Cambodial national work plan for implementation

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

Priority Areas, 2012-2014

Laboratory

Dr. Sau Sokunna

Deputy 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

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.

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

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

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

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

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 project

Surveillance, Outbreak

Investigation and Response

Emergency Preparedness and

Response

Risk Communication

Biosafety,

Quality Management System

Laboratory Networking

Lab diagnostics

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)

Lab diagnostics

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

Lab diagnostics

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 )

Other activities

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

A CHIEVEMENT 2012

• 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)

L ABORATORY N ETWORKING

 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

SLMTA in Cambodia, June 2011-2012

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

Achievement in 1

st

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

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?

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

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

Thank You

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