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Abstract

High-level isolation units (HLIUs) have been established by countries to provide safe and optimal medical care for patients with high-consequence infectious diseases. We aimed to identify global high-level isolation capabilities and determine gaps and priorities of global HLIUs, using a multiple method approach that included a systematic review of published and gray literature and a review of Joint External Evaluations and Global Health Security Index reports from 112 countries. A follow-up electronic survey was distributed to identified HLIUs. The landscape analysis found 44 previously designated/self-described HLIUs in 19 countries. An additional 33 countries had potential HLIUs; however, there were not enough details on capabilities to determine if they fit the HLIU definition. An electronic survey was distributed to 36 HLIUs to validate landscape analysis findings and to understand challenges, best practices, and priorities for increased networking with a global HLIU cohort; 31 (86%) HLIUs responded. Responses revealed an additional 30 confirmed HLIUs that were not identified in the landscape analysis. To our knowledge, this was the first mapping and the largest ever survey of global HLIUs. Survey findings identified major gaps in visibility of HLIUs: while our landscape analysis initially identified 44 units, the survey unveiled an additional 30 HLIUs that had not been previously identified or confirmed. The lack of formalized regional or global coordinating organizations exacerbates these visibility gaps. The unique characteristics and capabilities of these facilities, coupled with the likelihood these units serve as core components of national health security plans, provides an opportunity for increased connection and networking to advance the field of high-level isolation and address identified gaps in coordination, build an evidence base for HLIU approaches, and inform HLIU definitions and key components.

Introduction

In recent years, outbreaks of emerging and reemerging high-consequence infectious diseases (HCIDs) have presented challenges and risks to healthcare workers and communities at large. HCIDs are typically defined as diseases with high case-fatality rates that lack treatments with proven effectiveness and pose a threat of person-to-person transmission in healthcare settings and in the public (eg, Ebola virus disease [EVD], Middle East respiratory syndrome [MERS], Lassa fever, smallpox).^1,2 To provide optimal medical care for patients with HCIDs while simultaneously protecting healthcare workers, other patients, and the community, countries have established specially designed units for HCID cases, referred to here as high-level isolation units (HLIUs), since the early 1970s.^3,4

Distinct from conventional hospital isolation wards, HLIUs are equipped with engineering controls generally analogous to biosafety level (BSL) 4 laboratories, highly trained teams, and infection prevention and control measures atypical of routine clinical care.^2,5 The 2001 anthrax attacks in the United States and the 2003 severe acute respiratory syndrome (SARS) pandemic prompted the construction of several HLIUs in Europe and the United States; however, these facilities were used sparingly for infrequent HCID cases, if at all.^2,4,5 It was not until the 2014-2016 West Africa EVD epidemic that HLIUs were collectively leveraged during an outbreak, when confirmed cases were treated in HLIUs in Europe and the United States. Nosocomial transmission declined when patients were cared for in an HLIU, and mortality rates for patients treated in HLIUs in Europe and the United States were significantly lower than mortality rates for patients treated in West Africa during the outbreak (18.5% compared with ranges of 37% to 74%, respectively).^6–8 Since 2014, HLIUs have provided care for patients with Lassa fever,^9–11 Crimean-Congo hemorrhagic fever,^12,13 and Mpox (clade I),¹⁴ and they played pivotal roles during the early weeks of the COVID-19 pandemic, when SARS-CoV-2 emerged as a novel virus.¹⁵ Despite HLIUs providing these roles and several units published findings on their experiences,^7–14 little has been published on the current landscape of global high-level isolation,¹⁶ including locations, requirements or standards for HLIU designation, and formalized networks of HLIUs.

The National Emerging Special Pathogens Training and Education Center (NETEC) was established in 2015 to enhance capabilities of healthcare facilities within the United States to prepare for and respond to HCID events.¹⁷ In 2021, NETEC launched its International Partnerships and Programs (IPP) to strengthen collaboration and partnerships among global HLIUs.¹⁶ This focus was grounded on the recognition that increased collaboration among this unique cohort of facilities can advance the fields of high-level isolation and HCIDs by facilitating information-sharing and knowledge generation, promoting research collaborations and innovation, advancing practices, and demonstrating the value of HLIUs and accompanying specialized capabilities locally, nationally, and globally. In 2022, the NETEC IPP team conducted a landscape analysis to inform its strategy. The aims of this study were to identify global high-level isolation capabilities and previous HLIU efforts, determine gaps and priorities of global units, and ultimately establish relationships among existing global HLIUs. This article describes the methodology and key findings from that landscape analysis, as well as a subsequent survey conducted to validate and improve awareness of HLIU locations and priorities.

Methods

Landscape Analysis

A multipronged approach was used to identify global high-level isolation capabilities. We used the definition of HLIU from the European Network for Infectious Diseases (EUNID) in 2009: “a [healthcare] facility specifically designed to provide safe, secure, high-quality, and appropriate care, with optimal infection containment and infection prevention and control procedures, for a single patient or a small number of patients who have, or who may have, a highly infectious disease.”²

From January to April 2022, a literature review was conducted on PubMed and Embase using combinations of the keywords “biocontainment unit,” “high-level isolation unit,” “high-consequence infectious disease,” “special isolation,” “high-level containment,” and “highly infectious disease.” We used a snowballing method to identify other articles through reference checks to expand the search strategy. The literature search yielded 311 items. Titles and abstracts for all results were screened for peer-reviewed articles that included the following details about HLIUs: clinical and operational capabilities, location, experiences, and procedures and protocols. Full articles were reviewed if the abstract described an HLIU or facility that had potential high-level isolation capabilities.

Following the literature search, we conducted a web search of gray literature using combinations of the key terms described above. The search was augmented with the inclusion of specific continents or countries to aid in targeting the search. The web search identified approximately 80 news articles, websites, and publications relating to a confirmed or potential HLIU. Additionally, reports produced by organizations with mandates or interests related to HCIDs and their isolation were reviewed. These included Joint External Evaluation (JEE) reports from 112 countries,¹⁸ Biological Weapons Convention reports,¹⁹ Global Health Security Index 2021 country reports,²⁰ and select United Nations Security Council national reports related to resolution 1540.²¹ These reports were reviewed for keywords and information on confirmed or potential high-level isolation capabilities. All relevant journal articles, web sources, and reports were reviewed for specific information related to confirmed or potential HLIUs, including their locations, capabilities, and leadership contact information. Sources were then reviewed independently by 2 of the authors to determine if the facility met the EUNID definition of an HLIU. HLIUs were considered “confirmed” if they were previously designated/self-reported and information on capabilities or status was found since 2014, the time when many HLIUs were rapidly designated for the EVD epidemic. HLIUs were considered “potential” if they were previously designated but no updated information on status was found or there was reference to advanced capabilities but not enough information to determine if those capabilities would meet the definition of an HLIU. All sources were in English, although the Global Health Security Index country reports included non-English sources.

Survey of HLIU Priorities and Networking Interests

The landscape analysis was designed to identify potential HLIU partners and collaboration areas to inform NETEC IPP’s strategy and focus. Findings from the landscape analysis coupled with a list of HLIUs generated an opportunity to validate findings and further guide NETEC IPP efforts through a survey to existing HLIUs.

Of the 44 HLIUs identified in the landscape analysis, we found updated contact information for 36 units. In December 2022, a 42-question electronic survey, developed using Qualtrics software (Qualtrics, Provo, Utah), was disseminated via email to representatives from those 36 HLIUs. The survey aimed to understand HLIUs’ areas of challenges and best practices and priorities for increased networking and collaboration with a global HLIU cohort, as well as to inventory their high-level capabilities and engagement in HLIU networks or activities; the latter 2 areas are the subject of another manuscript. Participation in the survey was voluntary and individual responses were confidential. Data were coded and analyzed using descriptive statistics in Microsoft Excel.

Results

Landscape Analysis: Terminology and Definitions

Several terms and definitions have been adopted to describe both the specially designed units (referred to as HLIUs in this manuscript) and the diseases warranting this level of advanced isolation capabilities. We found HCID to be the most common and current term for the disease; however, the terms “highly infectious disease” and “highly hazardous communicable disease” were also used. “HLIU” was the most globally used term for the unit, but “biocontainment patient care unit” was most common in North American publications. Other terms used included “special pathogens unit,” “high-level containment care unit,” and “high degree isolation unit.”

Table 1 details terms, definitions, and pathogens warranting care in a specialized unit that have been adopted by networks or groups that have previously defined the terms. Pathogens vary substantially in the level of care required and include certain viral hemorrhagic fevers, Middle East respiratory coronavirus (MERS-CoV) and severe acute respiratory syndrome coronavirus (SARS-CoV-1), Nipah virus, smallpox, and emerging highly pathogenic agents.

Table 1.

Definitions, Terminology, and Lists of Diseases Warranting High-Level Isolation by Previous High-Level Isolation Unit Efforts

Source	Disease Terminology		Isolation Unit Terminology		List of Pathogens/Diseases
Source	Term	Definition	Term	Definition	Pathogens/Diseases Fitting Definition/Warrant Care in Unit
European Network for Infectious Diseases²	Highly infectious disease	“[A]n infection that is transmissible from person to person; is life-threatening; presents a serious hazard in the healthcare setting and the community; and requires specific control measures (eg, high-level isolation).”	High-level isolation unit	“[A healthcare] facility specifically designed to provide safe, secure, high-quality, and appropriate care, with optimal infection containment and infection prevention and control procedures, for a single patient or a small number of patients who have, or who may have, a highly infectious disease.”	Viral hemorrhagic fevers (Argentine hemorrhagic fever, Bolivian hemorrhagic fever, Brazilian hemorrhagic fever, Crimean-Congo hemorrhagic fever, Ebola virus disease, Lassa fever, Marburg virus disease, Venezuelan hemorrhagic fever) SARS-CoV Known or suspected multidrug- and extensively drug-resistant Mycobacterium tuberculosis Emerging highly pathogenic strains of influenza virus Smallpox and other orthopox infections (eg, mpox/monkeypox, camel pox, but excluding vaccinia virus) Other emerging highly pathogenic agents, including agents of deliberate release (eg, pneumonic plague)
US Consensus Meeting⁵	—	—	Biocontainment patient care unit	“[A] facility designed and operated to maximize patient care with appropriate infection control practices and procedures. These units are secure, physically separated from other patient care areas, and have special air-handling systems and advanced personal protective measures for staff.”	“A disease that poses extraordinary public health risks. highly communicable infectious diseases with high morbidity or mortality and limited treatment options.”
UK Health Security Agency¹	High-consequence infectious disease	“In the UK, a high consequence infectious disease (HCID) is defined according to the following criteria: acute infectious disease typically has a high case-fatality rate may not have effective prophylaxis or treatment often difficult to recognise and detect rapidly ability to spread in the community and within healthcare settings requires an enhanced individual, population and system response to ensure it is managed effectively, efficiently and safely”	HCID treatment center (high-level isolation unit used for contact HCIDs)	—	Contact HCIDs Argentine hemorrhagic fever (Junin virus) Bolivian hemorrhagic fever (Machupo virus) Crimean-Congo hemorrhagic fever Ebola virus disease Lassa fever Lujo virus disease Marburg virus disease Severe fever with thrombocytopenia syndrome Airborne HCIDs Andes virus infection (hantavirus) Avian influenza A H7N9 and H5N1 Avian influenza A H5N6 and H7N7 Middle East respiratory syndrome Mpox (clade I only) Nipah virus infection Pneumonic plague (Yersinia pestis) Severe acute respiratory syndrome
Cieslak et al²²	Highly hazardous communicable disease	A disease that is highly hazardous, highly infectious, and highly contagious for which there are no licensed, effective medical countermeasures.	High-level containment care unit	Highly specialized patient care facilities that employ a number of engineering and administrative controls exceeding those found in more conventional infection control patient care environments (such as airborne infection isolation rooms [AIIRs]). HLCC facilities typically have design features that include designated ‘cold, warm and hot’ or ‘clean and contaminated’ zones; negative pressure and specialized air handling; autoclaves for waste management; video monitoring systems; and secured access.	1. Persons with diseases having the potential for person-to-person transmission whose causative agents require handling under BSL-4 laboratory conditions, such as: viral hemorrhagic fevers (Argentine hemorrhagic fever, Bolivian hemorrhagic fever, Brazilian hemorrhagic fever, Crimean-Congo hemorrhagic fever, Ebola virus disease, Lassa fever, Lujo virus disease, Marburg virus disease, Venezuelan hemorrhagic fever) and henipavirus infections (Hendra, Nipah, smallpox) 2. Persons with other diseases caused by highly hazardous pathogens with the potential for person-to-person transmission, such as severe acute respiratory syndrome, Middle East respiratory syndrome, mpox, pneumonic plague, extensively drug-resistant tuberculosis, and novel and highly pathogenic influenza 3. Persons with apparently severe disease of unknown etiology for which optimal therapy and infection control measures are unknown 4. Persons with apparently severe disease for which public assurance concerns might warrant management under high-level containment conditions

Abbreviations: BSL-4, biosafety level 4; HCID, high-consequence infectious disease; HLCC, high-level containment care.

Landscape Analysis: Previous Efforts in HLIU Coordination

Two regional consensus efforts were conducted in the mid-2000s: (1) a 2006 US consensus meeting attended by civilian and military professionals with expertise in high-level isolation that concluded with a consensus statement outlining the key technical, infection control, and ethical issues in planning, designing, and constructing an HLIU⁵; and (2) meetings in Europe supported by the European Commission—through the EUNID (2006-2009) and European Network for Highly Infectious Diseases (EuroNHID) projects (2009-2011)—resulted in consensus recommendations for the framework and design of HLIUs, checklists to assess HLIUs, and a mapping of high-level isolation capabilities in Europe.^2,23,24 As of 2010, EuroNHID reported 18 HLIUs in Europe and mentioned national networks of HLIUs in France and Germany.²⁴ The US and European consensus efforts generated recommendations that remain the pillars for designing an HLIU.

National networks of HLIUs were identified in several countries, including France,²⁵ Germany,^26,27 Japan,²⁸ Spain,²⁹ the United Kingdom,³⁰ and the United States.³¹ While information on requirements for these facilities and descriptions of how HLIUs collaborate, coordinate, and network were available for some countries, this information was lacking for others.^26,27,30-33 We found 2 cases of international networking of HLIUs: (1) representatives from 22 HLIUs convened for a workshop in 2018 to share best practices and approaches based on experiences caring for HCID cases, and (2) an informal network of 5 HLIUs across the United States, Europe, and Asia was established in 2017 and was leveraged for rapid knowledge exchange in the first months of the COVID-19 pandemic.^34,35

NETEC’s IPP is building on both efforts by regularly convening HLIU representatives to discuss and address unique challenges facing HLIUs.³⁶ However, we found no formalized networks or convening bodies that oversee or convene HLIUs regionally or globally.

Landscape Analysis: Locations of Global HLIUs

Findings on global high-level isolation capabilities are detailed by country in Table 2 and mapped in Figure 1. Nearly all identified HLIUs are in high-income countries in Europe, North America, Australia, and Asia. We found references to “special isolation” facilities, designated hospitals for EVD cases in 2014, or dedicated infectious disease units in several low- or middle-income countries; however, further details on the existence and specific capabilities of these facilities were not available. Many HLIUs were established following the 2014-2016 West Africa EVD epidemic; for many of these units, however, it is uncertain whether those capabilities were maintained after the immediate threat of the epidemic waned due to a lack of references or updated information since 2015 or 2016. Conversely, we found several instances of HLIUs being established in the last several years.

Figure 1.

Global mapping of confirmed (established), in development (planned), and potential (possible) high-level isolation units (HLIUs) based on a search of peer-reviewed and gray literature, April 2022. Map created with mapchart.net.

Table 2.

Potential and Confirmed High-Level Isolation Capabilities, Organized by Country

Country by WHO Region	Description of Capabilities	Capabilities:Confirmed or Potential^a
Sub-Saharan African Region (AFRO)
Ghana	A 25-bed infectious disease treatment center opened in Accra in October 2020, originally conceived for EVD. High-level isolation capabilities of the center are unknown.³⁷	Potential
Nigeria	Two infectious disease hospitals were designated for EVD care in 2014. Capabilities and sustainability of those capabilities are unknown.³⁸	Potential
South Sudan	A 10-bed infectious disease unit was jointly developed by WHO and the South Sudan Ministry of Health for HCIDs and opened in December 2018. Details on the unit’s capabilities were not found.³⁹	Potential
Uganda	A hospital houses a 6-bed infectious disease isolation unit, designated for patients with EVD or Marburg virus disease. It is unclear if the facility meets the definition for an HLIU.⁴⁰	Potential
Region of the Americas (AMRO)
Argentina	In 2014, at least 2 hospitals were designated for EVD. Further details on capabilities or maintenance of designation after the West Africa EVD epidemic are unavailable.⁴¹	Potential
Brazil	A suspected case of EVD was transferred to a designated hospital in Rio de Janeiro in 2014.⁴¹ Further details on the hospital’s capabilities are not available.	Potential
Canada	Two biocontainment units were identified, in Alberta and British Columbia.^42,43	Confirmed
Mexico	The GHS Index country report⁴⁴ mentions capacity to isolate patients with EVD; however, the identified unit was a severe burn unit designated for suspected EVD cases in 2014. No further details were available.	Potential
United States^b	Ten HLIUs have been designated, with 1 in each of the 10 Health and Human Services Regions as Regional Emerging Special Pathogens Treatment Centers (RESPTCs). RESPTCs partner with the National Emerging Special Pathogens Training and Education Center.⁴⁵	Confirmed
Eastern Mediterranean Region (EMRO)
Afghanistan	In 2016, WHO and the Afghanistan Ministry of Health collaborated to build a dedicated 10-bed infectious disease unit specializing in infection prevention, including for Crimean-Congo hemorrhagic fever, considered by many groups to be an HCID.⁴⁶ No additional details were found on the unit’s capabilities.	Potential
Lebanon	Lebanon’s JEE (2016) names a hospital in Beirut with “isolation capabilities for suspected or confirmed EVD”; exact capabilities were not found.⁴⁷	Potential
Libya	The EuroNHID working group found media reports that refer to a “special isolation unit.”⁴⁸ No additional details were found.	Potential
Morocco	The EuroNHID working group found media reports that refer to a “special isolation unit.”⁴⁸ No additional details are available.	Potential
Saudi Arabia	As of 2015, 20 hospitals were designated for cases of MERS, considered an HCID. Two units were identified as having more advanced capabilities, but it is unclear if any of the hospitals or units would meet the standards of an HLIU.^49-51	Potential
Qatar	The Communicable Disease Center serves as an isolation hospital for pandemic events of emerging or reemerging infectious diseases, including for SARS, MERS, Ebola, and pandemic influenza.⁵² No additional information was provided on specific capabilities.	Potential
United Arab Emirates	The GHS Index country report mentioned 1 hospital that has an isolation ward designated “to handle diseases from leprosy to [Crimean-Congo hemorrhagic fever],” the latter of which is considered by many groups to be an HCID. Listed capabilities included negative pressure ventilation systems, security, and separated rooms; however, this is not enough information to determine if the isolation ward would be considered an HLIU.⁵³	Potential
European Region (EURO)
Andorra	The GHS Index country report for Andorra noted the government of Andorra announced in 2014 that it had a biocontainment patient care unit capable of caring for patients with an HCID. No information was found on its capabilities or if the unit was a temporary measure for the West Africa EVD epidemic.⁵⁴	Potential
Austria	The GHS Index country report for Austria noted a hospital in Vienna was reported to have an isolation unit for EVD cases in 2014 and also cared for patients with COVID-19 in January and February 2020, when SARS-CoV-2 was a novel pathogen.⁵⁵ No other information on HLIU capabilities in Austria was found.	Potential
Belarus	The GHS Index country report for Belarus cited a 2014 media report that a hospital had been designated as an Ebola treatment hospital; however, the capabilities described were limited and no additional information was found to indicate whether the hospital would be considered an HLIU.⁵⁶	Potential
Belgium	EUNID noted only partial data from Belgium in their HLIU mapping.⁵⁷ Information in the JEE and the GHS Index report related to HLIU capacity is nondescriptive, although a 2015 European Centre for Disease Prevention and Control mission report on EVD preparedness in Belgium mentioned 2 hospitals having a dedicated Ebola treatment ward.⁵⁸	Potential
Cyprus	The EuroNHID working group described special isolation capabilities within an airborne infection isolation unit in the country’s capital.⁴⁸ Specific information on capabilities was unavailable.	Potential
Czech Republic	A military hospital and a civilian hospital are both designated treatment centers for HCIDs and sufficient information was provided to classify both as HILUs.⁵⁹	Confirmed
Denmark	A 2017 reference reports 2 HLIUs in Denmark.⁶⁰	Confirmed
Finland	The EUNID and EuroNHID projects reported a hospital in Helsinki had an 8-room HLIU in a separate building from the main hospital.^24,57 Current capabilities and status of this unit were not found.	Potential
France	The EuroNHID project identified 5 HLIUs in France, each in a different city, while 6 were identified in the EuroNHID working group manuscript on HLIU capabilities in the Mediterranean region.^24,48 A 2015 article reported there were 12 referral centers for EVD in France, 9 within French national territory and 3 in overseas territories; however, it is unknown if all 12 would meet the definition of an HLIU.²⁵	Confirmed
Germany	Germany has 7 HLIUs that are organized into a permanent working group through the federal health organization, the Robert Koch Institute.^26,27	Confirmed
Greece	A hospital in Athens had previously been designated an HLIU during EuroNHID’s HLIU mapping.^24,48 Current status of the unit is unknown.	Potential
Ireland	The National Isolation Unit is an HLIU located in Dublin, Ireland. Initially established in 2008, it was redesigned and reconfigured in 2021-2022.^61,62	Confirmed
Israel	A freestanding HLIU in Haifa was described in response to 2014; however, current capabilities and status are unknown.^48,63	Potential
Italy	Two HLIUs were identified during the EUNID and EuroNHID projects; however, we found updated reference to only 1 of these in the literature, and it is unclear if the other is currently active.^24,57 Another HLIU was in development as of 2020.⁶⁴	Confirmed
Luxembourg	The National Service for Infectious Disease was reported to have the capability to house up to 2 patients with EVD. Specific capabilities of the isolation facility were unavailable. An agreement was established with France and Germany to enable Luxembourg to use university hospitals in France and Germany if national capacity was exceeded.⁶⁵	Potential
Malta	A 2-bed HLIU was completed in June 2021.⁶⁶	Confirmed
The Netherlands	An HLIU in Utrecht cared for a patient with EVD in 2014; however, current status of the unit is unknown.⁶⁷ A new HLIU opened in the Netherlands in 2022.⁶⁸	Confirmed
Norway	A national resource center for chemical, biological, radiological, nuclear, and explosives medicine is located in Oslo. It includes a 4-room HLIU that opened in 2008. The unit cared for a patient with EVD in 2014.⁶⁹	Confirmed
Poland	As of 2015, at least 1 hospital reported capabilities for isolating HCID cases, although examples given included EVD (an HCID), but also tuberculosis and malaria (not considered HCIDs).⁷⁰ Specific capabilities of the unit were not available.	Potential
Portugal	Two hospitals have designated 2-bed units for patients with VHFs.⁷¹ However, current capabilities and status of the units are unknown.	Potential
Slovakia	The GHS Index country report for Slovakia reports a hospital in Bratislava is the designated center for HCID cases and has capabilities that “meet the 4th degree of biological safety – BSL-4.”⁷² However, no date was assigned to the cited reference and no additional information on the hospital’s capabilities for providing HCID care were found.	Potential
Spain	A hospital in Madrid has a designated high-level isolation unit with experience with Congo-Crimean hemorrhagic fever and EVD.^8,12,73 An additional 5 hospitals have been identified as HLIUs, although experience and capabilities are unknown.²⁹	Confirmed
Sweden	Reference to 1 HLIU was found in Sweden. Capabilities of this unit were described in the 2009 EuroNHID project.^11,23	Confirmed
Switzerland	A hospital in Geneva cared for a repatriated patient with EVD in 2014, but current status and capabilities of the unit are unknown.⁷⁴	Potential
United Kingdom	There are 5 HCID treatment centers in England; all 5 are airborne HCID treatment centers and 2 are contact HCID treatment centers. The 2 contact HCID treatment centers meet the definition of an HLIU.¹	Confirmed
Southeast Asian Region (SEARO)
Bangladesh	An isolation unit at a hospital in Dhaka was established for management of MERS cases. No further details were available.⁷⁵	Potential
India	A 200-bed infectious disease hospital was being planned in Sarangpur as of 2020, with plans to include an HLIU.⁷⁶	In development
Indonesia	A 2016 report found Indonesia was 1 of 3 SEARO countries (excluding India) to have evidence of operational readiness to isolate and manage suspected or confirmed EVD cases, which was defined as suitable isolation rooms, extensively trained staff, appropriate supplies, and waste management systems. However, specifics and current status of these capabilities were not found.⁷⁷	Potential
Sri Lanka	A 2016 report found Sri Lanka was 1 of 3 SEARO countries (excluding India) to have evidence of operational readiness to isolate and manage suspected or confirmed EVD cases, which was defined as suitable isolation rooms, extensively trained staff, appropriate supplies, and waste management systems. However, specifics and current status of these capabilities were not found.⁷⁷	Potential
Thailand	A 2016 report found Thailand was 1 of 3 SEARO countries (excluding India) to have evidence of operational readiness to isolate and manage suspected or confirmed EVD cases, which was defined as suitable isolation rooms, extensively trained staff, appropriate supplies, and waste management systems. However, specifics and current status of these capabilities were not found.⁷⁷	Potential
Western Pacific Region (WPRO)
Australia	A 6-bed HLIU was established at a hospital in New South Wales in 2021.⁷⁸ A 2020 article stated that there are 13 VHF biocontainment units in Australia; however, no additional information about these capabilities were available.⁷⁹ A 2023 article on the New South Wales unit reports it is the first HLIU in Australia.⁸⁰	Confirmed
China	A hospital in Shanghai has specialized negative pressure wards and an HLIU was developed following the 2003 SARS outbreak.³⁵ In 2014, Taiwan established a tiered approach for emerging special pathogens, including 6 regional centers for care of Class I pathogens (smallpox, hemorrhagic fevers).⁸¹	Confirmed
Hong Kong (China)	A 110-bed infectious disease center is specially designed for the treatment of infectious diseases. It is unknown if the center includes an HLIU.⁸²	Potential
Japan	At least 4 hospitals were designated for HCIDs as of 2017. The capabilities of only 1 of those facilities were described; it is unclear if the other 3 designated hospitals would be considered HLIUs.^28,83	Confirmed
New Zealand	An “Ebola unit” was established in 2014 in Auckland while a 2020 article reported there were 4 VHF biocontainment units in New Zealand; however, no additional specifics were found on these capabilities or if the 2014 unit remains active.^79,84	Potential
Singapore	The National Centre for Infectious Disease, which opened in 2019, is a 330-bed purpose-built facility for infectious diseases. It includes a high-level isolation ward with 4 HLIUs and 8 beds.⁸⁵	Confirmed
South Korea	At least 2 hospitals were reported to have HLIUs, including 1 that was the MERS-designated hospital during the 2014 outbreak.^86,87	Confirmed

Note: High-level isolation capabilities were identified through a global landscape analysis of literature conducted January to April 2022.

“Confirmed” indicates the unit was previously designated or self-reported as an HLIU and information on unit capabilities/status have been published since 2014. “Potential” indicates previous designation as an HLIU with no information on status since 2014, or there was reference to advanced capabilities but not enough information to determine if those capabilities would meet the definition of an HLIU.

At the time of the landscape analysis, there were 10 federally designated HLIUs in the United States. In September 2022, an additional 3 HLIUs were designated.

Abbreviations: EUNID, European Network for Infectious Diseases; EuroNHID, European Network for Highly Infectious Diseases; EVD, Ebola virus disease; GHS, Global Health Security; HCID, high-consequence infectious disease; HLIU, high-level isolation unit; JEE, Joint External Evaluation; MERS, Middle East respiratory syndrome; SARS, severe acute respiratory syndrome; SEARO, South-East Asia Region Office; VHF, viral hemorrhagic fever, WHO, World Health Organization.

In total, we found 44 previously designated/self-described HLIUs in 19 countries. Of note, the landscape analysis was conducted prior to the naming of 3 additional US units as Regional Emerging Special Pathogens Treatment Centers⁸⁸; as such, only the 10 US HLIUs that were designated as of early 2022 were included in these data. Findings indicated another 2 units were in development; 1 of these units was in a country with a confirmed HLIU (Italy)⁶⁴ while the other was in a country without reference to established HLIUs (India).⁷⁶ An additional 33 countries had potential HLIUs; however, there were not enough details on capabilities to determine if they fit the HLIU definition. We found no confirmed reference to HLIUs in Sub-Saharan Africa, Latin America, or the Middle East and North Africa regions.

Survey of HLIU Priorities and Networking Interests

Of the 36 HLIUs that were sent the survey, 31 (86%) completed it, representing units from 16 countries in Asia, Europe, North America, and the Pacific. Notably, 2 of the 5 facilities that did not complete the survey no longer had active HLIU programs. Responding HLIUs were asked to list the number of HLIUs in their country and names of any HLIUs they currently networked or collaborated with outside of their country. Of the 16 countries represented in the survey, 12 (75%) had multiple HLIUs, although several respondents noted that capabilities varied between those designated units. In total, responses revealed an additional 30 confirmed HLIUs that were not identified in the landscape analysis. Several of these were considered “potential” HLIUs in the landscape analysis, as they were listed in the EuroNHID project as HLIUs but updated information on their capabilities was not available at the time of the study. However, most of these newly identified HLIUs are in addition to units in countries where we found reference to only 1 or 2 HLIUs through the landscape analysis.

Responding HLIUs reported several areas of challenges and best practices (Figure 2). Maintaining a cadre of highly trained staff was the most cited challenge (n=22, 71%), followed by global networking and coordination with other HLIUs and hospitals in their area (n=20, 65%), research (n=17, 55%), and training (n=18, 58%). All responding units indicated their willingness to share best practices with other HLIUs, with training (n=21, 68%), physical infrastructure/design (n=21, 68%), and infection prevention and control practices (n=19, 61%) being the most cited areas where these best practices were available. All 31 responding HLIUs (100%) reported interest in networking with other HLIUs, including through virtual or in-person meetings (n=30, 97%), joint trainings or exercises (n=30, 97%), knowledge-sharing webinars (n=29, 94%), and collaborative multisite clinical research protocols (n=27, 87%) (Figure 3).

Figure 2.

Reported best practices/innovations and challenges or areas that could benefit from increased global networking and collaboration, by percentage of responding HLIUs (N=31). Abbreviations: HLIU, high-level isolation unit; IPC, infection prevention and control; MCM, medical countermeasure.

Figure 3.

Reported priority areas for increased global networking and collaboration, by percentage of responding HLIUs (N=31). Abbreviation: HLIU, high-level isolation unit.

Discussion

The primary functions of HLIUs are to provide safe and effective care for patients with HCIDs and to mitigate transmission risks to healthcare personnel and the community through physical infrastructure and other engineering controls, administrative controls, personal protective equipment, and highly trained multidisciplinary teams.^2,5 As such, HLIU processes and approaches differ from routine clinical settings, and they face challenges atypical of other clinical teams. Common challenges reported by HLIUs in the literature (summarized in Lukowski et al⁸⁹) and in the survey include determining (1) the appropriate frequency, duration, and type of training necessary for HLIU team members to maintain competencies; (2) optimal infection prevention and control processes; (3) strategies to recruit and maintain highly trained teams, and (4) physical design and necessary infrastructure features. Although previous consensus efforts have agreed upon critical components of HLIUs,^2,5 and although facilities that have cared for patients with HCIDs have published their approaches,⁸⁹ there remains a lack of data and validation testing to guide process development and physical design. There is an opportunity to advance these approaches by cultivating forums for HLIUs to share best practices and collaborate to conduct translational and applied research.

It is unknown how frequently and to what extent existing global HLIUs are being assessed. The EuroNHID project developed checklists to assess isolation facilities in the European region in 2010 and used those checklists to evaluate the capabilities of 48 isolation facilities in 16 countries, including 18 facilities that fulfilled the definition of an HLIU.²⁴ However, this assessment was conducted over a decade ago, and no other information was found on how frequently, if at all, these 18 units have since been assessed nationally or regionally. In Germany, national regulations describe technical rules for biological agents including constructional and technical requirements for HLIUs, while the UK-designated facilities for airborne HCIDs have specifications from NHS England.^32,33 In the United States, NETEC facilitates annual assessments of the 13 federally designated HLIUs, a requirement for their designation by the US Administration for Strategic Preparedness and Response.⁹⁰ The EuroNHID project found that most isolation centers in Europe did not have access to legally binding regulations on issues of infrastructural or technical requirements at the time of establishment; it is unclear if over 10 years later more legal requirements are in place. It is also unknown if other countries have requirements (legal or otherwise) for HLIUs. The lack of a standard definition for what constitutes an HLIU results in ambiguity in a shared understanding of the minimum requirements and resources to optimally protect healthcare teams. Further, although outcomes of the US consensus meeting and the EUNID and EuroNHID projects continue to be guiding posts for the critical components of an HLIU, the last decade has vastly increased the operational experience of many HLIUs and transformed the field of HCID preparedness and response; indeed, there is much to be learned just from the roles HLIUs played in the early COVID-19 pandemic and their response to a novel pathogen. There is opportunity for the global HLIU community to collaborate to close this gap and update previous consensus efforts to define recommendations for HLIUs.

As evidenced by comparing results from the landscape analysis and HLIU survey, there are major visibility gaps in global high-level isolation capabilities. The survey identified an additional 30 HLIUs for which we found either no confirmed reference in the literature or web searches, or the reference(s) to the unit were dated more than 10 years ago. This lack of global visibility has several implications, including challenges in rapidly identifying hospitals to transport HCID cases within countries, regionally, or globally; gaps in perceived regional and global preparedness for HCID cases; HLIUs working in silos to address problems and challenges that many other units likely face (eg, recruiting and maintaining highly trained teams, funding and/or sustaining the unit and its capabilities, determining optimal infection prevention and control processes); and potential resource distribution gaps for HLIUs. Moreover, to our knowledge, informed by results of the landscape analysis and survey, we found no formalized networks or convening bodies that oversee HLIUs regionally or globally that would maintain a comprehensive list of known global HLIUs. There is an opportunity for an international organization to document these resources and convene a network to collectively advance the gaps, challenges, and issues identified in the landscape analysis and survey.

Notably, an initiative by the European Commission, the Strengthened International Health Regulations and Preparedness (SHARP) Joint Action project, published a report in fall 2023 (after our landscape analysis was complete) identifying 47 HLIUs in 16 European countries.⁹¹ While this is an important addition to the literature, results were self-reported by member states and not by individual HLIUs using a clinical vignette; it is unclear how many of those units would fit the definition of an HLIU. In addition to validating some of our landscape analysis findings, the SHARP Joint Action project reported HLIUs in several countries (eg, Estonia, Lithuania, Slovenia) where we found no previous HLIU reference. In addition to a mapping of HLIUs, the SHARP Joint Action project conducted a feasibility study for a formal HCID expert clinical support network. Such regional and international clinical networks can strengthen national HCID plans as well as broader global health security.

There is an economic element and inherent inequity to the location of HLIUs, as nearly all identified units were in high-income countries. HLIUs have previously reported significant financial and resource demands to establish capabilities and sustain readiness.³⁴ Although these costs are a barrier to HLIU development regardless of location, the lack of identified HLIUs in 3 populous world regions means that only a small minority of the global population has access to an HLIU. It is important to acknowledge that there has undoubtedly been successful management and care of patients in HCID outbreaks in non-HLIU facilities in these regions; however, HLIU capabilities offer additional safeguards to enhance the protection of healthcare teams and provide advanced controls for delivering higher-level supportive care. Further exploration is warranted to determine (1) whether capabilities exist in these regions (but are not public), (2) the barriers to establishing such capabilities in these regions, (3) interest of regional and national authorities to strengthen or establish these capabilities, and (4) the need for or potential value, structure, and role of HLIUs in these regions. There are also opportunities for the global HLIU collective to publish findings on how to optimize the HLIU program to offset costs of maintenance, which may include evaluating the return on investment for these units. Such an analysis should look at not only the individual hospital cost-benefits, but also those of the local, regional, and national communities.

This research was not without limitations. The list of identified HLIUs in the landscape analysis is not exhaustive; as was found in the survey, many countries/hospitals have high-level isolation capabilities but have not published or been publicized. The landscape analysis focused only on HLIU capabilities and did not capture the capacity of these units (ie, number of HLIU beds). The search was also conducted in English, which possibly excluded local or national references to high-level isolation capabilities. The current definitions of what constitutes an HLIU are vague; while the landscape analysis and subsequent selection of HLIUs for the survey included facilities that have been reported in the literature or media as HLIUs, the capabilities between these facilities vary. Moreover, many of the listed units in the landscape analysis had previously been identified as HLIUs, but their current capabilities and designations were unknown. This is especially true for many of the listed European units that were assessed in the 2009-2011 project; whether they maintain that designation over a decade later is unknown. Likewise, several units listed as “unknown capabilities” in some regions were designated units for EVD in 2014-2016, but we could find no further information on whether those capabilities were sustained after the epidemic ceased. Lastly, we did not validate the HLIUs that were reported by responding HLIUs in the survey.

Conclusion

NETEC’s IPP conducted a landscape analysis of global high-level isolation capabilities to inform its strategy and guide its efforts. To strengthen and validate the findings, we disseminated a survey to 36 known HLIUs identified in the landscape analysis. To our knowledge, this was the largest ever survey of global HLIUs. Survey findings identified major gaps in the visibility of HLIUs: while our landscape analysis initially identified 44 units, the survey unveiled an additional 30 HLIUs that had not been previously identified or confirmed. The additional fact that 2 of the HLIUs invited to respond to the survey were no longer active programs reflects the ever-evolving global landscape. The lack of formalized regional or global coordinating organizations exacerbates these visibility gaps.

The unique characteristics and capabilities of these facilities, coupled with the likelihood these units serve as core components of national health security plans, provides an opportunity for increased connection and networking to advance the field of high-level isolation and address identified gaps in coordination, build an evidence base for HLIU approaches, and inform HLIU definitions and key components. Increased networking of these units can enhance opportunities for research and collaboration to inform and improve approaches, procedures, and processes; in turn, this could lead to validation testing and evidence-based standards or guidelines, particularly around areas unique to HLIUs where evidence is currently scarce or lacking. More formalized mechanisms of engagement could increase visibility of these facilities and be leveraged to advocate for resourcing and funding to sustain HLIU programs. Lastly, facilitating networking of this unique cohort could generate innovation and knowledge advancements more broadly for HCID readiness.

Footnotes

Acknowledgments

The National Emerging Special Pathogens Training and Education Center is funded by the US Administration for Strategic Preparedness and Response (U3REP150549).

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High-Level Isolation: A Landscape Analysis of Global Capabilities and Opportunities to Advance the Field

Abstract

Introduction

Methods

Landscape Analysis

Survey of HLIU Priorities and Networking Interests

Results

Landscape Analysis: Terminology and Definitions

Landscape Analysis: Previous Efforts in HLIU Coordination

Landscape Analysis: Locations of Global HLIUs

Survey of HLIU Priorities and Networking Interests

Discussion

Conclusion

Footnotes

Acknowledgments

References