Informed

Consent

and

Documentation

JC Gerancher MD

Employee # 2674

Department 660

Disclosures

• I have no financial relationships to disclose.

• I am a speaker for Teleflex.

• It will be obvious that I am not a speaker for the big

name commercial EMR manufacturers.

Overview

• Informed Consent

-Definition of a Process

• Overview of anesthesia documentation issues related to

Patient Autonomy and Informed Consent

-Universal Protocols

-Do Not Resuscitate

• Anesthesia Documentation: Paper or Plastic?

-Why the current big-name commercial EMR’s aren’t

yet good enough for regional anesthesiologists.

Informed consent is required

• Ethics: required under the doctrine of patient

autonomy.

• Legal: required else regional anesthesia providers

are subject to accusation of battery in the absence of

complications or responsibility for complications

despite no breech of standard of care clinically.

• Regulatory Compliance: Joint commission and

ASA.

• Billing Compliance: CMS conditions of participation

The Process of Informed Consent:

• Disclosure of Information

• Understanding (or competency)

• Mutual decision making

Disclosure of Information

Legal

• Since 1980’s most states have

adopted a ‘reasonable patient’

approach to disclosure information

that a reasonable person would

deem pertinent to make his or her

decision.

• At the same time the ‘professional

rule’ might be a secondary

consideration—i.e. those things

that are common and those that

are very bad but uncommon.

Ethical

• Regional Anesthesia providers

have a duty to know their patients

, surgeons, surgeries,

perioperative course, and

anesthetics well enough to provide

appropriate disclosure.

• We perform regional anesthesia

and analgesia in the clinical

setting where the incidence of risk

versus the true benefit is not

currently known.

Understanding or Competency

• Inability to express choice or preferences.

• Inability to understand one’s situation.

• Inability to understand disclosed information.

• Inability to give a reason.

• Inability to give a rational reason, though having

some supporting ones.

• Inability to give a risk-benefit supported reason,

though having some supporting ones.

• Inability to give a reasonable decision as judged by

the reasonable patient.

-Beauchamp, Childress 1989

Mutual Decision Making

Good Pro-Con Discussions about

Written Informed Consent

• SAMBA Newsletter

January 2009

Nitsun

• ASRA Newsletter

August 2006

Green,Brull

• ASA Newsletter

July 2006

Domino,O’Leary,Bierstein,Sanford,Cheney

Including written consent in the

process of informed consent will

not..

• increase patient anxiety

• prevent lawsuits

• substitute for the process of informed consent

-Gerancher, 2007

Including written consent in the

process of informed consent

may..

• increase patient recall of information--provided the form is understandable to a seventh grader

--provided the form is given to patients

--despite the stress of medical situations (including labor)

• provide legal protection

• improve the process of consent

-Gerancher, 2007

Anesthesia Providers care

about blood administration….

A little bit high tech is

sometimes a good thing….

Better Patient Care?:

“The only way computers improve care is when

humans document as part of the process of

providing care. ”

“The electronic record, in most institutions, has progressed

while most anesthesia departments have stayed with paper.

I believe the most compelling reason to implement an AIMS

is that ..we (the field known for its advances in technology)

should not be left out of the electronic age”

Paper or Plastic?

-Kevin Tremper Ph.D, MD,

49th annual Rovenstine Lecture,

Anesthesiology 2011

Anesthesiologists

like forms and

checklists!

“We have been documenting on paper anesthesia records

for about the last hundred years and we have made it pretty

near perfect…Problem is, perfect is pretty damn hard to

improve on!”

Paper or Plastic?

- Randy Calicott MD, Vice Chair of Clinical

Operations WFUBMC Anesthesiology,

comment to the developer of our ORIS 2006.

Universal Protocol: patient autonomy

beyond regulatory compliance

-Hubbard 1909

Patriarchal

Medicine has

given way

to patient

autonomy

DNR history and the growth of

patient autonomy

• 1974: AMA recommended that decisions to forgo

resuscitation be formally documented.

• 1976: First DNR Order at MGH

• 1983 After a Presidential Commission, CPR became

a standard of care and became the only medical

therapy to require a physician’s order to be withheld.

• 1990: Patient Self-Determination Act provides that

any patient who enters an institution receiving

Medicare or Medicaid funds must be advised of his or

her right to execute advanced directives, including a

request for a DNR order.

DNR today

• Prior to 1991, it was widespread practice to routinely

suspend DNR orders during the intraoperative and

postoperative periods.

• ASA developed Guidelines for the Anesthesia Care

of patients with DNR orders. These were revised in

1993, 1998, 2001, and last reaffirmed in 2008.

• As many as 15% patients with DNR orders will

undergo surgery

-Margolis JO, Anesth Analg 1995.

• As few as 7% of MGH physicians correctly addressed

DNR issues during patient simulation.

-Waisel , Simulation in Healthcare, 2009.

What makes you

remember to

Document DNR

and SOTO?

Why current big-name Commercial EMR‟s aren‟t

good enough:

A tale of two „applet‟s

• This one allows data to

be entered and saves it to

the database.

• This one allows data to

be entered and saves it to

the database, plus

• This one will only allow

numbers and letters to be

saved.

A “fully functional” field needs 15

more powerpoint slides of code to:

• Provides for drop down choices, plus

• The ability to choose multiple choices at times, plus

• Free text choices in addition to these, plus

• Error checking of what is entered, plus

• Rules ensuring the field is not left blank after making

an entry but before it becomes part of the EMR.

• Other applications to modify the content of the drop

downs in the field, create reports of the field, and

view the field within a different application or field.

Two Very Different Electronic Forms

Health Information Technology

for Economic and Clinical Health

Act of the American Relief and

Recovery Act of 2009

• Around $20 billion to aid the development of a robust IT systems

• Large -sized hospitals implementing EMR could get $10 million

• Eligible Medical professionals who show meaningful use of

EMR’s will receive $44,000 in incentives per professional

• The ASA has recommended to CMS that ARRA will impede

EMR’s in the Operating Room unless CMS acts to:

Vendors sell IT

“Solutions” to

Hospitals

Administrators not to

Anesthesiologists

ARRA

Why current big-name Commercial EMR‟s aren‟t

good enough:

• Lack of specificity for anesthesiologists work flow and

processes.

• Reliance on electronic data recorded as narrative text

from dictation software or keystroke text by humans.

• Reliance on unity of data in the database and data in

the electronic medical record.

• Companies exist to support a cycle of sales,

installation, sales…….and you are not their customer.

• EMR’s do not automatically changes processes.

Wake Forest

Baptist Health

Electronic OR Schedule Board

Why current big-name Commercial EMR‟s aren‟t

good enough:

• Lack of specificity for anesthesiologists work flow and

processes.

• Reliance on electronic data recorded as narrative text

from dictation software or keystroke text by humans.

• Reliance on unity of data in the database and data in

the electronic medical record.

• Companies exist to support a cycle of sales,

installation, sales…….and you are not their customer.

• EMR’s do not automatically changes processes.

• EMR’s do not automatically change people.

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