Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 1.
TEXAS BOARD OF HEALTH
Subchapter W. PRIVACY POLICY
25 TAC §1.501
The Texas Department of Health (department) adopts new §1.501
concerning the privacy of health information. Section 1.501 is adopted with
changes to the proposed text as published in the December 6, 2002, issue of
the
Texas Register
(27 TexReg 11382). The
new section informs individuals of their rights under the federal Standards
for Privacy of Individually Identifiable Health Information, 45 C.F.R. Parts
160 and 164, and the Health and Safety Code, Chapter 181, and describes the
procedures for exercising their rights.
The new section informs individuals of the requirements for obtaining a
notice of the department's privacy practices; accessing protected health information
(PHI) about themselves; requesting the department to amend certain records
if the records are inaccurate; requesting a report of certain disclosures
of PHI; requesting that the department limit the department's uses and disclosures
of PHI; requesting communication by different means or at different locations
than would normally be used; and, filing complaints about the department's
privacy policies or practices. The section also sets standards for uses and
disclosures of PHI within the department, and exempts certain non-profit agencies
from the requirements of the section and the Health and Safety Code, Chapter
181.
The following comments were received concerning the proposed section. Following
each comment is the department's response and any resulting changes.
Comment: Concerning §1.501(d)(5), one commenter recommended that the
rule describe the circumstances in which an individual has the right to request
a review of the department's decisions concerning access to PHI in a designated
record set.
Response: The department agrees with the comment and has amended the section
accordingly.
Comment: Concerning §1.501(g)(1), one commenter recommended that the
final sentence be deleted because it is unnecessary.
Response: The department agrees and has amended the section accordingly.
The following comment was received from department staff.
Comment: Concerning §1.501(j), one commenter recommended that uses
and disclosures of PHI within the department be further limited.
Response: The department disagrees with the comment. The department must
share PHI within the department to accomplish its public health, health care
oversight, business, and other essential functions. However, as stated in
the rule, uses and discloses of PHI within the department shall be limited
in accordance with the federal HIPAA privacy regulations, as applicable. No
change was made as a result of the comment.
Comment: Concerning the rules in general, one commenter suggested that
this rule should include only the HIPAA privacy requirements at this time,
because HIPAA privacy requirements will implement on April 14, 2003, and the
requirements of Health and Safety Code, Chapter 181 do not implement until
September 1, 2003.
Response: The department agrees with the comment and has deleted the references
and sections relating to Health and Safety Code, Chapter 181, except those
relating to the rules required for non-profit organizations. The remaining
privacy requirements will be incorporated at a later time.
An individual and department staff offered comments and were generally
in support of the new section.
The new section is adopted under the Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of each duty imposed by law on the board, the department,
and the commissioner, and Health and Safety Code, §181.053, which requires
the department to adopt rules exempting certain non-profits from the provisions
of Health and Safety Code, Chapter 181.
§1.501.Privacy of Health Information.
(a)
Purpose.
(1)
The purpose of this section is to inform individuals of
the department's privacy practices and establish department procedures to
allow individuals to exercise their rights under the federal Standards for
Privacy of Individually Identifiable Health Information, 45 Code of Federal
Regulations (C.F.R.) Parts 160 and 164.
(2)
Unless otherwise specified, this section applies only to
HIPAA-covered programs within the department.
(b)
Definitions. Unless otherwise specified, terms have the
meaning assigned by the federal Standards for Privacy of Individually Identifiable
Health Information, 45 C.F.R. §§160.103 and 164.501, or their common
use meaning.
(1)
Department - The Texas Department of Health.
(2)
Designated record set - A group of records maintained by
or for the department that consists of:
(A)
the medical records and billing records about individuals
maintained by or for the department when the department provides direct health
care services;
(B)
the enrollment, payment, claims adjudication, and case
or medical management records systems maintained by or for health plans within
the department; or
(C)
records that contain protected health information used,
in whole or in part, by or for the department to make decisions about individuals
regarding eligibility, prior authorization, treatment, or payment.
(3)
HIPAA-covered program - A department program or office
identified by the department as a health care component in accordance with
the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 45
C.F.R. Parts 160 and 164.
(4)
Non-profit organization - An organization that:
(A)
does not have as its primary purpose the provision of or
payment for health care services, but may incidental to its primary purpose
pay for health care services or prescription drugs for indigent persons; and
(B)
is organized as a non-profit corporation under the Texas
Non-Profit Corporation Act, Article 1396-1.01 et seq., Vernon's Texas Civil
Statutes, unless organized under Article 1396-2.01(C) or (D); or
(C)
is organized and operated in a way that does not result
in accrual of distributable profits, realization of private gain resulting
from payment of compensation other than reasonable compensation for services
rendered by persons who are not members of the organization, or realization
of any other form of private gain.
(5)
Protected health information (PHI) - Individually identifiable
health information about an individual, including demographic information,
which relates to the individual's past, present, or future physical or mental
health condition, provision of health care, or payment for the provision of
health care.
(6)
Record - Any item, collection, or grouping of information
that includes PHI and is maintained, collected, used, or disseminated by or
for the department.
(c)
Right to notice of privacy practices.
(1)
An individual has the right to notice of how the department
uses and discloses PHI and of the individual's rights and the department's
duties with respect to PHI.
(2)
An individual may request a copy of the notice from:
(A)
the department clinic, hospital, or office where the individual
received or receives services;
(B)
the department's Internet web site; or
(C)
the department's Privacy Officer by sending a request in
writing to the department's Privacy Officer at the Privacy Officer's electronic
mail address indicated on the department's Internet web site or at 1100 West
49th Street, Austin, Texas 78756.
(d)
Right of access to protected health information.
(1)
An individual has the right to view or obtain a copy of
PHI about the individual.
(2)
An individual must follow the Public Information Act, Government
Code, Chapter 552, and the department's procedures in §1.251 of this
title (relating to Procedures for Handling Requests for Public Information)
to access PHI about the individual held by the department.
(3)
The department will follow the time requirements and access
procedures in the Public Information Act and in §1.251 of this title
for access to records under this section.
(4)
The department will assess charges in accordance with the
Public Information Act and §1.251 of this title for access to records
under this section.
(5)
An individual who is denied access to records in a designated
record set has a right to request a review of the department's decision if
the department denied access because:
(A)
a licensed health care professional decided that giving
the individual access to the information would likely put the individual or
another person in danger;
(B)
the information refers to another person other than a health
care provider, and a licensed health care professional decided that giving
the individual access to the information would likely cause the other person
substantial harm; or
(C)
the individual's personal representative asked for the
information, and a licensed health care professional decided that giving the
personal representative access to the information would likely cause the individual
or another person substantial harm.
(6)
If the denial is reviewable, the individual will be informed
in the denial letter. An individual may submit a written request for review
in accordance with instructions in the denial letter.
(e)
Right to request an amendment to a designated record set.
(1)
An individual has the right to request an amendment to
PHI about the individual in a designated record set.
(2)
An individual must follow the procedures in §1.502
of this title (relating to an Individual's Right to Correction of Incorrect
Information) to request an amendment to PHI in a designated record set.
(3)
The department will follow the procedures in §1.503
of this title (relating to Correction Procedure) for amendments to designated
record sets under this section.
(4)
The department may deny a request for amendment if:
(A)
the department could deny access to the information under
subsection (d) of this section;
(B)
the department did not create the information;
(C)
the information is not contained in a designated record
set; or
(D)
the information is correct and complete.
(5)
An individual may submit a written statement of disagreement
if the department denies the individual's request for amendment. The written
statement must state the basis for the disagreement with the department's
decision. The statement of disagreement must be submitted in accordance with
instructions in the denial letter.
(f)
Right to report (accounting) of certain disclosures made
by a HIPAA-covered program.
(1)
An individual has the right to receive a report of certain
disclosures of the individual's PHI made by a HIPAA-covered program.
(2)
The types of disclosures that must be included in the report
are described in 45 C.F.R. §164.528, and include disclosures for public
health activities.
(3)
An individual may submit a written request for a list of
the department's HIPAA-covered programs to the department's Privacy Officer
at the Privacy Officer's electronic mail address indicated on the department's
Internet web site or at 1100 West 49th Street, Austin, Texas 78756.
(4)
An individual may submit a written request for a report
of certain disclosures of the individual's PHI made by a HIPAA-covered program
to either:
(A)
the HIPAA-covered program that is in possession of the
individual's PHI; or
(B)
the department's Privacy Officer at the Privacy Officer's
electronic mail address indicated on the department's Internet web site or
at 1100 West 49th Street, Austin, Texas 78756.
(5)
A request for a report submitted to the department's Privacy
Officer must include the name(s) of the HIPAA-covered program(s) from which
a report is requested.
(g)
Right to request further limits on uses and disclosures
of protected health information.
(1)
An individual has the right to request that the department
restrict its uses and disclosures of PHI about the individual. However, the
department is not required to agree to any restrictions.
(2)
An individual may submit a written request for restrictions
of uses and disclosures to the department's Privacy Officer at the Privacy
Officer's electronic mail address indicated on the department's Internet web
site or at 1100 West 49th Street, Austin, Texas 78756.
(h)
Right to request confidential communication from a HIPAA-covered
program by different means or at different locations.
(1)
An individual has the right to submit a written request
that the individual receive communications of PHI from a HIPAA-covered program
in a way and in a place that is most appropriate for the individual. The written
request must specify the reasonable accommodations that are required and the
HIPAA-covered program. A request related to a HIPAA-covered program that is
a health plan must include a statement as to whether the normal means of communication
of PHI could endanger the individual.
(2)
An individual may submit a written request for accommodation
to:
(A)
the HIPAA-covered program that is in possession of the
individual's PHI; or
(B)
the department's Privacy Officer at the Privacy Officer's
electronic mail address indicated on the department's Internet web site or
at 1100 West 49th Street, Austin, Texas 78756.
(3)
The individual shall be provided with a written approval
or denial of the request for accommodation.
(i)
Complaints.
(1)
An individual has the right to complain about the department's
privacy policies or how the department complies with its privacy policies
related to PHI.
(2)
An individual may file a complaint by telephone to the
number printed on the TDH HIPAA Privacy Notice, or in writing to:
(A)
the department's Privacy Officer at the Privacy Officer's
electronic mail address indicated on the department's Internet web site or
at 1100 West 49th Street, Austin, Texas 78756; or
(B)
the Texas Attorney General's Office at P.O. Box 12548,
Austin, Texas 78711.
(j)
Uses and disclosures of protected health information within
the department.
(1)
Programs or offices within the department may share PHI
as necessary to accomplish the public health, health care oversight, business,
and other essential functions of the department.
(2)
The department will use and disclose PHI within the department
in accordance with the requirements in 45 C.F.R. §164.504, when applicable.
(k)
Exemption for non-profit agencies. Certain non-profit agencies
are exempt from the requirements of this section and Health and Safety Code,
Chapter 181. A non-profit agency must meet the following criteria to be exempt:
(1)
the agency does not provide health care services or prescription
drugs as its primary business or purpose; and
(2)
incidental to its primary business or purpose the agency
may provide health care services or prescription drugs to an indigent person
receiving other services from the agency.
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 February 27, 2003.
TRD-200301471
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 14, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
25 TAC §§49.1 - 49.15, 49.17
The Texas Department of Health (department) adopts amendments
to §§49.1-49.15, and §49.17 concerning the administration of
the Oral Health Improvement Services Program (program). Sections 49.2 - 49.5,
49.7 - 49.10, 49.12, 49.15 and 49.17 are adopted with changes to the proposed
text as published in the December 6, 2002 issue of the
Texas Register
(25 TexReg 11389) as a result of staff comments received
during the comment period. Sections 49.1, 49.6, 49.11, 49.13 and 49.14 are
adopted without changes and will not be republished.
Specifically, the amendments cover program purpose; definitions; program
priorities; application process; eligibility requirements; denial; modification;
suspension and termination of services; procedure for providing services;
providers; emergency selection of providers; payment for services; coordination
of benefits and recovery of costs; appeals; confidentiality; nondiscrimination
and income guidelines.
No public comments were received during the comment period. 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 proposed §49.2(3), the first word in the definition
portion was capitalized for accuracy.
Change: Concerning proposed §49.2(10), the words "a contract with"
were inserted for clarity and the words "from the program" were deleted for
clarity.
Change: Concerning proposed §49.2(12), the words "and regulations"
were deleted as being redundant.
Change: Concerning proposed §49.2(27), the word "state" in the definition
portion was capitalized for accuracy.
Change: Concerning proposed §49.2(30), the words "and federal" were
deleted for accuracy.
Change: Concerning proposed §49.3(b), the words "oral health services"
were inserted and "dental care" was deleted for accuracy and the words "for
Providers of Services" were inserted to properly recognize the title of the
document referenced in this subsection.
Change: Concerning proposed §49.3(c), the word "medical" was deleted
from the term "regional medical director" in two places to correctly reflect
the proper title.
Change: Concerning proposed §49.3(d), the final sentence in the proposed
subsection is deleted in order to more accurately reflect statutory requirements.
Change: Concerning proposed §49.4(a)-(b), the word "treatment" was
changed to "oral health" for accuracy.
Change: Concerning proposed §49.4(c)(1)-(2), these paragraphs were
deleted as portions from both paragraphs were combined with §49.4(c)
to ensure clarity.
Change: Concerning proposed §49.5(a), the word "treatment" was replaced
with "health" for accuracy.
Change: Concerning proposed §49.5(b)(3), the word "or" was replaced
with "and" for accuracy.
Change: Concerning proposed §49.5(b)(4), the final sentence in this
proposed subsection is deleted in order to more accurately reflect statutory
requirements.
Change: Concerning proposed §49.5(c)(3), the words "Fee for Service"
were inserted to reflect the title of the document referenced in this subsection.
Change: Concerning proposed §49.5(d)-(e) the words "or in his/her
absence, the state dental director" were added for accuracy.
Change: Concerning proposed §49.7, the word "treatment" was deleted
from the term "oral treatment services" in two places and replaced with "health"
in both places for accuracy.
Change: Concerning proposed §49.8(b), the words "Dental Care" were
inserted to properly recognize the title of the document referenced in this
subsection.
Change: Concerning proposed §49.8(e), the words "the contract of"
were added for clarification.
Change: Concerning proposed §49.8(i), the referenced subsection "
(i)" was deleted and replaced with the correct subsection "(g)."
Change: Concerning proposed §49.9(b), the word "medical" was deleted
from the term "regional medical director" in two places in order to correctly
reflect the proper title.
Change: Concerning proposed §49.9(b) the word "non-state" was changed
to, "non-workday" in two places for clarity.
Change: Concerning proposed §49.10(b), the words "or, in his or her
absence, the state dental director" were added for consistency.
Change: Concerning proposed §49.10(c), this subsection was divided
into §49.10(c) and new (d).
Change: Concerning proposed §49.10(d), this section was renumbered
as §49.10(e) to reflect the addition of new §49.10(d).
Change: Concerning proposed §49.12(1), the word "action" was deleted
and replaced with "decision."
Change: Concerning proposed §49.12(5)(b), the term "25 TAC §1.51-55"
was deleted and replaced by §§1.51 - 1.55 of this tile (relating
to Fair Hearing Procedures").
Change: Concerning proposed §49.12(6), verbiage from this section
was deleted and replaced with "The department shall render the final administrative
decision in a due process hearing to modify, suspend or terminate the approval
of a provider" in order to more properly spell out a provider's due process
rights.
Change: Concerning proposed §49.15, the words, "so that no person
in the United States shall, on the ground of race, color or natural origin
be excluded from participation in, be denied the benefits of or otherwise
subjected to discrimination under any program or activity receiving Federal
assistance" were deleted.
Change: Concerning proposed §49.17, the citation"7 CFR, Part 245"
was added and the words "these sections" were deleted for clarity.
The amendments are necessary in order to update terminology recognize pertinent
statutory recodification, add necessary terms and definitions to the chapter,
and simplify and clarify the operation of the program. The amendments are
also needed in order to reflect the changes in department policies regarding
job vacancies and criteria for eligible providers.
The department published a Notice of Intention to Review §§49.1-49.15
and 49.17 in the
Texas Register
on March 22,
2002 (27 TexReg 2264). No comments were received due to the publication of
this notice.
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). The department
reviewed §§49.1-49.15 and 49.17 and determined that reasons for
adopting the sections continue to exist yet the sections need revision as
described in this preamble.
The amendments are adopted under the Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with authority to adopt rules
to implement every duty imposed by law on the board, the department and the
commissioner of health; and under the Health and Safety Code, §43.004
which authorizes the department to provide comprehensive oral health services
to eligible individuals under the Oral Health Improvement Services program,
and authorizes the board to adopt rules to govern this program; and implement
Government Code, §2001.039.
§49.2.Definitions.
The following words and terms, where used in these sections, shall
have the following meanings, unless the context clearly indicates otherwise.
(1)
Act - The Texas Oral Health Improvement Act, Texas Health
and Safety Code, Chapter 43.
(2)
Action - Denial, modification, suspension or termination
of program benefits or participation rights of an applicant or a recipient
of the program.
(3)
Administrative review - A secondary level of review available
to a provider appealing a denied claim.
(4)
Administrative sanctions - Penalties imposed on a provider
who fails to comply with program rules, procedures and standards. Administrative
sanctions include, but are not limited to, recoupment of payments, modification,
suspension or exclusion of a provider from the program.
(5)
Applicant - A person applying for the program services,
but for whom eligibility has not been established.
(6)
Approval date - The date a submitted program voucher is
approved for payment.
(7)
Approved provider - An active, participating provider in
the program.
(8)
Board - The Texas Board of Health.
(9)
Commissioner - The commissioner of health of the Texas
Department of Health.
(10)
Conflict - The proposed modification, suspension or termination
of a contract with an approved provider.
(11)
Dentist-An individual licensed by the Texas State Board
of Dental Examiners to practice dentistry in the State of Texas.
(12)
Dentally accepted standards - Operating in accordance
with the laws relating to the practice of dentistry and the rules of the State
Board of Dental Examiners and normal standards of practice.
(13)
Department-The Texas Department of Health.
(14)
Division-The Division of Oral Health of the Texas Department
of Health.
(15)
Eligible individual-An individual who meets the criteria
necessary to receive oral health services under the Act.
(16)
Emergency care-Treatment for relief of pain and infection,
including extractions and basic restorative services to prevent premature
loss of teeth.
(17)
Nonapproved provider - A medical or dental provider authorized
to practice under state law but not currently participating in the program.
(18)
Oral health services- Preventive or treatment services
affecting the structures of the mouth, including the hard and soft tissues
such as teeth and jaws, gums, vestibule, tongue, cheeks, lips, floor, roof
of the mouth, and adjacent masticatory structures, and oral health education
and promotion activities.
(19)
Other benefit-A benefit to which an individual is entitled,
other than a benefit provided under the Act, for the payment of the costs
of oral health treatment services, including:
(A)
benefits available from:
(i)
an insurance policy, group oral health plan, or prepaid
oral care plan;
(ii)
Title XVIII or Title XIX of the Social Security Act, as
amended (42 U.S.C. §1395 et seq. and 42 U.S.C. §1396 et seq.);
(iii)
the Veteran's Administration;
(iv)
the Civilian Health and Medical Program of the Uniformed
Services; or
(v)
worker's compensation or any other compulsory employer's
insurance program;
(B)
a public program created by federal law, state law, or
the ordinances or rules of a municipality or political subdivision of the
state; or
(C)
benefits available to an individual applying for or receiving
treatment services from the department arising out of a cause of action for
dental or oral health treatment services expenses or a settlement or judgment
based upon the cause of action, if the expenses are related to the need for
treatment services provided under the Act.
(20)
Physician-An individual licensed by the Texas State Board
of Medical Examiners to practice medicine in the State of Texas.
(21)
Program-The State Fee for Service Dental Care Program
administered by the Division of Oral Health which provides oral health services
to eligible individuals.
(22)
Provider-A person who, through a contract with the department,
furnishes oral health treatment services which are purchased by the department
for the purpose of the Act.
(23)
Recipient - Any person currently eligible to receive program
benefits.
(24)
Regional dental director-The dental program director for
a public health region of the department.
(25)
Regional director - The chief authority and medical director
for a public health region of the department.
(26)
State Fee for Service Dental Care Program Manual for Providers
of Services - A manual prepared by the Division of Oral Health that sets out
the program's policies and procedures and includes program rules. Participating
providers will receive a copy of this manual and are expected to abide by
its provisions during participation in the program.
(27)
State dental director-The dental program director for
the State of Texas.
(28)
State fiscal year - The period from September 1 to August
31 of the following year.
(29)
Third-party nominator-A person aware of an applicant's
economic condition who refers the applicant to the program for services. Third-party
nominators include school administrators, school nurses, social workers, city
or county officials, public health clinics, community health centers, dentists,
physicians, or hospitals or any other source acceptable to the board.
(30)
Workday - Normal department operating hours from 8:00
a.m. - 5:00 p.m. Monday through Friday with the exception of state holidays.
§49.3.Program Priorities.
(a)
The provision of all services is subject to the availability
of funds.
(b)
In order to conform to budgetary limitations, priority
for services will be given to persons under the age of 19 years requiring
emergency care. Providers are bound by the guidelines for participation as
set forth in the State Fee For Service Dental Care Program Manual for Providers
of Services. Providers may deliver more comprehensive oral health services
to eligible recipients only with prior written approval of the regional dental
director, or in his/her absence, the state dental director.
(1)
The department adopts by reference the department's document
entitled State Fee For Service Dental Care Program Manual for Providers of
Services.
(2)
A copy of the State Fee for Service Dental Care Program
Manual for Providers of Services is indexed and filed in the Division of Oral
Health, Texas Department of Health, 1100 West 49th Street, Austin, and is
available for public inspection during regular business hours.
(c)
Occasionally, an individual cannot be treated in a dental
office or will require special treatment for aesthetic reasons or to restore
mastication. Examples include very young persons with rampant dental caries
who must be treated under general anesthesia or children whose front teeth
must be extracted and who need partials to prevent serious problems that could
be caused by their edentulous appearance. The program allows for such services,
subject to budgetary limitations. Approval of such services shall be determined
on a case by case basis by the state dental director. The attending dentist
or physician shall submit a special handling request form to the regional
dental director, or in his/her absence, the regional director. This special
handling request form includes a treatment plan, cost estimate of treatment,
and a recommendation as to the special dental needs necessitating the request.
The regional dental director, or in his/her absence, the regional director,
will add a recommendation in the appropriate space before forwarding the request
to the department for consideration. Payment will not be made for services
provided prior to the state dental director's approval, subject to the exceptions
in §49.9 of this title (relating to Emergency Selection of Providers).
(d)
Program services are available in every public health region
of the state. Program administration is carried out through the department's
public health regions.
§49.4.Application Process.
(a)
An applicant for oral health services must be referred
to the program by a third party nominator who knows the individual's economic
condition.
(b)
Each applicant for oral health services must complete or
cause to be completed an application form which shall include the following:
(1)
personal information, including name, address, birthdate,
gender and ethnicity;
(2)
a statement from the referring third party nominator that
the treatment services are necessary to prevent or reduce the probability
of pain, infection, or disease; and
(3)
a statement by the applicant or the person responsible
for the applicant's support that: services are requested; the individual is
a bona fide resident of Texas as set out in §49.5 of this title (relating
to Eligibility Requirements); the family income does not exceed the financial
guidelines; the applicant is not eligible for another program providing dental
care, and the applicant or the person responsible for the applicant's support
is financially unable to pay for all or part of the cost of the necessary
treatment services.
(c)
Each applicant who will be referred for oral health services
or who will be served directly by the department must obtain preapproval from
the regional dental director, or in his/her absence, the regional director,
or his her designee.
(d)
The denial of any application will be in writing and will
include the reason(s) for such denial. Unless the application is denied because
program funds are reduced or curtailed, the individual applying for services
has the right to an administrative review and a due process hearing as set
out in § 49.12 of this title (relating to Appeals).
(e)
An individual has the right to reapply for program coverage
at any time when there is a change of situation or condition.
§49.5.Eligibility Requirements.
(a)
In order for a person to receive oral health services,
he/she must meet the following criteria:
(1)
The person must be a bona fide resident of Texas.
(2)
A bona fide resident is a person who:
(A)
is physically present within the geographic boundaries
of the state;
(B)
has an intent to remain within the state, whether permanently
or for an indefinite period;
(C)
actually maintains an abode within the state (i.e., house
or apartment, not merely a post office box);
(D)
does not claim residency in any other state or country;
(E)
is a minor child residing in Texas and his/her parent(s)
or managing conservator or the court-appointed guardian is a bona fide resident
of Texas;
(F)
is a person residing in Texas who is the legal dependent
spouse of a bona fide resident; or
(G)
is an adult residing in Texas and his/her legal guardian
is a bona fide resident.
(b)
The person must establish a financial need for program
services. Financial need is established on the basis of family income, as
follows:
(1)
the family income used to determine eligibility is the
gross annual income of the applicant and his/her spouse, if applicable, or
the gross annual income of person(s) legally obligated to support the applicant;
(2)
gross annual income includes earned wages, pensions or
retirement benefits, child support payments received, alimony, unemployment
compensation, worker's compensation, income from rental properties, or any
monies received on a regular basis for family support purposes;
(3)
income guidelines are based on and may not exceed current
United States Department of Agriculture (USDA) poverty guidelines for determining
eligibility for free meals (school full-free lunch program guidelines); and
(4)
the guidelines are adopted by reference in §49.17
of this title (relating to Income Guidelines).
(c)
Following preapproval of an application in accordance with §49.4(c)(1)-(2)
of this title (relating to Application Process), an applicant will be referred
to a provider for a dental examination. The following criteria apply.
(1)
An applicant must have a demonstrable need for emergency
care, confirmed by a licensed dentist or physician to whom the applicant has
been referred.
(2)
The licensed dentist or physician shall certify to the
department that he/she has examined the individual and he/she has reason to
expect that the treatment services provided will prevent or reduce the probability
of the individual's experiencing pain, infection, or disease.
(3)
If the applicant meets the dental criteria, the provider
will perform the necessary treatment services as authorized by the State Fee
for Service Dental Care Program Manual for Providers of Services.
(4)
If the applicant does not meet the dental criteria, the
provider will be paid only for the examination services provided, according
to the fees authorized by the State Fee for Service Dental Care Program Manual
for Providers of Services.
(d)
Notwithstanding the provisions of subsection (c) of this
section, the final determination concerning an applicant's eligibility and
authorized services shall be made by the regional dental director or, in his/her
absence, the state dental director.
(e)
If the regional dental director or, in his/her absence,
the state dental director, determines that an applicant meets the dental criteria
and the program services delivered were authorized, the applicant's eligibility
date shall be the date upon which the application was preapproved as stated
in §49.4(c)(1)-(2) of this title (relating to Application Process). Eligibility
will be effective for the remainder of the state fiscal year in which eligibility
is established. Eligibility must be reestablished for each subsequent state
fiscal year in which program services are sought. To maintain eligibility
for program services, the individual must continue to be a bona fide resident
of the state and be in financial need in accordance with this section.
§49.7.Procedure for Providing Services.
Delivery of oral health services is accomplished by a combination of
the following delivery methods.
(1)
The department provides direct oral health services utilizing
mobile dental units in remote areas of the state unserved or underserved by
clinics or dental manpower.
(2)
The department contracts with providers for treatment of
eligible individuals. Requirements for provider participation and reimbursement
are according to the program guidelines and fee schedules set forth in the
State Fee for Service Dental Care Program Manual for Providers of Services
which is adopted by reference in §49.3 of this title (relating to Program
Priorities).
§49.8.Providers.
(a)
To apply for program participation, a prospective provider
shall, after receiving information on the program including the schedule of
current fees, sign a letter of agreement (contract) and submit such information
to the Division of Oral Health or to a Texas Department of Health regional
office. The agreement must include the prospective provider's dental license
number and social security number.
(b)
A prospective provider that meets the criteria for participation
as set forth in subsection (c) of this section is eligible to contract with
the program. After the contract is properly executed, the prospective provider
shall be notified of approval in writing and an accompanying State Fee for
Service Dental Care Program Manual for Providers of Services will be sent
as a referral guide.
(c)
Providers must meet the following criteria in order to
participate in the program.
(1)
Agree to abide by program rules and regulations.
(2)
Agree to accept program fees as payment in full.
(3)
Treat all patients without discrimination.
(4)
Ensure that program recipients or persons legally responsible
for program recipients are not billed for the difference between the provider's
regular fees and those paid by the program.
(5)
Be licensed to practice dentistry or medicine in Texas
and in good standing with the Texas boards of dental or medical examiners.
Prospective providers under suspension by their respective licensing boards
will not be approved to participate in the program.
(d)
The contract between the provider and the program may be
terminated without cause by either party with 30 days written notice.
(e)
The program may modify, suspend or terminate the contract
of any provider from the program for due cause. Due cause includes but is
not limited to:
(1)
breach of contract;
(2)
suspension or revocation of the provider's license by the
State Board of Dental Examiners or the State Board of Medical Examiners;
(3)
disciplinary action(s) taken by the State Board of Dental
Examiners or the State Board of Medical Examiners;
(4)
submission of false or fraudulent claims;
(5)
amendment or judicial interpretation of federal or state
laws or other requirements in a way that would make it unfeasible or impossible
for either party to fulfill the agreement, or if either party is unable to
agree on changes necessary for the substantial continuation of the agreement;
(6)
any violations of program rules; or
(7)
any other reason authorized by rule, regulation, statute,
or contract.
(f)
Any provider who submits false or fraudulent claims, fails
to provide and maintain quality services or dentally acceptable standards,
has his/her Texas medical or dental license suspended, by either the Texas
State Board of Dental Examiners, or the Texas State Board of Medical Examiners
is subject to the state dental director's review and/or administrative sanctions.
(g)
A due process hearing is available to any provider for
the resolution of conflict between the department and the provider in accordance
with §49.12 of this title (relating to Appeals).
(h)
The department may not terminate a contract during the
pendency of a hearing. The department may withhold payments during the pendency
of a hearing, but the department shall pay the withheld payments and resume
contract payments if the final determination is favorable to the provider.
(i)
Subsections (g) and (h) of this section do not apply if
a contract is canceled by the department because of exhaustion of funds, if
the contract expires according to its terms, or if the contract is canceled
because program services are restricted to conform to budgetary limitations.
§49.9.Emergency Selection of Providers.
(a)
The department may only pay nonapproved providers for emergency
care delivered in cases where approved providers are not available or able
to provide the emergency care and when delay in providing care would be detrimental
to the patient's health.
(b)
Nonapproved providers must request authorization to provide
immediate emergency services prior to the delivery of services. Such request
may be by phone to the regional dental director, or in his/her absence, the
regional director, who will, after consulting with the state dental director
or his/her designee, approve or disapprove services by phone, followed by
written confirmation of approval/disapproval. In the event immediate emergency
treatment is needed on a non-workday, a nonapproved provider may provide treatment,
with verbal approval to be obtained on the first state workday after services
are provided. No payment will be made for services provided before the date
verbal approval is given, except in situations when treatment is provided
on a non-workday workday and the regional dental director, the regional director,
or the state dental director cannot be contacted for prior approval.
§49.10.Payment for Services.
(a)
Payment will not be made to providers for services not
authorized by the program. Payment for any service may be made only after
the service has been delivered and the state dental director has made a final
determination that the program dental criteria were met and the services were
authorized. Providers must agree to accept program fees as payment in full
for the service provided, although such fees may be below usual and customary
charges.
(b)
Claims from providers will be paid if submitted on the
program voucher (Form N-18), services are provided within 60 days of the voucher's
approval date, and an affirmative final determination has been made by the
regional dental director or, in his or her absence, the state dental director.
The program voucher must be submitted to the regional dental director within
75 days of the voucher's approval date.
(c)
Claims will be denied if they contain incomplete or inaccurate
information, are submitted on the wrong form, are for unauthorized services,
are not submitted within the stated timeframe, or are for services provided
to persons ineligible for the program.
(d)
A claim that has been denied by the program may be reconsidered
for payment if the provider requests an administrative review. In order to
receive an administrative review of the denied claim, the provider must request
the administrative review in writing and return the claim, with the alleged
error identified, to the program within 30 days from receipt of the notice
of denial, accompanied by appropriate documentation for review.
(e)
The program may pay claims which are submitted beyond the
stated time limit on the program voucher if there are special or extenuating
circumstances which make it impossible or impractical for the provider to
complete services within that time period. Such claims will be evaluated by
the department on an individual basis, with due consideration given to the
circumstances and the regional dental director's recommendation for disposition
for the claim.
§49.12.Appeals.
Any applicant or recipient aggrieved by a program action may appeal
the action in the following manner:
(1)
Within 10 working days of receiving notice of the action,
any grievant who desires an administrative review shall notify the program
by mail of his/her request for an administrative review of the program's action.
Additional information bearing on the decision may be submitted at this time.
Failure to request an administrative review within the 10-day period is deemed
to be a waiver of the administrative review.
(2)
Upon timely receipt of a request for an administrative
review, a program administrative review team will affirm or reverse the proposed
action and respond in writing to the person, giving the reason(s) for the
decision.
(3)
If the action is upheld in whole or in part by the administrative
review team, the aggrieved may request a due process hearing from the program
within 10 days of receiving written notice of the administrative review team's
decision. The aggrieved must request a due process hearing by mail. Failure
to request the hearing within the 10-day period is deemed to be a waiver of
the due process hearing and the proposed action shall be taken.
(4)
Even if an aggrieved person does not request an administrative
review, the aggrieved person may request a due process hearing from the program
within 10 days of receiving notice of denial, modification, suspension, or
termination of benefits or participation rights. The aggrieved person's request
for a hearing shall be sent to the department by mail. Failure to request
a hearing within the 10-day period is deemed to be a waiver of the hearing
and the proposed action shall be taken.
(5)
The department will set a date, time, and place for each
due process hearing. The hearing will not be conducted under the contested
case provisions of the Administrative Procedure Act, Texas Government Code,
Chapter 2001, but shall include the following:
(A)
a timely written notice to the aggrieved person of the
matters asserted;
(B)
an opportunity for the aggrieved person to receive a fair
hearing by a hearing examiner, either by telephone conference call or in person,
under §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).
(C)
an opportunity for the aggrieved person to be represented
by counsel or other representative;
(D)
an opportunity for the aggrieved person or representative(s)
to be heard in person, to call witnesses, and to present documentary evidence;
(E)
an opportunity for the aggrieved person to cross-examine
witnesses;
(F)
a written recommendation by the hearing examiner to the
commissioner, setting forth the reasons for the recommendation and the evidence
upon which the recommendation is based; and
(G)
the final written decision to be made by the commissioner.
(6)
The department shall render the final administrative decision
in a due process hearing to modify, suspend or terminate the approval of a
provider.
§49.15.Nondiscrimination.
The Texas Department of Health operates in compliance with Title VI
of the Civil Rights Act of 1964 (Public Law 88-352) and 45 Code of Federal
Regulations Part 80.
§49.17.Income Guidelines.
The department adopts by reference the United States Department of
Agriculture (USDA) poverty guidelines for determining eligibility for free
meals set out in 7 CFR, Part 245. A copy of the guidelines is filed in the
Division of Oral Health, Texas Department of Health, 1100 West 49th Street,
Austin, Texas, and is available for public inspection during regular working
hours.
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 3, 2003.
TRD-200301498
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 23, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
25 TAC §84.1
The Texas Department of Health (department) adopts new §84.1
concerning the establishment of the State Preventive Health Advisory Committee
(committee). Section 84.1 is adopted with changes to the proposed text as
published in the December 6, 2002, issue of the
Texas Register
(27 TexReg 11395).
The committee was created in 1992 by federal legislation now codified in
42 USC §300w-4(d). The purpose of the committee is to provide advice
to the Texas Board of Health (board) and the department regarding activities
to be supported with Preventive Health and Health Services Block Grant (PHHSBG)
funds, the conduct of needs assessments, the allocation of payments, and the
collection of data.
Government Code, Chapter 2110 requires that each state agency adopt rules
on advisory committees. The rules must state the purpose and tasks of the
committee, describe the manner in which the committee will report to the agency,
and establish a date on which the committee will be automatically abolished
unless the governing body of the agency affirmatively votes to continue the
committee's existence.
The committee was previously exempt from Government Code, Chapter 2110,
relating to state agency advisory committees, because it is federally mandated.
However, the 77th Texas Legislature passed House Bill 2914 (Chapter 1158, §§45-52)
which amended the former legislation and resulted in the committee now being
subject to the provisions in the code.
No comments were received on the proposal during the comment period. However,
the department is making the following change due to a staff comment to clarify
the accuracy of the section.
Change: Concerning §84.1(m)(6), the word "rade" was deleted, and the
word "trade" was inserted.
The new section is adopted under the Health and Safety Code, §11.016,
which allows the board to establish advisory committees; the Government Code,
Chapter 2110, which sets standards for the evaluation of advisory committees
by the agencies for which they function; and Health and Safety Code, §12.001,
which provides the board with authority to adopt rules to implement every
duty imposed by law on the board, the department, and the commissioner of
health.
§84.1.The State Preventive Health Advisory Committee.
(a)
The committee. An advisory committee shall be appointed
under and governed by this section.
(1)
The name of the advisory committee shall be the State Preventive
Health Advisory Committee (committee).
(2)
The committee is established under Health and Safety Code, §11.016,
which authorizes the Texas Board of Health (board) to establish advisory committees
and is required by 42 USC §300w-4.
(b)
Applicable law. The committee is subject to the Government
Code, Chapter 2110, concerning state agency advisory committees.
(c)
Purpose. The purpose of the committee is to carry out the
tasks outlined in 42 USC §300w-4(d) regarding formulation of an annual
state plan for the Preventive Health and Health Services Block Grant (PHHSBG).
(d)
Tasks.
(1)
The committee shall make recommendations to the Texas Department
of Health (department) regarding the development and implementation of a state
plan, including recommendations on:
(A)
the conduct of assessments of the public health;
(B)
which of the activities authorized in 42 USC §300w-3
should be carried out in the state;
(C)
the allocation of payments made to the state under 42 USC §300w-2;
(D)
the coordination of activities carried out under the state
plan with relevant programs of other entities; and
(E)
the collection and reporting of data in accordance with
42 USC §300w-5(a).
(2)
The committee shall carry out any other tasks assigned
by the board.
(e)
Committee abolished. By January 1, 2007, the board will
initiate and complete a review of the committee to determine whether the committee
should be continued, consolidated with another committee, or abolished. If
the committee is not continued or consolidated, the committee shall be abolished
on that date.
(f)
Composition. The committee shall be composed of eight members.
(1)
The composition of the committee shall include three consumer
representatives and five non-consumer representatives.
(2)
The members of the committee shall be appointed by the
board as follows:
(A)
three consumers representing the interests of the general
public;
(B)
five non-consumer members, including the following:
(i)
the Commissioner of Health;
(ii)
the PHHSBG Coordinator;
(iii)
one department regional medical director;
(iv)
one official of a local health department; and
(v)
one representative from a Texas school of public health.
(g)
Terms of office. The term of office of each member shall
be six years.
(1)
Members shall be appointed for staggered terms so that
the terms of two members will expire on December 31 of each even-numbered
year.
(2)
If a vacancy occurs, a person shall be appointed to serve
the unexpired portion of that term.
(h)
Officers.
(1)
The Commissioner of Health serves as the presiding officer
of the committee. The presiding officer shall preside at all committee meetings
at which he or she is in attendance, call meetings in accordance with this
section, and cause proper reports to be made to the federal funding agency.
(2)
The committee shall select from its members an assistant
presiding officer. The assistant presiding officer shall perform the duties
of the presiding officer in case of the absence of the presiding officer.
(3)
If the office of assistant presiding officer becomes vacant,
it may be filled by vote of the committee.
(4)
The committee may reference its officers by other terms,
such as chairperson and vice-chairperson.
(i)
Meetings. The committee shall meet not less than twice
each federal fiscal year.
(1)
A meeting may be called by agreement of department staff
and either the presiding officer or assistant presiding officer.
(2)
Meeting arrangements shall be made by department staff.
Department staff shall contact committee members to determine availability
for a meeting date and place.
(3)
The committee is not a "governmental body" as defined in
the Open Meetings Act. However, in order to promote public participation,
each meeting of the committee shall be announced and conducted in accordance
with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception
that the provisions allowing executive sessions shall not apply.
(4)
Each member of the committee shall be informed of a committee
meeting at least five working days before the meeting.
(5)
A simple majority of the members of the committee shall
constitute a quorum for the purpose of transacting official business.
(6)
The committee is authorized to transact official business
only when in a legally constituted meeting with a quorum present.
(7)
The agenda for each committee meeting shall include an
opportunity for any person to address the committee on matters relating to
committee business. The presiding officer may establish procedures for such
public comment, including a time limit on each comment.
(j)
Attendance. Members shall attend committee meetings as
scheduled.
(1)
A member shall notify the presiding officer or appropriate
department staff if he or she is unable to attend a scheduled meeting.
(2)
It is grounds for removal from the committee if a member
cannot discharge the member's duties for a substantial part of the term for
which the member is appointed because of illness or disability or is absent
from at least four consecutive committee meetings.
(3)
The validity of an action of the committee is not affected
by the fact that it is taken when a ground for removal of a member exists.
(k)
Staff. Staff support for the committee shall be provided
by the department.
(l)
Procedures. Roberts Rules of Order, Newly Revised, shall
be the basis of parliamentary decisions except where otherwise provided by
law or rule.
(1)
Any action taken by the committee must be approved by a
majority vote of the members present once quorum is established.
(2)
Each member shall have one vote.
(3)
A member may not authorize another individual to represent
the member by proxy.
(4)
The committee shall make decisions in the discharge of
its duties without discrimination based on any person's race, creed, gender,
religion, national origin, age, physical condition, or economic status.
(5)
Minutes of each committee meeting shall be compiled by
department staff.
(A)
A draft of the minutes approved by the presiding officer
shall be provided to the board and each member of the committee within 30
days of each meeting.
(B)
After approval by the committee, the minutes shall be signed
by the presiding officer.
(m)
Statement by members.
(1)
The board, the department, and the committee shall not
be bound in any way by any statement or action on the part of any committee
member except when a statement or action is in pursuit of specific instructions
from the board, department, or committee.
(2)
The committee and its members may not participate in legislative
activity in the name of the board, the department, or the committee except
with approval through the department's legislative process. Committee members
are not prohibited from representing themselves or other entities in the legislative
process.
(3)
A committee member should not accept or solicit any benefit
that might reasonably tend to influence the member in the discharge of the
member's official duties.
(4)
A committee member should not disclose confidential information
acquired through his or her committee membership.
(5)
A committee member should not knowingly solicit, accept,
or agree to accept any benefit for having exercised the member's official
powers or duties in favor of another person.
(6)
A committee member who has a personal or private interest
in a matter pending before the committee shall publicly disclose the fact
in a committee meeting and may not vote or otherwise participate in the matter.
The phrase "personal or private interest" means the committee member has a
direct pecuniary interest in the matter but does not include the committee
member's engagement in a profession, trade, or occupation when the member's
interest is the same as all others similarly engaged in the profession, trade,
or occupation.
(n)
Reports to the board. The committee shall file an annual
written report with the board.
(1)
The report shall list the meeting dates of the committee,
the attendance records of its members, a brief description of actions taken
by the committee, a description of how the committee has accomplished the
tasks given to the committee by the board, the status of any rules which were
recommended by the committee to the board, and anticipated activities of the
committee for the next year.
(2)
The report shall identify the costs related to the committee's
existence, including the cost of agency staff time spent in support of the
committee's activities and the source of funds used to support the committee's
activities.
(3)
The report shall cover the meetings and activities in the
immediately preceding fiscal year and shall be filed with the board each January.
The report shall be signed by the commissioner.
(o)
Reimbursement for expenses. In accordance with the requirements
set forth in the Government Code, Chapter 2110, a committee member may receive
reimbursement for the member's expenses incurred for each day the member engages
in official committee business if authorized by the General Appropriations
Act or the budget execution process.
(1)
No compensatory per diem shall be paid to committee members
unless required by law.
(2)
A committee member who is an employee of a state agency,
other than the department, may not receive reimbursement for expenses from
the department.
(3)
Each member who is to be reimbursed for expenses shall
submit to staff the member's receipts for expenses and any required official
forms no later than 14 days after each committee meeting.
(4)
Requests for reimbursement of expenses shall be made on
official state travel vouchers prepared by department staff.
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 3, 2003.
TRD-200301499
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 23, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
Subchapter F. SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV)
25 TAC §§97.132, 97.133, 97.135, 97.136, 97.138, 97.139, 97.141, 97.143, 97.145, 97.146
The Texas Department of Health (department) adopts amendments
to §§97.132, 97.133, 97.135, 97.136, 97.138, 97.139, 97.141, 97.143,
97.145, and 97.146 concerning sexually transmitted diseases including acquired
immunodeficiency syndrome (AIDS) and human immunodeficiency virus (HIV). Sections
97.133 and 97.135 are adopted with changes to the proposed text as published
in the December 6, 2002, issue of the
Texas Register
(27 TexReg 11397). Sections 97.132, 97.136, 97.138, 97.139, 97.141,
97.143, 97.145, and 97.146 are adopted without changes and will not be republished.
Government Code §2001.039 requires that each state agency review and
consider for re-adoption each rule adopted by that agency pursuant to Government
Code, Chapter 2001 (Administrative Procedure Act). Sections 97.131-97.146
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist; however, §§97.131, 97.134, 97.137,
97.140, 97.142 and 97.144 are being adopted without changes.
Specific amendments cover: Who Shall Report Sexually Transmitted Diseases;
Reporting Information for Sexually Transmitted Diseases; Prophylaxis against
Ophthalmia Neonatorum; Guidelines for Testing Certain Indicted Persons for
Certain Diseases; Fee for Providing Written Notice of a Positive Human Immunodeficiency
Virus; Fee To Cover the Cost of Providing the Human Immunodeficiency Virus
(HIV) Counseling and Testing Course; Model HIV/AIDS Workplace Guidelines;
Anonymous and Confidential HIV Testing; and Confidentiality of HIV/STD Test
Results.
The department published a Notice of Intention to Review the §§97.131-97.146
as required by Government Code §2001.039 in the
Texas Register
on January 14, 2000 (25 TexReg 275). No comments were
received due to this publication.
The amendment to §97.132 makes minor changes for clarification of
the section regarding the reporting responsibility of a physician, dentist,
or chief administrative officer of a hospital, medical facility, or penal
institution.
The amendments to §97.133 clarify the information the program currently
collects from reporting entities.
The amendments to §97.135 clarify the requirement that a physician,
or other person permitted by law to attend a pregnant woman, test a pregnant
woman twice for syphilis, HIV, and hepatitis B once during gestation and again
upon admittance for delivery. The woman must be informed that the HIV test
will be performed and that she may refuse the test. The amendments clarify
other testing and counseling requirements as well as what information should
be provided the woman about syphilis, HIV and hepatitis B.
The amendments to §§97.136, 97.138, 97.139, 97.141, 97.143, 97.145,
and 97.146 delete and/or add punctuation and language to conform to the plain
language requirements found in the Texas Department of Health Operating Procedure,
OP-0657, "Plain Language Resolution."
The department is making the following changes due to staff comments.
Change: Concerning §97.133, the information received as a result of
the reporting requirements in this rule falls within one of the exceptions
under the Health Insurance Portability and Accountability Act (HIPAA) Privacy
Standards at 45 Code of Federal Regulations, §164.512(a). To ensure that
the department continues to receive the information it currently receives
after the privacy standards are implemented on April 14, 2003, changes were
made to §97.133 to reflect the information the program currently collects
from reporting entities. This change maintains the status quo for reporting
entities.
The following comment was received concerning the proposed section during
the public comment period. Following the comment is the department's response
and change.
Comment: Concerning §97.135(a)(1)(C)(ii) and §97.135(a)(2)(C)(ii),
an individual commented and wanted to clarify that a woman may object to being
tested for HIV.
Response: The department agrees and the language "unless the woman objects
to the test" was added to §97.135(a)(1)(C)(ii) and §97.135(a)(2)(C)(ii).
An individual was in favor of the rules and offered suggestions for clarification.
The amendments are adopted under the Health and Safety Code, §81.004,
which provides the Texas Board of Health (board) authority to adopt rules
necessary for the effective administration and implementation of Chapter 81,
Communicable Diseases; §85.016, which provides the board with authority
to adopt rules necessary to implement Subchapters A through F of Chapter 85,
Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus Infection;
and the Health and Safety Code, §12.001, which provides the board with
the authority to adopt rules for its procedure and for the performance of
each duty imposed by law on the board, the department, or the commissioner
of health.
§97.133.Reporting Information for Sexually Transmitted Diseases.
Reporting entities described in §97.132 of this title (relating
to Who Shall Report Sexually Transmitted Diseases) shall report all information
required by the department, to the extent that the information is collected
by the reporting entity, for any specimen derived from a human body that yields
microscopic, cultural, serological or any other evidence of AIDS, chancroid,
(1)
The department has established the reporting procedures
required under Texas Health and Safety Code, §81.044, including the designation
of specific forms and methods of reporting which may be in writing, by telephone,
by electronic data transmission, or by other means.
(A)
Reports of AIDS, HIV infection, CD4+ T Lymphocyte
cell count below 200 cells/microliter, or CD4+ T lymphocyte percentage
of less than 14% shall be made using all of the information collected by the
reporting entity found in the most current version of forms CDC 50.42B, CDC
50.42C, or STD-28.
(B)
Reports of chancroid shall be made using all of the information
collected by the reporting entity found in the most current version of form
STD-27 or STD-28.
(C)
Reports of
chlamydia trachomatis
infection shall be made using all of the information collected by
the reporting entity found in the most current version of form STD-27 or STD-28.
(D)
Reports of gonorrhea shall be made using all of the information
collected by the reporting entity found in the most current version of form
STD-27 or STD-28.
(E)
Reports of syphilis shall be made using all of the information
collected by the reporting entity found in the most current version of form
STD-27 or STD-28.
(F)
Reports pertaining to congenital syphilis shall be made
using all of the elements found in the most current version of the form adopted
by the Bureau of HIV and STD Prevention.
(G)
Reports pertaining to enhanced perinatal HIV surveillance
shall be made using all of the elements found in the most current version
of the form adopted by the Bureau of HIV and STD Prevention.
(2)
Completed written reports, electronic reports, and telephone
reports shall be made in accordance with §97.134 of this title (relating
to How to Report Sexually Transmitted Diseases).
(3)
Electronic reports shall be made in accordance with §97.134(i)
of this title.
§97.135.Serological Testing during Pregnancy and Delivery.
(a)
A pregnant woman shall be serologically tested for syphilis,
HIV infection, and hepatitis B infection, once during gestation and again
upon admittance for delivery.
(1)
At the time of the first prenatal examination and visit,
every physician or other person permitted by law to attend a pregnant woman
during gestation shall:
(A)
distribute to the woman printed materials about syphilis,
HIV, AIDS, and hepatitis B which shall be provided by the Texas Department
of Health and note on the woman's medical chart or health care record that
the distribution of material was made;
(B)
verbally notify the woman that an HIV test will be performed
if the patient does not object and note on the medical records that verbal
notification was given:
(i)
advise the woman that the result of the HIV test taken
under this action is confidential, not anonymous, and explain the difference
between an anonymous and confidential HIV test; and
(ii)
if the woman objects to the test for HIV infection, the
physician or other person may not conduct the test. The physician or other
person shall refer the woman to an anonymous HIV testing site or instruct
the woman about anonymous HIV testing methods.
(C)
take or cause to be taken a sample of the blood of the
woman and submit such sample to a laboratory certified by the Clinical Laboratory
Improvement Amendments of 1988 (CLIA-88; 42 United States Code §263a),
for:
(i)
a standard serological test for syphilis; and
(ii)
a standard serological test for HIV infection unless the
woman objects to the test; and
(iii)
a standard serological test for hepatitis B infection.
(2)
When a pregnant woman is admitted for delivery, the physician
or other person permitted by law to attend a pregnant woman shall:
(A)
distribute to the woman printed material provided by the
Texas Department of Health which outlines information about syphilis, HIV,
AIDS, and hepatitis B, and note on the woman's medical chart or health care
record that the distribution of material was made;
(B)
verbally notify the woman that an HIV test will be performed
if she does not object and note on the medical records that verbal notification
was given:
(i)
advise the woman that the result of the HIV test taken
under this section is confidential, not anonymous, and explain the difference
between an anonymous and confidential HIV test; and
(ii)
if the woman objects to the test for HIV infection, the
physician or other person may not conduct the test. The physician or other
person shall refer the woman who objects to the test to an anonymous HIV testing
site or instruct the woman about anonymous HIV testing methods.
(C)
take or cause to be taken a sample of the blood of the
woman and submit such sample to a laboratory certified by the Clinical Laboratory
Improvement Amendments of 1988 (CLIA-88; 42 United States Code §263a),
for:
(i)
a standard serological test for syphilis; and
(ii)
a standard serological test for HIV infection unless the
woman objects to the test; and
(iii)
a standard serological test for hepatitis B infection.
(3)
Every physician or other person required to report births
or fetal deaths shall state on each birth or fetal death certificate whether
a blood test for syphilis was performed during the pregnancy.
(4)
If a test for syphilis, HIV, or hepatitis B conducted under
this section shows that the woman is or may be infected with syphilis, HIV,
or hepatitis B, the physician or other person who submitted the sample for
the test shall:
(A)
provide or make available to the woman disease specific
information relating to treatment; or
(B)
refer the woman to an entity that provides treatment for
individuals infected with acquired immune deficiency syndrome.
(5)
provide or make available to the HIV infected woman counseling
which includes:
(A)
the meaning of the test result;
(B)
the possible need for additional testing;
(C)
measures to prevent the perinatal transmission of HIV;
(D)
the availability of appropriate health services;
(E)
the benefits of partner notification and the availability
of partner notification programs;
(F)
increased understanding of HIV infection;
(G)
explanation of the potential need for confirmatory testing
for HIV;
(H)
explanation of behavior changes to decrease the potential
of HIV transmission;
(I)
encouragement to seek appropriate medical care; and
(J)
encouragement to notify persons with whom there has been
contact capable of transmitting HIV.
(b)
A diagnosis of syphilis, HIV infection, AIDS, or hepatitis
B shall be reported in accordance with §§97.2 - 97.5 of this title
(relating to Control of Communicable Diseases).
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 February 28, 2003.
TRD-200301493
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 20, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts amendments to §§137.1-137.4,
137.11-137.13, 137.21-137.26, and 137.31-137.34, 137.36-137.43, 137.46-137.55,
and repeals of §§137.44-137.45 concerning the regulation of birthing
centers. Sections 137.25, 137.33, 137.48, 137.52, and 137.55 are adopted with
changes to the proposed text as published in the November 8, 2002, issue of
the
Texas Register
(27 TexReg 10538). Sections
137.1-137.4, 137.11-137.13, 137.21-137.24, 137.26, 137.31-137.32, 137.34,
137.36-137.43, 137.46-137.47, and 137.49-137.51, 137.53-137.54, and the repeals
of 137.44-137.45 are adopted without changes, and will not be republished.
The sections cover general provisions, licensing procedures, enforcement,
and operational and clinical standards for birthing centers.
Government Code, §2001.039 requires that each state agency review
and consider for re-adoption each rule adopted by that agency pursuant to
the Government Code, Chapter 2001 (Administrative Procedure Act). The sections
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist. However, revisions to the sections were necessary.
The department published a Notice of Intention to Review for §§137.1-137.4,
137.11-137.13, 137.21-137.26, and §§137.31 - 137.34 and 137.36 -
137.55 in the
Texas Register
in the July 26,
2002 issue (27 TexReg 6729). No comments were received due to publication
of this notice.
No comments were received during the comment period on the proposed amendments;
however, the department is making the following minor changes due to staff
comments.
Change: Concerning §137.25(g), the word "compaint" was deleted and
the word "complaint" was added to correct the spelling.
Change: Concerning §137.33(5), the phrase "are currently certified"
was deleted to clarify the intent and to improve the accuracy of the section.
Change: Concerning §137.48(d), the phrases "and/or a birth attendant"
and " The clinical care provider" were added and "during active labor, birth
and the immediate postpartum period" and "This person" were deleted to clarify
the intent of this section.
Change: Concerning §137.52(a)(2), the word "program" was added and
the word "plan" was deleted to clarify the intent of this section.
Change: Concerning §137.55(p)(2), "the" was deleted at the beginning
of the sentence.
Specifically, the amendment to §137.2 adds a definition for a "clinical
care provider" and deletes the definitions for "nosocomial infection" and
"quality". Definitions were renumbered as necessary to reflect the added and
deleted definitions. The amendment to §137.3 deletes obsolete information
regarding licensing fees. The amendment to §137.4 is to clarify the intent.
Amendments to §137.11 delete requirements for the application of a license
that are obsolete; wording is added for clarification; and is renumbered to
reflect the added and deleted information. The amendments to §137.12
and §137.13 are editorial. The amendments to §137.21 are to clarify
the intent of the section. The amendments to §137.22, §137.23, and §137.24
add and delete language to better enable the department to enforce the rules
of this chapter. These sections are renumbered to reflect the changes. Amendments
to §137.25 are editorial and portions are deleted to reflect current
departmental procedure for processing complaints. Amendments to §137.26, §137.31, §137.32,
and §137.33 are editorial. Amendments to §137.34 are editorial,
for clarification, reflect current standards of practice in birthing centers,
and are renumbered to reflect the added and deleted information. The amendments
to §137.26 are editorial and to clarify the intent. The amendments to §137.37
add and delete information to reflect current standards of practice in birthing
centers and are renumbered to reflect the changes. The amendments to §137.38
are editorial and for clarification. The amendments to §137.39 and §139.40
are editorial. The amendments to §137.41 deletes the words "commensurate
with the skill level of the attendant, but minimally" and adds a requirement
that a birthing center provide "other medications and equipment as approved
by the clinical director". Amendments to §137.42 and §137.43 are
editorial. Amendments to §137.44 and §137.45 delete these sections,
as they are considered duplicative of requirements in §137.55. The amendments
to §137.46 are editorial and delete the requirement for a physician consultant
to be "within a recommended 20 but with a required maximum of 30 minutes"
to reflect current standards of practice in birthing centers. The amendment
to §137.47 is editorial. The amendments to §137.48 delete "adult
minimally qualified person", add "clinical care provider", and add the requirement
that the person be capable of "assessing the client's fundus and blood loss".
Wording is changed for clarification and to reflect current standards of practice
in birthing centers. The amendments to §137.49 add the "clinical director"
and delete the "center" as responsible for duties under this section; deletes
the requirements concerning "prophylaxis to prevent opthalmia neonatorum"
and the "newborn screening program" under this section, and moves these requirements
to §137.55 to clarify the intent of this section. The amendments to §137.50
are editorial and to clarify the intent of this section. The amendments to §137.51
are editorial. The amendments to §137.52 delete some of the requirements
for the quality assurance program to reflect current standards of practice
in birthing centers and sections are renumbered to reflect the added and deleted
sections. The amendments to §137.53 and §137.54 are to clarify the
intent of these sections. The amendments to §137.55 are editorial, clarify
the intent of this section, and reflect current locations of statutes. Further
more, the amendments add requirements for birthing centers to comply with
"29 Code of Federal Regulations, Subpart K §1910.151 Medical services
and first aid"; "Health and Safety Code §81.091 concerning serologic
testing during pregnancy"; Health and Safety Code §81.091, concerning
opthalmia neonatorum prevention"; "Health and Safety Code §33.011 relating
to Test Requirement"; and "Texas Occupations Code §203.354 relating to
Newborn Screening".
Subchapter A. GENERAL PROVISIONS
25 TAC §§137.1 - 137.4
The amendments are adopted under Health and Safety Code (HSC),
Chapter 244, Texas Birthing Center Licensing Act; which provides the Board
of Health (board) with the authority to adopt rules governing the licensing
and regulation of Birthing Centers, and HSC §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.
Government Code §2001.039 is implemented by the adoption.
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 3, 2003.
TRD-200301508
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 23, 2003
Proposal publication date: November 8, 2002
For further information, please call: (512) 458-7236
25 TAC §§137.11 - 137.13
The amendments are adopted under Health and Safety Code (HSC),
Chapter 244, Texas Birthing Center Licensing Act; which provides the Board
of Health (board) with the authority to adopt rules governing the licensing
and regulation of Birthing Centers, and HSC §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.
Government Code §2001.039 is implemented by the adoption.
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 3, 2003.
TRD-200301509
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 23, 2003
Proposal publication date: November 8, 2002
For further information, please call: (512) 458-7236
25 TAC §§137.21 - 137.26
The amendments are adopted under Health and Safety Code (HSC),
Chapter 244, Texas Birthing Center Licensing Act; which provides the Board
of Health (board) with the authority to adopt rules governing the licensing
and regulation of Birthing Centers, and HSC §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.
Government Code §2001.039 is implemented by the adoption.
§137.25.Complaints.
(a)
In accordance with §137.42 of this title (relating
to Disclosure Requirements), all licensed centers are required to provide
a client, and her guardian if the client is a minor or if guardianship is
required, at the time of the initial visit, with a written statement that
complaints relating to the center may be registered with the Director, Health
Facility Licensing and Compliance Division, Texas Department of Health, 1100
West 49th Street, Austin, Texas 78756; Telephone (888) 973-0022; (512) 834-6650;
and Fax (512) 834-6653.
(b)
Complaints may be registered with the department by telephone,
fax or in writing at the address listed in subsection (a) of this section.
A complainant may provide his or her name, address, and phone number to the
department. Anonymous complaints may be registered if the complainant provides
sufficient information.
(c)
The department will evaluate all complaints received.
(d)
A complaint containing allegations which are a violation
of the Act or this chapter will be investigated by the department.
(e)
A department representative (surveyor) may enter the premises
of a center at reasonable times as necessary to assure compliance with the
Act and this chapter. The department is not required to notify the applicant
or licensee prior to a complaint investigation.
(f)
If the department determines that the complaint does not
come within the department's jurisdiction, the department shall advise the
complainant and, if possible, refer the complainant to the appropriate governmental
agency for handling such a complaint.
(g)
The department shall inform in writing a complainant who
identifies himself or herself by name and address of the final disposition
of the complaint.
(h)
A person may file a complaint with the department against
a birthing center licensed under this chapter. A person who files a false
complaint may be prosecuted under the Penal Code.
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 3, 2003.
TRD-200301510
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 23, 2003
Proposal publication date: November 8, 2002
For further information, please call: (512) 458-7236
25 TAC §§137.31 - 137.34, 137.36 - 137.43, 137.46 - 137.55
The amendments are adopted under Health and Safety Code (HSC),
Chapter 244, Texas Birthing Center Licensing Act; which provides the Board
of Health (board) with the authority to adopt rules governing the licensing
and regulation of Birthing Centers, and HSC §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.
Government Code §2001.039 is implemented by the adoption.
§137.33.Personnel Policies.
The center shall develop, implement, and enforce written policies
governing all personnel staffed by the center. The personnel policies shall
cover the following requirements:
(1)
job descriptions for all personnel providing client care;
(2)
orientation and training of all employees, volunteers,
students and contractors;
(3)
an annual written evaluation of employee performance;
(4)
in service and continuing education; and
(5)
certification of all birth attendants by the American Heart
Association or the American Red Cross in basic life support and the American
Academy of Pediatrics or the American Heart Association in neonatal resuscitation.
§137.48.Labor and Birth Procedures.
(a)
Labor and birth shall be managed and attended by a birth
attendant.
(b)
The birth attendant shall be trained in the use of emergency
equipment.
(c)
A center shall ensure that its birth attendants encourage
a client to seek medical care if the birth attendant recognizes a sign or
symptom of a complication to the client's childbirth.
(d)
Other clinical care provider(s) and/or a birth attendant,
shall be physically present in the center whenever a client is in the center.
The clinical care provider shall be capable of performing the following minimum
duties:
(1)
monitoring the fetal heartbeat;
(2)
monitoring the mother's blood pressure, pulse, and temperature;
(3)
performing adult and infant cardiopulmonary resuscitation,
if needed;
(4)
monitoring the infant's heart rate, respiratory rate and
body temperature; and
(5)
assessing the client's fundus and blood loss.
(e)
A birth attendant shall be physically present to conduct
the delivery and be available during the acute postpartum period.
(f)
Interventions shall be limited to those required to accomplish
a vaginal delivery.
(g)
No general, epidural, or subdural anesthetic agent shall
be administered in a center.
(h)
A center shall ensure that its documented midwives do not
violate the labor and delivery provisions of the Texas Midwifery Act, Texas
Occupations Code, Chapter 203, concerning prohibited acts and criminal penalties.
§137.52.Quality Assurance.
(a)
Quality assurance program. The center shall adopt, implement,
and enforce a written quality assurance (QA) program that includes all health
and safety aspects of client care for both mother and infant.
(1)
The quality assurance program shall include, but not be
limited to:
(A)
a review of the clinical record(s);
(B)
incidences of morbidity and mortality of mother and infant;
(C)
postpartum infections;
(D)
all cases transferred to a hospital for delivery, care
of infant, or postpartum care of mother;
(E)
incidents, problems and potential problems identified by
staff of the center, including infection control;
(F)
address issues of unprofessional conduct by any member
of the center's staff (including contract staff);
(G)
address the integrity of surgical instruments, medical
equipment, and patient supplies;
(H)
address client referrals and consultations;
(I)
address medication therapy practices, if applicable; and
(J)
problems with compliance with any federal and state laws
and rules.
(2)
This program must be reviewed and updated or revised at
least annually.
(3)
The results of the quality assurance program must be reviewed
and documented at least quarterly.
(b)
Quality assurance issues. The center shall identify and
address quality assurance issues and implement corrective action plans as
necessary. The outcome of any corrective action plans shall be documented.
The outcome of the remedial action shall be documented.
(c)
Departmental review.
(1)
A representative(s) of the department shall verify that
the center has a quality assurance program which addresses quality concerns
and that center staff know how to access that process.
(2)
Attempts by the center to identify and correct deficiencies
will not be used by the department as a basis for adverse action against the
center.
§137.55.Other State and Federal Compliance Requirements.
(a)
A center utilizing the services of a documented midwife
shall ensure that its documented midwife(ives) does not violate the Texas
Midwifery Act, Texas Occupations Code, Chapter 203, concerning prohibited
acts and criminal penalties, while functioning in his or her capacity at or
for the center.
(b)
A center shall ensure that its documented midwives comply
with Title 22 Texas Administrative Code, Chapter 831 (relating to Midwifery),
while functioning in his or her capacity at or for the center.
(c)
A center that provides laboratory services shall meet the
Clinical Laboratory Improvement Amendments of 1988, 42 United States Code, §263a,
Certification of Laboratories (CLIA 1988). CLIA 1988 applies to all centers
with laboratories that examine human specimens for the diagnosis, prevention,
or treatment of any disease or impairment of, or the assessment of the health
of, human beings. If a center accepts laboratory test results from another
state or foreign country, such as Mexico, the laboratory documents must be
reviewed and approved by a licensed health professional within his or her
scope of practice.
(d)
A center utilizing the services of a registered nurse(s)
shall ensure that its registered nurse(s) comply with the Nursing Practice
Act, Texas Occupations Code, Chapters 301, 303, and 304, while functioning
in his or her capacity at or for the center.
(e)
A center utilizing the services of a licensed vocational
nurse(s) shall ensure that its licensed vocational nurse(s) comply with Texas
Occupations Code, Chapters 302, 303, and 304, while functioning in his or
her capacity at or for the center.
(f)
A center utilizing the services of a physician(s) shall
ensure that its physician(s) comply with the Medical Practice Act, Texas Occupations
Code, Chapters 151-165, while functioning in his or her capacity at or for
the center.
(g)
A center utilizing the services of a physician assistant(s)
shall ensure that its physician assistant(s) comply with the Physician Assistant
Licensing Act, Texas Occupations Code, Chapter 204, while functioning in his
or her capacity at or for the center.
(h)
A center that provides pharmacy services shall obtain a
license as a pharmacy if required by the Texas Pharmacy Act, Texas Occupations
Code, Chapters 551-569.
(i)
A center shall comply with the following federal Occupational
Safety and Health Administration requirements:
(1)
29 Code of Federal Regulations, Subpart E, §1910.38,
concerning employee emergency plans and fire prevention plans;
(2)
29 Code of Federal Regulations, Subpart I, §1910.132,
concerning general requirements for personal protective equipment;
(3)
29 Code of Federal Regulations, Subpart I, §1910.133,
concerning eye and face protection;
(4)
29 Code of Federal Regulations, Subpart I, §1910.138,
concerning hand protection;
(5)
29 Code of Federal Regulations, Subpart L, §1910.157,
concerning portable fire extinguishers;
(6)
29 Code of Federal Regulations, Subpart Z, §1910.1030,
concerning blood borne pathogens; and
(7)
29 Code of Federal Regulations, Subpart Z, §1910.1200,
Appendices A-E, concerning hazard communication (hazardous use of chemicals).
(8)
29 Code of Federal Regulations, Subpart K, §1910.151,
concerning medical services and first aid.
(j)
A center shall not use adulterated or misbranded drugs
or devices in violation of the Health and Safety Code, §431.021. Adulterated
drugs and devices are described in Health and Safety Code, §431.111.
Misbranded drugs or devices are described in Health and Safety Code, §431.112.
(k)
A center shall not commit a false, misleading, or deceptive
act or practice as that term is defined in the Deceptive Trade Practices-Consumer
Protection Act, Business and Commerce Code, §17.46.
(l)
A birthing center must provide voluntary paternity establishment
services in accordance with:
(1)
the Health and Safety Code, §192.012, Record of Acknowledgment
of Paternity; and
(2)
the rules of the Office of the Attorney General found at
1 Texas Administrative Code, Chapter 55, Subchapter J (relating to Voluntary
Paternity Acknowledgment Process).
(m)
A birthing center shall comply with Health and Safety Code,
Chapter 47, relating to Hearing Loss in Newborns.
(n)
A center shall ensure that its birth attendants comply
with Health and Safety Code, §81.090 (relating to serologic testing
during pregnancy). The center shall ensure that the results of any HIV test
are kept confidential pursuant to the Health and Safety Code, §81.103.
(o)
A center shall ensure that its birth attendants comply
with the Health and Safety Code, §81.091, (relating to ophthalmia neonatorum
prevention).
(p)
A center shall ensure that its birth attendants cause the
newborn screening tests to be performed as required by:
(1)
the Health and Safety Code, §33.011 (relating to Test
Requirement); and
(2)
Texas Occupations Code, §203.354 (relating to Newborn
Screening).
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 3, 2003.
TRD-200301511
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 23, 2003
Proposal publication date: November 8, 2002
For further information, please call: (512) 458-7236
25 TAC §137.44, §137.45
The repeals are adopted under Health and Safety Code (HSC),
Chapter 244, Texas Birthing Center Licensing Act; which provides the Board
of Health (board) with the authority to adopt rules governing the licensing
and regulation of Birthing Centers, and HSC §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.
Government Code §2001.039 is implemented by the adoption.
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 3, 2003.
TRD-200301512
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 23, 2003
Proposal publication date: November 8, 2002
For further information, please call: (512) 458-7236
Subchapter A. RABIES CONTROL AND ERADICATION
25 TAC §§169.22, 169.27, 169.29, 169.31 - 169.33
The Texas Department of Health (department) adopts amendments
to §§169.22, 169.27, 169.29, and 169.31 - 169.33 concerning rabies
control and eradication. Sections 169.22 and 169.29 are adopted with changes
to the proposed text as published in the September 20, 2002 issue of the
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 Procedures Act). Sections 169.21
- 169.34 have been reviewed and the department has determined that reasons
for adopting the sections continue to exist in that rules on these subjects
are needed. The department also adopts §§169.21, 169.23 - 169.26,
169.28, 169.30, and 169.34 that were proposed without changes, and were open
for comments as published in the September 20, 2002 issue of the
Texas Register
(27 TexReg 8890).
The department published a Notice of Intention to Review for §§169.21
- 169.34 as required by Government Code, §2001.039 in the
Texas Register
on May 19, 2000 (25 TexReg 4598). The department received
no comments due to the publication of the notices.
Due to staff comments, the department made the following changes:
Change: Concerning §169.22(4)(C), the word "of" was substituted for
the word "for".
Change: Concerning §169.29(a), clarifying language regarding vaccine
administration was added to the subsection.
The following comments were received concerning the proposed sections.
Following the comments are the department's responses and any resulting change(s).
Comment: Concerning §169.29(a), one commenter opposed the rule and
recommended not allowing local jurisdictions to establish more stringent rules
than the department. The commenter recommended that this only be allowed under
very unusual circumstances such as a rabies epidemic.
Response: The department disagrees with the commenter. Statutory law (Health
and Safety Code, §§826.014 and 826.015) specifically states that
counties and municipalities may adopt local regulations that are more stringent
than the department's administrative rules. No changes were made as a result
of the comment.
Comment: One commenter recommended a rabies vaccine exemption be allowed
for the animals of people involved in holistic care who have unaltered animals
that are for show, competition, or breeding.
Response: The department responds that this issue is not germane to the
proposed rules. The department will take the comment under consideration for
action at a later time. No changes were made as a result of the comment.
Comment: Concerning §169.29(a), 159 commenters opposed the rule, stating
that changing the minimum vaccine requirement to every three years would have
a detrimental effect on public health.
Response: The department disagrees with the commenters and responds that
over a period of 25 years, 32 states have migrated to a three-year vaccination
interval. Their experience has shown that a three-year interval is sufficient
to prevent human rabies. Additionally, states which have changed to a three-year
interval did not experience an increase in the number of rabid dogs and cats.
No correlation exists between a state's required vaccination interval and
its incidence of rabid dogs and cats. No changes were made as a result of
the comments.
Comment: Concerning §169.29(a), one commenter opposed the rule, stating
that adverse reactions in animals are rare when vaccinating every year.
Response: The department disagrees with the commenter. The proposal to
change to a three-year vaccination interval is not based upon animal health.
The proposal stems from the fact that no public health justification exists
to require the public to obtain annual rabies vaccinations for their pets
when faccines approved for a three-year duration are available. No changes
were made as a result of the comment.
Comment: Concerning §169.29(a), one commenter opposed the rule, recommending
Texas maintain the population immunity required to control rabies by vaccinating
every year.
Response: The department disagrees with the commenter. Over a period of
25 years, 32 states have migrated to a three-year vaccination interval. Their
experience has shown that a three-year interval is sufficient to prevent human
rabies. Additionally, states which have changed to a three-year interval did
not experience an increase in the number of rabid dogs and cats. No correlation
exists between a state's required vaccination interval and its incidence of
rabid dogs and cats. No changes were made as a result of the comment.
Comment: Concerning §169.29(a), four commenters opposed the rule,
stating that the timing for changing rabies vaccination requirements is inappropriate
at this time in Texas because of the state's close proximity to a foreign
border, the current economic downtrend, and the threat of bioterrorism.
Response: The department disagrees with the commenters. Nothing precludes
cities and counties which lie along the Texas-Mexico border from requiring
a more stringent vaccination schedule. Additionally, the Oral Rabies Vaccination
Program maintains a 40-mile wide protected barrier of coyotes vaccinated against
rabies along the border. Obtaining the vaccination once every three years
rather than annually might represent a cost-savings to pet owners. Rabies
virus is not regarded as an appropriate agent for bioterrorism. No changes
were made as a result of the comments.
Comment: Concerning §169.29(a), two commenters opposed the rule and
recommended administering rabies vaccines every two years because three years
is too long.
Response: The department disagrees with the commenters and responds that
over a period of 25 years, 32 states have migrated to a three-year vaccination
interval. Their experience has shown that a three-year interval is sufficient
to prevent human rabies. Rabies vaccine is approved by the federal government
for use on an annual basis and a triennial basis. Requiring the vaccine be
administered every two years would be inconsistent with label recommendations,
a requirement the department has not placed on any other vaccination protocol.
Justification for using the vaccine on a two-year basis does not exist. No
changes were made as a result of the comments.
Comment: Concerning §169.29(a), 17 commenters opposed the rule, stating
that more than 50% of clients are delinquent returning for rabies vaccination
boosters and it will be harder for them to remember if the minimum requirement
goes to every three years.
Response: The department agrees with the commenters that annual boosters
may be easier to remember than longer intervals. However, veterinarians typically
mail or Email vaccination reminders to their clients. Additionally, states
which have migrated to a three-year interval did not experience an increase
in the number of rabid dogs and cats, thereby demonstrating that public health
is not jeopardized by a three-year interval. No changes were made as a result
of the comments.
Comment: Concerning §169.29(a), one commenter opposed the rule, stating
that there has been a 100% increase in the number of reported positive rabies
cases in East Texas.
Response: The department disagrees with the commenter. An increased number
of rabid wildlife has occurred in some parts of Texas as part of the normal
cyclical nature of rabies incidence in wildlife. Vaccination of dogs and cats
with the triennial vaccine will protect pets from acquiring rabies from wildlife.
No changes were made as a result of the comment.
Comment: Concerning §169.29(a), ten commenters opposed the rule, stating
that the majority of Texas is rural or semi-rural where exposure to rabies
is a constant possibility.
Response: The department agrees with the commenters regarding rabies exposure.
However, vaccination of dogs and cats with the triennial vaccine will protect
pets from acquiring rabies from wildlife. No changes were made as a result
of the comments.
Comment: Concerning §169.29(a), two commenters opposed the rule, stating
that the public perception would be that rabies is no longer a problem in
Texas if the minimum requirement goes to every three years.
Response: The department agrees with the commenters that this misperception
may occur. It is the collective challenge of state and local health departments,
veterinarians, and animal control agencies to promote vaccination of pets.
Data are not available to determine what effect migrating from a one-year
to a three-year interval had on the vaccination rates in other states. However,
it is clear that other states did not experience an increased incidence of
rabies in dogs and cats as a result of this change. No changes were made as
a result of the comments.
Comment: Concerning §169.29(a), one commenter opposed the rule, stating
that it would be difficult for cities and counties to make their rabies vaccination
requirements more stringent with no support from the state. The commenter
stated that multiple options for vaccination intervals will be difficult for
people traveling through the state and for airlines delivering dogs and cats
to Texas.
Response: The department disagrees with the commenter. Through historical
data analysis and risk assessment, department staff are available to assist
cities and counties in decision-making and subsequent risk communication to
their citizens and elected officials. No changes were made as a result of
the comment.
Comment: Concerning §169.29(a), two commenters opposed the rule and
recommended that the rabies vaccination protocol remain unchanged for the
next four years so that there can be further study and better scientific information
can be obtained.
Response: The department disagrees with the commenters. Thirty-two states
over a 25 year period have migrated from annual vaccination requirement to
a three-year interval without placing the public's health at risk. The department
feels that this provides adequate information. No changes were made as a result
of the comments.
Comment: Concerning §169.29(a), four commenters opposed the rule,
stating that animals will receive less preventative veterinary care and diseases
may be detected too late.
Response: The department responds that these rules for Rabies Control and
Eradication address public health issues, not animal health. These rules do
not pertain to the ongoing need for regular veterinarian visits to protect
animal health. No changes were made as a result of the comments.
Comment: Concerning §169.29(a), four commenters opposed the rule,
stating that the Texas rabies situation is different from that of any other
state in that Texas has reoccurring epizootics of canine rabies along the
border.
Response: The department agrees with the commenters and responds that the
Oral Rabies Vaccination Program maintains a 40-mile wide protected barrier
along the border. Additionally, should an outbreak of canine rabies occur,
the disease in coyotes could effectively be addressed by a localized, supplemental
delivery of the oral vaccine. Also, statutory law (Health and Safety Code, §§826.014
and 826.015) specifically states that counties and municipalities may adopt
local regulations that are more stringent than the department's administrative
rules. No changes were made as a result of the comments.
Comment: Concerning §169.29(a), one commenter opposed the rule, stating
that there is no evidence linking vaccinations with any canine disease.
Response: The department responds that these rules for Rabies Control and
Eradication address public health issues, not animal health. No changes were
made as the result of the comment.
Comment: Concerning §169.29(a), three commenters opposed the rule,
stating that the new protocol will deny cat owners a vaccine which will decrease
the incidence of fibrosarcomas.
Response: The department disagrees with the commenters. The proposed rule
allows use, according to labeling instructions, of any of the rabies vaccines
approved by the USDA, thereby allowing the veterinarian and the owner to select
the vaccine which they feel has the highest margin of safety. No changes were
made as a result of the comments.
Comment: Concerning §169.29(a), one commenter opposed the rule, stating
that in 1996 the department praised the veterinary community for helping to
abate a serious rabies outbreak. The commenter is concerned that the department
now chooses to ignore the frontline veterinarians regarding this issue.
Response: The department disagrees with the commenter. A series of ten
public meetings were held on this topic, and written comments were solicited
over an eight-month period. All comments were reviewed and carefully considered
before a rule modification was made. No changes were made as a result of the
comment.
Comment: Concerning §169.29(a), one commenter opposed the rule, stating
that North Carolina and other states went to a three-year vaccination protocol
several years ago and they are now experiencing a marked increase in rabies
incidence to both wildlife and domestic animals.
Response: The department disagrees with the commenter. North Carolina authorized
use of the triennial vaccine at three-year intervals in 1976. Between 1993
and 1997, North Carolina experienced an epizootic of rabies in wildlife, causing
the number of rabies cases to climb from 71 cases to 678 cases per year. There
is no temporal or causal relationship between the two occurrences. No changes
were made as a result of the comment.
Two hundred eighty-eight commenters were in favor of the rules in their
entirety, representing: Critter Fixer Pet Hospital, a veterinarian from Texas
A&M University, Frankford Crest Animal Hospital, Denton Humane Society,
Ingram Park Animal Hospital, Main Street Veterinary Hospital, Griffith Small
Animal Hospital, Metroplex Veterinary Centre, Crystal Mountain Animal Hospital,
DogBoys, Inc., University of North Texas, Lake Whitney Humane Society, The
Queenie Foundation, Professional Veterinary Relief Services, Austin Zoo, Bay
Creek Animal Clinic, Whiskers Rescue & Adoption, Inc., Paws for Learning,
2920 Companion Animal Hospital, Animal Trustees of Austin, Inc., Kathleen
Cailloux Humane Society, Austin Pets Alive!, and numerous individuals.
Commenters opposed to the proposed rules were Belvidere Animal Clinic,
Killeen Veterinary Clinic, El Paso Veterinary Medical Association, Tyler Animal
Control, Lake Joe Pool Animal Clinic, West Texas Veterinary Clinic, Animal
Hospital of Denison, Inc., Love Freeway Animal Hospital, Bonham Veterinary
Clinic, Guilbean Station Animal Hospital, Cold Springs Animal Hospital, Granbury
Animal Clinic, Dry Creek Veterinary Clinic, Southwestern Livestock Mineral
Co, Inc., Greenwood Veterinary Clinic, Taylor Veterinary Clinic, Nolana Animal
Hospital, Dripping Springs Animal Hospital, Cambridge Post Oak Veterinary
Clinic, Inc., Hines North Animal Hospital, Robertson Veterinary Services,
Highway 30 Veterinary Clinic, Inc., Cedarcrest Equine Clinic, Park Plaza Animal
Clinic, Bent Trail Animal Clinic, All Caring Animal Clinic, Hill Country Animal
Hospital, Pet Vet Animal Hospital, Texas Veterinary Medical Assocation, Hiway
620 Animal Hospital, U.T. M..D. Anderson Cancer Center, Cat Hospital of Las
Colinas, Claws & Paws Veterinary Hospital, Meadow Brook Animal Hospital,
Inc., Silsbee Animal Clinic, Cambridge Post Oak Veterinary Clinic, Inc., Echo
Lane Animal Clinic, Crossroads Animal Clinic, Southside Veterinary Clinic,
Inc., Loop 410 Veterinary Hospital, Fayette County Veterinary Clinic, Inc.,
Pet Medical Center of Duncanville, Towne North Animal Hospital, Perrin-410
Animal Hospital, Inc., Animal Health Associates Veterinary Clinic, Canyon
Creek Pet Hospital, Pet Medical Center of San Antonio, Heights Veterinary
Clinic, P.C., Mobile Veterinary Clinic, Affordable Pet Care NW, Carson County
Veterinary Clinic, Josey Ranch Pet Hospital, P.C., Meyerland Animal Clinic,
Champions Forest Animal Clinic, Grand Saline Veterinary Clinic, P.C., College
Hills Animal Hospital, Buna Animal Hospital, Memorial Town & Country Animal
Clinic, Crowley Animal Clinic, Inc., Glaze Veterinary Clinic, Kleman Veterinary
Services, Green Meadow Veterinary Hospital, Cat Hospital of Austin, Countryside
Veterinary Clinic, Cat Veterinary Clinic, Walnut Plaza Veterinary Hospital,
Allred Veterinary Hospital, P.C., Bozeman Animal Clinic, Creekwood Veterinary
Hospital, Antoine-Little York Animal Clinic, VCA Tanglewood Animal Hospital,
Parkside Animal Hospital, McCombs Veterinary Clinic, Springtown Veterinary
Hospital, Nacogdoches Road Veterinary Hospital, Inc., Alamo Feline Health
Center, Huebner Oaks Veterinary Hospital, Fannin County Veterinary Services,
Kerrville Veterinary Clinic, Ltd., Oubre Animal Clinic, Champion Wood Animal
Animal Hospital, Marbach Road Animal Hospital, Great Northwest Animal Hospital,
Alamont Veterinary Clinic, Muleshoe Animal Clinic, Klein Animal Hospital,
Hughes Springs Veterinary Hospital, Austin Avenue Pet Clinic, McGowan Veterinary
Hospital, Marbach Road Animal Hospital, Animal Health Associates Veterinary
Clinic, Taylor Veterinary Clinic, Castroville Veterinary Clinic, Highland
Lakes Veterinary Clinic, P.L.L.C., Texas Veterinary Medical Diagnostic Laboratory,
Mart Veterinary Clinic, Dodd Animal Hospital, South Arlington Animal Clinic,
Wise County Animal Clinic, Austin Avenue Pet Clinic, River Hills Animal Clinic,
Rhinehart Veterinary Hospital, Nueces Veterinary Hospital, North Street Veterinary
Clinic, Lewisville North Animal Clinic, Spencer Animal Hospital, Inc., Small
Animal Medical Center, Irving Animal Hospital, Inc., Groves Veterinary Clinic,
Animal Hospital of Paris, Lamar Veterinary Clinic, South San Gabriel Animal
Clinic, Crandall Animal Hospital, Katy Veterinary Clinic, Rose-Rich Veterinary
Clinic, Acres North Animal Hospital, Bellaire Stella Link Animal Clinic, El
Centro Pet Medical Center, Chachere Veterinary Clinic, Cat Hospital of Las
Colinas, Brykerwood Veterinary Clinic, Carrier Animal Hospital, Knox Park
Animal Hospital, Encino Park Veterinary Clinic, Jester Plaza Veterinary Clinic,
Creek View Veterinary Clinic, Brazos Valley Veterinary Medical Association,
Wharton Veterinary Clinic, Atlas Palmas Animal Clinic, Paris Veterinary Clinic,
Banfield Pet Hospital, Springtown Veterinary Hospital, Judge Ely Animal Hospital,
Lake Highlands Animal Clinic, South Gessner Pet Clinic, Animal Hospital of
Rowlett, Dr. Doolittle's Animal Hospital, Horizon Animal Hospital, Thompson
Animal Hospital, P.C., Shenandoah Animal Clinic, Southlake Animal Hospital,
a veterinarian from Texas A&M University, 85th & Quaker Pet Hospital,
Inc., Preston North Animal Clinic, Pavlov's Dog & Cat Hospital, Tanglewood
Animal Hospital, Parkview Veterinary Clinic, Atascazoo Animal Hospital, Brazos
Animal Hospital, Animal Medical Clinic, North Tyler Veterinary Clinic, Yoakum
Animal Clinic, Crossroads Veterinary Hospital, Inc., Dowlen Road Veterinary
Center, Ten West Bird Animal Hospital, Alvin Animal Clinic, Assure Vet Animal
Hospital, San Gabriel Animal Hospital, Hurst Animal Clinic, Arena Veterinary
Clinic, and City of Laredo Health Department. In addition, one member of the
department and numerous individuals commented.
The amendments are adopted under Health and Safety Code, Chapter
826, "Rabies," §826.011, which provides the Texas Board of Health (board)
with the authority to administer the rabies control program and adopt rules
necessary to effectively administer this program; §826.042, which requires
the board to adopt rules on rabies quarantine; 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.
§169.22.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Animal - Any mammal, domesticated or wild.
(2)
Assistance dog-A dog that is specially trained or equipped
to help a person with a physical challenge and that:
(A)
is used by a person with a physical challenge who has satisfactorily
completed a specific course of training in the use of the dog; and
(B)
has been trained by an organization generally recognized
by agencies involved in the rehabilitation of persons with a physical challenge
as reputable and competent to provide dogs with training of this type.
(3)
Cat-Any Felis catus.
(4)
Currently vaccinated - Vaccinated and satisfying the following
criteria.
(A)
The animal must have been vaccinated against rabies according
to the label recommendations of a United States Department of Agriculture
(USDA) approved vaccine.
(B)
At least 30 days have elapsed since the initial vaccination.
(C)
The time elapsed since the most recent vaccination has
not exceeded the label recommendations of the vaccine.
(5)
Custodian-A person or agency which feeds, shelters, harbors,
has possession or control, or has the responsibility to control an animal.
(6)
Department-The Texas Department of Health (TDH).
(7)
Dog-Any Canis familiaris, including hybrids.
(8)
Domestic animal-Any animal normally adapted to live in
intimate association with humans or for the advantage of humans.
(9)
Domestic dog-Any Canis familiaris, excluding hybrids.
(10)
Domestic ferret-Any Mustela putorius furo.
(11)
High risk animals-Those animals which have a high probability
of transmitting rabies; they include skunks, bats, species of foxes indigenous
to North America, coyotes, and raccoons.
(12)
Housing facility-Any room, building, or area used to contain
a primary enclosure or enclosures.
(13)
Humanely killed-To cause the death of an animal by a method
which:
(A)
rapidly produces unconsciousness and death without visible
evidence of pain or distress; or
(B)
utilizes anesthesia produced by an agent which causes painless
loss of consciousness, and death following such loss of consciousness.
(14)
Hybrid-Any offspring of two animals of different species.
(15)
Impoundment-The collecting and confining of an animal
because of a state or local ordinance or because of a contract with a county
or municipality.
(16)
Impoundment facility - An enclosure or a structure in
which an animal is collected or confined because of a state law or local ordinance
or because of a contract with a county or municipality.
(17)
Isolation - The separation of an animal exposed or potentially
exposed to rabies.
(18)
Local rabies control authority - The officer designated
by the municipal or county governing body under the Texas Health and Safety
Code, Chapter 826.
(19)
Low risk animals - Those which have a low probability
of transmitting rabies; they include all animals of the orders Marsupialia,
Insectivora, Rodentia, Lagomorpha, and Xenarthra.
(20)
Observation period - The time following a bite incident
during which the biting animal's health status must be monitored. The observation
period for domestic dogs, cats, and domestic ferrets (only) is 10 days (240
hours); the observation period for other animals, not including those defined
as high risk or low risk, is 30 days.
(21)
Police dog - Domestic dog that is owned or employed by
a governmental law enforcement agency.
(22)
Primary enclosure - Any structure used to immediately
restrict an animal or animals to a limited amount of space, such as a room,
pen, run, cage, compartment, or hutch.
(23)
Public health region - A contiguous group of Texas counties,
so designated by the board.
(24)
Quarantine facility - A structure where animals are held
for rabies observation.
(25)
Quarantine period - That portion of the observation period
during which a biting animal is physically confined for observation as provided
for in §169.27 of this title (relating to Quarantine Method and Testing).
(26)
Sanitize - To make physically clean and to destroy disease-producing
agents.
(27)
Therapy dog - A dog that helps a person with a diagnosed
emotional disorder for whom a letter has been issued by a physician stating
that the removal of the animal would be detrimental to the person's emotional
health.
(28)
Unowned animal - Any animal for which an owner has not
been identified.
(29)
Vaccinated - Properly injected by a licensed veterinarian
with a rabies vaccine licensed for use in that species by the United States
Department of Agriculture.
(30)
Zoonosis Control Division (ZCD) - The division within
the Texas Department of Health to which the responsibility for implementing
these rules is assigned.
(31)
Zoonosis control representative - Any person employed
by the ZCD.
§169.29.Vaccination Requirement.
(a)
The owner or custodian (excluding animal shelters) of each
domestic dog or cat shall have the animal vaccinated against rabies by four
months of age. The animal must receive a booster within the 12-month interval
following the initial vaccination. Every domestic dog or cat must be revaccinated
against rabies at a minimum of at least once every three years with a rabies
vaccine licensed by the United States Department of Agriculture. The vaccine
must be administered according to label recommendations. Livestock (especially
those that have frequent contact with humans), domestic ferrets, and wolf-dog
hybrids should be vaccinated against rabies. Nothing in this section prohibits
a veterinarian and owner or custodian from selecting a more frequent rabies
vaccination interval. Health and Safety Code, §§826.014 and 826.015
allow local jurisdictions to establish more frequent rabies vaccination intervals.
(b)
Official rabies vaccination certificates shall be issued
by the vaccinating veterinarian and contain the following information:
(1)
owner's name, address, and telephone number;
(2)
animal identification-species, sex (including neutered
if applicable), approximate age (three months to 12 months, 12 months or older),
size (pounds), predominant breed, and colors;
(3)
vaccine used-producer, expiration date, and serial number;
(4)
date vaccinated;
(5)
date vaccination expires (revaccination due date);
(6)
rabies tag number if a tag is issued;
(7)
veterinarian's signature or signature stamp and license
number.
(c)
A copy of each rabies vaccination certificate issued shall
be retained by the issuing veterinarian and be readily retrievable for a period
of not less than five years from the date of issuance.
(d)
If a veterinarian ceases the practice of veterinary medicine,
the duplicate rabies vaccination certificates retained by that practice shall
be turned over to the local rabies control authority. This does not apply
to the sale or lease of a practice, when the records of the practice are transferred
to a new owner.
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 February 27, 2003.
TRD-200301472
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 19, 2003
Proposal publication date: September 20, 2002
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts the repeal of §§241.1
- 241.7, and new §§241.1 - 241.9 concerning Texas crabmeat without
changes to the proposed text as published in the November 1, 2002, issue of
the
Texas Register
(27 TexReg 10305), and
therefore the sections will not be republished.
New §§241.3 - 241.5 were taken from repealed §241.3 concerning
licensing requirements. New §241.3 clarifies the licensing requirements, §241.4
clarifies the inspection requirements, and §241.5 clarifies the enforcement
process, including the assessment of administrative penalties. These changes
are adopted to promote conformity among programs within the Bureau of Food
and Drug Safety.
Title 21, Code of Federal Regulations (CFR), Part 123 contains the federal
Seafood Hazard Analysis Critical Control Point (HACCP) Regulation as administered
by the Food and Drug Administration (FDA). New §241.6 conforms to the
federal HACCP Regulation.
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 241.1
- 241.7 have been reviewed and the department has determined that reasons
for adopting the sections continue to exist.
The department published a Notice of Intention to Review §§241.1
- 241.7 in the
Texas Register
(26 TexReg 7582)
on September 28, 2001. The department received no comments on these sections
following publication of the notice.
There were no comments received regarding the proposed repeal and new sections
during the comment period.
Subchapter A. TEXAS CRAB MEAT
25 TAC §§241.1 - 241.7
The repeals are adopted under the Health and Safety Code, §436.112,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 436; and §12.001, which provides
the Texas Board of Health (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.
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 February 28, 2003.
TRD-200301491
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 20, 2003
Proposal publication date: November 1, 2002
For further information, please call: (512) 458-7236
25 TAC §§241.1 - 241.9
The new sections are adopted under the Health and Safety Code, §436.112,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 436; and §12.001, which provides
the Texas Board of Health (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.
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 February 28, 2003.
TRD-200301492
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 20, 2003
Proposal publication date: November 1, 2002
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts the repeal of §§241.50
- 241.67, and new §§241.50 - 241.71 concerning molluscan shellfish
without changes to the proposed text as published in the November 1, 2002
issue of the
Texas Register
(27 TexReg 10312),
and therefore the sections will not be republished.
New §241.50 changes the definition of a "repacker" which makes the
rules consistent throughout the sections. New §§241.58 - 241.60
were taken from §241.7, which was repealed concerning certification requirements.
Section 241.58 clarifies the certification requirements; §241.59 clarifies
the inspection requirements; and §241.60 clarifies the enforcement process
including the assessment of administrative penalties. These changes also promote
conformity among programs within the Bureau of Food and Drug Safety.
Title 21, Code of Federal Regulations (CFR), Part 123 contains the federal
Seafood Hazard Analysis Critical Control Point (HACCP) Regulation administered
by the Food and Drug Administration (FDA). The changes in §241.62 were
necessary to conform to the federal HACCP Regulation.
New §241.67 is a complete rewrite of repealed §241.64. These
changes were necessary to be in conformance with Issue 01-224 at the 2001
Interstate Shellfish Sanitation Conference. The addition of new §241.68
was necessary for the department to be in compliance with the National Shellfish
Sanitation Program's Model Ordinance. The State of Texas is required to institute
and maintain a
Vibrio vulnificus
Management
Plan for oysters.
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 241.50
- 241.67 have been reviewed and the department has determined that reasons
for adopting the sections continue to exist.
The department published a Notice of Intention to Review §§241.50
- 241.67 in the
Texas Register
(26 TexReg
7582) on September 28, 2001. The department received no comments on these
sections as a result of the publication of the notice.
There were no comments received regarding the proposed repeal and new sections
during the comment period.
25 TAC §241.50 - 241.67
The repeals are adopted under the Health and Safety Code, §436.112,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 436; and §12.001, which provides
the Texas Board of Health (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.
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 February 28, 2003.
TRD-200301497
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 20, 2003
Proposal publication date: November 1, 2002
For further information, please call: (512) 458-7236
25 TAC §§241.50 - 241.71
The new sections are adopted under the Health and Safety Code, §436.112,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 436; and §12.001, which provides
the Texas Board of Health (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.
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 February 28, 2003.
TRD-200301496
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 20, 2003
Proposal publication date: November 1, 2002
For further information, please call: (512) 458-7236
Subchapter I. TEXAS ENVIRONMENTAL LEAD REDUCTION
Chapter 49.
ORAL HEALTH IMPROVEMENT SERVICES PROGRAM
Chapter 84.
PREVENTIVE HEALTH AND HEALTH SERVICES BLOCK GRANT
Chapter 97.
COMMUNICABLE DISEASES
Chapter 137.
BIRTHING CENTERS
Subchapter B. LICENSING PROCEDURES
Subchapter C. ENFORCEMENT
Subchapter D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES
Chapter 169.
ZOONOSIS CONTROL
Chapter 241.
SHELLFISH SANITATION
Subchapter A. TEXAS CRABMEAT
Subchapter B. MOLLUSCAN SHELLFISH
Chapter 295.
OCCUPATIONAL HEALTH