Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 1.
TEXAS BOARD OF HEALTH
The Texas Department of Health (department) proposes the repeal of §1.2
and amendments to §§1.1, and 1.3 - 1.8 concerning procedures and
policies of the Board of Health (board).
Specifically the sections address the purpose of the sections, organization
of the board, powers and duties of the board, meetings of the board, actions
requiring board approval, the commissioner of health, and press and public
relations. The repeal of the section on membership of the board is proposed
in order to delete language which is redundant of state law.
Government Code, §2001.039 requires each state agency to review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Sections 1.1 - 1.8 have
been reviewed and the department has determined that the reasons for adopting
these sections, other than §1.2 on membership of the board, continue
to exist; however, the language of the sections should be updated and language
that is redundant of state law should be deleted. The language is redundant
of state law found in the Health and Safety Code, Chapters 11 and 12 relating
to appointments of the chair and vice-chair of the board, advisory committees
appointed by the board, meetings of the board, and reimbursement of expenses
of board members; Open Meetings Act, Texas Government Code, Chapter 551 relating
to meetings of governmental bodies; and Texas Civil Statutes, Article 6252-31
relating to dissenting votes in board meetings. In addition to clarifying
language throughout the sections, §§1.4, 1.6, and 1.7 are amended
to conform with House Bill 2641, enacted by the 76th Legislature. This law
establishes new relationships among the Health and Human Services Commission,
the Board of Health, and the Commissioner of Health (commissioner). Section
1.5(e) is added to state that time limits may be established for public comments
or testimony at board and committee meetings.
The department published a Notice of Intention to Review the sections in
the
Texas Register
(23 TexReg 9075) on September
4, 1998. No comments were received by the department on these sections.
Susan K. Steeg, General Counsel, has determined that for each year of the
first five years the repeal and amended sections are in effect, there will
be no fiscal implications to state or local governments as a result of enforcing
or administering the sections as proposed.
Ms. Steeg has determined that for each year of the first five years the
repeal and amended sections are in effect, the public benefit anticipated
as a result of enforcing or administering the sections will be improvement
of the language to make the sections more readable for the public and the
deletion of language that is redundant of state law. There will be no effect
on small businesses or micro-businesses because the sections only govern the
board, the department and the commissioner. There are no economic costs to
persons who are required to comply with the sections as proposed. There will
be no effect on local employment.
Comments on the proposal may be submitted to Susan K. Steeg, General Counsel,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512)
458-7236. Comments will be accepted for 30 days following publication of the
proposal in the
Texas Register
.
Subchapter A. PROCEDURES AND POLICIES
25 TAC §§1.1, 1.3 - 1.8
The amendments are proposed under the Health and Safety Code,
Chapters 11 and 12 which allow the board to adopt rules relating to advisory
committees and board meetings and §12.001 which provides the board with
the authority to adopt rules for its procedures and for the performance of
each duty imposed by law on the board, the department, and the commissioner
of health.
The amendments affect the Health and Safety Code, Chapter 12; Government
Code, Chapter 531, and Government Code, §2001.039.
§1.1. Purpose.
The purpose of
this subchapter
[
§1.3. Organization of the Board of Health
(a)
Chair and vice-chair. [
(1)
The chair shall preside at all
Board of Health (board)
[
(2)
(No change.)
[
Committees.]
(b)
[
(1)
The board may
establish
[
(2)
The chair may appoint board members to
serve on any [
[
Advisory committees.]
[
The board may appoint advisory
committees to assist the board in developing public health rules, policies
and procedures, and to assist the Department of Health in providing public
health services.]
[
The board shall adopt rules
covering the composition, duration, procedures, and expenses of the advisory
committees.]
§1.4. General Powers and Duties of the Board of Health.
(a)
The powers and duties of the
Board of Health (board) under this section are subject to the authority of
the Health and Human Services Commission (commission) under Government Code,
Chapter 531 and the memorandum of understanding between the commission and
the board.
(b)
[
(c)
[
(d)
[
(e)
[
§1.5. Meetings of the Board of Health.
[
The board shall meet in the
city of Austin or in other places determined by the board.]
[
The board shall meet at least
once each calendar quarter on dates determined by the board and shall hold
special meetings at the call of the chair. The chair shall give timely notice
to each member of any special meeting.]
(a)
[
[
The department shall post
notice of each meeting with the secretary of state's office at least seven
days prior to the date of the meeting. The notice shall specify the date,
time, subject(s) of the meeting.]
[
Special rules exist
for a meeting which needs to be convened in a case of emergency or urgent
public necessity.]
[
A case of emergency or urgent public necessity
is limited to imminent threats to public health and safety or reasonably unforeseeable
situations requiring immediate action.]
[
The department shall post notice of a meeting
involving an emergency or urgent public necessity with the secretary of state
at least two hours before the meeting is convened.]
(1)
[
[
Executive sessions are
closed meetings of the board which may be held only as expressly authorized
by the Open Meetings Act (Act). Persons who may attend and subjects which
may be discussed are described in the Act.]
(2)
[
(b)
[
(c)
[
[
During a meeting, a board member may dissent
against any board action and may enter a written statement of such dissent
into the official minutes of the meeting.]
(d)
[
[
Board members, in performing official duties,
shall receive no fixed salary but shall be paid compensatory per diem and
reimbursed for meals, lodging, and transportation in accordance with the General
Appropriations Act.]
(e)
The chair of the board may
limit each person presenting public comments or public testimony on any agenda
item to a certain number of minutes by announcing the period when comments
or testimony are given. The chair of each board committee may also set time
periods for comments or testimony given at committee meetings.
§1.6. Actions Requiring Board Approval.
(a)-(d)
(No change).
(e)
Of those appointments made by the commissioner, the following
shall be subject to the approval of the board:
(1)
the
executive deputy and
deputy commissioners
of the department;
(2)-(5)
(No change.)
(f)
(No change).
(g)
Other actions. The board may approve any other action
by the commissioner or the department where the approval of the board is required
by law
, delegated by the commissioner of the Health and Human Services
Commission,
or requested by the commissioner.
§1.7. Commissioner of Health.
(a)
The powers and duties of the commissioner of health
under this section are subject to the authority of the Health and Human Services
Commission (commission) under Government Code, Chapter 531 and the memorandum
of understanding between the commissioner of health and the commissioner of
the Health and Human Services Commission.
The commissioner of health,
as the executive
director
[
(b)
The commissioner
of health
shall:
(1)
administer and enforce federal and state health laws applicable
to the department by issuing orders, making decisions,
awarding and
executing contracts, and implementing the duties delegated or assigned to
the commissioner
of health
by the board
and the commissioner
of the Health and Human Services Commission
;
(2)
administer and implement department services, programs,
and activities, maintain professional standards within the department, and
represent the department as its chief executive. To accomplish this goal,
the commissioner
of health
is authorized to hire and supervise
personnel, establish appropriate organization, acquire suitable administrative,
clinical, and laboratory facilities, [
(3)-(5)
(No change.)
§1.8. Press and Public Relations.
(a)
Prior to each Board of Health meeting, copies of the [
(b)-(d)
(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 January 14, 2000.
TRD-200000295
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
25 TAC §1.2
(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 Health and Safety
Code, Chapters 11 and 12 which allow the board to adopt rules relating to
advisory committees and board meetings and §12.001 which provides the
board with the authority to adopt rules for its procedures and for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health.
The repeal affects the Health and Safety Code, Chapter 12; Government Code,
Chapter 531, and Government Code, §2001.039.
§1.2. Membership.
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 January 14, 2000.
TRD-200000296
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
Subchapter F. SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV)
25 TAC §97.141
The Texas Department of Health (department) proposes an amendment
to §97.141, concerning the addition of hepatitis C training to the counseling
course currently offered by the department, raising the fee charged for the
course, and allowing for a waiver of the fee in certain circumstances. The
changes are made to comply with Chapter 823 of the 76th Legislature, 1999,
which added Health and Safety Code, Chapter 93, Education and Prevention Program
for Hepatitis C.
Rose M. Brownridge, M.D., Acting Chief, Bureau of HIV and STD Prevention,
has determined that for each year of the first five year period the amended
section is in effect, there will be fiscal implications as a result of enforcing
or administering the section as proposed. The fee for taking the course will
increase the revenue to the state by approximately $6,300 per year. This revenue
will be used by the department to fund the development and teaching of the
additional curriculum required by the new law. It is estimated that the costs
to the department to administer the new provisions will equal the estimated
revenue increases. The authorizing statutes direct the department to set the
fee in an amount necessary to cover the costs of providing the course. Local
governments who are not under a current contract with the Bureau of HIV and
STD Health Resources Division will incur the cost of the course fee in the
amount of $300.
Rose M. Brownridge, M.D., Acting Chief, Bureau of HIV and STD Prevention,
has also determined that for each year of the first five year period the amended
section is in effect, the public benefit anticipated as a result of enforcing
or administering the section will be increased knowledge on the part of those
persons providing hepatitis C counseling. Those who complete the course will
have more information relating to the special needs of persons with positive
hepatitis C test results, including the importance of early intervention and
treatment and recognition of psychosocial needs. The HIV counseling course
has not been utilized by micro- businesses or small business. Therefore, there
is no anticipated cost to micro-businesses or small businesses. The only cost
to individuals will be to those who wish to take the course at their own expense.
The anticipated cost to such individuals is the course fee of $300. There
is no anticipated impact on local employment.
Comments on the proposal may be submitted to Mr. Jeffery Seider, Policy
Unit Manager, Bureau of HIV and STD Prevention, Texas Department of Health,
1100 West 49th Street, Austin Texas, 78756, (512) 490-2505. Comments will
be accepted for 30 days following the date of publication in the
Texas Register
.
The amendment is proposed under Health and Safety Code §85.087,
which requires the board to set a fee for the training of HIV counselors; §85.016,
which allows the department to adopt rules to implement this requirement;
Health and Safety Code §93.003 which requires the board to set a fee
for the training of hepatitis C counselors; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for the
performance of every duty imposed by law on the board, the department, and
the commissioner of health.
The proposed amendment affects Health and Safety Code §§85.087
and 93.003.
§97.141. Fee To Cover the Cost of Providing the Human Immunodeficiency Virus (HIV) Counseling and Testing Course.
(a)
Purpose. The purpose of this section is to implement the
provisions of the
Health and Safety Code, §85.087 and §93.003
[
(b)
Content. The training course shall include information
relating to
HIV risk reduction and to
the special needs of persons
with positive HIV
and/or Hepatitis C
test results[
(c)
Fee.
(1)
The fee will be
$300
[
(2)
Fees shall be made payable to the Texas Department
of Health. All fees are non-refundable and must be received by
the
department prior to participation in the course.
The accepted
[
(d)
Notice. Notice of the training courses will be announced
through correspondence to contractors and other appropriate entities. [
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 January 14, 2000.
TRD-200000282
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
Subchapter C. OPERATIONAL REQUIREMENTS
25 TAC §133.45
The Texas Department of Health (department) proposes an amendment
to §133.45 concerning voluntary paternity establishment services in hospitals.
The amendment adds new subsection (e) relating to voluntary paternity establishment
services. Hospitals licensed by the department that handle the birth of newborns
will be required to provide voluntary paternity establishment services in
accordance with the section as a condition of licensure.
Federal law found at 42 United States Code §666(a)(5) requires that
each state establish certain procedures concerning paternity establishment
services. The United States Department of Health and Human Services has adopted
regulations relating to the establishment of paternity. The regulations are
found at 45 Code of Federal Regulations §302.70(a)(5)(iii) and §303.5(g).
The federal regulations require that all private and public birthing hospitals
participate in the voluntary paternity establishment services program. The
Texas Legislature enacted Acts 1999, 76th Legislature, Chapter 556, (Senate
Bill 368) which amends the Family Code and the Health and Safety Code to incorporate
the requirements concerning paternity establishment which are required by
federal law.
This amendment requires hospitals to comply with Health and Safety Code, §192.012
relating to record of acknowledgment of paternity and the rules of the Office
of the Attorney General found at Title 1, Texas Administrative Code, Chapter
55, Subchapter J (relating to Voluntary Paternity Establishment). There is
no express entity identified in federal or state law, federal regulations,
or the rules of the Office of the Attorney General which would be responsible
for insuring enforcement of the law and rules. Therefore, this amendment is
being added to the hospital licensing rules as a condition of licensure in
order to ensure a hospital's compliance with the law and rules and to provide
a mechanism for sanctioning a hospital that fails to comply with the requirements
relating to voluntary paternity establishment services. Compliance will be
determined during licensing surveys and inspections.
Jann Melton-Kissel, Bureau of Licensing and Compliance, has determined
that for each year of the first five years the proposed section is in effect,
there may be no fiscal implications for state government as a result of enforcing
or administering this section. Since the department already surveys and inspects
hospitals for compliance with other laws and rules, this section will not
place any additional fiscal burden on the department. There may be fiscal
implications for state or local governments which operate a hospital that
handles the birth of newborns as a result of enforcing or administering this
section. If the hospital fails to comply with the section, the department
may assess an administrative penalty against the hospital. In addition to
the administrative penalties, additional costs may be incurred by the hospital
defending the imposition of the penalty or any other sanction. There are no
means of determining those costs at this time since penalties and costs may
vary greatly. The department does not anticipate that it will sanction a hospital
solely for noncompliance with the amendment. Although there will be additional
costs relating to the operation of the paternity establishment services, those
costs are a result of the application of the federal and state law and the
rules of the Office of the Attorney General, not because of this department's
rule. Therefore, those implications are not discussed here.
Ms. Melton-Kissel also has determined that for each year of the first five
years the section is in effect, the public benefit anticipated as a result
of enforcing the section will be to ensure compliance by hospitals that handle
the birth of newborns with requirements relating to voluntary paternity establishment
services. There will be an effect on small businesses which are hospitals
that handle the birth of newborns if the hospital is sanctioned by the department
for noncompliance. That effect is the same as described above for state or
local governments operating hospitals. There will be economic costs to persons
who are required to comply with the section as proposed if the hospital is
sanctioned for noncompliance with the rule. Those costs are the same as described
above for state or local governments operating hospitals. There will be no
effect on local employment.
Comments may be submitted to Tom Camp, Chief, Bureau of Licensing and Compliance,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512)
834-4503. Comments on the proposed section will be accepted for 30 days following
publication in the
Texas Register
.
The amendment is proposed under the Health and Safety Code, §241.026,
which requires the Texas Board of Health (board) to adopt and enforce rules
to further the purposes of the Texas Hospital Licensing Law including rules
relating to hospital services relating to patient care and compliance with
other state and federal laws affecting the rights of patients; the Family
Code, §160.215 which allows the department to adopt rules to implement
the requirements relating to acknowledgment or denial of paternity; the Health
and Safety Code, §191.003, which allows the board to adopt necessary
rules relating to vital statistics; 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 upon the board, the department, and commissioner
of health.
The amendment affects the Health and Safety Code, Chapters 191, 192 and
241, and the Family Code, Chapter 160.
§133.45.Miscellaneous Policies and Protocols.
(a)-(d)
(No change.)
(e)
A hospital that handles the birth of newborns
must provide voluntary paternity establishment services in accordance with:
(1)
the Health and Safety Code, §192.012,
Record of Acknowledgment of Paternity; and
(2)
the rules of the Office of the Attorney
General found at 1 Texas Administrative Code, Chapter 55, Subchapter J (relating
to Voluntary Paternity Establishment).
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 January 10, 2000.
TRD-200000145
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §135.3
and §135.21, the repeal of §§135.25 - 135.27, and new §§135.25
- 135.29, concerning ambulatory surgical centers. Specifically, the sections
cover fees, inspections, complaints, reporting of incidents, confidentiality,
emergency suspension, and administrative penalties.
The amendment to §135.3 increases the initial and renewal license
fees from $1,000 to $2,000 to cover the increased cost to the department of
conducting on-site licensing inspections of ambulatory surgical centers every
three years in accordance with Health and Safety Code §243.006(b), as
amended by Senate Bill (SB) 1249, 76th Legislature, 1999. The amendment to §135.21
adds new language to implement the amendment to Health and Safety Code §243.006(b)
concerning the on-site licensing inspections of ambulatory surgical centers
licensed by the department and certified under Title XVIII of the Social Security
Act once every three years while the center maintains the certification.
The repeal of §§135.25 - 135.27 will allow the reorganization
in a more appropriate order the sections within Subchapter A. New §§135.25
- 135.26 contain proposed new language to incorporate legislative mandates;
new §§135.27 - 135.29 contain the adopted language in existing §§135.25
- 135.27, with minor corrections to the text.
New §135.25 will implement certain provisions of SB 1249, 76th Legislative,
1999. Senate Bill 1249 (SB) amended Health and Safety Code, Chapter 243 by
adding §243.0115 which grants the department authority to issue an emergency
order to suspend a license issued under this chapter.
New §135.26 will implement House Bill 2085, Article 3, which amends
Health and Safety Code, Chapter 243, by adding §§243.015 and 243.016,
relating to administrative penalties for ambulatory surgical centers. These
sections set forth standard language developed by the Sunset Advisory Commission
regarding the imposition of an administrative penalty on a person who violates
Chapter 243 or a rule adopted under that chapter; the amount of the penalty;
the report and notice of a violation and penalty; the penalty to be paid or
hearing requested; a hearing; decision by the commissioner; options following
a decision to pay or appeal; stay enforcement of the penalty; collection of
penalty; decisions by the court; the remittance of penalty and interest; and
release of bond.
New §135.27 incorporates requirements from existing §135.25 relating
to complaints. New §135.28 incorporates requirements from the existing §135.26
relating to reporting of incidents. New §135.29 incorporates the requirements
of existing §135.27 relating to confidentiality.
Jann Melton-Kissel, Bureau of Licensing and Compliance, has determined
that for the first five years the proposed 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 increase in revenue
as a result of increased licensing fees. The revenue generated by increased
licensing fees will cover increased costs of administering the survey process;
conducting on-site licensing inspections and quality assurance review of survey
documents; and administrative support. The proposed license fee increase for
initial and renewal licenses from $1,000 to $2,000 is estimated to generate
revenues of $1,022,500 for fiscal years 2000-2004 as follows: For FY 2000,
$53,500; FY 2001, $225,000; FY 2002, $236,000; FY 2003, $248,000; and FY 2004,
$260,000. In regard to the new administrative penalty section, approximately
one-third of cases recommended for enforcement go through the hearing process,
with the remaining cases resolved through other means. The department estimates
a baseline of five violations in fiscal year 2000 at a rate of $3,000 per
violation. The estimated annual growth in the number of incidents is 10% and
collection rate is 75% each fiscal year, 2000-2004. The estimated total generated
in administrative penalties collected and deposited in the state treasury
to the credit of the general revenue fund for the same period would be $68,683
as follows: FY 2000, $11,250; FY 2001, $12,375; FY 2002, $13,613; FY 2003,
$14,974; and FY 2005, $16,471. There will be no effect on local government.
Ms. Melton-Kissel also has determined that for each year of the first five
years the sections are in effect, the public benefit anticipated as a result
of enforcing the sections will be to ensure compliance by ambulatory surgical
centers with the new legislative mandates. There will be no cost to small/micro
businesses (except ambulatory surgical centers) to comply with the sections
as proposed. A small or micro-business that is an ambulatory surgical center
will incur the cost of an additional $1,000 for initial and annual renewal
license fees. An ambulatory surgical center will incur the cost of an administrative
penalty only if an administrative penalty is assessed against the center.
Administrative penalties may not exceed $1,000 for each violation for each
day a violation continues; the maximum penalty is $5,000 for each violation.
There are no anticipated economic costs 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 Cecil Jones, Program Director,
Consolidated Programs, Health Facility Licensing and Compliance Division,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512)
834-6646. Comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
.
Subchapter A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS
25 TAC §§135.3, 135.21, 135.25 - 135.29
The amendments and new sections are proposed under Health
and Safety Code, Chapter 243, the Texas Ambulatory Surgical Center Licensing
Act; Health and Safety Code, §243.006, regarding inspections; Health
and Safety Code, §243.007, regarding fees; Health and Safety Code, §243.0115
which grants the department authority to issue an emergency suspension order
to suspend a license; Health and Safety Code, §§243.015 and 243.016,
which provides the department with the authority to assess administrative
penalties against an ambulatory surgical center for violation of Chapter 243
and the rules adopted thereunder; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
These sections affect Health and Safety Code, Chapters 12 and 243.
§135.3. Fees.
(a)
The Texas Board of Health has established the following
schedule of fees for licensure as an ambulatory surgical center:
(1)
initial license fee -
$2,000
[
(2)
renewal license fee -
$2,000
[
(b)-(e)
(No change.)
§135.21. Inspections.
(a)
The department shall conduct an initial on-site inspection
to determine if either the federal conditions of participation under Title
XVIII or the standards for licensing set forth in these sections are being
met. Prior to an inspection, the surveyor shall notify the applicant in writing
of the date and time of the inspection. The department will evaluate the ASC
on a standard-by-standard basis before the first annual license is issued,
unless waived in accordance with §135.20(b)(7) of this title (relating
to Application and Issuance of License for Initial Applicants). An on-site
inspection for ASCs that are not participating in the Title XVIII Program
may be conducted for license renewal.
An on-site inspection for ASCs
that participate in the Title XVIII Program may be conducted once every three
years.
An on-site inspection may be conducted if a change of ownership
of a licensed ASC has occurred, if the ASC has not demonstrated compliance
with standards, or if complaints against an ASC have been received by the
department.
(b)-(d)
(No change).
§135.25. Emergency Suspension.
(a)
The department may issue an emergency order to suspend
a license issued under this chapter if the department has reasonable cause
to believe that the conduct of a license holder creates an immediate danger
to the public health and safety.
(b)
An emergency suspension is effective immediately without
a hearing or notice to the license holder.
(c)
On written request of the license holder, the department
shall conduct a hearing not earlier than the 10th day or later than the 30th
day after the date the hearing request is received to determine if the emergency
suspension is to be continued, modified, or rescinded. The hearing and any
appeal are governed by the department's rules for a contested case hearing
and Government Code, Chapter 2001.
§135.26. Administrative Penalties.
(a)
Imposition of penalty.
(1)
The department may impose an administrative penalty on
a person licensed under this chapter who violates the Act, this chapter, or
order adopted under this chapter.
(2)
A penalty collected under this section shall be deposited
in the state treasury in the general revenue fund.
(3)
A proceeding to impose the penalty is considered
to be a contested case under Government Code, Chapter 2001.
(b)
Amount of penalty.
(1)
The amount of the penalty may not exceed $1,000 for each
violation, and each day a violation continues or occurs is a separate violation
for purposes of imposing a penalty. The total amount of the penalty assessed
for a violation continuing or occurring on separate days under this paragraph
may not exceed $5,000.
(2)
In determining the amount of an administrative penalty
assessed under this section, the department shall consider:
(A)
the seriousness of the violation, including the nature,
circumstances, extent, and gravity of the violation;
(B)
the threat to health or safety caused by the violation;
(C)
the history of previous violations;
(D)
the amount necessary to deter a future violation;
(E)
whether the violator demonstrated good faith, including
when applicable whether the violator made good faith efforts to correct the
violation; and
(F)
any other matter that justice may require.
(c)
Report and notice of violation and penalty.
(1)
If the department initially determines that a violation
occurred, the department shall give written notice of the report by certified
mail to the person alleged to have committed the violation not later than
90 days following the survey exit date.
(2)
The notice must include:
(A)
a brief summary of the alleged violation;
(B)
a statement of the amount of the recommended penalty based
upon the factors listed in subsection (b)(2) of this section; and
(C)
a statement of the person's right to a hearing on the
occurrence of the violation, the amount of the penalty, or both.
(d)
Penalty to be paid or hearing requested.
(1)
Within 20 days after the date the person receives the
notice under subsection (c) of this section, the person in writing may:
(A)
accept the determination and recommended penalty of the
department; or
(B)
make a request for a hearing on the occurrence of the
violation, the amount of the penalty, or both.
(2)
If the person accepts the determination and
recommended penalty or if the person fails to respond to the notice, the commissioner
of public health (commissioner) or the commissioner's designee by order shall
approve the determination and impose the recommended penalty.
(e)
Hearing.
(1)
If the person requests a hearing, the commissioner shall
refer the matter to the State Office of Administrative Hearings (SOAH).
(2)
As mandated by Health and Safety Code, §243.015(i),
the SOAH shall promptly set a hearing date and give written notice of the
time and place of the hearing to the person.
(A)
An administrative law judge of the SOAH shall conduct
the hearing.
(B)
The administrative law judge shall make findings of fact
and conclusions of law and promptly issue to the commissioner a proposal for
a decision about the occurrence of the violation and the amount of a proposed
penalty.
(f)
Decision by commissioner.
(1)
Based on the findings of fact, conclusions of law, and
proposal for a decision made by the administrative law judge under subsection
(e)(2) of this section, the commissioner by order may find that a violation
occurred and impose a penalty, or may find that a violation did not occur.
(2)
The commissioner or the commissioner's designee shall
give notice of the commissioner's order under paragraph (1) of this subsection
to the person alleged to have committed the violation in accordance with Government
Code, Chapter 2001. The notice must include:
(A)
a statement of the right of the person to judicial review
of the order;
(B)
separate statements of the findings of fact and conclusions
of law; and
(C)
the amount of any penalty assessed.
(g)
Options following decision: pay or appeal. Within 30 days
after the date an order of the commissioner under subsection (f)(1) of this
section that imposes an administrative penalty becomes final, the person shall:
(1)
pay the penalty; or
(2)
appeal the penalty by filing a petition for judicial
review of the commissioner's order contesting the occurrence of the violation,
the amount of the penalty, or both.
(h)
Stay of enforcement of penalty.
(1)
Within the 30-day period prescribed by subsection (g)
of this section, a person who files a petition for judicial review may:
(A)
stay enforcement of the penalty by:
(i)
paying the penalty to the court for placement in an escrow
account; or
(ii)
giving the court a supersedeas bond that is approved
by the court for the amount of the penalty and that is effective until all
judicial review of the commissioner's order is final; or
(B)
request the court to stay enforcement of the penalty by:
(i)
filing with the court a sworn affidavit of the person
stating that the person is financially unable to pay the penalty and is financially
unable to give the supersedeas bond; and
(ii)
sending a copy of the affidavit to the commissioner by
certified mail.
(2)
If the commissioner receives a copy of
an affidavit under paragraph (1)(B) of this subsection, the commissioner may
file with the court, within five days after the date the copy is received,
a contest to the affidavit. In accordance with Health and Safety Code, §243.016(c),
the court shall hold a hearing on the facts alleged in the affidavit as soon
as practicable and shall stay the enforcement of the penalty on finding that
the alleged facts are true. The person who files an affidavit has the burden
of proving that the person is financially unable to pay the penalty or to
give a supersedeas bond.
(i)
Collection of penalty.
(1)
If the person does not pay the penalty and the enforcement
of the penalty is not stayed, the department may refer the matter to the attorney
general for collection of the penalty.
(2)
As provided by the Health and Safety Code §243.016(d),
the attorney general may sue to collect the penalty.
(j)
Decision by court. A decision by the court is governed
by Health and Safety Code, §243.016(e) and (f), and provides the following.
(1)
If the court sustains the finding that a violation occurred,
the court may uphold or reduce the amount of the penalty and order the person
to pay the full or reduced amount of the penalty.
(2)
If the court does not sustain the finding that a
violation occurred, the court shall order that a penalty is not owed.
(k)
Remittance of penalty and interest and release of supersedeas
bond. The remittance of penalty and interest is governed by Health and Safety
Code, §243.016(g) and provides the following.
(1)
If the person paid the penalty and if the amount of the
penalty is reduced or the penalty is not upheld by the court, the court shall
order, when the court's judgement becomes final, that the appropriate amount
plus accrued interest be remitted to the person within 30 days after the date
that the judgment of the court becomes final.
(2)
The interest accrues at the rate charged on loans
to depository institutions by the New York Federal Reserve Bank.
(3)
The interest shall be paid for the period beginning
on the date the penalty is paid and ending on the date the penalty is remitted.
(l)
Release of bond. The release of supersedeas bond is governed
by Health and Safety Code, §243.016(h) and provides the following.
(1)
If the person gave a supersedeas bond and the penalty
is not upheld by the court, the court shall order, when the court's judgment
becomes final, the release of the bond.
(2)
If the person gave a supersedeas bond and the amount
of the penalty is reduced, the court shall order the release of the bond after
the person pays the reduced amount.
§135.27. Complaints.
(a)
The department or its authorized representative may enter
the premises of an ASC during normal business hours as necessary to assure
compliance with the Act and these sections. The investigation may be conducted
on-site, unannounced or announced, or may be investigated by phone or mail.
(b)
All licensed ambulatory surgical centers are required
to provide the patient and his/her guardian at time of admission a written
statement identifying the department as the responsible agency for ambulatory
surgical centers complaint investigations. The statement shall inform persons
to direct complaint to the Texas Department of Health, Health Facility Licensing
and Compliance Division, 1100 West 49th Street, Austin, Texas 78756, telephone
(888) 973-0022. Complaints may be registered with the department by phone
or in writing. A complainant may provide his/her name, address, and phone
number to the department. Anonymous complaints may be registered. All complaints
are confidential.
(c)
The department will evaluate all complaints against all
ambulatory surgical centers. Only those allegations determined to be relevant
to the Act will be authorized for investigation.
(d)
Conduct of the investigation will include, but not be
limited to:
(1)
a conference prior to commencing the on-site inspection
for the purpose of explaining the nature and scope of the inspection between
the department's authorized representative and the person who is in charge
of the ASC:
(2)
inspection of the ASC;
(3)
inspection of medical and personnel records, including
administrative files, reports, records, or working papers;
(4)
an interview with any willing recipient of ambulatory
surgical center services at the ASC or in the recipient's home if the recipient
grants permission in writing;
(5)
an interview with any health care practitioner or
ambulatory surgical center personnel who care for the recipient of ambulatory
surgical services;
(6)
a conference at the conclusion of the inspection
between the department's representative and the person who is in charge of
the ASC.
(A)
The department's representative will identify any records
that have been reproduced.
(B)
Any records that are removed from an ASC (other than those
reproduced) shall be removed only with the consent of the ASC.
(e)
The department will review the report of the investigation
and determine the validity of the complaint.
(f)
Following the on-site inspection for those ASCs that do
not participate under Title XVIII, the provisions of §135.21(b) , (c)
, (d)(1), (d)(4), (d)(6), and (d)(7) of this title (relating to Inspections)
will apply.
§135.28. Reporting of Incidents.
(a)
Certain situations and incidents that occur in an ASC
shall be reported directly to the department.
(b)
Upon learning of the incident, the ambulatory surgical
center shall report the incident to the Texas Department of Health in Austin.
A written letter of explanation with supporting documents must be mailed to
the department within 30 days of the incident. The mailing address is Texas
Department of Health, Health Facility Licensing and Compliance Division, 1100
West 49th Street, Austin, Texas 78756.
(c)
Reportable incidents include the following.
(1)
Complications that result in the death of a patient must
be reported.
(2)
Complications that result in emergency transfer of
a patient to a hospital from the ambulatory surgical center must be reported.
(3)
Reports of any fire or other damage sustained at
the ASC must be reported.
(d)
Any theft of drugs and /or diversion of controlled drugs
shall be reported to the local police agency, the State Board of Pharmacy,
the Texas Department of Public Safety, and/or the Drug Enforcement Administration,
and the Texas Department of Health.
§135.29. Confidentiality.
Request for information and access to records are governed by the Texas
Open Records Act, Texas Government Code, Chapter 552.
(1)
A written request for information is required. The request
must sufficiently identify the information requested.
(2)
The department may ask for a clarification if it
cannot reasonably understand a particular request.
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 January 14, 2000.
TRD-200000279
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
25 TAC §§135.25 - 135.27
(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 Health and Safety
Code, Chapter 243, the Texas Ambulatory Surgical Center Licensing Act; Health
and Safety Code, §243.006, regarding inspections; Health and Safety Code, §243.007,
regarding fees; Health and Safety Code, §243.0115 which grants the department
authority to issue an emergency suspension order to suspend a license; Health
and Safety Code, §§243.015 and 243.016, which provides the department
with the authority to assess administrative penalties against an ambulatory
surgical center for violation of Chapter 243 and the rules adopted thereunder;
and Health and Safety Code, §12.001, which provides the Texas Board of
Health (board) with the authority to adopt rules for the performance of every
duty imposed by law on the board, the department, and commissioner of health.
These sections affect Health and Safety Code, Chapters 12 and 243.
§135.25. Complaints.
§135.26. Reporting of Incidents.
§135.27. Confidentiality.
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 January 14, 2000.
TRD-200000278
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
Subchapter C. ENFORCEMENT
The Texas Department of Health (department) proposes the repeal of §137.23,
and proposes new §§137.23 - 137.25, concerning birthing centers.
Specifically, the sections cover emergency suspension, administrative penalties,
and complaints.
The repeal of §137.23 is only to allow the reorganization in a more
appropriate order the sections within Subchapter C which contain proposed
new language to incorporate legislative mandates. The adopted language in §137.23
is moved to proposed new §137.25. New §137.23 will implement certain
provisions of Senate Bill 1232, 76th Legislature, 1999, which grants the department
the authority to issue an emergency order to suspend a license.
New §137.24 will implement House Bill 2085, Article 4, which amends
Health and Safety Code, Chapter 244 by adding §244.015 and §244.016
relating to administrative penalties for birthing centers. These sections
set forth standard language developed by the Sunset Advisory Commission regarding
the imposition of an administrative penalty on a person who violates Chapter
244 or a rule adopted under that chapter; the amount of the penalty; the basis
for the amount of the penalty; the report and notice of a violation and penalty;
the penalty to be paid or hearing requested; a hearing; decision by the commissioner;
options following a decision to pay or appeal; stay enforcement of the penalty;
collection of penalty; decision by the court; the remittance of penalty and
interest; and release of bond. Section 137.24 incorporates the language of §244.015
and §244.016.
New §137.25 includes the adopted language of §137.23 that is
proposed for repeal. In addition, a new subsection (i) is added to implement
Health and Safety Code §244.0105, of Senate Bill 1232, 76th Legislature,
1999. The subsection sets forth standard language developed by the Sunset
Advisory Commission authorizing that a person may file a complaint with the
department against a birthing center licensed under Health and Safety Code,
Chapter 244, and that a person who files a false complaint may be prosecuted
under the Penal Code. Section §137.25(i) incorporates the language of §244.0105.
Jann Melton-Kissel, Bureau of Licensing and Compliance, has determined
that for the first five years the proposed sections are in effect, there will
be fiscal implications for state government as a result of enforcing or administering
the sections. The estimated total generated in administrative penalties collected
and deposited in the state treasury to the credit of the general revenue fund
for fiscal years 2000-2004 would be $98,345 as follows: FY 2000--$2,625; FY
2001--$20,625; FY 2002--$22,687; FY 2003--$24,956; and FY 2004--$27,452. There
will be no effect on local government.
Ms. Melton-Kissel also has determined that for each year of the first five
years the sections are in effect, the public benefit anticipated as a result
of enforcing the sections will be to ensure compliance by birthing centers
with the new legislative mandates. There will be no significant cost to small/micro
businesses to comply with the sections as proposed. There are no anticipated
economic costs to persons who are required to comply with the sections as
proposed unless a person operates a birthing center against which an administrative
penalty is assessed. Administrative penalties may not exceed $1,000 for each
violation for each day a violation continues; the maximum penalty is $5,000
for each violation. There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Cecil Jones, Program Director,
Consolidated Programs, Health Facility Licensing and Compliance Division,
Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, (512)
834-6646. Comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
.
25 TAC §137.23
(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 Health and Safety Code,
Chapter 244, which authorizes the department to issue an emergency suspension
order to suspend a license; which provides the department with the authority
to assess administrative penalties against a birthing center for violation
of Health and Safety Code, Chapter 244 and the rules adopted thereunder; and
Health and Safety Code, §12.001, which provides the Texas Board of Health
(board) with the authority to adopt rules for the performance of every duty
imposed by law on the board, the department, and commissioner of health.
The repeal affects Health and Safety Code, Chapters 12 and 244.
§137.23.Complaints.
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 January 14, 2000.
TRD-200000274
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
25 TAC §§137.23 - 137.25
The new sections are proposed under Health and Safety Code,
Chapter 244, which authorizes the department to issue an emergency suspension
order to suspend a license; which provides the department with the authority
to assess administrative penalties against a birthing center for violation
of Health and Safety Code, Chapter 244 and the rules adopted thereunder; and
Health and Safety Code, §12.001, which provides the Texas Board of Health
(board) with the authority to adopt rules for the performance of every duty
imposed by law on the board, the department, and commissioner of health.
The new sections affect Health and Safety Code, Chapters 12 and 244.
§137.23.Emergency Suspension.
(a)
The department may issue an emergency order to suspend
a license issued under this chapter if the department has reasonable cause
to believe that the conduct of a license holder creates an immediate danger
to the public health and safety.
(b)
On written request of the license holder, the department
shall conduct a hearing not earlier than the seventh day or later than the
10th day after the date the notice of the emergency suspension is sent to
the license holder to determine if the emergency suspension is to take effect,
to be modified, or to be rescinded.
(c)
The hearing and any appeal are governed by the department's
rules for a contested case hearing and Government Code, Chapter 2001.
§137.24.Administrative Penalties.
(a)
Imposition of penalty.
(1)
The department may impose an administrative penalty on
a person licensed under this chapter who violates the Act, this chapter, or
an order adopted under this chapter.
(2)
A penalty collected under this section shall be deposited
in the state treasury in the general revenue fund.
(3)
A proceeding to impose the penalty is considered to
be a contested case under Government Chapter, Code 2001.
(b)
Amount of penalty.
(1)
The amount of the penalty may not exceed $1,000 for each
violation. Each day a violation continues or occurs is a separate violation
for purposes of imposing a penalty. The total amount of the penalty assessed
for a violation continuing or occurring on separate days under this paragraph
may not exceed $5,000.
(2)
In determining the amount of an administrative penalty
assessed under this section, the department shall consider:
(A)
the seriousness of the violation, including the nature,
circumstances, extent, and gravity of the violation;
(B)
the threat to health or safety caused by the violation;
(C)
the history of previous violations;
(D)
the amount necessary to deter a future violation;
(E)
whether the violator demonstrated good faith, including
when applicable whether the violator made good faith efforts to correct the
violation; and
(F)
any other matter that justice may require.
(c)
Report and notice of violation and penalty.
(1)
If the department initially determines that a violation
occurred, the department shall give written notice of the report by certified
mail to the person alleged to have committed the violation not later than
90 days following the survey exit date.
(2)
The notice must include:
(A)
a brief summary of the alleged violation;
(B)
a statement of the amount of the recommended penalty based
on the factors listed in subsection (b)(2) of this section; and
(C)
a statement of the person's right to a hearing on the occurrence
of the violation, the amount of the penalty, or both.
(d)
Penalty to be paid or hearing requested.
(1)
Within 20 days after the date the person receives the notice
under subsection (c), the person in writing may:
(A)
accept the determination and recommended penalty of the
department; or
(B)
make a request for a hearing on the occurrence of the violation,
the amount of the penalty, or both.
(2)
If the person accepts the determination and recommended
penalty or if the person fails to respond to the notice, the commissioner
of health (commissioner) or the commissioner's designee by order shall approve
the determination and impose the recommended penalty.
(e)
Hearing.
(1)
If the person requests a hearing, the commissioner or the
commissioner's designee shall refer the matter to the State Office of Administrative
Hearings (SOAH).
(2)
As mandated by Health and Safety Code, §244.015(i),
the SOAH shall promptly set a hearing date and give written notice of the
time and place of the hearing to the person.
(A)
An administrative law judge of the SOAH shall conduct the
hearing.
(B)
The administrative law judge shall make findings of fact
and conclusions of law and promptly issue to the commissioner a proposal for
a decision about the occurrence of the violation and the amount of a proposed
penalty.
(f)
Decision by commissioner.
(1)
Based on the findings of fact, conclusions of law, and
proposal for a decision made by the administrative judge under subsection
(e)(2) of this section, the commissioner or the commissioner's designee by
order may find that a violation occurred and impose a penalty; or find that
a violation did not occur.
(2)
The commissioner or the commissioner's designee shall
give notice of the commissioner's order under paragraph (1) of this subsection
to the person alleged to have committed the violation in accordance with Government
Code, Chapter 2001. The notice must include:
(A)
a statement of the right of the person to judicial review
of the order;
(B)
separate statements of the findings of fact and conclusions
of law; and
(C)
the amount of any penalty assessed.
(g)
Options following decision: pay or appeal. Within 30 days
after the date the order of the commissioner or commissioner's designee under
subsection (f) of this section that imposes an administrative penalty becomes
final, the person shall:
(1)
pay the penalty; or
(2)
appeal the penalty by filing a petition for judicial
review of the commissioner's order contesting the occurrence of the violation,
the amount of the penalty, or both.
(h)
Stay of enforcement of penalty.
(1)
Within the 30-day period prescribed by subsection (g) of
this section , a person who files a petition for judicial review in accordance
with subsection (g) of this section may:
(A)
stay enforcement of the penalty by:
(i)
paying the penalty to the court for placement in an escrow
account; or
(ii)
giving the court a supersedeas bond that is approved by
the court for the amount of the penalty and that is effective until all judicial
review of the commissioner's order is final; or
(B)
request the court to stay enforcement of the penalty by:
(i)
filing with the court a sworn affidavit of the person stating
that the person is financially unable to pay the penalty and is financially
unable to give the supersedeas bond; and
(ii)
sending a copy of the affidavit to the commissioner by
certified mail.
(2)
If the commissioner receives a copy of an
affidavit under paragraph (1)(B)(ii) of this subsection, the commissioner
may file with the court, within five days after the date the copy is received,
a contest to the affidavit. In accordance with Health and Safety Code §244.016(c),
the court shall hold a hearing on the facts alleged in the affidavit as soon
as practicable and shall stay the enforcement of the penalty on finding that
the alleged facts are true. The person who files an affidavit has the burden
of proving that the person is financially unable to pay the penalty or to
give a supersedeas bond.
(i)
Collection of penalty.
(1)
If the person does not pay the penalty and the enforcement
of the penalty is not stayed, the department may refer the matter to the attorney
general for collection of the penalty.
(2)
As provided by Health and Safety Code, §244.016(d),
the attorney general may sue to collect the penalty.
(j)
Decision by court. A decision by the court is governed
by Health and Safety Code, §244.016(e), and provides the following:
(1)
If the court sustains the finding that a violation occurred,
the court may uphold or reduce the amount of the penalty and order the person
to pay the full or reduced amount of the penalty.
(2)
If the court does not sustain the finding that a violation
occurred, the court shall order that a penalty is not owed.
(k)
Remittance of penalty and interest and release of supersedeas
bond. The remittance of penalty and interest is governed by Health and Safety
Code, §244.016(g) and provides the following.
(1)
If the person paid the penalty and if the amount of the
penalty is reduced or the penalty is not upheld by the court, the court shall
order, when the court's judgment becomes final, that the appropriate amount
plus accrued interest be remitted to the person within 30 days after the date
that the judgment of the court becomes final.
(2)
The interest accrues at the rate charged on loans
to depository institutions by the New York Federal Reserve Bank.
(3)
The interest shall be paid for the period beginning
on the date the penalty is paid and ending on the date the penalty is remitted.
(l)
Release of bond. The release of supersedeas bond is governed
by Health and Safety Code, §244.016(h) and provides the following:
(1)
If the person gave a supersedeas bond and the penalty is
not upheld by the court, the court shall order, when the court's judgment
becomes final, the release of the bond.
(2)
If the person gave a supersedeas bond and the amount
of the penalty is reduced, the court shall order the release of the bond after
the person pays the reduced amount.
§137.25.Complaints.
(a)
In accordance with §137.42 of this title (relating
to Disclosure Requirements), all licensed centers are required to provide
a client, and her guardian if the client is a minor or if guardianship is
required, at the time of the initial visit, with a written statement that
complaints relating to the center may be registered with the Director, Health
Facility Licensing and Compliance Division, Texas Department of Health, 1100
West 49th Street, Austin, Texas 78756, Telephone (888) 973-0022.
(b)
Complaints may be registered with the department by telephone
or in writing at the address listed in subsection (a) of this section. A complainant
may provide his or her name, address, and phone number to the department.
Anonymous complaints may be registered if the complainant provides sufficient
information.
(c)
The department will evaluate all complaints received.
(d)
A complaint containing allegations which are a violation
of the Act or this chapter will be investigated by the department.
(e)
A department representative (surveyor) may enter the premises
of a center at reasonable times as necessary to assure compliance with the
Act and this chapter. The department is not required to notify the applicant
or licensee prior to a complaint investigation.
(f)
If the department determines that the complaint does not
come within the department's jurisdiction, the department shall advise the
complainant and, if possible, refer the complainant to the appropriate governmental
agency for handling such a complaint.
(g)
The department shall inform in writing a complainant who
identifies himself or herself by name and address of the following information:
(1)
the receipt of the complaint;
(2)
whether the complainant's allegations allege potential
violations of the Act or this chapter warranting an investigation;
(3)
whether the complaint will be investigated by the
department; and
(4)
whether and to whom the complaint will be referred.
(h)
The department shall, at least as frequently as quarterly,
notify the parties to the complaint of the status of the complaint until its
final disposition.
(i)
A person may file a complaint with the department against
a birthing center licensed under this chapter. A person who files a false
complaint may be prosecuted under the Penal Code.
This agency hereby certifies that the 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 January 14, 2000.
TRD-200000275
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
25 TAC §137.55
The Texas Department of Health (department) proposes an amendment
to §137.55 concerning voluntary paternity establishment services in birthing
centers. The amendment adds new subsection (1) relating to the voluntary paternity
establishment services. Birthing centers licensed by the department will be
required to provide voluntary paternity establishment services in accordance
with the section as a condition of licensure.
Federal law found at 42 United States Code §666(a)(5) requires that
each state establish certain procedures concerning paternity establishment
services. The United States Department of Health and Human Services has adopted
regulations relating to the establishment of paternity. The regulations are
found at 45 Code of Federal Regulations §302.70(a)(5)(iii) and §303.5(g).
The federal regulations require that all private and public birthing hospitals
participate in the voluntary paternity establishment services program. The
Texas Legislature enacted Acts 1999, 76th Legislature, Chapter 556, (Senate
Bill 368) which amends the Family Code and the Health and Safety Code to incorporate
the requirements concerning paternity establishment which are required by
federal law and to require birthing center administrators to comply.
This amendment requires birthing centers to comply with Health and Safety
Code, §192.012 relating to record of acknowledgment of paternity and
the rules of the Office of the Attorney General found at Title 1, Texas Administrative
Code, Chapter 55, Subchapter J (relating to Voluntary Paternity Establishment).
There is no express entity identified in federal or state law, federal regulations,
or the rules of the Office of the Attorney General which would be responsible
for insuring enforcement of the law and rules. Therefore, this amendment is
being added to the birthing center rules as a condition of licensure in order
to ensure a birthing center's compliance with the law and rules and to provide
a mechanism for sanctioning a birthing center that fails to comply with the
requirements relating to voluntary paternity establishment services. Compliance
will be determined during licensing surveys and inspections.
Jann Melton-Kissel, Bureau of Licensing and Compliance, has determined
that for the first five years the proposed section is in effect, there may
be no fiscal implications for state or local governments as a result of enforcing
or administering this section. Since the department already surveys and inspects
birthing centers for compliance with other laws and rules, this section will
not place any additional fiscal burden on state government.
Ms. Melton-Kissel also has determined that for each year of the first five
years the section is in effect, the public benefit anticipated as a result
of enforcing the section will be to ensure compliance by birthing centers
with requirements relating to voluntary paternity establishment services.
There will be an effect on small businesses which are birthing centers if
the birthing center is sanctioned by the department for noncompliance. There
will be economic costs to persons who are required to comply with the section
as proposed if the birthing center is sanctioned for noncompliance with the
rule. The effect on small businesses and the economic costs to persons will
be the payment of any administrative penalty or the costs of defending against
the imposition of any sanction. There are no means of determining those costs
at this time since penalties and costs may vary greatly. Although there will
be fiscal implications relating to the operation of paternity establishment
services, those implications arise because of the application of the federal
and state law and the rules of the Office of the Attorney General, not because
of this department's rule. Therefore, those implications are not discussed
here. There will be no effect on local employment.
Comments may be submitted to Tom Camp, Chief, Bureau of Licensing and Compliance,
Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, (512)
834-4503. Comments on the proposed section will be accepted for 30 days following
publication in the
Texas Register
.
The amendment is proposed under the Health and Safety Code, §244.009,
which requires the Texas Board of Health (board) to adopt rules under the
Texas Birthing Center Licensing Act including rules relating to the provision
and coordination of services; the Family Code §160.215 which allows the
department to adopt rules to implement the requirements relating to acknowledgment
or denial of paternity; the Health and Safety Code, §191.003, which allows
the board to adopt necessary rules relating to vital statistics; 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 upon the board,
the department, and commissioner of health.
The amendment affects the Health and Safety Code, Chapters 191-192 and
244, and the Family Code, Chapter 160.
§133.55.Other State and Federal Compliance Requirements.
(a)-(k)
(No change.)
(l)
A birthing center must provide voluntary
paternity establishment services in accordance with:
(1)
the Health and Safety Code, §192.012, Record of Acknowledgment
of Paternity; and
(2)
the rules of the Office of the Attorney General found
at 1 Texas Administrative Code, Chapter 55, Subchapter J (relating to Voluntary
Paternity Establishment).
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 January 10, 2000.
TRD-200000144
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
25 TAC §§143.2, 143.16, 143.17, 143.19, 143.20
The Texas Department of Health (department) proposes amendments
to §§143.2, 143.16, 143.17, 143.19 and 143.20 concerning the regulation
and certification of persons performing radiologic procedures. The amendments
cover definitions; dangerous or hazardous procedures; mandatory training programs
for non-certified technicians, hardship exemptions and alternative training
requirements.
The proposed amendments will add a definition for pediatric; add pediatric
radiography to the list of dangerous or hazardous procedures; change the total
number of hours needed to complete the mandatory training program for non-certified
technicians; add a new hardship exemption for x-ray equipment operators in
a physician's office who are participating in a new alternate training program;
make changes to the existing training requirements for podiatric medical assistants;
and add alternate training to be completed under a Texas Medical Association
approved program for x-ray operators in a physician's office.
Jann Melton-Kissel, Director of Budgets, Health Care Quality and Standards,
has determined that for each of the first five years the sections will be
in effect, there will be no fiscal implications to state or local government
as a result of enforcing or administering the sections as proposed.
Ms. Melton-Kissel has determined that for each year of the first five years
the sections as proposed are in effect, the public benefit anticipated as
a result of enforcing the sections as proposed will be to assure that the
public is protected from the harmful effects of radiation used for medical
purposes by regulating persons who perform radiologic procedures.
There could be a varying impact on micro businesses, small businesses,
and hospitals which are required to comply with the sections. Pediatric radiography,
excluding extremities, is being identified as a hazardous procedure which
may only be performed by a practitioner, medical radiologic technologist,
or by a registered nurse or physicians assistant who has completed specific
training. If the businesses do not already employ or engage such persons to
perform pediatric radiography, then there may be additional costs. However,
a practitioner may perform the procedure and the rules allow pediatric radiography
to be performed with the appropriate documentation if an emergency condition
exists resulting in no additional cost.
There are no anticipated economic costs to persons who are required to
comply with the sections as proposed. The anticipated effect on local employment
will be that only qualified persons will be allowed to perform a dangerous
or hazardous radiologic procedure.
Comments on the proposal may be submitted to Jeanette Hilsabeck, Administrator,
Medical Radiologic Technologist Certification Program, Professional Licensing
and Certification Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas, 78756-3183, (512) 834-6617; FAX (512) 834-6677. Comments will
be accepted for 30 days following publication of this proposal in the
The amendments are proposed under the Medical Radiologic Technologist
Certification Act, §601.052, Texas Occupations Code, which provides the
Texas Board of Health (board) with the authority to adopt rules necessary
to implement the Act; and the Texas 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.
These proposed amendments implement the Medical Radiologic Technologist
Certification Act, Title 3, Texas Occupations Code, Chapter 601.
§143.2. Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)-(37)
(No change.)
(38)
Pediatric--A person within the
age range of fetus to age 18 or otherwise required by Texas Law, when the
growth and developmental processes are generally complete. These rules do
not prohibit a practitioner taking into account the individual circumstances
of each patient and determining if the upper age limit requires variation
by not more than two years.
(39)
[
(40)
[
(41)
[
(42)
[
(43)
[
(44)
[
(45)
[
(46)
[
(47)
[
(48)
[
(49)
[
(50)
[
(51)
[
§143.16. Dangerous or Hazardous Procedures.
(a)-(b)
(No change.)
(c)
Hazardous procedures identified. Unless otherwise noted,
the list of hazardous procedures which may only be performed by a practitioner
or MRT are:
(1)-(9)
(No change.)
(10)
pediatric radiography, excluding
extremities, unless performed by an RN or physician assistant who is appropriately
trained, as set out in §143.17 or §143.20 of this title. If an emergency
condition exists which threatens serious bodily injury, protracted loss of
use of a bodily function or death of a pediatric patient unless the procedure
is performed without delay, a pediatric radiographic procedure is also excluded.
The emergency condition must be documented by the ordering practitioner in
the patient's clinical record and the record must document that a regularly
scheduled MRT, LMRT, RN or physician assistant is not reasonably available
to perform the procedure.
(d)-(j)
(No change.)
§143.17. Mandatory Training Programs for Non-Certified Technicians.
(a)-(c)
(No change.)
(d)
Training requirements.
As of July 1, 2000, in
[
(1)
prerequisite recommended for admission
include high school graduation or general equivalency diploma; certified medical
assistant; graduation from a medical assistant program; or six months full
time patient care experience, otherwise determined by the practitioner.
(2)
[
(A)
radiation safety and protection for the patient, self
and others--
22
[
[(B)
radiographic equipment, including safety
standards, operation and maintenance--25 classroom hours;]
(B)
[
(C)
radiographic equipment maintenance and
operation--16 classroom hours which includes at least six hours of quality
control, darkroom, processing, and Texas Control of Radiation Regulations;
and
[(D)
methods of patient care and management
essential to radiologic procedures, excluding CPR, BCLS, ACLS and similar
subjects--eight classroom hours; and]
(3)
[
(A)
skull (five views: Caldwell, Townes, Waters, AP/PA, and
lateral)--
10
[
(B)
chest--
eight
[
(C)
spine--
eight
[
(D)
abdomen, not including any procedures utilizing contrast
media--
four
[
(E)
upper extremities--
14
[
(F)
lower extremities--
14
[
(G)
podiatric--five classroom hours.
(e)-(i)
(No change.)
§143.19. Hardship Exemptions.
(a)
(No change.)
(b)
General.
(1)
(No change.)
(2)
The applicant must demonstrate a hardship as described
in subsection (c)
(5)
[
(3)-(4)
(No change.)
(c)
Required application materials.
(1)-(4)
(No change.)
(5)
The application shall be accompanied by one or more
of the following:
(A)-(J)
(No change.)
(K)
if the applicant employs for the purpose of performing
radiologic procedures, a person who
is registered to take the Texas Medical
Association's Physician's Training Program for X-ray Operators approved by
the department under §143.20 of this title,
[
(i)
[
(ii)
the name of the facility the training program will
be taken, the date the program will begin and the anticipated date of completion
[
(iii)
the name(s) of the certified medical radiologic
technologist instructor meeting the requirements set out in §143.17(c)
of this title
[
(iv)
the name(s) of the company and the name of the person(s)
who will be the designated equipment applications specialist knowledgeable
of the specific equipment to be utilized
[
(v)
a list of the anatomical categories to be included
in the training.
[
[(I)
the passing score shall be an unscaled
55;]
[(II)
a schedule of examinations indicating
the dates, locations, fees, examination application procedures, and application
deadlines will be provided to the person(s) named on the hardship exemption
application as person(s) performing radiologic procedures;]
[(III)
a maximum of three examination attempts
shall be allowed for each person covered by the hardship exemption;]
[(IV)
all examination application fees are
non-refundable and must be paid by the examination application deadlines established
by the department. A person who applied for a specific examination and who
failed to appear for the examination shall forfeit the examination fee, even
if notification is made prior to the examination that the person will be unable
to take the examination;]
[(V)
applications under this hardship exemption
may be postmarked up to and including October 31, 1998; and]
[(VI)
in no event shall any letters of exemption
issued under this subparagraph extend beyond the expiration date of October
1, 1999. If the person(s) performing radiologic procedures does not apply
for the examination to be administered on July 1999, the hardship exemption
will expire on the examination application deadline which is two months prior
to that examination.]
(6)-(7)
(No change.)
(d)-(g)
(No change.)
§143.20. Alternate Training Requirements.
(a)
Purpose. The purpose of this section is to set out the
minimum standards for registered nurses (RNs), physician assistants
,
[
(b)
Instructor direction required. All hours of the training
program completed for the purposes of this section must be live and interactive
and directed by an approved instructor. Distance learning activities and audiovisual
teleconferencing may be utilized, provided these include two-way, interactive
communications which are broadcast or transmitted at the actual time of occurrence.
Appropriate on-site supervision of persons participating in the distance learning
activities or teleconferencing shall be provided by the approved training
program. No credit will be given for training completed by self-directed study
or correspondence.
The provisions of this subsection shall not apply
to the out of classroom training requirements for podiatric medical assistants
and x-ray equipment operators in a physician's offices.
(1)-(3)
(No change.)
(c)
(No change.)
(d)
Training requirements for registered nurses and physician
assistants. A training program preparing RNs and physician assistants to perform
radiologic procedures shall be designed to build on the health care knowledge
base and skills acquired through completion of an educational program that
qualifies the person for licensure as an RN or physician assistant. The training
shall consist of:
(1)
(No change.)
(2)
one or more of the following units of classroom instruction
in radiologic procedures:
(A)
(No change.)
(B)
spine (non-pediatric)--
ten
[
(C)-(D)
(No change.)
(3)
(No change.)
(e)
Training requirements for podiatric medical assistants
PMAs
.
(1)
In order to successfully complete a program, a PMA must
complete the following training:
(A)
radiation safety and protection for the patient, self,
and others--
five
[
(B)
radiographic equipment used in podiatric medicine, including
safety standards, operation, and maintenance--
one
[
(C)
podiatric radiologic procedures, imaging production and
evaluation--
one
[
(D)
methods of patient care and management essential to radiologic
procedures, excluding CPR, BCLS, ACLS and similar subjects--
one
[
(2)
(No change.)
(3)
The out of classroom training hours
require successful completion of learning objectives approved by the department
as verified by the supervising podiatrist.
(f)
Training requirements for an x-ray equipment
operator in a physician's offices.
(1)
In order to successfully complete a program, a x-ray equipment
operator in a physician's office must complete the Texas Medical Association's
Physician's Training Program for X-ray Operators.
(2)
Successful completion of the x-ray operators training
program allows the x-ray operator to perform radiologic procedures only under
the instruction or direction of a physician.
(g)
[
(h)
[
(i)
[
(j)
[
(k)
[
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 January 14, 2000.
TRD-200000271
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
25 TAC §§146.1 - 146.10
The Texas Department of Health (department) proposes new §§146.1-146.10
relating to the creation of a voluntary training and regulation program for
promotoras or community health workers. These rules are proposed to implement
a portion of Chapter 857, 76th Legislature, 1999, creating Health and Safety
Code Chapter 46, which creates the voluntary training and regulation program
for promotoras or community health workers. Chapter 857 defines promotora
or community health worker and outlines the promotora training program and
the certification program for promotoras.
Specifically, the new sections are needed to accomplish the following:
define the terms in the legislation, discuss the formation and actions of
a permanent promotora/community health worker training and certification advisory
committee, establish applicability, establish application requirements and
procedures, propose the types of certificates and applicant eligibility criteria
for promotoras or community health workers, instructors, and sponsoring institutions
or training programs, establish the standards for the approval of curricula,
describe the process for certificate issuance and renewal, and to establish
continuing education requirements.
Concerning §146.1(1) the department would like comments on the department's
proposed definition of promotora or community health worker. The proposed
definition for promotora or community health worker is derived from the National
Community Health Advisor Study, June 1998 which defines the seven core roles
of a community health worker or promotora. The department has chosen to use
this definition because of its inclusiveness.
Concerning §146.2(f) the department would like comments on the department's
proposal to establish a permanent promotora/community health worker training
and certification advisory committee. Chapter 857 creates a temporary Promotora
Program Development Committee until September 1, 2001 whose function is to
study the development of a framework for a promotora development program and
to advise the department. The permanent promotora/community health worker
training and certification advisory committee would review applications and
recommend to the department qualifying applicants as sponsoring institutions,
training instructors, or promotora or community heath workers. The committee
would also recommend new or amended rules for the approval of the board.
Concerning §§146.4, 146.5, and 146.6 the department would like
comments on application requirements and procedures for promotoras or community
health workers, instructors, and sponsoring institutions or training programs.
Concerning §146.7(d), (e), and (f) the department would like comments
on applicant eligibility and 146.7(b) regarding special provisions for persons
who have performed previous promotora or community health worker services
and special provisions for persons who have performed previous service as
an instructor to promotoras or community health workers.
Concerning §146.8(b)(1) and (2) the department, in particular, would
like comments on core competencies for promotoras and community health workers
and the minimum number of clock hours of knowledge and skill-building per
core competency.
Concerning §146.10 the department would like comments on continuing
education requirements which a promotora or community health worker and instructor
must complete to maintain certification.
Donna C. Nichols, MSEd, CHES, Director, Public Health Promotion, has determined
that for each year of the first five year period the sections are in effect,
there will be no fiscal implication to state or local government as a result
of implementing these rules.
Donna C. Nichols, MSEd, CHES, Director, Public Health Promotion, has determined
that for each of the first five years the sections are in effect relevant
to the Training and Regulation of Promotoras, the public benefit anticipated
will be a trained, competent lay community health workforce which can support
local community health infrastructure and improve health status of community
residents by helping individuals and groups take greater control over their
health and their lives. There is no anticipated cost to small businesses or
micro businesses since this is a voluntary training and certification program.
There are no anticipated costs to persons or employees who are required to
comply with the sections as proposed since this is a voluntary training and
certification program. There will be no anticipated impact on local employment
since this is a voluntary training and certification program.
Comments on the proposal may be submitted to Donna C. Nichols, MSEd, CHES,
Director, Public Health Promotion (Suite M-631), Texas Department of Health,
1100 West 49th Street, Austin, Texas, 78756, (512) 458-7405. Comments will
be accepted for 30 days following the date of publication of this proposal
in the
Texas Register
.
The new sections are proposed under Health and Safety Code §46.003,
which requires the Texas Board of Health (board) to adopt rules that provide
minimum standards and guidelines, for issuance of a certificate to persons
who act as promotoras; and §12.001 which provides the board with the
authority to adopt rules for the performance of every duty imposed by law
on the board, the department and the commissioner of health.
The proposed new rules affect Health and Safety Code Chapter 46.
§146.1.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Administrator--The department employee designated as the
administrator of regulatory activities authorized by the Chapter 46 of the
Health and Safety Code.
(2)
Applicant--A promotora or community health worker
who applies to the Texas Department of Health for a certificate of competence,
a sponsoring institution or training program who applies to the department
to offer training or an instructor who applies to the department to train
promotoras or community health workers.
(3)
Board--The Texas Board of Health.
(4)
Certificate of Competence--A promotora or community
health worker certificate issued by the Texas Department of Health.
(5)
Committee--The Promotora/Community Health Worker Training
and Certification Advisory Committee established by §146.2 of this Chapter.
(6)
Department--The Texas Department of Health.
(7)
Instructor--An individual approved by the department
to provide instruction and training in public health education to promotoras
or community health workers in an educational setting.
(8)
Instructor certification--An authorization to train
or instruct promotoras or community health workers in public health education
services.
(9)
"Promotora" or "Community Health Worker"--A person
who, with or without compensation: provides cultural mediation between communities
and health and human service systems; informal counseling and social support;
and culturally and linguistically appropriate health education; advocates
for individual and community health needs; assures people get the health services
they need; builds individual and community capacity; or provides direct health
services.
(10)
Sponsoring institution or training program--An approved
educational, community health, training program or other program or facility
that offers or intends to offer promotora or community health worker training
or instructor preparation.
(11)
Sponsoring institution or training program certification--An
authorization to offer promotora or community health worker training or instructor
preparation.
§146.2.Promotora/Community Health Worker Training and Certification Advisory Committee.
(a)
The committee. An advisory committee shall be appointed
under and governed by this section.
(1)
The name of the committee shall be the Promotora/Community
Health Worker Training and Certification Advisory Committee.
(2)
The committee is established under the Health and
Safety Code, §11.016, which allows the Board of Health (board) to establish
advisory committees.
(b)
Applicable law. The committee is subject to Texas Government
Code, Chapter 2110, concerning state agency advisory committees.
(c)
Purpose. The purpose of the committee is to review applications
and to recommend to the department qualifying applicants as sponsoring institutions,
training instructors or as promotoras or community health workers. The committee
shall also recommend new or amended rules for the approval of the board.
(d)
Tasks.
(1)
The committee shall advise the board concerning rules to
implement standards adopted under Chapter 46 relating to the training and
regulation of persons working as promotoras or community health workers.
(2)
The committee shall recommend to the department qualifying
sponsoring institutions or training programs, instructors, and promotoras
or community health workers.
(3)
The committee shall carry out any other tasks given
to the committee by the board.
(e)
Review and duration. By November 1, 2003, the board will
initiate and complete a review of the committee to determine whether the committee
should be continued, consolidated with another committee or abolished.
(f)
Composition. The committee shall be composed of nine members
appointed by the board. The composition of committee shall include:
(1)
two certified promotoras or community health workers or
the equivalent;
(2)
one public member;
(3)
one member from the Texas Higher Education Coordinating
Board;
(4)
one licensed physician, physician assistant or nurse
practitioner who practices in a community setting and has experience in working
with promotoras or community health workers;
(5)
two higher education faculty who have teaching experience
in community health, public health or adult education; and
(6)
two members from the Texas Department of Health who
have public health program or professional experience in working with promotoras
or community health workers.
(g)
Terms of office. The term of office each member shall be
four years, and may be reappointed.
(1)
If a vacancy occurs, a person shall be appointed to serve
the unexpired portion of that term.
(2)
Members shall be appointed for staggered terms so
that the terms of three members will expire on January 1 of each even-numbered
year.
(h)
Officers. The committee shall elect a presiding officer
and an assistant presiding officer at its first meeting after August 31st
of each year.
(1)
Each officer shall serve until the next regular election
of officers.
(2)
The presiding officer shall preside at all committee
meetings at which he or she is in attendance, call meetings in accordance
with this section, appoint subcommittees of the committee as necessary, and
cause proper reports to be made to the board. The presiding officer may serve
as an ex-officio member of any subcommittee of the committee.
(3)
The assistant presiding officer shall perform the
duties of the presiding officer in case of the absence or disability of the
presiding officer. In case the office of presiding officer becomes vacant,
the assistant presiding officer will serve until a successor is elected to
complete the unexpired portion of the term of the office of presiding officer.
(4)
A vacancy which occurs in the offices of presiding
officer or assistant presiding officer may be filled at the next committee
meeting.
(5)
A member shall serve no more than two consecutive
terms as presiding officer and/or assistant presiding officer.
(6)
The committee may reference its officers by other
terms, such as chairperson and vice-chairperson.
(i)
Meetings. The committee shall meet only as necessary to
conduct committee business.
(1)
A meeting may be called by agreement of Texas Department
of Health (department) staff and either the presiding officer or at least
three members of the committee.
(2)
Meeting arrangements shall be made by department staff.
Department staff shall contact committee members to determine availability
for a meeting date and place.
(3)
Each meeting of the committee shall be announced and
conducted in accordance with the Open Meetings Act, Texas Government Code,
Chapter 551.
(4)
Each member of the committee shall be informed of
a committee meeting at least five working days before the meeting.
(5)
A simple majority of the members of the committee
shall constitute a quorum for the purpose of transacting official business.
(6)
The committee is authorized to transact official business
only when in a legally constituted meeting with quorum present.
(7)
The agenda for each committee meeting shall include
an item entitled public comment under which any person will be allowed to
address the committee on matters relating to business. The presiding officer
may establish procedures for public comment, including a time limit on each
comment.
(j)
Attendance. Members shall attend committee meetings as
scheduled. Members shall attend meetings of subcommittees to which the member
is assigned.
(1)
A member shall notify the presiding officer or appropriate
department staff if he or she is unable to attend a scheduled meeting.
(2)
It is grounds for removal from the committee if a
member cannot discharge the member's duties for a substantial part of the
term for which the member is appointed because of illness or disability, is
absent from more than half of the committee and subcommittee meetings during
a calendar year, or is absent from at least three consecutive committee meetings.
(3)
The validity of an action of the committee is not
affected by the fact that it is taken when a ground for removal of a member
exists.
(4)
The attendance records of the members shall be reported
to the board. The report shall include attendance at committee and subcommittee
meetings.
(k)
Staff. Staff support for the committee shall be provided
by the department.
(l)
Procedures. Roberts Rules of Order, Newly Revised, shall
be the basis of parliamentary decisions except where otherwise provided by
law or rule.
(1)
Any action taken by the committee must be approved by a
majority vote of the members present once quorum is established.
(2)
Each member shall have one vote.
(3)
A member may not authorize another individual to represent
the member by proxy.
(4)
The committee shall make decisions in the discharge
of its duties without discrimination based on any person's race, creed, gender,
religion, national origin, age, physical condition, or economic status.
(5)
Minutes of each committee meeting shall be taken by
department staff.
(A)
A draft of the minutes approved by the presiding officer
shall be provided to the board and each member of the committee within 30
days of each meeting.
(B)
After approval by the committee, the minutes shall be signed
by the presiding officer.
(m)
Subcommittees. The committee may establish subcommittees
as necessary to assist the committee in carrying out its duties.
(1)
The presiding officer shall appoint members of the committee
to serve on subcommittees and to act as subcommittee chairpersons. The presiding
officer may also appoint nonmembers of the committee to serve on subcommittees.
(2)
Subcommittees shall meet when called by the subcommittee
chairperson or when so directed by the committee.
(3)
A subcommittee chairperson shall make regular reports
to the advisory committee at each committee meeting or in interim written
reports as needed. The reports shall include an executive summary or minutes
of each subcommittee meeting.
(n)
Statement by members. The board, the department, and the
committee shall not be bound in any way by any statement or action on the
part of any committee member except what a statement or action is in pursuit
of specific instructions from the board, department, or committee.
(o)
Reports to board. The committee shall file an annual written
report with the board.
(1)
The report shall list the meeting dates of the committee
and any subcommittees, the attendance records of its members, a brief description
of actions taken by the committee, a description of how the committee has
accomplished the tasks given to the committee by the board, the status of
any rules which were recommended by the committee to the board, anticipated
activities of the committee for the next year, and any amendments to this
section requested by the committee.
(2)
The report shall identify the costs related to the
committee's existence, including the cost of agency staff time spent in support
of the committee's activities.
(3)
The report shall cover the meetings and activities
in the immediate preceding 12 months and shall be filed with the board each
January. It shall be signed by the presiding officer and appropriate department
staff.
§146.3.Applicability.
(a)
The purpose of this section is to describe who is eligible
for this voluntary training and certification program under Health and Safety
Code, Chapter 46.
(b)
The provisions of this chapter apply to any promotora or
community health worker, and instructor, representing that he or she performs
or will perform as a certified promotora or community health worker or, trains
or will train promotoras or community health workers respectively. It also
applies to any institution or training program that will sponsor or sponsors
or provides training programs for promotoras or community health workers,
who will expect certification under this chapter.
(c)
Nothing in this chapter requires promotoras or community
health workers, instructors, sponsoring institutions or training programs
to participate in this voluntary training and certification program.
§146.4.Application Requirements and Procedures for Promotoras or Community Health Workers.
(a)
Purpose. The purpose of this section is to set out the
application procedures for certification of promotoras or community health
workers.
(b)
Promotora or community health worker certificate of competence.
(1)
Unless otherwise indicated, an applicant must complete
all required information and documentation on official department forms and
submit the required information and documentation electronically or in hard
copy to the department.
(2)
The department shall send a notice listing the additional
materials required to an applicant whose application is incomplete. An application
not completed within 30 days after the date of notice shall be invalid unless
the applicant has advised the department of a valid reason for the delay.
(c)
Required application materials. The application form shall
contain the following items:
(1)
specific personal data, social security number or status,
birth date, current and previous promotora or community health worker activity
(if applicable), and any educational and training background;
(2)
a statement that the applicant understands Health
and Safety, Chapter 46 and this chapter and agrees to abide by them;
(3)
the applicant's permission to the department to seek
any information or references which are material in determining the applicant's
qualifications;
(4)
a statement that the applicant, if issued a certificate,
shall return the certificate and identification card(s) to the department
upon the expiration, revocation, or suspension of the certificate;
(5)
a statement that the applicant understands that the
materials submitted become the property of the department and are nonreturnable
(unless prior arrangements have been made);
(6)
a statement that the information in the application
is truthful and that the applicant understands that providing false or misleading
information which is material in determining the applicant's qualifications
may result in the voiding of the application and failure to be granted any
certificate or the revocation of any certificate issued;
(7)
a statement that the applicant shall advise the department
of his or her current mailing address within 30 days of any changes of address;
(8)
the dated signature of the applicant certifying the
truth of the information submitted; and
(9)
the signature of the instructor, sponsoring institution
or training program indicating successful completion of the promotora or community
health worker training and the date when the training was successfully completed.
(d)
Application approval.
(1)
The committee shall be responsible for reviewing all applications
and recommending promotoras or community health workers to be certified to
the administrator.
(2)
The administrator shall approve any application which
is in compliance with this chapter and which properly documents applicant
eligibility, unless the application is disapproved under the provisions of
subsection (e) of this section.
(e)
Disapproved applications.
(1)
The department may disapprove the application if the applicant:
(A)
has not met the eligibility and application requirements
set out in this section;
(B)
has not successfully completed an approved competency-based
promotora or community health worker training;
(C)
has failed or refused to properly complete or submit any
application form(s) or has knowingly presented false or misleading information
on the application form, or any other form or documentation required by the
department to verify the applicant's qualifications for certification;
(D)
has engaged in unprofessional conduct; or
(E)
has developed an incapacity, which in accordance with the
Americans with Disabilities Act, prevents the practice of promotora or community
health worker service with reasonable skill, competence, and safety to the
public as the result of:
(i)
an illness;
(ii)
drug or alcohol dependency; or
(iii)
another physical or mental condition or illness;
(2)
If the administrator determines that the
application should not be approved, the administrator shall give the applicant
written notice of the reason for the disapproval and of the opportunity for
re-application;
(3)
The applicant whose application has been disapproved
under paragraph one of this subsection shall be permitted to reapply after
a period of not less than six months from the date of the disapproval and
shall submit a current application, the certification fee and proof, satisfactory
to the department, of compliance with the then current requirements of this
chapter and the provisions of the Act.
(f)
Application processing. A written notice stating that the
application has been approved may be sent in lieu of the notice of acceptance
of a complete application. The following periods of time shall apply from
the date of receipt of an application until the date of issuance of a written
notice that the application is complete and accepted for filing or that the
application is deficient and additional specific information is required:
(1)
letter of acceptance of application for certification--30
days.
(2)
letter of application deficiency--30 days.
§146.5.Application Requirements and Procedures for Instructors.
(a)
Purpose. The purpose of this section is to set out the
application procedure for certification of instructors.
(b)
Instructor certificate.
(1)
Unless otherwise indicated, an applicant must complete
all required information and documentation of credentials on official department
forms and submit the required information and documentation electronically
or in hard copy to the department.
(2)
The department shall send a notice listing the additional
materials required to an applicant whose application is incomplete. An application
not completed within 30 days after the date of notice shall be invalid unless
the applicant has advised the department of a valid reason for the delay.
(c)
Required application materials. The application form shall
contain the following items:
(1)
specific personal data, social security number or status,
birth date, current and previous places of employment, other state licences
and certificates held, and educational and training background;
(2)
a statement that the applicant understands the Health
and Safety Code, Chapter 46 and this chapter and agrees to abide by them;
(3)
the applicant's permission to the department to seek
any information or references which are material in determining the applicant's
qualifications;
(4)
a statement that the applicant, if issued a certificate,
shall return the certificate and identification card(s) to the department
upon the expiration, revocation, or suspension of the certificate;
(5)
a statement that the applicant understands that the
materials submitted become the property of the department and are nonreturnable
(unless prior arrangements have been made);
(6)
a statement that the information in the application
is truthful and that the applicant understands that providing false or misleading
information which is material in determining the applicant's qualifications
may result in the voiding of the application and failure to be granted any
certificate or the revocation of any certificate issued;
(7)
a statement that the applicant shall advise the department
of his or her current mailing address within 30 days of any changes of address;
(8)
the dated signature of the applicant certifying the
truth of the information submitted; and
(9)
the signature of the executive officer of a sponsoring
institution or training program which attests to the competence of the instructor.
(d)
Application approval.
(1)
The committee shall be responsible for reviewing all applications
and recommending those to be certified by the administrator.
(2)
The administrator shall approve any application which
is in compliance with this chapter and which properly documents applicant
eligibility, unless the application is disapproved under the provisions of
subsection (e) of this section.
(e)
Disapproved applications.
(1)
The department may disapprove the application if the applicant:
(A)
has not met the eligibility and application requirements
set out in this chapter;
(B)
does not have the appropriate training or experience to
qualify as an instructor;
(C)
has failed or refused to properly complete or submit any
application form(s) or has knowingly presented false or misleading information
on the application form, or any other form or documentation required by the
department to verify the applicant's qualifications for certification;
(D)
has engaged in unprofessional conduct; or
(E)
has developed an incapacity, and in accordance with the
Americans with Disabilities Act, that prevents the instructor from practicing
with reasonable skill, competence, and safety to the public as the result
of:
(i)
illness;
(ii)
drug or alcohol dependency; or
(iii)
another physical or mental condition or illness;
(2)
If the administrator determines that the
application should not be approved, the administrator shall give the applicant
written notice of the reason for the disapproval and of the opportunity for
re-application;
(3)
The applicant whose application has been disapproved
under paragraph one of this subsection shall be permitted to reapply after
a period of not less than six months from the date of the disapproval and
shall submit a current application satisfactory to the department, of compliance
with the then current requirements of this chapter and the provisions of the
Health and Safety Code, Chapter 46.
(f)
Application processing. A written notice stating that the
application has been approved may be sent in lieu of the notice of acceptance
of a complete application. The following periods of time shall apply from
the date of receipt of an application until the date of issuance of a written
notice that the application is complete and accepted for filing or that the
application is deficient and additional specific information is required:
(1)
letter of acceptance of application for certification--130
days.
(2)
letter of application deficiency--30 days.
§146.6.Application Requirements and Procedures for Sponsoring Institutions and Training Programs.
(a)
Purpose. The purpose of this section is to set out the
application procedures for certification of sponsoring institutions and training
programs.
(b)
Sponsoring institution or training program certificate.
(1)
Unless otherwise indicated, an applicant must complete
all required information and documentation of credentials on official department
forms and submit the required information and documentation electronically
or in hard copy.
(2)
The department shall send a notice listing the additional
materials required to an applicant whose application is incomplete. An application
not completed within 30 days after the date of notice shall be invalid unless
the applicant has advised the department of a valid reason for the delay.
(c)
Required application materials. The application form shall
contain the following items:
(1)
specific organizational data, current and previous experience
with training or sponsoring training for promotoras or community health workers,
educational and training qualifications of staff, accrediting information,
curricula and collateral materials, workplace assurances, registration policies
and procedures for promotoras or community health workers.
(2)
a statement that the applicant understands Health
and Safety Code, Chapter 46 and this chapter and agrees to abide by them;
(3)
the applicant's permission to the department to seek
any information or references which are material in determining the applicant's
qualifications;
(4)
a statement that the applicant, if issued a certificate,
shall return the certificate(s) to the department upon the expiration, revocation,
or suspension of the certificate(s);
(5)
a statement that the applicant understands that the
materials submitted become the property of the department and are nonreturnable
(unless prior arrangements have been made);
(6)
a statement that the information in the application
is truthful and that the applicant understands that providing false or misleading
information which is material in determining the applicant's qualifications
may result in the voiding of the application and failure to be granted any
certificate or the revocation of any certificate issued;
(7)
a statement that the applicant shall advise the department
of the organization's current mailing address within 30 days of any changes
of address; and
(8)
the dated signature of the chief executive officer
certifying the truth of the information submitted.
(d)
Application approval.
(1)
The committee shall be responsible for reviewing all applications
and recommending those to be certified to the administrator.
(2)
The administrator shall approve any application which
is in compliance with this chapter and which properly documents applicant
eligibility, unless the application is disapproved under the provisions of
subsection (e) of this section.
(e)
Disapproved applications.
(1)
The department may disapprove the application if the applicant:
(A)
has not met the eligibility and application requirements
set out in this chapter; or
(B)
has failed or refused to properly complete or submit any
application form(s) or has knowingly presented false or misleading information
on the application form, or any other form or documentation required by the
department to verify the applicant's qualifications for certification.
(2)
If the administrator determines that the application
should not be approved, the administrator shall give the applicant written
notice of the reason for the disapproval and of the opportunity for re-application;
(3)
The applicant whose application has been disapproved
under paragraph one of this subsection shall be permitted to reapply after
a period of not less than six months from the date of the disapproval and
shall submit a current application, the certification fee and proof, satisfactory
to the department, of compliance with the then current requirements of this
chapter and the provisions of the Act.
(f)
Application processing. A written notice stating that the
application has been approved may be sent in lieu of the notice of acceptance
of a complete application. The following periods of time shall apply from
the date of receipt of an application until the date of issuance of a written
notice that the application is complete and accepted for filing or that the
application is deficient and additional specific information is required:
(1)
letter of acceptance of application for certification--30
days.
(2)
letter of application deficiency--30 days.
§146.7.Types of Certificates and Applicant Eligibility.
(a)
Purpose. The purpose of this section is to set out the
types of certificates issued and the qualifications of applicants.
(1)
The Texas Department of Health (department) shall issue
promotora or community health worker certificates of competence, instructor
certificates, and sponsoring institutions or training program certificates.
(2)
Certificates shall be signed by the commissioner of
the department and presiding officer of the advisory committee. Identification
cards issued to promotoras/community health workers and instructors shall
bear the signature of the commissioner.
(3)
Any certificate or identification card(s) issued by
the department remains the property of the department and shall be surrendered
to the department on demand.
(4)
A promotora or community health worker and instructor
shall carry the original identification card. A sponsoring institution or
training program shall display the original certificate at the training or
educational site. Photocopies shall not be carried or displayed.
(5)
A person certified as a promotora or community health
worker shall only allow his or her certificate to be copied for the purpose
of verification by employers, professional organizations, and third party
payors for credentialing and reimbursement purposes. Other persons and/or
agencies may contact the administrator in writing or by phone to verify certification.
(6)
No one shall display, present, or carry a certificate
or an identification card which has been altered, photocopied, or otherwise
reproduced.
(7)
No one shall make any alteration on any certificate
or identification card issued by the department.
(b)
Special provisions for persons who have performed promotora
or community health worker services during the three year period, preceding
the effective date of these rules Upon submission of the application forms
by the practicing promotora or community health worker and upon approval by
the department, the department shall issue a certificate of competence to
a person who has performed promotora or community health services for not
less than 12 consecutive months, as documented on form(s) prescribed by the
department.
(c)
Special provisions for persons who are nationally certified
health education specialists in good standing and for promotoras or community
health workers who have acted as supervisors, have experience in performing
promotora or community health services and have attended a competency-based
training program within the three years from the date these rules are final.
Upon submission of the application forms by an instructor or certified health
education specialist and upon approval by the department, the department shall
issue an instructor certificate to a person who is certified by the National
Commission for Health Education Credentialing, Inc. and to a promotora or
community health worker who meets the above qualifications.
(d)
Minimum eligibility requirements for promotora or community
health worker certification. The following requirements apply to all individuals
applying for certification who do not meet the requirements of subsection
(b) of this section:
(1)
attainment of 18 years of age or an eligible and informed
minor as determined by the committee;
(2)
freedom from physical or mental impairment, in accordance
with the Americans with Disabilities Act, interferes with the performance
of duties or otherwise constitutes a hazard to the health or safety of clients;
(3)
submission of a satisfactory completed application
on a form supplied by the department; and
(4)
successful completion of an approved competency-based
training program.
(e)
Minimum eligibility requirements for instructor certification.
The following requirements apply to all individuals applying for certification
who do not meet the requirements of subsections (c) of this section:
(1)
graduation from high school or its equivalent as determined
by the sponsoring institution or the training program or six years of continuous
service as a promotora or community health worker;
(2)
attainment of 18 years of age or an eligible and informed
minor as determined by the committee;
(3)
attendance at an instructor/trainer program by an
approved sponsoring institution or training program;
(4)
freedom from physical or mental impairment, which
in accordance with the Americans with Disabilities Act, interferes with the
performance of duties or otherwise constitutes a hazard to the health or safety
of participants; and
(5)
submission of a satisfactory completed application
on a form supplied by the department.
(f)
Minimum eligibility requirements for sponsoring institution
or training program certification. The following requirements apply to all
institutions or programs applying for certification:
(1)
usage of an approved curriculum for promotora or community
health worker training, instructor certification and/or for continuing education
of promotoras/community health workers and instructors that meets the standards
and guidelines established by the department and as set forth in §146.8
of this chapter; and
(2)
submission of a satisfactory completed application
on a form supplied by the department.
§146.8.Standards for the Approval of Curricula.
(a)
Purpose. The purpose of this section is to establish the
minimum standards for approval of curricula and programs to train persons
to perform promotora or community health worker services and to quality for
the certificate of competence.
(b)
All curricula to be used and programs developed to train
individuals to perform promotora or community health worker services or to
act as instructors must:
(1)
assure that the eight core competencies, identified in
the National Community Health Advisor Study, June 1998 for promotoras or community
health workers, including communication, interpersonal, service coordination,
capacity-building, advocacy, teaching and organizational skills and knowledge
base are addressed;
(2)
include at a minimum five clock hours of knowledge
and skill-building per core competency for promotoras or community health
workers and include at a minimum 40 clock hours for instructor training;
(3)
evaluate and document the acquisition of knowledge
and mastery of skills by the individual and the success of the training program
according to the performance measures framework established within the National
Community Health Advisor Study, June 1998;
(4)
be approved by the department and be offered within
the geographic limits of the State of Texas;
(5)
be submitted to the department at least ten weeks
prior to the starting date of the program to be offered by a sponsoring institution;
(6)
be submitted to the department along with supporting
materials in a three-ring binder with all pages clearly legible and consecutively
numbered with a table of contents and divided with tabs identified to correspond
to the core competencies, including evaluation materials and other programmatic
information and assurances required within this section;
(7)
provide a list of approved instructors, facilities
and locations for the training program;
(8)
provide a yearly calendar of scheduled training events
by dates, times and locations;
(9)
identify the method for recruiting persons to the
program;
(10)
report the names of individuals to the department
who have successfully completed the training program within 30 days of program
completion;
(11)
maintain an accurate record of each person's attendance
and participation for not less than five years;
(12)
be live and interactive and directed by an approved
instructor; and
(13)
focus on the seven core roles of the promotora or
community health worker as noted in the definition of promotora or community
health worker.
§146.9.Certificate Issuance and Renewals.
(a)
Purpose. The purpose of this section is to set out the
rules for issuing certificates and certificate renewal.
(b)
Issuance of certificates.
(1)
Upon approval of the application, the department shall
issue the promotora or community health worker, instructor or sponsoring institution
or training program a certificate with an expiration date and a certificate
number. An identification card shall be included for the promotora or community
health worker and the instructor.
(2)
The department shall replace a lost, damaged, or destroyed
certificate or identification card upon written request.
(c)
Certificate renewal. Each promotora or community health
worker, instructor and sponsoring institution or training program shall renew
the certificate biennially.
(1)
Each promotora or community health worker, instructor and
sponsoring institution is responsible for renewing the certificate before
the expiration date. Failure to receive notification from the department prior
to the expiration date will not excuse failure to file for renewal.
(2)
Each promotora or community health worker, instructor
and sponsoring institution is responsible for completing a renewal form.
(3)
The department may not renew the certificate of a
promotora or community health worker, instructor or sponsoring institution
or training program who is in violation of the Act or this chapter at the
time of renewal.
(d)
Expired certificates. The department, by certified mail
using the last address known, shall attempt to inform each promotora or community
health worker, instructor, or sponsoring institution or training program who
has not timely renewed a certificate, after a period of more than 10 days
after the expiration of the certificate that the certificate has automatically
expired. A person or institution or training program whose certificate automatically
expires is required to surrender the certificate and identification cards
to the department.
(e)
Right to inspect. The department reserves the right to
inspect facilities and documentation and to monitor sponsoring institutions,
training programs, and instructors.
§146.10.Continuing Education Requirements.
(a)
Purpose. The purpose of this section is to establish the
continuing education requirements which a promotora or community health worker
and instructor must complete to maintain certification. The requirements are
intended to maintain and improve the quality of professional services provided
by promotoras or community health workers and instructors and to keep these
individuals knowledgeable of current programs, techniques and practices. Approved
sponsoring institutions and/or training programs can offer continuing education
opportunities for promotoras or community health workers and instructors.
(b)
General. Continuing education requirements for recertification
shall be fulfilled during each biennial renewal period. A promotora or community
health worker must complete 16 contact hours of continuing education acceptable
to the department during each biennial renewal period. An instructor must
complete 16 contact hours of continuing education acceptable to the department
during each biennial renewal period.
(1)
At least 50% of the required number of hours shall be satisfied
by attendance and participation in instructor-directed activities.
(2)
No more than 50% of the required number of hours may
be satisfied through verifiable independent self-study. These activities include
reading materials, audio materials, audiovisual materials, or a combination
thereof which meet the requirements set out in this section.
(3)
A contact hour shall be defined as 50 minutes of attendance
and participation. One-half contact hour shall be defined as 30 minutes of
attendance and participation during a 30-minute period.
(c)
Content. All continuing education activities should provide
for the professional growth of the community health worker or promotora and
instructor.
(1)
At least 50% of the required hours must be skill-based
activities which are directly related to promotora or community health worker
competencies.
(2)
The remaining 50% can be related to new knowledge
base or programmatic activity.
(d)
Types of acceptable continuing education. Continuing education
shall be acceptable if the experience or activity is at least 30 consecutive
minutes in length and is offered by an approved sponsoring institution and/or
training program.
(e)
Reporting of continuing education. Each promotora or community
health worker and instructor is responsible for and shall complete and file
with the department at the time of renewal a continuing education report form
approved by the department listing the title, date and number of hours for
each activity for which credit is claimed. The sponsoring institution or training
program must provide a list of instructors, promotoras or community health
workers who successfully complete continuing education contact hours within
30 days of the continuing education event.
(f)
Failure to complete the required continuing education.
(1)
An instructor, promotora or community health worker may
request a one time only 120-day extension in order to complete the continuing
education requirement.
(2)
An instructor, promotora, or community health worker
who has not corrected the deficiency by the expiration date of the 120-day
extension shall be considered as noncompliant with the renewal requirements
and may no longer be certified under the expired certificate.
(3)
An instructor, promotora or community health worker
may take the required training again to become an instructor, promotora or
community health worker if deadlines for renewal were not met.
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 January 14, 2000.
TRD-200000297
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
Subchapter B. MEAT AND POULTRY INSPECTION
25 TAC §§221.11 - 221.15
The Texas Department of Health (department) proposes amendments
to existing §§221.11 - 221.14, and new §221.15 concerning meat
and poultry inspection. Sections 221.11 - 221.14 are being proposed with changes,
and are open for comment.
Section 221.11 adds the requirements that bison meat or buffalo meat must
contain the words bison meat or buffalo meat on the label, as appropriate.
Section 221.13 adds new definitions of alternate source food animals, bison,
bison meat, buffalo, buffalo meat, commissioner, director, and grant of poultry/rabbit
exemption; and requirements have been revised to include poultry/rabbit exemption.
Section 221.13 is being amended to include new language under Administrative
Penalties, Severity Level V, for any person failing to maintain records of
custom operations. In §221.14, new language concerning the labeling of
insecticides and rodenticides in or near food areas has been added.
Proposed changes to §§221.11 - 221.14 include new definitions
to facilitate understanding of proposed new §221.15, establish the relationship
between United States Department of Agriculture (USDA) officials and department
officials, and incorporate new provisions required by HB 1145 as passed by
the 75th Legislature. Other changes are proposed to clarify intent and to
be consistent with changes in USDA regulations.
Pursuant to the Government Code, §2001.039 (formerly known as Rider
167), each state agency is required to review and consider for readoption,
each rule adopted by that agency. The sections have been reviewed and the
department has determined that reasons for adopting the sections continue
to exist.
Proposed new §221.15 concerns rules for inspection of alternate source
food animals, such as exotic wild game, quail, rabbits, ostrich, emus, and
other related species. The proposed new sections are intended to establish
standards for the sanitary handling of meat beginning with the slaughter and
dressing operations. Effective control over sanitary dressing procedures is
vital to the production of a clean, wholesome and safe product. It is the
principal objective of sanitary dressing procedures to remove or clean the
hide or skin and to remove the gastrointestinal tract and other internal organs
with minimum contamination of the meat. The process is difficult enough in
healthy animals. It is more complicated in animals with localized or generalized
diseases, many of which are not detected until the dressing operation has
been partially or entirely completed. Since inspectional procedures are designed
to detect and remove these abnormal conditions and since it is not known with
certainty, prior to inspection, all the animals which are affected, sanitary
dressing procedures must be designed to eliminate common contact of skinned
carcasses during dressing operations. The diseased animal may also pose a
serious contamination threat and public health hazard via other tissues and
fluids, such as bile, urine, milk and fluids and tissues from the reproductive
tract. All diseased tissues and associated fluids (such as pus) must not be
allowed to contaminate the product, workers, equipment or environment. When
such contamination does occur, by accidental or other means, strict, careful
correction must be immediately accomplished. This emphasizes the necessity
of the plant and equipment being designed, constructed and arranged so that
they are easy to clean. The slaughtering and viscera separation departments,
in addition to handling a large volume and variety of clean and unclean materials,
are supplied with abundant moisture and warm temperatures. This is ideal for
rapid growth of microorganisms; therefore, strict sanitation and orderly handling
of the product to ensure rapid chilling are essential.
Dr. Lee C. Jan, Director, Meat Safety Assurance 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 state or local governments as a result
of enforcing or administering the rules as proposed.
Dr. Jan has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated will be continued
assurance of consumer safety by enforcing current USDA regulations and current
and new Texas Administrative Code regulations relating to meat and poultry
slaughter and processing. There will be no significant cost to micro or small
businesses or individuals who are required to comply with these sections as
proposed, due to the fact that proposed §221.15 codifies rules under
which voluntary inspection of alternate species is currently carried out.
There will be no impact on local employment.
Comments on the proposal may be submitted to Lee C. Jan, D.V.M., Director,
Meat Safety Assurance Division, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756, 512/719-0205. Comments will be accepted for 30
days following publication of the proposal in the
Texas Register
.
The amendments and new section are proposed under the Health
and Safety Code, Chapter 433, which provides the department with the authority
to adopt necessary regulations pursuant to the enforcement of Chapter 433;
and §12.001, which provides the Texas Board of Health (board) with the
authority to adopt rules for the performance of every duty imposed by law
on the board, the department, and the commissioner of health.
The amendments and new section affect the Health and Safety Code, Chapter
433; Chapter 12; and the Government Code, §2001.039, as passed by the
76th Legislature.
§221.11.Federal Regulations on Meat and Poultry Inspection.
(a)
The Texas Department of Health
(TDH)
adopts
by reference the following federal requirements in the Code of Federal Regulations
(CFR), as amended:
(1) - (17)
(No change.)
(18)
9 CFR, Part 319, "Definitions and standards of identity
or composition"
, TDH adds the following requirements:
(A)
products prepared from bison meat must
contain the words "bison meat," "North American bison meat" or "Native American
bison meat"; and
(B)
products prepared from buffalo meat must
contain the words "water buffalo meat," or "Asian buffalo meat";
(19) - (31)
(No change.)
(32)
9 CFR, Part 381, "Poultry products inspection regulation"
, except §381.10(a)(3) through §381.10(c)
;
(33) - (34)
(No change.)
(b)
(No change.)
§221.12.Meat and Poultry Inspection.
(a)
(No change.)
(b)
Definitions. The following words and terms, when used in
these sections, shall have the following meanings, unless the context clearly
indicates otherwise.
(1) - (2)
(No change.)
(3)
Alternate source food
animals--Animals slaughtered and processed for food that are amenable to inspection
under the Texas Meat and Poultry Inspection Act but are not amenable to inspection
under the federal meat and poultry inspection acts.
(4)
Bison--An animal known
by the scientific name Bovidae bison bison, commonly known as the North American
prairie bison; or an animal known by the scientific name Bovidae bison athabascae,
commonly known as the Canadian woods bison.
(5)
Bison meat The meat or
flesh of a bison.
(6)
Buffalo--An animal known
by the scientific name Bovidae bubalus bubalus, commonly known as the Asian
Indian buffalo, water buffalo, or caraboa; an animal known by the scientific
name Bovidae syncerus caffer, commonly known as the African buffalo or the
Cape buffalo; an animal known by the scientific name Bovidae anoa depressicornis,
commonly known as the Celebes buffalo; or an animal known by the scientific
name Bovidae anoa mindorenis, commonly known as the Philippine buffalo or
Mindoro buffalo.
(7)
Buffalo meat The meat
or flesh of a buffalo.
(8)
[
(A)
A change in the business organization operating the business
which changes the legal entity responsible for operation of the business;
or
(B)
any change in control of the business; or
(C)
any change in ownership of the business which requires
a reapplication to the Texas Department of Health for a grant of inspection
and/or custom exemption to operate.
(9)
Commissioner--Commissioner
of Health. The term secretary when used in 9 CFR, for the purposes of this
subchapter, shall mean commissioner.
(10)
[
(11)
[
(12)
[
(13)
[
(14)
Director-- Meat Safety Assurance
Division Director. The term Administrator, when used in 9 CFR, Parts 301-417,
for the purpose of this section, shall mean director.
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(21)
Grant of poultry/rabbit
exemption--An authorization from the department to engage in a very low volume
business of slaughtering and processing poultry or rabbits of his/her own
raising on his/her own property and personally distributing the carcasses
and/or parts, provided that the following conditions are met:
(A)
the person slaughters 1000 but not more than
10,000 birds or rabbits in a calendar year;
(B)
the person does not buy and sell other poultry
products (except live chicks);
(C)
only sound healthy poultry or rabbit are slaughtered
and all processes and handling are conducted under sanitary standards and
procedures resulting in poultry and rabbit products that are not adulterated;
(D)
the product bears the processor's name and address
and the statement "Exempted P.L. 90-492"; and
(E)
the poultry is not a ratite.
(22)
[
(23)
[
(24)
[
(25)
[
(26)
Ratite Poultry such as ostrich, emus,
or rhea.
(c)
Grant of inspection
,
[
(1)
Basic requirements.
(A)
A person shall not engage in a business subject to the
Act unless that person has met the standards established by the Act, the federal
regulations
as adopted by the department
, and these sections, and
has obtained the appropriate grant of inspection
,
[
(B)
(No change.)
(C)
A person shall not engage in exempted poultry
or rabbit slaughter and processing operations unless that person has met the
standards established by the Act, the federal regulations, and these sections,
and has obtained a grant of poultry/rabbit exemption issued by the department.
(2)
Application. To apply for a grant of inspection
,
[
(3)
Duration. The applicant who has complied with the
standards in the Act, the federal regulations, and these sections will receive
a grant of inspection and/or custom exemption for an indefinite period subject
to the denial, suspension, and revocation provisions in paragraph
(6)
[
(4) - (5)
(No change.)
[
(6)
[
(A)
The department may deny a grant of inspection and/or custom
exemption to any applicant who does not comply with the standards of the Act,
the federal regulations, and these sections.
(B)
The department may suspend or revoke a grant of inspection
and/or custom exemption of any person who violates the standards of the Act,
the federal regulations, and these sections.
(C)
A person whose grant has been denied, suspended, or revoked
is entitled to an opportunity for a formal hearing in accordance with §§1.21-1.34
of this title (relating to Formal Hearing Procedures).
(d)
(No change.)
§221.13.Administrative Penalties.
(a)
Purpose. The purpose of this section is to establish the
criteria and procedures by which the commissioner of health will assess administrative
penalties for violations
relating to
[
(b)
(No change.)
(c)
The seriousness of the violation.
(1)
(No change.)
(2)
The severity of a violation shall be increased if
the violation involves deception[
(3)
The following are examples only of severity levels;
they are not exhaustive or controlling.
(A)
Severity Level I shall apply to:
(i)
(No change.)
(ii)
any person causing an unidentified or incorrectly identified
and undecharacterized meat or poultry (such as meat from condemned livestock
or livestock that died other than by slaughter) to be placed in food channels
where it could enter the human food chain undetected;
or
[
(iii)
(No change.)
(B)
Severity Level II shall apply to:
(i)
(No change.)
(ii)
any person selling livestock slaughtered without approved
state or federal ante-mortem and post-mortem inspection;
or
[
(iii)
(No change.)
(C)
Severity Level III shall apply to:
(i)
(No change.)
(ii)
any person denying access to review the records and/or
a place of business where livestock products are being slaughtered, processed,
sold, or made available for sale;
or
[
(iii)
(No change.)
(D)
Severity Level IV shall apply to:
(i)
any person failing to maintain records of business transactions
which will correctly identify all purchases and sales involving livestock
product;
or
[
(ii)
(No change.)
(E)
Severity Level V shall apply to:
(i) - (iii)
(No change.)
(iv)
any person selling or making available for sale ground
beef, hamburger, or similar items whose fat content exceeds the standard limitation
or the fat content stated on the product label as set out in Title 9, Code
of Federal Regulations, §319, titled "Definitions and Standards of Identity
or Composition," as amended; [
(v)
any person failing to correct labeling irregularities as
set out in Title 9, Code of Federal Regulations, §317, titled "Labeling,
Marking Devices, and Containers," as amended
; or
[
(vi)
any person failing to maintain records
of custom operations as required by these sections.
(d) - (i)
(No change.)
§221.14.Custom Slaughter and Processing.
(a)
Custom slaughter requirements. The requirements of this
section shall apply to the custom slaughter by any person of livestock, as
defined in §221.12(b) of this title (relating to Meat and Poultry Inspection),
delivered by or for the owner thereof for such slaughter, not for sale to
the public and exclusively for use, in the household of such owner, by him
and members of his household and nonpaying guests. The requirements of this
section do not apply to hunter killed game animals, hunter killed exotic animals,
and hunter killed feral swine, as defined in §221.12(b) of this title.
(1)
Animals for slaughter. No adulterated animals as defined
in §221.12(b)(2) of this title shall be accepted for custom slaughter.
Only healthy animals, exhibiting no abnormalities, may be accepted for custom
slaughter at custom slaughter establishments. Unhealthy or unsound animals
are those that exhibit any condition that is not normally expected to be exhibited
in a healthy and sound member of
[
(A) - (B)
(No change.)
(2) - (3)
(No change.)
(4)
Facilities.
(A)
The custom slaughter establishment shall maintain well
distributed, sufficient light of good quality, and sufficient ventilation
for all rooms and compartments to
ensure
[
(B)
(No change.)
(5) - (9)
(No change.)
(10)
Rodent and pest control.
[
A rodent and pest control and surveillance
program shall be implemented to exclude flies, rats, mice, and other vermin
from custom slaughter establishments. The use of poisons for any purpose in
rooms or compartments where any carcass is stored or handled is forbidden.
The use of insecticides,
rodenticides
[
[
(11) - (15)
(No change.)
(16)
Operations, procedures, and clothing.
(A) - (B)
(No change.)
(C)
All tools, utensils, and equipment
which become contaminated
[
(D)
All persons that handle any product within the custom slaughter
establishment shall keep their hands clean. All persons shall wash their hands
after using the toilet rooms or urinals before handling any product, tool,
utensil, or equipment used in the preparation of product.
(E) - (G)
(No change.)
(17) - (19)
(No change.)
(20)
Marking and labeling of custom prepared products.
Carcasses and parts therefrom that are prepared on a custom basis shall be
marked at the time of preparation with the term "Not for Sale" in letters
at least three-eighths inch in height, and shall also be identified with the
owner's name or a code that allows identification of the carcass or carcass
part to its owner. Ink used for marking such products must be
labeled
[
(21) - (23)
(No change.)
(b)
Custom processing requirements. The requirements of this
section shall apply to the custom processing by any person of uninspected
livestock carcasses or parts, delivered by or for the owner thereof for such
processing, not for sale to the public and exclusively for use, in the household
of such owner, by him and members of his household and nonpaying guests. The
requirements of this section shall not apply to processing hunter killed game
animals, hunter killed exotic animals, and hunter killed feral swine as defined
in §221.12(b) of this title.
(1) - (3)
(No change.)
(4)
Facilities.
(A)
The custom processing establishment shall maintain well
distributed, sufficient light of good quality, and sufficient ventilation
for all rooms and compartments to
ensure
[
(B)
(No change.)
(5) - (9)
(No change.)
(10)
Rodent and pest control.
[
A rodent and pest control and surveillance
program, shall be implemented to exclude flies, rats, mice, and other vermin
from custom processing establishments. The use of poisons for any purpose
in rooms or compartments where any carcass is stored or handled is forbidden.
The use of insecticides, rodenticide, and similar pest control substances
in inedible product departments, outbuildings, or similar places, or in storerooms
containing canned products may be used provided they
are labeled for
use in areas or near areas where food is present
[
[
(11) - (14)
(No change.)
(15)
Operations, procedures, and clothing.
(A) - (B)
(No change.)
(C)
All tools, utensils, and equipment
which become contaminated
[
(D) - (G)
(No change.)
(16) - (22)
(No change.)
(23)
Approval of substances for use.
(A) - (B)
(No change.)
(C)
Nitrates shall not be used in curing bacon.
(i)
Nitrites in the form of sodium nitrite may be used at 120
parts per million (ppm) ingoing (or in the form of potassium nitrite at 148
ppm ingoing) maximum for injected, massaged, or immersion cured bacon; and
550 ppm of sodium ascorbate or sodium erythorbate (isoascorbate) for injected,
massaged, or immersion cured bacon
shall
[
(ii) - (iv)
(No change.)
(D)
(No change.)
(24) - (25)
(No change.)
§221.15.Inspection of Alternate Source Food Animals.
(a)
Requirements. Specific requirements of this section shall
be in addition to those required by the rules adopted for inspection of livestock,
under the Texas Meat and Poultry Inspection Act, and federal regulations as
listed in §221.11 of this title (relating to Federal Regulations on Meat
and Poultry Inspection).
(b)
Fees. Fees shall be assessed in one-half hour increments
for inspection services, provided by a department Meat Safety Assurance Division
(MSA) inspector to a facility holding a grant of inspection, as specified
in §221.12(d) of this title (relating to Meat and Poultry Inspection).
Failure of a grant holder to promptly pay invoices will result in cessation
of overtime inspection services. Inspection time includes, but is not limited
to:
(1)
the MSA inspector's time in the field during a hunt;
(2)
the MSA inspector's time spent completing inspection
records;
(3)
the MSA inspector's time spent waiting for any purpose
to facilitate the processor;
(4)
the MSA inspector's time for travel between hunt sites;
and
(5)
the MSA inspector's time for travel from the inspector's
official duty location to the field site and return.
(c)
Sanitary dressing procedures. The following are general
guidelines of sanitary dressing applicable to all species of livestock slaughtered.
(1)
The person performing slaughter operations must not permit
any contamination of edible portions of the carcass with materials such as
feces, urine, hair, ingesta, milk, bile, pathological tissues and exudates,
and other filth. All controls of slaughter and dressing procedures must be
aimed at accomplishing this purpose.
(2)
Slaughter operations must be conducted in a manner
that precludes contamination, i.e., adequate separation of carcasses, parts,
and viscera during dressing; routine cleaning and disinfection of certain
equipment and hand tools; design and arrangement of equipment to prevent the
contact of successive carcasses and parts; and appropriately located, functional
lavatories and disinfection units.
(3)
In the event that contamination does occur, it must
be handled promptly and in a manner that ensures adequate protection to the
remaining product. Contamination with feces, milk, pus, or pathological tissue
or exudate must be promptly removed by trimming. Removal must be complete.
Enough tissue must be removed so only clean meat remains. Scraping with the
edge or back of a knife, wiping with a cloth or towel, or the use of a water
spray are unacceptable procedures for removal of this type of contamination.
(d)
Exotic animal.
(1)
Sanitation. All slaughter operations, including field slaughter,
are to be conducted in a way that precludes contamination. The following conditions,
as a minimum, shall be met.
(A)
The slaughter facility or mobile slaughter unit shall be
constructed of smooth and impervious material capable of being thoroughly
cleaned and sanitized prior to commencing operations and must be so maintained.
(B)
Only potable water shall be used in conjunction with exotic
animal slaughter procedures. Water from private water wells shall be tested
for potability by an approved laboratory within six months prior to use. Water
from portable water tanks shall be tested by an approved laboratory every
six months to determine that potable water remains potable after being in
the portable tanks. Results of such testing shall be made available to the
TDH inspector.
(C)
Hot water at a minimum of 180 degrees Fahrenheit is required
on the skinning/evisceration floor for equipment and unit sanitization during
pre-operational and operational sanitation procedures. For emergency situations
involving loss of unit power, an approved procedure should be available for
utilizing chemical sanitization in lieu of hot water for sanitization during
the remaining period of the hunt.
(D)
Mobile as well as fixed slaughter units shall provide adequate
measures to control flies, other insects, and dust.
(E)
A sufficient number of inedible barrels must be available
during each harvest. Barrels shall be marked "INEDIBLE" in letters at least
two inches high. An adequate amount of denaturant will be used on all products
placed in the "INEDIBLE" barrels.
(2)
Ante-mortem procedures.
(A)
The producer must certify by completing and signing form
MSA-71, Microchip Certification and Drug Advisory For Alternate Food Animal
Species, whether the animal(s) have been identified with a microchip device.
(B)
For mobile slaughter, the assigned inspector will accompany
the vehicle carrying the hunter for the purpose of performing ante-mortem
inspection to assure that the animals being harvested appear healthy. Once
an animal has been shot, the animal will be bled as soon as possible in the
field with a properly sanitized knife.
(C)
For field slaughter, the inspector shall designate the
number of animals that may be slaughtered before it is necessary to return
to the mobile slaughter unit for skinning and eviscerating. The time lapse
will depend on several factors such as environmental temperature and the anatomical
site of bullet entry. High environmental temperature may shorten the time
lapse prior to dressing, as dressing must begin before the abdomen of the
carcass becomes distended due to intestinal gas formation. The TDH inspector
has the final decision in determining the actual time allowed between bleeding
and skinning; however, a two and one half hour time lapse shall not be exceeded.
(3)
Post-mortem procedures.
(A)
The vehicle used for transporting the slaughtered exotic
animals shall be clean prior to use and shall be cleaned as needed, during
the operation.
(B)
Dressing procedures are to begin at the slaughter unit
as soon as practical after slaughter.
(C)
Heads from animals slaughtered by gunshot to the head shall
not be used for food purposes. Such heads shall be denatured and placed into
inedible containers.
(D)
In the event that an animal is shot in an area other than
the head, the resulting wound area and/or bruised areas must be trimmed of
all contamination.
(E)
The dressing of any animal whether it be the removal of
a foot, head, or any part is strictly forbidden in any area other than inside
the slaughter unit, regardless of the size of the animal. However, the removal
of the antlers only is permitted prior to entering the slaughter facility.
(4)
Dressing procedures.
(A)
It is imperative that persons butchering an animal keep
their hands as clean as possible; adequate facilities for washing hands must
be readily accessible.
(B)
Skinning operations begin at the hind legs and must be
conducted in a sanitary manner.
(C)
As the pelt is removed, care must be taken to prevent contamination
of the carcass by dirty hands, knife or pelt.
(D)
If a pelt puller is used in such a manner that the carcass
is raised to a horizontal position, the carcasses of the female animals must
be checked closely for urine leakage.
(E)
Scalping is done after the pelt is loosened from the carcass.
Heads that the establishment elects not to scalp must remain with the carcass
until inspection is completed. Nasal and oral cavities should be flushed before
heads are placed on inspection tables.
(F)
Overall washing of carcasses should be accomplished before
any openings are made for inspection or evisceration. The washer should take
care to prevent filling the rectum with water during washing operations.
(G)
The knife or other instrument used to open the breast must
be disinfected after each use.
(H)
The bung is not to be dropped until washing is completed.
After opening the pelvic area, the neck of the bladder and the dropped bung
should be grasped firmly and held until they clear the body cavity.
(I)
Evisceration must be accomplished in a manner that precludes
contamination of the carcass with contents from the bladder or intestine;
viscera is to be placed in an inspection pan.
(J)
If intestines are to be saved, contamination should be
prevented by stripping and/or tying between the large and small intestine
before removing from the table and sending to the next station.
(5)
Processing. Processing of carcasses shall be
conducted in a manner and location that complies with requirements for processing
all livestock carcasses, including the provisions adopted under §221.11
of this title.
(e)
Ratites.
(1)
Purpose. Meat from ratites (ostrich, emu, and rhea) is
becoming a popular alternate meat food source. It is essential in the public
interest that the health and welfare of consumers be protected by assuring
that meat and meat food products derived from ratites are wholesome, unadulterated,
properly marked, labeled, and packaged. It is also essential to ensure that
the preparation of ratite bird meat and meat food products does not result
in adulteration of other meat and meat food products that may be produced
at the same establishment. Specific requirements of this subsection shall
be in addition to those already required by the Texas Meat and Poultry Inspection
Act and other parts of this subchapter.
(2)
Facilities.
(A)
Ante-mortem facilities shall be furnished as required to
provide for adequate inspection of the birds, at rest and in motion. An adequate
suspect pen shall be furnished as required.
(B)
A separate pre-evisceration area equipped with an exhaust
fan will be available for operations described in paragraph (4) of this subsection
(related to Slaughter procedures -- pre-evisceration).
(C)
Slaughter facilities shall be provided which allow humane
slaughter and production of a wholesome product. It shall meet the standards
as set forth by the Act and by the regulations.
(D)
Rails shall be of sufficient height to allow dressing to
be accomplished without causing contamination of the carcass.
(3)
Ante-mortem procedures.
(A)
Microchip certification. The producer must certify by completing
and signing form MSA-71, Drug Certification For Exotic Game and Alternative
Species Animals, whether the bird(s) had been identified by use of a microchip
device and state the location of the chip implant. The producer must also
certify whether the previous owner used a microchip implant for identification
and state the location of the implant.
(B)
Ante-mortem inspection. The bird shall be observed at rest
and in motion to ascertain that no abnormal conditions exist. Some examples
of abnormal conditions are:
(i)
loose stools characterized by excessive fecal stains around
the vent and/or a pasty vent;
(ii)
bloody diarrhea;
(iii)
regurgitation of food;
(iv)
disinclination to rise from sternal recumbency; and
(v)
weight loss, particularly notable over back and thighs.
(4)
Slaughter procedures - pre-evisceration.
(A)
Stunning and bleeding. The bird shall be rendered unconscious
by an electrical stunner, a captive bolt device, or other humane method; hobbled/shackled
prior to or after stunning; and hoisted from a designated dry landing area,
by one or both legs. A cut shall be made through the thoracic inlet to sever
the heart and/or major arteries and veins exiting the heart to ensure complete
bleeding. Because of the peculiar external fat layer of emus, immediate removal
of the head may be an acceptable alternative to severing the heart and/or
major arteries and veins exiting the heart. The removed head shall be presented
for inspection.
(B)
Air injection. To facilitate feather and skin removal after
the bird has bled thoroughly, an approved filtered air injection system may
be used to inject air via needle beneath the skin.
(C)
De-feathering. Feathers are removed and collected in an
acceptable container. Wing tips and tail set may be removed to facilitate
complete feather removal.
(5)
Slaughter procedures - skinning and evisceration.
De-feathered carcasses are transferred to the evisceration area. If the operator
also works in the pre-evisceration area, the operator's hands, arms and apron
must be washed to remove dust and dander prior to beginning the skinning and
evisceration operations.
(A)
Head removal. If the head was not removed immediately after
stunning, the head should be removed by cutting the skin of neck to expose
the esophagus and trachea. The esophagus is loosened from the neck, cut at
the head, stripped and tied. If the head was removed immediately after slaughter,
the esophagus should be exposed, stripped from the neck and tied. When the
breast plate is removed to facilitate evisceration, tying the esophagus may
not be required. The head and trachea shall be removed from the neck and presented
for inspection.
(B)
Feet (toes) removal. The feet/toes shall be removed prior
to proceeding with the skinning operations. Using a gambrel for hanging the
carcass by both legs will reduce the possibility of the ligaments tearing
and the carcass falling to the ground. A sanitized chain may be attached proximal
to the hock joint and attached to a hook for hanging the carcass.
(C)
Venting/bunging. The vent shall be excised, taking care
to prevent contamination from cloacal material. After the attachments to the
vent are loosened, the vent shall be drawn from the carcass and encased in
a plastic bag and tied.
(D)
Skinning. Skinning shall be done in a manner that does
not result in carcass contamination. "Fisting" or "knuckling" whereby the
skin is removed leaving the fat attached to the carcass to be removed in a
second step, does not provide a sanitary dressing procedure.
(E)
Neck removal. If the length of the neck causes its contamination
by touching the floor it shall be removed. The neck is to be identified appropriately
with the carcass.
(F)
Evisceration. Evisceration and pluck removal shall be accomplished
in such a manner as not to cause contamination of any part of the carcass.
(6)
Post-mortem inspection. Each carcass and all
parts thereof (except feathers and toes), and accompanying viscera, shall
be presented for inspection. Any carcass or viscera exhibiting physiological
or pathological (disease) characteristics shall be tagged "Texas Retained"
and held for inspection by a MSA veterinarian.
(A)
Microchip implants. Birds that have been identified with
microchip implants must have all implanted chips removed in toto. If a chip
cannot be located, the entire part where the chip was implanted will be condemned
and placed in an acceptable container marked "condemned". This condemned part
may not be allowed to enter normal rendering operations unless assurance is
made that the part will not be used in processing animal foods.
(B)
Final trim and rinse. The carcass shall first be trimmed
of all visible contamination and then thoroughly rinsed with potable water.
The inspector-in-charge shall make a final inspection prior to final rinse.
Trimmed parts including external fat containing pin feathers or feather quills
shall be placed in acceptable containers marked "inedible". The permit for
transport to the rendering facility may be issued by the region. The passed
carcass shall be stamped with the approved Texas Inspected and Passed brand
bearing the appropriate "V" and number.
(7)
Pathological conditions.
(A)
The following abnormalities may be suggestive of pathological
conditions:
(i)
low body fat - may indicate septicemia;
(ii)
thickening or granulomatous lungs - may indicate air sacculitis;
(iii)
thickening of intestine, enlargement of spleen, miliary
pattern of liver - may suggest tuberculosis; or
(iv)
splenomegaly - any swelling of the spleen may suggest
a pathological condition.
(B)
The following may also suggest pathological conditions:
(i)
hemorrhagic changes in the intestinal tract;
(ii)
petechial to ecchymotic hemorrhages on serosal aspect
of the intestine;
(iii)
intestinal lumen devoid of digesta, but containing serosanguinous
fluid;
(iv)
subcapsular hepatic hemorrhage;
(v)
ecchymotic hemorrhage of epicardium and/or endocardium;
(vi)
hemoperitoneum;
(vii)
weight loss, particularly notable over back and thighs;
(viii)
depressed attitude; or
(ix)
swelling of one or more joints.
(8)
Temperature and chilling requirements. Ratites
slaughtered and prepared in official establishments are to be chilled in accordance
with 9 CFR, Chapter III, Subchapter C, §381.66, MPI Regulations. Specifically,
the internal temperature of the carcasses shall be reduced to 40 degrees Fahrenheit
or less within 16 hours by air chilling.
(f)
Rabbits. See 9 CFR, Part 354, as adopted by §221.11
of this title.
(g)
Migratory water fowl, game birds, squab. See 9 CFR, Part
362, as adopted by §221.11 of this title.
(h)
Certified products for dogs, cats, and other carnivora.
See 9 CFR, Part 355, as adopted by §221.11 of this title
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 January 14, 2000.
TRD-200000270
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
25 TAC §253.1
(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 Texas Department of Health (department) proposes
the repeal of §253.1 concerning the incorporation by reference of federal
regulations affecting federal grants and assistance relating to environmental
functions.
This rule was adopted by the Texas Department of Health Resources (TDHR)
in 1976. At the time, TDHR (and later its successor, department) was responsible
for environmental protection programs such as, for example, solid waste (including
hazardous waste), drinking water, protection of public drinking water supplies
and bodies of water, on-site sewage disposal systems, and on-site wastewater
treatment research. These environmental protection programs were and are eligible
for federal grants. Adoption of these rules was necessary to ensure eligibility
for federal grants relating to these environmental protection programs. Authority
and responsibility for these environmental programs now reside at the Texas
Natural Resource Conservation Commission (except pesticide regulation which
is at the Texas Department of Agriculture). The Texas Natural Resource Conservation
Commission and the Texas Department of Agriculture -- not the department --
apply for and receive relevant grants from the U.S. Environmental Protection
Agency. The department no longer has authority to pursue grants contemplated
by the underlying federal regulations. Therefore these rules are being repealed.
Mr. John A. Jacobi, P.E., Chief, Bureau of Environmental Health, has determined
that the proposed repeal will have no fiscal implications for state or local
governments as a result of enforcing or administering the repeal.
Mr. Jacobi has also determined that the public benefit anticipated as a
result of enforcing the repeal will be the elimination of a potential source
of public confusion regarding responsibility for certain environmental issues.
There will be no adverse impact on public health. There will be no adverse
economic effect on micro-businesses and/or small businesses because the department
does not apply for or receive federal grants relating to environmental programs
transferred to the Texas Natural Resource Conservation Commission and the
Texas Department of Agriculture. There are no anticipated costs to persons
who are required to comply with the repeal. There will be no effect on local
employment.
Comments regarding the proposed repeal may be sent to John A. Jacobi, P.E.,
Chief, Bureau of Environmental Health, Texas Department of Health, 1100 West
49th Street, Austin, Texas, 78756-3199, (512) 834-6640. Comments regarding
the proposed repeal will be accepted for 30 days following publication in
the
Texas Register
.
The repeal is proposed under the Health and Safety Code, §12.001,
which provides the Board of Health (board) with authority to adopt rules to
implement every duty imposed by law on the board, the department and the Commissioner
of Health.
The repeal does not affect any Texas statute.
§253.1.Federal Regulations of Environmental Protection.
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 January 14, 2000.
TRD-200000281
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 27, 2000
For further information, please call: (512) 458-7236
Chapter 401.
SYSTEM ADMINISTRATION
Subchapter D. CONTRACTS MANAGEMENT FOR COMMUNITY-BASED SERVICES
these sections
]
is to establish requirements concerning the organization of the Board of Health,
(board)
[
the
] policies and procedures which the board will
follow in implementing the duties imposed by law on the board, and the related
responsibilities of the commissioner of health.
The governor, no later than
September 1 of each odd-numbered year, shall designate one board member as
chair and one member as vice-chair.
]
board
] meetings, call special meetings of the board, and
provide for
[
give
] timely notice of a special meeting to
each member. Meetings are described further in §1.5 of this title (relating
to Meetings of the Board of Health).
(b)
(1)
] Board of
Health
[
health
] committees.
appoint
] standing and special committees consisting of board members to expedite
the board's work. The committees will be working extensions of the board.
board
] committee [
for a specific purpose if
the chair determines that an appointment is necessary
].
(2)
(A)
(B)
(a)
] The Health and Safety Code
provides that the
board
[
Board of Health
] was established
to better protect and promote the health of the people of the State of Texas
and have general supervision and control over all matters relating to the
health of the people of the State of Texas.
(b)
] The board, in discharging
its legal responsibilities as the Texas Department of Health's (department)
governing body, shall establish rules, policies, and procedures, which shall
provide the commissioner of health with the authority and direction to administer
the department's services, programs, and activities.
(c)
] The board may delegate or
assign to the commissioner, or to the person acting as commissioner in the
commissioner's absence, any power or duty imposed by law on the board, including
the authority to issue final orders and make decisions; however, the board
may not delegate to the commissioner the power or duty to adopt rules.
(d)
] The board shall supervise
the commissioner's administration and enforcement of federal and state health
laws and implementation of the powers and duties delegated or assigned by
the board
or by the commission
to the commissioner.
(a)
(b)
(c)
] All meetings
of the Board
of Health
shall comply with the Texas Open Meetings Act, Texas Government
Code, Chapter 551.
(1)
(2)
(A)
(B)
(3)
] All meetings shall
be open to the public, except for executive sessions [
which are discussed
in paragraph (4) of this subsection
]. All or any part of the public
meeting may be recorded by any person in attendance by means of tape recorder,
video camera, or any other means of sonic or visual reproduction. The chair
will determine the location of any such equipment and the manner in which
the recording is conducted, provided that the determination does not prevent
or unreasonably impair camera coverage or tape recording.
(4)
(5)
] The board must have a
quorum present to convene a meeting and to conduct official business. A quorum
of the board is four members.
(6)
] The board shall conduct a
meeting in accordance with Robert's Rules of Order, latest edition, unless
there are rules or statutes that require otherwise.
(7)
] An affirmative vote by a majority
of the board membership present and voting is required for the adoption of
a rule, policy, or procedure.
(8)
(9)
] The board shall keep official
minutes of the meetings as required by the Open Meetings Act. The Office of
the Board of Health
shall prepare
[
prepares
] the minutes,
the board
must approve
[
approves
] them, and the chair
and vice-chair
must
sign them. Before the board approves them,
the minutes
shall be
[
are
] sent to each member for review,
comment, or correction prior to approval. The official minutes of all board
meetings are kept in the Office of the Board of Health and are available for
public review as authorized by the Open Meetings Act.
(10)
head
] of the Texas Department
of Health (department), shall perform the duties delegated and assigned by
the Board of Health (board)
, the commissioner of the Health and Human
Services Commission,
and state law. [
Subject to §1.6 of this
title (relating to Actions Requiring Board Approval), the board conducts all
department business through the commissioner.
]
and
] obtain sufficient financial
support
, provide for the operation of the department, and further delegate
to departmental personnel duties delegated or assigned by the board and the
commissioner of the Health and Human Services Commission
;
preliminary
] agenda shall be sent to the Capitol press corps, governor's
office,
Office of the Secretary
[
secretary
] of State
[
state
], and Legislative Budget Board.
Chapter 97.
COMMUNICABLE DISEASES
Communicable Disease Prevention and Control Act, §§85.081-85.089
], which
require
[
requires
] that the Texas Department
of Health (department) develop and offer a training course for persons providing
HIV
and/or hepatitis C
counseling, and
authorizes the department
to
charge a [
reasonable
] fee for the course.
, including
the importance of early intervention and treatment and recognition of psychosocial
needs
].
The department's Bureau of HIV and STD Prevention sets
the content. Detailed information about the course may be obtained from the
Bureau of HIV and STD Prevention, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756- 3199.
$150
] for each
participant whose affiliation is with an entity that does not contract with
the department.
The Bureau of HIV and STD Prevention may waive the fee
according to established internal procedures.
Accepted form
]
forms
of payment
are
[
shall
include
] cashiers check or money order. No other form of payment will
be accepted.
Detailed information about the course can be obtained from the Bureau of HIV
and STD Prevention, Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756-3199.
]
Chapter 133.
HOSPITAL LICENSING
Chapter 135.
AMBULATORY SURGICAL CENTERS
$1,000
].
$1,000
].
Chapter 137.
BIRTHING CENTERS
Subchapter D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES
Chapter 143.
MEDICAL RADIOLOGIC TECHNOLOGISTS
(38)
] Physician--A person
licensed by the Board of Medical Examiners (BME) to practice medicine.
(39)
] Physician assistant--A
person licensed as a physician assistant by the Texas State Board of Physician
Assistant Examiners.
(40)
] Podiatrist--A person
licensed by the Board of Podiatry Examiners (BPE) to practice podiatry.
(41)
] Portable x-ray equipment--Equipment
designed to be hand-carried.
(42)
] Practitioner--A doctor
of medicine, osteopathy, podiatry, dentistry, or chiropractic who is licensed
under the laws of this state and who prescribes radiologic procedures for
other persons for medical reasons.
(43)
] Radiation--Ionizing
radiation in amounts beyond normal background levels from sources such as
medical and dental radiologic procedures.
(44)
] Radiologic procedure--Any
procedure or article intended for use in the diagnosis of disease or other
medical or dental conditions in humans (including diagnostic x-rays or nuclear
medicine procedures) or the cure, mitigation, treatment, or prevention of
disease in humans that achieves its intended purpose through the emission
of ionizing radiation.
(45)
] Registered nurse--A
person licensed by the Board of Nurse Examiners (BNE) to practice professional
nursing.
(46)
] Registry--A list of
names and other identifying information of non-certified technicians.
(47)
] Sponsoring institution--A
hospital, educational, or other facility, or a division thereof, that offers
or intends to offer a course of study in medical radiologic technology.
(48)
] Supervision--Responsibility
for and control of quality, radiation safety and protection, and technical
aspects of the application of ionizing radiation to human beings for diagnostic
and/or therapeutic purposes.
(49)
] Temporary certification,
general or limited--An authorization to perform radiologic procedures for
a limited period, not to exceed one year.
(50)
] TRCR--Texas Regulations
for the Control of Radiation, 25 Texas Administrative Code, Chapter 289 of
this title (relating to Texas Regulations for the Control of Radiation). The
regulations are available from the Standards Branch, Bureau of Radiation Control,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3189
(phone 1-512-834-6688).
In
] order to successfully complete a program, each student must
complete the following
minimum
training:
(1)
] courses which are fundamental
to diagnostic radiologic procedures:
40
] classroom hours;
(C)
] image production and evaluation--
24
[
25
] classroom hours; and
(2)
] one or more of the
following units of applied human anatomy and radiologic procedures of the:
16
] classroom hours;
15
] classroom hours;
20
] classroom hours;
eight
] classroom hours;
15
] classroom
hours;
15
] classroom
hours; and/or
(4)
] of this section in employing
an MRT, LMRT, or NCT.
had at least
one year of experience performing radiologic procedures and who, by July 31,
1999, has completed four hours of study in radiation safety and protection
in a program approved by the department under §143.9 of this title, §143.11
of this title (relating to Continuing Education Requirements), §143.17
of this title, or §143.20 of this title, or provided by a person who
meets the requirements of §143.9(h)(1)-(2) of this title, excluding the
phrase, "the subjects assigned." This subparagraph shall expire October 1,
1999.
]
a sworn affidavit indicating the
[
The
]
following items must be submitted:
a sworn affidavit indicating
] the name(s)
, date of birth, and social security number
of the person(s) who will
perform radiologic procedures pursuant to this hardship exemption;
a sworn affidavit or other documentation stating the person(s)
had at least one year of experience performing radiologic procedures between
January 1, 1993, and July 1, 1998
];
an original verification statement, certificate
of completion or transcript indicating that the person(s) named in the hardship
exemption application has completed or will complete by July 31, 1999, a four-hour
course of study in radiation safety and protection. Documentation of completion
of the four-hour course of study in radiation safety and protection shall
be submitted prior to placement on the department's registry under §143.18
of this title (relating to the Registry of Non-Certified Technicians)
];
if the applicant is a
practitioner or FQHC, proof that the person(s) was registered in accordance
with rules adopted under §2.08 of the Act at the time of application
under this section
];
and
an acknowledgment that the persons performing
radiologic procedures, as an alternative to training, will take and pass the
core section of the limited certificate examination, as described in §143.8
of this title (relating to Examinations) covering radiation protection, radiographic
equipment operation and maintenance, image production and evaluation, and
patient care and management. An examination candidate must pass the examination
on or before July 1999. A person who passes the examination described in this
clause shall be included on the department's registry under §143.18 of
this title. A person listed on the registry is not required to complete the
training described in §143.17 of this title or §143.20 of this title.
A person who does not pass the examination by the third attempt will be notified
by the department that the person may no longer perform radiologic procedures
under this hardship exemption. The following shall apply to this hardship
exemption and the special examination administered under this clause:
]
and
] podiatric medical assistants (PMAs)
and x-ray
equipment operators in a physician's offices
.
10
]
classroom hours;
ten
] classroom hours
and five
out of classroom hours
;
three
]
classroom
hour
[
hours
]
and two out of classroom
hours
;
five
] classroom
hour
[
hours
]
and four out of classroom hours
; and
two
] classroom
hour
[
hours
]
and one
out of classroom hour
.
(f)
] Application procedures for
training programs. The Texas Department of Health (department) shall use the
same process as described in §143.17(e) of this title.
(g)
] Application materials. The
department shall require the same materials as described in §143.17(f)
of this title.
(h)
] Application approval. The
department shall use the same process as described in §143.17(g) of this
title.
(i)
] Application processing. The
department shall use the same process as described in §143.17(h) of this
title.
(j)
] Renewal. The department shall
use the same process as described in §143.17(i) of this title.
Chapter 146.
TRAINING AND REGULATION OF PROMOTORAS
Chapter 221.
MEAT SAFETY ASSURANCE
(3)
] Change in ownership--
(4)
] Custom operations--The
slaughtering of livestock or the processing of an uninspected carcass or parts
thereof for the owner of that livestock animal, carcass, or parts or the selling
of livestock, inspected carcasses, or parts to be slaughtered and/or processed
by the purchaser on premises owned or operated by the seller for the exclusive
use of the purchaser.
(5)
] Custom processor--A
person who prepares meat food products from uninspected livestock carcasses
or parts thereof for the owner of those carcasses or parts [
or sells
inspected carcasses or parts to be prepared by the purchaser on premises owned
or operated by the seller for the exclusive use of the purchaser
].
(6)
] Custom slaughterer--A
person who slaughters livestock for the owner of the livestock animal for
the exclusive use of the owner of the livestock or sells livestock to be slaughtered
by the purchaser on premises owned or operated by the seller, for the exclusive
use of the purchaser of the livestock.
(7)
] Department--Texas Department
of Health.
(8)
] Exotic animal--A member
of a species of game not indigenous to this state, including an axis deer,
nilgai
[
nilga
] antelope, [
red sheep,
] or other
cloven
hoofed
[
hooved
] ruminant animal.
(9)
] Federal regulations--The
regulations adopted by reference by the department in §221.11 of this
title (relating to Federal Regulations on Meat and Poultry Inspection).
(10)
] Feral swine--Nondomestic
descendants of domestic swine that have either escaped or were released and
subsequently developed survival skills necessary to thrive in the wild. Some
are out-crossed with "Russian boar."
(11)
] Game animals--Wild
animals that are hunted for food or recreational purposes and for which the
hunter must obtain a hunting license from the Texas Parks and Wildlife Department
prior to hunting such animals.
(12)
] Grant of custom exemption--An
authorization from the department to engage in a business of custom slaughtering
and/or processing livestock for the owner of the livestock for the owner's
personal use.
(13)
] Grant of inspection--An
authorization from the department to engage in a business subject to inspection
under the Act.
(14)
] Heat-treated--Meat
or poultry products that are ready-to-eat or have the appearance of being
ready-to-eat because they received heat processing.
(15)
] Livestock--Cattle,
sheep, swine, goats, horses, mules, other equines, poultry, domestic rabbits,
exotic animals, or domesticated game birds.
(16)
] Person--Any individual,
partnership, association, corporation, or unincorporated business organization.
(17)
] Poultry--A live or
dead domesticated bird.
and/or
] custom
exemption
, and/or poultry/rabbit exemption
.
and/or
] custom exemption
, and/or poultry/rabbit exemption
issued
by the department.
and/or
] custom exemption
, and/or poultry/rabbit exemption
, a person shall complete department application forms which can be
obtained from the Meat Safety Assurance Division, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756.
(7)
] of this subsection.
(6)
Temporary exemption. Each person
engaged in a business subject to the Act at the time of enactment of the Act
may be allowed a maximum period of 36 months to provide the drawings (blueprints
of the business's physical plant) as required by the federal regulations and
to bring the facility into compliance with these drawings. This 36-month period
will begin upon the date the department gives the person official notice by
certified mail that the person has 36 months to provide the drawings.
]
(7)
] Denial, suspension and
revocation.
by persons operating
under
] the provisions of the Texas Meat and Poultry Inspection Act,
Health and Safety Code, Chapter 433, these rules, and licenses and orders
issued pursuant to the Act
or
[
of
] the rules.
, fraud,
] or other indication
of willfulness. In determining the severity of a violation, there shall be
taken into account the economic benefit gained by a person through noncompliance.
and
]
and
]
and
]
and
]
and
]
.
]
by
] that species.
insure
] sanitary
condition, as specified in the department's guideline titled "Construction
Guide No. 1, Texas State Inspected Meat Packing Plants: A Guide to Construction
and Layout," dated May 1995.
(A)
]
rodenticide
],
and similar pest control substances in hide cellars, inedible product departments,
outbuildings, or similar places, or in storerooms containing canned products
may be used provided they
are labeled for use in or near areas when exposed
food is present
[
have been approved by the U.S. Department of Agriculture
(USDA)
]. So-called rat viruses shall not be used in any part of an establishment
or the premises of the custom slaughter establishments.
(B)
A list of approved pest control substances
is available upon request from the Scientific Services, Meat and Poultry Inspection,
Food Safety and Inspection Service, U.S. Department of Agriculture, Washington,
D.C. 20250.
]
used
] in dressing carcasses shall be thoroughly cleansed
and dipped in hot water having a minimum temperature of 180 degrees Fahrenheit
or in a disinfectant used and prepared according to a written procedure, developed
by the custom slaughterer specifying mixing methods, concentrations, contact
time, the need to rinse with clean water, and storage of mixed solutions.
The use of disinfectant solutions must be safe and effective. [
A list
of approved disinfectants is available upon request from the Scientific Services,
Meat and Poultry Inspection, Food Safety and Inspection Service, U.S. Department
of Agriculture, Washington, D.C. 20250.
]
USDA approved
] for such purpose. Ink containing FD&C
Violet No. 1 shall not be used.
insure
] sanitary
condition, as specified in the department's guideline titled "Construction
Guide No. 1, Texas State Inspected Meat Packing Plants: A Guide to Construction
and Layout," dated May 1995.
(A)
]
have been approved
by the United States Department of Agriculture (USDA)
]. So-called rat
viruses shall not be used in any part of an establishment or the premises
of the custom processing establishments.
(B)
A list of approved pest control substances
is available upon request from the Scientific Services, Meat and Poultry Inspection,
Food Safety and Inspection Service, U.S. Department of Agriculture, Washington,
D.C. 20250.
]
used
] in
processing
[
deboning
] carcasses
or parts, shall be thoroughly cleansed and dipped in hot water having a minimum
temperature of 180 degrees Fahrenheit or in a disinfectant used and prepared
according to a written procedure, developed by the custom processor specifying
mixing methods, concentrations, contact time, the need to rinse with clean
water, and storage of mixed solutions. The use of disinfectant solutions must
be safe and effective. [
A list of approved disinfectants is available
upon request from the Scientific Services, Meat and Poultry Inspection, Food
Safety and Inspection Service, U.S. Department of Agriculture, Washington,
D.C. 20250.
]
may
] be used.
Chapter 253.
ENVIRONMENTAL ENGINEERING
Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION