Tuesday, October 20, 2009

HIT Policy Committee - Information Exchange Workgroup

There will be many challenges to electronically sharing laboratory data. The HIT Policy Committee’s Information Exchange Workgroup met on October 20 with the focus of the meeting on electronic exchange of laboratory data. The workgroup is a task force of the Health IT Policy Committee that advises the Health and Human Services Department’s (HHS) Office of the National Coordinator for Health Information Technology.

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the CLIA. In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

Roughly 8,000 hospital labs and 6,000 independent clinical labs perform three quarters of the lab testing in the United States and some of those facilities have installed interfaces that enable standardized electronic delivery of the results, Jonah Frohlich, Deputy Secretary of Health Information Technology at California's Health and Human Services Agency, testified before the Information Exchange Workgroup.

Without interfaces in place, many lab results that could be sent electronically are scanned and faxed to physicians, he said. “While approximately one-quarter of physicians nationally have an EHR, many still receive faxed lab results that are either manually entered or scanned into the patient record. This is a limitation of both the lab and EHR industry,” Frohlich said.

Meeting Materials:
Rough Draft Transcript:


Good morning everybody, and welcome to the HIT Policy Committee and mentation Exchange work group. The work group is holding a public hearing today on the subject of laboratory data. This meeting is being held in public which means it is being webcast over the Internet, and broadcast over the phone line. There will be minutes from this meeting and I just request them committee members as it would please identify themselves when speaking for attribution for the minutes and also for those listening of the web and on the phone.


With that, Alaska each member to briefly introduce yourself so you can briefly state or name and organization and perhaps of the about your position at that organization and we will begin on my right.


Good morning, I am stephen stack, a trustee with the American Medical Association and the chair with the medical advisory group. I am also a practicing emergency physician in Lexington, Kentucky.


I am like flag a physician and epidemiologist and I am Dean of the John Hopkins Bloomberg School of health.


Dave [indiscernible] and I and the commissioner of finance and administration for the state of Tennessee.


Paul Ackerman, a software entrepreneur and member of the policy committee.


[speaker/audio faint and unclear] responsible for interfacing at epic and I hear in place of Judea Faulkner. She has done a lot of interfacing work with the particular labs and topics that they will be discussing today.


IBM [indiscernible] the state representative from Florida and also in members of the policy committee.


I am Micky Tripathi, a member of that CC zero collaborative and co-chair of the work group.


I and Kevin McGraw and I am a member of the privacy work group and a co-chairman of the work group with Micky Tripathi, and also on the policy committee.


I am Karen from the centers of the Medicare and Medicaid, and not a member of that committee but coordinating activities with respect to Clea and information exchanges.


And I believe we have a number of members on the telephone line.


Terms Kennedy, vice-president of Health itea for WellPoint and a member of the committee.


Any of the committee members?


This is Connie Delaney. I and dean and professor of the School of nursing at the University of Minnesota and a member of the committee.


Anyone else?


Jonah frolic here [speaker/audio faint and unclear] house preservation.


Thank you all. I will turn it over to Devon and Mickey.


Thank you all. I appreciate the attendance here, and I particularly wanted to say thank you right at the beginning to all of those who are one to testify today, and share their expertise with us. I know that you all have a lot going on in your day-to-day lives and to take the time to be with us today, again, it will greatly Inform what we're doing and we appreciate it.


I want to take a couple of minutes to put this hearing in the context of what we have been doing as a workgroup. Again, are charged in summary basically is to recommend policies and technology requirements that are needed to support the electronic exchange of health information, and we have talked about that both in terms of health information exchange has a further, the sharing of information, regardless of the format, also with the commonly referred to now on a some sort of formal that work and on the landscape today we have both and we will need policies essentially that can support couples.


In particular lately we have been focusing on what policies and requirements are needed to facilitate the exchange to meet the meaningful his criteria. In August, we recommended that there would be extinct standards that were enforced largely through consumer acidification that would enable texting to the information for meaningful use regardless of the mechanism of exchange, so whether that is point the point or some sort of formalize network, there would be some kind of policies and standards in place that needed to show that to happen. Those would need to strike a balance between what might be needed to again allow for this exchange to occur regardless of the format, also not being so stringent that in fact it kills innovation, and that is obviously a difficult balance to strike.


We do hope in the near future to do some exploration of the other areas of meaningful use in 2011 which is E prescribing, but today the focus is on the exchange of laboratory information. With that I will turn it over to the co-chair.


Of like to follow Devon to thank all of you, for coming in and are expert witnesses because I know a lot of you are incredibly busy and who have come a long way. Or some like Jonah, have tried to come along with that were left at the airport. So just to reiterate the point that Devon made, lab results and E prescribing, those two transactions are incredibly important not only for the many fleas [indiscernible] criteria by -- at the end of the day we if we have high level objectives which I think we do wrong population house being able to major any more meaningful way what is going on in the health-care sector with respect to quality reporting, utilization and all of those things that I think all of us are receiving that are necessary in the health-care sector to move to the next level, and results are just fundamental to that. We will not be able to make a la of progress on the high level in the sense that we have as a country until we can get our arms around some of the nitty gritty details around just the vexing issue of the results and giving greater standardization to help us facilitate some of those higher level of emissions that we have. So having a good perspective [indiscernible] from the point of view of various stakeholders who are living it in various different ways to try to get our arms around what might be those issues and what might be Wheat Board in terms of getting us to a better place with respect to how lab's work today.


I will say that we have a very tight hearing, it is always a challenge to try to get that holistic view and packaging to a reasonable amount of time that allows enough of that advice two come and that expert testimony two come, and get it out on the table, but also allow enough time for discussion with the panel members and a little bit of that back and forth. So we have a timer said and I understand it is five minutes per speaker and it will start to see, it kind of looks like that as a demonstration. Forty-five seconds before you need to be done it -- 45 seconds. This is how problems start. Forty-five seconds you will see that flash on the screen and one of us will remind you orally that you have 45 seconds, and let me just a Paulist apologize in advance if we are a little bit firm, politely firm about sticking to the time lines because what we want to do is, we have your written testimony, it is available, and we don't want to go through all that but what we want to do is take advantage of the fact that you are here and have face-to-face dialogue with the committee members. So I apologize in advance for the impolite as that I am about to impose on all of you as you go through testimony.


With that, if we turn it over to the first panel.


Yes. Could we call up the first panel please? Is Angela here yet?


Well, Kelly, you are on your own. We will start with Kelly, and from the office of the coordinator for Health Information Technology, and my hope is that Angela [indiscernible] difficult [indiscernible] hopefully she will be here momentarily, and we will put her in, but in the meantime if you could go ahead and start, that would be great.


If it's good to see everyone here instead of having these long conversations over the phone, and I am hoping that Angela does make it on time, primarily because [indiscernible] part of the issues they were talking about today is regulatory in nature and [indiscernible] Angelo will elaborate on to get things started. So just to give a very quick overview of what I wanted to cover in less than five minutes, I thought it would be helpful [indiscernible] lab data is so important to us moving forward and why this is critical time to the focusing on the barriers and what we need to do collectively to address the issues. To cap will briefly on what we need to do today, to discuss [indiscernible] the barriers and challenges in particular, and then what a treat as has been doing, and shall elaborate on that. And Mickey pointed out that on it strategic level, and also probably on the strategic or objective or a major global, the elected up with most likely be an important element. We can specify what ... will involve but if we look at recommendations from the full committee on meaningful use, there are many different objectives and measures that were specific to the exchange of lab data, so I think we need to keep that in mind, even many quality measures as well and stand them, I think we would decide would be dependent upon the availability of Let's and being able to keep those -- take those into account and count them for denominators for majors. And obviously we need standardized glad exchanged not only between critical care and Public Health Labs but also [indiscernible] labs. A separate set of labs that we need to be thinking about as Mr. to understand this universe. And of course their is a lot of potential with reducing costs as we are able to have more patient centric six exchange of lab data that would allow for historical and clinical relevant [indiscernible] duplicative tests would be avoided and certainly that could be a cost saver.


In terms of current practices, I think we all know and hear a lot about a lot of blood results today existing electronic format, or they are by fax or transmitted by paper or phone. There are obviously pockets in this area but it is not anywhere near where we hope to see it over the next couple of years. And there are a lot of different issues without which will talk about, but part of that is because there is variability in the standards that are being used, and well HHS has name standards based on the work of the health 90 standards panel they have not been universally adopted. And there is a lot of customization being done which includes naming conventions, nomenclature and lab compendiums or order sets that are used across a number of different labs and those become .2. customize interfaces that are burdensome and require a lot about keep and are also quite costly. And it is often the case where providers have to wait for an extended amount of time in order to get their .2. interfaces to receive the lab results the need to form their practice.


So in terms of these specific areas, we know that in some cases it is a lack of definition of terminologies but we know that there has been the again, standards have been advanced to process these that have been established Alaska oblivious to the National level, but there has not been necessarily an attempt to come up with a compendium. There have been many across a variety of different labs. Kelly had a diverse blackmarket and obviously small independent labs, a large labs, hospital labs, physician based labs, it is a complicated space to work across particularly when you are talking about standards adoption and a more patient bottle of data. They're is a lack of network services and a lack of incentives to share data. But ideally where we are talking about going is trying to get to -- The collector is not working. -- the cooker is not working.


Okay. [laughter] I didn't realize I wasn't talking fast enough. We have a fair amount of studies and is the most recently that in the spring we did a study to dig into these issues to get a current assessment of where everything is. The previous committee that was focusing on these issues had workers that was very focused on this issue and established these cases with the health ITT [indiscernible] standards are not only names but [indiscernible] we still have a problem standards adoption. We have also seen some real world experience and the trials of limitations.


So today I think just building off of what Mickey and dad have already opened with a clear trend two get a belt and comprehensive view of the issues that exist. They're not just regulatory, there other types of policy issues of why this isn't working, and we want to find a way that we can [indiscernible] patient eccentric seat results in an efficient way but as needed you can query and retrieve data that indeed if you are in treating Can clinician and you need information to make good evidence base decisions. Also we would like to identify the role of government, not just federal government but state government because we have a state HIE program and we need to figure out what authorities and Resources can leverage to get labs on board and it really focus more on a piece of centric model of Health Information Exchange, but we also have clear steps which should be taking a month provider groups and other parts of industry. So hopefully after we had some rich discussion, panels and the questions and all the materials, it has an incredible site think this is an opportunity for us to get her head around this and be fresh on the issues and think about what are the party is moving forward, what should we be thinking about in terms of actionable steps, and how might we sequence those. What should we have plank for second and third? Clearlake HHS is poised to do something on this and I think Angela will be talking about things more specifically when she arrives and we can get her end.


She is here, perfect.


Would you like to come up, Angela?


Thank you. I appreciate the opportunity.


Thank you for coming.


Basically when we began to look at it in CMS, we look at a number of things over probably the past year or so. What I wanted to cover today are basically four innings. One is sort of a basic overview of clinical Laboratory Improvement Act, sort of a brief synopsis of that provision, that legislation. The second thing I will talk about is that infrastructure we currently have in place to employment CLEA.


The third thing is to touch on the challenges or obstacles that some people may refer to with respect to getting to where I think all of us may ideally want to be in terms of the electronic health records and laboratory services. The fourth thing I want to share with you are what we sort of proposed in terms of an approach to addressing it from a CLEA prospective. In short, we do not believe that there is any barrier or significant obstacle from the CLEA prospective to implementing the electronic health record in the HIE provision in terms of leaning toward that technology. Self I will have a preliminary or proposed approach that I would like to highlight.


First let me go over an overview of the clinical Laboratory Improvement Act of 1988. Basically it was an act to provide by law accurate and reliable laboratory testing results. It arose from a lot of laboratory Mills, if you willed, or errors and Pap smears and Denver Holt, a whole host of issues. But it was about accurate and reliable lab testing results.


It applies to all entities performing human testing regardless of sights and physical site persay.


And what we referred to the fore as a way of testing were included from CLIA standards. So when you look at that universe of labs that are under their umbrella of CLIA, there are about 2,499 labs currently and about 62 percent of them were 129,219 are actually waved labs that are not under all of the standards that we have under CLIA with regard to that Director, Quality assurance Press the seas and the like.


CLIA requires Laboratories performing non wave tests or more complex tests to report test results to the individual or authorized person has defined regulation, and I think you'll find reference under that where we reiterate that point in terms of the authorized personally use the results of the patient treatment for that purpose of treatment.


CLIA does not prohibit descending or transmitting patient results to a second source after or at the same time as the authorized person. I am focusing on at the same time for reason and you will hear that in a little bit. It requires all information and test results remain strictly academic strictly confidential, and that is currently in our regulations now.


That covers the overview and now I look like to shift to the infrastructure we have in place for CLIA. In terms of information sharing, of course their is a regulation or a statute, and then there is what we refer to as manual instructions or state operations manual or interpret the guidelines that we codify in the state operations manual. Those are the things that that that surveyors use to basically effectuate or inspect the laboratories in revealing them against the standards that are laid out.


We frequently used certification memos that began on Fridays and would basically inform the community of surveyors of any new information that we want this to implement either immediately or in some short point of time [indiscernible].


The Main Avenue of the work of surveyors is really derived to what we refer to as the 1864 agreement, which is a provision of Social Security Act where we basically have a contract or agreement with every state for them to implement or perform inspection as weak guide them in terms of our policy or directions that are codified through the [indiscernible] or the survey and acidification memos of the interpretive guidelines. So that is pretty much the infrastructure.


We have roughly about 20 or so staff in central office, and probably another 80 or so in the various regional offices, and then of course a number of several hundred estate agency surveyors in terms of performing laboratory services.


The next point I wanted to share is or the third aspect I wanted to share, some of the challenges that we examine when we started thinking about an approach to how CLIA would fit in the electronic health record or the HIE effort. And we sort of had three little elements I'd like to refer to in terms of consideration analysis and thought, and consideration I refer to is sort of scenario building or options that we begin to think about in terms of approaches and how this would it fit in with CLIA. Then we sort of went through the analysis related to those approaches, and this opportunity before us today is an opportunity two refine our thoughts around proposed ideas, and to hopefully gain some insight from hearing from any of the panel members about the current state of affairs.


Getting into the challenges, but because you're a few of them to share some of the experiences that CLIA has had as a result of that.


For example, as a look at the probable to challenges related to laboratory tests around HIE, a lot a lot about the CLIA regulations and how that definition of authorize persons is stated as an individual authorized under state law to order or C test results or both.


Now CLIA refers to state law because of the diversity of loss on that subject. So when we in the early years of the 80's and 90's began to implement CLIA, we recognize up front that some states permit physician ordering, the typical sort of Model I guess, if you will, of test and receipt of this test. And some test submit a patient to order their own test and see the results and some state laws are smiling on that, so I think that will probably address a state lost status and what the state of affairs is there.


They're also is the appearance that there may not be any assurance of accuracy and reliability of test results after they put this into that HIE. As we try to use technology as much as we can and CMS, there is always the issue around the transfer of information and whether that is picked up as accurately as it was put in.


Speaking of Technology, which also where it's sorta challenged by some of the notions or some of the thoughts and information we have about physician office labs. And the transition between office and office labs, there are great computer systems being used and will those computer systems be able to be interface and share the information with the HIE in terms of operations, in terms of maintenance functions, in terms of upgrades and programming changes and in terms of the validation and the whole gamut of activity and information around those computer databases.


I sort of touched on the differences in laboratories and by also recognize that the institution providers, oftentimes the labs that may be functioning in the ER or emergency department may not be able to communicate with the pediatric lab or the on call syllabic, so those systems sometimes pose some challenges for all of us in terms of working with them.


The last thing I wanted to cover was really sort of the approach or proposed approach that we have been giving some thought two from the CLIA prospective. As I stated before, we don't believe that CLIA opposes any significant barrier or obstacle two pursuing the health information technology and electronic health record part of lab results to that medium, but there were three things that were sort of the key principles around our proposed process. And the first is that the conditions proposing the laboratory testing on their patients would need to identify the health information exchanges electronic address on the test to enable laboratories to transmit patient demographics and test results to the HIE of toys, and to the authorized person at the same time. So our proposal is pursuing an approach of simultaneous information to the authorized party and to the HIE.


The second principle is the patient test result reporting would not change, and the laboratories would continue to be responsible for the accuracy of test results reported to the authorized person, so again, from the CLIA prospective, standards that are set through CLIA, there would be no change in terms of the expectation of accurate reporting to the responsible authority.


Third would be, after its results are reported to the authorized person, then our view would be CLIA oversight authority pretty much ants from the perspective of, that is where our corner of the world is, if you will, and our responsibility lies, so that would keep everything pretty much in the same order, yet be able to support the HIE effort.


I think, and you can imagine, that there may be some panel members here that made you different sequencing of the events that we are certainly open two consideration and I thought, but in light of the technology and capability of that technology, we thought that if the information pretty much is it the same data and data fields that are commonplace in the CLIA world, then it could all go simultaneously and we could maximize the use of that technology was simultaneous information sharing.


That concludes what I wanted to share with you, and I can either opened it up for questions or certainly open it up to moving on to the next panel member.


I am certain there will be questions. But thank you both very much. That is very helpful to kick it off, and on-air time keeping responsibilities, Mickey and I had made a decision two allow both Angela and Kelly a little more time because it is so critical to get the background information out there. It does not mean that we are waiting the time requirement for other larger panels where we need to be more disciplined. So for those of you sitting in the audience waiting to return, don't expect to get that much time.


With that, I would like to open it up two panel members.


Gail "Herald." I just want to make sure I a understand what you're saying. You do not viewed CLIA as a problem for the exchange of the data? The definition of authorized person, you feel it is adequate and does not present the problem, and are you going to abstain from the rest of the meeting because I think the reading I have done over the last weekend, that is not what we will hear from additional panelist, so I would hope you're going to stay and listen to the rest of the discussion. But with love to hear your thoughts and comments after we hear from the rest of the panelists. And I would like your interpretation and rebuttal to some of what they are saying, please.


We will be able to stay probably until early afternoon. I have a meeting with the Senator on a problem issue that we're trying to help resolve. But with me today is Judy who is our director of laboratory services and CMS, and she will be able to stay the entire day. And I have a team of Laboratory Specialist in the office that I understand are watching this via the Internet, so they could certainly try to address and think more surly about many of the concerns that are raised here.


When I said that we do not see CLIA as a significant use, that doesn't mean that we do not perceive that there may be and we need to revise our interpretive guidelines.


At this point, we have not shared any of our scenario or approach with our legal advisers, so that is certainly something that we have to do as we move forward. However, in their informal discussions, and are on a probing into the office, we do believe in a lesser evil versus a more rigorous time consuming approach such as regulatory changes that we could use to interpret the guidelines as a vehicle two agree fission or corporation or some of the key concepts that we believe would be needed to effectuate this through a laboratory provision.


Dave?


Thank-you for coming.


I guess, it is the second point that seem to come up most often in the written testimony that I had the opportunity to review. And the recommendation from several of the speakers is that, they're the a certification of the interface to either the HIE or that medical records system itself that it is intact receiving the information as defined under CLIA, and sent under those regulations, and as long as that certification takes place, then how that information takes place, a bill that has met its responsibility. And it would be mad at the door of the receiving entity or designated entity which is a term we use under our state law, and then, it would therefore -- the individual certifications that would have to occur, what seems to be kind of the burden that seems to bother people the most is that, in each individual installation, and have to go in and spend a significant amount of resources and time in that verification process, the laboratories do, and therefore, if we could have a certified electronic health record that we tested and made possible on the front and, similar to what goes on in the pharmacy area, that would meet the requirement. But I think you probably have to relieve the lapse of that requirement or otherwise they would still feel like, the lawyers probably tell them, that there would have to go into each individual installation as opposed to relying on the certification process having in fact worked. Is that the way you see it?


I think you may have a good point. I certainly don't want to disembowel any merit to the concerns, so at this point, this is one of the benefits of this panel opportunity, to sort of make sure that we're hearing and we are scoping out our area of responsibility in such a way that either addresses it, or maybe some other party should address that specific concern as it relates to the HIE piece, but from the CLIA perspective, we're still interested in trying to address any of the concerns, or at least examine it in terms of its merit.


Are there any panel members on the phone who would like to raise a question with our first panel?


Thank you, Angela, for that testimony. It seems that you have pointed to the heterogeneity across states because CLIA defers to state law on this, so I was wondering if you could talk a little bit more about that and in particular, I think there is another issue, which there seems to be widely varying enforcement of what might be CLIA provisions across states as well, which seems to create a lot of confusion in the market, is my sense of that. And I just wanted to get your perspective on that and how much of that is sort of something vision of CMS, there is a good awareness of?


Let me first tackle the consistency issue because that is a pet peeve. The issues around differences in state law for example. What we have tried to do to mitigate that is, really, almost a consistency in almost any information or training material that we provide to the state surveyors. Typically, we are meeting with them at least annually and sometimes more frequently, but everything is standardized in terms of my jewels of information and -- in terms of modules of information and in terms of sharing with them in terms of problem-solving.


When we have identified areas where we are concerned about consistency, oftentimes, we will pull, pull the responsibility in house to a sort of use and worker kind of approach to tackle the problem of consistency, so that we can understand, what are people thinking, what are the variations, and why are they thinking that way, then we turn that information around into new instructions or provisions or policy statements in terms of how to approach things. So that it's an approach we are using in terms of trying to deal with consistency, our review of data, a review of enforcement activities. And we also received complaints. If people complain that the surveyor seems to be really harsh or the state seems to be very harsh, we receive those complaints and we delve into it in terms of examining, what does the data say, what does the enforcement data say in terms of that activity? , and we drill down from there, in terms of, it is it a state issue or a survey a specific issue or what is really going on? Or is it because of state law, or a preponderant of referral labs in certain states, and if they feel like their is different standard, if you will. So we try to use the data and information that we have to address any specific problems and any aggregate problems that we seek bubble up from the information.


Maybe I am asking is two the question, if there is any committee member that has a question, feel free. I am getting down to the stupid question level.


In terms of the responsibilities of the surveyors, if we could drill down into that. What is the responsibility of a surveyor in a particular state, particularly as it relates to the lab and, but say you have community hospital labs who are deploying interfaces to a variety of players, whether it is individual EMRs or health information Exchange where that is available, how does that way and on the part of the transaction?


The Laboratory may ask for guidance on a lot of that because I am not sure that we have a lot of information with respect to the technology piece of it.


What we have currently is information around the standards and protocols for all of the various lab tests in terms of expectations for the laboratory itself in terms of review of typical findings as reagents have expired. And in this day and age, you don't see many findings as related to that. We may also find credentials of the lab director or the performance issues of the lab director, or we might find issues around the quality assurance process these. It's a really the surveyor is applying all of the surveyor guidance or what we refer to as interpreted guidelines to that lab, sort of as their standard protocol and the review or survey of that lab in a comprehensive fashion.


So the majority of their responsibilities and activities it sounds like and correct me if I am wrong is really about the performance of a lad as a lab with respect to the accuracy and diligence around laboratory resulting and clinical lab performance, and this new technology that is being introduced, I guess it is fair to say that that is something that is generally knew, even to the surveyors.


It really is. Even on the non CLIA aside, we're beginning to face issues on how you do inspections or reviewed data when you are used to seeing a hard copy medical record. How do you do that with electronic health records without disclosing your hand in terms of what you are looking at. And how do you get the access to that information? How do you get the sample pulled in a way that avoids any possibility of manipulation in terms of what is really going on. So we are already sort of faced with that challenge, and I think that laboratory areas are probably moving a little quicker in this area. But I think it is a valuable. To do it in because everyone typically from health care perspective gets a lab test. Such is the extent that we can fine-tune the technology and get there, I think that would be unwelcome approach to improving health care. -- a welcome approach. We worry from the point of physician office labs because we see, when we look at the universe of physician office labs, we see that roughly 53 percent of those physician office labs continue to do away the testing, and there is about the remainder of the 47 percent that are doing the higher complex tests. Or the private sector information, we are concerned that a lot of opposition offices may not be fully up to speed in terms of electronic health records and computer systems to be able to get that information two or through and HIE, and we are also concerned about how long that would take if we use a phase in the approach or if the Committee moves towards an approach that gets us to some kind of these and approach, how long would it take to get there? So those are some of the thoughts that I am sure that you are sort of struggling with as well in terms of that information. We even thought about the wave testing that typically goes on in a hospital. Being a registered nurse in the ICU setting up for a number of years, it was typical that we would use a "counter to get the glucose reading of certain patients on the floor, and in the electronic record age, I sort of wonder if sometimes that information -- yes, we would documented in the nurses' notes are that patient notes, but how does that get into the pathway for the lead in terms of communicating.


That key information in there, in terms of glucose status in 1920, since technically it wasn't in the lab. Using my point. So there are a lot of wave tests that are done routinely on the floor setting that do not get captured, and I wonder if we look to the full spectrum of information that we are desiring to get.


A have a little different tact. In reading over the material that has been presented, one of the things that comes up our standards in nomenclature. And this suggestion has been that CLIA would have the authority two require standards be established, and in fact, do you have that statutory authority? And how long does it take to implement and go through the regulatory process? And in addition, to that, we have the offering of guidance, and I know what a guidance letter is. And do you have the authority two -- how to go about ensuring that guidance on things that are perhaps somewhat different from the regulations under which DEC guidance is being given?


Okay. But the tackled the regulation one first. Typically it can take up to three years, sometimes longer. We like to believe we can do it more quickly than that the, but that is usually the standards operations in CMS, to try to do the regulations in three years.


To the extent that our legal advisers believe that what we currently have in regulation does not -- it is not in conflict with the approach that we want to pursue, then untypically we can simply clarify -- then typically we can simply clarify or modify but we want to address and incorporate. A lot of times they will look at the legislative history, the law and provisions, and sort of examine with their philosophical concern about this issue. Was it silent? Did we address it in the preamble, so we sort of thought about it but we did not put meat on the bones, if you will. If we can avoid making a regulatory change, clearly that is the quicker pathway for addressing this effort through interpretive guidelines as we referred to.


Getting to the first part of your question in terms of standards, to the extent that the standards are identical two CLIA, or not very much different, then I do not see a provisional barrier of being able to do what you suggested. If it is different, that may be something we need to follow up more closely.


In follow-up, because there seems to be a difference among labs and what things are called in nomenclature and how that is interpreted, if you were to look at your existing regulations, do you have the authority two require or imposed upon labs the standard of nomenclature?


I would say it probably depends, and I don't mean to sort of give a response that sounds like I am sort of trying to negotiate on the nature of it. I think it depends upon the specifics of change, because, who knows, it could be something that we have contemplated in terms of updating our CLIA in terms of guidelines. Or maybe it is not, and we haven't considered it, but maybe it fits with the principles that are already there in regulation, so I want to sort of marginalize my opportunity to sort of examine specifically that standards of nature that you are referring to.


Actually, it doesn't stand up very well. We are running out of time for this panel. We have Steve and Dave in Kiel and Karen, we will slide you and ask people to be succint as possible in both questions and answers so we can move along and be mindful of the time constraints.


Thank you. We have one question on the phone when you get a minute.


This is a request for the question.


Charles, we will put you in the queue but the rest of us are trying to be prompt.


This, it is based on what you just said, and that is that the wave test or the point of Cure test flight accurate check and hemo cults, segmentation the parties is probably a value. Because the value of those tests, the bedside good, enter meeting, the spade with time. And for posterity, it is less valuable to know when someone's kidney function test was which is important over a longer span of time, so I don't know that 100% capture is necessarily needed or even desirable, certainly at the early stages of HIE and as a verb for sharing this information.


The reason I pointed that exampled out, when we look at data for the wave tests or a wave labs, over time, we have, of the 209,000, I think I mentioned that 129,000 are waits. And in 1995, we had about 65,000. So we basically doubled. And it seems to be that there is no shifting that trend line. It is going up. And at the point I was trying to make is, more and more of Veritas are certainly looking like they are going to be weighed tests.


(BRIEF PAUSE IN CAPTIONING WHILE CAPTIONERS TRANSITION).


And then actually delivered to the person who ordered the test. Hutzpah been given in a test, ones that enters the public realm, the PHR, - all the other places for all the potential inaccuracies and error, once that is outside of that small loaf loop.


We had great debate not only in the confidentiality, but the privacy and breach potential. We have had some heated discussion on that topic. And how you put the fire wall there and how to make sure it gets to the right person and all those insurances that give us convert that may be the insurance down the road that it does not hold it against us that we have this [ INDISCERNIBLE ]. What ever. There is a lot of things and concerns. That have been voiced by others. Probably in some proposed legislation that tried to address these concerns. Yes, we have given some thought to that.


Okay.


In an effort the discontinued to try to find some pass through the thicket, assuming that Kelly and [ INDISCERNIBLE ] has a with 42 certified EHR and set up certifications standard for lab transmission into EHRs which I guess maybe question also bought the for that for later. Assuming that you can be satisfied that in fact that transmission standard could be met. If it in fact seemed to - how much can be fit under the delegation to states under statute. The allow that to occur. As long as the status of following the guidelines are established by your office and by ONC and allow this to occur under certified situation, is that a work around to the issue of the second problem possibly? I know you cannot give an answer to that today, but I am trying to figure out a path.


Sometimes we look at the state law in the provision that it is more stringent provision to protect private privacy confidentiality and so forth. Should we defer to the state in the circumstances or should there be a broader federal approach? I suspect that if we chose the path of a broader federal approach, that would make it the same and would usurp state law that would likely require regulatory change because - - [ OVERLAPPING SPEAKERS ]


Charles, you are up after Karen.


I would like to clarify what Angela has been saying and talk about what we're going to do at CMS when we have gotten to the end of this day. We will be looking back at everything that we have heard to say what needs to be done and then we will look at the statutory authority, regulatory authority and what we can put out and guidance, what we may not have authority to address but perhaps ONC and other aspects of H. H. S. do have more authority in that way. We were talking about doing at the end of the day, looking at the new environment and figuring out how to slice it up in a way that is not being done today.


Thank you, Karen. Charles Kennedy on the phone.


Good morning. I am hopeful that [ INDISCERNIBLE ] rules out will empower individual patients when it comes to disease management. Just from listening as a policy document, it feels provider centric not patient center. What was mentioned in the testimony, we looked at the provider to have an accountability to identify others who can resist particular test results. My question, the you agree that CLIA is more provider centric and secondly, can you comment on whether CLIA can accommodate on a patient being able to specify who will be able to receive the test results other than the ordering doctor.


It is understandable that people may view as a provider of centric in terms of CLIA, but when I think about how CLIA came into being it is really about patients. About the results they got or did not get. The errors that were received and how that affected their future treatment of plant and care. CLIA is about accurate reporting. We believe that Acura reporting will help the patient and move forward in terms of the right treatment path or plan or care that day and their physician or primary care see fit. I am not sure I certainly recognize that there is a lot of nomenclature now run patient centered activity, but I do not believe CLIA is even a barrier to that. I think it all began with patients. And what result or no results or error results that they received. I think we are a fit from that perspective. Oftentimes, CMS because we are often pairs for services, the laboratory community is very interested in making sure that they are in compliance with all of our company conditions of participation and CLIA provisions related to being in compliance for lab services. From the payment perspective. I think that is a recognized aspect of our program that exist.


Becoming as the patient component, and the patient specify additional set entities to mislead the results?


Your earlier testimony - the patient being able to see promptly thereafter, the ordering - or simultaneous, can you share more?


Initially, we sort of heard some of the debate early on by the different organization and organization in respect to sequencing. And when we said it is technology, what can we do it at the same time? In part, we also hope that one should do with the same time and if all the provisions crosswalk in a transferable way with [ INDISCERNIBLE ] and in theory, assuming that we have some beta testing and go through the right kind of validation process that information is there simultaneously, we do not have to deal with the sequencing pieces. We examine and sort of - there are some pluses and minuses and I am not at liberty to talk about right now. A lot of the times, we examined it a little bit and we said well, let's do it at the same time.


I suspect we will have some - we need to close and move on to the next panel. I know the issues are being raised in the next panel. I appreciate your testimony here. We will definitely be taking you both up on offers to continue to address questions that we had after this hearing. We are expecting to spend the months of the next two meetings as a workgroup coming up with some specific recommendations that result from this that will impact work from in both agencies. I know that as Karen mentioned, CMS is actively listening and the whole purpose is to surface these issues and come up with raced to resolve them and we appreciate to continue to be engaged in this.


You will be here for a little while, a couple of hours? We may reserve the right to ask a couple of questions.


Thank you. If we could have the next panel come up, please.


Well there are coming up, maybe I could run down brief introductions for each of them. And I think we will have them speak in this order. We have Mike Nolte, vice-president and general manager for marketing at DT Healthcare ITP ID and then we have the Sue Manjrekar who is the interface division at eClinicalWorks and EHR company.


Then we have Phil Marshall who is the - - WebMD Health Services. Tim Ryan, director of Enterprise application for Qwest diagnostics and then Susan Neill, the director of laboratory services for the Texas Department of hot state health services and - - welcome.


Will begin with mic'd. Good morning.


If you could move in a little closer together.


[ LAUGHTER ] I hope you are being sarcastic. [ LAUGHTER ]


There should be no hugging over here [ LAUGHTER ]


Good morning, I am Mike Nolte, I AM General Manager for ERT GE Health Systems bedded I am pleased to have this opportunity to discuss these issues for the electronic extinct exchange for laboratory data. GE Health Care is a leading vendor for Health Information Technology having wide range solution to support medical practices and hospitals and integrated delivery networks, public health and pair groups by in we have been a strong supporter of the high-tech and the policy committee and we believe your work as utilized by ONC and CMS can produce a great leap forward health care quality and efficiency. Especially pleased to that be testifying with such a distinguished colleagues. When we talk about of - I will go through some specific recommendations. The principles are over all improving patient safety and care as the two most important concept that guides the health care and solutions. The exchange of patient lab results is critical and occurs at multiple points in the care continue on and vital in providing the right patient care in the timely manner. There are barriers to timely accurate and effective exchange. The most notable are the lack of standard terminology and accepted, and workflow in related to the, lab information. As a result, it reaches the appropriate the explanation is often difficult, expensive and time-consuming. Based on careful analysis, we suggest that the workgroup considers at several points. With customers in a wide range of market segments. We refer you to our responses in your questionnaire for greater detail. Much like the standards that exist in other areas, but the standard for mechanism for exchanging should be implemented and certified both for laboratories and all EHRs to ensure accurate and efficient mechanism for getting the right patient results to the provider. She supports the standards body that are working tirelessly to improve the infrastructure specifically we was support the standards of the Hitsbee - recommended by the standards committee it recognized by the Department of Health and Health Services in 2008 and the ongoing work that meet the laboratory extension request. Standards workflow and mechanism for collecting and dissemination is making sure that the right people and write rules are doing the information. We can ensure that patients security is protected and information is complete, readable and accessible. Leveraging infrastructure such as a standard based its IP and Exchange technology can eliminate the expensive .. lab that currently exist. Secured - - for transporting data can eliminate the high cost. And amending the - - . And should be solved with existing advance health care IT Solutions. Regulatory decisions and policy must be a simple and clear as possible and issue with considerable advance notice in order to cricket predictable path for providers and vendors. GA believes that the work done by HHS and committee and Hitsbee will transfer the help system and believe that the patient care and safety and involvement will continue to be top priority for Policy and Standards decision. The exchange of lab results is central to providing timely health care and eager to support policy and standards. We look forward to working with HHS and Policy and Standards Committee in support of the - - and Health IT settings. Thank you very much.


Thank you for setting an exemplary example of staying in the five minutes. 45 minutes to spare.


Thank you. IM thus the Manjrekar, I believe the enterprise - - I am responsible for the interface not just Labs, clinical. Another 80 i Exchange that take place. To give you an overview, our product - is used not only in enterprise hospital systems. Wheat is also used in community - to look at business multi specialty practices. We have a broad, the first customer base prided these provide as with - software if it is installed either on a local practice server, locally - or it can be [ INDISCERNIBLE ] at any of our data centers been meaningful use, the component is delivery of electronic lab results or lab interfaces. It becomes important. Not only from the perspective that the labs need to be delivered electronically in the EHR system that the EHR system and has to make meaningful use of that data. There are some decisions that surround it. And then feed that data back as quality measure reporting to any of the public health board. And health Exchange that exist. Or will exist. That being said, the question is not about the delivering of the lab results and EHR for us. It is about meaningful use of the lab data that is delivered to us by different lab companies. When I say let companies, we work with National Labs, regional Labs, local, and we work with hospitals. Our goal is to make sure that when a physician gets an EHR, they get that with the lab interface part of that goal of EHR. That lab interface has to have meaningful use. We have spoken a lot [ INDISCERNIBLE ] for several years, to make sure that we meet this goal and objective, but there are certain challenges that we face and that aspect.


We definitely believe with meaningful use, that option of health records is going to grow significantly. The more we delay this, the more we - the sooner we address the issue of making this goal and making the lab data available as part of the goal, it will be better I put some - in our testimony, on an average, we get about 175 lead interface request from all practices. We are able to deliver about 120. At any point there is a batch blog. When position started opening the help record, if we go in this space and not make any changes, the batch lot will significantly grow. We have seen some challenges and the process. A few of the banners - The panel members have talked about it. One is the CLIA regulation around making the lab companies validate how the result look into any adjust systems. That is a time-consuming and laborious process. I will " examples. With national let companies like Qwest Labs, we have done over 1000 interfaces even today, for every interface that we install, they are supposed to verify for each practice that this interface meets the regulations. That causes a lot of manual labor and this process of testing and certifying and verifying. We believe the solution or quick solution and this is our recommendation. Lab company should be responsible only for the delivery of the lab results. The interface is should be pre cert. There has to be recertification or some other process. That should be part of the certification as well. That will help with the lab interface testing process. If you look at the diagram that I sent and the process, it is the lab implementation process - I will go quick. It is a plug-and-play process. No significant steps that need to be taken. The second point is the lab dictionary of the lab compendium which consist of orders and attributes. Those need to be standardized. It is not just about - we believe if there is a standardization it will make the process easier not just for importing the lab results but also for the quality measures. It will help a long way. Not just that, it will help the ongoing lab maintenance that need to be done at the practice level. Those processes need to be automated as well. As part of - I will have to cut you off.


Thank you.


A pleasure to be with you again pin whether we have provided some testimony, I will not going to be read that. I will summarize it to say that when it comes to supporting patients or consumers and their ability to access the test results, and support of their health care improvement and improved decision-making in health care and ability for employers to support them is not the business of technical issues that we find a significant rather it is in fact the regulatory framework that we live in. I am pleased here today to be able to share with you a consensus letter that we and other leaders in the industry have created addressed to the director of Civil Rights and that active administrator of CMS highlighting the regulatory issue recommending what we feel are common-sense changes to the regulations and the benefits of making those changes. You should have a copy of the consensus letter and I will summarize. As we know, HIPAA allows consumers impact access to their health data and that was expanded upon with the high-tech act. We also know that there is a carve out treating lead data covered under CLIA has a special case. We are recommending to changes to regulation that we believe could be significant and and very important. Their recommendation are swallows. To remove subsections 83 a from 45 CFR 1.64.24-page which will eliminate the disparate treatment of levels compared to other health information other HIPAA and to change the language under authorized persons which is 42 CFR .93.9 1/2 to read test results that much released only to authorized persons, and applicable to the individual at the responsible and the person that initially requested and upon request, the test subjects. This change would clarify that individuals impact in fact can received the result upon request. We feel there will be very many benefits and should not do any harm as we know covered entities providers, Labs, under HIPAA will have to 30 days to release those results and this could provide great flexibility in how those results are delivered. We already see it quite a bit of evidence across the country where results are delivered directly to consumers and this has been published as helping to support positive patient relationships. We know the number of test results are lost and approximately 7% are never reported to patients potentially doing quite a bit of harm. We also know that approximately 14% I have heard higher of lab tests are drawn as a result of simply not having access to Prior results. They are duplicates causing a lot of extra cost. Another benefit, it is in use of this exploding number of health management products and services on the marketplace. Consumers need to be able to take advantage of these products and services that could greatly use access to lab test results. We feel like these attitude recommended changes listed above would significantly help consumers to manage and improve their health and make better decisions. We understand that these two changes at the federal level do not necessarily address the complex tapestry of state regulations which may stand in the way. Since Friday, this consensus letter have received nearly 150 signatures from individuals and organizations. Including Dr. Black from Middleton, Harvard, Colin Evans, [ INDISCERNIBLE ] of Microsoft, Dr. [ INDISCERNIBLE ] of Harvard, Dr. David [ INDISCERNIBLE ], the genetic Alliance, and many others. We have this printed out with the signatures and what I am happy to share that document with you. I will simply say that we know the patients do wish to have access directly to the test results. When the [ INDISCERNIBLE ] Foundation published the 63% survey that they would like to able to be able to manage and track and I will share part of the letter that I received on Friday. From a gentleman named James Renfrow from Fayetteville, Georgia. Who is a triple decorated Vietnam vet to. I will take a snippet. In December of 04, I was diagnosed with my Loma cancer and began treatments in January 05. I went through three rounds in Atlanta and was sent to a Little Rock, Arkansas, for test. To see if I was a - - after [ INDISCERNIBLE ] meeting with the assigned Dr., announced why I was being treated since my test results I had a non Hutchison and Paul MOB. If I had access to my test results, I would not have gone through - - for the wrong cancer. This is an important change to me. It is time. We believe that with the recommended changes, we will taking a major step forward. Thank you for your time.


I am testifying today on both the American Association or AC L.A. and Qwest diagnostic regarding the business issues. AC L.A. represent national and regional and its members including Qwest diagnostic. As widely acknowledged, laboratory tested influence within 70% of clinical decisions ensuring high quality and data at interoperability pay in my testimony will highlight some of the business and operational dimensions that currently prevent life skill interoperability and Exchange. I will conclude with my recommendations. That we start with the financial dimension. EHR vendor and and growing number of exchanges or HIT, often expect laboratories to pay for the licensees and the cost of implementation for each a implementation. Second, in regard to quality, the CLIA regulation Section 42 - bashed States and I quote, laboratory must have laboratory manual or electronic system in place to make sure that test results and other prisons to the data are accurate and reliable and the point of - - in a timely manner. This requires laboratory perform validation of every eight EHR lab interface for over a decade, major laboratories seven best it significantly in electronic data interchange offering the customers a broad range of laboratory capabilities that enhance the - - and efficacy. This process of - capability has result in greater use satisfaction and improve the efficiencies and reduced costs for the laboratories. Reflecting the important goal of getting the data needed at the time is needed. Duplicating these capabilities and HIE, is typically not a priority for the vendors. These capabilities must be considered an integral part for word HIE our EHR certification. Some examples of loss to reduce functionality with a physician Michael is from laboratory ordering and resulting to an EHR HIE may include lack of robust capabilities including billing information. Ability to - - step Advanced or ABN for Medicare patients with identification and specific pricing of the limited covered test. The ability to split recommendations been frozen versus room temperature. In addition to the operational impact, if IT did not typically offer that technique the book - for - or feel sick architecture to guarantee the delivery or acceptable levels of a laboratory transaction therefore - - to ensure compliance that clear requirements for laboratory report of record. Because of multiple handoff between system and stakeholders, connectivity is not often obvious who owns a service issue when a failure occurs. Which can result in an overly long with potential ramifications. Given these circumstances and resulting cost and quality implications, there are not clear business justification for the lab to support this transaction integration and exchange. This is amplified for the smaller physician practices. Another challenge is the lack of standard test compendium from work and implementation Guide with little to a different technological and implementation - for receiving and maintaining compendium. JCL they are working with a final set of requirements for standard framework including full definitions and field guns for the electronic delivery of tests compendium. At the close with my recommendation that will grade the environment for meaningful lab transaction interoperability and Exchange. Mick bidirectional into a lab - - four EHR system. Including functionality pertinent all the live data needed for proper testing and patient matching and billing. As part of the initial EHR deployment and not an afterthought. Accordingly this may provide the environment to determine - circumstance of lab for being charged - - . Amending the CLIA regulations and - or eight IEPs system is accurate and contains all the required CLIA information. This will recommend and operators of HIE will be responsible in ensuring presentation. Information display or edit authorized person as transmitted by the performing laboratory. Required EHR vendors - - . This will improve integration speed and quality. Clarify the CLIA regulation to enable the performing laboratory to certify by version and not for each individual practitioner. Adopting the recommendations will be the key to achieving the industry's objective for a wide scale and meaningful lead data into operability. Thank you . I look forward to your?





Susan thank you very much and thank you for the opportunity to provide testimony on the issues on behalf of the Public Health Laboratories. My name is Susan Neill and currently the president of Public Health Laboratories and director of the Texas Department of State Health Services. Our Public Health Laboratories and organization play a critical role in the protection of all states to the performance of laboratory test and public health importance. I am going to emphasize a couple of key issues and try not to repeat. We have been actively involved in federal activity focused on electronic exchange of lab information. Aware membership acquired special - - . For the past four years, we have been engaged in the implementation of the data standards and electronic messaging system. This project referred to as a public health laboratory otherwise as a flip is developed scalable system and process to achieve the Electronic Exchange of the test orders and results for purposes of surveillance, search and continuity. We submit that the dialing need to progress beyond the restricted data exchange to that of laboratory and permission messaging. The term not only refers to the laboratory test results put the electronic transmission of test orders print the ability to transmit and acknowledge and respond to test orders is crucial. The ability to monitor test orders could be one of that early as indicators of a change in health conditions or means for the tech outbreak of the new disease. As of for example the ability for one of the state's laboratory to come to the aid of New Orleans was made possible through establishing a Web based system for receiving test orders and submitting results. Our last observation is related to the vast disparity in the capability for electronic messaging across the country. Disparity is not true for state or public health and departments, but also for doctors' offices, clinics and hospitals. We have some labs that have state-of-the-art with information technology experts and hardware and software analysis and programmers. We have many laboratories that still does not have operational laboratory information management systems at all I care using early level eight EDI system and the current state-of-the-art systems. It is more disappointing at some labs even though federal levels are still reported by mail or facts. By promoting effective program and public policy, we provide to provide the resources to protect the health of residents and prevent and control disease globally. And to promote policies and programs which are continuous improvement in the lab practices. Thank you for this opportunity and I would be happy to respond to any questions.


Terrific. Thank you very much, Susan. We have just under an hour for open discussion and questions from the committee so let me start with Mike.


Thank you for the presentations and for the written testimony. I find them enlightening. I am Mike [ INDISCERNIBLE ] I have a question for bus to Manjrekar. You mentioned that you have done over 0000 lab interfaces and most of the speaker - that we have this repetitive process. The have any data from those certification and lab enterprises and reviewing the error rates of pride problems that would and perform the decision about whether to change the current practice ?


When you refer to data, what kind of data?


You are saying it is redundant and not work doing? You have done 1000. What did do you have that it is redundant and not worth doing other than saying it is troublesome and it should be - it should be a certification of the vendor and not a clear requirement or interpretation of clear requirement that every interface to every provider be ascertained for accuracy. So when you do that, how often you find the problem?


Most often, the problem is a round of practice preference and what they think of the workflow. Nothing to do with same repeatable interface that we apply in each practice. Some issue come around and some version of the [ INDISCERNIBLE ] to software and some functionality that changes with the practices or physician interpretation of the data is delivered. The changes of some workflow. The workflows are the first typically, we installed the [ INDISCERNIBLE ] windigo to rigorous testing with our lab partners print we are pretty much installing the same interface in every [ INDISCERNIBLE ] we get.


Can I follow? I understand that it is basically the same interface and basically look and feel it is different? When you say it is a workflow problem, what exactly do you mean?


Workflow problem would be around the how the physician prefers how the lab our results are delivered. What are the preferences, does he need [ INDISCERNIBLE ] or final only? Does he need the Parcel to be ordered in the final? Does this need to - does it need to be to go to the lab assistant? There are certain manipulations done on how the workflow will be set.


How would you see under - given your recommendations - we have some competing recommendations about who is whose bailiwick this falls in, how easy this issue being handled given your recommendation, basically, those issues are not the physician workflows, you are no longer respond to them? At the laboratory companies have to deal with that? The laboratory companies are saying different thing that you are saying bit there saying it should be the EHR vendor who deals with the installation and should not be a CLIA issue. You told us that it lab company should be responsible.


That is not more than a few workflow. That can happen in the practice. We asked them this questions up front. Based on DISA that we set up.


Whether that interface install, it is this in interface with the lab company. All the changes are particular settings of - the physician workflow need to be set for.


Okay.


I think Gil is next and and Paul.


thank you. This is Gail in looking the testimony from 10 from the lab perspective and then from the from Mike, from the vendor perspective. There is a significant difference in what the lab is looking for from what the vendor is looking for. With the vendor does within the electronic record. Is there a way to meet both those me needs or it does CLIA have to be the one to present to make that happen. It seems to me that the lab is looking for more out of the vendor. In a way of - for instance, information, if you have to have a special letter signed by the recipient, the patient saying that they have to be responsible for the information for the payment, things of that sort. You have two things, the of the regulatory and what CLIA requires, but you have a burden issue in what the vendor is not meeting the lab need and the lab is not looking to the vendor and the vendor is looking to the lab to pay for the interface. Can you address both those issues in order to make the system work? Let's find solutions that can make the system worked.


I think there are key issues that can help solve the problem across the workflow between EHR and lab whether it is a regional or ID and / or national lab like Qwest or LabCorp. Comes down to consistency and ownership and and things like vocabulary, one thing that buys a Manjrekar did not mention is that when air raids that you find has to do with the fact that a lot of cases when you map information are around Labs, is a completely different mapping. Common vocabulary it like [ INDISCERNIBLE ] for example and the standard version of HL7, all helped to mitigate some of that. Right off the bat, it takes complexity out of the interface. The kind of work that have to happen whether it is a lab or EHR vendor that does it is simplified. Second thing is it is ownership of data. I don't know if it is national or ONC or CLIA that has to designate that, but who has custody of information and what point and how is that managed out the workflow within the context of a patient view from my perspective which is one thing that patient should have access, but they should have access in context. Where they understand where they are what they are looking at and interpretation and how that is managed. Both the process by which that chain of custody is decided takes variability of the process and standards also take variabilities out of the process to the point where if you can standardize interfacing, or link to a more available services like health information exchange or Web services, ideally down the road, you take the complexity and cost of interfacing completely and then it becomes less of an issue who does the implementation process and focus instead on how to give patients availability to the right information on their labs with the right context of and understand how to interpret them.


I want to hear from Tim Ryan on the left-side.


Thanks, Gail. On a couple of things of note, as far as standard vocabularies, we talk about some of the issues that occur in the matching of the results. Some are due to the lack of a patient identifier. The different vendors have different criteria for matching patients. We talked about lab results, but the key to some lab results matching in an EMR is that the order information gives them that information to match the result. Or drink information is not clear and pertinent, the EMR on the back and has to come up with algorithm that determines whether it is a match. We find that a lot of the concerns that the practitioners have is - results going to their error log. We talk about standard vocabulary and Standard compendium, that is not going to solve the meshing issues. Our thoughts are from the standards from a compendium around the framework. Right now there is multiple version. Everyone has their own interpretation of HL7. Quest in particular supports half a dozen different versions. Not to mention some the STM interfaces that are 20-years-old. We need to create the framework and start there. We are all using the same mechanism to send a compendium between the laboratories and the EMR or HIE. There is no magic bullet. Mike mentioned the Web services and I agree that is a reality today from a transmission. Something that Quest has been doing for several years. Increases our efficiencies and time. And removes the communication issue pay and does not remove the error matching and patient matching issue. Does not remove the CLIA interpretive guidelines that says that the laboratory is responsible for the data. Our thoughts are - the laboratory should be responsible up until it hands of the information. Once we hand of the information, it is difficult to have to have a different - processed to make sure that the results are being sent to authorize provider correctly in a timely manner. Some of the information - HIE perspective, there are a lot of different handoff. And we think when the [ INDISCERNIBLE ] are doing the results may be in a different place because there may be future upgrades that we are not aware of. What we tested may not in fact a true Sans - nine or 12 months later.


We have heard from the so Manjrekar and Mike about the error rates associated with interfaces and transmission, and then we heard from Vasu about the implementation of relatively standard interfaces for a given lab. And then talked about the variation being around how individual this is an users once the presentation to happen and application. You had said that CLIA requires that you validate the interface did I think is the exact or the use. How far does the validation work as it goes to what Vasu was talking about and validation of the position office ?


What we do is to work with the practitioner and view their results on their screen as they see them to ensure that the information that we send via the interface is properly being displayed within their system and follows the CLIA guidelines. Thank you.


I think Paul is next.


I am not - item Paul Ackerman. I want to thank you, all for coming. The material and information is terrific. I want to follow up on Kale ' s exploration in the difference of EHR and laboratory and which is a class. I do not understand what you are saying about compendium or vocabulary. If I heard your recommendation correctly, Tim, you are saying that you want certification of the EHR vendors are around a single compendium at I did not hear you say the laboratory vendors have to be certified around the compendium. I don't know if I heard it right, can you explain why they need to be certified and you don't ?


In the compendium, what we are suggesting is this compendium Primark and being defined as the order result codes and entry questions and anything that you find as people refer to as Master files. We are in favor from a certification perspective of everyone being compliant with this framework. It is not saying that the that EMR vendor has to be certified and the laboratories do not. It means we are all following the standards framework so that when the information gets loaded into the EMR system initially and for further updates, there is an easy technological solution that would really improve the current process today. The current process today for the loading of the compendium into the EMR system the majority of the EMR vendors and hospital ALS Systems do not have that technology in place where they are automatically loaded into the system. That becomes a manual process which the hospital or practitioner is responsible for. It is a very onerous. And time consuming.


I still do not understand the concept of what you referred to when you are talking about framework. Compendium like [ INDISCERNIBLE ] or Snowmed question expect a framework is the standard. You view that as a standard. Within the framework, you are going to have the order code and description and description is going to be X number of characters long. And you will include that a 0 E question and include the difference - the medical results aren't text will result. There will be different criteria for the test. Not just going to say the CBC is test code number 1, two, three. You need that framework first. You will need to have a common framework. Think of it as an architecture so everyone is following the same architecture and every EMR vendor and every hospital a less than their end laboratory knows that this is the format that all the compendiums need to be in so we can exchange the information easily and efficiently.


I am advocating for a single, Pentium. Suppose we want to standardized around Snowmed and Snowmed as we and not advocating ?


We are not saying that the current price the day that is the way to go. Right now we need to look at the framework first. I think everyone is open to determining the future options. We do not have a from work today.


As Quest has its own compendium?


Quest has different compendiums. Quest is growing by acquisition. There's a difference - there's the requirements and test from a Glo ) perspective, different variation on why the clock was is being ordered. It is not just to say the order of glucose, to order a glucose. Within Quest, it is standardizing their system. But not 100% when compendium per say from an Order Code Pritts provide the as Vasu and Mike have a comment on this ?


I am not sure how to think about framework. I do agree that there needs to be a set of common standards and come and play, but in terms of the data set. That both laboratory and EHR work off. Another thing I did not mention is that there is data that gets picked up along the cycle laboratories that may or may not end up back in that EHR, some of that take place in the draw center without phlebotomist and the defining of the common data elements, defining the big vocabulary use for the exchange of the data elements. At least from our perspective makes a ton of sense and [ INDISCERNIBLE ] and Snowmed common vocabulary is feel like the right foundation for that. Using the HL7 standards for transmission, NCD A pour how are we exchange between EHR vendors by to maybe that amounts to a recommendation for a free market. Our belief is that if you want to make sure that within the workflow that the full range of data is well understood that the definition are clear and you have a simplicity around connectivity to the information exchange and the EHR or any lab whether it is regional or - you need to be working off a common vocabulary. That is where the complexity comes from. That every time that we go through the process with interfacing, with mapping of vocabularies, it is prone to errors. You're talking about several thousands definitions that have to be mapped in some cases in each particular clinical setting.


Thank you . I think we have Mike and [ INDISCERNIBLE ]


To questions. The first is -


This is [ INDISCERNIBLE ] and I would like to speak.


The first question is - this sounds like good advice. Why hasn't it happened. What has been around and Snowmed has been around, why our laboratories and EHR using - what are the barriers?


I can take that. [ INDISCERNIBLE ] and Lev companies that and to distribute the data and companies like [ INDISCERNIBLE ] mentioned on the high and side that have all the technological capabilities and other companies and hospitals that [ INDISCERNIBLE ] and tells you electronically. We try to approach a lot of quality measure projects to the hospital system and [ INDISCERNIBLE ] National reference labs and local, they do not have the capabilities. Did not understand what LOINK is. If there is some mandate about making LOINK as part of the vocabulary because each hospital maintains its own articles, [ INDISCERNIBLE ] code and if there are some link associated with that and make it will not solve the problem or the standard vocabulary would have how feasible is that or feasible laboratory or hospitals if you mandate CLIA or SNOMED - test LOINK or SNOMED?


It depends on the technology or structure. What they have as part of this - if you can take that Susan.


A couple of points. Lot of us I use in the LOINC of SNOMED. One of the things that to be a will of, that it has grown over time and not sat down. People did not sit down and this is what we are going to do. And pretty system. We have 10 different people called the test using the LOINC and Snowmed, each 10 could be correct and each 10 has stood as has different codes. That is the reason why it is not working well and taking so much effort, we are talking about standard dictionary even though we are using LOINC and Snowmed is not consistent. One of the suggestions and my answer to the question is considered going the route to where the laboratory and test vendor is getting a new test and prove to the FDA ordered 10 K or what ever approval submission is to have them fine the appropriate code to use. If you do that, then all the labs will be in the same page and writing the same codes. And the flip project I mentioned earlier, the biggest hurdle and we were dealing with the state Public Health Laboratories. The original pilot project only included five of the laboratories almost a year it was coming to consensus how the code all the different test for influence of. That was our pilot project turned out to be for two it is with what is going on with influence that this year. Within a few months, we've had total of six labs as part of the FLIP project. We are going from flew to other diseases of public health significance in this project and to have five instead state public was coming to this year on how to code on how to do different tests for influenza, is how complex this issue.


Can I add something to this?


If it is factual or clarification of otherwise I have to put you in the queue PIF Emmit it is relevant to the question of capabilities for LOINC and Snowmed.


Go ahead.


In a rare experience, from California - this is Jonah, in our experience in supporting interfaces and labs and outreach with Bell Labs, there is minimum capability to - within LOINC code and the institutions that were developing interfaces. We have required only a small subset of 150 test LOINC coded and a thousand of tests. In particular lab dictionary. We found firsthand that there is very little capability and most hospitals and Labs required some outside technical systems to do this. One potential solution would be to have a stepwise approach that over time would require more LOINC coating so that by 2050, it is required by most lab tests. And by requiring it, the requisition or procurement process for lab in both hospitals and ambulatory independent labs, that in there procurements system or procurement process, for lab information systems and machines, that they would include all the tests be LOINC coded pay and so there will be a process by which over time that LOINC for example is institutional.


[ Please stand by while captioners are transitioning. ]


The complexity as a sounding to someone that is just looking at it and not in the industry. But understanding within your own company, 10, how can you accept that kind of complexity within an operation and not have forced that just in an effort to be an efficient organization?


There are things under way and on going and have been for a period of time to make it less complex, but it is insignificantly complex environment and I think sometimes what happens is it gets oversimplified, and this is something easy, that could be done in a matter of weeks, and that is just unrealistic. We have found out internally ourselves. One thing, talking about the three codes, I think there are different interpretations to what they can be used for. But some people refer to them as part of the result code and some look at it as part of the order code. The California or health care foundation under the E links standard which had a different implementation Guide, the LOINC codes are included as part of that transmission, I believe for 80 or 85% of the results that are going out, and John Mack and probably correct me if I don't have the correct number there, and that is something that the laboratory are currently supporting. So that code can be sent out in instances as part of the result. In addition, to the local result code that the laboratory sends.


It seems that this is enormously complex set of circumstances, and as a result of that, some 95 percent of the tests are -- or transactions -- are covered by 200 types of tests. Why not start with those? And kind of work your way out? You might believe the tests that are not done very often often in the ether, but it seems like it would be at everyone's interest to have that happening.


Today, as a matter of fact, as well as yesterday and a few months before, the ACLA is working on a project right now to create this remark. And our belief is to create a framework first. And the ACLA is in the process of treating this framework two come up with recommendations, and it may be a good idea to really have different perspectives at a table and more of detail of a deep dive, be be facilitated by an independent party to say, let's get at the root cause of some of the issues, and recommendations of how to move forward. As I stated forward, some of these things have been done in a vacuum and some of the labs have not been privy to the logical suggestions, or at least as they were developed, to give their guidance in laboratory expertise from more of a medical perspective.


Looking at 2011, as a meaningful use criteria and the ordering of the acceptance of a lab data, I don't know how -- I am trying to figure out how this is going to happen under that.


I am not sure what your definition of meaningful use is. Some vendors are stated today that they qualify for a meaningful use under the current mechanism because they are getting the Laboratory Information, so I think some of the meaningful use definitions need to be better because there is some ambiguity and under what is being required.


When I think about the rural doctor in Tennessee, I am not sure if this will work. They can't move more quickly than what I am hearing and with this discussion of the free market, this seems to be a little bit of a need for some urgency.


It is very complicated.


Let's go to [indiscernible], then we have Connie and Devon and steep.


I have two questions. I'll switch the order since we are talking so much about LOINC and compendiums, but do you see in your vision of the framework they talked about the inclusion in the framework of the common denominator, if you will, be it LOINC or SNOMED or something, that we describe in net a unique way in the same text. So in the future we cannot come to a consensus that a single compendium, which could at least do as you suggest, that that EHR [indiscernible] from additional local let's but there is a common denominator, and we are able to figure out that that is the same across all of them reporting labs. So do you see that common denominator being part of the frame Mark.


That is one part of the question. Second, can you think of any help on a regulatory or standards basis, and Susan just mention something very interesting. Assign this cause the moment you got back a test. Is this something that could get as their relatively fast?


I am just trying to make sure &. When you talk about Coates, who have the order Coates and the result coats, codes, which are two different perspectives. From the result code said, LOINC is something that is being used today. It is probably not as widespread as some would like to see happen, and I am sure that most of us wish this was behind us. Some labs, including Quest are sending out the LOINC codes as part of the result transaction, at a transactional level. Not in all cases, but in certain cases with the goal of the widespread. So regarding the free market, sir, there is the possibility that there could be some common denominator put in as part of the free market. In the architecture first before you jump to the vocabulary or the actual code. It is like you to ready to name a fire, or pretty fire came. We need to make sure that things are in place, and things can code to the standards. And ACLA, because of the sense of urgency they have, they are calling off of -- they want to develop a framework that they can share with everyone and let's come to a reasonable conclusion on the best way to do this. That is not only good for public Tories but also EHR vendors and the industry itself, and ultimately the patient.


I am sure you had another part of the question which I would ask you to repeat.


The delete you answer that part of my question, but I have a different question altogether. You mentioned a lot of issues in matching a patients. Do you see these issues when the order a rise to the lab in an electronic format?


Not to avoid the question, but all of that depends upon the accuracy of the order. When the talk about some of the ordering system secreted by the laboratories, their success rate is higher than if you get the order electronically from the EHR vendors. From a cost perspective, sometimes the operational cost increases when they move from a quest electronic ordering and resulting system to some of the EHR systems because some of the information is not given to less accurately, whether that the information around the order court information around a billing perspective. So there is a lot of variability in the EMRs and that is why I wanted to -- order with the recommendations were, makes the order -- part of the process because that is primarily absent today when you look at some of the certification that has previously occurred. So you want to make that robust and the functionality that the laboratories require.


Do you see the problems that you just described in order messaging that describe the patient themself? And probably an order in identifier? Your examples had to do with, what is the portable, what is the insurance requirement, and what is the placer of the Order?


Let me give you an example. My formal name is Timothy Ryan. Depending upon the EMR, the match by patient name. So in the match system, by name is Timothy Ryan. But on the requisition, the doctor might write Tim Ryan. I would go to the electronic service center and if there is no electronic order, I would hand in my script and write down Tim Ryan, the result goes out as Tim O'Brien, and now there is a name mismatch. And some EMRs me reject that as a match and it goes into the error log. Some people view this as an interface or a laboratory issue, when in reality, it is more of lack of a standard issue of getting the same information across the different systems.


I completely understand your example, but my question had to do with the inclusion of an electronic order, not the paper requisition going to the lab. So you have an electronic message having a patient identifier on it, hopefully having an order identifying in it. Do you see a matching problem when you resolved these types of orders to the sending EMR?


Again, a lot of that depends. There are also different stages. When you talk about different vendors that support different mechanisms from electronic ordering perspectives, using my same example. Let's say, to get the electronic order from that peak nine. Well there is another function of the because now there is other systems involved. Save the patient shows up at a patient service center. But the order is not sent to the patient service center system, that patient service center does not have that is order electronically, and that is commonly referred to as patient service center hold. So now when they go to the patient service center, even though that EMR sent it electronically, it is not there in the session system any more at the patient electronic service center system and sometimes it is entered manually, sometimes it says, we already have this information, or called a pass through, because the standards are all different. They're is a lot of variability and I am not trying to over complicate things, but sometimes we try to oversimplify some of the issues not only from patient care but from operational. And there are a lot of changes from the HIEs that are another handoff which further complicates and further mandates the need for some of this framework two ensure that all of the [indiscernible] -- robust implementation Guide and the time spent to ensure some of those results that went back, and information must anodize, and there was less ambiguity, and I do think that helps in that instance. That is from those results.


Connie?


Thank-you. It is clear that extensive works has been done over decades in developing terminology and standards in the United States, many of which are extended to the international arena. It is also clear that the actual full adoption of these standards has been delayed.


As the comments have articulated, there is the continuing proliferation of proprietary terminologies both in Health Systems and within the vendor community.


Can you offer a comment that articulates a preferred positioning in encouraging the adoption and the positioning that that would have within either certification and/or the exchange certifications?


Was that directed to me?


Was that a particular person or the panel in general?


The panel in general.


I think you are absolutely right, first of all. And I think increasing complexity is the best way. If you think about genetic testing and the types of things on the horizon, this is a problem from a boat Headley stand point that will get worse instead of better without some sort of standardized vocabulary. But I think it comes down, really, when you think about the exchange of information, to a couple of things. One is, whether it is a framework or vocabulary or agreed upon dictionary, but a common set of terminology around at least the most common laboratory results and orders. And as has been pointed out, the vast majority of volume within Laboratories is accounted for only a few hundred lab tests, and many are exceptions. I would say that second, a commonly used set of data elements across the full board flow, so that key pieces of information used Surratt the process are captured in all of the relevant systems, so that in it has the elements that are relevant throughout the Cross station all the way back to the lab, and as the order result comes back into the EHR. And I think the last thing addresses some of the parts of the demographic issues. And I think that some of the standard laboratory at the fires that allow at least the patients information to be correctly correlated with a lead at any point in the process makes a ton of sense in order to start to move forward, but I think the reality is out today that you have a couple of hundred EHR vendors and a wide variety of different technology used in Labs, even within national labs, we have different standards not even beginning to get into a IDNs and acute care labs. So the need to move to some set of data standards and Exchange standard is is what is required to fill in some of those gaps.


I think there are some simple baby steps to do that.


Tim, did you have a perspective?


Well, I apologize for repeating myself, but I do think that free-market as most important thing we need to get done, because without that, you don't have a foundation to build upon. And we talk about the couple hundred test, there is different methodologies involved. Glucose may not be glucose may not be a glucose, and we understand that and should not oversimplify that and really start with the foundation. My concern is, if we don't do the foundation correctly, several years from now there will be a similar forum and someone will make a similar statement and say, how come this wasn't done three years ago or five years ago, and that is because we lacked patience in doing it correctly.


Of like to share my prerogative. To that point, and I think Gale mentioned it also, 2011 is a living. And I think we talked about this announces that it could do that says 200 to 400 test could account for the results that are actually transacted if we consider the subset that will be required for a demonstration of meaningful use with respect to quality measurement were just the measurement that is being performed.


If we say that you have until -- that CMS will come out with this rule before the end of the year, there will be a comment. After that and I agree on know that we said, you have until the first quarter of 2010 to get this done, what would be your reaction to that?


Well with the LOINC comments being sent out with a 7% of the transaction of the test, that is already being [indiscernible] with E of thanks and I think it has been successful from our perspective and I think that would enable the meaningful use criteria to be realized, and that becomes that common link. I also believe from getting the ordering information in that part of the certification criteria is to include the orders component of the interface, and [indiscernible] unfortunately.


And the recommendation of the rules.


Right, but to improve the process and a sense of urgency, the electronic order has a huge impact. Because we haven't talked about the financial impact, and that has to be part of the equation. And from the laboratory expert, perspective, speaking from quest knowledge, financially it could be more quest burdensome to have results only interface, because of the different ways of getting the order in and that is not really in the patient's best interest.


One last thing, and we will go to Devon. You said to this point you just mentioned, having a LOINC code delivered with the result. Is that the quest does that in some cases. Why only some cases?


We have a multitude of systems and with art and the process of rolling that functionality into all of our systems.


That is just part of the legacy of different companies that you have acquired?


Yes. And that is something that is ongoing.


Debt and?


I have a small point and a question for Phil. The small point being just a note that this issue of matching patients two their data came out of the privacy curing and it is not necessarily unique to lead the, to we. And it is probably on deck to be resolved in a bigger context.


My question is, Phil, I wanted to thank you for providing specific recommendations of how to resolve the issue of getting patients timely access to their lab data. You mentioned that the current Hipaa privacy will provide for what is actually at least 30 days for the provider on the timeframe two get the patient a copy of their [indiscernible] a standpoint to delay. From my own perspective, I think that needs to be changed to reflect that it is easier, or should be easier to provide patients with an electronic copy when have an electronic system. Are your recommendations dependent upon the 30 days remaining intact? Or can you give me a little flexibility on that if there are those of us that might otherwise support your proposal is the timeframe when Jock?


It isn't predicated on any specific time frame per say, it is predicated on the removal of special treatment of lab test results under the law.


Do patients requesting their lab test results want to have to wait 30 or 60 or 90 days.


No. I have yet to talk to anybody who thinks that is a reasonable timeframe. So I think everybody would want a reconsideration of that time frame. But this particular letter recognizes the existence of a 30 day window for protective health information. It is in some sense up to 30 days, because it may it could be released immediately. Bust of the health systems that have decided to tackle this issue have decided to release results that are part of normal routine tests within a certain short period of time or other sensitive tests which might be like a cancer screening or a sexually transmitted disease test or what have you, they might wait a longer period of time before automatically releasing those to their patients two allowed a little bit more time for review. Those kinds of practical considerations are going to have to be had, and so my guess is, if we remove the special treatment of lab tests under the law, and it but still adhere to the current, up to 30 days, or 62898 option, things would settle into a reasonably pragmatic settling point. Plasma might release retain test at some time point and hold off on others for patients, that is my guess. But your point, we would like to see a reconsideration of 30 days. This particular letter is not predicated upon the change.


Just a follow up, we heard from Angela this morning about one of the key principles being about simultaneous deliberate being two the authorized person on the HIE. With address what you're getting at in a consensus letter?


To hear any mention of the ability to simultaneously release results to the authorized person, and two others, but say, the patient, came as a real surprise. I have yet to hear anybody interpret existing law two allow simultaneous release to patients, for example. I would be interested to hear how that would be the case, because after all, folks like quest and lab core now have an on-line system for providers to be able to access the results within minutes of the results being completed, which means to their release or their access is almost immediate, which means that point of view of allowing simultaneous release, in these to the patients could be almost simultaneous. I have yet to run into anybody who has interpreted the law two allow that, so I would be interested in hearing more. I and think they work behind -- the work behind the consensus letter was pretty rigorous and aware of the laws, I believe, so I would be surprised if simultaneous releases were allowable, but I would certainly encourage it.


We have it Jodie, then stephen and Gail.


My question actually follows off of Mickey 's questions. I have heard everybody pretty much talking about compendium and free market and having more consistency -- and free market and having more consistency, and I heard from Susan about these new lab tests and how the federal government might help to lead and by those standards through the FDA process.


It also sounds like their is a business desire to do this both on the lab side as well as the vendor site. So my question is, this work group advises a committee which advises HHS. Are the things that HHS can do to facilitate the actions in the space where is this something the industry is working on like you said and will be developing on their own? What is the role for federal government here, not only in the new lab tests but the ones that are existing?


From the public health perspective, and I realize we are governmental so we might be different than some other laboratories, but we really do see that whether it be CN as for the CDC or someone along those lines that would help with standardizing all of this coding terminology, to cut about to the issue that you can code it exactly correctly that have coding problems from someone else. And I think there are -- it may not get it down to a simple choice for every test and retest a result, but you could get it down to where it is not nearly as complex as it is, and I think that is a lot of the issue right now. And the capping a centralized focus to do that would be beneficial because I think in the different industries we have different work groups trying to do the same thing right now.


I need from an LA perspective, using LOINC as an example. Today, when new tests are developed, then the three codes are not codified shortly thereafter. Within that LOINC code, there is a code that says no code is developed currently and sometimes that can take months or longer. And I am not qualified to talk about the permanent [indiscernible] from the business perspective, but the laboratory's position is in regards to federal oversight, so I would suggest that maybe if you take and do some more qualified -- I am and I T Guy with annual laboratory innovation. The new questions the laboratory came out with, who want to make sure that any new process doesn't slow down innovation which could really impact patient care.


Speaker that is a central body, that CTC that maintains these and releases these, it becomes easier not only from a better perspective but also to distribute these on an ongoing basis. It is not just [indiscernible] lives, once your life, you still need to distribute and maintain these. Cell that is similar to the (BRIEF PAUSE IN CAPTIONING WHILE ICD nine and other [indiscernible] particular to one vendor or another, just a standardized the cabaret that we can download from a centrally managed source.


I look at it from an analogy standpoint to the way Billings is standard today. And the way that process is managed by CMS. And from my perspective it does not need to be dissimilar from that. It may need to be comprehensive which could be a talents, but I agree, I think about how new information and new testing, I mentioned New testing earlier that I think will grow in complexity, but I think that category is standard and comprehensive and it takes at least from what my perspective is cost out of the process that does not need to necessarily be there.


Okay, we are eating into air brake a little bit, and we have two left, Steve and Gail.


The next panel will also be on business issues. So if either of you feel like --


And Jody answered my question very well.


Steve, do you have a question for these individual specifically? If you do, that is great.


I do because of the vendors here. The EMR vendors. This is refreshingly simple to solve. I have a question, with all the book had a discussion you just add, is a condition trying to use this information? When you do results data, to the standards you are talking about also include interactive data necessary to interpret the test? So normal ranges and the type of test? Some of them is very Port that the methodology used is validated for certain conditions. That is one issue. The other issue is, for a component test or white count range, there is a range that is normal for any contest. So, one does that include the transmission of the data necessary to interpret the test? And number two, in your opinion, for vendors, how ready as the industry two provide the type of functionality necessary for a provider, clinical providers at the point of care to satisfy it meaningful use requirements related to laboratory data in 2011? And that is for any three or four of you, potentially.


All right. I will try to answer the first question. Today there is a variety of ranges of normal, depending on what that you are getting results back from, what is defined as normal can vary across the board. So while I think some standardization may make sense, the talents as you might guess is normal for one patient and it may be different in terms of the interpretation of normal for another patient. So you have two layers of complexity. One is that the definition coming back from the lag may be different from latitude lab. Second is that the patients condition may dictate what that represents, so I think you have to be careful about thinking about getting into more clinical decision support and the management of lead information within the context of a EHR.


Not the individual patient, I am talking about the analytical component with ranges for the lead.


That definition definitely gets delivered as part of the standard results information. The question is, let we plan today, this definition definitely very.


-- flab to lappet today, the debt the definition is berries.


It may vary by laboratory, as well as the specimen requirements may vary. Different methodologies. So all of that would be part of the free market and all of that is in the HL7 that goes back to their practitioner today. But some of it is discrete information and some is not discreet. It depends upon the EMR functionality in most cases.


Great. Thank you everyone and thank you very much to the panel. We have gone five minutes into the break, so we will start in 10 minutes exactly. Thank you.


(The Information Exchange Workgroup is currently taking a ten-minute break, and will resume at approximately 11:45 a.m. ET).


Can everyone please return to their seats so we can get started? Thank you. Are Work group members?


Okay, great. Thank you all very much. Are we missing anyone?


Okay. This is our second panel on business issues. And we have, or hopefully it will have, Laura Rosas, who is the director of policy and compliance at the primary care project which is a bureau at that Department of Health and Mental Hygiene, Sarah [indiscernible] who is the medical director of primary [indiscernible] ink which is a federally qualified health center in West Virginia.


Raymond Scott who co-founded [indiscernible] corporation two provide electronic workflow solutions for communities and health-care providers, and I will not do a good job with your name --


Okay. Senior vice president and foundation laboratory, and Jim Timmons who is the IT and LAS manager apple [indiscernible] laboratory.


I will start and he can answer questions.


[speaker/audio faint and unclear] -- to race got, everyone, just for the committee --


(lost audio)


(I am redialing).


-- incorporate EHR into their practice and reach the benefits of its full potential. They have achieved [indiscernible] -- Electronic Data Interface is oratorical tore product. Laboratory perform a critical have to roll a 6270 percent of decisions. That's are even more vital to appease the IP as much of our position on an exit measures are reliant on back orders and results. For example key measures and decision support have been established for functional without EHR and her portable laboratory results. Unfortunately electronic web interface has happened prevent to one of the is spares of this project. -- dedicated staff witness to provide electronic web interfaces to approximately two-thirds of our practice is over a period of two years. That has been nearly impossible under current processes to ensure that practices have an electronic web interface at the same time at the go live on EHR, and many of these practices witted months before they had an electronic interface and had a complicated work ground in the interim. -- [indiscernible] practice takes about 10 to 14 weeks, occasionally lumber. We have heard from that companies and other sickle is that the clear regulations and [indiscernible] difficulty arising lab interfaces.


The lab ... $20 million in the extension of health information technology and the exchange and there is a key feature of the [indiscernible] agenda. Updates appear regulations must take into account Hall -- greater status venture lab orders are properly receipt and executed and the results are accurately obtained and communicated. [indiscernible] this work group to update the current regulations in light of the electronic health records and electronic health exchange.


We understand that the levers the seasons but to the CLIA committee [speaker/audio faint and unclear] support the electronic [indiscernible] of Latvia. A change of a CLIA regulations will recognize that the results the Marietta police, from the laboratory to the position, two commission -- Terry has as or from laboratories regional health information organization. The government structure of health information exchanges. As CLIA is currently constructed the clock this data is included in at least two ways. CLIA as currently constructed holds up towards responsible for the format in view of the position -- Bear by delivery of the standard as misses context through clinical information systems. The format for display of the laboratory results and the user interface is largely but not totally out under control of the sender and may be a reprieve for -- certification of Electronic house record problems rendering [indiscernible] received by physicians.


CLIA as currently constructed request laboratories to test and validate each individual interface. A laborious and time-consuming process which in many cases is redundant pickets a single master interface connecting laboratories and vendors can and should standardize and consistent delivery of laboratory information. Therefore clear relationship two modify to recognize there's hub to hub into pieces on a more streamlined approval of each new practice being added to the message interface. The hub should be certified and validate by laboratories and EHR vendors working together to ensure a corporate accuracy, privacy and security and related to standards and requirements.


Wants validated these hubs should bear the responsibility and liability of the lead results EHR. In increasing the regulatory restraint [indiscernible] -- should courage lavatories to implement interfaces that the practice at the high volume of orders. [indiscernible] integrates -- little incentive two amend interfaces as all practices.


In addition, to these changes and the clear regulations we propose this work group also and undertake a review of several issues that impede the electronic exchange of critical laboratory data and the 20 sentry health-care environment.


Can you take less than a minute to wrap up?


We believe that policy can be influential in the development and eventual regulatory [indiscernible] -- lavatory interfaces. Use a point "and that the Tories would be one, endorsement of the standard escorting system for laboratory would be another entirely routine [indiscernible] compendium updates for health-care providers and other stakeholders. Provide additional detail regarding the suggestions in thinking for the opportunity to present on this topic and electronic lab interfaces and would be happy to answer questions.


Great, thank you, Laura, and we have your written remarks as well which is helpful.


Sarah?


Thank-you, and I think you for the invitation to be here. I did not prepare formal comments because I wanted to react to what I heard this morning and that is what I have done so far. What I can provide is the non vendor, not policy, boots on the ground, world health care provider that has no money and who can't figure out what we really need, and I hope that is why I am at the table. I would like to talk about two sets of threes. The first three being, what did electronic health records. And the second, I think as a policy committee, what I think you need to do next, in my humble opinion.


The EHR implementation process for as was really around these key issues. Why are we doing this? To improve health outcomes. It was not to digitize micrococcus. Tell one of the things -- my current practice.


So one of the things -- a practice medicine in a fundamentally different way than I have had before because of technology and because of my new awareness of thinking about quality in the context of the population of people.


What I do in the exam room with each individual is largely unchanged. What I do in medical school or the practices are still apply that what we do as a practice is very different.


So with viewing patients in the context of a population, we think about diabetic control across the clinic. Maybe Mr. Smith 's diabetes is well controlled and Mrs. Smith 's is poorly controlled but where can we improve and where do we need to concentrate our efforts? What I learned, per clinician is that people are good at certain things and as a practice we are good at certain things and that allows us to focus our efforts. The only way we could have done that is with data and an emphasis on quality. So that is different than what we have done before and this was probably over the last three years.


The second thing is cost. The electronic elves record that I use is born out of the Virginia 's election on Cal's record called vista. When I use is a version of the Indian Health Service's electronic health record which is called R PMS. It is sort of a clunky name, but what people say is, you are that Doctor that uses Battista. Well, no but it is the same platform. There are proprietary pieces to it. But we've really started this out is, okay, what we want to do is provide provide health outcome, not digitize our practice, and can we do it and can we do it at a lower cost?


One of the main areas that costs us is technology, so have tried to limit that and eliminate redundancy, which is a large part of this issue with the labs and who can see it and Can specialist at the labs on the ones that I order, etc., and also engaging patients in self management. That matters, because how can we get patients two so manage their conditions if they don't know what they have or what their that values are unless they happen to show up in our office. So a routine practice of a diabetic patient would be to come in every three months. And routine practices, it is a 15 minute office visit. So let's say at best case scenario come at the half an hour and a half in front of condition annually but we don't put an emphasis on self management. That has to change. Harkin with that themself manage if we don't give them their data?


The third thing insuring that data. A touch on that already, but my personal opinion -- sharing that data. I tests on already but my personal opinion is the health record makes the most sense. This is the simple version but shouldn't that be available to the patient and the patient shows up somewhere we didn't anticipate and they can use that data if they are asking in France and landed in the emergency room or they are at a specialist on the street. So those are the key things I think we need to think about in this exchange peace and it is relevant to this discussion. I guess my three recommendations are not new but I think the three that have been offered so far that are the most relevant are that we focus on standardization, that we continue that effort that is already under way under the master patient index, and that you all support the two recommendations and consensus statement that Phill Marshal mentioned earlier. If there is time, and I am overtime already, but I look like to comment on when detail with lab data that has not been mentioned, is that okay? I will be quick.


One thing that hasn't been mentioned so far is tracking old versions of codes. I try not to practice defensive medicine but at the same time, it is crazy not to on some days. We need to keep in mind with the labs, as things change, but it's not scrap the old stuff, and replace it with new, but keep a record. Because, for instance, the Coast levels, does have changed and have been pushed down as compared to what is considered normal. Well let's land a patient in an attorney's office and she says, and have really been a diabetic for 20 years. But 20 years ago the acceptable level for glucose was different than it is today and we need to have our hands on that and know that is the case.


(BRIEF PAUSE IN CAPTIONING WHILE CAPTIONERS TRANSITION).


We are the provider of health information exchange technology to the leading exchanges in the U.S., the largest, the oldest statewide exchanges. Over the last 14 years, we have had considerable experience of interfacing with labs, both the local down to the community hospital and national labs. Some things stand out from that experience and talked about a little this morning and separate the issue generation from those of delivery and presentation degeneration of information is what the labs do. That is the testing part. , the delivery and presentation may have been the problems of the labs in days gone by. When the only delivery of is in paper. We are now delivering this information in a variety of modes and presenting in a variety of modes. The concept of being able to hand over the responsibility to a certified organization to carry out that delivery and perhaps the same certified organization to perform the presentation makes a lot of sense if you think about presentation, the concept of inspecting when a lab might look like these days, when you don't know the resolution of the screen and that it is going to be presented on whether there will be a screen or handheld is nonsense. How can you make statements whether critical are abnormal will appear. You cannot. We should leave that to the people who are experts in presentation. Another thing that stands at is the separation between the problems around ordering and problems aren't results of the liver it. Very different. Results delivery is a much easier problem to solve and has more impact and more potential value. To offer health care system in the short-term. It has fewer business and economic issues surrounding it. I would recommend the use of consistent coding system, LOINC is good and it is present and many of the national labs. It is not present in the community Labs. Within it of any high degree. But if we are talking about using HIE for a mechanism to distribute our delivering it, then the opportunity within that they tend to up code that information. That is and in fact we do with the width every lab that did not supply as with the LOINC ) when we are trying to draw information from multiple Labs, we can't use the mechanism to do that and present a longitudinal picture to the physician. People did not talk much about today in reaching the right physician identification is still a problem. We would permit the use of national provider identifier to be able to do that consistently. That is not enforced yet. I would also put a plug in for timely delivery. It was mentioned, but it is a difficult problem if you have a physician who ordered a panel of tests that take five hours to perform on the other five minutes, but it would be due to deliver that back? The separate the panel, that is not what the physician may like, but that is important for the patient and the care of the patient pays a lot of issues around timely delivery and we should be moving to realtime and not batch delivery. Which is the mode of operation at the end of the day when the delivery is on paper. I believe that encryption should be and we should rely on the standards that accessed for the transmission of transported data on the Net Networks the we are using today. We do not need anything different or special, they are perfectly adequate. Finally I would look to standardizing the compendium for simplifying the majority of the panel that are ordered in the ambulatory care.


Thank you, Ray. Good morning, my name is Areg Boyamyan I represent addition laboratory and the senior vice president. I am joined by Jim Timmons head of IT operations. I would like to think the committee for inviting Foundation Laboratory for being part of the event and we will come the community - to share our knowledge pertaining to exchange involving the end users. Foundation Laboratory throughout the 40 years of existence has been involved in implementation of numerous and Electronic Exchange, protocol and processes are most recent venture with the state of California Department of Corrections also known as CDC our opinion has been the most advanced and complex and includes a bit module in developing and currently piloting that institutions. The impact of the project with CCR will be substantial for both California Foundation and laboratory we currently provide to more than 170,000 patients throughout the CBC annually. With the utilization rate with greater than 20% per month. The creation and implementation of Data Exchange and system has become the most effective and efficient method of providing better care for patients while reducing operational costs by eight to 11% annually according to estimations. Some of the immediate short-term benefit that CCR and Foundation Laboratory will realize in the near future are the following - number 1, reducing repeat tests by 50%. Lab results for patients will be available for all system users when we anticipate there repeat testing when the patient is move between the six facilities and transferred it No. two, eliminating laboratory paper work by 75 to 80%. Anticipating 100% elimination of paper results during the next three months. No. three, levels are available in the click of the baht button. We expect annual reduction in and will cost through labor savings alone since vocals will no longer have to be necessary to get lab results. It is without a single doubt that the establishment of electronic data exist exchange between CCR and Foundation lab has been the most crucial step in achieving patient care and substantially reducing costs during these economic times. Needless to say, the road has not been easy. I remember one year ago we had that initial cupboards call with three Oracle, IBM and CCR and foundation personnel regarding the center. It seemed to be a daunting and difficult goal to achieve. One year later with many challenges behind us, we are piloting system although the benefits of EMR are we easily realized on the main issues, but we have the costs associated with the EMR interface and average and interface will cost the laboratory from anywhere from [ INDISCERNIBLE ] 20,000 depending on the complexity. Because drivers are spread evenly between the as - and software hardware equipment and labor purchased by the laboratory to establish a connection. The second most common issue with most of the EMR setup would be the differences between the [ INDISCERNIBLE ] and the EMR vendor. Under have appealed requirements for different segments. This was not an issue with CCR because of the HL7 2.5 R 1. On the connection sites, one of the issues are the time to ticks to take the LMS and EMR vendors to make minor and adjustments to the VPN setup. Usually takes four to six weeks for LMS or EMR vendors to make the changes. Training has yet been another issue that we experienced during the plantation because the training has to be conducted by the laboratory and the EMR vendor. We have noticed the continuity in orchestrating the program and successfully implementing them. Their direct result of lack of training as been the errors and the end user to reject change and that respect to active cultures. Oftentimes we have an end user ridiculing the new system and it will not work and not last, et cetera. We have the compress a training program in place before any lived activity is necessary to achieve the seamless. The continuous maintenance of the EMR connection and the integrity as it pertains to changes and addition to the system. On numerous occasions we have problems when adding the test or menu or client has requested special panel. We definitely say that having EMR connection with clients has hindered our ability ability to become flexible to the client's needs. In conclusion, we believe that EMR are the way it in the future and welcome and increase the concept. But the exchange development implementation and proper usage are still areas that need immediate and continuous attention. Thank you.


Think you very much to all the panelist and will open it up to workgroup members the key for that. Two things that one was the cost. Of 22,120,000 per interface. Can you talk about that a little more? I don't think that is what the national labs charge. - - 20,000 to 120,000.


the other thing that you mentioned that I wanted to speak to if you could is we heard earlier from Tim Ryan about the validation that they do in his representation that he needs to validate because of clear requirements, how the Lapham sorts are percentage of its position in every install? Are you going through the process as well.


I will divert the second to Jim Timmons. On the first question, the costs vary. I am glad you asked a question there is a an important facet the we have not talked about. What happens to the small clinician? Suppose there is a small outfit, and EMR vendor that goes out and sells the product, the physician buys and the physician calls the vendor and said I want my lab results. The contact us and we contact the EMR provider and they say it is 10,000. We look at the books and the client is very small. They hardly see one or two patients per week. How do you justify spending that money for having the enterprise? That becomes a huge problem. In addition, the cost are usually in for the end of this very pump five to $10,000. We have about the same and labor associated. It is bidirectional. If it is a single, it is cheaper and bidirectional is more expensive and difficult to accomplish. The position want a special panel to include a lipid, liver and CRP for some reason did to the sign that, it picked a lot of resources to call the EMR vendor to make sure that your code matches the translation code and presented properly in order properly all in all, the cost can range from 20,000 to 120,000. The point I was trying to drive home is is a very difficult for the small practitioner to take advantage of EMR systems. The way that the cost structure Connolly is, the laboratory is responsible to pay up for that end of the decoration. I don't think that should be the case. The physician should be explained a front and this is the software and if you would like to add X-ray, this is the cost. You have to invest in the program that you buy into and not expect the lab to paper it. Another thing happens, who is the responsible party? You call the EMR vendor, or maybe we have an issue, it called the physician and can you call the vendor to put pressure on a to get as the information. The chain of command gets screwed up.


Jim was going to talk about -


I would like to add that when it comes to the cost of the interface, we as the foundation has a modernized completely in the last two years in the lab. Between the different interfaces, we have gotten to the point where our monthly costs alone are being equated into that. The LMS cost along with the EMR vendors are part of the cost that we are getting we are getting nailed. I am getting three to five requests a week on EMR and I have to go with [ INDISCERNIBLE ] Areg and - . I would love to say yes and each one of my request, but because of the cost, it is not has been official. To the validation point come up with I do normally is the current one is the the CCR, I give them a sample of the reports come out we have everything itemized by departments in our case, chemistry and hematology et cetera. When they input it on the screen I get screen capture and I get terminal access. Test to see that we look at the patient and everything is grouped together and we have problems with the formats. And including [ INDISCERNIBLE ] that we recently service some HIV testing on the PC are based, when I sent the information to IBM and Oracle, the, but in the test and they put the codes around and the groupings around. They took the information I sent to them in the email and completely gutted backwards. Stuff like that is very important. This happen in the live system, not in the test system. A lot of capabilities of the EMRs especially with the CDC are using the Unix. Because of everything, using the link values, most of the transmission are able to map if we change the CDC code, they have the link value and able to pull back through.


I have Karen and and Gail.





Hi, Karen to Dell. One of the presenters mentioned that with respect to generation deliver in presentation in many cases, the laboratory is not in charge of the delivery of the presentation and to the extent that they were in the paper world. If we were to change policy to recognize that in some cases, laboratories are not responsible for these activities, should that firms be predicated on the entities that are now responsible for delivery and presentation meaning some sort of requirements are criteria ?


Yes, I talked about certified organizations to do that presentation and the delivery, we already have certification for a [ INDISCERNIBLE ] for CCHT and in the process of getting certification for HIEs through CCIT in which for instance rather than vendor is certified which is correct because that instance is going to be doing the delivery. I think the wheels are turning in that direction and I think it lays it could - a ground work for us to do that. The separation of responsibilities.


Gail.


Thank you, Gayle Harrell. I am concerned about small practices. And rural hospitals and small hospitals that offer Labs services in small communities. I come from a small community with a community-based hospital. And there are many small practices. This is - when you talk about 10 to $20,000 of costs in doing an enterprise, what is the impact going to be on that the small rural hospital who also provides lab tests for the small doctors, the one into practice doctors and the community being in West Virginia you are familiar with this situation as well. I would like you to address and I don't know which one of you is the one to do this and I would like some discussion from the small laboratory perspective from their rural community based hospital perspective and how all the individual of a general practitioner in Florida is going to be able to link and get those lab tests. What is it going to cost and how can that happen? Give me some possibilities and solutions civic and make this available - to make it to the majority of people out there in the community.


I think one thing we should consider is for the small entities, we can have a Web based program. I think that is something we should consider because it is easier to implement, companies like cost LAN and Corporation and ourselves, there is a Web based program that is easily tailor to the client's needs and we do not need all the connection issues to discuss. In your example, is the client - has the client or physician bought an EMR system for their practice?


Most of the individuals are looking now because of their incentive dollars bid I will be strapped to find a cached to do it, but there are - there would very much like to do that. You also have the rural hospital that provide most of the testing for them. They provide the lab. How is the rural hospital going to be able to have the ability to link with that ?


In that scenario, the hospital will be equivalent to the reference lab Lab. And the current structure, the laboratories are responsible for the connections. The physician will buy the software, and then, the physician will ask to the laboratory to connect with the software. That cost is currently on the lab side, but what happens if the physician is only doing one patient a day or one patient - they go down at a priority as a setup. Every setup takes a lot of time. That becomes the issue bigger the clients, the more heavier volume of lab lab work that they generate and they get prior to on the setup. That becomes one of the problems put in an equation like that, I would recommend a Web based technology.


And that is that small hospital going to provide that and how does that mean to the CLIA requirement?


It depends on what that small hospital partly how to. If the small hospital is in the business of doing laboratory work for the community to have an outreach program, then they have to consider the option. The have to consider what ally as system they are using and how that system is compatible with the M. R. system that are out there. If they're going to connect with the EMR system, the hospital has to look at that cost structure.


They did not correct connect directly to the [ INDISCERNIBLE ], but it correct to the connect to the HIE which provides a single pipe and one interface for each of the lab trying to do that and it becomes the HIE responsibility to connect to the EHR that the lab this serving. It provides - the HIE provides and connection to the EHR. If you are in an environment where the physician is doing when business with more than one hospital or one more than one reference lab because of insurance constraints, the that needs to be brought together and orders need to be sent out, but you can provide a single pipe into the cloud if you wish, for both the labs and that EHRs for having that HIE in place. That provides an economic answer for the small practices and a small hospital.


I am from New York and not from rural area. New York has a lot of a small practices because it is the opposite of if you can make it here you can make it anywhere. There is a huge population that the small practice can exist. It is under resources and overburdened. The problem with web-based portals and most of the large commercial laboratories that have those, the results do not integrate into the EHR. They are available and a separate portal and cannot aggregate measure and not trigger decision support and no one in the practice that will hand enter all the data. You will lose a tremendous amount of rump hybrid of reporting and all the department use. That is a barrier. We agree. Connected to a central hub whether the hub sits at an HIE or state or someplace else, having a one pipe connection is the way to go, but we are in the process of grading that hub.


If you are connecting to a hub, how do you need to and you are already doing this or in the process of doing that, at do you need to CLIA requirements for the delivery ?


That is the issue. Right now our vendor has a habit hub. In order to bring down the amount of time in testing, we created a lab hub ACW that ACW did. We are in the process of treating a way of also having a centralize compendium and centralized Insurance file to try to be able to push those changes out and other pieces hard to and really important to understand, we are not talking about a single lab interface, we are talking about two or more interfaces that are required because due to insurance issues, a patient may only be able to use Qwest. You cannot have one interface. We have patients requesting 546 and there's no way we can provide that because most small laboratories and in New York, there are a lot of small laboratories. The cannot do the coding and not resources to do that enterprises. We are moving the market toward the [ INDISCERNIBLE ] large commercial laboratories because they cannot do a lot of these and they struggle to be able to meet that competition. It is a very difficult - - - the poster child of the fragmented system and you don't see the pieces come together. Insurance is another part that we have not addressed yet.


We have heard this morning from Angela Smith about and from Phil Marshall allowing keep principal simultaneous delivery of that - that has not taken - you're talking about single pride that is being the efficient way of doing this which it could be if we have simultaneous the liver, suggest that you still need point-to-point. That is one interpretation. I want to know that your thought.


My thought is simultaneous is achieved if you have a single pipe. What Angeles said - this morning, delivery to a health information exchange if it were something that was out there that was used the people wanted to look at the intermission. I regret that exchange serving two purposes. It provides platform for sharing that it provides a platform for delivery also. Delivering into the platform achieved that objective. It may go to the ordering physician and the [ INDISCERNIBLE ] physician simultaneously, but it may be present for subsequent queries by other physicians or even by patients.


I agree with - real quick in the single pipeline. That solution will be a cheaper solution to the equation but coming back to your question, yes, the results will be available in an electronic format but is it wise to have it available to the patient without going through an authorized individual like the physician? That is a very tough question to answer. You may have a result that needs to be reviewed by physician before presenting to the patient. Thus the patient have - should the patient see that result? Case in point, you have a 40-year-old mail walks into the doctor's office and the doctor orders chlamydia and gonorrhea. There is a cross contaminant something happens and the committee is positive. There is no indication on this person's history that this person should have chlamydia. The doctor needs to look at that and say what wait a second there is a problem, let me run it again on have the lab look into it. Versus the patient looking at the result one hour later on line and then you have an issue in the marriage, and raises all sorts of questions and liabilities. There should be a point where the physician looks at the result and% to the patient after that point, the patient can request the result after all, it is theirs and have the right to it. This should be presented by the physician. There will be - it should be available simultaneously and most electronic things are like that.


My in the queue, we have data and Mike.


and then Paul.


thank you for coming. As a person and the state also who oversees the Medicaid program for better or for worse, it worries me how we are going to reach the clinics and FDIC and small practitioner, RO and urban. At the existence in both places. How we are going to make that work. Dr. Chouinard, one of the questions I have for you, you are using the open source system, I assume there were some costs in getting that installed what would you have done if that had not been available?


I don't think we are on an EHR we would be on an EHR. One of the things that have sort of reactions, talking about how you can do it, was your question about where you are in a small committee, how can you get on board? Our solution was through a network of community health centers throughout the state of West Virginia. We had to have a critical mass of by Ian, conceptual by in that says yes, we want to do this to make it so that we can do a subscription subscription price depending on the size of the clinic. Yes, it is open source, what that really means is we do not pay for a license. That is where we save on upfront cost. For instance, with the interface that we have in our lab a vendor it was $60,000. That cost is shared within all these providers and it was last that was in the individual clinics, you can take that and divide that by the number of clinic involved. Getting into the quality peas and died meaningful use and what we do with their that is what we say, what does everybody use? And we put the names and the pot and say here is how much money we have literally, this is what we did and pick a dander and says that seems to be the one we used the most and if we get a data from nine LabCorp vendor, then we make sure that gets into the quality person to put it in a place where we can collect and report back in that data. That is incredibly manuals, human error prone process. If one of my patients get a Pap smear and does not go to LabCorp and I am trying to track my rate on women who have had Pap smears, guess what, I so again, it is all where you start as well. It never dawned on me to attract rates of Pap smears five years ago. Never dawned on me to take a list of the 600 women who were do and get somebody to call them and say, you need one. We are way down the line on where we started, but at the same time, if you happen to not used LabCorp, your data may or may not get track or not get the benefit of the outreach.


Mr. Scott, - the name of this is the Exchange work-group. Obviously, I personally don't know how we deal with this complexity except to the idea of exchange and you have been an advocate for that for obvious reasons. How would you, is it feasible to deal with the complexity that we are talking about in a way that 10 fact brings to the normalization without everybody having to go back and rip out years and years of investment as we heard in the first panel, is it possible to utilize the intermediary of the exchange to bring some rationality to this? And how would you do with ?


It is very practical. You - when it you put up an extension the medical turning air, we analyze the lab results for the last few years and this statistics that have shown that if you are able to code the 200 most frequently used test, you will end up around 97% of all tests. If LOINC codes are not provided for an example from the various blouse trading in to the exchange, we - our enterprise will transfer translate the local code and build a table to do that and will not take long takes about two hours.


The actual going in and find out what they're sending your -


Getting the Lab Director takes longer. Doing it takes about two hours. That allows us to least get common codes. We do not normalize and mathematical sense. We do not take into account some of the complexities of the reference ranges. We carry the referenced changes all the time and display them all the time. Physicians are aware of the differences, but we did not attend to normalize referenced a rain - we normalize the Standard as presentation. It does not matter which allowed the result comes, it looks the same for the physician. We are not preserving doubt presentation format on the lab, we% - we are not preserving the presentation format. We are have a common performance It is very practical and we have been doing it for 15 years and we have about 80,000 health care professionals using the system and technology. It is entirely web-based. It is on a subscription model which is mentioned before. No capital outlay and the cost to the position on average is less than a cellphone plan.


The case in point in Ventura County in California, very similar system that Mr. Scott explained. Many physicians got together and their subscription is $25 per month I think. Very low. What happened with this company, they approached us up front and they said there is this many physician that want to buy a product. They like to use Foundation Laboratory and what can we do? We went in with our own program with our own deal that every interface we would carry the lab cost with his another $15. No big deal and it everybody is happy. That could work in an individual settings are you have small providers, but in we just basically the interface into a hub into their own pub. And gets disseminated.


Mike, you are next. We have about 10 minutes. This is a shorter panel and I am going to remove myself from the queue. So we will go Mike and Paul and then if there's time I will ask my question.


I am going to ask a similar question and let me ask a polyps from Mr. Scott. We heard this morning that LOINC codes are granular and lots of differences between them and in fact, for a given task where it was done and ordered, how do you get the data to up code that LOINC data from the lab.


There are about 9000 LOINC code. As I said earlier, about 200 are useful to the amateur care physician and that is their assessment. The new lenses that occur because of the LOINC, are mostly addressing acute-care issues and not ambulatory. If you focus on ambulatory can simplify the problem. It might help it for somebody to identify a common set of 200 rather than rather than we have to do it with every community. It is perfectly feasible for the ambulatory solution.


Paul?


I have a couple questions. First for the people from foundation Labs, I am following up on the LOINC codes. If there is regulation to provide a LOINC on every results, the interface, but would be the impact on you? Is that something that you could do work is that the most horrible thing Cosmos, but we will have no impact. We are currently 95% of the test compendium with Doug speaker volume. I spend about six months going down eight through Z and working with with the resources that made available with the grant received from California and I was able to get this done. Without that [ INDISCERNIBLE ] help, that applies - we are going halfway through it, of continuous work. I spent three or four hours per day of a six month. Working on this. If we are hearing from the other - independent laboratories - somehow converting to LOINC is burdensome to the point of impossible, is that reasonable?


No, it is about. If you take the time or if you have the necessity to do with, you will do it. We were required to because of the enterprise. There was no way around it. I personally like their idea of LOINC the test. Even then with and that 200 depending on the methodology, you can have a different code. That is one of the problems, you have to make sure that the LOINC code matches the methodology and some of them came down to I have to talk to the medical director or and these are the same values, and the methodology is to beg and we went through everything and look at that are as zero p and this thing looks the best. That came out about 40 of them. What I spend about two hours with my lab director going all of those.


Is the wobbles, but it is time consuming.


There was an issue associated with rural hospitals and community hospitals where the lab system that is providing the service as at the reference lab is purchased for acute care. The vendor of those systems are the ones that will need we will need to address. Like the coding issues. It is not a lab%, it is a vendor of lab information system. Then you have to deal with the replacement cycle for that system. Whether it is - that will take time.


In regard to the ally as bender, there are problems such especially in older system. With 45 and the reference lab, - - if you are on an older version and has not been updated and that two years, you will not have the capabilities of adding a LOINC on your database. It has been in the last year's that [ INDISCERNIBLE ] did it. AM Tech went live two years ago, they are in the forefront of the MIS software. When you get into the acute care, where you have multiple types you may have it custom made for that hospital, it will be a major problem.


Thank you.


Given that we are standing between lunch and finishing the meeting and lunch, I am sure folks are hungry. But we can wrap this up. One thing that Mickey and I want to suggest and I am looking at Judy sparrow picture this is okay. This panel was a shorter one than the previous one and there are a lot of issues thrown up by both business panels and would like to invite you if you would like, provide as with additional remarks in and reaction to what you've heard and some of the questions that you heard the panelists address and they have not gotten opportunity to fully address and we want to put this to both the panel's that we have heard today and if not the panel that it to come after lunch and we want to make this announcement now because we may lose a few of you. As we break for lunch. Is that, is that okay, Judy? I think we need to hear from you ideally by the end of the month of October because we are in the meeting to deliberate these issues by November 3rd. For whatever you want to give us a tab input, we need to get it by then, but we invite you to do so, we would be pleased if you do so because we have a small amount of time to vigorously debate all of this, but it and to the extent that you have a lot of things, that you did not get a chance to add or after you leave here, send it in, to us and we will be glad to distribute to the committee members.


Is that only four panel members or for people listening?


We will take it from the members of the public listening as well.


Is that going to bring down the servers? [ LAUGHTER ]


We could collect and make them available to the committee members. I am not sure about timing that we would have time for the ONC the process. The raw data is great. We will take the raw data.


With that, we will break and we need to return and begin promptly at 130. With our final panel and public comment period.


[ Break until 1:30 p.m. (EDT). ]


For those committee members on the phone, please remember to meet your phone when you are not speaking.


Thank you.


- - mute your phone.


We do not have loads of time. With IE workgroup members, lingering in the audience, please come take your seats. What you say in Tennessee, y'all are light.


I cannot do it so well. I did make it. [ LAUGHTER ] I believe we are. Although - do we know where Walter is?


Finishing up.


If our panelists are here, can restart?


We are missing one panelist is back now, add to our dialing in. John and Walter.


Super.


will come back pay and thank you for coming back. We've got our 130 Panel on the regulatory and policy issues and let me do some quick introductions and then get under way. On this panel, thank you very much for coming, we have Joy Pritts who is on the faculty at Georgetown University. With the nail Institute and a research associate professor with the Health Policy Institute. Don Horton is the president of public advocacy at LabCorp. Jonah Frohlich and Walter Sujansky are both on the phone. John as the Deputy Secretary of Health Information Technology at California Health and Human Service Agency and a member of the help exchange working group and Walter Sujansky is the president of the - and the psocids which is a consulting firm. And in particular, there have been the technical lead on the eve links a project which you have heard are lots when we begin with the testimony, and will start with you.


Can I interject, we have a role with the panel is the we are not allowing them to do slides because of the brevity of the presentation, but in Joy's, she performed some work that was funded by in by the Office of National coordinator. There was a small exception because she will speak about some of that. I did not want the other panelists to think we were playing favorites. Even though we are good friends. That is right, Deven.


She would never do that.


As Deven said, we at Georgetown are funded by ONC to conduct a study of state laws addressing the state stability of clinical labs to release technical results. - - clinical results. We conducted this last year and still under clearance and that and talk about it in general terms. In order to make the full report available and in the near future. You have heard earlier today that there are issues surrounding how clear and the state law works and what we have here this HIPAA permits providers to share health of information with each other for treatment health care and operations fairly broadly and CLIA restricts restricts some of that permitted exchange of information. CLIA provide test results must be it released only to authorized persons and the individual responsible for using the test results on the laboratory that initially requested the test button three general categories the individual responsible for using the test, the labs and authorized persons. The individual responsible for using the test is now defined in the statute or regulation and there had been up some language back and I think it was in 2000 that came out went h h as was working on other rules that indicated that that phrase meant that the person who ordered the test. But CLIA does describe who an authorized person is in the finest that as being the individual authorized under the state law to order test, received or both. That was the focus of our study. Looking at who was on authorized person under state law. We have done a lot of work in state laws so we have this down pat on how to go about reviewing these. There are two primary areas that we looked at which included when there and clinical [ INDISCERNIBLE ] a health-care provider and the second one is could they share directly with the patience to the patient would not necessarily have to have to go through with it who ordered the test. When we looked at the state laws, our general findings, we have a little map to give you a visual presentation of where things ended up paying we have looked at this language of the sketches as anybody knows, you can read them different ways we looked at statues and regulations and 80 opinions and laws that interpreted those things. But we focused on the express language of the statute and regulations were looking at 26 states that pretty much are silent as to how the information could be exchanged so you look primarily to CLIA in those states. There were 16 states in the statutes and regulations, specified that test results could be released only to the person who requested the test or the designee or as directed by the person who authorized the test-beds practically means that the test results have to go back to the individual all may be construed as they have to get their permission to be shared with other providers been there were two states where the provider that test results could be released to the provider who provided the test - ordered the test for to others for us to have written permission from the patient so that is a different model. That gives a person is Pam Mary control. - - primary control. There are 10 states that the statutes and regulations also included the two persons are wrap authorized responsible for using the test. That is a list of the broader category that theoretically will allow the state and 11 that state to share test results somebody who is treating the patient and they may be responsible for using the test results. But not necessarily with other entities. Giving that to 26 states were silenced and you have other figures, approximately 42 states allow medical test results clearly. You can argue legal with others is, but 42 states under the express language of statutes, labs can released tap results only to the person who ordered for who they designate. Also important when you are looking at the loss, they are connected with a practitioner loss. And the states that we found that released and restricted the reveals the results that provided the licensed within their states. Related did not mean that and surely they did. We looked at whether the individual patients can directly access their test results from the clinical laboratory and this was discussed at various points during the morning. It is rather convoluted analysis as to how you get to where and the final results and although his, but gives patients access but there is a carve out under CLIA where the patient is not permitted to access, CLIA they do not have the right to access under HIT up and so you read his butt and CLIA and CLIA cents you to state law. So the state law is controlling over whether the patient may access their own health information directly from a clinical lab. Here is the other visual representation here. Where - there are not many states that expressly make it clear or very clear that a patient can directly access the lab test results from directly from the clinical lab. There are six that make crystal clear that a lab is to provide that information upon the patient's request and May for private. There is one state - - provided. There is one state that makes that available after awaiting period. For the first seven days, if you want to get the lab results from the laboratory, it cannot. You have to go through your provider. After that initial seven day waiting period they're presuming that the provider has contacted the patient that give them the opportunity to do that and at that point after a seven day waiting period. , their patients may result - accessed directly from the provider. Maryland it is similar, but a little different in the notify the provided that the patient has asked and which gives the provided the opportunity to weigh in on that. In seven states, test results can only be released with the permission of the ordering provider Brian in California, you will hear that they have a specific.


On that and they actually limit the types of tests that results can ever be conveyed electronically. Dues are all primarily in the medical clinical lab licensing laws and you need to look at medical record access laws which may be another avenue for individuals to gain access to their own records under state law. Most of those are unclear because they do not define what a health-care provider is by and that is pretty much delay of the land.


- - the lay of the land is back the key for the opportunity to testify today - - of the clinical laboratory - and LabCorp regarding the that regulatory and policy issues been JCL a represents National reasons and laboratories and members including LabCorp of leveraging information technology to enable the secure and exchange of data that need LED data for care and legitimate secondary uses. My testimony will focus on to regulatory issues impeding the Lab Data and associated policy implications. The first relates to application's to whom the lab may transmit test results which we referred to as [ INDISCERNIBLE ] and the person to relate to the lab to make sure that the lab will reach the final destination in a timely and accurate and reliable manner which we refer to as the interface issue. Regulations underr CLIA - - provides that test results must be released only to authorized persons and applicable, the individual responsible to using the test results and the laboratory that initially requested that has been authorized person means that the person authorized under state law and to order tests and both by in most states around - the primarily including the provider or fail to define what price perceptions of test results in which case, most Labs the for to the CLIA. Which most interpret to mean the ordering provider. Many part is other than the ordering provider made data for - - person rather than from the provider who ordered it. Assuming the HIPAA rules will otherwise permit the disclosure without patient authorization, most Labs interpret CLIA to transmit test results to non ordering third party if either the recipient is defined as an authorized person under state law or the ordering provider authorizes the disclosure. The rationale for the interpretation is that it will be unreasonable to prohibit the lead to make such disclosure if authorized by the ordering provider were the ordering provider can make this and disclosure to the sum third party. Well obtaining the authorization may not be difficult and respect to a single test result, for example to a non or during peak trading provider, it is far more difficult - - for Health Information Network for example for treatment purposes or for peer-to-peer transmission who needs large quantities of data for secondary uses, for example, health plan for improvement and patient safety or paid for performance initiatives. Labs that - - to contractual representation and warranties from data recipients, but this workaround is inefficient and not always effective. ACLA has developed proposed amendments about the statute and regulations that would resolve the issue by expanding the list of authorized persons that can see the test results. To include the business associates as defined by hip-hop. Our proposal will operate as the pre-emption of state laws. State will continue to be defined as the authorized person as long as they do not - . We would also clarify that the changes will not be construed to permit disclosure of when disclosure of that type of test is are the was productive. The intent is to the US that's permissible recipients. Not to expand the purposes by which the test results will be used to disclose which are already governed by HIPAA. Uses and disclosure forbidden by HIPAA without authorization would require patient authorization under these amendments. Disclosure to covered entities and this is a social is that will otherwise be permitted by HIPAA without permission but be prohibited by CLIA without providing authorization would be permitted without ordering provider authorization under these CLIA amendments. With respect to the interface - one minutes.


With respect to the issues, they must have an adequate in place - - or actually for Lab [ INDISCERNIBLE ] four-point of the entry and - bust the final report destination in a timely manner. Is a typical method of validation. Electronic health vendors often modify the test report transmitted by clinical laboratory to the ordering provider to customize the appearance of report. But the fact that the clinical our Tory have no control over modifications, but they hold them responsible for ensuring that the required - - Missy - - once the results are transmitted and despite the fact that such exchange may modify the data content for the purpose of meeting the exchange and the final report destination for any given report is necessarily an unknown. The laboratory that transmitted the result painful and the current electronic health information exchange and Arman, a final report destination becomes meaningless. No longer proper to use that term and policies governing the - - when the intermediary controller% - - . Should and once the result is provided to the ordering provider EHR or the system of other permitted the second or the intermediary contractually obligated to send a result to the recipient. NCLA has about proposed legislative and a menace to address the issue to measure the opportunity to testify and look forward to your questions.


Thank you. Jonah, are you on?


Thank you to Mickey and Deven and members, the afternoon and thank you for the opportunity. I apologize to not be there in person pay and forces in the airline industry were - - . Apps as you've heard today, let market has is fragmented. There are over 200,000 clinical labs and the U.S. Well Hospital based and labs' together represent - -% of the labs. It performed [ INDISCERNIBLE ] of the test. 1/4 a physician or electronically have an electronic health record and many are still receiving fax the lab results either manually or scanned in a patient record. The limitation of both the lab and EHR industry. The lab industry technical industry is variable. From March Labs using oriented architecture to small hospitals using - - most labs fall into the latter category. The hospital based labs are far - IT Resources and less expertise to labs ordering and resulting. They provide a significant - - and the market today.


Virtually no standardization of lab messaging in the industry. In my experience, working and that evening project all hospital need outside assistance to comply with the standard. Are unprepared to - - the Lab Information System the hospital operated has internal proper tera codes and little expertise to match these codes to LOINC. The labs rely on external technical assistance to do the mapping for the most frequent 95% of required test. Hospitals were unprepared to complete the mapping for many thousands of tests and the databases three and the current process first establishing interface between LED and EHR are labor intensive and expensive. The process require testing and private networks or web-based connections and planning encoding interfaces, extending and verifying test messages, training and go live. And all we found the process takes three months or more to complete. The plug-and-play we expect from our IPhones. The current process is also expensive. The costs are often passed on from EHR vendor to the physician purchasing the product typically with $5000 per charge the end the lab may internalize their own cost. In some cases, if the physician is a high-volume customers, the lab may pay the vendor charge. If the physician is low volume, the lab may decide not to split the interface of all. The physician may be required to send the sub - - if they have an exclusive contract with that lab. The physician may be stuck with faxed lab results in pitting the workflow and processes for the patients. While some of the testing process as described can be shortened by standardizing Web messages and orders, much of the implementation - - . As you have heard from Mr. Horton, CLIA may require blabs to verify the EHR display results correctly. This may require on-site verification by lab personnel as if test this display correctly paean Labs makes business decision and must do so based on their arithmetic that they bear considerable cost for each interface. For this reason, less may decide that they do not make business sense to send the business results the supposition that do not represent an of business. We recommend the following to CLIA and coordinate - - to support rapid. First, under the federal EHR certification process, acquire that EHR system adopt standards such as E-links and his plight display it in a CLIA compliant way. Under CLIA, verify that the receiving EHR is certified. Third, also under CLIA require labs to send results using the same national standards that EHR vendor are certified against and fourth, under meaningful use, require meaningful use eligible hospital that provide outreach services to comply with No. two and three. As one of the meaningful use criterion. Under the - - package, this represents a massive expansion from the current adoption rate of EHR in the U.S. Approximately 25% and five years. To accomplish meaningful use, physicians must have working 11 to faces. The industry and the current with a terrific more could not support demand today and completely unprepared for the expected explosion of demand. The issues need to be addressed immediately and using lacklustre framework above will address these issues. Thank you very much for allowing me 2% today.


Thank you.


Water Walter, are you on ?


Yes, I am. Can you hear me ?


Good afternoon, I am Walter Sujansky, I am the president of the Sujansky and Associates. I would like to thank the workgroup for inviting me to testify today. For the past five plus years, my firm has been heavily involved in live information exchange. As mentioned earlier, under the sponsorship of the California Healthcare Foundation, will lead the development of the - - E-links that was designed for the reporting of laboratory results and outpatient setting been we helped a dozen physician practices, EHR and laboratories to implement E-links in the production interface. We are participating in the Hitsbee working group developing implementation guides for lab's test developing and for exchanging let compendium between lab and EHRs. Much of what we have learned through these experiences has been mentioned by the other speakers today and I will try not to go over that again especially at this late point in the proceedings. I would like to amplify on a few of those points and perhaps introduce a couple new items. With regard to the CLIA issue, as we already heard, Laboratories have limited resources to verify the electronic results are being displayed by a chart for the CLIA requirement and in the level of verifying EHR at large practice and the small practice at roughly the same hence the business reason that Laboratories off and prioritize practices that provide them larger testing volume with the result that small practices can't face significant delays in completing to their EHR or find the labs and willing to provide electronic interface at all. The issue is most acute large reference laboratories. These nationalized first and largest number practices requesting interfaces and lack the multifaceted Russian ship that hospital have with their community physician given that largest labs and you hear me talking about LabCorp and Quest, perform 25% of ambulatory testing in the U.S. and practices five or fewer it position order about 2/3 of all let's. The current bottleneck in certifying EHR interface in small practices could delay interoperability in much of the outpatient setting. It is important to of knowledge the magnitude of this FX. The need for standardizing test results extends beyond the LOINC coding of the test. Lev interoperability is impeded by the absence of highly specific messaging standard. The HL7 observation that most organization use today to report levers of this greatly under specified. The message includes 4000 elements. 3400 of these are optional. The result is a 11 EHR that are both 100% compliant today and which the interoperate must discuss and resolve the many options and variances that the HL7 standard allows. This is time-consuming that must be done over and over again for each new interface. In our works with E-links, we found that 400 of the 4000 are needed to report the bristles of outpatient setting. Many of the 400 can be tightly specified. We believe a highly constrained implementation Guide were built into EHR and laboratory systems, you could obviate much of the work much - of the interfaces. For example, through the Hitsbee standards [ INDISCERNIBLE ] process. I would like to reinforced the - - . [ Please stand by whilecaptioners are transitioning. ]


Hence, even if every laboratory faithfully reported codes today, there would still remain mapping task. EHRs to roll up LOINC codes to clinically relevant extraction's used within the EHR had made in the mapping as those codes are added. It does not reduce the value of the widespread LOINC coating on the part of the lands which remains a and valuable and important step but it turns out that for the standards development may be helpful.


One minute.


Lastly, with regard to the relationship between ordering and results reporting, it is not necessary to have a universal patient ID to correctly matched patient results to patient records on the results were reported back to the EHR from which the order originated.


And -- recorded by the performing repertory and be faithful and returned by that result data. An electronic [indiscernible] makes it easier and reliable but it is not needed for strict matching of correct lab results.


Thank you for the opportunity two testify today and welcome any questions the committee may have.


Great, thank you. That ends the testimony from this panel, let me open it up to questions from the committee.


Devon?


Don, I want to probe a little bit on your suggestions for allowing clinical lab results to go to a covering entity or a business associate. Any covered entity? Any business as as the IT? This is why I asked. Currently under HIPAA, the -- you could as a cover entity asked for that results that didn't pertain to patients you were even treating, and as long as you get them and use them to treat other patients, that would be permissible under the rule. And I get that the problem that we're trying to fix is this issue of, does it just a to the provider ordering the test when there are so many more in the pipeline of treating that particular patient that we might want you to allow to have access, but the language that is adjusted one could read as long as they qualify as such under the HIPAA rule.


I would agree that that is the effect of telling which we have proposed. But I guess the question I would ask is, why is it that labs can only send [indiscernible] to a small particular set set of individuals or entities where as any other provider can send them to any covered entity or business associate. So really what we're suggesting is a greater degree of parity be offered for exchange of laboratory protected health information in comparison to how other providers are treated.


I get that. I guess I would be inclined to fix that by making it applicable across the board brothers and exacerbating what some would perceive to be a loophole with -- a potential loophole with respect to acting. One of the things may be the privacy role is not so good at its regulating how the information comes into an antique purses with the entity can do with it once they have it, and in an electronic world, where entities have any ability two pull data rather than just push it, that would be my greater inclination. But the structure is currently in a lot but I confess that I am disinclined to fix it by essentially taking what is arguably an enormous loophole in HIPAA, and the need for it to be updated to match this new environment and a companies two do the same. -- allowing lab companies two do the same.


I have a question for joy. I doctor as maps were great and eliminating. And one of the questions was, do those represent the differences in loss, you could see them. They're also seems to be widely variant enforcement in a particular category of law. I was just wondering if you could comment on that and how much you were able to read into that?


We were not able to look into that in our initial study with ONC. However our National Association of State Health Policy is undertaking a deeper look at a select group of states to see how their laws -- what they did is, they looked across the categorization that we have found in our first study and selected states that represent the different approaches, and are conducting interviews with the states to see how some of the matters are enforced, and as you said, I think it is safe to say that we have heard that enforcement. A lot. And some of it seems like it is very tight. And others do not.


Well, we have heard a lot about this CLIA and the requirement for accurate delivery. I just wanted to say that we did look at that issue in our study, I did not talk about it because of my five minute limit here, but we did look at it to see if their state laws that impacted their requirement. And we did not find state laws that replay Really in implicated as separately. They either cross referenced to CLIA or in corporate IT CLIA in their entirety but they did not in a general world established independent status as standards or higher standards than 95 delivery requirement. -- other than that that CLIA delivery requirement.


What else did you find in that study?


They're is a lot in there.


That is a white paper that is in review and should be released -- do we have a date? Del.


Joy, when you are looking at the state laws and looking at what CLIA provides and what HIPAA provides, what kinds of recommendations which you make that would be able to simplify this, and can you do it through CLIA? Can you through the federal mechanism and through a letter of guidance as opposed to having to go through a regulatory process, change that authorized definition through CLIA, where does that actually take either a statutory change at the federal level or is statutory change at the state level?


The changes to the rules under CLIA that would not be made at a statutory level. This-it underlined CLIA is broadly based and it gives the rulemaking authority to the Secretary of HHS, so the statute is not really the issue and would not need to be changed for anything that has been discussed in this room today as far as, from my perspective. I do want to clarify, I am speaking with my professor of Georgetown have on and not representing Poland's the on this at all because I am sure that they have their own perspective on things. Or else I would have to get it cleared, or it would give back your next year.


Was in the regulation itself, the authorized person is defined in the statute [indiscernible] receives the test results or both, and there is not a lot of wiggle room and not specific part of the room for guidance that would broaden things a lot. I think there is more wiggle room in the freeze, the individual responsible for using the test. Because that has not been defined indictments, and when could I think very reasonably say, a health-care provider that is providing treatment would be responsible for using the test results. That may get you part of addressing some of the issues that were raised today but it would not unnecessarily address all of the concerns addressed by the various stakeholders. To address all of those, I believe we would require a change of the regulation and that takes approximately three years.


I will trust you on that one.


That is what I believe we heard today.


That does not apprise me to hear that, however, that is not written in stone anywhere, but it has to take that long, I understand as a practical matter it is probably going to be long time.


On the other hand though, there are states that reduce their own laws and have started to make some changes to authorize recipients beyond the provider that order of the test, and that process works well in some states and would take an even longer time in many states to follow that process because they don't even meet their legislature -- their legislature does not meet on a regular basis.


Does a letter of guidance from a CLIA or a regulatory change from a CLIA preempt state statute?


A regulation from the HHS has the same weight as a law, or as a statute. As a general matter. So you have to go back to the original statute and see what the preemption format is there.


The statute itself, it is of a bit more problematic.


So the state law would be paramount then most likely?


It depends on how it is written. It is very difficult to answer that question without having the exact language before me as to how that would have an effect. Regulations can redefine an authorized person in a regulation, and then it will not unnecessarily deferred to state law, but there is also an additional clause here, which is the individual responsible for using the test results, and at least, the way I read this provision, it says, test results must be released only to authorized persons, which is Doris Day provision, and the individual responsible for using the test. So that second criteria may or may not raise the same implications about state law as the first one does. Am I making myself clear on that?


I am still -- I don't know whether you can give me a good answer.


I am trying to get a feel for what possible solutions exist out there. If it takes a three year regulation two change the definition of authorized person, or, even if you change that definition of that regulation two define the authorized person in a more broader aspect of the treating physicians, does that regulation that negate the various states that have very specific laws that say who that authorized person is? Or do you go the route of having to change individual state law statutes? What is the best way two come to some resolution on this issue in your opinion?


Well, I think different parts of the problem may be solvable with different solutions. The path of least resistances try to issue guidance because that can generally be done on a quicker basis.


Yes, but does guidance get as where we need to go before have state laws out there if we have state guidance out there? And Do we have the ability two issue that guidance on the regulation?


In my opinion, it is possible to use guidance two interpret the phrase individual responsible for using the test results perhaps and a broader interpretation in the past. And the way I am reading this, there are three categories. You have one says, and that to be certified must be released for this category and for these categories under state law. I don't know that that necessarily would preempt state law, but what it does do is, there are 26 states at least around that rely totally on CLIA for their interpretations. So that gives you at least part of the way where you need to go. It may not be a full solution but it is a partial solution because a lot of states rely totally on CLIA, so when you clarify that, you solve a problem in the states.


IT follow up of that, a letter of guidance would do that?


Would clarify that -- yes.


And you were here this morning and heard the conversation?


No.


I wanted to make sure because there were a lot of points brought up by both laboratories and bender is buy that use of the authorized person.


That provision I think is a little bit more problematic. At one thing about that provision that seems to get overlooked a lot, that is really intertwined with state practitioner licensing laws as well. And when you step back and look at the whole way that this is structured, what the states are doing is, they're regulating the practice of medicine in their state. And so in some states, they say, certain providers can only order certain types of tests, or they say puts her in providers can't order any tests. Chiropractors in some states are not allowed to order or receive test results. So it is a complicated. Because what you're looking at is, not only this here, but you don't want to interfere with necessarily how a state is regulating the practice that is medicine as an unintended consequence of releasing test results. And that is great it's pretty complicated.


Steve?


Gail has kind of already explored in great detail the point I have. Interpreting the "personally responsible for using the data I think is important because, there are at least three [indiscernible] ordering some other practitioner as some other point caring for the patient but who did not order it, and then there is the patient. And the patient is responsible for using the data and I think that Ann liberal definition of that to the fact that state law doesn't preclude it is probably important, but I don't think they're will be an answer for this, it is very difficult because if one doctor wants to send information two another, they could do that. Or is the lead is specifically asked to send information to someone and they are allow CLIA law that is [indiscernible]. When I am having a difficult time conceptualizing is where you have a system where a patient shows up in some care givers office or hospital or emergency department and tries to reach out two something or somewhere two try to pull down a person's information, and that seems like a science fiction at the moment based on what I am hearing for this complexity.


Well, it is even complicated in the paper world, which is what we have heard. So in laboratory when they receive a request like this in the paper world, they have to share five like they do in the electronic world that the person requesting that information is actually who they say they are, so there is a way two do that. That now electronically that might become easier to do because you be able to identify who is requesting that test.


We have heard concerns that the person that is requesting the test actually have a relationship with the patient.


About the discreet question we have heard, I have heard [indiscernible] discrete things that if he were two to identify the specific tests, in the capture like 75 percent of ambulatory lab tests. That maybe clumsily clumsily worded perhaps, but is there a way for the panelists or others two help us understand if there is a way two help us protest a subset of the universe of codes, to try to get 90 or 95 President things done more expeditiously and not worry about the four or 5 percent of things that we missed, that may be the one strategy, that if, maybe if people can fall of Commons, that could inform us as to what we need to express in the next month. And what else I would express to Dawn or joy on the phone is coming to the extent that you [indiscernible] exchange of land data, how to wobble is it that clinicians are going to be able to comply with the current expectations in 2011?


At nic it is largely a matter of being able to meet the demand. The thing that has been stated before that at the current pace we're not want to be able to fit it in.


This is Johnna in California. I think I am in the current regulatory framework and business investment, so depending on how the final rules come out with meaningful use, providers are required to report for all their patients, all lab tests electronically, and nothing changes, then there will be a considerable amount of manual work that small practices will have to do in order to get results into their EHR that are being faxed to them by labs that will not send them electronic data feed. So that will be repercussion, and it will depend on how high the bar is placed when CMS issues the final rule on meaningful use.


Don, he said he will not be able to meet demand, what are the two or three things that he would say of the major things in the way of meeting demand?


Currently that constraint we have with the interface issue is CLIA and the ability two verify the display at the users and of the system, that slows things down. So if there is a way we could confirm that the results were getting from Point A to Point B as they were intended to in an accurate and verifiable manner, that would be helpful. And there are several ways we could do that. By this to the certification process or through the development of some sort of acknowledgment transaction.


Before you move to the next two or three, is a visual verification part of the law, or does the law states that?


That is how it has been interpreted.


Okay. So you and quest may interpret that differently? Or community hospital?


I think with respect to that particular issue, we're probably on the same page.


Okay. You said you had one or two other things?


You have heard the certification process, or through the development of an automated transaction which would acknowledge receipt of the result with all of the CLIA required content that would come back to the lab similar to what we do on the fly side. I could do some digging along similar lines on the clinical side.


Jody?


This is bored joy, and you said you were here this morning for all of the testimony. But there was a consensus letter that was given to us that was talked about by still marshal from WebMD talking about how individuals could to get access to their data from the lab. And the things he mentioned in that letter were changed to the HIPAA requirements and getting rid of the provision that said, if it is covered by CLIA, there are different rules of access and the second rule of changing the clear regulations to add that the test test results Shawn now be released upon request to the test subject. And I don't know if you have seen this at all but there are two questions, one, what is your view of, yes HHS or to consider this and there was just a change in the regulations, since there are HIPAA regulations be made, what would be the implications is being made in states -- what would be the implications generally in your view, and -- I am just wondering, if we just took that one recommendation, what would that mean, and the second is, adding upon request to the test subjects, how would that, in your view, kind of connect up with the state laws that actually specifically only allow it, either preclude the authorized person from including the test subject, would that be in your view of preemption of the state laws or does that go back to statutory language and you have to look at it?


So the first question, if the only [indiscernible] were the HIPAA regulations, what would be Oracle interpretation of that, and then the other was, how with that interpretation to CLIA actual work?


Can I see the language?


Okay. If you were just to remove the card out under HIPAA, they space are left with being required to do and applied it repeal and analysis. And the board dealing with two sets of regulations, and I'd think that if you were to issue guidance at the time when the you issued the repeal of the carve out, then you intended that to take precedence over the CLIA at regulation, that that might indicate the change, and essentially preempt CLIA as a matter of law.


If one were to go that route, one would surely want to make a lot of noise about it, because people tend two read the section of the regulation that the nic applies to them and not necessarily read -- if you are a clinical lab, you read the clinical lab regulations, it dawned necessarily read that Health IT access rule. So it is a legal way of doing it, but it would require a lot of Education two insure that everybody knew the effect of that change.


So that was one.


Next question.


The language that was recommended for the change and CLIA or for the test subject. But how that would in your view connect with the state laws and that would actually protect the subject from the under authorized person. I guess it is similar to the interpretation of the personal responsible for using.


Right.


I think there is a potential there. It is a minority of states, there is only like a minority of them that do that. So we are looking at the seven states that say you have to ask the provider's first. Only with the permission of the ordering provider.


Can I ask you, are you also making the change to HIPAA? Because when you make the change to HIPAA, Health IT has a preemption -- HIPAA has a pre-emption clause in it that is very clear and is more stringent with respect to the patient with access to health information, and it means that the patient is provided more access. As with a state provides less access, HIPAA would preempt that law.


Which arguably, if you just made it the HIPAA change, you would get that effect.


So what HIPAA does is it addresses that issue much more clearly. Because what HIPAA had said, I kind of backed into this, and I skipped the first step, because there is a state law that comes with with a federal standard and the state law is preempted. That the state law says it is and has a right of access to medical records and the state law says that they don't, that state law is pre-empted. Cell that is the HIPAA framework. There is an exception to that but it doesn't apply in this case because it is a conflict in the state law is not more stringent than federal. Sell federal law wins. That is a much more clear way of addressing the issue.


Don, you said you wanted to wait and?


I just wanted to make clear that, number one, if you remove the CLIA exception to the right under HIPAA, to have to agree with CLIA and state law, otherwise he would require [indiscernible] to violate and in some cases state and federal law by making [indiscernible] [indiscernible] deciding as a matter of policy ought that the provision of laboratory result data directly from laboratories to patience in places where that is not currently permitted. I will mention briefly that there is some difference of opinion among ACLA members on this issue so I am giving you my perspective.


There is no state where patients cannot obtain their that results from their ordering provider. So there is really no need for making it available directly from the laboratory. They can already get it from a physician. Number two, if you essentially [indiscernible] the risk provider, they are getting [indiscernible] without the communication. The advised [indiscernible] that have all of the information two protect result into conflict, context and in some cases that can be harmful to patient care. So I would advise you to tread carefully.


This is Walter. I just wanted to throw in a point on this general topic with regards to CLIA regulations and as far as prioritization of Perry's policy initiatives of this Workgroups and CMS and so forth, it appears to me, it seems to me that with regard to meaningful use criteria and in a NA plan providers to meaningfully as criteria, the issue of direct delivery tool lab results of patients is less important than that issue of the level of effort created by current interpretations of CLIA regulations toward the plummeting and creating electronic lab result interfaces.


I don't know -- is there a feeling that that is not the case?


Walter, are you asking us whether one is a higher priority than the other, are suggesting that one is a higher priority than the other, and if I disagree?


I don't know that I disagree with you but I don't know that everyone in the work group is prepared to choose between one or the other.


That came to mind because we spent a lot of time talking about this issue that we were just talking about a moment ago. And in my opinion, or that the state this as a test of fire, in my opinion, it is the other issue related to CLIA that is more important more relevant with respect to the near term urgently needs of enabling providers to meet meaningful use criteria.


Okay. Choy, did you want to weigh and a?


Allow


I it wanted to weigh in.


The issue of whether patients should be able to obtain their clinical results from the clinical that has been kicked around for a number of years. And I think that almost everyone agrees is that the patient and the doctor sit down and discuss what the results of their test where. Unfortunately, that doesn't happen all the time and the studies that are in this letter, there was a study that was recently released that showed patients aren't getting their lab results in any sycophant about of time, even when they are actors results, and that is problematic. The quality of care issue. I think bust people to go to their doctor and get their that results from their doctor, but there are times when that doesn't happen and it is good to have a second Avenue for that.


Buy and what exactly sure about the prioritization, but I would say that it would be most beneficial for the individual to get the results electronically and, to the extent that that takes place first, that would probably be beneficial two patients also.


Okay, next on the question this is me. Let me change the topic a little bit and ask, in no, we are in working group of the policy committee, so we don't set standards, www.said certification requirements, but we could certainly offer policy recommendations about using those and other levers two try to resolve barriers as we see them, and Jonah, you had some very specific policy recommendations that I wanted to talk more about and wanted to have more discussion on back welcome you to talk about any of those but the ones that have gotten a lot of discussion today but you had as part of your recommendations were, having as a part of meaningful use requirements or hospitals, that they abide by standards that you had described. It was wondering if you could talk about that or any other recommendations you might have?


Tie would be happy to. In my view, again, California is at different state but hospitals provide up large share of the testing market. And local quality would be provided by Medicare or Medicaid or Medi-Cal program for meaningful use. And for those that do qualify for meaningful use, in order to demonstrate and qualify for the maximum bonus, if they are providing that outreach services, they should comply with the same standards for delivering lab results and the comply with the standards that the EHR standards are able to comply with in order to make sure their stations meet meaningful use. One thing that we investigate as a state as we implement are on Medicaid medically this program is, do you want to put an additional requirement on hospitals that provide outreach services, are reached lab services, and that they also must deliver lab results using the same federal standards that EHR vendors are required to use and adopt as part of that certification process. And we think that is an important lever for the Medicaid agency, but would be far more powerful if adopted at a federal level if both Medicaid and Medicare offices could qualify for balls. If Medicaid and Medicare polls have the same meaningful use criterion, there is much more of market driven incentive for hospitals with lab outreach services to adopt the standards for delivering lab tests and lab results.


This is Walter. If I could just quickly --


Hold on just a second.


Do you have any statistics as to what that would cost for each hospital two do that and how many hospitals two have the capability, and what would that do two small community-based hospitals and rural hospitals that are perhaps one of the few resources for positions in small communities? Not the only but the primary source. What would that do two small hospitals?


ITT has a question would be what does it do to the providers serving those hospitals where they are the lead in town. And that is a question that I think you have to answer on both sides. So for the small hospital, it does put a burden on them to two implement a standard. Many of them will be asked by their provider customers, their circle of providers who are already using them as a source of lab services, it will be increasingly asked to support these interfaces. So at the very least, there is a regulatory requirement that would provide gains to say, well, if you are going to support multiple lab interfaces for all of your customers, you will now be required to use one standard, and this is the standard. And if you do it, he will be rewarded.


The flip side is, if they are not required and they do the mathematics and they say, I am not required in order to meet meaningful use to adopt standards and use the clinical lab tests, that all of the outlining providers that are serviced by then, and there are a lot of rural providers that depend on them, they are left out. And they will therefore it is out on the need for his opportunity and many of them are Medicaid providers and safety net providers, so it deacons are safety net. -- it weakens our safety net.


In terms of cost, we have 400 hospitals in California and the majority of those have led outreach services and most of those have some sort of infrastructure, much of which is rudimentary. In my previous slide, which supported some of the E Link programs and put a price tag of about $15,000 on each implementation of E Link, and perhaps half would go to the that and the other half to the EHR bender, and it may not have even been enough. But it costs $4,000 or more to the payment each one.


Can that problem be solved through real or HIE?


I think it can be simplified, and that requires some some of the patients to CLIA. If you have an information exchange organization or a state like entity, he could have -- you could have what is called a service oriented architecture or you could allow for every one of those World hospitals two connect wants to that service, what they call enterprise service bus. Use the same standards, and if you have for example, is eight service in that bus, the lead Standard and compendium result report [indiscernible] you could develop one interface for the hospital and that would allow results to go two every one of their customers through the hub. So that could significantly streamline result and that is what will will anticipate and endeavor to do in California at least.


This is Walter. I would add to that that that HIE real approached, having been involved with some of those also, if every laboratory is doing things differently, they have their own proprietary coding system and their own way of configuring HL7 messages, the amount of work for them to standardize with en HIE is not much different than the amount of work that would be required of them to establish a non proprietary [indiscernible] and LOINC fought back. But by shifting the work to HIE, you're shifting the work and the cost. The nature of the work and the amount of work in total is the same. If everyone were to individually implant to a standard that was going to enable Point to Point Interoperability in the absence appellate end HIE and built that into their individual software systems, then they could it to robbery without a HIE. And the work to do that is not much different than the work that is required to interface each of those entities with the HIE.


I think one other final point on this is, we are talking about, if you make it a part of the meaningful use criteria, that perception is you are getting the benefit to do this, so it is fair enough to say they have to pay that we're talking about, according to the CMS report of the summer, $45 million going to the providers on the physician side as well as the hospital side and presumably some of that money was for this kind of thing. So let's not lose sight of the fact that while it may be a cost, they are only bearing the cost because they want to take advantage of the incentives coming down the road.


If I could just add one more thing in the realm of public policy, and that is that the prevailing Model today is that hospitals provide interfaces to the largest practices. They just kind of to IT business speculation, and that leaves the smaller ones without, and they are the ones that, even under that many for this incentives, Bailey's financial problems of the hospital. The public policy is, do you require the hospitals hospitals, to have certain standards of any provider organization that is also complaint with the standards can into her operate.


If a [indiscernible] when did to the lab core and they say, I have blood drawn six weeks ago, I look like a copy of my results, can they get a copy of their results?


If that patient is in a state which allows that.


Okay. So what if a emergency department position taxes air release of medical information form, or is it even possible that there is someone two do that to a lab core is a that the patient is thing that had blood drawn to not to go, here is a release form and I and treating them now, can I have this test results, is there a way for that court to facts back not even using technology?


To send the results to the patient?


Not even using the medical release form.


Look look to the authorization of the provider who ordered the test.


I think that means that life is going to get more complex in the next year, because if you go to the hospital that is a reference lab, the patient can walked in off the street, because there is no state law that precludes a passion for getting a copy of their medical records which includes their laboratory and diagnostic testing. So if you walk into a hospital, you can get that stuff. So if the decision executes a properly signed release form by patient, I can fax that to a hospital and the hospital is to provide that to me if they are able so I can use that to treat the patient. So it sounds like it is a little bit different than perhaps with the independent laboratories that aren't in the form of hospitals. So I guess that is what we need to get so there is more consistency for the access data.


We have to move to our final public comment period.


This is just a single question. Don, you had talked about what you called the interface issue. So my question is, what is seen to be asking for is relief about this presentation. But how would that corporation responded someone were to say to you, will give you exactly what you want provided that on all interfaces, and you give us the LOINC code for every single test result, when that court be able to do that?


We could come pretty close. We have just about every test in LOINC come as a technologically, that is not a big deal for as. We have some of the newer tests where we don't have that, there is a little like for those but for that vast majority yes.


Thank you.


Can I clarify something I said to Gail.


To is asking about the presumption issue, and I was sitting here thinking earlier, I don't know if there is a preemption condition in that the CLIA Act itself. I am assuming if there isn't. If there was not come to was an executive order issued earlier this year that pretty much dissuaded agencies from preempting state law by virtue of regulation.


Okay.


Judy, is there a protocol two begin the public comment?


Let me say that this is the part of the meeting or the public gets to make any comments they would like. And those in the room that wish to make a comment, please queue up at the mike and the operator could tell the folks on the line how they could make comments if they would like.


If you would like to ask a question of the audio portion, please press star went over your telephone keypad at this time.


Okay. Good afternoon, my name is Tony Mack and I and director of quality services at America's blood centers. ABC is an National Association of of nonprofit Community blood centers and are centers provide half the nation's blood supply. I have been a clinical laboratories and does for over 26 years focus on hematology and blood bank operations. Last year I retired from the Air Force where I serve as an officer in various management and leadership positions in the blood bank and clinical laboratory. I have this is at that time was quality and regulation management and regulation requirements. I am also an ABB presenter and I present at the annual meeting. We are here today to urge the health ID policy community at the national coordinator two consider the need of blood Center Laboratories regulated under CLIA. Blood centers are stakeholders in an electronic health records network and it should have access to funding. Thus, in your deliberations should encompass the critical work that Independent Community blood centers are doing to enhance our create systems that better track life-saving products from Conard to patient and to help ensure that the right patient gets the right blood.


ABC members centers are regulated under CLIA, either by accreditation by private nonprofit accreditation [indiscernible] or a state licensure program approved by CMS. Some 18 at the ABC members Center is provide pharmaceutical and central transfusion services to partner hospitals. Buy the remaining ABC members serve as their hospital clients with clinical reference lab testing. Blood bank Laboratories Exchange permission with transfusion centers, test requests and final reports, the content of which is of great early to buy CLIA. We do red cell typing for sickle cell patients, 88 typing, across matching for blood transfusions and other types of work that hospitals use such as red blood cell in by the detection and identification. Member that space and number of ITT on is it meeting CLIA requirements especially in the area of electronic test requests and reporting. Blood centers are disadvantaged as a result of the standard IDE interface between blood centers and hospitals. This process can be performed electronically, it enhances blood and patient safety. For example, electronic records of patients with red cell antibodies would significantly enhance that's a transfusion of these patients by providing accurate and timely recovery of their entire body history.


And ABC sponsored work group has obtained approval from the International HL7 organization two work on it blood Center extension of that standard. This project entails developing the triggers, passages and fields that will allow the exchange of electronic health record information between the blood center in the private sector.


Other you see members are actively working to implement IP Systems, a performance and prices eased to attract blood from doctor to patient to reduce the number of transfusion errors. And transfusion transmitted infections in the hospital setting. In addition, ABC members are working with partner hospitals to monster blood used to ensure that patients get the blood that they need. For example, on this ring appropriate lighting use.


ID systems being implemented include those based on radio frequency identification and bar code labeling for tracking blood from the honor to recipient. The use of data miners and Data [indiscernible] other hospitals and nationally monitoring disease markers and blood donors as early warnings of trends. The American recovery Act includes several grant programs for which ABC members should be eligible to apply. Title 13 of the legislation Health Information Technology contains the health 80 provisions including grant programs, technical assistance and hospital and eligible provider incentives. Blood centers are included in Section 1301 under the definition of health care provider for the purposes of title 13. However, the eligible recipients and application process for the majority of the grant programs in the HIT sections are unclear, and thus, blood centers have been stymied in applying for the funding. Blood centers are stakeholders in any electronic health records network and should have access to HIT.


Could I ask you to wrap up? We have several people behind you.


If you can please take 30 seconds to wrap up.


Does your deliberations should encompass the critical work that Independent Community blood centers are doing to enhance or craze systems that better track life-saving blood products from the donor two be patient and help ensure that the patient gets the right blood.


Thank-you. Next in line.


I and Jason and I am with the American clinical Laboratories Association, we have had a couple of our members testify. And I just wanted to provide a little clarification and just a couple of comments on thoughts or opinions that were omitted today.


The first was Mr. Betts, you had raised a question earlier about what, in fact, if anything has the lead industry done to help advance efforts with in the standardization of orders and results, and just to respond to that in a couple of ways priest, many companies have tried in and of themselves two come up with standards. The have use CPT and they have used LOINC and that has trials two see if those systems would work without any success. And also, ACLA has gotten involved to try to involve standardization. What you heard a couple times today, and Walter talk about E Link, which was started at the behest of the original ONC coordinator, Doctor David breather. And I served [indiscernible] as well as California Health Organization and that actually turned out to be a pretty robust Standard and I did something that work group could take a hard look at in terms of incorporating into that vehicle use definition.


And more recently, even a year ago, we tried working with the electronic health records Association, the EHR A two develop some kind of test compendium or framework and unfortunately that projected not come to a positive outcome, so hence the latest effort to develop the framework. And just to fill in a little more about that particular project, by the end of the year, we hope to finish our initial draft of what that framework is going to look like, release it to the public much like that certification for health information technology is done previously and open it up to public comment and recommendations and we plan to do so with a lot of other advisory bodies ONC as well.


The last point I will make, not to take too much time, and again, I think it was Jonah Fralich to who raised this issue, but you might be surprised that in a total number said, hospitals to a lot more types of tests than other independent labs, but for our members, the lab core, the quest, the bio reference, the specter of laboratory reference in North Carolina, they actually represent some of the most robust and cutting edge taking place within a health mighty space today, both within the lab and IT, and frankly I think that does contrast, that I think Gail, you raise this point of what community hospitals will be able to be doing, there is a big gap between what some of the independent labs like our members are doing and those being done by hospitals across the country.


Thank you. We have one caller on the phone.


The public comment will be coming from Daniel Freeman.


This is Daniel Freeman for the [indiscernible] Institute and we are involved in a lot of Health Information Exchange and that also follow up with the development of LOINC here at Reagan. Following up on a couple of comments, I wanted to mention that we did an analysis of the past frequency volume. The Indiana that work for patient care and a published the results of that in a paper that confirms what everyone has said, that is a relatively small number of test that accommodates a vast majority and frequency. Those are actually included in the LOINC distribution and you can use the present program to help but the research is to only those common to us. But I wanted to just speak in support of that as a practical step forward in moving the ball. Thanks.


Thank you. And a final comment in the room please?


My name is Diana and I wanted to applaud the group for all of their work, I think this truly was a tough nut and if you bracket, it will be an extraordinarily step forward.


I am a physician and the Lab Director, supply and the one who actually answers to those CLIA rules, and specifically, I am a lab director at what appear Medical Center, for those of you that don't now, we are in a hospital of the Bronx at the Albert Einstein College of Medicine and we look at the inpatient and outpatient world, and [indiscernible] I am sure you guys are interested in.


So I have also spent several years and [indiscernible] and kaynine I.D. world so I know a little bit about how software is developed. I just wanted to make two quick comments. I happen to be here on the behalf of the pathology tells but I don't want to speak for them.


One thing is the CLIA rule with respect to verification that the accuracy of test results. We have seen all sorts of interesting rules, you do stress testing and edge testing and I wish that we thought that as you have heard, lab core and Quest, the officially at results. That is not software testing. And if EHR wants to put in will suffer testing with a real specification, I think that would be a great step forward but more broadly than that, it requires specification and a think we have heard several people here including Walter talks about how LOINC is a great step forward but under a specified the work that Tim Horton and Tim Ryan and Don Horton spoke about the fact that there was a framework is in here and that the specification was not quite there. And sell [indiscernible] not only in applying the CLIA rules, but also the encouragement to truly [indiscernible] would be a great value. Thank you.


Thank-you, and I think that completes our public comment.


Great, and thank you everyone for attending. I think it has been a very informative and we thank all the participants and all the members [indiscernible] and we reiterate our openness two receiving comments from panel members and I have been getting comments from of the folks that our policy committee members. So either way it would be -- that is Gale, she has been located as well. That at any rate, it that to us by the end of October, ideally, and then, that way we can feed them into our continuing conversations about what recommendations we will make in light of what we have heard today.


So I think you again, my thanks to the work group members as always for your dedication.


We are adjourned.
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