1 / 53

Wisconsin Critical Access Hospital Coalition

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.

khanh
Download Presentation

Wisconsin Critical Access Hospital Coalition

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Wisconsin Critical Access Hospital Coalition December 6, 2005

  2. 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

  3. Disclaimer • Not licensed in Wisconsin • Specific issues should be referred to your corporate counsel or malpractice carrier

  4. Informed Consent • Overview of the Requirements • Who is responsible for informed consent? • Special requirements • Documentation

  5. Perspective • If the surgery is on me, it is never a…. • Minor procedure!!!!

  6. What is informed consent? • Process not a form • Mutual understanding of what will happen • Setting reasonable expectations • Acceptance by patient

  7. Authorization to Release Information vs. Clinical Consent • HIPAA, Confidentiality Statutes, Regulatory Rules • Specific Authorizations Required to comply. • Release limited without a signed authorization.

  8. Why informed consent? • Common Law • Statute • Regulatory Requirement • Hospital Policy

  9. 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

  10. Statute • 448.30 448.30Information 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.

  11. Regulations WI Admin Code Med 18.03Communication 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.

  12. 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.

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

  14. Federal Regulatory Requirement • Center for Medicare and Medicaid Services: • Conditions of Participation (CoPs)

  15. 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.

  16. 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.”

  17. Hospital Policy • Multiple Policies • Admissions: Condition of Admission • Clinic: Consent to Treat

  18. 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.

  19. Who is responsible for informed consent? • Who is doing the procedure? • Surgeon • Technician • Nurse

  20. Surgery • “Risks and Benefits Explained” • Procedure Specific Consents

  21. Consent: Anesthesia • Varies by type: general, regional, local • ASA status • Type of procedure • Separate or Part of General Procedure Consent

  22. Special Consents: Blood • Reactions • Exposure to various viruses or diseases • Informed Refusal

  23. Special Consents: OB • Vaginal delivery • Forceps or vacuum extractor • VBAC • C-section

  24. Nursing and Auxiliary Services • X-ray: CT with contrast • MRI • Sedation

  25. Injections: It won’t hurt a bit!

  26. 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).

  27. 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

  28. 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.

  29. Clinical Research • IRB approved form • FDA Regulations

  30. Sterilization • Tubal Ligation • Hysterectomy • Vasectomy

  31. 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.

  32. 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

  33. Minors: General Rule • Under 18 • Parent

  34. Delegation • Sports • Other relative or significant others • Court Order • Foster Care (maybe, if parental rights terminated) • In loco parentis • Show me the paper!!

  35. Multiple Visits • Allergy shots • PT • Well or sick child visits

  36. 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+)

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

  38. Minors: Emergency • Failure to provide treatment would be more harmful to the patient than treatment. • WI Stat. 448.30

  39. Grey Area: • Birth Control and Contraception • Family Planning • Treatment of Pregnancy • Abortion

  40. Emancipation • Legal Basis • Court Decides • Termination of Parental Rights • Financial Independence • Married Minor

  41. Minor Parent • Can consent for their child

  42. Divorced Parent • OK to consent • Unless rights terminated by court order

  43. Developmental Disabled • Matter of degree • Independent • Financially responsible for themselves

  44. Behavioral Health-Inpatient • Wis. Statutes: 51.61 • To perform labor • Medication and treatment unless court ordered • Psychosurgery or other drastic treatment • Filming or taping

  45. 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

  46. Problem Areas • Medicalese • No meat-risks and benefits discussed • Too distant in time • Assume a level of knowledge that is not really there

  47. 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)

  48. Good Practices • Look at whole process • Handouts • Drawings • Models • CT and Radiology Images

  49. Take Credit for What You Have Done • Patient Education • Handouts • Questions answered or referred to physician

  50. Opportunity to ask questions • Early discussions • Questions from family members • Can change their mind

More Related