Establishment, present condition, and developmental direction of the new Korean healthcare accreditation system.

On July 23rd, 2010 a revised medical law (Article 58) was passed to change existing evaluation system of medical institutions to an accreditation system. The new healthcare accreditation system was introduced to encourage medical institutions to work voluntarily and continuously to improve patient safety and medical service quality. Changes regarding the healthcare accreditation system included the establishment of an accreditation agency, the voluntary participation of medical institutions, accreditation standards centering on the treatment process and patient safety, tracing methodology, and the announcement of comprehensive results concerning accreditation. Despite varying views on the healthcare accreditation system, including some that are critical, it is meaningful that the voluntary nature of the system acknowledges that the medical institutions must be active agents in improving medical service quality. Healthcare quality is not improved instantaneously, but instead gradually through continuous communication within the clinical field. For this accreditation system to be successful, followings are essential: the accreditation agency becomes financially independent and is managed efficiently, the autonomy and regulation surrounding the system are balanced, the professionalism of the system is ensured, and the medical field plays an active role in the operation of the system.

INTRODUCTION

As interest in the quality of healthcare increases, there is a global increase in the number of countries implementing accreditation systems for medical institutions. In developed countries including the United States, there have been previous attempts to assess the quality of healthcare. South Korea has also enforced the evaluation of medical institutions since 2004, as public interest in quality standards of medical service has increased (1).

During two cycles which lasted 3 yr each, the evaluation system of medical institutions achieved positive outcomes such as an increase in medical institutions' interest in medical service quality, improved standards of service, and the introduction of clinical quality indicators (2). However, there were limitations in the professionalism and objectivity of the evaluation, as it was operated dualistically. The Korean Health Industry Development Institute (KHIDI) developed the evaluation criteria and the framework of the evaluation system's operation, while the Korean Hospital Association (KHA) was responsible for the actual evaluations (3). Since the evaluation emphasized structural aspects, there were problems with expenses, as medical institutions invested in new equipment in order to receive good evaluations (4, 5). Also, excessive competition was generated between medical institutions, as they were evaluated compulsorily and were ranked according to the results (6). To supplement and improve the evaluation system of medical institutions, at the end of 2008, the Prime Minister's Office selected improvement of the medical institution evaluation system as one of the main agendas and enacted policy directions that included the installation of an official organization. The Ministry of Health and Welfare decided to switch from the evaluation system to an accreditation system in June 2009, and in June 2010 medical law was revised to enforce this change to a voluntary accreditation system (3). Establishment of a professional accreditation organization, the voluntary participation of medical institutions, accreditation standards centering on the treatment process, specialization of inquiry methods, and the announcement of composite results regarding accreditation were especially groundbreaking improvements in the new system compared to the previous evaluation system.

A HISTORY OF QUALITY EVALUATION OF MEDICAL INSTITUTIONS IN KOREA

1967-1993: Interest in improving the quality of medical services existed in Korea even before the implementation of the evaluation system of medical institutions. Since 1967, the Ministry of Health and Social Affairs has entrusted the KHA with determining the current status of medical service as part of its inquiry into training hospitals and intern-resident hospitals. In 1981, the KHA developed a voluntary Hospital Standardization Program (HSP) targeted at intern-resident training hospitals and hospitals with 200+ beds by modifying the criteria of the United States' accreditation system to suit the Korean medical system. However, in the United States, an organization independent from medical providers, the Joint Commission on Accreditation of Healthcare Organizations, evaluated medical service quality, while in Korea, the KHA, an organization of medical providers, was the evaluating body. This obvious potential conflict of interest led to credibility problems related to the evaluation results (3).

1994-1999: Due to the aforementioned independence of evaluation agents and credibility problems with the Hospital Standardization Program, the Commission on Healthcare Reform recommended the introduction of a new comprehensive accreditation program (7). This recommendation led to the Council on Service Evaluation Program for Healthcare Organizations being organized in December of 1994. Evaluation criteria were developed and distributed in June 1995, and a demonstration evaluation was implemented in 39 tertiary hospitals beginning in December 1995. However, these evaluations could not be continued after 1999 due to controversy regarding standards and survey methods. Specifically, the fact that this system was based on heteronomous evaluations by public agents led to constant resistance from the medical community (3).

2002-2008: In 2002, the government decided that the introduction of an evaluation system of medical institutions based on strong regulations was necessary and established a law requiring the compulsory evaluation of medical service, in consultation with the KHDI (which was responsible for the assessment of medical service at the time). After this law, which specified that there would be the compulsory appraisal of medical institutions with 100+ beds, went into effect, 78 large hospitals were evaluated in 2004 despite resistance from interest groups and controversy within academic circles. A total of 840 million Won was expended on the evaluation process in which 477 investigators participated. The evaluation results were published in April 2005 amidst national interest (5).

However, there were problems during the first 3-yr cycle of medical institution evaluations. First, evaluation criteria were composed of structural aspects rather than processes and results, so they were unable to evaluate medical service quality comprehensively. Second, there were difficulties in performing evaluation tasks efficiently, as the process was divided into two different assessment institutions: the KHIDI and the KHA. Third, excessive competition occurred amongst medical institutions because results were officially announced via rankings. Furthermore, the evaluation process was not effective in improving medical service quality or the people's right to know because the evaluation results did not lead to any improvements being made by the institutions (5, 8).

Various suggestions from academia and medical institutions were collected in terms of correcting these problems, and an improved second cycle of evaluations began in 2007. The KHIDI's improvements for the second cycle of evaluations were as follows (7). 1) The appraisal of patient safety and quality improvement activities were strengthened, and clinical quality indicator realms were added. 2) Similar evaluation questions were aligned to avoid repetition, and standards that did not agree were readjusted. 3) Evaluation questions that had been department-centered were refocused on treatment process, and the patient satisfaction survey was improved to obtain credible evaluation results. 4) Finally, the evaluation system was adjusted so results for individual institutions were officially announced separately (9). Despite these efforts for improvement, the second cycle of evaluations was not greatly different from the first cycle. The evaluations struggled to overcome the basic limitation of the heteronomous evaluation system, and their improvements were limited to only the partial enhancement of the existing system.

The second cycle had several problems. One problem was the variation by evaluators. While the KHIDI developed the evaluation standards and analyzed the results, the KHA was responsible for the organization of the evaluation teams and the on-site assessment. Further, these evaluation teams consisted of health professionals who were temporarily recruited to be evaluators. As a result, there was a substantial variation in evaluation personnel case by case, making it difficult to maintain continuity in the evaluation process and to improve the evaluation process through the accumulation of evaluator experience. This led to a lack of professionalism and objectivity. Confusion about task performance and controversy about responsibility also occurred. In relation to evaluation standards, while they had been refocused on treatment process, the evaluations were still sectoral evaluations that centered on departments and were divided into treatment, medical records, nutrition, examination, emergency, etc., and it was noted that the evaluation revolved around what could be assessed rather than what should be assessed. The publicized evaluation results were confusing to the general public and did not provide useful information about the use of medical services. Finally, the evaluation could not validate its professionalism and objectivity, so medical institutions that achieved excellent evaluation results could not receive administrative or economic support from the government (9).

CONVERSION TO AN ACCREDITATION SYSTEM FOR MEDICAL INSTITUTIONS

Background of policy change

As was examined in the developmental process of evaluation systems for medical institutions above, compulsory evaluation under law was positive in that it awakened medical institutions' interest and responsibility in healthcare quality control, but faced the following limitations to operate continuously (10, 11). First, the governmental heteronomous evaluation only elicited a temporary response "for show" from medical institutions and was not effective in promoting motivation for quality improvement or any actual quality improvements in medical practice. Second, the standards were not effective in promoting practical quality improvement for medical institutions because they were disjointed from medical field demands, unrealistic, and comprised of structural and fragmentary categories. Third, there was a limit in the effectiveness in evaluating medical institution quality with non-professional survey agents filling out a checklist. Fourth, the excessive release of detailed information could lead to controversy about information validity. Medical institutions may have become too focused on securing good results, which could have led to the manufacturing of information to impress the public. Fifth, since the evaluation agents acted with a closed and bureaucratic attitude and management style, there was a limit in the flexibility the system had to respond to the changes and requirements in the field. The fundamental cause of this was the compulsory and heteronomous evaluation system. Under such compulsory evaluation systems, there is no reason for the evaluation agent to redesign the system to meet the needs of the field. This led to the rigid and bureaucratic operation of the evaluation system (11).

There is a political consensus among medical institutions and medical professionals that to resolve these problems, there is a need for the following: 1) an evaluation system of the professional survey agents; 2) the utilization of process-centered standards that can check the entire management process of the institution rather than the use of structural and fragmented surveys; 3) the establishment of an official organization that can secure the professionalism and independence of the evaluation system; and 4) bilateral choice option of both the evaluating agent and the medical institution being assessed. The evaluating agent also needs to arrange policy incentives to constantly pursue improvement in the accreditation system. For this improvement, conversion to a voluntary evaluation system is necessary (8, 11, 12).

Process of policy change

The Ministry of Health and Welfare listened to suggestions for improving the medical institution evaluation system, and a policy task force composed of the major interest groups was formed to discuss the conversion to an accreditation system in June 2009. Apart from this, the Prime Minister's Office considered the importance of the medical institution evaluation system, and following an evaluation of the current policy, advised overall improvement. Accordingly, the Ministry of Health and Welfare decided to change the system from the compulsory evaluation system to a voluntary accreditation system. Both a committee for healthcare accreditation composed of representatives from the major interest groups to promote the practical implementation of the new system and an accreditation establishment promotion team to conduct the actual task of designing were established. After the establishment promotion team for healthcare accreditation designed the detailed aspects of the system, the supporting legislation was passed in June 2010 and the system went into effect. The Korea Institute for Healthcare Accreditation was established to operate and support the accreditation system and continues to do so. A summary of the major policy milestones are provided in Table 1 (13).

Table 1

Implementation process of medical institution accreditation

Major contents of revised medical law

According to the Korean medical law, the healthcare accreditation system provides good quality of medical service by encouraging medical institutes to work voluntarily and continuously for patient safety and healthcare quality improvement through the accreditation of medical institutes. In principle, when a medical institute applies voluntarily for accreditation, a professional team from the accreditation organization evaluates whether the requirements are met for accreditation, and depending on the results, a decision is made for accreditation (4 yr), conditional accreditation (valid for 1 yr), or disqualification (14). Major contents of the partially revised medical law regarding medical institution accreditation are shown in Table 2.

Table 2

Major contents of the partially revised medical law regarding medical institution accreditation (enforced: 2011.1.24)

According to this revised medical law, the new healthcare accreditation system includes several changes. First, the main purpose of medical institution accreditation is the improvement of patient safety and medical service quality. The accreditation system is implemented through voluntary application and is applicable to all medical institutions. However, long-term, mental, and geriatric hospitals are obligated to apply for accreditation within a certain grace period due to the characteristics of their particular medical service and the protection of patient rights. In the evaluation system, the government covered the costs of an inquiry since it had been compulsory, but as the accreditation system is voluntary, the applying medical institution covers all costs for accreditation. However, the government can arrange standards to support the accreditation costs for the compulsorily accredited medical institutions such as long-term hospitals and small hospitals with less than 300 beds located in rural communities. To maintain the accreditation system's independence, professionalism, and objectivity, an official agency (Korea Institute for Healthcare Accreditation) was established as a non-profit juridical foundation to which the government can consign the accreditation duties. To resolve the inconvenience of overlapping evaluations of emergency medical institutions, public hospitals, oriental hospitals, dental hospitals and long-term hospitals, the Korea Institute for Healthcare Accreditation was permitted to integrate and implement these various evaluations. Second, a medical institution accreditation committee composed of the Vice-Minister of Health acting as chairperson, medical providers, civil groups, and healthcare professionals was formed to operate the accreditation system objectively, transparently, and in the interest of the public. Third, accreditation standards stressed the importance of patient safety and treatment process content and were made to be applicable to all hospitals. The newly developed accreditation standards stressed the importance of patient safety, continuity of treatment, patient evaluation and treatment system, leadership and organization, and business management, and following the advice of the International Society for Quality in Healthcare, standards were designed to satisfy the areas of approachability, suitability, acceptability, effectiveness, efficiency, sensitivity, safety, and continuity (9, 15). Investigation was changed to a tracer methodology, where patient trace and system trace are both utilized, so the investigation can be conducted throughout the year. The accreditation levels proposed by the Korea Institute for Healthcare Accreditation are divided into accreditation, conditional accreditation (valid for 1 yr), and disqualification, and accreditation is valid for 4 yr. Fourth, when there is any grievance about the investigation process for accreditation or the results, an appeal can be made. The validity of accreditation and evaluation results are officially published on the accreditation agency's homepage, and accredited medical institutions are obligated to use the accreditation certificate and mark to notify the public of their accreditation status. In addition, to encourage participation in the accreditation system and induce efforts for quality improvement, accreditation results could be utilized to designate senior general hospitals and specialized hospitals and as a method to determine which institutes receive funding from various government-funded projects. The misrepresentation of accreditation status by medical institutions was made a punishable offense to secure the credibility of the accreditation system and prevent harm to patients. A summary of the differences between the healthcare accreditation system and the previous evaluation system is provided in Table 3 (3).

Table 3

Comparison of evaluation system and accreditation system

The Korea Institute for Healthcare Accreditation also plans to provide consulting services for medical institutions to help medical institutions transition from the evaluation to the accreditation system. The types of consulting offered are: 1) basic training for accreditation preparation (ie, education about accreditation standards and tracer methodology); 2) accreditation preparation consulting (ie, mock investigation and accreditation preparation training); 3) customized consulting post-investigation (ie, consulting about problems and weaknesses revealed in investigation results); 4) quality management consulting (ie, consulting about quality improvement activities, patient safety and risk management, and clinical indicator and treatment improvement); and 5) service and management improvement consulting (ie, service and management improvement strategy advice for medical institutions) (3).

Composition of accreditation standards

Problems with the evaluation system included the subjectivity of the assessing agents, having survey questions that failed to reflect reality, large deviations in the range and depth of investigations, and a vague definition of standards (16-18). The newly developed accreditation standards considered these problems. As a result, the new standards were developed centering on the medical institution's function and treatment processes, and were made applicable to hospital scale medical institutions to satisfy international accreditation standards. Furthermore, sections of accreditation standards were selectively applied or excluded based on the size and nature (general, recuperation, psychiatric, etc.) of the hospital. The accreditation standards as of September 2010 are comprised of 4 domains, 13 chapters, 41 categories, 83 standards, and 404 measurement elements (Table 4) (19).

Table 4

Content of accreditation standards

ME, measurement elements.

Compared to the evaluation system's standards, there is a greater emphasis on patient safety. Further, measures of medical service quality improvement activities and organizational management were added. The assessments of facilities and equipment were removed to improve the competitive situation of medical institutions, and the accreditation standards are open to continual modification and supplementation (2).

Method and procedure for accreditation

When a medical institution applies for accreditation, the official agency assesses whether accreditation standards are satisfied and notifies the medical institution in question of the results of the assessment. Investigation teams are composed of both full-time investigation specialists from the accreditation agency and selected health professionals (doctors, nurses, nutritionists, medical records keepers, health administrators) who undergo a training program and are utilized as part-time investigators to improve professionalism (2) (Fig. 1).

Fig. 1

Detailed procedure of medical institution accreditation.

As tracing methodology is introduced, the capabilities of individual investigators become more important. Therefore, investigators participate in the crosschecking of each other's assigned projects and offer opinions in meetings to minimize the subjectivity of investigators. The entire medical treatment process is traced through various investigation methods such as interviews, medical records inspection, and observation. This investigation method is expected to increase the accuracy and expediency of the accreditation process, because any problems the medical institution has will surface during the investigation process (9).

Accreditation results and utilization

The accreditation standards, term of validity, and the results of the evaluations are revealed on the accreditation agency's homepage to provide the public with its right to know. If more detailed information was provided to the public, particularly in terms of why a particular hospital failed accreditation, there is concern that institutions would choose to avoid accreditation. Therefore, only the level of accreditation and the main evaluation results are published. This will be expanded in stages as the accreditation system becomes more established. Accreditation results can be utilized for criteria for administrative and economic support measures, and for determination of senior general hospitals and specialized hospitals. Utilizing accreditation results as criteria for being awarded funding from various government-funded projects, such as support for emergency medical institutions and public hospitals, regional designation of cardio-cerebral vascular centers, and designation of neonatal intensive care facilities and biobank units, can also be considered (2).

DEVELOPMENTAL DIRECTION OF ACCREDITATION SYSTEM

Civil groups have raised concerns about the transparency of the system and the possibility that the new accreditation system can become useless. Specifically, they argue that as there are no strong incentives for accreditation, only a few medical institutions will seek accreditation since most hospitals are excluded from compulsory evaluation. Further, they argue that the published evaluation results do not include enough detailed content (20). For the accreditation system to become stable, assure patient safety, and improve medical service quality, several issues need to be resolved. First, the accreditation agency must be economically independent. Support from the government should be minimal to nurture the fundamental spirit of voluntary accreditation. It is fundamental for the medical institution undergoing accreditation to cover all costs for accreditation (cost for investigation and operation). This is the case in the United States and Australia, two countries where voluntary accreditation systems have been implemented. However, in South Korea, the government had been covering all costs for evaluating medical institutions since the evaluations were compulsory. As the change to the accreditation system is made in South Korea, the cost for accreditation will shift to the medical institution, which may cause financial burden for the institutions. If these financial burdens are too large, they could prevent the firm establishment of the accreditation system, because institutions would benefit financially by not applying for accreditation. Therefore, in the initial stage of the accreditation system, the government must partially support the operating costs of the accreditation agency. However, long-term, it is vital for the Korea Institute for Healthcare Accreditation to achieve financial independence from the government (3, 21). Second, the management of the accreditation agency must be efficient. The main functions of the accreditation agency are to develop rational accreditation standards that can assure patient safety and quality improvement, and to investigate and decide the accreditation status of medical institutions that apply for accreditation. To perform these functions appropriately, the accreditation agency must enlist professional personnel who can efficiently manage the accreditation system and minimize the cost of operating the agency (3, 21). Third, the regulations and autonomy surrounding the accreditation system must be balanced. The accreditation system is fundamentally voluntary, but there are compulsory elements included. Accreditation is a mandatory to be designated a senior general hospital or specialized hospital, and accreditation is compulsory for recuperation hospitals and mental hospitals. Autonomy has been largely distorted as the accreditation committee (with the Vice Minister of Health as chairperson) was formed to deliberate about accreditation standards, publication, and the utilization of the accreditation. Further, medical law enumerates items that should be included in the accreditations standards. However, there is autonomy through operation as accreditation is not directly executed by the Ministry of Health and Welfare, but rather is consigned to the Korea Institute for Healthcare Accreditation. If system operation is excessively coercive, medical institutions may avoid participating in accreditation (3), while interest in accreditation may be low if there is no strong incentive for medical institutions to achieve accreditation (20). Therefore, to justly fulfill the purpose of the medical institution accreditation system, the elements of regulation and autonomy must be adequately balanced. Fourth, it is important to ensure the professionalism of the system. For a voluntary accreditation system to be viable and stable, the credibility of the system must be secured. The accreditation system should convince the medical institutions that the investigations are professional and that patient safety and the medical service quality of the institution will improve through this system. Accreditation standards must be reasonable, and professionalism must be exhibited in the investigation process. Therefore, it is especially important that the system has investigators who through education and training are competent and credible (3, 13, 18). Fifth, the independence of the medical field in operation of this system is important. The medical sector must be active in providing quality service to patients through the accreditation system rather than be forced by regulation to manage medical treatment quality. Quality service will not be improved instantaneously, but rather through the continuous effort to provide service according to the accreditation standards. The medical sector should have an active, autonomous role in the accreditation system and view the accreditation system as an opportunity to advance medical treatment quality in South Korea (3, 13).

CONCLUSION

Various conflicting views exist about the medical institution accreditation system. Some criticize that the accreditation system freed medical institutions from compulsory evaluation and that it is one step towards the privatization of healthcare. On the other hand, others feel that while technically voluntary, it is in fact functionally compulsory. However, it is meaningful this system acknowledges that the medical institutions must be the active agent in improving medical service. The accreditation system is faced with the task of obtaining society's confidence and need to do so by demonstrating that the voluntary accreditation of medical institutions is more effective than compulsory evaluation in improving medical service quality. Quality medical service is not achieved at one point but rather gradually developed through continuous communication within the clinical field (22). Therefore, for the accreditation system to be optimally effective, both the active participation of medical institutions and the willingness of government and the accreditation agency to listen to suggestions are necessary. Through the communication and active participation of various relevant interest groups, the healthcare accreditation system now being started is anticipated to develop into a valuable asset for the well-being of the general public.