Part 1. DEPARTMENT OF STATE HEALTH SERVICES
Chapter 37. MATERNAL AND INFANT HEALTH SERVICES
Subchapter S. NEWBORN HEARING SCREENING
The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts amendments to §§37.501 - 37.512, concerning newborn hearing screening without changes to the proposed text as published in the December 1, 2006, issue of the Texas Register (31 TexReg 9678) and, therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The sections were adopted in May, 2000, to implement Health and Safety Code, Chapter 47. Birthing facilities subject to Health and Safety Code, Chapter 47, have been operating since September 2001, and are currently providing hearing screening for 98 percent of all infants born in the state according to the sections.
Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 37.501 - 37.512 have been reviewed; and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.
SECTION-BY-SECTION SUMMARY
Section 37.501 has been amended to simplify and increase the readability of the text.
Section 37.502(3) has been amended to incorporate the department's current name. Section 37.502(4) has been amended because the 79th Texas Legislature changed the name of the "Texas State Board of Physician Assistant Examiners" to the "Texas Physician Assistant Board." Section 37.502(9) has been amended because the 79th Texas Legislature changed the name of the "Texas State Board of Medical Examiners" to the "Texas Medical Board."
Section 37.503(g) has been amended to change the name of the "Interagency Council on Early Childhood Intervention" to "Early Childhood Intervention Services" and to clarify that the reference "25 TAC §621.45 of this title (relating to Primary Referral Requirements)" was transferred to 40 TAC §108.61, effective March 1, 2004. Section 37.503(g) has also been amended to require that facilities refer infants with confirmed or suspected hearing loss to Early Childhood Intervention Services, either directly or through the department. Section 37.503(h) has been amended to clarify how facilities that are not subject to Health and Safety Code, Chapter 47, and that did not accept an equipment grant from the department must refer newborns delivered at those facilities to other participating facilities and enter necessary data concerning the referral facility into the system. New §37.503(i) requires facilities that are not required by law to screen newborns for hearing loss but choose to do so, to notify the department and comply with all applicable certification requirements.
Section 37.504(5) has been amended to change the name of the "Interagency Council on Early Childhood Intervention" to "Early Childhood Intervention Services" and to clarify that follow-up, as well as screening results, must be reported to the department.
Section 37.505(b) has been amended to increase the clarity of the section.
New subparagraphs (C) in §37.506(a)(2) and (3) clarify that, during both Standard and Distinguished certification review, programs will retain their then-current certifications. Existing subparagraphs (C) in §37.506(a)(2) and (3) have been relettered as §37.506(a)(2)(D) and (3)(D), respectively. Section 37.506(d) has been deleted because the option is outdated and no longer relevant to the administration of the newborn hearing screening program. Subsections (e) and (f) of §37.506 have been relettered as §37.506(d) and (e), respectively.
Section 37.507(b) has been amended to increase the clarity of the section.
Section 37.508 has been amended to clarify that birthing facilities that operate certified newborn hearing screening programs may request needed technical assistance and training.
Section 37.509(c) has been deleted, thereby requiring all birthing facilities subject to Health and Safety Code, Chapter 47, to utilize information management, reporting, and tracking software provided by the department. With the deletion of §37.509(c), §37.509(d) has been relettered as §37.509(c); and the word "hospitals" has been deleted and added to new §37.509(e) to clarify the responsibility of hospitals for follow-up referrals. New §37.509(d) clarifies the responsibilities of hearing professionals concerning referrals of infants with late onset hearing loss.
The title of §37.510 has been amended to increase clarity and readability.
Section 37.511(b) has been amended to clarify that the Interagency Council on Early Childhood Intervention now functions as Early Childhood Intervention Services, a part of the Department of Assistive and Rehabilitative Services. Additionally, §37.511(b) has been amended because §621.45 of this title (relating to Primary Referral Requirements) was transferred to 40 TAC §108.61, effective March 1, 2004. Section 37.511(d) has also been amended to reflect the current name of the department and the program.
Section 37.512(d) has been deleted because it is outdated, referring to the initiation of newborn hearing screening at certain birthing facilities as mandated by Health and Safety Code, Chapter 47, not later than 2001.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared responses to comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The commenters were governmental entities and groups, including the following: Parkland Health and Hospital System (Parkland) and Pediatrix Medical Group (Pediatrix). The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of the comments.
Comment: Concerning §37.509(c), Parkland stated that, according to its cost analysis, if it were forced to change its current protocol and print and distribute letters notifying parents and physicians of screening results using the state system, it will incur an additional annual cost of at least $75,000. In the alternative, Parkland requested that the department consider allowing it to utilize a different method of notification. Parkland stated that the department's cost analysis revealed no anticipated fiscal impact to the state or local governments and is, therefore, inaccurate.
Response: The commission disagrees because Parkland's cost analysis was based on its unique system, which utilizes a different workflow than that used by the state. The state's cost analysis was based on the state's system. The department acknowledges Parkland's request to continue to utilize its current procedure, rather than the state's notification method, and has worked with the state's software vendor to add a discharge field to the state's newborn hearing screening application. This field can be used in lieu of printing letters from the system and will address Parkland's concern over the duplicate cost of documentation. No change was made as a result of this comment.
Comment: Concerning §37.509(c), Pediatrix encouraged the department to continue the variance facility interface program application that has been in place since September 1, 2001, and also asked that all of its current operational programs have access to the interface.
Response: The commission disagrees because the interface application continues to be unstable and unreliable and, therefore, should no longer be utilized. The department has determined that costs to replace and maintain an interface application for nine facilities would be excessive. Thirty-six other hearing screening programs managed by Pediatrix already use the state system, and the department has no reason to believe the eight facilities in addition to Parkland that currently utilize the variance interface could not begin using the state's web-based system. Health and Safety Code, §47.007(a), states that the department shall provide each birthing facility that provides newborn hearing screening under the state's medical assistance program provided under Human Resources Code, Chapter 32, with the appropriate information management, reporting and tracking software for the program, but does not require the department to continue indefinitely to support an alternative software interface application. No change was made as a result of this comment.
Comment: Concerning §37.509(c), the commenter, representing Pediatrix Medical Group, stated in public comment that using the Pediatrix system minimizes human errors by eliminating the need to duplicate data entry while inputting data and has allowed Pediatrix to use more of their human resources towards achieving the hearing screening goals for their program.
Response: The commission disagrees because the state newborn hearing screening application has a feature that allows users to upload identified data from the system for use in other systems, so duplicate data entry is unnecessary. No change was made as a result of this comment.
LEGAL CERTIFICATION
The Department of State Health Services, General Counsel, Cathy Campbell, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The adopted rules are authorized by Health and Safety Code, §47.004(d) and §47.008(c); and by Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter, 1001. Review of the sections implements Government Code, §2001.039.
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 March 14, 2007.
TRD-200701020
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: April 3, 2007
Proposal publication date: December 1, 2006
For further information, please call: (512) 458-7111 x6972