1. Disclosure of Unanticipated Outcomes
Responding When Things Go Wrong in Healthcare with Transparency,
Empathy and Integrity

2. Presented for:
XXXXX
Presenter: Kathleen Fitzgerald, RN, BSN Risk Management Consultant OmniSure Consulting Group, Inc.

3. Objectives Discuss Human Factors and Systems Approach
and their influence on handling medical errors
Review Hindsight Bias
Examine the Disclosure Process
Identify the steps in Incident Investigation
Review the process of Discussing Incidents with
patients and families

4. A Word about Human Factors
Approximately 80% of medical errors are system- derived.
Meaningful safety efforts must involve both
the systems and the culture in which we deliver care
The culture affects expectations of performance and attitudes about mistakes.
Errors are inevitable in complicated systems operated by
humans.

5. A Systems Approach ~ What does that mean?
A Systems approach is the process of understanding how things influence one another within a whole. In healthcare organizations, systems consist of people, structures, and processes that work together to make an organization healthy or unhealthy. In healthcare, approximately 80% of errors are related to systems issues.
Systems thinking is an approach to problem solving, by viewing "problems" as parts of an overall system - a culture of safety, rather than reacting to specific persons, parts, outcomes or events . Systems thinking is based on the belief that the component parts of a system can best be understood in the context of relationships with each other and with other systems, rather than in isolation. In other words, when an error occurs it is not helpful to blame the person who made the mistake. Rather, the system should be analyzed for ways in which it did not support the clinician at the point of care – where the accident or mistake occurred. Human involvement in patient care necessitates understanding that errors will occur . Its important to also point out that humans prevent and avoid many errors, as well.

6. Swiss Cheese Model
Systems that demand error- free performance (punitive culture) will fail
Human Factor: Human beings make mistakes

7. Swiss Cheese Model Defenses System Opportunity for failure System
ACCIDENT

8. Swiss Cheese Model Defenses Policies Opportunity for failure
Staff Experience
Patient Safety Initiatives
The model includes, in the sequence of human failures that leads to an error, both active failures and latent failures. The concept of active failures encompasses the unsafe acts that can be directly linked to an accident, such as (in the case of aircraft accidents) pilot errors. The concept of latent failures encourages the study of contributory factors in the system that may have lain dormant for a long time (days, weeks, or months) until they finally contributed to the accident.
Michelle: Can you give us an example that would illustrate this model?
Communications
ACCIDENT

9. Swiss Cheese Model Defenses System Human Factors; System Weaknesses
An example of this is the well-published case of the KCL versus NS injected into an infant’s IV in an NICU. Root Cause Analysis revealed that the vials of KCL and NS were the same size - and had the same lid color - and were in close proximity in the med cart. The system modification called for better labeling at the pharmaceutical company level – and storing KCL under lock and key.
Michelle: “Now that we better understand how systems can fail, can you discuss hindsight bias and how it can get in the way of patient safety and a just culture?
Kathy: I would be happy to, Michelle.”
System
ACCIDENT

10. Hindsight Bias
Prior to the error, multiple factors and options must be considered before taking action.
After the accident, it seems clear that a different course should have been followed.
Hindsight bias: how an error occurred seems obvious after it has occurred.

11. Hindsight Bias
Before the Accident
After the Accident A B

12. The worst-feared word in healthcare: OOPS!

13. Hindsight Bias: Focuses on the cause of the error
Does not consider the whole picture (including environmental, emotional, political and system issues)
Limits a complete and thorough investigation
Enhances the chance of a “cover-up”
Ignores system issues and focuses on individuals

14. Normalization of Deviance
Normalization of deviance occurs over a long-term
Often involves shortcuts and work-arounds
Individuals or teams repeatedly accept a lower standard of performance until that lower standard becomes the “norm”.
Space shuttle Challenger disaster – “O” Ring damage seen as acceptable

15. An expert consultant was hired to do a root cause analysis after a subsequent accident involving the space shuttle Columbia, which blew up due to damage to the tiles needed to deflect heat during reentry. The damage caused insulating foam to break off from an external fuel tank during launch and the foam hit some tiles.
What she discovered was that due to NASA budgetary challenges, decreased manpower and resulting time constraints, tolerance for small defects increased over time. Furthermore, other launches of shuttles with the same problems had occurred without incident. They became expected and accepted.
Michelle: Can you tie the concept of normalization of deviance to healthcare?
Kathy:
In office practices, normalization of deviance occurs when policy shortcuts are taken and standards of care are compromised – often in the interest of saving time. These shortcuts become acceptable and are even taught to new staff entering the system. Thus a deviant work-around becomes status quo and completely tolerated.
In the cases of the Challenger and Columbia, a combined loss of 14 lives occurred.

16. Physician Practices/Diabetes Care Centers
What Can Go Wrong?
Communication Issues
Patient Hand-Offs
Missed/Incomplete Diagnoses
Failure to Recognize a Complication
Treatment Delay
Missed Critical Test Results
So – how do things go South in patient care? Included in the many potential issues are [READ SLIDE]

17. Physician Practices/Diabetes Care Centers
What Can Go Wrong?
Documentation Issues
Collaboration/Supervision Issues
Medication/Prescription Issues
Curbside Consults
Consent Issues
Confidentiality Breaches
Other things that can go wrong in the course of care for patients in a busy practice include: [READ SLIDE]
A couple of examples of lawsuits related  to common causes of accidents and errors in practices such as yours will now be briefly discussed.

18. Example #1 Patient Hand-Offs and Critical Test Results
Patient Hand-Offs and also Critical Test Results - Problems with handoff communication are listed as one of the root causes in up to 70% of adverse sentinel events compiled by the Joint Commission.
This process was not completed when an endocrinologist was called for a consult on a  patient with unstable blood sugars. As a part of the  endocrinologists’ workup, an EKG was ordered for syncopal episodes. The EKG showed serious cardiac issues which were not reported to the primary physician. After discharge, the patient suffered an MI, which he did not survive.

19. Example #2 Treatment Delay
Another case involved treatment delay. A middle aged, obese, diabetic male patient well known to the clinic with many, frequent somatic complaints called the physician office after hours with a number of vague complaints. Included in the long list were a severe headache and right arm weakness. The patient was advised to take Xanax, Tylenol - and rest - and to call back if that didn’t help. The patient subsequently suffered a stroke and required months of rehab. He did not regain much of his pre-stroke function.

20. Communication is a skill, not an art.
It can be improved with practice.

21. Channels of Communication
Physician
Patient
Physicians
Other
Hospital
Staff
Pharmacy
Family
Patient’s
Diagnostic
Testing
Office
Operation
Business

22. QUESTIONS?
Mark: Are there any questions from the attendees, at this point?
PAUSE for questions.
Mark: Now let’s begin the discussion of disclosure in healthcare – specifically in a physician practice setting.

23. Disclosure Dis`clo´sure
Noun. The act of disclosing, uncovering or revealing; bringing to light; exposure.
“He feels it [his secret] beating at his heart, rising to his
throat and demanding disclosure.” ~ D. Webster

24. Disclosure in Healthcare
Discussion of the FACTS of an incident that results in harm, could have resulted in harm or might result in future harm to a patient.

25. Where It All Started ~ The VAMC in Lexington, KY
1987 ~ two malpractice judgments totaling more than $1.5 million
Instituted a program as part of their risk management efforts: When incidents result in harm the VA has a policy of "extreme honesty." Patients and their families are told the facts, directly and with empathy.

26. The Disclosure Process and Legal Implications
The patient should receive an expression of regret for any harm that they have suffered as a result of a clinical incident. 
An apology or expression of regret must not include any admission of liability or fault.
WHAT’S THE DIFFERENCE?
HOW CAN YOU TELL BAD FACTS WITHOUT
ADMITTING LIABILITY?

27. The Disclosure Process and Legal Implications
The responsibility to inform a patient and family of an adverse health care outcome is an inevitable part of providing health care.
Adverse events or disappointing outcomes occur; not necessarily as a result of an error or negligent care.
Events may be correlated to the patient’s diagnosis or co-morbidities, side effects of medication or treatment, or, as is sometimes the case, tied to the unrealistic expectations of patients or families.

28. The Disclosure Process and Legal Implications
The health care provider-patient relationship is built on trust and honesty.
Open, honest communication positively affects the patient, outcomes, satisfaction, and often reduces professional liability losses.
When pre-litigation settlements do occur, they are usually much smaller and less costly than lawsuits

29. Key Principles of Effective Disclosure
Sincere expression of regret
Disclosure of known facts of a clinical incident
FOLLOW-THROUGH
Staff support and training
Patient support
Clinical governance
Confidentiality
Just, honest and open process

30. Key Principles of Effective Disclosure Continued
Maintain the patient’s best interests, provide competent and compassionate care, and exercise respect for other health care professionals.

31. INVESTIGATION GUIDELINES ~ Fact Gathering
WHO ~ Investigator
(Office Manager/Director/Supervisor/Risk Manager)
WHEN ~ Date and Time Investigation initiated?
WHERE ~ On-site? Telephonic?

32. INVESTIGATION GUIDELINES ~ Continued
Incident / Event Report
  Obtain AND review Incident Report and all investigation documentation
Medical Record, Care Plan, MAR, etc.
Obtain AND review all clinical documentation

33. INVESTIGATION GUIDELINES ~ Continued
Evidence to Secure
 Equipment, Supplies, Physical evidence:
Remove from service and sequester all relevant physical evidence including all equipment, IV set- ups with remaining fluids, devices and other items involved in the event.
(Do not clean or test medical devices)
Other evidence

34. INVESTIGATION GUIDELINES ~ Continued
 Interviews
Staff interviews (prior to other witnesses, patients and family members)
Office Practice Leaders
Other staff and witnesses
NOTE:
If interviewing others, do not attempt to write down every statement made. Summarize the conversation.

35. INVESTIGATION GUIDELINES ~ Continued
Policies and Procedures
Obtain copies of all relevant policies and procedures that were in effect at the time of the event
Digital Photography:
Obtain any photos relevant to the investigation
Reports and Notifications:
Claims Management, The State, etc.

36. THE DISCUSSION
Error and apology are part of a cultural change that is necessary in healthcare.
We must acknowledge we are fallible, that mistakes are inevitable even in the practices and involving the best caregivers.

37. THE DISCUSSION ~ Continued
Initially: Tell what you know about what happened – no more and no less.
Do not speculate, become defensive or take responsibility ~
"It looks like something has happened. We are not sure exactly what has occurred. We are looking into it and we will let you know as soon as we complete our investigation."
Do not throw your colleagues under the bus
It is best to have the initial discussion as soon as you are aware of the incident and as soon as you can say something intelligent about it. The more the discussion occurs in real time, the better.

38. THE DISCUSSION ~ Continued
If an error is involved, coordinate with the risk manager, claims manager and/or legal counsel to determine which information would be protected and which details should be reviewed prior to the discussion with the patient/family.

39. THE DISCUSSION ~ Continued
WHO
Person known to patient or family, familiar with facts, good communicator, empathetic, able to maintain relationship through the process
WHAT
~ An incident that has a significant clinical effect on
the patient.
~ An incident that necessitates a change in the
patient’s care or level of care.
~ An incident with a risk of serious future health
consequences, even if very small.

40. THE DISCUSSION ~ Continued
WHEN
~ Initial: ASAP
~ Final: When investigation is completed
HOW
~ Notify the patient of the incident and the facts that are known up to that point.
~ Undertake an investigation of the incident.
~ Develop an agreed plan for the ongoing care of the patient.
~ Document the final discussion using a scribe

41. What’s a SCRIBE? Michelle:
A scribe’s only role is to document. They would normally sit in the background. This allows the person or persons responsible for the disclosure to focus on the discussion without distractions. It is also sometimes disconcerting (as it can appear quite defensive) when the person conducting the disclosure is constantly pausing to write stuff down.

42. PUTTING IT ALL TOGETHER
Event occurs
Stabilize patient
Initial investigation, incident report, document control, device and equipment control
Communicate with patient and family as soon after the incident as possible with INITIAL findings
Continue investigation
Sit down with patient and family to report detailed findings
Express sympathy and regret
Listen
Document

43. QUESTIONS?
Mark: Are there any questions from the attendees, at this point?
PAUSE for questions.
Mark: Now let’s begin the discussion of disclosure in healthcare – specifically in a physician practice setting.

44. RESOURCES Joint Commission: www.jointcommission.org
Sorry Works: www. sorryworks.net
rors+to+patients-ao

45. Kathy Fitzgerald, RN, BSN
Ms. Fitzgerald earned a Bachelor of Science in Nursing with honors from Indiana University Southeast in She was named Nursing Student of the Year in Her professional experience includes 24 years of nursing practice in clinical, leadership and management roles. This experience encompasses Healthcare Risk Management, Medical Liability Claims, Patient and Resident Safety, Employee Safety, Legal Nurse Consulting, In-House Defense Medical Malpractice Support, Operating Room Nursing, Dialysis, Labor and Delivery, Hospice and Psychiatry. Her work has allowed her to attend and assist in the preparation for trials, mediations and depositions. Proactively, she has assisted healthcare providers to promote resident , patient and employee safety ~ and to successfully identify, address and manage risks.