BBI Japanese Editor
TOKYO, Japan – Some 2,000 hospital managers, doctors, nurses and health care product company representatives attended the 29th Healthcare Engineering Association (HEA) of Japan's two-day meeting held in mid-November at Tokyo Big Site, listening to presentations and exchanging views on issues and problems currently surrounding Japan's health care systems and the industry catering to it.
At the accompanying HOSPEX Japan 2000 product exhibition, nearly 235 companies displayed their products or services in about 700 booths, with just over 35,000 hospital staff members and industry representatives visiting over a four-day period.
Ken-Ichi Matsumoto, HEA chairman and the president of Sakura Seiki Company Ltd. (Tokyo), said in his opening address that "the 21st Century will be the era in which consumers will choose health care and welfare, and, accordingly, Japan's health insurance system needs to be reformed to allow private capital funding health care expenditures and accelerating introduction of advanced high-tech medicines." With an alarmingly low birth rate and an aging population in Japan, he stressed the need for speeding up developments in the areas of gene therapy, cellular medicine, tissue engineering, home health care, less-invasive treatments, artificial and/or hybrid organ technologies and information technology (IT), including telemedicine.
Prevention of medical accidents
Prevention of malpractice, or adverse incidents was one of the important themes of symposiums during the HEA gathering. One speaker cited an example at Musashino Red Cross Hospital (Musashino City, Tokyo) which introduced a risk management procedure routinely used by airlines under which a "general risk manager" is appointed to oversee a risk management committee in the hospital. Each department of the hospital is required to submit incident reports or near-miss reports each time such events occur. The incident reports form a basis for spotting sources of human errors which are then documented, identifying critical paths, formulating a preventive manual, compiling a check list to be used by nurses and pharmacists, feeding back the data for the purpose of educating all staff members, including doctors and sharing the data throughout the hospital. Based on the safety manual, medical audits are regularly conducted.
In response to that presentation, T. Ibe, senior nursing officer at St. Luke's International Hospital (Tokyo), proposed: 1) creation of a tierless human relationship in hospitals in order to foster voluntary reporting, 2) rendering efforts for the prevention of malpractices rather than auditing, 3) emphasizing pursuit of what caused the accident rather than who is accountable for it, and 4) establishing an appropriate allocation standard for nurses in order to prevent overfatigue.
F. Tsuchiya, a board member of the Japan Hospital Pharmacists Association, said that 32% of all malpractice cases are attributable to injections and 40% to drug prescriptions. Causes of accidents relating to medical devices largely involve mistaken operations and failures due to manufacture. Tsuchiya proposed the introduction of national guidelines for designing products taking into account possible human errors. A draft for a new medical device risk management standard is now being completed at the Ministry of International Trade and Industry and is expected to be published shortly. The Ministry of Health and Welfare (MHW) also is said to be in the process of standardizing a safety measure in health care settings, but is working on it with extreme caution for fear of inadvertently inviting mistakes in the system's phase-in period.
MHW sponsored a study on near-miss cases in Japanese hospitals in which 777 hospitals representing slightly over half of the 1,500 hospitals with more than 300 beds, were randomly selected. According to the responses from the 218 hospitals that returned the questionnaire, 11,148 near-miss cases occurred in 1999. Of these incidents, 31.36%, or 3,492 cases, were related to care, including falls that represent half of the cases, and 46.7%, or 5,202 cases, were related to ancillary services that include medication-related cases. While precise data on nationwide incidents of significant proportion are unknown since the reporting of accidents in hospitals is not yet mandated in Japan, the number of incidents recorded by MHW through mass media reports totaled 124 cases in 21 months from January 1999 to September 2000.
Doctors are not fit for risk managers
During a panel meeting involving all the presenters, Ibe cited an interesting and descriptive real-world situation existing in most Japanese hospitals. She noted that many mistakes committed by doctors are discovered by nurses, and that doctors are not subjective to supervisors. As a result, few incidents are voluntarily reported by doctors themselves. Both the individuals responsible for mistakes and the individuals who discover the mistakes should be equally responsible for reporting such errors, she said. Ibe said it would be inappropriate to appoint a doctor as a risk manager who cannot function as a part of the system. Ibe also pointed out that hospitals currently lack viable documentation systems. In other words, information systems in the hospitals are not catching up with developments at the forefront of treatments because too much time is consumed in checking inputs made into computers.
Roles of clinical engineers
Safety management of instruments also is at risk in many hospitals, Ibe said. She noted that experts in operation of instruments are not necessarily the experts at maintaining the instruments. At St. Luke's International Hospital, a licensed clinical engineer and the chief nurse together regularly patrol wards, but there is little contact between clinical engineers and the nurses. Ibe emphasized the need for clinical engineers to educate nurses about instruments the nurses are assigned to operate, since 90% of the malfunctions occurring with instruments are attributable to mistaken operations, and she added that hospital managers should place more importance on the roles played by clinical engineers in maintenance and inspection of instruments used in the hospitals.
Another speaker at the panel meeting noted that elderly patients often respond to a call by a nurse for some other person's name. Mistaken identities are regarded as a serious error by health care providers in Japan, so ID bands for elderly persons have been introduced in more than 800 facilities, and perhaps many more.
A news article reported two mistaken surgeries that occurred by switching patients at Yokohama City Hospital, so the practice of tagging patients gained respectability. As this article was being written, an incident of injecting a medicine into the wrong patient and another of infusing a patient with the wrong blood type, resulting in the patient's death, were reported. One was caused by a nurse not checking care instructions against a patient's ID band, the other by a nurse failing to identify the correct patient.
The panel agreed that drastic measures are needed to improve risk prevention systems in most hospitals. Panelists also agreed that there should be a mechanism for evaluating the adequacy of staffing in health care settings nationwide. Shortages exist in the number of doctors, nurses and pharmacists. A variety of suggestions for improving the safety measures were made at the panel meeting, including providing a fully developed risk management guideline, allocating a reimbursement rate on safety management, borrowing ideas on risk management from other industries and requiring verbal confirmation of actions to be taken.
IT is pivotal for risk management
MHW has concluded that the nationwide organization of information technology will be the key to sharing information on risk management programs developed by various hospitals or expert organizations broadly among hospitals, manufacturers or suppliers of drugs and pharmaceuticals. A speaker said MHW should standardize the incident report into one format for use both within the facility and for submission to the designated central authority in order to streamline clerical processing. Another speaker also proposed that all accidents occurring in health care settings be scientifically and centrally analyzed by the designated organization, and all claims should be processed through one channel. The way the news media reports medical incidents is also viewed as creating problems.
MHW is believed to be planning in the next year to lift bans on private companies entering into the health care business and allowing health care facilities to advertise their services, both of which have been banned in Japan. These steps are expected to foster healthy competition for improved management of quality and risks.
JGC Corp. (Yokohama), one of the leading companies specializing in the design and construction of hospitals, displayed at the HOSPEX show a patient record system called Hybrid Digicard. The credit card-sized Digicard is a hybrid between CD-ROM and an IC chip, and is designed to store patient identification, blood type and other basic health information about the bearer, as well as being capable of writing about 100 entries, such as results of health checks, health history, treatment records and drugs prescribed. Data cannot be overwritten when the space is full, requiring a new card to be issued. Information contained in the card, fully encrypted, cannot be accessed without the bearer's PIN number, while the bearer can read the content using any type of PC. The information contained in the card may be integrated into a hospital information system in the future allowing hospitals to have access to relevant insurance organizations.
The development of the product itself is a hybrid by nature in that the initial hardware was acquired by SAS Japan (Tokyo) from a firm in Singapore. JGC has developed an application software in collaboration with SAS Japan. On the other hand, a CD-R and a writing unit were developed by Japan Victor (Tokyo) in collaboration with SAS Japan. The products, manufactured by Japan Victor, will be jointly marketed by SAS Japan and JGC. It is possible that the Hybrid Digicard may become a standard medical record card in Japan, with the potential for being integrated into the forthcoming nationwide standard hospital information system.