1. HOUSE STAFF ORIENTATION 2014 Charles Conklin Director, Risk Management TUHS John R. O’Donnell, Esquire Senior Counsel TUHS

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

3. When to Call Issues involving patient care that may present a risk or compromise patient safety –Untoward outcomes, complications, medication errors, iatrogenic injuries –Incident reporting –Ethical concerns –Informed Consent Capacity, Involuntary Commitment (302), Guardianship

4. Incident Reporting

5. 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 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

6. Incident Reporting Electronic On-Line reporting system –MIDAS –Available on all desktops –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 –May be entered anonymously by title only

7. Ethics Consults

8. 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 Call the Risk Management Department

9. Informed Consent

10. 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

11. 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.

12. 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.

13. 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 non- delegable. Must be obtained by a physician or where appropriate a physician extender.

14. 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.

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

16. 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 Decision- makers fall into one of three categories: (1) Agent; (2) Guardian (3) Health Care Representative

17. 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).

18. 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.

19. 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.

20. 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, (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.

21. 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.

22. Permanent Unconsciousness A medical condition that has been diagnosed in accordance with currently accepted medical standards and with reasonable medical certainty as total and irreversible loss of consciousness and capacity for interaction with the environment. The term includes, without limitation, an irreversible vegetative state or irreversible coma.

23. End-stage Medical Condition An incurable and irreversible medical condition in an advanced state caused by injury, disease or physical illness that will, in the opinion of the attending physician to a reasonable degree of medical certainty, result in death, despite the introduction or continuation of medical treatment.

24. 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

25. Risk Management Departments TUH – Main Campus –Risk Management on-site 8am- 12midnight –Risk Manager On-Call 24/7 TUH – Episcopal Campus –Risk Management on site 8:30am – 5pm –Risk Manager On-Call 24/7 TUH – Jeanes & Fox Chase –Risk Management on site 8:30am – 5pm –Risk Manager On-Call 24/7

26. Questions ? ?