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) proposes amendments to §601.2 and §601.9, concerning informed consent.

BACKGROUND AND PURPOSE

These amendments are proposed 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

Proposed amendments to §601.2(a) adds anesthesia risks and hazards for "deep sedation" in paragraph (5) and "moderate sedation" in paragraph (6). The proposed 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 proposed 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 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.

FISCAL NOTE

Jon Huss, Associate Commissioner, Division for Regulatory Services, has determined that for each year of the first five years that the sections will be in effect, there will be no fiscal impact to state or local governments as a result of administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Mr. Huss also has determined that there are no anticipated economic costs to small businesses or micro-businesses that are required to comply with the amendments as proposed because regulated facilities already have an obligation to disclose risks and hazards related to medical care and surgical procedures. The amendments will not add additional costs.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There will be no economic costs to persons required to comply with the sections as proposed, and there will be no impact on local employment.

PUBLIC BENEFIT

In addition, Mr. Huss also has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing or administering these amended disclosure rules will be that patients are better informed about the risks and hazards related to dental surgical procedures they are considering in connection with deciding whether to consent to them.

REGULATORY ANALYSIS

The panel has determined that this proposal is not a "major environmental rule" as defined by Texas Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environment exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The panel has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Pamela Adams, Program Specialist, Facility Licensing Group, Regulatory Licensing Unit, Division of Regulatory Services, Department of State Health Services, Mail Code 2835, P.O. Box 149347, Austin, Texas 78714-9347, (512) 834-6600, extension 2607, by fax to (512) 834-4514, or by email to pamela.adams@dshs.texas.gov. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

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.

The amendments affect Texas Civil Practice and Remedies Code, Chapter 74.

§601.2.Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A.

(a) Anesthesia.

(1) - (4) (No change.)

(5) Deep sedation.

(A) Memory dysfunction/memory loss.

(B) Medical necessity to convert to general anesthesia.

(C) Permanent organ damage.

(D) Brain damage.

(6) Moderate sedation.

(A) Memory dysfunction/memory loss.

(B) Medical necessity to convert to general anesthesia.

(C) Permanent organ damage.

(D) Brain damage.

(7) Prenatal/Early Childhood Anesthesia. Potential long-term negative effects on memory, behavior, and learning with prolonged or repeated exposure to general anesthesia/moderate sedation/deep sedation during pregnancy and in early childhood.

[(5) Monitored Anesthesia Care (MAC) (conscious sedation).]

[(A) Permanent organ damage.]

[(B) Memory dysfunction/memory loss.]

[(C) Medical necessity to convert to general anesthesia.]

[(D) Brain damage.]

(b) - (v) (No change.)

§601.9.Disclosure 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)

[Figure: 25 TAC §601.9(1)]

(2) Spanish form.

Figure: 25 TAC §601.9(2) (.pdf)

[Figure: 25 TAC §601.9(2)]

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on August 7, 2017.

TRD-201702971

Noah Appel, M.D.

Chairman

Texas Medical Disclosure Panel

Earliest possible date of adoption: September 17, 2017

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