1. After the Diagnosis… Difficult Issues in Patient Consent An Examination of Issues Involved in Informed Consent, Advanced Directives & Surrogate Decision Makers By: Barron P. Bogatto

2. Patient Consent is an Evolving Doctrine  Battery – an unauthorized touching or invasion of a person’s body.  If patient gives permission, no battery exists.  Originally, consent was either given or it was not. (Original Historical Basis for Patient Consent)

3. Codification of Legal Requirements for Informed Consent  1977 - Medical Liability and Insurance Improvement Act  2003 – Codification in Chapter 74, subchapter C of Texas Civil Practice and Remedies Code (Texas Civil Practice and Remedies Code)

4. Patient Consent Required: Now “Informed” Consent  Basically, Texas law requires that a physician disclose the risks and hazards of certain procedures to a patient when obtaining consent. (Texas Civil Practice and Remedies Code § 74.101)

5. Informed Consent Becomes a Negligence Issue  Statue provides that: “…the only theory on which recovery may be obtained is that of negligence in failing to disclose the risks or hazards that could have influenced a reasonable person in making a decision to give or withhold consent.” (emphasis added) (Texas Civil Practice and Remedies Code § 74.101)

6. Whose duty to obtain informed consent?  It’s the Physician’s duty Physician performing procedure or prescribing treatment Not necessarily a referring physician’s duty It cannot be delegated!  Nurses and hospital staff Assist Act in ministerial capacity

7. Which procedures require disclosure of potential risks and hazards?  Texas law creates the Texas Medical Disclosure Panel to determine the risks and hazards to be disclosed  The panel is composed of 9 members chosen by the Commissioner of Health 3 attorneys 6 physicians (Texas Civil Practice and Remedies Code §§ 74.102-74.103)

8. Texas Medical Disclosure Panel Lists (Texas Administrative Code Chapter 601) The Medical Disclosure Panel prepares lists of medical treatments and surgical procedures that do and do not require disclosure, the degree of disclosure, and the form of disclosure.

9. Lists (continued)  List A requires full disclosure.  List B requires no disclosure.  The Panel also provides some model disclosure forms.  Lists in Texas Administrative Code, accessible on Internet at www.sos.state.tx.us

10. Examples of disclosure from the lists  List A example: The disclosure of risks and hazards for epidural anesthesia include: Persistent back pain, Bleeding/epidural hematoma, Infection Potential to convert to a general anesthetic if the block fails or the procedure outlasts the block, and Brain damage

11. Examples (continued)  List B examples of procedures that do not require disclosure of risks and hazards include: Local anesthesia, Appendectomy, Suture of skin, and Lung biopsy

12. Hypothetical “List C”  Lists A and B are not all-inclusive.  For any procedures not included in Lists A or B, duty of disclosure is as “otherwise imposed by law”  Disclosure is only required to the extent that risks or hazards could have influenced a reasonable person in making a decision to give or withhold consent.  Standard based on the expectations of a reasonable patient.  Not permissible for physician to withhold relevant information to protect the patient’s sensitivities.

13. What constitutes a valid informed consent for List A procedures? Effective consent must be:  in writing,  signed by the patient or person authorized to give consent,  signed by a competent witness, and  specifically state the risks and hazards to degree required by the Disclosure Panel. (Texas Civil Practice and Remedies Code § 74.105)

14. Consent forms created by Disclosure Panel 1. General Disclosure and Consent (§601.4) 2. Radiation Therapy (§ 601.5) 3. Electroconvulsive Therapy (§ 601.7) 4. Hysterectomy (§ 601.8)  Additionally, for patient contemplating an abortion Must provide informational material created by Texas Department of Health (TDH) Prior to abortion procedure, patient must sign informed consent form created by TDH (25 Texas Administrative Code)

15. Hypothetical List C – Only “material” risks must be disclosed  Risk must be: Inherent to the procedure, and Type that could influence the person’s decision  Focus on hypothetical “reasonable” patient Case-by-case analysis 1 in 1,000,000 risk 1 in 1,000 Gray area in between??? (Barclay v. Campbell, 704 S.W.2d 8 (Tex. 1986)

16. Best Practices for “List C” Disclosure  Put disclosure in writing  Have witnessed by at least one competent person  Err on side of caution and over disclosure

17. Informed Refusal  A variation of informed consent  Focus is not on risks but on benefits  Again, show the patient’s decision to decline was based on full understanding of all facts necessary to make that decision.

18. 6 Components to Informed Refusal 1. Describe treatment or procedure 2. Identify reasons treatment has been offered 3. Identify potential benefits 4. Note patient has been told of risks of not accepting the treatment 5. Clearly document the patient has unequivocally and without condition, declined the treatment 6. Identify why the patient refused, particularly if decision was rational

19. Capacity/Competency Why is competency important?  A patient must be competent in order to give informed consent.  If patient is not competent, consent must be obtained from a surrogate decision maker. (Texas Health and Safety Code § 166.002)

20. How is competency defined under Texas law?  The ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of a treatment decision, including: significant benefits and harms of, and reasonable alternatives to a proposed treatment decision. (Texas Health and Safety Code § 166.002)

21. Other Considerations Regarding Competency  Determination is made at the time when the procedure is explained to the patient and is almost always made by physician.  Presumption of competency.  Determination of competency is a subjective decision.  Competency may change. A patient may be competent one day, hour, or minute) and not the next.

22. Hendrick Administrative Policy  Hendrick Medical Center Policy regarding informed consent and competency  Administrative Policy 6010-1.

23. Advanced Directives There are three types of advanced directives:  Directive to Physician  Out-of-Hospital DNR Order  Medical Power of Attorney (Texas Health and Safety Code Title 2, Subtitle H, Chapter 166)

24. Directive to Physician  An instruction… to administer, withhold, or withdraw life-sustaining treatment in the event of a terminal or irreversible condition. (Texas Health and Safety Code §166.031)

25. Out-of-Hospital DNR Order  A legally binding out-of hospital do-not- resuscitate order, in form specified by the Texas Board of Health  Prepared and signed by attending physician  Documents the instructions of the person (or their legal rep) to direct health care professionals in out-of-hospital setting not to initiate or continue specified life- sustaining treatments: (Texas Health and Safety Code §166.081)

26. Specified Life Sustaining Treatments  Cardiopulmonary resuscitation,  Advanced airway management,  Artificial ventilation,  Defibrillation,  Transcutaneous cardiac pacing,  Other life-sustaining treatment specified by Board under §166.101, and

27.  Does not include authorization to withhold medical interventions or therapies necessary to provide comfort or care Alleviate pain Provide water or nutrition

28. Medical Power of Attorney  Designates an agent who will make health care decisions for the patient (the “principal”) if the principal becomes incompetent  Disclosure statement required before executing a medical power of attorney  Principal’s physician must certify in the principal’s medical record that he/she is incompetent (Texas Health and Safety Code §§ 166.151 – 166.166)

29. Patient’s decision still controls no over the principal’s objection Even if the principal is incompetent and there is a medical power of attorney, no treatment may be given or withheld over the principal’s objection. (Texas Health and Safety Code §§ 166.152)

30. What are the requirements of a medical power of attorney? It must be:  in writing,  signed by the principal,  signed by two witnesses, and  at least one witness must be a disinterested party. (Texas Health and Safety Code §§ 166.154)

31. Persons who may not serve as agent:  The principal’s health care provider  An employee of the principal’s health care provider, unless that person is a relative of the principal (Texas Health and Safety Code §§ 166.153)

32. Procedures that agent cannot consent to on behalf of the principal:  voluntary inpatient mental health services,  convulsive treatment,  psychosurgery,  abortion, and  neglect of the principal through the omission of care. (Texas Health and Safety Code §§ 166.152)

33. Can the health care provider be held liable for following an agent’s instructions?  A health care provider is not subject to criminal or civil liability for an act or omission that: 1) is done in good faith, 2) in accordance with the medical power of attorney, the directives of the agent, and the provisions of the Health and Safety Code, and 3) does not constitute a failure to exercise reasonable care. (Texas Health and Safety Code §§ 166.160)

34. Revoking a Medical Power of Attorney  By notice of principal’s intent to revoke or by execution of a new medical power of attorney  Notice can be either to agent or health care provider  Principal does not need to be competent to revoke (Texas Health and Safety Code §§ 166.155)

35. Hendrick Administrative Policy  Hendrick Medical Center Policy regarding Advance Directives  Covered in Administrative Policy 8310-23.

36. Recommended Best Practices  Communication  Identify barriers to informed consent  Educational materials  Written consent  Chart documentation

37. Communication  Be sure to have a detailed discussion of the treatment or procedure.  Cover risks, expected outcome, and alternatives.  Give the patient the opportunity to ask questions.  Make sure the patient understands what was just explained to him/her.

38. Barriers to “Informed” Consent  Impaired mental status  Language NOTE: 2 procedures require bilingual consent  hysterectomy  abortion  Illiteracy  Disability  Overly complex forms

39. Educational Materials Provide patients with additional materials giving them more information on the procedure or treatment:  Pamphlets  Brochures  Package inserts  PDR - Physicians Desk Reference  Videotapes/closed circuit videos

40. Written consent  Have all consent in writing and witnessed by appropriate individuals.  If worth having a signed consent, its worth having a witness.

41. Chart Documentation  Include heavy documentation in the patient’s medical chart.  Include details of the conversation and the procedures discussed.  Include notes regarding the patient’s competency at the time of the discussion.  Possibly include signatures of witnesses, agents, nurses, etc.

42. After the Diagnosis… Difficult Issues in Patient Consent An Examination of Issues Involved in Informed Consent, Advanced Directives & Surrogate Decision Makers By: Barron P. Bogatto