25 TAC §§601.4, 601.6, 601.8
The Texas Medical Disclosure Panel (panel), by majority vote
of the panel on January 13, 1998, enters this order finally adopting amendments
to §601.4 and §601.6, and adopting new §601.8, concerning
informed consent with changes to text as published in the October 31, 1997,
issue of the
Texas Register
(22 TexReg 10615).
The proposed amendments and new section were published in the October 17,
1997, issue of the Texas Register (22 TexReg 10236) in error without the
proposed disclosure and consent forms, and with the wrong certifying official.
The proposal was republished correctly in the October 31, 1997.
Section 601.4 adopts the form to be used to inform a patient or person
authorized to consent for the patient of the possible risks and hazards involved
in the medical treatments and surgical procedures named on the form. The
amendment to §601.4 adds language providing exceptions to using the
general disclosure and consent form. The language addresses the exceptions
to using the general disclosure and consent form for radiation therapy, electroconvulsive
therapy, and the new exception, hysterectomy procedures. There are no changes
to the disclosure and consent form for medical and surgical procedures. Section
601.4(a) is adopted with minor clarification changes.
Section 601.6 provides a history of rule actions. The amendment to §601.6
updates the history of rules changes, by including the rules adopted by the
panel effective October 3, 1995, as stated in new subsection (g); the rules
adopted by the panel effective October 23, 1997, as stated in new subsection
(h); and these rules which were adopted by the panel on January 13, 1998,
with an effective date of February 18, 1998, as stated in new subsection
(i). Section 601.6 (g), (h), and (i) is adopted with minor clarification
changes. The panel clarified language in subsection (i) to include the effective
date of the adoption and to include the legislative directive that the section
applies to hysterectomies performed at least 90 days following publication
of the adopted section in the Texas Register.
New §601.8 establishes a new disclosure and consent form which shall
be used by a physician or health care provider to inform a patient or person
authorized to consent for the patient of the possible risks and hazards involved
in performing a hysterectomy. The form was established in response to House
Bill 723, which amended the Medical Liability and Insurance Improvement Act
of Texas (Act), Texas Civil Statutes, Article 4590i, Subchapter F, by adding
§6.08, which requires the panel to develop and prepare written materials
to inform a patient or person authorized to consent for a patient of the
possible risks and hazards of a hysterectomy. The form includes the information
required by HB 723 and incorporates current language from the general disclosure
and consent form to meet the requirements of §6.08(d) of the Act, which
requires a physician or health care provider to obtain informed consent under
both §6.05 and §6.08 of the Act from a patient or person authorized
to consent for the patient before performing a hysterectomy. The form also
incorporates the risks associated with the use of blood and blood byproducts
previously adopted by the panel. Sections 6.08(a)-(b) of the Medical Liability
and Insurance Act required the panel to develop and prepare the materials
to be available in English, Spanish, and any other language the panel considers
appropriate. The panel determined that it was only appropriate to prepare
the form in English and Spanish at this time. The English form is published
as part of the rule. Both English and Spanish versions of the form will be
available from the Texas Department of Health. In response to a comment received
during the comment period, the panel has included a designation for hysterectomies
performed using endoscopy/laparoscopy, together with the risks and hazards
for same,
to the consent form. The panel has also added clarifying language to specify
that the form is required for hysterectomies performed at least 90 days after
publication of the adopted section, and that the Spanish version is available
from the Texas Department of Health.
The following is a summary of written comments received during the comment
period ending December 1, 1997. All comments concern the disclosure and consent
form for a hysterectomy in §601.8.
COMMENT: A commenter suggested that the language contained in the "NOTICE"
portion of the form be changed to read, "Refusal to consent to a hysterectomy
will not result in the withdrawal or withholding of any benefits provided
by programs or projects receiving federal funds or state funds or otherwise
affect your right to future care or treatment." The commenter also suggested
changing the language in the third sentence of paragraph six of the consent
form to read, "I understand that I have the right to seek a second opinion
from a second physician if I so desire."
RESPONSE: The panel appreciates the comment but determined that the suggested
changes would exceed the panel's statutory authority since the language in
the proposed rule is mandated by House Bill 723. No change was made as a result
of the comments.
COMMENT: A commenter stated that "Section 1 of House Bill 723, §§6.08(a)-(b)
of the Medical Liability Insurance Act requires the panel to develop and prepare
materials available in English, Spanish, and any other language the panel
considers appropriate. While the proposed form includes the required statutory
material in English, it does not provide the material in Spanish as required
by §6.08(b). Also, the proposed rule does not specify if the panel considers
any other language as appropriate." The commenter asked, since proposed §601.8
provided that, "the form shall be available in both English and Spanish,"
whether it is assumed that the panel has determined that no other language
is appropriate at this time." The commenter further recommended that, since
§2 of House Bill 723 states that the panel shall prescribe the form and
content of the materials required to be distributed under §6.08, the
panel should also publish the required form in Spanish.
RESPONSE: No comments were received suggesting that the form be made available
in any other languages. The panel has determined that the form shall be available
only in English and Spanish at this time. However, the provider must present
the information in a manner understandable to the individual patient regardless
of what languages the panel has deemed be made available pursuant to House
Bill 723. In response to the commenter's recommendation that the panel publish
the form in Spanish, on advice of the Texas Department of Health's Office
of General Counsel (OGC), House Bill 723 does not require the panel to publish
the form in Spanish. Both the English and the Spanish version of the form
will be provided by the Texas Department of Health. The OGC believes that
this meets the intent of House Bill 723. No change was made as a result of
the comments.
COMMENT: One commenter suggested that the panel include a Spanish version
of the form for Spanish speaking patients as required by House Bill 723, and
add a signature line for an interpreter to sign if the patient is in need
of an interpreter to understand the consent form. The commenter further stated
that by adding these components the form would meet the federal Medicaid requirement.
RESPONSE: The panel appreciates the comments and, as previously noted,
is not publishing the form in Spanish. The Spanish version of the form will
be available from the Texas Department of Health. In response to the commenter's
other concern, providers are free to include additional documentation when
an interpreter is used. No change was made as a result of the comments.
COMMENT: One commenter expressed concern, "that as a result of the new
law it appears a facility may need three consents prior to performing a hysterectomy,"
referencing the new Texas Medical Disclosure Panel consent form, the consent
form with National Heritage Insurance Corporation (NHIC) language, and the
"routine facility consent form." The commenter wanted the panel to be aware
of these factors when considering the implementation of the consent form.
The commenter is in favor of streamlining the process.
RESPONSE: The panel appreciates the commenter's concern, however, the panel
has promulgated the form required by House Bill 723. The form meets the requirements
of §6.05 and §6.08, as set forth in House Bill 723. While the panel
supports attempts to streamline the process of obtaining consent, it would
exceed the panel's charge to attempt to incorporate language required by NHIC
and the panel is not aware of the content or purpose of a "routine facility
consent form." No change was made as a result of the comment.
COMMENT: One commenter suggested, "that a designation for endoscopy/laparoscopy,
together with the risks and hazards for same, be added to the proposed consent
form." The commenter believes that, if the suggested change is made, a patient
undergoing a laparoscopically assisted vaginal hysterectomy (LAVH), for example,
will only need to sign one form. "Otherwise, practitioners will either have
to have the patient sign the standard form in addition to the hysterectomy
form, or else they will have to write in the endoscopy/laparoscopy information
on the hysterectomy form. Neither of these latter choices would seem preferable
to the signing of one, completely pre-printed form."
RESPONSE: The panel agrees and has revised the form to list the additional
risks associated with endoscopy/laparoscopy.
COMMENT: Concerning §601.8, a commenter asked if the rules included
a Spanish version of the form as required by House Bill 723.
RESPONSE: As previously stated, the Spanish version of the form will be
available from the Texas Department of Health. No change was made as a result
of the comment.
The commenters include a representative from Representative Dawnna M. Duke's
office; Texas Hospital Association, Austin, Texas; Hermann Hospital, Houston,
Texas; Providence Health Center, Waco, Texas; Texas State Board of Medical
Examiners, Austin, Texas; and an individual. The commenters were generally
in favor of the rules, but expressed concerns, asked questions, and made recommendations
as previously mentioned.
The amendments and new section are adopted under the Medical
Liability and Insurance Improvement Act of Texas, Texas Civil Statutes, Article
4590i, §6.04, which provides the Texas Medical Disclosure Panel with
the authority to prepare lists of medical treatments and surgical procedures
that do and do not require disclosure by physicians and health care providers
of the possible risks and hazards and to prepare the form(s) for the treatments
and procedures which do require disclosure; and §6.08 which requires
the panel to develop and prepare written materials to inform a patient or
person authorized to consent for a patient of the risks and hazards of a
hysterectomy.
§601.4.Disclosure and Consent Form.
(a)
The Texas Medical Disclosure Panel adopts the following
form which shall be used by a physician or health care provider to inform
a patient or person authorized to consent for the patient of the possible
risks and hazards involved in the medical treatments and surgical procedures
named in the form. Except for the procedures shown in subsection (b) of this
section, the following form shall be used for the medical treatments and
surgical procedures described in §601.2 of this title (relating to Procedures
Requiring Full Disclosure--List A).
Figure 1: 25 TAC §601.4(a)
(b)
Informed consent for:
(1)
radiation therapy shall be provided in accordance with
§601.5 of this title (relating to Radiation Therapy Disclosure and
Consent Form);
(2)
electroconvulsive therapy shall be provided in accordance
with §601.7 of this title (relating to Informed Consent for Electroconvulsive
Therapy); and
(3)
hysterectomy procedures shall be provided in accordance
with §601.8 of this title (relating to Hysterectomy Disclosure and Consent
Form).
§601.6. History.
(a)-(f)
(No change.)
(g)
Effective October 3, 1995, §601.1 - 601.4 of this
title were repealed and replaced with new §601.1 of this title (relating
to General), §601.2 of this title (relating to Procedures Requiring Full
Disclosure (List A), §601.3 of this title (relating to Procedures Requiring
No Disclosure (List B), and §601.4 of this title (relating to Disclosure
and Consent Form), §601.5 of this title (relating to Radiation Therapy
Disclosure and Consent Form), this section, and §601.7 of this title
(relating to Informed Consent for Electroconvulsive Therapy). The sections
were repealed to incorporate List A and List B into Texas Register format.
In addition, sections were added to include general provisions; to provide
a history of the rules of the panel; and to adopt a section which addresses
informed consent for electroconvulsive therapy.
(h)
Effective October 23, 1997, §601.2 of this title
was amended to update risks and hazards requiring full disclosure prior to
performing abdominal endoscopic/laparoscopy procedures and endoscopic surgery
of the thorax.
(i)
Effective February 18, 1998, §601.4 of this title
and this section were amended and new §601.8 of this title (relating
to Hysterectomy Disclosure and Consent Form) was added to address legislative
requirements relating to informed consent for hysterectomies. Section 601.8
of this title adopts a form to be used in providing informed consent prior
to performing a hysterectomy and applies to hysterectomies performed at least
90 days after the date of publication of adopted §601.8 of this title
in the Texas Register.
§601.8.Hysterectomy Disclosure and Consent Form.
The Texas Medical Disclosure Panel adopts the following form which
shall be used to provide informed consent to a patient or person authorized
to consent for the patient of the possible risks and hazards involved in
the hysterectomy surgical procedure named in the form. This form is to be
used in lieu of the general disclosure and consent form adopted in §601.4
of this title (relating to Disclosure and Consent Form) for disclosure and
consent relating to only hysterectomy procedures. Providers are required
to use the form to obtain consent for hysterectomies performed at least 90
days following publication of this adopted section in the Texas Register.
Providers shall have the form available in both English and Spanish language.
The Spanish version is available from the Texas Department of Health.
Figure 1: 25 TAC §601.8
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 January
29, 1998.
TRD-9801382
Melba W. Swafford, M.D.
Chairperson
Texas Medical Disclosure Panel
Effective date: February 18, 1998
Proposal publication date: October 31, 1997
For further information, please call: (512) 458-7236