Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 96.
BLOODBORNE PATHOGEN CONTROL
25 TAC §§96.101, 96.201 - 96.203, 96.301 - 96.304, 96.401, 96.402, 96.501, 96.601
The Texas Department of Health (department) proposes new §§96.101,
96.201-96.203, 96.301-96.304, 96.401-96.402, 96.501, and 96.601, concerning
the standards for occupational exposure of governmental unit employees to
bloodborne pathogens. New §96.101 provides definitions. New §96.201
clarifies the applicability of the "minimum standards". New §96.202 adopts
the exposure control plan required by Health and Safety Code §81.304.
The exposure control plan described in §96.202 will be published as a
"miscellaneous document" in the
Texas Register
.
New §96.203 clarifies the plan and explains how it should be used. New §96.301
recommends that governmental units use particular types of injury protection
devices, and provides a method of obtaining a waiver from this recommendation
as required by Health and Safety Code §81.305. New §96.302 establishes
criteria for manufacturers of devices to register the device with the department
as required by Health and Safety Code §81.307. New §96.303 establishes
procedures for the registration of eligible devices. New §96.304 establishes
a fee to register a needleless system devise. New §96.401 requires that
sharps injuries be entered into a log maintained by the employer, and reported
to the department as required by Health and Safety Code 81.306. New §96.402
establishes the confidentiality of information reported to the department
or its agents. New §96.501 provides for a one year waiver from these
rules for certain rural counties, as required by Chapter 1411 (House Bill
2085), §26.02, 76th Legislature. New §96.601 specifies the effective
date of these rules.
The rules are needed to adopt minimum standards for an exposure control
plan. The plan would decrease the risk of exposure to bloodborne pathogens
for employees who work in governmental units by increased training and education;
increased use of vaccination for employees; and increased use of personal
protective equipment. The recommendation for the use of needleless systems
and sharps with engineered sharps injury protection will reduce the risk of
injury and transmission of bloodborne pathogens to governmental unit employees.
Data regarding the number of needlestick or sharp injuries occurring is based
on published estimates. This rule requiring governmental units to report these
injuries will provide a more accurate number of injuries occurring in Texas.
This reported information provides a basis for future recommendations regarding
intervention measures and a basis on which to assess the impact of future
interventions. The new sections are required by Health and Safety Code, Chapter
81, Subchapter H, which were added by Chapter 1411 (House Bill 2085), §§26.01-
26.03, 76th Legislature, to extend the protections provided to employees of
private entities by Occupational Safety and Health Administration (OSHA) rules,
to employees of state and local governments, and for related purposes.
Sharilyn K. Stanley, M.D., Associate Commissioner, Disease Control and
Prevention, has determined that for the first five year period that the sections
are in effect there will be fiscal implications as a result of administering
the sections as proposed. The annualized average costs to the department,
due to a graduated compliance and implementation schedule, will be approximately
$73,000 the first two years, and the annualized average cost for each year
of the next three years will be approximately $41,000. The new rules will
also generate income to the state by the collection of a fee for the registration
of devices with the department. The effect on state government will be an
estimated $75,000 per year for the first two years in fee-generated revenue.
The department will review the estimated fee-generated revenue and consider
changing the fee after the first two years.
Dr. Stanley has also determined that for each year of the first five years
these sections are in effect, the public benefit anticipated as a result of
enforcing the sections will be the protection of public employees and volunteers
from exposure to bloodborne illnesses, a greater epidemiological understanding
of exposures to bloodborne illnesses, and a greater public awareness of engineered
systems to prevent such exposures. The anticipated cost to micro businesses,
and small businesses, is zero because the statute was written to cover governmental
employers only.
There will be costs to those state and local agencies required to comply
with the rules (those operating health care facilities, or who otherwise have
employees at risk of exposure to bloodborne pathogens). These costs may be
reduced due to graduated compliance with the recommendation to implement needleless
systems or sharps with engineered sharps injury protection (§96.301).
Rural counties may have costs slightly lower during the first year because
they may seek a waiver during this period under §96.501.
These costs represent the cost of preventing serious communicable diseases,
and over time they should be offset by reductions in the costs of treating
these diseases; such costs are frequently borne, directly or indirectly, by
state and local governments. These costs are in many cases only theoretical
since many responsible employers already implement many of the techniques
required by the exposure control plan, though they have not been legally required
to do so. Most other employers are already covered by similar federal rules
under the OSHA Act. There is no anticipated impact on local employment.
Based on Title 29 Code of Federal Regulation §1910.1030, Occupational
Safety and Health Administration (OSHA), Bloodborne Pathogens Standard (Vol.
56 No. 235, December 6, 1991), the compliance cost for each affected government
outpatient clinic was estimated to be $978 annually. Based on OSHA estimates
from corporate tax schedules, compliance costs as a percentage of sector revenue
(or budgets) ranged from 0.04% to 0.7% for affected establishments.
Based on estimates from a local health department with a client base of
45,000, the cost for the first year will be approximately $1,900 and in subsequent
years $1,200. These costs may fluctuate based on salary structures and prior
implementation of techniques required by the exposure control plan.
Comments may be submitted in writing to Sharilyn K. Stanley, M.D., Associate
Commissioner, Disease Control and Prevention, 1100 West 49th Street, Austin,
Texas 78756. Comments will be accepted for 45 days following the date of publication
of this proposal in the
Texas Register
.
These new rules are proposed under Health and Safety Code §81.303
which requires the department to establish an exposure control plan; Health
and Safety Code §81.304 which requires the board to adopt minimum standards
to implement the exposure control plan; Health and Safety Code §81.305
which requires the board to recommend by rule that governmental units implement
needleless systems; Health and Safety Code §81.306 which requires the
board to require the reporting of information concerning exposure incidents;
Health and Safety Code §81.307 which requires the board to implement
a registration program for existing needleless systems and sharps with engineered
sharps injury protection; Chapter 1411 (House Bill 2085), §26.02, 76th
Legislature, which allows the board by rule to waive application of Health
and Safety Code, Chapter 81, Subchapter H, for certain rural counties; Health
and Safety Code §81.021 which requires the board to exercise its power
in matters relating to protecting the public health to prevent the introduction
of disease into the state; Health and Safety Code §81.004 which allows
the board to adopt rules necessary for the effective administration and implementation
of Chapter 81; and Health and Safety Code, §12.001, which provides the
board with authority to adopt rules to implement every duty imposed by law
on the board, the department, and the commissioner of health.
The new sections affect Health and Safety Code, Chapter 81.
§96.101.Definitions.
The following words and terms when used in this chapter shall have
the following meanings unless the context clearly indicates otherwise.
(1)
Blood - Human blood, human blood components, and products
made from human blood.
(2)
Bloodborne pathogens - Pathogenic microorganisms that
are present in human blood and that can cause diseases in humans, and include:
(A)
hepatitis B virus (HBV);
(B)
hepatitis C virus (HCV); and
(C)
human immunodeficiency virus (HIV).
(3)
Contaminated equipment - Any equipment used in
the workplace that has been soiled with blood or other potentially infectious
materials on an item or surface.
(4)
Contaminated sharps injury - Any sharps injury that
occurs with a sharp used or encountered in a health care setting that is contaminated
with human blood or body fluids.
(5)
Device - An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory that is:
(A)
recognized in the official United States Pharmacopoeia
National Formulary or any supplement to it;
(B)
intended for use in the diagnosis of disease or other conditions,
or in the cure, mitigation, treatment, or prevention of disease in man or
other animals; or
(C)
intended to affect the structure or any function of the
body of man or other animals and that does not achieve any of its principal
intended purposes through chemical action within or on the body of man or
other animals and is not dependent on metabolization for the achievement of
any of its principal intended purposes.
(6)
Employee - An individual who works for a governmental
unit or on premises owned or operated by a governmental unit whether or not
he or she is directly compensated by the governmental unit.
(7)
Employs - Engages the services of employees.
(8)
Engineered sharps injury protection - A physical attribute
that:
(A)
is built into a needle device used for withdrawing body
fluids, accessing a vein or artery, or administering medications or other
fluids and that effectively reduces the risk of an exposure incident by a
mechanism, such as barrier creation, blunting, encapsulation, withdrawal,
retraction, destruction, or another effective mechanism; or
(B)
is built into any other type of needle device, into a nonneedle
sharp, or into a nonneedle infusion safety securement device that effectively
reduces the risk of an exposure incident.
(9)
Exposure incident - A specific eye, mouth, other
mucous membrane, nonintact skin, or parenteral contact with blood or other
potentially infectious materials that results from the performance of an employee's
duties.
(10)
Governmental unit - This state and any agency of
the state, including a department, bureau, board, commission, or office and
includes:
(A)
a political subdivision of this state, including any municipality,
county, or special district; or
(B)
any other institution of government, including an institution
of higher education.
(11)
HBV - Hepatitis B virus.
(12)
HCV - Hepatitis C virus.
(13)
Health care professional - A person whose legally
permitted scope of practice allows him or her to independently evaluate an
employee of a governmental unit and determine the appropriate interventions
after an exposure incident; this would include hepatitis B vaccination and
postexposure evaluation and follow up.
(14)
HIV - Human immunodeficiency virus.
(15)
Needleless system - A device that does not use a
needle and that is used:
(A)
to withdraw body fluids after initial venous or arterial
access is established;
(B)
to administer medication or fluids; or
(C)
for any other procedure involving the potential for an
exposure incident.
(16)
Occupational exposure - A reasonably anticipated
skin, eye, mucous membrane, or parenteral contact with blood or other potentially
infectious materials that may result from the performance of an employee's
duties.
(17)
Other potentially infectious materials include:
(A)
the following human body fluids: semen, vaginal secretions,
cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal
fluid, amniotic fluid, saliva in dental procedures, any body fluid that is
visibly contaminated with blood, and all body fluids in situations where it
is difficult or impossible to differentiate between body fluids;
(B)
any unfixed tissue or organ (other than intact skin) from
a human, living or dead; and
(C)
HIV-containing cell or tissue cultures, organ cultures,
and HIV- or HBV- containing culture medium or other solutions; and blood,
organs, or other tissues from experimental animals infected with HIV or HBV.
(18)
Personal protective equipment - Specialized
clothing or equipment worn by an employee for protection against a hazard.
General work clothes (eg, uniforms, pants, shirts, or blouses) not intended
to function as protection against a hazard are not considered to be personal
protective equipment.
(19)
Regulated waste/special waste from health care-related
facilities - Solid waste which if improperly treated or handled may serve
to transmit an infectious disease(s) and which is composed of the following:
(A)
animal waste;
(B)
bulk blood, bulk human blood products, or bulk human body
fluids;
(C)
microbiological waste;
(D)
pathological waste; or
(E)
sharps.
(20)
Sharp - An object used or encountered in a health
care setting that can be reasonably anticipated to penetrate the skin or any
other part of the body and to result in an exposure incident and includes:
(A)
needle devices;
(B)
scalpels;
(C)
lancets;
(D)
a piece of broken glass;
(E)
a broken capillary tube;
(F)
an exposed end of a dental wire; or
(G)
a dental knife, drill, or bur.
(21)
Sharps injury - Any injury caused by a sharp,
including a cut, abrasion, or needlestick.
(22)
Universal precautions/standard precautions - Approaches
to infection control as defined in Title 29 Code of Federal Regulation §1910.1030,
Occupational Safety and Health Administration (OSHA), Bloodborne Pathogens
Standard and Morbidity and Hospital Infection Control Practices Advisory Committee,
Guideline for isolation precautions in hospitals published in Infection Control
Hospital Epidemiology, 1996;17:53-80, and
American
Journal of Infection Control
, 1996;24:24-52. According to the concept
of universal precautions, all human blood and certain human body fluids are
treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.
§96.201.Applicability.
(a)
These minimum standards apply to a governmental unit that
employs employees who:
(1)
provide services in a public or private facility providing
health care-related services, including home health care organizations; or
(2)
otherwise have a risk of exposure to blood or other
material potentially containing bloodborne pathogens in connection with exposure
to sharps.
(b)
These governmental units would include, but are not limited
to, hospital district hospitals, city hospitals, county hospitals, city/county
hospitals, hospital authority hospitals, local health departments, regional
health departments, state hospitals, Mental Health Mental Retardation state
hospitals and state schools, community mental health mental retardation centers,
Texas Youth Commission, Texas Department of Criminal Justice, local- or state-funded
university student infirmaries, public school district clinics, emergency
medical services, local- or state-funded long term care facilities, and blood
banks.
(c)
Employees who are directly compensated by a governmental
unit are subject to all provisions of this chapter. Employees who are subject
through their private employer to the Occupational Safety and Health Administration
(OSHA), Bloodborne Pathogens Standard and uncompensated employees are subject
only to the log and reporting provisions of §§96.401 of this title
(relating to Sharps Injury Log), and 96.402 of this title (relating to Confidentiality
Statement) unless otherwise required by contract.
§96.202.Exposure Control Plan.
(a)
The exposure control plan (plan), developed by the Texas
Department of Health (department), is adopted as the minimum standard to implement
Health and Safety Code, 81.304. The plan is designed to minimize exposure
of employees as described in §96.201 of this title (relating to Applicability)
and includes policies relating to occupational exposure to bloodborne pathogens,
training and educational requirements for employees, measures to increase
vaccination of employees, and increased use of personnel protective equipment
by employees.
(b)
Copies of the plan are available on the Internet at http://www.tdh.state.tx.us/ideas/report/sharps.htm
or from the Texas Department of Health Public Health Regional offices.
§96.203.Minimum Standards.
(a)
This exposure control plan (plan) is provided by the Texas
Department of Health (department) to be analogous with Title 29 Code of Federal
Regulation §1910.1030, Occupational Safety and Health Administration
(OSHA), Bloodborne Pathogens Standard as specified in Health and Safety Code, §81.304.
(b)
Employers should review the plan for particular requirements
as applicable to their specific situation. Governmental units may modify the
plan appropriately to their respective practice settings. Employers will need
to include provisions relevant to their particular facility or organization
in order to develop an effective, comprehensive exposure control plan specific
to their facility or organization.
(c)
Employers will annually review their exposure control plan,
update when necessary, and document when accomplished.
§96.301.Safety Recommendations.
(a)
The Texas Department of Health (department) recommends
that governmental units implement needleless systems and sharps with engineered
sharps injury protection for employees.
(b)
Waiver for undue burden.
(1)
The recommendation adopted in subsection (a) of this section
does not apply to the use of a needleless system or sharps with engineered
sharps injury protection in circumstances and in a calendar year in which
an evaluation committee, created in conformance with subsection (c) of this
section, has established that the use of needleless systems and sharps with
engineered sharps injury protection:
(A)
will jeopardize patient or employee safety with regard
to a specific medical procedure; or
(B)
will be unduly burdensome.
(2)
A report of the evaluation committee's decision
to request a waiver shall be submitted in writing prior to January 1st of
each year to the Associate Commissioner, Disease Control and Prevention, 1100
West 49th Street, Suite G-401, Austin, Texas 78756.
(3)
Waivers for one year periods will be issued beginning
January 1, 2001.
(4)
The use of a prefilled syringe that is approved by
the federal Food and Drug Administration may not be prohibited. This prohibition
expires on May 1, 2003.
(c)
Evaluation committee.
(1)
At least half of the members of an evaluation committee
established by a governmental unit to implement subsection (b) of this section
must be employees who are health care workers who have direct contact with
patients or provide services on a regular basis.
(2)
Whenever possible, the governmental entity establishing
the evaluation committee shall consider using committees with similar duties
in existence on September 1, 1999.
§96.302.Device Registration
(a)
The Texas Department of Health (department) shall compile
and maintain a list of needleless system devices and sharps devices with engineered
sharps injury protection that are available in the commercial marketplace
and registered with the department to assist governmental units to comply
with this chapter.
(b)
Each needleless system device or sharps device with engineered
sharps injury protection that is the subject of the department's device registration
application shall be in conformance with all applicable premarket notification
or premarket approval requirements established by the U.S. Food and Drug Administration
(FDA) unless otherwise exempted from such requirements.
(c)
Each device manufacturer who manufactures a needleless
system device or sharps device with engineered sharps injury protection and
who desires to register the device for the first time with the department
shall apply for registration in accordance with the procedures found in §96.303
of this title (relating to Registration Procedures).
(d)
If a device manufacturer introduces more than one needleless
system device or sharps device with engineered sharps injury protection into
commerce, the manufacturer shall register each device separately in order
for the device to be included on a list maintained by the department.
(e)
Each sharps device with engineered sharps injury protection
that is the subject of the department's device registration application shall
contain physical attributes consistent with those recognized as effective
for engineered sharps injury protection, as defined in §96.101(8) of
this title (relating to Definitions).
(f)
The department may accept reports from authorities in other
jurisdictions, including the FDA, to determine the extent of compliance with
these sections and with the provisions of Health and Safety Code, Chapter
81, Subchapter H.
(g)
The department shall register a needleless system device
or sharps device with engineered sharps injury protection that meets the requirements
of these sections.
(h)
Registration of a needleless system device or sharps device
with engineered sharps injury protection by the department does not constitute
an endorsement or recommendation of such device.
(i)
Registration certificates shall not be transferable from
one device to another or from one device name to another. Any request for
transfer of registration due to a change in ownership shall be made pursuant
to the requirements in subsection (l) of this section.
(j)
All device registration certificates shall expire on December
31, 2001 and annually thereafter.
(k)
Renewal of registration.
(1)
Upon expiration of a device registration, the registration
may be renewed by filing an application for renewal on a form prescribed by
the department, accompanied by the appropriate renewal fee.
(2)
The renewal registration certificate shall be valid
through December 31st of the year issued.
(3)
The appropriate registration renewal form and renewal
fee for each device should be submitted to the department not later than 30
days following the expiration date of the current device registration in order
to maintain the device on the department's list of existing needleless system
devices and sharps devices with engineered sharps injury protection.
(4)
The department shall renew the registration of a needleless
system device or sharps device with engineered sharps injury protection following
receipt of the appropriate renewal form and renewal fee.
(l)
The device manufacturer shall notify the department in
writing of any change that would render the information required in the initial
registration application no longer accurate. Upon receipt of a written notification
involving a change, the department may update the information contained in
its list of needleless system devices and sharps devices with engineered sharps
injury protection in order to reflect the change.
§96.303.Registration Procedures.
(a)
Any device manufacturer desiring to register a needleless
system device or sharps device with engineered sharps injury protection shall
make written application for registration on forms provided by the Texas Department
of Health (department). A separate completed application is required for each
device to be registered. Registration application forms may be obtained from
the Texas Department of Health, Bureau of Food and Drug Safety, 1100 West
49th Street, Austin, Texas, 78756.
(b)
The initial application for device registration shall include
the following information:
(1)
name, model, common name, and available sizes of the device;
(2)
premarket notification or approval number assigned
by the U.S. Food and Drug Administration, unless otherwise exempted;
(3)
name, mailing address, and telephone number of the
device manufacturer;
(4)
name of the contact person for the device manufacturer;
(5)
designation as either a needleless system device or
sharps device with engineered sharps injury protection;
(6)
if a sharps device with engineered sharps injury protection,
a description of the physical attribute(s) that effectively reduces the risk
of sharps injury; and
(7)
name and signature of the person responsible for submitting
the device registration application.
§96.304.Registration Fees.
The Texas Department of Health (department) shall charge a fee to register
a needleless system device or sharps device with engineered sharps injury
protection.
(1)
An initial registration fee of $1,500 shall be required
for each device registered.
(2)
An annual renewal fee of $1,000 shall be required
for renewing the registration of each device.
(3)
Initial and renewal registration fees will be assessed
to cover the costs associated with the review and processing of device registration
applications and in the administration of these sections and are therefore
nonrefundable.
§96.401.Sharps Injury Log.
(a)
The chief administrative officer for each facility within
a governmental unit shall report, as required by this section, each employee,
as defined in §96.101(6) of this title (relating to Definitions), who
sustains a contaminated sharps injury, as defined in §96.101(4) of this
title. The chief administrative officer of the governmental unit may designate
an employee for each facility within the governmental unit to serve as the
reporting officer.
(b)
Information concerning each contaminated sharps injury
shall be recorded in a written or electronic sharps injury log which shall
be maintained by a governmental unit, in accordance with Health and Safety
Code, Chapter 81, Subchapter H, and this chapter.
(c)
The following information must be recorded in the sharps
injury log:
(1)
name and address of facility where injury occurred;
(2)
name and phone number of the chief administrative
officer or reporting officer;
(3)
date and time of the injury;
(4)
age and sex of the injured employee;
(5)
type and brand of sharp involved;
(6)
original intended use of the sharp;
(7)
whether the injury occurred before, during, or after
the sharp was used for its original intended purpose;
(8)
whether the exposure was during or after the sharp
was used;
(9)
whether the device had engineered sharps injury protection,
as defined in §96.101(8)(A) and (B) of this title (relating to Definitions),
and if yes, was the protective mechanism activated and did the exposure incident
occur before, during, or after activation of the protective mechanism;
(10)
whether the injured person was wearing gloves at
the time of the injury;
(11)
whether the injured person had completed a hepatitis
B vaccination series;
(12)
whether a sharps container was readily available
for disposal of the sharp;
(13)
whether the injured person received training on the
exposure control plan during the 12 months prior to the incident;
(14)
the involved body part;
(15)
the job classification of the injured person;
(16)
the employment status of the injured person;
(17)
the location/facility/agency and the work area where
the sharps injury occurred; and
(18)
a listing of the implemented needleless systems and
sharps with engineered sharps injury protection for employees available within
the governmental entity.
(d)
Information concerning each contaminated sharps injury
shall be reported not later than ten working days after the end of the calendar
month in which it occurred.
(e)
A chief administrative officer for each facility within
a governmental unit or the designee shall report the contaminated sharps injury
to the local health authority where the facility is located. The local health
authority, acting as an agent for the Texas Department of Health (department),
shall receive and review the report for completeness, and submit the report
to the department. If no local health authority is appointed for the jurisdiction
where the facility is located, the report shall be made to the regional director
of the Texas Department of Health (department) regional office in which the
facility is located.
(f)
A contaminated sharps injury shall be reported on the department's
Contaminated Sharps Injury Reporting Form or through an electronic means established
by the department. Copies of the Contaminated Sharps Injury Reporting Form
can be obtained on the Internet at http://www.tdh.state.tx.us/ideas/report/sharps.htm
or from the Texas Department of Health Public Health Regional offices.
§96.402.Confidentiality Statement.
(a)
All information and materials obtained or compiled by the
Texas Department of Health (department) or an agent of the department in connection
with a report under this chapter are confidential and not subject to disclosure
under Government Code, Chapter 552, and not subject to disclosure, discovery,
subpoena, or other means of legal compulsion for their release by the department
or its agents. For the purposes of these rules, all local health authorities
are agents for the department.
(b)
The department shall make available, in aggregate form,
the information described in Health and Safety Code §81.305(b) and this
chapter, provided that the name and other information identifying the facility
is deleted and the information is provided according to public health regions
established by the department.
(c)
All information and materials obtained or compiled by the
department or an agent of the department in connection with this chapter,
are considered information relating to cases or suspected cases of diseases
or health conditions, and may be released only as allowed by Health and Safety
Code §81.046.
§96.501.Waiver for Rural Counties.
(a)
The Texas Department of Health (department) shall waive
the application of Health and Safety Code, Chapter 81, Subchapter H, to a
rural county if the department finds that the application of the Subchapter
to the county would be burdensome.
(b)
Waivers granted under this section expire December 31,
2001.
(c)
A "Rural County" is a county that:
(1)
has a population of 50,000 or less; or
(2)
has a population of more than 50,000 but:
(A)
does not have located within the county a general or special
hospital licensed under Chapter 241, Health and Safety Code, with more than
100 beds; and
(B)
was not, based on the 1990 federal census, completely included
within an area designated as urbanized by the Bureau of the Census of the
United States Department of Commerce.
(d)
A request for a waiver under the provisions of this section
shall be submitted in writing prior to January 1, 2001 to the Associate Commissioner,
Disease Control and Prevention, 1100 West 49th Street, Suite G-401, Austin,
Texas 78756.
§96.601.Effective Dates.
(a)
The exposure control plan (plan) and the rules are effective
September 1, 2000.
(b)
Except as provided in §96.501 of this title (relating
to Waiver for Rural Counties), a governmental unit shall comply with this
chapter not later than January 1, 2001.
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 February 25, 2000.
TRD-200001441
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §§103.1
- 103.2, the repeal of §§103.3 - 103.9, and new §§103.3
- 103.15 concerning a trauma reporting and analysis system.
Government Code §2001.039, added by Chapter 1499, Art. 1, §1.11(a),
76th Legislature (1999), requires that each state agency review and consider
for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Sections 103.1 - 103.9
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist. Sections 103.1 103.2 are being amended and §§103.3
- 103.9 are being repealed and proposed as new rules.
The department published a Notice of Intention to Review the sections as
required by Government Code §2001.039 in the
Texas Register
on December 17, 1999, (24 TexReg 11541). There were
no comments received due to the publication of the Notice.
These amendments and new sections implement Health and Safety Code, Chapter
773, Subchapter E concerning the establishment of a trauma reporting and analysis
system, formerly implemented by Title 25, Texas Administrative Code §157.129,
and the Health and Safety Code, §92.002 which requires the Board of Health
to adopt rules necessary to implement a system of injury reporting. The trauma
reporting and analysis system has been maintained by the Trauma Registry program
which moved from the Bureau of Emergency Medical Services to the Bureau of
Epidemiology in 1993.
Specifically, the amendment to §103.1 clarifies the statutory authority
for the implementation of the trauma registry. The amendment to §103.2
adds eight new definitions and amends three others to clarify the intent of
the rules. New §103.3 adds trauma patients and transported traumatic
injuries to the list of reportable injuries and the repeal of §103.3
deletes language specifying type of data to be reported. Sections §§103.4
- 103.9 are being repealed and replaced with new §§103.4 - 103.15.
The repeal of §103.4 and new §§103.4 - 103.15 are needed to
clarify existing injury reporting requirements, describe reporting requirements
for trauma patients and transported traumatic injuries, and clarifies the
Technical Advisory Committee on Injury Reporting. These sections specify who
is to report, type of data to be reported, procedure for reporting, frequency
of reporting, and clarifies the operations of the Technical Advisory Committee
on Injury Reporting.
Specifically, §§103.5, 103.6, 103.7 and 103.8 are being renumbered
to new §§103.11, 103.12, 103.13 and 103.14 respectively due to new §§103.4-103.10.
Other than renumbering, new §103.11 (formerly §103.5) will have
no revisions. New §103.12 (formerly §103.6) updates the chapter
number of the Injury Prevention and Control Act of the Health and Safety Code
from Chapter 87 to Chapter 92, to be consistent with the renumbering of this
statute by the legislature; adds language formerly in §103.4 relating
to the authority of the department to contact entities attending a person
with a case or suspected case of a reportable injury; and adds language formerly
in §103.4 regarding the department's authority to provide summary data
to local and regional health departments. New §103.13 (formerly §103.7)
changes the name State Trauma Registry to Texas Trauma Registry and adds language
concerning the provision of data to reporting health care entities and other
department bureaus. New §103.14 (formerly §103.8) changes the former
agency name of Texas Workers Compensation Commission to the new agency name
of Texas Workforce Commission.
New §103.15 (formerly §103.9) revises provisions relating to
the operation of the Technical Advisory Committee on Injury Reporting. Specifically,
language is revised to reference the Government Code; to continue the committee
until November 1, 2003; to clarify that members holdover until their replacement
is appointed; to state that the presiding and assistant presiding officers
shall be appointed by the chairman of the board for a term of two years; to
allow a temporary vacancy in the office of assistant presiding officer to
be filled by vote of the committee until appointment by the chairman of the
board occurs; to clarify that the committee is prohibited from holding an
executive session (closed meeting) for any reason; to clarify that the committee
and its members may not participate in legislative activity in the name of
the board, the department, or the committee except with certain approval;
and to require the committee's annual report in November. These changes will
clarify procedures for the committee and emphasize the advisory nature of
the committee.
David F. Zane, Director, Injury Epidemiology and Surveillance Program,
has determined that for the first five year period that the sections are in
effect that there will be no fiscal implications to state or local government
as a result of enforcing and administering the sections as proposed because
the types of injuries and methods of reporting are not being substantially
changed.
Mr. Zane has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing the sections as proposed will be improved knowledge of the prevalence
of injuries and an expanded ability to identify common causes of injuries
in Texas. There will be no adverse economic effect on micro-businesses and/or
small businesses and persons who may be required to comply with these sections
as proposed because the types of injuries and methods of reporting are not
being substantially changed. There are no anticipated economic costs to persons
who are required to comply with the sections as proposed. The finding of no
adverse economic effect on micro-businesses and/or small businesses is based
on proper business management practices by those entities required to comply
with these sections as proposed. There will be no impact on local employment.
Comments on the proposal may be submitted to David F. Zane, Director, Injury
Epidemiology and Surveillance Program, Bureau of Epidemiology, Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756-3180, (512)458-7266.
Comments will be accepted for 30 days following the publication in the
25 TAC §§103.1-103.15
The amendments and new sections are proposed under the Health
and Safety Code, §92.002, which requires the board to adopt rules necessary
to implement the reporting of injuries; the Health and Safety Code, §§773.112(c)
and 773.113(a)(3), which require the department to adopt rules necessary to
implement a trauma reporting and analysis system; and Health and Safety Code, §12.001,
which allows the board to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health; and Government
Code §2001.039, added by Chapter 1499, Art. 1, §1.11(a), 76th Legislature
(1999) is implemented by this proposal.
The amendments and new sections affect the Health and Safety Code, Chapters
92 and 773.
§103.1.Purpose.
These sections implement the Texas Injury Prevention and Control Act,
Health and Safety Code, Chapter 92, which authorizes the Texas Board of Health
to adopt rules concerning the reporting and control of injuries.
These
sections also implement Health and Safety Code, §§773.112(c) and
773.113(a)(3), which require the department to establish and maintain a trauma
reporting and analysis system.
These sections also implement Chapter
893, 75th Legislature, 1997, which amends the Texas Injury Prevention and
Control Act to include traumatic brain injuries as reportable injuries. Nothing
in the rules shall be construed to preempt or impede the authority of a health
authority, a local health department, a public health district, a municipality,
or a county to conduct the same activities within its jurisdiction.
§103.2.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1) - (7)
(No change.)
(8)
Hospital Reporting Guidelines - The
Texas Trauma Registry's manual for hospitals which documents reporting procedures
and format. A copy of the current guidelines can be obtained from the Trauma
Registry, Bureau of Epidemiology, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756.
(9)
[
(10)
Pre-hospital Reporting Guidelines
- The Texas Trauma Registry's manual for pre-hospital providers which documents
reporting procedures and format. A copy of the current guidelines can be obtained
from the Trauma Registry, Bureau of Epidemiology, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756.
(11)
Program - The Injury Epidemiology
and Surveillance Program.
(12)
Regional Trauma Registry - The organization
which receives and collects trauma data for a designated area of the state
and maintains the system by which the collected information is reported to
the department.
(13)
[
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
Transported traumatic injuries -
Traumatic injuries transported by a pre-hospital provider to a hospital or
traumatic injuries transferred by a pre-hospital provider from one hospital
to another hospital.
(20)
Trauma - An injury or wound to a
living body caused by the application of an external force or violence, including
burn injuries. Poisonings, near- drownings and suffocations, other than those
due to external forces, are to be excluded from this definition.
(21)
Trauma Patient - A patient that meets
the following criteria: Has sustained at least one injury (International Classification
of Diseases 9th Revision Clinical Modification diagnostic codes between 800.0
and 959.9, excluding 905-909, 910-924, and 930- 939), and admitted to a hospital
inpatient setting (for more than 24 hours), or died after receiving any evaluation
or treatment or was dead on arrival, or transferred into or out of the hospital.
For subsequent editions of the International Classification of Diseases, equivalent
codes should be used.
(22)
Trauma Service Area - A multi-county
area in which an emergency medical services and trauma care system has been
developed by a Regional Advisory Council and has been recognized by the department.
(23)
[
(24)
[
§103.3.List of Reportable Injuries and Conditions.
(a)
Submersion injuries.
(b)
Traumatic spinal cord injuries.
(c)
Traumatic brain injuries.
(d)
Information on trauma patients.
(e)
Transported traumatic injuries.
§103.4.Who Shall Report.
(a)
The following persons or their designees shall report all
newly diagnosed cases or suspected cases of submersion injuries:
(1)
a physician who diagnoses or treats a submersion injury
or suspected case of a submersion injury;
(2)
a medical examiner;
(3)
justice of the peace;
(4)
a hospital that diagnoses or treats a submersion injury
or suspected case of a submersion injury; or
(5)
a pre-hospital provider that transports a submersion
injury or suspected case of a submersion injury to a hospital;
(b)
The following entities or their designees shall report
all newly diagnosed cases of, or suspected cases of traumatic spinal cord
injuries and traumatic brain injuries:
(1)
a physician who diagnoses or treats a traumatic spinal
cord injury or a traumatic brain injury or a suspected case of a traumatic
spinal cord injury or a traumatic brain injury;
(2)
a medical examiner;
(3)
justice of the peace;
(4)
a hospital that admits a patient with a traumatic
spinal cord injury or a traumatic brain injury or a suspected case of a traumatic
spinal cord injury or a traumatic brain injury; or
(5)
an acute or post-acute rehabilitation facility that
admits or treats a patient with a traumatic spinal cord injury or a traumatic
brain injury or a suspected case of a traumatic spinal cord injury or a traumatic
brain injury;
(c)
A physician shall be exempt from reporting if a hospital
admitted the patient and fulfilled the reporting requirements as stated in §103.5
of this title (relating to Reporting Requirements for Hospitals).
(d)
A hospital that diagnoses, treats or admits a trauma patient
shall report all newly diagnosed cases on trauma patients.
(e)
A pre-hospital provider that transports a patient with
traumatic injuries to a hospital or transfers a patient with traumatic injuries
from one hospital to another hospital shall report all transported traumatic
injuries.
§103.5.Reporting Requirements for Hospitals.
(a)
For submersion injuries and traumatic brain injuries caused
by anoxia due to near drowning.
(1)
The data required to be reported by hospitals shall include,
but is not limited to:
(A)
patient's name, date of birth, gender, race/ethnicity,
county of residence, address;
(B)
date and time of injury, address of injury, place of injury;
(C)
circumstances of injury, cause of injury, circumstances
of rescue;
(D)
alcohol use, drug use;
(E)
date of hospital admission, date of hospital discharge,
medical record number; and
(F)
pulse, respiration rate, glasgow coma score, status and
deficits at discharge, discharge destination and payor.
(2)
The procedure for reporting is described in §103.9
of this title (relating to Reporting by Paper Form).
(b)
For traumatic brain injuries (excluding those caused by
anoxia due to near drowning) and traumatic spinal cord injuries.
(1)
The data required to be reported by hospitals shall include,
but is not limited to:
(A)
patient demographics including race/ethnicity, sex, date
of birth, and county of residence;
(B)
date and time of injury, county of injury, cause of injury,
and place of injury;
(C)
facility number, date and time of hospital arrival, trauma
number, blood alcohol level tested, blood pressure, respiration rate, pulse,
glasgow coma score, and revised trauma score;
(D)
discharge destination, discharge condition, date and time
of discharge or death;
(E)
diagnoses, injury severity score, payor, and billed hospital
charges; and
(F)
protective device use, ambulance firm number, and transfer
status.
(2)
Required, conditional data (if applicable) reported
by hospitals shall include:
(A)
alcohol level, facility number to which patient was discharged;
and
(B)
pre-hospital information including vital signs (respiratory
rate, systolic blood pressure, and glasgow coma score) at scene, dispatch
time, arrival time and departure time, vehicle extrication, referral facility,
date and time of arrival to referral facility, and date and time of departure
from referral facility.
(3)
Optional data which may be reported by hospitals
shall include:
(A)
medical record number, patient's name, social security
number, length of stay, and intensive care unit days; and
(B)
abbreviated injury severity codes, procedure codes, pre-existing
conditions, and reimbursement.
(4)
The procedure for reporting is described in §103.10
of this title (relating to Electronic Reporting). If a hospital does not
have the ability to report electronically as described in §103.10 of
this title (relating to Electronic Reporting), the hospital may report by
paper form as described in §103.9 of this title (relating to Reporting
by Paper Form).
(c)
For information on trauma patients.
(1)
The data required to be reported by hospitals shall include,
but is not limited to:
(A)
patient demographics including race/ethnicity, sex, date
of birth, and county of residence;
(B)
date and time of injury, county of injury, cause of injury,
and place of injury;
(C)
facility number, date and time of hospital arrival, trauma
number, blood alcohol level tested, blood pressure, respiration rate, pulse,
glasgow coma score, and revised trauma score;
(D)
discharge destination, discharge condition, date and time
of discharge or death;
(E)
diagnoses, injury severity score, payor, billed hospital
charges; and
(F)
protective device use, ambulance firm number, and transfer
status.
(2)
Required, conditional data (if applicable) reported
by hospitals shall include:
(A)
alcohol level, facility number to which patient was discharged;
and
(B)
pre-hospital information including vital signs (respiratory
rate, systolic blood pressure, and glasgow coma score) at scene, dispatch
time, arrival time and departure time, vehicle extrication, referral facility,
date and time of arrival to referral facility, and date and time of departure
from referral facility;
(3)
Optional data which may be reported by hospitals
shall include:
(A)
medical record number, patient's name, patient's social
security number, length of stay, and intensive care unit days; and
(B)
abbreviated injury severity codes, procedure codes, pre-existing
conditions, and reimbursement.
(4)
The procedure for reporting is described in §103.10
of this title (relating to Electronic Reporting).
(5)
Information on a trauma patient that sustained a single
injury with an abbreviated injury score of 2 or less or a hip fracture may
be reported but is not required.
(d)
If a hospital does not admit any patients sustaining a
traumatic brain injury or a traumatic spinal cord injury or does not treat
any trauma patients within any given month, and therefore does not have any
electronic records to transmit for that month, the hospital must complete
and submit to the program within ninety days a form prescribed by the program
stating that it did not have any cases to report for that month.
§103.6.Reporting Requirements for Physicians, Medical Examiners, and Justices of the Peace.
(a)
For submersion injuries and traumatic brain injuries caused
by anoxia due to near drowning.
(1)
The data required to be reported by physicians, medical
examiners, and justices of the peace shall include, but is not limited to:
(A)
patient's name, date of birth, gender, race/ethnicity,
county of residence, address;
(B)
date and time of injury, address of injury, location of
injury;
(C)
circumstances of injury, cause of injury, circumstances
of rescue;
(D)
alcohol use, drug use;
(E)
date of hospital admission, date of hospital discharge,
medical record number; and
(F)
pulse, respiration rate, glasgow coma score, status and
deficits at discharge, discharge destination and payor.
(2)
The procedure for reporting is described in §103.9
of this title (relating to Reporting by Paper Form).
(b)
For traumatic brain injuries (excluding those caused by
anoxia due to near drowning) and traumatic spinal cord injuries.
(1)
The data required to be reported by physicians, medical
examiners, and justices of the peace shall include, but is not limited to:
(A)
name, race/ethnicity, sex, date of birth, and county of
residence;
(B)
date of injury, county of injury, cause of injury, and
place of injury;
(C)
date of hospital arrival, blood alcohol concentration,
blood pressure, respiration rate, and glasgow coma score;
(D)
discharge destination, discharge condition, date and time
of discharge or death, and destination facility;
(E)
diagnoses, injury severity score, payor, and billed hospital
charges;
(F)
prehospital information including vital signs at scene,
dispatch time, arrival time and departure time; and
(G)
protective device use, and referral facility;
(2)
The procedure for reporting is described in §103.9
of this title (relating to Reporting by Paper Form). A physician shall be
exempt from reporting if a hospital admitted the patient and fulfilled the
reporting requirements as stated in §103.5 of this title (relating to
Reporting Requirements for Hospitals).
§103.7.Reporting Requirements for Pre-hospital Providers.
(a)
For submersion injuries and transported traumatic injuries.
(1)
The data required to be reported by pre-hospital providers
shall include, but is not limited to:
(A)
pre-hospital provider firm number, run report identification
number, date of call, pick up hospital code, county of incident, zip code
of incident;
(B)
type of run, call received time, dispatch time, arrive
scene time, depart scene time, arrive destination time;
(C)
date of birth, county of residence, sex, race, payment
source, glasgow coma score, respiration rate at scene, systolic blood pressure
at scene;
(D)
cause of injury, whether work-related, type of injuries,
place of injury; and
(E)
preventive aid, prior aid, vehicle extrication, basic and
advanced life support provided, destination hospital, destination facility
type, date of hospital arrival, total provider charges.
(2)
Optional data that may be reported by pre-hospital
providers shall include:
(A)
vehicle number, district/station number, city of incident,
state of incident and return to service time;
(B)
patient's name, patient's city of residence, and patient's
state of residence; and
(C)
revised trauma score, pulse, severity and body location
of injuries, and training levels of EMS personnel.
(3)
The procedure for reporting is described in §103.10
of this title (relating to Electronic Reporting).
(b)
If a pre-hospital provider does not transport any patients
sustaining an injury within any given month, and therefore does not have any
electronic records to transmit for that month, the pre-hospital provider must
complete and submit to the program within ninety days a form prescribed by
the program stating that it did not have any cases to report for that month.
§103.8.Reporting Requirements for Rehabilitation Facilities.
For traumatic brain injuries and traumatic spinal cord injuries.
(1)
The data required to be reported by acute or post-acute
rehabilitation facilities shall include, but not be limited to:
(A)
patient's name, race/ethnicity, sex, and date of birth;
(B)
date of injury, and cause of injury;
(C)
date of admission, date of discharge, and discharge destination;
(D)
functional independence measure score at admission, functional
independence measure score at discharge, diagnoses; and
(E)
type of services provided, payor, and billed charges.
(2)
The procedure for reporting is described in §103.10
of this title (relating to Electronic Reporting).
§103.9.Reporting by Paper Form.
(a)
Physicians, Medical Examiners, Justices of the Peace, and
Hospitals shall report submersion injuries and traumatic brain injuries due
to anoxia in writing on a form or forms prescribed by the department within
ten working days to the local health authority, or where there is no local
health authority, the regional director of the department. A local health
authority or regional health authority shall transmit any reports of submersion
injuries to the Bureau of Epidemiology, Texas Department of Health, 1100 West
49th Street, Austin, Texas 78756-3180, on a weekly basis.
(b)
Physicians, Medical Examiners, Justices of the Peace, and
Hospitals unable to report electronically as described in §103.10 of
this title (relating to Electronic Reporting) shall report traumatic brain
injuries and traumatic spinal cord injuries in writing on a form or forms
prescribed by the department within ten working days to the Bureau of Epidemiology,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3180.
(c)
Transmission of reports shall be made by mail, courier,
or electronic transfer
(1)
If by mail or courier, the reports shall be placed in a
sealed envelope, marked "Confidential Medical Records."
(2)
If by electronic transmission by telephone (verbal
or fax), it shall be made in a manner and form authorized by the commissioner
or his or her designee in each instance. Any electronic submission of the
reports must provide at least the same degree of protection against unauthorized
disclosure as those of mail or courier transmission. The commissioner or his
or her designee shall, before authorizing such transmission, establish guidelines
for establishing and conducting such transmission.
§103.10.Electronic Reporting.
(a)
Hospitals shall submit reports to the Texas Trauma Registry
within three months of discharge from their facility for the diagnosis or
treatment of traumatic brain injuries, traumatic spinal cord injuries, and
information on trauma patients. Pre-hospital providers shall submit reports
to the Texas Trauma Registry within three months of the treatment and transport
of traumatic injuries and submersion injuries. Acute or post-acute rehabilitation
facilities shall submit reports to the program within three months of treatment
of traumatic brain injuries and traumatic spinal cord injuries.
(1)
A hospital or pre-hospital provider may submit to the regional
trauma registry located in its Trauma Service Area.
(2)
If a hospital or pre-hospital provider transmit data
to its regional trauma registry, the hospital or pre-hospital provider will
only be considered in compliance for injury reporting if the Texas Trauma
Registry electronically receives the hospital's or pre-hospital provider's
data from the regional trauma registry in the manner described in this section.
(b)
Data shall be transmitted by computer modem or by other
electronic means approved by the program at least quarterly; monthly submissions
are recommended.
(c)
Hospitals shall report data in the electronic format as
described in the current Hospital Reporting Guidelines.
(d)
Pre-hospital providers shall report data in the electronic
format as described in current Pre-hospital Reporting Guidelines.
§103.11.General Control Measures for Reportable Injuries.
The commissioner or his or her duly designee shall, as circumstances
may require, proceed as follows.
(1)
Investigation may be made by staff of the Texas Department
of Health (department)for the purpose of verifying the diagnosis, ascertaining
the cause of the injury, obtaining a history of circumstances surrounding
the injury, and discovering unreported cases.
(2)
Subject to the confidentiality provisions of these
sections, the department may collect, or cause to be collected, medical, demographic,
or epidemiological information from any medical or laboratory record or file
to help the department in the epidemiologic investigation of injuries and
their causes.
(3)
Information concerning the injury or its prevention
may be given to the patient or a responsible member of the patient's household
to prevent further injury(ies).
§103.12.Powers and Duties of the Department.
(a)
The Texas Department of Health (department) may enter into
contracts or agreements as necessary to carry out Injury Prevention and Control
Act, Health and Safety Code, Chapter 92. The contracts or agreements may provide
for payment by the state for materials, equipment, and services.
(b)
The department may seek, receive, and spend any funds received
through appropriations, grants, donations, or contributions from public or
private sources for the purpose of identifying, reporting, or preventing those
injuries determined by the Board of Health to be harmful or to be a threat
to the public health.
(c)
Subject to the confidentiality provisions of this chapter,
the department shall evaluate the reports of injuries to establish the nature
and magnitude of the hazards associated with those injuries, to reduce the
occurrence of those risks, and to establish any trends involved.
(d)
The department may make inspections and investigations
as authorized by the Health and Safety Code, Chapter 92, and other law.
(e)
The department may contact a medical examiner, justice
of the peace, physician, hospital, or acute or post-acute rehabilitation facility
attending a person with a case or suspected case of a reportable injury.
(f)
The department may provide annual summary data to the local
and regional health authorities.
§103.13.Confidential Nature of Case Reporting.
(a)
All information and records relating to injuries received
by the local health authority or the Texas Department of Health (department),
including information electronically submitted to the Texas Trauma Registry
and information from injury investigations, are confidential records and not
public records. These records shall be held in a secure place and accessed
only by authorized personnel.
(b)
Information or records relating to any personal injury
may not be released or made public on subpoena or otherwise, except that release
may be made:
(1)
for statistical purposes, but only if a person and/or health
care entity is not identified;
(2)
with the consent of each person and health care entity
identified in the information released; or
(3)
to medical personnel in a medical emergency to the
extent necessary to protect the health or life of the named person.
(c)
The commissioner, the commissioner's designee, or an employee
of the department may not be examined in a judicial or other proceeding about
the existence or contents of pertinent records of, investigation reports of,
or reports or information about a person examined or treated for an injury
without that person's consent.
(d)
The program will provide, upon written request, data back
to the respective reporting health care entity from records previously submitted
to the program from the respective reporting health care entity.
(e)
The program may release data to other bureaus of the department,
provided that the disclosure is required or authorized by law. All communications
of this nature shall be clearly labeled "Confidential" and will follow established
departmental internal protocols and procedures.
§103.14.Investigations.
(a)
The Texas Department of Health (department) shall investigate
the causes of injuries and methods of prevention.
(b)
The commissioner or the commissioner's designee may enter
at reasonable times and inspect within reasonable limits a public place or
building, including a public conveyance, in the commissioner's duty to prevent
an injury.
(c)
The commissioner or the commissioner's designee may not
enter a private residence to conduct an investigation about the causes of
injuries without first receiving permission from a lawful adult occupant of
the residence.
(d)
When the department investigates work-related injuries,
the Texas Workforce Commission shall be informed at the earliest opportunity.
(e)
When the department investigates traumatic spinal cord
injuries and traumatic brain injuries, the Texas Rehabilitation Commission
shall be informed at the earliest opportunity.
(f)
When the department investigates traumatic brain injuries,
the Texas Traumatic Brain Injury Advisory Board shall be informed at the earliest
opportunity.
§103.15.Technical Advisory Committee on Injury Reporting.
(a)
The committee. An advisory committee shall be appointed
under and governed by this section.
(1)
The name of the committee shall be the Technical Advisory
Committee on Injury Reporting.
(2)
The committee is established under the Health and
Safety Code, §92.002 that the board shall appoint a technical advisory
committee to advise the board of injuries other than spinal cord injuries,
traumatic brain injuries, and submersion injuries to be reported under this
chapter.
(b)
Applicable law. The committee is subject to the Government
Code, Chapter 2110, concerning state agency advisory committees.
(c)
Purpose. The purpose of the committee is to advise the
board on injuries to be reported under this chapter.
(d)
Tasks.
(1)
The committee shall advise the board concerning injuries
to be reportedunder this chapter.
(2)
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. If
the committee is not continued or consolidated, the committee shall be abolished
on that date.
(f)
Composition. The committee shall be composed of nine members
appointed by the board. The composition of the committee shall include:
(1)
three doctors of medicine or doctors of osteopathic medicine
licensed to practice in this state;
(2)
three hospital representatives, one of whom must represent
a public hospital; and
(3)
three consumers of services of which are provided
either by the department or by industries or occupations regulated by the
department.
(g)
Terms of office. The term of office of each member shall
be six years. Members shall serve after expiration of their term until a replacement
is appointed.
(1)
Members shall be appointed for staggered terms so that
the terms of three members will expire on January 1st of each even-numbered
year.
(2)
If a vacancy occurs, a person shall be appointed to
serve the unexpired portion of that term.
(h)
Officers. The chairman of the board shall appoint a presiding
officer and an assistant presiding officer to begin serving on November 1
of each odd-numbered year.
(1)
Each officer shall serve until the next regular appointment
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 appointed
to complete the unexpired portion of the term of the office of presiding officer.
(4)
If the office of assistant presiding officer becomes
vacant, it may be filled temporarily by vote of the committee until a successor
is appointed by the chairman of the board.
(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 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)
The committee is not a "governmental body" as defined
in the Open Meetings Act. However, in order to promote public participation,
each meeting of the committee shall be announced and conducted in accordance
with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception
that the provisions allowing executive sessions shall not apply.
(4)
Each member of the committee shall be informed of
a committee meeting at least five working days before the meeting.
(5)
A simple majority of the members of the committee
shall constitute a quorum for the purpose of transacting official business.
(6)
The committee is authorized to transact official business
only when in a legally constituted meeting with 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 committee 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.
(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 summary of the meeting 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 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.
(1)
The board, the department, and the committee shall not
be bound in any way by any statement or action on the part of any committee
member except when a statement or action is in pursuit of specific instructions
from the board, department, or committee.
(2)
The committee and its members may not participate
in legislative activity in the name of the board, the department or the committee
except with approval through the department's legislative process. Committee
members are not prohibited from representing themselves or other entities
in the legislative process.
(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, and anticipated
activities of the committee for the next year.
(2)
The report shall identify the costs related to the
committee's existence, including the cost of department 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
November. It shall be signed by the presiding officer and appropriate department
staff.
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 February 25, 2000.
TRD-200001440
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
25 TAC §§103.3 - 103.9
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under the Health and Safety
Code, §92.002, which requires the board to adopt rules necessary to implement
the reporting of injuries; the Health and Safety Code, §§773.112(c)
and 773.113(a)(3), which require the department to adopt rules necessary to
implement a trauma reporting and analysis system; and Health and Safety Code, §12.001,
which allows the board to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health; and Government
Code §2001.039, added by Chapter 1499, Art. 1, §1.11(a), 76th Legislature
(1999) is implemented by this proposal.
The repeals affect the Health and Safety Code, Chapters 92 and 773.
§103.3.List of Reportable Injuries and Conditions.
§103.4.Reporting Requirements.
§103.5.General Control Measures for Reportable Injuries.
§103.6.Powers and Duties of the Department.
§103.7.Confidential Nature of Case Reporting.
§103.8.Investigations.
§103.9.Technical Advisory Committee on Injury Reporting.
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 February 25, 2000.
TRD-200001439
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes a repeal of §157.25
and new §157.25 concerning the statewide protocol required for use of
an Out-Of-Hospital Do Not Resuscitate (DNR) Order and DNR form.
In accordance with Senate Bill 1260, 76th Legislature, 1999, the department
is required to amend rule §157.25 to coincide with the consolidation
of Chapters 672 and 674 of the Health and Safety Code; and Chapter 135, Civil
Practice and Remedies Code. These chapters used the same terminology and provisions
but maintained inconsistencies that were confusing to individuals who wanted
to develop advance directives and confusing to providers who would carry out
the advance directives. Senate Bill 1260 amends the Health and Safety Code
Chapter 773 and designates the Health and Safety Code Title 2, Chapter 166
as the Advance Directives Act. The DNR form was also changed to follow those
same directions.
Kathryn Perkins, Acting Bureau Chief, has determined that for the first
five years the proposed repeal and new section are in effect there will be
no fiscal impact on the state or local governments.
Ms. Perkins has also determined that for the first five-year period the
sections are in effect, the public will benefit from the uniform provisions
governing the execution of the DNR form. The revision affects the form and
not the price of the form, therefore the economic effect on small businesses
or micro-businesses will not be affected. The logo on the form has been changed
to black to make the form easier to duplicate. 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.
Written comments on the proposal may be submitted to Kathryn Perkins, Acting
Chief, Bureau of Emergency Management, 1100 West 49th Street, Austin, Texas
78756, (512) 834-6700, or Fax (512) 834-6736. Comments will be accepted for
30 days following publication of the proposal in the
Texas Register
.
Subchapter B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES
25 TAC §157.25
(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, Chapter 773, which provides the Board of Health (board) with the authority
to adopt rules to implement the Emergency Medical Services Act; 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 repeal affects the Health and Safety Code, Chapter 773 and §12.001.
§157.25.Out-of-Hospital Do Not Resuscitate (DNR) Order.
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 February 25, 2000.
TRD-200001451
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
The new section is proposed under the
Health and Safety Code, Chapter 773, which provides the Board of Health (board)
with the authority to adopt rules to implement the Emergency Medical Services
Act; 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 new section affects the Health and Safety Code, Chapter 773 and §12.001.
§157.25.Out-of-Hospital Do Not Resuscitate (DNR) Order
(a)
Purpose. The purpose of this section shall be to establish
a statewide DNR protocol as required in the Health and Safety Code, Title
2, Chapter 166.
(b)
DNR order. A DNR order may be issued by an attending physician
for any patient. That attending physician has responsibility for ensuring
that the form is filled out in its entirety and that the information regarding
the existence of a DNR order is entered into the patient's medical record.
(c)
Protocol development. A DNR protocol in accordance with
this section, shall apply to all out-of-hospital settings including cardiac
arrests which occur during interfacility transport. The protocol shall include
the following:
(1)
a copy of the Texas Department of Health (department) standardized
DNR form listing the designated treatments that shall be withdrawn or withheld.
Those treatments shall be:
(A)
cardiopulmonary resuscitation;
(B)
advanced airway management;
(C)
artificial ventilation;
(D)
defibrillation; and
(E)
transcutaneous cardiac pacing.
(2)
an explanation of the patient identification
process to include an option to use a department-standardized identification
device such as a necklace or bracelet; and
(3)
an on-site DNR dispute resolution process which includes
contacting an appropriate physician.
(d)
Recordkeeping. Records shall be maintained on each incident
in which an out-of- hospital DNR order or DNR identification device is encountered
by responding healthcare professionals, and the number of cases where there
is an on-site revocation of the DNR order shall be recorded.
(1)
The data documented should include:
(A)
an assessment of patient's physical condition;
(B)
whether an identification device or a DNR form was used
to confirm DNR status and patient identification number;
(C)
any problems relating to the implementation of the DNR
order;
(D)
the name of the patient's attending physician; and
(E)
the full name, address, telephone number, and relationship
to patient of any witness used to identify the patient.
(2)
If the patient is transported, the original DNR
order or a copy of the original order will be kept with the patient.
(3)
Copies of the original DNR order may be put on file
with concerned parties, and the original order shall remain in the possession
of the patient, a legal guardian, or the healthcare facility responsible for
the patient's care.
(4)
At the time of relicensure, the out-of-hospital provider
shall submit a report to the Bureau of Emergency Management with the following
information:
(A)
number of times personnel have been presented with DNR
documentation;
(B)
number of times there was a problem and the DNR order could
not be honored; and
(C)
any problems that were encountered using the standardized
form.
(e)
Out-of-state DNR Orders. Personnel may accept an out-of-hospital
DNR order or device that has been executed in any other state, if there is
no reason to question the authenticity of the order.
(f)
Failure to honor a DNR order. If there are any indications
of unnatural or suspicious circumstances, the provider shall begin resuscitation
efforts until such time as a physician directs otherwise.
(g)
Pregnant persons. A person may not withhold the designated
treatments listed in subsection (c)(1) from a person known by responding healthcare
professionals to be pregnant.
(h)
DNR Form. The Bureau of Emergency Management or their appointees
shall furnish DNR forms to physicians, clinics, hospitals, nursing homes,
hospices and home health agencies throughout the state upon request.
(1)
The form shall contain all the information as prescribed
in the Health and Safety Code, Chapter 166.
(2)
The form shall be 8-1/2 inches by 14 inches, printed
front and back, and in the format specified by the board as follows.
Figure: 25 TAC §157.25(h)(2)
(i)
Identification devices. A vendor under contract with the
Texas Department of Health shall make the identification bracelet and necklace
according to the following specifications.
(1)
The bracelet shall be made of stainless steel in 8 inches
length with an engravable section which is 2 inches long, 0.5 inches wide
and 0.060 inches thick. The statewide standardized DNR logo will be on the
front in red and white colors as specified.
(2)
The necklace shall be made of stainless steel 1 inch
in diameter and 0.060 inches thick. There will be a stainless steel chain
approximately 27 inches in length permanently attached without a clasp. The
statewide standardized DNR logo will be on the front in red and white colors
as specified.
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 February 25, 2000.
TRD-200001452
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
25 TAC §157.129
(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 §157.129 concerning the establishment of a trauma reporting
and analysis system.
Government Code §2001.039, added by Chapter 1499, Art. 1, §1.11(a),
76th Legislature (1999), requires that each state agency review and consider
for re-adoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). This existing rule for
trauma reporting and analysis found in Chapter 157 on Emergency Medical Services
Trauma Systems has been reviewed and is being repealed and included in proposed
new rules in Chapter 103 on Injury Prevention and Control which is the more
appropriate place.
The department published a Notice of Intention to Review the section as
required by Government Code §2001.039 in the January 21, 2000, issue
of the
Texas Register
(25 TexReg 398). There
were no comments received due to the publication of the Notice.
David F. Zane, Director, Injury Epidemiology and Surveillance Program,
has determined that for the first five year period the proposed repeal is
in effect, there will be no fiscal implications to state or local government
as a result of enforcing and administering the repeal.
Mr. Zane has also determined that for each year of the first five years
that the repeal is in effect, the public benefit anticipated as a result of
enforcing the repeal will be improved knowledge of the prevalence of injuries
and an expanded ability to identify common causes of injuries in Texas. There
will be no adverse economic effect on micro-businesses and/or small businesses
and persons who may be required to comply with the repeal. The finding of
no adverse economic effect on micro-businesses and/or small businesses is
based on proper business management practices by those entities required to
comply with the repeal. There will be no impact on local employment.
Comments on the proposal may be submitted to David F. Zane, Director, Injury
Epidemiology and Surveillance Program, Bureau of Epidemiology, Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756-3180, (512) 458-7266.
Comments on the proposed repeal will be accepted for 30 days following the
publication in the
Texas Register
.
The repeal is proposed under the Health and Safety Code, §92.002,
which requires the board to adopt rules necessary to implement the reporting
of injuries; the Health and Safety Code, §773.112(c) and §773.113(a)(3),
which require the department to adopt rules necessary to implement a trauma
reporting and analysis system; and Health and Safety Code, §12.001, which
allows the board to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health; and Government
Code §2001.039, added by Chapter 1499, Art. 1, §1.11(a), 76th Legislature
(1999) is implemented by this proposal.
The repeal will affect the Health and Safety Code, Chapters 92 and 773.
§157.129. State Trauma Registry.
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 February 25, 2000.
TRD-200001432
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
25 TAC §159.1
The Texas Department of Health (department) proposes new §159.1
concerning reimbursement for tertiary medical services and stabilization services.
House Bill 1398, passed in 1999 by the Texas Legislature, added Chapter
46 to the Health and Safety Code, which establishes a method by which the
department may allocate funds to certain facilities for unreimbursed tertiary
medical services and unreimbursed stabilization services provided to persons
who reside outside the service area of the county, public hospital, or hospital
district that is responsible for indigent health care under the Health and
Safety Code, Chapter 61, in the area in which the eligible facility is located.
Chapter 46 established the tertiary care account in the state treasury, from
which funds are appropriated to the department for the purposes of this chapter.
Chapter 46 requires the Board of Health (board) to adopt rules governing
the collection of information relating to unreimbursed tertiary medical services
or stabilization services. The proposed rules specify the information eligible
facilities are required to provide to the department in order to receive funding
under this chapter. The rules establish a process for allocation of funds
when the total costs certified are greater than the amount available in the
tertiary care account and a process by which eligible facilities may apply
for reimbursement under extraordinary emergencies.
Joe Moritz, Health Care Financing Budget Director, has determined that
for the first five-year period the section is in effect, there will be fiscal
implications to state or local governments as a result of enforcing or administering
the section as proposed. In accordance with the department Rider 74 of the
General Appropriations Act for the fiscal year 2000-2001 biennium, $1,000,000
will be transferred to the tertiary care account from Strategy E.2.1, County
Indigent Health Care, in fiscal year 2000, to reimburse eligible facilities
under this chapter. According to estimates by the Legislative Budget Board,
the tertiary care account could receive up to $16.5 million from unclaimed
lottery funds during fiscal year 2001, to reimburse eligible facilities under
this chapter. Funding after fiscal year 2001 has not yet been determined by
the Texas Legislature. State or local governmental agencies that own or operate
an eligible facility may receive reimbursement, however, the department is
unable to determine at this time the dollar amount which will be reimbursed
to governmental facilities.
Mr. Moritz has also determined that for each year of the five years the
rule is in effect, the public benefit anticipated as a result of the rule
is allocation of funds to eligible facilities to compensate the facilities
for the costs of unreimbursed tertiary medical services and unreimbursed stabilization
services. Facilities who seek payment under this chapter may incur minimal
administrative costs in compiling the required data. There are no other anticipated
economic costs to persons who are required to comply with the section as proposed.
There will be no effect on small businesses or micro-businesses because none
of the eligible facilities are small businesses or micro-businesses. There
is no impact on local employment.
Comments may be submitted to Henry Welles, Program Specialist, Health Care
Financing, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3168, (512) 794-6858. Comments will be accepted for 30 days following
publication of this proposal in the
Texas Register
.
The new section is proposed under the Health and Safety Code,
Chapter 46, as added by Acts 1999, 76th Legislature, Chapter 1377 (House Bill
1398), Article 2, which provides the board with the authority to adopt rules
concerning tertiary medical care; 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 new section affects the Health and Safety Code, Chapter 46 as added
by House Bill 1398.
§159.1. Reimbursement to Tertiary Care Facilities and Level IV Trauma Facilities.
(a)
Introduction. The Texas Department of Health (department)
shall, on an annual basis, allocate available funds to eligible facilities
to compensate the facilities for the costs of unreimbursed tertiary medical
services and unreimbursed stabilization services.
(b)
Definitions. The following words and terms, when used
in this chapter, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Emergency reserve - 5% of the total amount of funds in
the Tertiary Care Account to be used only for reimbursement of unreimbursed
tertiary medical services or unreimbursed stabilization services resulting
from an extraordinary emergency.
(2)
Stabilization services - Services provided by a tertiary
care facility or a designated level IV trauma center that are necessary to
assure, within reasonable medical probability, that no material deterioration
of a patient's medical condition is likely to result from or occur during
the transfer of the patient to a tertiary care facility.
(3)
Tertiary Care Account - An account in the state treasury.
(4)
Tertiary care facility - A primary teaching hospital
of a medical school or a designated level I, II or III trauma center.
(5)
Tertiary medical services - Services provided by
tertiary care facilities including, but not limited to, state-designated trauma
center services, burn center treatment, neonatology level III unit services,
pediatric surgery, trauma surgery, neurosurgery, cardiothoracic and vascular
surgery, organ transplant, services provided for a life-threatening dermatologic
illness, services provided to a person with a high-risk pregnancy or cancer,
and radiation oncology.
(6)
Unreimbursed stabilization services - Stabilization
services for which a tertiary care facility or a designated level IV trauma
center has not received full payment from any public or private source.
(7)
Unreimbursed tertiary medical services - Tertiary
medical services for which a tertiary care facility has not received full
payment from any public or private source.
(c)
Eligibility for funds.
(1)
The department shall allocate available funds for unreimbursed
tertiary medical services to tertiary care facilities who submit the required
information on a timely basis.
(2)
The department shall allocate available funds for
unreimbursed stabilization services to tertiary care facilities and designated
level IV trauma centers who submit the required information on a timely basis.
(3)
A facility must have operated as a tertiary care
facility or level IV trauma facility during the previous calendar year in
order to claim costs of unreimbursed services.
(d)
Application for funds.
(1)
On an annual basis, the department, in writing, will inform
each tertiary care facility and level IV trauma facility of the following:
(A)
that it may apply for funds to compensate it for the costs
of unreimbursed tertiary medical services (tertiary care facilities only)
and unreimbursed stabilization services (tertiary care facilities and level
IV trauma facilities) provided to persons who reside outside the service area
of the county, public hospital, or hospital district that is responsible for
indigent health care under the Health and Safety Code, Chapter 61, in the
area in which the tertiary care facility or level IV trauma facility is located;
(B)
the estimated, total amount of funding available at the
end of the reporting period;
(C)
the number of facilities eligible to apply for funds;
(D)
the information required to be submitted to the department
in order to apply for the funds;
(E)
the date by which the information must be submitted to
the department; and
(F)
the date by which the department expects to certify amounts
to the state comptroller of public accounts.
(2)
By the date established by the department, each
tertiary care facility or level IV trauma facility must submit the following
information on a form provided by the department:
(A)
name of the facility;
(B)
location including mailing address, city and county;
(C)
total costs of unreimbursed tertiary medical services
(tertiary care facilities only) provided during the reporting period to persons
who reside outside the service area of the county, public hospital, or hospital
district that is responsible for indigent health care under the Health and
Safety Code, Chapter 61, in the area in which the tertiary care facility is
located; and
(D)
total costs of unreimbursed stabilization services (tertiary
care facilities and level IV trauma facilities) provided during the reporting
period to persons who reside outside the service area of the county, public
hospital, or hospital district that is responsible for indigent health care
under the Health and Safety Code, Chapter 61, in the area in which the tertiary
care facility or level IV trauma facility is located.
(3)
The form must be signed by the chief operating
officer and the chairman of the facility's board of directors.
(4)
The form must be notarized.
(5)
A form postmarked after the due date will not be
considered for allocation of funds.
(6)
If a facility receives partial reimbursement from
another source for its tertiary medical services or stabilization services
provided to persons who reside outside the service area of the county, public
hospital, or hospital district that is responsible for indigent health care
under the Health and Safety Code, Chapter 61, in the area in which the tertiary
care facility or level IV trauma facility is located, the facility may request
compensation for the portion of the costs not covered by the partial reimbursement.
(7)
By signing the application form, a facility that
is reimbursed in full by a private or public source for tertiary medical services
or stabilization services after the services have been reported to the department,
agrees to promptly reimburse the State of Texas for such funds paid to the
facility under this section.
(e)
Reporting period. A facility's annual application for
funds shall apply to costs incurred during the preceding state fiscal year,
beginning with State Fiscal Year 2000 (September 1, 1999 to August 31, 2000).
(f)
Allocation of funds.
(1)
If the total cost of unreimbursed tertiary medical services
certified for all eligible facilities exceeds the amount available in the
Tertiary Care Account, the department shall allocate funds based on percentages
computed by dividing the costs of each facility's unreimbursed tertiary medical
services by the total cost of all facilities' unreimbursed tertiary medical
services.
(2)
If the total cost of unreimbursed stabilization services
certified for all eligible facilities exceeds the amount available in the
Tertiary Care Account, the department shall allocate funds based on percentages
computed by dividing the costs of each facility's unreimbursed stabilization
services by the total cost of all facilities' unreimbursed stabilization services.
(g)
Certification to comptroller. Once the department has
determined the amount of reimbursement allotted for each eligible facility,
the department will certify those amounts to the state comptroller of public
accounts for processing of payments.
(h)
Emergency reserve.
(1)
The department may allocate funds to tertiary care facilities
or level IV trauma centers to compensate the facilities for the costs of unreimbursed
tertiary medical services or unreimbursed stabilization services resulting
from an extraordinary emergency.
(2)
An extraordinary emergency shall be certified by
the department:
(A)
if the governor issues an executive order or a proclamation
under Government Code, Chapter 418, pertaining to emergency management;
(B)
if a disaster is declared by the president of the United
States under the Robert T. Stafford Disaster Relief and Emergency Assistance
Act (42 U.S.C. §5121
et seq
.); or
(C)
for another similar disaster the department finds has
resulted in an extraordinary cost to a tertiary care facility or level IV
trauma facility.
(3)
A facility which incurs costs as a result of
an extraordinary emergency may apply to the department at any time; however,
reimbursement may be provided only for costs incurred during the emergency.
(4)
The facility must submit, in writing, the following
information:
(A)
name of the facility;
(B)
location including mailing address, city and county;
(C)
total costs of unreimbursed tertiary medical services
(tertiary care facilities only) resulting from an extraordinary emergency;
(D)
total costs of unreimbursed stabilization services (tertiary
care facilities and level IV trauma facilities) resulting from an extraordinary
emergency; and
(E)
a description of the extraordinary emergency.
(5)
The written statement must be signed by the
chief operating officer and the chairman of the facility's board of directors.
(6)
The department will review requests for emergency
funds and certify costs to the state comptroller of public accounts until
the emergency reserve is exhausted.
(i)
Audits. The department may conduct random, on-site audits
of documentation used by the facilities to calculate their reported costs
for unreimbursed services.
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 February 25, 2000.
TRD-200001431
Kim Wolfe
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §289.118
and new §289.228, concerning radiation safety requirements for analytical
and other industrial radiation machines.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.118 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however revisions to the rule are necessary.
The section proposed for repeal adopts by reference Part 34, titled "Radiation
Safety Requirements for Analytical X-Ray Equipment" of the Texas Regulations
for Control of Radiation. The proposed new section incorporates language from
Part 34 that has been rewritten into Texas Register format and includes addition
and revision of subsections of the section. The repeal and new section are
part of the renumbering phase in the process of rewriting the department's
radiation rules in the Texas Register format. The new section reflects the
renumbering.
Additional language was added to the section to clarify that the requirements
include industrial radiation machines. Definitions for local components, other
industrial radiation machines, and safety devices were also added for clarification.
Equipment requirements for radiation source housings and generator cabinets
were added to reflect federal standards. The word "analytical" was deleted
throughout the section because the section includes requirements for both
analytical and other industrial x-ray equipment. References to other sections
of this chapter are clarified to reflect the Texas Register format. Other
minor grammatical changes are made to the section for clarification. This
section is part of the department's continuing effort to update, clarify,
and simplify its rules regarding the control of radiation based upon technological
changes, public concerns, legislative directives, or other factors.
The department published a Notice of Intention to Review for §289.118
as required by Government Code §2001.039 in the
Texas Register
(25 TexReg 219) on January 7, 2000. No comments were
received by the department on this section.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the sections will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the sections as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed sections will be in effect, the public benefit anticipated
as a result of enforcing the sections will be to ensure that registrants comply
with radiation safety requirements for analytical and other industrial radiation
machines and that equipment is properly maintained, ensuring the safety of
workers and the public is protected from unnecessary exposure to radiation.
There will be no effect on micro businesses or small businesses. 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.
The amendment primarily reformats and clarifies existing requirements. It
imposes no additional requirements such as record keeping, procedures, or
processes. Therefore, there are no economic effects associated with the section
as proposed.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, (512)834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 10:30 a.m., Tuesday,
March 28, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
Subchapter C. TEXAS REGULATIONS FOR CONTROL OF RADIATION
25 TAC §289.118
(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, Chapter 401, which provides the Texas Board of Health (board) with authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The repeal affects Health and Safety Code, Chapter 401; the Health and
Safety Code, Chapter 12; and Government Code §2001.039.
§289.118. Radiation Safety Requirements for Analytical X-Ray Equipment.
Filed with the
Office of the Secretary of State, on February 25, 2000.
TRD-200001434
Kim Wolfe
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
25 TAC §289.228
The new section is proposed under the Health and Safety Code,
Chapter 401, which provides the Texas Board of Health (board) with authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The new section affects Health and Safety Code, Chapter 401; the Health
and Safety Code, Chapter 12; and Government Code §2001.039.
§289.228. Radiation Safety Requirements for Analytical and Other Industrial Radiation Machines.
(a)
Purpose. This section establishes requirements for the
use of analytical and other industrial radiation machines not otherwise covered
by this chapter.
(b)
Scope.
(1)
The requirements of this section are in addition to and
not in substitution for other applicable requirements of this chapter.
(2)
In addition to the requirements of this section,
all registrants, unless otherwise specified, are subject to the requirements
of §289.203 of this title (relating to Notices, Instructions, and Reports
to Workers; Inspections), §289.204 of this title (relating to Fees for
Certificates of Registration, Radioactive Material(s) Licenses, Emergency
Planning and Implementation, and Other Regulatory Services), §289.205
of this title (relating to Hearing and Enforcement Procedures), §289.226
of this title (relating to Registration of Radiation Machine Use and Services),
and §289.231 of this title (relating to General Provisions and Standards
for Protection Against Machine-Produced Radiation).
(3)
Radiation safety requirements and registration procedures
for industrial radiography are specified in §289.255 of this title (relating
to Radiation Safety Requirements and Licensing and Registration Procedures
for Industrial Radiography).
(c)
Definitions. The following words and terms, when used
in this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Analytical radiation machine - This includes, but is not
limited to, x-ray equipment used for x-ray diffraction, fluorescence analysis,
spectroscopy, or particle size analysis.
(2)
Fail-safe characteristics - A design feature that
causes beam port shutters to close, or otherwise prevents emergence of the
primary beam, upon the failure of a safety or warning device.
(3)
Local components - A part of an x-ray system that
includes areas that are struck by x-rays, such as radiation source housings,
port and shutter assemblies, collimators, sample holders, cameras, goniometers,
detectors, and shielding, but does not include power supplies, transformers,
amplifiers, readout devices, and control panels.
(4)
Open-beam configuration - A radiation machine in
which an individual could accidently place some part of his/her body in the
primary beam path during normal operation.
(5)
Other industrial radiation machine - This includes,
but is not limited to, x-ray equipment (including cabinet x-ray equipment)
used for cathodolumnescence, ion implantation, gauging, or electron beam welding.
(6)
Primary beam - Ionizing radiation that passes through
an aperture of the source housing by a direct path from the x-ray tube located
in the radiation source housing.
(7)
Safety device - A device that prevents the entry
of any portion of an individual's body into the primary x-ray beam path or
that causes the beam to be shut off upon entry into its path.
(8)
X-ray system - A group of components utilizing x
rays to determine the elemental composition or to examine the microstructure
of materials.
(d)
Equipment requirements.
(1)
Safety devices.
(A)
A safety device shall be provided on all open-beam configurations.
(B)
A registrant may apply to the agency for an exemption
from the requirement of a safety device in accordance with §289.231 of
this title. Any such request shall include:
(i)
a description of the various safety devices that have
been evaluated;
(ii)
the reason each of these devices cannot be used; and
(iii)
a description of the alternative methods that will be
employed to minimize the possibility of an accidental exposure, including
procedures to assure that operators and others in the area will be informed
of the absence of safety devices.
(2)
Warning devices.
(A)
Open-beam configurations shall be provided with a visible
indication of:
(i)
x-ray tube status (ON-OFF) located near the radiation
source housing, if the primary beam is controlled in this manner; and/or
(ii)
shutter status (OPEN-CLOSED) located near each port on
the radiation source housing, if the primary beam is controlled in this manner.
(B)
The x-ray control shall provide visual indication whenever
x-rays are produced.
(C)
Warning devices shall be labeled so that their purpose
is easily identified and shall have fail-safe characteristics.
(3)
Ports. Unused ports on radiation machine source
housings shall be secured in the closed position in a manner that will prevent
inadvertent opening.
(4)
Labeling. Each registrant shall ensure that each
radiation machine is labeled in a conspicuous manner to caution individuals
that radiation is produced when it is energized. This label shall be affixed
in a clearly visible location on the face of the control unit. If the radiation
machine is not visible from the control, the radiation machine shall have
a visible indication that it is energized.
(5)
Shutters. On open-beam configurations, each port
on the radiation source housing shall be equipped with a shutter that cannot
be opened unless a collimator or a coupling has been connected to the port.
(6)
Radiation source housing. Each x-ray tube housing
shall be equipped with an interlock that shuts off the tube if it is removed
from the radiation source housing or if the housing is disassembled.
(7)
Generator cabinet. Each x-ray generator shall be
supplied with a protective cabinet that limits leakage radiation measured
at a distance of 5 centimeters from its surface such that it is not capable
of producing a dose in excess of 0.5 millirem (5.0µSv) in any one hour.
(e)
Area requirements.
(1)
Radiation levels. The local components of an x-ray system
shall be located and arranged and shall include sufficient shielding or access
control such that no radiation levels exist in any area surrounding the local
component group that could result in a dose to an individual present in the
area in excess of the dose limits specified in §289.231 of this title.
(2)
Surveys.
(A)
Radiation surveys, as required by §289.231 of this
title, of all radiation machines and x-ray systems sufficient to show compliance
with paragraph (1) of this subsection shall be performed:
(i)
upon installation of the equipment;
(ii)
following any change in the initial arrangement, number,
or type of local components in the system;
(iii)
following any maintenance requiring the disassembly
or removal of a local component in the system;
(iv)
during the performance of maintenance and alignment procedures
if the procedures require the presence of a primary x-ray beam when any local
component in the system is disassembled or removed;
(v)
any time a visual inspection of the local components in
the system reveals an abnormal condition; or
(vi)
whenever individual monitoring devices show a significant
increase over the previous monitoring period or the readings are approaching
the radiation dose limits.
(B)
Radiation survey measurements shall not be required if
a registrant can demonstrate, to the satisfaction of the agency, compliance
with paragraph (1) of this subsection in some other manner.
(3)
Posting. Each area or room containing radiation
machines shall be conspicuously posted with a sign or signs bearing the radiation
symbol and the words "CAUTION - X-RAY EQUIPMENT," or words having a similar
intent.
(f)
Operating requirements.
(1)
Procedures. Operating and safety procedures shall be written
and made available to all radiation machine operators. No person shall be
permitted to operate radiation machines in any manner other than that specified
in the procedures unless that person has obtained written approval of the
radiation safety officer.
(2)
Bypassing. No person shall bypass a safety device
unless that person has obtained the approval of the radiation safety officer.
When a safety device has been bypassed, a visible sign bearing the words "SAFETY
DEVICE NOT WORKING," or words having a similar intent, shall be placed on
the radiation source housing.
(3)
Repair or modification of radiation machines. Except
as specified in paragraph (2) of this subsection, no operation involving removal
of covers, shielding materials, or tube housings or modifications to shutters,
collimators, or beam stops shall be performed without ensuring that the tube
is off and will remain off until safe conditions have been restored. The main
switch, rather than interlocks, shall be used for routine shutdown in preparation
for repairs.
(g)
Personnel requirements.
(1)
Instructions. No person shall be permitted to operate
or maintain radiation machines unless such person has received instruction
in and demonstrated competence in the following.
(A)
Identification of radiation hazards associated with the
use of the radiation machine.
(B)
Radiation warning and safety devices incorporated into
the radiation machine, or the reasons they have not been installed on certain
pieces of equipment and the extra precautions required in such cases.
(C)
Operating and safety procedures for the radiation machine.
(D)
Symptoms of an acute localized exposure.
(E)
Proper procedures for reporting an actual or suspected
exposure in excess of the limits specified in §289.231 of this title.
(2)
Personnel monitoring. Notwithstanding the requirements
of §289.231(n)(1)(A) of this title, finger dosimetric devices shall be
provided to and shall be used by:
(A)
radiation machine workers using systems having an open-beam
configuration and not equipped with a safety device; and
(B)
personnel maintaining radiation machines if the maintenance
procedures require the presence of a primary x-ray beam when any local component
in the x- ray system is disassembled or removed.
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 February 25, 2000.
TRD-200001433
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
Subchapter D. GENERAL
25 TAC §289.204
The Texas Department of Health (department) proposes an amendment
to §289.204, concerning fees for certificates of registration, radioactive
material licenses, emergency planning and implementation, and other regulatory
services. The amendment adjusts the fee amounts to reflect recovery of increased
regulatory costs as a result of departmental salary adjustments mandated by
the 76th Legislature. The amendment increases radioactive material license
fees by at least 10% to correct an imbalance in the percentage of costs recovered
from radiation machine certificate of registration fees versus license fees
when compared to the percentage of program costs charged against registered
activities versus licensed activities. The fees for mammography certification
are increased by 30% to recover 100% of the regulatory costs for mammography
certification. The fee for dental and veterinary facilities that possess 10
or more radiation machines is increased to correct an error in the amount
as compared to the fee for dental and veterinary facilities possessing one
to nine radiation machines. This amendment is part of the department's ongoing
evaluation of program fees to comply with the provisions of Health and Safety
Code §401.301.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed. The department will receive an additional $405,177
in revenue for each year of the first five-year period. State or local government
entities that possess a radioactive material license will have an increase
of at least 10% over the current annual fee. The fiscal impact to state or
local government entities that possess 10 or more radiation machines at a
dental or veterinary facility will be an annual increase of $50 in the certificate
of registration fees.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section will be in effect, the public benefit anticipated
as a result of enforcing the section will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
by recovering the majority of the costs of the regulatory program from those
entities possessing sources of radiation. The effect on small businesses and
micro-businesses required to comply with the section as proposed will vary
depending on the uses of radioactive material authorized on a license and
the types and number of dental or veterinary radiation machines authorized
on a certificate of registration. There is no anticipated impact on local
employment.
Comments on the proposal may be presented to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512)834- 6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Wednesday,
March 29, 2000, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The amendment affects Health and Safety Code, Chapter 401 and Chapter 12.
§289.204.Fees for Certificates of Registration, Radioactive Material [
(a)
(No change.)
(b)
Scope. Except as otherwise specifically provided, the requirements
in this section apply to any person who is the following:
(1)
an applicant for, or holder of:
(A)
a radioactive material license issued in accordance with
[
(B)
(No change.)
(C)
a certificate of registration for radiation machines and/or
services, or sources of laser radiation, issued in accordance with §289.226
of this title (relating to Registration of Radiation Machine Use and Services), §289.230
of this title (relating to Certification of Mammography Systems
and Accreditation
of Mammography Facilities), or §289.301 of this title (relating to Registration
and Radiation Safety Requirements for Lasers)
[
(2)-(3)
(No change.)
(c)-(d)
(No change.)
(e)
Payment of fees.
(1)
(No change.)
(2)
A nonrefundable fee, in accordance with subsection
(f) of this section shall be paid annually for each radioactive material license
and/or for each general license acknowledgement. The fee shall be paid in
full each year on or before the last day of the expiration month of the license
or general license acknowledgement. For example, if the license or general
license acknowledgement expires May 31,
2010
[
(3)
(No change.)
(4)
In the case of a single certificate of registration
that authorizes more than one category of use, the category listed in subsection
(i) of this section and assigned the higher
of the
fee[
(5)
Each application for reciprocal recognition of an
out-of-state license in accordance with §289.252(s) of this title, an
out-of-state registration in accordance with §289.226 of this title,
or an out-of-state laser registration in accordance with
§289.301
[
(6)-(8)
(No change.)
(f)
Schedule of annual fees for radioactive material licenses.
The following schedule contains the annual fees for radioactive material licenses:
Figure: 25 TAC §289.204(f)
[
(g)
Fee for Evaluation of a Sealed Source and/or Device.
(1)
Each time a manufacturer submits a request for evaluation
of a unique sealed source, one of the following fees shall be paid:
(A)
for an initial evaluation, a fee of
$3,614
[
(B)
for an amendment requiring re-evaluation, a fee of
$1,804
[
(2)
Each time a manufacturer submits a request for
evaluation of a unique device, one of the following fees shall be paid:
(A)
for an initial evaluation, a fee of
$7,233
[
(B)
for an amendment requiring re-evaluation, a fee of
$3,619
[
(3)
(No change.)
(h)
Fees for certification of mammography systems.
(1)
An application for certification of mammography systems
shall be accompanied by a fee of
$422
[
(2)
The annual fee for mammography systems is
$422
[
(i)
Schedule of annual fees for certificates of registration
for radiation machines, lasers, and services. The following schedule contains
the annual fees for certificates of registration for radiation machines, lasers,
and services:
Figure: 25 TAC §289.204(i)
[
(j)
(No change.)
(k)
Failure to pay prescribed fees.
(1)
(No change.)
(2)
In any case where the agency finds that a licensee
or registrant has failed to pay a fee prescribed by this section by the due
date, the licensee or registrant shall pay an annual late payment fee of 20%
of the annual fee prescribed in [
(3)-(4)
(No change.)
(l)
Schedule of fees for uranium recovery and byproduct material
disposal facility licenses. The following schedule contains the fees for uranium
recovery and byproduct material disposal facility licenses:
Figure: 25 TAC §289.204(l)
[
(m)
(No change.)
(n)
One-time fee adjustments for uranium recovery and byproduct
material disposal facility licenses. For the addition of the following items
after an environmental assessment has been completed on a facility, a one-time
fee corresponding to the item shall be paid:
(1)
$22,389
[
(2)
$55,977
[
(3)
$8,777
[
(4)
$39,653
[
(5)
$55,977
[
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 February 25, 2000.
TRD-200001453
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: April 9, 2000
For further information, please call: (512) 458-7236
Chapter 419.
MEDICAID STATE OPERATING AGENCY
Subchapter O. ENROLLMENT OF MEDICAID WAIVER PROGRAM PROVIDERS
Chapter 103.
INJURY PREVENTION AND CONTROL
(8)
] Injury-Damage to the
body that results from intentional or unintentional acute exposure to thermal,
mechanical, electrical, or chemical energy, or from the absence of essentials
such as heat or oxygen.
(9)
] Reportable injury -
Any injury or condition required to be reported under this chapter.
(10)
] Report of an injury
- The notification to the appropriate health authority of the occurrence of
a specific injury in a human, including all information required by the rules
and forms promulgated by the Board of Health.
(11)
] Spinal cord - That
portion of the central nervous system which extends from the foramen magnum
to the cauda equina. All nerve roots within the spinal canal are included.
(14)
] Submersion injury-A
drowning (a death resulting from suffocation within 24 hours of submersion
in water) or near-drowning (survival for at least 24 hours after suffocation
from submersion in water).
(15)
] Suspected case-A case
in which an injury is suspected, but the final diagnosis is not yet made.
(13)
]
Texas
[
State
] Trauma Registry-A statewide database
administered by the
Injury and Epidemiology and Surveillance Program
which documents and
integrates medical and system information related to the provision of trauma
care by health care entities.
(16)
] Traumatic brain injury-An
acquired injury to the brain, including brain injuries caused by anoxia due
to near drowning. The term does not include brain dysfunction caused by congenital
or degenerative disorders or birth trauma. The following International Classification
of Diseases 9th Revision Clinical Modification (ICD-9- CM) diagnostic codes
are to be used to identify cases of traumatic brain injury: 800.0-801.9, 803.0-804.9
and 850.0-854.1. The ICD-9-CM diagnostic code to be used to identify traumatic
brain injury caused by anoxia due to near drowning is 348.1
or 994.1.
For subsequent editions of the International Classification of Diseases, equivalent
codes should be used
.
(12)
]
Traumatic spinal
[
Spinal
] cord injury-An acute, traumatic lesion of the neural
elements in the spinal canal, resulting in any degree of sensory deficit,
motor deficits, or bladder/bowel dysfunction. The neurologic deficit or dysfunction
can be temporary or permanent. The following International Classification
of Diseases 9th Revision Clinical Modification (ICD-9-CM) diagnostic codes
are to be used to identify cases of
traumatic
spinal cord injury:
806.0-806.9 and
952.0-952.9
[
952.0-953.9
].
For
subsequent editions of the International Classification of Diseases, equivalent
codes should be used.
Chapter 157.
EMERGENCY MEDICAL CARE
Subchapter G. EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS
159.
TERTIARY MEDICAL CARE
Chapter 289.
RADIATION CONTROL
Subchapter E. REGISTRATION REGULATIONS
Chapter 289.
RADIATION CONTROL Material(s) ] Licenses, Emergency Planning and Implementation, and Other Regulatory Services.
§289.127 of this title (relating to Licensing of Naturally Occurring
Radioactive Material (NORM)),
] §289.252 of this title (relating
to Licensing of Radioactive Material), §289.254 of this title (relating
to Licensing of Radioactive Waste Processing and Storage Facilities),
§289.259 of this title (relating to Licensing of Naturally Occurring
Radioactive Material (NORM)),
or §289.260 of this title (relating
to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities);
or
§289.2 of this
title (relating to Control of Laser Radiation Hazards)
]; or
1994
],
annual fees are due on or before May 31 of each calendar year. In the case
of a single license that authorizes more than one category of use, the annual
fee shall be the prescribed fee for the highest license category plus 25%
of the applicable prescribed fee for each additional license category authorized.
,
]
or base fee plus corresponding machine/service fee, as applicable, will be
used.
§289.2
] of this title shall be accompanied by the
applicable annual fee, provided that no such fee has been submitted within
12 months of the date of commencement of the proposed activity.
Figure: 25 TAC §289.204(f)
]
$3,285
]; or
$1,640
].
$6,575
]; or
$3,290
].
$325
] for each
unit.
$325
] for each unit.
Figure: 25 TAC §289.204(i)
]
this subsection and
] subsections
(f), (h), [
and
] (i)
and (l)
of this section, in addition
to the annual license and registration fee. The annual late payment fee shall
not exceed $10,000 for each licensee or registrant who fails to pay the fees
prescribed by this section.
Figure: 25 TAC §289.204(l)
]
$20,354
] for in situ wellfield
on noncontiguous property;
$50,888
] for in situ
satellite;
$7,979
] for wellfield
on contiguous property;
$36,048
] for non-vacuum
dryer; or
$50,888
] for disposal
(including processing, if applicable) of byproduct material.
Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION