1. The Basics of Informed Consent: Past, Present & Future DPH RAP Session September 15, 2011 Presented by Elizabeth Plott Tyler TYLER & WILSON 5455 Wilshire Boulevard, Suite 1925 Los Angeles, California 90036 Phone (323) 655-7180 Fax (323) 655-7122 Copyright © 2011 Tyler & Wilson

2. Consent: The Primary Issue Consent to Treatment ▪Guiding Principle: The fundamental right of self-determination (to make decisions for one’s own self) ▪The right to self-determination continues even if a patient is no longer able to advocate for himself ▪The right to self-determination exists even if a health care professional disagrees with the patient’s decision

3. Where It All Began Cobbs v Grant, (1972) 8 Cal. 3d 229 ▪A patient can only effectively exercise the right of self-determination if the patient possesses adequate information to make an intelligent choice ▪Physician must disclose whatever information is material to the patient’s decision ▪Specifically, Physicians must disclose: ▸ Risk of death or serious harm ▸ Complications that might possibly occur ▸ Such additional information as a skilled practitioner of good standing would provide under similar circumstances

4. What is Not New The Definition of Informed Consent for California SNFs ▪22 CCR Section 72052 ▸ Informed consent means the voluntary agreement of a patient or a representative of an incapacitated patient to accept a treatment or procedure after receiving information in accordance with Tittle 22 Sections 72527(a)(5) and 72528

5. What is Not New The Informed Consent Rights of California SNF Patients ▪22 CCR Section 72527(a)(5) ▸ Patients have the right –to receive all information that is material –to an individual patient’s decision –concerning whether to accept or refuse any proposed treatment

6. What is Not New The Duties of an Attending Physician in a California SNF ▪22 CCR Section72528(a) ▸ It is the responsibility of the attending licenced healthcare practitioner ▸ To determine what information a reasonable person ▸ In the patient’s condition and circumstances ▸ Would consider material ▸ To a decision to accept or refuse a proposed treatment or procedure

7. What is Not New The Duties of the SNF and its Nurses ▪22 CCR Section 72528(c) -- ▸ To verify that the patient’s health record contains documentation that the patient has given informed consent ▸ Before initiating the administration of: --psychotherapeutic drugs, or --physical restraints, or --the prolonged use of a devise that may lead to the -- inability to regain use of a normal bodily function

8. What is Not New Policies SNFs are Required to Have ▪22 CCR Section 72527(a)(5) The facility shall establish and implement written patients’ rights policies and procedures ▪22 CCR section 72527(e)(1) Those concerning informed consent shall include –How the facility will verify that informed consent was obtained

9. What is Not New Documentation of Informed Consent ▪It is up to each SNF to decide what type of documentation it will allow ▪Physicians are not required to do the actual documentation in the SNF chart (their job is to have the discussion) ▪Documents requiring signatures of patients or responsible parties are not required ▪Informed Consent is “not simply” about documentation

10. What is Not New Every Order Does Not Require New Informed Consent ▪Informed consent is required only when: ▸ A new order is made, or ▸ The dose on an existing order is increased --Out of the original dosage range

11. What is Not New The Exceptions ▪22 CCR Section 72528(e) ▸ In cases of emergency ▪22 CCR Section 72528(f) ▸ When the patient has specifically waived the right to information about risk ▸ When the physician feels that full information would “unhinge” the patient –(but only if a patient’s “representative” gives informed consent)

12. What is New The Handling of Preexisting Orders ▪AFL 11-08 dated 1/7/11 (See also DOM 11- 03) “Change in the Guidance regarding Title 22 Section 72528 (c)” ▪Now ▸ Surveyors must confirm that health records contain documentation that the patient gave informed consent” for applicable drugs and restraints ▸ “Including those admitted with preexisting orders”

13. What is New DPH ‘Suggestions’ for Compliance ▪“In order to be in full compliance, the Department suggests a few methods that are permitted under the current regulations and/or statutes” ▸ “1. Obtain documentation that informed consent had been obtained from the patient for the proposed therapy and is in the patient’s medical record” ▸ “2. Obtain new informed consent as described in Section 72528(c) and place the informed consent documentation in the patient’s medical record”

14. What is New (sort of) Complicating Factors ▪Bedhold and Readmission Rights ▪Following Physician’s Orders ▪Not Accepting or Retaining Patients for whom care cannot be provided ▪Administering Drugs or Applying Restraints Without Proof of Informed Consent in the Medical Record

15. What Else is New Prolonged Use of Devices that Permanently Impact Normal Body Function ▪None exist now but, “With the advancement of medical technology, there may be future devices which fit this description”

16. In Summary Informed Consent ▪Must be Obtained by the Attending Physician ▸ It is outside the scope of practice for RN or LVN ▪Physician must explain “material” risks, complications, benefits and alternatives in the context of the patients co-morbidities ▪But there are Exceptions ▪The role of the SNF and its Nurse is to verify informed consent was obtained and make sure evidence of it is in the Medical Record

17. Capacity An Adult With Capacity to Give Informed Consent ▪May consent to or refuse medical treatment ▪All persons are presumed to have capacity ▪A patient with decision making capacity has the right to make a “bad decision” in the opinion of others

18. Capacity Determinations ▪Capacity: ability to understand nature and consequences of proposed health care, including significant risks, benefits and alternatives ▪Patient presumed to have capacity ▪Determination made by the attending physician ▪Attending physician must record in medical record ▪Above applies generally to health care decision making; law regarding conservatorship is more detailed and specific

19. Capacity A Conserved Adult ▪Not all conservatees lack capacity to make health care decisions ▪Actual conservatorship papers must be reviewed ▪There is usually not an issue if both conservator and conservatee agree ▪Public Guardian may or may not be a legal conservator; a court proceeding is required ▪Legal counsel may be needed if there is disagreement

20. Lack of Capacity Power of Attorney for Health Care ▪Appointment of friend or family member as agent ▪Chosen by the patient so most likely more aware of values, opinions and wishes ▪Agent required must follow patient’s wishes, if known, otherwise best interests in consideration of patient’s personal values

21. Lack of Capacity Surrogate decision maker ▪Appointed by patient “personally informing” the primary physician or, if unavailable, the health care provider ▪Effective only for “course of treatment or illness” or stay in facility to a maximum of 60 days ▪Does not replace Power of Attorney for Health Care unless revoked

22. Lack of Capacity Family members ▪“Closest available relative” doctrine (Cobbs v. Grant) ▪“Relative” not defined ▪Registered domestic partner legally same as spouse under California law

23. Lack of Capacity Family Disagreements ▪No statutory priority placing one family member over another ▪Maintain life/status quo and suggest to all family members they seek conservatorship

24. Lack of Capacity Resolution of Family Disagreements ▪Education regarding contested medical issues ▪Social services and nursing support ▪“Bio Ethics Mediation” ▪Physician contact with family ▪Court as last resort

25. Lack of Capacity And Lack of a Responsible Party ▪Health & Safety Code Section 1418.8 ▪Allows for IDT to Authorize without Informed Consent ▸ If done in accordance with acceptable standards of practice

26. Informed Consent Elizabeth Plott Tyler TYLER & WILSON 5455 Wilshire Boulevard, Suite 1925 Los Angeles, California 90036 Phone (323) 655-7180 Fax (323) 655-7122 Note: This class is intended to provide general information only. For specific legal advice applicable to your personal situation, please consult an attorney. No attorney-client relationship with the firm Tyler & Wilson or any of its attorneys created by this presentation. Thank you for your time and attention!