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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

Scientific Contribution

Evaluation of Health Care Service in Japan: From the Viewpoint of Patient-Centered Health Care

Shinko ICHINOHE

(Faculty of Nursing, Jobu University, E-Mail: [email protected]) Abstract: Compared with 50 years ago, our life expectancy has increased by more than 20 years. It is possible to survive for a much longer time than previously. Medical accidents also occurred more frequently as well, and many patients lost their lives through such accidents. Reconstitution of the health care system so that patients can feel safe and satisfied has becomes an important issue. To guarantee quality of health care service, many Western countries have begun to assess those services through organizations such as JCAHO. In this paper, I first investigate the evaluation of JCQHC in Japan, and analyze it from the viewpoint of patient-centered health care. Further, I analyze standards of foreign countries and compare those standards with those of Japan. A patient and that patient's family are included in concept of "the patient" when comparing U.S.A. and Australian standards. I have clarified those areas which are of most importance when evaluating health care service from the view point of patient-centered health care. It seems that the viewpoint of the consumer (a person who is not now a patient, but is likely to become a patient in the future) is important. Keywords: evaluation, patient-centered health care, quality, health care system, safety, Informed Consent, self-determination, JCQHC, JCAHO, ACHS

Introduction The present conditions of the health care service offered in our country are as follows: the total number of hospitals is 9,239 (2001) with 8,171 general hospitals among these1. These hospitals are classified by number of beds (table 1). Institutions sponsoring health care services of our country are classified roughly into hospitals and

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

clinics by medical law beside social services. The total number of clinics is 158.316(2001) and 94.019 general clinics and include 64.297 dental clinics.

Table 1: The Number of Hospitals by the Number of Beds Type 20-99 beds 100-299 beds 300-499 beds 500+beds Number of 3.781 3.851 1.111 496 Hospitals Source: Statistics and Information Department, Minister's Secretariat, MHW, "Survey

of Medical Institutions" (2001)

Japan Council for Quality Health Care (JCQHC) The Japan Council for Quality Health Care (JCQHC) was established in July 19952 as the only nationally authorized organization to accredit hospitals in JAPAN. After a two year feasibility study, a hospital accreditation program was started in 1997. Now it is the only third party organization working on hospital evaluation. JCQHC's objectives are to assure trustworthy, quality health care and to work continuously to improve care. JCQHC does neutral assessment from an academic perspective and offers support for improvement. JCQHC is a non-profit, independent organization. JCQHC survey A JCQHC survey consists of two assessments; document assessment (Document assessment sheet for current status and Self-assessment) and on-site survey. The number of applicants for the hospital accreditation increases annually, over 200 hospitals in 2000 and over 500 hospitals in 2002. At present, of the 9239 hospitals in Japan, more than 2000 hospitals have applied for hospital accreditation and more than 1500 hospitals have been surveyed and accredited (as if May, 2005). A surveyor team is composed of 4-7 people (physicians/nurses/administrators). The background requirements are

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

management experience of at least 5 years. They attend 5 days of initial training (including survey simulation) and on-the-job training. To improve the quality of the survey, they attend annual refresher training as well. Survey frameworks are classified as follows: Emergency hospitals or multiple care hospitals are divided into four categories: up to 99 beds, 100-199 beds, 200-499 beds, and more than 500 beds. Hospitals offering only psychiatric care or long-term care (including hospitals offering both types of care) are divided into three categories: up to 199 beds, 200-399 beds, and more than 400 beds. After an on-site survey, the surveyor team makes a report which is reviewed by a Review Task Force. The Evaluation Committee makes the final decision regarding accreditation. Hospital Accreditation Standards V4.0 A new version of the accreditation standard was introduced in 2002. Integrative Standards Ver.4.0 applies to all applicant hospitals. Integrative Standards Ver.4.0 consists of 6 areas: (1.0 Administration and Roles in the Medical Organization, 2.0 Patients Rights and Safety, 3.0 Living Arrangements and Patient Service, 4.0 Assurance of Quality Medical Care, 5.0 Appropriateness of Delivering Nursing Care, 6.0 Rationality of Hospital Administration). In addition, Specific Function Standards are used to evaluate psychiatric and long-term care. Hospitals accredited by the Integrative Standards Ver.4.0 are eligible to apply for the option of Module Standards (Emergency Medical Services, Rehabilitation Services, Palliative Care Services) (Table 1). Omichi says3 that the subject area of evaluation, and individual item systems were largely revised to comply with current medical treatment standards. JCQHC standards are made up of three-tiers and comprise 1st-tier, 2nd-tier, and 3rd-tier items. 1st-tier items (large items) indicate the framework of subject areas. 2nd-tier items (medium items) are scored on a five-point scale (5: extremely appropriately implemented/considered

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

as a model for others, 4: appropriately implemented/existing and appropriately/actively implemented, 3: intermediate/moderate, 2: slightly lacking in appropriateness/existing, but lacking appropriateness/negatively implemented, 1: not appropriate/ nonexistent/ not implemented). 3rd-tier items (small items) are scored on a three-point scale (a: appropriate, b: intermediate/moderate, c: not appropriate). Usually, a certificate will be issued if scores for all medium items are above "3" unless there is some special reason. Evaluation board will discuss whether a certificate will be issued or not in case of the existence "2" or "1" scores. Table 2 : Hospital Accreditation Standards (JCQHC Ver.4.0)

1.0 Administration and Roles in the Medical Organization 2.0 Patients Rights and Safety 3.0 Living Arrangements and Patient Service 4.0 Assurance of Quality Medical Care 5.0 Appropriateness of Delivering Nursing Care 6.0 Rationality of Hospital Administration 7.0 Specific Function Standards (Psychiatric Care) 8.0 Specific Function Standards ( Long-term Care) Module Standards Ver.1.0 Module Standards for Emergency Medical Function Module Standards for Rehabilitation Function Module Standards for Palliative Care Function

Comparison with JCAHO and ACHS JCAHO (Joint Commission on Accreditation of Healthcare Organizations) 4 is an American evaluation organization with a history of more than 50 years, the oldest in the world. JCAHO's Hospital Accreditation Standards 5 are shown in table 3. Standards are divided into three sections: (Section1: Patient-Focused Functions, Section2: Organization Functions, Section3: Structures with Functions). Each

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

section is divided into specific areas. Patient-Focused Functions (Section1) consists of four area: Ethics, Rights, and Responsibilities (RI), Provision of Care, Treatment, and Services (PC), Medication Management (MM), Surveillance, Prevention, and Control of Infection(IC). Organization Functions. (Section2) consists of five areas: Improving Organization Performance (PI), Leadership (LD), Management of Environment of Care (EC), Management of Human Resources (HR), and Management of Information (IM). Structures with Functions (Section3) consist of two areas: Medical Staff (MS) and Nursing (NR). JCAHO assumes that a patient-centered function is important, and for high quality hospital service, standards for evaluation are important. ACHS (The Australian Council on Healthcare Standards)6 is the Australian evaluation organization. Healthcare Standards of ACHS7 are shown in table 4. Standards consist of six functions: (Function1: Continuum of Care, Function2: Leadership and Management, Function3: Human Resources Management, Function4: Information Management, Function5: Safe Practice and Environment, Function6: Improving Performance). With these standards, ACHS places the consumer who is a potential patient as a part of healthcare service evaluation as well as the patient. Function 1 is evaluated in four items with guidelines to guarantee quality of consumer-centered continuous care. With standard 1.3 (Consumer/patient needs for quality and safe care with desirable outcomes) are addressed through the planning, delivery and evaluation of care in particular. ACHS evaluates the standard from two criteria: Criterion 1.3.1 is that care is planned and delivered in partnership with the consumer/patient and when relevant, the care-taker, to achieve the best possible results. Criterion 1.3.2 is that care is evaluated by health care providers together with the consumer/patient and when appropriate, with the care-taker. ACHS evaluates a consumer-centered health care service offer and aims at healthcare delivery systems with consumer/patient participation.

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

Table 3 : Hospital Accreditation Standards (JCAHO CAMH2004)

Section1:Patient-Focused Functions Ethics, Rights, and Responsibilities(RI) Provision of Care, Treatment, and Services(PC) Medication Management(MM) Surveillance, Prevention, and Control of Infection (IC) Section2: Organization Functions Improving Organization Performance(PI) Leadership(LD) Management of the Environment of Care(EC) Management of Human Resources(HR) Management of Information ( IM) Section3: Structures with Functions Medical Staff(MS) Nursing (NR)

Table 4 : Healthcare Standards (ACHS Third edition)

Function1 Continuum of Care Standard 1.1 Standard 1.2 Standard 1.3 Standard 1.4 Standard 2.1 Standard Consumers/patients have access to health care appropriate to their needs. A comprehensive assessment by competent professionals identifies the clinical, non-clinical and social needs of consumers/patients, as the basis for providing quality and safe care. Consumer/patient needs for quality and safe care with desirable outcomes are addressed through the planning, delivery and evaluation of care. Consumer/patient and carer needs for ongoing care are addressed through the coordination of services and the provision of timely and useful information. The governing body leads the organization's strategic direction and establishes an operational framework to ensure the provision of quality, safe services. The governing body promotes the safety of all persons within the organization by

Function2 Leadership and Management

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

2.2 Standard 2.3 Standard 2.4 Standard 3.1 Standard 4.1 Standard 4.2

its pro-active approach to preventing and managing clinical and non-clinical risks. The governing body leads the organization in its commitment to continuous improvement and the quality and safety of care service. The governing body is committed to consumer participation as a strategy to assist the improvement of quality, safe care and service. The management of human resources supports the delivery of quality and safe care and service. Valid information sources support decision making and the identification of consumer/patient care outcomes. Information is created and is used to meet strategic and operational needs and to support quality and safety. A systematic risk management program is used to manage services and facilities and ensure that the safety and health of all persons within the organization are protected. The organization provides quality and safe care and service through its commitment to improving performance.

Function3 Human Resources Management

Function4 Information Management

Function5 Safe Practice and Environment Standard 5.1

Function6 Improving Performance Standard 6.1

Patient Right and Safety Next, I will analyze the evaluation of patient-centered healthcare in Japan. Table 5 shows the list of evaluation items of the second area (Patient Rights and Safety) and the rating distribution8. Data are as of May 17, 2004, and the total number of subject hospitals is 349. The second area consists of seven items: (2.1: Respect for patient rights and patient: Health care provider partnership, 2.2: Informed Consent, 2.3: Patient safety management system, 2.4: Establishment of patient safety procedures, 2.5: Improvement of information collection and analysis for patient safety, 2.6: Response to health care accidents, 2.7: Nosocomial infection control). There were no ratings for item 1 at all.

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

Several evaluation items gained a rating of 5, at 2 or 3 hospitals. Five items which earned a rating of 2 appeared at more than 4 hospitals: 2.1.1: Policies on patient rights and professional ethics are clear and publicized to patients and staff members systematically, 2.2.1: A system is established to implement informed consent, 2.3.3: There is organizational education and training on patient safety, 2.6.1: Health care accident procedures are clear and understood by staff members, 2.7.2: Specific actions are taken to reduce the risk of nosocomial infection. These items include the keywords: Education, Staff, and a system. This means that an education system for all staff is important. Table 5 : 2.0 Patient Rights and Safety (JCQHC Ver.4.0) Standards and Score

Standards No. Score Respect for patient rights and patients :Health care 2.1 provider partnership Policies on patient rights and professional ethics are clear 2.1.1 and publicized to patients and staff members systematically. There is a system to foster a patient-provider partnership 2.1.2 for quality of healthcare and patient safety. 2.2 2.2.1 2.2.2 perspective. There is an established system for disclosure of medical 2.2.3 records in response to patient inquiry. 2.3 2.3.1 for patient safety assurance. There are established policies and procedures for 2.3.2 in-hospital patient safety. There is organizational education and training on patient 2.3.3 safety. 0.00% 27.22% 71.63% 1.15% 0.00% 0.00% 67.34% 32.66% 0.00% 0.00% Patient safety management system There is an established organization management system 0.86% 50.72% 48.42% 0.00% 0.00% 0.00% 49.86% 49.57% 0.57% 0.00% Informed Consent A system is established to implement informed consent. Patients are given a careful explanation with regard for their 0.29% 30.95% 68.77% 0.00% 0.00% 0.29% 40.69% 57.59% 1.43% 0.00% 0.00% 41.26% 58.17% 0.57% 0.00% 0.00% 35.53% 61.60% 2.87% 0.00% 5 4 3 2 1

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

2.4 2.4.1 patient safety in each department. Improvement of information collection and analysis for 2.5 patient safety There is an established system to investigate patient safety 2.5.1 factors and carry out measures for improvement. There are established cooperative system for patient safety 2.5.2 outside the hospital. 2.6 2.6.1 by staff members. 2.7 2.7.1 operation. Specific actions are taken to reduce the risk of nosocomial 2.7.2 infection. Reforms taken to counter nosocomial infection are based 2.7.3 on an understanding of isolates or cases of infectious disease. 2.7.4 Education on nosocomial infections is carried out. 0.29% 57.88% 41.83% 0.00% 0.00% 0.29% 61.89% 37.54% 0.29% 0.00% 0.00% 36.10% 60.74% 3.15% 0.00% Nosocomial infection control Nosocomial infection management is an organizational 0.00% 75.93% 23.78% 0.29% 0.00% Response to health care accidents Health care accident procedures are clear and understood 0.00% 60.46% 37.82% 1.72% 0.00% 0.00% 49.00% 50.43% 0.57% 0.00% 0.00% 46.13% 53.58% 0.29% 0.00% Establishment of patient safety procedures There are specific, established crucial clinical procedures for 0.00% 32.66% 66.76% 0.57% 0.00%

As of 2004.5.17 349 Hospitals by JCQHC

Evaluation of Informed Consent: Comparing JCQHC with JCAHO The evaluation standard of JCQHC was revised in 2005. With version 5.0, evaluation items for patient-centered health care service were reinforced and the number of evaluation items concerning informed consent increased (Table 6). A list of informed consent items from JCAHO is shown in table 7. I will attempt to compare items about informed consent from JCQHC with those of JCAHO. Many of the points are common in a comparison of JCQHC and JCAHO, but

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

there are some outstanding differences. Specifically, in the evaluation items of JCAHO9, the following items which patient and their family discuss are included: (TX.5.2 Before obtaining informed consent, the risks, benefits, and potential complications associated with procedures are discussed with the patient and family, TX.5.2.2 Discussions with the patient and family about the need for, risk of, and alternatives to blood transfusion when blood or blood components may be needed are considered). Let me suggest what this means. Informed consent is based on the principle of autonomy of the patient. But when the outcome of surgery, blood transfusion, etc. is not desirable, shouldn't the family be allowed to influence the decision on carrying out the procedure? In Japan, the common practice regarding serious conditions, such as cancer notification, consent information is usually given to a family member first rather than to the patient. This seems opposed to the principle of self-determination of the patient. However, it seems that there were a few objections from family members about informed consent. This appears to be a cognitive difference between Japanese and U.S. approaches to informed consent. When the principle of self-determination gradually develops in Japan, evaluation items similar to those in the U.S.A. will be required. Table 6 : Standards Related to Informed Consent (JCQHC Ver.5.0)

2.3.1 2.3.1.1 2.3.1.2 4.18.2.2 5.2.1 5.2.1.1 5.2.1.2 5.2.1.3 5.4.2.2 Organization which does informed consent is established. A policy about informed consent is clear. A procedure to inform of, and obtain consent is clear. An informed consent is done adequately in a treatment and examination of high risk. Determination and explanation of hospitalization are done adequately. The purpose of hospitalization is made clear. Hospitalization treatment planning is done adequately. Explanation about hospitalization is done, and confirms whether the patient understands and agrees. The plan is explained adequately to the patient / family and gets agreement.

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006 Before medical staff do invasive examinations, they obtain an agreement after having adequately explained the procedure. Medical staff do an explanation and education about the manner of taking medicine tor the patient. Explanation about transfusion is done for the patient and an agreement is obtained. Enough explanation do about an operation /anesthesia for the patient, and an agreement is obtained. Adequate explanation about contents of rehabilitation for the patient is done, and an agreement is obtained. When medical staff carry out physical restraint, adequate explanation is done for the patient and an agreement is obtained. Explanation about discharge is done adequately, and an agreement is obtained.

5.5.2.1

5.5.3.1 5.5.4.2 5.5.5.2

5.5.7.2

5.5.8.3 5.5.11.2

Table 7 : Standards Related to Informed Consent (JCAHO CAMH2000)

RI.1.2 RI.1.2.1 RI.1.2.1.1 Patients are involved in all aspects of their care. Informed consent obtained. All patients asked to participate in a research project are given a description of the expected benefits. All patients asked to participate in a research project are given a description of the potential discomforts and risks. All patients asked to participate in a research project are given a description of alternative services that might also prove advantageous to them. All patients asked to participate in research project are given a full explanation of the procedures to be followed, especially those that are experimental in nature. All patients asked to participate in research project are told that they may refuse to participate,a and that their refusal will not compromise their access to services. The hospital protects patients and respects their rights during research, investigation, and clinical trials involving human subjects. All consent forms address the information specified RI.1.2.1.1through RI.1.2.1.5; indicate the RI.3.1 name of the person who provided the information and the date the form was signed; and address the participant's right to privacy, confidentiality, and safety. TX.2.2 Anesthesia options and risks are discussed with the patient and family prior to

RI.1.2.1.2

RI.1.2.1.3

RI.1.2.1.4

RI.1.2.1.5

RI.3

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006 administration. TX.5.2 TX.5.2.1 TX.5.2.2 Before obtaining informed consent, the risks, benefits, and potential complications associated with procedures are discussed with the patient and family. Alternative options are considered. Discussions with the patient and family about the need for, risk of, and alternatives to blood transfusion when blood or blood components may be needed are considered. The medical record contains sufficient information to identify the patient, support the IM.7.2 diagnosis, justify the treatment, document the course and results, and promote continuity of care among health care providers.

Conclusion Through comparison with U.S.A. and Australian standards, it seems that many points might be usefully added to the standards in Japan. Among other things which I think might be useful are the following two points. In evaluation of quality patient-centered health care service, Japanese standards divide the patient and family in to separate concepts of "the patient." We should, perhaps, think of them as the same. Second, a viewpoint of the "consumer" (a person who is not now a patient, but who has the likelihood of becoming a patient in the future) is important. In conclusion, I suggest that it is important to develop standards while thinking about the patient, the family, and the consumer in evaluation of patient-centered health care service. References

Ministry of Health, Labor and Welfare, http://ww.mhlw.go.jp Japan Council for Quality Health Care, http://jcqhc.or.jp 3 Hisashi Omichi: Significance and profile of hospital function evaluation, Hospital Facilities Vol.45 No.6 (256) 2003; pp.11-16. (in Japanese) 4 Joint Commission on Accreditation of Healthcare Organizations http://www.jointcommission 5 Joint Commission: Comprehensive Accreditation Manual for Hospitals: The Official Handbook, 2004. 6 The Australian Council on Healthcare http://www.achs.org.au 7 ACHS The EQulP Guide: A framework to improve quality and safety of health

1 2

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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.43-55, July 2006

care, Third edition, 2003. 8 JCQHC: Partnership between health care provider and patient. 2004; pp.62.(in Japanese) 9 Joint Commission: Informed Consent, 2000; pp.7.

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