Massachusetts CDC EHDI GRANT (2001)

GRANT NARRATIVE

1. Understanding the Problem

(a). Program requirements and purpose

The Massachusetts Department of Public Health (DPH) seeks funding for a Level I Early Hearing Detection and Intervention cooperative agreement. Funds will permit the Office of Statistics and Evaluation (OSE) of the Department's Bureau of Family and Community Health to establish a tracking and surveillance system for newborn and childhood hearing loss. OSE oversees data systems for Bureau programs in the areas of maternal and perinatal health, injury control, nutrition and primary care, special health care needs, school aged and. adolescent health, and adult health and wellness. OSE is also responsible for all Bureau information technology operations. The Childhood Hearing Data System (CHDS) will: enhance accuracy, timeliness, and completeness of newborn hearing screening, diagnosis and intervention through automated tracking of children from birth through discharge from Early Intervention (and possibly beyond); enhance DPH capacity for quality assurance and quality improvement among hospitals, diagnostic centers and Early Intervention programs which participate in newborn hearing detection and intervention; conduct epidemiologic studies concerning hearing loss in infants; and conduct long-term studies concerning the effectiveness of different interventions to promote language development among infants with hearing loss. While the project will focus primarily on newborns and secondarily on other children who acquire hearing loss before age 3 in its first year, efforts will be made to incorporate children and teens with hearing loss in future years.

(b). Challenges

The major barrier to creation of an effective hearing screening data system is funding. The state has mandated universal newborn hearing screening and follow-up, but state funds have been allocated only to pay for screening. DPH has used other sources to pay the basic costs of program implementation, but lacks resources to develop and staff an effective data system for the program. The impact of this limitation in funding is discussed further in (c)., below.

Other challenges to effective tracking and surveillance include: (1) the need to link data from disparate sources; (2) the need to ensure that data are downloaded promptly from existing systems to permit prompt follow-up and then prompt enrollment of children in services; (3) the need to create a new data collection system to capture movement of children who have screened positive through the state's diagnostic centers; (4) the need to build strong connections and a common sense of purpose between staff responsible for the automated tracking system described in this proposal, and those involved in the programmatic side of universal newborn hearing screening; and (5) the need to obtain parent consent for tracking of children beyond the age of 3 to permit long-term research on outcomes of intervention at a time when concerns about privacy of health records are widespread. An additional challenge which will become more important after Year 1 of the project, is the development of a method (or methods) for incorporating older children with hearing loss in the system, in order to achieve universal childhood tracking. No system exists from which such data can be readily captured. Over the long run, Massachusetts seeks to develop a single integrated system for surveillance of childhood special health needs. Integration of the CHDS into that comprehensive system is a long term goal of this proposal, and will pose multiple challenges related to technology and policy.

(c). Current status of hearing screening in Massachusetts and need for an EHDI program

As of 1998, Massachusetts state law mandates that all newborns be screened for hearing loss prior to discharge from birth hospitals or birth centers (see Appendix E). The law requires DPH to approve audiological diagnostic testing centers that have capacity to evaluate newborns who screen positive for hearing loss. Since passage of this law, the DPH has:

• Established a multidisciplinary Universal Newborn Hearing Screening Advisory Committee,
• Amended the hospital and birth center licensing regulations to include requirements for newborn hearing screening programs,
• Developed and distributed hospital and birth center guidelines,
• Drafted guidelines for DPH approved diagnostic centers, and
• Initiated a change in the Massachusetts Registry of Vital Records and Statistics electronic birth certificate, to include the results of newborn hearing screening.

DPH review of hospital protocols submitted in compliance with the new law indicates that about 95% of the 82,000 infants born annually in the state are now being screened. Fifty-one of 53 birth hospitals report that they have instituted universal screening. These figures represents a dramatic increase over prior years, and reflect both the efforts of the UNHSP, and the developing acceptance of newborn screening as a standard of care by pediatricians.

Both the law and the regulations also require that hospitals and birth centers to provide families with written information prior to screening and written results of hearing screening to parents and primary care clinicians. Because the screen is required by law, however, hospitals are not required to obtain consent for the procedure. Once a child screens positive, Massachusetts state law and amended hospital and birth center licensure regulations require referral to a DPH approved audiological testing centers. DPH currently has a list of 26 approved centers throughout Massachusetts. After final review and release of new DPH diagnostic center guidelines (which is imminent), diagnostic centers will be required to submit protocols for evaluation and referral to DPH for approval.. As the CHDS is implemented, these guidelines will be revised to require timely submission of child-specific data by diagnostic centers to DPH.

Massachusetts has limited capacity to document and track progress of children from screening, through diagnosis, to intervention. As noted above, the state's electronic birth certificate (EBC) is now being changed to include information on the date and outcomes of hearing screening. The EBC will, therefore, contain information on newborns who do not pass screening, or are missed by their hospital screening program. These data offer a means for tracking hearing screening among newborns.

Absent EHDI funding, our current plan is to download birth certificate information on children who have either screened positive for hearing loss or have no reported screening results. Current capacity, based on limited state funding for the UNHSP and a grant from the Health Resources and Services Administration to staff UNHSP follow-up activities, will permit manual review of downloaded birth data to flag children with positive screening results. The number of children missed during initial implementation of UNHS is, however, expected to exceed our current capacity for follow-up. Staff will contact pediatricians, parents, diagnostic centers and Early Intervention programs, to ensure that children who screen positive do make it into care, but this process will be entirely manual. Once data are downloaded from the birth file, children will be tracked through direct contact rather than any kind of automated or data-based process.

The present status of screening in Massachusetts makes the opportunity presented by the EHDI initiative particularly exciting. We have the foundation, in terms of the law, the active participation of stakeholders in an active Advisory Group, an effective core staff, and strong support of key players within DPH, for a strong program to address newborn and childhood hearing loss. EHDI funding would fill a critical gap in current capacity to achieve that goal.

(d). Systems integration

The UNHSP has established close working relations with two systems that are critical for effective tracking of newborn hearing loss in this state. Staff of the Registry of Vital Records have been active in the planning of UNHS, in this state, and have agreed and acted upon plans to amend the Massachusetts birth certificate to include the detailed results of each newborn hearing screening.. Other data which can be captured from the EBC and incorporated into the CHDS include demographics (including ancestry, race, language preference, and education of both mother and father), pregnancy risk factors, method of delivery and complications of labor and delivery, child and maternal health information. status (including information on birth defects and congenital anomalies) and information on hospital stay, transfer and discharge.

The UNHSP is housed within the same DPH division as the state's Early Intervention program. EI staff played a strong role in UNHS planning even prior to passage of the 1998 state law. A designated EI staff person has served and will continue to serve as liaison between the two programs. In addition, the parent who manages the state's Early Intervention Parent Leadership Program sits as a parent representative on the UNHSP Advisory Committee. Parallel to this programmatic linkage between EI and UNHSP, responsibility for the EI Information System (EIl S) resides in the unit of OSE in which this project will be housed. The Director of the OSE Disability Unit supervises EI data staff and will supervise staff hired to implement the CHDS. There is, therefore, strong commitment to integration of relevant EI data into the CHDS. EI screening of children from 0-3 will also provide an opportunity for the CHDS to incorporate data on young children who acquire hearing loss after birth.

Other relevant screening systems that the newborn screening information will be linked to include the DPH First Link Home Visiting Program. First Link uses birth certificate information to screen for risk factors and offers home visits to consenting families with newborns that meet established risk factors. Newborns that do not pass or miss a screening will be offered a First Link home visit, which will reinforce follow-up efforts of UNHSP. (Note that First Link has not been implemented in all communities of the state, so it cannot Serve as the universal basis for follow-up, however.) Also, information collected in the newborn hearing screening data will be linked to the congenital anomalies surveillance data system at DPH. Integration with this system will help to track trends such as pockets of hearing loss in certain geographic areas.

While we do not envision direct linkage with the Massachusetts system for metabolic blood screening in the near future, opportunities for continued collaboration do exist. The state's metabolic screening program is carried out by the University of Massachusetts, which operates the New England Regional Newborn Screening Program (NERNSP) for Massachusetts and other New England health departments.. This system operates outside of DPH and is separate from the state's birth reporting system. - Collaboration with the program is ongoing, however, and includes sharing of materials, participation in advisory committees, and some joint training of hospital staff about the respective requirements of the two systems. DPH staff have also worked with NERNSP staff to promote EI enrollment of all children who screen positive for metabolic conditions (for which they are automatically eligible, .based on the state's inclusion of "at risk" . children in EI). As the CHDS is implemented, staff will explore possibilities for closer integration of data and surveillance systems in the future.

(a). Goals of the Universal Hearing Screening Program

The long-term goal of the UNHSP is the optimal development of children who are born with or acquire hearing loss in this state. Shorter-term goals of the UNHSP are: I) early hearing screening of all newborns in the state; II) prompt diagnostic testing of all children with evidence of hearing loss; and III) enrollment of all children with hearing loss in high quality, family-centered, developmental services.

(b). Goals of the Childhood Hearing Data Project

The CHDS is ultimately intended to support the goals of the UNHSP. The CHDS will enable DPH staff and other involved parties to design and implement optimal policies and procedures for detection and intervention around childhood hearing loss. The children of the state are the indirect target population for the CHDS; direct target groups are the individuals and systems who require information to design and implement optimal services for children. CHDS goals are:

1. That DPH staff and staff of birth hospitals have information needed to ensure that all Massachusetts children are screened for hearing loss as soon after birth as possible;
2. That DPH staff and staff of hospitals and diagnostic centers have information needed to ensure that all children who screen positive receive prompt diagnostic testing upon discharge from a birth hospital;
3. That DPH staff, staff of diagnostic centers and Early Intervention programs, parents, and pediatricians have the information needed to ensure that all children diagnosed with hearing loss are enrolled promptly in effective developmental services;
4. Ongoing system improvement, both within Massachusetts and in other states implementing similar programs, through identification of barriers to screening, diagnosis and enrollment in early intervention of children with hearing loss;
5. Advancement of the state of the art in relation to prevention and early intervention, through provision of information and analyses concerning the distribution and nature of hearing loss and the outcomes of different intervention strategies.

Objectives related to general start-up of the project, to be achieved by 12/1 S/00, are: to staff the CHDS; to create an internal DPH CHDS team and to create a subcommittee of the UNHSP Advisory Committee focused on surveillance and research.

Objectives related to Goal I are:

I.1. By 2/10/00 develop methodology to receive EBC records for children with a positive screen or no screen;

I.2. By 10/1/00, in collaboration with Vital Statistics staff and staff of the UNHSP, initiate training and TA to hospital staff concerning completion of EBC fields related to newborn hearing screening ;

I.3. By 11/l/00 design and implement protocol for identifying and correcting missed screens;.

I.4. By 4/2/01 design and implement procedure for ascertaining and recording cause of missed screens.

Objectives related to Goal II are:

II.1. By 4/13/01 design and implement fax form I and procedures and train diagnostic centers (DCs) to report when child presents following positive screen;

II.2. By 4/13/01 design and implement form and procedures and train DCs to report outcome of diagnostic testing;

II.3. By 5/14/01 develop procedure and train DCs to obtain and report parent consent for contact by EI program and/or Mass Commission for the Deaf and Hard of Hearing;

II.4. By 4/13/01 design and implement protocols for entry of data from DCs into Childhood Hearing Data System and for flagging missed reports at start or completion of diagnostic testing;

II.5. By 5/14/01 develop and implement procedures for follow-up with DCs to correct missed reports and for referral to program staff when missed report reflects that child has not presented at DC, completed diagnostic testing, or received a referral to EI after a positive screen;

II.6. By 5/14/01 develop and implement procedures for ascertaining and recording cause of delay in presentation at DC or completion of diagnostic testing.

Objectives related to Goal III areas follows:

III.1. By 5/31/01 create protocol to download data from MIS concerning EI referral and enrollment, receipt of EI services and discharge from EI of children diagnosed with hearing loss; III.2. By 9/3/01 establish procedures to refer case to appropriate staff when documentation of EI enrollment is not found for child diagnosed with hearing loss; (referral will be made first to EIIS staff to check if lack of documentation reflects reporting error, then to EI program staff if lack of documentation is accurate indication that child is not receiving services);

III.3. By 5/14/01 establish procedure to ascertain and record cause of non-enrollment or delayed enrollment of child diagnosed with hearing loss.

Objectives related to Goal IV are:

IV.1. By 8/1/01 issue and disseminate first regular monthly CHDS report;

IV.2. By 2/14/01 institute process for review of monthly report by Advisory Committee;

IV.3. By 9/30/01 issue and disseminate first annual CHDS report;

IV.4. By 8/31 /O1 hold annual meeting of Advisory Committee and interested staff of hospitals, diagnostic centers, and EI programs, as well as providers and parents, to review annual findings.

Objectives related to Goal V are:

V.1. By 10/1/00 develop and review. preliminary plan for proposed research in meetings with CHDS team and Surveillance and research Subcommittee of Advisory Committee;

V.2. By 8/31/01 and into year 2 draft report on process and results of first year implementation and barriers to screening, diagnosis and care;

V.3. By 8/31/01 and into year 2 outline paper on nature and extent of hearing loss in the state.

With the achievement of these objectives the CHDS will have all the necessary systems in place to permit identification and tracking of all newborns and most other infants and toddlers with hearing loss in Massachusetts. These systems will be designed and implemented during Year 1 of the project, with the expectation of full implementation as of January 1, 2002, and thus, complete ascertainment and tracking of hearing loss in newborns within the 2002 birth cohort. As spelled out in Section 3, below, efforts will be made in Years 2-5 of this project to incorporate data on older children who develop hearing loss.

It should also be noted that the system, as initially designed and implemented, is not envisioned as permanent. In later years of the project, staff of the CHDS will work with staff of other DPH programs which serve children with special needs to lay the foundation for an integrated special needs surveillance system. The new system, which has been under discussion for some time, will incorporate and build on CHDS and other existing data systems. Once implemented, it will enhance Massachusetts' capacity to ensure comprehensive, coordinated services to children with a broad range of disabilities and special needs, including hearing loss. During the transition period to implementation of this unified system (which is expected to be several years) the project will rely on the system described above to meet tracking, surveillance and research needs associated with Universal Newborn Hearing Screening.

(a). Program and Methodology

The Massachusetts Childhood Hearing Data System will serve all newborns in the state of Massachusetts (approximately 82.,000 per year) and their families. Starting in Year 1 of the project, and then with each subsequent birth cohort, the System will track the 3-5/100 newborns

expected to screen positive for hearing loss, including approximately 4/1000 newborns expected to be diagnosed with hearing loss following a positive screen. In any given year, the CHDS will also track some 640 children between the ages of 1 and 3. who were diagnosed with hearing loss in either of the prior two years. Following Year 1, efforts will be made to incorporate children

who experience late onset or progressive hearing loss into the CHDS.

The project will achieve these goals by creating a new Childhood Hearing Data System (CHDS) which incorporates elements of existing systems along with new components to track children through the diagnostic process. Data to be collected, and sources for these data, are:

• Demographic information on child and family (birth certificate)
• Results of screen (birth certificate)
• Cause(s) of missed screen (hospital report to CHDS staff);
• Successful referral to diagnostic center (diagnostic center form 1)
• Result of diagnostic evaluation, including confirmation of hearing loss when found, and further detail on nature and extent of loss (diagnostic center form 2);
• Referral to EI (diagnostic center form 2);
• Parent consent to be contacted by EI program and/or Massachusetts Commission for the Deaf and Hard of Hearing (diagnostic center form 2);
• Cause(s) of delay in diagnostic evaluation (diagnostic center, pediatrician, family report to UNHSP staff);
• Initial contact with EI (EIIS);
• Enrollment in EI and creation of IFSP (EIIS);
• Parental consent for ongoing tracking after discharge from EI (EI fax form);
• Site and extent of services received in EI (EIIS);
• Cost of and payer for services received in EI (EIIS);
• Results of developmental assessments (EIIS);
• Developmental outcome upon discharge from EI (EIIS);
• Site of ongoing services (if any) immediately post EI (EIIS).

CHDS data will be presented in standardized reports to be designed by staff in response to stakeholder interests and concerns. Our preliminary expectation is that reports will address:

• Number, geographic distribution, race/ethnicity, and primary family language of children born, screened, diagnosed, referred and enrolled;
• Completeness, accuracy and timeliness of reporting;
• A typology of hearing loss within birth cohort;
• Barriers at each step in the process reported by institutions, parents and providers;
• Frequency with which parents select different language acquisition options for their children;
• Outcomes experienced by the population as a whole at age 3; and
• The nature and extent of services in which children are enrolled after EI "graduation".

Additional analyses may include: studies on geographic patterns and other correlates of hearing loss; studies of hospital screening performance (both completeness and accuracy, which can be inferred from referral of children later found not to have hearing loss); and studies of developmental outcomes in relation to a variety of independent variables, including the nature, extent and duration of developmental services.

The initial focus of the project will be on identification and tracking of children aged 0-3 with hearing loss. The system as a whole will be designed to incorporate data on infants with inborn hearing loss, as described previously; infants and toddlers who acquire hearing loss after the newborn period will be identified through diagnostic centers, which will be instructed to report on all children identified with hearing loss before age 3, and/or EI programs, which will enter children with later onset loss into the EIIS. This is not a closed system, however. If parents seek diagnosis and care from sites other than DPH-approved diagnostic centers and then choose not to enroll their children into EI, their children will not be captured by the system described here. Efforts will be made by UNHSP staff to educate pediatricians to promote use of approved diagnostic centers and enrollment in EI, but both are matters of parental choice.

No system presently exists that has the capacity to capture older children diagnosed with hearing loss. This limitation in the system will be addressed after Year 1, through collaboration with DPH child care and school health staff as well as pediatricians and audiologists.

Initial products of the project will include: a first year data report, as outlined above; a report describing the process and tools employed for identification and tracking, and an analysis of barriers to identification and care. Out year products will include regular annual reports, and analytical and research articles related to the extent, distribution, and correlates of hearing loss, and the developmental outcomes associated with different intervention methods. UNBHSP and CHDS staff will work with members of the Advisory Committee to define and implement a research agenda from the .start of the project, in order to ensure that necessary data are collected.

(b). Year 1 Timeline

[Initials used to identify responsible staff are: OSE Disability Unit Director-OSEUD; Childhood Hearing Data System Epidemiologist-Epi; Childhood Hearing Data System Research Analyst-RA; Universal Newborn Hearing Screening Program Director-UNHSPD; Universal Newborn Hearing Screening Program Staff-UNHSS; Vital Statistics Staff-VSS; Early Intervention staff liaison to UNHSP-EIL; Early Intervention Data Staff-EIDS]

4. Evaluation

The timeline included in Section 3 will serve as the basis for process evaluation of this project. Responsibility for monitoring completion of timeline activities will lie with the Director of the Office of Statistics and Evaluation Disability Unit, in collaboration with the Director of the Universal Newborn Hearing Screening Program. Given the central importance of establishment of the CHDS to the overall success of universal hearing screening in Massachusetts, these managers will have joint discretion to shift priorities or temporarily move program staff to assist in data-related activities to promote completion of these tasks.

The UNHSP Advisory Committee Research and Surveillance Subcommittee will play a key role in formative evaluation of the CHDS. Members will be recruited to ensure representation of organizations involved at every stage of data collection: birth hospitals, diagnostic centers, and EI programs. Parent representatives will be recruited to ensure that concerns about confidentiality are addressed and that system effectiveness is reviewed from a parent perspective.

As indicated in Section 2, this project is. intended to increase capacity of DPH staff and other stakeholders to achieve Universal Newborn Hearing Screening Program goals. The ultimate test of system implementation and performance will be the capacity of the DPH staff to identify and track, and of the UNHSP to identify and serve, children with hearing loss. We will aim for full documentation on 75% of newborns in the state at the end of calendar year 2001 and of 95% of newborns by the end of calendar year 2002. Evaluation will shift focus in later years of program implementation to the goal of a unified special needs data system, as discussed above.

DPH staff met with audiology staff of diagnostic centers in the, mid-1990's to discuss the possibility of universal newborn hearing. screening in Massachusetts. Based on this discussion, the centers formed the Massachusetts Task Force on Early Identification of Hearing Loss, which took a lead role in passage of Massachusetts' screening law.. The Task Force is now a subcommittee of the UNHS Advisory Committee; focused on the role of diagnostic centers in UNHS.

Over the past year, the UNHSP has established strong ties to hospitals and the state Early Intervention network, as well as diagnostic centers, through the UNHSP Advisory Committee. These relationships will provide the basis for collaboration around establishment of the CHDS. The UNHSP Advisory Committee has provided a critical forum for collaborative planning and problem solving around implementation of screening; formation of a Research and Surveillance subcommittee will provide an opportunity to involve key players in planning and problem solving around the CHDS. Appendix E provides a complete list of current Committee members; additional members will be recruited as needed for this new data-focused subcommittee.

Advisory Committee relationships have created opportunities for DPH to reach important stakeholder groups about hearing screening. The Massachusetts Hospital Association convened a meeting to which all birth hospitals were invited, at, which UNHSP staff introduced the new screening-related hospital regulations. The UNHSP Director gave an invited presentation on screening at the Massachusetts Speech and Hearing Association annual convention on universal newborn hearing screening. And a training session on diagnosis of hearing loss was included in the annual meeting held by EI providers.

As noted in previous sections, the UNHSP has strong ties within DPH to staff of EI, the Vital Statistics Registry, and other key programs. Based on involvement of EI staff in UNHSP implementation, EI developed and implemented a mandatory training program for EI vendor agencies on universal newborn hearing screening. The impact of strong ties to Vital Records and the First Link Program, in terms of access to and screening of EBC data, have been discussed previously. Preliminary discussion has taken place and discussion will continue with the Massachusetts Center for Birth Defects Research and Prevention to explore future collaboration. Tracking and surveillance systems for both of these programs, as for CHDS, are housed in OSE.

The University of Massachusetts, which operates the New England Regional Newborn Screening Program (NERNSP), is funded through an interagency agreement overseen by the Commissioner of Public Health, senior officials of the University's Medical School, and other senior medical staff. UNHSP collaboration with the NERNSP has included two joint informational seminars conducted over the past year. The two programs will continue to explore potential benefits of and strategies for collaboration.

A regional meeting of the New England state health departments, conducted in November 1999, laid the groundwork for information-sharing and further potential collaboration around early childhood screening, including metabolic, hearing and developmental screening programs. Massachusetts UNHSP has establish links with other states through participation in the Marion Downs National Center for Infant Hearing project. Staff from UNHS and EI have shared information with other states through annual conferences, internet updates, and conference calls. Recently, the National Center for Infant Hearing requested permission to post the Massachusetts hospital guidelines on their web site as a model which could be used by other states.

The principal investigator for the Childhood Hearing Data System will be. the Director of the Disability Unit of the Office of Statistics and Evaluation (OSE) in the Massachusetts Department of Public Health, Bureau .of Family and Community Health. This unit provides dedicated technical and statistical support to programs of the Bureau's Division for Special Health Needs. The Division is home to the state's Title V Children with Special Health Care Needs Program, and the Massachusetts Universal Newborn Hearing Screening Program and is lead agency for Early Intervention in the state. Key participants in planning and implementation of the CHDS, along with the OSE Unit Director, will be the Director of the UNHSP, and the Director of the Division for Special Health Needs. Appendix A includes resumes for each.

As indicated in her resume, the OSE Unit Director, Dr. Nancy Wilber, manages a range of systems development and research projects. She has had the lead role in development of a stateof-the-art management information system for the state Early Intervention Program and is currently providing leadership for planning of the integrated special needs data system discussed above. She also oversees DPH research related concerning the epidemiology of secondary conditions among adults with disabilities.

The UNHSP Director has played the central role in design and implementation of what is widely recognized as a model program for state universal screening; her work in this area was recognized last year with a "Pride in Performance" award, the highest honor given to Massachusetts state employees. Ms. Farrell has been called upon by other states and national advocacy groups to provide technical assistance on program design and implementation.

The Director of the Division for Special Health Needs is an experienced program planner and manager with responsibility for a broad range of programs serving children and adults with special needs. Dr. Allen's training includes a doctorate in public health and she is directly involved in program evaluation arid research on health and disability.

These three individuals will comprise the management team for the CHDS. Additional staff who will play key roles include the Early Intervention liaison, who currently serves as EI staff representative on the UNHSP Advisory Committee and will assure effective linkage between the CHDS and EI program and data staff. She has extensive experience as an EI provider and current responsibility for statewide oversight of specialized services in EI, including services for children who are deaf and hard of hearing. The manager of the EI Information System (EIIS) will also participate in the CHDS project team, ensuring that linkages between the two systems are carefully planned and implemented. State Vital Statistics staff will be represented on the project team by the Director of the Natality Unit within the Vital Records system. The two remaining team members team will be the epidemiologist and the research assistant hired to create and maintain the CHDS.

The Massachusetts Department of Public Health has both the organizational capacity and the facilities required to implement this project. The Bureau of Family and Community Health is home to the state's Title V Maternal and Child Health and Prevention Block Grants, as well as its Early Intervention and WIC programs. An internal Administration and Finance unit provides. grant management assistance to all Bureau programs.

CHDS will be housed within the Bureau's Office of Statistics and Evaluation. The mission of OSE is to provide accurate, relevant, and timely data to the state, the Department of Public Health, other organizations and agencies and the public, to inform decisions about policies and programs designed to improve the health status of Massachusetts residents. In addition, OSE provides technical assistance to the Bureau of Family and Community Health to support the implementation and ongoing assessment of its programs.

OSE has comprehensive information technology. (IT) and technical support services. The IT infrastructure is a Novell NetWare client/server network connected through an Ethernet wiring system. The network fileserver supports print, file, email and Internet services to all client PCs on the network. File servers are fully backed up daily using the Grandfather-Father-Son tape backup schedule. Monthly tapes are stored off-site at the end of each month.

In addition, there is an IBM 3090 Mainframe computer and, in tandem, a large-scale Hitachi computer both running the MVS operating system. Application subsystems include TSO/ISPF and CICS. Mainframe computing facilities are maintained by ITD in Chelsea, MA.

Every OSE staff member, and all staff who will comprise the CHDS team, have desktop Pentium class PCs running Windows 95, 98 or NT. Each PC supports MS Office97, Lotus cc:Mail, Eudora, Microsoft Outlook, SAS, Mainframe terminal emulation, Internet access with Netscape Navigator or MS internet Explorer, and Map Info.

Support for applications and systems repair at MDPH is provided from 9-5 Mon-Fri by three senior in-house systems administrators. In addition to day-to-day operations, technical staff also manage product life cycles of both hardware and software systems.

CHDS staff will be sited in the Department's central office in downtown Boston, providing immediate access to UNHSP and EI staff, and close access to state Vital Statistics staff. 8.

Most of the activities projected as part of the CHDS fall within the Department's responsibility for public health surveillance and will not, therefore, require human subjects review. We do intend to have Diagnostic Centers seek parent consent to permit EI programs and/or the Massachusetts Commission for the Deaf and Hard of Hearing to engage in proactive outreach when a child is diagnosed with hearing loss. Since this is purely a matter of consent for service, however, it will not require human subjects approval either.

Approval will be required, however, for long-term tracking proposed as part of this system. When children are identified with hearing loss at diagnostic centers or EI programs (if they experience hearing loss after rather than at birth) we will ask parents if they are willing to provide information to permit long-term tracking, as the basis for ongoing research studies on outcomes of different intervention approaches. We do intend to seek human subjects approval for acquisition of this information and for the proposed research efforts.