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2017 Events

 

September 2017: Training Workshop on Quality Management Systems for the Vaccine Preventable Disease Laboratory Network in India

Between 18-22 September 2017, NRL took part in a five day training workshop in New Delhi, India, for 33 participants from the Vaccine Preventable Disease (VPD) Laboratory Network. The World Health Organization (WHO) Country Office for India and Regional Office for South-East Asia (SEARO) approached NRL to provide technical assistance at the workshop on quality management systems.  The training workshop was composed of presentations covering topics of quality management systems, performing internal audits, corrective and preventive action, continual improvement mechanisms (including the PDCA Cycle) and external quality assessment schemes (EQAS). The lecture-based content was interspersed with a series of group activities, which included mapping a laboratory process; developing an audit checklist; performing an audit; problem solving using the PDCA cycle and root cause analysis; and identifying quality indicators.  In addition, a daily round table discussion was held to answer participant questions and incorporate the experience and knowledge of the WHO facilitators Dr Lucky Sangal, Ms Sirima Pattamadilok, Dr Mick Mulders and Mr David Featherstone.

Workshop on Laboratory Quality Management Systems

Participants attending the WHO Workshop on  Laboratory
Quality Management Systems

Day 3 of the training workshop was largely devoted to an interactive auditor training session where participants worked in teams to develop audit checklists, practice auditing techniques and deliver an audit report on their findings.  The purpose of this activity was to provide practical experience regarding the steps required to plan, execute and report on an internal audit; and build confidence when performing an audit. The enthusiasm and engagement of all participants, along with input from the facilitators sharing their auditing experiences, ensured this activity was a valuable learning experience.

NRL would like to thank the participants from the VPD Laboratory Network in India for their active participation in the training.  NRL would also like to acknowledge and thank the WHO Country Office for India and WHO SEARO for organising the training workshop and for their continued support of laboratory capacity building in the region.


September 2017: Viral Hepatitis Laboratory Assessment in Mongolia 2017

Mongolia has the highest hepatitis C virus (HCV) prevalence in the Western Pacific region, and also has a high burden of hepatitis B virus (HBV) and hepatitis delta virus (HDV). To address this burden, the Mongolian government approved the Healthy Liver Program (HLP) Resolution in April this year to stop HBV transmission and eliminate HCV. To achieve this goal, the Mongolian Ministry of Health (MOH) informally requested the World Health Organisation (WHO) to provide technical support to review and assess the quality and technical capacity of hepatitis laboratories in Mongolia. The WHO Regional Office for the Western Pacific (WPR) conducted the assessment jointly with Margaret Littlejohn and Theo Karapanagiotidis from the Victorian Infectious Diseases Reference Laboratory (VIDRL), and Susie Braniff from the NRL.

The laboratory assessment teams carried out brief site visits for laboratory assessments at 21 of the public and private laboratories designated to perform HCV viral load testing, using a custom checklist, developed for this mission. The site visits also included primary and secondary health care facilities in one province, comprising a family health care centre, a Soum health care centre, a WHO mobile health unit and the district hospital. Following the site visits the laboratory assessment team reported its findings to the MOH in Ulaanbaatar. Recommendations have been made to help strengthen the quality of rapid testing and the collection, storage and transport of samples across the testing network. Mongolia is currently leading the world in implementing viral hepatitis screening of the entire population to stop HBV transmission and eliminate HCV. The site visits carried out by the laboratory assessment teams have identified potential areas of improvement to assist the Healthy Liver Program to successfully meet its goals.


Viral Hepatitis Laboratory Assessment in Mongolia 2017

Assessors who reviewed the quality and technical capacity
of hepatitis laboratories in Mongolia

July 2017: NRL Workshop on Evaluation of In Vitro Diagnostic (IVD) Medical Devices in Vietnam

On behalf of the World Health Organisation (WHO) office in Vietnam Susie Braniff from NRL delivered a four day training workshop entitled “Evaluation of In Vitro Diagnostic (IVD) Medical Devices” in Hanoi from the 04 – 07 July, 2017. The first 3 training days brought together 42 technical experts from the organisations that currently contribute to the national IVD dossier review programme.

Vietnam Group Photo July 2017

Participants from Vietnam attending the Workshop on Evaluation
of IVD Medical Devices

Approaches to the evaluation of IVDs were presented along with a breakdown of the required administrative and technical elements of an IVD dossier. Multiple practical sessions gave participants the opportunity to apply their analytical skills for evaluating the material provided in IVD dossiers being considered for registration. On the final day 14 participants from the Department of Medical Equipment and Construction (DMEC) focussed on standardising methods for data analysis and reporting, as well as a planning discussion on the current and future structure of the IVD medical device evaluation programme in Vietnam.

NRL would like to thank the technical experts contributing to the IVD dossier review in Vietnam for their active participation in the training and the team members from DMEC for their commitment to strengthening the national IVD evaluation programme.  In addition, NRL would like to acknowledge the Ministry of Health, Vietnam and the WHO Vietnam office for their continued support of laboratory capacity building.


July 2017: NRL Accredited as a WHO Prequalification Evaluating Laboratory   WHO logo

On the 25 July 2017, NRL was accepted as a WHO Prequalification Evaluating Laboratory allowing NRL to independently evaluate in vitro diagnostic devices (IVDs) for HIV, HCV and HBV Nucleic Acid Testing and HIV, HCV, HBV and Syphilis serology. The aim of the WHO Prequalification of IVDs is to promote and facilitate access to safe, appropriate and affordable IVDs of acceptable quality. Products submitted for prequalification are subjected to a comprehensive, standardized assessment to determine if WHO prequalification requirements are met. The assessment comprises three components:

  • Review of a product dossier;
  • evaluation of performance and operational characteristics; and
  • manufacturing site(s) inspection.

As part of a small selection of laboratories qualified to undertake this work, NRL looks forward to offering this service.


July 2017: NRL Training in Tajikistan

During 17 – 25 July 2017, NRL (represented by Susie Braniff and Marlene Tschaepe) conducted the 2nd visit to Dushanbe, Tajikistan under the framework of the project with the United Nations Development Program (UNDP) Tajikistan, entitled Technical assistance for the implementation of External Quality Assessment Schemes for the Republican AIDS Centre HIV/AIDS Laboratory Network”.

The purpose of the 2nd visit was to follow up on the training that NRL had delivered to the Republican and Regional centres of the HIV/AIDS Laboratory Network in Tajikistan last year.  During the visit the following activities were conducted:-


i)  
EQAS Production Training Workshop (17–21 July 2017)

The Republican AIDS Centre (RAC) is the national reference laboratory for HIV/AIDS in Tajikistan.  Through support from UNDP Tajikistan, the RAC plans to establish a national EQAS programme for HIV serology and provide panels to regional and district HIV/AIDS laboratories throughout Tajikistan. The workshop was attended by six participants from RAC, and focussed on the laboratory based activities of EQAS production to produce pilot serology panels for HIV.  With support from NRL, the participants were able to manufacture HIV serology EQAS panels for distribution to 10 laboratories within the HIV/AIDS Laboratory Network in Tajikistan.

 

ii) Laboratory Supervision & Monitoring Workshop (17–21 July 2017)

This workshop was attended by 12 participants from RAC, City AIDS Centre of Dushanbe and four Regional HIV/AIDS centres (Kurgan-Tyube, Kulyab, Sughd and GBAO). The aim of the workshop was to increase knowledge of supervision and monitoring approaches and tools that can be used to assist with the monitoring of the quality systems of centres within the HIV/AIDS Laboratory Network of Tajikistan.  The topics covered during the workshop included:

 
  • Laboratory Quality Management Systems;
  • Principles of auditing;
  • Components of a laboratory audit checklist;
  • Using checklists to monitor laboratory quality;
  • Train the Trainer                                                                                                                 
 

Tajikistan Training Group-July 2017

Tajikistan trainees attending the EQAS Production
Training Workshop

NRL would like to express gratitude to the staff of the RAC, City AIDS Centre of Dushanbe and the Regional HIV/AIDS Centres for their participation and contributions during the training workshops. Special thanks to UNDP Tajikistan for their efforts in support of laboratory strengthening activities in Tajikistan.


June 2017: Standardisation of Genomic Amplification Techniques and Serology/ Standardisation of Infection Diagnostics (SoGATS/SID) Workshop in London
NIBSC Logo

NRL staff attended the SoGATS/SID meeting held in London between 26 and 28 June 2017.  The aim of this meeting is for relevant parties to come together and discuss International Standards to be planned, designed and proposed to the World Health Organization Expert Committee on Biological Standards (ECBS).  Previously, this meeting has focused on nucleic acid testing (NAT) in blood safety. Subsequently the meeting has been expanded to discuss clinical diagnostic NAT and serology. In 2017, this was further built upon by addressing the need for standardisation in bacteriology, parasitology, rapid diagnostic devices and in next generation sequencing.  There were a number of new proposals for International Standards discussed that will be put forward to the ECBS.  In addition, as a group, SoGATS will be making a recommendation to all users of International Serology Standards on how these should be applied appropriately. An example of their application would be to determine vaccine efficacy, but not to calibrate diagnostic serology tests (e.g. rubella) in the quest for a quantitative result value.


June 2017: 27th Regional Congress of the ISBT in Copenhagen

NRL staff members (Wayne Dimech and Joe Vincini) attended the 27th Regional Congress of the ISBT in Copenhagen between 17 and 21 June 2017, providing representation at both the Trade Exhibition and in the Scientific Programme. 

ISBT-Coppenhagen 2017

 

Joe Vincini delivered a presentation on an alternative method to monitor infectious diseases testing QC which sparked some discussion on the merits of QConnect Limits in serology and NAT and how this would impact on current practices.  Participating in the Trade Exhibition at the Congress allowed NRL staff to speak to key customers and manufacturers of diagnostic assays directly, offering a convenient location to discuss current projects and plan for future NRL activities.


 

May 2017: NRL Training:Myanmar

ASCP-NRL Sub-Contract

NRL conducted its second visit to Myanmar under the ASCP-NRL sub-contract between 22 – 31 May 2017.  The aim of this trip was for NRL Scientist, Liza Cabuang, to visit HIV viral load testing sites at the National Health Laboratory (NHL), Mingalardon Specialist Hospital (MSH) and Magway General Hospital (MGH), to conduct on-site technical training and mentoring. 

Participants in the onsite technical training for HIV viral load testing sites

Trainees from Mandalay Public Health Laboratory (MPHL) also participated in the training conducted at MGH.  As a means of ensuring sustainability of the training and mentoring conducted, NRL was accompanied by a staff member from NHL for the training at MSH and MGH.  The aim of this additional mentorship was to build upon resources at NHL to provide support in-country, for troubleshooting technical issues that may arise.  During this visit, NRL also supported the development of standard operating procedures related to practical elements that are crucial to ensuring the quality of HIV viral load testing.

NRL would like to thank all partners and stakeholders, especially colleagues from the Ministry of Health and Sport, National Health Laboratory, National AIDS Program, Mingalardon Specialist Hospital, Magway General Hospital and CDC Myanmar, for their kind hospitality and contributions towards making the visit a success.

Participants in the onsite technical training for HIV viral load testing sites

ASLM-NRL Sub-Contract

Between 24 – 30 May 2017, NRL (represented by Sue Best, Geraldine Kong, Susie Braniff and Marlene Tschaepe) conducted its second visit to Myanmar under the ASLM-NRL sub-contract.  A number of activities were conducted during this visit which included:

  • A training workshop entitled “Site Assessment Tools - Training of Trainers”, (24 - 26 May 2017).  This workshop was a continuation of the first Site Assessment Tool training workshop conducted in March 2017.  The workshop was attended by 15 participants from 10 international non-governmental organisations.  It included a “Train-the-Trainer” focus and interactive sessions on how to deliver training to new users of the NRL Australia adapted SPI-RT Checklist.  The final day of the workshop included a teach-back session where the participants were provided with an opportunity to practice and utilise their trainer skills through the delivery of a presentation.
  • A meeting with in-country partners and stakeholders to discuss the operational and policy issues concerning the development of a standardised, national training plan for HIV testing services (HTS) in Myanmar.
  • A mapping workshop to review the various assessment tools currently in use in Myanmar and consider options for streamlining and refining current systems for the supervision and monitoring of HTS test sites.

Training for HTS in Myanmar taking place

 

NRL would like to thank all partners and stakeholders, especially colleagues from Ministry of Health and Sport, National Health Laboratory, National AIDS Program, Myanmar offices of CDC, WHO, Save the Children and ICAP at Columbia University, for their kind hospitality and contributions in making the visit a success.

 

 

 

             Training for HTS in Myanmar taking place

April 2017: The HMSTrust Biobank

NRL is proud of its partnership with St Vincent’s Institute of Medical Research (SVI) in housing the HMSTrust biobank onsite. Recently, media outlets reported that SVI has launched a ‘Living Biobank’, to support research into diseases that affect Australians, including diabetes and cancer.

SVI’s recently established Living Biobank, and the HMSTrust Biobank was launched in 2015 and is a mechanism for research that can potentially lead to the prevention, treatment or cure of a disease in an individual.

Samples collected for the Living Biobank may be used immediately for research projects, or ‘banked’ and kept for longer-term storage in the HMSTrust Biobank.

The SVI Biobank Program is a partnership between SVI, NRL and St Vincent's Hospital Melbourne.

April 2017: Workshop on Hepatitis Strategic Information and Laboratory Capacity, Mongolia

The World Health Organization (WHO) Western Pacific Regional Office (WPRO) aims to establish the first Regional Hepatitis Reference Laboratory Network based on existing networks for HIV, measles and rubella. WHO WPRO is also seeking to further develop disease surveillance mechanisms in the region.  To this end a Workshop organised by WHO, was held in Ulaanbaatar, Mongolia and attended by 90 public and private laboratory staff and managers, clinicians, and epidemiologists. NRL was represented as one of the facilitators, along with medical, surveillance and laboratory staff from the Doherty Institute/Victorian Infectious Disease Reference Laboratory, US CDC, Korean CDC and the WHO.

To assist in the development of the Regional Hepatitis Reference Laboratory Network, NRL and VIDRL created a laboratory capacity survey and a self-assessment tool that were piloted at a workshop in Mongolia. Prior to the workshop a questionnaire, translated into Mongolian, was distributed by the WHO Country Office to public and private laboratories throughout the country.  The questionnaire was comprehensive and included questions relating to hepatitis A, B, C, D and E. It was comprised of 90 questions, many with sub-questions, reviewing the type of testing performed, participation in quality assessment schemes, testing  of quality control samples, presence of testing strategies, referral of samples and reporting of surveillance data.   The results of the survey were translated back to English and returned to the collaborating Australian laboratories for analysis. A second self-assessment tool was developed.  This tool had seven sections – laboratory organisation, specimen management, testing and process control, quality assurance, data management, reagent and equipment procurement and laboratory safety. Each section contained a series of points relating to the section’s topic.  The workshop participants rated each point from 1 to 4, where 1 was “not present/not available” and 4 was “complete and functional”. 

The results of the survey and the assessment tool identified gaps in the testing capacity. These gaps in laboratory capacity, along with recommended actions, were reported to the WHO regional office and the Mongolian Ministry of Health. Similar surveys and workshops will be conducted in other WPRO Member States. WPRO (and their collaborators) have committed to organise national workshops in 5 further high burden countries in the coming 12 months (China, Philippines, Laos, Vietnam and Cambodia).

March 2017: NRL Training in Myanmar

In the first quarter of 2017, NRL was awarded two sub-contracts, which allowed the continuation of capacity development activities in Myanmar.  Both sub-contracts were funded by the United States President’s Emergency Plan for AIDS Relief (PEPFAR), through the US Centers for Disease Control and Prevention (CDC).

One of the sub-contracts was between the African Society for Laboratory Medicine (ASLM) and NRL.

The objectives of this project were to support the following:

(i) Supervision and monitoring of quality at decentralised HIV point-of-care testing sites in Myanmar, through the development of an assessment tool appropriate to the local context; and

(ii) Development of a standardised, national training plan for HIV testing services in Myanmar. 

Between 20-24 March 2017, Susie Braniff, Marlene Tschaepe and Geraldine Kong visited Yangon under the auspices of this ASLM-NRL sub-contract.  During the visit, NRL staff:

  • Conducted training for the Ministry of Health and Sports (MOHS) National Health Laboratory (NHL), Yangon and 12 international non-governmental organisations in the use of an assessment tool adapted from the CDC Stepwise Process for Improving the Quality of HIV Rapid Testing (SPI-RT) Checklist, to suit the local context in Myanmar. 
  • Trialled the use of the assessment tool for suitability to the local context, through practical training sessions.
  • Undertook meetings with in-country partners and stakeholders to discuss operational and policy issues concerning the development of a standardised, national training plan for HIV testing services in Myanmar.

NRL would like to thank all partners and stakeholders, especially colleagues from NHL, National AIDS Program, as well as the Myanmar offices of CDC, Save the Children and ICAP at Columbia University, for their kind hospitality and contributions towards making the visit a successful and fruitful one. 


The second sub-contract was between the American Society for Clinical Pathology (ASCP) and NRL.  The objective of this project was to support the implementation of the national HIV viral load scale-up plan in Myanmar. 

Between 20-31 March 2017, NRL staff member Liza Cabuang and Consultant Scientist Johanna Wapling visited Yangon under the auspices of the ASCP-NRL sub-contract.  During the visit, both team members:

  • Conducted technical training on HIV viral load testing for laboratory staff from the National Health Laboratory (NHL), Mandalay Public Health Laboratory, Mingalardon  Specialist Hospital and Magway General Hospital.
  • Undertook site visits and participated in meetings and discussions aimed at supporting the national HIV viral load scale-up plan for Myanmar. 

NRL would like to thank all partners and stakeholders, especially colleagues from NHL, National AIDS Program, and CDC Myanmar, for their kind hospitality and contributions towards the success of the visit

Myanmar March 2017

 ASCP Working Group

Myanmar March 2017

  ASLM Working Group