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Challenges in Diagnostic

Support Services:
Laboratory Services
Role of The Laboratory

1. Support for rapid investigation of


disease outbreaks

2. Support for improved surveillance

3. Provide early warning system for


emergence/reemergence pathogens
Main Challenges to the Laboratory

1. Analyse data and provide feedback of the


results to public health authorities

2. Develop and maintain testing resources,


standard procedures and quality
assurance

3. Provide technical support, training,


guidance and quality assurance to all
laboratories within the country
Specific demands when
investigating outbreaks

 Unexpected event
 Need to investigate quickly
 Pressure for answers
 Multiple agencies
 Work carried out at many levels
 In the media spotlight
Data:
Report

Lab confirmed

Clinical specimen

Seek medical attention

Symptoms

Infected

Exposed
Outbreak Detection and Response
First
Case
Detection/ Opportunity
Reporting for control
90
Confirmation
80 Investigation
70
Response
60
CASES 50
40
30
20
10
0
10

13

16

19

22

25

28

31

34

37

40
1

DAY
Responsibilities of Hospital Labs

 Identification of infectious agent using


standard procedures and reagents
 Refer to the National Ref lab for
isolate identification and/or serotyping
 Reporting results
 Coordination with case investigators
 Coordination and implementation of
containment activities
Responsibilities of National Reference Labs (1)

 Identification of infectious agent by


serology and/or isolation using standard
procedures and reagents
 Referral of isolates (eg: influenza) to
the Global Specialized Labs / WHO
Collaborating Centre
 Reporting results in a timely manner
 Serve as centre for training the
laboratory personnel from hospital
laboratories
Responsibilities of National Reference Labs (2)

 Provide guidelines for proper specimen


collection, transportation and laboratory
testing
 Coordination and implementation of
containment activities
 Coordination with case investigators
Responsibilities of Global Specialized Labs

 Definitive identification of isolates using


all available technologies, including
genetic characterization, to reveal the
origin of isolates
 Preparation and distribution of relevant
standards, reference reagents and
training materials
 Provision of consultants to evaluate and
advise on lab services and provide
specialized training
Effective laboratory support requires:

that health-care professionals are aware


of the system and its requirements
 appropriate specimens are collected and
sent to a laboratory capable of
performing the necessary tests
 reliable equipment is used and tests
performed correctly
 timely feedback is provided to the
appropriate authorities
 the integrity of the surveillance system is
monitored on an ongoing basis
Preparedness: Some measures needed

1. Bio-safety Level 3 Laboratory (P3 Lab)


2. Training
3. International Linkages
4. Resources
5. Guidelines for Collection and
Transportation of Specimens
The Outbreak Control Team

 Membership
 Leadership
Co-ordinate further investigation and
response
 Responsibilities
 Lines of communication
 Communication and decision making
process
Report to and advise higher authorities
Virology Unit, IDRC, IMR

- In 2002 initiated focus surveillance for:


 HFMD
 Influenza
 Dengue

- 16 March 2003, designated National


Reference Laboratory for SARS

- 2004 designated as the National Reference


Laboratory for Avian Influenza
SARS OUTBREAK
Laboratory Facilities:
(i) BSL3 facilities and BSL3 work
practices:
samples processing and virus
isolation

(ii) BSL2 facilities with stringent BSL3


work practices:
PCR, IFA and EM
Virology Laboratory, IMR

 Setting up of the operations room


 Teams by function
 Retraining
 All staff buy-in
 Morale building
 Guidelines
Guidelines

 Specimen collection
 Specimen transport
 Containment
 Documentation
 Information flow
Specimens collection
 The following should be considered for
collection of specimen for culture:
 Timing
 Appropriate site
 Proper collection
 Proper transportation
 Alert the laboratory of disease
suspected especially agents that
requires special culture media
Flow Chart For Specimen Receipt At IMR Specimen
Reception Counter
Clinical Specimen

Use PPE

Transfer Specimen to biohazard cabinet

Other specimen, process in


If Class 3 or 4 Pathogen
usual manner
DO NOT OPEN

Leave specimen in biohazard cabinet

Contact Virology Unit


Flow Chart for Specimen Receipt At Virology Unit Specimen
Reception Counter/Guard House

Clinical Specimen

Inform Officer and Technician in-charge

Use PPE

Place Specimen in Containment Box

Transfer Specimen to P3 Laboratory


Laboratory Tests Investigation (1)

Cell culture

Nucleic acid testing


Processing
Specimen P3

Electron microscopy

Immunoflourescence
Laboratory Tests Investigation (2)

 use validated test methods


 standard operating procedures
 false positive/false negative results
 verify test results
Verification process

Laboratory results Head of Virology

Director General
Of Health

Deputy –Director General of Health

Minister of Health

CDC
Problems Encountered

Inappropriate Specimen:
 Only swabs received (not suitable for EM)
 Only serum/blood received
Transportation of Specimen:
 Unsealed box/not labeled
 Not packed separately from other specimens for routine
tests.
 Staples used
Request Form:
 Request form packed together with sample
 Blank/incomplete request form
Virology Unit, IDRC, IMR (4)

- Prepared for future pathogen level 3


outbreak investigation

- P3 laboratory adequately equipped

- Staff confident and prepared to cope


with future outbreaks.
PPE
Process Specimen in the
BSL-3 Cabinet

Autoclave Biohazard Collect Specimen From Pass-


Bag/Waste through Box
Conclusion

Both the public health authority and the lab have a


role in ensuring optimum lab services:

 Public health: to educate the health-care


providers on the importance of lab testing and to
make sure that the lab resources are accessible

 Lab: to develop and maintain testing resources, SOP


& QAP, and to analyze data and provide feedback to
the public health authorities
Lessons learnt

 Be prepared for eventualities -training


 Contingency plans- evaluate capabilities
 Optimize resources : team work
 Leadership role
 Hands on
 Keep cool and level headed

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