legal aspects 9 and 10

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Patient Consent, Rights, and 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

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

Verbal consent

Binding as written consent

More difficult to prove

Written consent

Visible proof of a patient’s wishes

When a proposed treatment may some unusual risk to the patient

Elements of Informed Consent

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

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

Voluntarily submit to a procedure thereby implying consent (through actions not words)

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.

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

Physicians reveal to their patients information that skilled physicians of good standing would provide under the same or similar circumstance

NOT under duty to elucidate every little detail or all possible risk

Must adequately present material facts (ex: risks of a serious nature)

Consent is not valid if the patient does not understand

Course of Treatment Case: Patient’s Decision

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

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.

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.

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.

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.

Hospitals: Informed Consent

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

Hospitals will be held liable if physician is an employee, but not an agent/independent contractor

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

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.

Validity of Consent

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.

Validity of Consent

Subjective test

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

Relies on patient testimony

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: Limited POA

Signed at the time of admission

For routine services

Unwarranted reliance for specific and potentially high-risk procedures/treatments

Limited power of attorney

Written authorization to represent or act on another's behalf in some legal matter

School officials or others acting on parents or guardians’ behalf in case of emergency care

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.

Who May Consent

Competent patients

Guardianship

Guardian is an individual who, by law, is vested with the power and charged with the duty of taking care of a patient

Parental consent

Usually required, though in some circumstances courts have held consent of minors to be valid

Emancipated minor

Parental consent not required

Who May Consent

Many states recognize that treatment of certain conditions will not require parental consent

Pregnancy, venereal disease, drug dependency

Matter of public policy: minor may not seek treatment if parental consent is needed

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

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 because it is against public policy

Experimental treatments may be an exception to this

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.

Assignment 2

Due 4/28/22 by end of day -submit via BB

Explain what HIPPA is and what the federal law's position on patient privacy is.

Look up and list two laws (statutes) in the Act.

Research and list 3 state laws on patient privacy using the state you were assigned in a previous announcement

Do NOT copy and paste

summarize the gist of EACH law in 2-3 sentences

provide the citation for the 3 laws

specify whether this a statute or regulation

Assignment 2

Read the court case Tarasoff v. Regents of University of California

Do you agree with the court's decision? Why or why not?

Provide a discussion in light of HIPPA and the state laws that you found for Q2. Make sure you explain your reasoning

Please follow writing tips, comments and feedback from Paper 1

In-text citations and bibliography required

Text should be double-spaced; tables and bibliography single-spaced

Individual Exercise 1: Research Laws

Look up statutory consent laws for your assigned state

Where is the law located?

What does the law say about consent in emergency situations?

Patient Rights

Know one’s rights

HC orgs should educate patients about their rights

Patient’s bill of rights

42 CFR §483

Explanation of rights

Know caregivers

Ask questions

Patient Rights

Admission

Discrimination prohibited by federal law

Government facilities: no right of admission if not within statutory class (ex: veterans).

Hospital still has duty to extend reasonable care to those who need immediate assistance

Assessments and reassessments

Participate in care decisions

Informed consent

Patient Rights

Right to treatment

discrimination prohibited

Refuse treatment

Patient Self Determination Act of 1990

In some cases, courts will perform a balancing test to determine whether override a competent adult’s decision to refuse medical treatment

State interests (ex: protection of third parties) vs. patient rights

Patient Rights

Pain management

Process whereby caregivers work with the patient to develop a pain control plan

“The facility must ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person- centered care plan, and the residents’ goals and preferences.”

Quality care

Patient Rights

Appoint a surrogate decision maker

Joint Commission: “When a patient is unable to make decisions about his or her care, treatment, and services, the hospital involves a surrogate decision maker in making these decisions.”

Have special needs addressed

Execute advance directives

Advance directives are legal documents where a person specifies what actions should be taken for their health if they are no longer able to make decisions for themselves because of illness or incapacity

Patient Rights

Compassionate care

Confidentiality

“The patient has right to the confidentiality of his or her clinical records.”

Exception: making the necessary info available to others involved in the patient’s care

Privacy and HIPAA

HIPPA: Patients have a right to receive a “Notice of Privacy Standards”

Patient Rights

Privacy and HIPAA

Disclosures permitted without patient authorization

To other providers who may be caring for the patient in order to provide safe treatment

To third-party payers to obtain payment of services

For healthcare operations

If required by law enforcement agency

When required to avert a serious threat to public health or safety

Required by military command authorities for their medical records

Patient Rights

Privacy and HIPAA

Disclosures permitted without patient authorization

To worker’s compensation or similar programs for processing of claims

In response to a subpoena for a legal proceeding

To a coroner or medical examiner for purposes of identification

Patient Rights

Privacy and HIPAA

Limitations on disclosures

Right to request restrictions regarding information used or disclosed about treatment or care

Right to request a list of the disclosure made of information released regarding his/her care

Right to amend: if a patient believes medical info is incorrect, right to request that it be corrected

Right to inspect and copy medical information that may be used to make care decisions

Patient Rights

Privacy and HIPAA

Limitations on disclosures

Right to file a complaint with the provider or DHHS if privacy rights are violated

Right to a paper copy of a notice pertaining to the patient

Right to know restriction on rights

Patient Rights

Patient advocate

Long-term care ombudsmen programs

Investigate reports of resident abuse in nursing homes

Established by the Older Americans Act in 1978

Ethics consultation

When faced with challenging treatment decisions that involve ethical dilemmas

However, not binding

Chaplaincy services

Patient Rights

Discharge orders and instructions for follow-up care must be provided to the patient prior to discharge from the hospital

Detainment – which intentional tort?

Patients have a right to be transferred to an appropriate facility when the admitting facility is unable to meet a patient’s needs

Use of transfer agreements

Right to choose receiving facility (pretransfer hearing)

Review of decision to discharge: clear and convincing evidence

Patient Rights

Access medical records

Know hospital’s adverse events

“Patients have a right to have access to any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident.”

Know third-party relationships that may influence care

Ex: educational institutions, insurers, other HC providers

Patient Rights

Patient education

Ex: Medication safety, nutrition, access to community resources, equipment use

Transparency and hospital charges

Failure to disclose insurance applicants’ HIV status

North Carolina Health Care Cost Reduction and Transparency Act

Patient Responsibilities: Contemporary Perspective

Practice a healthy lifestyle

Maintain current medical records

Keep appointments

Provide full disclosure of medical history

Accurately describe symptoms

Patient Responsibilities: Contemporary Perspective

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

Avoid self-administration of medications

Actively participate in care

Comply with hospital policy

Respect

Understand medicine has limits

Patient Responsibilities: Contemporary Perspective

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?”