By Arnold Mackles, MD, MBA, LHRM - FOMA

By

Arnold Mackles, MD, MBA, LHRM

The Sullivan Group

- Author of on line CME courses

- Volunteer member of Advisory Board

Innovative Healthcare Compliance Group, Inc.

- CME speaker

- Consultant

“I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.”

“warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.”

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed.”

Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University.

“I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know.”

“Above all, I must not play at God.”

“I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. “

—Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.

“Do unto others as you would have others do unto you”

… However, these messages of provider fairness, compassion, quality, honesty and “The Golden Rule” are not always received by our patients…

“Nightshift

Nightmare”

- Readers Digest, 2007

.

“White Coat Confessions”

- December, 2010

“50 Secrets Surgeons Won’t Tell You”

- October, 2012

“What Your Doctor’s Really Thinking…But Won’t Say to Your Face”

- October, 2014

“50 Secrets Hospitals Wont Tell You!”

- Reader’s digest

February, 2016

1) Autonomy

2) Beneficence

3) Nonmaleficence

4) Justice

The patient’s independence, liberty.

Capable adults have right to make decisions (without manipulation or coercion).

Capable adult patients can accept or decline treatment.

Providers must act in patient’s best interest.

Promote patient healing, good health, and well being.

“First, do no harm!”

Do not harm patients due to:

Carelessness

Distain, malice, vengeance

Treatments intended to cure

(benefits must outweigh risks)

Fair distribution of health care resources.

Who should receive scarce medical resources?

Goal of Justice Principle:

- Fair healthcare system

The World Medical Association Declaration of Geneva (1948) Physician's Oath: “…I will not use my medical knowledge contrary to the laws of humanity…” Issued in response to the medical atrocities committed during WWII by physicians in Nazi Germany.

http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.page

http://www.nursingworld.org/codeofethics

The four Principles of Medical Ethics: Autonomy Beneficence Nonmaleficence Justice

Can be applied to any practice situation. In complicated cases, it is often difficult to determine which of the principles should be given more weight in decision making.

Ethical decision making must always be based on:

• Principles of medical ethics.

Standards of medical practice.

Accepted medical guidelines, protocols, and

The law.

• In 1975, Karen Quinlan sustained a ”respiratory arrest,” received resuscitation, and was left in a comatose, “vegetative” state.

• Her parents requested removal of mechanical ventilation, in order to let her to die.

• Physicians refused to remove the ventilator.

Fine, R. “From Quinlan to Schiavo: medical, ethical, and legal issues in severe brain injury.”Baylor University Medical Center Proceedings. 2005 October; 18(4): 303–310. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1255938/ Accessed April 18, 2013

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1255938/

• The New Jersey Supreme Court ruled in 1976 that the ventilator could be removed.

• The court stated that “families are adequate surrogates for incapacitated patients who did not and could not make their wishes known.”




• The ventilator was withdrawn, however Karen lived for 10 years, receiving nutrition via a feeding tube.

• Her Parents did not request removal of the feeding tube.



In 1990, 26 y/o female sustained cardiac arrest with anoxic brain injury, leaving her in a severely damaged neurological condition, requiring tube feedings. Her husband requested that everything be done to sustain Terri.

In 1998, eight years later, her husband (who had been appointed legal guardian) requested discontinuing the feeding tube, stating that Terri would not want to continue living in her present vegetative condition.

• Terri’s parents disagreed with husband.

• Case received national attention.

• Congressional hearings followed.

• Florida Legislature passed “Terri’s Law.”

• Terri’s Law declared unconstitutional.

• Feeding tube removed by judge’s order

on March 18, 2005.

• Terri died 13 days later.

Underscores the need for “Advance Directives.”

Advance Directive:

“Written instructions recognized under law relating to the provision of health care when an individual is incapacitated.”

Carroll, R. Risk Management Handbook for Health Care Organizations, Student Edition. American Society for Healthcare Risk Management. 2009. San Francisco. P.P. 567

Mayo clinic staff “Living wills and advance directives for medical decisions. Mayo Clinic. ”http://www.mayoclinic.com/health/living-wills/HA00014 Accessed April 20, 2013

Types of Advanced Directives • Living Will • Medical or Health Care Power of Attorney (POA) • Do Not Resuscitate (DNR) Order

http://www.mayoclinic.com/health/living-wills/HA00014





Living Will: • Written legal document. • Lists types of treatments/life sustaining

measures patient does or does not want. - ex. mechanical ventilation, tube feedings, etc.

• Also called “Health Care Declarations” or “Health Care Directives,” in some states.






Medical or Health Care Power of Attorney (POA): • Legal document designating an individual as a

health care agent or proxy for a patient. • Agent or proxy can make medical decisions for

patient in event that patient is unable to do so. • Different from financial POA.






• California was first state to legally provide for living wills in 1975.

• In 1976, Texas became the second state to pass legislation allowing for Living Wills.


1) Medical Indications 2) Patient Preferences 3) Quality of Life 4) Contextual Features

Jonsen, A., Siegler, M.,Winslade, W. Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. 2010. McGraw Hill. New York.


Principles: Beneficence, Nonmaleficience • What is the patient’s problem? (acute/chronic/critical/reversible/terminal)? • What are the goals of treatment? • In what circumstances is treatment not indicated? • What are the probabilities of success? • How can patient benefit from care… and not be harmed?


Principles: Autonomy • Did you inform patient of risks and benefits? Was consent

obtained? • Does the patient understand the information? Is the patient

mentally capable and competent? - If so, what are the patient’s treatment preferences?

• If not capable or incapacitated, what were prior wishes? Who is the medical proxy or surrogate?

• Is the patient unable / unwilling to receive treatment? Why?


Principles: Beneficence, Nonmaleficience, Autonomy

• What are prospects for return to normal life w/wo treatment? What deficits may persist with treatment?

• How (on what grounds) can you judge what is “quality of life” for the patient?

• Do you have biases in evaluating patient’s quality of life? • Do quality of life evaluations suggest changing treatment

plans? • What is rationale and plan if you forgo life sustaining

measures?


Principles: Justice, Fairness • Are there business, professional or financial interests that

could create a conflict of interests with treatment plan? • Do other parties (family, friends, etc.) have an interest in

clinical decisions? • Is the allocation of scarce resources effecting decisions?


Principles: Justice, Fairness • Are there religious or legal issues that might influence

decisions? • Are there medical research or educational factors that

could effect decisions?

Mrs. J, a 59 y/o female with a documented history of gastric carcinoma is a patient in your hospital. 1 ½ years prior to this admission, she was diagnosed via biopsy obtained during a esophagogastroduodenoscopy. Following this diagnosis, despite numerous and documented discussions with physicians she refused all suggested interventions and treatment options. She missed follow up appointments and did not return phone calls.

Two months prior to this admission, Mrs. J was seen by a new gastroenterologist and she requested a second biopsy, which again revealed the diagnosis of gastric carcinoma. The patient developed gastric bleeding several days later, had emergency surgery at which time a partial gastric resection was performed and a stoma was created for decompression. The patient suffered a stroke at the time of surgery and was sent to recover in a rehabilitation facility. The surgeon documented lengthy discussions with family members concerning the patient’s condition.

Three weeks later Mrs. J was readmitted to the hospital with bowel obstruction. A CT scan of abdomen and pelvis showed widespread liver metastases. The GI obstruction was felt to be secondary to the metastatic lesions.

The hospitalist had many discussions with the patient and family stating that all doctors involved felt that no further intervention would be helpful (other than placing a PEG tube and comfort measures). The patient demanded further treatment and requested a meeting with all physicians involved.

The hospitalist then requested assistance from the Ethics Committee…

1) Refuse to offer further treatment due to futility.

2) Offer to transfer patient to a tertiary center if accepted.

3) Offer one course of chemotherapy.

4) Suggest sending the patient to hospice.

5) None of the above.

The Ethics Committee recommendations:

Await the outcome of the family meeting with all providers.

Psychiatric consultation to determine patient’s capacity for decision making due to earlier denial of condition.

Prior to family meeting, the Oncologist met privately with patient and offered one course of chemotherapy, warning that treatment could precipitate demise.

Patient did well for one week, then decompensated with hypotension and septic shock.

After multiple discussions, 3 days later the family agreed to remove patient from intensive care and institute comfort measures only.

The patient expired the following day.

Autonomy

A competent patient or proxy has the right to accept or deny treatment.

Providers have the right not to perform procedures or treatment felt to be to more dangerous than beneficial.

Providers cannot force medical treatment against a competent patient’s will.

Beneficence

• Physicians initially felt that no benefit would be obtained by further treatment.

• The oncologist did change position but warned of dangers.

Non-maleficence

• Physicians initially all agreed that risks of treatment outweighed benefits.

Justice

• Access to scarce resources did not appear

to be an issue in this case.

Provider Responsibilities: “Fiduciary Duty”

- An obligation to act in the best interest of the patient.

- A legal relationship based on trust and confidentiality.

http://definitions.uslegal.com/b/breach-of-fiduciary-duty Accessed May 5, 2013

http://definitions.uslegal.com/b/breach-of-fiduciary-duty








Provider Responsibilities: Provide the best care possible.

Provider Responsibilities: Confidentiality and Privacy

HIPPA regulations.

EMR, Internet issues.

Privacy concerns in healthcare settings

(discussions in hallways, elevators).

Provider Responsibilities: Avoid conflicts of interest

Self referrals.

Bias due to financial ties and incentives.

Provider Responsibilities: Communicate in a clear and ethical manner so that individual patients can understand.

Start with a warm introduction

Greet patient by name

Make eye contact

Review the chart before entering room

- First impressions count…

- Patients do not want to see the top of your head

as you read the chart!

Remember, patients may be anxious

Take a seat after entering room

Face the patient

Listen to patient concerns; acknowledge

Avoid interrupting patient if possible

Focus on patient Do not talk too much about yourself

Avoid asking…“Do you understand?”

Confirm understanding via “teach-back”

Provide patients with written instructions

“Ask Me 3”

1) What is my main problem?

2) What do I need to do?

3) Why is it important for me to do this?

Partnership for Clear Health Communication http://www.askme3.org/PFCHC/what_is_ask.asp

Accessed August 13, 2007

http://www.askme3.org/PFCHC/what_is_ask.asp

Provider Responsibilities: Full disclosure:

Patient’s condition.

All accepted treatments (meds/ surgeries/ therapy, etc.).

Risks and benefits of treatment.

What to expect without treatment.

Provider Responsibilities: Full disclosure (continued):

Informed consent.

Research protocols.

Medical errors.

Cost of medical care?

Healthcare reform?

Allocation of scarce resources?

Rationing of care?

Shortage of trained providers?

Privacy, confidentiality issues with:

- Electronic medical records?

- Use of internet, texting, social media for treatment, care, consultations?

Cloning, genetic engineering?

Clinical research oversight?

Autonomy

Beneficence Nonmaleficence

Justice

Documents

By Arnold Mackles, MD, MBA, LHRM - FOMA