Professional Documents
Culture Documents
Shozo MIYAKE
There had been a number of cases of medical world can learn from the field of aviation, a
malpractice at Musashino Red Cross Hospital, matter I have been studying.
and since the autumn of 1994 the hospital has
been engaged in activities to prevent such mal- Traditional Approaches to Medical
practice. Today, I will begin with the history of
Malpractice
this situation.
Next, I will describe approaches to the estab- In response to medical malpractice the tra-
lishment of risk management systems from the ditional form of investigation focuses on what
perspective of both a health care institution happened, who was responsible for it, and who
and as an individual concerned with patient had previously been responsible. Then the inci-
safety. dent is eventually settled by punishing the re-
Lastly, I will point out what the medical sponsible person. Most medical malpractice has
been dealt with in this manner, in what is called to establish the overall direction and level of
the responsibility-oriented approach. It never health care in the hospital, I started to imple-
improves the situation. ment measures to prevent medical malpractice.
It is necessary to implement a cause-oriented The first goal we set was to raise the aware-
approach, or to discuss causes and required mea- ness of medical malpractice among medical
sures in order to prevent such incidents. professionals.
We thought that the Quality Control (QC)
Approaches to Preventing Medical activities, that have supported Japanese indus-
tries, were the most appropriate means for this
Malpractice
purpose.
Let me introduce a brief history of the situa- We asked a QC group in each work unit to
tion at Musashino Red Cross Hospital. There select topics through a top-down approach,
have been a number of cases of medical mal- focusing on the prevention of medical malprac-
practice at Musashino Red Cross Hospital. Dur- tice. A total of 11 groups started QC activities.
ing the 5 years between 1988 and 1992 there All QC group activities ceased after about 2
were 5 major cases of medical malpractice. The years because the top-down system was adopted
hospital paid settlement packages of over 250 instead of the preferable bottom-up system, and
million yen, which involved payments of 7 to the majority of the topics covered by the QC
20 times the insurance premium. The highest activities concerned problems related to nurses
demand for compensation was 340 million yen, alone. We are currently trying to resume QC
but it was finally reduced to 110 million yen. activities with a bottom-up approach.
I was appointed as a Vice-President of the hos- We learned a lot from the QC activities over
pital in 1992. In 1993, a manager of the insur- these two years, and I believe that the experi-
ance company through which the hospital was ence established the basis for future activities to
covered visited the president of the hospital. I prevent medical malpractice in our institution.
met him in behalf of the president who was The nursing section has traditionally been
absent, and I became involved with the matter. involved in efforts to prevent medical mal-
Some of his comments impressed me greatly. practice. In association with this new venture,
Let me illustrate an example. When a fire they started to make various improvements
occurs in a factory, the company investigates its including revision of their accident report forms.
cause through various means. As a result, the Within a period of 18 months, the nursing sec-
company rarely repeats the same type of acci- tion developed a manual entitled “Accident
dent. In contrast, accidents of the same type Prevention.” On completion of the manual,
repeatedly occur in the same hospital. He said, doctors were pressed to take action. But I could
“Why does it happen? Is it impossible to learn not respond to their concern.
from mistakes in medical care?” His words In response, the doctors themselves decided
shook me and I thought I had to do something to introduce an incident reporting system. We
to improve the situation. In addition, the insur- organized a “Medical Practice Evaluation Com-
ance company strongly requested the introduc- mittee,” that was later renamed the “Medical
tion of institutional preventive measures to pre- Risk Management Committee.” It is composed
vent medical malpractice. of 11 doctors. I will give you the details later.
In the Musashino Red Cross Hospital, each Then we tried to establish a risk prediction
department has its own way of medical practices. system. All of the department heads were asked
In a sense, however, an individual doctor starts to prepare a list of accidents that were most
a private practice in a hospital. As I thought likely to occur in medical care in their depart-
that there was no institutional control system ments and to formulate and submit measures
to prevent them. These reports have been in- cialists say that it should not be registered.
corporated into appropriate chapters of the However, because of three consecutive inci-
“Manual to Prevent Medical Accidents.” dents caused by the same doctor in the hospi-
tal, we do not discuss the registered system.
Risk Management Technology in Another major problem is that the incident
reporting system is not legally enforceable, which
the Field of Aviation
is closely related to the matter of registration.
At the beginning of our attempt to deal with If it is expected that information will become
medical malpractice, Dr. Isao Kuroda, then a available by some other route for other pur-
professor at the School of Human Sciences poses, including legal affairs, reporting cannot
of Waseda University, suggested the introduc- be effectively implemented.
tion of risk management technology developed Therefore, I consider it necessary for the gov-
in the field of aviation because malpractice in ernment to urgently provide legal protection for
health care resembles the accidents that occur the incident reporting system. In Japan, it has
in aviation. been regarded as a kind of taboo to review the
There is a well-known saying of “chain of medical practices of doctors in investigating
events” in aviation accidents. Meaning that medical accidents. Accordingly, medical inci-
three or more minor incidents always occur in dents that come into a gray zone of malpractice
a row before a larger, more serious accident. remain unresolved. This situation will decrease
This is called a chain of events. Every pilot is confidence of doctors as leaders of the team in
instructed to faithfully report every incident medical practices. I believe that the objective
that occurs during a flight regardless of its seri- evaluation of various problems in medical mal-
ousness (including near-miss incidents). They practice, even if they are minor, will be of ben-
are assured that filing such reports will in no efit to the entire hospital.
way affect their chances of promotion or future
pay increases. This encourages honest report- Establishment and Responsibility of
ing. Safety in aviation is ensured by compiling the Medical Practice Evaluation
and analyzing these incident reports to cut the
Committee1–7)
chain of events at an early stage.
A properly functioning system with self-
appraisal by doctors to resolve their own prob-
Incident Reporting
lems will reduce medical malpractice in a hos-
We still use a registered incident/accident pital. The Management Conference approved
report form. It requires completion of the fol- my proposal to organize a Medical Practice
lowing sections: Diagnosis; place, date and time, Evaluation Committee based on this concept.
type and conditions of the accident; subsequent In order to obtain the consensus of the hospital
reaction to the accident; evaluation of the degree staff, I explained the purpose at department
of risk; mental and physical health status of the head meetings and wrote an article for a inter-
medical personnel involved; views on the cause nal hospital newsletter.
of the accident; and thoughts on the steps to be Later it was renamed the “Medical Risk
taken in future. These are submitted to the gen- Management Committee,” and consists of 11
eral affairs section, and transferred to me. doctors from 11 departments, including 6 de-
However, there are some problems in the inci- partment heads and 5 assistant heads. The stan-
dent reporting system. One problem is whether dard for selection was based on the capacity to
a report will be registered or not. Because a reg- provide experienced and balanced judgement.
istered report requires strict control, some spe- The committee meets once a month. Based on
the incident reports, this committee investi- Xylocaine in 1,000 mg ampules is usually used
gates various factors such as problems related to prevent arrhythmia in medical drips in ICUs
to medical technology, appropriateness of clini- and CCUs, but it is rarely used in emergency
cal judgements, the working backgrounds, and departments. As the availability of 1,000 mg
the psychological condition of the medical staff. ampules of Xylocaine in wagons in the emer-
It is most important to note that an incident gency department can result in mistakes, all of
seemingly caused by an individual mistake is them were transferred from the wagon to a
sometimes the result of the hospital system it- cabinet.
self. In this case, the system should be changed At the same time, the Committee investi-
or revised. Also the monitoring functions within gated drug names that can easily be confused,
the hospital need to be reviewed. in cooperation with the pharmacy. A list of these
Such a review sometimes discloses problems was distributed to all doctors. Now, all the drug
on the part of the patients. names that can be easily confused are listed in
It was also hoped that the committee would our Manual.
play the role of a medical audit system. At first In addition, the Committee emphasized the
the committee was going to hold CPC (clinico- verification of ampules containing active drugs,
pathological conference) or inquiries related to especially dangerous drugs, at meetings of the
deaths, but they have been restricted to prior department head.
hospital incidents due to various internal con- I think that it is not possible to avoid mis-
ditions. I think that as a result the committee takes such as mistaking a 1,000 mg ampule for
has strengthened its function as a medical audit a 100 mg ampule in a busy emergency depart-
system. ment even though the volumes are obviously
different.
I asked Astra Japan, a distributor of Xylo-
Learning from Actual Cases
caine to make the difference in ampule volume
Let me introduce two malpractice incidents. more distinguishable both visually and impress-
A 49-year-old patient with a pacemaker was ibly. I even suggested that the 1,000 mg ampules
carried into the emergency department after a could be triangular in shape. After around two
tachycardia attack. The doctor in attendance months, I received a polite letter from the com-
ordered 50 mg of Xylocaine. Intravenous injec- pany saying that as they distributed medicines
tion of the fluid in the provided syringe relieved all over the world, they could not change their
the tachycardia, but made the patient uncon- dosage forms for financial reasons. They said
scious with muscle cramps. The doctor did not they would take my suggestion into consider-
realize what had happened, and moved the ation in future revisions. After all, they did
patient to the ICU where the patient was satis- nothing.
factorily treated. The doctor found that the Further investigation revealed that many med-
injection he had administered was an ampule icines are contained in ampules of the same
containing 1,000 mg of Xylocaine, not 100 mg. shape. I hope that it would be possible to differ-
His prescription had been for 50 mg of Xylo- entiate between these same-shaped ampules by
caine, but he actually administered 500 mg. This making changes such as the addition of a few
caused an acute Xylocaine adverse reaction in grooves as a minimum distinguishable mark.
the patient. The same thing can be said for oral medi-
Based on this experience, the Committee re- cines. For four years, I continually appealed
organized medicines in the emergency depart- to manufacturers regarding my concern that
ment. The committee discussed the necessity many oral medicines are similarly packaged.
of providing 1,000 mg ampules of Xylocaine. Packages or dosage forms should be designed
Doctor
oriented thinking, importance of confirmation, errors resulting from unavoidable human factors,
and a humble attitude on the part of medical such as memory decline and misunderstand-
professionals, is important. ings, should not cause major accidents if the
Awareness, a factor that is emphasized in warnings from those around us are accepted.
the field of aviation, is the basis for communi- I think that the relationship among medical
cation, leading to CRM (crew resource man- professionals is extremely important.
agement). Every communication is indispens-
able; one between medical professionals and
Characteristics of Medical Disputes
the patients, as well as among medical profes-
sionals, such as doctors and nurses, doctors and There are some common characteristics in
technicians, and nurses and technicians. All medical disputes. As a lawyer involved in medi-
these communications should be on an equiv- cal disputes often said, while half of the medi-
alent level. In fact, however, there is always cal disputes involve a financial settlement, the
attempt to distinguish each rank vertically among other half concern the personality of the doctor.
medical staff. Appeals are made just to punish the doctor. In
This vertical relationship should be converted fact, these kinds of cases seem to be increasing.
to a parallel or horizontal one (Fig. 1). Human According to statistics in the United States,
Pilot
Safety of aircraft
70% of medical disputes arise even in the In a cockpit, there are three persons, a pilot,
absence of errors on the part of the medical an assistant pilot and an engineer, and now
staff. They stem from a lack of communication there are two in almost all cases. CRM aims at
between the medical professionals and the utilizing every item of information and resources
patients. in a cockpit to the greatest extent possible. In
Although communication seems to be re- the past, as pilots had absolute authority, no
lated to conversation, patients reportedly feel other crews were available to warn them and
distrust based on expression of the face and this often resulted in accidents.
eyes, as well as the behavior of medical profes- In CRM, it is most important to develop
sionals. An initial germ of distrust can grow a parallel relationship between crews in the
gradually through consecutive medical treat- cockpit in order to avoid human errors. The
ment, finally leading to a medical dispute even training system for this is called LOFT (Line
in the absence of errors. Oriented Flight Training). In the simulator,
We cannot omit the factor of personal prob- three crews operate an aircraft in various set-
lems in cases of medical disputes. In fact, they tings from Tokyo to Osaka, for example. They
are related to the quality, personality, and tech- review the recorded flight process, and find
nical level of medical professionals. some means of improving the situation by them-
selves. I think that this can be introduced into
Learning from the Risk Management the medical field.
The awareness that I mentioned before is on
System in the Field of Aviation8–9)
the basis of teamwork. It is important to con-
I will address some advantages of risk man- sider other people’s problems as your own, to
agement technology in the field of aviation pay continuous attention to the surroundings,
from which we can learn a lot. I have not yet and to exchange information. In addition, what
implemented them, but I am planning to do so. is required of the pilot as the leader is clearly
Risk management system in the field of avia- established. This can be applied to doctors.
tion is called CRM (cockpit resource manage- A pilot should be a confident person capable
ment). It is now called Crew Resource Man- of being responsible for his or her actions, a
agement, which is a more comprehensive term self-controlled person based on creative judg-
(Fig. 2). ment, a person with a high learning capacity,
and a person who can detect the problem and required to have both medical expertise and
resolve it by himself or herself. This can also be medical skills, and “doctormanship,” which is
applied to doctors. a humane quality and involves a sense of obli-
In conclusion, a leader should be a self- gation and responsibility. This has not been
controlled person. An organization consisting emphasized in medical education in Japan.
of people with self-control can flexibly response
to various crises or pressures and overcome
7 Points to Prevent Errors
various obstacles. Therefore, the field of avia-
tion reportedly emphasizes the fostering of All Nippon Airways (ANA) distribute “7
self-controlled people. points to prevent field errors” to employees, as
In the medical field, the doctor is responsible a practical approach to dealing with human fac-
for the cure, the nurse for care, and the tech- tors (Table 3). I take it up because it can be
nician provides skills to ensure the safety of applied to the medical field.
patients. Other staff involved in the medical 1) Self-monitoring with a humble attitude,
field, including clerks, all contribute to the treat- 2) team-monitoring with sensitive attention to
ment of patients. others, 3) raising awareness in unusual and
Based on this concept, a parallel relationship high-risk conditions, 4) information sharing
to allow free mutual monitoring can be estab- though sufficient communication, 5) risk pre-
lished by recognizing that all staff including diction leading to safety, 6) no violation of basic
doctors, nurses, technicians and others have understandings, 7) proposals for improving
their own roles to play. This mutual monitoring oneself and others.
only is a matter of preventing normal human I believe that these can be combined into
errors. the concept of transparency in medicine. In
The techniques of the pilot are divided into other words, it concerns recording, account-
flying skills and “airmanship”. The term “air- ability, patient-oriented medicine, and disclo-
manship” originated from noblésse oblíge, what sure of information.
is called aristocracy in the United Kingdom, The hospital convenes a Medical Council
meaning leadership based on quality, morality, consisted of the president, vice-president, head
responsibility and obligation. It is as highly of the nursing department, corporate secretary,
desirable a quality as operating skills. and chief manager of the general section to dis-
This can be applied to doctors. Doctors are cuss corrective measures when a medical dis-
pute occurs. I serve as the general risk man- Musashino Red Cross Hospital. Byoin 1999;
ager, supported by a Risk Management Com- 58: 764–765, 860–861, 966–967. (in Japanese)
mittee consisting of 15 members including doc- 4) Miyake, S.: Practice of medical risk manage-
tors, pharmacists, laboratory technicians, clerks ment. Chiryo 1999; 58: 2871–2881. (in Japanese)
5) Miyake, S.: Challenges for risk management in
and risk management nurses.
medicine— Standpoint of hospitals—. Journal
I have spoken about the control and preven- of Japan Medical Association 2000; 123: 622–
tion of medical malpractice based on experi- 628. (in Japanese)
ences at the Musashino Red Cross Hospital. 6) Miyake, S.: Causes and preventive measures
Thank you for listening. of medical incidents. Medical White Paper.
Nippon Iryo Kikaku, 2000; pp.229–240. (in
Japanese)
REFERENCES 7) Miyake, S.: Approach to risk management in
medical practice: Standpoint of hospital. Asian
1) Miyake, S.: Organizational approaches to med- Med J 2001; 44(1): 1–10.
ical accidents. Nippon Byoinkai Zasshi 1999; 8) Sakuma, H.: Human Factor Guidebook (not
46: 775–787. (in Japanese) for sale). Japanese Institute for Aviation Tech-
2) Miyake, S.: Risk management in medicine. nology, 1995. (in Japanese)
Nippon Byoinkai Zasshi 1999; 46: 1534–1568. 9) Kuwahara, K., Maeda, S. and Tsukahara, T.:
(in Japanese) Pilot Risk Management. Kodansha, 1997. (in
3) Miyake, S.: Medical risk management at Japanese)