Originally presented in 2011, this talk gives an overview of informed consent, do not resuscitate, and electronic medical record issues for anesthesia providers. This talk may be interesting for doctors and nurses that work in the operating room as well as hospital administrators and those working in health care informatics .

1. Informed
Consent
and
Documentation
JC Gerancher MD
Employee # 2674
Department 660

2. 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.

3. 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.

4. 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

5. The Process of Informed Consent:
• Disclosure of Information
• Understanding (or competency)
• Mutual decision making

6. Disclosure of Information
Legal
Ethical
•
•
•
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.
•
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.

7. 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

8. Mutual Decision Making

9. 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

10. 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

11. 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

13. Anesthesia Providers care
about blood administration….

14. A little bit high tech is
sometimes a good thing….

15. Better Patient Care?:
“The only way computers improve care is when
humans document as part of the process of
providing care. ”

16. Paper or Plastic?
“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”
-Kevin Tremper Ph.D, MD,
49th annual Rovenstine Lecture,
Anesthesiology 2011

17. Anesthesiologists
like forms and
checklists!

18. Paper or Plastic?
“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!”
- Randy Calicott MD, Vice Chair of Clinical
Operations WFUBMC Anesthesiology,
comment to the developer of our ORIS 2006.

20. Universal Protocol: patient autonomy
beyond regulatory compliance

22. Patriarchal
Medicine has
given way
to patient
autonomy
-Hubbard 1909

23. 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.

24. 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.

25. What makes you
remember to
Document DNR
and SOTO?

28. 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.

33. 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.

34. Two Very Different Electronic Forms

35. 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:

36. Vendors sell IT
“Solutions” to
Hospitals
Administrators not to
Anesthesiologists
ARRA

37. 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.

38. Wake Forest
Baptist Health
Electronic OR Schedule Board

39. 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.

41. Visit us
@