Biosafety and Biosecurity Challenges in the Caribbean Region Valerie Wilson Caribbean Med Labs Foundation Anticipating Global Biosecurity Challenges Istanbul,

Biosafety and Biosecurity Challenges in the Caribbean Region Valerie WilsonCaribbean Med Labs FoundationAnticipating Global Biosecurity Challenges Istanbul, TurkeyJuly, 2011

Caribbean Med Labs Foundation

Outline

Caribbean Region – the realities Biosafety Assessment Results Major Issues Some Solutions



Caribbean Region Key strategic location linking North and South

America Most tourism dependant region in the world:

North America Europe China India

Highly vulnerable to biosafety and biosecurity risks – anthrax, H1N1, SARS, etc.

Major potential impact on economy and local and regional populations


Background Caribbean Med Labs Foundation – Caribbean

Region 23 countries:

English, French, Spanish, Dutch

Major economic differences – GDPs: Haiti - $600 US per capita Cayman Islands - $44,000 US

Major population differences – Haiti – 8 million; Montserrat – 4,000


Caribbean Med Labs Foundation Objectives:

Developing the supportive environment for high quality regional laboratory services

Advocating at the highest levels for laws, regulations and accreditation of laboratories

Mobilising resources for lab strengtheningMapping of a regional sustainability strategy


The Caribbean Laboratory Network

Bermuda

Guyana

Suriname

Caribbean Biosafety Assessment Results


Target Institutions

Medical Labs Public Health Labs Veterinary Labs Agriculture Labs Labs conducting Zoonotic disease testing Food and Water Labs


Assessment Tool

Total of 204 Questions in 20 Categories addressing: General Infrastructure at National Level International Health Regulations Laboratory Safety Standards

Initial focus on medical and public health laboratories (major national labs) in 13 countries

Assessment Results

General


Formal Network for Co-ordination of Laboratory Operations in country

1.5 Is there a formal or National Laboratory Network allowing for coordination of laboratory operations in the country?

54%

46%Yes

No


Network and labs involved in Animal testing

1.6 Does this Network include labs that are involved in:e. Animal Testing

8%

30%

31%

8%

23%

Yes No Not Applicable Don't Know No Response


Formal collaboration between MOH and Min of Agriculture on Zoonotic diseases

1.11 Is there a formal mechanism for the collaboration between Min of Health and Min of Agriculture on Zoonotic diseases?

23%

31%

31%

15%

Yes No Don't Know No Response

Assessment Results

International Health Regulations


Adoption of WHO policies for laboratory biosafety nationally

2.1 a. Have WHO regulations, policies or strategies for laboratory biosafety been adopted nationally?

15%

62%

23%

Yes No Don't Know


National regulations or policies for laboratory biosafety

2.1b. Have national regulations, policies or strategies for laboratory biosafety been developed?

15%

62%

23%

Yes No Don't Know


Regulatory framework for enforcement

2.2.Is there a regulatory framework for enforcement of these guidelines nationally?

8%

54%

23%

15%

Yes No Not Applicable Don't Know


Accessibility of biosafety guidelines

2.3 Are biosafety guidelines accessible to individual laboratories?

39%

15%8%

38%



Responsibility for laboratory biosafety and biosecurity nationally

2.4 Has a responsible entity e.g. expert committee, institution or national centre of biosafety expertise/excellence” within Min Health, been designated for laboratory

biosafety and biosecurity at the national level?

8%

61%

31%

Yes

No

Don't Know


Biosafetly guidelines, manuals and SOP dissemination

2.5 Are biosafety guidelines, manuals or SOPs disseminated to laboratories?

30%

31%

8%

31%



Staff training in biosafety

2.6 Are relevant staff trained in biosafety guidelines?

54%

23%

23%

Yes No Don't Know


National System for biosafety levels

2.8 Is there a national system of biosafety levels for laboratories (ie clear criteria for the design and operation at each biosafety level)?

8%

61%

31%

Yes No Don't Know


Biosafety Inspection Responsibility

2.9 Has an institution or person been designated responsibilty for inspection (including certification of biosafety equipment) of laboratories for compliance with

biosafety requirements?

15%

62%

23%

Yes

No

Don't Know


Implementation and Monitoring

2.10 Are biosafety procedures implemented and regularly monitored nationally?

8%

61%

31%

Yes

No

Don't Know


Biorisk Assessments

2.11 Has biorisk assessment been conducted in laboratories to guide and update biosafety regulations, procedures and practices, including

decontamination and management of infectious waste?

54%

46% No

Don't Know


Biocontainment Engineering Expertise

2.13 Is there biocontainment engineering expertise to design, build, and maintain these laboratories?

77%

23%

No

Don't Know

Assessment Results

Laboratory Safety Standards


Laboratory Biosafety Levels

13 countries responded Only 2 of these countries have a Biosafety

Level 3 laboratory (or Level 2.5 with 3 practices) – mainly developed for TB testing

There are 3 other Biosafety Level 3 labs already existing or under development within the region


Safety ManagementQuestion Yes No DK/

NR

Safety Officer 9 4

Safety/Biosafety Officer 7 4 2

Documented evidence of staff training 2 9 2

Medical Surveillance and Occupational Health Programme

4 6 3

Records of staff immunisation 8 4 1

Annual safety audit 2 10 1

Formal system for risk assessment 1 9 3

Safety Committee 6 6 1

Safety Manual available to staff 6 7


PPE and other protective equipmentQuestion Yes No DK/

NR

PPE – coats and gowns - available 13

Other PPE – goggles and glasses available as necessary

11 2

Gloves available 13

Respiratory protection (masks, respirators) available as necessary

11 2

Respirators used in accordance with training

4 3 3 (3 NA)

BSCs provided for BSL II (as necessary) and BSL III

10 2 1

BSCs installed and certified annually 7 5 1 NA

Major Issues and Solutions


Major Issues Major gaps in biosafety implementation within the

Caribbean region evident including: Lack of national policies and regulatory mechanisms

for biosafety Lack of systems for biorisk assessment – nationally

and at laboratory level Challenge with assignment of time for safety functions Limited adoption and monitoring of safety standards Limited access to biosafety Level 3 facilities


Some Solutions Regional reference laboratory for communicable diseases –

CAREC/PAHO/WHO in 1975 – transitioning to Caribbean Public Health Agency (CARPHA)

Development of national reference laboratories has progressed significantly over the past 5-10 years e.g. Haiti, Dom Rep, Guyana, Suriname, Jamaica (support from CDC, EU, etc.)

Small size of countries supports development of regional networks

Regional network laboratories require systems for ensuring efficient transport, facilitation of Customs, management of data, legislation, quality of results, financing

Capacity building for implementation of safety systems urgently needed

Special thanks to the members of the Caribbean Laboratory network for their support in conduct of the assessments, to IFBA for providing the initial guidance and funding

http://cmedlabsfoundation.net

Documents

Biosafety and Biosecurity Challenges in the Caribbean Region Valerie Wilson Caribbean Med Labs Foundation Anticipating Global Biosecurity Challenges Istanbul,