With the goal of raising awareness concerning medical safety, The Ministry of Health, Labour and Welfare (MHLW) designated the year 2001 as "The Year of Patient Safety," and decided to set one week, including November 25, every year as "Medical Safety Promotion Week." At the same time, MHLW published "10 Points to Providing Safe Medical Care" ("10 Points"), constituting 10 mottos condensing the fundamental ideas of medical safety, and released a brochure containing descriptions and specific usage of each motto, encouraging medical institutions to build their own mottos in accordance with their individual characteristics. However, the status of the dissemination of these materials had not been surveyed. We conducted a questionnaire survey at medical institutions across the country to investigate their recognition of "Medical Safety Promotion Week" and "10 points," and their efforts toward creating their own mottos.
The targets of the survey were 80 university hospitals, the National Cancer Center, the National Cardiovascular Center, 918 other hospitals, and 594 clinics with beds. The survey was conducted in two stages using a self-rating questionnaire. 428 responses were returned in the first stage, and 118 in the second stage.
Only half of the respondents recognized "Medical Safety Promotion Week". Just one-third of them answered that they were aware of "10 points", displaying rather poor recognition. Approximately 30% of those surveyed had created their own motto. However, institutions with higher awareness of safety management reported a variety of efforts, many of which were applicable to and effective in other institutions. We expect observation of our study to contribute to the creation of a safe culture in which every institution provides safer medical care.

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It is very important for patient safety to first find the risks which lie behind medical processes and manage them. One effective way to identify the weak points is to institute a reporting system on close-calls and adverse events.
In 1999, a serious medical error of patient mix-up took place in one of the prestigious university hospitals. A committee was formed to investigate the root cause of the accident and announced its findings, and to create the measures to prevent wrong person surgery/procedures. In 2000, MoHLW revised enforcement regulations of Medical Law. This is the beginning of the Institutionalization of patient safety. In 2002, MoHLW revised Medical Law again and safety control systems, including an in-house reporting system for patient safety, were established. As well, MoHLW established voluntary national reporting system for close-calls. In 2004, MoHLW took administrative measures to collect mandatory reports on adverse events from the majority of university hospitals and national hospitals, etc.
Because Japanese society and hospitals are confronted with rapid and radical change, there are some problems including the following:
1. Lack of human resources that maintain patient safety control systems in each hospital
2. Deficiency of incentives to report close-calls and adverse events
3. Misunderstanding about nationwide reporting systems
We must solve these problems and construct a solid basis for patient safety.

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In Japan, patient safety activity began just after the occurrence of a medical accident at Yokohama City University Hospital on January 11th, 1999. In the USA, the IOM issued its first report on patient safety in November, 1999. The year 1999 has left a profound impression on Japanese and American health care professionals.
In 2001, the Board of Japanese National University Hospital Directors proposed some measures to secure patient safety. They were to assign a full-time risk-manager, establish a Committee of Preventing Medical Accidents, implement an incident reporting system, and so on.
By contrast, as of October 1, 2003, the Health Ministry mandated that the directors of all hospitals and clinics with beds initiate four measures for securing patient safety.: 1) a guideline of administration for patient safety, 2) an intra-institutional reporting system, 3) a committee on patient safety, 4) education on patient safety for staff. Furthermore, The Health Ministry mandated that all hospitals with special functions (Tokutei-Kinou Byouin) and teaching hospitals (Rinshou-Kenkyu Byouin) perform some measures in April, 2004.
Immediately after the occurrence of a medical accident at the end of February 2000, Kyoto University Hospital (KUH) started taking some steps regarding patient safety. This case forced KUH in the direction of securing patient safety. KUH arranged two General Risk Mangers and adopted an incident reporting system. Additionally, in April 2002, KUH established a Patient Safety Division, which consists of three full-time staff members (a doctor, a registered nurse and an officer), under the direct supervision of the Hospital Director.
In the text, our patient safety activities at KUH are introduced from the view-points of daily activities and emergencies.

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In Japan, the incident-accident reporting system has been playing a major role in improving patient safety, but some problems are becoming clear. One of the most serious problems is the uncertainty of the effect of the reports. Actually, in many cases, it is difficult to present the effective remedy for reported incidents. We fear an increase in such cases will prompt medical staff to lose their trust that this system improves patient safety. Another major problem concerns the proper way to use the system. Although most of the area hospitals adopt it, doctors haven't reported any incidents or accidents in half of the hospitals. This might mean that the provision for patient safety is not appropriately conducted in at least 50% of the hospitals. For the sake of patient safety, it is necessary to use the incident-accident reporting system properly, with understanding of its defects.

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This article reviews the present condition of adverse events related to surgery and anesthesia, errors in operating rooms, and new methods regarding patient safety, and then focuses on risk management including informed consent. According to reports from the United States, Australia, and New Zealand, adverse events (AEs) associated with surgery account for 24-66% of all AEs. Preventable errors that tend to occur in operating rooms are wrong site/wrong patient surgery, retained surgical instruments, and drug errors. In order to prevent these errors, more comprehensive check systems are required. The environment of operating rooms has some characteristics similar to those of aviation. Incident reporting systems and Crew Resource Management (CRM) are examples of the patient safety management systems learned from aviation. On the other hand, informed consent and risk communication are essential for risk management in surgery and anesthesia. Nevertheless, it was revealed that explanations concerning anesthesia varied among hospitals and are not standardized in Japan. Further attention needs to be focused on how to improve informed consent documentation. High-risk industries, such as nuclear and aviation systems might have many ideas to be introduced into clinical risk management, especially in the areas of surgery and anesthesia.

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This study estimas the medical cost incurred by incidents and adverse events. The authors identified 112 cases from 487 incident/accident reports where additional medical care and treatment were required due to incidents and adverse events. The medical costs for these cases were estimated using claimed data. Of the 112 cases, the number of incident and adverse event cases was 99 and 13, respectively. The average medical cost of incident and adverse event cases was approximately ¥10,000, and ¥120,000, respectively. The medical costs of all incidents and adverse events totaled about ¥1,950,000. When patients experienced adverse events, they needed intensive treatments, and some of them required a prolonged stay, so the average medical costs were raised. Of the identified incidents/accidents cases in this study, there were more than a few preventable cases. It is very important to prevent all adverse events that can be prevented.

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The purpose of this study was to describe the incidence and nature of adverse events (AEs) in obstetrics of "Incidence of adverse events in Japanese Hospitals: A National Survey" from the point of view of medical quality assurance, according to the retrospective chart review in some another countries. As a reason, there are a lot of lawsuits in obstetrics in Japan. In this study, an adverse event is defined as 1) an unintended injury or complication, 2) which resulted in temporary or permanent disability, and 3) which was caused by health care management rather than disease process. We analyzed 313 obstetric cases in the charts we randomly selected from inpatients discharged from 13 hospitals in fiscal year 2002. In the first stage review, nurse reviewers screened all the qualified charts and selected charts that satisfied one or more of 18 criteria to indicate a potential AE. In the second stage review, more than one physician reviewers reviewed the screened charts, identified AEs and assessed their preventability.
AEs were detected in 2.9% of obstetric admissions. The distinguishing characteristic of AEs in obstetrics was that almost all of them were judged difficult to prevent. But we could detect highly preventable AE's in which appropriate treatment for hemorrhage was not taken promptly. We suggest that the highly preventable event like this should be devised a proper countermeasure.

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The ENEIS study aimed to estimate the frequency of adverse events (AE) in public and private hospital, both for events leading to hospitalisation and for those identified during hospitalisation, to assess their preventability rate and to describe their main actives errors and systemic failures.
This was an incidence study on hospitalised patients observed over a maximum of 7 days. The sample was randomised using a three-stage cluster stratified process. In each selected ward, a nurse detected adverse events using 17 criteria, and a physician, in collaboration with the practitioner in charge of the patients and using the medical record, assessed the causality and preventability of AE and their active failures. A root cause analysis was subsequently conducted in a subsample of these AE.
8,754 patients, from 292 wards in 71 hospitals, were observed over a total of 35,234 days of hospitalisation, 17,104 in medical wards and 18,129 in surgical wards. Among the 450 AE (247 in surgery and 203 in medicine), 40% were considered preventable. In the course of the 7 day follow-up per unit, at least one AE was observed in 66% of surgical units and in 58% of medical units. They occurred above all in vulnerable or frail patients, 4 years older than the mean age of the sample.
Adverse events were the cause of 3.9% (CI 95% [3.4-5.6]) of overall hospitalisations. Two thirds resulted from medical care provided in the community (GPs), and the others were readmissions following previous hospitalisation. Among these AE, 47% were considered as preventable. Medication was implicated in nearly 40%.
The incidence density of AE in the course of hospitalisation was 6.6 to 1000 days of hospitalisation (CI 95% [5.7-7.5]). Among these, 35% were considered preventable. Invasive procedure, in particular surgery interventions, were the source of half of AE occurring during hospitalisation.
The active errors related to preventive and diagnostic care were more frequently preventable than to therapeutic care. Systemic failures were present in 37 out of the 45 AE analysed (82.2%) . Among a total of retrieved 145 failures, the team failures were most frequently and closely related to the occurrence of AE.
Each year at national level 125,000 to 200,000 hospitalisations and 120,000 to 190,000 AE during hospitalisation can be considered as preventable. The perioperative period and geriatric patient management should deserve closer attention. Above all, a risk-management culture based on sensitisation, training, error and event analysis are needed urgently and on a wide scale.

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Many error proofing solutions have been implemented successfully in healthcare. Most of them, however, are implemented in relative isolation, without the benefit of the knowledge of the wider body of error proofing solutions in related healthcare areas. Moreover, most of them are implemented after errors cause serious accidents, a more proactive approach using FMEA is necessary. This paper understood that a process of implementing error proofing solutions was consisted of three phases: (1) identifying improvement opportunities, (2) generating solutions, and (3) evaluating and selecting solutions, and then identified the difficulties in each phase. It also provided three support tools for overcoming these difficulties: (1) HGFM (Health-care General Failure Modes), (2) QGEPS (Questions for Generating Error Proofing Solutions) and (3) SPN (Solution Priority Number), and discussed the effectiveness of these tools through six actual error proofing projects in healthcare. As for the results, the three phase approach and the supporting tools were found to be useful for increasing the number of failure modes listed for each subprocess and the number of error proofing solutions generated for each critical failure mode, and can enable us to implement error proofing solutions more efficiently.

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Avian influenza has been surged in the mainland of China. The outbreaks and the occurrence of human cases are testing China's capacity to cope with a potential pandemic. China's government has taken precautions to strengthen its public health system and improved its transparency and accountability after SARS crisis. However, rural areas, extremely vulnerable spots in the country's public health system during a long period, remain a concern. There are obstacles to prevent and control the disease, such as a high opportunity of human exposure to infected poultry, a limited access to disease information, and lack of human and material resources for medical facilities. Thus, relevantly high risks of acquiring the infection lie in China's rural areas. To re-establish the primary level of public health system, to reduce poverty in rural areas, and to avoid the potential threat of the pandemic, the government shoulders a heavy responsibility.

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