HOUSE STAFF ORIENTATION

2013Charles Conklin

Director, Risk Management TUHS

John R. O’Donnell, EsquireSenior Counsel TUHS

What is Risk Management?

A coordinated system-wide process which identifies, prevents, or minimizes events that may present potential harm to our patients, visitors, volunteers, and staff.

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 Issues

• Capacity, Involuntary Commitment (302), Guardianship

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• 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– 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– Remember—Always report—Never cover up– These reports present the first opportunity to effect change

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• Call the Risk Management Department

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 - Con’t• (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 - Con’t• Description of Procedure• Consent is informed if the patient has been given a

description of a procedure 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. The physician shall be entitled to present evidence of the description of that procedure and those risks and alternatives that a physician acting in accordance with accepted medical standards of medical practice would provide.

Case Example – Informed Consent

2/21/12 - 78 yo Hispanic female with suspected diagnosis of Temporal Arteritis. Ophthalmologist recommended left temporal artery biopsy (TAB).

2/29/12 - Ophthalmologist called Vascular Surgery to arrange for the surgery . Ophthalmologist verbally reported to vascular surgeon that a right sided TAB needed to be performed. Vascular surgery accepted the referral for a right TAB.

2/29/12 - Ophthalmologist office completed the electronic Operation Room Request and the pre-admission testing order for a left TAB.

3/1/12 - When the procedure was listed on the OR schedule it was listed correctly as a left TAB. The case was then assigned to the Ambulatory Care Operating Room and was recorded on their OR schedule simply as a TAB – no laterality.

3/2/12 - The patient presented to the hospital. A history and physical was completed that morning and laterality was not noted by the resident completing the H&P but was noted by the attending vascular surgeon to be on the right side. The resident obtained the informed consent for a TAB – with no laterality noted. The patient entered the operating room, a time out was completed and documented, confirming that a right TAB was to be performed and the right side had been marked by the attending vascular surgeon. A right TAB was performed without complication and the patient was discharged to home to return in ten days for suture removal.

The patient returned in ten days for suture removal accompanied by her son who asked the question of the surgeon, “Why was the surgery done on the right side when it was the left side that was bothering her.”

Capacity• Patient has the mental ability to understand

and evaluate his/her own condition, the nature and likely effect of the proposed treatment, and the risks and benefits associated with the proposed treatment or lack of treatment. – This determination can be made by any

treating physician and does not necessarily require a psychiatry evaluation.

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.

Surrogate Healthcare Decision Makers• A Surrogate Healthcare Decision Maker is an individual

authorized by law to make healthcare decisions on behalf of a patient who lacks capacity to make her/his healthcare decisions. Whether the patient lacks capacity must be determined by a physician. Surrogate Healthcare Decision Makers fall into different categories that carry varying levels of authority to act on behalf of an incapacitated patient. If an incapacitated patient regains capacity, the surrogate decision maker loses authority to act on behalf of the patient.

Surrogate Healthcare Decision Makers• Healthcare Agent - A Healthcare Agent is someone

selected by the principal (patient), when the principal was of sound mind, to make healthcare decisions on her/his behalf. Healthcare Agents are: (1) Healthcare Power of Attorney; or (2) a designee pursuant to an Advanced Directive. Healthcare Agents must provide documentation establishing their status as such. Healthcare Agents may withdraw or withhold medical care. However, Healthcare Agents must act in the best interests of the patient to fulfill their fiduciary duty to the patient.

Surrogate Healthcare Decision Makers• Legal Guardians and Healthcare Representatives – A Legal

Guardian (or Plenary Guardian) is an individual (or individuals) appointed by the court to make decisions on behalf of someone who has been adjudicated by the court to be an incompetent person. A Healthcare Representative is an individual, not selected by the patient, who may make health care decisions for an incapacitated patient who lacks a Healthcare Agent and/or a Legal Guardian. 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 an ESMC must be verified by two physicians.

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.

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.

 

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

Questions ? ?