TITLE 25. HEALTH SERVICES

PART 7. TEXAS MEDICAL DISCLOSURE PANEL

CHAPTER 601. INFORMED CONSENT

25 TAC §601.2, §601.9

The Texas Medical Disclosure Panel (panel) adopts amendments to §601.2 and §601.9 of Title 25 of the Texas Administrative Code concerning informed consent. Amendments to §601.2 are adopted without changes to the proposed text as published in the August 18, 2017, issue of the Texas Register (40 TexReg 4089), and therefore will not be republished. Amendments to §601.9 are adopted with changes.

BACKGROUND AND PURPOSE

These amendments are adopted in accordance with the Texas Civil Practice and Remedies Code, §74.102, which requires the panel to determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients and to establish the general form and substance of such disclosure.

Section 601.2 contains the List A procedures requiring full disclosure of specific risks and hazards to patients before being undertaken; and §601.9 contains the disclosure and consent form for anesthesia and/or perioperative pain management (analgesia).

SECTION-BY-SECTION SUMMARY

Amendments to §601.2(a) adds anesthesia risks and hazards for "deep sedation" in paragraph (5) and "moderate sedation" in paragraph (6). The amendments also add the anesthesia risks and hazards for "prenatal/early childhood anesthesia" in paragraph (7) related to the prolonged or repeated exposure to general anesthesia/moderate sedation/deep sedation during pregnancy and in early childhood.

The amendments to §601.9 revise the English and Spanish versions of the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia) to add the words "or anxiety" to paragraph 3 of the form, and adds risks and hazards for "deep sedation" and "moderate sedation." Also, "prenatal/early childhood anesthesia" was added under Additional comments/risks concerning the risks and hazards related to the prolonged or repeated exposure to general anesthesia/moderate sedation/deep sedation during pregnancy and in early childhood.

COMMENTS

The 30-day comment period ended September 18, 2017.

During this period, the panel received comments regarding the proposed rules from eight commenters, including Driscoll Children's Hospital, Tejas Anesthesia, Texas Children's Hospital, Children's Medical Center, MD Anderson Cancer Center, Dell Children's Medical Center, Texas Tech University Health Sciences Center El Paso; and Texas Medical Association.

Comment: Concerning §601.9, the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia), multiple commenters supported the proposed changes.

Response: No changes were made as a result of these comments.

Comment: Concerning §601.9, the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia), one commenter supported the proposed changes, but requested that the proposed language for Prenatal/Early Childhood Anesthesia be placed in the body of the consent form instead of, as part of the checkbox section.

Response: The panel partially agreed and moved the language for Prenatal/Early Childhood Anesthesia under the heading of Additional comments/risks on the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management in §601.9(1) and §601.9(2).

STATUTORY AUTHORITY

The amendments are authorized under the Texas Civil Practice and Remedies Code, §74.102, 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.

§601.9Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia).

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 anesthesia and/or perioperative pain management (analgesia). Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Department of State Health Services.

(1) English form.

Figure: 25 TAC §601.9(1) (.pdf)

(2) Spanish form.

Figure: 25 TAC §601.9(2) (.pdf)

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 4, 2017.

TRD-201704960

Noah Appel, M.D.

Chairman

Texas Medical Disclosure Panel

Effective date: December 24, 2017

Proposal publication date: August 18, 2017

For further information, please call: (512) 776-6972