Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Subchapter F. HEMOPHILIA ASSISTANCE PROGRAM
The Texas Department of Health (department) adopts the repeal of §§37.111
- 37.125 and new §§37.111 - 37.119, concerning the hemophilia assistance
program. New §§37.111 - 37.116 are adopted with changes to the proposed
text as published in the January 30, 2004, issue of the
Texas Register
(29 TexReg 770). Repealed §§37.111 - 37.125
and new §§37.117 - 37.119 are adopted without changes and, therefore,
the sections will not be republished.
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
has reviewed the sections and has determined that reasons for adopting the
sections continue to exist; however, revisions were needed to provide for
clarity and consistency of language and to facilitate compliance with and
administration of the rules.
The department published a Notice of Intent to Review for §§37.111
- 37.125 in the
Texas Register
on April 28,
2000 (25 TexReg 2799). No comments were received due to publication of this
notice.
Specifically, the new sections cover general requirements; recipient eligibility
requirements; residency and residency documentation requirements; application
and eligibility date; financial criteria; limitations and benefits provided;
participating providers; forms; and confidentiality of information.
The new rules define medical, financial and residency requirements, benefits
and limitations, and participation criteria for providers.
One comment was received on the proposal during the comment period. In
addition, the department is making minor changes due to staff comments to
clarify the intent and improve the accuracy of the sections.
Comment: Concerning §37.112(6), a commenter requested that the program
cover the 20% co-insurance for recipients eligible for Medicare, since the
program covers the co-insurance liability for recipients who have private
insurance.
Response: The department disagrees with the commenter and wishes to clarify
that the program does not cover the co-insurance liability for recipients
who have private insurance. According to §37.116(d), recipients who have
private/group insurance may be eligible to receive benefits from the program
only after they have exhausted their coverage under their private insurance
plan. Once they have exhausted their coverage, they are no longer considered
to have insurance coverage. No change was made as a result of this comment.
Change: Concerning §37.111(b)(2), the words "through a participating
provider" were deleted because the reference is unnecessary.
Change: Concerning §37.112(b)(6), the word "or" was added after the
phrase "on individual or group insurance", and the word "plan" was deleted
and the word "plans" was added after the word "medical", so that the paragraphs
are grammatically correct.
Change: Concerning §37.112(b)(6), the words "and health insurance
plans under the Social Security Act, Title XVIII, as amended" were deleted
because the reference no longer applies to recipients of the Hemophilia Assistance
Program.
Change: Concerning §37.113(e), the words "or person establishing residency
for the applicant under subsections (b) and (c) of this section" and "Texas
Medicaid" were deleted in order to clarify the requirements of this section.
Change: Concerning §37.113(f), new paragraph (f) was added to clarify
the requirements of this section and the subsequent subsections were re-lettered.
Change: Concerning §37.113(h)(2), the word "or" was added at the end
of the sentence, so that the paragraph is grammatically correct.
Change: Concerning §37.113(h)(3), paragraph (3) was deleted in its
entirety because the reference does not apply to recipients of the Hemophilia
Assistance Program and the subsequent paragraph was renumbered.
Change: Concerning §37.114(1)(D), the sentence "If the applicant,
or person(s) who has a legal obligation to support the applicant is currently
approved to receive benefits from Texas Medicaid, Temporary Assistance for
Needy Families (TANF), or Food Stamps, no verification of income is required"
was deleted because the reference is not necessary.
Change: Concerning §37.115(2), the sentence "Supplemental Security
Income (SSI) for the disabled applicant is not included as income" was deleted
because the reference is not applicable to recipients of the Hemophilia Assistance
Program.
Change: Concerning §37.116(b), the words "allowable products" were
added after the word "those" because they were omitted in the original submission.
Change: Concerning §37.116(c), the words "per recipient" were added
after the word "products" in order to clarify the intent of the paragraph.
25 TAC §§37.111 - 37.125
The repeals are adopted under Health and Safety Code, §12.001,
which provides the 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; and Health and Safety Code Chapter 41, relating
to hemophilia.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on April 16, 2004.
TRD-200402532
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§37.111 - 37.119
The new rules are adopted under Health and Safety Code, §12.001,
which provides the 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; and Health and Safety Code Chapter 41, relating
to hemophilia.
§37.111.General.
(a)
Purpose. The purpose of this chapter is to establish rules
for the Hemophilia Assistance Program (HAP). The authority for these rules
is granted in the Texas Health and Safety Code, Chapter 41.
(b)
Definitions. The following words and terms, when used in
this chapter, shall have the following meaning unless the context clearly
indicates otherwise.
(1)
Allowable product--Blood derivatives, blood concentrates,
and manufactured pharmaceutical products indicated for the treatment of hemophilia
and approved for payment by the Hemophilia Assistance Program.
(2)
Applicant--An individual whose application has been submitted
and has not received a final determination of eligibility. This includes an
individual whose application is submitted by a representative or person with
legal authority to act for the individual.
(3)
Department--The Texas Department of Health.
(4)
HAP--The Hemophilia Assistance Program.
(5)
Hemophilia--A human physical condition, characterized by
bleeding, resulting from a genetically determined deficiency of a blood coagulation
factor or hereditarily resulting in an abnormal or deficient plasma procoagulant.
(6)
Inhibitor--A type of antibody, more common in severe hemophilia
A than hemophilia B, which requires the use of higher doses of blood factor
to contain a bleeding episode. This is usually confirmed by the Bethesda inhibitor
assay and reported as the Bethesda titer. The development of an inhibitor
rarely occurs in those with mild hemophilia.
(7)
Participating provider--Any individual or entity with HAP
approval to provide allowable products to HAP recipients.
(8)
Recipient--An individual who is eligible to receive HAP
benefits.
§37.112.Recipient Requirements.
(a)
A person shall meet all of the following requirements to
be eligible for benefits from the Hemophilia Assistance Program (HAP):
(1)
have a diagnosis of hemophilia certified by a licensed
physician;
(2)
be 21 years of age or older;
(3)
be a resident of Texas as determined in §37.113 of
this title (relating to Residency and Residency Documentation Requirements)
and not be:
(A)
incarcerated in a city, county, state, or federal jail,
or prison; or
(B)
a ward of the state.
(4)
submit an application for benefits to the HAP;
(5)
meet, or the person(s) who have a legal obligation to support
the applicant meet, the financial guidelines as outlined in §37.115 of
this title (relating to Financial Criteria). The person or persons who have
a legal obligation to support the recipient will be determined by the applicable
state law; and
(6)
not be eligible for Medicare or Medicaid.
(b)
A recipient may have all HAP benefits modified, suspended,
or terminated for any of the following reasons:
(1)
failure to maintain Texas residency or, upon demand, furnish
evidence of such using the criteria in §37.113 of this title;
(2)
failure to provide income data as requested to determine
continued HAP eligibility;
(3)
recipient is incarcerated in a city, county, state, or
federal jail, or prison;
(4)
recipient becomes a ward of the state;
(5)
recipient makes a material misstatement or misrepresentation
on their application or any document required to support their application;
(6)
failure to continue premium payments on individual or group
insurance or prepaid medical plans, where such plans provide benefits for
the care and treatment of persons who have hemophilia and the person's eligibility
for benefits under the plan(s) was effective prior to eligibility for HAP,
or provide a statement on the application form outlining the reason(s) why
such insurance cannot be maintained; or
(7)
failure to receive services through a participating provider.
(c)
When eligibility for HAP benefits is terminated for any
of the reasons outlined in subsection (b) of this section, an applicant shall
reapply for HAP benefits.
(d)
A recipient whose benefits are modified, suspended, or
terminated may appeal the HAP decision under the procedure contained in §§1.51
- 1.55 of this title (relating to Fair Hearing Procedures).
§37.113.Residency and Residency Documentation Requirements.
(a)
The following conditions shall be met by an applicant and
maintained by a recipient to satisfy the residency requirements in this section:
(1)
physically reside within the state; and
(2)
maintain a home or abode within the state.
(b)
If the applicant is a legal dependent of, and residing
with, a resident (such as an adult child or spouse); or is a person under
legal guardianship, then the resident providing support or the legal guardian
of the applicant shall meet the requirements of subsection (a) of this section.
(c)
If the applicant is a parent residing with their adult
child who is a resident of Texas, residency may be determined through the
adult child. If the applicant is a parent being supported by their adult child,
whether or not the child is a resident of Texas, the residency may be determined
by the adult child providing the required documents supporting the Texas residency
of the parent. These provisions apply even if no legal guardianship has been
established.
(d)
All documents submitted to establish the residency of an
applicant shall be in English or accompanied by an accurate English translation,
if required by the Hemophilia Assistance Program (HAP).
(e)
An applicant who is currently a Texas resident and has
been currently approved to receive benefits from Temporary Assistance for
Needy Families (TANF) or Food Stamps, is not required to provide additional
residency verification.
(f)
A person establishing residency for the applicant under
subsections (b) and (c) of this section, who is currently a Texas resident
and has been currently approved to receive benefits from Texas Medicaid, Temporary
Assistance for Needy Families (TANF), or Food Stamps, is not required to provide
additional residency verification.
(g)
An applicant, or person establishing residency for the
applicant under subsections (b) and (c) of this section, may submit a copy
of any one of the following documents as evidence of residency. All documents
shall be in the applicant's name, or in the name of the person establishing
residency for the applicant, and provide some verification of a Texas address
or domicile:
(1)
a valid Texas driver's license, or an identification card
issued by the Texas Department of Public Safety;
(2)
a valid Texas voter's registration card, or a copy of a
validated (at the county clerk's office) application for a voter's registration
card;
(3)
a current Texas motor vehicle registration or automobile
license plate registration renewal form;
(4)
a mortgage payment receipt from any of the three months
immediately preceding the date of the application;
(5)
a rent payment receipt from any of the three months immediately
preceding the date of the application;
(6)
a statement reflecting that the applicant is currently
receiving rent-free housing. The statement must be signed by the individual
providing the rent-free housing and must include the address and phone number
of the individual providing the rent-free housing;
(7)
a utility payment receipt from any of the three months
immediately preceding the date of the application;
(8)
a Texas property tax receipt for the most recently completed
tax year;
(9)
a payroll or retirement check dated within the three months
immediately preceding the date of the application;
(10)
employment/unemployment records prepared within the three
months immediately preceding the date of the application;
(11)
a statement from a financial institution issued within
the three months preceding the date of the application; or
(12)
social security supplemental income or disability income
records, or social security retirement benefit records issued within the three
months immediately preceding the date of the application.
(h)
Applications submitted under subsections (b) and (c) of
this section shall also include evidence of the legal relationship between
the applicant and the resident, such as:
(1)
a marriage license or declaration of non-ceremonial marriage
to document the marriage of the applicant and spouse;
(2)
a birth certificate establishing the parent/child relationship
between the applicant and the resident; or
(3)
an income tax return showing name and relationship of the
applicant to the resident.
(i)
Any difference between the name of the applicant and the
name on any document must be explained by additional documentation (Example:
marriage license, divorce decree, or adoption decree).
§37.114.Applications and Eligibility Date.
Persons meeting the eligibility requirements set forth in §37.112(a)(1),
(2), (3), (5) and (6) of this title (relating to Recipient Requirements) must
make an application for benefits through the Hemophilia Assistance Program
(HAP).
(1)
Complete application. A complete application is required
before any eligibility determination will be made. A complete application
shall consist of all of the following:
(A)
a complete Application for Benefits, with the applicant's,
or the applicant's representative's, original signature or "mark";
(B)
a diagnosis of hemophilia certified by a licensed physician;
(C)
documentation of Texas residency as required by §37.113
of this title (relating to Residency and Residency Documentation Requirements);
(D)
applicant financial data. Acceptable data to establish
the applicant's financial qualifications shall be submitted with the application.
Changes in income or financial qualifications that would affect the applicant's
eligibility shall be reported to the HAP.
(i)
The applicant, or the person(s) who has a legal obligation
to support the applicant, may submit any of the following documents to verify
income:
(I)
copy of the most recent paycheck;
(II)
copy of the most recent paycheck stub or monthly employee
earnings statement;
(III)
employee's written verification of gross monthly income;
(IV)
pension/allotment award letters;
(V)
a copy of the IRS individual income tax return form and
supporting schedules for the most recently completed tax year; or
(VI)
any other documents considered valid by HAP.
(ii)
If the applicant, or person(s) who has a legal obligation
to support the applicant, is unemployed, a statement of termination from the
employer, or other documentation acceptable to HAP, is required.
(2)
Incomplete applications. Any application which does not
meet all of the requirements of paragraph (1) of this subsection is incomplete.
Incomplete applications may be returned to the submitting person for correction
or completion.
(3)
Eligibility date for HAP benefits. The HAP eligibility
date will be either:
(A)
the date HAP receives a completed application; or
(B)
the date of conditional authorization for allowable products,
if all written information to establish eligibility is received within 30
days of the date of conditional authorization.
(4)
Eligibility date for reinstatement of HAP benefits. If
HAP benefits are terminated, the eligibility date for any subsequent benefit
period will be the date on which HAP receives a subsequent completed application
for HAP benefits.
(5)
An applicant whose eligibility for benefits is denied may
appeal HAP's decision under the procedure contained in §§1.51 -
1.55 of this title (relating to Fair Hearing Procedures).
§37.115.Financial Criteria.
Financial need is established on the basis of income legally available
to the applicant or the person(s) who have a legal obligation to support the
applicant.
(1)
The income used to determine eligibility is the combined
gross income of the applicant and of all persons who have a legal obligation
to support the applicant.
(2)
Income includes earned wages, pensions or allotments, alimony,
or any monies received on a regular basis for support purposes. Verification
of income data will be required as set out in §37.114(1)(D) of this title
(relating to Applications and Eligibility Date).
(3)
The income level for eligibility is based on a percentage
of the Federal Poverty Level Guidelines currently published by the U.S. Health
and Human Services and adopted by the Texas Department of Health (department).
Priority levels are based on available funds and may be adjusted by the department
in order to meet budgetary limitations. Priority levels are as follows.
(A)
Priority 1 - 100% or below;
(B)
Priority 2 - 101% - 115%;
(C)
Priority 3 - 116% - 130%;
(D)
Priority 4 - 131% - 145%;
(E)
Priority 5 - 146% - 160%;
(F)
Priority 6 - 161% - 185%; or
(G)
Priority 7 - 186% - 200%.
§37.116.Limitations and Benefits Provided.
(a)
The Hemophilia Assistance Program (HAP) provides limited
reimbursement to participating providers for blood derivatives, blood concentrates,
and manufactured pharmaceutical products indicated for the treatment of hemophilia
and prescribed to eligible recipients for use in medical or dental facilities
or in the home.
(b)
All HAP benefits are limited to those allowable products
prescribed by a licensed physician and received in Texas from a participating
provider.
(c)
Depending on the recipient's eligibility status, HAP will
pay for allowable products per recipient based upon:
(1)
available funds;
(2)
established limits for allowable products by type or category
of product; and
(3)
the reimbursement rates established by the Texas Department
of Health (department).
(d)
Recipients eligible for coverage of allowable products
under a private/group health insurance plan are not eligible to receive HAP
benefits. A recipient that has exhausted this coverage may be eligible to
receive benefits from HAP.
(e)
To meet budgetary limitations, the department may:
(1)
adjust the priority level for receipt of benefits, as outlined
in §37.115(3) of this title (relating to Financial Criteria);
(2)
adjust the reimbursement rates established by the department;
(3)
restrict the allowable products paid for under the HAP;
(4)
adjust the established limits for allowable products;
(5)
adjust the limits established based on the inhibitor status
of the recipient or applicant;
(6)
limit the number of providers approved to participate in
the HAP; or
(7)
establish a waiting list of persons eligible for HAP. Appropriate
information will be collected from each applicant who is placed on a waiting
list. The information will be used to facilitate contacting the applicant
when benefits become available and to allow efficient enrollment of the applicant
for those benefits.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on April 16, 2004.
TRD-200402533
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts the repeal of §§100.1-100.11
and new §§100.1-100.8, concerning the immunization registry. New §§100.1
and 100.3 are adopted with changes to the proposed text as published in the
January 30, 2004, issue of the
Texas Register
(29
TexReg 776). Repealed §§100.1-100.11 and new §§100.2,
100.4-100.8 are adopted without changes and will not be republished.
The immunization registry is a statewide repository for immunization information
on Texas children. The information is available to public health districts,
local health departments, physicians, schools, child-care facilities, and
parents when record request criteria are met. The proposed rules are necessary
to simplify reporting immunization histories to the department and to enhance
the effectiveness of the immunization registry under its current authorized
legislation. As mandated by House Bill 1921, 78th Legislature, Regular Session
(2003), which revised Health and Safety Code, §161.007, the proposed
rules will help populate the registry by relieving payors and providers of
the responsibility for maintaining consent for the registry; will allow parents
to submit immunization histories directly to the department; will require
healthcare providers to send immunization records directly to the department;
will require the department to verify parental consent for each record submitted;
and will expand data access to any provider authorized to administer vaccines,
payors and state agencies with legal custody of a child.
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
has reviewed §§100.1-100.11 and has determined that reasons for
adopting the sections continue to exist; however, a repeal of the current
rules and the proposal of new rules are necessary to simplify the rules and
implement House Bill 1921.
The department published a Notice of Intention to Review for §§100.1-100.11
in the
Texas Register
on May 31, 2002 (27
TexReg 4745). No comments were received due to publication of this notice.
In general, public comments made at the public hearing and sent to the
department by mail, facsimile, and electronic mail were favorable to the rules
as proposed. The commenters agreed that the rules as proposed here for adoption
simplify reporting immunization histories to the department and enhance the
effectiveness of the immunization registry under its current authorized legislation.
Following each comment is the department's response and any resulting change(s).
Comment: Concerning §100.3(a), a commenter recommended the department
change the word "communicable" to "vaccine-preventable" disease.
Response: The department agrees. Information in the registry is specific
to diseases that may be prevented by vaccinations. The subsection was amended
as recommended.
Comment: Concerning §100.3(c), a commenter recommended the department
change "type of immunization" to "vaccine."
Response: The department agrees. The term vaccine improves clarity. The
department made the change to the subsection as recommended.
Comment: Concerning §100.3(d)(1), a commenter recommended the department
change the term "immunization information" to "immunization history".
Response: The department disagrees. "Immunization information" is the appropriate
term. No change was made as a result of this comment.
Comment: Concerning §§100.6(b), 100.6(c), 100.6(d)(2), 100.6(d)(3),
and 100.8(c)(2), a commenter recommended the department change the word "immunization"
to "vaccination".
Response: The department disagrees. The rules are consistent with the statutory
language in House Bill 1921. No change was made as a result of this comment.
The comments received were generally favorable of the rules as proposed;
however, commenters had questions or specific concerns, or offered suggestions
for changes, including changes in terminology, consistency, and clarity.
Some comments were general in nature and suggested no changes to the rules.
These general comments addressed registry procedures relating to local registries
and data reporting activities. The department will collaborate with local
registries to address procedural issues relating to implementation of the
rules. The department will also work with providers concerning the impact
of data entry and reporting of immunization information to the registry. No
changes to the rules resulted from these comments.
Commenters included the March of Dimes, VaccineWorks, San Antonio Metropolitan
Health District, and an individual.
The department made the following changes due to staff comments for clarity
and consistency:
Change: Concerning §100.1(6), restructuring of the definition "immunization
record" provides grammatical accuracy. The last sentence which reads, "The
report generated from the immunization registry is considered an official
immunization record." was deleted to eliminate redundancy in the rules.
Change: Concerning §100.1(12), the word "immunization" was inserted
so definition reads, "Vaccine - Includes toxoids and other immunologic agents
which are administered to children to elicit an immune response (immunization)
and thus protect against infectious diseases.
In addition, a public hearing was held at the department during the public
comment period on February 18, 2004, in order to listen to public comments
and concerns. During the public hearing one individual made comments.
25 TAC §§100.1 - 100.11
The repeals are adopted under the authority of Health and
Safety Code, §161.007, which gives the Texas Board of Health (board)
the right to develop rules to implement the immunization registry; and Health
and Safety Code, §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.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on April 16, 2004.
TRD-200402543
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§100.1 - 100.8
The new rules are adopted under the authority of Health and
Safety Code, §161.007, which gives the Texas Board of Health (board)
the right to develop rules to implement the immunization registry; and Health
and Safety Code, §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.
§100.1.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Child--The person or individual younger than 18 years of
age to whom a vaccine has been administered.
(2)
Consent--A statement signed by a parent agreeing that the
child's immunization history can be included in the registry and that the
child's immunization record may be released from the registry.
(3)
Data elements--Consistent with 42 U.S.C. §300aa-25,
as amended, data elements are defined as the information a provider who administers
a vaccine is required to record in a medical record, including:
(A)
the date the vaccine is administered;
(B)
the type of vaccine administered, vaccine manufacturer
and lot number; and
(C)
the name, address, and, if appropriate, the title of the
provider administering the vaccine.
(4)
Department--The Texas Department of Health.
(5)
Immunization history--An accounting of all vaccines that
a child has received, or evidence of immunity, and other identifying information.
(6)
Immunization record--A record containing the name and date
of birth of the person to whom a vaccine was administered; dates of vaccine
administration; types of vaccine administered; and name and address of the
provider that administered the vaccines; or other evidence of immunity to
a vaccine-preventable disease.
(7)
Immunization registry--The database or single repository
that contains immunization histories, which include necessary personal data
for identification. This database is confidential, and access to content is
limited to authorized users.
(8)
Parent--A parent, managing conservator, or legal guardian.
(9)
Payor--An insurance company, a health maintenance organization,
or another organization that pays a health care provider to provide health
care benefits, including the administration of vaccines to a person younger
than 18 years of age.
(10)
Provider--Any physician, health care professional, or
facility personnel duly licensed or authorized to administer vaccines.
(11)
User--An entity or individual authorized by the department
to access immunization registry data.
(12)
Vaccine--Includes toxoids and other immunologic agents
which are administered to children to elicit an immune response (immunization)
and thus protect against infectious diseases.
§100.3.Informing Parent, Managing Conservator, or Guardian.
(a)
A parent shall be informed that the department has established
and maintains a single repository of immunization records to be used in aiding,
coordinating, and promoting efficient and cost-effective childhood vaccine-preventable
disease prevention and control efforts.
(b)
The department shall provide written materials and forms
to providers for the purpose of informing a parent about the immunization
registry and specific information collected in that registry.
(c)
The department and providers may use the registry to provide
notices by mail, telephone, personal contact, or other means to a parent regarding
his or her child who may be due or overdue for a particular vaccine according
to the department's immunization schedule.
(d)
The first time the department receives registry data, from
a person other than the child's parent, for a child for whom the department
has received consent to be included in the registry, the department shall
send a written notice to the parent disclosing:
(1)
that providers and payors may be sending the child's immunization
information to the department;
(2)
the information that is included in the registry;
(3)
the persons to whom the information may be released;
(4)
the purpose of the registry;
(5)
the procedure to exclude a child from the registry; and
(6)
the procedure to report a violation if a parent discovers
a child is included in the registry after exclusion has been requested.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on April 16, 2004.
TRD-200402544
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts the repeal of §§117.3,
117.11 - 117.14, new §§117.11 - 117.14, and amendments to §§117.15,
117.16 and 117.84, concerning the regulation of end stage renal disease facilities.
Sections 117.11, 117.14 and 117.15 are adopted with changes to the proposed
text as published in the January 30, 2004, issue of the
Texas Register
(29 TexReg 780). Sections 117.12, 117.13, 117.16, and
117.84, and the repeal of §§117.3, 117.11 - 117.14, are adopted
without changes and, therefore, the sections will not be republished.
The amendments and new sections are required as a result of revisions and
additions to sections of the Health and Safety Code. House Bill (HB) 2292,
78th legislature, 2003, revised Health and Safety Code, §§12.0111
and 12.0112, and requires two-year licenses effective January 1, 2005; Senate
Bill 1152, which amended Government Code, Chapter 2054 for the Texas Online
authority; and Senate Bill 162, 78th legislature, 2003, which amended Health
and Safety Code, §251.062, and added new §251.0621, to include probation
and emergency suspension to the list of enforcement actions that can be taken
against a facility.
Specifically, the sections adopted for repeal address licensing fees, general
requirements for a license, application and issuance of a temporary initial
license and first annual license, application and issuance of annual renewal
license, and change of ownership or services. The new sections cover general
requirements for a license, application and issuance of initial license, application
and issuance of renewal license, and fees. The repeal of existing rules and
new sections allows for the reorganization and renumbering of the sections
for clarification, and for the inclusion of language to implement the provisions
of the new legislation. New §117.13 addresses the conversion to two-year
license cycles beginning January 1, 2005. New §117.14 includes fees for
both 12-month and two-year license renewal cycles, and for the recovery of
costs associated with application and renewal application processing through
Texas Online. The amendment to §117.15 updates references to other sections.
Amendment to §117.16 eliminates unnecessary language and clarifies that
inspections are conducted to determine compliance with HSC, Chapter 251, and
this chapter. The amendment to §117.84 addresses the addition of probation
and emergency suspension to the list of enforcement actions that can be taken
against a facility.
The department received no public comments concerning the proposal during
the comment period. However, the department is making the following changes
to clarify the intent of the sections and improve the accuracy of the sections.
Change: Concerning §117.11(e)(1)(B), the comma was deleted from the
end of the subparagraph for correct
Texas Register
formatting.
Change: Concerning §117.14(b)(2)(A), the word "issue" was changed
to "issued" for grammatical correctness.
Change: Concerning §117.14(b)(2)(B)(ii), the department changed the
word "if" to "of" to clarify the basis for determining the license fee.
Change: Concerning §117.15(e), the department changed "the" to "this"
to clarify that the word title refers to Title 25. Health Services.
Subchapter A. GENERAL PROVISIONS
25 TAC §117.3
The repeal is adopted under Health and Safety Code, §251.003,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §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 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 April 19, 2004.
TRD-200402567
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§117.11 - 117.14
The repeals are adopted under Health and Safety Code, §251.003,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §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 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 April 19, 2004.
TRD-200402568
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§117.11 - 117.16
The new sections and amendments are adopted under Health and
Safety Code, §251.003, concerning rules and minimum standards to protect
and promote the public health and welfare by providing for the issuance, renewal,
denial, suspension, and revocation of each level of license; and Health and
Safety Code, §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 commissioner of health.
§117.11.General Requirements for a License.
(a)
License required. A facility shall obtain a license prior
to admitting patients.
(b)
Display. A facility shall prominently and conspicuously
display the license in a public area of the licensed premises that is readily
visible to patients, employees, and visitors.
(c)
Alteration. A facility license shall not be altered.
(d)
Transfer or assignment prohibited. A facility license shall
not be transferred or assigned. The facility shall comply with the provisions
of §117.12(h) of this title (relating to Application and Issuance of
Initial License) in the event of a change in the ownership.
(e)
Changes which affect the license.
(1)
A facility shall notify the department in writing prior
to the occurrence of any of the following:
(A)
any construction, renovation, or modification of the facility
buildings;
(B)
cessation of operation of the facility; or
(C)
change in facility name, telephone number or administrator.
(2)
A facility shall obtain written approval from the department
prior to the utilization of added services or an increased number of stations.
The written request shall be submitted 30 calendar days prior to the planned
change.
(A)
For an additional service or increase in stations, the
department may request that the facility provide evidence of appropriate staffing
and policies and procedures which demonstrate the intent to comply with the
applicable requirements, and any other documentation it determines is necessary
to evaluate the request.
(B)
For an increase in stations, the facility shall also be
required to submit written evidence that the water treatment system is of
sufficient size to accommodate the increase and maintain a safe water supply.
(C)
The department may conduct on on-site inspection prior
to taking action on the requested change.
(D)
No later than three weeks after initiating the use of the
new stations, the facility is required to complete chemical and bacteriological
cultures of the product water to ensure they are in compliance with §4.2.1
(relating to Water Bacteriology) and §4.2.2 (relating to Maximum Level
of Chemical Contaminants) of the American National Standard, Water Treatment
Equipment for Hemodialysis Applications, August 2001 Edition, published by
the Association for the Advancement of Medical Instrumentation, 1110 North
Glebe Road, Suite 200, Arlington, Virginia 22201, 703-525-4890. Deviations
from acceptable levels must be immediately reported to the department. The
reports must be kept on file at the facility and made available to department
staff during the next on-site inspection.
(3)
The department shall send the facility written notice of
the approval or disapproval of the requested change.
(f)
Facility relocation.
(1)
A facility planning to relocate shall notify the department
a minimum of 60 days prior to the planned relocation. Relocations must be
within the same geographical area, and services shall continue to be provided
to the facility's existing patient population.
(2)
The facility shall submit the following to the department:
(A)
a copy of a current fire safety survey indicating approval
by the local fire authority in whose jurisdiction the new location is based;
(B)
results of chemical and bacteriological cultures of the
product water at the new location to ensure they are in compliance with §§4.2.1
(relating to Water Bacteriology) and 4.2.2 (relating to Maximum Level of Chemical
Contaminants) of the American National Standard, Water Treatment Equipment
for Hemodialysis Applications, August 2001 Edition, published by the Association
for the Advancement of Medical Instrumentation, 1110 North Glebe Road, Suite
200, Arlington, Virginia 22201, (703) 525-4890;
(C)
documentation verifying compliance with paragraph (1) of
this subsection; and
(D)
a written plan for the orderly transition of all patient
services to the new location.
(3)
The department shall conduct the design and space inspection
described in §117.16(b)(1)(A) of this title (relating to Inspections)
prior to issuance of the initial license, unless the department waives the
requirement.
(4)
The department may conduct additional on-site inspections,
or request additional information, before approving the relocation.
(5)
The department will notify the facility in writing of the
approval or disapproval of relocation. If approved, the license will be reissued
for the new location effective on the day that patient services are transferred
to the new location.
§117.14.Fees.
(a)
General.
(1)
All fees paid to the department are nonrefundable.
(2)
All fees shall be paid to the department.
(b)
License fees.
(1)
The fee for an initial license is $2,000 per 12-month period.
(2)
Renewal license fees.
(A)
For renewal licenses issued prior to January 1, 2005, the
license fee is determined by multiplying the number of treatments in the previous
12-month period by $.25, except that the minimum fee is $1,000 and the maximum
fee is $2,500.
(B)
For renewal licenses issued January 1, 2005 or later, the
license fee will be determined as follows.
(i)
For licenses that the department determines will be valid
for 12 months, the license fee is the total number of treatments in the past
12-month period multiplied by $.25, except that the minimum fee is $1,000
and the maximum fee is $2,500.
(ii)
For licenses that the department determines will be valid
for 24 months, the license fee is the total number of treatments in the past
12-month period multiplied by $.50, except that the minimum fee is $2,000
and the maximum fee is $5,000.
(c)
Other fees. For all applications and renewal applications,
the department is authorized to collect subscription and convenience fees,
in amounts determined by the Texas Online Authority, to recover costs associated
with application and renewal application processing through Texas Online,
in accordance with Texas Government Code, §2054.111.
§117.15.Time Periods for Processing and Issuing a License.
(a)
General.
(1)
The date a license application is received is the date
the application reaches the Texas Department of Health (department).
(2)
An application for an initial license is complete when
the department has received, reviewed, and found acceptable the information
described in §117.12 of this title (relating to Application and Issuance
of Initial License).
(3)
An application for an annual renewal license is complete
when the department has received, reviewed and found acceptable the information
described in §117.13 of this title (relating to Application and Issuance
of Renewal License).
(b)
Time Periods. An application from a facility for an initial
license or a renewal license shall be processed in accordance with the following
time periods.
(1)
The first time period begins on the date the department
receives the application and ends on the date the license is issued, or if
the application is received incomplete, the period ends on the date the facility
is issued a written notice that the application is incomplete. The written
notice shall describe the specific information that is required before the
application is considered complete. The first time period is 45 calendar days.
(2)
The second time period begins on the date the last item
necessary to complete the application is received and ends on the date the
license is issued. The second time period is 45 calendar days.
(c)
Reimbursement of fees.
(1)
In the event the application is not processed in the time
periods stated in subsection (b) of this section, the applicant has the right
to request that the department reimburse in full the fee paid in that particular
application process. If the department does not agree that the established
periods have been violated or finds that good cause existed for exceeding
the established periods, the request will be denied.
(2)
Good cause for exceeding the period established is considered
to exist if:
(A)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(B)
another public or private entity utilized in the application
process caused the delay; or
(C)
other conditions existed giving good cause for exceeding
the established periods.
(d)
Appeal. If the request for reimbursement as authorized
by subsection (c) of this section is denied, the applicant may then appeal
to the commissioner of health for a resolution of the dispute. The applicant
shall give written notice to the commissioner requesting reimbursement of
the fee paid because the application was not processed within the established
time period. The department shall submit a written report of the facts related
to the processing of the application and good cause for exceeding the established
time periods. The commissioner will make the final decision and provide written
notification of the decision to the applicant and the director.
(e)
Hearings. If a hearing is proposed during the processing
of the application, the hearing shall be conducted pursuant to the Administrative
Procedure Act, Texas Government Code, Chapter 2001, and the department's formal
hearing procedures in Chapter 1 of this title (relating to the Texas Board
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 April 19, 2004.
TRD-200402569
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
25 TAC §117.84
The amendment is adopted under Health and Safety Code, §251.003,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §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 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 April 19, 2004.
TRD-200402570
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 30, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts amendments to §§134.2,
134.22, 134.23, 134.26, 134.81 and 134.83, and adopts new §134.47, concerning
private psychiatric hospitals and crisis stabilization units. Sections 134.2,
134.22, 134.47 and 134.83 are adopted with changes to the proposed text as
published in the January 16, 2004, issue of the
Texas Register
(29 TexReg 441). Sections 134.23, 134.26, and 134.81
are adopted without changes and, therefore, the sections will not be republished.
The amendments and new section are required as a result of revisions and
additions to sections of the Health and Safety Code. House Bill (HB) 2292,
78th legislature, 2003, revised Health and Safety Code, §§12.0111
and 12.0112, and requires two-year licenses effective January 1, 2005; Senate
Bill 162, 78th legislature, 2003, which amended Health and Safety Code, §577.016,
and added probation to the list of enforcement actions that can be taken against
a facility; and HB 1614, 78th legislature, 2003, which amended Health and
Safety Code, Chapter 577, by adding Subchapter B, which establishes a patient
safety program.
Amendments to §134.2 include additional definitions for action plan,
adverse event, medical error, reportable event, and root cause analysis. Amendments
to §§134.22 and 134.23 implement the process for converting to two-year
licensing renewal cycles beginning January 1, 2005, and adds a requirement
to submit to the department an annual events report, and a best practices
report prior to the expiration of the license. Amendments to §134.26
increase licensing fees in order to implement the full cost recovery requirement
for licensing programs. New §134.47 includes requirements related to
development and implementation of a patient safety program, and establishes
annual reporting requirements related to specific events occurring at the
facility, and submission of best practice reports. The amendment to §134.81
clarifies limitations on the department's access related to a root analysis
and action plan. Amendments to §134.83 reflect the addition of probation
to the list of enforcement actions that can be taken against a facility.
The following comments were received concerning the proposed sections.
Following each comment is the department's response and any resulting change(s).
Comment: Concerning §134.2(2), a commenter was opposed to the scope
of the definition of "adverse event" in the proposed rule, and recommended
that the department adopt the Institute of Medicine's definition of that term.
Response: The department agrees. Since the Institute of Medicine is a nationally
recognized authority on health care quality and patient safety, it is appropriate
to use their definition of the term "adverse event". The rule has been changed
to include the definition found in the Institute of Medicine's 2004 publication
entitled Patient Safety: Achieving a New Standard of Care.
Comment: Concerning §134.47(a)(1)(B)(ii)-(iv), one commenter asked
that the department clarify that these reporting requirements apply only to
the facility's internal reporting systems, and not to any external reporting
requirements.
Response: Although §134.47(a)(1)(B)(ii)-(iv) as proposed did not place
any external reporting requirements on the facility, the department agreed
to include the revised language in §134.47(a)(1)(B)(ii)-(iv) to provide
the additional clarification requested by the commenter.
Comment: Concerning §134.47(a)(1)(B)(vi), one commenter stated that
the requirement that facilities have in place a support system for staff members
who were involved in medical errors would be unduly burdensome for small and
rural facilities.
Response: The rationale for including this requirement in the proposed
rule was based on the recommendations of nationally recognized patient safety
organizations who emphasize that a patient safety program can only be successful
if it is presented in a non-punitive manner and with an organizational commitment
to providing support to those who voluntary report medical errors. However,
the department agrees that making this support system mandatory could be burdensome
on some facilities, therefore, §134.47(a)(1)(B)(vi) has been deleted
and the subsequent clauses renumbered. Facilities are encouraged to voluntarily
provide a support system for staff who are involved in a medical error.
Comment: Concerning §134.47(a)(1)(C), a commenter requested that the
proposed rule requiring that facilities include a process for educating patients
regarding their shared responsibility for patient safety be deleted, as the
language would be unduly prescriptive.
Response: The rationale for including this requirement in the proposed
rule was based on the Institute of Medicine's recommendation that health care
organizations implement polices designed to assist patients and their families
in understanding their roles in assuring the safety of patients while they
are in the facility. However, the department understands that some facilities
may find compliance with this requirement excessively burdensome, therefore
the requirement has been deleted from the final rule. Facilities are strongly
encouraged to voluntarily include patient safety issues in their patient education
activities. Subparagraph (C) was deleted from subsection §134.47(a)(1),
and the remaining subparagraph was renumbered.
Comment: Concerning §134.47(a)(1)(D), one commenter stated that, although
training of certain personnel could be inferred to be a reasonable component
of a facility's patient safety program, the requirement to provide patient
safety education and training to all clinical and administrative staff was
excessive. The commenter believed it was not necessary to extend this requirement
to administrative staff, and recommended that rule be revised to reflect that
the training was required only for those staff directly involved with the
patient safety program.
Response: The department agrees and has revised renumbered §137.47(a)(1)(C)
to reflect the change.
Comment: Concerning §134.47(a)(2), one commenter stated that the proposed
rule requiring that the facility designate an individual to serve as the Patient
Safety Program Coordinator could create an unworkable standard in many institutions.
The commenter recommended that the rule be revised to allow more than one
individual, or an interdisciplinary group, to be designated as responsible
for the management of patient safety program.
Response: The department agrees, and has revised §134.47(a)(2) to
reflect this change as well as grammatical changes to the subparagraphs of
the paragraph.
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 §134.2(25), the definition of "medical error" was
changed to reflect the definition by the Institute of Medicine, a nationally
recognized authority on health care quality and patient safety. The definition,
which is in the Institute's 2004 publication entitled Patient Safety: Achieving
a New Standard of Care, was changed for purposes of clarity and for consistency
with other department rules.
Change: Concerning §134.2(46), word "hospital" was changed to "facility"
in the definition of "reportable event" to clarify the rule pertains to both
private psychiatric hospitals and crisis stabilization units. An editorial
change was also made to the rule.
Change: Concerning §134.22(d)(2)(B), a comma was added after the date
to be consistent with the punctuation following dates throughout the chapter.
Change: Concerning §134.47(a)(1)(B), the comma was deleted after the
word "and" to be consistent with the punctuation throughout the chapter.
Change: Concerning §134.47(a)(3) and (b)(1)(A) and (B), the word "hospital"
was changed to "facility" to clarify the rule pertains to both private psychiatric
hospitals and crisis stabilization units.
Change: Concerning §134.47(b)(1)(A) and (2)(A), language has been
added to clarify the submission requirements for the annual events report
and best practices report, and that the best practices report is for each
facility, not for each type of reported occurrence. The change to paragraphs
(1)(A) and (2)(A) of the subsection is consistent with legislative intent
and with other department rules.
Change: Concerning §134.47(b)(2)(B), the word "practice" was changed
to "practices" to be consistent with the language used in the paragraph.
Change: Concerning §134.83(14)(A), the word "decision's" was changed
to "decision" for grammatical correctness.
The commenter was the Texas Hospital Association. The commenter was generally
in favorable of the rules, however, the commenter had specific concerns and
offered suggestions for changes.
Subchapter A. GENERAL PROVISIONS
25 TAC §134.2
The amendment is adopted under Health and Safety Code, Chapter
577, concerning private mental hospitals and other mental health facilities;
and Health and Safety Code, §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.
§134.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Action plan--A written document that includes specific
measures to correct identified problems or areas of concern; identifies strategies
for implementing system improvements; and includes outcome measures to indicate
the effectiveness of system improvements in reducing, controlling or eliminating
identified problem areas.
(2)
Adverse event--An event that results in unintended harm
to the patient by an act of commission or omission rather than by the underlying
disease or condition of the patient.
(3)
Applicant--The person legally responsible for the operation
of the facility, whether by lease or ownership, who seeks a license from the
department.
(4)
Board--The Texas Board of Health.
(5)
Community center--A center established under Health and
Safety Code, Chapter 534, Subchapter A.
(6)
Contaminated linen--Linen which has been soiled with blood
or other potentially infectious materials or may contain sharps. Other potentially
infectious materials means:
(A)
the following human body fluids: semen, vaginal secretions,
cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal
fluid, amniotic fluid, saliva in dental procedures, any body fluid that is
visibly contaminated with blood, and all body fluids in situations where it
is difficult or impossible to differentiate between body fluids;
(B)
any unfixed tissue or organ (other than intact skin) from
a human (living or dead); and
(C)
Human Immunodeficiency Virus (HIV)-containing cell or tissue
cultures, organ cultures, and HIV or Hepatitis B Virus (HBV) containing culture
medium or other solutions; and blood, organs, or other tissues from experimental
animals infected with HIV or HBV.
(7)
Crisis stabilization unit (CSU)--A mental health facility
operated by a community center or other entity designated by the Texas Department
of Mental Health and Mental Retardation in accordance with Texas Health and
Safety Code, §534.054, that provides treatment to individuals who are
the subject of a protective custody order issued in accordance with Texas
Health and Safety Code, §574.022.
(8)
Dentist--A person licensed to practice dentistry by the
State Board of Dental Examiners. This includes a doctor of dental surgery
or a doctor of dental medicine.
(9)
Department--The Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756-3199.
(10)
Dietitian--A person who is currently licensed by the Texas
State Board of Examiners of Dietitians as a licensed dietitian or provisional
licensed dietitian, or who is a registered dietitian with the American Dietetic
Association.
(11)
Director--The director of the Health Facility Licensing
and Compliance Division, Texas Department of Health.
(12)
Division--The Health Facility Licensing and Compliance
Division, Texas Department of Health.
(13)
Emergency medical condition--A medical condition manifesting
itself by acute symptoms of sufficient severity (including severe pain, psychiatric
disturbances or symptoms of substance abuse) such that the absence of immediate
medical attention could reasonably be expected to result in one or all of
the following:
(A)
placing the health of the individual (or with respect to
a pregnant woman, the health of the woman or her unborn child) in serious
jeopardy;
(B)
serious impairment to bodily functions;
(C)
serious dysfunction of any bodily organ or part; or
(D)
with respect to a pregnant woman who is having contractions:
(i)
that there is inadequate time to effect a safe transfer
to another hospital before delivery; or
(ii)
that transfer may pose a threat to the health or safety
of the woman or the unborn child.
(14)
Facility--A private psychiatric hospital or a crisis stabilization
unit.
(15)
Facility administration--Administrative body of a facility
headed by an individual who has the authority to represent the facility and
who is responsible for the operation of the facility according to the policies
and procedures of the facility governing body.
(16)
Fast-track projects--A construction project in which it
is necessary to begin initial phases of construction before later phases of
the construction documents are fully completed in order to establish other
design conditions or because of time constraints such as mandated deadlines.
(17)
Governing body--The governing authority of a facility
which is responsible for the facility's organization, management, control,
and operation, including appointment of the medical staff; includes the owner
or partners for facilities owned or operated by an individual or partners.
(18)
Governmental unit--A political subdivision of the state,
including a hospital district, county, or municipality, and any department,
division, board, or other agency of a political subdivision.
(19)
Hospital--A private psychiatric hospital.
(20)
Inpatient services--Services provided to a patient admitted
to a hospital for an intended length of stay of 24 hours or greater.
(21)
Learning disability--When a severe discrepancy exists
when the individual's assessed intellectual ability is above the mentally
retarded range, but where the individual's assessed educational achievement
in areas specified is more than one standard deviation below the individual's
intellectual ability.
(22)
Legally reproduced form--A medical record retained in
hard copy, microform (microfilm or microfiche), or other electronic medium.
(23)
Licensed vocational nurse--An individual who is currently
licensed as a licensed vocational nurse (LVN) by the Board of Vocational Nurse
Examiners in accordance with Texas Occupations Code, Chapter 302.
(24)
Licensee--A person or governmental unit who has been granted
a private psychiatric hospital license or crisis stabilization unit license.
(25)
Medical error--The failure of a planned action to be completed
as intended, the use of a wrong plan to achieve an aim, or the failure of
an unplanned action that should have been completed, that results in an adverse
event.
(26)
Medical staff--Licensed physicians and other licensed
practitioners permitted by law and by the facility to provide medical care
independently in the facility.
(27)
Mental health services--All services concerned with research,
prevention, and detection of mental disorders and disabilities and all services
necessary to treat, care for, supervise, and rehabilitate persons who have
a mental illness.
(28)
Mental illness--An illness, disease, or condition (other
than a sole diagnosis of epilepsy, senility, substance use disorder, mental
retardation, autism, or pervasive developmental disorder) that:
(A)
substantially impairs a person's thought, perception of
reality, emotional process, or judgment; or
(B)
grossly impairs an individual's behavior as demonstrated
by recent disturbed behavior.
(29)
Mental retardation--Significantly subaverage general intellectual
functioning that is concurrent with deficits in adaptive behavior and originates
during the developmental period.
(30)
Minor--A person under 18 years of age who is not and has
not been married or who has not had the disabilities of minority removed for
general purposes.
(31)
Mobile unit--Any pre-manufactured structure, trailer,
or self-propelled unit equipped with a chassis on wheels and intended to provide
shared medical services to the community on a temporary basis. Some of these
units are equipped with expanding walls, and designed to be moved on a daily
basis.
(32)
Oral surgeon--A person licensed by the State Board of
Dental Examiners in the specialty of dentistry which includes the diagnosis,
surgical and adjunctive treatment of diseases, injuries, and defects involving
both the functional and esthetic aspects of the hard and soft tissues of the
oral and maxillofacial regions.
(33)
Outpatient services--Services provided to patients whose
medical needs can be met in less than 24 hours and are provided within the
facility.
(34)
Owner--One of the following persons which will hold or
does hold a license issued under Health and Safety Code, Chapter 577, in the
person's name or the person's assumed name:
(A)
a corporation;
(B)
a governmental unit;
(C)
a limited liability company;
(D)
an individual;
(E)
a partnership if a partnership name is stated in a written
partnership agreement or an assumed name certificate;
(F)
all partners in a partnership if a partnership name is
not stated in a written partnership agreement or an assumed name certificate;
or
(G)
all co-owners under any other business arrangement.
(35)
Patient--An individual who is receiving mental health
services under this chapter.
(36)
Person--An individual, firm, partnership, corporation,
association, joint stock company, joint venture, or local authority, and includes
a receiver, trustee, assignee, or other similar representative of those entities.
(37)
Pharmacist--A person who is licensed to practice pharmacy
by the Texas Board of Pharmacy in accordance with Texas Occupations Code,
Chapter 558.
(38)
Physician--An individual who is:
(A)
licensed as a physician by the Texas State Board of Medical
Examiners in accordance with Chapter 155 of the Texas Occupations Code; or
(B)
authorized to perform medical acts under an institutional
permit at a Texas postgraduate training program approved by the Accreditation
Council on Graduate Medical Education, the American Osteopathic Association,
or the Texas State Board of Medical Examiners.
(39)
Podiatrist--A podiatrist licensed by the Texas State Board
of Podiatry Examiners.
(40)
Political subdivision--A county, municipality, or hospital
district in this state but does not include a department, board, or agency
of the state that has statewide authority and responsibility.
(41)
Practitioner--A health care professional licensed in the
State of Texas, other than a physician.
(42)
Premises--A premises may be any of the following:
(A)
a single building where inpatients receive hospital services;
or
(B)
multiple buildings where inpatients receive hospital services,
provided that the following criteria are met:
(i)
all inpatient buildings and inpatient services are subject
to the control and direction of the governing body of the hospital;
(ii)
all inpatient buildings are within a 30-mile radius of
the main address of the licensee;
(iii)
there is integration of the organized medical staff of
the hospital;
(iv)
there is a single chief executive officer who reports
directly to the governing body and through whom all administrative authority
flows and who exercises control and surveillance over all administrative activities
of the hospital;
(v)
there is a single chief medical officer who reports directly
to the governing body and who is responsible for all medical staff activities
of the hospital; and
(vi)
each building that is geographically separate from other
buildings contains at least one nursing unit for inpatients, unless providing
only diagnostic or laboratory services, or a combination thereof, in the building
for hospital inpatients.
(43)
Private psychiatric hospital--A hospital that provides
inpatient mental health services to individuals with a mental illness or with
a substance use disorder except that, at all times, a majority of the individuals
admitted are individuals with a mental illness. Such services include psychiatric
assessment and diagnostic services, physician services, professional nursing
services, and monitoring for patient safety provided in a restricted environment.
(44)
Registered nurse--An individual who is licensed as a registered
nurse by the Board of Nurse Examiners in accordance with Texas Occupations
Code, Chapter 301.
(45)
Relocatable unit--Any structure, not on wheels, built
to be relocated at any time and provide medical services. These structures
vary in size.
(46)
Reportable event--A medical error or adverse event or
occurrence which the facility is required to report to the department, as
set out in §134.47 of this title (relating to Patient Safety Program).
(47)
Root cause analysis--An interdisciplinary review process
for identifying the basic or contributing causal factors that underlie a variation
in performance associated with an adverse event or reportable event. It focuses
primarily on systems and processes, includes an analysis of underlying cause
and effect, progresses from special causes in clinical processes to common
causes in organizational processes, and identifies potential improvements
in processes or systems.
(48)
Stabilize--With respect to an emergency medical condition,
to provide such medical treatment of the condition necessary to assure, within
reasonable medical probability, that no material deterioration of the condition
is likely to result from or occur during the transfer of the individual from
a facility, or that the woman has delivered the child and the placenta.
(49)
Transfer--The movement (including the discharge) of an
individual outside a facility at the direction of any person employed by (or
affiliated or associated, directly or indirectly, with) the facility, but
does not include such a movement of an individual who has been declared dead,
or leaves the facility without the permission of any such person.
(50)
Transportable unit--Any pre-manufactured structure or
trailer, equipped with a chassis on wheels, intended to provide shared medical
services to the community on an extended temporary basis. These units are
designed to be moved periodically, depending on need.
(51)
Universal precautions--Procedures for disinfection and
sterilization of reusable medical devices and the appropriate use of infection
control, including hand washing, the use of protective barriers, and the use
and disposal of needles and other sharp instruments as those procedures are
defined by the Centers for Disease Control (CDC) of the United States Public
Health Service. This term includes standard precautions as defined by CDC
which are designed to reduce the risk of transmission of blood borne and other
pathogens in facilities.
(52)
Violation--Failure to comply with the licensing statute,
a rule or standard, special license provision, or an order issued by the commissioner
of health or the commissioner's designee, adopted or enforced under the licensing
statute. Each day a violation continues or occurs is a separate violation
for purposes of imposing a penalty.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on April 19, 2004.
TRD-200402571
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 16, 2004
For further information, please call: (512) 458-7236
25 TAC §§134.22, 134.23, 134.26
The amendments are adopted under Health and Safety Code, Chapter
577, concerning private mental hospitals and other mental health facilities;
and Health and Safety Code, §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.
§134.22.Application and Issuance of Initial License.
(a)
Application submittal. The applicant shall submit the following
documents to the department no earlier than 60 calendar days prior to the
projected opening date of the facility:
(1)
an accurate and complete application form;
(2)
a copy of the facility's patient transfer policy which
is developed in accordance with §134.43 of this title (relating to Patient
Transfer Policy) and is signed by both the chairman and secretary of the governing
body attesting to the date the policy was adopted by the governing body and
the effective date of the policy;
(3)
a copy of the facility's memorandum of transfer form which
contains at a minimum the information described in §134.43(d)(10)(B)
of this title;
(4)
for existing facilities, a copy of a fire safety survey
indicating approval by the local fire authority in whose jurisdiction the
facility is based that is dated no earlier than one year prior to the opening
date. For new construction, additions, and renovation projects, written approval
by the local building department and local fire authority shall be submitted
at the time of the final construction survey by the department;
(5)
documentation of accreditation by the Joint Commission
on Accreditation of Healthcare Organizations, if applicable;
(6)
the appropriate license fee as required in §134.26
of this title (relating to Fees);
(7)
if the applicant is a sole proprietor, partnership with
individuals as a partner, or a corporation in which an individual has an ownership
interest of at least 25% of the business entity, the names and social security
numbers of the individuals; and
(8)
a multiple hospital location application form for multiple
hospitals to be licensed under a single license number, if applicable.
(b)
Additional documentation for new facilities or conversions
from nonfacility buildings. In addition to the document submittal requirements
in subsection (a) of this section, the following shall be completed prior
to the issuance of a license.
(1)
Preliminary and final architectural plans and specifications
shall be submitted for review and approval by the department in accordance
with §134.127 of this title (relating to Preparation, Submittal, Review
and Approval of Plans).
(2)
For new construction, surveys shall be conducted by the
department in accordance with §134.128(b) of this title (relating to
Construction, Surveys, and Approval of Project) to determine that the facility
was constructed or remodeled in accordance with this chapter.
(3)
When an applicant intends to reopen and license a building
formerly licensed as a hospital or crisis stabilization unit, an on-site survey
shall be conducted by the department in accordance with §134.128(b) of
this title to determine compliance with applicable construction and fire safety
requirements.
(4)
All plan review and construction survey fees shall be paid
to the department.
(5)
A certificate of occupancy approved by the local fire authority,
and issued by the city building inspector, if applicable, shall be obtained
and a copy submitted to the department.
(6)
A complete and accurate Final Construction Approval form
signed by facility administration shall be submitted to the department.
(c)
Presurvey conference. The applicant or the applicants representative
shall attend a presurvey conference at the office designated by the department.
The purpose of the presurvey conference, which is conducted by department
staff, is to review licensure rules and survey documents and provide consultation
prior to the on-site licensure survey. The department may waive the presurvey
conference requirement.
(d)
Issuance of license. When it is determined that the facility
has complied with subsections (a)-(c) of this section, the department shall
issue the license to the applicant.
(1)
Effective date. The license shall be effective on the date
the facility is determined to be in compliance with subsections (a)-(c) of
this section. The effective date shall not be prior to the date of the final
construction survey conducted by the department.
(2)
Expiration date.
(A)
For initial licenses issued prior to January 1, 2005.
(i)
If the effective date of the license is the first day of
a month, the license expires on the last day of the 11th month after issuance.
(ii)
If the effective date of the license is the second or
any subsequent day of a month, the license expires on the last day of the
12th month after issuance.
(B)
For initial licenses issued January 1, 2005, or after.
(i)
If the effective date of the license is the first day of
a month, the license expires on the last day of the 23rd month after issuance.
(ii)
If the effective date of the license is the second or
any subsequent day of a month, the license expires on the last day of the
24th month after issuance.
(e)
Withdrawal of application. If an applicant decides not
to continue the application process for a license or renewal of a license,
the application may be withdrawn. The department shall acknowledge receipt
of the request to withdraw.
(f)
Denial of a license. Denial of a license shall be governed
by §134.83 of this title (relating to Enforcement).
(g)
Survey. During the initial licensing period, the department
shall conduct a survey of the facility to ascertain compliance with the provisions
of the Health and Safety Code, Chapter 577 and this chapter.
(1)
A facility shall request an on-site survey to be conducted
after one inpatient has been admitted and provided services.
(2)
A facility shall be providing services to at least one
inpatient in the facility at the time of the survey.
(3)
If a hospital has applied to participate in the federal
Medicare program, the survey may be conducted in conjunction with the licensing
survey to determine compliance with 42 Code of Federal Regulations, Part 482
(relating to Medicare Conditions of Participation for Hospitals).
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on April 19, 2004.
TRD-200402572
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 16, 2004
For further information, please call: (512) 458-7236
25 TAC §134.47
The new section is adopted under Health and Safety Code, Chapter
577, concerning private mental hospitals and other mental health facilities;
and Health and Safety Code, §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.
§134.47.Patient Safety Program.
(a)
General.
(1)
The facility must develop, implement, maintain and enforce
an effective, ongoing, organization-wide, data driven Patient Safety Program
(PSP).
(A)
The governing body must ensure that the PSP reflects the
complexity of the facility's organization and services, including those services
furnished under contract or arrangement, and focuses on the prevention and
reduction of medical errors and adverse events.
(B)
The PSP must be in writing, approved by the governing body
and made available for review by the department. It must include the following
components:
(i)
the definition of medical errors, adverse events and reportable
events;
(ii)
the process for internal reporting of medical errors,
adverse events and reportable events;
(iii)
a list of events and occurrences which staff are required
to report internally;
(iv)
time frames for internal reporting of medical errors,
adverse events and reportable events;
(v)
consequences for failing to report events in accordance
with facility policy;
(vi)
mechanisms for preservation and collection of event data;
(vii)
the process for conducting root cause analysis;
(viii)
the process for communicating action plans; and
(ix)
the process for feedback to staff regarding the root cause
analysis and action plan.
(C)
The facility must provide patient safety education and
training to staff who have responsibilities related to the implementation,
development, supervision or evaluation of the PSP. Training must include all
PSP components as set out in subparagraph (B) of this paragraph.
(2)
The facility must designate one or more individuals, or
an interdisciplinary group, qualified by training or experience to be responsible
for the management of the patient safety program. These responsibilities shall
include:
(A)
coordinating all patient safety activities;
(B)
facilitating assessment and appropriate response to reported
events;
(C)
monitoring root cause analysis and resulting action plans;
and
(D)
serving as liaison among facility departments and committees
to ensure facility-wide integration of the PSP.
(3)
Within 45 days of becoming aware of a reportable event
specified under subsection (b)(1)(A) of this section, the facility must:
(A)
complete a root cause analysis to examine the cause and
effect of the event through an impartial process; and
(B)
develop an action plan identifying the strategies that
the facility intends to employ to reduce the risk of similar events occurring
in the future. The action plan must:
(i)
designate responsibility for implementation and oversight;
(ii)
specify time frames for implementation; and
(iii)
include a strategy for measuring the effectiveness of
the actions taken.
(C)
must make the root cause analysis and action plan available
for on-site review by department representatives.
(b)
Reporting requirements. The following requirements are
effective July 1, 2004.
(1)
Annual events report.
(A)
On the renewal of the facility's license, or annually based
on the facility's original licensing date, the facility shall submit to the
department a report that lists the number of occurrences at the facility,
including any outpatient facility owned or operated by the facility, of each
of the following events occurring during the preceding year:
(i)
a medication error resulting in a patient's unanticipated
death or major permanent loss of bodily function in circumstances unrelated
to the natural course of the illness or underlying condition of the patient;
(ii)
the suicide of a patient in a setting in which the patient
received care 24 hours a day;
(iii)
the sexual assault of a patient during treatment or while
the patient was on the premises of the facility;
(iv)
a hemolytic transfusion reaction in a patient resulting
from the administration of blood or blood products with major blood group
incompatibilities;
(v)
a patient death or serious disability associated with the
use or function of a device designed for patient care that is used or functions
other than as intended.
(B)
The facility is not required to include any information
other than the total number of occurrences of each of the events listed under
subparagraph (A) of this paragraph.
(2)
Best practices report.
(A)
On the renewal of the facility's license, or annually based
on the facility's original licensing date, the facility shall submit to the
department at least one report of the best practices and safety measures related
to a reported event.
(B)
The best practices report may be submitted on a form to
be prescribed by the department, or the facility may submit a copy of a report
submitted to a patient safety organization.
(C)
Facilities may voluntarily report additional best practices
and safety measures.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed
with the Office of the Secretary of State on April 19, 2004.
TRD-200402573
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 16, 2004
For further information, please call: (512) 458-7236
25 TAC §134.81, §134.83
The amendments are adopted under Health and Safety Code, Chapter
577, concerning private mental hospitals and other mental health facilities;
and Health and Safety Code, §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.
§134.83.Enforcement.
Enforcement is a process by which a sanction is proposed, and if warranted,
imposed on an applicant or licensee regulated by the department for failure
to comply with statutes, rules and orders applicable to them.
(1)
Denial, suspension or revocation of a license. The department
has jurisdiction to enforce violations of the Acts or the Rules adopted under
this chapter. The department may deny, suspend, or revoke a license for, but
not limited to, the following reasons:
(A)
fails to comply with any provision of Health and Safety
Code (HSC), Chapters 577 and 571;
(B)
fails to comply with any provision of this chapter (25
Texas Administrative Code, Chapter 134);
(C)
fails to comply with a special license condition;
(D)
fails to comply with an order of the commissioner of health
(commissioner) or another enforcement procedure under HSC, Chapters 577 and
571;
(E)
has a history of failure to comply with the rules adopted
under this chapter relating to patient environment, health, safety, and rights;
(F)
has aided, abetted or permitted the commission of an illegal
act;
(G)
has committed fraud, misrepresentation, or concealment
of a material fact on any documents required to be submitted to the department
or required to be maintained by the facility pursuant to the provisions of
this chapter;
(H)
fails to pay administrative penalties in accordance with
HSC, Chapter 571;
(I)
fails to implement plans of corrections to deficiencies
cited by the department; or
(J)
fails to comply with applicable requirements within a designated
probation period.
(2)
Denial of a license. The department has jurisdiction to
enforce violations of the HSC, Chapters 577 and 571, and this chapter. The
department may deny a person a license for, but not limited to, the following
reasons:
(A)
fails to provide the required application or renewal information;
(B)
discloses any of the following actions against or by the
applicant, or the licensee, or against or by affiliates, or managers of the
applicant or the licensee within the two-year period preceding the application:
(i)
operation of a facility that has been decertified or had
its contract cancelled under the Medicare or Medicaid program in any state;
(ii)
federal Medicare or state Medicaid sanctions or penalties;
(iii)
federal or state tax liens;
(iv)
unsatisfied final judgments;
(v)
eviction involving any property or space used as a hospital
in any state;
(vi)
unresolved state Medicaid or federal Medicare audit exceptions;
(vii)
denial, suspension, or revocation of a hospital license,
a private psychiatric hospital license, or a license for any health care facility
in any state; or
(viii)
a court injunction prohibiting ownership or operation
of a facility.
(3)
Order for immediate license suspension. The department
may suspend a license for 10 days pending a hearing if after an investigation
the department finds that there is an immediate threat to the health or safety
of the patients or employees of a licensed facility. The department may issue
necessary orders for the patients' welfare.
(4)
Probation. In lieu of suspending or revoking the license,
the department may schedule the facility for a probation period of not less
than 30 days if the facility is found in repeated non-compliance and the facility's
noncompliance does not endanger the health and safety of the public.
(5)
Administrative penalty. The department has jurisdiction
to impose an administrative penalty against a person licensed or regulated
under this chapter for violations of the HSC, Chapters 577 and 571, this chapter
(25 TAC, Chapter 134), or for any reasons outlined in paragraphs (1) through
(3) of this subsection. The imposition of an administrative penalty shall
be in accordance with the provisions of the HSC, §571.025 and §577.060.
(6)
Licensure of persons with criminal backgrounds. The department
may deny a person a license or suspend or revoke an existing license on the
grounds that the person has been convicted of a felony or misdemeanor that
directly relates to the duties and responsibilities of the ownership or operation
of a facility. The department shall apply the requirements of the Texas Occupations
Code, Chapter 53.
(A)
The department is entitled to obtain criminal history information
maintained by the Texas Department of Public Safety (Government Code, §411.122),
the Federal Bureau of Investigation Identification Division (Government Code, §411.087)
or any other law enforcement agency to investigate the eligibility of an applicant
for an initial or renewal license and to investigate the continued eligibility
of a licensee.
(B)
In determining whether a criminal conviction directly relates,
the department shall consider the provisions of Occupations Code, §53.022
and §53.023.
(C)
The following felonies and misdemeanors directly relate
because these criminal offenses indicate an inability or a tendency for the
person to be unable to own or operate a facility:
(i)
a misdemeanor violation of HSC, Chapter 571;
(ii)
a misdemeanor or felony involving moral turpitude;
(iii)
a misdemeanor or felony relating to deceptive business
practices;
(iv)
a misdemeanor or felony of practicing any health-related
profession without a required license;
(v)
a misdemeanor or felony under any federal or state law
relating to drugs, dangerous drugs, or controlled substances;
(vi)
a misdemeanor or felony under the Texas Penal Code (TPC),
Title 5, involving a patient or a client of any health care facility, a home
and community support services agency or a health care professional;
(vii)
a misdemeanor or felony under the TPC:
(I)
Title 4 - offenses of attempting or conspiring to commit
any of the offenses in this clause;
(II)
Title 5 - offenses against the person;
(III)
Title 7 - offenses against property;
(IV)
Title 8 - offenses against public administration;
(V)
Title 9 - offenses against public order and decency;
(VI)
Title 10 - offenses against public health, safety or morals;
or
(VII)
Title 11 - offenses involving organized crime.
(viii)
Offenses listed in subparagraph (C) of this paragraph
are not exclusive in that the department may consider similar criminal convictions
from other state, federal, foreign or military jurisdictions which indicate
an inability or tendency for the person to be unable to own or operate a facility.
(ix)
A license holder's license shall be revoked on the license
holder's imprisonment following a felony conviction, felony community supervision
revocation, revocation of parole, or revocation of mandatory supervision.
(7)
Notice. If the department proposes to deny, suspend or
revoke a license, the department shall send a notice of the proposed action
by certified mail, return receipt requested, at the address shown in the current
records of the department or the department may personally deliver the notice.
The notice to deny, suspend, or revoke a license shall state the alleged facts
or conduct to warrant the proposed action, provide an opportunity to demonstrate
or achieve compliance, and shall state that the applicant or license holder
has an opportunity for a hearing before taking the action.
(8)
Acceptance. Within 20 days after receipt of the notice,
the applicant or license holder may notify the department, in writing, of
acceptance of the department's determination.
(9)
Hearing request.
(A)
A request for a hearing by the applicant or license holder,
shall be in writing and submitted to the department within 20 calendar days
of receipt of the notice. Receipt of the notice is presumed to occur on the
30th day after the notice is mailed by the department to the last address
known of the applicant or license holder.
(B)
A hearing shall be conducted pursuant to the Administrative
Procedure Act, Government Code, Chapter 2001.
(10)
No response to notice. If the applicant or license holder
fails to timely respond to the notice or does not request a hearing in writing
within 30 days after proper notice, the person is deemed to have waived the
opportunity for a hearing as outlined in the notice and the proposed action
shall be taken by default.
(11)
Notification of department's decision. The department
shall send the license holder or applicant a copy of the department's decision
for denial, suspension or revocation of license by registered mail, which
shall include the findings and conclusions on which the department based its
decision.
(12)
Admission of new patients upon suspension or revocation.
Upon the department's determination to suspend or revoke a license, the license
holder may not admit new patients until the license is reissued.
(13)
Return of original license. Upon suspension, revocation
or non-renewal of the license, the original license shall be returned to the
department upon the effective date of the department's determination.
(14)
Reapplication following denial or revocation.
(A)
One year after the department's decision to deny or revoke,
or the voluntary surrender of a license by a facility while enforcement action
is pending, a facility may petition the department, in writing, for a license.
Expiration of a license prior to the department's decision becoming final
shall not affect the one-year waiting period required before a petition can
be submitted.
(B)
The department may allow a reapplication for licensure
if there is proof that the reasons for the original action no longer exist.
(C)
The department may deny reapplication for licensure if
the department determines that:
(i)
the reasons for the original action continues;
(ii)
the petitioner has failed to offer sufficient proof; or
(iii)
the petitioner has demonstrated a repeated history of
failure to provide patients a safe environment or has violated patient rights.
(D)
If the department allows a reapplication for licensure,
the petitioner shall be required to meet the requirements as described in §134.22
of this title (relating to Application and Issuance of Initial License).
(15)
Expiration of a license during suspension. A facility
whose license expires during a suspension period may not reapply for license
renewal until the end of the suspension period.
(16)
Surrender of a license. In the event that enforcement,
as defined in this subsection, is pending or reasonably imminent, the surrender
of a facility license shall not deprive the department of jurisdiction in
regard to enforcement against the facility.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on April 19, 2004.
TRD-200402574
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 9, 2004
Proposal publication date: January 16, 2004
For further information, please call: (512) 458-7236
Subchapter D. STANDARDS FOR ALLOWABLE METHODS OF EUTHANASIA FOR ANIMALS IN THE CUSTODY OF AN ANIMAL SHELTER
25 TAC §§169.81 - 169.83
The Texas Department of Health (department) adopts new §§169.81
- 169.83, concerning standards for allowable methods of euthanasia for animals
in the custody of an animal shelter. Section 169.83 is adopted with changes
to the proposed text as published in the December 19, 2003, issue of the
These rules were required by statute. The department feels these rules
represent the best compromise between humane euthanasia of animals, the efficient
use of human and material resources, and compliance with legislative mandates.
Specifically, the sections cover purpose; definition; and allowable methods
of euthanasia. The new sections set standards for animal shelter personnel
euthanizing a dog or cat in the custody of an animal shelter by administration
of sodium pentobarbital or commercially compressed carbon monoxide.
Due to staff comments, the department made the following changes:
Change: Concerning §169.83(b), the word "apply" was substituted for
the words "shall be met".
Change: Concerning §169.83(b)(4), the words "an area" were substituted
for the words "a room".
Change: Concerning §169.83(b)(5), the word "area" was substituted
for the word "room".
Change: Concerning §169.83(b)(7), the word "must" was substituted
for the words "need to".
Change: Concerning §169.83(b)(8), the word "dark" was removed, the
word "area" was substituted for the word "room", and the words "physical contact
with" were added between the words "from" and "other".
Change: Concerning §169.83(c), the word "apply" was substituted for
the words "shall be met".
Change: Concerning §169.83(c)(1), the word "effectiveness" was substituted
for the words "specifications and standards".
Change: Concerning §169.83(c)(3)(A), the words "for indoor chambers"
were added between the words "fan" and "which", and the words "prior to the
chamber being opened" were substituted for "in one minute".
Change: Concerning §169.83(c)(3)(B), the words "for the canister"
were added after the word "meter".
Change: Concerning §169.83(c)(3)(F), new subparagraph "(F)" has been
added with the wording "explosion-proof electrical equipment if equipment
is exposed to carbon monoxide", and the existing subparagraphs were renumbered
from "(F)-(G)" to new "(G)-(H)".
Change: Concerning §169.83(c)(4), the words "not to exceed 10% due
to flammability and explosiveness" were added between the words "concentration"
and "throughout".
Change: Concerning §169.83(c)(6), the reference to paragraph (3)(A)-(H)
was corrected, and the words "in accordance with the manufacturer's instructions
and specifications" were deleted.
Change: Concerning §169.83(c)(7), the words "be left in the chamber
for a minimum of 20 minutes after the carbon monoxide level reaches a minimum
of 6.0% and" were deleted.
Change: Concerning §169.83(c)(9), the sentence "Chamber surfaces must
be constructed and maintained so they are impervious to moisture and can be
readily sanitized" was added at the end.
Change: Concerning §169.83(c)(11), the word "area" was substituted
for the word "room".
Change: Concerning §169.83(e), the word "must" was substituted for
the word "may".
The following comments were received concerning the proposed sections.
Following the comments are the department's responses and any resulting change(s).
Comment: Concerning §169.83(b)(1), one commenter opposed the rule
stating that persons performing the euthanasia must be thoroughly trained
in the proper methods, but the rule does not identify what an acceptable training
course is.
Response: The department responds that statutory law (Health and Safety
Code, §821.055) specifies requirements for acceptable euthanasia training
courses. Courses must meet all requirements in order to be approved by the
department. No change was made as a result of the comment.
Comment: Concerning §168.83(c)(13), one commenter opposed the rule
stating that "compatible animals" should be more thoroughly defined.
Response: The department responds that the wording will allow for the use
of professional judgment in determining which animals are compatible. No change
was made as a result of the comment.
Comment: Concerning §169.83(b)(6), one commenter opposed the rule
stating that requiring weighing of animals would be frightening for the animals
and would result in animal control officers being bitten and scratched. Weighing
the animals would also double the time it takes to euthanize an animal and
few shelters have scales.
Response: The department responds that weighing the animal is necessary
to determine the correct dose of sodium pentobarbital needed to assure the
humane and successful euthanasia of the animal. Weighing an animal is not
time-consuming and many techniques exist for weighing an animal while minimizing
stress to the animal and risk of injury to the handler. The cost of obtaining
suitable scales for weighing is not prohibitive. No change was made as a result
of the comment.
Comment: One commenter recommended utilizing the animals' bodies after
death. The commenter stated that there could be a controlled government program
that has exclusive use of the animals' bodies for furs, bone tools and crafts,
and quarterly local roasts where the meat is cooked and sold.
Response: The department responds that Health and Safety Code, Chapter
821, does not authorize the department to mandate disposal methods for carcasses
except those which involve public health implications. No change was made
as a result of the comment.
Comment: Concerning §169.83(c), three commenters opposed the rule
stating that carbon monoxide gas chambers should not be used in any animal
shelter.
Response: The department disagrees and responds that statutory law (Health
and Safety Code, §821.052) requires the use of carbon monoxide, or sodium
pentobarbital in the euthanasia of dogs and cats in the custody of an animal
shelter. No change was made as a result of the comment.
Comment: Concerning §169.83(b)(1), one commenter recommended that
veterinarian oversight be required, especially for injection of sodium pentobarbital.
Response: The department responds that requiring a veterinarian to be present
for each act of euthanasia using sodium pentobarbital would be logistically
and financially prohibitive, particularly for small and rural shelters. No
change was made as a result of the comment.
Comment: Concerning §169.83(b), one commenter recommended adding the
following language: "Two people are required to restrain an animal for humane
administration of a pre-anesthetic, tranquilizing agent or sodium pentobarbital."
Response: The department responds that requiring two people to restrain
an animal would be logistically and financially prohibitive for shelters with
limited staff. Many shelters and animal control programs in Texas have only
one employee. Acceptable methods of chemical and physical restraint are available
to allow for one person to effectively and safely perform sedation and euthanasia.
No change was made as a result of the comment.
Comment: Concerning §169.83(b), one commenter recommended adding the
following language: "All animal shelters must comply with all Drug Enforcement
Agency (DEA) requirements regarding licensure, procurement, secure storage
and record keeping of sodium pentobarbital and any other controlled agents
used for the purpose of these rules."
Response: The department disagrees that it is necessary to include a statement
about DEA requirements for controlled agents. Those are federal requirements
over which the department has no jurisdiction. All animal shelters in Texas
possessing controlled agents must currently comply with these federal requirements.
No change was made as a result of the comment.
Comment: Concerning §169.83(c)(3)(E), one commenter recommended deleting
"and in a separate location in the facility, and to an automated gas flow
shut-off valve" stating that this requirement has no functional utility regarding
euthanasia.
Response: The department agrees and has deleted these requirements from
the rules.
Comment: One commenter stated there should be a requirement for a log sheet
entry to be completed each day the carbon monoxide euthanasia cabinet is used,
which would attest to the fact that all gauges and alarms are functioning
properly. The commenter recommended that the log sheet be posted in the carbon
monoxide euthanasia room.
Response: The department responds that this requirement is unnecessary.
The proposed rules state that all required equipment must be in proper working
order when used. The current language provides for the use of professional
judgment by shelter personnel to develop a means for determining and documenting
that all equipment meets this requirement. No change was made as a result
of the comment.
Comment: One commenter stated that §169.83(c)(3)(D) and §169.83(c)(5)
are incompatible with §169.83(c)(2). The commenter stated that it is
unreasonable and unnecessary to expect the air temperature inside the euthanasia
cabinet to be 85 degrees Fahrenheit except when the ambient air temperature
outside is 85 degrees Fahrenheit.
Response: The department agrees. However, the department feels that for
humane purposes, animals should not be placed in a hot chamber and 85 degrees
Fahrenheit is the benchmark cited in the Animal Welfare Act. The proposed
language requiring that a chamber's ambient air temperature "...must not exceed
85 degrees Fahrenheit..." has been changed to "...should not exceed 85 degrees
Fahrenheit..." to allow for individual circumstances.
Comment: Concerning §169.83(c)(6), one commenter would like to add
"unless carbon monoxide euthanasia equipment was designed and constructed,
at a minimum, to equal the specifications and standards of a commercially
manufactured chamber as provided in (c)(1) of this chapter" at the end.
Response: The department responds that regardless of whether or not a chamber
is designed and constructed to equal specifications and standards of a commercially
manufactured chamber, concerns for the effective and humane administration
of euthanasia and personal safety require that all equipment referenced in §169.83(c)(6)
be utilized and in proper working order when used. Additionally, based on
comments received, the department has changed the requirement in §169.83(c)(1)
that non-commercially manufactured carbon monoxide chambers be designed and
constructed to "...equal specifications and standards..." of commercially
manufactured chambers to be designed and constructed to equal the "...effectiveness..."
of commercially manufactured chambers. Also, based on comments received, the
department removed the language in §169.83(c)(6) that all equipment associated
with a chamber must be used "...in accordance with the manufacturer's instructions
and specifications".
Comment: Concerning §169.83(c)(12), one commenter would like the wording
to be changed to "Carbon monoxide should not be used to euthanize an animal
less than ten weeks of age or with a compromised respiratory system." The
commenter stated there are frequently animals which are injured or sick which
would be just as humanely, if not more so, euthanized without having to handle
or restrain them for a venipuncture. The commenter stated that intraperitoneal
injection of sodium pentobarbital is less humane than euthanasia by bottled
carbon monoxide.
Response: The department responds that the "2000 Report of the American
Veterinary Medical Association Panel on Euthanasia", which is the standard
mandated by the Legislature, recommends limitations on the use of carbon monoxide
in animals under 16 weeks of age or which have decreased ventilation. As a
result of this and one other comment, the language in §169.83(c)(12)
was extensively rewritten, deleting references to "...old, injured, pregnant,
or sick" animals. This section now reads: "Carbon monoxide should not be used
to euthanize animals reasonably presumed to be less than 16 weeks of age or
suffering from decreased respiratory function. Very young animals are resistant
to the effects of carbon monoxide and the time required to achieve death in
these animals may be significantly increased. In animals with decreased respiratory
function, carbon monoxide levels rise slowly, making it more likely that these
animals will experience elevated levels of stress. The use of noninhalant
methods of euthanasia should be considered for such animals."
Comment: Concerning §169.83(b), one commenter opposed the rule stating
that the use of sodium pentobarbital by the animal control facility was not
possible. Therefore, animals that could not be euthanized by the use of the
carbon monoxide chamber would have to be delivered to private veterinarians
at an expense that would be cost prohibitive.
Response: The department responds that statutory law (Health and Safety
Code, §821.052) specifies that euthanasia of dogs and cats in the custody
of an animal shelter may be accomplished only by the administration of sodium
pentobarbital or commercially compressed carbon monoxide. Many shelters currently
use sodium pentobarbital for euthanasia of animals. The use of sodium pentobarbital
by shelter personnel is neither financially nor logistically prohibitive.
No change was made as a result of the comment.
Comment: Concerning §169.83(c)(3)(F), renumbered as §169.83(c)(3)(G),
one commenter opposed the rule stating that the department's requirement of
a window being placed on the chamber to have the animal control officer watch
them die is more traumatic to the personnel than the currently utilized method
(a simple, closed, self-constructed carbon monoxide chamber) is for the animal.
Response: The department responds that the requirement for a viewport is
necessary to detect mechanical malfunctions or untoward reactions by the animals
as well as to allow for visual verification of the cessation of vital signs
prior to venting of the chamber and removal of the animal, as required by §169.83(c)(7).
The department removed the language "...direct..." from §169.83(c)(3)(G)
and "...at all times..." from §169.83(e) to avoid the implication that
persons performing euthanasia must visually observe the animal constantly
throughout the euthanasia process.
Comment: Concerning §169.83(c)(12), one commenter opposed the rule
stating that the rule infers that carbon monoxide is not effective on animals
that are less than four months old or sick and that is incorrect.
Response: The department responds that the "2000 Report of the American
Veterinary Medical Association Panel on Euthanasia" recommends limitations
on the use of carbon monoxide in animals under 16 weeks of age or which have
decreased ventilation. As a result of this and one other comment, the language
in §169.83(c)(12) was extensively rewritten, deleting references to "...old,
injured, pregnant, or sick" animals. This section now reads: "Carbon monoxide
should not be used to euthanize animals reasonably presumed to be less than
16 weeks of age or suffering from decreased respiratory function. Very young
animals are resistant to the effects of carbon monoxide and the time required
to achieve death in these animals may be significantly increased. In animals
with decreased respiratory function, carbon monoxide levels rise slowly, making
it more likely that these animals will experience elevated levels of stress.
The use of noninhalant methods of euthanasia should be considered for such
animals."
Comment: One commenter opposed §169.83 in its entirety stating that
the required changes in the carbon monoxide chambers, the use of sodium pentobarbital,
and the resulting staffing needs are cost prohibitive.
Response: The department responds that statutory law (Health and Safety
Code, §821.052) specifies that euthanasia of dogs and cats in the custody
of an animal shelter may be accomplished only by the administration of sodium
pentobarbital or commercially compressed carbon monoxide. The proposed requirements
in §169.83 associated with the use of sodium pentobarbital and carbon
monoxide for euthanasia are necessary for the safe and effective use of these
methods. No change was made as a result of the comment.
Comment: One commenter agreed with proposed §169.83 in its entirety.
Response: The department agreed with the commenter. However, the department
has made several changes to §169.83 in response to staff and stakeholder
comments.
One individual commenter was in favor of the rules in their entirety.
One individual commenter and several members of the department were generally
in favor of the rules, but suggested clarifying language concerning specific
provisions in the rules.
Commenters opposed to the proposed rules were members of the City of Lubbock,
Crosstimbers Animal Services, San Antonio Metropolitan Health District, Pflugerville
Police Department, and some individuals.
The new sections are adopted under Texas Health and Safety Code,
Chapter 821, "Euthanasia of Animals," §821.053, which requires the Texas
Board of Health (board) to establish the requirements and procedures for administering
sodium pentobarbital to euthanize an animal in the custody of an animal shelter; §821.054,
which requires the board to establish standards for a carbon monoxide chamber
used to euthanize an animal in the custody of an animal shelter and the requirements
and procedures for administering commercially compressed carbon monoxide to
euthanize an animal in the custody of an animal shelter; 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.
§169.83.Allowable Methods of Euthanasia.
(a)
Only sodium pentobarbital or commercially compressed carbon
monoxide gas may be used to euthanize a dog or cat in the custody of an animal
shelter.
(b)
When sodium pentobarbital is used to euthanize an animal,
the following requirements apply.
(1)
Persons administering sodium pentobarbital must be thoroughly
trained in the proper methods and techniques for euthanizing animals. A person
has until the 120th day following the date of initial employment to complete
this training.
(2)
The routes of injections of sodium pentobarbital, listed
in the order of preference, shall be:
(A)
intravenous injection by hypodermic needle;
(B)
intraperitoneal injection by hypodermic needle; or
(C)
intracardiac injection by hypodermic needle.
(3)
All injections must be administered using an undamaged
sterilized hypodermic needle of a size suitable for the size and species of
the animal.
(4)
Injection shall be conducted in an area out of public view.
(5)
The area used for injection shall have sufficient lighting
to allow for visual accuracy during the injection process.
(6)
Each animal shall be weighed to determine the correct dose
of sodium pentobarbital.
(7)
Animals given sodium pentobarbital by intraperitoneal injection
must be given 3 to 4 times the intravenous dose.
(8)
Animals given sodium pentobarbital by intraperitoneal injection
shall be placed in a quiet area, separated from physical contact with other
animals during the dying process.
(9)
Intracardiac injection may not be used unless the animal
is heavily sedated, unconscious, or anesthetized.
(10)
Carcasses of animals euthanized by sodium pentobarbital
must be stored and disposed of in a manner that minimizes the potential for
scavenging by animals or humans.
(c)
When commercially compressed carbon monoxide gas is used
to euthanize an animal, the following requirements apply.
(1)
It must be performed in a commercially manufactured carbon
monoxide chamber or one designed and constructed, at a minimum, to equal the
effectiveness of a commercially manufactured chamber.
(2)
The chamber must be located outdoors or in a well ventilated
room.
(3)
The chamber must be airtight and equipped with the following:
(A)
an exhaust fan for indoor chambers which is capable of
evacuating all gas from the chamber prior to the chamber being opened and
is connected by a gas-type duct to the outdoors;
(B)
a gas flow regulator and flow meter for the canister;
(C)
a gas concentration gauge;
(D)
an accurate temperature gauge for monitoring the interior
of the chamber;
(E)
if located indoors, a carbon monoxide monitor on the exterior
of the chamber that is connected to an audible alarm system, which will sound
in the room containing the chamber;
(F)
explosion-proof electrical equipment if equipment is exposed
to carbon monoxide;
(G)
a view-port with either internal lighting or external lighting
sufficient to allow visual surveillance of all animals within the chamber;
and
(H)
if designed to euthanize more than one animal at a time,
independent sections or cages to separate individual animals.
(4)
The gas concentration process must achieve at least a 6.0%
carbon monoxide gas concentration not to exceed 10% due to flammability and
explosiveness throughout the chamber within 5 minutes after the introduction
of carbon monoxide into the chamber is initiated.
(5)
The ambient temperature inside the chamber should not exceed
85 degrees Fahrenheit (29.4 degrees Celsius) when it contains live animals.
(6)
All equipment, as specified in paragraph (3)(A)-(H) of
this subsection, must be in proper working order and used at all times during
the operation of the chamber.
(7)
Animals must not be removed from the chamber until at least
5 minutes after cessation of respiratory movement.
(8)
The chamber must be thoroughly vented prior to removing
any carcasses.
(9)
The chamber must be thoroughly cleaned after the completion
of each cycle. Chamber surfaces must be constructed and maintained so they
are impervious to moisture and can be readily sanitized.
(10)
Persons operating the chamber must be thoroughly trained
in the proper methods and techniques for euthanizing animals. A person has
until the 120th day following the date of initial employment to complete this
training.
(11)
Operation, maintenance, and safety instructions and guidelines
must be displayed prominently in the area containing the chamber.
(12)
Carbon monoxide should not be used to euthanize animals
reasonably presumed to be less than 16 weeks of age or suffering from decreased
respiratory function. Very young animals are resistant to the effects of carbon
monoxide and the time required to achieve death in these animals may be significantly
increased. In animals with decreased respiratory function, carbon monoxide
levels rise slowly, making it more likely that these animals will experience
elevated levels of stress. The use of noninhalant methods of euthanasia should
be considered for such animals.
(13)
Only compatible animals of the same species may be placed
in the chamber simultaneously.
(14)
No live animal may be placed in the chamber with a dead
animal.
(d)
All animals other than cats and dogs, including birds and
reptiles, in the custody of an animal shelter shall be humanely euthanized
only in accordance with the methods, recommendations and procedures set forth
in the 2000 Report of the American Veterinary Medical Association Panel on
Euthanasia applicable to each species of animal.
(e)
When using any of the allowable methods of euthanasia,
the animal must be monitored between the time euthanasia procedures have commenced
and the time death occurs, and the animal's body must not be disposed of until
death is confirmed by examination of the animal for cessation of vital signs.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on April 16, 2004.
TRD-200402513
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: December 19, 2003
For further information, please call: (512) 458-7236
Subchapter E. PERMITS, FEES AND ENFORCEMENT
The Texas Department of Health (department) adopts the repeal of §§217.91
- 217.93 and new §§217.91 - 217.92, concerning permits, fees, and
enforcement relating to the Milk and Dairy Program and the Frozen Dessert
Manufacturer Program. Section 217.91 is adopted with a change to the proposed
text as published in the December 19, 2003, issue of the
Texas Register
(28 TexReg 11226). The repeal of §§217.91
- 217.93 and new §217.92 are adopted without changes to the proposed
text as published and, therefore, will not be republished.
The new rules are necessary to implement Senate Bill (SB) 1152, 78th Legislature,
2003, which amended Government Code, Chapter 2054, to require participation
in Texas Online; House Bill (HB) 2292, 78th Legislature, 2003, which revised
Health and Safety Code, §§12.0111 and 12.0112, and requires recovery
of all costs associated with operating the program effective January 1, 2004,
and requires two-year licenses effective January 1, 2005; SB 1454, 78th Legislature,
2003, which amended Health and Safety Code, Chapter 440, to expand enforcement
authority; and HB 3542, 78th Legislature, 2003, which amended Health and Safety
Code, Chapter 435, to provide an election of penalties for firms regulated
under the Pasteurized Milk Ordinance, provide for the assessment of administrative
penalties, and expand enforcement authority.
Government Code, §2001.039, requires each state agency to review each
rule adopted by that agency pursuant to Government Code, Chapter 2001 (Administrative
Procedure Act). The current rules have been reviewed and the department has
determined that reasons for adopting the sections continue to exist. However,
because substantial changes have been made to simplify the sections and implement
legislation, the existing rules are being repealed and new rules adopted.
The department published a Notice of Intention to Review for §§217.91
- 217.93 in the
Texas Register
(29 TexReg
2000) on February 13, 2004.
No comments were received on the proposal. However, the department is making
one minor change due to a staff comment to incorporate the requirement for
participation in Texas Online.
Change: Concerning proposed §217.91(c), a new paragraph (4) is being
added to implement SB 1152 and to meet the requirement for participation in
Texas Online.
25 TAC §§217.91 - 217.93
The repeals are adopted under the Health and Safety Code, §§431.241,
435.009(c), and 440.006, which provide the department with the authority to
adopt necessary regulations pursuant to the enforcement of Chapter 431, 435,
and 440; 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 April 16, 2004.
TRD-200402548
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: December 19, 2003
For further information, please call: (512) 458-7236
25 TAC §217.91, §217.92
The new rules are adopted under the Health and Safety Code, §§431.241,
435.009(c), and 440.006, which provide the department with the authority to
adopt necessary regulations pursuant to the enforcement of Chapter 431, 435,
and 440; 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.
§217.91.Milk Facilities and Operations Permit and Frozen Dessert License Procedures.
(a)
Permit/license required. A current permit/license is required
for every dairy farm, milk plant, receiving station, transfer station, raw
for retail milk dairy farm, milk tank truck, and frozen dessert manufacturer
located and operating in the state of Texas. Every milk plant and frozen dessert
manufacturer that imports milk, milk products or frozen desserts into the
State of Texas is required to obtain a current permit/license.
(1)
All milk facilities, frozen dessert manufacturers and operations
shall be approved by the department prior to the issuance of a permit.
(2)
Permit or license fees are non-refundable.
(3)
A current permit or license shall only be issued when all
past due fees and late fees have been paid for all years of operation in Texas.
(b)
Application. Applications may be obtained by contacting
the Milk and Dairy Division, Texas Department of Health (department), 1100
West 49th Street, Austin, Texas 78756, 512-719-0260. Applications are also
available on-line at www.tdh.state.tx.us/bfds. The applicant must submit an
accurate, complete application and pass an inspection in order to receive
a permit/license to operate.
(c)
Permit/license fees.
(1)
Permitted or licensed facilities and operations in Texas
shall pay the following fees. If applications are made after March 1 of any
year, the fee will be prorated.
(2)
This paragraph applies to all new and renewal applications
received by the department prior to January 1, 2005. Permits issued under
this subsection are valid up to one year and expire on August 31 (expiration
date).
(A)
Milk plant - $400 per year. An invoice for the permit fee
will be sent to the permitted entity when the entity has been approved by
the department to begin production.
(B)
Producer dairy farm - $100 per year. An invoice for the
permit fee will be sent to the permitted entity when the entity has been approved
by the department to begin production.
(C)
Receiving and transfer station - $400 per year. An invoice
for the permit fee will be sent to the permitted entity when the entity has
been approved by the department to begin production.
(D)
Milk transport tanker - $100 per year. Each tanker is required
to submit payment with the application and a copy of the inspection, which
shall not be over 90 days from the date of inspection. Permit fees will be
determined by the date of inspection.
(E)
Grade A raw for retail - $400 per year. An invoice for
the permit fee will be sent to the permitted entity when the entity has been
approved by the department to begin production.
(F)
Frozen desserts manufacturers - $400 per year. An invoice
for the permit fee will be sent to the permitted entity when the entity has
been approved by the department to begin production.
(3)
This paragraph applies to all new and renewal applications
received on or after January 1, 2005. Permits issued under this subsection
are valid for up to two years and expire on August 31 (expiration date).
(A)
Milk plant - $800 every two years. An invoice for the permit
fee will be sent to the permitted entity when the entity has been approved
by the department to begin production.
(B)
Producer dairy farm - $200 every two years. An invoice
for the permit fee will be sent to the permitted entity when the entity has
been approved by the department to begin production.
(C)
Receiving and transfer station - $800 every two years.
An invoice for the permit fee will be sent to the permitted entity when the
entity has been approved by the department to begin production.
(D)
Milk transport tanker - $200 every two years. Each tanker
is required to submit payment with the application and a copy of inspection,
which shall not be over 90 days from the date of inspection. Permit fees will
be determined by the date of inspection.
(E)
Grade A raw for retail - $800 every two years. An invoice
for the permit fee will be sent to the permitted entity when the entity has
been approved by the department to begin production.
(F)
Frozen desserts manufacturers - $800 every two years. An
invoice for the permit fee will be sent to the permitted entity when the entity
has been approved to begin production.
(4)
For all applications and renewal applications, the department
is authorized to collect subscription and convenience fees in amounts determined
by the Texas Online Authority, to recover costs associated with application
and renewal application processing through Texas Online.
(d)
Renewal of a permit/license.
(1)
Milk plants, producer dairy farms, receiving and transfer
stations, grade "A" raw for retail, and frozen desserts manufacturers must
submit a renewal application and the required fee prior to September 1 of
the permitting year. A person who submits a renewal application and required
fee after the expiration date shall pay an additional $100 as a delinquency
fee.
(2)
Milk transport tankers must submit a renewal application
and required fee prior to September 1 of the permitting year. All tankers
shall have an inspection no more than one year old on file prior to issuance
of the renewal permit sticker.
(e)
Amendment of permit/license.
(1)
Fee. A permit/license that is amended, including a change
of name, ownership, or a change in location of a permitted place of business
will require submission of a new permit, application, and the required fee
pursuant to subsection (a) of this section.
(2)
Change of ownership. A permit is not transferable.
(3)
The department must be notified in writing at least 30
days prior to the effective date of the name, ownership, or location change.
(f)
All applicants shall comply with §1.301 of this title
(relating to Suspension of License for Failure to Pay Child Support).
(g)
Applicability of other law.
(1)
Health and Safety Code (HSC), Chapter 431, applies to the
conduct of a person licensed under HSC, Chapter 440, and to a frozen dessert,
an imitation frozen dessert, a product sold in semblance of a frozen dessert,
or a mix for one of those products subject to HSC, Chapter 440. A frozen dessert,
an imitation frozen dessert, a product sold in semblance of a frozen dessert,
or a mix for one of those products is a food for purposes of HSC, Chapter
431.
(2)
A person who holds a license under HSC, Chapter 440, related
to the manufacturing of a product regulated under that Chapter and is engaging
in conduct within the scope of that license, is not required to hold a license
as a food manufacturer, food wholesaler, or warehouse operator under HSC,
Chapter 431, Subchapter J.
(3)
Health and Safety Code, Chapter 431, applies to the conduct
of a person licensed under HSC, Chapter 435, and to milk or a milk product
subject to HSC, Chapter 435. Milk, or a milk product, is a food for purposes
of HSC, Chapter 431.
(4)
A person who holds a license under HSC, Chapter 435, related
to the processing, producing, bottling, receiving, transferring, or transporting
of Grade "A" milk or milk products, and who is engaging in conduct within
the scope of that permit, is not required to hold a license as a food manufacturer,
food wholesaler, or warehouse operator under HSC, Chapter 431, Subchapter
J.
(h)
Inspection fees.
(1)
All milk or milk products processed, manufactured, or bottled
by milk plants, and offered for sale within the State of Texas shall be assessed
a $0.045 per hundredweight inspection fee or shall pay a minimum fee of $5.00
each month, whichever is greater. This fee shall be assessed on a monthly
basis. The inspection fee includes the cost of analyzing samples for milk
or milk products. Milk plants shall submit monthly production data to the
department no later than 15 days after the end of each reporting month as
designated by the department, accompanied by the fee required by this section.
Each milk plant is required to furnish, upon request from the department,
production records for the preceding three years for auditing purposes. This
fee shall be considered delinquent if it is not received by the department
within 30 days after the end of the reporting period.
(2)
All frozen desserts manufactured by frozen dessert manufacturing
plants and intended for sale within the State of Texas shall be assessed a
$0.015 per hundredweight inspection fee or shall pay a minimum fee of $5.00
each month, whichever is greater. This fee shall be assessed on a monthly
basis. The inspection fee includes the cost for analyzing frozen dessert samples.
Manufacturers shall submit monthly production data to the department no later
than 15 days after the end of each monthly reporting period designated by
the department, accompanied by the required fee. Also, each plant will be
required to furnish, upon request, production records for the preceding three
years for auditing purposes. This fee shall be considered delinquent if it
is not received by the department within 30 days after the end of the reporting
period.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed
with the Office of the Secretary of State on April 16, 2004.
TRD-200402549
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: December 19, 2003
For further information, please call: (512) 458-7236
Subchapter B. MEAT AND POULTRY INSPECTION
25 TAC §221.11
The Texas Department of Health (department) adopts an amendment
to §221.11, concerning meat and poultry inspection. Section 221.11 is
being adopted with changes to the proposed text as published in the December
19, 2003, issue of the
Texas Register
(28
TexReg 11228). The title of 9 Code of Federal Regulations, Part 430, in §221.11(a)(35)
was changed to "Requirements For Specific Classes of Product", and the order
of listing is changed so that the federal regulations are listed numberically
rather than chronologically. The amendment to §221.11 adopts new United
States Department of Agriculture regulations that require official establishments
that produce certain ready-to-eat (RTE) meat and poultry products prevent
product adulteration by the pathogenic environmental contaminant
Listeria monocytogenes
.
In particular, under these regulations, establishments that produce RTE
meat and poultry products that are exposed to the environment after lethality
treatments and that support the growth of
L. monocytogenes
will be required to have, in their hazard analysis and critical control
point (HACCP) plans, or in their sanitation standard operating procedures
or other prerequisite programs, controls that prevent product adulteration
by
L. monocytogenes
. The establishments must
share data and information relevant to their controls for
L. monocytogenes
with the department. The establishments must furnish
the department with information on the production volume of products affected
by the regulations. The establishments may make claims on the labels of their
RTE products regarding the processes they use to eliminate or reduce
There were no comments received during the 30-day public comment period.
However, the department is making the following minor changes due to staff
comments to make the rule language consistent with the federal regulations.
Change: Concerning §221.11(a)(35) and (36), the titles of 9 CFR, Parts
430 and 441 in the federal regulations were changed; therefore, the department
is amending this rule to be consistent with the federal regulations.
The amendment is adopted under the Health and Safety Code, Chapter
433, which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 433; 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.
The amendment affects the Health and Safety Code, Chapter 433.
§221.11.Federal Regulations on Meat and Poultry Inspection.
(a)
The Texas Department of Health (TDH) adopts by reference
the following federal requirements in the Code of Federal Regulations (CFR),
as amended:
(1)
9 CFR, Part 301, "Definitions";
(2)
9 CFR, Part 303, except 303.1(a) and (b), "Exemptions";
(3)
9 CFR, Part 304, "Application for inspection; grant of
inspection";
(4)
9 CFR, Part 305, "Official numbers; inauguration of inspection;
withdrawal of inspection; reports of violation";
(5)
9 CFR, Part 306, "Assignment and authorities of program
employees";
(6)
9 CFR, Part 307, "Facilities for inspection";
(7)
9 CFR, Part 309, "Ante-mortem inspection";
(8)
9 CFR, Part 310, "Post-mortem inspection";
(9)
9 CFR, Part 311, "Disposal of diseased or otherwise adulterated
carcasses and parts";
(10)
9 CFR, Part 312, "Official marks, devices, and certificates";
(11)
9 CFR, Part 313, "Humane slaughter of livestock";
(12)
9 CFR, Part 314, "Handling and disposal of condemned or
other inedible products at official establishments";
(13)
9 CFR, Part 315, "Rendering or other disposal of carcasses
and parts passed for cooking";
(14)
9 CFR, Part 316, "Marking products and their containers";
(15)
9 CFR, Part 317, "Labeling, marking devices, and containers";
(16)
9 CFR, Part 318, "Entry into official establishments;
reinspection and preparation of products";
(17)
9 CFR, Part 319, "Definitions and standards of identity
or composition", TDH adds the following requirements, which shall apply except
in the case of restaurant menus and signs.
(A)
The label of products prepared from bison meat must contain
the words "bison meat," "North American bison meat" or "Native American bison
meat".
(B)
The label of products prepared from buffalo meat must contain
the words "water buffalo meat," or "Asian buffalo meat".
(18)
9 CFR, Part 320, "Records, registration, and reports";
(19)
9 CFR, Part 321, "Cooperation with States and territories";
(20)
9 CFR, Part 322, "Exports";
(21)
9 CFR, Part 325, "Transportation";
(22)
9 CFR, Part 327, "Imported products";
(23)
9 CFR, Part 329, "Detention; seizure and condemnation;
criminal offenses";
(24)
9 CFR, Part 331, "Special provisions for designated States
and Territories; and for designation of establishments which endanger public
health and for such designated establishments";
(25)
9 CFR, Part 335, "Rules of practice governing proceedings
under the Federal Meat Inspection Act";
(26)
9 CFR, Part 350, "Special services relation to meat and
other products";
(27)
9 CFR, Part 352, "Exotic animals; voluntary inspection";
(28)
9 CFR, Part 354, "Voluntary inspection of rabbits and
edible products thereof";
(29)
9 CFR, Part 355, "Certified products for dogs, cats and
other carnivora; inspection, certification, and identification as to class,
quality, quantity, and condition";
(30)
9 CFR, Part 362, "Voluntary poultry inspection regulations";
(31)
9 CFR, Part 381, "Poultry products inspection regulation",
except §381.10(a)(3) through §381.10(c);
(32)
9 CFR, Part 416, "Sanitation";
(33)
9 CFR, Part 417, "Hazard Analysis and Critical Control
Point (HACCP) Systems";
(34)
9 CFR, Part 424, "Preparation and Processing Operations";
(35)
9 CFR, Part 430, "Requirements for Specific Classes of
Product"; and
(36)
9 CFR, Part 441, "Consumer Protection Standards: Raw Products".
(b)
Copies of these regulations are indexed and filed in the
Meat Safety Assurance Division, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756 and are 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 April 16, 2004.
TRD-200402547
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 6, 2004
Proposal publication date: December 19, 2003
For further information, please call: (512) 458-7236
Subchapter K. TEXAS FOOD ESTABLISHMENTS
Chapter 100.
IMMUNIZATION REGISTRY
Chapter 117.
END STAGE RENAL DISEASE FACILITIES
Subchapter B. APPLICATION AND ISSUANCE OF A LICENSE
Subchapter B. FACILITY LICENSING
Subchapter F. CORRECTIVE ACTION PLAN AND ENFORCEMENT
Chapter 134.
PRIVATE PSYCHIATRIC HOSPITALS AND CRISIS STABILIZATION UNITS
Subchapter B. APPLICATION AND ISSUANCE OF A LICENSE
Subchapter C. OPERATIONAL REQUIREMENTS
Subchapter E. ENFORCEMENT
Chapter 169.
ZOONOSIS CONTROL
Chapter 217.
MILK AND DAIRY
Chapter 221.
MEAT SAFETY ASSURANCE
Chapter 229.
FOOD AND DRUG