(a) The procedures requiring full disclosure--List
A, the procedures requiring no disclosure--List B and the disclosure
and consent form were first published in the December 15, 1981, issue
of the Texas Register as §601.1
of this title (relating to Procedures Requiring Full Disclosure (List
A)), §601.2 of this title (relating to Procedures Requiring No
Disclosure (List B)), and §601.3 of this title (relating to Disclosure
and Consent Form) and initially became effective on June 1, 1982.
(b) The first amendments to §601.1 of this title
and §601.2 of this title were published in the December 3, 1982,
issue of the Texas Register and became
effective on January 1, 1983.
(c) The second amendments to §601.1 of this title
and §601.2 of this title were published in the November 23, 1984,
issue of the Texas Register and became
effective on January 1, 1985.
(d) The third amendments to §601.1 of this title
and §601.2 of this title were published in the April 19, 1988,
issue of the Texas Register and became
effective on May 2, 1988.
(e) The fourth amendment to §601.1 of this title
was published in the July 21, 1989, issue of the Texas Register and became effective on August
3, 1989.
(f) Further amendments to §601.1 of this title
and §602.2 of this title and new §601.4 of this title (relating
to Radiation Therapy Disclosure and Consent Form) were published in
the February 2, 1990, issue of the Texas
Register and became effective on May 3, 1990.
(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601.4 of this title were repealed and replaced with new §601.1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repealed to incorporate List A and List B into Texas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) were 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 .
(j) Effective September 1, 2003, by Acts 2003, 78th
Texas Legislature, Regular Session, Chapter 204, §10.01, Texas
Civil Statutes, Article 4590i, Subchapter F, relating to informed
consent was recodified to the Texas Civil Practice and Remedies Code,
Chapter 74, Medical Liability, Subchapter C, §74.102 (relating
to Texas Medical Disclosure Panel).
(k) Effective March 18, 2004, §601.2 of this title
(relating to Procedures Requiring Full Disclosure--List A) was amended
to include the addition of clarifying and new language to subsection
(g) concerning female genital system treatments and procedures. Risks
were identified for dilation and curettage of uterus (diagnostic/therapeutic);
surgical abortion/dilation and curettage/dilation and curettage/dilation
and evacuation; and medical abortion/non-surgical procedures.
(l) Effective October 16, 2005, §601.2 of this
title (relating to Procedures Requiring Full Disclosure of Specific
Risks and Hazards--List A) was amended to include the addition of
clarifying and new language concerning the cardiovascular system and
nervous system treatments and procedures. Section 601.3 of this title
(relating to Procedures Requiring No Disclosure of Specific Risks
and Hazards--List B) was amended to remove procedures relating to
the nervous system and radiology. Sections 601.4 and 601.5 were amended
to include a Spanish language version of the disclosure and consent
form for medical and surgical procedures, and the disclosure and consent
form for radiation therapy. Section 601.8 was amended to make editorial
corrections to the disclosure and consent for hysterectomy form and
correct a difference between the English and Spanish language versions
of the form.
(m) Effective March 4, 2007, §601.2 of this title
(relating to Procedures Requiring Full Disclosure of Specific Risks
and Hazards--List A) was amended to include procedures and risks and
hazards for anesthesia, the digestive system treatments and procedures,
the endocrine system treatments and procedures, and the hematic and
lymphatic system. Section 601.3 of this title (relating to Procedures
Requiring No Disclosure of Specific Risks and Hazards--List B) was
amended to add and rename procedures relating to the digestive system.
(n) Effective January 16, 2012, §601.2 of this
title (relating to Procedures Requiring Full Disclosure of Specific
Risks and Hazards--List A) was amended to revise and include procedures
and risks and hazards for the cardiovascular system, digestive system
treatments and procedures, eye treatments and procedures, female genital
system treatments and procedures, male genital system, maternity and
related cases, musculoskeletal system treatments and procedures, radiology,
respiratory system treatments and procedures, urinary system and pain
management procedures. Section 601.3 of this title (relating to Procedures
Requiring No Disclosure of Specific Risks and Hazards--List B) was
amended to revise and include procedures relating to maternity and
related cases, musculoskeletal system, respiratory system, urinary
system, and pain management procedures. Section 601.9 of this title
(relating to Disclosure and Consent Form for Anesthesia and/or Perioperative
Pain Management (Analgesia)) was added to include a disclosure and
consent form for anesthesia and/or perioperative pain management (analgesia).
(o) Effective December 5, 2012, §601.2 of this
title (relating to Procedures Requiring Full Disclosure of Specific
Risks and Hazards--List A) was amended to revise and include procedures
and risks and hazards for the following systems: anesthesia, cardiovascular,
musculoskeletal, and radiology. Section 601.3 of this title (relating
to Procedures Requiring No Disclosure of Specific Risks and Hazards--List
B) was amended to revise and include procedures for the following
systems: cardiovascular, musculoskeletal, and radiology. A Spanish
language version of the Disclosure and Consent Form for Anesthesia
and/or Perioperative Pain Management (Analgesia) was added to §601.9
of this title (relating to Disclosure and Consent Form for Anesthesia
and/or Perioperative Pain Management (Analgesia)).
(p) Effective January 15, 2015, §601.2 of this
title (relating to Procedures Requiring Full Disclosure of Specific
Risks and Hazards--List A) was amended to revise procedures and risks
and hazards for the Hematic and Lymphatic System. Additionally, a
new subsection (u) was added for Dental Surgery Procedures. Section
601.3 of this title (relating to Procedures Requiring No Disclosure
of Specific Risks and Hazards--List B) was amended to revise procedures
for anesthesia. Section 601.9 of this title (relating to Disclosure
and Consent Form for Anesthesia and/or Perioperative Pain Management
(Analgesia) was amended to add Deep Sedation and Moderate Sedation
to the anesthesia consent form. Both the English and Spanish language
versions of the forms were amended.
(q) Effective January 7, 2016, §601.2 of this
title (relating to Procedures Requiring Full Disclosure of Specific
Risks and Hazards--List A) was amended to revise procedures and risks
and hazards for female genital system treatments and procedures and
laparoscopic/thoracoscopic surgery, and adds a new subsection (v)
plastic surgery. Section 601.4 of this title (relating to Disclosure
and Consent Form) for medical and surgical procedures, and §601.8
of this title (relating to Disclosure and Consent Form for Hysterectomy)
were amended to add risks and hazards related to the use of blood
and blood products, risks and hazards related to the use of a power
morcellator in laparoscopic surgery, and deletion of references to
anesthesia.
(r) Effective December 24, 2017, §601.2 of this
title was amended to revise procedures and risks and hazards for Anesthesia.
Section 601.9 of this title (relating to Disclosure and Consent Form
for Anesthesia and/or Perioperative Pain Management (Analgesia)) was
amended to remove "Monitored Anesthesia Care" and to add risks and
hazards related to potential long-term negative effects with the use
of prolonged (greater than 3 hours) or repeated exposure to anesthesia
on the fetus of a woman in her 3rd trimester of pregnancy and on a
child up to 3 years of age.
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