Transcript Session 2 - Disclosure of Medical Error

Medical Error
Root Cause Analysis and Disclosure
Ethan Cumbler MD, FACP
Dimitriy Levin MD
Hospitalist Section
University of Colorado Hospital
2012
How do Physicians Respond to
Medical Error?
CASE
Transfers Can Be
Hazardous To Your Health
18 year old female notices
fatigue, dyspnea on
exertion, periorbital and
extremity swelling and
decreased urine output
No significant past history
No allergies to medications
Takes no medications
Social and family history
are unrevealing
Blood pressure 190/105
Blood urea nitrogen 142
Creatinine 10.5
Potassium 6.9
Phosphorous 10
Hemoglobin 6
Ultrasound shows
small scarred
atrophic solitary
kidney
Admitted for initiation of dialysis for End Stage
Renal Disease
Her half-sister agrees to a living-donor
transplant
She is re-admitted for kidney transplantation
4 days after transplant she is ready for
transfer to the floor.
ICU
General Medical Ward
Note on Day of Transfer
House officer using computerized pre-printed
progress notes which include vitals, labs, and
meds.
Note on day of transfer out of ICU says:
Doing well. Cr 1.5 cyclosporine held yesterday
because of severe headache. CT head
reassuring so will plan to restart today. Continue
steroids and mycophenolate.
HTN- amlodipine started yesterday
Headache-Head CT without significant findings
Prophylaxis- cont nystatin, gancyclovir, bactrim.
start ca/vit D, fosamax
Day of Transfer
Furosemide 20mg IV bid
Ranitidine 150mg p.o. bid
Ganciclovir 1000mg p.o bid
Ferrous sulfate 300mg p.o bid
Amlodipine 5mg p.o. qam
Mycophenolate 1000mg po bid
Pravastatin 20mg po phs
SMX-TMP 800 1 MWF
Magnesium gluconate 500mg po
daily
Docusate 100mg po qam
Combivent 4 puffs q4hrs
Aspirin 81mg po qam
Nystatin 500000 Units qid
Prednisone 20mg p.o qday
Prednisone 5mg p.o. qday
Prednisone 10mg po qpm
Prednisone 20mg po qam
Insulin lispro 2-3 Units sq qhs
Insulin human 5 Units sq daily
Insulin lispro 1-8 Units sq tid
Insulin human 5 Units sq qhs
Hand-written Orders on Transfer
Furosemide 20mg IV bid
Ranitidine 150mg p.o. bid
Ganciclovir 1000mg p.o bid
Ferrous sulfate 300mg p.o bid
Amlodipine 5mg p.o. qam
NOT ORDERED-Mycophenolate
Pravastatin 20mg po phs
SMX-TMP 800 1 MWF
Magnesium gluconate 500mg po daily
NOT ORDERED-Docusate
Combivent 4 puffs q4hrs
Aspirin 81mg po qam
Nystatin 500000 Units qid
Prednisone 20mg p.o qday
NOT ORDERED-Insulin
NEW Cyclosporine25mg po bid
NEW Alendronate 70mg po q7days
NEW Ergocalciferol 400 IU po bid
NEW Calcium Carbonate 500mg po bid
PRN Percocet
PRN Xanax
PRN Hydralazine
What Set-ups For Error Can You
Identify?
Day 1 after Transfer
Physician different than the one who wrote the
transfer orders uses computerized preprinted
progress note
Computer generated med list lists the
medications ordered on transfer
House officer has underlined the most important
medications by hand
Mycophenolate is not on the list as it was not
ordered on transfer
Day 1 after Transfer
A/P- Doing great. Cr 1.5
Will restart cyclosporine with up-titration now
that neuro issue resolved.
Continue Mycophenolate and steroids
Was this an error of Omission or Commission?
Day 2 after Transfer
Computerized preprinted progress note
used. Most important meds underlined
Mycophenolate still not on med list
A/P- Doing great. Cr 1.6 Approaching
discharge.
Continue steroids and mycophenolate.
Change cyclosporine to 125/150 in pm
Day 3 after Transfer
Computerized preprinted progress note
used. Most important meds underlined
Mycophenolate still not on med list
A/P- Creatinine now 2.0
Continue mycophenolate, prednisone
20mg, cyclosporine 125/150
Day 4 after Transfer
Computerized preprinted progress note
used. Most important meds underlined
Mycophenolate still not on med list
A/P- Cr 2.5 urine output decreasing.
Biopsy today
Continue cyclosporine and mycophenolate
Day 5 after Transfer
Computerized preprinted progress note
used. Most important meds underlined
Mycophenolate still not on med list
A/P- Cr 2.8
Biopsy results returned with rejection
Plan- IV methylprednisolone burst started
Continue cyclosporine and mycophenolate
Increase cylcosporine
Day 6 after Transfer
Computerized preprinted progress note
used. Most important meds underlined
Mycophenolate still not on med list
A/P- Cr 3.0
Continue IV methylprednisolone
Continue cyclosporine and mycophenolate
Day 7 after Transfer
Computerized preprinted progress note used.
Most important meds underlined
Mycophenolate still not on med list
A/P- Clinically doing well
Cr 3.2
s/p 3 days IV methylprednisolone- change to
prednisone
Prednisone 60mg, cyclosporine 250 bid, and
mycophenolate 1000mg bid.
Mycophenolate is circled in the A/P with a note
which reads “where is this?”
Day 7 after Transfer
Patient restarted on IV steroids.
Addendum comments on the patient
missing 7 days of mycophenolate which
“had fallen off the MAR for some reason”
Selective Perception
– Information we receive will be processed in a manner
that harmonizes with and supports our current beliefs.
Root Cause Analysis
But
WHY????
What is RCA
Systematic investigation to find the root
cause(s) of an event
» There is always a root cause
Five Identifiable Steps
1. Define the problem
2. Collect data
3. Identify possible causal factors
4. Identify Root Causes
5. Recommend and implement solutions
Adverse events vs. errors
Adverse event is injury from medical care
Error is doing the wrong thing
(commission) or not doing the right thing
(omission)
» Not all adverse events are due to errors
Adverse events due to error are potentially
preventable
Define the problem
Collect Data
Proof?
Expert and front line input
Impact of the problem
Identify Causal Factors
As many potential causal or contributing
factors
Tools
–
–
–
–
Appreciation
5 Whys
Drill Down
Fishbone/Cause and Effect Diagrams
Identify the Root Cause (s)
Why does the causal factor exist?
Above the surface:
“The Weed”
Below the surface:
“The Root”
How to RCA
Domains
Domains
Domains
Contributing
factor
Identified
Problem
How to RCA
Create a fishbone diagram
Select a domain
Ask why
Repeat until a root cause is identified
Process inputs - Domains
1. Materials
2. People
3. Machines
4. Environment
5. Management
6. Methods
Process inputs
Materials
– Defective, shortage, wrong type
People
– Lack of skills, lack of knowledge, lack of
motivation, stress, lack of capability
Machines
– Wrong tools, improper maintenance, bad
design, defective
Process inputs
Environment
– Physical layout of the workspace, physical
demands of the task, forces of nature
Management
– Inattention, lack of supervision, lack of
communication, lack of proper training
Methods
– Lack of process/procedure, deviation from
written procedures, poor communication
Recommend and Implement Solutions
“An Ounce of prevention”
Implementation logistics
Risks
Our Case
Domains
Domains
Domains
Contributing
factor
Identified
Problem
DISCLOSURE
What would you disclose in this case
Would you apologize
How?
We Don’t Disclose
In one study of house staff, 50% did not discuss a
serious clinical error with colleagues1
– only 25% disclosed to the patient or family.
X
Disclosure rate is 30%-50% across a number
of surveys in Europe and America2-4.
Why Don’t We Disclose?
Fear of increasing chance of litigation
Desire not to lose the trust of the patient
– Particularly if the event did not result in
harm
Desire to avoid conflict
Desire to avoid shame
Preservation of our self image
We don’t know how to do it well.
What Are the Consequences?
Patients who discover error causing an
adverse event later are likely to lose trust.8
– May be more likely to pursue legal action
A culture of non-disclosure prevents open
discussion of errors, which impairs the
ability of the system to improve.
What does the evidence show?
98.8% of patients report desiring disclosure of even
minor errors.8
12% of patients report that they would sue for a
moderate severity error if the physician informed the
patient about the error.7
– An even higher 20% of patients report they would sue if they
discovered the error by another means.
36% of parents report that they would be less likely to
pursue legal action if an error involving their children
was disclosed.15
Impact of
Disclosure/Apology/Compensation
The Lexington Kentucky VA16
– Claims payment rate went from one of the
highest in the nation to one of the lowest.
Michigan Statewide policy17
– Reduced lawsuits and total cost almost by half
Copic 3Rs program18
State Protections for Disclosure Vary
Many states offer immunity for sympathy but not
for statements of fault.
Colorado has one of the strongest protections– A 2003 Colorado statute reads, “In any civil action brought by an
alleged victim of an unanticipated outcome of medical
care….any and all statements, affirmations, gestures, or conduct
expressing apology, fault, sympathy, commiseration, condolence,
compassion, or a general sense of benevolence which are made
by a health care provider….related to the discomfort, pain,
suffering, injury, or death of the alleged victim as the result of the
unanticipated outcome of medical care shall be inadmissible as
evidence of an admission of liability.”
Would You Disclose?
Would you disclose an error that led to fatality?
Would you disclose an error that led to a major harm?
Would you disclose an error that led to minor harm?
Would you disclose an error which reached the patient
but did not cause an adverse event?
Would you disclose an error that did not reach the
patient?
When do you Have to Disclose a
Mistake?14
If the event had a perceptible clinical effect
If an event necessitated a change in patient care
If an event presents a known risk in the future
If a near-miss was evident to the patient or
family member
You do not have to disclose errors which were
corrected prior to reaching the patient.
Two Forms of Regret
 “I’ m sorry your dog was run over”
versus
 “I’m sorry I ran over your dog”
The first apology is appropriate for a complication that
occurs despite standard of care.
The second is the more appropriate apology for a
medical error.
How do you accomplish this?
Preparation
Setting
Participants
Body Language
Content
Preparation
Make sure the facts are known completely before
disclosure.
It is appropriate to tell a patient or family that an
adverse event is being investigated prior to your
full discussion with them.
– This may require two meetings to do correctly
Discuss an medical error leading to major adverse
event, especially if it involves other individuals,
with risk management prior to talking to family
Setting
The setting should be one that conveys
calm.
Participants should be at the same level,
preferably sitting.
Avoid interruptions.
Participants
Avoid having too many people present.
Avoid finger pointing between participants.
You may want a representative from other
disciplines (nursing, pharmacy) if the
explanation of the error involves
processes with which you are not familiar.
You may want the patient care advocate.
You may want a representative from risk
management.
Body Language
Patient and physician at the same level
Open body posture (not crossing arms or
legs)
Leaning forward
Avoiding expressions of psychomotor
agitation (tapping feet).
Unconscious mimicry of body position
Eye contact
Content
Factual Explanation
Expression of Regret
Recognition of Distress
Redress of Harm
Keep it simple.
Avoid becoming defensive.
Take responsibility (if appropriate)
Apologize personally (if appropriate
)
Content
Offer concrete actions that will be taken to
rectify the situation
– You will need risk management to assist with
any financial promises.
Discuss how this event will create
change in your actions or in the
system.
Why do Apologies Fail
Appearing insincere
Overly vague--“I am sorry for any errors that were
made.”
Using passive tense--“Mistakes were made.”
Adding conditions--“If any errors occurred, then I am
sorry.”
Unacceptable explanations--“I had to leave the surgery
to go to the bank.”
Arrogance--“Even the best doctors make mistakes at
times.”
A botched apology may be worse than no apology at all.
Case of Difficult Disclosure
Two volunteers
– Transplant Recipient
– Attending Physician post-transfer
Not individual who committed the error of omission but was
the doctor who cared for the patient for the last 4 days before
error identified
Pharmacist also did not catch error
Lets Role Play!
References
1.
2.
3.
4.
5.
Wu AW, Folkman S, McPhee SJ, Lo B. So House Officers Learn
From Their Mistakes? JAMA 1991;265:2089-2094
Gallagher TH, Waterman AD, Garbutt JM, et al. US and Canadian
Physicians’ Attitudes and Experiences Regarding Disclosing
Errors to Patients. Arch Intern Med 2006;166:1605-1611
Boyle D, O’Connell D, Platt FW, Albert RK. Disclosing Errors and
Adverse Events in the Intensive Care Unit. Crit Care Med
2006;34:1532-1537
Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W.
Patients’ and Physicians’ Attitudes Regarding the Disclosure of
Medical Errors. JAMA 2003;289:1001-1007
Gallagher TH, Garbutt JM, Waterman AD et al. Choosing Your
Words Carefully: How Physicians Would Disclose Harmful
Medical Errors to Patients. Arch Intern Med 2006;166:1585-1593
References
6.
7.
8.
9.
10.
Stewart RM, Corneille MG, Johnston J, et al. Transparent and
Open Discussion of Errors Does Not Increase Malpractice Risk in
Trauma Patients. Ann Surg 2006;243:645-651
Witman AB, Park DM, Hardin SB. How Do Patients Want
Physicians to Handle Mistakes? A Survey of Internal Medicine
Patients in an Academic Setting. Arch Intern Med
1996;156:abstract
Mazor KM, Simon SR, Yood RA, et al. Health Plan Members’
Views About Disclosure of Medical Errors. Ann Intern Med
2004;140:409-418
Gallagher TH, Studdert D, Levinson W. Disclosing Harmful
Medical Errors to Patients. NEJM 2007;356:2713-0
Brazeau C, Disclosing the Truth About a Medical Error. AAFP
1999;60:
References
11.
12.
13.
14.
15.
Lazare A. Apology in Medical Practice. JAMA 2006;296:14011404
Malaty W, Crane S. How Might Acknowledging a Medical Error
Promote Patient Safety? Journal of Family Practice 55:775-780
Berlin L. Will Saying “I’m Sorry” Prevent a Malpractice Lawsuit?
ARJ 2006;187:10-15
Butterfield S. Apologize like a Pro.ACP Hospitalist Jan 2008:1416
Hobgood C, et al. Parental Preferences for Error Disclosure,
Reporting, and Legal Action After Medical Error in the Care of
Their Children Pediatrics 2005; 116:1276 -1286
References
16.
17.
18.
Kraman SS, Hamm G. Risk management: extreme honesty may
be the best policy. Ann Intern Med 1999;131:963-967
Clinton HR, Obama B. Making patient safety the centerpiece of
medical liability reform. N Engl J Med 2006;354:2205-2208
http://www.callcopic.com/home/what-we-offer/coverages/medicalprofessional-liability-insurance-co/physicians-medicalpractices/special-programs/3rs-program/ Last accessed
2/28/2012.