Preparedness at Japan's Hospitals Designated for Patients with Highly Infectious Diseases

Abstract

In 2015, in order to assess the preparedness of Japan's special hospitals that have been designated to admit and treat patients with highly infectious diseases, we conducted a cross-sectional study of all 47 hospitals with this designation, using a self-report questionnaire that addressed 5 issues: (1) hospital characteristics and the occupation of the respondents; (2) the availability and content of the hospital guidelines for managing patients with suspected or confirmed viral hemorrhagic fever; (3) the implementation of preparedness activities in the context of the recent Ebola crisis; (4) characteristics of admission rooms for patients; and (5) human resources and occupational issues. Although our study found that most of Japan's designated hospitals were well-equipped, several areas of concern were also identified, including the lack of an effective clinical protocol, problems with management of human resources, and occupational issues. Developing a more feasible response protocol to any possible outbreak of new or reemergent infectious diseases is essential not only for Japan but for the global community in view of the threat posed by highly infectious diseases.

To assess the preparedness of Japan's special hospitals that have been designated to admit and treat patients with highly infectious diseases, the authors conducted a cross-sectional study of all 47 hospitals with this designation, using a self-report questionnaire. The study found that most of Japan's designated hospitals were well-equipped, but several areas of concern were identified, including the lack of an effective clinical protocol, problems with management of human resources, and occupational issues.

On March 29, 2016, the World Health Organization (WHO) lifted the public health emergency of international concern designation regarding the Ebola virus disease (EVD) outbreak in West Africa.¹ By then 28,000 people had been infected and 11,000 had died, including more than 800 local health workers who were infected and more than 500 who died.^2,3 Developed nations were also affected when 3 healthcare workers in the United States and Spain contracted EVD.^4,5 These facts underscore the heightened risk of highly infectious disease transmission in hospital environments and the crucial importance, even outside epidemic areas, of taking measures to ensure the safety of healthcare workers, who are particularly vulnerable to infection.

The mounting danger of global epidemics prompted the Japanese government to pass the Act on the Prevention of Infectious Diseases and Medical Care for Patients Suffering Infectious Diseases (the Act) in 1999. The Act categorized 7 highly infectious diseases as category 1 infectious diseases—EVD, Marburg hemorrhagic fever, Crimean-Congo hemorrhagic fever, South American hemorrhagic fevers, Lassa fever, plague, and smallpox—based on the level of infectiousness, seriousness of symptoms, and the threat to public health.^6,7 The Act requires the governor of each of Japan's 47 prefectures to designate at least 1 hospital for category 1 disease treatment (class 1 hospital) while also requiring the Ministry of Health, Labour and Welfare to designate some hospitals as medical institutions for both category 1 diseases and highly infectious diseases of unknown origin (“specified hospitals”).⁶ The Act also requires that all class 1 and specified hospitals (henceforth collectively referred to as “designated hospitals”) prepare at least 1 or more isolation units for patients with highly infectious diseases. When we began our study in September 2015, there were 47 designated hospitals. Of these, 44 were class 1 hospitals and 3 were specified hospitals furnishing a total of 95 isolation units in 40 prefectures, a high state of preparedness in view of the fact that no category 1 disease case has been reported in Japan since the occurrence of an imported case of Lassa fever in 1987.⁸

Experience with the SARS epidemic of 2003 and the recent Ebola outbreak has demonstrated the importance of intensive care in the treatment of highly infectious diseases. The protocol for such care should include dedicated staff who receive regular training, optimization of shift length, and maintenance of adequate isolation units.^9-14 Although the Act regulates facility conditions, including minimum room size, inclusion of an anteroom, and so on, it does not contain concrete provisions concerning protocols of operation and audit. Further, while some European nations have assessed preparedness using either checklists or on-site visits by experts under government auspices,^15-17 the level of preparedness of Japan's designated hospitals was unknown. Our goal was to assess the preparedness of Japanese designated hospitals and to identify areas requiring improvement.

Methods

This cross-sectional study targeted all 47 dedicated hospitals in Japan. Our self-report questionnaire was based on that used in the PREPARE [Platform for European Preparedness Against (Re-)emerging Epidemics] consortium's study in August to September 2014, which assessed the preparedness of 236 hospitals in 38 European and western Asian countries for EVD treatment.¹⁷ The PREPARE study mainly addressed 4 issues: (1) hospital characteristics and the occupation of the respondents; (2) availability and content of hospital guidelines or protocols for managing patients with suspected or confirmed viral hemorrhagic fever (VHF), including triage criteria, arrangement for EVD diagnostics and other routine diagnostic tests (eg, blood cell count, clinical chemistry tests, and malaria rapid diagnostic tests), infection control, clinical management and treatment, and the rationale of the guidelines; (3) the performance of preparedness activities in response to the recent Ebola crisis, including a revision of local hospital guidelines, training and education of healthcare workers, exercises to test the protocols, formation of a hospital outbreak management team, and participation in a regional or national outbreak preparedness committee; and (4) the characteristics of admission rooms.

In addition to the base furnished by the PREPARE survey, we developed questions to address human resource and occupational issues, including the availability of full-time physicians in the department of infectious diseases, adult intensive care units, and pediatric intensive care units; the availability of full-time certified nurses for infection control; the availability of pre-identified patient care teams; and their shift length. We translated the questionnaire into Japanese, with additional items evaluating the hospitals' capacity to provide comprehensive and long-term care. These items covered hospital guidelines or protocols, including external communication with local health centers or local government about transportation of EVD patients; management of challenging cases (eg, pediatric patients, pregnant women, and non–Japanese-speaking foreign residents); and preparation activities, including the management and disposal of medical waste and dead EVD patients. We assessed the preparedness of Japan's designated hospitals on August 31, 2015. The questionnaire is available as Supplementary online material (http://online.liebertpub.com/doi/suppl/10.1089/hs.2016.0056).

Our research was approved by the Institutional Review Board of Okinawa Prefectural Nanbu Medical Center and Children's Medical Center in Okinawa, Japan, and granted an official exemption by the Institutional Review Board of Harvard T. H. Chan School of Public Health.

After pilot testing the questionnaire at 2 hospitals, we mailed it to the head of infection control at each of the 47 designated hospitals. The questionnaires were mailed on September 9, 2015, and responses were accepted until November 30, 2015. A reminder was sent to 5 nonrespondents on October 22. Anonymized data were used for analysis, and descriptive statistics were calculated using Excel (Microsoft) and SPSS version 18 (SPSS, Inc.). The results were then compared with those obtained from hospitals in the PREPARE study, which stated in their response that they would accept patients with suspected EVD. Chi-square test and Fisher's exact test were used to compare differences in discrete variables. Statistical calculations were performed with the help of Epi Info version 7.2.0.1 (CDC), and a p-value of less than 0.05 was considered to indicate statistical significance.

Results

Characteristics and Occupation

Of the 47 designated hospitals, 43 (92%) participated in this study. The number of inpatient beds in these hospitals ranged from 304 to 1,132 (median: 660) (Table 1). All participating hospitals in this study had an emergency department or center. Of the respondents, 65% were nurses, and 93% of them were certified nurses for infection control (Table 2).

Table 1.

Number and percentage of facilities ordered by number of inpatients beds. Data obtained from survey of representatives from 43 designated hospitals across Japan, from September to November 2015

	N (%)
301-600	17 (39)
601-900	21 (49)
901-1200	5 (12)
Total	43 (100)

Table 2.

Type, number, and percentage of occupation of survey respondents. Data obtained from survey of representatives from 43 designated hospitals across Japan from September to November 2015

Type of Occupation		N (%)	N (%)
	Infectious disease physician	11 (74)
Doctor	Pulmonologist	2 (13)	15 (35)
	Other	2 (13)
Nurse	CNIC	26 (93)	28 (65)
	Other	2 (7)
Total		43 (100)

CNIC = certified nurse for infection control

Hospital Guidelines for Managing VHF

Of the 43 participating hospitals, 39 (91%) reported having their own guidelines for viral hemorrhagic fever, including EVD (Table 3), based on several sources—namely, the Japanese national government, the National Institute of Infectious Diseases, the National Center for Global Health and Medicine (92%), the WHO (44%), the US Centers for Disease Control and Prevention (CDC) (44%), and the European Centre for Disease Prevention and Control (41%). Clinical management and diagnostic topics covered in these local guidelines were procedures for routine diagnostic assessment (69%), Ebola virus diagnostic assessment (64%), and clinical management and treatment of patients (44%) (Table 3). Only 8% of the guidelines addressed the management of so-called rare and challenging cases (above).

Table 3.

Guidelines, preparedness activities, and characteristics of admission rooms for patients with suspected Ebola virus disease in Japanese and European hospitals. Data obtained from survey of representatives from 43 designated hospitals across Japan from Sept-Nov 2015. Also included are data obtained from 111 hospitals in the PREPARE study from Aug-Sept 2014 that would be expected to admit patients with suspected Ebola virus disease.

	Japan's Designated Hospitals (%)	PREPARE Study ¹⁷ (%)	p
Number of respondents	43	111	—
Hospital guidelines
Yes	39 (91)	93 (84)	—
No	3 (7)	13 (12)	—
Do not know	1 (2)	5 (4)	—
Topic covered
Infection control	37 (95)	93 (100)	0.082
Triage criteria	35 (90)	90 (97)	0.223
External communication^a	35 (90)	NA	—
Other routine diagnostic tests^b	27 (69)	90 (97)	<0.001
Ebola virus diagnostics	25 (64)	82 (88)	0.003
Clinical management/treatment	17 (44)	79 (85)	<0.001
Management of challenging cases^c	3 (8)	NA	—
Preparedness efforts
Training healthcare workers	42 (98)	81 (73)	<0.001
Exercise	41 (95)	51 (46)	<0.001
Revision/actualization of guidelines	39 (91)	95 (86)	0.594
Regional/national outbreak preparedness committee	36 (84)	57 (51)	<0.001
Hospital outbreak management team	32 (74)	79 (71)	0.839
Contracts on management of medical waste	33 (77)	NA	—
Contracts on management of dead body	3 (7)	NA	—
Equipment
Anteroom	43 (100)	97 (87)	0.042
Negative pressure	43 (100)	77 (69)	<0.001
Dedicated ventilation system	43 (100)	65 (59)	<0.001
Independent ensuite bathroom	42 (97.7)	NA	—
HEPA filter	41 (95.3)	47 (42)	<0.001

External communication with local health centers or local government about transportation of EVD patients.

Arrangement for other routine diagnostic tests (eg, blood cell count, clinical chemistry tests, and malaria rapid diagnostic tests).

Management of challenging cases (eg, pediatric patients, pregnant women, and non–Japanese-speaking foreign residents)

Preparedness Activities

The preparation exercises for responding to an EVD outbreak are given in Table 3. Japan's designated hospitals implemented these activities at rates that were equal to or better than those of comparable hospitals in the PREPARE study; however, a quarter of our respondents (23%) had no protocol for the management and disposal of medical waste, and most respondents (93%) had no protocol for the management and disposal of dead bodies.

Characteristics of Admission Rooms

Admission facilities for patients with suspected EVD were statistically well equipped in most hospitals in accordance with regulations of the Act (Table 3).

Human Resources and Occupational Issues

The number of full-time doctors in the infectious diseases department, the intensive care unit, and the pediatric intensive care unit and full-time certified nurses for infection control is given in Table 4. Although nearly all responding institutions (95%) had 1 or 2 full-time certified nurses for infection control, 28 of 38 (74%) had no full-time physicians in the pediatric intensive care unit, 16 of 39 (41.0%) had no full-time physicians in the intensive care unit, and 15 of 43 (35%) had no full-time physicians in the infectious disease department.

Table 4.

Number of full-time physicians in the departments of infectious diseases, adult intensive care unit, pediatric intensive care unit, and full-time certified nurses for infection control. Data obtained from survey of representatives from 43 designated hospitals across Japan from September to November 2015

	Infectious Diseases (n = 43) (%)	Intensive Care Unit (n = 39) (%)	Pediatric Intensive Care Unit (n = 38) (%)	Certified Nurse for Infection Control (n = 40) (%)
0	15 (35)	16 (41)	28 (74)	2 (5)
1-5	22 (51)^a	10 (26)	7 (18)	38 (95)
6-10	5 (12)^a	8 (20)	3 (8)	0 (0)
11≧	1 (2)	5 (13)	0 (0)	0 (0)

One hospital supplied the number of full-time physicians in the department of infectious diseases and respiratory medicine.

Of 43 participating institutions, 40 (93%) had some pre-identified staff members comprising a specific care team for Ebola patients. The number and planned shift length of the staff are shown in Tables 5 and 6. The number of nurses in pre-identified patient care teams exceeded 7 in 75% of responding hospitals, while the number of physicians was 3 or fewer in more than 51% of respondents. Although 38 of 40 (95.0%) surveyed hospitals had already determined the shift lengths for pre-identified patient care team nurses, only 16 of 40 (37%) had considered the shift lengths for physicians on the team. Although 25 of 32 respondents (78%) had set each shift length at less than 8 hours for nurses, 11 of 15 respondents (72%) had set the shift length for physicians at 12 or 24 hours.

Table 5.

Number of members in preidentified patient care team. Data obtained from survey of representatives from 43 designated hospitals across Japan from September to November 2015

	Physicians (n = 39) (%)	Nurses (n = 39) (%)
1-3	20 (51)	6 (15)
4-6	15 (39)	4 (10)
7-9	2 (5)	5 (13)
10≧	2 (5)	24 (62)

Table 6.

Planned shift length for members in preidentified patient care team. Data obtained from survey of representatives from 43 designated hospitals across Japan from September to November 2015

Hours	Physicians (n = 15) (%)	Nurses (n = 32) (%)
2	0 (0)	1 (3)
4	1 (7)	2 (6)
4-8	0 (0)	2 (6)
8	1 (7)	20 (63)
12	8 (52)	5 (16)
24	3 (20)	0 (0)
Others^a	2 (14)	2 (6)

10, 8-12, 8 (day shift) and 16 (night shift)

Discussion

This is the first study to investigate the preparedness of Japan's designated hospitals against highly infectious diseases, and the response rate in our study was excellent (92%). Our research found that admission facilities for patients with suspected EVD in Japan's designated hospitals were well equipped, and that they were better prepared than comparable facilities in the PREPARE study. However, the latter difference was likely due in part to the fact that PREPARE assessed more than 200 hospitals in 38 countries that varied widely in terms of regulations and resources. In Japan, the Act specifies the conditions required at designated isolation units, and our research was conducted almost 1 year after the PREPARE study, which immediately followed the WHO declaration. Furthermore, the importance of preparedness became more pronounced following the PREPARE study when 3 incidents of nosocomial EVD transmission occurred in Spain and the United States.^4,5 In addition, between October 2014 and February 2015, the National Center for Global Health and Medicine in Japan provided a training course for staff at class 1 hospitals and dispatched experts to conduct workshops at 19 class 1 hospitals.⁶ These events also influenced our findings.

Our study also identified several areas for improvement at Japan's designated hospitals, including the need for guidelines and clinical preparedness, and unresolved human resource and occupational issues. Moreover, even though our study was conducted a year after that of PREPARE, the designated hospital guidelines for clinical management, treatment, and diagnostic assessment were less covered than those of the hospitals in the PREPARE study, which stated they would receive patients with suspected EVD.

Another area for improvement is in contracting for management of medical waste and disposal of dead bodies, where 77% and 7% of respondents, respectively, report having contracts in place. Although some clinical reports indicated that aggressive supportive care may improve prognosis,^18-20 and some research groups have pointed out the importance of including intensivists in EVD care teams,^9,12-14,21 many designated hospitals lacked specialists for adult and pediatric intensive care or infectious disease specialists. Moreover, the number of pre-identified patient care team physicians and their planned shift length were potentially problematic. Schieffelin and colleagues reported that the mean hospital stay for patients who survived EVD was 15.3 ± 3.1 days,²² but many hospitals responded it would not be feasible to provide patients with comprehensive and long-term care because of the dearth of pre-identified patient care team physicians and the excessive length of shifts. One reason for this may be that the medical personnel lacked experience treating category 1 diseases. On the other hand, Europe has experienced a greater number imported VHF cases,^23-25 and some preparedness assessments were done not only in response to, but even in anticipation of, an emergency.^15-17 Another reason may be the lack of clinical experts on infectious diseases in many Japanese designated hospitals, who in addition to clinical care are expected to play a primary role in planning for and responding to infectious disease events. According to the Japanese Association for Infectious Disease, the number of certified infectious disease specialists (per 1 million people) in Japan is 9.7, while the Japanese Society of Intensive Care has certified almost the same number of infectious disease specialists as intensive care specialists. This is a very small number especially of intensive care specialists, in comparison with 25.9 and 32.2 in the United States and 7.3 and 15.2 in the United Kingdom, respectively.^26-28 The need for staff better trained to care for highly infectious disease patients could be addressed in 2 ways: first, the National Center for Global Health and Medicine and other national agencies could develop and provide training based on evidence-based practices targeting areas needing improvement for the benefit of healthcare workers charged with caring for highly infectious disease patients; and second, the Act could be amended to promote the securing of designated specialists.

It may not be possible to resolve all these challenges or to increase the capacity to provide comprehensive long-term care for patients with highly infectious diseases at all designated hospitals. In order to consolidate resources, the United States adopted a tiered approach to hospital preparedness in 2015, allocating all acute care facilities into 3 categories: frontline healthcare facilities, Ebola assessment hospitals, and Ebola treatment centers.²⁹ Using Japan's efficient transportation network and hospital infrastructure, the Japanese government could designate some class 1 hospitals or specified hospitals in areas with adequate infrastructure, materials, and human resources more than standards for designation, which should be set by experts in highly infectious diseases, infection prevention and control, and occupational health, as regional treatment centers for highly infectious diseases as a practical cost-cutting measure. Other hospitals could then be designated as assessment facilities to manage suspected highly infectious disease patients for a few days until confirmation of the diagnosis and the patient's transfer to a regional center.

Additionally, as our study and others have indicated, an audit is helpful in identifying problem areas and ensuring preparedness at designated hospitals. For example, the US government created the Hospital Preparedness Program Ebola Preparedness and Response Activities fund as a financial incentive for developing Ebola assessment and treatment centers in line with a tiered approach, and it required awardees to report the status of their preparedness annually.³⁰ This approach, or the periodic evaluation by experts using checklists in on-site visits, may make it possible for designated hospitals to continue identifying areas to improve in order to strengthen their capabilities. Each designated hospital should also maintain their strengths and attempt to improve their inadequacies by updating and improving their guidelines and preparedness efforts, recruiting specialists, and planning feasible pre-identified patient care teams and shift lengths.

This study has 4 limitations. First, 4 of the 47 designated hospitals did not respond, possibly causing a nonresponse bias with the result that the participating hospitals may have appeared to be better prepared. Nonetheless, the response rate exceeded 90%, and the 4 missing hospitals were geographically dispersed across Japan. Although inspection or third-party assessment is better than a survey based on a questionnaire, our results may show potential gaps in the preparedness of designated hospitals in Japan.

Second, the difference in the occupation of respondents may have resulted in a bias. However, the Act mandates the formation of an infection control committee dedicated to improving the readiness of hospitals to perform their designated tasks. Our questionnaires were addressed to the chief of infection control at each participating hospital, who might also have been a member of this committee. In response to our inquiries regarding preparedness, only 1 respondent replied “Do not know” to the question about the availability of hospital guidelines. The effect of this response is likely to be minimal.

The third limitation pertains to our method of inquiry about the number of full-time doctors in the infectious disease departments, intensive care units, and pediatric intensive care units. An answer of “zero” might mean that there was no full-time staff, department, or unit. For example, some hospitals that answered “zero” may have some infectious disease or intensive care specialists belonging to another department, such as internal medicine.

Finally, we compared the results between designated hospitals in Japan and hospitals in the PREPARE study, which stated in their response that they would admit patients with suspected EVD. As mentioned above, the latter were hospitals in 38 countries that varied widely in terms of regulations and resources. Differences in our study should be interpreted with caution.

Conclusion

This study demonstrated a high level of preparedness among designated hospitals in Japan in terms of equipment and the rigor of preparation against possible highly infectious disease outbreaks. However, some facilities lacked adequate clinical guidance, lacked dedicated infectious disease and intensivist staff, lacked plans on shift length of staffs, and identified means for disposal of wastes and dead bodies. We recommend that the Japanese government consider modifying their approach to hospital preparedness to use the better staffed and resourced facilities as reference centers for care of people with highly infectious diseases and to monitor and improve their preparedness routinely. It is essential not only for Japan but also for other nations to prepare for the next wave of highly infectious diseases, which may well prove more transmissible and virulent than EVD.

Footnotes

Acknowledgments

We are grateful for the cooperation and support of the members and staff of all the designated hospitals in Japan. We are also grateful to Professor de Jong of the Academic Medical Center in Amsterdam in The Netherlands for sharing his questionnaire and advising us in our research, and to Dr. Richard A. Cash of the Department of Global Health and Population of the Harvard T. H. Chan School of Public Health in the United States. This study was done with support from the Takemi Program in International Health at the Harvard School of Public Health and supported by a grant from the Research Project for Emerging and Re-emerging Infectious Diseases of the Ministry of Health, Labour and Welfare of Japan (H26-Shinkogyosei-Shitei-001).

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