MSF-OCA Medical Policy Revision Date: February 2013

Reporting of Medical Incidents leading to Preventable Adverse

Events

1 Background ..................................................................................................................................... 1
2 Definition of a reportable medical incident .................................................................................... 1
3 Responsibility for Medical Incidents ............................................................................................... 2
4 Process for handling medical incidents in MSF-OCA projects ........................................................ 2
5 References & further reading ......................................................................................................... 5
6 ANNEX 1 .......................................................................................................................................... 6

1 Background
Errors are human, and although we do our best to create the safest possible environment for our
patients, we cannot expect to prevent all errors. The complexity and uncertainty inherent in the
practice of medicine make it unlikely that medical errors will ever be eliminated completely.1 It is
estimated that 10% of hospitalised patients in well resourced settings are affected by medical error
or what is referred to here, as a preventable medical incident. In the more challenging
environments in which MSF works, the potential for errors is much greater. While continuing to
increase patient safety within our clinics and hospitals, there inevitably remains a need for a
procedure to handle medical incidents when they do occur.

Objectives:
 Learn from occurred incidents and – if necessary – make corrections to prevent further
incidents of a similar kind
 Create a culture of patient safety in our projects
 Ensure appropriate disclosure and follow up for patients adversely affected by medical
incidents
 Decrease MSF’s legal liability / vulnerability to claims by creating openness around occurred
incidents

2 Definition of a reportable medical incident

In this policy document, we define reportable medical incidents as those that arise from medical
errors that have a direct impact (or potential impact) on patient care. A (preventable) medical error
in turn, is defined according to the widely used Institute of Medicine definition as “the failure of a
planned action to be completed as intended or the use of a wrong plan to achieve an aim.”2 There
are several types of medical errors, as described in the textbox.

Among the problems that commonly occur during the course of providing health care are adverse
drug events and medical incidents, improper transfusions, surgical injuries, and anaesthetic
incidents. Some incidents are those of omission, e.g. failure of physician to attend a patient when
called, failure of nursing staff to give medication or monitor the patient appropriately.

1
Kathleen M. Mazor, EdD et al. Health Plan Members' Views about Disclosure of Medical Incidents. Annals of
Internal Medicine 2004.
2
Institute of Medicine: To err is human: building a safer health system. 1999
The majority of the medical
incidents can be corrected easily
and do not end up causing harm to
the patient. In some cases,
however, the medical incident leads
to an adverse medical event:
unintended injury caused by the
treatment rather than by the
underlying medical condition.
A near miss or close call event is an
incident or mishap that has the
potential to cause an adverse event
but fails to do so because of chance
or because it is intercepted. Near
miss events do not involve any
injury to the patient and therefore
do not normally need to be
disclosed to the patient; however as
these events are very good learning
tools, it is encouraged that near
misses also be reported internally.
Types of Reportable Incidents
Diagnostic
Incident or delay in diagnosis
Failure to employ indicated tests
Use of outmoded tests or therapy
Failure to act on results of monitoring or testing
Treatment
Incident in the performance of an operation,
procedure, or test
Incident in administering the treatment
Incident in the dose or method of using a drug
Avoidable delay in treatment or in responding to an
abnormal test
Inappropriate (not indicated) care
Preventive
Failure to provide prophylactic treatment
Inadequate monitoring or follow-up of treatment
Other
Failure of communication
Equipment failure
Other system failure

Adapted from: Leape, Lucian; Lawthers, Ann G.; Brennan, Troyen A., et al.
Preventing Medical Injury. Qual Rev Bull. 19(5):144–149, 1993. Taken from:
3 Responsibility for Medical Institute of Medicine: To err is human: building a safer health system. 1999
Incidents
Although it is normally an individual health worker who makes the mistake, there are system-factors
involved as well. The individual health worker and the organisation share the responsibility for
medical incidents and the damage that is caused to patients. In situations where we work in
Ministry of Health facilities or with Ministry staff, the responsibility is shared.

Keeping accurate medical records and files is essential to the investigation and reporting of medical
incidents. In liability cases, incomplete medical files are often interpreted to the disadvantage of the
health worker.

4 Process for handling medical incidents in MSF-OCA projects

The following procedure applies to medical incidents that have caused an adverse medical event,
i.e. have harmed the patient. In this event, the first step for the responsible health worker to take is
disclosure. Firstly, the incident needs to be immediately reported internally. Second, the incident
should be disclosed to the patient.

A. Internal reporting of medical incidents leading to a adverse medical event

Reasons for immediate internal reporting of the medical incident:
- The most important reason for reporting is to enhance patient safety by learning through
the failures of the health system. This will allow organizational adjustments / corrections
thereby reducing the risk of repetition of the incident.

In addition, an internal reporting system will:

- Enable line management to ensure that the individual/family harmed is supported
appropriately
- Enable MSF to prepare for possible organisational consequences in an early stage

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Reporting of medical incidents must be safe for the individual reporting. Individuals reporting
adverse events must not be punished or otherwise made to feel negative consequences as a result
of their reporting of the incident. It is therefore important to separate out clearly human resource
issues and the learning environment that should be fostered through reporting of medical incidents.

Procedure:
1. Responsible health worker reports the medical incident to their line-manager and the
medical team leader /medical focal point and Medco. In all communication regarding the
medical incident, the confidentiality of patient’s information must be strictly protected.
2. The MedCo must immediately inform the HoM as well as the Health Advisor.

B. Immediate and full disclosure to the patient

Reasons for full and immediate disclosure of medical incidents causing an adverse medical event to
the patient:
- The patient has a right to information regarding his/her health and treatment and it is the
health care worker’s ethical responsibility to provide this information.
- Full and immediate disclosure of the incident limits damage to the patient’s trust in the
health worker and in MSF.
- There is some evidence that full and immediate disclosure reduces the probability of the
patient seeking legal advice.3,4

Only in the case of a substantial and immediate risk to the security or the capacity of the program
to continue to function, can the duty to disclose to the patient be over-ruled. The decision not to
disclose is exceptional and must be taken in consultation with Headquarters.

Practical steps for immediate disclose of an incident to the patient5

Disclosure is a step-wise process. At the time of the incident, information about what has happened
needs to be conveyed. At this early stage, it is not possible to have a full analysis of why the incident
happened, so the initial disclosure is limited to facts needed for the immediate care of the patient.
For example, a patient is told that an incorrect dose of a medication has been given and for that
reason an antidote is being administered or additional monitoring put in place. The patient is also
told that there will be follow up to determine what caused the incident. Further information is
shared in a separate conversation once the immediate medical concerns are addressed and
stabilised. Often a further follow up meeting is needed as more information is gathered.

Organizing the conversation:

Inform the clinical team + Medco.
Gather all the facts: carefully review the medical records.
Determine who from the medical team should have the conversation with the
patient/family.
Try to anticipate questions and/or concerns that may be raised and be prepared with
answers. Give careful thought to the words that you will use in the disclosure conversation.
Determine who should be present with the patient. If the patient is a minor or is
incompetent, parents and/or guardians should be present for the conversation.
Ensure that the conversation takes place in a private setting.
3
Kathleen M. Mazor, EdD et al. Disclosure of Medical Incidents What Factors Influence How Patients Respond? JGIM 2006.
Only when medical incidents entailed a missed allergy, was there a unambiguous effect on the patient’s seeking legal
advice.
4
Kathleen M. Mazor, EdD et al. Health Plan Members' Views about Disclosure of Medical Incidents. Annals of Internal
Medicine 2004.
5
Taken from a compilation by the University of Michigan, see references

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Having the conversation
Convey the information slowly in simple terms that are understandable to the patient,
avoiding any medical jargon, and in a manner that minimizes distress to the patient.
Explain what happened, when and where it occurred, any decisions that were made
including those in which the patient participated, any repercussions and recommended
corrective action.
Let the patient/family know what will be done to follow-up, both with regards to preventing
this from happening again and how the patient's care will be managed from this point on.
Allow space for questions
Express appropriate regret for the incident and concern for the welfare of the
patient/family.
Try to avoid making a direct admission of fault at this point. Only a thorough objective
review of facts can give an unbiased determination of fault.
Consider offering psychosocial care to patient and/or their direct family members
Advise the patient/family that they will continue to get regular updates on the situation
including feedback on the results of the internal review.

C. Follow-up at field level

1. An internal review led by the project physician in charge (or other individual as appointed by
the Medco) is done to establish the facts of the case within a week of the event. Where
needed, expert opinion should be sought through HQ support. It is critical that the review
be held in an open, non-blaming fashion. The objectives are to understand the facts, and
identify any factors that could prevent such an outcome in the future.
2. The medical coordinator should review the results of the internal review together with the
Health Advisor and relevant specialist.
3. Medical incidents leading to adverse medical event must be documented, using the Medical
Incident report format (see appendix). It is also strongly encouraged to document near miss
events. Medical incident reports should be written as quickly as possible after the
occurrence of the event by the responsible health worker. Reports are sent to the MedCo,
who forwards to the Health Advisor and the Medical Director.
4. In rare cases disciplinary action may be necessary against the individual(s). Additionally, if a
fitness to practice issue or breach of medical ethics issue is raised, it may be necessary to
follow up with the individual’s regulatory body. The decision to do so for expatriates rests
with the Medical Director.
5. Consider offering psychosocial care to the health care worker or team.

D. Follow-up at HQ
1. Responsibility of the HA is to immediately alert the Medical Director of the occurrence of the
incident. In the absence of the Medical Director, the Head of Department should be alerted.
2. Internal review of the case report from the field by the Medical Director.
3. Liaise with malpractice insurance to prepare for possible legal consequences if judged
necessary.
4. Findings of the Medical Director review can be as follows:
a. All appropriate action taken
b. Requires further review at HQ level
c. Additional action required either for mission or organisation
5. Provide feedback to the field on the outcome
6. Share the report with appropriate HQ staff (e.g. Health Advisors, relevant specialists)
7. Maintain a register of incidents at HQ.

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E. Maintaining a register of incidents
The purpose of maintaining a register of incidents is to allow analysis of incidents over time and
place. This will allow common trends or themes to be identified for remedial action. The database
should be analysed at least annually by the Medical Director or delegate of the Medical Director.
The resulting report with anonymised data and recommendations is to be shared with the field and
headquarters staff to help ensure the learning is disseminated throughout the organisation.

5 References & further reading

- WHO Patient Safety Site: http://www.who.int/patientsafety/en/

- Institute of Medicine: To err is human: building a safer health system. 1999.
http://www.nap.edu/html/to_err_is_human/reportbrief.pdf
- Communicating with your patient about harm: Disclosure of Adverse Events. Canadian Medical
Protective Association:
http://www.cmpa-
acpm.ca/cmpapd04/docs/resource_files/ml_guides/disclosure/pdf/com_disclosure_toolkit-
e.pdf (English)
http://www.cmpa-
acpm.ca/cmpapd04/docs/resource_files/ml_guides/disclosure/pdf/com_disclosure_toolkit-
f.pdf (French)
- Banja J. “Implementing a Process for Disclosure.” University Health System Consortium
Conference on Clinical and Economic Imperative for Patient Safety. (October 2001)
- Liang B. "A system of medical incident disclosure." Quality and Safety in Health Care. 11
(2002):64-68.
- Mazor, K.M., et al. Disclosure of Medical Incidents What Factors Influence How Patients
Respond? JGIM 2006.
- Mazor, K M. et al. Health Plan Members' Views about Disclosure of Medical Incidents. Annals of
Internal Medicine 2004.
- Moore S. "The toughest task: How to break bad news." Excellence in Clinical Practice. 3.2 (2nd
Quarter 2002):1-3
- Wu A. et al. “To Tell the Truth: Ethical and Practical Issues in Disclosing Medical Mistakes to
Patients.” Journal of General Internal Medicine. 12.12(December12, 1997):770-775

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6 ANNEX 1
MSF-OCA MEDICAL INCIDENT REPORT

Reported By: Date:

Project/health
Country:
facility:

DETAILS
---------------------------------------------------------------------------------

 DATE AND TIME: (Describe when the incident occurred as precisely as possible.)

 RESPONSIBLE HEALTH CARE WORKER: (Give position of individual not the

name!)

 DESCRIPTION OF THE INCIDENT: (Describe as precisely as possible what went

wrong)

 Patient age and sex

 Diagnosis and treatment

 How was the incident discovered/intercepted?

 Patient outcome: (harm caused by the incident)

 Generic and brand names of all medication involved:

 IMMEDIATE ACTIONS TAKEN: (Detail any decisions and actions taken immediately
following the incident.)

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 WHO HAS BEEN INFORMED AND WHEN: (Detail to whom the incident has been
reported to: patient / family / MSF-staff / MoH. Give time and date of notification.)

 WHAT IS THE ANALYSIS OF ROOT CAUSE OF THE INCIDENT:

 FURTHER ACTIONS TO BE TAKEN: (Detail the decisions and actions to be undertaken

in response to the incident. State any recommendations for improving patient safety and
prevention of future similar incidents.)

 WAS COMPENSATION OFFERED TO THE PATIENT/FAMILY? If not, why not?

Headquarters Feedback:

 All appropriate action taken

 Requires further review at HQ level
 Additional action required either for mission or organisation
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