Transcript Document

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?
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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
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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 1-800-2322522 (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
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•
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:
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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
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Medicalese
No meat-risks and benefits discussed
Too distant in time
Assume a level of knowledge that is not
really there
Procedure Specific Consent
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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
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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?