1. International Health Regulations (2005) and the Laboratory Role in Disease Surveillance

2. The Quality Management System
Organization
Personnel
Equipment
Purchasing & Inventory
Process Control
Information Management
Documents & Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities & Safety
International Health Regulations

3. Brief History of the International Health Regulations (IHR)
1851: first International Sanitary Conference, Paris
1951: first International Sanitary Regulations (ISR) adopted by WHO member states
1969: ISR replaced and renamed the International Health Regulations (IHR)
1995: call for Revision of IHR
2005: IHR (2005) adopted by the
World Health Assembly
2006: World Health Assembly vote that IHR (2005) will enter into force in June 2007
International Health Regulations

4. The purpose and scope of IHR
To prevent, protect against, control and provide a public health response to the international spread of disease
To establish a single code of procedures and practices for routine public health measures
International Health Regulations

5. Major Changes in IHR (2005)
Widened scope: to report all major events, that may constitute Public Health Emergency of International Concern (PHEIC)
Notification by designated National IHR Focal Points
National core capacities for detection and response
Real time event management system
International Health Regulations

6. Public Health Emergency of International Concern (PHEIC)
Definition (Article 1):
“public health emergency of international concern means an extraordinary event which is determined, as provided in these Regulations:
(i) to constitute a public health risk to other States through the international spread of disease and
(ii) to potentially require a coordinated international response”
International Health Regulations

7. Decision Instrument
Annex 2 of the Regulations is an instrument that directs States to notify WHO of events that may constitute a PHEIC
International Health Regulations

8. Is an event notifiable to WHO?
Is the public health impact of the event serious?
Is the event unusual or unexpected?
Is there a significant risk of international spread?
Is there a significant risk of international restrictions to travel and trade?
International Health Regulations

9. Core Capacity Requirements
Countries must have capacities “to detect, report and respond” to risks in general, and to those at international ports, airports and land crossings:
Annex 1A: core capacity requirements for surveillance and response
Annex 1B: core capacity requirements for
designated airports, ports and ground crossing
International Health Regulations

10. Capacities at three levels
the local community level
intermediate public health response levels
at the national level
International Health Regulations

11. Capacities at the national level
Capacities for assessment and notification:
(a) to assess all report of urgent events within hours; and
(b) to notify WHO immediately (within 24 h assessing a PHEIC) through the National IHR Focal Point
Capacities for public health response:
(a) – (h) to determine the control measures, to provide support, to provide direct operational link, etc.
International Health Regulations

12. National IHR Focal Points
“the national centre, designated by each State Party which shall be accessible at all times for communication with WHO Contact Points” (Article 4)
National IHR Focal Point shall be accessible at all times for communications with WHO IHR Contact Points
WHO shall designate IHR Contact Points, which shall be accessible at all times for communications with National IHR Focal Points
International Health Regulations

13. Support for States Parties
WHO will coordinate the provision of international assistance at the request of States Parties, in support of activities
Through the Global Outbreak Alert and Response Network, the affected Member State will have access to over 120 network partners
When requested, WHO will work closely and confidentially with the affected Member State for verification and assessment of the risks, and organization of the response.
International Health Regulations

14. Global Outbreak Alert and Response Network A “network of networks”
120 institutions and networks who pool resources for outbreak alert and response, and daily assessment of disease outbreaks
Rapid assistance (identification, verification and communication)
Global outbreak preparedness
and response strategies
International Health Regulations

15. Laboratory role in context of IHR
“Laboratory” is quoted 6 times in the text, in 5 sections in IHR (2005)
Detection  laboratory data to be reported - if available - as an early warning signal (annex 1)
Assessment of events (insufficient laboratory capacity = serious event) (annex 2)
Notification to WHO (continuous communication of laboratory results) (art. 6)
Response element (laboratory analysis of samples, domestically or through collaborating centres) (annex 1)
Recommendations by WHO with respect to the persons may include any laboratory analysis (art. 18)
International Health Regulations

16. Core requirements in a nutshell (1)
Inventory of country laboratory capacity
Designation of laboratories for surveillance and response with clear role and responsibilities
Collection, packaging and shipment of samples
Collaboration with outside collaborating centers when no corresponding domestic capacity available
An IHR national laboratory coordinator to ensure the coordination of the laboratory system
International Health Regulations

17. Core requirements in a nutshell (2)
Strong focus on quality assurance:
compliance of the reference laboratories with the internationally recognized standards
development of national quality assurance programs
successful participation in External Quality Assessment program(s)
International Health Regulations

18. WHO Office in Lyon a key component of WHO’s IHR Coordination Programme
a unique resource for WHO Regional and country Offices
Provide Member States:
training for laboratory specialists
laboratory quality assurance programmes
laboratory standards and guidelines
IHR laboratory capacity assessment tools
surveillance systems strengthening
International Health Regulations

19. IHR timeframe May 2005 World Health Assembly adopted the revised IHR
15 June 2007 IHR entered into force and are binding on 194 States Parties
Member States assess and improve their national core capacities for surveillance and reporting
2012 the core capacities are in place and functioning
For more information visit:
International Health Regulations

20. Purchasing & Inventory Information Management Occurrence Management
Organization
Personnel
Equipment
Purchasing & Inventory
Process Control
Information Management
Documents & Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities & Safety
Questions? Comments?
International Health Regulations