Wisconsin Critical Access Hospital Coalition

December 6, 2005

Michael W. Rausch, JD

• Senior Risk Management Consultant– PIC Wisconsin

• 10 years as a risk manager and staff attorney with a tertiary care hospital

• Private practice in Arizona, including work with small rural facilities

Disclaimer• Not licensed in

Wisconsin• Specific issues

should be referred to your corporate counsel or malpractice carrier

Informed Consent

• Overview of the Requirements

• Who is responsible for informed consent?

• Special requirements

• Documentation

Perspective

• If the surgery is on me, it is

never a….

–Minor procedure!!!!

What is informed consent?• Process not a form

• Mutual understanding of what will happen

• Setting reasonable expectations

• Acceptance by patient

Authorization to Release Information vs. Clinical Consent• HIPAA, Confidentiality Statutes,

Regulatory Rules

• Specific Authorizations Required to comply.

• Release limited without a signed authorization.

Why informed consent?

• Common Law

• Statute

• Regulatory Requirement

• Hospital Policy

Common Law-Wisconsin

• Improper touching=battery– Trogun v. Fruchtman 1973

• Cases:– Scaria v. St. Paul 1975– Mathias v. St. Catherine’s Hospital 1997– Hannemann v. Boyson 2005

Statute• 448.30

448.30 Information on alternate modes of treatment.  Any physician who treats a patient shall inform the patient about the availability of all alternate, viable medical modes of treatment and about the benefits and risks of these treatments.  The physician's duty to inform the patient under this section does not require disclosure of: 448.30(1) (1) Information beyond what a reasonably well-qualified physician in a similar medical classification would know. 448.30(2) (2) Detailed technical information that in all probability a patient would not understand. 448.30(3) (3) Risks apparent or known to the patient. 448.30(4) (4) Extremely remote possibilities that might falsely or detrimentally alarm the patient. 448.30(5) (5) Information in emergencies where failure to provide treatment would be more harmful to the patient than treatment. 448.30(6) (6) Information in cases where the patient is incapable of consenting.

Regulations WI Admin Code• Med 18.03 Communication of alternate modes of treatment. 

Med 18.03(1) (1) It is the obligation of a physician to communicate alternate viable modes of treatment to a patient. The communication shall include the nature of the recommended treatment, alternate viable treatments, and risks or complications of the proposed treatment, sufficient to allow the patient to make a prudent decision. In the communication with a patient, a shall take into consideration: Med 18.03(1)(a) (a)  A patient's ability to understand the information; Med 18.03(1)(b) (b)  The emotional state of a patient; and, Med 18.03(1)(c) (c)  The physical state of a patient. Med 18.03(2) (2) Nothing in sub. (1) shall be construed as preventing or limiting a physician in recommending a mode of treatment which is in his or her judgment the best treatment for a patient.

Regulations: Exceptions• Med 18.04(1)

(1) A physician is not required to explain each procedural or prescriptive alternative inherent to a particular mode of treatment. Med 18.04(2) (2) In an emergency, a physician is not required to communicate alternate modes of treatment to a patient if failure to provide immediate treatment would be more harmful to a patient than immediate treatment. Med 18.04(3) (3) A physician is not required to communicate any mode of treatment which is not viable or which is experimental. Med 18.04(4) (4) A physician may not be held responsible for failure to inform a patient of a possible complication or benefit not generally known to reasonably well-qualified physicians in a similar medical classification. Med 18.04(5) (5) A physician may simplify or omit communication of viable modes of treatment if the communication would unduly confuse or frighten a patient or if a patient refuses to receive the communication.

Documentation

• Med 18.05 Recordkeeping.  A physician shall indicate on a patient's medical record he or she has communicated to the patient alternate viable modes of treatment. 

Federal Regulatory Requirement• Center for Medicare and Medicaid

Services:– Conditions of Participation (CoPs)

CMS: Conditions of Participation 42 C.F.R. 482.51• Surgical Services

• A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies.

WI. Admin Code “Unprofessional Conduct”• U-”Failure to inform a patient about the

availability of all alternate, viable medical modes of treatment, and about the benefits and risks associated with the use of extended wear contact lenses.”

Hospital Policy

• Multiple Policies– Admissions: Condition of Admission– Clinic: Consent to Treat

General Consent• I understand that I have a health

problem requiring hospitalization, diagnosis and treatment. I voluntarily consent to hospital care, necessary general diagnostic procedures, and routine medical or x-ray treatment ordered by my physician or his/her assistant.

Who is responsible for informed consent?• Who is doing the

procedure?

• Surgeon• Technician• Nurse

Surgery

• “Risks and Benefits Explained”

• Procedure Specific Consents

Consent: Anesthesia• Varies by type:

general, regional, local

• ASA status• Type of procedure• Separate or Part of

General Procedure Consent

Special Consents: Blood

• Reactions

• Exposure to various viruses or diseases

• Informed Refusal

Special Consents: OB

• Vaginal delivery

• Forceps or vacuum extractor

• VBAC

• C-section

Nursing and Auxiliary Services• X-ray: CT with contrast

• MRI

• Sedation

Injections: It won’t hurt a bit!

Immunizations

• FDA Specific Consent Forms

• National Childhood Vaccine Injury Act of 1986 (P. L.99-660), which established the National Vaccine Injury Compensation Program (VICP).

Covered Vaccines• The vaccines currently covered include: diphtheria,

tetanus, pertussis (DTaP, DT, TT or Td), measles, mumps, rubella (MMR or any components), polio (IPV), hepatitis A, hepatitis B, haemophilus influenza type b (Hib), varicella, rotavirus, pneumococcal conjugate, and trivalent influenza (given annually). As of December 1, 2004, hepatitis A vaccine was added for coverage under the VICP. As of July 1, 2005, the influenza vaccines, which are given annually, were added to the VICP

Vaccination Information• By law, parents, guardians, or patients must

be given information in writing about the risks and benefits of vaccination before a vaccine is administered. You can obtain copies by calling the CDC National Immunization Program information hotline at 1-800-232-2522 (English) or 1-800-232-0233 (Spanish), or view the information on the National Immunization Program's home page.

Clinical Research

• IRB approved form

• FDA Regulations

Sterilization

• Tubal Ligation

• Hysterectomy

• Vasectomy

Organ Donation/ Anatomical Gift• Wisconsin Act 298 states that "any member of the following

classes of individuals in the order priority listed may make an anatomical gift of all or parts of the decedent's body for transplantation, therapy, medical or dental science":

• The spouse of the decedent; • An adult son or daughter (18 years of age) of the decedent; • Either parents of the decedent; • An adult brother or sister (18 years of age) of the decedent; • A grandparent of the decedent; or • A guardian of the person of the decedent at the time of death.

Who can consent?

• Patient, if adult and competent– Impaired due to injury, EtOH or

medications of drugs

• Guardian

• Court Order

• Surrogate Decision Maker– Healthcare Power of Attorney

Minors: General Rule

• Under 18

• Parent

Delegation• Sports • Other relative or significant others• Court Order• Foster Care (maybe, if parental rights

terminated)• In loco parentis

• Show me the paper!!

Multiple Visits

• Allergy shots

• PT

• Well or sick child visits

Minor: Consenting for Themselves• Outpatient EtOH or drug of abuse-WI.

Stat. 51.47 (12+)

• Sexually Transmitted Diseases WI. Stat.252.11

• HIV testing WI Stat 252.15 (14+)

• Outpatient Mental Health Treatment WI Stat 51 (14+)

Minor

• Blood and Bone Marrow Donation WI stat146.33 (17+)

Minors: Emergency

• Failure to provide treatment would be more harmful to the patient than treatment.

• WI Stat. 448.30

Grey Area:

• Birth Control and Contraception

• Family Planning

• Treatment of Pregnancy

• Abortion

Emancipation

• Legal Basis– Court Decides– Termination of Parental Rights

• Financial Independence

• Married Minor

Minor Parent

• Can consent for their child

Divorced Parent

• OK to consent

• Unless rights terminated by court order

Developmental Disabled

• Matter of degree

• Independent

• Financially responsible for themselves

Behavioral Health-Inpatient

• Wis. Statutes: 51.61– To perform labor– Medication and treatment unless court

ordered– Psychosurgery or other drastic treatment– Filming or taping

Documentation• Hospital Consent

– Spells out procedure– Who will perform the procedure– Generic risks and benefits– Any questions or concerns?– Miscellaneous other provision

• Disposal of parts• Educational photo or video

Problem Areas

• Medicalese

• No meat-risks and benefits discussed

• Too distant in time

• Assume a level of knowledge that is not really there

Procedure Specific Consent

• Detailed description of procedure

• General risks of surgery

• Specific risk of this procedure

• Reference to anesthesia and blood risks

• Specific risks for this patient (fill in the blank)

Good Practices

• Look at whole process

• Handouts

• Drawings

• Models

• CT and Radiology Images

Take Credit for What You Have Done• Patient Education

• Handouts

• Questions answered or referred to physician

Opportunity to ask questions• Early discussions

• Questions from family members

• Can change their mind

Patient’s Perspective

• Bobble head consents

• Language Barriers

• Cultural Barriers

George Carlin

• Some people see things that are and ask, Why?

• Some people dream of things that never were and ask, Why not?

• Some people have to go to work and don't have time for all that.

Questions?