine. Understand. Been there. Recognize those challenges.
Any questions about the next steps in relationship to this letter and the process, so that Les will be sharing this letter for comment, or his thoughts and where he’s at, sometime between now and the end of the month, as CDC was charged by the Secretary to bring their roadmap to the AHIC meeting rather than have that reviewed specifically by our Workgroup? Any questions? (Pause) Okay. Les, adverse events updates?
>> Leslie Lenert:
I don’t really have much to add on that outside of we have some we’re traveling up to Washington next week to meet with the FDA for some further commentaries. We appreciate Lisa making herself available and some of her staff there. And we’ve had some consultations from our HL7 experts to look at sort of a unifying language for reporting that may allow the FDA to and the CDC and hopefully AHRQ, at some point, to work together on a common basis for reporting.
>> Lisa Rovin:
We’re looking forward to the meeting.
>> Leslie Lenert:
Thank you, Lisa. So yeah, as I say, I have four or five people coming up today to meet with them to go over the next step.
>> Kelly Cronin:
Les, we also wanted to make sure we’re addressing FDA’s comments about this ad hoc workgroup that was going to both in the process of being organized, and we talked a little bit about this last time, but we just wanted to recognize FDA’s concern about the scope of it and how we what we’d be potentially calling this effort as well.
>> Lisa Rovin:
Thanks, Kelly. We appreciate that.
>> Leslie Lenert:
Yes, I think we’re just looking into the technical feasibility of unifying all the standards under one approach, you know, with the so that’s our
>> Lisa Rovin:
Well, I think we’re talking about two different things. I think the meeting you’re coming up for next week, Les, is separate from what Kelly’s talking about. With respect to the recommendations, we had expressed some concerns over the last couple of months about anything that somebody might take to be a, quote-unquote, “minimum dataset” for AE reporting, because in our experience and there’s some hands-on experience with this when people start into that world, they start taking the minimum as the maximum. And we’re already having trouble getting all the data elements that we need reported now, and particularly because of the vast, vast differences in AE reporting, not just across drugs, which is alone a vast difference, you know, depending on the nature of the reaction. But across all medical products, you know, you could be looking at an immune response or you could be looking at a headache.
But we had talked with Kelly and Dr. Kolodner about the possibility, particularly under the rubric of the public health reporting use case that was circulated for comment several months ago, of looking at whether we couldn’t identify some data elements that would be very useful for all the public health agencies CDC as well as AHRQ and to move forward on that basis under the rubric of the existing use case. So I think that is where we are heading. Is that correct, Kelly?
>> Kelly Cronin:
Yeah, and with that understanding, I think we were still trying to target what based on testimony and what we’ve all talked about in the past, still trying to target nosocomial infections and medical products as sort of, you know, two major types of adverse event reports that would be considered. So we wouldn’t take on, you know, all types of adverse events or medical errors, which we know that the data requirements, you know, could probably never be specified at this point. They’re not they’re not understood enough. So I think we probably need to be, in the next week or so, trying to revisit what exactly the scope would be and then trying to, at the same time, think through who from the agencies and who also from either industry or academia could we pull together to do this over the next 3 months.
>> Kristen:
Kelly, this is Kristen. Are you talking about revisiting that letter?
>> Kelly Cronin:
I was just talking about this ad hoc workgroup that we’re setting up similar to two other ad hoc workgroups that are trying to identify more specific information that can’t be addressed by the use case team.
>> Kristen:
All right. Is that the former Adverse Event Workgroup that Steve led?
>> Kelly Cronin:
Well, it’s different in that it’s not necessarily just Workgroup members: We wanted to get experts from, you know, government and the outside that can really think at a more detailed level about what kind of data elements can we be leveraging for various types of reporting initiatives.
>> Kristen:
Sure.
>> Lisa Rovin:
Part of the background here Kelly, maybe this will help. This is Lisa at FDA. We had the use case on public health reporting, and it’s a very at the last minute after the use case had been drafted, the thinking was, “Well, why don’t we add adverse events into it to expand its scope beyond the standard what we think of as standard public health reporting?” But it turns out that the workflows are very, very different. In fact, I discovered as I was putting together the FDA comments on the use case that HL7 had tried to develop a workflow diagram for both and had, my understanding was, just given up and I won’t bore the Group with why, but, you know, feel free to call, or if you want me to talk about that, I can and that we suggested that instead of trying to make the workflows in the use case, you know, bend them in a way that could work for adverse events, which would then make them not reflect CDC-type public health reporting that it would be perhaps more productive, from an ONC and AHIC standpoint, to identify some data elements which we could all use, regardless of workflow, that the commonalities would be in the data elements rather than in the workflows. (Background speech) And somebody needs to be on mute. And the discussion had more does that work, Kelly?
>> Kelly Cronin:
Yeah, I think that’s right. I think it’s just going to be how do we go about pulling this together, leveraging what might have already been considered for the use case so far. And I still think there’s less known about the data elements that would be needed for the medical products and nosocomial infection side of this, but we’ll have to figure out how to approach it such that we’re considering this together.
>> Lisa Rovin:
I think that’s right, and I agree that it’s tricky, but I think it’s much more likely to be productive than any kind of workflow, you know, attempting to match workflows that really very much don’t match and that other people have tried and failed to match.
>> Kelly Cronin:
Okay, so Lisa, perhaps we can walk work together offline to figure out who might be involved in this. And Amy, if you have any interest in helping or getting involved, it would be great to hear from you as well.
>> Amy Helwig:
Yeah, I can help out with that.
>> Lisa Rovin:
Absolutely. And I’ve already let Dr. Woodcock know that this is happening and for her to help me identify who would be useful from our end.
>> Amy Helwig:
Okay, great. Thank you.
>> John Lumpkin:
Okay, shall we move on to the priorities? (Pause) Right. We went through the process of identifying the priorities for the Workgroup. And thank you, all out of those of you who were able to do that re-ranking late or very deep into the holiday season. We have a worksheet which, depending upon which way you want to look at it, shows that the when you look at the counts of 1 and 2 rankings, so a weighted average of sorts, the #1 was bidirectional; the second was a tie between registries and mater MCH, maternal and child health; and the third was adverse event detection and reporting, tied with integration with HIEs. If you look at the average at the rankings, taking into all the levels of 1 through 11, or so, the bidirectional maintained its #1 ranking, followed by registries, integration with HIEs, and then #4 is a tie between adverse event detection and reporting tied with maternal and child health.
So it seems that we have a reasonable degree of concurrence on five areas of work. I’d like to sort of move this process forward by first seeing if anyone wants to make an argument to move something that’s not in the five up into the top five, and then we can look at, then, are we comfortable with the order of ranking, or how we want to rank those initial five. So do we have a nominee? (Pause) Hearing none now, you all have your dots with you in your office? Because that would be the next step in the nominal group process would be to have you all put dots on which one you want as number one. Not being able to do that, it appears that the #1 priority would be bidirectional. Is there any disagreement with that? (Pause)
Okay. We have, depending on how you count them but based upon the 1 and 2 rankings, we have a tie between registries and maternal and child health. Would anyone like to argue for one or the other to be second, the other one third? (Pause)
Okay. Do we have a roll call? Can we get a roll call? I’d like the members on the call to vote for either registries or maternal and child health for the second rating. So you can just one or the other.
>> Judy Sparrow:
I can read down the list who I have here. Scott Becker?
>> Scott Becker:
Oh, do I have to go first?
>> Judy Sparrow:
(Laugh) (Inaudible) your number. You’re a B, Scott. Yes, unfortunately.
>> Scott Becker:
Okay.
>> John Lumpkin:
Your whole life, you’ve been a B. You should be used to going.
>> Scott Becker:
I am. I okay, registries.
>> Judy Sparrow:
No federal, right? Federal? Theri Cullen? Theri?
>> Theresa Cullen:
Registries.
>> Judy Sparrow:
Amy Helwig?
>> Amy Helwig:
I would vote for registries. And I kind of note that some of the maternal and child health almost looks like they could be subcategories of the registries, but so I would vote registries.
>> Judy Sparrow:
Brian Keaton?
>> Brian Keaton:
Registries.
>> Judy Sparrow:
Lisa Rovin?
>> Lisa Rovin:
Registries.
>> Judy Sparrow:
LuAnn Whittenburg?
>> LuAnn Whittenburg:
Registries.
>> Judy Sparrow:
Lisa Dwyer? (Pause) Gone. Angela Fix?
>> Angela Fix:
Registries.
>> Judy Sparrow:
Valerie Rogers? (Pause) Les Lenert?
>> Leslie Lenert:
I’d go for maternal and child health.
>> Judy Sparrow:
Laura Conn? (Pause) Okay. All right, I think that’s it. Did I miss any Workgroup members that are on the call that aren’t on my list?
>> Jonathan Einbinder:
Yeah, I’m Jonathan Einbinder’s on the call now.
>> Judy Sparrow:
Okay.
>> Jonathan Einbinder:
I agree with Amy’s comment that I think they’re related, but I’ll say registries.
>> Judy Sparrow:
Anybody else that I missed?
>> John Lumpkin:
Just me, and I would vote for MCH, but okay, it’s pretty clear that we want to do registries #2, recognizing there may be a little bit of overlap. And a number of activities of MCH are in classical registries. The third would be MCH, unless someone wants to argue for moving up adverse event detection and reporting or integration with HIEs.
>> Theresa Cullen:
Well, this is Theri. I would argue for adverse event detection and reporting moving up. But that’s because I believe that the important functionality in the MCH can be covered by registries.
>> John Lumpkin:
Okay. So what we’re going to do is go through a vote again, unless someone wants to argue for the third slot to go to H integration with HIEs. Anyone want to pull that up?
>> Amy Helwig:
This is Amy Helwig with AHRQ, and I’m leaning towards that, again, because I’m when I look at the maternal and child health, which I do support, I look at the perinatal birth and newborn screening and school health, and I see that easily would fall under integration with health information exchange, as essentially a dataset that you could move around within the health information exchange. So I think between the registries and the HIEs, we may want to highlight some key functionalities that we would like to see better developed that will relate to maternal and child health.
>> John Lumpkin:
Okay, so we’re going to take the next three items. You get one vote to see which will fall into the third spot.
>> Sunanda McGraw:
Could you clarify, then, what the next three are?
>> John Lumpkin:
Oh. I will. The three items are maternal and child health, adverse event detection and reporting, and integration with HIEs. So you have one vote, and in pure sympathy with that, why don’t we start from the bottom and work our way up?
>> Jonathan Einbinder:
This is Jon Einbinder. Can I just ask a quick question?
>> John Lumpkin:
Sure.
>> Jonathan Einbinder:
If something is not in the top three, what are the implications?
>> John Lumpkin:
Well, that gets to the next question, which is that we’ll get to, which is, after we decide what our five priorities are, we have to have a discussion about what we’re going to do with them.
>> Jonathan Einbinder:
I guess I would just I sort of I do agree that a lot of these things are intertwined, but it’s not quite clear to me where some of the adverse events detection and reporting work that we’ve done to date has landed or will be going. I know we’ll talk about where things are going to go, but I’d hate to see that completely fall of the radar screen.
>> John Lumpkin:
Well, I still think we have an active you know, Les has been working on this issue, so I’m actually not quite sure if there’s anything in here that would not be already included in the work that we have under way.
>> Jonathan Einbinder:
Right, thanks.
>> John Lumpkin:
So if that’s the question, Les or anyone may want to suggest why this would be anything in addition to what we’re already doing.
>> Leslie Lenert:
I didn’t see anything new in it myself. That’s why I was kind of more interested in other subjects.
>> Lisa Rovin:
I agree with that.
>> John Lumpkin:
Okay, so why don’t we take adverse events off, because that’s already a legacy priority that we’re going to be working on, as opposed to new items that we’re going to do some additional work on. Is that agreeable?
>> Leslie Lenert:
Good.
>> Sunanda McGarvey:
Yes.
>> :
Yes.
>> John Lumpkin:
Okay, so now we are taking a straw poll on ranking between maternal and child health and integration with HIEs. Maybe we can do the roll call from the bottom.
>> Judy Sparrow:
Okay. LuAnn Whittenburg?
>> LuAnn Whittenburg:
I would vote for the integration with HIE.
>> Judy Sparrow:
Lisa Rovin?
>> Lisa Rovin:
Integration.
>> Judy Sparrow:
Brian Keaton?
>> Brian Keaton:
I’d do integration. I think maternal and child health comes out of the registries and the integration.
>> Judy Sparrow:
Amy Helwig?
>> Amy Helwig:
Integration, please.
>> Judy Sparrow:
Jon Einbinder?
>> Jonathan Einbinder:
I’ll say maternal and child health.
>> Judy Sparrow:
Teri Cullen?
>> Theresa Cullen:
Integration.
>> Judy Sparrow:
Scott Becker?
>> Scott Becker:
Integration.
>> Judy Sparrow:
John Lumpkin?
>> John Lumpkin:
I think I’ll stick with MCH.
>> Judy Sparrow:
And Les Lenert?
>> Leslie Lenert:
Sticking with M maternal and child health.
>> Judy Sparrow:
Did I miss anyone?
>> Angela Fix:
This is Angela Fix. I would go with MCH as well.
>> John Lumpkin:
Okay, it seems by my count that the majority still goes with HIE #4 will be MCH but that we would, as a Workgroup, seem to think that aspects of MCH should be included in both the registries and integration with HIEs.
We now have a priority list. I guess, as this process usually goes, we give a final opportunity for someone to make an argument for if anyone can’t live with the ranking, being #1, bidirectional; #2, registries; #3, integration with HIE; and #4 being MCH. Is there anyone who can’t live with that? (Pause) Okay.
Where do we go from here? The I’m looking at my agenda. We have a certain timeline for AHIC, as we know it. You know, the Secretary’s agreement with AHIC and the letting of the contract, which probably Kelly can give us clearer information than I have but the AHIC will be going through a transition somewhere around summer of this year, with the goal of moving it into a public-private venture that will have some staying power, given the fact that government goes in through transition on a fairly regular basis. How that new entity will function is yet to be determined. But we do believe those of us who’ve been committed to it that population-related issues are going to be important both as they are now, but also after the transition of AHIC. What we don’t know is the capacity of the new AHIC to manage a fair number of detailed recommendations, such as the one that we are just sending now on event management response management.
So given that, we have a number of ways that we can address this priority list. One way would be is to try to develop detailed recommendations on as we have done in the past, starting off with bidirectional, then developing them on registries. The alternative would be to flesh out the recommendations, not doing the work, but identifying what work needs to be done within each of those areas. So doing a much higher-level kind of recommendation than we have done in the past on each of those four areas.
Any thoughts on approach? (Pause) Hmm. Okay, we’ll do both. Anyone on the line?
>> :
We’re still here. We’re listening to you.
>> John Lumpkin:
Okay. So the two alternatives my recommendation would be that we take the second path, which is to essentially set the agenda for population health connections with clinical care for the post-transition AHIC, rather than identifying the specifics of that, as we have in prior proposals. And what that would mean is that we would, I believe, have discussions in our remaining meetings, and I think we can probably spend one meeting per item, and use that meeting to sort of flesh out what we think are the data and information issues in those topics that will need to be addressed, sort of setting the agenda in each one of those four areas. (Pause) So I’m guessing that since no one is speaking up, they agree with that.
>> :
Yes.
>> :
Good.
>> :
Sounds like a plan.
>> Kelly Cronin:
I think it sounds very reasonable.
>> Leslie Lenert:
I think we need to be conservative as to what we take on, given the life span that we have.
>> John Lumpkin:
Great. So we’ve now set the priorities, and we’ve discussed some of the next steps for our committee. I think that we will the Chairs will certainly work to look at our time frame and make sure that we do have adequate time between now and June to accomplish those you know, to have those four discussions. I think that it might be helpful if we had volunteers to lead the discussion on each one of those four areas. And what we’ll do is, rather than put you on the spot on this call is to send out an email asking for one or two volunteers for each area to sort of kick off the discussion.
>> Kelly Cronin:
John, one thing we may want to consider this is Kelly given that the some of these topics are really interrelated, that the integration of HIEs could really enable many of the functions of the other categories, I’m wondering if we might want to try to take a stab at an outline for these and share them to see where some of the natural relationships for interdependencies would occur, so we could know how best to organize the discussions.
>> John Lumpkin:
That sounds reasonable.
>> Kelly Cronin:
And also, you know, staff can be pulling together some relevant background information and be helpful in trying to organize how we might try to think about these conceptually.
>> John Lumpkin:
So let’s suggest that maybe Les and I Les, if you’re agreeable, you and I can work with staff to kind of put together a straw outline straw man outline.
>> Leslie Lenert:
Sure. I think that that’s a good idea and that what we would need to do is try to identify a few experts to talk (inaudible) the critical issues, of course, on you know, for each area. Do we feel that we I think we certainly have a lot of expertise on the committee, but we may need to bring in a few outside experts for some of these issues. I think that’s what you’re getting at, right? As part of the outline of our discussions that we’re trying to but I mean, I think we obviously have to lead what’s going on, but it would be difficult to not seek some additional input.
>> John Lumpkin:
Yeah, It may be that what we can do is, you know, work with staff to develop an outline, send it out to the partner organizations for their comment before we bring it back to the full Workgroup. And I think that will achieve your recommendation. And certainly we might want to include, you know, some key organizations that may not exactly be directly the current set of partners. The MCH coalition MCH directors, for example, might be a group that we may want to reach out to.
That sounds like a plan. Any other any thoughts on that, disagreements, comments? (Pause) Okay. The AHIC meeting is scheduled for January 22, so we will be getting our materials in by the 14th. So we pretty much, I think, have a finalized document. We also are going to encourage people to give input on the public health use cases. In the coming year, we will expect to give some input immunization response management we expect this year, as well as public health case reporting. We’re expecting that the potentially January if things go right, there will be a public comment period on those, so that will, again, be something that we will want to monitor as a Workgroup.
And I guess the last item under “Next Steps” is a Clinical Decision Support Workgroup that’s meeting cuts across many of the AHIC workgroups, and that group will there’s a cross-cutting workgroup that meet on January 16. So if there are anything that seems to be worthy of Workgroup discussion on that, we will bring it to our next meeting. Do we
>> Kelly Cronin:
Yeah, and John, just to let the Workgroup members know, Les Lenert will be representing the Workgroup’s interest in that meeting.
>> John Lumpkin:
Right. Thank you, Les.
>> Leslie Lenert:
Glad to (inaudible) do that.
>> John Lumpkin:
So that brings us up to do we have a date for our February meeting, or are we going to send out
>> Judy Sparrow:
It’s February 6. Wednesday, February 6.
>> John Lumpkin:
Okay. February 6? It says February 4 on the slide.
>> Judy Sparrow:
No, I have the 6th. I’ll double-check that, send it on email to the Workgroup.
>> John Lumpkin:
Okay. Great, I think that’s the end of our agenda. Do we have anything else? We will have public comment and at the end, so I just want to make sure, before we go to public comment, if there are any other items that we haven’t included. And I have the 6th on my calendar also.
>> Judy Sparrow:
Okay. All right, shall we bring in the public?
>> Alison Gary:
Okay. For those that are online, you’ll see a slide on how to call in to comment or ask a question. If you’re already on the phone, just press star-1 on your phone right now so that you can make a comment. Any wrap-up comments while we’re waiting for the public input?
>> John Lumpkin:
Well, thank you all for a very efficient meeting. We’ve gone through sending back to AHIC a revised letter. I think we’ve we’ll be starting out the new year in a very strong position.
>> Leslie Lenert:
And I’ll be sending out some details next week as to what our the CDC’s roadmap looks like. As I say, I think we need a little bit more work before we can make our materials public at this point.
>> Alison Gary:
And we don’t have any comments from the public.
>> John Lumpkin:
Great. Well, thank you all. Happy New Year, and we’ll be talking to you in February.
(General thanks and farewells)