Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Subchapter P. SURVEILLANCE AND CONTROL OF BIRTH DEFECTS
25 TAC §§37.301 - 37.306
The Executive Commissioner of the Health and Human Services
Commission on behalf of the Department of State Health Services (department)
proposes amendments to §§37.301 - 37.306, concerning the surveillance
and control of birth defects.
BACKGROUND AND PURPOSE
The amended sections correlate with current state law on birth defect monitoring
(Health and Safety Code, Chapter 87, Birth Defects) and allow for passive
data collection and reporting of Fetal Alcohol Syndrome (FAS) cases identified
at any age.
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 37.301
- 37.306 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
Amendments to §§37.301 - 37.306 provide for revisions to clarify
text and delete references to legacy agency names and redundant language.
Amendment to §37.303 adds a new definition for "surveillance" and provides
clarification to other definitions. The new §37.305(b)(4) adds new language
to provide guidance for passive data collection and reporting of Fetal Alcohol
Syndrome. Amendment to §37.305(d)(2) adds new language to clarify passive
data collection.
FISCAL NOTE
Mark Canfield, Ph.D., Manager, Birth Defects Epidemiology and Surveillance
Branch, has determined that for the first five-year period the sections are
in effect, there will be no fiscal implications to state or local government
as a result of enforcing or administering the sections as proposed, because
there is no cost impact to state or local government.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Dr. Canfield has also determined that there will be no effect on small
businesses or micro-businesses required to comply with the sections as proposed.
This was determined by interpretation of the rules that small businesses and
micro-businesses will not be required to alter their business practices in
order to comply with the sections. There are no anticipated economic costs
to persons who are required to comply with the sections as proposed. There
is no anticipated negative impact on local employment.
PUBLIC BENEFIT
In addition, Dr. Canfield has also determined that for each year of the
first five years the sections are in effect, the public will benefit by an
enhanced ability for the department to collect data on FAS and implement early
intervention strategies.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendments do not restrict
or limit an owner's right to his or her property that would otherwise exist
in the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Mark Canfield, Ph.D., Department
of State Health Services, 1100 West 49th Street, Austin, Texas 78756 (512)
458-7232, fax (512) 458-7330. Comments will be accepted for 30 days following
publication of the proposal in the
Texas Register
.
STATUTORY AUTHORITY
The amendments are proposed under Health and Safety Code, §87.021,
which requires the department to adopt rules on the operation of the birth
defects program; §87.022 which requires the department to adopt rules
on how information will be collected and made available; 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 Chapter 1001, Health and Safety
Code.
The proposed amendments affect Health and Safety Code, Chapters 87 and
1001; and Government Code, Chapter 531. Review of the rules implements Government
Code, §2001.039.
§37.301.Purpose.
These sections implement the provisions of [
§37.302.Policy.
(a)
(No change.)
(b)
It is the policy of the
program
[
(c)
It is also the policy of the
program
[
§37.303.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1) - (2)
(No change.)
(3)
Case finding--The process used to identify potential cases
for inclusion in the central registry of the
program
[
(4)
Central registry--Cases of birth defects obtained through
the surveillance activity of the
program
[
(5)
Commissioner--The
Department of State Health Services
Commissioner [
(6)
(No change.)
(7)
Department--The
Department of State Health Services
[
(8) - (9)
(No change.)
(10)
Health facility--Any of the following types of facility:
(A) - (C)
(No change.)
(D)
a state hospital [
(E) - (H)
(No change.)
(11) - (13)
(No change.)
(14)
Surveillance--The systematic collection,
analysis interpretation, and dissemination of health data on an ongoing basis.
(A)
Active surveillance--program staff regularly contact or
visit data sources to find and collect data on cases.
(B)
Passive surveillance--program receives case reports from
data sources.
(15)
[
§37.304.Confidentiality of Information Provided to the Department.
(a)
Reports, records, and other information collected by, or
provided to the
department
[
(b)
(No change.)
§37.305.Surveillance of Birth Defects: Central Registry.
(a)
(No change.)
(b)
In order for information related to a child to be included
in the central registry, the following conditions must be met.
(1) - (3)
(No change.)
(4)
In addition, reports of Fetal Alcohol
Syndrome Disorders (FASD), regardless of the affected person's age, will be
collected under Health and Safety Code, §87.021(f), of the statute providing
for passive data collection.
(c)
(No change.)
(d)
Interaction between department staff and staff at facilities
is detailed below:
(1)
(No change.)
(2)
Potential cases are obtained by department staff through
review of medical and health records, logs, indices, appointment rosters,
and other records.
Cases may also be obtained through passive reporting
from health facilities and health professionals.
(3)
(No change.)
(e)
(No change.)
§37.306.Access to Information in the Central Registry.
(a)
An application for access to any confidential data elements
for individual patients identified as part of the operation of the central
registry must contain a protocol and be submitted to the
program manager
[
(1) - (12)
(No change.)
(b)
After the
program manager
[
(c)
The evaluation criteria for approval by the
program
[
(1) - (10)
(No change.)
(d)
(No change.)
(e)
If the applicant intends to contact individuals whose names
were provided by the
program
[
(f)
If the protocol is approved by both the
program
[
(g)
If permission is granted, the applicant shall be responsible
for costs incurred by the
program
[
(h)
Prior to release of any data, the
program manager
[
(1)
the applicant shall not allow any person other than those
identified in the protocol, to access, use, or otherwise review the data supplied
by the
program
[
(2)
there shall be no deviation from the protocol without explicit
advance review and approval by the
program
[
(3)
information obtained in the course of activities undertaken
or supported using the data from the
program
[
(4)
all data, data tapes and disks, hard copy output, interview
questionnaires or other materials provided by the
program
[
(5)
the
program
[
(6)
the applicant agrees to notify the
program manager
[
(7)
the applicant shall notify the
program manager
[
(8)
the applicant must agree to reimburse the
program
[
(i)
While the
program
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on June 16, 2005.
TRD-200502501
Cathy Campbell
Director, Legal Services
Department of State Health Services
Earliest possible date of adoption: July 31, 2005
For further information, please call: (512) 458-7236
The Executive Commissioner of the Health and Human Services Commission
on behalf of the Department of State Health Services (department) proposes
amendments to §§97.101 and 97.102, concerning the statewide immunization
of children and immunizations required upon admission of a child to the Texas
Department of Criminal Justice, Department of Aging and Disability Services,
Department of State Health Services, or the Texas Youth Commission and new §97.221,
concerning the Department of State Health Services Immunization Schedule.
BACKGROUND AND PURPOSE
During the 78th Legislative session, the Texas Legislature passed House
Bill 2292, implemented by Health and Safety Code, §161.004, which allows
an additional exemption from immunizations for Texas children and students
for reasons of conscience, including a religious belief. The implementation
of this legislative mandate required minor revisions to §§97.101
and 97.102. The proposed amendments to §§97.101 and 97.102 update
section numbers for accurate reference of the previous rules updates and also
update numerous subsections to accurately reflect changes to the immunization
requirements, which were approved in 2004, for Texas child-care facilities,
public or private primary and secondary schools, and students enrolled in
health-related and veterinary courses in institutions of higher education.
The proposed §97.221, for the adoption of a Department of State Health
Services Immunization Schedule, also requires revisions to §§97.101
and 97.102. The new §97.221, Department of State Health Services Immunization
Schedule, will serve as an immunization reference to directors and school
nurses at child-care facilities, public or private primary and secondary schools,
and institutions of higher education. Physicians and hospitals will also benefit
from the adoption of the Department of State Health Services Immunization
Schedule as a reference for determining age-appropriate vaccination of their
patients. The Department of State Health Services will make the schedule available
on the Immunization Branch's website at www.ImmunizeTexas.com. The department
consulted with the Texas Department of Criminal Justice, Texas Youth Commission,
Department of Aging and Disability Services, Department of Family Protective
Services, and Texas Education Agency in developing these rules.
SECTION-BY-SECTION SUMMARY
Amendments to §§97.101 and 97.102 provide clarifications to the
rules and corrections to section numbers within the rule language. Section
97.101 provides a new definition of the immunization record information that
providers may be required to furnish on children that have been immunized
or referred for immunizations. Section 97.102 adds new language that allows
the periodic review of facilities immunization records and provides a new
definition of the immunization record information that facilities are required
to maintain. Section 97.221 is a schedule that indicates the recommended ages
for routine administration of currently licensed childhood vaccines for children
through age 18 years.
FISCAL NOTE
Casey S. Blass, Section Director, Disease Prevention and Intervention Section,
has determined that for each year of the first five years that the sections
will be in effect there will be no fiscal implications to state or local government
as a result of enforcing and administering the sections as proposed.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Mr. Blass has also determined that there will be no effect on small businesses
or micro-businesses required to comply with the sections as proposed. This
was determined by interpretation of the rules that small businesses and micro-businesses
will not be required to alter their business practices in order to comply
with the sections. There are no anticipated economic costs to persons who
are required to comply with the sections as proposed. There is no anticipated
negative impact on local employment.
PUBLIC BENEFIT
In addition, Mr. Blass has also determined that for each year of the first
five years the sections are in effect, the public will benefit from adoption
of the sections. The public benefit anticipated as a result of enforcing or
administering §§97.101 and 97.102 is to increase the clarity and
accuracy of the sections involved in this proposal. The public benefit anticipated
as a result of enforcing and administering §97.221 as proposed will be
to increase the availability of an immunization schedule.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendments and new rule
do not restrict or limit an owner's right to his or her property that would
otherwise exist in the absence of government action and, therefore, do not
constitute a taking under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Victoria Brice, Disease Prevention
and Intervention Section, Department of State Health Services, 1100 West 49
th Street, Austin, Texas 78756, (512) 458-7111, extension 6658, or (800) 252-9152.
Comments will be accepted for 30 days following publication of this proposal
in the
Texas Register
.
Subchapter D. STATEWIDE IMMUNIZATION OF CHILDREN BY HOSPITALS, PHYSICIANS, AND OTHER HEALTH CARE PROVIDERS
25 TAC §97.101, §97.102
STATUTORY AUTHORITY
The amendments are proposed under Health and Safety Code, §81.023,
which requires the State Health Services to develop immunization requirements
for children; and 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 Chapter 1001, Health and Safety Code.
The amendments affect Health and Safety Code, §81.023, and Chapter
1001; Government Code, Chapter 531; Texas Education Code, §§38.001
and 51.933; and Human Resource Code, §42.043.
§97.101.Statewide Immunization of Children.
(a)
Every person less than 18 years old shall be immunized
against vaccine-preventable diseases in accordance with the immunization schedule
adopted by the
Executive Commissioner of the Health and Human Services
Commission as referenced in §97.221 of this title (relating to the Department
of State Health Services Immunization Schedule)
[
(b)
The vaccine requirements shall be those required for children
and students under §§97.61 -
97.72
[
(c) - (e)
(No change.)
(f)
If requested by the local health unit, local health department,
public health district, or the department, the provider shall furnish identifying
information on those children who have been immunized or referred for immunizations.
The information must include at least the name and date of birth of the child,
the child's address, the name and telephone number of a parent or guardian,
the month, day, and year of vaccine administration, the name or type of vaccines
administered, the name and address of the provider that administered the vaccines;
or other evidence of immunity to a vaccine-preventable disease.
[
(g)
Children are exempt from immunizations
as referenced
in §97.62 of this title (relating to Exclusions from Compliance).
[
[
[
§97.102.Immunizations Required upon Admission of a Child to the Texas Department of Criminal Justice, [
(a)
On admission of a child to a facility of the
Department
of Aging and Disability Services, Department of State Health Services
[
(b)
The provisions of §97.62 of this title (relating
to Exclusions of Compliance) and
§§97.66 - 97.69
[
(c)
The facility covered by this section shall keep an individual's
immunization record during the child's period of admission, detention, or
commitment in the facility.
Representatives of the department and local
health authorities may advise and assist these agencies in meeting these requirements.
The department may conduct periodic review of these agencies' identified immunization
records in order to allow public health officials to obtain information required
for public health purposes. The information must include at least the name
and date of birth of the child, the child's address, the name and telephone
number of a parent or guardian, the month, day, and year of vaccine administration,
the name or type of vaccines administered, the name and address of the provider
that administered the vaccines; or other evidence of immunity to a vaccine-preventable
disease.
[
[(d)
This section does not affect the requirements
of the Education Code, §2.09 and §2.091, or the Human Resources
Code, §42.043, or sections of this chapter written under their authority.]
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on June 17, 2005.
TRD-200502529
Cathy Campbell
Director, Legal Services
Department of State Health Services
Earliest possible date of adoption: July 31, 2005
For further information, please call: (512) 458-7236
25 TAC §97.221
The new rule is proposed under Health and Safety Code, §81.023,
which requires the State Health Services to develop immunization requirements
for children; and 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 Chapter 1001, Health and Safety Code.
The new rule affects Health and Safety Code, §81.023, and Chapter
1001; Government Code, Chapter 531; Texas Education Code, §§38.001
and 51.933; and Human Resource Code, §42.043.
§97.221.Department of State Health Services Immunization Schedule.
This schedule indicates the recommended ages for routine administration
of childhood vaccines.
Figure: 25 TAC §97.221 (.pdf)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on June 17, 2005.
TRD-200502528
Cathy Campbell
Director, Legal Services
Department of State Health Services
Earliest possible date of adoption: July 31, 2005
For further information, please call: (512) 458-7236
Chapter 602, §1,
73rd Legislature, adding
] Chapter 87 to the Health and Safety Code.
Chapter 87 provides the Texas Board of Health with the authority to adopt
rules relating to the surveillance and control of birth defects. The legislation
directs the Texas Department of Health [
(department)
] to develop
a statewide surveillance program.
The Texas Department of Health and
the Texas Board of Health were abolished by Chapter 198, §§1.18
and 1.26, 78th Legislature, Regular Session, 2003. Health and Safety Code,
Chapter 1001, establishes the Department of State Health Services (department),
which now administers these programs. Government Code, §531.0055, provides
authority to the Executive Commissioner of the Health and Human Services Commission
to adopt rules for the department.
Texas
Birth Defects Monitoring Division
] to limit medical researcher contact
with individuals and families identified by the central registry to only those
studies with high scientific merit with no feasible alternate means of conducting
the study.
Texas Birth Defects Monitoring Division
] to protect patient information
from disclosure through the legal process and Government Code, Chapter 552.
Texas
Department of Health's Texas Birth Defects Monitoring Division
]. Potential
cases are obtained through review of medical and health records, logs, indices,
appointment rosters and other records.
Texas Birth Defects
Monitoring Division
].
of the Texas Department of Health
].
Texas Department of Health
].
or state school
] maintained
and managed by the
Department of State Health Services and a state mental
retardation facility maintained and managed by the Department of Aging and
Disability Services
; [
Texas Department of Mental Health and Mental
Retardation
]
(14)
] Toxic substance--A substance
that has or may have toxic, carcinogenic, mutagenic, teratogenic, or other
harmful effects on humans, and includes a product that contains a toxic substance
that poses or may pose a substantial hazard to human health.
Texas Department of Health (department)
] relating to persons known to have, or suspected of having a birth
defect are confidential records and not public information and may not be
released except as described in subsection (b) of this section. The confidential
records include medical and other information obtained as part of epidemiologic
or other investigations and the records and information gathered as part of
the operation of the central registry.
Texas Department of Health's (department) director of the Texas
Birth Defects Monitoring Division
]. The protocol shall explain the applicant's
"valid scientific interest" by describing, at length:
director of
the Texas Birth Defects Monitoring Division
] receives the completed
request for information, the protocol will be reviewed by a
program
[
divisional
] review panel. The panel shall consist of the
program
manager
[
director of the Texas Birth Defects Monitoring Program
], the
unit manager
[
chief of the Bureau of Epidemiology
], and a departmental epidemiologist. Upon approval by the
program
[
divisional
] panel, the protocol shall be evaluated and
judged by the department's institutional review board. Final approval of the
protocol shall require the approval of both the
program
[
divisional
] panel and the institutional review board and shall be based
on an evaluation of the criteria listed in subsection (c) of this section.
divisional
] review panel shall include the following.
Texas Birth Defects Monitoring
Division
], the protocol must contain strong methodologic support for
the need for such contact.
divisional
] panel and the institutional review board, then the researcher
shall be considered to have established a valid scientific interest as required.
The
program manager
[
Director of the Texas Birth Defects Monitoring
Division
] shall so advise the Commissioner. The researcher will be required
to comply with the conditions of subsections (g) and (h) of this section before
any data will be released.
Texas Birth Defects Division
] in making the data available in compliance with
established procedures
for handling requests for public information.
[
§1.251 of this
title (relating to Procedures for Handling Requests for Public Information)
and Texas Department of Health Operating Procedure OP 1355.
] The applicant
shall incur the cost of the
program
[
Texas Birth Defects Monitoring
Division
] to monitor all contact with human subjects. The date of delivery
of data shall be determined by the
program manager
[
Director
of the Texas Birth Defects Monitoring Division
] based on workload and
the nature of the request.
director of the Texas Birth Defects Monitoring Division
]
shall receive from all applicants, including the principal investigators,
staff, and consultants who will receive access to any confidential central
registry data, a signed written statement guaranteeing that:
Texas Birth Defects Monitoring Division
];
Texas Birth Defects
Monitoring Division
] panel, the department's institutional review board,
and the Commissioner;
Texas Birth
Defects Monitoring Program
] shall not be used for any purpose other
than the exact purpose for which it was supplied;
Texas Birth Defects Monitoring Division
] are considered the property
of the
department
[
Texas Department of Health
] and shall
be returned to the department at the completion of the study. Any confidential
information which is copied or otherwise transferred, electronically or through
other means, shall be destroyed at the completion of the research unless otherwise
stated in the research protocol;
Texas Birth Defects Monitoring
Division, Texas Department of Health
] shall be acknowledged as a source
of birth defects or other data in all written reports, data tabulations or
publications that are produced by use of these data;
director of the Texas Birth Defects Monitoring Division
]
immediately upon receiving any request for access to data in the applicant's
possession;
director of the Texas Birth Defects Monitoring Division
] on receiving
notice of any legal action that might affect disclosure of the data, either
by subpoena, discovery, or other means; and
Texas Birth Defects Monitoring Division
] for reasonable
costs it incurs in protecting patient information from legal disclosure.
Texas Birth Defects
Monitoring Division
] utilizes
some
vital records information,
that information is the responsibility and property of the department's
Vital Statistics Unit (unit)
[
Bureau of Vital Statistics (bureau)
]. Investigators who request vital records information from the
unit
[
bureau
] must obtain approval according to the policies
of the
unit
[
bureau
].
Chapter 97.
COMMUNICABLE DISEASES
Board of Health
]. The immunization requirements are also adopted as a statewide "control
measure" for communicable diseases as that term is used in the Health and
Safety Code,
§§81.081 and 81.082
[
§81.081 and §81.082
], and as an "instruction of the department" as that term is used in
the Health and Safety Code, §81.007.
97.77
]
of this title (relating to Immunization Requirements in Texas Elementary and
Secondary Schools and Institutions of Higher Education). Additional copies
of Immunization Requirements in Texas Elementary and Secondary Schools and
Institutions of Higher Education may be obtained from
the Department
of State Health Services,
[
Texas Department of Health,
] 1100
West 49th Street, Austin, Texas 78756-3180, (512) 458-7284.
The information must include at least the child's name, child's date of birth,
child's address, a parent's name, a parent's telephone number, and if applicable,
the name or type of vaccine administered, and the month, day, and year that
the vaccine was administered.
]
if:
]
(1)
immunization conflicts with the tenets
of an organized religion to which parent, managing conservator or guardian
belongs; or
]
(2)
the immunization is medically contraindicated
based on an examination of the child by a physician licensed to practice by
any state in the United States.
]
Texas Department of Mental Health and Mental Retardation ] Department of Aging and Disability Services, Department of State Health Services , or the Texas Youth Commission.
Texas Department of Mental Health and Mental Retardation
], the Texas
Department of Criminal Justice, or the Texas Youth Commission, the facility
physician shall review the immunization history of the child and administer
any needed immunization(s) or refer the child for immunization(s) to another
health care provider. Required immunizations are those set out in §97.63
of this title (relating to Required Immunizations). Copies of Immunization
Requirements in Texas Elementary and Secondary Schools and Institutions of
Higher Education may be obtained from
the Department of State Health
Services
[
Texas Department of Health
], 1100 West 49th Street,
Austin, Texas 78756-3180, (512) 458-7284.
§97.71
] of this title (relating to Provisional Enrollment) apply
to this section.
The records shall be open to inspection at all reasonable
times by a representative of the local health unit, local health department,
public health district or the department. The immunization record will record
the name or type of vaccine administered; and the month, day and year that
the vaccine was administered.
]
Subchapter J. DEPARTMENT OF STATE HEALTH SERVICES IMMUNIZATION SCHEDULE PROVIDERS