Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 128.
PERMITS FOR CONTACT LENS DISPENSERS
The Texas Department of Health (department) proposes amendments to §§128.3,
128.9, and 128.11-128.12, the repeal of §128.5, and new §128.5,
concerning the regulation of persons filling contact lens prescriptions.
The repeal and new rule implement the "Fairness to Contact Lens Consumers
Act", Public Law 108-164, a change in federal law affecting the dispensing
of contact lenses. The amendments are necessary to implement House Bill 2985,
78th Legislature, 2003, which added Occupations Code, Chapter 101, Subchapter
G, which establishes the Office of Patient Protection within the Health Professions
Council and requires additional fees to fund it; Senate Bill 1152, 78th Legislature,
2003, which amended Government Code, Chapter 2054, to require participation
in Texas Online; House Bill 2292, 78th Legislature, 2003, which revised Health
and Safety Code, §§ 12.0111 and 12.0112, and requires two-year licenses
effective January 1, 2005; and Senate Bill 161, 78th Legislature, 2003, which
amends Occupations Code, Chapter 353, relating to emergency suspension. The
amendments also clarify the department's current complaint process.
An amendment to §128.3 lists the additional fees that will be imposed,
and clarify that the renewal fee for a permit with a two year term will be
twice the amount required for the current annual renewal. New §128.5
references the new federal statute. The amendment to §128.9 further clarifies
that a permit may be issued for a one or a two year term. The amendment to §128.11
clarifies the department's current complaint process. New language is added
to amend §128.12 to reference the new statutory authority of the department
to impose an emergency suspension.
Jim Zukowski, Ed. D., Chief, Bureau of Licensing and Compliance, has determined
that for each year of the first five years the sections are in effect, there
will be fiscal implications as a result of enforcing or administering the
sections as proposed. The effect on state government will be an estimated
increase in revenue to the state of approximately $1,000 per year. It is estimated
that costs to the state to administer the new provisions will be equal to
the estimated fee increases. No fiscal impact to local government is expected.
Dr. Zukowski has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing or administering the proposed sections will be to assure the issuance
of permits and the regulation of contact lens dispensers in Texas. There will
be no effect on small businesses or micro-businesses because the maximum fee
increase amount of $10 for a new applicant and $6 annually for a renewal is
too small to impact businesses engaged in sale of contact lenses. There are
anticipated economic costs of up to $10 to persons who are required to comply
with the sections as proposed. There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Yvonne Feinleib, Program Director,
Texas Department of Health Contact Lens Permit Program, 1100 West 49th Street,
Austin, Texas 78756, (512) 834-4515. Comments will be accepted for 30 days
following publication of the proposal in the
Texas
Register
.
25 TAC §§128.3, 128.5, 128.9, 128.11, 128.12
The amendments and new section are proposed under the Occupations
Code, Chapter 353, which authorizes the Texas Board of Health (board) to adopt
rules necessary to implement the section; and the 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.
The amendments and new section affect the Occupations Code, Title 3, Chapter
353.
§128.3.Fees.
(a)
The [
(1)
$50
for a one year term and $100 for a two year term
for an optician who has registered with the department under the Opticians'
Registry Act, Occupations Code, Chapter 352;
(2)
$75
for a one year term and $150 for a two year term
for an optician who has not registered with the department under the
Opticians' Registry Act, Occupations Code, Chapter 352; and
(3)
$300
for a one year term and $600 for a two year term
for a business entity.
(b)
For all applications and renewal applications,
the department is authorized to collect fees to fund the Office of Patient
Protection, Health Professions Council, as mandated by law.
(c)
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.
§128.5.Sale or Delivery of Contact Lenses.
An individual or business holding a permit shall comply with the federal
"Fairness to Contact Lens Consumers Act" Public Law 108-164, and applicable
standards in Occupations Code, Chapter 353. If federal and state laws establish
conflicting standards for the dispensing of contact lenses, permit holders
shall comply with federal law.
§128.9.Renewal of Permit.
(a)
(No change.)
(b)
When issued, a permit is valid for one year
or two
years, as determined by the department,
commencing on the date of issuance
of the initial permit.
(c)
A permit holder must renew the permit annually
or
every two years
. The renewal date of a permit shall be the last day
of the month in which the permit was originally issued.
(d) - (i)
(No change.)
(j)
A person whose permit has been expired for 90 days or less
may renew the permit by paying to the department a renewal fee that is equal
to one and one-half times the normally required [
(k)
A person whose permit has been expired for more than 90
days but less than one year may renew the permit by paying to the department
a renewal fee that is equal to two times the normally required [
(l) - (p)
(No change.)
§128.11.Filing Complaints and Complaint Investigations.
(a) - (c)
(No change.)
(d)
The department shall investigate the complaint [
(e)
The
department
[
(f)
If the
department
[
§128.12.Grounds for Disciplinary Action.
(a) - (e)
(No change.)
(f)
The department may impose an emergency
suspension for a violation of the Act or this chapter in accordance with the
procedures established in Occupations Code, §353.2025.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on April 15, 2004.
TRD-200402503
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §128.5
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Occupations Code,
Chapter 353, which authorizes the Texas Board of Health (board) to adopt rules
necessary to implement the section; and the 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.
The repeal affects the Occupations Code, Title 3, Chapter 353.
§128.5.Sale or Delivery of Contact Lenses.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on April 15, 2004.
TRD-200402504
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§129.4, 129.7 - 129.9, 129.11
The Texas Department of Health (department) proposes amendments
to §§129.4, 129.7 - 129.9, and 129.11, concerning the voluntary
registration of opticians.
The amendments are necessary to implement House Bill 2985, 78th Legislature,
2003, which added Occupations Code, Chapter 101, Subchapter G, which establishes
the Office of Patient Protection within the Health Professions Council and
requires additional fees to fund it; Senate Bill 1152, 78th Legislature, 2003,
which amended Government Code, Chapter 2054, to require participation in Texas
Online; House Bill 2292, 78th legislature, 2003, which revised Health and
Safety Code, §§12.0111 and 12.0112, and requires two-year licenses
effective January 1, 2005; and Senate Bill 161, 78th legislature, 2003, which
amends Occupations Code, Chapter 352, relating to emergency suspension.
An amendment to §129.4 lists the additional fees that will be imposed,
and clarifies that the renewal fee for a registration with a two year term
will be twice the amount required for the current annual renewal. Amendments
to §§129.7 and 129.8 further clarify that a registration may be
issued for a one or a two year term. The amendment to §129.9 clarifies
that the number of continuing education hours to be accrued for a registration
with a two year term will be twice that of the current annual renewal, and
add language to require that registrants report carryover continuing education
hours in the renewal period in which they were earned. New language is added
to amend §129.11 to reference the new statutory authority of the department
to impose an emergency suspension.
Jim Zukowski, Ed. D., Chief, Bureau of Licensing and Compliance, has determined
that for each year of the first five years the sections are in effect, there
will be fiscal implications as a result of enforcing or administering the
sections as proposed. The effect on state government will be an estimated
increase in revenue to the state of approximately $1,000 per year. It is estimated
that costs to the state to administer the new provisions will be equal to
the estimated fee increases. No fiscal impact to local government is expected.
Dr. Zukowski has also determined that for each year of the first five years
the proposed sections are in effect, the public benefit anticipated as a result
of enforcing or administering the sections will be to assure the voluntary
registration and regulation of opticians in Texas. There will be no effect
on small businesses or micro-businesses because this registration as an optician
is a voluntary registry. There are anticipated economic costs of up to $10
to persons who are required to comply with the sections as proposed, based
on anticipated fees assessed for new applicants. There is no anticipated impact
on local employment.
Comments on the proposal may be submitted to Yvonne Feinleib, Program Director,
Texas Department of Health Opticians' Registry, 1100 West 49th Street, Austin,
Texas 78756, (512) 834-6661. Comments will be accepted for 30 days following
publication of the proposal in the
Texas Register
.
The amendments are proposed under the Occupations Code, Chapter
352, which authorizes the board to adopt procedural and substantive rules
in accordance with the statute; and the Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The amendments affect the Occupations Code, Title 3, Chapter 352.
§129.4.Fees.
(a)
Schedule of fees. The fees are as follows:
(1)-(2)
(No change.)
(3)
registration renewal fee:
(A)
for a registration issued for one year
--$50;
(B)
for a registration issued for two years--$100;
(4)
dual registration renewal fee:
(A)
for a registration issued for one year
--$80;
(B)
for a registration issued for two years--$160;
(5)-(7)
(No change.)
(b)-(c)
(No change.)
(d)
For all applications and renewal applications,
the department is authorized to collect fees to fund the Office of Patient
Protection, Health Professions Council, as mandated by law.
(e)
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.
§129.7.Issuance of Certificate of Registration.
(a)-(g)
(No change.)
(h)
Expiration of initial registration. The initial registration
certificate is valid through the registrant's next birth month
for a
one or two year term, as determined by the department
.
§129.8.Renewal of Registration.
(a)
(No change.)
(b)
General.
(1)
When issued, a registration certificate is valid through
the registrant's next birth month
for a one or two year term, as determined
by the department
.
(2)
A registrant must renew the registration certificate
in order to remain registered
[
(3)-(7)
(No change.)
(c)-(e)
(No change.)
§129.9.Requirements for Continuing Education.
(a)
Purpose. The purpose of this section is to establish the
continuing education requirements a registrant shall meet [
(b)
Number of hours required. Proof of having earned five contact
hours of continuing education credit in each area for which the registrant
is renewing shall be required at the time of renewal for each registration
issued for a one year term, or proof of having earned ten contact hours of
continuing education credit in each area for which the registrant is renewing
shall be required at the time of renewal for each registration issued for
a two year term
. A contact hour is 50 minutes.
(1)
The hours must have been completed within 12 months prior
to the date of expiration of
a
[
(2)
(No change.)
(3)
If applying for dual registration renewal the applicant
must have a total of 10 contact hours of continuing education
for a registration
issued for a one year term, or 20 contact hours of continuing education for
a registration issued for a two year term. Half of the
[
(c)-(d)
(No change.)
(e)
Accrual carryover. Earned continuing education hours exceeding
the minimum requirements in a previous renewal period shall first be applied
to the continuing education requirements for the current renewal period. A
maximum of five additional clock hours may be accrued during a registration
period to be applied to the next consecutive renewal period. A maximum of
10 additional clock hours may be accrued for dual registrants during a registration
period to be applied to the next consecutive renewal period.
To be eligible
for carryover, all hours earned must be reported to the department in the
previous renewal period.
§129.11.Violations, Complaints, Investigation of Complaints, and Disciplinary Actions.
(a)-(c)
(No change.)
(d)
Investigation of complaints.
(1)-(4)
(No change.)
(5)
If the administrator determines that there are sufficient
grounds to support the complaint, the administrator may propose to deny, suspend,
revoke, probate, or not renew a registration [
(6)
(No change.)
(e)-(f)
(No change.)
(g)
The department may impose an emergency
suspension for a violation of the Act or this chapter in accordance with the
procedures established in Occupations Code, §352.254.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on April 15, 2004.
TRD-200402507
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§130.4, 130.11, 130.12, 130.15, 130.20
The Texas Department of Health (department) proposes amendments
to §§130.4, 130.11, 130.12, 130.15, and 130.20, concerning the registration
of code enforcement officers.
The amendments are necessary to implement House Bill 2985, 78th Legislature,
2003, which added Occupations Code, Chapter 101, Subchapter G, which establishes
the Office of Patient Protection within the Health Professions Council and
requires additional fees to fund it; Senate Bill 1152, 78th Legislature, 2003,
which amended Government Code, Chapter 2054, to require participation in Texas
Online; House Bill 2292, 78th Legislature, 2003, which revised Health and
Safety Code, §§12.0111 and 12.0112, and requires two-year licenses
effective January 1, 2005; and Senate Bill 161, 78th Legislature, 2003, which
amends Occupations Code, Chapter 1952, relating to administrative penalties.
An amendment to §130.4 lists the additional fees that will be imposed,
and clarifies that the renewal fee for a registration with a two year term
will be twice the amount required for the current annual renewal. Amendments
to §§130.11 and 130.12 further clarify that a registration may be
issued for a one or a two year term. New language is added to amend §130.15
to reference the new statutory authority of the department to impose administrative
penalties. The amendment to §130.20 clarifies that the number of continuing
education hours to be accrued for a registration with a two year term will
be twice that of the current annual renewal.
Jim Zukowski, Ed.D., Chief, Bureau of Licensing and Compliance, has determined
that for each year of the first five years the sections are in effect, there
will be fiscal implications as a result of enforcing or administering the
sections as proposed. The effect on state government will be an estimated
increase in revenue to the state of approximately $7,000 per year. It is estimated
that costs to the state to administer the new provisions will be equal to
the estimated fee increases. No fiscal impact to local government is expected.
Dr. Zukowski has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing or administering the proposed sections will be to assure the registration
and regulation of code enforcement officers in Texas. There will be no effect
on small businesses or micro-businesses because this registration as a code
enforcement officer is a voluntary registry. There are anticipated economic
costs of up to $10 to persons who are required to comply with the sections
as proposed, based on anticipated fees assessed for new applicants. There
is no anticipated impact on local employment.
Comments on the proposal may be submitted to Yvonne Feinleib, Program Director,
Texas Department of Health Code Enforcement Officer Registration Program,
1100 West 49th Street, Austin, Texas 78756, (512) 834-4512. Comments will
be accepted for 30 days following publication of the proposal in the
The amendments are proposed under the Occupations Code, Chapter
1952, which authorizes the Texas Board of Health (board) to adopt standards,
education requirements, and fees by rule for the registration of code enforcement
officers; and the 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.
The amendments affect the Occupations Code, Title 12, Chapter 1952.
§130.4.Fees.
(a)
The schedule of fees is as follows:
(1)
(No change.)
(2)
renewal fee
:
[
(A)
for a registration issued for a one year
term--$50; and
(B)
for a registration issued for a two year
term--$100;
(3)-(7)
(No change.)
(b)-(c)
(No change.)
(d)
For all applications and renewal applications,
the department is authorized to collect fees to fund the Office of Patient
Protection, Health Professions Council, as mandated by law.
(e)
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.
§130.11.Code Enforcement Officer Registration.
(a)
(No change.)
(b)
Issuance of registrations.
(1)
(No change.)
(2)
A certificate of registration issued under this Act is
valid for one year
or for two years, as determined by the department,
and may be renewed
as provided in §130.12 of this title (relating
to Code Enforcement Registration Renewal)
[
(3)
(No change.)
(c)-(d)
(No change.)
§130.12.Code Enforcement Registration Renewal.
(a)
(No change.)
(b)
General.
(1)
A registrant must renew the registration annually
or every two years
.
(2)-(5)
(No change.)
(c)-(f)
(No change.)
§130.15.Violations, Complaints, Investigations, and Disciplinary Actions.
(a)-(f)
(No change.)
(g)
The department may assess administrative
penalties for a violation of the Act or this chapter in accordance with the
procedures established in Occupations Code, Chapter 1952, Subchapter F.
§130.20.Continuing Education.
(a)-(b)
(No change.)
(c)
Each registered code enforcement officer and code enforcement
officer in training must obtain and show proof of not less than six continuing
education hours as set forth in this section within the twelve months preceding
renewal of
a
[
(d)-(q)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on April 15, 2004.
TRD-200402505
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §157.25,
concerning Out of Hospital Do Not Resuscitate Orders and §157.41, concerning
Automated External Defibrillators; repeal of §157.130, concerning the
emergency medical services and trauma care system account; and new §157.5
concerning rule exception request for Emergency Medical Services (EMS) personnel
and applicants for EMS certification or licensure; new §157.130, concerning
the emergency medical services and trauma care system account and emergency
medical services, trauma facilities, and trauma care system fund; and new §157.131,
concerning the designated trauma facility and emergency medical services account.
Specifically, the sections cover out of hospital Do Not Resuscitate Orders,
minimum standards for Automated External Defibrillator training, rule exceptions
requests for EMS personnel and applicants for EMS certification or licensure
and funding formulas/eligibility criteria for the emergency medical services
and trauma care system account and emergency medical services, trauma facilities,
and trauma care system fund and the designated trauma facility and emergency
medical services account.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedures Act). The sections
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist; however, revisions to the sections are necessary
and described in this preamble.
The department published a Notice of Intention to review and consider for
readoption, revision, or repeal Chapter 157, Subchapter B, Emergency Medical
Services Provider Licenses, §157.25; Subchapter C. Emergency Medical
Services Training and Course Approval, §157.41 and Subchapter G, Emergency
Medical Services Trauma Systems, §157.130 in the September 12, 2003,
issue of the
Texas Register
(28 TexReg 8013).
There were no comments received due to the publication of notice.
Kathryn C. Perkins, Bureau Chief of the Bureau of Emergency Management,
has determined that for each year of the first five years the sections will
be in effect, there will be fiscal implications to state and local governments
as a result of enforcing or administering the sections as proposed concerning
the EMS/Trauma System. The impact is related to the projected increased revenue
from the newly created accounts authorized by Health and Safety Code, §773.006
and Health and Safety Code, §780.003. The department anticipates that
the proposed new §§157.130 and 157.131 will increase funding available
to licensed EMS providers, department designated trauma facilities and department
recognized regional advisory councils thus strengthening the EMS/Trauma System.
There is an anticipated cost associated with the proposed new rules resulting
from the need to provide technical assistance, contract development and contract
management to the above entities regarding the availability and distribution
of funds from the newly created accounts. One percent of the funds appropriated
from the designated trauma facility and the emergency medical services account
are dedicated to the department. Additionally, three percent of the funds
appropriated from the emergency medical services trauma care system account
and emergency medical services, trauma facilities, and trauma care system
fund are dedicated to the department.
The fiscal note outlined on May 19, 2003, from John Keel, Director, Legislative
Budget Board, projected new revenue to the designated trauma facility and
the emergency medical services account will be as follows: Fiscal Year (FY)
2004, $100,938,603; FY 2005, $220,363,936; FY2006, $229,385,665; and FY 2007,
$353,135,665. Appropriation Rider 68 appropriated $59,338,603 in FY 2004 and
$112,613, 914 in FY 2005 to the department.
The fiscal note outlined on May 4, 2003, from John Keel, Director, Legislative
Budget Board, projected new revenue to the emergency medical services and
trauma care system account and emergency medical services, trauma facilities,
and trauma care system fund will be as follows: Fiscal Year (FY) 2004, $3,082,000;
FY 2005, $4,709,000; FY2006, $4,798,0000; and FY 2007, $4,890,000; and FY08,
$4,982,000.
Ms. Perkins has also determined that for each year of the first five years
the proposed sections are in effect the public health benefit anticipated
as a result of administering the sections will be a strengthening of the EMS/Trauma
System due to increased funding and an improvement in understanding of and
clarification of the Do Not Resuscitate form for out of hospital providers
and healthcare practitioners utilizing the form. The proposed sections concerning
rule exceptions requests for EMS personnel and applicants for EMS certification
or licensure will cause a fiscal implication on small business, micro-business,
and to persons who are required to comply with the sections proposed. A $30
nonrefundable application fee will be required for entities/personnel that
choose to request an exception to rule. The proposed sections concerning Out
of Hospital Do Not Resuscitate Orders, minimum standards for Automated External
Defibrillator training and EMS/Trauma System Funding will cause no fiscal
implication on small business, micro-business, and to persons who are required
to comply with the sections proposed. There are no anticipated economic costs
to person(s)/entities that are required to comply with the sections as proposed.
There is no anticipated effect on local employment.
Comments on the proposal may be submitted to Kathryn C. Perkins, Chief,
Bureau of Emergency Management, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756, telephone (512) 834-6700, or kathy.perkins@tdh.state.tx.us.
Comments will be accepted for 30 days after publication of the proposal in
the
Texas Register
.
Subchapter A. EMERGENCY MEDICAL SERVICES-PART A
25 TAC §157.5
The new section is proposed under the Texas Health and Safety
Code, Chapter 773, Emergency Medical Services, which provides the department
with the authority to adopt rules to implement the Emergency Medical Services
Act; and §12.001, which provides the Texas Board of Health with the authority
to adopt rules for its procedure and for the performance of each duty imposed
by law on the board, the department or the commissioner of health.
The new section affects Health and Safety Code, Chapter 166, 773, 779 and
780. The review of the rule implements Government Code, §2001.039.
§157.5.Rule Exemption Requests.
(a)
EMS personnel and applicants for EMS certification or licensure
may request an exemption to rules of this title by:
(1)
submitting an exemption request application form with a
nonrefundable fee of $30, if applicable, in addition to any other applicable
applications and fees required by this title;
(2)
providing a letter of explanation and other documented
evidence which establishes that patient care will not be diminished, or the
health and safety of the public affected, if the exemption is approved;
(3)
providing a signed and dated written statement of support
from the medical director of the licensed emergency medical services (EMS)
provider or registered first responder organization with whom the applicant
is affiliated or will be affiliated; and
(4)
providing a written plan under which the applicable requirement
will be met as soon as possible.
(b)
In determining whether to grant the exemption, the bureau
chief shall take into consideration the best interests of the people in a
rural area who are served by the licensed EMS provider or registered first
responder organization with whom the applicant is affiliated or will be affiliated,
if approved. For the purposes of this section, a rural area is defined to
be:
(1)
a county of 50,000 or less; or
(2)
a sparsely populated area in a county with a population
of more than 50,000, as determined by the Federal Office of Rural Health Policy
designation (of rural areas within metropolitan areas).
(c)
If the request is approved, an exemption may be granted
temporarily. The applicant will be notified by the bureau chief, in writing,
and the notification shall include:
(1)
the date the exemption begins and expires;
(2)
an explicit statement which specifically describes the
rule requirements exempted and any related conditions which must be met for
the exemption to apply or continue to apply.
(d)
This exemption process may be utilized to temporarily allow
a person in a rural area, described in subsection (b)(1) and (2) of this section,
to practice at a higher level prior to receiving the higher level of certification.
(1)
To apply to receive this allowance for up to two months
after course completion, the applicant must:
(A)
meet the requirements of subsection (a)(1)-(4) of this
section;
(B)
be currently certified by the department as an ECA, EMT,
or EMT-Intermediate; and
(C)
submit a course completion certificate for the higher level
of training.
(2)
If granted through written approval from the bureau chief,
the candidate may practice at the higher level only if accompanied by an individual
who is certified or licensed by the department at the same or a higher level
of certification or licensure.
(3)
This allowance shall be automatically and immediately forfeited
upon notification of the candidate's failure of the National Registry written
or practical examination.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on April 16, 2004.
TRD-200402508
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §157.25
The amendment is proposed under the Texas Health and Safety
Code, Chapter 773, Emergency Medical Services, which provides the department
with the authority to adopt rules to implement the Emergency Medical Services
Act; and §12.001, which provides the Texas Board of Health with the authority
to adopt rules for its procedure and for the performance of each duty imposed
by law on the board, the department or the commissioner of health.
The amendment affects Health and Safety Code, Chapter 166, 773, 779 and
780. The review of the rule implements Government Code, §2001.039.
§157.25.Out-of-Hospital Do Not Resuscitate (DNR) Order.
(a) - (c)
(No change.)
(d)
Recordkeeping. Records shall be maintained on each incident
in which an out-of-hospital DNR order or DNR identification device is encountered
by responding healthcare professionals, and the number of cases where there
is an on-site revocation of the DNR order shall be recorded.
(1)
(No change.)
(2)
These records must be maintained
and shall meet records retention requirements for each health care profession.
(3)
[
(4)
[
[
[
[
[
(e) - (g)
(No change.)
(h)
DNR Form. The Bureau of Emergency Management or their appointees
shall furnish DNR forms to physicians, clinics, hospitals, nursing homes,
hospices and home health agencies throughout the state upon request.
(1) (No change.)
(2) The form shall be 8-1/2 inches by 11 inches, printed front
and back, and in the format specified by the board as follows.
Figure: 25 TAC §157.25(h)(2) (.pdf)
[
(i) (No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on April 16, 2004.
TRD-200402509
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §157.41
The amendment is proposed under the Texas Health and Safety
Code, Chapter 773, Emergency Medical Services, which provides the department
with the authority to adopt rules to implement the Emergency Medical Services
Act; and §12.001, which provides the Texas Board of Health with the authority
to adopt rules for its procedure and for the performance of each duty imposed
by law on the board, the department or the commissioner of health.
The amendment affects Health and Safety Code, Chapter 166, 773, 779 and
780. The review of the rule implements Government Code, §2001.039.
§157.41.Automated External Defibrillators.
(a) - (c)
(No change.)
(d)
Training required. A person acquiring and/or using an AED
shall successfully complete a training course in CPR and AED operation in
accordance with the guidelines
established by the device's manufacturer
and as
approved by the American Heart Association, the American Red
Cross, other nationally recognized associations, or the medical director of
the local emergency medical services provider. The person shall maintain that
training in accordance with the guidelines established by the training association.
(e)
Notification required. A person or entity
that
[
(f)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on April 16, 2004.
TRD-200402510
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §157.130
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Texas Health and
Safety Code, Chapter 773, Emergency Medical Services, which provides the department
with the authority to adopt rules to implement the Emergency Medical Services
Act; and §12.001, which provides the Texas Board of Health with the authority
to adopt rules for its procedure and for the performance of each duty imposed
by law on the board, the department or the commissioner of health.
The repeal affects Health and Safety Code, Chapter 166, 773, 779 and 780.
The review of the rule implements Government Code, §2001.039.
§157.130.Emergency Medical Services and Trauma Care System Account.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on April 16, 2004.
TRD-200402511
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §157.130, §157.131
The new sections are proposed under the Texas Health and Safety
Code, Chapter 773, Emergency Medical Services, which provides the department
with the authority to adopt rules to implement the Emergency Medical Services
Act; and §12.001, which provides the Texas Board of Health with the authority
to adopt rules for its procedure and for the performance of each duty imposed
by law on the board, the department or the commissioner of health.
The new sections affect Health and Safety Code, Chapter 166, 773, 779 and
780. The review of the rules implements Government Code, §2001.039.
§157.130.Emergency Medical Services and Trauma Care System Account and Emergency Medical Services, Trauma Facilities, and Trauma Care System Fund.
(a)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Extraordinary emergency--An event or situation which may
disrupt the services of an EMS/trauma system.
(2)
Rural county--A county with a population of less than 50,000
based on the latest official federal census population figures.
(3)
Urban county--A county with a population of 50,000 or more
based on the latest official federal census population figures.
(4)
Emergency transfer--Any immediate transfer of an emergent
or unstable patient, ordered by a licensed physician, from a health care facility
to a health care facility which has the capability of providing a higher level
of care or of providing a specialized type of care not available at the transferring
facility.
(5)
Trauma care--Care provided to patients who underwent treatment
specified in at least one of the following ICD-9 (International Classification
of Diseases, 9th Revision, of the National Center of Health Statistics) codes:
between 800.00 and 959.9, including 940.0-949.0 (burns), excluding 905.0-909.0
(late effects of injuries), 910.0-924.0 (blisters, contusions, abrasions,
and insect bites), 930.0-939.0 (foreign bodies), and who underwent an operative
intervention as defined in paragraph (9) of this subsection or was admitted
as an inpatient for greater than 23-hours or who died after receiving any
emergency department evaluation or treatment or was dead on arrival to the
facility or who transferred into or out of the hospital.
(6)
Uncompensated trauma care--The sum of "charity care" and
"bad debt" resulting from trauma care as defined in paragraph (5) of this
subsection after due diligence to collect. Contractual adjustments in reimbursement
for trauma services based upon an agreement with a payor (to include but not
limited to Medicaid, Medicare, Children's Health Insurance Program (CHIP),
etc.) is not uncompensated trauma care.
(7)
Charity care--The unreimbursed cost to a hospital of providing
health care services on an inpatient or emergency department basis to a person
classified by the hospital as "financially indigent" or "medically indigent".
(A)
Financially indigent--An uninsured or underinsured person
who is accepted for care with no obligation or a discounted obligation to
pay for the services rendered based on the hospital's eligibility system.
(B)
Medically indigent--A person whose medical or hospital
bills after payment by third-party payors (to include but not limited to Medicaid,
Medicare, CHIP, etc.) exceed a specified percentage of the patient's annual
gross income, determined in accordance with the hospital's eligibility system,
and the person is financially unable to pay the remaining bill.
(8)
Bad debt--The unreimbursed cost to a hospital of providing
health care services on an inpatient or emergency department basis to a person
who is financially unable to pay, in whole or in part, for the services rendered
and whose account has been classified as bad debt based upon the hospital's
bad debt policy. A hospital's bad debt policy should be in accordance with
generally accepted accounting principles.
(9)
Operative intervention--Any surgical procedure resulting
from a patient being taken directly from the emergency department to an operating
suite regardless of whether the patient was admitted to the hospital or discharged
from the hospital.
(10)
Calculation of the costs of uncompensated trauma care--For
the purposes of this section, a hospital will calculate its total costs of
uncompensated trauma care by summing its charges related to uncompensated
trauma care as defined in paragraph (6) of this subsection, then applying
the cost to charge ratio defined in paragraph (12) of this subsection and
derived in accordance with generally accepted accounting principles. The calculation
of cost to charge ratios shall be based on the most recently completed and
audited prior fiscal year of the hospital or hospital system.
(11)
County of licensure--The County within which lies the
location of the business mailing address of a licensed ambulance provider,
as indicated by the provider on the application for licensure form that it
filed with the department.
(12)
Cost-to-charge ratio--Hospital's overall cost-to-charge
ratio, as determined from its Medicaid cost report it submitted for its fiscal
year ending in the previous calendar year. The latest available Medicaid cost
report will be used in the absence of the cost report for the hospital fiscal
year ending in the previous calendar year.
(b)
Reserve. On September 1 of each year, there shall be a
reserve of $500,000 in the emergency medical services (EMS) and trauma care
system account and the emergency medical services, trauma facilities, and
trauma care system fund (accounts) for extraordinary emergencies. During the
fiscal year, distributions may be made from the reserve by the commissioner
of health based on requests which demonstrate need and impact on the EMS and
trauma care system (system). Proposals not immediately recommended for funding
will be reconsidered at the end of each fiscal year, if funding is available,
and need are still present.
(c)
Allotments. The EMS allotment shall be 50%, the trauma
service area (TSA) allotment shall be not more than 20%, and the uncompensated
care allotment shall be at least 27% of the funds remaining from the accounts
after any amount necessary to maintain the extraordinary emergency reserve
of $500,000 has been deducted.
(1)
Allotment Determination. Each year, the department shall
determine:
(A)
eligibility of all EMS providers, regional advisory councils
(RACs), and trauma facilities;
(B)
the amount of the TSA allotment, the EMS allotment, and
the uncompensated care allotment;
(C)
each county's share of the EMS allotment for eligible recipients
in the county;
(D)
each RAC's share of the TSA allotment; and
(E)
each designated trauma facility's share of the uncompensated
care allotment.
(2)
EMS Allotment. The department shall contract with each
eligible RAC to distribute the county shares of the EMS allotment to eligible
EMS providers based within counties which are aligned within the relevant
RAC. Prior to distribution of the county shares to eligible providers, the
RAC shall submit a distribution proposal, approved by the RAC's voting membership,
to the department for approval.
(A)
The county portion of the EMS allotment shall be distributed
directly to eligible recipients without any reduction in the total amount
allocated by the department and shall be used as an addition to current county
EMS funding of eligible recipients, not as a replacement.
(B)
The department shall evaluate each RAC's distribution plan
based on the following:
(i)
fair distribution process to all eligible providers, taking
into account all eligible providers participating in contiguous TSAs;
(ii)
needs of the EMS providers; and
(iii)
evidence of consensus opinion for eligible entities.
(C)
A RAC opting to use a distribution plan from the previous
fiscal year shall submit, to the department, a letter or email of intent to
do so.
(D)
Eligible EMS providers may opt to pool funds or contribute
funds for a specified RAC purpose.
(3)
TSA Allotment. The department shall contract with each
eligible RAC to distribute the TSA allotment. Prior to distribution of the
TSA allotment, the RAC shall submit a budget proposal to the department for
approval. The department shall evaluate each RAC's budget according to the
following:
(A)
budget reflects all funds received by the RAC, including
funds not expended in the previous fiscal year;
(B)
budget contains no ineligible expenses;
(C)
appropriate mechanism is used by RAC for budgetary planning;
and
(D)
program areas receiving funding are identified by budget
categories.
(4)
Uncompensated Care Allotment. The department shall contract
with each eligible RAC to distribute shares of the uncompensated care allotment
to eligible designated trauma facilities within the RAC's TSA. Prior to distribution
of the uncompensated care allotment, the RAC shall submit a distribution proposal,
approved by the RAC's voting membership, to the department for approval.
(A)
The department shall evaluate each RAC's distribution plan
based on the following:
(i)
fair distribution process to all eligible providers;
(ii)
needs of designated trauma facilities; and
(iii)
evidence of consensus opinion from eligible entities.
(B)
A RAC opting to use a distribution plan from the previous
fiscal year shall submit, to the department, a letter or email of intent to
do so.
(C)
Eligible designated hospitals may opt to pool funds or
contribute funds for a specified RAC purpose for novel or innovative projects.
(d)
Eligibility requirements. To be eligible for funding from
the accounts, all potential recipients (EMS Providers, RACs, Registered First
Responder Organizations and hospitals) must maintain active involvement in
regional system development. Potential recipients must also meet requirements
for reports of expenditures from the previous year and planning for use of
the funding in the upcoming year.
(1)
Extraordinary Emergency Funding. To be eligible to receive
extraordinary emergency funding, an entity must:
(A)
be a licensed EMS provider, a licensed general hospital,
or a registered first responder organization;
(B)
submit to the department a signed written request, containing
the entity name, contact information, amount of funding requested, and a description
of the extraordinary emergency; and
(C)
timely submit a signed and fully completed extraordinary
emergency information checklist (on the department's form) to the department.
(2)
EMS Allotment. To be eligible for funding from the EMS
allotment, an EMS provider must meet the following requirements:
(A)
maintain provider licensure as described in §157.11
of this title (relating to Requirements for An EMS Provider License) and provide
emergency medical services and/or emergency transfers;
(B)
demonstrate utilization of the RAC regional protocols regarding
patient destination and transport in all TSAs in which they operate (verified
by each RAC);
(C)
demonstrate active participation in the regional system
performance improvement (PI) program in all TSAs in which they operate (verified
by each RAC);
(D)
if an EMS provider is licensed in a county or contracted
to provide emergency medical services in a county that is contiguous with
a neighboring TSA, it must participate on at least one RAC of the TSAs:
(i)
participation on both RACs is encouraged;
(ii)
RAC participation shall follow actual patient referral
patterns;
(iii)
an EMS provider, contracted to provide emergency medical
services within a county of any one TSA and whose county of licensure is another
county not in or contiguous with that TSA, must be an active member of the
RAC for the TSA of their contracted service area and meet that RAC's definition
of participation and requirements listed in subparagraph (E)(i)-(vi) of this
paragraph; and
(iv)
it is the responsibility of an EMS provider to contact
each RAC in which it operates to ensure knowledge of the provider's presence
and potential eligibility for funding from the EMS allotment related to that
RAC's TSA;
(E)
if an EMS provider is serving any county beyond its county
of licensure it must provide to the department evidence of a contract or letter
of agreement with each additional county government or taxing authority in
which service is provided:
(i)
inter-facility transfer letters of agreement and/or contracts,
as well as mutual aid letters of agreement and/or contracts, do not meet this
requirement;
(ii)
contracts or letters of agreement must be dated and submitted
to the department on or before August 31 of the respective year, and be effective
more than six months of the upcoming fiscal year;
(iii)
effective dates of the contracts or letters of agreement
should be provided;
(iv)
EMS providers with contracts or letters of agreement on
file with the department which include contract service dates that meet the
required time period need not resubmit.
(v)
EMS providers are responsible for assuring that all necessary
portions of their contracts and letters of agreement have been received by
the department; and
(vi)
air ambulance providers must meet the same requirements
as ground transport EMS providers to be eligible to receive funds from a specific
county other than the county of licensure; and
(F)
if an EMS provider is licensed in a particular county and
has a contract (with a county government or taxing authority) for a service
area which is a geopolitical subdivision (examples listed below) whose boundary
lines cross multiple county lines, it will be considered eligible for the
911 EMS Allotment for all counties overlapped by that geopolitical subdivision's
boundary lines. A contract with every county that composes the geopolitical
subdivision is not necessary. And, the eligibility of EMS providers, whose
county of licensure is in a geopolitical subdivision other than those listed
in clauses (i) - (vi) of this subparagraph, will be evaluated on a case-by-case
basis.
(i)
Municipalities.
(ii)
School districts.
(iii)
Emergency service districts (ESDs).
(iv)
Hospital districts.
(v)
Utility districts.
(vi)
Prison districts.
(3)
RAC Allotment. To be eligible for funding from the RAC
allotment, a RAC must:
(A)
be officially recognized by the department as described
in §157.123 of this title (relating to Regional Emergency Medical Services/Trauma
Systems);
(B)
be incorporated as an entity that is exempt from federal
income tax under §501(a) of the United States Internal Revenue Code of
1986, and its subsequent amendments, by being listed as an exempt organization
under §501(c)(3) of the code;
(C)
submit documentation of ongoing system development activity
and future planning;
(D)
have demonstrated that a regional system performance improvement
(PI) process is ongoing by submitting to the department the following:
(i)
lists of committee meeting dates and attendance rosters
for the RAC'S most recent fiscal year;
(ii)
committee membership rosters which included each member's
organization or constituency; and
(iii)
lists of issues being reviewed in the system performance
improvement meetings; and
(E)
submit all required EMS allocation eligibility items addressed
in paragraph (2)(B)-(C) of this subsection.
(4)
To be eligible to distribute the EMS, Uncompensated Care
and TSA allotments, a RAC must be incorporated as an entity that is exempt
from federal income tax under §501(a) of the Internal Revenue Code of
1986, and its subsequent amendments, by being listed as an exempt organization
under §501(c)(3) of the code.
(5)
Uncompensated Care Allotment. To be eligible for funding
from the Uncompensated Care allotment, a hospital must be a department designated
trauma facility or a Department of Defense hospital that is a department designated
trauma facility.
(A)
To receive funding from the Uncompensated Care allotment,
an application must be submitted within the time frame specified by the department
and include the following:
(i)
name of facility;
(ii)
location of facility including mailing address, city and
county; and
(iii)
Texas Provider Identifier (TPI number) or accepted federal
identification number.
(B)
The application must be signed and sworn to before a Texas
Notary Public by the chief financial officer, chief executive officer and
the chairman of the facility's board of directors.
(C)
A copy of the application shall be distributed by Level
I, II, or III facilities to the trauma medical director and Level IV facilities
to the physician director.
(D)
The department may opt to use data from applications submitted
by qualified hospitals in accordance with §157.131(d)(5) (relating to
Designated Trauma Facility and Emergency Medical Services Account) for the
distribution of funds outlined in subsection (e)(3) of this section.
(E)
Additional information may be requested at the department's
discretion.
(e)
Calculation Methods. Calculation of county shares of the
EMS allotment, the RAC shares of the TSA allotment, and the TSA's share of
the uncompensated care allotment.
(1)
EMS allotment.
(A)
Counties will be classified as urban or rural based on
the latest official federal census population figures.
(B)
The EMS allotment will be derived by adjusting the weight
of the statutory criteria in such a fashion that, in so far as possible, 40%
of the funds are allocated to urban counties and 60% are allocated to rural
counties.
(C)
An individual county's share of the EMS allotment shall
be based on its geographic size, population, and number of emergency health
care runs multiplied by adjustment factors, determined by the department,
so the distribution approximates the required percentages to urban and rural
counties.
(D)
The formula shall be: ((the county's population multiplied
by an adjustment factor) plus (the county's geographic size multiplied by
an adjustment factor) plus (the county's total emergency health care runs
multiplied by an adjustment factor) divided by 3)) multiplied by (the total
EMS allocation). The adjustment factors will be manipulated so that the distribution
approximates the required percentages to urban and rural counties. Total emergency
health care runs shall be the number of emergency runs electronically transmitted
to the department in a given calendar year by EMS providers.
(2)
TSA allotment.
(A)
A RAC's share of the TSA allotment shall be based on its
relative geographic size, population, and trauma care provided as compared
to all other TSAs.
(B)
The formula shall be: ((the TSA's percentage of the state's
total population) plus (the TSA's percentage of the state's total geographic
size) plus (the TSA's percentage of the state's total trauma care) divided
by 3)) multiplied by (the total TSA allotment). Total trauma care shall be
the number of trauma patient records electronically transmitted to the department
in a given calendar year by EMS providers and hospitals.
(3)
Uncompensated care allotment.
(A)
The uncompensated care allotment shall be based on a TSA's
relative geographic size, population, and a TSA's percentage of the state's
total reported uncompensated trauma care.
(B)
The formula shall be: ((the TSA's percentage of the state's
total population) plus (the TSA's percentage of the state's total geographic
size) plus (the TSA's percentage of the total reported cost of uncompensated
trauma care by qualified hospitals that year) divided by 3) multiplied by
(the total uncompensated care allotment).
(C)
For purposes of subparagraphs (A)-(B) of this paragraph,
the reporting period of a facility's uncompensated trauma care shall apply
to costs incurred during the preceding calendar year.
(f)
Loss of funding eligibility. If the department finds that
an EMS provider, RAC, or trauma facility has violated the Health and Safety
Code, §773.122, or fails to comply with this section, the department
may withhold account monies for a period of one to three years depending upon
the seriousness of the infraction.
§157.131.Designated Trauma Facility and Emergency Medical Services Account.
(a)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Extraordinary emergency--An event or situation which may
disrupt the services of an EMS/trauma system.
(2)
Rural county--A county with a population of less than 50,000
based on the latest official federal census population figures.
(3)
Urban county--A county with a population of 50,000 or more
based on the latest official federal census population figures.
(4)
Emergency transfer--Any immediate transfer of an emergent
or unstable patient, ordered by a licensed physician, from a health care facility
to a health care facility which has the capability of providing a higher level
of care or of providing a specialized type of care not available at the transferring
facility.
(5)
Trauma care--Care provided to patients who underwent treatment
specified in at least one of the following ICD-9 (International Classification
of Diseases, 9th Revision, of the National Center of Health Statistics) codes:
between 800.00 and 959.9, including 940.0-949.0 (burns), excluding 905.0-909.0
(late effects of injuries), 910.0-924.0 (blisters, contusions, abrasions,
and insect bites), 930.0-939.0 (foreign bodies), and who underwent an operative
intervention as defined in paragraph (9) of this subsection or was admitted
as an inpatient for greater than 23-hours or who died after receiving any
emergency department evaluation or treatment or was dead on arrival to the
facility or who transferred into or out of the hospital.
(6)
Uncompensated trauma care--The sum of "charity care" and
"bad debt" resulting from trauma care as defined in (a)(5) of this section
after due diligence to collect. Contractual adjustments in reimbursement for
trauma services based upon an agreement with a payor (to include but not limited
to Medicaid, Medicare, Children's Health Insurance Program (CHIP), etc.) is
not uncompensated trauma care.
(7)
Charity care--The unreimbursed cost to a hospital of providing
health care services on an inpatient or emergency department basis to a person
classified by the hospital as "financially indigent" or "medically indigent".
(A)
Financially indigent--An uninsured or underinsured person
who is accepted for care with no obligation or a discounted obligation to
pay for the services rendered based on the hospital's eligibility system.
(B)
Medically indigent--A person whose medical or hospital
bills after payment by third-party payors (to include but not limited to Medicaid,
Medicare, CHIP, etc.) exceed a specified percentage of the patient's annual
gross income, determined in accordance with the hospital's eligibility system,
and the person is financially unable to pay the remaining bill.
(8)
Bad debt--The unreimbursed cost to a hospital of providing
health care services on an inpatient or emergency department basis to a person
who is financially unable to pay, in whole or in part, for the services rendered
and whose account has been classified as bad debt based upon the hospital's
bad debt policy. A hospital's bad debt policy should be in accordance with
generally accepted accounting principles.
(9)
Operative intervention--Any surgical procedure resulting
from a patient being taken directly from the emergency department to an operating
suite regardless of whether the patient was admitted to the hospital or discharged
from the hospital.
(10)
Active pursuit of department designation as a trauma facility--means
that by December 31, 2003, a licensed hospital, applying for a designation
from the department as a trauma facility, must have submitted:
(A)
a complete application to the department's trauma facility
designation program or appropriate agency for trauma verification;
(B)
evidence of participation in Trauma Services Area (TSA)
Regional Advisory Council (RAC) initiatives;
(C)
evidence of a hospital trauma performance improvement committee;
and
(D)
data to the department's EMS/Trauma Registry.
(11)
Calculation of the costs of uncompensated trauma care--For
the purposes of this section, a hospital will calculate its total costs of
uncompensated trauma care by summing its charges related to uncompensated
trauma care as defined in paragraph (6) of this subsection, then applying
the cost to charge ratio defined in paragraph (13) of this subsection and
derived in accordance with generally accepted accounting principles. The calculation
of cost to charge ratios shall be based on the most recently completed and
audited prior fiscal year of the hospital or hospital system.
(12)
County of licensure--The County within which lies the
location of the business mailing address of a licensed ambulance provider,
as indicated by the provider on the application for licensure form that it
filed with the department.
(13)
Cost-to-charge ratio--Hospital's overall cost-to-charge
ratio, as determined from its Medicaid cost report it submitted for its fiscal
year ending in the previous calendar year. The latest available Medicaid cost
report will be used in the absence of the cost report for the hospital fiscal
year ending in the previous calendar year.
(b)
Reserve. On September 1 of each year, there shall be a
reserve of $500,000 in the designated trauma facility and emergency medical
services account (account) for extraordinary emergencies. During the fiscal
year, distributions may be made from the reserve by the commissioner of health
based on requests which demonstrate need and impact on the EMS and trauma
care system (system). Proposals not immediately recommended for funding will
be reconsidered at the end of each fiscal year, if funding is available, and
a need is still present.
(c)
Allocations. The EMS allocation shall be not more than
2%, the TSA allocation shall be not more than 1%, and the hospital allocation
shall be at least 96% of the funds appropriated from the account after any
amount necessary to maintain the extraordinary emergency reserve of $500,000
has been deducted.
(1)
Allocation Determination. Each year, the bureau of emergency
management (department) shall determine:
(A)
eligible recipients for the EMS allocation, TSA allocation,
and hospital allocation;
(B)
the amount of the TSA allocation, the EMS allocation, and
the hospital allocation;
(C)
each county's share of the EMS allocation for eligible
recipients in the county;
(D)
each RAC's share of the TSA allocation; and
(E)
each facility's share of the hospital allocation.
(2)
EMS Allocation. The department shall contract with each
eligible RAC to distribute the county shares of the EMS allocation to eligible
EMS providers based within counties which are aligned within the relevant
RAC. Prior to distribution of the county shares to eligible providers, the
RAC shall submit a distribution proposal, approved by the RAC's voting membership,
to the department for approval.
(A)
The county portion of the EMS allocation shall be distributed
directly to eligible recipients without any reduction in the total amount
allocated by the department and shall be used as an addition to current county
EMS funding of eligible recipients, not as a replacement.
(B)
The department shall evaluate each RAC's distribution plan
based on the following:
(i)
fair distribution process to all eligible providers, taking
into account all eligible providers participating in contiguous TSAs;
(ii)
needs of the EMS providers; and
(iii)
evidence of consensus opinion for eligible entities.
(C)
A RAC opting to use a distribution plan from the previous
fiscal year shall submit, to the department, a letter or email of intent to
do so.
(D)
Eligible EMS providers may opt to pool funds or contribute
funds for a specified RAC purpose.
(3)
TSA Allocation. The department shall contract with eligible
RACs to distribute the TSA allocation. Prior to distribution of the TSA allocation,
the RAC shall submit a budget proposal to the department for approval. The
department shall evaluate each RAC's budget according to the following:
(A)
budget reflects all funds received by the RAC, including
funds not expended in the previous fiscal year;
(B)
budget contains no ineligible expenses;
(C)
appropriate mechanism is used by RAC for budgetary planning;
and
(D)
program areas receiving funding are identified by budget
categories.
(4)
Hospital Allocation. The department shall distribute funds
directly to facilities eligible to receive funds from the hospital allocation
to subsidize a portion of uncompensated trauma care provided or to fund innovative
projects to enhance the delivery of patient care in the overall EMS/Trauma
System. Funds distributed from the hospital allocations shall be made based
on, but not limited to:
(A)
the percentage of the hospital's uncompensated trauma care
cost in relation to total uncompensated trauma care cost reported by qualified
hospitals that year; and
(B)
availability of funds.
(d)
Eligibility requirements. To be eligible for funding from
the account, all potential recipients (EMS Providers, RACs, Registered First
Responder Organizations and hospitals) must maintain active involvement in
regional system development. Potential recipients also must meet requirements
for reports of expenditures from the previous year and planning for use of
the funding in the upcoming year.
(1)
Extraordinary Emergency Funding. To be eligible to receive
extraordinary emergency funding, an entity must:
(A)
be a licensed EMS provider, a licensed hospital, or a registered
first responder organization;
(B)
submit to the department a signed written request, containing
the entity name, contact information, amount of funding requested, and a description
of the extraordinary emergency; and
(C)
timely submit a signed and fully completed extraordinary
emergency information checklist (on the department's form) to the department.
(2)
EMS Allocation. To be eligible for funding from the EMS
allocation an EMS provider must meet the following requirements:
(A)
maintain provider licensure as described in §157.11
of this title and provide emergency medical services and/or emergency transfers;
(B)
demonstrate utilization of the RAC regional protocols regarding
patient destination and transport in all TSAs in which they operate (verified
by each RAC);
(C)
demonstrate active participation in the regional system
performance improvement (PI) program in all TSAs in which they operate (verified
by each RAC);
(D)
if an EMS provider is licensed in a county or contracted
to provide emergency medical services in a county that is contiguous with
a neighboring TSA, it must participate on at least one RAC of the TSAs:
(i)
participation on both RACs is encouraged;
(ii)
RAC participation shall follow actual patient referral
patterns;
(iii)
an EMS provider contracted to provide emergency medical
services within a county of any one TSA and whose county of licensure is another
county not in or contiguous with that TSA must be an active member of the
RAC for the TSA of their contracted service area and meet that RAC's definition
of participation and requirements listed in subparagraph (E)(i)-(vi) of this
paragraph; and
(iv)
it is the responsibility of an EMS provider to contact
each RAC in which it operates to ensure knowledge of the provider's presence
and potential eligibility for funding from the EMS allotment related to that
RAC's TSA;
(E)
if an EMS provider is serving any county beyond its county
of licensure it must provide to the department evidence of a contract or letter
of agreement with each additional county government or taxing authority in
which service is provided:
(i)
inter-facility transfer letters of agreement and/or contracts,
as well as mutual aid letters of agreement and/or contracts, do not meet this
requirement;
(ii)
contracts or letters of agreement must be dated and submitted
to the department on or before August 31 of the respective year, and be effective
more than six months of the upcoming fiscal year;
(iii)
effective dates of the contracts or letters of agreement
should be provided;
(iv)
EMS providers with contracts or letters of agreement on
file with the department which include contract service dates that meet the
required time period (noted in this subsection) need not resubmit;
(v)
EMS providers are responsible for assuring that all necessary
portions of their contracts and letters of agreement have been received by
the department; and
(vi)
air ambulance providers must meet the same requirements
as ground transport EMS providers to be eligible to receive funds from a specific
county other than the county of licensure; and
(F)
if a EMS provider is licensed in a particular county and
has a contract (with a county government or taxing authority) for a service
area which is a geopolitical subdivision (examples listed below) whose boundary
lines cross multiple county lines, it will be considered eligible for the
911 EMS Allocation for all counties overlapped by that geopolitical subdivision's
boundary lines. A contract with every county that composes the geopolitical
subdivision is not necessary. And, the eligibility of EMS providers, whose
county of licensure is in a geopolitical subdivision other than those listed
in clauses (i) - (vi) of this subparagraph, will be evaluated on a case-by-case
basis.
(i)
Municipalities.
(ii)
School districts.
(iii)
Emergency service districts (ESDs).
(iv)
Hospital districts.
(v)
Utility districts.
(vi)
Prison districts.
(3)
RAC Allocation. To be eligible for funding from the TSA
allocation, a RAC must:
(A)
be officially recognized by the department as described
in §157.123 of this title (relating to Regional Emergency Medical Services/Trauma
Systems);
(B)
be incorporated as an entity that is exempt from federal
income tax under §501(a) of the United States Internal Revenue Code of
1986, and its subsequent amendments, by being listed as an exempt organization
under §501(c)(3) of the code;
(C)
submit documentation of ongoing system development activity
and future planning;
(D)
have demonstrated that a regional system performance improvement
process is ongoing by submitting to the department the following:
(i)
lists of committee meeting dates and attendance rosters
for the RAC'S most recent fiscal year;
(ii)
committee membership rosters which included each member's
organization or constituency; or
(iii)
lists of issues being reviewed in the system performance
improvement meetings.
(E)
Submit all required EMS allocation eligibility items addressed
in paragraph (2)(B)-(C) of this subsection.
(4)
To be eligible to distribute the EMS and TSA allocations,
a RAC must be incorporated as an entity that is exempt from federal income
tax under §501(a) of the Internal Revenue Code of 1986, and its subsequent
amendments, by being listed as an exempt organization under §501(c)(3)
of the code.
(5)
Hospital Allocation. To be eligible for funding from the
hospital allocation, a hospital must be a department designated trauma facility
or in active pursuit of a department designation as a trauma facility or a
Department of Defense hospital that is a department designated trauma facility
or in active pursuit of a department designation as a trauma facility.
(A)
To receive funding from the hospital allocation, an application
must be submitted within the time frame specified by the department and include
the following:
(i)
name of facility;
(ii)
location of facility including mailing address, city and
county;
(iii)
Texas Provider Identifier (TPI number) or accepted federal
identification number.
(B)
The application must be signed and sworn to before a Texas
Notary Public by the chief financial officer, chief executive officer and
the chairman of the facility's board of directors.
(C)
A copy of the application shall be distributed by Level
I, II, or III facilities to the trauma medical director and Level IV facilities
to the physician director.
(D)
Additional information may be requested at the department's
discretion.
(E)
A TDH-designated trauma facility in receipt of funding
from the hospital allocation that fails to maintain designation through December
31, 2005, must return an amount as follows to the account by no later than
January 31, 2006:
(i)
1 to 60 days lapsed designation: 0% of the facility's hospital
allocation for FY04 and FY05;
(ii)
60 to 180 days lapsed designation: 25% of the facility's
hospital allocation for FY04 and FY05 plus a penalty of 10%;
(iii)
greater than 180 days lapsed designation: 100% of the
facility's hospital allocation for FY04 and FY05 plus a penalty of 10%; and
(iv)
the department may grant an exception to subparagraph
(E) of this subsection if it finds that compliance with this section would
not be in the best interests of the persons served in the affected local system.
(F)
A facility in active pursuit of designation but has not
achieved TDH-trauma designation by December 31, 2005, must return to the account
by no later than January 31, 2006, all funds received from the hospital allocation
in FY04 and FY05 plus a penalty of 10%.
(e)
Calculation Methods. Calculation of county shares of the
EMS allocation, the RAC shares of the TSA allocation, and the hospital allocation.
(1)
EMS allocation.
(A)
Counties will be classified as urban or rural based on
the latest official federal census population figures.
(B)
The EMS allocation will be derived by adjusting the weight
of the statutory criteria in such a fashion that, in so far as possible, 40%
of the funds are allocated to urban counties and 60% are allocated to rural
counties.
(C)
An individual county's share of the EMS allocation shall
be based on its geographic size, population, and number of emergency health
care runs multiplied by adjustment factors, determined by the department,
so the distribution approximates the required percentages to urban and rural
counties.
(D)
The formula shall be: (((the county's population multiplied
by an adjustment factor) plus (the county's geographic size multiplied by
an adjustment factor) plus (the county's total emergency health care runs
multiplied by an adjustment factor) divided by 3)) multiplied by (the total
EMS allocation). The adjustment factors will be manipulated so that the distribution
approximates the required percentages to urban and rural counties. Total emergency
health care runs shall be the number of emergency runs electronically transmitted
to the department in a given calendar year by EMS providers.
(2)
TSA allocation.
(A)
A RAC's share of the TSA allocation shall be based on its
relative geographic size, population, and trauma care provided as compared
to all other TSAs.
(B)
The formula shall be: (((the TSA's percentage of the state's
total population) plus (the TSA's percentage of the state's total geographic
size) plus (the TSA's percentage of the state's total trauma care) divided
by 3)) multiplied by (the total TSA allocation). Total trauma care shall be
the number of trauma patient records electronically transmitted to the department
in a given calendar year by EMS providers and hospitals.
(3)
Hospital allocation.
(A)
There will be one annual application process from which
all distributions from the hospital allocation, plus any unexpended portion
of the EMS and TSA allocations, in a given fiscal year will be made. The department
will notify all eligible designated trauma facilities and those hospitals
in active pursuit of designation at least 90 days prior to the due date of
the annual application. Based on the information provided in the application,
each facility shall receive:
(i)
an equal amount, with an upper limit of $50,000, from up
to 15 percent of the hospital allocation; and
(ii)
an amount for uncompensated trauma care as determined
in subparagraphs (B)-(C) of this paragraph, less the amount received in clause
(i) of this subparagraph.
(B)
Any funds not allocated in subparagraph (A)(i) of this
paragraph shall be included in the distribution formula in subparagraph (D)
of this paragraph.
(C)
If the total cost of uncompensated trauma care exceeds
the amount appropriated from the account, minus the amount referred to in
subparagraph (A)(i) of this paragraph, the department shall allocate funds
based on a facility's percentage of uncompensated trauma care costs in relation
to the total uncompensated trauma care cost reported by qualified hospitals
that year.
(D)
In the first year of distribution, the hospital allocation
formula for Level I, II, III and IV trauma facilities and those facilities
in active pursuit of designation shall be: (((the facility's reported costs
of uncompensated trauma care) divided by (the total reported cost of uncompensated
trauma care by qualified hospitals that year))) multiplied by (total money
available for facilities minus the amount referred to in subparagraph (A)(i))
of this paragraph.
(E)
In subsequent years of distribution, the hospital allocation
formula for Level I, II, III and IV trauma facilities and those facilities
in active pursuit of designation shall be: (((the facility's reported costs
of uncompensated trauma care) minus (any collections received by the hospitals
for any portion of their uncompensated care previously reported for the purposes
of this section) divided by (the total reported cost of uncompensated trauma
care by qualified hospitals that year))) multiplied by (total money available
for facilities minus the amount distributed in subparagraph (A)(i)) of this
paragraph.
(F)
For purposes of subparagraphs (D) - (E) of this paragraph,
the reporting period of a facility's uncompensated trauma care shall apply
to costs incurred during the preceding calendar year.
(G)
Hospitals should have a physician incentive plan that supports
the facility's participation in the trauma system.
(f)
Loss of funding eligibility. If the department finds that
an EMS provider, RAC, or hospital has violated the Health and Safety Code, §780.004,
or fails to comply with this section, the department may withhold account
monies for a period of one to three years depending upon the seriousness of
the infraction.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on April 16, 2004.
TRD-200402512
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §§229.181-229.184
and new §§229.181-229.184, concerning the licensure of food manufacturers,
food wholesalers, and warehouse operators relating to food operations for
the programs within the Bureau of Food and Drug Safety.
The new rules are necessary changes to implement Senate Bill (SB) 1152,
78th Legislature, 2003, which amended Government Code, Chapter 2054, to require
participation in Texas Online; House Bill 2292, 78th Legislature, 2003, which
revised Health and Safety Code, §§12.0111 and 12.0112, and requires
two-year licenses effective January 1, 2005; SB 381, 78th Legislature, 2003,
which amended Health and Safety Code, Chapter 431, to create an exception
from licensing for certain restaurants; SB 1826, 78th Legislature, 2003, which
amended Health and Safety Code, Chapter 431, to change the definition of manufacture
to include relabeling, and increased criminal penalties for violations of
the chapter; and SB 1803, 78th Legislature, 2003, which amended Health and
Safety Code, Chapter 431, to increase criminal penalties for violations of
the chapter, and established authority to license warehouse operators and
register certain food wholesalers who meet the requirements of the chapter.
The new rules rename the subchapter, reorganize the sections, and clarify
license requirements and fees.
Derek Jakovich, Director, Licensing and Enforcement Division, has determined
that for each year of the first five-year period the sections are in effect,
there will be no fiscal implications to the state as the proposed license/registration
fees will generate the same amount of revenue as the current license fees
(approximately $800,000 each year). There will be no effect on local government.
Mr. Jakovich has also determined that for each of the first five years
the rules are in effect, the public benefit anticipated as a result of enforcing
and administering the proposed rules will be the ability to ensure that food
products stored, distributed in Texas, and offered to the public are fully
inspected and regulated and that those products that are adulterated and/or
misbranded can be removed from the market so as to protect public health and
safety. Since most food wholesalers will be paying a $50 annual registration
fee prior to January 1, 2005, and then a $100 registration fee for a two-year
license on or after January 1, 2005, there will be no adverse economic effect
on micro-businesses and/or small businesses or persons who are required to
comply with the sections. There will be no anticipated impact on local employment.
Government Code, §2001.039, requires each state agency to review and
consider for adoption 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 rules continue to exist. However, because substantial changes are made
to implement legislation and reorganize the rules, the current rules are being
repealed and new rules are proposed.
The department published a Notice of Intention to Review for §§229.181
- 229.184 in the
Texas Register
on October
24, 2003 (28 TexReg 9295). No comments were received as a result of the publication
of the notice.
Comments on the proposed rules may be submitted to Derek Jakovich, Director,
Licensing and Enforcement Division, Bureau of Food and Drug Safety, Texas
Department of Health, 1100 West 49th Street, Austin, Texas 78756-3189, (512)
719-0222. Comments will be accepted for 30 days following publication of the
proposed rules in the
Texas Register
.
Subchapter L. LICENSURE OF FOOD MANUFACTURERS AND FOOD WHOLESALERS--INCLUDING GOOD MANUFACTURING PRACTICES AND GOOD WAREHOUSING PRACTICES IN MANUFACTURING, PACKING AND HOLDING HUMAN FOOD
25 TAC §§229.181 - 229.184
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under the Health and Safety
Chapter 431, §431.241, which authorizes the Texas Board of Health (board)
to adopt rules for the efficient enforcement of Chapter 431; and the Health
and Safety Code, §12.001, which provides the Texas Board of Health (board)
with the authority to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health.
The repeals affect the Health and Safety Code, Chapters 12 and 431. The
review of the rules implements Government Code, §2001.039.
§229.181.Definitions.
§229.182.Licensing Fee and Procedures.
§229.183.Minimum Standards for Licensure.
§229.184.Refusal, Revocation, or Suspension of Licensure.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on April 15, 2004.
TRD-200402501
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
25 TAC §§229.181 - 229.184
The new rules are proposed under the Health and Safety Chapter
431, §431.241, which authorizes the Texas Board of Health (board) to
adopt rules for the efficient enforcement of Chapter 431; and the Health and
Safety Code, §12.001, which provides the Texas Board of Health (board)
with the authority to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health.
The new rules affect the Health and Safety Code, Chapters 12 and 431. The
review of the rules implements Government Code, §2001.039.
§229.181.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Direct seller--An individual:
(A)
who is not affiliated with a permanent retail establishment
and who engages in the business of:
(i)
in-person sales of prepackaged nonperishable foods, including
dietary supplements, to a buyer on a buy-sell basis, a deposit-commission
basis, or a similar basis for resale in a home; or
(ii)
sales of prepackaged nonperishable foods, including dietary
supplements, in a home;
(B)
who receives substantially all remuneration for a service,
whether in cash or other form of payment, which is directly related to sales
or other output, including the performance of the service, and not to the
number of hours worked; or
(C)
who performs services under a written contract between
the individual and the person for whom the service is performed, and the contract
provides that the individual is not treated as an employee with respect to
federal tax purposes.
(2)
Food--Any article of food or drink for man; chewing gum;
or an article used for components of any such article.
(3)
Food manufacturer--A person who combines, purifies, processes,
or packages food for sale through a wholesale outlet. The term also includes
a retail outlet that packages or labels food before sale and a person that
represents itself as responsible for the purity and proper labeling of an
article of food by labeling the food with the person's name and address.
(4)
Food service establishment--Any place where food is prepared
and intended for individual portion service, and includes the site at which
individual portions are provided. The term includes any such place regardless
of whether consumption is on or off the premises and regardless of whether
there is a charge for the food. The term also includes delicatessen-type operations
that prepare sandwiches intended for individual portion service. The term
does not include private homes where food is prepared or served for individual
family consumption, retail food stores, the location of food vending machines,
and supply vehicles.
(5)
Food wholesaler--A person who distributes food for resale,
either through a retail outlet owned by that person or through sales to another
person. The term "food wholesaler" shall not include a commissary which distributes
food primarily intended for immediate consumption on the premises of a retail
outlet under common ownership or an establishment engaged solely in the distribution
of nonalcoholic beverages in sealed containers.
(6)
Manufacture--The process of combining or purifying food
or packaging food for sale to a person at wholesale or retail, and includes
repackaging, labeling, or relabeling of any food.
(7)
Package--Any container or wrapping in which a consumer
commodity is enclosed for use in the delivery or display of that consumer
commodity to retail purchasers. The term includes wrapped meats enclosed in
papers or other materials as prepared by the manufacturers thereof for sale.
The term does not include:
(A)
shipping containers or wrappings used solely for the transportation
of a consumer commodity in bulk or in quantity to manufacturers, packers,
or processors, or to wholesale or retail distributors; or
(B)
shipping containers or outer wrappings used by retailers
to ship or deliver a commodity to retail customers if the containers and wrappings
do not bear printed matter relating to any particular commodity.
(8)
Place of business--Each location where a person manufactures
food, where food for wholesale is distributed, or a warehouse where food is
stored.
(9)
Sale--The manufacture, production, processing, packaging,
exposure, offer, possession, or holding of any such article for sale; and
the sale, dispensing, and giving of any such article, and the supplying or
applying of any such articles in the conduct of any food, drug, or device
place of business.
(10)
Warehouse--Any structure used for the storage of food.
(11)
Warehouse operator--A person that operates a warehouse
where food is stored.
§229.182.Licensing Fee and Procedures.
(a)
License required.
(1)
A person who manufactures food must obtain a food manufacturer's
license for each place of business as described in subsection (b)(1) or (2)
of this section; also, a food manufacturer who distributes its own food, and/or
food from another manufacturer must only obtain a food manufacturer's license.
When calculating the amount of the licensing fee, the manufacturer must include
the total for all food manufactured and wholesaled from the place of business.
(2)
A person who distributes food, but who does not manufacture
food, must obtain a food wholesaler's license for each place of business as
described in subsection (b)(3) or (4) of this section.
(3)
A person who distributes food, but who does not manufacture
food, and who chooses to store that food with a warehouse operator licensed
under subsection (b)(8) or (9) of this section, must register as a food wholesaler
under subsection (b)(7) of this section.
(4)
A person who distributes food and drugs, food and medical
devices, or food and drugs and medical devices, must obtain a wholesaler with
combination products license, as described in subsection (b)(5) or (6) of
this section, for each place of business; this license is required even if
the products are stored in a separate warehouse or with a warehouse operator
licensed under subsection (b)(8) or (9) of this section.
(5)
A warehouse operator storing food for a registered food
wholesaler must obtain a warehouse operator license as described in subsection
(b)(8) or (9) of this section for each such warehouse. A warehouse operator
who distributes only food is required to obtain only a warehouse operator
license. A warehouse operator who distributes combination products (food and
drugs, food and medical devices, or food, drugs, and medical devices) and
is also required to obtain a wholesaler's license under subsection (b)(5)
or (6) of this section will be issued only one license. The license fee to
be paid will be the higher of the two applicable fees.
(6)
A warehouse operated by a food manufacturer which is totally
separate from any manufacturing location, including locations from which foods
are held for limited periods of time for distribution, must obtain a warehouse
operator license as described in subsection (b)(8) or (9) of this section
for each such warehouse.
(7)
A retail food store that also manufactures food and is
required to be permitted by the Texas Department of Health (department) pursuant
to Health and Safety Code, Chapter 437, and the Texas Food Establishment Regulations, §§229.370
- 229.371 of this title (relating to Permitting Retail Food Establishments),
will be issued only one license or permit. The license or permit fee to be
paid will be the higher of the two applicable fees.
(8)
A wholesaler who distributes combination products and who
is also required to be licensed as a warehouse operator under this section
will be issued only one license. The license fee to be paid will be the higher
of the two applicable fees.
(9)
A food manufacturer required to be licensed exclusively
pursuant to Health and Safety Code, Chapter 432, relating to Food, Drug, Device
and Cosmetic Salvage, Chapter 433, relating to Meat and Poultry Inspection,
Chapter 435, relating to Dairy Products, Chapter 436, relating to Aquatic
Life, or Chapter 440, relating to Frozen Desserts, is not required to license
pursuant to this chapter.
(b)
Licensing and registration fees.
(1)
Food manufacturer. This subsection applies to all new and
renewal applications received by the department prior to January 1, 2005.
Licenses issued under this subsection are valid up to one year and expire
on the date printed on the license. All food manufacturers in Texas shall
obtain a license annually with the department and shall pay a license fee
as follows:
(A)
$25 for each place of business having gross annual manufactured
food sales of $0.00-$9,999.99;
(B)
$50 for each place of business having gross annual manufactured
food sales of $10,000-$24,999.99;
(C)
$100 for each place of business having gross annual manufactured
food sales of $25,000-$99,999.99;
(D)
$250 for each place of business having gross annual manufactured
food sales of $100,000- $199,999.99;
(E)
$400 for each place of business having gross annual manufactured
food sales of $200,000-$999,999.99;
(F)
$500 for each place of business having gross annual manufactured
food sales of $1 million-$9,999,999.99; and
(G)
$750 for each place of business having gross annual manufactured
food sales greater than or equal to $10 million.
(2)
Food manufacturer. This subsection applies to all new and
renewal applications received by the department on or after January 1, 2005.
Licenses issued under this subsection are valid up to two years and expire
on the date printed on the license. All food manufacturers in Texas shall
obtain a license every two years with the department and shall pay a license
fee as follows:
(A)
$50 for each place of business having gross annual manufactured
food sales of $0.00-$9,999.99;
(B)
$100 for each place of business having gross annual manufactured
food sales of $10,000- $24,999.99;
(C)
$200 for each place of business having gross annual manufactured
food sales of $25,000-$99,999.99;
(D)
$500 for each place of business having gross annual manufactured
food sales of $100,000-$199,999.99;
(E)
$800 for each place of business having gross annual manufactured
food sales of $200,000- $999,999.99;
(F)
$1000 for each place of business having gross annual manufactured
food sales of $1 million-$9,999,999.99; and
(G)
$1500 for each place of business having gross annual manufactured
food sales greater than or equal to $10 million.
(3)
Food wholesaler. This subsection applies to all new and
renewal applications received by the department prior to January 1, 2005.
Licenses issued under this subsection are valid up to one year and expire
on the date printed on the license. All food wholesalers in Texas shall obtain
a license annually with the department. Except as provided for in paragraph
(5) of this subsection, food wholesalers shall pay a license fee as follows:
(A)
$100 for each place of business having gross annual food
sales of $0.00-$199,999.99;
(B)
$200 for each place of business having gross annual food
sales of $200,000-$499,999.99;
(C)
$300 for each place of business having gross annual food
sales of $500,000-$999,999.99;
(D)
$400 for each place of business having gross annual food
sales of $1 million-$9,999,999.99; and
(E)
$600 for each place of business having gross annual food
sales of greater than or equal to $10 million.
(4)
Food wholesaler. This subsection applies to all new and
renewal applications received by the department on or after January 1, 2005.
Licenses issued under this subsection are valid up to two years and expire
on the date printed on the license. Except as provided for in paragraph (7)
of this subsection, all food wholesalers in Texas shall obtain a license every
two years with the department and shall pay a license fee as follows:
(A)
$200 for each place of business having gross annual food
sales of $0.00-$199,999.99;
(B)
$400 for each place of business having gross annual food
sales of $200,000-$499,999.99;
(C)
$600 for each place of business having gross annual food
sales of $500,000-$999,999.99;
(D)
$800 for each place of business having gross annual food
sales of $1 million-$9,999,999.99; and
(E)
$1200 for each place of business having gross annual food
sales of greater than or equal to $10 million.
(5)
Wholesaler with combination products. This subsection applies
to all new and renewal applications received by the department prior to January
1, 2005. Licenses issued under this subsection are valid up to one year and
expire on the date printed on the license. A wholesaler who is required to
be licensed under this section and who is also required to be licensed as
a wholesale distributor of drugs under §229.252(a)(1) of this title (relating
to Licensing Fee and Procedures) and/or as a device distributor under §229.439(a)(1)
of this title (relating to Licensure Fees) shall pay a combined licensure
fee for each place of business. The licensure fee shall be based on the combined
gross annual sales of these regulated products (foods, drugs, and/or devices)
as follows:
(A)
$200 for each place of business having combined gross annual
sales of $0.00-$199,999.99;
(B)
$300 for each place of business having combined gross annual
sales of $200,000-$499,999.99;
(C)
$400 for each place of business having combined gross annual
sales of $500,000-$999,999.99;
(D)
$500 for each place of business having combined gross annual
sales of $1 million-$9,999,999.99; and
(E)
$750 for each place of business having combined gross annual
sales greater than or equal to $10 million.
(6)
Wholesaler with combination products. This subsection applies
to all new and renewal applications received by the department on or after
January 1, 2005. Licenses issued under this subsection are valid up to two
years and expire on the date printed on the license. A wholesaler who is required
to be licensed under this section and who is also required to be licensed
as a wholesale distributor of drugs under §229.252(a)(1) of this title
(relating to Licensing Fee and Procedures) or as a device distributor under §229.439(a)(1)
of this title (relating to Licensure Fees) shall pay a combined licensure
fee for each place of business. The licensure fee shall be based on the combined
gross annual sales of these regulated products (foods, drugs, and/or devices)
as follows:
(A)
$400 for each place of business having combined gross annual
sales of $0.00-$199,999.99;
(B)
$600 for each place of business having combined gross annual
sales of $200,000-$499,999.99;
(C)
$800 for each place of business having combined gross annual
sales of $500,000-$999,999.99;
(D)
$1000 for each place of business having combined gross
annual sales of $1 million-$9,999,999.99; and
(E)
$1500 for each place of business having combined gross
annual sales greater than or equal to $10 million.
(7)
Food wholesaler registration. Except as provided in subsections
(5) and (6) of this section, a food wholesaler is not required to obtain a
license under this section for a place of business if all of the food distributed
from that place of business will be stored in a warehouse licensed under this
section. A registration issued under this subsection is valid until expiration
on the date printed on the registration. A food wholesaler that is not required
to obtain a license for a place of business under this section shall register
each place of business with the department pursuant to subsection (d)(2) of
this section, but only one registration fee must be paid by each such food
wholesaler. A food wholesaler who meets this subsection's requirements shall
pay a registration fee as follows:
(A)
$50 for an annual registration, on a form received by the
department prior to January 1, 2005;
(B)
$100 for a two-year registration, on a form received by
the department on or after January 1, 2005;
(8)
Warehouse operator. This subsection applies to all new
and renewal applications received by the department prior to January 1, 2005.
Licenses issued under this subsection are valid up to one year and expire
on the date printed on the license. All warehouse operators in Texas shall
obtain a license annually with the department. The fee paid must be based
on the maximum amount of square feet dedicated to food storage during the
licensing period. A warehouse operator shall pay a license fee as follows:
(A)
$175 for each place of business having food storage of
0 - 6,000 square feet;
(B)
$350 for each place of business having food storage of
6,001 - 24,000 square feet;
(C)
$525 for each place of business having food storage of
24,001 - 75,000 square feet;
(D)
$700 for each place of business having food storage of
75,001 - 250,000 square feet; and
(E)
$1000 for each place of business having food storage of
250,001 or more square feet.
(9)
Warehouse operator. This subsection applies to all new
and renewal applications received by the department on or after January 1,
2005. Licenses issued under this subsection are valid up to two years and
expire on the date printed on the license. All warehouse operators in Texas
shall obtain a license every two years with the department. The fee paid must
be based on the maximum amount of square feet dedicated to food storage during
the licensing period. A warehouse operator shall pay a license fee as follows:
(A)
$350 for each place of business having food storage of
0 - 6,000 square feet;
(B)
$700 for each place of business having food storage of
6,001 - 24,000 square feet;
(C)
$1,050 for each place of business having food storage of
24,001 - 75,000 square feet;
(D)
$1,400 for each place of business having food storage of
75,001 - 250,000 square feet; and
(E)
$2,000 for each place of business having food storage of
250,001 or more square feet.
(10)
A firm that has more than one business location may request
a one-time proration of fees when applying for a license for each new location.
Upon approval by the department, the expiration date of the license for the
new location will be established the same as the firm's previously licensed
locations.
(11)
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.
(12)
All license/registration fees paid under this section
are non-refundable.
(13)
If the license/registration category changes during the
license period, the license shall be renewed in the proper category at the
time of renewal.
(c)
License forms. License forms may be obtained from the Bureau
of Food and Drug Safety, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756-3182, or from the website at www.tdh.state.tx.us/bfds/lic/apps.html.
(d)
License application. All food manufacturers, food wholesalers,
and warehouse operators shall file a license application on a form authorized
by the department.
(1)
The application form shall be signed and verified, and
shall contain the following information:
(A)
the name of the legal entity to be licensed, including
the name under which the business is conducted;
(B)
the physical address of the place of business in the state
that is licensed;
(C)
the mailing address of the place of business in the state
that is licensed;
(D)
if a sole proprietorship, the name of the proprietor; if
a partnership, the names of all partners; if a corporation, the name of the
corporation, the date and place of incorporation and name and address of its
registered agent in the state; or if any other type of association, the names
of the principals of such association;
(E)
the names of those individuals in an actual administrative
capacity which, in the case of a sole proprietorship shall be the managing
proprietor; in a partnership, the managing partner; in a corporation, the
officers and directors; in any other association, those in a managerial capacity;
and
(F)
a list of categories of gross annual sales or square footage
as applicable, which must be marked and adhered to by the licensee in the
determination and paying of the license fee.
(2)
Food wholesalers who meet the requirements to register
under subsection (b)(7) of this section, must submit a registration form authorized
by the department which shall be signed and verified, and contain the following
information:
(A)
the name of the legal entity to be registered, including
the name under which the business is conducted;
(B)
the name, telephone number, and physical address of the
licensed warehouse where the food wholesaler's food products are or will be
stored;
(C)
the physical address where the food wholesaler's distribution
records are located and available for review upon inspection;
(D)
the mailing address and telephone number where the food
wholesaler may be contacted; and
(E)
a description of the type of food products being distributed
by the food wholesaler.
(e)
Two or more establishments. If the food manufacturer, food
wholesaler, or warehouse operator operates more than one place of business,
each place of business shall be licensed separately by listing the name and
address of each place of business on the license application.
(f)
Issuance of license. As applicable, the department may
license/register a manufacturer, food wholesaler, or warehouse operator who
meets the requirements of this section and §229.183 of this title (relating
to Minimum Standards for Licensure).
(1)
The initial license/registration shall be valid for one
year from the start date of the regulated activity which becomes the anniversary
date, for all applications received by the department prior to January 1,
2005, and for two years from the anniversary date for all applications received
on or after January 1, 2005.
(2)
The renewal license/registration shall be valid for one
year from the anniversary date, unless an amendment occurs, for all applications
received by the department prior to January 1, 2005, and for two years from
the anniversary date for all applications received on or after January 1,
2005.
(3)
A current license/registration shall only be issued when
all past due fees and late fees are paid.
(g)
Renewal of license.
(1)
For each licensing/registration period, the food manufacturer,
food wholesaler, or warehouse operator shall renew its license/registration
as applicable following the requirements of this section and §229.183
of this title.
(2)
A person who holds a license/registration issued by the
department under the Health and Safety Code shall renew the license/registration
by filing an application for renewal on a form authorized by the department
accompanied by the appropriate licensing/registration fee. A licensee must
file for renewal before the expiration date of the current license. A person
who files a renewal application after the expiration date must pay an additional
$100 as a delinquency fee.
(3)
Failure to submit the renewal during the licensing/registration
period may subject the food manufacturer, food wholesaler, or warehouse operator
to the offense provisions under the Health and Safety Code, Chapter 431, to
the provision of §229.184 of this title (relating to the Refusal, Revocation,
or Suspension of License), and to the provisions of §229.222 of this
title (relating to Penalties).
(h)
Amendment of license.
(1)
Fees. A license or registration that is amended during
the licensing or registration period, including a change of name, ownership
(change in legal entity), or a notification of a change in the location of
a licensed or registered place of business required under the Health and Safety
Code, §431.2251, will require a new application and submission of license
or registration fees as outlined in subsection (b) of this section.
(2)
Change in name, ownership, status, or location of business.
(A)
Not later than the 31st day before the date of the change
in the name, status, or location of a licensed place of business, the license
holder shall provide written notice to the department of the intended change.
The notice shall include, as applicable:
(i)
The new name of the legal entity to be licensed or registered,
including the name under which the business is conducted;
(ii)
The physical and mailing address of the new location;
(iii)
The name and physical address of the licensed warehouse
where the food wholesaler's food products will be stored;
(iv)
The physical address where the food wholesaler's distribution
records are located and available for review upon inspection; and
(v)
The mailing address and telephone number where the food
wholesaler may be contacted.
(B)
Not later than the 10th day after completion of the change
of location, the licensee or registrant shall forward to the department the
name and residence address of the individual in charge of the new place of
business.
(C)
Notice is considered adequate if the licensee or registrant
provides the intent and verification notices to the department by certified
mail, return receipt requested, mailed to Texas Department of Health, Bureau
of Food and Drug Safety, 1100 West 49th Street, Austin, Texas 78756-3182.
(i)
This section does not apply to:
(1)
a person, firm, or corporation that harvests, packages,
washes, or ships raw fruits or vegetables;
(2)
a direct seller who is not otherwise engaged in manufacturing;
(3)
a person engaged solely in the distribution of alcoholic
beverages in sealed containers by holders of licenses or permits issued under
the Alcoholic Beverage Code, Chapters 19, 20, 21, 23, 64, or 65;
(4)
a food service establishment or a commissary which distributes
food primarily intended for immediate consumption on the premises of a retail
outlet under common ownership unless the business regularly engages in the
labeling, combining, and purifying of food which is either sold for resale
or packaged for sale in other than individual portions; or
(5)
a restaurant that provides food for immediate human consumption
to a political subdivision or to a licensed nonprofit organization if the
restaurant would not otherwise be considered a food wholesaler.
§229.183.Minimum Standards for Licensure.
Food manufacturers, food wholesalers, and warehouse operators.
(1)
All food manufacturers, and warehouse operators in Texas
shall comply with §§229.211 - 229.221 of this title (relating to
Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing,
Packing, or Holding Human Food) in addition to the existing standards contained
in the Health and Safety Code, Chapters 431, 434, and 438.
(2)
All food wholesalers in Texas, including those food wholesalers
registered under §229.182 of this title (relating to Licensing Fees and
Procedures), shall comply with §§229.211 - 229.219 of this title,
in addition to the existing standards contained in the Health and Safety Code,
Chapters 431, 434, and 438.
(3)
Living areas. No manufacturing or holding of foods for
distribution shall be conducted in any room used as living or sleeping quarters.
All food manufacturing and storage shall be separated from any living or sleeping
quarters by complete partitioning.
(4)
Food labeling. If a person, firm, or corporation labels
an article of food, the label shall meet the requirements of the Health and
Safety Code, Chapter 431.
§229.184.Refusal, Revocation, or Suspension of Licensure.
(a)
Basis. The department may, after providing an opportunity
for a hearing, refuse an application for a license/registration from a food
manufacturer, food wholesaler, or warehouse operator, or may revoke or suspend
a license/registration for violations of the requirements in §229.182
of this title (relating to Licensing Fee and Procedures), and §229.183
of this title (relating to Minimum Standards for Licensure), or for interference
with the department in the performance of its duty under these rules.
(b)
Hearings. Any hearings for the refusal, revocation, or
suspension of a license/registration are governed by §§1.21, 1.23,
1.25, and 1.27 of this title (relating to Formal Hearing Procedures).
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on April 15, 2004.
TRD-200402502
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 30, 2004
For further information, please call: (512) 458-7236
Subchapter K. REGISTRATION OF SANITARIANS
annual
] permit fees are as
follows:
annual
] permit
fee.
annual
] permit fee.
and
report the findings to the enforcement review committee (ERC) of the Bureau
of Licensing and Compliance
]. If the
department
[
ERC
] determines that the complaint is not within the department's jurisdiction,
the complainant will be notified. If warranted, the complaint may be referred
to another governmental agency for review.
ERC
] may
determine
[
recommend
] that the permit be revoked, suspended, placed
on probation or that other appropriate action as authorized by law be taken.
ERC
] determines
that there are insufficient grounds to support the complaint, the complaint
shall be dismissed. Written notice of the dismissal will be provided to the
permit holder or person against whom the complaint has been filed and the
complainant.
Chapter 129.
OPTICIANS' REGISTRY
annually
].
annually
]
to maintain registration. The requirements are intended to maintain and improve
the quality of services provided to the public by registered spectacle dispensing
opticians and registered contact lens dispensers. Continuing education credit
includes programs beyond the basic preparation which are designed to promote
and enrich knowledge, improve skills, and develop attitudes for the enhancement
of dispensing opticians, thus improving health care to the public. The Texas
Department of Health (department) assumes dispensing opticians will maintain
the high standards of the profession in selecting quality educational programs
to fulfill the continuing education requirements.
the
] registration
issued for a one year term, or within 24 months prior to the date of expiration
of a registration issued for a two year term
.
Five
]
contact hours must be offered or approved by the American Board of Opticianry
and
half of the
[
five
] contact hours must be offered
or approved by the National Contact Lens Examiners.
with the concurrence or
ratification of the Complaints Subcommittee, if such subcommittee exists
].
Chapter 130.
CODE ENFORCEMENT REGISTRY
--$50;
]
annually on payment
of the required renewal fee
].
their
] registration
issued for one
year, or not less than 12 continuing education hours as set forth in this
section within the 24 months preceding renewal of a registration issued for
two years
, at least one hour of which must be in legal/legislative issues
as provided in subsection (j)(12) of this section.
Chapter 157.
EMERGENCY MEDICAL CARE
Subchapter B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES
(2)
] If the patient is transported,
the original DNR order or a copy of the original order will be kept with the
patient.
(3)
] Copies of the original DNR
order may be put on file with concerned parties, and the original order shall
remain in the possession of the patient, a legal guardian, or the healthcare
facility responsible for the patient's care.
(4)
At the time of relicensure,
the out-of-hospital provider shall submit a report to the Bureau of Emergency
Management with the following information:]
(A)
number of times personnel have been presented
with DNR documentation;]
(B)
number of times there was a problem and the
DNR order could not be honored; and]
(C)
any problems that were encountered using the
standardized form.]
Figure: 25 TAC §157.25(h)(2)]
Subchapter C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL
who
] acquires an AED shall immediately notify all local emergency medical
service providers of the existence, physical location and type of device.
Subchapter G. EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS
Chapter 229.
FOOD AND DRUG
Subchapter L. LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS
Chapter 265.
GENERAL SANITATION