TITLE 25. HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 37. MATERNAL AND INFANT HEALTH SERVICES

On behalf of the State Medicaid Director, the Texas Department of Health (department) adopts new §§37.501 - 37.512 concerning implementation of a statewide newborn hearing screening, tracking, and intervention program. Sections 37.502 - 37.512 are adopted with changes to the proposed text as published in the December 3, 1999, issue of the Texas Register (24 TexReg 10715) as a result of comments received during the comment period. Section 37.501 is adopted without change, and therefore will not be republished.

The sections implement Health and Safety Code, Chapter 47, which requires the Texas Board of Health (board) to adopt minimum standards for implementation of newborn hearing screening programs in birthing facilities. Specifically, the sections cover the purpose of the rules; definitions; newborn hearing screening, tracking, and intervention programs; program performance standards and goals; program certification; information concerning screening results and follow-up care; technical assistance by the department; the information management, reporting, and tracking system; Texas Department of Health responsibilities; confidentiality and general access to data; and authorized Medicaid newborn hearing services.

The department used the same methodology to develop these sections that was used to create benchmarks for the department's Fiscal Year 2001-2005 Strategic Plan. The sections concerning minimum standards in the newborn hearing screening, tracking, and intervention program were developed in accordance with the federal government's "Healthy People 2010" goals, the endorsement by the American Academy of Pediatrics of universal newborn hearing screening, and the national principles and guidelines of the Joint Committee on Infant Hearing, and in response to state legislation.

The purpose of the sections is to ensure that Texas newborns receive early identification of hearing loss and needed intervention services. Because infants whose hearing loss is identified after six months of age function at around 60% of their mental potential due to reduced brain stimulation, this adverse impact on newborns can be reduced or eliminated if hearing loss is identified at birth and if intervention services are provided prior to six months of age. Health and Safety Code, Chapter 47 requires the department to ensure the transition of newborns with hearing loss into intervention services. The sections implement a program designed to meet the needs of the citizens of Texas while following national standards.

The sections as proposed for final adoption include changes made in response to numerous comments, with the objective of increasing flexibility during implementation of the program in a manner consistent with the intent of the legislation. Particular concerns and suggestions by stakeholders regarding such issues as software data elements, program protocols, training for birthing facility staff, program certification, and consent for the disclosure of individually identifying information were raised through the public comment process, and are addressed in this preamble.

Several comments address the requirements for reporting data outlined in the rules, the perception that collection and reporting of data will impose an undue burden on hospitals, and whether birthing facilities will be required to use only software provided by the department. Although Health and Safety Code, Chapter 47 does require the department to provide software to birthing facilities for the purposes of information management, reporting, and tracking, the law does not require birthing facilities to accept and use that software. Whatever software individual birthing facilities use, Health and Safety Code, §47.007(a) requires that the information management system "...must be capable of providing the department with information and data necessary to plan, monitor, and evaluate the program, including the program's screening, follow- up, diagnostic, and intervention components." The department anticipates that birthing facilities that elect to use the software provided by the department should not incur significantly increased staffing costs. The software contractor to be selected by the department will be required to make the management, reporting, and tracking of data as easy as possible for birthing facilities.

Issues related to program protocols included questions about whether the department has the authority to approve protocols, and allegations that the rules concerning protocols lack specificity. Health and Safety Code, §47.003(b) states that "the department or the department's designee shall approve program protocols". However, the department expects and encourages adoption of protocols which may utilize different procedures for addressing similar situations in birthing facilities across the state. The sections outline categories of protocols for which procedures must be developed, thereby allowing each birthing facility to determine which approaches best address its needs.

Concerns were raised regarding the fact that the department or its designee will provide training to birthing facility staff, questioned whether the department had statutory authority to do training, and shared concerns that the department is duplicating training offered by others. The department has a statutory requirement to establish certification criteria for implementing a program. The department was given funding by the legislature to purchase software licenses, technical support, training on the software provided by the department, and training for program implementation. Most of the 300 birthing facilities in Texas do not currently have programs in place to screen all of their newborns for hearing loss. The implementation training will ensure that all programs are given equal assistance in setting up viable programs. Staff of a particular birthing facility who successfully complete the department's training may train other staff at the facility. Training on newborn hearing screening equipment will be provided by the equipment manufacturers whose products are chosen by each of the birthing facilities.

Several commenters addressed the department's rationale for certification of programs and certification criteria. Health and Safety Code, §47.004(a), states that "...the department or the department's designee shall establish certification criteria for implementing a program". In order to determine whether a birthing facility is meeting certification criteria, the department must evaluate the data reported by each birthing facility, and to ensure that all facilities are monitored fairly, the department must obtain the same categories of information from each facility. Experience gained from the department's "Sounds of Texas" newborn hearing screening demonstration project indicates that data collected and transmitted electronically is much more accurate than data that is manually reported and entered into a database.

Commenters also addressed confidentiality of newborn hearing screening data. Health and Safety Code, §47.003(a), states that parents of a newborn must be offered a hearing screening, "...and the parents shall be informed that information may be provided to the department upon their written consent." Health and Safety Code, Chapter 47, specifically addresses consent and confidentiality in order to protect parents' rights. Birthing facilities should be able to amend their standard consent forms to address consent for disclosure of newborn hearing screening information which individually identifies a newborn.

Mike Montgomery, Acting Chief, Bureau of Children's Health, has determined that for the first five-year period the sections are in effect, there will be fiscal implications as a result of enforcing or administering the sections as adopted. The effect on state government of offering grants to certain birthing facilities for the purchase of newborn hearing screening equipment as authorized by §37.502(2)(C)(ii), as amended, will be increased expenditures of up to $389,922 (federal maternal and child health block grant funds) in FY 2000 and approximately $109,978 in FY 2001-2002.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning §37.502(2)(C)(ii), the word "paragraphs" has been substituted for the word "subsections".

Change: Concerning §37.504(1), the program certification criterion has been clarified by emphasizing that programs must assure the department that procedures concerning data confidentiality and access comply with state and federal requirements.

Change: Concerning §37.504(5), minor wording changes have been made for clarity and uniformity of syntax.

Change: Concerning §37.506(b)(1), the meaning of "fraudulent" submission of screening data by a program as one of the criteria for decertification has been clarified.

Change: Concerning §37.509(b), the department's intent that birthing facilities may accept but are not required to use software offered by the department has been clarified.

Change: Concerning §37.511(f), a typographical error, "§49.009", has been changed to §47.009.

The following comments were received concerning the rules. After each comment is the department's response and any resulting change(s).

Comment: Concerning the fiscal note paragraph in the Proposed Preamble, several commenters requested information clarifying the estimated increase in costs for local governments of approximately $8 per newborn screened.

Response: The department estimated that birthing facilities would incur higher costs for staffing and supplies averaging approximately $8 per newborn screened, based on information collected during the department's demonstration project. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that compliance with the rules should present no problems.

Response: The department revised the sections in response to comments to facilitate successful implementation of a universal newborn hearing screening program in Texas. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that the department should adopt no changes in the rules which would effectively reduce the quality of care or remove any of the checks and balances designed to ensure a quality program. The commenter also encouraged the department to require the reporting of all data elements it believes are necessary to establish a high quality database.

Response: The department agrees because the success of the newborn hearing screening program will depend primarily upon the quality of the services delivered to infants and their families. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that his agency's program has been successful because its design reflects that of the Texas demonstration model program. The commenter added that the following three elements are vital for a successful program: careful monitoring of the screening passes and referrals using a sophisticated computer- managed patient data tracking system; electronic linkage from the screening technologies to the patient data tracking system; and an automated screening algorithm that is certain to identify hearing loss.

Response: The department agrees and has included these elements among the specifications for the software the department will distribute to participating birthing facilities.

Comment: Concerning the subchapter as a whole, one commenter strongly supports the proposed rules as having been admirably crafted and based on hard data obtained from the pilot project, which the commentor characterized as the most comprehensive program in the nation. The commenter urged the department to implement the proposed rules without delay.

Response: The department acknowledges the commenter's support. No changes were made as a result of this comment.

Comment: Regarding the subchapter as a whole, one commenter encouraged efforts to identify children with auditory problems early because hearing loss or deafness can cause developmental delay. The commenter added that accurate identification of children who need developmental and communication supports would increase children's capacities to learn and develop language.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter supported universal newborn hearing screening by hospitals as a means to help close the gap between identification, services, and intervention.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter supported the rules because they should yield individual health dividends for children with hearing loss by ensuring diminished disability and improved quality of life. The commenter added that the potential community health impact of earlier and more equitable deployment of intervention resources justifies the additional costs of the program.

Response: The department agrees that early detection will result in future cost savings for communities and improved quality of life for individual children. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated on behalf of a hospital that since quality newborn hearing screening is being done on almost all births, and no additional staff have been needed, compliance with the rules should be achievable in a timely manner.

Response: The department agrees that most birthing facilities should be able to achieve the program performance standards set out in §37.505. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter strongly supported the rules, stating that they represent quality measures which are both realistically attainable and in the best healthcare interests of patients.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, several commenters asked the department to consider all software on the market rather than only the software used for the department's demonstration project.

Response: The department extended its offer to purchase software licenses to all qualified vendors. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that medical professionals must be better educated regarding the law, the rules, and the intervention that is available for newborns who are hearing impaired and urged that the rules be implemented without delay.

Response: The department agrees and will work with professional associations and organizations to increase physicians' awareness of the law, the rules, and the consequences of undetected hearing impairment in infants. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that the proposed rules are consistent with the Joint Committee on Infant Hearing's national principles with regard to access to screening, development of screening protocols, establishment of benchmarks for hospitals, confirmation of hearing loss, protection of infant and family rights, and the establishment of a strong information infrastructure.

Response: The department agrees. Health and Safety Code, Chapter 47, was based on national standards for newborn hearing screening, and the proposed rules were drafted to implement the statute. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter strongly supported both Health and Safety Code, Chapter 47, and the proposed rules as a way to improve the quality of life for thousands of babies and families in Texas. The commenter urged that the rules be adopted as quickly as possible.

Response: The department agrees and appreciates the commenter's support. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that the proposed rules are consistent with rules established in other states, as well as "a national agenda that advocates early identification and treatment of hearing impairment."

Response: The department agrees. The department drafted the proposed rules with full knowledge of national guidelines as well as legislation and rules adopted in other states. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter who is the parent of a two month old infant whose hearing loss was discovered in the newborn nursery expressed the extreme importance of the newborn hearing screening program and added that birthing facilities' concerns about increased costs in time and resources to implement the program should be afforded less weight when compared to the importance of early detection of hearing loss.

Response: The department acknowledges the commenter's support for the rules. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, several commenters jointly urged the department to certify "workable programs", and not to adopt restrictive procedures.

Response: The department agrees, and has set certification requirements for birthing facilities that reflects the national standards of the American Academy of Pediatrics and the Joint Committee on Infant Hearing. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, several commenters stated that by choosing software used in the "Sounds of Texas" demonstration project for distribution to birthing facilities under Health and Safety Code, Chapter 47, the department appears to have ignored other software on the market.

Response: The department disagrees. The department used the knowledge gained during the three-year "Sounds of Texas" demonstration project, but has not currently purchased licenses for software for distribution to any birthing facilities. The department's request for offers sought bids for the software licenses, technical support, and implementation training from all qualified vendors. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that the department should not use the name of the "Sounds of Texas" for the statewide program, since it was used during the demonstration.

Response: The department has chosen "Sounds of Texas" as the name for the statewide newborn hearing screening program mandated by Health and Safety Code, Chapter 47 because many people are already familiar with the name. The department believes that continuing to use the name of the demonstration project will have no adverse impact on the program. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter questioned the cost of distributing the software from the demonstration project to participating birthing facilities, compared to the cost of acquiring other available software, and asked whether alternative software will be allowed and paid for by the department.

Response: The department will provide to birthing facilities only the software acquired through its request for offers at no charge. Since the department has not yet selected a vendor, no cost comparisons can be made. The department's request for offers includes technical support for the software selected for distribution during implementation of the program. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter asked whether a genetics committee in the state could assist the department with integrating newborn hearing screening information into other databases concerning newborns.

Response: Although the department appreciates the offer of assistance, the newborn hearing screening program was based on knowledge gained during a three-year demonstration project as well as the published standards of national organizations, and implementation assistance will be provided by a vendor selected through a competitive procurement process. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter asked whether the department has compared the costs of upgrading the current metabolic and genetic screening computer system with the cost of creating the newborn hearing screening database proposed in the rules.

Response: The department considered many options, and elected to purchase nonexclusive licenses for currently existing software in order to comply with mandated statutory time frames for implementing an operational program statewide. Either a request for software development or modification of the current newborn screening database would have required more time and greater expenditures than the Legislature provided. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter asked why the department was not taking advantage of the "infrastructure already existing for newborn screening case management and follow-up".

Response: The department disagrees that an opportunity for coordinated use of the newborn screening case management infrastructure was disregarded. The existing infrastructure for newborn screening case management serves providers of blood testing and genetics services and does not overlap in any way with the required capabilities of the newborn hearing screening infrastructure. Additionally, provision of case management services by the department to newborn hearing screening clients according to the newborn screening model would require up to 45 new staff members. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter questioned the department's statement that implementation of the rules would have no impact on local employment, since follow-up would require increased staff time.

Response: The department believes that its statement concerning a lack of impact on local employment is accurate. The software to be distributed by the department must be able to collect data and maintain records with minimal data input by birthing facility staff, and ensuring follow- up will be the department's responsibility. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter asked how home births will be handled.

Response: Health and Safety Code, §47.003 requires "birthing facilities", as defined at §47.001(2), to offer hearing screening to the parents of a newborn. A home birth, no matter who acts as the birth attendant, does not take place in a birthing facility and so is not affected by Health and Safety Code, Chapter 47, or the department rules. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, two commenters strongly supported the program implementation process described in the rules and the documentation required because they stated that they understand the need for surveillance, screening, and follow-up. The commenters added that if their own daughter had been screened at birth, the gap in services for her hearing loss and habilitation would have been shortened.

Response: The department acknowledges the commenters' support and concerns. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, several commenters asked whether the department will provide assistance during program implementation to address frequent turnover in nursing staff and noise in various test environments.

Response: The department will require its contractor to provide training during program implementation that is easily accessible by new staff at birthing facilities. The department will also share strategies in implementation training which were developed during the demonstration project to address noise in the environment. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated on behalf of a large birthing center with 70-90 births per day that the facility's program already meets or exceeds the department's certification guidelines and strongly supports universal newborn hearing screening.

Response: The department congratulates the facility for provision of consistently high- quality services to parents and their infants. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter expressed concern about the qualifications of the vendor for the software and support service which the department will select.

Response: The department agrees that the support provided to birthing facilities by its contractor will be critical to the success of the program. The department included staffing requirements in the procurement specifications to ensure that the contractor is capable of providing training and support according to the rules. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter asked the department to consider requiring newborn hearing screening with two technologies for all newborns who fail the first screen.

Response: The department disagrees. Data from the department's demonstration project indicates that use of two different types of technology for newborns who fail the first screen does not appear to be significantly more effective than performing the second screen with the same technology. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter questioned the ability of some birthing facilities to provide a newborn hearing screen during the birth admission if parents stay only a short time or the birth occurs on the weekend. The commenter also stated that the request of some parents for the screening test could result in a longer stay in the birthing facility, thereby increasing everyone's cost. The commenter suggested that the department's time frames should be more flexible.

Response: State law requires each birthing facility to offer a hearing screen to the parents of a newborn during the birth admission. Data on over 80,000 newborns screened during the department's demonstration project indicate that performance of screens did not affect the length of stay in the facility. The department will share this and other information gained during the demonstration project during implementation training to assist facilities. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter asked whether the department was aware that upgraded newborn hearing screening software is available for less than half the cost of creating a new database.

Response: The department is aware of several software packages available for a variety of uses. However, the department has chosen to utilize a competitive procurement process to acquire licenses for software which will facilitate compliance with statutory requirements for the statewide newborn hearing screening program and also provide the best value for the state. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter recommended that the department acquire licenses for particular software in order to save money, and that the resulting savings be directed toward equipment for treatment and follow-up.

Response: The department disagrees. The Legislature appropriated funding to the department for newborn hearing screening software licenses, technical support, training, implementation, follow-up monitoring, and diagnostic services, as required by Health and Safety Code, Chapter 47. Although the department did not receive additional funding for purchase of newborn hearing screening equipment, the department has decided to allocate funds for grants to exempt facilities that could not otherwise afford to purchase screening equipment. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that stakeholders should focus on the fact that one or two babies are born every day somewhere in Texas with a hearing loss that is undetected. The commenter added that she is personally familiar with the heartbreak caused by a missed opportunity to develop language, because of her work in deaf education and the fact that her own hearing loss was not detected until she was 18 years old. The commenter stated that without a language base, children cannot learn easily, but that early intervention will make a difference. She concluded that the rules can always be amended and improved, but that the newborn hearing screening program should be implemented without further delay.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that the department requested contact names at each birthing facility in September 1999, but has provided no information concerning program implementation, although the commenter did find information on the department's website.

Response: The department has not written to the contact persons at each birthing facility because little substantive information concerning program implementation will be available until the rules become effective and a contractor has been selected to provide software and training. The department began posting information on its website regarding details of implementation to allow program staff to devote more time to developing the rules and procurement specifications. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated on behalf of a birthing facility that testing supplies may cost $70,000 a year, excluding equipment and labor, and suggested methods by which birthing facilities may obtain reimbursement for those expenses.

Response: The department agrees that the cost of screening supplies may be significant for some birthing facilities. Data from the department's newborn hearing screening demonstration project indicate that supply costs alone vary from $1 to $12 per baby, depending upon the type of newborn hearing screening equipment selected by the birthing facility. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that staff of birthing facilities should seek to ensure that babies are connected to follow-up care, because many parents want to leave before further testing is done. The commenter noted that although designation of staff to facilitate follow-up on each infant would be beneficial, such a policy would also be expensive. The commenter expressed a desire to do the right thing for the babies and asked when implementation of the project would begin.

Response: The department agrees. The department will begin implementation as soon as the final rules become effective and a contract has been fully executed with a vendor for software licenses and training support services. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated on behalf of both a national organization and a state association of hearing health care professionals that the Texas law is superior to those in other states, and that Texas has unique funding sources not available in other states. The commenter stated that the Texas statute will save money through early identification and a focus on the babies. The commenter also praised the department's demonstration project, stating that, in large part, the statute resulted from information obtained from the project.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter expressed concern about the role of the department's designee in setting up protocols, certification of newborn hearing screening programs in birthing facilities, collecting and analyzing data, tracking patients, and training personnel because the department's designee may be encumbered by financial or scientific interests that influence how these functions are performed.

Response: The department disagrees. The department is responsible for approving final protocols and certification criteria. A determination by the department regarding which data will be collected, how it will be analyzed, how patients will be tracked to ensure they receive follow- up services, and how training of birthing facility personnel will be conducted will be finalized through a contract with a vendor for these services. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, a commenter stated that the department should seek additional funding and obtain approval from an appropriate institutional review board (IRB) if the data is being required for research, but should not pass the expense of data collection on to birthing facilities.

Response: The department agrees that requiring birthing facilities to incur the expense of collecting data purely for research desired by the department would be inappropriate. However, Health and Safety Code, §47.007(a) mandates collection of data necessary to plan, monitor, and evaluate the newborn hearing screening program, including the program's screening, follow- up, diagnostic, and intervention components. The department's procurement specifications require the selected vendor to provide software that can perform these functions. Software already licensed or created by birthing facilities must be capable of providing the same data elements to the department. Collection of data directly mandated by state law for purposes within the scope of the department's public health responsibilities does not constitute research for which IRB approval is required under federal regulations. Finally, birthing facilities may send individually identified information to the department only with the written consent of the infant's parent. No changes were made as a result of these comments.

Comment: Concerning the subchapter as a whole, one commenter stated that some hearing professionals believe otoacoustic emissions (OAE) screening will become the standard for the State of Texas, and cited literature which supports the use of auditory brainstem response (ABR) technology.

Response: The department disagrees. Both OAE and ABR technology are used to screen newborns. The department evaluated and compared both technologies in the demonstration project, and found that either type of technology can be used effectively for screening newborns. Although the department found that use of one technology requires substantially greater expenditures for supplies than the other, the department has not established either type of technology as the standard or required that birthing facilities must choose a specific type of screening equipment. The department requires only that whatever equipment a birthing facility purchases must meet the criteria in the rules as finally adopted. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) is very interested in monitoring of facilities that occurs more frequently than once every three years. The commenter added that JCAHO is also very concerned about the competency of individuals who perform specific tasks and has incorporated individual competency measures into its accreditation standards. The commenter stated that JCAHO's concerns and its approach support the department's decision to require reporting of individual screener information.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, a commenter stated that the role of the hospital in follow-up care is to facilitate linkages to the care that is coordinated by the physician.

Response: The department agrees that birthing facilities are required by Health and Safety Code, §47.004(b)(5) to provide information to parents, as recommended by the department, on follow-up services. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, the commenter stated that the United States Food and Drug Administration (FDA) approves or clears a medical device for sale or marketing, but does not render any formal opinion as to the effectiveness or accuracy of a device.

Response: The department agrees that FDA clearance of a Class II medical device as "substantially equivalent" to a predicate device; i.e., a device previously classified or cleared by FDA or one being marketed prior to May 28, 1976, indicates only that the device is as safe and effective as and that it does not raise different questions of safety and effectiveness than does the predicate device. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that security, confidentiality, and consent for release of newborn hearing screening data are concerns of not only hospitals, but also of the Health Care Financing Administration and the Social Security Administration. The commenter added that Health and Safety Code, Chapter 47 addresses each of these issues.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter commended the Texas Medical Association for its approach to the issue of follow-up care and urged the department to move forward so that babies being born daily will have their hearing loss identified.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that since the rules apparently include substantive changes, perhaps they should be reproposed.

Response: The department disagrees. The department has incorporated public comments into the sections which affect no different subjects of regulation and no new parties. Therefore, republication of the proposed rules is not legally required. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter stated that some birthing facilities and members of the public appear to be confused about the kinds of data required for the Texas newborn hearing screening program. The commenter, a member of the Centers for Disease Control's Newborn Hearing Screening National Data Committee, identified care of infants, compliance and quality monitoring of services provided, and epidemiology and federal reporting as objectives of the Texas program and urged the department to collect from birthing facilities all data that is necessary to comply with statutory requirements.

Response: The department agrees. The department intends to collect that data needed for compliance with statutory requirements. No changes were made as a result of this comment.

Comment: Concerning the subchapter as a whole, one commenter characterized several decisions and actions by department staff as "arbitrary" and "capricious" and stated that the company represented should not be prevented from competing for business in Texas because department staff does not "like" the company.

Response: The department disagrees that any decisions by staff concerning procurement specifications or procedures for purchasing software, training, and other support services have been arbitrary, capricious, or based on personal enmity toward any potential vendors. The proposed rules were based on national standards and data from the department's demonstration project, which in fact helped establish some national benchmarks. The department has no interest in which hearing screening equipment a birthing facility selects as long as the equipment is capable of performing in compliance with guidelines developed to protect Texas newborns. No change was made as a result of this comment.

Comment: Concerning the subchapter as a whole, several commenters asked what data would be collected and how it would be used by the department.

Response: Health and Safety Code, §47.005(b) states that "... a birthing facility that operates a program shall report screening results to the parents, the newborn's attending physician or health care provider, and the department." Health and Safety Code, §47.007(a) states that the information management, reporting, and tracking system utilized by the department is capable of providing to the department information and data necessary to plan, monitor and evaluate the program, including the program screening, follow-up, diagnostic, and intervention components. The specific data elements which birthing facilities must report to the department will be included in the software for which licenses will be purchased by the department through a competitive procurement process not yet completed. All functions needed for the department to meet its mandated responsibilities will be included in the software selected. The software will be offered at no charge to birthing facilities. Data entry by birthing facility staff should require only a few minutes, and several automatic functions such as statistical reporting and electronic transfer of information should ease the burden for birthing facilities. However, facilities that do not elect to use the software offered by the department must nevertheless report the required data in the required format. No changes were made as a result of this comment.

Comment: Concerning §37.502(2)(C), several commenters stated that the definition of "birthing facility" at Health and Safety Code, §47.001(2) precludes the department from expanding the definition as proposed in §37.502(2)(C).

Response: The department agrees, and has amended §37.502(2)(C) to permit but not require birthing facilities which are not otherwise included in §37.502(2)(A) or §37.502(2)(B) to provide hearing screening services for newborns. The department will offer hospitals and birthing centers not included in the statutory definition of "birthing facility" one-time grants for the purchase of newborn hearing screening equipment prior to August 31, 2002, if they choose to participate in the program. The department has also added §37.503(h), which requires a birthing facility that does not offer newborn hearing screening to refer parents of each newborn delivered in the facility to another birthing facility participating in the newborn hearing screening program.

Comment: Concerning §37.502(2)(C), one commenter expressed concern that if a hospital or birthing center that is exempt under the law refers parents of a newborn to a participating birthing facility, the facility which receives the referral would be required to provide the hearing screening.

Response: The department acknowledges that Health and Safety Code, Chapter 47 and this subchapter require only the birthing facility in which the infant was delivered to offer and provide hearing screening. However, the department hopes that existing patient referral networks will facilitate provision of hearing screening services to newborns by birthing facilities on an outpatient basis. No change was made as a result of this comment.

Comment: Concerning §37.502(5), one commenter stated that the department should require that screening equipment be capable of detecting hearing loss of 30 dB HL as defined by law.

Response: The department disagrees. Health and Safety Code, §47.001(4) defines "hearing loss" as loss of "30 dB HL or greater in the frequency region important for speech recognition". In order to meet revised national standards, the department has amended §37.502(5) and §37.504(4)(C) to require that screening equipment must be capable of detecting hearing loss that averages 30 - 40 dB HL or more in the frequency region important for speech recognition and comprehension.

Comment: Concerning §37.502(13), several commenters stated that obtaining consent for release of individually identifying hearing screening data for all newborns would require additional time, resulting in further costs to hospitals.

Response: The department agrees that compliance with this section by birthing facilities will require additional time and will therefore result in increased costs for some facilities. Although Health and Safety Code §§47.003(a) and 47.007(c) require that parents must be informed and must consent in writing if individually identifying information is provided to the department, the burden of increased costs incurred by participating birthing facilities should be mitigated because the department will require individually identified information, and corresponding written consent from parents, only for those newborns who fail the hearing screen. All other information may be sent to the department in deidentified form. No change was made as a result of this comment.

Comment: Concerning §37.502(14)(A), one commenter stated that "mother" should be used instead of "parent" to minimize questions about paternity.

Response: The department disagrees. The definition of "parent" at Health and Safety Code §47.001(8) is not specific concerning gender, and therefore includes fathers as well as mothers. No change was made as a result of this comment.

Comment: Concerning §37.502(14)(C), one commenter asked the department to consider adding the child's first newborn screening serial number as a possible identifier.

Response: The department disagrees. Use of the newborn screening serial number as a personal identifier would delay transmission of data by some birthing facilities to the department because the number is assigned by the department's laboratory where newborn screening blood tests are performed, and no secure system currently exists for transmission of the numbers electronically. No change was made as a result of this comment.

Comment: Concerning §37.502(14)(C), one commenter suggested that the department amend the subsection to include the mother's identifying information.

Response: The department disagrees that the subsection should be amended to include other types of personal identifiers because the rule as proposed lists examples but does not exclude other types of personal identifiers. No change was made as a result of this comment.

Comment: Concerning §37.502(15), several commenters asked how and when protocols would be made available to birthing facilities, what type of monitoring would be done to ensure compliance with the protocols, and whether the protocols would meet national standards.

Response: The department has listed the minimum categories which birthing facility protocols must address in §37.503(e). Protocols as well as program certification categories are based on national standards published by the American Academy of Pediatrics (AAP) and the draft recommendations of the Joint Committee on Infant Hearing. Sample protocols will be offered to all birthing facilities during program implementation after program rules become effective. The data provided electronically to the department by birthing facilities should enable the department to determine whether protocols are being utilized appropriately. The department or its designee will make on-site monitoring visits if needed.

Comment: Concerning §37.502(15), several commenters suggested that the department consider a process to approve newborn hearing screening protocols for programs in operation prior to September 1, 1999.

Response: The department will develop a process for approving newborn hearing screening protocols for programs in operation on or before September 1, 1999. No change was made as a result of this comment.

Comment: Concerning §37.503, one commenter stated that small birthing facilities that are not exempt under the statute would have difficulty complying with the rules in a cost effective manner and asked if such facilities could contract with other facilities for provision of newborn hearing screening services and either refer parents to those facilities or arrange for the contractor to visit its facility to perform the newborn hearing screening.

Response: Although birthing facilities may contract with any persons or entities they choose to perform newborn hearing screening at the birthing facility prior to discharge from the birth admission, each birthing facility will remain responsible for the screening done at the facility, whether by an employee or a contractor. Parents may be referred to other facilities for diagnostic testing, but Health and Safety Code, §47.003(a) states that the birthing facility shall offer parents of a newborn a hearing screening during the birth admission. No changes were made as a result of this comment.

Comment: Concerning §37.503, a commenter stated that the rules assure that infants and families receive appropriate care and that the state can effectively monitor the program and the health of its citizens.

Response: The department agrees. The rules were promulgated according to Health and Safety Code, Chapter 47 to ensure that parents of all newborns are offered a hearing screening and that intervention is available for newborns who require it. No change was made as a result of this comment.

Comment: Concerning §37.503, two commenters strongly supported the legislation and asked all parties involved to move quickly to implement the law so that Texas will have a program that assures that every baby with a problem gets the care he/she deserves.

Response: The department agrees. No change was made as a result of the comments.

Comment: Concerning §37.503(a), several commenters stated that the section conflicts with the definition of "birthing facility" in Health and Safety Code, §47.001(2), which exempts hospitals in counties with populations of fewer than 50,000 persons, and birthing centers in counties with populations of fewer than 50,000 persons and fewer than 100 births per year.

Response: The department agrees, and has amended §37.502(2)(C) to permit but not require birthing facilities which are not otherwise included in subsections 37.502(2)(A) or 37.502(2)(B) to provide hearing screening services for newborns. The department will offer hospitals and birthing centers not included in the statutory definition of "birthing facility" one-time grants for the purchase of newborn hearing screening equipment prior to August 31, 2002, if they choose to participate in the program. The department has also added new §37.503(h), which requires a birthing facility that does not offer newborn hearing screening to refer parents of each newborn delivered in the facility to another birthing facility participating in the newborn hearing screening program.

Comment: Concerning §37.503(a), a commenter asked why the section requires that a hearing screen be offered to and written consent for disclosure obtained from only Medicaid eligibles rather than all newborns.

Response: The department has amended §37.502(2)(C) to require participation in the newborn hearing screening program only by hospitals and birthing centers which are defined as "birthing facilities" in Health and Safety Code §47.001(2). The department cannot require other exempted facilities to offer hearing screening services, but will assist those exempted facilities that choose to do so.

Comment: Concerning §37.503(b), one commenter stated that it might be difficult to screen all newborns prior to discharge, and suggested that the time frame be extended to two weeks after birth.

Response: The department disagrees. Health and Safety Code, §47.001(1) defines "birth admission" as the time after birth that a newborn remains in the birthing facility before being discharged, and Health and Safety Code, §47.003(a) states that the hearing screen shall be offered during the birth admission. Experience gained during the department's demonstration project suggests that screening newborns prior to discharge is quite feasible, even in large birthing facilities. During the program implementation process the department's designee will assist programs with the details of managing an effective and efficient newborn hearing screening program. No change was made as a result of this comment.

Comment: Concerning §37.503(d), one commenter suggested that the department should amend the section to provide uniform language for consent by parents for disclosure of individually identifying information to the department.

Response: Health and Safety Code, Chapter 47 does not require the department to adopt standard consent language which all birthing facilities must utilize, and the department disagrees that such language is necessary. No change was made as a result of this comment.

Comment: Concerning §37.503(d), one commenter suggested that the section should be amended to require that only parents whose children do not pass the newborn hearing screen must be informed that they must consent in writing for the disclosure of individually identifying information to the department.

Response: The department disagrees because Health and Safety Code §47.003(a) requires that "parents", without limitation, shall be so informed. No change was made as a result of this comment.

Comment: Concerning §37.503(d), one commenter stated that when newborns are transferred to another birthing facility for neonatal care, the receiving facility should be responsible for informing parents of the need for written consent.

Response: The department agrees and has amended §37.503(c) and §37.503(d) to clarify that if a newborn is not offered a hearing screening before transfer to another facility for neonatal care, the receiving hospital must do so, if the hospital is a birthing facility as defined by §37.502(2).

Comment: Concerning §37.503(e), one commenter stated that the section should be changed to allow facilities to meet their own specific program needs.

Response: The department agrees, and has amended the section to permit programs with protocols already in place to submit them to the department for approval. The categories listed in the section as amended will allow programs to write protocols which meet their needs while complying with national standards. If differences with the department concerning a facility's proposed protocols cannot be resolved, the birthing facility may request a fair hearing.

Comment: Concerning §37.503(e), one commenter expressed concern that "the stringent rules and protocols" cannot be implemented in birthing facilities regardless of the size of their birth populations. The commenter also suggested that birthing facilities can meet the guidelines of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) without the need to operate like other programs.

Response: The department disagrees. The protocols are specific to newborn hearing screening, which is not addressed by JCAHO standards. Birthing facilities of all sizes have successfully implemented newborn hearing screening programs. Although the size of the birth populations in different birthing facilities will affect staffing needs, the need for uniform standards of care in a statewide program remains. Although program protocols may be worded in different ways in different birthing facilities, the same protocol categories will be employed statewide. No changes were made as a result of this comment.

Comment: Concerning §37.503(e), one commenter suggested that the rules should allow birthing facilities to utilize guidelines that would assure a high quality program and also enable the facilities to meet their patients' needs.

Response: The department agrees. Birthing facilities will be able to establish protocols that address both goals. No changes were made as a result of this comment.

Comment: Concerning §37.503(e), one commenter asked for clarification concerning the process for protocol approval by the department's designee.

Response: The department has amended §37.503(e) to list the categories of procedures which, at a minimum, each birthing facility protocol must address. The department's designee will determine whether a birthing facility's protocol does so, and the section also provides that a birthing facility may request a fair hearing if the department's designee refuses to approve a birthing facility's protocol.

Comment: Concerning §37.503(e), one commenter who had participated in an informal work group for development of the rules asked that the protocol category descriptors be clarified.

Response: The department agrees and has amended the section to add protocol categories.

Comment: Concerning §37.503(e), several commenters stated that program protocols should be included in the rules because the Texas Administrative Procedure Act, Government Code, Chapter 2001, affords them the right to review any standards by which their activities will be monitored or regulated before adoption as rules.

Response: The department disagrees. The rules have been expanded to include categories needed for addressing program protocols. The department is not advocating the use of only one model of language for protocols, just that all categories have been addressed in a manner commensurate with national standards. Birthing facilities will submit their protocols for approval by the department, according to Health and Safety Code, §47.003(b), and will have a method of appeal should we not be able to agree. No changes were made as a result of this comment.

Comment: Concerning §37.503(e), two commenters asked the department to add the guidelines developed by the American Academy of Pediatrics (AAP) Task Force on Newborn and Infant Hearing to this section.

Response: The department disagrees. The department utilized the AAP guidelines as well as draft recommendations of the Joint Committee on Infant Hearing (JCIH) 2000 Position Statement to develop protocol categories. However, the department's designee will approve a birthing facility's program protocols not according to how completely they incorporate all the AAP guidelines, but according to whether the protocols address each of the required categories of procedures in a meaningful way. No changes were added as a result of this comment.

Comment: Concerning §37.503(f), one commenter stated that the department will be collecting much more data for "quality assurance" than is collected by other states, and that this will impose increased personnel costs upon birthing facilities.

Response: The department agrees that birthing facilities in Texas will be required to provide more data than is required by most other states. However, Health and Safety Code, Chapter 47, imposes substantially greater responsibilities upon the department than do statutes in other states. The department must collect data to certify and renew certification of programs rather than for traditional periodic "quality assurance" monitoring. The department is aware of the scope of this data reporting and has required that the software to be licensed must perform many data collection and reporting functions automatically to make compliance by birthing facilities as cost-efficient as possible. No changes were made as a result of this comment.

Comment: Concerning §37.503(f), one commenter asked about data the department will maintain and the safeguards for protecting genetic data from misuse.

Response: The department acknowledges that some newborn hearing screening data may include information on genetic conditions which may have caused the hearing loss or may result in additional hearing loss in the future. The department has amended §37.504(1) to require that program certification criteria shall require that all data, whether it includes genetic information or not, will be protected in accordance with state and federal guidelines for confidentiality.

Comment: Concerning §37.503(f) one commenter requested that the section be amended to state that the department will maintain individually identifying data on only newborns who fail the hearing screen, and that the department will collect only aggregate data on newborns who pass the hearing screen.

Response: The department disagrees, and will maintain data on both newborns who pass as well as newborns who fail the birth screen. However, the department will require individually identified information only for newborns who fail the birth screen. Deidentified information will be required for newborns who pass the birth screen. Health and Safety Code, §47.007(a) states that the information, reporting, and tracking system must be capable of providing the department with information and data necessary to plan, monitor, and evaluate the program, including the program's screening, follow-up, diagnostic, and intervention components. Also, in order to meet federal reporting requirements, the department will require raw data rather than aggregate data on all newborns and infants. This data may be either identified or deidentified.

Comment: Concerning §37.503(f), a commenter stated that by acquiring data on children who pass the hearing screen, the department can track and counsel children who develop future hearing loss, and that for the first time this information will be available to hearing professionals.

Response: The department agrees. Health and Safety Code, §47.007(b) provides that, with written consent from the child's parent, qualified hearing professionals across the state may access the information management, reporting, and tracking system. No change was made as a result of this comment.

Comment: Concerning §37.503(g), one commenter asked who was responsible for ensuring that referrals are sent to the Interagency Council on Early Childhood Intervention (ECI) and when the referrals should be made. The commenter stated that the birthing facility should not be responsible once a newborn is discharged.

Response: Health and Safety Code, §47.003(d) states that the department shall ensure that intervention is available and is managed by state programs specified in the statute. Section 621.45 of this title (relating to Primary Referral Requirements) provides that newborns in need of comprehensive early intervention services must be referred within two working days of identification to a contracted provider for evaluation and assessment. The department has amended §37.504(5) as a result of this comment.

Comment: Concerning §37.504, one commenter asked whether contract newborn hearing screening service providers must be certified.

Response: The department may by law certify only birthing facility programs, not independent providers of newborn hearing screening services. No changes were made as a result of this comment.

Comment: Concerning §37.504, one commenter stated that program certification criteria should be more specific.

Response: The department agrees and has amended §37.504 and §37.505 to clarify the intended meaning of the sections.

Comment: Concerning §37.504(1), a commenter stated that the required data elements are consistent with those currently required by the Centers for Disease Control (CDC), and those expected to be required in the future. The commenter added that policy drafted by the Joint Committee on Infant Hearing (JCIH) addresses accountability, setting benchmarks, and achieving excellence at the hospital, state, and national level.

Response: The department agrees. Health and Safety Code, §47.007 requires that "the information management, reporting and tracking system must be capable of providing the department with information and data necessary to plan, monitor, and evaluate the program, including the program's screening, follow-up, diagnostic, and intervention components." No changes were made as a result of this comment.

Comment: Concerning §37.504(3), one commenter asked what the department considers a "sufficient" number of screening staff for birthing facilities.

Response: A "sufficient" number of screening staff at a particular birthing facility will be the number of persons necessary to administer the program in a manner that meets certification standards. No changes were made as a result of this comment.

Comment: Concerning §37.504(3), one commenter suggested that the department should integrate newborn hearing screening with the newborn screening program so that consent would be required for genetic testing.

Response: The department disagrees. Although the department is studying integration of its databases which track newborn information, Health and Safety Code, Chapter 47 does not authorize the department to require consent for genetic testing. No changes were made as a result of this comment.

Comment: Concerning §37.504(3), several commenters asked for clarification of the term "qualified hearing screener".

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.504(3), one commenter asked why the department will be training hospital staff in the use of hearing screening equipment when the Act does not require this.

Response: The department agrees that Health and Safety Code, Chapter 47 does not require the department to train hospital staff in the use of newborn hearing screening equipment. Such training should be provided by the manufacturers of the equipment chosen by each birthing facility. Section 37.504(3) refers to technical training on the software provided by the department and training concerning implementation of sections and program protocols. No changes were made as a result of this comment.

Comment: Concerning §37.504(3), one commenter asked whether the training to be provided by the department would duplicate the training done in-house by each birthing facility, and stated that the department's training should be provided only on an as-needed basis.

Response: The department agrees that all birthing facility staff need not be trained directly by the department or its designee, and has amended the section to allow persons who successfully complete the department's training to train other staff members at their respective facilities.

Comment: Concerning §37.504(3), several commenters asked what, where, and how training will be offered by the department.

Response: The department will provide technical support, training on the software, and implementation training to birthing facilities at no cost. Until the department has selected a vendor of these services through the competitive procurement process currently under way, no details concerning the training to be provided will be available. The same training will be offered to all birthing facilities to ensure that each has access to the same information regarding certification requirements. No changes were made as a result of these comments.

Comment: Concerning §37.504(4), one commenter asked why Texas requires an electronic link between the department's software and the screening equipment at each birthing facility but the California program does not.

Response: The State of California has no statutory mandate, but provides grants to qualifying pediatric hospitals to perform screening, diagnostic testing, tracking, and follow-up services. The software made available to participating hospitals by California allows electronic linkage, at the option of each facility. Texas law, however, requires birthing facilities only to offer hearing screening and mandates that the information management, reporting, and tracking system must be capable of providing the department with information and data necessary to plan, monitor, and evaluate the program, including the screening, follow-up, diagnostic, and intervention components. No changes were made as a result of this comment.

Comment: Concerning §37.504(4), one commenter stated that a birthing facility which has already purchased equipment cannot be assured that the equipment will be on the department's approved list.

Response: The department agrees that the facility faces a dilemma. The department consistently suggested that programs should wait for the rules to be adopted before deciding which equipment to purchase, and reminded birthing facilities that Health and Safety Code, §47.004(b)(1) states that in order to be certified, newborn hearing screening programs must provide hearing screening using equipment recommended by the department. No changes were made as a result of this comment.

Comment: Concerning §37.504(4), several commenters stated that the department did not have statutory authority to set equipment criteria and that any equipment approved by the United States Food and Drug Administration (FDA) could be used for newborn hearing screening.

Response: The department agrees that 21 U.S.C. §360k(a) prohibits a state from establishing any requirement for a device intended for human use which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device. The department has amended §37.504(4)(B) to clarify that devices must be cleared or approved by FDA for marketing for the purpose of hearing screening and to delete the provisions concerning the devices' "pass-refer" criteria. The department has added §37.504(4)(C) to integrate the definition of hearing loss which will trigger a referral for follow-up. Therefore, the department believes the certification criteria in §37.504(4) do not conflict with federal law.

Comment: Concerning §37.504(4), one commenter stated that the department's decision not to publish a list of approved newborn hearing screening equipment at this time was delaying implementation of the program.

Response: The department disagrees that implementation of the program has been unnecessarily delayed. The department cannot publish a list of approved hearing screening equipment until these sections have been approved by the Board of Health and a contract for software licenses and training and technical support services has been fully executed. No changes were made as a result of this comment.

Comment: Concerning §37.504(4), one commenter stated that the department should publish the equipment list as soon as possible before funds allocated for purchase of newborn hearing screening equipment by birthing facilities are used for other purposes.

Response: The department agrees that the program must be implemented as quickly as the necessary software, services, and technical specifications are available. The department revised and reposted its procurement document requesting offers to supply software licenses, training, and technical support services because of comments received from hospitals and vendors, which has extended the original procurement time schedule. No changes were made as a result of this comment.

Comment: Concerning §37.504(4), one commenter stated that loading, managing, and tracking data was the responsibility of the department and not birthing facilities, and that the department should allow birthing facilities to transmit newborn hearing screening equipment data in ASCII format.

Response: Health and Safety Code, §47.004(b)(3) requires certified programs to maintain and report birth admission screening data electronically as required by the department. The department will consider all file formats that can be transmitted in a manner that conforms to state and federal confidentiality guidelines and will work with its contractor/designee to ensure that birthing facilities meet this requirement. No changes were made as a result of this comment.

Comment: Concerning §37.504(4), a commenter stated that the department should allow use of all equipment that has been recognized by national associations, such as the American Speech-Language-Hearing Association (ASHA), the American Academy of Pediatrics (AAP), and the Joint Committee on Infant Hearing (JCIH). The commenter added that the department should not assume the liability of selecting and recommending equipment for use by birthing facilities.

Response: The department disagrees. Statements by the ASHA, AAP, and JCIH refer only to categories of testing equipment and do not "approve" specific makes and models of equipment. However, Health and Safety Code, §47.004(b)(1) requires that in order to be certified, newborn hearing screening programs must use equipment recommended by the department. The department will provide a list of approved equipment, from which birthing facilities may choose. No changes were made as a result of these comments.

Comment: Concerning §37.504(4)(A), two commenters asked whether an electronic data link to the department is essential to the successful operation of the hearing screening program or if exchange of data files on disks would suffice.

Response: The department will consider allowing transmission of files by diskette after the specific software to be used has been selected and the department has evaluated the software's capability to accept diskette data without costly interventions. No changes were made as a result of this comment.

Comment: Concerning §37.504(4)(A)-(B), a commenter asked whether equipment that does not meet the criteria stated in these sections will be "grand fathered", and if not, whether the department will provide "loaner" equipment to birthing facilities at no charge until approved equipment can be purchased.

Response: Health and Safety Code, §47.004(b)(3) requires that in order to be certified, a birthing facility must maintain and report data electronically as required by the department. Health and Safety Code, §47.007(a) states that the information, reporting, and tracking system must be capable of providing the department with information and data necessary to plan, monitor and evaluate the program, including the program's screening, follow-up, diagnostic, and intervention components. Therefore, equipment that meets the requirements of the department may be used whenever it was purchased, and equipment that does not meet the requirements may not be used by a certified program. The department has chosen not to lend equipment to birthing facilities because plans for disposition of the equipment, now four years old, have already been made. No changes were made as a result of this comment.

Comment: Concerning §37.504(4)(A)-(B), a commenter stated that the American Academy of Pediatrics guidelines support the equipment criteria listed in these sections. The commenter added that the rules do not prevent any equipment manufacturer from selling in Texas, but require evidence that the equipment is effective.

Response: The department agrees. No changes were made as a result of this comment.

Comments: Concerning §37.504(4)(A)-(B), several commenters stated that the department should approve any equipment that has been approved nationally.

Response: The department disagrees. No list of "nationally approved" equipment exists. Approval by the United States Food and Drug Administration authorizes the manufacturer to market the equipment nationally. The integrity and the success of the statewide newborn hearing screening program require that screening equipment be capable of transmitting data to the department's newborn hearing screening information management and tracking system. The department has amended the paragraph to require that the screening equipment be capable of identifying hearing loss as defined at §37.502(5).

Comment: Concerning §37.504(5), one commenter stated that use of the word "proceedings" appears to be a typographical error.

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.504(5), one commenter stated that communication of screening results to "health care providers" as required by Health and Safety Code §47.005(b) has been omitted.

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.504(5), one commenter asked whether birthing facilities were responsible for reporting to all stakeholders mentioned in the rule.

Response: Health and Safety Code §47.005(b) requires that birthing facilities report screening results only to the parents, the newborn's attending physician or health care provider, and the department. No changes were made as a result of this comment.

Comment: Concerning §37.504(5), one comment stated that the section should be reworded to clarify that babies who fail the newborn hearing screening must be linked to the next step of appropriate care.

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.504(5), a commenter recommended that the words "and follow-up services" be deleted.

Response: The department has amended the section to clarify its intent, and deletion of the phrase is no longer required.

Comment: Concerning §37.504(6), several commenters asked who would provide and pay for the "standardized educational materials".

Response: The department has amended the subsection to clarify that the department will provide educational materials at no charge to birthing facilities.

Comment: Concerning §37.504(6), several commenters asked to whom the standardized educational materials must be given.

Response: The section as proposed stated that standardized educational materials must be distributed to parents, health care providers, and physicians. No changes were made as a result of this comment.

Comment: Concerning §37.504(6), several commenters asked who would be responsible for distribution of standardized educational materials.

Response: Health and Safety Code, §47.004(b)(4) states that in order to be certified, birthing facility programs must distribute educational materials. The department has amended the subsection to clarify this responsibility.

Comment: Concerning §37.504(6), several commenters asked whether birthing facilities could develop their own materials for distribution.

Response: The department has amended the subsection to clarify that birthing facilities may develop educational materials in addition to, but not in lieu of, those developed and provided by the department for distribution to parents, health care providers, and physicians.

Comment: Concerning §37.505, one commenter stated that it is imperative for the department to develop minimum standards for infant hearing screening programs if the statewide program is to be effective. The commenter expressed support for the proposed screening goals stated as percentages of babies to be screened and followed, and added that the goals are realistic and within the capabilities of any enrolled institution to accomplish.

Response: The department agrees. No changes were made as a result of this comment.

Comment: Concerning §37.505, several commenters stated that medical professionals must be better educated regarding the law, the rules, and intervention that is available for newborns who are hearing impaired, and described how one newborn hearing evaluation center was educating professionals. The commenters urged the department to implement the rules without delay.

Response: The department agrees that time is required for individuals affected by any new legislation to become aware of changes necessary in their current practices, and it commends those providers of newborn hearing screening who have taken an active role in educating medical professionals. The department is working with educators to develop materials which will be made available to hearing health care professionals and families. Minimum acceptable levels of performance are included in the rules to ensure that parents of newborns are offered a newborn hearing screening, and that each newborn with abnormal screening results are reported to the newborn's physician or health care provider. No changes were made as a result of these comments.

Comment: Concerning §37.505, several commenters stated that the language in this section may not agree with the statute, and suggested that birthing facilities should be required to offer the screen to parents of all newborns, rather than require the screen for 98% of newborns during the first month of life.

Response: The department agrees, and has changed the language to reflect that the screen should be offered to all parents, and has deleted the language regarding the 98% of newborns during the first month of life.

Comment: Concerning §37.505, one commenter stated that basing certification on the number of newborns who pass the screening creates an incentive to manipulate test results in order to maintain certification.

Response: The department disagrees. Because some birthing facilities may attempt to falsify screening results to remain in compliance with minimum certification criteria, the department requires the electronic record of the screen, which makes manipulation of test results difficult. The national standards developed by the American Academy of Pediatrics and the draft of the proposed Joint Committee on Infant Hearing, 2000 Position Statement recommend an even higher infant "pass percentage" than the department is proposing as one of the indicators of an effective program. No changes were made as a result of this comment.

Comment: Concerning §37.505, one commenter stated that certification should be awarded to programs that develop approved protocols and purchase equipment meeting the criteria set in the rules.

Response: The department agrees and has added §37.504(8), "approved program protocols" as a program certification criterion.

Comment: Concerning §37.505(a), one commenter expressed strong support for the newborn hearing screening initiative and suggested that the department should strive toward screening 100% of babies, with 95% as the acceptable standard for certification. The commenter added that the hospital at which she works requires 3/4 of one full-time equivalent (FTE) to handle all aspects of the charting, referral, and data entry of screening results.

Response: The department disagrees that screening 100% of newborns should become the minimum standard. The department has amended the subsection to clarify that although birthing centers must offer the parents of all newborns a hearing screen prior to discharge from the birth admission visit, 95% of newborns must actually be screened as a minimum acceptable level of performance. Not all newborns will be screened before discharge for many reasons, including parental preference and transfer of the newborn to another facility for neonatal care. The requirement that 95% of babies shall be screened during the birth admission is consistent with national standards.

Comment: Concerning §37.505(a)(1), several commenters stated that newborns whose parents refuse the screen should not be counted when determining whether 95% of newborns have been screened during the birth admission visit at a particular birthing facility.

Response: The department agrees, and has amended the section accordingly.

Comment: Concerning §37.505(a)(3) and §37.505(b)(3), one commenter stated that birthing facilities have no control over how many newborns pass the hearing screening, and therefore should not be held accountable, since many of their birth population may include sick babies whose incidence of hearing loss is higher.

Response: The department disagrees. National studies indicate that approximately four percent of all newborns, including sick babies, require a referral for further testing after the birth admission screen, and national associations have established 4% as the recommended standard. The department has found that reports of failure by more than 10% of newborns indicates that the screen itself is not being administered accurately. The department recognizes that the national benchmark of a 4% referral rate may be difficult to achieve until a program has been in operation for at least a year. Section 37.505(a)(3) establishes 90% as the minimum pass rate because the department will be monitoring compliance with program certification criteria in Texas. No changes were made as a result of this comment.

Comment: Concerning §37.505(a)(3) and §37.505(b)(3), one commenter stated that the 90% was too low and might encourage improper test interpretation.

Response: The department disagrees. Although the department has found that reports of failure by more than 10% of newborns indicates that the screen itself is not being administered accurately, the department also recognizes that the national benchmark of a 4% referral rate may be difficult to achieve until a program has been in operation for at least a year. Section 37.505(a)(3) establishes 90% as the minimum pass rate because the department will be monitoring compliance with program certification criteria in Texas. No changes were made as a result of this comment.

Comment: Concerning §37.505(a)(4), one commenter stated that establishing 70% as the minimum performance standard for provision of follow-up services to infants during the first three months of life encourages failure to provide services to 30% of the all infants screened.

Response: The department agrees and has amended the paragraph to require that all newborns with abnormal screens must be reported to the infant's attending physician or health care provider.

Comment: Concerning §37.505(a)(4), several commenters stated that provision of follow-up services within the first three months of the infant's life is not the responsibility of the birthing facility, and that the $8 fee mentioned in the proposed preamble would not cover the follow-up tracking expenses.

Response: The department agrees that Health and Safety Code, §47.005(c) states that the newborn's attending physician or health care provider, rather than the birthing facility, shall direct and coordinate follow-up care. The $8 estimate of increased costs to birthing facilities was never intended to cover follow-up tracking. The department has amended the paragraph to clarify that newborns with abnormal screening results shall be reported to the newborn's physician or health care provider for follow-up, and has deleted the performance standard which suggested that birthing facilities were responsible for assuring that newborns received follow-up services within the first three months of life.

Comment: Concerning §37.505(a)(4), one commenter asked about the responsibility of contracted service providers for follow-up care.

Response: The department acknowledges that it lacks statutory authority to regulate contracts by birthing facilities with providers of follow-up services. The department has amended the paragraph to clarify that birthing facilities are responsible only for referring newborns with abnormal screening results to the newborn's physician or health care provider for follow-up care.

Comment: Concerning §37.505(a)(4), one commenter asked whether follow-up activities by birthing facilities would require increased staff time which might result in an effect on local employment.

Response: The department has amended the paragraph to clarify that birthing facilities are not responsible for provision of follow-up care.

Comment: Concerning §37.506, a commenter stated that it appears that certification and decertification determinations will be based on large amounts of data collected for each newborn.

Response: The department agrees. The screening data will enable each birthing facility to monitor the performance of its staff as well as the screening process. The department's software procurement specifications require that many data collection functions be performed automatically to reduce the burden on birthing facility staff. In addition, the department's contractor will be required to monitor and notify any facility that fails to meet certification standards for any two- month period, which will enable the facility to identify and address potential problems. No changes were made as a result of this comment.

Comment: Concerning §37.506, several commenters asked the purpose of the designating levels of certification. The commenter described other hospital accreditation programs that use only two levels of certification and do random samples for review purposes.

Response: The department created "preliminary" certification lasting six months to allow programs with no prior experience in newborn hearing screening to become proficient before they qualify for "standard" certification. The department has amended §37.506(a)(2)(A) to provide that programs that comply with certification criteria and minimum performance standards may qualify for "standard" certification for 24 months. The department has amended §37.506(a)(3)(A) to authorize "distinguished" certification for a period of 36 months to reward programs which demonstrate the ability to exceed minimum standards as specified by §37.505(b). "Provisional" certification is available to programs already certified which fail to meet performance standards for a period of time. The programs then have an opportunity to return to compliance without being decertified. With reference to other hospital accreditation programs, the purpose for that monitoring and the certification monitoring for newborn hearing is very different. Hospitals choose whether to have the type of general accreditation being cited; many do not choose to participate. The statute requires that the department establish certification criteria for this program.

Comment: Concerning §37.506, one commenter stated that programs should either be certified or not. The commenter described other hospital accreditation programs that include only two levels of certification and obtain random samples for review purposes.

Response: The department disagrees, because the three levels of certification are intended to designate programs' capacities to meet increasingly rigorous performance standards and goals. The department has amended the section to differentiate performance levels by awarding certification for longer periods to birthing facilities which exceed minimum standards. Although hospitals may choose to participate in other accreditation programs, Health and Safety Code, §47.004 requires the department to establish certification criteria for newborn hearing screening programs and to certify and recertify programs. The purposes of accreditation monitoring and certification monitoring for newborn hearing screening programs are therefore quite different. No changes were made as a result of this comment.

Comment: Concerning §37.506, one commenter asked why local communities will provide follow-up services rather than the department, in contrast to the newborn metabolic screening program.

Response: The department disagrees that the newborn metabolic screening program should be considered a model for provision of follow-up services in department programs. Audiology intervention services and educational intervention services are done in the local communities by service providers and by the Interagency Council on Early Childhood Intervention, and are not the responsibility of the department. Health and Safety Code, §47.007(a) requires that the reporting and tracking system must be capable of providing the department with the information and data needed to plan, monitor, and evaluate the program, including the follow-up component. However, actual follow-up services will be directed and coordinated by the infant's physician or health care provider. No changes were made as a result of this comment.

Comment: Concerning §37.506, a commenter stated that the certification process appears to be complicated, frequent, and encumbered with excessive paperwork and personnel.

Response: The department disagrees. All the data necessary to monitor compliance with program certification criteria will be collected by the department through the software which will be offered to all birthing facilities. The information management, reporting, and tracking software described in the department's procurement specifications should require minimal labor by staff of birthing facilities which elect to use it. Procurement specifications for training services also request offers of training methods which will best meet the needs of the department and the birthing facilities. No changes were made as a result of this comment.

Comment: Concerning §37.506, one commenter asked how the department can provide training and monitor certification without costs being prohibitive.

Response: The department disagrees that costs of providing training and monitoring certification will be prohibitive. Each birthing facility's software, whether supplied by the department or in use on or before September 1, 1999, must be capable of providing the department with information necessary to allow the department to monitor the program. Such automated data gathering capability, as well as the department's procurement specifications for provision of training to birthing facilities, are intended to promote cost-efficiency. No changes were made as a result of this comment.

Comment: Concerning §37.506(b), one commenter suggested that the department should adopt a procedure for considering appeals from programs that are decertified.

Response: The department agrees, and has amended the subsection by adding paragraph (b)(3).

Comment: Concerning §37.506(b), one commenter stated that the title of §37.506 should be changed to "decertification and plan of correction", and facilities that fail to meet one or more of the certification criteria should be offered the opportunity to comply with a plan of correction rather than being decertified.

Response: The department disagrees. Section 37.506(e)(1), as amended, already requires that as part of the certification process, programs which have been notified of failure to meet performance standards must submit a "corrective action plan". No changes were made as a result of this comment.

Comment: Concerning §37.506(b) and §37.506(e), several commenters requested clarification of the consequences of decertification for a program, specifically including whether the program might lose Medicaid funding.

Response: Health and Safety Code, Chapter 47 does not authorize the department to impose administrative sanctions on birthing facilities which are decertified. No changes were made as a result of this comment.

Comment: Concerning §37.506(d), several commenters asked why the hospitals that participated in the department's demonstration project are eligible to receive a higher level of initial certification than other programs which provide newborn screening but did not participate in the project.

Response: The department agrees, and has amended the subsection to state that all facilities that were providing newborn hearing screening to all newborns on September 1, 1999 may receive "standard" or "distinguished" certification based on their compliance with certification criteria and performance standards. The same certification criteria will therefore be applied to all birthing facilities whether or not they participated in the department's demonstration project.

Comment: Concerning §37.506(e), one commenter suggested that the department should delete the requirement that a notice of decertification be posted in the birthing facility.

Response: The department agrees and has deleted the subsection.

Comment: Concerning §37.506(g), now renumbered as §37.506(f), a commenter stated that the department should charge fees for certification activities, since the department will incur costs in the certification process.

Response: Health and Safety Code, §47.004(e) states that a fee may not be charged to certify or re-certify a program. No changes were made as a result of this comment.

Comment: Concerning §37.507(a), one commenter stated that consent is only required to send individually identified information to the department.

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.507(b), one commenter stated that the subsection describes information concerning follow-up services "approved" by the department which birthing facilities must provide to parents. The commenter stated that Health and Safety Code, §47.005(a) does not include that term, and recommended an amendment.

Response: The department agrees and has amended the section to refer to information "recommended" by the department .

Comment: Concerning §37.507(b), one commenter asked which follow-up services will be approved by the department.

Response: The department will be recommending information about follow-up services available to parents, not approving the services themselves. No changes were made as a result of this comment.

Comment: Concerning proposed §37.507(c), several commenters stated that birthing facilities are not responsible for coordination of follow-up care.

Response: The department agrees and has deleted the subsection.

Comment: Concerning proposed §37.507(c), one commenter suggested that the department should perform case management services in the newborn hearing screening program as it is does in the newborn metabolic screening program.

Response: The department estimates that utilizing a case management model similar to that used in the newborn metabolic screening program would require as many as 45 new staff members. The newborn hearing screening program is charged with ensuring that follow-up occurs, not with providing the services. No changes were made as a result of this comment.

Comment: Concerning §37.508, one commenter stated that too many staff at some facilities may become trained to perform screening.

Response: The department agrees that birthing facilities may enhance quality of service as well as efficiency by relying upon a smaller number of well trained staff who are very proficient, rather than a larger number of staff who may not use their screening skills often enough to maintain their proficiency. No changes were made as a result of this comment.

Comment: Concerning §37.508, one commenter expressed concern that the rules do not address fees for providing staff training, and that persons or organizations other than the department's designee may not train staff.

Response: The department agrees. Training will be provided at no cost to birthing facilities by the department or its designee regarding the software and implementation guidelines, including protocols and certification standards. Manufacturers of screening equipment should also provide training on the use of their hardware. The department's procurement specifications require potential vendors to address the issue of ongoing training, and the department anticipates that potential vendors will offer creative solutions. No changes were made as a result of this comment.

Comment: Concerning §37.508, one commenter asked whether the department would provide technical assistance for both software and hardware, and whether the assistance will be provided on-site or by telephone.

Response: The department's procurement specifications require the selected vendor to provide technical assistance 24 hours a day, seven days a week concerning the software provided by the department and its interface with hospital hardware. Technical assistance will be provided both on-site and by telephone. Neither the department nor its designee will provide technical assistance for questions regarding newborn hearing screening equipment, since each birthing facility will choose its own equipment vendor. No changes were made as a result of this comment.

Comment: Concerning §37.508, a commenter asked what types of technical support and services will be provided, whether software upgrades will be free of charge to the facilities and for how long, and what time lines will be used for training.

Response: The department's procurement specifications describe in general the scope of services and time lines for training for which offers from vendors have been requested. Until the department has a fully executed contract, the department cannot provide a specific response. The department will make any software upgrades produced by the contractor during the contract period available to birthing facilities without cost. The department has amended the section to acknowledge its obligation to provide both training and technical assistance to certified programs.

Comment: Concerning §37.509, one commenter stated that requiring birthing facilities to send large amounts of data presents a medical-legal risk to the birthing facility because of possible breaches of patient confidentiality. The commenter added that deidentifying large data sets will be cumbersome, and that birthing facility staff will be spending time collecting and sending data instead of providing services to newborns.

Response: The department disagrees. Health and Safety Code, §47.008(a) requires that information sent to the department must be in a format that ensures confidentiality according to required state and federal privacy guidelines. All individually identifying information sent to the department requires written consent from the parent, and information sent in a deidentified form present no confidentiality risk. The department's procurement specifications require that software provided to facilities must be capable of sending all required data with minimal effort on the part of the screener in a format which protects confidentiality. No changes were made as a result of this comment.

Comment: Concerning §37.509, two commenters stated that requiring frequent transmission of information to the department would have a negative impact on birthing facilities.

Response: The department believes that any costs to birthing facilities for transmission of data, as frequently as necessary for each facility, are far outweighed by the benefits to infants whose hearing loss is discovered through screening at birth. Health and Safety Code, §§47.003 and 47.007, require the department to ensure that intervention is available for newborns with hearing loss, and that this intervention is managed by state programs. Human Resources Code, §32.024, requires the department to provide any necessary diagnostic follow-up care before the child is 30 days old. National early identification literature indicates that the window of opportunity for maximizing auditory input to the brain is very small. Referral of the infant to audiology and educational intervention must occur prior to six months of age, and experience obtained during the department's demonstration project as well as national literature indicate that newborns must be receiving services prior to three months of age so they will have auditory experience prior to six months of age. No changes were made as a result of this comment.

Comment: Concerning §37.509, several commenters asked whether data reported by birthing facilities in the newborn hearing screening program could be integrated into the metabolic and genetic screening database currently in use by the department or suggested that the hearing screening data should be integrated to eliminate duplication and reduce costs. The commenters also stated that several national organizations have urged state health departments to consider the integration of all databases concerning newborns.

Response: The department disagrees. The metabolic and genetic screening database cannot be electronically linked to hearing screening equipment. The metabolic and genetic screening data is obtained from newborn screening lab forms completed by hospital staff and the information is added to the department's database manually at least one week after the newborn's test sample is taken. It is often difficult to arrange for follow-up testing since abnormal tests results are usually received some time after the baby has been discharged from the birthing facility. Because the incidence of hearing loss is approximately three times that of all metabolic and genetic disorders combined, the department estimates that an additional 45 staff persons would be required to perform the same type of follow-up for infants with hearing loss. The department is examining information currently collected on newborns in existing databases to facilitate communication among these systems. The department also recognizes the significant legal concerns relating to confidentiality and access to sensitive information in several integrated databases. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter asked who would pay for the technical support and supplies needed for testing and whether software will be provided to managing audiologists who are not employees of the birthing facility.

Response: Birthing facilities will be responsible for the cost of testing equipment and supplies, as well as the cost of any software other than that provided by the department. The department will provide software to birthing facilities, not to individuals. Each birthing facility will be responsible for determining access to that software for use by managing audiologists who are not its employees. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter asked the department to allow facilities to post aggregate data on a confidentiality secured web site, rather than requiring facilities to send data directly to the department electronically.

Response: The department disagrees. Health and Safety Code, §47.007(a) provides that the information management, reporting, and tracking software furnished to each birthing facility by the department must be capable of providing the required information to the department, not making the information available for collection by the department. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter stated that determining whether newborns have risk factors that include delayed onset of hearing loss would require a chart audit conducted by the nursing staff. The commenter added that the department should not require collection of this information for research.

Response: The department disagrees. National standards from the Joint Committee on Infant Hearing recommend tracking of newborns with conditions which cause delayed onset of hearing loss to ensure that the infants receive appropriate follow-up care. Experience gained during the department's demonstration project indicates that a significant amount of risk information about newborns becomes known when the infants receive their hearing screen, and that the data can be entered at that time by the screener. The department seeks data not to conduct research, but to comply with Health and Safety Code, §47.007, which requires the department to ensure that all newborns with hearing loss receive follow-up care, including diagnostic testing and intervention. No changes were made as a result of this comment.

Comment: Concerning §37.509, several commenters affirmed the value of obtaining information concerning conditions which cause delayed onset of hearing loss for tracking needed follow-up.

Response: The department agrees. No changes were made as a result of these comments.

Comment: Concerning §37.509, several commenters stated that the department should request aggregate data, rather than data on each newborn, in a variety of formats, including floppy disk, electronic transfer in a password protected/secured web site, or on paper, since some birthing facilities already use their own systems for storing their data.

Response: The department has determined that accepting data which then must be manually entered into the department's database is not financially feasible. In order to ensure that follow-up services are available as required by Health and Safety Code, §47.003(d)-(e), the department requires complete records in an electronic format. Raw rather than aggregate data on all newborns who pass the screen may be provided in deidentified form. The department will also consider allowing transmission of files by diskette after the specific software to be used has been selected and the department has evaluated the software's capability to accept diskette data without costly interventions. No changes were made as a result of this comment.

Comment: Concerning §37.509, several commenters asked whether the department would assist birthing facilities which use their own systems to interface with the department's system.

Response: The department's software procurement specifications require that the selected vendor provide appropriate technical assistance regarding linkage with the department by birthing facilities that do not wish to use the software provided by the department. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter suggested that the department should collect only information required by the Centers for Disease Control (CDC), as the newborn screening database for metabolic and genetic data is operated.

Response: The department disagrees. Health and Safety Code, §47.007(a), requires the department to provide an information management, reporting, and tracking system to birthing facilities for purposes which differ from those of the CDC or the department's own newborn metabolic and genetic services program. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter asked why facilities should be required to change procedures and protocols each time the department changes its data management systems, and why the department does not provide services to newborns with metabolic or genetic disorders and hearing loss at the same time.

Response: Implementing changes to its data management systems by the department requires significant expenditures of budgetary and staff resources. The department does not anticipate making such changes with any greater frequency than would individual birthing facilities. Although the department is studying the integration of its program databases, provision of services to newborns with metabolic or genetic disorders and hearing loss at the same time has not been considered because the metabolic screening database as currently maintained is not automated and requires manual entry. Further, only a very small percentage of children whose conditions are tracked in the metabolic screening database also have hearing loss. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter suggested that the tracking software should reside at the department and not at each birthing facility, and added that the department already has an effective tracking and follow-up system in the metabolic screening database.

Response: The department disagrees, because the information to be tracked by the software originates at each birthing facility, and the department's metabolic screening database cannot be modified to serve as an information management, tracking, and reporting system for the newborn hearing screening program in time to meet statutory implementation deadlines and without expenditure of significant resources. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter asked whether the department has compared the costs of database management systems used in other states with the cost of the system being proposed for Texas.

Response: The department's efforts to establish an integrated process for newborn hearing screening and intervention in a cost effective manner have been supported by a grant from the Marion Downs National Center for Infant Hearing in Colorado awarded for that purpose. Because most states are only beginning to address issues concerning the cost of information management and outcomes, the department is not aware of relevant cost-outcome data from other states. No changes were made as a result of this comment.

Comment: Concerning §37.509, one commenter asked why the department requires that the software it will offer birthing facilities be installed on newborn hearing screening equipment, and expressed concern that this might impact the equipment's FDA approval.

Response: Neither this section nor the department's software procurement specifications require that the software be installed on particular newborn hearing screening equipment, or that the software co-reside on the same computer that the hearing screening equipment is attached to. Moreover, federal law and FDA regulations apply only to persons who market medical devices, not to birthing facilities which use the equipment. No changes were made as a result of this comment.

Comment: Concerning §37.509(a)-(c), several commenters asked whether birthing facilities with tracking software in place for a newborn hearing screening program are required to use the department's system. The commenters added Health and Safety Code, §47.007(a) states that the department shall provide appropriate information management, reporting, and tracking software to birthing facilities under the State's medical assistance program, not that birthing facilities shall use the software.

Response: The department agrees that birthing facilities with their own tracking software already in place may use their own systems, so long as the required data are sent in the format specified by the department. The department has amended §37.509(b) and §37.509(c) accordingly.

Comment: Concerning §37.509(a)-(c), one commenter asked whether birthing facilities using the department's software might incur "hidden" costs.

Response: The department is unaware of "hidden" costs that birthing facilities using the department's software might incur. The department is providing the software to birthing facilities at no cost, the software to be licensed should require minimal data entry time needed for its use, and the vendor selected will be required to assist birthing facilities to develop the linkages needed for reporting the required data. No changes were made as a result of this comment.

Comment: Concerning §37.509(b), several commenters expressed concern about how frequently birthing facilities will be required to report data to the department.

Response: The department has amended the section to require reporting according to a time frame specified by the department. Those determinations will reflect, at a minimum, the number of births at the facility and how frequently they occur.

Comment: Concerning §37.509(b), one commenter asked whether the proposed language in this section was strong enough.

Response: The department agrees that the responsibilities of birthing facilities for reporting data to the department should be stated more specifically. The department has amended the subsection to require reporting in a format and time frame specified by the department.

Comment: Concerning §37.509(b)-(c), one commenter suggested amendments to the sections listing specific data fields and formats in which information may be sent to the department from birthing facilities not using the department's software and asking that birthing facilities send only a minimal data set in formats of their choice.

Response: The department disagrees. The department recognizes that many formats are available for downloading data, and the department will work with the vendor selected to provide software and technical assistance to identify formats which will be effective. The department is required by Health and Safety Code, §47.007(a) to obtain information and data necessary to plan, monitor, and evaluate the program. No changes were made as a result of this comment.

Comment: Concerning §37.509(c), one commenter agreed that it is reasonable to ask birthing facilities to follow a universal format for data downloading and asked the department to define the criteria for deciding that equipment is compatible with the department's software.

Response: The department's procurement specifications require that the vendor whose software is licensed provide a universal link to newborn hearing screening equipment for data download. The department recognizes that there are a variety of formats for data downloading, and will work with the selected vendor to identify these formats. The department also has amended §37.504(1) to clarify that data must be electronically transferred in a format that meets both state and federal confidentiality requirements. No changes were made as a result of this comment.

Comment: Concerning §37.509(c), one commenter stated that the subsection should be amended to authorize birthing facilities to use software other than that provided by the department.

Response: The department agrees and has amended the subsection accordingly.

Comment: Concerning §37.509(c), a commenter asked if birthing facilities which do not serve Medicaid eligibles will be required to purchase some type of data program.

Response: Health and Safety Code, §47.003(a), requires that all birthing facilities, as defined by Health and Safety Code, §47.001(2), must participate in the screening program, but Health and Safety Code, §47.007(a) requires the department to provide the software to only birthing facilities participating in the Medicaid program. No changes were made as a result of this comment.

Comment: Concerning §37.509(c), one commenter suggested that the word "compatible" does not effectively indicate that the information must be reported in a specified format and time schedule.

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.509(d), one commenter suggested that the section be amended to state that persons who receive referrals shall either provide the services needed or refer the child to another provider "and with consent shall provide the following information, where available, to the department or its designee".

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.509(d), one commenter asked how one may become a "qualified hearing screening provider".

Response: The department has amended §37.504(3) to further define the term.

Comment: Concerning §37.510, one commenter asked why the department was duplicating existing quality assurance monitoring by other entities.

Response: The department's "quality assurance measures" refer only to the hearing screening program certification process, not other quality assurance monitoring which hospitals and birthing centers undergo because of licensing, liability insurance, or facility certification requirements. No changes were made as a result of this comment.

Comment: Concerning §37.510, several commenters asked how the department has used the data it has collected.

Response: The department has used the data collected during the demonstration project to serve children with hearing loss, to examine evidence of trends regarding the incidence of hearing loss in various public health regions, to document the cost effectiveness and efficacy of newborn hearing screening, and to compare the incidence of hearing loss in children in Texas with national data. Because the "Sounds of Texas" project addresses outcomes and outputs and is considered one of the best national models, department staff have been invited to make presentations at conferences by national and international organizations. Data collected statewide following program implementation will be used to serve children with hearing loss, examine epidemiological trends, track newborns with hearing loss to ensure that they receive services, and report nationally as required by statute. No changes were made as a result of this comment.

Comment: Concerning §37.510, several commenters questioned why the department was requiring birthing facilities to report more data than is collected in other states.

Response: The department believes that its statutory mandate to ensure follow-up and ntervention services and to certify and monitor birthing facility programs clearly supports the level of data required by the rules. Other state statutes do not include all these responsibilities. No changes were made as a result of this comment.

Comment: Concerning §37.510, one commenter stated that some other commenters at the public hearing held on February 22, 2000 appeared to be confused regarding the data needed for the newborn hearing screening program concerning care of infants, compliance and quality monitoring of services provided, and epidemiological and federal reporting. As a member of the Centers for Disease Control (CDC) National Data Committee, the commenter described the data reporting requirements anticipated in the next few years by both CDC and the federal government's Maternal and Child Health Bureau according to category of need and stated that the department should ask for no more or less than is needed for the program.

Response: The department agrees that compliance with the rules concerning data reporting is essential to the long-term success of the program. No changes were made as a result of the comment.

Comment: Concerning §37.510, one commenter stated that the word "providers" should be deleted to make the rule consistent with Health and Safety Code, Chapter 47.

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.511, one commenter stated that the issues of consent and confidentiality are addressed in the law, and therefore the department may not adopt rules inconsistent with the statute.

Response: The department agrees. Health and Safety Code, §47.007(c), requires that written consent be obtained before any individually identifying information is released, and Health and Safety Code, §47.008 states that the information management system must meet confidentiality requirements in accordance with required state and federal guidelines. No changes were made as a result of this section.

Comment: Concerning §37.511(a), one commenter asked whether birthing facilities must obtain consent from the newborn's parent to send identified data for newborns who pass the screen, and asking for clarifying language.

Response: The section is consistent with Health and Safety Code, §47.007(c), which requires that written consent be obtained before any individually identifying information is released through the information management, reporting, and tracking system. No changes were made as a result of this comment.

Comment: Concerning §37.511(c), one commenter stated that the department should develop a standardized consent form.

Response: The department disagrees and will provide only a sample of appropriate consent language which birthing facilities may choose to include in existing forms. No changes were made as a result of this comment.

Comment: Concerning §37.511(c), several commenters asked when the consent language will be available and in which languages.

Response: Samples of consent language will be provided during program implementation training. Birthing facilities are already responsible for providing translations of consent and other forms as may be necessary to assure that effective communication with their patients takes place. The department has no plans to provide translations. No changes were made as a result of this comment.

Comment: Concerning §37.511(c), one commenter suggested that an integrated consent form should be created to apply to all newborn screening, including hearing and metabolic testing, since currently no consent is required for metabolic screening.

Response: The department disagrees. The consent form for newborn hearing screening applies to the release of individually identifying information, not consent to perform the screen, and is required by Health and Safety Code, §47.007(c). No consent is required for newborn metabolic screening because Health and Safety Code, §33.011, requires that the test be performed. No changes were made as a result of this comment.

Comment: Concerning §37.511(f), one commenter stated that additional persons or groups should be included among those granted criminal and civil immunity by Health and Safety Code, §47.009.

Response: The department agrees, and has amended the section accordingly.

Comment: Concerning §37.512(a), one commenter asked how payment to birthing facilities in a Medicaid managed care environment will be made.

Response: Unless notified in the bimonthly Medicaid Bulletin that other procedures have been approved, birthing facilities should submit claims for services provided to newborns whose mothers are enrolled in Medicaid managed care at the time of birth to the managed care organization in which the mother is enrolled. No changes were made as a result of this comment.

Comment: Concerning §37.512(c), one commenter asked what the payment rate would be for Medicaid newborns receiving the hearing screen.

Response: Hospitals and birthing centers which provide newborn hearing screening services to Medicaid clients are reimbursed by the diagnosis related groups (DRG) methodology, or based on costs, per diem, or negotiated rates. Birthing facilities will receive no separate fee or payment specifically designated as reimbursement for provision of newborn hearing screening services. No changes were made as a result of this comment.

Comment: Concerning §37.512(c), one commenter stated that DRG payments have the impact of an unfunded mandate.

Response: The department is uncertain what the commenter means by an "unfunded mandate". However, birthing facilities which must provide newborn hearing screening services as required by statute will receive no additional reimbursement for doing so because of the diagnosis related groups methodology. Each birthing facility must evaluate the effects of these factors on its operations. No changes were made as a result of this comment.

Comment: Concerning §37.512(d), two commenters suggested that many birthing facilities with more than 1000 births per year will be unable to implement their newborn hearing screening programs by May 1, 2000, and asked that the implementation date be changed.

Response: Since the department cannot initiate program implementation until these sections become effective, programs in birthing facilities with more than 1000 births per year that are not currently operational cannot be implemented by May 1, 2000. However, the department will begin implementation training as soon as the rules are approved and a vendor has been selected. The department cannot change program implementation dates, which were established by the Legislature. No changes were made as a result of this comment.

The following commenters were in favor of the rules: American Speech-Language-Hearing Association; Children's National Medical Center; CHRISTUS St. Mary Hearing Screening Program; Deaf and Hard of Hearing Commission; Hearing Health Institute; Methodist Medical Center; OZ Systems; Sunshine Cottage School for the Deaf; Texas Medical Association; The University of Texas at Austin, Department of Communication Sciences and Disorders; Texas Speech-Language-Hearing Association; and Texas Tech University Health Sciences Center.

The following commenters were generally in favor of the rules, but had concerns, questions, and/or suggestions for change: Texas Organization of Rural and Community Hospitals (TORCH); Hendrick Medical Center; Coalition for Nurses in Advanced Practice; Harris Methodist Ft. Worth/Texas Health System; Hermann Hospital; McAllen Medical Center; Texas Organization of Nurse Executives; Memorial Hermann Healthcare; Parkland Health and Hospital System; St. Luke's Episcopal Hospital; Scott and White Hospital; Texas ENT Specialists, P.A. representing Northeast Medical Center; Texas Hospital Association; Texas Interagency Council on Early Childhood Intervention; The University of Texas Health Sciences Center at San Antonio, Division of Genetics and Birth Defects; The University of Texas Health Sciences Center at San Antonio, Department of Otolaryngology; West Texas Rehabilitation Center, Abilene; West Texas Rehabilitation Center, San Angelo; and Women's Hospital of Texas - Houston.

The following commenters had questions and suggestions for change, but were neither for nor against the rules in their entirety: Texas Health Resources and Natus Medical, Inc.

The new sections are adopted under Human Resources Code, §32.021 and Government Code §531.021, which provide the Health and Human Services Commission with the authority to adopt rules to administer the state's medical assistance program and are submitted by the Texas Department of Health under its agreement with the Health and Human Services Commission to operate the purchased health services program as authorized under Chapter 15, §1.07, Acts of the 72nd Legislature, First Called Session (1991). The new sections are adopted under Health and Safety Code, §47.008(c); Human Resources Code, §32.024(v); and Chapter 1347, §7, Acts of the 76th Legislature, 1999 (HB 714) which authorize the Texas Board of Health (board) to adopt rules to implement the state's newborn hearing screening program. The new sections are also adopted under Health and Safety Code, §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§37.502. Definitions.

The following words and terms pertain explicitly to this chapter and shall have the following meanings, unless the context clearly indicates otherwise.

(1)

Birth admission - The time after birth that a newborn remains in the birthing facility before the newborn is discharged. If a newborn is transferred to an intensive care nursery, the hearing screen must be done after the newborn is medically stable, but before the newborn or infant is released from the hospital.

(2)

Birthing facility -

(A)

a hospital licensed under Health and Safety Code, Chapter 241 that offers obstetrical services and is located in a county with a population of more than 50,000;

(B)

a birthing center licensed under Health and Safety Code, Chapter 244 that is located in a county with a population of more than 50,000 and that has 100 or more births per year; or

(C)

a hospital that offers obstetrical services or a birthing center licensed under Health and Safety Code, Chapter 244:

(i)

that participates in the State's medical assistance program; and

(ii)

is not otherwise included in paragraphs (2)(A) or (2)(B) of this section but agrees with the department to provide hearing screening services for newborns in compliance with Health and Safety Code, Chapter 47, and accepts a one-time grant from the department for the purchase of newborn hearing screening equipment prior to August 31, 2002.

(3)

Department - The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(4)

Health care provider - A registered nurse recognized as an advanced practice nurse by the Board of Nurse Examiners or a physician assistant licensed by the Texas State Board of Physician Assistant Examiners.

(5)

Hearing loss - A hearing loss averaging 30 to 40 dB HL or greater in the frequency region important for speech recognition and comprehension in one or both ears, approximately 500 through 4000 Hz.

(6)

Infant - A child who is at least 30 days but who is younger than 24 months old.

(7)

Newborn - A child younger than 30 days old.

(8)

Parent - A natural parent, stepparent, adoptive parent, legal guardian, or other legal custodian of a child.

(9)

Physician - A person licensed to practice medicine by the Texas State Board of Medical Examiners.

(10)

Intervention or follow-up care - The early intervention services described in the Individuals with Disabilities Education Act, 20 U.S.C. §§1431 - 1445.

(11)

Program - A newborn hearing screening, tracking, and intervention program certified by the department or the department's designee.

(12)

State - The State of Texas.

(13)

Consent - A statement signed by a parent, as defined in §37.502(8) of this title (relating to Definitions) agreeing that individually identified newborn information may be disclosed to the department.

(14)

Individually identifying information includes:

(A)

the name of the child or the child's parent;

(B)

the address of the child; and

(C)

a personal identifier, such as the child's social security number or Medicaid number.

(15)

Protocols - The guidelines used by the birthing facility for conducting a certified newborn hearing screening program.

§37.503. Newborn Hearing Screening, Tracking, and Intervention Program.

(a)

A birthing facility, through a program certified by the department under this subchapter, shall offer the parents of a newborn a hearing screening for the newborn for the identification of hearing loss. A birthing facility as defined at §37.502(2)(C) of this title (relating to Definitions) may offer a hearing screening to the parents of newborns who receive medical assistance (Medicaid).

(b)

The hearing screening shall be provided during the birth admission.

(c)

The parents of a newborn who is transferred to another hospital for neonatal care may be offered a hearing screening prior to discharge. If the receiving facility is a birthing facility as defined in §37.502(2) of this title (relating to Definitions) and the transferring facility did not offer the newborn's parents a hearing screening, the receiving facility shall offer a hearing screening prior to discharge.

(d)

The parents shall be informed that, upon their written consent, individually identifying information shall be disclosed by the birthing facility or the (receiving facility as defined in subsection (c) of this section to the department.

(e)

The department or the department's designee shall approve program protocols which must include procedures concerning at least the following: newborn hearing screening records; informed consent for individually identifying information to be sent to the department; disclosure of information; newborn hearing screening staff, technology, and screening procedures; reporting and referral; and data transfer. Birthing facilities which provided hearing screening services to all newborns prior to September 1, 1999, shall provide their program protocols to the department or the department's designee for review and approval. If the department's designee declines to approve a birthing facility's program protocols, the birthing facility may request a hearing concerning the decision to be conducted according to §§1.51-1.55 of this title (relating to Fair Hearing Procedures).

(f)

The department may maintain data and information on each newborn who receives services under a program.

(g)

Program protocols shall require appropriate referrals to the Interagency Council on Early Childhood Intervention as required by §621.45 of this title (relating to Primary Referral Requirements).

(h)

If a birthing facility is not required by Health and Safety Code, Chapter 47, to offer newborn hearing screening, and has chosen not to accept an equipment grant from the department to conduct newborn hearing screening, the facility must refer the parents of each newborn delivered in the facility to another birthing facility which offers newborn hearing screening.

§37.504. Certification of Screening Programs.

Program certification criteria shall include the following:

(1)

procedures for maintaining and reporting data electronically to the department, including assurances that confidentiality and general access to data meet state and federal guidelines;

(2)

obtaining parental consent according to §37.511 of this title (relating to Confidentiality and General Access to Data);

(3)

assuring that a sufficient number of screening staff, including managers and screeners, successfully complete training provided by the department or the department's designee during program implementation. Staff members who complete the department's training successfully shall be considered qualified hearing screening providers, and may train other staff members at their facilities;

(4)

providing hearing screening using equipment that meets department criteria, including but not limited to the following:

(A)

a demonstrated ability to link electronically to the department's newborn hearing screening information system;

(B)

clearance or approval for marketing for hearing screening by the Food & Drug Administration, if applicable; and

(C)

capability to identify hearing loss that meets the definition in §37.502(5) of this title;

(5)

communicating with parents, physicians or health care providers, the department, and the Interagency Council on Early Childhood Intervention with appropriate procedures for reporting screening results and providing information to parents regarding follow-up services;

(6)

procedures for distribution by birthing facilities of standardized educational materials developed and provided by the department, as well as additional materials it may select, to parents, health care providers, and physicians;

(7)

performance of program services in compliance with §37.505 of this title (relating to Program Performance Standards and Goals); and

(8)

approved protocols for program operation.

§37.505. Program Performance Standards and Goals.

(a)

Minimum acceptable levels of performance include:

(1)

All parents of newborns shall be offered a newborn hearing screen during the birth admission, and given the results of the screen;

(2)

95% of newborns shall be screened during the birth admission. Newborns whose parent(s) refuse the screening shall not be counted in reaching this percentage;

(3)

90% of newborns shall pass the birth admission screen; and

(4)

All newborns with abnormal screening results shall be reported to the newborn's attending physician or health care provider, and the department.

(b)

Goals for program performance include:

(1)

All parents of newborns shall be offered a newborn hearing screen during the birth admission, and given the results of the screen;

(2)

98% of newborns shall be screened during the birth admission;

(3)

95% of newborns shall pass the birth admission screen. Newborns whose parent(s) refuse the screening shall not be counted in reaching this percentage; and

(4)

All newborns with abnormal screening results shall be reported to the newborn's attending physician or health care provider, and the department.

§37.506. Program Certification.

(a)

The department shall certify programs in the following classifications.

(1)

Preliminary.

(A)

Preliminary certification may be awarded for a period of not more than six months to a program which has never been previously certified and has met the criteria described in §37.504 of this title (relating to Certification of Screening Programs) and §37.505(a) of this title (relating to Program Performance Standards and Goals).

(B)

A program holding preliminary certification may seek recertification based on performance data for the three months immediately preceding the program certification review.

(C)

A program holding preliminary certification may be awarded Provisional or Standard status, or may be decertified.

(2)

Standard.

(A)

Standard certification may be awarded for a period of not more than 24 months to a program that has met the criteria described in §37.504 and §37.505(a) of this title.

(B)

A program holding standard certification may seek recertification based on performance data for the 24 months immediately preceding the program certification review.

(C)

A program holding standard certification may be awarded Provisional, Standard, or Distinguished status, or may be decertified.

(3)

Distinguished.

(A)

Distinguished certification may be awarded for a period of not more than 36 months to a program that has met the criteria described in §37.504 and §37.505(b) of this title.

(B)

A program holding distinguished certification may seek recertification based on performance data for the 36 months immediately preceding the program certification review.

(C)

A program holding distinguished certification may be awarded Provisional, Standard, or Distinguished status, or may be decertified.

(4)

Provisional.

(A)

Provisional certification shall be valid for no more than six months.

(B)

Provisional certification shall be given to a program which fails to meet one or more of the criteria described in §37.504 or §37.505(a) of this title upon recertification review.

(C)

A program holding provisional certification may seek recertification review based on performance data for the six months immediately preceding the program certification review.

(D)

A program holding provisional certification may be awarded Standard status, or may be decertified.

(b)

Decertification.

(1)

A program holding a Preliminary, Provisional, Standard, or Distinguished certification may be decertified if the department or department's designee determines that the program has knowingly submitted data that does not accurately reflect the screening results obtained from each newborn or infant tested.

(2)

A program holding a Provisional certification may be decertified if it fails to meet one or more of the certification criteria or performance standards in §37.504 or §37.505(a) of this title.

(3)

If the department or the department's designee proposes to decertify a program, the department or the department's designee shall notify the program in writing and shall provide the program an opportunity for a hearing in accordance with §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures) to determine if there is evidence to support the proposed action. The program may submit a written request for a hearing to the department or the department's designee within 10 working days after receiving the notice.

(c)

Recertification Following Decertification.

(1)

A program may apply for recertification following decertification based on performance data for the six months immediately preceding the review.

(2)

A program applying for recertification after decertification may receive Standard status or may remain decertified.

(d)

Certification For Operational Programs. Hospitals that were providing newborn hearing screening to all newborns on September 1,1999, may be awarded Standard or Distinguished certification based upon compliance with §37.505(a) or §37.505(b) of this title.

(e)

Notice of Failure to Meet Performance Standards. The department or the department's designee shall notify in writing any certified program which fails to meet applicable performance standards during any two-month period.

(1)

A program notified of failure to meet performance standards shall provide to the department or the department's designee within 30 days of receipt of the notice a corrective action plan and the time frame needed to return the program to compliance.

(2)

Failure by the program to provide a written corrective action plan within 30 days may result in an immediate certification review.

(f)

Fees. No fees shall be charged for certification or re-certification.

§37.507. Information Concerning Screening Results and Follow-up Care.

(a)

Birthing facilities shall provide information regarding the results of the birth admission hearing screen to the parents, attending physician or health care provider, and to the department or the department's designee. Individually identified information will be reported to the department upon written consent of the parents.

(b)

Birthing facilities must provide information recommended by the department to the parents regarding available follow-up services for newborns and infants with abnormal screening results.

§37.508. Training and Technical Assistance by Department.

The department or its designee will provide training and technical assistance associated with the implementation or maintenance of a certified program.

§37.509. Information Management, Reporting, and Tracking System.

(a)

The department shall provide appropriate information management, reporting, and tracking software to birthing facilities that provide newborn hearing screening under the State's medical assistance program provided under Human Resources Code, Chapter 32.

(b)

The department shall offer birthing facilities participating in the medical assistance program software for the newborn hearing screening program. Birthing facilities must report the resulting information in a format and according to a time frame specified by the department.

(c)

Birthing facilities which, on September 1, 1999, were offering newborn hearing screening to all newborns utilizing information management, reporting, and tracking software not provided by the department, or that do not participate in the medical assistance program shall cooperate with the department's designee to report screening information to the department in a format and according to a time frame specified by the department.

(d)

Hospitals, audiologists, qualified hearing screening providers, intervention specialists, educators, and others who receive referrals from programs under this chapter shall either provide the needed services or refer the children to another provider of the needed services, and with consent shall provide the following information, where available, to the department or its designee:

(1)

results of follow-up care;

(2)

results of audiologic testing of infants identified with hearing loss;

(3)

reports on initiation of intervention services; and

(4)

results of follow-up and testing on children served under the state's medical assistance program under Human Resources Code, Chapter 32, who are eligible for services and hearing aids through the department's Program for Amplification for Children of Texas.

§37.510. Texas Department of Health Responsibilities.

(a)

The department shall use the information provided under §37.509 of this title (relating to Information Management, Reporting, and Tracking System) to plan, monitor and evaluate programs, including the screening, follow-up, diagnostic, and intervention components.

(b)

The department may use the collected information to monitor for health events of epidemiological importance.

§37.511. Confidentiality and General Access to Data.

(a)

The birthing facility shall obtain a statement of consent from the parent, guardian, or managing conservator if individually identifying information for newborns tested under this chapter is disclosed to the department or its designee.

(b)

All primary referral sources identified in §621.45 of this title (relating to Primary Referral Requirements) shall provide information concerning children diagnosed with hearing loss to the Interagency Council on Early Childhood Intervention.

(c)

The department shall prepare appropriate language for consent forms for disclosing individually identifying information and shall make samples available to birthing facilities.

(d)

At any time a parent may request in writing that individually identifying information concerning his or her child be removed from the department's newborn hearing screening system by contacting the Texas Department of Health, Audiology Services Program, 1100 West 49th Street, Austin, Texas, 78756. The department shall act on any request in a timely manner.

(e)

All information which identifies individuals shall be protected as confidential medical information in accordance with the Medical Practice Act, Occupations Code, Chapter 159.

(f)

A birthing facility and any other entity or person cited in Health and Safety Code, §47.009 which discloses individually identifying information regarding newborn hearing screening results to the department in good faith pursuant to this section is not subject to civil or criminal liability, as provided by Health and Safety Code, §47.009.

(g)

If consent to disclose individually identifying information to the department is obtained, the facility obtaining consent shall maintain the consent in the patient's medical record.

§37.512. Authorized Medicaid Newborn Hearing Services.

(a)

A newborn hearing screening test performed by a birthing facility in accordance with Health and Safety Code, Chapter 47 and the requirements of this subchapter for a newborn who receives medical assistance or who is Medicaid-eligible is a covered service of the Texas Medical Assistance (Medicaid) Program.

(b)

Any necessary diagnostic follow-up care related to the newborn hearing screening test provided to a newborn who receives medical assistance or who is Medicaid-eligible is a covered service of the Texas Medical Assistance Program.

(c)

The reimbursement rates and methodology for covered services described in this section shall be established by the Texas Health and Human Services Commission.

(d)

A Medicaid birthing facility described in §37.502(2)(A) or (B) of this title (relating to Definitions) shall implement its newborn hearing screening program by the dates required by Chapter 1347, §6, Acts of the 76th Legislature, 1999 (HB 714).

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 21, 2000.

TRD-200002862

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: May 11, 2000

Proposal publication date: December 3, 1999

For further information, please call: (512) 458-7236

Chapter 157. EMERGENCY MEDICAL CARE

Subchapter C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL

25 TAC §157.41

The Texas Department of Health (department) adopts new §157.41 concerning the minimum training required to use an automated external defibrillator (AED) with changes to the proposed text as published in the December 3, 1999, issue of the Texas Register (24 TexReg 10729).

In accordance with the Health and Safety Code, §779.002(b), 76th Legislature, 1999, the department is required to adopt rules concerning minimum training standards for AED, an electronic medical device which is capable of recognizing the presence or absence of cardioventricular fibrillation and is capable of determining whether defibrillation should be performed.

The department received two public comments during the comment period. The department is making the following minor changes due to comments to clarify the intent and improve the accuracy of the section.

Comment: Two commenters suggested deleting the definition of a Semi Automated External Defibrillator since individuals using the device are not covered by the immunity law. The commenters also suggested training by nationally recognized organizations for Cardio Pulmonary Resuscitation (CPR) and Automated External Defibrillators be added to the section.

Response: The department agrees and has deleted the reference to Semi Automated External Defibrillators in §157.41(c)(2), (d), (e), and (f).

Comment: Concerning §157.41(d), the commenters requested that a clarifying statement referring to the American Heart Association, the American Red Cross or other nationally recognized association for a training course in CPR or AED operation be added.

Response: The department agrees and has added the statement.

The comments on the proposed rule were received from the American Heart Association.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the section.

Change: Concerning §157.41(c)(1), staff suggested changing the word "delivers" to" requests the operator to deliver" because the electrical impulse is not automatic.

Change: Concerning §157.41(a), the acronym AED has been added for clarity.

The new section is adopted under the Health and Safety Code, Chapter 779, which provides the Board of Health (board) with the authority to adopt rules to implement the Emergency Medical Services Act; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§157.41. Automated External Defibrillators.

(a)

Purpose. The purpose of this rule is to establish minimum standards and requirements for training of persons using automated external defibrillators (AED).

(b)

Exemption. This section shall not apply to persons who are licensed, certified or registered under the Texas Health and Safety Code, Chapter 773.

(c)

Definitions.

(1)

Automated External Defibrillator (AED) - An electronic medical device approved by the United States Food and Drug Administration which is capable of recognizing the presence or absence of cardioventricular fibrillation or rapid cardioventricular tachycardia; is capable of determining, without interpretation of cardiac rhythm by an operator, whether defibrillation should be performed and, on determining that defibrillation should be performed, automatically charges and requests the operator to deliver an electrical impulse to an individual's heart.

(2)

Cardiopulmonary Resuscitation (CPR) - A life saving procedure involving closed chest compressions and artificial respiration to an individual who is pulseless and apneic or who is experiencing agonal respiration.

(d)

Training required. A person acquiring and/or using an AED shall successfully complete a training course in CPR and AED operation in accordance with the guidelines approved by the American Heart Association, the American Red Cross, other nationally recognized associations, or the medical director of the local emergency medical services provider. The person shall maintain that training in accordance with the guidelines established by the training association.

(e)

Notification required. A person or entity who acquires an AED shall immediately notify all local emergency medical service providers of the existence, physical location and type of device.

(f)

Guidelines and procedures for use. Use of an AED shall be in accordance with the guidelines established as nationally recognized standards and shall be in accordance with the manufacturer's operating procedures.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 21, 2000.

TRD-200002845

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 1, 2000

Proposal publication date: December 3, 1999

For further information, please call: (512) 458-7236