Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 137.
BIRTHING CENTERS
Subchapter D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES
25 TAC §137.55
The Texas Department of Health (department) adopts an amendment
to §137.55 concerning voluntary paternity establishment services in birthing
centers, with changes to the proposed text as published in the January 28,
2000, issue of the
Texas Register
(25 TexReg
507), as a result of comments received during the 30-day comment period.
The amendment adds new subsection (l) relating to the voluntary paternity
establishment services. Birthing centers licensed by the department will be
required to provide voluntary paternity establishment services in accordance
with the section as a condition of licensure.
Federal law found at 42 United States Code §666(a)(5) requires that
each state establish certain procedures concerning paternity establishment
services. The United States Department of Health and Human Services has adopted
regulations relating to the establishment of paternity. The regulations are
found at 45 Code of Federal Regulations §302.70(a)(5)(iii) and §303.5(g).
The federal regulations require that all private and public birthing hospitals
participate in the voluntary paternity establishment services program. The
Texas Legislature enacted Acts 1999, 76th Legislature, Chapter 556, (Senate
Bill 368) which amends the Family Code and the Health and Safety Code to incorporate
the requirements concerning paternity establishment which are required by
federal law and to require birthing center administrators to comply.
This amendment requires birthing centers to comply with Health and Safety
Code, §192.012 relating to record of acknowledgment of paternity and
the rules of the Office of the Attorney General found at Title 1, Part 3,
Texas Administrative Code, Chapter 55, Subchapter J (relating to Voluntary
Paternity Acknowledgment Process). There is no express entity identified in
federal or state law, federal regulations, or the rules of the Office of the
Attorney General which would be responsible for insuring enforcement of the
law and rules. Therefore, this amendment is being added to the birthing center
rules as a condition of licensure in order to ensure a birthing center's compliance
with the law and rules and to provide a mechanism for sanctioning a birthing
center that fails to comply with the requirements relating to voluntary paternity
establishment services. Compliance will be determined during licensing surveys
and inspections.
The department received no public comments during the comment period for
this amendment. However, the department is making the following minor change
in order to reflect the correct title of Subchapter J (relating to Voluntary
Paternity Acknowledgment Process) in rules proposed by the Office of Attorney
General at Title 1, Part 3, Texas Administrative Code, Chapter 55, as published
in the January 7, 2000, issue of the
Texas Register
(25 TexReg 19).
Change: Concerning §137.55(l)(2), the title of Subchapter J has been
corrected to read Voluntary Paternity Acknowledgment Process.
The amendment is adopted under the Health and Safety Code, §244.009,
which requires the Texas Board of Health (board) to adopt rules under the
Texas Birthing Center Licensing Act including rules relating to the provision
and coordination of services; the Family Code §160.215 which allows the
department to adopt rules to implement the requirements relating to acknowledgment
or denial of paternity; the Health and Safety Code, §191.003, which allows
the board to adopt necessary rules relating to vital statistics; and the Health
and Safety Code, §12.001, which provides the board with the authority
to adopt rules for the performance of every duty imposed by law upon the board,
the department, and commissioner of health.
§137.55.Other State and Federal Compliance Requirements.
(a)
A center utilizing the services of a documented midwife
shall ensure that its documented midwife(ives) does not violate the Texas
Midwifery Act, Texas Civil Statutes, Article 4512i, §17 or §18,
concerning prohibited acts and criminal penalties, while functioning in his
or her capacity at or for the center.
(b)
A center shall ensure that its documented midwives comply
with §§37.171-37.185 of this title (relating to Midwives), while
functioning in his or her capacity at or for the center.
(c)
A center that provides laboratory services shall meet the
Clinical Laboratory Improvement Amendments of 1988, 42 United States Code, §263a,
Certification of Laboratories (CLIA 1988). CLIA 1988 applies to all centers
with laboratories that examine human specimens for the diagnosis, prevention,
or treatment of any disease or impairment of, or the assessment of the health
of, human beings. If a center accepts laboratory test results from another
state or foreign country, such as Mexico, the laboratory documents must be
reviewed and approved by a licensed health professional within his or her
scope of practice.
(d)
A center utilizing the services of a registered nurse(s)
shall ensure that its registered nurse(s) comply with the Nursing Practice
Act, Texas Civil Statutes, Articles 4525a and 4525b, concerning professional
nurse reporting and peer review, while functioning in his or her capacity
at or for the center.
(e)
A center utilizing the services of a licensed vocational
nurse(s) shall ensure that its licensed vocational nurse(s) comply with the
Board of Vocational Nurse Examiners rules at 22 Texas Administrative Code, §§240.11-240.13,
concerning licensed vocational nurse peer review and reporting, while functioning
in his or her capacity at or for the center.
(f)
A center utilizing the services of a physician(s) shall
ensure that its physician(s) comply with the Medical Practice Act, Texas Civil
Statutes, Article 4495b, while functioning in his or her capacity at or for
the center.
(g)
A center utilizing the services of a physician assistant(s)
shall ensure that its physician assistant(s) comply with the Physician Assistant
Licensing Act, Texas Civil Statutes, Article 4495b-1, relating to supervision
requirements, while functioning in his or her capacity at or for the center.
(h)
A center that provides pharmacy services shall obtain a
license as a pharmacy if required by the Texas Pharmacy Act, Texas Civil Statutes,
Article 4542a-1.
(i)
A center shall comply with the following federal Occupational
Safety and Health Administration requirements:
(1)
29 Code of Federal Regulations, Subpart E, §1910.38,
concerning employee emergency plans and fire prevention plans;
(2)
29 Code of Federal Regulations, Subpart I, §1910.132,
concerning general requirements for personal protective equipment;
(3)
29 Code of Federal Regulations, Subpart I, §1910.133,
concerning eye and face protection;
(4)
29 Code of Federal Regulations, Subpart I, §1910.138,
concerning hand protection;
(5)
29 Code of Federal Regulations, Subpart L, §1910.157,
concerning portable fire extinguishers;
(6)
29 Code of Federal Regulations, Subpart Z, §1910.1030,
concerning blood borne pathogens; and
(7)
29 Code of Federal Regulations, Subpart Z, §1910.1200,
Appendices A-E, concerning hazard communication (hazardous use of chemicals).
(j)
A center shall not use adulterated or misbranded drugs
or devices in violation of the Health and Safety Code, §431.021. Adulterated
drugs and devices are described in Health and Safety Code, §431.111.
Misbranded drugs or devices are described in Health and Safety Code, §431.112.
(k)
A center shall not commit a false, misleading, or deceptive
act or practice as that term is defined in the Deceptive Trade Practices-Consumer
Protection Act, Business and Commerce Code, §17.46.
(l)
A birthing center must provide voluntary paternity establishment
services in accordance with:
(1)
the Health and Safety Code, §192.012, Record of Acknowledgment
of Paternity; and
(2)
the rules of the Office of the Attorney General found
at 1 Texas Administrative Code, Chapter 55, Subchapter J (relating to Voluntary
Paternity Acknowledgment Process).
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on May 22, 2000.
TRD-200003524
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 11, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts the repeal of existing §289.118
and new §289.228, concerning radiation safety requirements for analytical
and other industrial radiation machines. New §289.228 is adopted with
changes to the proposed text as published in the March 10, 2000, issue of
the
Texas Register
(25 TexReg 1958), as a
result of department comments received during the 30-day comment period. The
repeal of §289.118 is adopted without changes and therefore will not
be republished.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.118 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist in that a rule on this subject is needed; however,
the rule needed revision and new §289.228 contains updated requirements.
The revision clarified that the requirements in the section also include
other 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 were clarified to reflect the
Texas
Register
format. Other minor grammatical changes were made to the section
for clarification. The revision was also part of the department's continuing
effort to update, clarify, and simplify its rules regarding the control of
radiation based upon technological advances, 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 January 7, 2000, issue
of the
Texas Register
(25 TexReg 219). No
comments were received by the department on this section.
The department received no public comments during the comment period for
this amendment. However, the department is making the following changes due
to staff comments to clarify the intent and improve the accuracy of the section.
Change: Concerning §289.228(b)(2), the department changed the word
"Material(s)" to "Material" to be consistent with the title of §289.204
of this chapter.
Change: Concerning §289.228(c)(2), the department deleted the letter
"A," started the definition with the words "Design features," and changed
the words, "Causes" and "prevents" to the plural form to be grammatically
correct.
Change: Concerning §289.228(c)(3), the department deleted the words,
"A part," changed "includes" to "include," and changed "does" to "do" to be
grammatically correct. The hyphen was deleted from the word "x-rays" because
the term is not hyphenated when used as a noun, but is hyphenated when used
as an adjective.
Change: Concerning §289.228(c)(5), the department corrected the misspelled
word "cathodolumnescence" to "cathodoluminescence."
Change: Concerning §289.228(d)(2)(B), the department deleted the hyphen
from the word "x-rays," because the term is not hyphenated when used as a
noun, but is hyphenated when used as an adjective.
Change: Concerning §289.228(d)(4), the department added the word "unit"
to clarify the intent of the section.
Change: Concerning §289.228(d)(7), the department spelled out the
word, "microsieverts" before the symbol "µSv" because it was the first
time used in the section.
Change: Concerning §289.228(g)(1)(A)-(E), the department replaced
the period with a colon after the word "following" in paragraph (1) and began
each subparagraph with lower case letters because the subparagraphs are not
complete sentences.
Change: Concerning §289.228(g)(2), the department changed the word
"Notwithstanding" to "In addition to," to clarify the intent of the rule.
Subchapter C. TEXAS REGULATIONS FOR CONTROL OF RADIATION
25 TAC §289.118
The repeal is adopted under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with the authority to
adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health. Government Code §2001.39 is implemented by the adoption.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on May 22, 2000.
TRD-200003525
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 1, 2000
Proposal publication date: March 10, 2000
For further information, please call: (512) 458-7236
25 TAC §289.228
The new section is adopted under the Health and Safety Code,
Chapter 401, which provides the Texas Board of Health (board) with the authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner
of health. Government Code §2001.39 is implemented by the adoption.
§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 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 -- Design features that
cause beam port shutters to close, or otherwise prevent emergence of the primary
beam, upon the failure of a safety or warning device.
(3)
Local components -- Parts of an x-ray system that
include 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 do 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 machines -- This includes,
but is not limited to, x- ray equipment (including cabinet x-ray equipment)
used for cathodoluminescence, 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 unit, 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 (5.0 microsieverts (µSv))
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; and
(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. In addition to 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 adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed
with the Office of the Secretary of State on May 22, 2000.
TRD-200003526
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 1, 2000
Proposal publication date: March 10, 2000
For further information, please call: (512) 458=7236
Subchapter D. GENERAL
Chapter 289.
RADIATION CONTROL
Subchapter E. REGISTRATION REGULATIONS
Chapter 289.
RADIATION CONTROL