Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 97.
COMMUNICABLE DISEASES
Subchapter F. SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV)
25 TAC §97.141
The Texas Department of Health (department) adopts an amendment
to §97.141, concerning the addition of hepatitis C training to the human
immunodeficiency virus (HIV) counseling and testing course currently offered
by the department, and raising the fee charged for the course. Section 97.141
is adopted with a change to the proposed text as published in the January
28, 2000, issue of the
Texas Register
(25
TexReg 498), as the result of staff comments.
During the 76th Legislature, 1999, Chapter 823 (House Bill 1652) was passed
which added Chapter 93, Education and Prevention Program for Hepatitis C,
to the Health and Safety Code. The amendment adds hepatitis C education and
prevention to the established HIV counseling and testing course to comply
with the legislative change. The department also added an amendment to increase
the fee the department charges participants in the course from $150 to $300
to recoup actual expenses for presenting the course. The public benefit anticipated
as a result of enforcing or administering the section will be increased knowledge
on the part of those persons providing hepatitis C counseling. Those who complete
the course will have more information relating to the special needs of persons
with positive hepatitis C test results, including the importance of early
intervention and treatment and recognition of psychosocial needs.
No comments were received during the comment period on the proposed amendments;
however the department is making a minor grammatical change.
Change: Concerning §97.141(b), hepatitis was published as "Hepatitis"
and should be "hepatitis".
The amendment is adopted under Health and Safety Code §85.087,
which requires the board to set a fee for the training of HIV counselors; §85.016,
which allows the department to adopt rules to implement this requirement;
Health and Safety Code §93.003 which requires the board to set a fee
for the training of hepatitis C counselors; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for the
performance of every duty imposed by law on the board, the department, and
the commissioner of health.
§97.141.Fee To Cover the Cost of Providing the Human Immunodeficiency Virus (HIV) Counseling and Testing Course.
(a)
Purpose. The purpose of this section is to implement the
provisions of the Health and Safety Code, §85.087 and §93.003, which
require that the Texas Department of Health (department) develop and offer
a training course for persons providing HIV and/or hepatitis C counseling,
and authorizes the department to charge a fee for the course.
(b)
Content. The training course shall include information
relating to HIV risk reduction and to the special needs of persons with positive
HIV and/or hepatitis C test results. The department's Bureau of HIV and STD
Prevention sets the content. Detailed information about the course may be
obtained from the Bureau of HIV and STD Prevention, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756-3199.
(c)
Fee.
(1)
The fee will be $300 for each participant whose affiliation
is with an entity that does not contract with the department. The Bureau of
HIV and STD Prevention may waive the fee according to established internal
procedures.
(2)
Fees shall be made payable to the Texas Department
of Health. All fees are non-refundable and must be received by the department
prior to participation in the course. The accepted forms of payment are cashiers
check or money order. No other form of payment will be accepted.
(d)
Notice. Notice of the training courses will be announced
through correspondence to contractors and other appropriate entities.
This agency hereby certifies that the 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 24, 2000.
TRD-200003677
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
25 TAC §§123.4, 123.7, 123.9, 123.10, 123.12
The Texas Department of Health (department) adopts the amendments
to §§123.4, 123.7, 123.9, 123.10 and 123.12, concerning the regulation
and certification of respiratory care practitioners. Sections 123.10 and 123.12
are adopted with changes to the proposed text as published in the December
3, 1999, issue of the
Texas Register
(24 TexReg
10725). Sections 123.4, 123.7, and 123.9 are adopted without changes and therefore,
the sections will not be republished. The amendments cover fees; types of
certificates and temporary permits and applicant eligibility; certificate
renewal; continuing education requirements; and professional and ethical standards.
The amendments delete the specific reactivation and reinstatement fees
as these are determined by the renewal fee and the standard conforming Sunset
language relating to late renewal processing, add a fee for verification of
certification status, extend the period for which an initial respiratory care
practitioner certificate is issued, describe and clarify the renewal processing
procedures, increase the continuing education credits allowed for certain
activities and examinations relating to respiratory care, allow additional
verifiable continuing education opportunities based on current trends in continuing
education, and update and clarify existing language.
Section 123.4 is amended by deleting the reinstatement and reactivation
fees, and adding a fee for written verification of certification status. The
reinstatement fee has become a late renewal fee. This fee and the reactivation
fees are now based on multipliers of the renewal fee, according to conforming
standard Sunset language.
Section 123.7 is amended by extending the time-period for which an initial
certificate is issued. The amendment will allow certificates to be issued
for not less than seven months, rather than four months based on the former
language.
Section 123.9 is amended to correct typographical errors; to add language
that is consistent with §123.7 regarding initial certificates; to allow
the department to be discretionary regarding specific information requested
for renewal; to revise the procedures for late renewal (formerly identified
as "reinstatement"); adds conforming standard Sunset language which limits
late renewals to less than one year after certificate expiration; and simplifies
the procedures and reduces the continuing education relating to reactivating
a certificate.
Section 123.10 is amended to clarify existing language relating to continuing
education, to specify the content, to allow Internet or computer-based activities,
to increase the credit allowed for certain examinations relating to respiratory
care, to allow more credits to be earned for advance life support courses;
to specify the reporting procedures for continuing education; to delete the
term "reinstate," to authorize random audits of continuing education to determine
compliance; and to clarify when credits may be carried over to the next continuing
education period.
Section 123.12 is amended to specify that any misrepresentations of professional
qualifications or credentials is considered a violation or professional and
ethical standards.
The following comments were received concerning the proposed sections.
Following each comment is the department's response and any resulting change(s).
Comment: Regarding §123.10, one commenter stated that the 12 hours
of continuing education (CE) credit required for annual renewal was excessive.
The commenter was concerned that the department had increased the number of
CE hours and the renewal fee at the same time, causing added expenses to licensees.
Response: The department disagrees with the comment. The proposed amendments
did not cover any changes regarding the number of CE hours required for renewal
or renewal fees. Rather, the increases in CE hours and the renewal fee were
adopted in 1997. These were the first increases in CE and fees adopted after
the RCP rules were promulgated in 1986. The increases were effective for the
first renewal cycle which occurred after September 1, 1997. No changes were
made as a result of the comment.
Comment: A commenter asked that §123.10(c) be amended to allow CE
credit for audio and audio-video taped CE activities.
Response: The department disagrees with this comment. The department is
concerned about the opportunity to obtain CE credit without actually studying
and completing the materials. No change was made as a result of this comment.
Comment: A commenter asked that §123.10(c) be amended to allow CE
credit for directed readings contained in the Journal of the American Association
for Respiratory Care (AARC).
Response: The department disagrees with this comment. The department is
concerned about the opportunity to obtain CE credit without actually studying
and completing the materials. No change was made as a result of this comment.
Comment: Regarding §123.10(c)(4), a commenter submitted favorable
comments regarding the proposal to accept four hours of "Internet study" for
CE credits.
Response: The department acknowledges the favorable comment. No changes
were made as a result of the comment.
Comment: Concerning §123.10(c)(4), one commenter urged the department
to not limit the acceptance of "electronic" CE credits to "only those approved
by the AARC." The commenter asked that the requirement that CE courses be
"approved by the AARC" be removed from the rules as proposed. The commenter
stated the rules relating to the acceptance or approval of "electronic" CE
credits should be flexible because educational opportunities are expanding
quickly.
Response: The department agrees that the rules relating to CE approval
should be as flexible as possible in order to allow the acceptance of new
or non-traditional CE activities. The department is also concerned that the
course content should be directly related to the profession of respiratory
care. Therefore, the language in §123.10(c)(4) has been amended to agree
with the requirements in §123.10(c)(2)(A) and (C).
Comment: Concerning §123.10(c)(4), a comment was received requesting
that the department add language allowing CE credits for self-directed Internet
or computer-based study approved and provided by the Texas Society for Respiratory
Care. The commenter asked that the new types of CE delivery not be limited
to activities approved by the AARC.
Response: The department agrees in principle that the rule regarding the
organization which approves Internet or computer-based CE should not be limited
to the AARC. However, rather than specify the organizations in the rules,
the department has changed the wording of the rule to allow more flexibility.
Existing language in §123.10(c)(2)(A) and (C) will apply to Internet
or computer-based CE activities. A list of the agencies and organizations
approved by the advisory committee is available from the department and will
be provided upon request.
Comment: Concerning §123.10(d)(4), a commenter noted that the title,
"certified respiratory therapy technician" recredentialing examination was
outdated and should be changed to reflect the current title, "certified respiratory
therapist" recredentialing examination.
Response: The department agrees and the wording has been changed.
Comment: Concerning §123.10(d)(4) - (7), a commenter suggested that
the department allow the same number of CE credits as does the AARC for the
various recredentialing and advanced practice examinations offered by the
National Board for Respiratory Care.
Response: The department agrees except for changing the number of credits
allowed for the Registered Respiratory Therapist (RRT) exams, which would
be reduced from 18 hours of credit to 15. The credits allowed for the other
exams would increase based on the recommendation. The language in §123.10(d)(4),
(7), and (9) has been amended based on the comment. In addition, the number
of credits proposed under paragraph (10) for the polysomnographic technologist
exam has increased from nine to ten so that, all exams receive equal credit.
No changes to paragraphs (5) and (6) were made based on the comment.
Comment: Regarding §123.10(c)(4), a commenter noted the correct name
of the national association was the "American Association for Respiratory
Care," not the "American Association of Respiratory Care."
Response: The department agrees with the comment. No change will be made
based on the comment because the name of the association is being removed
from the rule based on other comments.
Comment: Concerning §123.12, Professional and Ethical Standards, a
commenter recommended updating the statutory reference to reflect the correct
section of the Texas Occupations Code.
Response: The department agrees and the language has been amended.
Comments were received from the American Association for Respiratory Care
and the Texas Society for Respiratory Care.
The amendments are adopted under the Respiratory Care Practitioner
Certification Act, Texas Occupations Code, Chapter 604, §604.052 (a)
and (c) (formerly Texas Civil Statutes, Article 4512l §3(a) and (e))
which provides the Texas Board of Health (board) with the authority to adopt
rules necessary to implement the Act; and the Texas Health and Safety Code §12.001,
which provides the board with the authority to adopt rules for the performance
of every duty imposed by law on the board, the department, and the commissioner
of health.
§123.10.Continuing Education Requirements.
(a)
Purpose. The purpose of this section is to establish the
continuing education requirements which a respiratory care practitioner must
complete annually to maintain certification. These requirements are intended
to maintain and improve the quality of professional services in respiratory
care provided to the public and keep the practitioner knowledgeable of current
research, techniques, and practice and provide other resources which will
improve skill and competence in respiratory care.
(b)
General. Continuing education requirements for renewal
shall be fulfilled each renewal year.
(1)
The initial period shall begin with the date the department
issues the certificate and end on the last day of the birth month at the time
of the second renewal.
(2)
At the time the certificate is mailed, each practitioner
shall be notified of the beginning and ending dates of the continuing education
period.
(3)
A practitioner must complete 12 clock hours of continuing
education acceptable to the department during each renewal year.
(4)
A clock hour shall be 50 minutes of attendance and
participation in an acceptable continuing education experience.
(c)
Types of acceptable continuing education. Continuing education
must be in skills relevant to the practice of respiratory care and must have
a direct benefit to patients and clients and shall be acceptable if the experience
falls in one or more of the following categories:
(1)
respiratory care course work seminars, workshops, review
sessions, or other organized educational programs completed at or through
any respiratory care education program;
(2)
participation in any program (e.g., in-service educational
training programs, institutes, seminars, workshops and conferences) which
is:
(A)
directly related to the profession of respiratory care;
(B)
instructor directed; and
(C)
approved, recognized, accepted, or assigned continuing
education credits by professional organizations or associations or offered
by a federal, state, or local governmental entity. A list approved by the
advisory committee is available from the department upon request;
(3)
instruction or teaching in programs set out in
paragraphs (1) and (2) of this subsection, provided that such instruction
or teaching is not a part of, or required as a part of, one's employment,
or;
(4)
up to four credit hours during each renewal period
of self-directed Internet- based or computer-based studies, including a post-test,
which meets the requirements described in paragraphs (2)(A) and (2)(C) of
this subsection.
(d)
Determination of clock hours. The department shall credit
continuing education experiences as follows.
(1)
Completion of course work at or through a respiratory care
educational program as set out in subsection (c)(1) of this section shall
be credited on the basis of 15 clock hours for each semester hour successfully
completed for credit or audit, evidenced by a certificate of successful completion
or official transcript.
(2)
Parts of programs, activities, workshops, seminars,
sessions, etc., which meet the criteria of subsections (c)(1) or (2) of this
section shall be credited on a one-for-one basis with one clock hour for each
clock hour spent in the continuing education activity.
(3)
Teaching in programs which meet the department's criteria
as set out in subsection (c)(3) of this section shall be credited on the basis
of two clock hours for each hour actually taught.
(4)
Passing the certified respiratory therapist recredentialing
examination shall be credited on the basis of ten clock hours.
(5)
Passing the written registry examination for advanced
respiratory therapy practitioners for credentialing or recredentialing shall
be credited on the basis of nine clock hours.
(6)
Passing the registered respiratory therapist clinical
simulation examination for credentialing or recredentialing shall be credited
on the basis of nine clock hours.
(7)
Passing the National Board for Respiratory Care, Inc.
(NBRC) pediatric specialty examination shall be credited on the basis of ten
clock hours.
(8)
Successful completion of the initial course in advanced
cardiac life-support, pediatric advanced life-support, the neonatal advanced
life-support course, basic trauma life-support or pre-hospital trauma life-support
shall be credited on the basis of 12 clock hours. Recertification courses
shall be credited for the number of hours actually completed during the recertification
course, but shall not count for more than 12 hours.
(9)
Passing the certification examination for entry level
pulmonary function technologists or the registry examination for advanced
pulmonary function technologists for credentialing shall be credited on the
basis of ten clock hours.
(10)
Passing the registration examination offered by the
Board of Registered Polysomnographic Technologists shall be credited on the
basis of ten clock hours.
(e)
Reporting of continuing education. Each practitioner shall
be responsible for reporting to the department the continuing education activities
completed.
(1)
A practitioner shall report the number of hours of continuing
education completed during the renewal period. If requested by the department,
each practitioner shall submit proof of completion of the required continuing
education activity to the department at the time of certificate renewal, or
at other times as directed by the department. However, if an extension has
been granted in accordance with subsection (g) of this section, the practitioner
shall file the continuing education hours immediately following completion
of the activity.
(2)
Each continuing education activity filed by a practitioner
must be accompanied by appropriate documentation of the continuing education
claimed as follows:
(A)
for a program attended, signed certification by a program
leader or instructor of the practitioner's participation in the program by
certificate, or letter on letterhead of the sponsoring agency, or official
continuing education validation form or official transcript of the sponsoring
agency accompanied by a brochure, agenda, program, or other applicable information,
indicating content of the program;
(B)
for teaching or instruction in approved programs, a letter
on sponsoring agency's letterhead giving name of program, location, dates,
and subjects taught, and giving total clock hours of teaching or instruction;
(C)
for completion of course work at or through respiratory
care education programs, a certificate of successful completion or an official
transcript.
(f)
Activities unacceptable as continuing education. The department
may not grant continuing education credit to any practitioner for:
(1)
education incidental to the regular professional activities
of a practitioner such as learning occurring from experience or research;
(2)
organization activity such as serving on committees
or councils or as an officer in a professional organization;
(3)
any program or activity which is not approved in accordance
with subsection (c)(2) of this section;
(4)
any experience which does not fit the types of acceptable
continuing education in subsection (c) of this section;
(5)
any continuing education activity completed before
or after the renewal year for which the continuing education credit is submitted
except as allowed under subsection (g)(1) of this section;
(6)
self-study continuing education programs or activities
except those set out in subsection (c)(4) of this section; or
(7)
activities which have been completed more than once
during the continuing education period.
(g)
Failure to complete required continuing education.
(1)
A practitioner who has failed to complete the requirements
for continuing education as specified in subsection (b) of this section may
be granted up to a 90-day extension to a reporting period if the renewal fee
is paid on or prior to the expiration date. The 90-day extension is the maximum
that may be granted and there will be no exceptions.
(A)
Following the receipt of the current renewal form and fee,
the department shall issue identification cards which are certificates valid
for a 90-day period beginning with the day following the expiration date of
the practitioner's annual certificate and a written notice that the continuing
education period has been extended.
(B)
If the deficiency is made up prior to the end of the extension,
the department will notify the practitioner that the next reporting period
commences on the day following the completion of the credits to correct the
deficiency. The new reporting period shall end on the next renewal date. In
other words, whenever an extension is granted, the time is borrowed from the
next reporting period.
(C)
If an excess number of credits were earned during an extension,
the excess will be credited toward the new reporting period.
(D)
A practitioner may not receive another extension at the
end of the 90-day extension.
(2)
A practitioner who has failed to complete the
requirements for continuing education as specified in subsection (b) of this
section and who has not completed the continuing education requirement during
the 90-day extension shall return the certificate and identification cards
to the department and shall not advertise or represent himself or herself
as a respiratory care practitioner in any manner. The person may renew the
certificate or reapply for a new certificate in accordance with §123.9(e)
of this title (relating to Certificate Renewal).
(h)
Other miscellaneous provisions.
(1)
Audiovisual programs may be accepted by the department
if such a program represents one of the instructional methods or strategies
rather than constituting the entire program and provided the program meets
the criteria as set out in subsection (c) of this section.
(2)
A practitioner who also holds a current license, registration,
or certification in another health care profession or a current license, registration,
or certification as a respiratory care practitioner in another state, territory,
or country may satisfy the continuing education requirements for renewal in
Texas with hours counted toward renewal of another license, registration,
or certification as long as all of the hours meet all of the requirements
of this section.
(3)
Hardships will be considered and granted by the department
on a case by case basis.
(4)
The department may conduct random audits of continuing
education completed by practitioners to determine compliance with this section.
(5)
No continuing education hours may be carried over
from one renewal period to another renewal period unless the hours were earned
during a continuing education extension as set out in subsection (g) of this
section.
§123.12.Professional and Ethical Standards.
The purpose of this section shall be to establish the standards of
professional and ethical conduct required of a practitioner pursuant to the
Act, §604.201(b)(4).
(1)
Professional representation and responsibilities.
(A)
A practitioner shall not misrepresent any professional
qualifications or credentials or provide any information that is false, deceptive,
or misleading to the department, for employment or work assignment as a respiratory
care practitioner, or fail to disclose any information that could affect the
decision to employ or assign a task as a respiratory care practitioner.
(B)
A practitioner shall not make any false or misleading claims
about the efficacy of any services or methods of treatment.
(C)
A practitioner shall not extend his or her practice beyond
his or her competence and authority vested in him or her by a physician or
this Act.
(D)
A practitioner shall not permit the use of his or her name
for the purpose of documenting that respiratory care services have been rendered
unless that practitioner has provided those services.
(E)
A practitioner shall not promote or endorse products, services,
or equipment in a manner that is false and misleading.
(F)
A practitioner shall maintain knowledge and skills for
continuing professional competence. A practitioner shall participate in continuing
education programs and activities as set out in §123.10 of this title
(relating to Continuing Education Requirements).
(G)
A practitioner shall not use alcohol or any drugs in any
manner which detrimentally affects the provision of respiratory care.
(H)
A practitioner shall have the responsibility of reporting
alleged misrepresentations or violations of the Act or these sections to the
department.
(I)
The practitioner shall be responsible for competent and
efficient performance of his assigned duties and shall report to the department
incompetence and illegal or unethical conduct of members of the profession.
(J)
A practitioner shall not retaliate against any person who
reported in good faith to the department alleged incompetence; illegal, unethical,
or negligent conduct of any practitioner; or alleged misrepresentation or
any violation(s) of the Act or these sections.
(K)
A practitioner shall keep his or her file updated by notifying
the department of changes in preferred mailing address and telephone number.
(L)
A practitioner shall not make any false, misleading, or
deceptive claims in any advertisement, announcement, presentation, or in competitive
bidding.
(M)
A practitioner shall conform to medically accepted principles
and standards of respiratory care which are those generally recognized by
the profession as appropriate for the situation presented, including those
promulgated or interpreted by or under the AART, the NBRC, the Texas Society
for Respiratory Therapy, the board, the department, and other professional
or governmental bodies.
(N)
A practitioner shall not delegate respiratory care functions
or responsibilities to a person who lacks the ability or knowledge to perform
the function or responsibility. A practitioner providing respiratory care
services may be assisted by an aide or orderly. Aides/orderlies may not perform
respiratory care procedures.
(O)
A practitioner shall not leave an assignment without being
properly relieved by appropriate personnel.
(P)
The department shall consider the failure of a practitioner
to respond to a request for information or other correspondence relating to
the certification process or these sections as unprofessional conduct and
grounds for disciplinary proceedings in accordance with §123.14 of this
title (relating to Violations, Complaints and Subsequent Actions).
(2)
Relationships with patients/clients.
(A)
A practitioner shall make known to a prospective patient
the important aspects of the professional relationship, including fees and
arrangement for payment which might affect the decision to enter into a contractual
relationship.
(B)
A practitioner shall not receive or give a commission or
rebate or any other form of direct or indirect remuneration or benefit for
the referral of patients/clients for professional services.
(C)
A practitioner shall disclose to patients or clients any
interest in commercial enterprises which the practitioner promotes through
patients or clients for the purpose of direct or indirect personal gain or
profit.
(D)
A practitioner shall not accept gratuities for preferential
consideration of the patient. The practitioner shall guard against conflicts
of interest.
(E)
A practitioner shall take reasonable action to inform a
patient's/client's physician and any appropriate allied health care provider
in cases where a patient's/client's cardiorespiratory status indicates a change
in medical status.
(F)
A practitioner shall not violate any provision of any federal
or state statute relating to confidentiality of patient/client communication
and/or records. All inquiries shall be referred to the physician in charge
of the patient's medical care.
(G)
A practitioner shall not engage in any activities that
seek to meet the practitioner's personal needs at the expense or detriment
of a patient/client.
(H)
A practitioner shall practice respiratory care only under
the direction of a qualified medical director or other physician licensed
by the Texas State Board of Medical Examiners. For the purpose of this section
direction shall mean:
(i)
assuring that established policies are carried out;
(ii)
monitoring and evaluating the quality, safety, and appropriateness
of respiratory care services and taking action based on findings; and
(iii)
providing consultation whenever required, particularly
on patients receiving continuous ventilatory or oxygenation support.
(3)
Billing information required; prohibited
practice.
(A)
On the written request of a client, a client's guardian,
or a client's parent, if the client is a minor, a practitioner shall provide,
in plain language, a written explanation of the charges for respiratory care
services previously made on a bill or a statement for the client. This requirement
applies even if the charges are to be paid by a third party.
(B)
A practitioner may not persistently or flagrantly overcharge
or overtreat a client.
(4)
Sanctions. A practitioner shall be subject to
disciplinary action by the board if the practitioner is issued a public letter
of reprimand, is assessed a civil penalty by a court, or has an administrative
penalty imposed by the attorney general's office under the Crime Victims Compensation
Act, Code of Criminal Procedure, Article 56.31 et seq.
(5)
Disclosure. A practitioner shall make a reasonable
attempt to notify each client of the name, mailing address, and telephone
number of the department for the purpose of directing complaints to the department
by providing notification:
(A)
on each written contract for services of a practitioner;
(B)
on a sign prominently displayed in the primary place of
business of each practitioner; or
(C)
in a bill for service provided by a practitioner to a client
or third party.
(6)
Unlawful false, misleading, or deceptive advertising.
(A)
A practitioner shall not use advertising that is false,
misleading, or deceptive or that is not readily subject to verification.
(B)
False, misleading, or deceptive advertising or advertising
that is not readily subject to verification includes advertising that;
(i)
makes a material misrepresentation of fact or omits a fact
necessary to make the statement as a whole not materially misleading;
(ii)
makes a representation likely to create an unjustified
expectation about the results of a health care service or procedure;
(iii)
compares a health care professional's services with another
health care professional's services unless the comparison can be factually
substantiated;
(iv)
contains a testimonial;
(v)
causes confusion or misunderstanding as to the credentials,
education, or licensure of a health care professional;
(vi)
advertises or represents that health care insurance deductibles
or copayments may be waived or are not applicable to health care services
to be provided if the deductibles or copayments are required;
(vii)
advertises or represents that the benefits of a health
benefit plan will be accepted full payment when deductibles or copayments
are required;
(viii)
makes a representation that is designed to take advantage
of the fears or emotions of a particularly susceptible type of patient; or
(ix)
advertises or represents in the use of a professional
name a title or professional identification that is expressly or commonly
reserved to or used by another profession or professional. A "health care
professional" includes a certified respiratory care practitioner, temporary
permitted respiratory care practitioner, or any other person licensed, certified,
or registered by the state in a health-related profession.
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 24, 2000.
TRD-200003675
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: December 3, 1999
For further information, please call: (512) 458-7236
Subchapter C. OPERATIONAL REQUIREMENTS
25 TAC §133.45
The Texas Department of Health (department) adopts an amendment
to §133.45 concerning voluntary paternity establishment services in hospitals
with changes to the proposed text as published in the January 28, 2000, issue
of the
Texas Register
(25 TexReg 499), as
a result of comments received during the 30-day comment period.
The amendment adds new subsection (e) relating to voluntary paternity establishment
services. Hospitals licensed by the department that handle the birth of newborns
will be required to provide voluntary paternity establishment services in
accordance with the section as a condition of licensure.
Federal law found at 42 United States Code §666(a)(5) requires that
each state establish certain procedures concerning paternity establishment
services. The United States Department of Health and Human Services has adopted
regulations relating to the establishment of paternity. The regulations are
found at 45 Code of Federal Regulations §302.70(a)(5)(iii) and §303.5(g).
The federal regulations require that all private and public birthing hospitals
participate in the voluntary paternity establishment services program. The
Texas Legislature enacted Acts 1999, 76th Legislature, Chapter 556, (Senate
Bill 368) which amends the Family Code and the Health and Safety Code to incorporate
the requirements concerning paternity establishment which are required by
federal law.
This amendment requires hospitals to comply with Health and Safety Code, §192.012
relating to record of acknowledgment of paternity and the rules of the Office
of the Attorney General found at Title 1, Texas Administrative Code, Chapter
55, Subchapter J (relating to Voluntary Paternity 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 hospital licensing rules as a condition of licensure in
order to ensure a hospital's compliance with the law and rules and to provide
a mechanism for sanctioning a hospital that fails to comply with the requirements
relating to voluntary paternity establishment services. Compliance will be
determined during licensing surveys and inspections.
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, edition of the
Texas Register
(25 TexReg 19).
Change: Concerning §133.45(e)(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, §241.026,
which requires the Texas Board of Health (board) to adopt and enforce rules
to further the purposes of the Texas Hospital Licensing Law including rules
relating to hospital services relating to patient care and compliance with
other state and federal laws affecting the rights of patients; the Family
Code, §160.215 which allows the department to adopt rules to implement
the requirements relating to acknowledgment or denial of paternity; the Health
and Safety Code, §191.003, which allows the board to adopt necessary
rules relating to vital statistics; and the Health and Safety Code, §12.001,
which provides the board with the authority to adopt rules for the performance
of every duty imposed by law upon the board, the department, and commissioner
of health.
§133.45.Miscellaneous Policies and Protocols.
(a)
Determination of death and autopsy reports. The hospital
shall adopt, implement, and enforce protocols to be used in determining death
and for filing autopsy reports which comply with Health and Safety Code (HSC),
Title 8, Subtitle A, Chapter 671 (Determination of Death and Autopsy Reports).
(b)
Organ and tissue donors. The hospital shall adopt, implement,
and enforce a written protocol to identify potential organ and tissue donors
which is in compliance with the Texas Anatomical Gift Act, HSC, Chapter 692.
The hospital shall make its protocol available to the public during the hospital's
normal business hours.
(1)
The hospital's protocol shall include all requirements
in HSC, Chapter 692, §692.013 (Hospital Protocol).
(2)
A hospital which performs organ transplants shall
be a member of the Organ Procurement and Transplantation Network in accordance
with 42 United States Code, §274 (Organ Procurement and Transplantation
Network).
(c)
Disaster preparedness. A hospital shall adopt, implement,
and enforce a written policy for publicly known natural disaster preparedness
for the reception, treatment, and disposition of casualties. The written policy
shall:
(1)
be developed through a joint effort of the hospital governing
body, administration, medical staff, and hospital personnel;
(2)
include a plan for the reasonable mechanism for triaging
patients, the notification of appropriate personnel and patients in the event
of a disaster, the identification of appropriate community resources, and
the identification of possible evacuation procedures; and
(3)
include the applicable information contained in the
National Fire Protection Association 99, Standard for Health Care Facilities,
1996 edition, Annex 1 (Health Care Emergency Preparedness), published by the
National Fire Protection Association (NFPA), and the State of Texas Emergency
Management Plan. Information regarding the State of Texas Emergency Management
Plan is available from the city or county emergency management coordinator.
The NFPA document referenced in this section may be obtained by writing or
calling the NFPA at the following address and telephone number: 1 Batterymarch
Park, Post Office Box 9101, Quincy, Massachusetts 02269- 9101, (800) 344-3555.
(d)
Illegal remuneration. A hospital shall adopt, implement,
and enforce a policy to ensure that the hospital complies with HSC, Chapter
161, Subchapter I (Illegal Remuneration).
(e)
A hospital that handles the birth of newborns must provide
voluntary paternity establishment services in accordance with:
(1)
the Health and Safety Code, §192.012, Record of Acknowledgment
of Paternity; and
(2)
the rules of the Office of the Attorney General found
at 1 Texas Administrative Code, Chapter 55, Subchapter J (relating to Voluntary
Paternity 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 24, 2000.
TRD-200003681
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
Subchapter A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS
The Texas Department of Health (department) adopts amendments to §135.3
and §135.21, the repeal of §§135.25-135.27, and new §§135.25-135.29,
concerning the regulation of ambulatory surgical centers, without changes
to the proposed text as published in the January 28, 2000, issue of the
The amendment to §135.3 increases the initial and renewal license
fees from $1,000 to $2,000 to cover the increased cost to the department of
conducting on-site licensing inspections of ambulatory surgical centers every
three years in accordance with Health and Safety Code §243.006(b), as
amended by Senate Bill 1249, 76th Legislature, 1999. The amendment to §135.21
adds new language to implement the amendment to Health and Safety Code §243.006(b)
concerning the on-site licensing inspections of ambulatory surgical centers
licensed by the department and certified under Title XVIII of the Social Security
Act once every three years while the center maintains the certification.
The repeal of §§135.25-135.27 provides reorganization of the
sections within Subchapter A. New §135.25 and §135.26 contain language
to incorporate legislative mandates; new §§135.27-135.29 contain
the language that was previously in repealed §§135.25-135.27, with
minor text updates.
New §135.25 implements certain provisions of Senate Bill 1249, 76th
Legislative, 1999. Senate Bill 1249 amended Health and Safety Code, Chapter
243 by adding §243.0115 which grants the department authority to issue
an emergency order to suspend a license issued under this chapter.
New §135.26 implements House Bill 2085, Article 3, which amended Health
and Safety Code, Chapter 243, by adding §243.015 and §243.016, relating
to administrative penalties for ambulatory surgical centers. These sections
set forth standard language developed by the Sunset Advisory Commission regarding
the imposition of an administrative penalty on a person who violates Chapter
243 or a rule adopted under that chapter; the amount of the penalty; the report
and notice of a violation and penalty; the penalty to be paid or hearing requested;
a hearing; decision by the commissioner; options following a decision to pay
or appeal; stay enforcement of the penalty; collection of penalty; decisions
by the court; the remittance of penalty and interest; and release of bond.
New §135.27 incorporates requirements from repealed §135.25 relating
to complaints. New §135.28 incorporates requirements from the repealed §135.26
relating to reporting of incidents. New §135.29 incorporates the requirements
of repealed §135.27 relating to confidentiality.
All comments received during the 30-day comment period concerned the proposed
amendment to §135.3 which increases the licensing fees. Following each
comment is the department's response and any resulting change(s).
Comment: Concerning §135.3, four commenters stated their opposition
to the increase in licensing fees. One commenter felt it was unreasonable
to have an annual license fee of $2,000 for his ambulatory surgical center
(ASC) which remains idle three days a week. In fact, the commenter felt the
current $1,000 fee was excessive. Another commenter stated he believes the
increase is an inappropriate charge because there is no indication that $6,000
is what is required to inspect ambulatory surgical centers (ASCs), and believes
it is quite a bit less on an every three years basis. One commenter stated
the proposed rules seem to be more representative of a tax increase than a
fee and that there is no evidence given that the proposed fee increase will
result in a corresponding increase in benefit to the public, particularly
in the cases of smaller ASCs or ASCs which already undergo strict surveys.
The fourth commenter stated the fee increase might not seem a significant
amount to a larger multi-specialty surgical facility but is quite onerous
to a private practitioner doing a limited amount of surgery.
Response: The department disagrees. Senate Bill 1249 amended the Health
and Safety Code, Chapter 243, to authorize on-site licensing inspections of
ASCs licensed by the department and certified under Title XVIII of the Social
Security Administration once every three years while the center maintains
the certification. The license fee increase is necessary to cover the increased
cost to the department of conducting the on-site licensing inspections in
accordance with the statute. No change was made as a result of the comment.
Comment: Concerning §135.3, one commenter felt the increase was inappropriate
because there was no indication that the increased fee was what was required
to inspect surgery centers on a three year basis. The commenter was concerned
that by failing to detail anticipated increases in costs, leaves open the
possibility that the increased revenue will exceed the cost of inspection
ASCs triennial and maintaining records of those inspections, and that under
such circumstances, a fee increase beyond that necessary to cover increased
costs would amount to a tax specifically targeted at ASCs. The commenter also
stated that neither the law nor the proposed rules set forth a required frequency
with which the department must inspect ASCs, but rather a frequency with which
the department may perform inspections. The commenter further stated that
without firm policy regarding the frequency of inspections, it would be improper
to increase an annual licensing fee. The commenter recommended the establishment
of an inspection fee to be charged at the time of the on-site inspection.
Response: The department disagrees with the commenter. Current statutory
language found at Health and Safety Code §243.007, Fees, stipulates that
"the board shall set fees imposed by this chapter in amounts reasonable and
necessary to defray the cost of administering this chapter" and §243.008
Ambulatory Surgical Center (ASC) Licensing Fund stipulates that "all fees
collected under this chapter shall be deposited in the state treasury to the
credit of the ASC Licensing Fund and may be appropriated to the department
only to administer and enforce this chapter". The ASC Licensing Fee Fund was
abolished through funds consolidation, therefore, the licensing fees would
be raised to cover the increased cost of the Act. The department fully intends
to conduct the surveys and will require the additional licensing fees as projected
in fiscal notes to the Legislative Budget Board in order to implement the
provisions of the statute. No change was made as a result of the comment.
Comment: Two commenters offered comments concerning accreditation by independent
accreditation organizations. One of the commenters stated ASCs were required
to have deemed status approval inspections by the Joint Commission on Accreditation
of Health care Organizations (JCAHO), that the surveys cost a great deal
of money, and that they seem to do the same thing as a licensure survey. The
other commenter stated that in many cases, such as JCAHO's "deemed status,"
the accreditation includes triennial, unannounced inspections of ASCs as required
by the Health Care Financing Administration for Medicare certification. The
commenter wanted to know if the department would perform its own, redundant,
inspections of ASCs, or will it ask that the ASC make the results of the independent
surveys available for review? The commenter stated that, if so, it would appear
that the state is engaging in the expenditure of state funds for redundant
inspections. The commenter recommended filing fees for processing and reviewing
the results of third-party inspections in the place of department inspections
under the same rules.
Response: The department disagrees with the commenters concerning accreditation
and deemed status approval. There is no authorization in the statute to recognize
accreditation by accreditation organizations nor is there a requirement for
centers to obtain accreditation for licensure purposes. Accreditation and
Medicare certification are strictly voluntary programs, licensure is not.
The department does not agree that the surveys would be redundant. No change
was made as a result of the comment.
Comment: Concerning §135.3, two commenters recommended fees based
upon the size of the center. One of the commenters suggested a scale of licensure
fees, that in his opinion, would be more appropriate for the type of facility
being inspected. The commenter felt was felt this would be more in line with
the fee schedules of organizations such as Joint Commission of Accredited
Health Organizations and Accreditation Association of Ambulatory Health Care.
The other commenter stated the increase in costs created by the inspection
of ASCs is certain to be uneven due to the fact that ASCs range greatly in
size, and that a unilateral licensing fee increase made to cover the department's
increased costs places an undue, almost punitive burden on smaller ASCs such
as those with fewer than three operating rooms. The commenter said that other
entities that perform on-site inspections set charges for those inspections
by the number of operating rooms so as to ensure that the fee charged is commensurate
with the inspection costs. The commenter recommended the use of graduated
inspection fees for ASCs that the department inspects and filing fees for
processing and reviewing the results of third-party inspections in the place
of department inspections.
Response: The department disagrees with the commenters. The fee increase
is necessary to defray the cost of administering the program in accordance
with the Health and Safety Code §243.006. The department does not control
appropriation of funds to manage the program, that is determined by the legislature.
The additional revenues must be sufficient to cover the costs of the appropriation
as well as any indirect costs associated with the implementation of the provisions
of Senate Bill 1249. No change was made as a result of comments.
The commenters included the Texas Ophthalmological Association and three
individuals, all of whom were not in favor of the amendment to the rules which
increases the licensing fees. The commenters were not against the rules in
their entirety, however, they expressed concerns, asked questions and suggested
recommendations for change as discussed in the summary of comments.
25 TAC §§135.3, 135.21, 135.25 - 135.29
The amendments and new sections are adopted under Health and
Safety Code, Chapter 243, the Texas Ambulatory Surgical Center Licensing Act;
Health and Safety Code, §243.006, regarding inspections; Health and Safety
Code, §243.007, regarding fees; Health and Safety Code, §243.0115
which grants the department authority to issue an emergency suspension order
to suspend a license; Health and Safety Code, §243.015 and §243.016,
which provides the department with the authority to assess administrative
penalties against an ambulatory surgical center for violation of Chapter 243
and the rules adopted thereunder; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
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 24, 2000.
TRD-200003683
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
25 TAC §135.25 - 135.27
The repeals are adopted under Health and Safety Code, Chapter
243, the Texas Ambulatory Surgical Center Licensing Act; Health and Safety
Code, §243.006, regarding inspections; Health and Safety Code, §243.007,
regarding fees; Health and Safety Code, §243.0115 which grants the department
authority to issue an emergency suspension order to suspend a license; Health
and Safety Code, §243.015 and §243.016, which provides the department
with the authority to assess administrative penalties against an ambulatory
surgical center for violation of Chapter 243 and the rules adopted thereunder;
and Health and Safety Code, §12.001, which provides the Texas Board of
Health (board) with the authority to adopt rules for the performance of every
duty imposed by law on the board, the department, and commissioner of health.
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 24, 2000.
TRD-200003684
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
Subchapter C. ENFORCEMENT
The Texas Department of Health (department) adopts the repeal of §137.23,
and new §§137.23 - 137.25, concerning the regulation of birthing
centers. Section 137.24 is adopted with changes to the proposed text as published
in the January 28, 2000, issue of the
Texas Register
(25 TexReg 504). The repeal of §137.23 and new §§137.23
and 137.25 are adopted without changes and therefore the sections will not
be republished.
The repeal of §137.23 allows the reorganization in a more appropriate
order the sections within Subchapter C which contain new language to incorporate
legislative mandates. The adopted language in §137.23 is moved to new §137.25.
New §137.23 implements certain provisions of Senate Bill 1232, 76th Legislature,
1999, which grants the department the authority to issue an emergency order
to suspend a license.
New §137.24 implements House Bill 2085, Article 4, which amends Health
and Safety Code, Chapter 244 by adding §244.015 and §244.016 relating
to administrative penalties for birthing centers. These sections set forth
standard language developed by the Sunset Advisory Commission regarding the
imposition of an administrative penalty on a person who violates Chapter 244
or a rule adopted under that chapter; the amount of the penalty; the basis
for the amount of the penalty; the report and notice of a violation and penalty;
the penalty to be paid or hearing requested; a hearing; decision by the commissioner;
options following a decision to pay or appeal; stay enforcement of the penalty;
collection of penalty; decision by the court; the remittance of penalty and
interest; and release of bond. Section 137.24 incorporates the language of §244.015
and §244.016.
New §137.25 includes the adopted language of §137.23 that is
repealed. In addition, a new subsection (i) is added to implement Health and
Safety Code §244.0105, of SB 1232, 76th Legislature, 1999. The subsection
sets forth standard language developed by the Sunset Advisory Commission authorizing
that a person may file a complaint with the department against a birthing
center licensed under Health and Safety Code, Chapter 244, and that a person
who files a false complaint may be prosecuted under the Penal Code. Section §137.25(i)
incorporates the language of §244.0105.
No comments were received on the proposal during the comment period.
The department is making the following change due to staff comments to
reflect proper reference to Government Code, Chapter 2001.
Change: Concerning §137.24(a)(3), proper reference is given to the
Government Code, Chapter 2001.
25 TAC §137.23
The repeal is adopted under Health and Safety Code, Chapter
244, which authorizes the department to issue an emergency suspension order
to suspend a license; which provides the department with the authority to
assess administrative penalties against a birthing center for violation of
Health and Safety Code, Chapter 244 and the rules adopted thereunder; and
Health and Safety Code, §12.001, which provides the Texas Board of Health
(board) with the authority to adopt rules for the performance of every duty
imposed by law on the board, the department, and commissioner of health.
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 24, 2000.
TRD-200003679
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
25 TAC §§137.23 - 137.25
The new sections are adopted under Health and Safety Code,
Chapter 244, which authorizes the department to issue an emergency suspension
order to suspend a license; which provides the department with the authority
to assess administrative penalties against a birthing center for violation
of Health and Safety Code, Chapter 244 and the rules adopted thereunder; and
Health and Safety Code, §12.001, which provides the Texas Board of Health
(board) with the authority to adopt rules for the performance of every duty
imposed by law on the board, the department, and commissioner of health.
§137.24.Administrative Penalties.
(a)
Imposition of penalty.
(1)
The department may impose an administrative penalty on
a person licensed under this chapter who violates the Act, this chapter, or
an order adopted under this chapter.
(2)
A penalty collected under this section shall be deposited
in the state treasury in the general revenue fund.
(3)
A proceeding to impose the penalty is considered to
be a contested case under Government Code, Chapter 2001.
(b)
Amount of penalty.
(1)
The amount of the penalty may not exceed $1,000 for each
violation. Each day a violation continues or occurs is a separate violation
for purposes of imposing a penalty. The total amount of the penalty assessed
for a violation continuing or occurring on separate days under this paragraph
may not exceed $5,000.
(2)
In determining the amount of an administrative penalty
assessed under this section, the department shall consider:
(A)
the seriousness of the violation, including the nature,
circumstances, extent, and gravity of the violation;
(B)
the threat to health or safety caused by the violation;
(C)
the history of previous violations;
(D)
the amount necessary to deter a future violation;
(E)
whether the violator demonstrated good faith, including
when applicable whether the violator made good faith efforts to correct the
violation; and
(F)
any other matter that justice may require.
(c)
Report and notice of violation and penalty.
(1)
If the department initially determines that a violation
occurred, the department shall give written notice of the report by certified
mail to the person alleged to have committed the violation not later than
90 days following the survey exit date.
(2)
The notice must include:
(A)
a brief summary of the alleged violation;
(B)
a statement of the amount of the recommended penalty based
on the factors listed in subsection (b)(2) of this section; and
(C)
a statement of the person's right to a hearing on the occurrence
of the violation, the amount of the penalty, or both.
(d)
Penalty to be paid or hearing requested.
(1)
Within 20 days after the date the person receives the notice
under subsection (c), the person in writing may:
(A)
accept the determination and recommended penalty of the
department; or
(B)
make a request for a hearing on the occurrence of the violation,
the amount of the penalty, or both.
(2)
If the person accepts the determination and recommended
penalty or if the person fails to respond to the notice, the commissioner
of health (commissioner) or the commissioner's designee by order shall approve
the determination and impose the recommended penalty.
(e)
Hearing.
(1)
If the person requests a hearing, the commissioner or the
commissioner's designee shall refer the matter to the State Office of Administrative
Hearings (SOAH).
(2)
As mandated by Health and Safety Code, §244.015(i),
the SOAH shall promptly set a hearing date and give written notice of the
time and place of the hearing to the person.
(A)
An administrative law judge of the SOAH shall conduct the
hearing.
(B)
The administrative law judge shall make findings of fact
and conclusions of law and promptly issue to the commissioner a proposal for
a decision about the occurrence of the violation and the amount of a proposed
penalty.
(f)
Decision by commissioner.
(1)
Based on the findings of fact, conclusions of law, and
proposal for a decision made by the administrative judge under subsection
(e)(2) of this section, the commissioner or the commissioner's designee by
order may find that a violation occurred and impose a penalty; or find that
a violation did not occur.
(2)
The commissioner or the commissioner's designee shall
give notice of the commissioner's order under paragraph (1) of this subsection
to the person alleged to have committed the violation in accordance with Government
Code, Chapter 2001. The notice must include:
(A)
a statement of the right of the person to judicial review
of the order;
(B)
separate statements of the findings of fact and conclusions
of law; and
(C)
the amount of any penalty assessed.
(g)
Options following decision: pay or appeal. Within 30 days
after the date the order of the commissioner or commissioner's designee under
subsection (f) of this section that imposes an administrative penalty becomes
final, the person shall:
(1)
pay the penalty; or
(2)
appeal the penalty by filing a petition for judicial
review of the commissioner's order contesting the occurrence of the violation,
the amount of the penalty, or both.
(h)
Stay of enforcement of penalty.
(1)
Within the 30-day period prescribed by subsection (g) of
this section, a person who files a petition for judicial review in accordance
with subsection (g) of this section may:
(A)
stay enforcement of the penalty by:
(i)
paying the penalty to the court for placement in an escrow
account; or
(ii)
giving the court a supersedeas bond that is approved by
the court for the amount of the penalty and that is effective until all judicial
review of the commissioner's order is final; or
(B)
request the court to stay enforcement of the penalty by:
(i)
filing with the court a sworn affidavit of the person stating
that the person is financially unable to pay the penalty and is financially
unable to give the supersedeas bond; and
(ii)
sending a copy of the affidavit to the commissioner by
certified mail.
(2)
If the commissioner receives a copy of an
affidavit under paragraph (1)(B)(ii) of this subsection, the commissioner
may file with the court, within five days after the date the copy is received,
a contest to the affidavit. In accordance with Health and Safety Code §244.016(c),
the court shall hold a hearing on the facts alleged in the affidavit as soon
as practicable and shall stay the enforcement of the penalty on finding that
the alleged facts are true. The person who files an affidavit has the burden
of proving that the person is financially unable to pay the penalty or to
give a supersedeas bond.
(i)
Collection of penalty.
(1)
If the person does not pay the penalty and the enforcement
of the penalty is not stayed, the department may refer the matter to the attorney
general for collection of the penalty.
(2)
As provided by Health and Safety Code, §244.016(d),
the attorney general may sue to collect the penalty.
(j)
Decision by court. A decision by the court is governed
by Health and Safety Code, §244.016(e), and provides the following:
(1)
If the court sustains the finding that a violation occurred,
the court may uphold or reduce the amount of the penalty and order the person
to pay the full or reduced amount of the penalty.
(2)
If the court does not sustain the finding that a violation
occurred, the court shall order that a penalty is not owed.
(k)
Remittance of penalty and interest and release of supersedeas
bond. The remittance of penalty and interest is governed by Health and Safety
Code, §244.016(g) and provides the following.
(1)
If the person paid the penalty and if the amount of the
penalty is reduced or the penalty is not upheld by the court, the court shall
order, when the court's judgment becomes final, that the appropriate amount
plus accrued interest be remitted to the person within 30 days after the date
that the judgment of the court becomes final.
(2)
The interest accrues at the rate charged on loans
to depository institutions by the New York Federal Reserve Bank.
(3)
The interest shall be paid for the period beginning
on the date the penalty is paid and ending on the date the penalty is remitted.
(l)
Release of bond. The release of supersedeas bond is governed
by Health and Safety Code, §244.016(h) and provides the following:
(1)
If the person gave a supersedeas bond and the penalty is
not upheld by the court, the court shall order, when the court's judgment
becomes final, the release of the bond.
(2)
If the person gave a supersedeas bond and the amount
of the penalty is reduced, the court shall order the release of the bond after
the person pays the reduced amount.
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 24, 2000.
TRD-200003680
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
25 TAC §§143.2, 143.16, 143.17, 143.19, 143.20
The Texas Department of Health (department) adopts amendments
to §§143.2, 143.16, 143.17, 143.19 and 143.20 concerning the regulation
and certification of persons performing radiologic procedures. Sections 143.16,
143.17, 143.19 and 143.20 are adopted with changes to the proposed text as
published in the January 28, 2000, issue of the
Texas Register
(25 TexReg 508). Section 143.2 is adopted without changes,
and therefore the section will not be republished. The amendments cover definitions;
dangerous or hazardous procedures; mandatory training programs for non-certified
technicians; hardship exemptions and alternative training requirements.
The amendments add a definition for pediatric; add pediatric radiography
to the list of dangerous or hazardous procedures; change the total number
of hours needed to complete the mandatory training program for non-certified
technicians; add a new hardship exemption for x-ray equipment operators in
a physician's office who are participating in a new alternate training program;
make changes to the existing training requirements for podiatric medical assistants;
and add alternate training to be completed under a Texas Medical Association's/Texas
Osteopathic Medical Association's approved program for x-ray operators in
a physician's office.
The new hardship will function as an extension to the January 1, 1998,
statutory deadline for completing the training for non-certified technicians
(NCTs). The new hardship will be issued to physicians having x-ray equipment
operators completing a Texas Medical Association's/Texas Osteopathic Medical
Association's approved program. The Texas Medical Association's/Texas Osteopathic
Medical Association's Physician's Training program is being added as an alternate
training program for placement on the NCT registry. The amendment to the existing
training requirements for podiatric medical assistants will allow for out
of classroom hours. Additional minor changes were made to update and clarify
existing rules.
The following comments were received concerning the proposed sections.
Following each comment is the department's response and any resulting changes.
Comment: One commenter was concerned because there is not a radiologist
or a radiography representative on the Board of Health to evaluate the medical
radiologic technologist rules as proposed.
Response: §601.052, Texas Occupations Code provides that the Texas
Board of Health may adopt rules necessary to implement this chapter.
Comment: Concerning the definition of pediatric in §143.2, a commenter
recommended lowering the age range from fetus to age 18 as proposed, to fetus
to age five.
Response: The department disagrees with the commenter regarding the lowering
of the age range from fetus to age 18. No change was made as a result of this
comment to the definition in §143.2 however, language has been added
to §143.16(c)(10) which includes pediatric radiography as a dangerous
or hazardous procedure to address the commenters concerns.
Comment: Concerning §143.16, several commenters were in opposition
to the removal of pediatric radiography requesting that it remain in the rules.
Response: The department disagrees because pediatric radiography is being
added not removed. No change was made as a result of comments.
Comment: Concerning §143.16, numerous comments were received expressing
the need for and the approval of adding pediatric radiography to the rules.
Response: The department agrees. No changes were made as a result of the
comments.
Comment: Concerning §143.16(c)(10), one commenter noted that in the
proposal invasive cardiovascular technicians were excluded from performing
pediatric cardiac catheterization procedures.
Response: The department agrees. The section was amended to include individuals
who hold a limited medical radiologic technology certificate with the cardiovascular
specialty.
Comment: Concerning §143.16(c)(10), one commenter recommended lowering
the age range from fetus to age 18 as proposed, to fetus to age five in the
definition of pediatric. The commenter felt that children above the age of
five should not be categorized as pediatric for radiography purposes and should
not be listed as such under dangerous and hazardous procedures.
Response: The department disagrees. Exposure to radiation at any age is
considered dangerous. Language in the proposal addressed action to be taken
under emergency conditions. After review of the comment, additional language
has been added to address actions to be taken if other extenuating circumstances
deemed by the practitioner exist. In both situations documentation would need
to be placed in the patient's clinical record. No changes were made as a result
of this comment.
Comment: Concerning §143.17, several commenters were against the reduction
in hours from 187 to 120 for the non-certified technician training program.
The commenters felt that 120 hours are not sufficient.
Response: The department disagrees. An Ad Hoc Committee on Training was
established to review the non-certified technician training program for minimum
training requirements and recommended a reduction in the hours from 187 to
120 along with recommended prerequisites for admission into the training programs.
The Medical Radiologic Technologist Advisory Committee approved the recommendation
from the Ad Hoc Committee on Training. Completion of the training program
places the individual on the registry of non-certified technicians. An individual
listed on the registry must work under the supervision of a licensed practitioner.
No changes were made as a result of the comments.
Comment: Concerning §143.17, several commenters were in agreement
for the reduction in hours from 187 to 120 for the training program for non-certified
technicians.
Response: The department agrees. The Ad Hoc Committee on Training recommended
the reduction in hours. No changes were made as a result of the comments.
Comment: Concerning §143.17, several comments were received in opposition
to reducing the number of training program hours involving methods of patient
care and radiation safety and protection.
Response: The department disagrees. The Ad Hoc Committee on Training reviewed
the training program and recommended prerequisites which would account for
the hours in patient care. The hours in radiation safety will be incorporated
in each section of the curriculum. No changes were made as a result of the
comments.
Comment: Concerning §143.17, commenters felt the reduction in hours
would compromise patient care, and that the non-certified technician training
program was not in the best interests of the patient.
Response: The department disagrees that patient care would be compromised.
House Bill 1200 passed by the 74th Texas Legislature in 1995 amended the Medical
Radiologic Technologist Certification Act. House Bill 1200 mandated that the
department establish minimum training requirements which a person must complete
in order to perform a radiologic procedure on or after January 1, 1998. The
department believes that the minimum training requirements are in the best
interests of patients. No changes were made as a result of the comments.
Comment: Concerning §143.19, several commenters were concerned about
the hardship exemption for individuals becoming certified by passing the core
section of the limited certification examination with the score of 55% in
lieu of training.
Response: The hardship exemption for passing the core section of the limited
certification examination in lieu of training expired October 1, 1999. Individuals
taking the examination needed to be listed on the hardship. Upon passing the
examination the individual's name was listed on the registry of non-certified
technicians. No changes were made as a result of the comments.
Comment: Concerning §143.19, several comments were received noting
that only 200 individuals took the core section of the limited certified certification
examination out of 3000 offices that had trained individuals.
Response: The hardship exemption for passing the core section of the limited
certification examination in lieu of training expired October 1, 1999. To
be eligible to take this examination an individual needed to be listed under
the hardship exemption. An individual was not eligible to apply for the examination
on their own. They needed to be listed on the hardship. No changes were made
as a result of the comments.
Comment: Concerning §143.19(c)(5)(K), commenters were concerned about
physicians using their own facilities instead of sending the individuals to
imaging centers to complete the positioning portion of the program.
Response: The training will be limited to a specific anatomical category
and be limited to a specific piece of equipment in the physicians facility.
No changes were made as a result of these comments.
Comment: Concerning §143.19(c)(5)(K), several commenters were against
the department sanctioning any specific political group for a hardship exemption
taking a training program for x-ray operators, but recommended that all similar
groups that represent any licensed practitioner (doctors of medicine osteopathic,
podiatric, dental or chiropractic) be included.
Response: The department is not sanctioning any specific group. The Texas
Medical Association presented their proposal for this alternate training program
for placement on the registry of non-certified technicians. Adding this hardship
does not jeopardize any group from applying for existing hardship exemptions.
The department has added language that requires the physician, when applying
for this particular hardship, to also include justification for application
under the existing hardship exemptions.
Comment: Concerning §143.19(c)(5)(K), several commenters were against
changing the current hardship exemptions noting that no significant safety
or medical concern had demonstrated a need for significant change.
Response: The department disagrees. Adding the hardship exemption for persons
who are registered to take the Texas Medical Association's/Texas Osteopathic
Medical Association's Physician's Training Program for X-ray Operators will
allow the department to monitor the effectiveness of the physician's training
program. No changes were made as a result of these comments.
Comment: Concerning §143.19(c)(5)(K), a commenter remarked that the
hardship would be on the patient.
Response: The department disagrees. The hardship would require the individuals
listed under the hardship to complete training. Completion of the training
program places the individual on the registry of non-certified technicians.
This training is more than is required under the existing hardship exemptions.
No changes were made as a result of this comments.
Comment: Concerning §143.20(f), numerous commenters were concerned
about public safety and patient care. They noted that academically and clinically
untrained technicians would be performing diagnostic procedures on patients.
They felt that the individuals would be improperly trained and should not
be called x-ray technicians.
Response: The department disagrees. This is a subjective opinion. The department
perceives the training received under this hardship will be more valuable
than no training at all. The other hardship exemptions do not require training.
Individuals completing this training program would be placed on the registry
of non-certified technicians, would be registered under the physician's license,
and could not perform dangerous or hazardous procedures. No changes were made
as a result of these comments.
Comment: Concerning §143.20(f), many commenters indicated that this
type of training would be beneficial only to the physician by allowing them
to pay low salaries to the personnel doing radiologic procedures.
Response: The department does not have statistics on the salaries of any
individuals working in physician offices. No changes were made as a result
of these comments.
Comment: Concerning §143.20(f), several commenters expressed their
concern for the lack of the training program being monitored and the lack
of standardized or third party examination.
Response: The Medical Radiologic Technologist Certification Act, Texas
Occupations Code, Chapter 601 does not provide the authority for an examination.
The training program curriculum will provide a written examination after each
module. No changes were made as a result of these comments.
Comment: Concerning §143.20(f), several commenters expressed their
concern about physicians not being qualified or having adequate training to
teach the program.
Response: The department disagrees. The physician has the option of teaching
the program or to have a medical radiologic technologist who is also currently
credentialed as a radiographer by the American Registry of Radiologic Technologists
and who meets the instructor qualification as set out in §143.9, Standards
for the Approval of Curricula and Instructors, teach the program. No changes
were made as a result of these comments.
Comment: Concerning §143.20(f), many comments considered the hours
for the training program to be insufficient and that the program would only
train an individual to be a "button pusher" and not a technologist qualified
to take x-rays.
Response: The department disagrees. After completion of the training program
the individual would be placed on the registry of non-certified technicians,
be registered with the physicians licensing board and could not perform dangerous
or hazardous procedures. No changes were made as a result of these comments.
Comment: Concerning §143.20(f), many medical radiologic technologists
commented that their jobs would be put in jeopardy or taken away to be replaced
with uneducated personnel.
Response: The department disagrees. There is currently a manpower shortage.
Furthermore, individual's completing this alternate training program would
not be able to perform in the same capacity as a radiologic technologist.
Individuals completing the alternate training program would be placed on the
registry of non-certified technicians, be registered with the physicians licensing
board, and could not perform dangerous or hazardous procedures. No changes
were made as a result of these comments.
Comment: Concerning §143.20(f), one commenter noted that the physician's
training program could help to alleviate the shortage of technologists, but
that training should be obtained from currently accredited or approved programs
for medical radiologic technologists, limited medical radiologic technologists,
and non-certified technician training programs.
Response: The department agrees. The legislature mandated training for
persons performing radiologic procedures after January 1, 1998, and this program
would function as an additional alternate program along with the existing
programs for registered nurses, physician assistants and podiatric medical
assistants. No change was made as a result of this comment.
Comment: Concerning §143.20(f), commenters noted that all procedures
are considered dangerous or hazardous and that the program seems to be poorly
thought out.
Response: The department disagrees. The program was recommended by the
Ad Hoc Committee on Training and approved by the Medical Radiologic Technologist
Advisory Committee. The minimum amount of training provided in the program
is more than is currently required under existing hardship exemptions. No
changes were made as a result of the comments.
Comment: Concerning §143.20(f), several commenters felt that since
medical radiologic technologists were required to report continuing education
hours that there is a need for continuing education requirements for individuals
placed on the registry of non-certified technicians.
Response: The department disagrees. The Medical Radiologic Technologist
Certification Act, Texas Occupations Code, Chapter 601 does not authorize
the department to require continuing education for individuals on the registry
of non-certified technicians. Continuing education hours are required by some
practitioner licensing boards. No changes were made as a result of these comments.
Comment: Concerning §143.20(f), one commenter was concerned about
uneducated individuals performing barium enemas.
Response: The department agrees but procedures that utilize contrast media
are dangerous or hazardous procedures as listed in §143.17 of the rules
and may only be performed by a practitioner, medical radiologic technologist
or a registered nurse or physician assistant who assists in the performance
of the procedure under the supervision of a practitioner. No changes were
made as a result of this comment.
Comment: Concerning §143.20(f), several commenters were concerned
that individuals completing the training would feel that they are qualified
to take x-rays in other physician offices or clinics and use unfamiliar equipment.
Response: The department disagrees. The non-certified technician would
need to complete additional training if they change employment. Training would
be limited to a specific anatomical category and a specific piece of equipment.
No changes were made as a result of the comment.
Comment: Concerning §143.20(f), one commenter indicated that a hospital
would never hire an individual with training from this alternate program.
Response: The department agrees. An individual completing this program
would not be eligible to work in a hospital. The program is physician and
site specific. No changes were made as a result of the comment.
Comment: Concerning §143.20(f), several commenters noted that after
completion of the physician's training program the individual would be restricted
from being employed by another physician unless the individual completed additional
training.
Response: The department agrees. The physician's training program is site
and equipment specific and would require additional training if the individual
sought employment elsewhere. No changes were made as a result of the comments.
Comment: Concerning §143.20(f), a commenter remarked that the physician
would have to train each time a new employee is hired.
Response: The department agrees. The physician's training program, being
site and equipment specific, would require training for new personnel to perform
radiologic procedures under the physician's license. No changes were made
as a result of the comment.
Comment: Concerning §143.20(f), a commenter was concerned about the
physicians' ability to grant a license to individuals who have no formal training.
Response: A physician cannot issue a license to an individual completing
the training program. Upon completion of the physician's training program
an individual will be placed on the registry of non-certified technicians,
be registered under the physician's license and would not be eligible to perform
dangerous or hazardous procedures. No changes were made as a result of this
comment.
Concerning §§143.17, 143.19, and 143.20 additional minor changes
were made to update and clarify the rules due to department staff comments.
The comments on the proposed rules received by the department during the
comment period were submitted by Senator Jane Nelson, Texas Society of Radiologic
Technologists, Inc., American Society of Radiologic Technologists, Northwest
Texas Healthcare Systems, University Medical Center - Lubbock, Tarrant County
College students, Angelina College, Center for Rural Health Initiatives, Texas
MedClinic, Texas Academy of Family Physicians, Trinity Mother Frances Medical
Clinic, Complete Healthcare Services, Texas Nurses Association, Texas Medical
Association, Christus St. Elizabeth Family Practice Center, Texas Radiation
Advisory Board, North Blanco Family Physicians, Hi-Plains Hospital, East Texas
Orthopedics and Sports Medicine, Texas Hospital Association. In addition,
numerous individuals commented. All commenters were not against the rules
in their entirety, however they expressed concerns, and suggested recommendations
for change as discussed in the summary of comments.
The amendments are adopted under the Medical Radiologic Technologist
Certification Act, §601.052, Texas Occupations Code, which provides the
Texas Board of Health (board) with the authority to adopt rules necessary
to implement the Act; and the Texas Health and Safety Code §12.001, which
provides the board with the authority to adopt rules for the performance of
every duty imposed by law on the board, the department, and the commissioner
of health.
§143.16.Dangerous or Hazardous Procedures.
(a)
Purpose. The purpose of this section is to identify the
radiologic procedures which are dangerous or hazardous and may only be performed
by a practitioner, medical radiologic technologist (MRT) or limited medical
radiologic technologist (LMRT). There are specific procedures identified in
subsections (b) and (c) of this section which may be performed by a registered
nurse (RN) or a physician assistant trained under §143.17 of this title
(relating to Mandatory Training Programs for Non-Certified Technicians) or §143.20
of this title (relating to Alternative Training Programs). A person trained
under §143.17 or §143.20 of this title and placed on a registry
under §143.18 of this title (relating to Registry of Non-Certified Technicians)
is not an MRT, LMRT or otherwise certified under the Medical Radiologic Technologist
Certification Act (Act) and shall not perform a dangerous or hazardous procedure
identified in this section unless expressly permitted under this section.
(b)
Dangerous procedures identified. Unless otherwise noted,
the list of dangerous procedures which may only be performed by a practitioner
or MRT are:
(1)
nuclear medicine studies;
(2)
administration of radio-pharmaceuticals, unless performed
by an RN or physician assistant who is appropriately trained as authorized
by the department's Bureau of Radiation Control for licensure of radioactive
materials;
(3)
radiation therapy, including simulation and brachytherapy;
(4)
computed tomography (CT) or any variation thereof;
(5)
interventional radiographic procedures, including
angiography, unless performed by an LMRT with a certificate issued in the
cardiovascular category;
(6)
fluoroscopy and/or fluorography, unless performed
by an LMRT with a certificate issued in the cardiovascular category, or by
an RN or physician assistant who assists in the performance of the procedure
under the supervision of a practitioner; and
(7)
cineradiography (including digital acquisition techniques),
unless performed by an LMRT with a certificate issued in the cardiovascular
category.
(c)
Hazardous procedures identified. Unless otherwise noted,
the list of hazardous procedures which may only be performed by a practitioner
or MRT are:
(1)
conventional tomography;
(2)
skull radiography, excluding anterior-posterior/posterior-anterior
(AP/PA), lateral, Townes, Caldwell, and Waters views;
(3)
mobile radiography;
(4)
spine radiography, excluding AP/PA, lateral and lateral
flexion/extension views;
(5)
spine radiography, excluding lumbar oblique views
performed by an RN or physician assistant who performs the procedure under
the supervision of a practitioner;
(6)
shoulder girdle radiographs, excluding AP and lateral
shoulder views, AP clavicle and AP scapula, unless performed by an RN or physician
assistant who performs the procedure under the direction and supervision of
a practitioner;
(7)
pelvic girdle radiographs, excluding AP or PA views;
(8)
sternum radiographs, unless performed by an RN or
physician assistant who performs the procedure under the direction and supervision
of a practitioner; and
(9)
radiographic procedures which utilize contrast media,
unless performed by an RN or physician assistant who assists in the performance
of the procedure under the supervision of a practitioner.
(10)
pediatric radiography, excluding extremities, unless
performed by an RN or physician assistant who is appropriately trained, as
set out in §143.17 or §143.20 of this title or an LMRT with the
cardiovascular specialty. If an emergency condition exists which threatens
serious bodily injury, protracted loss of use of a bodily function or death
of a pediatric patient unless the procedure is performed without delay, or
if other extenuating circumstances deemed by the practitioner exist, a pediatric
radiographic procedure is also excluded. The emergency condition or extenuating
circumstance must be documented by the ordering practitioner in the patient's
clinical record and the record must document that a regularly scheduled MRT,
LMRT, RN or physician assistant is not reasonably available to perform the
procedure.
(d)
Performance of a hazardous procedure by an LMRT. An LMRT
may perform a radiologic procedure listed in subsection (c) of this section
only if the procedure is within the scope of the LMRT's certification, as
described in §143.7(f) of this title (relating to Types of Certificates
and Applicant Eligibility).
(e)
Performance of a dangerous or hazardous procedure by a
practitioner. This section does not authorize a practitioner to perform a
radiologic procedure which is outside the scope of the practitioner's license.
(f)
Dental radiography. This section does not apply to a radiologic
procedure involving a dental x-ray machine, including panarex or other equipment
designed and manufactured only for use in dental radiography.
(g)
Mammography. In accordance with the Health and Safety Code, §401.421
et seq, mammography is a radiologic procedure which may only be performed
by an MRT (not an LMRT) who meets the qualifications set out in §289.230(d)(2)
of this title (relating to Mammography). Mammography shall not be performed
by a practitioner, an LMRT, an NCT, or any other person.
(h)
Prohibited act. A person who performs a dangerous or hazardous
procedure in violation of the Act, §2.13(a)(1) commits a Class B misdemeanor,
punishable by up to 180 days in jail or a fine up to $2,000, or both.
(i)
Effective date.
(1)
This section shall become effective on June 1, 1997.
(2)
On or after January 1, 1998, an RN or physician assistant
must be trained under §143.17 of this title or §143.20 of this title,
or have been approved to perform radiologic procedures under a hardship exemption
granted under §143.19 of this title (relating to Hardship Exemptions),
in addition to performing the listed procedure under the direction and supervision
of a practitioner. Subsections (b)(6) and (c)(8) shall not be construed to
authorize an RN or physician assistant to independently perform fluoroscopy,
fluorography or procedures utilizing contrast media.
(j)
Student performance of dangerous or hazardous procedures.
The procedures identified in this section are not considered dangerous and
hazardous for purposes of §2.05(g) of the Act if the person performing
the procedures is a student enrolled in a program which meets the minimum
standards adopted under §2.05 of the Act and if the person is performing
radiologic procedures in an academic or clinical setting as part of the program.
Therefore, such students may perform these procedures in such settings. Students
may not perform procedures in an employment setting.
§143.17.Mandatory Training Programs for Non-Certified Technicians.
(a)
Purpose. The purpose of this section is to set out the
minimum standards for approval of mandatory training programs, as required
by the Medical Radiologic Technologist Certification Act (Act), §2.05(f),
which are intended to train individuals to perform radiologic procedures which
have not been identified as dangerous or hazardous. Individuals who complete
an approved training program may not use that training toward the educational
requirements for a general or limited certificate as set out in §143.7
of this title (relating to Types of Certificates and Applicant Eligibility).
Effective January 1, 1998, before a person performs a radiologic procedure,
the person must complete all the hours in subsection (d)(1)(A)-(D) of this
section, and at least one unit in subsection (d)(2)(A)-(G) of this section.
(b)
Instructor direction required. All hours of the training
program completed for the purposes of this section must be live and interactive
and directed by an approved instructor. No credit will be given for training
completed by self-directed study or correspondence.
(c)
Instructor qualifications.
(1)
An instructor(s) shall have education and not less than
six months classroom or clinical experience teaching the subjects assigned,
shall meet the standards required by a sponsoring institution, if any, and
shall meet at least one or more of the following qualifications:
(A)
be a currently certified MRT who is also currently credentialed
as a radiographer by the American Registry of Radiologic Technologists (ARRT);
(B)
be a currently certified LMRT (excluding a temporary certificate)
whose limited certificate category(ies) matches the category(ies) of instruction
and training; or
(C)
be a practitioner who is in good standing with all appropriate
regulatory agencies including, but not limited to, the department, the Texas
State Board of Chiropractic Examiners (BCE), Texas State Board of Medical
Examiners (BME), or Texas State Board of Podiatry Examiners (BPE), the Texas
Department of Human Services, the United States Department of Health and Human
Services.
(2)
A limited medical radiologic technologist (LMRT)
may not teach, train, or provide clinical instruction in a portion of a training
program which is different from the LMRT's level of certification. For example,
an LMRT holding a limited certificate in the chest and extremities categories
may not participate in the portion of a training program relating to radiologic
procedures of the spine. The LMRT may participate in the portions of the training
program which are of a general nature and those specific to the specific categories
on the limited certificate.
(d)
Training requirements. As of July 1, 2000, in order to
successfully complete a program, each student must complete the following
minimum training:
(1)
prerequisites recommended for admission include high school
graduation or general equivalency diploma; certified medical assistant; graduation
from a medical assistant program; or six months full time patient care experience,
otherwise determined by the practitioner.
(2)
courses which are fundamental to diagnostic radiologic
procedures:
(A)
radiation safety and protection for the patient, self and
others-22 classroom hours;
(B)
image production and evaluation-24 classroom hours; and
(C)
radiographic equipment maintenance and operation-16 classroom
hours which includes at least six hours of quality control, darkroom, processing,
and Texas Control of Radiation Regulations; and
(3)
one or more of the following units of applied
human anatomy and radiologic procedures of the:
(A)
skull (five views: Caldwell, Townes, Waters, AP/PA, and
lateral)-10 classroom hours;
(B)
chest-eight classroom hours;
(C)
spine-eight classroom hours;
(D)
abdomen, not including any procedures utilizing contrast
media- four classroom hours;
(E)
upper extremities-14 classroom hours;
(F)
lower extremities-14 classroom hours; and/or
(G)
podiatric--five classroom hours.
(e)
Application procedures for training programs. An application
shall be submitted to the department at least 30 days prior to the starting
date of the training program. Official application forms are available from
the department and must be completed and signed by an approved instructor,
who shall be designated as the training program director. The training program
director shall be responsible for the curriculum, the instructors, and determining
whether students have successfully completed the training program.
(1)
Official application forms must be executed in the presence
of a notary public and shall be accompanied by the application fee in accordance
with §143.4 of this title (relating to Fees). Photocopied signatures
will not be accepted.
(2)
Application forms and fees shall be mailed to the
address indicated on the application materials. The department is not responsible
for lost, misdirected, or undeliverable application forms. An application
received without the application fee will be returned to the applicant.
(f)
Application materials. The application shall include, at
a minimum:
(1)
the beginning date and the anticipated length of the training
program;
(2)
the number of programs which will be conducted concurrently
and whether programs will be conducted consecutively;
(3)
the number of students anticipated in each program;
(4)
the daily hours of operation;
(5)
the location, mailing address, phone and facsimile
numbers of the program;
(6)
the name of the training program director;
(7)
a list of the names of the approved instructors and
the topics each will teach, and a list of management and administrative personnel
and any practitioners who will participate in conducting the program;
(8)
clearly defined and written policies regarding the
criteria for admission, discharge, readmission and completion of the program;
(9)
evidence of a structured pre-planned learning experience
with specific outcomes;
(10)
a letter or other documentation from the Texas Workforce
Commission, Proprietary Schools Section indicating that the proposed training
program has complied with or has been granted exempt status under the Texas
Proprietary School Act, Texas Education Code, Chapter 32 and 19 Texas Administrative
Code, Chapter 175. If approval has been granted by the Texas Higher Education
Coordinating Board, a letter or other documentation from the Texas Workforce
Commission, Proprietary Schools Section is not necessary; and
(11)
specific written agreements to:
(A)
provide the training as set out in subsection (d) of this
section and provide not more than 75 students per instructor in the classroom;
(B)
advise students that they are prohibited from performing
radiologic procedures which have been identified as dangerous or hazardous
in accordance with §143.16 of this title (relating to Dangerous or Hazardous
Procedures) unless they become an LMRT, medical radiologic technologist (MRT)
or a practitioner;
(C)
use written and oral examinations to periodically measure
student progress;
(D)
keep an accurate record of each student's attendance and
participation in the program, accurate evaluation instruments and grades for
not less than five years. Such records shall be made available upon request
by the department or any governmental agency having authority;
(E)
issue to each student who successfully completes the program
a certificate or written statement including the name of the student, name
of the program, dates of attendance and the types of radiologic procedures
covered in the program completed by the student;
(F)
retain an accurate copy for not less than five years and
submit an accurate copy of the document described in subparagraph (E) of this
paragraph to the department within 30 days of the issuance of the document
to the student; and
(G)
permit site inspections by employees or representatives
of the department to determine compliance with this section.
(g)
Application approval.
(1)
The administrator shall be responsible for reviewing all
applications for training program approval. The administrator shall approve
any application which is in compliance with this section. A letter of approval
shall be issued for a period of one year.
(2)
A program shall be denied approval if the application
is incomplete or not submitted as set out in this section. The training program
director shall be notified in accordance with §113.1 of this title (relating
to Processing Permits for Special Health Services Professionals).
(3)
If approval is proposed to be denied, the training
program director shall be notified in writing of the proposed denial and shall
be given an opportunity to request a formal hearing within ten days of the
training program director's receipt of the written notice from the department.
The formal hearing shall be conducted according to the department's formal
hearing procedures in Chapter 1 of this title (relating to Texas Board of
Health). If no hearing is requested, the right to a hearing is waived and
the proposed action shall be taken.
(h)
Application processing. The department shall use the same
process as described in §143.6(f) of this title (relating to Application
Requirements and Procedures), except the time periods are as follows:
(1)
letter of acceptance--30 days;
(2)
letter of application deficiency--30 days;
(3)
letter of approval--42 days; and
(4)
letter of denial of approval--42 days.
(i)
Renewal.
(1)
The training program director shall be responsible for
renewing the approval of the training program on or before the anniversary
date of the initial application.
(2)
The department shall send a renewal notice to the
training program at least 60 days prior to the anniversary date. The department
is not responsible for lost, misdirected, undeliverable or misplaced mail.
(3)
The renewal is effective if the official renewal form
and fee in accordance with §143.4 of this title are postmarked or delivered
to the department on or before the anniversary date.
(4)
Failure to submit the renewal form and renewal fee
in accordance with §143.4 of this title by the deadline will result in
the expiration of the training program's approval.
(5)
A training program which does not renew the approval
shall cease representing the program as an approved training program. The
program director shall notify, or cause the notification of currently enrolled
students that the training program is no longer approved under this section.
The notification shall be in writing and must be issued within ten days of
the expiration of the approval.
(6)
The training program may reapply for approval and
meet the then current requirements for approval under this section.
§143.19.Hardship Exemptions.
(a)
Purpose. The purpose of this section is to set out the
procedure for applying for a hardship exemption under the Medical Radiologic
Technologist Certification Act (Act), §2.05(i) and (j) for a hospital,
federally qualified health center (FQHC), or practitioner.
(b)
General.
(1)
A hospital, FQHC or practitioner may apply to the Texas
Department of Health (department)for an exemption from employing a medical
radiologic technologist (MRT), limited medical radiologic technologist (LMRT),
or non-certified technician (NCT).
(2)
The applicant must demonstrate a hardship as described
in subsection (c)(5) of this section in employing an MRT, LMRT, or NCT.
(3)
The applicant shall not allow a person who is not
an MRT, LMRT, or NCT to perform a radiologic procedure until the department
grants a hardship exemption.
(4)
A hardship exemption granted by the department does
not constitute licensure, certification, registration, or authorization to
perform a dangerous or hazardous radiologic procedure or mammography.
(c)
Required application materials.
(1)
The applicant must apply for a hardship on the forms prescribed
by the department. The date of application shall be the date the application
is postmarked. If there is no visible postmark, or if the application is hand-delivered,
the application date shall be the date the administrator received the application.
(2)
The application must be accompanied by documentation
clearly indicating that the applicant is a licensed hospital, FQHC or licensed
practitioner. A copy of the current hospital license, certificate of qualification
issued to the FQHC, or current license of the practitioner shall be acceptable
documentation.
(3)
If the application is from a hospital or FQHC, the
administrator or chief executive officer of the hospital or FQHC must sign
the application form. If the applicant is a practitioner, the practitioner
must sign the application form.
(4)
The application must include a list of the person(s)
performing radiologic procedures who is not a MRT, LMRT, or NCT
(5)
The application shall be accompanied by one or more
of the following:
(A)
if the applicant is unable to attract or retain an MRT
or LMRT, a sworn affidavit describing in narrative form the applicant's attempts
to attract and retain an MRT or LMRT at a comparable salary for the area;
(B)
if the applicant is located more than 50 highway miles
from the nearest school of medical radiologic technology approved in accordance
with §143.9 of this title (relating to Standards for the Approval of
Curricula and Instructors), a sworn affidavit describing in narrative form
the physical address of the nearest school of medical radiologic technology;
the physical address of the applicant hospital, FQHC, or primary practice
location of the practitioner; and the actual distance in highway miles between
the school and the applicant hospital, FQHC, or practitioner's primary practice.
The applicant shall include a map of the area clearly indicating the locations
of each entity;
(C)
if the nearest school of medical radiologic technology
approved in accordance with §143.9 of this title has a waiting list of
school applicants due to a lack of faculty or space, a sworn affidavit from
the applicant indicating that admissions to the school are pending because
of a lack of faculty or space;
(D)
if the need for graduates in medical radiologic technology
of the applicant exceeds the number of graduates from the nearest school of
medical radiologic technology approved in accordance with §143.9 of this
title, a sworn affidavit from the applicant indicating that the number of
graduates from the nearest school does not meet the applicant's needs for
radiologic technologists;
(E)
if emergency conditions have occurred during the 90 days
prior to making application for the hardship exemption, a sworn affidavit
from the applicant describing the emergency conditions, the hardship(s) the
emergency conditions have created and how long the hardship(s) is anticipated
to continue. For the purposes of this subparagraph, emergency conditions may
include a disaster, epidemic, or other catastrophic event;
(F)
documentation that the United States government has declared
a state of war;
(G)
if the equipment operated is a bone densitometry unit(s)
which utilizes x-radiation, a sworn affidavit from the applicant indicating
the name of the person operating the equipment and proof that the person is
a certified densitometry technologist in good standing with the International
Society for Clinical Densitometry (ISCD) or has completed at least 20 hours
of training as follows:
(i)
specific bone densitometry equipment utilizing x-radiation
to be used by the operator--16 hours presented by a medical radiologic technologist
(MRT) or an equipment applications specialist knowledgeable of the specific
equipment to be utilized; and
(ii)
radiation safety and protection for the patient, self
and others--four hours presented by an MRT or a licensed medical physicist
within the 24-month period prior to application or reapplication for a hardship
exemption;
(H)
if the applicant uses only a hand-held fluoroscope with
a maximum operating capability of 65 kilovolts and 1 milliampere, or a similar
type of x-ray unit for imaging upper extremities only, at the location indicated
on the application form and the applicant believes that the radiation produced
by the radiographic equipment represents a minimal threat to the patient and
the operator of the equipment, the following is required to be submitted:
(i)
a copy of the current certificate of registration issued
by the Bureau of Radiation Control; and
(ii)
a sworn affidavit describing the equipment used; the types
of radiographs performed; the training completed by the operator of the equipment
within the 24-month period prior to application or reapplication for a hardship
exemption; the date(s) the training was completed by the operator; the radiation
safety measures taken for the patient, operator and others; the level or amount
of supervision provided by an MRT or a practitioner(s) to the operator while
performing the radiographic procedure; and the equipment manufacturer's specifications
for the diagnostic radiographic equipment utilized at the location indicated
on the application form, including the maximum operating capability;
(I)
if the applicant employs, for the purpose of performing
radiologic procedures, a person registered in accordance with rules adopted
under §2.08 of the Act on or before January 1, 1998, a sworn affidavit
indicating the name(s) of the person(s) and proof that the person(s) was registered
on or before January 1, 1998. Such affidavit shall be on a form attesting
that the training under §143.17 of this title (relating to Mandatory
Training Programs for Non- Certified Technicians) or §143.20 of this
title (relating to Alternate Training Requirements) causes a fiscal hardship
for the applicant. The affidavit shall include a statement that the person(s)
performing radiologic procedures is adequately supervised and trained for
the procedures being performed. If the applicant is a practitioner or FQHC,
the person who will perform radiologic procedures must be registered in accordance
with rules adopted under §2.08 of the Act at the time of application
for the hardship exemption. If the person who will perform radiologic procedures
is not an RN, the name of the practitioner for whom the radiologic procedures
are performed, as named on the current registration permit, shall match the
name or location of the applicant for whom the hardship is granted;
(J)
if the applicant is a hospital accredited by the Joint
Commission on the Accreditation of Health Care Organizations or which participates
in the federal Medicare cost reimbursement program, an original letter on
hospital letterhead stating the name(s) of the person(s) performing radiologic
procedures in compliance with § 2.07(d) of the Act on or before January
1, 1998. The letter shall be accompanied by a sworn affidavit from the applicant
attesting that the training under §143.17 or §143.20 of this title
causes a fiscal hardship for the applicant. The affidavit shall include a
statement that the person(s) performing radiologic procedures is adequately
supervised and trained for the procedures being performed;
(K)
if the applicant employs for the purpose of performing
radiologic procedures, a person who is registered to take the Texas Medical
Association's/Texas Osteopathic Medical Association's Physician's Training
Program for X-ray Operators approved by the department under §143.20
of this title, a sworn affidavit including justification for application under
one of the requirements described in paragraph (5)(A)-(J) of this subsection.
The following items must be submitted:
(i)
the name(s), date of birth, and social security number
of the person(s) who will perform radiologic procedures pursuant to this hardship
exemption;
(ii)
the name of the facility where the training program will
be taken, the date the program will begin and the anticipated date of completion;
(iii)
the name(s) of the certified medical radiologic technologist
instructor meeting the requirements set out in §143.17(c) of this title;
(iv)
the name(s) of the company and the name of the person(s)
who will be the designated equipment applications specialist knowledgeable
of the specific equipment to be utilized; and
(v)
a list of the anatomical categories to be included in the
training.
(6)
All application materials and information
are subject to verification by the department.
(7)
The department shall send a written notice listing
the additional materials required to an applicant whose application is incomplete.
An application not completed within 30 days after the date of the written
notice shall be invalid unless the applicant has advised the department of
a valid reason for the delay.
(d)
Application approval.
(1)
The administrator shall be responsible for reviewing all
applications. The administrator shall approve any application which is in
compliance with this section and which properly documents applicant eligibility.
(2)
If granted by the department, a letter of exemption
shall be issued for a period of one year.
(e)
Disapproved applications.
(1)
The department shall disapprove the application if the
applicant has not met the application requirements set out in this section
or has failed or refused to complete or submit any form or documentation required
by the department to verify the eligibility for the exemption.
(2)
If the administrator determines that the application
should not be approved, the administrator shall give the applicant written
notice of the reason for the disapproval. The applicant may appeal the decision
to the associate commissioner over the administrator by submitting a written
request within ten days after receipt of the written notice of the reason(s)
for the disapproval.
(3)
Based upon the application and any additional information
submitted by the applicant or the administrator, the associate commissioner
shall approve or disapprove the application.
(4)
An applicant whose application has been disapproved
under this subsection shall be permitted to reapply after a period of not
less than one year from the date of the disapproval and shall submit a new
application and supporting information. The applicant may reapply for an exemption
any time the basis for the exemption application changes.
(f)
Application processing. The department shall use the same
process as described in §143.6(f) of this title (relating to Application
Requirements and Procedures), except the time periods are as follows:
(1)
letter of acceptance--30 days;
(2)
letter of application deficiency--30 days;
(3)
letter of approval--42 days; and
(4)
letter of denial of exemption--42 days.
(g)
Reapplication for hardship exemption.
(1)
The hospital, FQHC, or a practitioner must reapply annually
for the exemption and meet the then current requirements for a hardship exemption.
(2)
A hospital, FQHC, or a practitioner who does not reapply
for an exemption shall not allow a person to perform a radiologic procedure
unless the person is a practitioner, MRT, LMRT, or NCT.
§143.20.Alternate Training Requirements.
(a)
Purpose. The purpose of this section is to set out the
minimum standards for registered nurses (RNs), physician assistants, podiatric
medical assistants (PMAs) and x-ray equipment operators in a physician's office
. .
(b)
Instructor direction required. All hours of the training
program completed for the purposes of this section must be live and interactive
and directed by an approved instructor. Distance learning activities and audiovisual
teleconferencing may be utilized, provided these include two-way, interactive
communications which are broadcast or transmitted at the actual time of occurrence.
Appropriate on-site supervision of persons participating in the distance learning
activities or teleconferencing shall be provided by the approved training
program. No credit will be given for training completed by self-directed study
or correspondence. The provisions of this subsection shall not apply to the
out of classroom training requirements for podiatric medical assistants and
x-ray equipment operators in a physician's offices.
(1)
Effective January 1, 1998, before an RN or physician assistant
performs a radiologic procedure, the RN or physician assistant must complete
the hours stated in subsection (d) of this section, or the hours stated in §143.17
of this title (relating to Mandatory Training Programs for Non-Certified Technicians).
(2)
Effective January 1, 1998, before a PMA performs a
radiologic procedure, the PMA must complete the hours stated in subsection
(e) of this section, or the hours stated in §143.17(d) of this title
concerning podiatric radiologic procedures.
(3)
Individuals who complete training approved under this
section may not use that training toward the educational requirements for
a general or limited certificate as set out in §143.7 of this title (relating
to Types of Certificates and Eligibility).
(c)
Approved instructors.
(1)
For purposes of this section, an individual is approved
by the Texas Department of Health (department) to teach in a training program
if the individual meets the requirements of §143.9(h)(1)-(2) of this
title (relating to Standards for the Approval of Curricula and Instructors).
The application for the training program must demonstrate that the instructors
meet the qualifications. No application for individual instructor approval
is required.
(2)
A limited medical radiologic technologist (LMRT) may
not teach, train, or provide clinical instruction in a portion of a training
program which is different from the LMRT's level of certification. For example,
an LMRT holding a limited certificate in the chest and extremities categories
may not participate in the portion of a training program relating to radiologic
procedures of the spine. The LMRT may participate in the portions of the training
program which are of a general nature and those specific to the specific categories
on the limited certificate.
(d)
Training requirements for registered nurses and physician
assistants. A training program preparing RNs and physician assistants to perform
radiologic procedures shall be designed to build on the health care knowledge
base and skills acquired through completion of an educational program that
qualifies the person for licensure as an RN or physician assistant. The training
shall consist of:
(1)
a minimum of 30 classroom hours of coursework that are
fundamental to diagnostic radiologic procedures covering all of the following
items:
(A)
radiation safety and protection for the patient, self,
and others--ten classroom hours;
(B)
radiologic equipment--ten classroom hours;
(C)
image production and evaluation--ten classroom hours; and
(2)
one or more of the following units of classroom
instruction in radiologic procedures:
(A)
chest and abdomen (non-pediatric)--eight classroom hours;
(B)
spine (non-pediatric)--ten classroom hours;
(C)
skull (non-pediatric)--eight classroom hours;
(D)
extremities (including pediatric)--eight classroom hours;
and
(3)
if the RN or physician assistant will perform
pediatric radiologic procedures other than extremities, a minimum of two classroom
hours for each of the areas identified in paragraph (2)(A)-(C) of this subsection.
(e)
Training requirements for podiatric medical assistants
PMAs.
(1)
In order to successfully complete a program, a PMA must
complete the following training:
(A)
radiation safety and protection for the patient, self,
and others-five classroom hours and five out of classroom hours;
(B)
radiographic equipment used in podiatric medicine, including
safety standards, operation, and maintenance-one classroom hour and two out
of classroom hours;
(C)
podiatric radiologic procedures, imaging production and
evaluation-one classroom hour and four out of classroom hours; and
(D)
methods of patient care and management essential to radiologic
procedures, excluding CPR, BCLS, ACLS and similar subjects-one classroom hour
and one out of classroom hour.
(2)
Successful completion of PMA training allows
the PMA to perform radiologic procedures only under the instruction or direction
of a podiatrist.
(3)
The out of classroom training hours require successful
completion of learning objectives approved by the department as verified by
the supervising podiatrist.
(f)
Training requirements for an x-ray equipment operator in
a physician's office.
(1)
In order to successfully complete a program, an x-ray equipment
operator in a physician's office must complete the Texas Medical Association's/Texas
Osteopathic Medical Association's Physician's Training Program for X-ray Operators.
(2)
Successful completion of the x-ray operators training
program allows the x- ray operator to perform radiologic procedures only under
the instruction or direction of a physician.
(g)
Application procedures for training programs. The Texas
Department of Health (department) shall use the same process as described
in §143.17(e) of this title.
(h)
Application materials. The department shall require the
same materials as described in §143.17(f) of this title.
(i)
Application approval. The department shall use the same
process as described in §143.17(g) of this title.
(j)
Application processing. The department shall use the same
process as described in §143.17(h) of this title.
(k)
Renewal. The department shall use the same process as described
in §143.17(i) of this title.
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 24, 2000.
TRD-200003685
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 13, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
Subchapter B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES
The Texas Department of Health (department) adopts the repeal and
new §157.25, concerning the statewide protocol required for use of an
Out-Of-Hospital Do Not Resuscitate (DNR) Order and DNR form. New §157.25
is adopted with changes to the text as published in the March 10, 2000,
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 Health and Safety Code, Title 2, Chapter 166 as
the Advance Directives Act. The DNR form was also changed to follow those
same directions.
The department is making the following minor changes due to staff comments
to clarify the intent and improve the accuracy of the section.
Change: Concerning §157.25(h)(2), minor changes were made to the layout
of the DNR form to facilitate use by the public.
Change: Concerning §157.25(h)(2), the size of the DNR form was changed
from "8-1/2 inches by 14 inches" to "8-1/2 inches by 11 inches".
The following comment was received concerning the proposed section.
Comment: Concerning the DNR form, one commenter questioned the need for
dual signatures on the DNR form, but approved the rule as proposed.
Response: The need for dual signatures was mandated by statute. No change
was made as a result of the comment.
The comment was sent by the Texas State Board of Medical Examiners (board).
The commenter was not against the rule in its entirety; however a representative
of the board expressed concerns, asked questions and suggested recommendations
for changes as discussed in the summary of comments.
Chapter 123.
RESPIRATORY CARE PRACTITIONER CERTIFICATION
Chapter 133.
HOSPITAL LICENSING
Chapter 135.
AMBULATORY SURGICAL CENTERS
Chapter 137.
BIRTHING CENTERS
Chapter 143.
MEDICAL RADIOLOGIC TECHNOLOGISTS
Chapter 157.
EMERGENCY MEDICAL CARE