Prof Stuart D. Blacksell

Mahidol-Oxford Tropical Medicine Research Unit (MORU) Bangkok, Thailand.

FAO Regional Biosafety Coordinator

FAO Regional Biosafety Program

Core and Biosafety Assessments 2012-2016

Laboratory mapping is an essential basis for:

• Generating reliable and accurate data

• support the development of strong disease prevention and control systems by indicating the overall functionality of a laboratory

• Generating a picture of laboratory functionality within and across regions

• underpinning regional and global approaches to laboratory strengthening

• Analysing needs

• indication of the actions required to update and improve the functionality of individual laboratories or of all the laboratories within a region

Laboratory mapping is an essential basis for:

• Helping laboratories to assess their own functionality • identify priorities and gaps through comparisons with good

practice scenarios

• Providing a baseline • against which objectives can be set and progress monitored

• Enabling development partners to recognize laboratory functionality and take appropriate and sustainable measures to support the improvement of laboratory capacities

FAO CORE Lab Mapping Tool

• Developed by FAO as a standardised metric to assess laboratory

capacity and infrastructure

• Identifies gaps (opportunities for funding)

• KPIs for annual assessments

• Initially developed for vet labs

• Developed by FAO HQ in 2012 to assess HPAI labs• Mia Kim, Pawin Padungtad Beatrice Moulle, Gwenaelle Dauphin & others

• Cornerstone of FAO regional biosafety program 2012-2017

• >90 assessments

• 11 countries

• >35 labs

• English, French, Thai, Chinese (more coming soon)

FAO Biosafety/Safety Lab Mapping Tool (BLMT)

• Developed by FAO 2015-16

• Assessing biosafety and safety capacity

• Developers

• Gwenaelle Dauphin (FAO HQ)

• Beatrice Mouille (FAO HQ)

• Sharon Heitela (UC Davis)

• Stuart Blacksell (MORU/Oxford)

• Field assessments

• USDA - ~10 vet labs in Africa (2015)

• FAO – 7 vet labs in Lao, Vietnam, Myanmar (2015-2017)

• MORU/DTRA – 9 hospital labs in Cambodia (2015-2017)

• FAO/DTRA – 12 vet labs in Thailand (2016)

• FAO – 7 vet labs in Vietnam (2016)

• English, French, Thai, Chinese

Geographic location

Laboratory Budget

Basic supply

Organization

Infrastructure

Equipment

Reagent supply

Staff skil ls + availabil ity

Sample accession

Available technology

Training

Quality Assurance

Biosafety/Biosecurity

Staff Security/Health

Communication means

National lab networking

Laboratory collaboration

Grand total (%) Lab A

01/10/2011

- Self

Assessment

A

01/10/2012

- Self

Assessment

B

01/10/2014

- Current

assessment

C

Progress

2011-

2014

66.7 66.7 66.7 0.0

44.4 77.8 66.7 22.2

77.8 88.9 83.3 5.6

66.7 66.7 66.7 0.0

40.7 74.1 95.2 54.5

40.0 54.2 75.0 35.0

18.5 29.6 29.6 11.1

57.1 66.7 76.2 19.0

8.3 16.7 25.0 16.7

44.4 77.8 86.1 41.7

23.8 57.1 85.7 61.9

18.2 51.5 51.5 33.3

27.8 33.3 33.3 5.6

22.2 22.2 22.2 0.0

0.0 16.7 33.3 33.3

66.7 55.6 44.4 -22.2

55.6 74.1 70.4 14.8

35.6 54.3 60.3 24.7

Compilation LMT results * for Lab A

LMT - "snapshot" view of functionality and evolution over time• Lab• Country • Region

General Laboratory

Profile

Infrastructure,

equipment,

supplies

Laboratory

Performance

Biosafety/Biosecurit

y

Lab collaboration &

networking

Core LMT• 5 Areas• 17 Categories• 108 Questions

Area Category

Administration

General

Personnel Health & Safety

Training & Competency

Biosafety Manual/ SOPs

Operational

Good Lab Practices

Containment

Containment BSL3

Waste Disposal

Shipping of Infectious substances

Animal facilities

Engineering

Premises

Chemical hazard containment

Chemical Security

Emergencies

Fire hazard

Electrical

BSC

PPE

General Situation

Use of PPE

PPE disposal

LMT-BM• 4 Areas• 20 Categories• 97 Questions

Details of all LMT results* for YVDL

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

Geographic location

Laboratory Budget

Basic supply

Organization

Infrastructure

Equipment

Reagent supply

Staff skills + availability

Sample accession Available technology

Training

Quality Assurance

Biosafety/Biosecurity

Staff Security/Health

Communication means

National lab networking

Laboratory collaborationAll LMT Results

11/11/2012

01/10/2014

General laboratory profile

Infrastructure, equipment, supplies

Lab performanceQA, Biosafety/BiosecurityLab collaboration and networking

FAO Lab Mapping Tools – Core/Biosafety

On-site LMT assessment protocols

• Objective • Understand the lab

• Understand the staff

• Time • 1-2 days

• Method • Meetings with staff

• Onsite lab visits

• Output • LMT assessments

• Formal report

The LMT Excel file

ScoresFor each of the 108 subcategories, one out of four options can be selected

Scores for the 5 areas, the 18 LMT categories and an overall score will be automatically calculated and graphics generated in the ‘’Summary’’

Excel file

Example LMT Excel file

Spider graph

Sub-cat summary Area summary

Comparing results following baseline LMT assessmentAssessment 1 Assessment 2

Assessments Overlaid

LMT Mobile application

• Developed for Core LMT and all LMT modules

• Android and Apple iOS

• Multi-language support

• Can see previous assessments and visualize results

• Can be offline during data collection

• Sends excel to assessors email and FAO portal (voluntary data

sharing)

• Camera integration, pictures can be included for salient points

LMT App - Some screenshots

Splash screen First launch

LMT App - Some screenshots

FAO LMT Portal

• Database compiling all LMT assessments

• Anonymized results

• Published by category and subcategory, for national,

regional or global view.

• Laboratory metadata management

• Assessment and users management

• Data analysis and reporting

• National portals available soon

FAO Biosafety activities

South and South East Asia

Laboratory assessments 2012 - 2016• 2012-2015 (FAO) – mainly Core LMT (44 assessments)

• Indonesia 10 labs x 2 assessments

• Lao PDR 1 lab x 3 assessments

• Cambodia 1 lab x 3 assessments

• Myanmar 2 lab x 2 assessments

• Philippines 1 lab x 2 assessments

• Bangladesh 2 lab x 2 assessments

• Nepal 1 lab x 2 assessments

• Bhutan 1 lab x 2 assessments

• Malaysia 1 lab x 2 assessments

• Vietnam 2 lab x 2 assessments

• 2016 (Core and BM-LMT) (17 assessments)

• Thai DLD – DTRA CBEP – MORU/NIAH (11 Labs)

• Vietnam - FAO (4 Labs)

• Myanmar -FAO – (2 Labs)

• Cambodia - FAO – (1 Labs)

• More to follow (Lao PDR, Cambodia, Nepal, Bangladesh)

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

80,0

90,0

100,0

Available technology

Basic supply

Biosafety/Biosecurity

Communication means

Equipment

Geographic location

Infrastructure

Laboratory Budget

LaboratorycollaborationLinkage with satellite

labsOrganization

Quality Assurance

Reagent supply

Sample accession

Staff Security/Health

Staff skills + availability

Training

Use ofdatabases/platforms

Total

Mean 2012

Mean 2014

Core LMT 2012-2014 – Baseline Study

Mean: + 11.6% 2012 : 50.1%2014 : 61.7%

Lab ChangeHighest: +19.8%Lowest : -0.7%

Range2012 : 24.2%-75.4%2014 : 26.2%- 79.6%

Core LMT 2012-2014 – Analysis

Strengths • Organization• Basic Supplies• Staff skills and availability

Weaknesses <50%• Biosafety/Biosecurity • Staff security and Health• Training• Budget • Sample accession

2013-2014 Focused development activities • Biosafety/Staff health

Improvements• Biosafety/Biosecurity +16.5%• Staff security and Health +21.3%

Range2012 : 24.2%-75.4%2014 : 26.2%- 79.6%

Mean: + 11.6% 2012 : 50.1%2014 : 61.7%

Lab ChangeHighest: +19.8%Lowest : -0.7%

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

80,0

90,0

100,0

Available technology

Basic supply

Biosafety/Biosecurity

Communication means

Equipment

Geographic location

Infrastructure

Laboratory Budget

LaboratorycollaborationLinkage with satellite

labsOrganization

Quality Assurance

Reagent supply

Sample accession

Staff Security/Health

Staff skills + availability

Training

Use ofdatabases/platforms

Total

Mean 2012

Mean 2014

• 18 Labs assessed • Mean: 55.5% SD=13%• Range: 31% (New Lab) -78% (Nat Ref Lab)• Generally low heterogeneity

• Inter-lab scores (CV:24%)

• Strengths• Organisation• Basic supply

• Weaknesses • Training • Lab budget• LIMS

Core LMT Assessments2016 Summary

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

80,0

90,0

100,0

Geographic location

Laboratory Budget

Basic supply

Organization

Infrastructure

Equipment

Reagent supply

Staff skills + availability

Sample accessionAvailable technology

Training

Quality Assurance

Biosafety/Biosecurity

Staff Security/Health

Communication means

National lab networking

Laboratory collaboration

Mean

SD

0,010,020,030,040,050,060,070,080,090,0

100,0

Geographiclocation

LaboratoryBudget

Basic supply

Organization

Infrastructure

Equipment

Reagent supply

Staff skills +availability

Sample accessionAvailable

technology

Training

QualityAssurance

Biosafety/Biosecurity

StaffSecurity/Health

Communicationmeans

National labnetworking

Laboratorycollaboration

• 18 Labs assessed • Similar results (pattern)

• LMIC Country A = 59.4% SD 18%• Range: 31% (New Lab) -78% (Nat Ref Lab)

• Other SEA Labs = 49.0% SD 7%• Range: 39%-58%

• Moderate heterogeneity • Inter-lab scores (CV 30%; 14%)

• Strengths• Organisation• Basic supply

• Weaknesses • Training • Lab budget• LIMS

Core LMT Assessments2016 Summary

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

80,0

90,0

Geographic location

Laboratory Budget

Basic supply

Organization

Infrastructure

Equipment

Reagent supply

Staff skills + availability

Sample accession

Available technology

Training

Quality Assurance

Biosafety/Biosecurity

Staff Security/Health

Communication means

National lab networking

Laboratory collaboration

Grand total (%) Lab x

Mean

SDOther SEA labs n=7

Thai labs n=11

Biosafety LMT Assessments 2016 Summary

• Summary • Mean = 41.3% SD=14%• Range: 18% -64% • Higher heterogeneity

• Inter-lab scores (CV 34%)

• Strengths• BSCs• PPE disposal

• Weaknesses (<40%) • Personnel H&S• Use of PPE• Chemical storage and security • Electrical • Fire hazards• Biosafety manuals/SOPs

0,0

10,0

20,0

30,0

40,0

50,0

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70,0

80,0

General

Personnel Health & Safety

Training & Competency

Biosafety Manual/ SOPs

Good Lab Practices

Containment

Waste Disposal

Shipping of Infectioussubstances

Premises

Chemical hazardcontainment

Chemical Security

Emergencies

Fire hazard

Electrical

BSC

PPE General situation

Use of PPE

PPE disposal

Mean

SD

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

80,0General

Personnel Health & Safety

Training & Competency

Biosafety Manual/ SOPs

Good Lab Practices

Containment

Waste Disposal

Shipping of Infectioussubstances

Premises

Chemical hazardcontainment

Chemical Security

Emergencies

Fire hazard

Electrical

BSC

General Situation

Use of PPE

PPE disposal

Mean

SD

0

10

20

30

40

50

60

70�General

� Personnel Health &Safety� Training & Competency

� Biosafety Manual/ SOPs

�Good Lab Practices

�Containment

�Waste Disposal

!Shipping of Infectioussubstances

�Premises�Chemical hazard

containment�Chemical Security

�Emergencies

�Fire hazard

Electrical

�BSC

�PPE General situation

Use of PPE

�PPE disposalOverall Score

Biosafety LMT Assessments 2016 Summary

Thai labs

Other SEA labs

• Similar results (pattern) • LMIC Country A = 61.7% SD 17%• Other Regional Labs = 36.8% SD 17%

• Context – relatively OK • Variable heterogeneity

• Inter-lab scores (CV 27%; 46%)

• Strengths• BSCs• PPE disposal

• Weaknesses (<40%) • Personnel H&S• Use of PPE• Chemical storage and security • Electrical • Fire hazards• Biosafety manuals/SOPs

Waste

Special mention – Electricals

Biosafety Training and Advocacy

• Team effort-Partnership

• FAO regional biosafety program

• MORU

• CDC

• USAID

• DTRA-CBEP

• Classroom-based

• Basics of biosafety

• Risk assessment

• Risk perception

• Activity-based training • PPE Donning and Doffing • Respirator fit tests• Biosafety Cabinet Certification

• Biosafety toolbox • Activity-based Posters• Stickers• Manuals

Asian LMT training• 1st training – Thailand

• Feb 2016

• Trainees

• 30 Department of livestock development staff

• Quality/Biosafety

• 2nd training – Thailand

• Trainees

• 25 Regional Vet Lab Biosafety staff

BSC certification training

• Training of local staff• BSC Certifications

• BSC Decon/Basic repairs

• Cambodia • Collaboration- CDC, MORU, MoH

• MORU SMEs• Rob Dandy/Marcel Fiocchi

• Training and technical mentioning• NSF 49

• Vietnam• FAO – MORU - RAHO6

• BSC ToT 28 Nov-2 Dec 2016

BSC Testing TrainingOnline Preparation Module - 20-25 minutes

BSC testing results – 2012-2016

32,0%

23,0%

12,5%

20,0%

22,5%

17,0%

9,0%

15,6%

2012 2013 2014 2016

BSC failures 2012-2016

Overall failure rate Enrolled since 2012

n=130 n=149 n=192 n=162

46

78

9

12 12

15

23

46Number enrolled

Summary • Independent assessment of lab capabilities using LMT Core and Biosafety

• Identify gaps for future development activities

Safety/Biosafety• Strengths

• BSCs• PPE disposal

• Weaknesses• Personnel H&S• Use of PPE• Chemical storage and security • Electrical • Fire hazards• Biosafety manuals/SOPs

Core • Strengths

• Organization• Basic Supplies• Staff skills and availability

• Weaknesses• Biosafety/Biosecurity • Staff security and Health• Training• Budget • Sample accession

Weaknesses are focus for future activities

Communication between WHO, OIE, FAO, CDC, DTRA, and other

stakeholders (One Health approach) is crucial and FAO would like to

coordinate with partners to avoid duplication of efforts and look for

synergies on capacity building activities on biosafety/biosecurity and

occupational health

Thank you

FAO RomeLidewij WiersmaBeatrice MoulleGwenaelle DauphinSharon Heitela

FAO RAP BangkokWantanee KalpravidhFilip ClaesSanipa Suradhat