Feature: Risk Management in Medical Practice

APPROACH TO RISK MANAGEMENT

IN MEDICAL PRACTICE:
STANDPOINT OF A HOSPITAL*

Shozo MIYAKE**

Asian Med. J. 44 (1): 1–10, 2001

Abstract: There had been a number of incidences of medical malpractice at
Musashino Red Cross Hospital, and since 1995 the hospital has been engaged in
“activities to prevent medical malpractice”. In the early days, efforts were focused
on quality control (QC) by introducing an incident reporting system that was pat-
terned after risk management techniques developed in the field of aviation. To
evaluate these incident reports, a “Committee to Assess Medical Services” (later
renamed the Medical Risk Management Committee) was established. Every month
this committee reviews each incident from the standpoint of medical technology,
medical judgment, human factors, labor conditions, hospital systems, and the super-
visory functions of the hospital. The results of these evaluations are used to improve
defects in the above system. The committee also conducts medical audits in the
hospital. Our approach to the prevention of malpractice is described in this paper.
Key words: Risk management in health care; Medical risk management;
Policies to prevent medical malpractice

Introduction
Generally speaking, when an accident occurs in an industry, every effort pos-
sible is made to prevent a recurrence, thereby minimizing the risk of recurrence of
the same type of accident within that industry. In health care, however, accidents
of the same type repeatedly occur in the same hospital. One might even suspect
that it is impossible to learn from mistakes in medicine. Confronted with this
situation, there is apprehension that doctors in a team practice may lose the trust
that the other team members have always placed in them. To improve this situa-
tion, hospitals must make efforts systematically to change health care risk manage-
ment so that medical malpractice can be prevented.
On the other hand, human beings always make mistakes, therefore, making
every effort to prevent errors and provide safe and high-quality health care is the
most important mission of health care organizations, and the practices employed
at the Musashino Red Cross Hospital are described below from this standpoint.
* This article is a revised English version of a paper originally published in the Journal of the
Japan Medical Association (Vol. 123 No. 5, 2000, pages 622–628).
** Vice President, Musashino Red Cross Hospital
2 S. MIYAKE Asian Med. J. 44(1), 2001

The first goal we set in our attempt to prevent medical malpractice was to
raise the awareness of those in the frontlines of medical practice. We believed that
quality control (QC) activity was the most appropriate means for this purpose and
organized a QC group in each work unit in a top-down format. The head of each
section was to lead the group, and a total of 11 groups were formed. First, they set
the major goal of “prevention of malpractice” and selected topics accordingly.
Each group held meetings once a month, from which we learned a great deal.
However, the majority of the topics of the QC activities concerned problems
related to nurses alone, and because the results of the discussions overlapped
accident prevention activities in the nursing section and measures to improve
nursing works, the burden on the nurses became even more onerous. After about
2 years, all QC group activities ceased.
These initial efforts, however, established the basis for future activities to
prevent medical malpractice in our institution. We came to realize that the QC
activities must be reorganized in the original bottom-up format, and we are cur-
rently engaged in reorganizing our improvement activities, with the support of the
Union of Japanese Scientists and Engineers.

Construction of a Medical Risk Management System

within an Organization
1. The nursing section
The nursing section has traditionally been involved in efforts to prevent medi-
cal malpractice. In association with this new venture, they revised their accident
report forms, organized a “committee to prevent accidents” within the nursing
section, reviewed accident reports forwarded from the wards, and fed the results
back to the meetings of the chief nurses. The nursing section drew up a manual
called “Accident Prevention” within a period of 18 months. Since early 1999, a risk
management nurse has been assigned to each ward to gather and analyze informa-
tion on each incident and send back the details of the analysis in the form of
feedback (Fig. 1).

2. Doctors
There are numerous problems concerning doctors, and policies affecting doc-
tors will be mainly presented in this section.
Traditionally, doctors have seemed to regard themselves as privileged and
expected everyone else to serve them, this attitude may have helped doctors to
become self-righteous. Doctors have tended to avoid disclosing the details of their
practice in investigations of medical malpractice, always leaving behind a so-called
“gray zone”. However, the modern societies offer a wealth of medical information,
and the public is better informed than ever. If doctors do not shake themselves
free of their arrogant attitude, it may be impossible to prevent recurrences of
medical malpractice, and doctors, as leaders of the health care groups, may lose the
trust of the other team members. Faced with the situation described above, our
programs were undertaken.
Another motivation for starting these programs was doubts about the appro-
 RISK MANAGEMENT FOR HEALTH CARE 3

Director
Medical Disputes Risk Management

Medical Affairs Conference General Risk Manager (Vice President)

President, Vice president,

Head of the nursing department, Medical Risk Management Committee
Head of the business department,
Head of the general affairs section Physician, Pharmacist, Medical technologist,
Business section staff, Risk management nurse

Business Medical Laboratory Medical Nursing section

department social department department
service Pharmacy Head of the nursing section
department department
Risk Management Nurse

Nurse Risk Management

Committee

Risk Manager Risk Manager

Section Section Section Department Department Head of Head of Head of

head head head head head nursing nursing nursing
section section section
Department Department Head of Head of
head head nursing nursing
section section

Fig. 1 Organizational chart of medical risk management (Musashino Red Cross Hospital, June 1, 1999)

priateness of our former method of hospital management. There are a number of

medical departments within a hospital, and each operates within its own specialty.
If each operates independently without regard for the other departments, the
cohesion desired in a hospital is lost. Organized health care becomes possible only
when the goals and quality of medical service of the hospital as a whole are main-
tained and managed. We believe that there is a definite need for a system to
monitor the health care actions of the hospital as a whole.

Introduction of an Incident Reporting System

Following the advice of Dr. Isao Kuroda, then a professor in the School of
Human Science of Waseda University, who suggested “the introduction of risk
management technology that had been developed in the field of aviation because
malpractice in health care resembles the accidents that occur in association with
aviation” (1995), we decided to adopt the risk management incident reporting
system for doctors.
There is a well known saying that there is a “chain of events” in aviation
accidents, because “3 or more minor incidents always occur in a row before a
larger, more serious accident.” Every pilot is instructed to faithfully report every
incident that occurs during a flight regardless of its seriousness (including near-miss
4 S. MIYAKE Asian Med. J. 44(1), 2001

Incident/Accident Report
(Circle one) Date: , 200
Work site Position Years of work experience Name
Years (Personal seal)

Patient’s name Age Diagnosis

(male or female)
Site of the accident Ward Department on an outpatient basis
occurred
Date and time of Date: Time:
the accident
Date the accident was Date: Time:
discovered
Time treatment was Date: Time:
started
Time a report was made Date: Time:
to the department head
Type of accident

[Classification] 1. oversight or misunderstanding, 2. misidentification,

[Classification] 3. error in dosage, 4. complication, 5. iatrogenic disease, 6. others
Process during which
the accident happened

Response and steps

taken after the accident

Explanation given after

the accident and
the subsequent
response of the patient
Evaluation of the gravity Llife-threating: □ very grave; □ grave; □ possible; □ little; □ none
of the risk involved Patient’s trust: □ greatly damaged; □ slightly damaged; □ not much affected
in the accident
Health status of □ good; physically fatigued [□ by work; □ for personal reasons]
the medical personnel □ good; psychologically fatigued [□ by work; □ for personal reasons]
involved □ others (remarks: )
Views on the cause
of the accident

[Classification] 1. lack of observation, 2. delay in testing, 3. delayed diagnosis,

[Classification] 4. inadequate technology, 5. surgical mistake,
[Classification] 6. inadequate communication, 7. inadequate explanation, 8. others
Thoughts on the steps
to be taken in future

Fig. 2 Incident Report Form

incidents) by filing an incident report. They are assured that filing such reports will
in no way affect their chances for promotion or future pay increases. Accident
prevention policies have been established and major accidents have been averted
by gathering and analyzing these reports describing minor incidents.
 RISK MANAGEMENT FOR HEALTH CARE 5

When we introduced our incident reporting system, we distributed the follow-

ing letter to doctors and pharmacists: “We all make mistakes at one time or
another. Instead of feeling ashamed and hiding such mistakes, we would like you
to share your mistakes with the hospital as valuable experiences that can be accu-
mulated as an organizational asset. Individuals will not be accused of errors, so
please report only the facts in the incident reports. The background of the incident
or accident will be evaluated, and if a problem of the system in the hospital as a
system is uncovered, it will be corrected immediately. The experiences will be used
as a common asset to be shared by the entire hospital to enable us to offer safer
and higher quality health care services. We hope that you will fill out the reports
completely, and we assure you that there will be no personal repercussions.”
The form for reporting incidents has been designed to be as simple and easy
to fill out as possible. It somewhat resembles the accident report forms now being
used by nurses (Fig. 2).
As a rule, the incident report is voluntarily submitted by individuals, but the
heads of the department have been assigned the role of risk managers and asked
to urge their staff to prepare a report on any medical action that may be a cause
for concern. In fact, however, few reports were submitted in the first 3 months.
Therefore at a meeting of the department heads, the author stated the following:
if there is no incident report from the department involved and a patient files a
complaint, the management is forced to question the managerial responsibility of
the department head. Department heads must have a thorough understanding of
the medical actions of their staff, and if a problem is recognized, the head of the
department is to instruct the staff member to file an honest report. I also empha-
sized that it is a non-punitive reporting system. In addition, when information has
become available by some other route, the author has directly contacted the doc-
tors in charge and asked them to submit a report.
As a result, reports started to trickle in. One member of the risk management
committee in particular made a special effort to urge his staff to submit reports,
and this seemed to have a priming effect. The number of reports has increased
since then, and the increase is a reflection of the gradually increasing awareness
among doctors that health care accidents can be prevented and that their reports
are important in achieving this end. It also shows that the psychological burden of
writing a report has gradually been alleviated.

Establishment of the Medical Practice Evaluation Committee

In introducing the incident reporting system, it was recognized that the reports
should be evaluated objectively by a third party. Therefore, 11 persons considered
capable of rendering sensible judgments were selected from among the department
heads and assistant heads actively involved in clinical practice, and assigned to
organize a “Medical Practice Evaluation Committee” (later renamed the “Medical
Risk Management (MRM) Committee”). At the time the committee was estab-
lished, its aims were explained at management conferences and department head
meetings to obtain a consensus throughout the hospital. It is believed that the
process to obtain this consensus was extremely important.
6 S. MIYAKE Asian Med. J. 44(1), 2001

Based on the incident reports, this committee investigates various factors lead-
ing up to the occurrence of accidents and they look for answers to health-care-
related questions such as: the possible existence of problems in hospital manage-
ment and steps to correct them; problems related to medical technology; appro-
priateness of clinical judgments; the working conditions of the medical staff; the
psychological condition of the medical staff when the incident occurred; and pos-
sible problems related to patients. It was also hoped that the committee would
have the function of a medical audit.
Currently, the MRM Committee meets once a month. If a problem is discov-
ered in the hospital system, the general risk manager immediately corrects it.
When problems related to medical technology or clinical judgment are uncovered,
specific plans to resolve them are studied by the departments involved. In the
course of studying these problems, the labor conditions of doctors will inevitably
surface, and they should be improved as much as possible through negotiation
between the senior leaders and the doctors.
If a single incident involves more than one department, doctors from each of
them (other than the committee members) are asked to participate in the investi-
gation. The results of these investigations are transmitted to each department as
feedback. If the problem involves to the entire hospital, it is reported in the inter-
nal hospital newspaper (Musashino Nisseki Shinbun) as a “Report from the Risk
Management Committee” so that all hospital employees will be informed.
Thus, the MRM Committee also has the functions of a medical audit.

The Risk Management System

In the United States, risk management is defined as “the science by which the
risk for an economic loss is identified, evaluated, and managed”. Three approaches
to organizing a risk identification system has been reported..
(1) Incident reporting system: Accident reports are expected to be voluntarily filed
by employees: 5 to 30% of all accidents can be identified by this approach.
(2) Occurrence reporting system: A list of potential accidents is prepared in
advance and employees are expected to voluntarily report them whenever
they occur. Approximately 40 to 60% of all accidents can be identified by this
approach.
(3) Occurrence screening system: Professional employees identify incidents by
chart inspections based on written criteria. It has been reported that 80 to 85%
of all accidents can be identified by this approach.1)
The risk management policies adopted in the United States include: (1) pro-
tecting the hospital’s assets; (2) improve the quality of health care (improvement
of patients’ safety); and (3) following legally sound risk management policies.
Of the three policies listed above, (2) has been discussed, adopted, and
regarded as the most probable approach in Japan at the moment. It appears to
conform best to Japanese customs and traditions, which is most important. It is also
related to [(1) protection of the hospital’s assets]; but more importantly, our efforts
should be based on an intent to [(2) improve the quality of health care (and to
ensure patient safety)].
 RISK MANAGEMENT FOR HEALTH CARE 7

Introduction of the Risk Predicting System

To introduce (2) an occurrence reporting system for the risk management
system described above, the following steps were taken.
All of the department heads were assigned to the position of risk manager and
asked to prepare a list of accidents that are most likely to occur in relation to
medical care in their department and to formulate and submit measures to prevent
them. These reports have been incorporated into appropriate chapters of the
“Manual to Prevent Medical Accidents”. As reference material, informed consent
to various procedures that are frequently conducted in each department are
included (when the consent is written, it is often accompanied by statistics on risk).
A list of drug names that are easily confused and photographs and names of
ampules containing drugs for parenteral use are included in the manual so errors
should not go unnoticed.
It is said that about half of the disputes concerning medical care involve
financial settlement, whereas the other half concern the personality of the doctor
(appeals are made just to punish doctors for their actions). According to the sta-
tistics in the United States, 70% of the medical disputes arise in the absence of
errors on the part of the medical staff. These disputes stem from a lack of commu-
nication between the patients and doctors or other medical staff members. Appar-
ently, what appears to have been a careless manner of speaking, attitude, or facial
expression of the doctor generates distrust on the part of the patient, which even-
tually leads to medical complaint. With this in mind, the overview section of this
“Manual to Prevent Medical Accidents” describes doctors’ methods and manner of
dealing with patients under the heading of “Basic Rules to Prevent Medical Acci-
dents”. In this section, attention is called to basic manners required by doctors,
including the need for a patient-oriented medical process, confirmation of each
procedure, assuming a humble attitude, with undivided attention given to what the
patient wants to talk about, building a good patient-doctor relationship, and pro-
viding methods for fill out medical records.
This “Manual to Prevent Medical Accidents” was distributed to all doctors
working at the hospital. Doctors are expected to peruse even the sections that do
not actually involve them. Their critiques are useful in preparing the next edition,
and three revisions were made. It required 8 months to prepare the first edition,
which was published in August 1997. The second edition was completed in October
1998. In each of the revised editions we hope to include the experiences of doctors
who have learned from the accident prevention steps taken in other departments
and re-evaluated and reinforced the accident preventive measures in their own
department. We also hope that the manual will be used by all doctors in the
hospital, but the process of preparing it is even more important. The author
believes that by experiencing the process by which policies to prevent accidents are
drawn up, they will become more sensitive to the possibility of accidents. In other
words, the manual to prevent medical accidents is most meaningful when each
hospital prepares its own unique version.
8 S. MIYAKE Asian Med. J. 44(1), 2001

Introduction of the Occurrence Screening System

The nursing section of our hospital assigned a risk management nurse late in
1999 and prepared its own screening system. We expect good results from this
movement.
In the areas in which doctors are involved, the medical care in each depart-
ment is extremely diverse and the magnitude of the risk involved is several times
that of nursing section. Since the area involved is believed to be too large to be
managed by a single risk manager, the department heads may have to be asked to
act as risk managers; and doctors will be expected to improve their awareness of
the need to prevent medical accidents.

Response to the Development of Medical Disputes

When a medical malpractice that might develop into a medical dispute occurs,
the basic rule is that the doctor in charge immediately reports the accident to the
head of the department, and that the department head in turn reports it to the
head of the administrative department, the vice president (general risk manager),
or the president of the hospital. The doctor then waits for their directions before
responding further.
What is important in these procedures is that those involved express their
sincerity and consideration toward the patients and their families by their attitudes
and speech. Next, there is a need to establish a single channel to handle the
procedures for dealing with patients or their families. At our hospital, the general
affairs section is in charge. It is essential that the doctors in charge or the head of
the department involved not apologize to patients or their families on their own
nor tell them about the possible future response of the hospital based on their own
interpretation. Doctors or department heads should always discuss the matter with
the management of the hospital before they respond to outsiders. They should
explain to them that the matter will be handled by the general affairs section, and
then quickly report and discuss any future steps with hospital management through
the procedures explained above. The initial response by the doctor in charge or
department head often determines future developments.
After taking the steps described above, those who are directly involved in the
accident should promptly fill out an “accident report” (a form that has been pre-
pared by an insurance company) and submit it to the general affairs section. Based
on this accident report, future steps to be taken will be discussed at the Medical
Affairs Conference (composed of the president, vice president, head of the nursing
section, business manager, and head of the General Affairs Section). At Red Cross
Hospitals, such reports are sent to Red Cross Headquarters and the insurance
company.
When the evidence is seized or a patient files a claim leading to a legal dispute,
a conference is held between the attorney representing the patient and the insur-
ance company, and the response by the attorney is discussed at a Medical Affairs
Conference.
 RISK MANAGEMENT FOR HEALTH CARE 9

Amount (yen)

Fig. 3 Changes in total amounts of money paid out for financial settlements annually by Musashino
Red Cross Hospital

Conclusion
In reality, personal elements (e.g., personalities or personal attainment) are
involved in medical accidents. However, even when an accident appears to have
been the fault of a single individual, the cause may be in the management system
of the hospital. Therefore, it is important that the person involved report the
accident faithfully and that a system capable of evaluating such incidents objec-
tively be in continuous operation in the hospital. When such a practice is estab-
lished in a hospital, a more trusting relationship between doctors and the hospital
management will be established. Backed up by a system such as described above,
doctors can be assured of their positions and can concentrate on their own jobs. At
the same time, they are reminded that their medical services are being monitored
by a third party. Such an environment should produce a change in the doctors’
attitude toward the medical care they provide. It is hoped that this change in the
doctors’ attitude will result in reduced medical malpractice.
It has been five years since we instituted the steps described above to deal
with medical accidents. The changes in the amounts of money that our hospital
has paid for financial settlements since 1973 are displayed to show the results of
our efforts over the years (Fig. 3). Fortunately, no major disputes have occurred
(except for one incident early in 1996, when we had just undertaken activities to
prevent malpractice). However, valid evaluation should be conducted at 10-year
intervals. We hope that the effort by the hospital as a whole will continue.
10 S. MIYAKE Asian Med. J. 44(1), 2001

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1999. (in Japanese)
4) Miyake, S.: Medical risk management at Musashino Red Cross Hospital. Byoin 58:
764–765, 860–861, 966–967, 1999. (in Japanese)
5) Miyake, S.: Practice of medical risk management. Chiryo 58: 2781–2881, 1999. (in
Japanese)