Cambodian National Work plan for Implementation of IHR Minimum Core Capacities and APSED

Priority Areas, 2012-2014

Laboratory

Dr. Sau SokunnaDeputy Director of DHS

Ministry of Health

30 April 2013

Team members

Department of Hospital Services/MoH:• 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

Partners:WHO, IPC, US CDC, NAMRU-2, AFRIMS, Foundation Merieux, DMDP,

ITM, URC, CAREID, UHS, DTRA, IQLS, Temasek Foundation.

2

Key Components

• Accurate laboratory diagnosis

• Laboratory support for surveillance and response

• Coordination and laboratory networking

• Biosafety

Core Capacity Area 8 Laboratory

Component: 8.1 Laboratory Diagnostic and Confirmation Capacity

CROSS REFER to OTHER Components

Status reported in 2011 Status reported in 2012

Planned actions by June 2013 Planned Actions by June 2014

Eventual Goal

There is a national Lab policy but nothing on Lab quality standards nor any licensing procedures. There are SoPs to deal with outbreaks involving national and international labs s and more than 10 suspect H5N1 samples are tested annually. There is EQA system for CD4 counts for HIV and H5N1 tests but not for bacteriology.

A nation al policy for lab quality standards had been approved  A bacteriology lab network, connecting the national, sub national and research labs together is developed Bacteriology EQA has started

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.

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

MoH: CDC, NIPH, HSD, IPC, DDF, Provincial Bacteriology Labs

Rest of Government:

Partners involved US CDC, USAID, WHO,

Core Capacity Area 8 LaboratoryComponent: 8.2 Laboratory Biosafety and Biosecurity

CROSS REFER to OTHER ComponentsStatus reported in 2011

Status reported in 2012

Planned actions by June 2013

Planned Actions by June 2014

Eventual Goal

Some basic training has been provided to labs to practice biosafety and biosecurity

US CDC has started a biosafety programme for HIV testing

Development of generic Biosafety and Biosecurity SoPs for all labs including management of infectious waste

Identify a biosafety focal person for each lab

Start a rolling programme of biosafety and biosecurity for selected high throughput labs.

 

To have in place working practices in the labs to ensure safe working environment in the labs.

Government involvement

MoH: CDC, NIPH, HSD, IPC, DDF, Provincial Bacteriology Labs

Rest of Government:

Partners involved US CDC, USAID, WHO,

Progress against APSED priorities• Accurate laboratory diagnosis

– 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.

• Laboratory support for surveillance and response– 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.

• Coordination and laboratory networking– Establishment of a National Medical Microbiology Laboratory Network (NMMLN).

• Biosafety– 3 workshops on Biosafety and Biosecurty.

Ongoing activities• Accurate laboratory diagnosis

– 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.

• Laboratory support for surveillance and response– 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.

• Coordination and laboratory networking– Strengthening of National Medical Microbiology Laboratory Network (NMMLN). – Development of CamLab Network, a website dedicated to the NMMLN.

• Biosafety– Development of National Laboratory Biosafety Guidelines.– Certification of Biological Safety Cabinets.

IHR Indicators related Laboratory (IHR Core Capacity 8)

Indicator No. YES

8.1.1 Laboratory Services available to test for priority health threats

10/15 (66 %)

8.2.1 Laboratory biosafety and biosecurity practices in place

3/6 (50 %)

Challenges and constraints• 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.

Priority Activities for next year

• 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.

Thank you!

IHR Priority

Activity2013 2014

Estimated Budget

(USD)

Source of

FundsComme

ntsJan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Lab diagnostics

Roll out national Laboratory Information System (CamLIS) to at least 10 referral hospitals (2 additional national and 2 provincial.

X X X X X X X X X X X X

                             

Lab diagnostics

Training of lab staff at 4 referral hospital on CamLIS

X X X X X X X X X X X X

                             

Lab diagnostics

Laboratory data is routinely collected from these labs

  X X X X X X X X X X X

                             

Lab diagnostics

Expand Microbiolgy EQA program to include 4 additional laboratories

X X X X X X X X X X X X

                             

Lab diagnostics

Development of IQC guidelines for the labs

         X X X X X X X

                             

Lab diagnostics

Training on IQC methodology for selected lab staff                        

X X X X X X                 

Lab diagnostics

Perform assessment of laboratory quality management      

X X X X X X X X X X X X                       

Lab diagnostics

Implement a laboratory quality management system in 5 laboratories of the NMMLN

X X X X X X X X X X X X

Lab diagnostics

Continue strengthening of the NMMLN X X X X X X X X X X X X

Lab diagnostics

Develop a standard list of laboratory equipment X X X X X X

Lab diagnostics

Implement annual workshop on how to ensure the supply of laboratory reagents and equipment are included in the AOP

X

Lab diagnostics

Development biosafety and biosecurity guidelines for laboratory

X X X X X X

Lab diagnostics

Select and train a biosafety and quality 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

X X X X X X X X X X X X

Lab diagnosti

cs

Setting up a log book for adverse events on

biosecurity and biosafety in labs for each lab

X X X X X X X X X X X X

Lab diagnosti

cs

Develop an up to date inventory of public

laboratories involved in surveillance and

outbreak response

X X X X X

APSED 2010

APSED (2010)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

CAREID projectSurveillance, Outbreak

Investigation and Response

Emergency Preparedness and Response

Risk Communication

Biosafety, Quality Management System

Laboratory Networking

Lab diagnostics

Activity

Responsible Agencies/

Depts

2013 2014

1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q

Roll out national Laboratory Information System (CamLIS) to at least 10 referral hospitals (2 additional national and 2 provincial

BMLS/DHS,WHO/

SubTWG Done               

Training of lab staff at 4 referral hospital on CamLISWHO/ BMLS  On going

            

Laboratory data is routinely collected from these labs BMLS/DHSStill Process

           

Expand Microbiolgy EQA program to include 4 additional laboratories

BMLS/DHSWHO/NIPH

Done             

Development of IQC guidelines for the labsBMLS/DHSWHO/NIPH

   Not Yet        

Training on IQC methodology for selected lab staffBMLS/DHSWHO/NIPH

 Not Yet

     

Perform assessment of laboratory quality management

BMLS/DHSWHO/NIPH

Others Partner

Not Yet(May/13 to March/14)

       

Lab diagnostics

Activity

Responsible Agencies/ Depts

2013 2014

1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q

Implement a laboratory qualitymanagement system in 5 laboratories of

the NMMLN

BMLS/DHSWHO/

   No ( May/13 to Jan/14 )       

Continue strengthening of the NMMLN

BMLS/DHSWHO/DMDP/

FM/NUMR-2/AFRIMSIT

M.

Done            

Develop a standard list of laboratory equipment

BMLS/DHSWHO

Ongoing               

Implement annual workshop on how toensure the supply of laboratory reagents and equipment are included in the AOP BMLS/DHS

    No(Nov/13)        

Development biosafety and biosecurity guidelines for laboratory

BMLS/DHSWHO No ( May to Dec/13 )

Select and train a biosafety and quality officer in NMMLN

BMLS/DHSWHO No ( May to Dec/13 )

Lab diagnostics

Activity

Responsible Agencies/ Depts

2013 2014

1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q

Roll out of biosafety training to additional CPA 3 and national labs

BMLS/DHSWHO/

   

    

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/DHSWHO

Ongoing( April to Aug/13) 

             

Other activities

Activity

Responsible Agencies/

Depts

2013 2014

1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q

Develop a National Quality Manual Template of

laboratory BMLS/DHS/Sub TWG   Done

           

Provide Training of National labs and Labs CPA3

1st step at 11 referral hospitals on NQMT and each labs must be prepared/SOPS

BMLS/DHS/Sub TWG

 

  On going

         

laboratories assessment in legal private sector (supervisory checklist)

BMLS/DHS/Sub TWG On going

 

Develop one-year AET curriculum CDC, WHO                

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)

Achievement 2012

21

Laboratory Networking

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

SLMTA in Cambodia, June 2011-2012

Equipment Maintenance

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.

Slide 23

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 10-14 Sept, 2012 Sunway Hotel,

CAREID

Advanced Biorisk Management WorkshopHanoi, Vietnam, February 13th – 17th, and Bank Kok, Thailand, 5-10

June, 2012 CAREID

Achievement in 1st Quarter/ 2013

• 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

1st Quarter/ 2013

Cambodia MOH signed an MOU with TLL on March 2013 at Sunway Hotel

On Capability and Capacity Building in lab Biorisk Management and Biosafety

Training workshop on EQAS, 15 March, 2013 at Cambodiana Hotel. Supported by WHO

1st Quarter/ 2013

Meeting of NMMLN, 08 April, 2013 at Sunway Hotel. Supported WHO

Workshop on Blood Culture. 21-22 Feb, 2013 at UHS Supported by WHO, DMDP,ITM,FM ,NAMRU-2 AND HSCH

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

Year 1 Guide on establishing a public health diagnostic laboratory developed

Year 2 EQA mechanism for dengue established

Year 3 Public health diagnostic laboratories established

Year 5 Functional exercise to test public health laboratory system

IHR Indicators related Laboratory (IHR Core Capacity 8)

Indicator No. YES

8.1.1 Laboratory Services available to best for priority health threats

15/10 (66 %)

8.2.1 Laboratory biosafety and biosecurity practices in place

6/3 (50 %)

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

Priority Activities for next year

• Need support- 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

Thank You