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CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) convenes the May, 1999 EARLY HEARING DETECTION AND INTERVENTION AD HOC GROUP TELECONFERENCE The verbatim transcript of the EHDI Ad Hoc Group Teleconference convened at 2:00 p.m. on Tuesday, May 4, 1999 Table of Contents I. Welcome and Announcements II. Georgia Legislation IV. AAP Subcommittee on Information gathering V. Intervention Survey Krista Biernath JUNE HOLSTRUM: Good afternoon, everybody. I'm June Holstrum from the Centers for Disease Control and Prevention. Welcome to our May teleconference on Early Hearing Detection and Intervention and thank you for joining us. Please remember to mute your microphone when you're not talking. Today's conference is being recorded and the transcript will be available on the Internet. Before we begin our scheduled program, are there any questions, comments, or announcements from any of our listeners? MARTHA CARMEN: June, this is Martha Carmen from Congressman Walsh's office. JUNE HOLSTRUM: Yes, Ms. Carmen. Go ahead. MARTHA CARMEN: Good afternoon, everybody. I'm Martha Carmen in Congressman Walsh's office, and we're working on a federal infant screening. Though many of you know about it, I've had several inquiries about any Senate activity and I'm pleased to tell you that Senator Olympia Snow from the State of Maine will be introducing legislation today that will be the same as ours on the House side. Our bill is HR1193. We currently have seventy-eight co-sponsors. She'll be introducing the same thing on the Senate side looking to get support for that. So for those that were curious about that, I am pleased to bring that update to you. MIKE MARGE: Martha, this is Mike Marge. How are you? MARTHA CARMEN: Fine. MIKE MARGE: Is there a Senate number? MARTHA CARMEN: No. They'll be introducing it today and it'll be on the record for tomorrow. MIKE MARGE: Okay. Thank you. JUNE HOLSTRUM: Thanks for that update, Martha. Any questions for Martha? (No response) Our first announcement is about our upcoming Hearing Genetics Workshop, and Kim Van Naarden is here to tell you about it. KIM VAN NAARDEN: Good afternoon, everyone. This is Kim Van Naarden. I'm here at the CDC with June in Atlanta, and I'd like to announce the workshop entitled "Genetics of Congenital Hearing Impairment." And it's being co-sponsored by the CDC and Gallaudet University. The workshop will be held on June 7th of this year from 8 a.m. to 5 p.m., at the CDC at the Chamblee facility in Atlanta, Georgia. We have four main objectives for the workshop. The first objective is to discuss the public health role significance of research in population-based research and genetics of congenital hearing impairment. The second objective is to develop strategies for population-based study of genetics in congenital hearing impairment. The third objective is to exchange ideas on the ethical and policy implications of public health research in this area. The fourth objective is to build partnerships between federal, state, academic, and private organizations to address activities for population genetics and congenital hearing loss. The workshop will provide a forum to discuss the strengths and limitations of various study approaches that could be used to document the needed population-based research. We're interested in strategies that involve collaboration with the EHDI programs and we're particularly interested in the perspective of genetic ethicists, the deaf and hard-of-hearing communities, and state and local participants in the Universal Newborn Hearing Detection and Intervention Programs. The discussions in the workshop will be used to help us at CDC to determine future program directions in this area, and all the participants are encouraged to bring to the workshop information materials and references that may be useful in the process. The announcement for the workshop has gone out via e-mail, which includes the registration form and the preliminary agenda, as well as the information that I just shared with you on the objectives for the day. If you haven't received the e-mail yet and you'd like to register, you can send a request via e-mail to higen@cdc.gov. We have a limited number of participant slots. So we will have teleconference capabilities, and if you're interested in participating by teleconference, you can place the call at anytime during the day. The bridge number for federal participants is 404/639-4100 and for non-federal participants is 1-800/713-1971. The conference name is "Genetics of Congenital Hearing" and the conference code is 486602. We're requesting registration forms from all the participants, which includes those participating by teleconference. So if you have any specific questions or you need that information, again, it will be on the transcript from this teleconference, but you can also e-mail any questions to higen@cdc.gov or you can call me directly at 770/488-7184. Thanks. Do you have any questions? JUNE HOLSTRUM: Thank you, Kim. Any questions for Kim? Next, I would like to take a moment to thank all of you who responded to our two requests that we sent out on behalf of a couple of families with special needs. Many of you sent in some very helpful suggestions and ideas for resources and materials and your responses were very much appreciated by those families. So we thank you. Next, Mike has an announcement on Healthy People 2000. MIKE ADAMS: This is Mike Adams at CDC. I have agreed to inform you about a scheduled progress review. For those of you who recall, the objectives are set up at the beginning of each of the decades, and then there are three reviews of how we're doing on the objectives. The third of the progress reviews in the maternal and infant health chapter is going to be held tomorrow. It's going to be by satellite and will be available to those of you who have a large satellite dish that can access it. And for those of you who would like more information, you can find the information on the web at: http://telehealth.hrsa.gov/hp2000/healthy.htm. I need to point out that in Healthy People 2000, the hearing loss objective was not in the maternal and infant health chapter, but those of you who do have access to satellite, you can get a feel for what it's going to be like as we go through the progress reviews on the Healthy People 2010. JUNE HOLSTRUM: Thank you, Mike. Any questions for Mike? MIKE MARGE: Mike, this is Mike Marge. Where is it located? Where is the objective for newborn hearing screening found? MIKE ADAMS: Now, let's be clear here. There are the Healthy People 2000 objectives. That's going to be the review tomorrow. MIKE MARGE: I got it. I got a little worried there. I got a little tense when you mentioned that it doesn't appear. You mean for the 2000 objectives? Okay. MIKE ADAMS: Right. The hearing objectives in the Year 2000 Healthy People were in Chapter 17. JUNE HOLSTRUM: This month we have new legislation from two states. First, we'll have the good news from the State of Georgia, and Rick Ward from the Georgia Chapter of the AAP will tell us about that. Rick, are you on? RICK WARD: Yes, Dr. Holstrum. Thank you. I'm joined by a colleague of mine, Wendy LaRoche. We had passed this legislation -- Our session just ended in mid-March. We had began meeting with a coalition that included Dr. Adams, Dr. Holstrum, and the usual suspects here, audiologists, parent advocates, the Hospital Association, our organization, and others, to look at different bills and try to review the routes that we could go, and we settled on the Colorado bill as a model. The Colorado bill is somewhat permissive. It's not an insurance mandate, it sets up a commission or an advisory committee inside their public health department to work with the hospitals to try to encourage them to move towards an eighty-five percent standard of all newborns screened about two years out from the date of the final effectiveness of the bill. What they did not have in there was a budget mandate and they also didn't have a budget issue in terms of requiring that the public health department fund these screenings. And we knew that absent payment from Medicaid and other payers, this would be difficult to get all the hospitals to do and, sure enough, the Hospital Association itself was unwilling to support any kind of required screening unless they knew this payment was going to be there. So the one provision in the Colorado bill that we ended up taking out because we couldn't get the Hospital Association to agree to is that in Colorado, after two years, if they don't reach an eighty-five percent threshold of all newborns being screened, then the bill seeded authority to their public health department to require by regulation that all hospitals perform universal newborn hearing screenings, and our Hospital Association wasn't willing to accept that. So in order to make them cooperative and not oppose the bill, we ended up taking that part out and we, basically, then said that this commission will try to work with all those various parties, mainly hospitals, to get them to reach a ninety-five percent standard of all newborns being screened, because by this time, in February, the AAP statement had come out and they used the ninety-five percent threshold. So we inserted that, but, basically, if we don't get there at ninety-five percent in two years, nothing really happens to the hospitals, meaning there's going to be no requirement that it be done. We'll just continue to work with them and to encourage them to do it on a voluntary basis. That's about it in a nutshell. JUNE HOLSTRUM: Thanks, Rick. Are there any questions for Rick? UNIDENTIFIED SPEAKER: Has it been your experience, Rick, that over time you can persuade an institution like a hospital to really come around? I mean, what kind of pressure are you going to place on them so that they recognize their responsibility? RICK WARD: Well, that's the sixty-four-dollar question and it's too early to tell. That's the short answer to that question. We just got our bill signed about three weeks ago. It will be effective July 1. So once the bill sits out there, and it does have the force of law at least in terms of creating certain requirements for the hospitals to our Department of Public Health, et cetera, then we also plan internally, generated here at the Georgia Chapter of the AAP, to write all the pediatricians, especially targeting the heads of pediatric departments and all the maternity hospitals, as well. Perhaps also to all our neonatologists, urging them to urge their hospitals to implement these universal screening programs. That's, I guess, the sort of pressure that we bring to bear. We have the Academy statement, we have the commitment of our own chapter, and beyond that, we'll just have to wait and see. What we are going to do next year is to push Medicaid to fund these. If Medicaid comes on board and begins paying for these, then we think that the hospitals, the ones that have been crying that they can't swallow unfunded mandates anymore, that that excuse will evaporate. Once they get Medicaid payment, the rest of the crowd should be close behind. JUNE HOLSTRUM: Thanks again, Rick. I just recently heard that Kansas has also passed a new bill, and Lori Michel has graciously agreed to tell us about it. So, Lori? LORI MICHEL: Thank you for the opportunity to provide information about the hearing screening law in Kansas. It was signed into law on April 14th, 1999. It is a very simple law; less than a page. The law mandates that every child born in Kansas will have a screening examination for detection of significant hearing loss. It allows the Kansas Department of Health and Environment (KDHE) to develop rules and regulations in order to assure that screening is conducted in accordance with acceptable medical practices and in a manner prescribed by the KDHE. It includes statements about informed consent by parents and that the information shall be confidential. It repeals our law that is related to screening for risk for hearing loss (a paper screen.) How this came about is interesting. I represent the KDHE on the Kansas Commission for the Deaf and Hard-of-Hearing (KCDHH). Also on that Commission is Dr. Rebecca Gaughan, an ENT. At the KCDHH meeting, she said we needed to have legislation in Kansas requiring universal newborn hearing screening. She asked if she had the support of the KCDHH; it was so approved. We looked at various models of legislation. Dr. Gaughan worked with her Representative (to the KS. House), and provided a model bill to that Representative. The Representative noted that the bill was too long and probably would not pass. The result was the one-page bill. It went through the House without any dissenting votes. It rested in the Senate Public Health and Welfare Committee while the fiscal note was reviewed. (The fiscal note related to KDHE administering the legislation. Neither the bill nor the fiscal note addressed issues relative to payment to hospitals for screening, or the role of insurance.) The bill then passed the Senate with the addition of the confidentiality statement, and went back to the House and again passed. The bill had the support of the Kansas Medical Society and the Kansas Hospital Association. The KCDHH was instrumental in providing consumers for testimony. It becomes law once it is written into statute, and it is our (KDHE) responsibility now to develop regulation. People are working at the committee level to develop screening guidelines, some of which will eventually be reworded into regulation. We spoke with Medicaid personnel who did a search on the number of hearing evaluations they had reimbursed for children under the age of one. They determined the amount of money that they spent for these evaluations. Once the infant was identified as at-risk for hearing loss (the paper screening), the infant was eligible for an evaluation. Screening reimbursement rates will be different from evaluation reimbursement rates. For those who are working with Medicaid: if Medicaid can do a search for you on how much in total they are reimbursing for hearing evaluations, those data might provide some additional information and support regarding newborn hearing screening. The Kansas legislative effort was definitely a grass roots effort. KEN ROSENBERG: I've got a question, Ken Rosenberg in Oregon, for both Georgia and Kansas. Does the legislation provide money for your health departments and is there any concept of a centralized state registry? LORI MICHEL: The legislation does not provide money for local health departments. It does provide a small fiscal note to implement the program at the KDHE. The hospitals will send data to the state and we are looking at utilizing the electronic birth certificate (EBC) system for data transmission. We are using Colorado as the model. We need to determine the process of data transmission for the hospitals that are not on the EBC system. We also need to determine the data transmission process for NICU babies when the birth certificate information would already have been transmitted prior to the time that the baby would have hearing screened. The fiscal note for KDHE will hopefully provide funds for another person at the state level to help do some of the training in the hospitals, review the data, do the follow-up etc. UNIDENTIFIED SPEAKER: I have a question for Kansas. You spoke a little bit about informed consent that was in your bill. Could you say more about that? Was it a requirement to have a verbal or a written consent? LORI MICHEL: The legislation doesn't indicate whether informed consent is to be verbal or written, only that informed consent of parents shall be obtained, and if any parent or guardian objects to the mandatory screening examination, they're exempt. Most hospitals have a standard consent form because of PKU, galactosemia and other newborn screenings. We will need to address this issue in regulation. UNIDENTIFIED SPEAKER: Thank you. RICK WARD: To answer the previous question from Georgia, the answer is, in terms of fiscal note, yes, we got about a hundred and sixty thousand dollars into the budget to crank up the committee and staff it and collect some data and crunch the numbers, et cetera, and that will probably be an annual expenditure. And to the question of registry, no, although we did pass an immunization registry bill three years ago and we're still trying to get that thing put together, which is one heck of a task. So I suppose it's feasible that this thing could be lumped in there once the immunization registry gets up and running because a lot of the public health people wanted to emphasis that the registry could have broader uses than immunization. So that may be down the pipe, but it wasn't contemplated in this legislation. I had actually a question for Kansas of my own. I guess I'm not quite clear of the basis of your bill. Does it, in fact, require hospitals to perform universal newborn hearing screenings, or is it on a voluntary basis? LORI MICHEL: The bill does not specify who does the screening. It requires that every child shall be given the hearing screening within three to five days for normal births and five to eight days for premature births. The basic assumption is that the screening would occur at the hospital prior to hospital discharge. The issue can be clarified in regulation. RICK WARD: But they didn't interpret this, then, as a mandate for them? LORI MICHEL: I believe the Kansas Hospital Association interpreted it as hospitals doing the screening. The KHA certainly wants to be involved in developing the regulations.. RICK WARD: And they didn't whine to you about payments? LORI MICHEL: While the Hospital Association was supportive of the bill, the only request that we had was that they would be involved in the development of regulations and I welcomed that. RICK WARD: Sure. Good. HALLIE MORROW: Hallie Morrow from California. In both Georgia and Kansas, who's responsible for doing the tracking and monitoring and follow-up that these children actually get their rescreenings, evaluations, and diagnoses done? LORI MICHEL: In Kansas, those issues are not addressed in the legislation, though these are questions asked. Kansas has Infant-Toddler Services (Part C of IDEA) statewide, and we have a hospital to home transition system in place as part of Infant-toddler Services. A failed screening can be a flag them to our early intervention network at the community level. So we'll be exploring that link for further follow-up. This newborn hearing screening legislation would link with Part C of IDEA. This newborn infant hearing screening act mandates only that a hearing screening is given. RICK WARD: In Georgia on that issue, we did talk about this kind of extensively in our coalition, and I can't say that our bill reached into the follow-up issue in great detail, but we do have a proviso that when we list the duties of the advisory committee, one of them is guidelines for reporting and the means to assure that they identify children receiving referral for appropriate follow-up services. So at least it's on the radar screen in the bill. HALLIE MORROW: All right. Thank you. JUNE HOLSTRUM: I think we'll go on to our next item. The AAP subcommittee on information gathering has been collecting information on screening and intervention, and Liz Osterhus is here to tell you a little more about the activities of that group. Liz? LIZ OSTERHUS: Hi. This is Liz. Basically, as you know, the AAP published a policy statement on universal newborn hearing screening in February of this year, and what we're doing now is trying to gather those materials that will help physicians, parents, and administrators of public and private programs implement the recommendations. So the subcommittee on information gathering is doing just that, gathering those materials. What I wanted to do is invite anyone who's on this call to contribute to the information and resources that we're putting together. -f you do have some resources that you think we might not have already gathered from Marian Downs or the National Center for Hearing Assessment and Management or other sort of prominent places, then I would appreciate it if you would send me an e-mail and I'll send you a form back by e-mail, or you can contact me by fax or phone. My e-mail address is losterhus@aap.org. That's losterhus@aap.org. I can send you more information if you would like me to mail it or fax it to you. So that's all I have to say, really. JUNE HOLSTRUM: Thanks, Liz. Any questions for Liz? RICK WARD: Yes. I had one. Liz, I noticed it in the March issue of "Pediatrics" there was sort of the con point of view about universal newborn hearing screening. Has there been any -- LIZ OSTERHUS: Right. The Jack Paradise commentary. Yes. There are different folks who are providing a response to that commentary and that will be published at some point in the future. We're not exactly sure which issue it will come out in. RICK WARD: Thank you. JUNE HOLSTRUM: Next, we have Krista Biernath who is working with us here at CDC. She's also doing some information gathering. She's going to update you on her project. Krista? KRISTA BIERNATH: Good afternoon. This is Krista Biernath. I would like to take a few minutes to describe a project that I am currently working on to assist the CDC in identifying public health issues related to information dissemination to families about the intervention process. So this is actually what we were just talking about after the screening. We are preparing to conduct a preliminary survey of individuals from nine states. This preliminary survey would help to identify and describe organizations or resources within the states functioning to provide information to families about intervention choices for infants and young children identified with hearing loss. The states that we plan to target would be those currently offering universal newborn hearing screening. Eligibility criteria for state participation in this survey currently consists of the existence of legislation concerning statewide universal newborn hearing screening. From the information that we have, states that are eligible include: Hawaii, Rhode Island, Colorado, Mississippi, Connecticut, Utah, West Virginia, Virginia, Massachusetts, California, Kansas, and Georgia. If you are aware of an error in this information, please let us know. As there are twelve states that currently meet the criteria and we are only able to survey individuals from nine states, we will be choosing states randomly. We plan to contact three individuals from each state participating: the Director of Speech and Hearing Programs and Welfare Agencies or the DSPSHWA; the Part C coordinator; and a parent advocate. After agreement to participate by the individual contacted, a brief description of the purpose of the preliminary survey and a list of interview questions will be faxed and a telephone appointment will be arranged. Information will be collected via telephone survey, either voice or TTY, a few days after the initial contact. Through the survey questions we are developing, we hope to identify as many resources as possible within the states. We also hope to describe the methods of referral for families to these resources, the existing links between the information resources, and the state's universal newborn hearing screening program, and the perceived strengths and weaknesses of these resources among other things. We hope to begin the contacting and interviewing process by the middle or end of this month. Are there any questions or comments about this? If you do have any questions or comments or suggestions later, please feel free to contact me. My e-mail: kob9@cdc.gov. EVEY CHEROW: This is Evey Cherow. I have a question. I guess I'm wondering, when you're talking about state-specific resources, are you including professional resources, as well as organizational resources, and does that mean you'll be doing counts, for example, of otolaryngologists -- pediatric otolaryngologists or audiologists that specialize in pediatric assessment and amplification fitting or linkages to Part C agencies? Exactly what will be your criteria for determining resources in those states? KRISTA BIERNATH: Okay. Really a two-part question. First of all, we're not looking for statewide organizations. We're looking for any resources within the states that these individuals feel are helpful to families in information dissemination. We're looking really at the process of information dissemination, teaching families about services and about intervention choices as opposed to actually providing them with resources such as specific ENT's or specific audiologists. What we want to look at is information about educating the parents. Does that answer your question? EVEY CHEROW: To some extent. I just would like to bring to your attention, you may know about it already, the Joint Committee on hearing did a special issue of Pediatric Clinics of North America on universal newborn hearing screening, diagnosis and intervention, and I had an opportunity to do a chapter with Steve Epstein and Donna Dickman in that special issue on resources for families. So that may be helpful to you from a national prospective about the agencies that are available to families in any state for information about intervention choices. I guess that's why, I guess, I was a little confused about what types of resources you'll be delineating. KRISTA BIERNATH: Right. That's very helpful. Thank you. We're also looking at local resources, but we are looking at the national resources. So I'll look into that information. Thank you very much. EVEY CHEROW: I can send you a reprint of that chapter. KRISTA BIERNATH: That would be great. JACKIE CUNDALL: This is Jackie Cundall from Tennessee. Will this survey be similar to the one that the nineteen states participating in on the Colorado grant on intervention services? KRISTA BIERNATH: I guess I'm not familiar with the specific survey that you're discussing. JACKIE CUNDALL: Is there anybody from Colorado? ARLENE STREDLER-BROWN: This is Arlene Stredler-Brown at the Marion Downs National Center. I'm not sure how much information you want right now, but we did survey nineteen states, specifically around early intervention, the services, the agencies, and the link from diagnostic audiology services to intervention. Just this morning, I was writing the article on those results. I should be able to share with you both the survey questions and some of the preliminary, the raw data, that we have by state and then aggregated from my state if that would help or influence the questions that you'll be asking in your survey. I can give you my e-mail address while we're all on the line. It's arlene.brown@state.co.us. My phone number at the Marian Downs National Center is 303/492-3037. KRISTA BIERNATH: Thank you. That would be really, really helpful. JUNE HOLSTRUM: Thank you very much, Arlene. That would be very helpful. Next, the State of Virginia is developing a unique way of dealing with tracking children who are deaf and hard-of-hearing to tell us about their TONE system. We have Pat Dewey from the Virginia Department of Health and John Pestian from the Center for Pediatric Research. Go ahead. PAT DEWEY: Hi. This is Pat Dewey. First of all, let me give you a brief background. Since 1987, Virginia has had a legislative mandate for all hospitals with newborn nurseries to identify and report to the Department of Health infants who are at risk for hearing loss, and those facilities with neonatal intensive care services to also screen the hearing of those infants that they identified at risk from their intensive care unit prior to discharge, and included the reporting of those results, as I said, to VDH. Reporting of diagnostic audiological follow-up was strictly on a voluntary basis. The system tracked and sent letters to families regarding their need for screening or follow-up to screening received in the hospital. Then last year, the Virginia General Assembly passed and the Governor signed amendments to the Code that required hospitals with newborn intensive care services to begin to screen the hearing of all infants prior to discharge after birth beginning July 1 of 1999 and requiring the Board of Health to provide by regulation for the giving of hearing screening tests for all infants born in all hospitals by July 1 of 2000. Now, we are drafting regulations, amended regulations actually, that will require that all other hospitals screen hearing of all infants prior to discharge after birth beginning July 1 of 2000. So, the program will be phased in. In Virginia, we have sixty-seven hospitals with newborn nurseries, one hospital with a neonatal intensive care services (that is Children's Hospital of The King's Daughters) and there are also three military hospitals that are currently not reporting to us. Our births average about ninety-two thousand a year. Because the database that we developed as a result of this original program was over ten years old and, obviously, not Y2K-compliant, we needed to develop a new one. In addition to that, we wanted to have a system that would replace the current paper reporting system that we have, that good old form, with an automated one that would ease the burden on hospitals as well as the burden on our one staff person that's responsible for doing all that data entry and also to give us a better way to track these children from the screen through the diagnosis to intervention. For some years now, we have had a group of persons, both within the Health Department and outside the Health Department, working on trying to implement an integrated system for hospitals that would involve the newborn hearing screening, the program for congenital anomalies reporting, a voluntary at-risk children reporting, and also possibly even including the metabolic screening, and that we utilize the demographic information from the electronic birth certificates as many of the states are doing, as you heard Lori talk about earlier. Our efforts in this regard have been slowed by a lot of things: reorganizations, staff changes, and certainly, confidentiality issues have played a major role here. We're still confident that this can be accomplished in the near future. Because this new mandate last year did require us to modify the entire program beginning in July of this year, we decided to proceed with development of this new database, independent of some of these others that I have previously mentioned, certainly with the potential that it could be modified to incorporate these other systems in the future. So we talked with other agencies and with our Virginia Hospital and Health Care Association. We discussed designing a simple system, perhaps written in Access, that hospitals would submit information to us via. The Center for Pediatric Research, which is located at Eastern Virginia Medical School here in Virginia, was chosen as the vendor for this new database, and John Pestian, who is at that Center, he's also Assistant Professor of Pediatrics, he'll tell you the rest of the story. JOHN PESTIAN: Thanks, Pat. As Pat indicated, I am an Assistant Professor of Pediatrics at the Center for Pediatric Research, a joint program of eastern Virginia Medical School and Children's Hospital of The King's Daughters in Norfolk, Virginia. I direct the health informatics and clinical outcome as research. In our health informatics section we are dedicated to creating technological interventions that will enhance the health of a community. So, we were very excited about the opportunity to develop an interactive system for the collecting and reporting of newborn hearing screening. As Pat explained, we debated different architectural designs, one being a distributed design using Microsoft Access. Using this design, the Commonwealth would send out a program for collecting the information. Based on a predetermined schedule the state's birthing facilities would send exported files via the mail, modem or some other method. Alternately, we could develop a web-based system using the state's secure infrastructure. This design would eliminate the need to maintain information about the hardware at each site, and allow for real-time data submission and report. After a month or so of deliberation we decided to develop the web-based system. The system we are now developing uses a standard Internet browser and connects to the central site. Each hospital has a secure log in. We have a series of firewalls that test the integrity of the equipment trying to access the central system. We use a one-hundred twenty-eight bit encryption. We meet all the HCFA requirements for the transmission of patient information using the Internet. The system allows each hospital to enter the various screening information along with demographic information. A series of reports is available. For example, referral letters can be generated, information to the child's primary care physician can be faxed or e-mailed, frequency information and so forth. There's also an administrative module that rests in the hands of the Virginia Department of Health. This module allows VDH the opportunity to aggregate the data and study the data based on various parameters. Are there any questions? UNIDENTIFIED SPEAKER: John, there are some of us who might like to contact you and learn more technically about what you're doing. JOHN PESTIAN: Oh, sure. UNIDENTIFIED SPEAKER: Phone number? JOHN PESTIAN: My phone number is 757/668-7340. My E-mail address is jpestian@chkd.com Feel free to call. I can add a little bit about the technical side of it. What we have developed is an Oracle back end database that uses an open architecture. Ultimately this system will merge with other tracking components. As Pat said, we're working now for making the TONE (Test Our Newborns' Ears) available to Virginia's hospitals in July 1999. The goal was to make this one component in an integrated newborn screening that includes the metabolic and genetic screening and another at-risk program. Continuing on the technical discussion, as I said, it's an Oracle back end database and we use a secure web server and -- Our research center has its own T1 lines coming in. We can scale those up, depending the demand. PAT RICE: This is Pat Rice from Minnesota. I'm curious about what kind of dollars we're looking at to set up the system and ongoing management of it. JOHN PESTIAN: Yeah, that's a good question. Pat, I think we're -- for us to develop it, we've got -- Pat, you might -- What was it? Was it about seventy thousand? PAT DEWEY: Yeah. About seventy-six thousand. JOHN PESTIAN: We haven't signed the contract yet. We're still -- PAT DEWEY: Right. We're still negotiating the contract. About seventy-six thousand. JOHN PESTIAN: And then the ongoing management of it. If you do it -- I think the best estimates we have, whether you would require a Center like us to do the ongoing management and maintaining it yourself, you could probably expect about fifty thousand dollars a year to manage all the data do the reporting, do the backups, making sure that everything remains secure, having a help desk for the hospitals, all those other different management functions. UNIDENTIFIED SPEAKER: Fifty thousand dollars a year would be for you guys to do it or for the state health department to do it? JOHN PESTIAN: If the state health department did it, I suspect that once you figure in the cost of the equipment, the cost of software, on-going maintenance, personnel, electricity, telephone, etc, etc it will be roughly the same. KIRSTEN McDANIEL: This is Kirsten from Arkansas. I was wondering, are you gathering any at-risk information or demographic information, or is it just name and test results? PAT DEWEY: Yes, Kirsten, we are gathering demographic information on infants who do not pass the screening. We are wanting to give a break to hospitals in terms of reporting. So we're asking them to report that information only on infants who do not pass, or for some reason might be missed, or also who are at risk for progressive loss. The other information would be reported to us in total. Because it's a phased-in system from July 1 of this year to July 1 of next year, there will be many hospitals who will only be reporting infants at risk. So we will be getting risk information as well. UNIDENTIFIED SPEAKER: Do you have a plan to eventually link this with birth certificates? PAT DEWEY: Yes. That's our hope. JOHN PESTIAN: Yes. We're starting to work with the electronic birth certificate folks to determine the optimal technological solution. PAT DEWEY: We have our own version of the EBC. We started out with, I think, the version that a lot of states have. Then our IS department developed their own. JUNE HOLSTRUM: Is there a way that primary care physicians can access this to find out information about their patients? PAT DEWEY: Not currently. I know that the immunization system is working like that, and the immunization system is linked to our statewide information system, which is called VISION. Once our integrated efforts take place, June, I think that could become a reality for the future. JOHN PESTIAN: Yes. That's ultimately the long-term plan. JUNE HOLSTRUM: Any other questions for Pat or John? (No response) I appreciate you two being on today. I know you had to do a little scrambling of your activities, but I appreciate the information and you may be getting more questions as you progress. JOHN PESTIAN: Sure. Thanks for the opportunity to discuss it. We're pretty excited about it. Pat has done a great job in keeping us moving on it. PAT DEWEY: Thanks. JUNE HOLSTRUM: Next on our program, we have Amy Donahue from NIH to give us a summary of the December Genetics Conference. Amy? AMY DONAHUE: Hi. How are you today? I'm glad to be here. Let me give you an update on a recent working group that NIDCD had on considerations for developing and implementing genetic diagnostic tests for heredity hearing impairment. Basically, two of ongoing and seemingly unrelated endeavors converged to provide the impetus for this working group. First, a number of clinically significant genes for heredity hearing impairment have been identified; and within some patient groups, the number of genes responsible appears to be limited to a few. For example, mutations in one particular gene that codes for the gap junction protein connexin 26 are reported to be among the most common cause of receptive deafness in several parts of the world. Second, newborn hearing screening, as we've been discussing, is being initiated, providing a population of infants with a hearing loss that is detected immediately after birth. The rapidly advancing information on connexin 26 genetic mutations have led some to suggest genetic testing of all infants who fail routine newborn hearing screening for these mutations. There is now a clinical population identified at birth who could be accessible to the geneticists who wish to perform genetic testing. With the identification of genes that contribute to hearing function, genetic testing does become feasible. However, prior to implementing any genetic tests, there are several issues that have to be addressed to assess the clinical utility of those tests; and those issues are scientific, ethical, legal, and social in nature. These include informed consent, education about the risk and benefits of testing, follow-up care, communication accommodations for deaf and hearing-impaired individuals, risks and benefits that are unique to some populations, and privacy issues. There are many issues that have to be discussed under the context of identifying the goals of genetic testing, whether or not the goals are achievable, and whether or not the goals are desirable. The NIDCD rapidly felt that we needed to address this issue rapidly. We wanted to support the scientific community in their efforts to advance in genetic knowledge, but we wanted to bring forward the issues that have to be considered so that any genetic testing that occurs will be done in a very systematic and thoughtful manner that's of benefit to individuals with hearing impairment. Just because you can do a test doesn't mean that you should; and if you do provide someone information, it doesn't mean that everyone will use it the same way. Those are the sort of the global issues that must be considered. So we pulled together a group of individuals in relevant areas, medical geneticists, genetic counselors, genetic ethicists, legal advisors, educators of the deaf, otolaryngologists, audiologists, et cetera, to address this issue. We asked this working group to consider the role of genetic testing as it pertains to the research community that's engaged in the genetics of hearing impairment, but, separately, as it impacts on the clinical research and the clinical practice community, the individuals who actually see the patient. Also, of course, although not the primary focus of this working group, we asked for research questions to address our knowledge gaps, information that without which would impede our ability to go forward. So what were the recommendations? First, because there are many clinical, ethical, and social issues that have not been adequately addressed, the workgroup recommended that routine screening for connection twenty-six mutations is premature outside of the well-designed control clinical trials. They also noted that there is much information that needs to be gained in clinic genetic studies. These would be studies to determine the prevalence of various mutations in normal hearing population, as well as in populations with hearing impairment; that we need longitudinal and comprehensive studies of individuals with deafness and hearing impairment to address genotype/phenotype correlations; study design issues; determining the impact of genetic testing and the utilization of that information on the attitudes and behaviors of various cultural groups, et cetera. The working group met on Dec. 8, 1998 and I think it was a -- we considered it to be a very positive day. There's a lot of information that was shared and a lot of necessary next steps were noted. Some of the next steps that we here at the NIDCD have undertaken are a couple. One is we have -- are having a working group on May 25th on communicating informed consent to individuals who are deaf or hard-of-hearing. In this instance, we want to have recommendations that are helpful for all health-related research efforts for appropriate informed consent. Further, we just recently issued in conjunction with the Human Genome Research Institute here at the NIH, a request for applications on studies of ethical, legal and social implications of research into genetic human variations. We have a request for applications, for grant applications, for individuals to conduct studies that address the ethical, legal and social issues that arise in the course of research in genetic variation and how this information will be used by different cultural groups, different socioeconomic factors and concepts of race, ethnicity, culture. So we have both of those activities ongoing. Then, of course, CDC will be having a follow-up working group that Kim mentioned earlier in the meeting which will be a next step to this. So let me -- It's almost 3:00. So let me see if there's any questions. EVEY CHEROW: This is Evey. Do you have, Amy, a copy of that report? Is that available for the -- AMY DONAHUE: Oh, yes, absolutely. In fact, I should have said so. Thank you. That report is on the NIDCD home page on the web, and that can be found at www.nih.gov/nidcd. The minutes of that working group are up on the web and accessible, and we actually encourage them to be as widely distributed as possible. We sent it to many of the organizations, both scientific organizations and public community organizations that are involved or may be involved with these issues. So we're tried to widely disseminate and we very much encourage everyone else to do it. In fact, we would appreciate it. Also, please if you have trouble finding it, feel free to call and we can send them to you. My phone is 301/402-3458 or amy_donahue@nih.gov. We'll be glad to send them out to you also. JUNE HOLSTRUM: Thank you, Amy, for being with us. Any further questions for Amy or for any of our other speakers? JACKIE CUNDALL: This is Jackie Cundall in Tennessee. I had just gotten a fax from you today on a Genetics Congenital Hearing Impairment workshop on June 7th, and it sounds like it was just about what she was talking about. Is that a planning meeting for the December meeting then? AMY DONAHUE: The NIDCD meeting actually already occurred in December, 1998. But, yes, it does seem very similar. However, CDC's will be to follow up and take it to the next step. While our meeting was geared to researchers and clinicians -- Kim, if you're still on the line, you can interrupt here, but I believe that CDC's next step is sort of to take our working group report and to a next step to the public health community. Many of the same individuals will be involved. The CDC workshop will actually discuss how to design issues and interact with the individuals out there in the community who may be involved in some of these ventures. So it's , I think, a very healthy next step and will involve a different community. KIM VAN NAARDEN: Amy, I think that's a good synopsis. Thanks. I just want to thank you, too, because I think your review is a very good summary of where we're going with the workshop. Yes, for the workshop, we're going to go through the different strategies from a public health prospective and look at population-based research and what would be the considerations and we're set to do that. JUNE HOLSTRUM: Anyone else have any final comments, questions, announcements that they would like to make before we sign off? EVEY CHEROW: June, it's Evey again. Sorry to be so verbal today, but I was thinking in regard to our earlier discussion on the family intervention piece that I haven't shared, other than through ASHA's dissemination of the brochure, a teleseminar that we're offering, a continuing education program on Thursday, July 29th. It's called "Family-Centered Early Intervention for Children Who Are Deaf and Hard-of-Hearing, Strategies and Outcomes," and our two faculty are Arlene Stredler-Brown and Mary Pat Moller from BoysTown National Research Hospital. Arlene is from the Marian Downs National Center. It will be from 1 to 3 p.m. on Thursday, July 29th. Information on signing up as a site for that program can be obtained from Ann Parks here at ASHA at 301/897-5700, extension 4236. JUNE HOLSTRUM: Thank you, Evey. We'd certainly be interested in listening in on that. EVEY CHEROW: Great. JUNE HOLSTRUM: Any other questions, comments, or announcements? KIRSTEN McDANIEL: This is Kirsten from Arkansas. I just wanted to let everyone know, in case you haven't heard, but we passed legislation as well. It was signed on April 15th, Act 1559, and it mandates that any hospital with fifty births or more must provide universal newborn hearing screening and report it. It also mandates Medicaid to pay in addition to the per diem. It set up an advisory board as well. JUNE HOLSTRUM: Thank you, Kirsten. No, I didn't know about that one. Thanks for letting us know. JACKIE CUNDALL: This is Jackie Cundall in Tennessee again. We have legislation also in front of the legislators and it was started with grass roots organizations, and it would mandate that hospitals provide it prior to discharge and it would mandate that we do work with our early intervention Part C program, which we had already had in the plans anyway, but I'm not sure where that's going to go. JUNE HOLSTRUM: Good luck and thank you for letting us know. Anyone else? If not, that's our program for today. Our next meeting will be July 6th. Again, thank you for joining us and we'll talk to you in July. |