HOUSE STAFF ORIENTATION 2016 Charles Conklin Director Risk

HOUSE STAFF ORIENTATION 2016 Charles Conklin Director, Risk Management TUHS John R. O’Donnell, Esquire Senior Counsel TUHS

Topics • Incident reporting • Ethical concerns • Informed Consent – Capacity – Surrogate Decision Makers • Advanced Directive Proxy, Power of Attorney • Legal Guardians, Health Care Representative • End-stage medical condition, permanent unconsciousness

What is Risk Management? A coordinated system-wide process which identifies, prevents, or minimizes events that may present potential risk to our patients, visitors, volunteers, and staff.

Incident Reporting

Incident Reporting • An incident report should be filed for any of the following issues/conditions – Any untoward outcome/harm to a patient not expected in the normal course of treatment including near misses • Complications of procedures, medication misadventures, iatrogenic injuries – Risk Management reviews all incidents filed in the system and may follow-up w/ you if clarification is necessary. – For very serious incidents, Root Cause Analysis may be conducted and your participation may be required – this is a non-punitive peer review protected process

Incident Reporting • Electronic On-Line reporting system – MIDAS – Available on all desktops as well as TUHS Employee Home Page under references – Report should be filed as soon after the incident as possible before the end of shift - 24 hours – Report should contain only the facts, no opinions, should be objective not subjective – personal comments are not appropriate – May be entered anonymously by title only

Ethics Consults

Ethics Consults • The Ethics Committee membership will schedule an ethics consult when requested. Issues involving the need for an ethics consult may include: – End of Life Decision Making – Withdrawal of care – Conflicts of care decision between family and/or medical team • You should enter an order to request a consult and you can call the Risk Management Dept.

Informed Consent

Medical Care Availability and Reduction of Error Act (MCARE-Act 13) • 1303. 504 Informed Consent • Duty of Physicians—except in emergencies a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to conducting the following procedures: • (1) Performing surgery, including the related administration of anesthesia • (2) Administering radiation or chemotherapy

Informed Consent Cont’d… • (3) Administering a blood transfusion • (4) Inserting a surgical device or appliance • (5) Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.

Informed Consent Cont’d… • Description of Procedure • Consent is informed if the patient has been given a description of a procedure as set forth in Duty of Physician and the risks and alternatives that a reasonable prudent patient would require to make an informed decision as to that procedure.

Lack of Informed Consent • Constitutes a battery which is an unwanted/unauthorized touching of the patient. • Consent form must be complete. If not recorded it was not said. • The duty to obtain informed consent is nondelegable. Must be obtained by a physician or where appropriate a physician extender.

Case Example • Ophthalmologist recommends LEFT Temporal Artery Biopsy (TAB) • Ophthalmologist verbally advises vascular surgeon of need for RIGHT TAB • Vascular accepts for RIGHT TAB • Ophthalmology office correctly completes OR booking and preadmission testing order for LEFT TAB • OR schedule reflects LEFT TAB • Laterality noted on H & P or Informed Consent • Vascular surgeon notes indicate RIGHT TAB • Time-out in OR confirms RIGHT TAB to be performed • RIGHT TAB performed resulting in wrong site surgery

CAPACITY - A patient is deemed to have capacity when the following conditions exist: • Understands the potential material benefits, risks and alternatives involved in a specific proposed health care decision. • Makes that health care decision on his/her own behalf. • Communicates that health care decision to any other person.

CAPACITY This determination can be made by any treating physician and does not necessarily require a psychiatric evaluation

Surrogate Healthcare Decision Makers – A Surrogate Decision-maker is a person designated by law to make health care decisions and consent to care on behalf of the patient. Surrogate Decisionmakers fall into one of three categories: (1) Agent; (2) Guardian (3) Health Care Representative

Agent An Agent is someone selected by the principal (i. e. patient), when the principal had capacity, in an advance health care directive (i. e. Power of Attorney or Living Will).

Guardian - A Guardian is someone who is appointed by the Court to make decisions on behalf of an incapacitated person. A Guardian will have a Court Order designating them as the Guardian for the person who lacks capacity.

Health Care Representative - A person who is at least 18 years of age can be a health care representative and may make a health care decision for an individual whose attending physician has determined that the individual lacks capacity. Health Care Representatives may be used after determination that there is no guardian appointed by the Court, there is no Health Care Power of Attorney or a Health Care Power of Attorney is not reasonably available.

Health Care Representative Cont’d… • Any member of the following classes, in descending order of priority, who is reasonably available, may act as health care representative: • (i) The spouse, unless an action for divorce is pending, and the adult children of the patient who are not the children of the spouse. • (ii) An adult child. • (iii) A parent. • (iv) An adult brother or sister. • (v) An adult grandchild. • (vi) An adult who has knowledge of the patient's preferences and values, including, but not limited to, religious and moral beliefs, to assess how the patient would make health care decisions.

SURROGATE DECISION MAKERS • Legal Guardians and Healthcare Representatives may not withdraw or withhold medical care (e. g. DNR) unless the patient is (1) Permanently unconscious (PU) or (2) is suffering from an end stage medical condition (ESMC). Either a PU or ESMC must be verified by two physicians.

Summary • Risk Management On-Call 24/7 • Incident Reporting • Ethics consults • Informed Consent – Capacity – Surrogate Decision Makers • Advanced Directive Proxy, Power of Attorney • Legal Guardians, Health Care Representative • End-stage medical condition, permanent unconsciousness

Risk Management Departments • TUH – Main Campus – Risk Management on-site • 8 am- 12 midnight M-F, 8 am-8 pm Saturdays & Sundays – Risk Manager On-Call 24/7 • TUH – Episcopal & Northeastern Campuses – Risk Management on site • 8: 30 am – 5 pm – Risk Manager On-Call 24/7 • TUH – Jeanes & Fox Chase – Risk Management on site • 8: 30 am – 5 pm – Risk Manager On-Call 24/7

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