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

2. 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

3. 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.

4. Incident Reporting

5. 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

6. 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 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

7. Ethics Consults

8. 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.

9. Informed Consent

10. Medical Care Availability and Reduction of Error Act (MCARE-Act 13)
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. 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 not 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

16. 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.

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

18. 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

19. 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).

20. 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.

21. 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.

22. 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.

23. 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.

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

26. Questions ? ?