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Chapter 14

Patient Consent,

Rights, and Responsibilities

Learning Objectives (1 of 2)

Discuss the differences among verbal, written, and implied consent.

Describe the role of the patient, physician, nurse, and hospital in informed consent.

Describe the theories under which the validity of consent might be proven.

Explain how consent differs among competent patients, minors, guardians, and incompetent patients.

Learning Objectives (2 of 2)

Discuss the importance of understanding patient rights.

Discuss the importance of understanding patient responsibilities.

Patient Consent

[N]o right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person.

—Union Pacific Ry. Co. v. Botsford

Consent

Voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow something proposed by another to be performed on himself or herself

Forms of Consent

Express consent can take the form of:

Verbal agreement

Written document authorizing medical care

Implied consent

Determined by some act or silence, which raises a presumption consent has been authorized

Generally applicable to emergency situations

Informed Consent (1 of 2)

Legal doctrine where a patient has a right to know potential risks, benefits, and alternatives of a proposed procedure

Patient has absolute right to know about and select from available treatment options.

Predicated on duty of physician to disclose sufficient information to enable a patient to evaluate proposed medical or surgical procedures before submitting to them

Informed Consent (2 of 2)

Verbal consent

Binding as written consent

More difficult to prove

Written consent

Visible proof of a patient’s wishes

Elements of Informed Consent (1 of 2)

Nature of patient’s illness or injury

Procedure or treatment consented to

Purpose of proposed treatment

Risks and probable consequences of the proposed treatment

Probability proposed treatment will be successful

Elements of Informed Consent (2 of 2)

6. Alternative methods of treatment, plus their risks and benefits

7. Risks and prognosis if no treatment is rendered

8. Patient understands nature of proposed treatment, alternatives, risks, and probable consequences of treatment

9. Signatures of patient, physician, and witnesses

10. Date the consent is signed

Implied Consent

Unconscious patients are presumed under law to approve treatment

Generally presumed when immediate action is required to prevent death or permanent impairment

Unconscious patients presumed to approve treatment

Emergency from auto accident

Statutory Consent

Legislation allows emergency care

Eliminating need for written consent

Presumption:

A reasonable person would consent to lifesaving medical intervention.

Document need for immediate care

Attempt to contact family

Consider court order if necessary

Second opinion when in doubt

Judicial Consent

May be necessary in those instances where there is concern as to the absence or legality of consent.

Judge should be contacted only after alternative methods have been exhausted.

Some courts may require an attorney to initiate the call.

Written protocol should be available in ED.

Ensure staff education and training.

Physicians: Informed Consent

Physicians are expected to disclose to patients risks, benefits, and alternatives of recommended procedures.

Disclosure should include what a reasonable person would consider material to his or her decision of whether or not to undergo treatment.

Doctrine of informed consent is firmly rooted in the notions of liberty and individual autonomy.

Informed consent is not merely a tool to avoid lawsuits.

Physicians: Informed Consent Cases

Physicians Must Disclose Alternatives

Paternalism Fails

Physicians Duty to Advise: Delicate Medical Judgment

Adequacy of Consent

Lack of Consent

Course of Treatment Case: Patient’s Decision (1 of 2)

Elderly woman living alone fell and fractured her hip

Orthopedic surgeon ordered bed rest

Plaintiff maintained independent style of living

Expert testimony

Bed rest inappropriate treatment

Patient successful in proving that she was not informed of alternative treatment

Course of Treatment Case: Patient’s Decision (2 of 2)

Court held “necessary to advise a patient when considering alternative courses of treatment”

Physician should have explained alternatives

Risks & likely outcomes of alternatives

Matthies v. Mastromonaco

Lack of Consent: Riser v. American Medical Intern, Inc. (1 of 3)

Patient had multiple medical diagnoses.

Physician ordered bilateral arteriograms to determine cause of patient’s impaired circulation.

Hospital could not accommodate physician’s request & patient was transferred to a radiologist at St. Jude Hospital.

He performed a femoral arteriogram, not the bilateral brachial arteriogram ordered by the ordering physician.

Patient was prepared for transfer back to De La Ronde Hospital.

Shortly after ambulance departed, the patient suffered a seizure in the ambulance and was returned to St. Jude.

Lack of Consent: Riser v. American Medical Intern, Inc. (2 of 3)

Patient’s condition deteriorated, and the patient died 11 days later

Plaintiffs claimed patient was a poor risk for procedure

District court ruled for plaintiffs.

The defendant appealed.

What did the appeals court determine?

Lack of Consent: Riser v. American Medical Intern, Inc. (3 of 3)

The Court of Appeals held that there was a breach in the standard of care by subjecting the patient to a procedure that would have no practical benefit to the patient.

The physician had failed to obtain informed consent from the patient.

Information to Be Disclosed (1 of 2)

Physicians should provide as much information about treatment options as is necessary.

Based on a patient’s personal understanding of the physician’s explanation of risks and the probable consequences of treatment.

Needs of each patient can vary depending on age, maturity, and mental status.

Individual responsible for obtaining consent must weigh importance of giving full disclosure to the patient against the likelihood that such disclosure will adversely affect the patient’s decision.

Information to Be Disclosed (2 of 2)

Courts generally utilize an “objective” or “subjective” test to determine whether a patient would have refused treatment if the physician had provided adequate information as to the risks, benefits, and alternatives of the procedure.

Hospitals: Informed Consent (1 of 2)

Hospitals generally do not have an independent duty to obtain informed consent.

Caveat: Cases where hospitals have been found to owe a duty to provide patients with informed consent

For example: CT scan involves injection of a contrast dye. Keel was given no information concerning risks attendant to the procedure. The dye was injected and the plaintiff developed a thrombophlebitis at the site of the injection.

Hospitals: Informed Consent (2 of 2)

The Kentucky Supreme Court held that expert testimony was not required to establish lack of informed consent and that the hospital had a duty to inform the patient of the risks associated with the procedure.

Keel v. St. Elizabeth Medical Center, Ky.

Hospitals: Life or Death: Right to Choose

Jehovah’s Witness, in Stamford Hospital v. Nelly E. Vega, executed a release requesting that no blood or its derivatives be administered during her hospitalization.

Hospital filed a complaint requesting the court issue an injunction.

Connecticut Supreme Court determined hospital had no common law right or obligation to thrust unwanted medical care on a patient.

Nurses: Informed Consent

A nurse generally has no duty to:

Advise a patient as to a procedure to be employed

A nurse may confirm with the patient that the physician has explained the procedure.

Obtain a patient’s informed consent

Policy and procedures may provide that the nurse may witness that the risks, benefits, and alternatives have been explained.

Validity of Consent

Subjective test

Must determine if the individual patient would have chosen the procedure if fully informed

Objective test

Must show that a reasonable person would not have undergone a procedure if properly informed

Objective test preferred

Assessing Decision-Making Capacity

Includes patient’s ability to:

Understand risks, benefits, and alternatives of a proposed test or procedure

Evaluate information provided by the physician

Express his or her treatment preferences

Voluntarily make decisions regarding his or her treatment plan

Without undue influence by family, friends, or medical personnel

Admission Consent Forms

Signed at the time of admission

For routine services

Limited power of attorney

School officials when other options lacking

Consent for Specific Procedures

Variety of consent forms

Specifically describe the risks, benefits, and alternatives of particular procedures

Anesthesia

Cardiac catheterization

Surgery

Radiation & chemotherapy therapy

Blood and blood by-products, etc.

Limited Power of Attorney

Authorizes, for example, school officials, teachers, and camp counselors act on the parents’ or legal guardian’s behalf

When seeking emergency care

Limited protection

Active ongoing contact of family necessary

Who May Consent

Competent patients

Guardianship

Parental consent

Emancipated minor

Incompetent Patients

When there is doubt as to a patient’s capacity to consent, the consent of the legal guardian or next of kin should be obtained.

Ability to consent is a question of fact.

Physicians are in the best position to make that determination.

Spousal consent

Right to Refuse Treatment and Religious Beliefs

Patients have a right to refuse treatment.

Must be conscious and mentally competent

Hospitals must honor a patient’s decisions when treatment is refused.

Religious beliefs

Blood or blood products

Exculpatory Agreements

An agreement that relieves one from liability when he or she has acted in good faith

Exculpatory agreements in the medical setting are generally considered invalid.

Case: Cudnik v. William Beaumont Hospital

Release Form

A patient’s refusal to consent to treatment, for any reason, religious or otherwise, should be noted in the medical record, and a release form should be executed.

A completed release provides documented evidence of a patient’s refusal to consent to a recommended treatment.

Proving Lack of Consent

Reasonably prudent person in patient’s position would not have undergone treatment if fully informed

Lack of informed consent is proximate cause of injury for which recovery is sought

Informed Consent: Claims and Defenses

Risk not disclosed is commonly known.

Patient assured the practitioner that he or she would undergo treatment regardless of the risk.

For example: Patient did not want to know about the risks.

Consent was not reasonably possible.

Practitioner reasonably believed manner and extent of disclosure could reasonably be expected to adversely and substantially affect patient’s condition.

Patient Rights

Patient Rights (1 of 8)

Know one’s rights

Patient’s bill of rights

Explanation of rights

Know caregivers

Ask questions

Patient Rights (2 of 8)

Admission

Discrimination prohibited

Government facilities

Assessments and reassessments

Participate in care decisions

Informed consent

Patient Rights (3 of 8)

Right to treatment

Refuse treatment

Pain management

Quality care

Appoint a surrogate decision maker

Patient Rights (4 of 8)

Have special needs addressed

Execute advance directives

Compassionate care

Confidentiality

Patient Rights (5 of 8)

Privacy and HIPAA

Disclosures permitted without patient authorization

Limitations on disclosures

Patient advocate

Ethics consultation

Chaplaincy services

Patient Rights (6 of 8)

Discharge orders

News: don't leave the hospital until you know what comes next

Discharge or detainment

Release from hospital contraindicated transfer

Failure to override physician’s discharge order

Patient Rights (7 of 8)

Transfer

Access medical records

Know hospital’s adverse events

Know third-party relationships

Patient education

Patient Rights (8 of 8)

Transparency and hospital charges

Failure to disclose insurance applicants’ HIV status

Transparency not so transparent

Patient Responsibilities

Patient Responsibilities: Historical Perspective (1 of 4)

Cornwall General Hospital’s Rules for Patients (posted in 1897)

1. Patients on admission to the Hospital must have a bath, unless orders to the contrary are given by the Attending Medical Attendant . . .

6. Patients must be quiet and exemplary in their behaviour and conform strictly to the rules and regulations of the Hospital, and carry out all orders and prescriptions of the various officers of the establishment . . .

Patient Responsibilities: Historical Perspective (2 of 4)

8. No male patient shall, under any pretense whatever, enter the apartments or wards for the females, nor shall a female patient enter the apartments or wards for males, without express orders from the Medical Attendant or Lady Superintendent . . .

10. Every patient shall retire to bed at 9 p.m. from First May to First November, and at 8 p.m. from November to May; and those who are able shall rise at 6 a.m. in the Summer and 7 a.m. in the Winter . . .

11. Such patients as are able, in the opinion of the physicians and surgeons, shall assist in nursing others, or in such services as the Lady Superintendent may require . . .

Patient Responsibilities: Historical Perspective (3 of 4)

13. Patients must not take away bottles, labels or appliances when leaving the Hospital.

14. No patients shall enter into the basement story, operating theater, or any of the officers’ or attendants’ rooms, except by permission of an officer of the Hospital . . .

Patient Responsibilities: Historical Perspective (4 of 4)

17. Any patient bringing spirituous liquors into the Hospital or the grounds, or found intoxicated, will be discharged.

18. Whenever patients misbehave or violate any of the standing rules of the Hospital, the Attending Physician may remove or discharge them, as provided by clauses 91 and 93 of Rules for Medical Staff.

Patient Responsibilities: Contemporary Perspective (1 of 4)

Practice a healthy lifestyle

Maintain current medical records

Keep appointments

Provide full disclosure of medical history

Accurately describe symptoms

Patient Responsibilities: Contemporary Perspective (2 of 4)

Responsibility to disclose information

Communicate care preferences

Stay informed

Report unexpected changes in health status

Adhere to agreed upon treatment plan

Patient Responsibilities: Contemporary Perspective (3 of 4)

Avoid self-administration of medications

Actively participate in care

Comply with hospital policy

Respect

Understand medicine has limits

Patient Responsibilities: Contemporary Perspective (4 of 4)

Ask questions

“What is this medication for?”

“What diet am I on?”

“Since you are going to change my dressing, did you wash your hands?”

Tips for Patients: Help Prevent Medical Errors (1 of 7)

Medications

Inform your doctors about medicine you are taking.

Bring your medicines and supplements to doctor visits.

Inform your doctor about any allergies and adverse reactions you have had to medicines.

Make sure you can read your doctor’s prescription order.

Tips for Patients: Help Prevent Medical Errors (2 of 7)

Ask for information about your medicines in terms you understand—both when your medicines are prescribed and when you pick them up.

When you pick up your medicine from the pharmacy, ask: “Is this the medicine that my doctor prescribed?”

Make queries about any questions and directions on your medicine labels; don’t be afraid to ask.

Tips for Patients: Help Prevent Medical Errors (3 of 7)

Ask your pharmacist for the best device to measure your liquid medicine.

Ask for written information about the side effects your medicine could cause.

Tips for Patients: Help Prevent Medical Errors (4 of 7)

Hospital stays

If you are in a hospital, consider asking all healthcare workers who will touch you whether they have washed their hands.

When you are being discharged from the hospital, ask your doctor to explain the treatment plan you will follow at home.

Tips for Patients: Help Prevent Medical Errors (5 of 7)

Surgery

If you are having surgery, make sure that you, your doctor, and your surgeon all agree on exactly what will be done.

If you have a choice, choose a hospital where many patients have had the procedure or surgery you need.

Tips for Patients: Help Prevent Medical Errors (6 of 7)

Other steps

Speak up if you have questions or concerns.

Make sure that someone, such as your primary care doctor, coordinates your care.

Make sure doctors have your health information.

Tips for Patients: Help Prevent Medical Errors (7 of 7)

Ask a family member or friend to go to appointments with you.

Know that “more” is not always better.

If you have a test, do not assume that no news is good news—be sure to follow up.

Learn about your condition and treatments by asking your doctor, nurses, and other reliable sources.

Review Questions (1 of 3)

Discuss the rights and responsibilities of patients as reviewed in this chapter.

Discuss the distinction among verbal, written, and implied consent.

Describe the role of the patient, physician, nurse, and hospital in obtaining informed consent.

Explain how consent differs among competent patients, minors, guardians, and incompetent patients.

Review Questions (2 of 3)

5. Explain the available defenses for defendants as it relates to informed consent.

Can a patient consent to a procedure and then withdraw it? Discuss your answer.

Discuss under what circumstances parental consent for a minor might not be necessary.

Review Questions (3 of 3)

8. Describe the rights and responsibilities of patients.

9. Why should caregivers should consider themselves patient advocates?

10. Describe what can patients can do to help prevent medical errors.