Dr. Sau Sokunna
Deputy Director of DHS
Ministry of Health
30 April 2013
• Bureau of Medical Laboratory Services (BMLS):
– Dr Sau Sokunna, Director
– Pharm Sam Sopheap, Chief
– Pharm Monipheap, Vice Chief
•
National Institutes of Public Health(NIPH)
– Prof Chuop Sokheng, Head of NIPH
• National Blood Safety Program (NBTC)
– Dr Hok Kim Cheng, Director
• Sub TWG for Blood Safety and Lab Services
WHO, IPC, US CDC, NAMRU-2, AFRIMS, Foundation Merieux, DMDP,
ITM, URC, CAREID, UHS, DTRA, IQLS, Temasek Foundation.
2
Core Capacity Area
Component:
8
8.1
Laboratory
Laboratory Diagnostic and Confirmation Capacity
CROSS REFER to OTHER Components
Status reported in 2011 Status reported in
2012
There is a national Lab policy but nothing on
Lab quality standards nor any licensing procedures.
A nation al policy for lab quality standards had been approved
There are SoPs to deal with outbreaks involving national and international labs s and more than 10 suspect
H5N1 samples are tested annually.
A bacteriology lab network, connecting the national, sub national and research labs together is developed
There is EQA system for CD4 counts for HIV and H5N1 tests but not for bacteriology.
Bacteriology EQA has started
Planned actions by June 2013 Planned Actions by June
2014
Development of National
Lab. Information System
Sustaining the Lab EQA programme and enlarging it
To build on national diagnostic bacteriology lab network and create a public health lab network involving at least 1 national and 2 sub national labs which practice IQC and are enrolled in an EQA programme
To have a fully functional national lab
Information System which can provide surveillance data and help with outbreak detection.
Eventual Goal
To have a public health lab network, capable of diagnosing most common pathogens and referring unusual pathogens for further diagnosis to national or international referral centres.
Government involvement
Partners involved
MoH: CDC, NIPH, HSD, IPC, DDF,
Provincial Bacteriology Labs
US CDC, USAID, WHO,
Rest of Government:
Core Capacity Area
Component:
8
8.2
Laboratory
Laboratory Biosafety and Biosecurity
CROSS REFER to OTHER Components
Status reported in
2011
Some basic training has been provided to labs to practice biosafety and biosecurity
Government involvement
Partners involved
Status reported in
2012
US CDC has started a biosafety programme for
HIV testing
Planned actions by June
2013
Development of generic Biosafety and
Biosecurity SoPs for all labs including management of infectious waste
Identify a biosafety focal person for each lab
MoH: CDC, NIPH, HSD, IPC, DDF,
Provincial Bacteriology Labs
US CDC, USAID, WHO,
Planned Actions by June
2014
Start a rolling programme of biosafety and biosecurity for selected high throughput labs.
Rest of Government:
Eventual Goal
To have in place working practices in the labs to ensure safe working environment in the labs.
– Development of Laboratory Quality Standards.
– Establishment of EQA programme for Microbiology in 2012 in 5 laboratories.
– Expansion of the EQA programme to include Microbiology, Hematology and
Biochemistry in 9 referral laboratories in 2013.
– Development of a poster with instructions for collection of specimens for laboratory testing.
– Provision of in service mentorship to referral microbiology laboratories.
– Provision of laboratory supplies and reagents to ensure uninterrupted and high quality microbiology diagnostics.
– Implementation of a LQMS (SLMTA) in select laboratories.
– Development of an electronic Laboratory Information System (LIS), pilot of the
LIS, training of laboratory staff, and roll out to 10 referral laboratories.
– Development of a national training programme for integration of laboratory and epidemiology responses during an infectious disease outbreak.
– Establishment of a National Medical Microbiology Laboratory Network (NMMLN).
– 3 workshops on Biosafety and Biosecurty.
– EQA programmes for Microbiology, Hematology and Biochemistry in 9 referral labs.
– Implementation of LQMS in 5 referral lab (starts in May 2013).
– Distribution of posters with instructions for collection of specimens for lab testing.
– Provision of in service mentorship to referral microbiology labs.
– Provision of supplies and reagents for microbiology labs.
– Integration of Laboratory Information System (LIS) into the Health Management
Information System (HMIS).
– Development of blood culture diagnostics and antibiotic resistance surveillance in 6 sentinel referral hospitals.
– Assessment of 28 laboratories that contribute to IHR capacity (July to October).
– Upgrading 2 provincial laboratories to provide microbiology diagnostics.
– Strengthening of National Medical Microbiology Laboratory Network (NMMLN).
– Development of CamLab Network, a website dedicated to the NMMLN.
– Development of National Laboratory Biosafety Guidelines.
– Certification of Biological Safety Cabinets.
Indicator
8.1.1 Laboratory Services available to test for priority health threats
No. YES
10/15 (66 %)
3/6 (50 %)
8.2.1 Laboratory biosafety and biosecurity practices in place
• The implementation of a National Strategic Plan for Medical Laboratory
Services (2010-2015) is progressing slowly because of lack of human and financial resources.
• Lack of laboratory biosafety regulations.
• No government funding to support review of the National Policy for Medical
Laboratory Services.
• No budget for dissemination of National Laboratory Quality Standards.
• Limited MoH budget to support laboratories and activities aimed at strengthening laboratories.
• No national curriculum for Quality Management Systems training.
• Limited commitment for strengthening of Laboratory Network.
• Limited authority of MoH over laboratories in national referral hospitals.
• No authority of MoH over private laboratories.
• Limited knowledge of clinicians in the rational use of laboratory diagnostics leading to under utilization of laboratory services.
• Fragmentation of the laboratory system among vertical programmes.
• Limited influence on procurement of laboratory commodities.
• Lack of preventive and curative maintenance of lab equipment.
• Need support
Upgrade CPA3 facilities to host microbiology labs capable of bacterial identification and Antibiotic Sensitivity
Testing (AST).
Strengthen a team of national assessors to provide regular lab audits.
Develop a Quality Manual.
Disseminate National Laboratory
Quality Standards.
Support training on lab supervision at provincial levels.
Regulation of private laboratories.
Development of IQC guidelines for laboratories.
• Support available
Implementation of a LQMS.
Strengthening the NMMLN.
Provide training courses for basic laboratories equipment maintenance
Regular assessment of laboratories that contribute to IHR capacity.
Selection and training of biosafety officers.
Development of a national EQA programme.
Analysis of laboratory data for surveillance obtained through LIS reports.
Develop a standard list of laboratory equipment.
Develop an up to date inventory of public laboratories involved in surveillance and outbreak response.
IHR
Priority
Activity
2013
Ja Fe M n b ar
A pr
M ay
Ju Ju Au Se Oc n l g p t
No De Ja v c n
Fe M b ar
2014 r
Ap Ma Ju y n l
Ju Au g
S O ep ct
No De
Estimate d Budget
Source of Comme v c (USD) Funds nts
Lab diagnos tics
Roll out national
Laboratory Information
System (CamLIS) to at least 10 referral hospitals
X X X X X X X X X X X X
(2 additional national and 2 provincial.
Lab diagnos tics
Training of lab staff at
4 referral hospital on
CamLIS
X X X X X X X X X X X X
Lab diagnos tics
Laboratory data is routinely collected from these labs
Lab diagnos tics
Expand Microbiolgy
EQA program to include 4 additional laboratories
X X X X X X X X X X X
X X X X X X X X X X X X
Lab diagnos tics
Development of IQC guidelines for the labs
Lab diagnos tics
Training on IQC methodology for selected lab staff
Lab diagnos tics
Perform assessment of laboratory quality management
X X X X X X X
X X X X X X
X X X X X X X X X X X X
Implement a laboratory quality management
Lab system in 5 laboratories diagnosti of the NMMLN cs
X X X X X X X X X X X X
Lab
Continue strengthening diagnosti of the NMMLN cs
X X X X X X X X X X X X
Lab Develop a standard list diagnosti of laboratory equipment cs
X X X X X X
Implement annual workshop on how to ensure the supply of
Lab laboratory reagents and equipment are included diagnosti in the AOP cs
X
Lab and biosecurity diagnosti guidelines for laboratory cs
Development biosafety
X X X X X X
Lab Select and train a diagnosti biosafety and quality cs officer in NMMLN
X X X X X X X
Lab diagnosti cs
Roll out of biosafety training to additional
CPA 3 and national labs
Setting up a log book for
Lab diagnosti biosecurity and biosafety cs adverse events on in labs for each lab
Lab diagnosti cs
Develop an up to date inventory of public laboratories involved in surveillance and outbreak response
X X X X X
X X X X X X X X X X X X
X X X X X X X X X X X X
1. Surveillance, Risk Assessment and
Response
2. Laboratory
3. Zoonoses
4. Infection Prevention and Control
5. Risk Communication
6. Public Health Emergency
Preparedness
7. Regional Preparedness, Alert and
Response
8. Monitoring and Evaluation
Responsible
Agencies/
Depts 1st Q 2nd Q
2013
3rd Q 4th Q 1st Q
Activity
Roll out national Laboratory Information System
(CamLIS) to at least 10 referral hospitals (2 additional national and 2 provincial
Training of lab staff at 4 referral hospital on CamLIS
BMLS/DHS,
WHO/
SubTWG
Done
WHO/ BMLS
On going
2014
2nd Q 3rd Q 4th Q
Still Process
Laboratory data is routinely collected from these labs BMLS/DHS
BMLS/DHS
WHO/NIPH
Expand Microbiolgy EQA program to include 4 additional laboratories
Development of IQC guidelines for the labs
BMLS/DHS
WHO/NIPH
Done
Not Yet
Not Yet
Training on IQC methodology for selected lab staff
Perform assessment of laboratory quality management
BMLS/DHS
WHO/NIPH
BMLS/DHS
WHO/NIPH
Others Partner
Not Yet
(May/13 to March/14)
Activity
Implement a laboratory quality management system in 5 laboratories of the
NMMLN
Responsible
Agencies/
Depts 1st Q
BMLS/DHS
WHO/
Continue strengthening of the NMMLN
BMLS/DHS
WHO/DMDP/FM
/NUMR-
2/AFRIMSI
TM.
BMLS/DHS
WHO
Ongoing
2nd Q
2013
3rd Q
Done
4th Q
No ( May/13 to Jan/14 )
Develop a standard list of laboratory equipment
Implement annual workshop on how to ensure the supply of laboratory reagents and equipment are included in the AOP
BMLS/DHS
No( Nov/13 )
Development biosafety and biosecurity guidelines for laboratory
Select and train a biosafety and quality officer in NMMLN
BMLS/DHS
WHO
BMLS/DHS
WHO
No ( May to Dec/13 )
No ( May to Dec/13 )
1st Q 2nd Q
2014
3rd Q 4th Q
Activity
Roll out of biosafety training to additional
CPA 3 and national labs
Responsible
Agencies/
Depts
1st Q 2nd Q
2013
3rd Q 4th Q 1st Q 2nd Q
2014
3rd Q 4th Q
BMLS/DHS
WHO/
Setting up a log book for adverse events on biosecurity , biosafety in labs for each lab
BMLS/DHS
/NIPH/WHO
Develop an up to date inventory of public laboratories involved in surveillance and outbreak response
BMLS/DHS
WHO
Ongoing
( April to Aug/13 )
2013
Activity
Responsible
Agencies/
Depts 1st Q
Develop a National Quality Manual Template of laboratory BMLS/DHS
/Sub TWG
Provide Training of National labs and Labs CPA3
1 st step at 11 referral hospitals on NQMT and each labs must be prepared/SOPS
BMLS/DHS
/Sub TWG laboratories assessment in legal private sector (supervisory checklist)
BMLS/DHS
/Sub TWG
2nd Q 3rd Q 4th Q 1st Q 2nd Q
Done
On going
On going
2014
3rd Q 4th Q
CDC, WHO Develop one-year AET curriculum
Conduct one-year AET course
Training of AET Supervisors (FET Plus) CDC, WHO Done
• Developed the national laboratory network
• Developed and publish the NMLQS, but not yet dissemination to PHLs
• Developed and CamLIS , 6 pilot.
• Workshop on Biosafety Implementation and Biorisk Analysis, 4-8 April 2012 Sunway Hotel,
BMLS/DHS-AFRIMS
• Workshop on Biosafety and Shipment 10-14 Sept, 2012 Sunway Hotel, CAREID
• Launching Workshop for development of the National Laboratory Network in Cambodia, and
Training opportunity Jul 2012 – Dec, 2013
• QMS/ Writing the QM ongoing, will finishing in Q1/2013
• EQA for Microbiology 2012 5 microbiology labs (3 national levels and 2 provincials)
NMMLN was nominated in Cambodia 2012 by the MoH
ToR document defining core, associate and advisory members approved by MoH
RR document created and also work plan to address specific QMS objective to support of NSP 2010 -2015.
CARIED Project.
QA/QC
Lab network
Biosafety and Epi/Lab
SLMTA Implementation in Cambodia
Foundation Merieux in Cambodia ( Globe network)
Others
21
Improvement in the Score of the
Safety Section of the Checklist
Cambodian MOH delegation developing SLMTA action plan at the CDC office in Phnom Penh.
Equipment Maintenance
Launching Workshop for development of the
National Laboratory Network in Cambodia, and
Training opportunity Jul 2012 – Dec, 2013
Under opening ceremony by HE. Prof Ung Sam
An, Director of NIPH, Chairman of Sub TWG
Workshop on Biosafety Implementation and
Biorisk Analysis, 4-8 April 2012 Sunway Hotel,
BMLS/DHS-AFRIMS
Workshop on Biosafety and Shipment
CAREID
Advanced Biorisk Management Workshop
Hanoi, Vietnam, February 13th – 17th, and Bank Kok, Thailand, 5-10
June, 2012 CAREID
st
• 2 times for Sub TWG and 4 times for small group lab services
• Workshop on blood culture, are 7 sites 5 Provinces and 1 NIPH supported by 5 sponsor namely
WHO, ITM, SHCH, DMDP, ITM ,FM with the collaboration BMLS/DHS and UHS, 21-22 Feb,
2013
• Workshop on EQAS program, there are 9/10 sites with upgrade 3 labs
• ( 6/2012 and 3/2013) 15 March, 2013 at Cambodiana Hotel
• W/s on Biosafety and Biorisk management and BSC hazard Inc MoU between MoH and TLL,
26-29 March, 2013
• Meeting of NMMLN at Sunway Hotel, 8 April, 2013
1 st Quarter/ 2013
Training workshop on EQAS, 15 March, 2013 at
Cambodiana Hotel. Supported by WHO
Cambodia MOH signed an MOU with TLL on March 2013 at Sunway Hotel
On Capability and Capacity Building in lab Biorisk
Management and Biosafety
1st Quarter/ 2013
Workshop on Blood Culture. 21-22 Feb, 2013 at UHS
Supported by WHO, DMDP,ITM,FM ,NAMRU-2 AND HSCH
Meeting of NMMLN, 08 April, 2013 at Sunway Hotel.
Supported WHO
Ongoing 2nd Quarter/2013
• W/s on Calibration and BSC at Siem Reap, 29-31 April, 2013
• LQSI workshop 7-9 May, 2013 at Cambodiana Hotel,
• Finished a Quality Manual
• Finished and upgrade CamLIS and CamLab Website
• EQA for Microbiology 2013: from 5 to 9 microbiology labs
APSED Key milestones, where are we?
28
IHR Indicators related Laboratory
(IHR Core Capacity 8)
Indicator
8.1.1 Laboratory Services available to best for priority health threats
No. YES
15/10 (66 %)
6/3 (50 %)
8.2.1 Laboratory biosafety and biosecurity practices in place
Challenges and constraints
-
-
-
-
-
-
The implementation of a National strategy that seeks to improve testing quality in public health laboratories is progressing slowly because lack of human and financial resources (Quality testing)
There is no Biosafety guideline. Bio-safety manual will use to protect hazard and address the challenges identified by APSED priority and IHR. In public and private
No budget to dissemination and publish ( NQLS and National Quality Manual Template)
No transportation
No government funding to support review NLP and NSP
No national curriculum for QMS training
• Need support
Priority Activities for next year
Strengthening a roadmap to implement a
QMS and strengthening
NMMLN opportunity
Upgrade the (CPA3) to have microbiology labs capable of bacteria culture identification and AST
,
-
Develop and build up national
Assessor team and implementation
Publish and dissemination on Quality
Manual template include National
Laboratory Quality Standard
Support training on lab supervision at provincial levels
Support a transportation
Support budget for annual workshop on evaluation EQA Program.
• Need available
Provide training courses for basic laboratories equipment maintenance
Support laboratories assessment in public and legal private sector