They operate as referral centres for 63 provincial public health laboratories which together form a national communicable disease surveillance network. Peter McMinn has worked with both major laboratories over the past five years, to strengthen their capacity to provide leadership in national communicable disease surveillance. Vietnam is now one of a handful of countries in Asia Pacific, and the only developing country, with internationally accredited public health laboratories. Vietnam is a developing country with a population of nearly 90 million people that suffer from a
large burden of communicable disease. The World Health Organization has recommended that member nations should maintain functional laboratory surveillance systems to define disease burdens and trends, to identify epidemics and to monitor the effectiveness of public health interventions such as immunsation. The need for Vietnam to conduct pandemic surveillance has been highlighted by its central role in the SARS and avian influenza epidemics of the past decade.
At the commencement of the project, both the National Institute of Hygiene and Epidemiology in Hanoi and
Pasteur Institute in Ho Chi Minh City supported a small number of highly functioning laboratories that generated excellent surveillance data. A feature common to these laboratories was that they received external funding from WHO and the Global Fund, and were linked to international research and surveillance networks. Most of the laboratories, however, were poorly funded, received very few specimens for testing, experienced low staff morale and provided a poor quality of service. Further, senior management was not providing the leadership required to deliver the change necessary to improve their institute’s quality of service.
Thus the aim of the project was to embed international best practice in laboratory quality management at the
two institutes. The primary goal has been to assist the institutes and laboratories achieve accreditation against the International Standards Organization standard for medical laboratory quality systems - ISO15189: 2007 Medical Laboratories - Particular Requirements for Quality and Competence. The project has received strong support from the Vietnamese Ministry of Health and the WHO, and has been funded by WHO and the Australian Government.
The first phase of the project involved the formation of writing groups comprising people from the University of Sydney, and senior staff from the laboratories in Ho Chi Minh and Hanoi. The groups met frequently to oversee the complex task of the drafting institute-specific quality manuals and associated documentation in both English and Vietnamese. Preparation of documents was central to the success of the project, so a 9-12 month period was set aside to ensure that the final documents met the needs of both institutes and were also compliant with ISO15189. It was also necessary to ensure that the Vietnamese translations accurately reflected the meaning of technical documents initially drafted in English. This required translators who were fluent in both English and Vietnamese, and also trained and experienced medical laboratory scientists who understood the concepts outlined in the documents and possessed the required technical vocabulary in both languages. Needless to say, people with such a mix of skills are very rare!
During the period of document drafting, the Sydney
The National Institute of Hygiene and Epidemiology, Hanoi.
team also developed a number of training courses and programs, including training-of-trainer programs in quality management, and training courses in quality auditing, equipment calibration and method validation. These focused on the technical and managerial requirements of ISO15189. Two adult educators from Learning Solutions at the University of Sydney were recruited to the project in order to ensure that best practice adult learning techniques were applied. The completed training course notes and presentations were then translated into Vietnamese.
Training of trainers in quality management was
undertaken in Hanoi and Ho Chi Minh City in 2009-10. In December 2010, the first group of quality management trainers from laboratories in 20 southern provinces were trained at Pasteur Institute. Collectively, trainers from the two major institutes have trained more than 250 laboratory staff in the principles and practice of quality management in 15 separate courses. The first provincial laboratory Quality Management training course was held at My Tho, Tien Giang Province, in February 2011, with trainers from Pasteur and laboratories collaborating in the delivery of this course. It was very gratifying to observe the realisation of our goal of sustainability in quality management training in Vietnam.
Auditing is an essential aspect of laboratory quality management. It is necessary to audit each component of the quality system at least once per year to ensure its integrity and to identify and correct non-conformances. Audit training was provided at Pasteur in Ho Chi Minh in July 2010 and at National Institute of Hygiene and Epidemiology in Hanoi, and in the southern city of Can Tho in April 2011, resulting in a total of 68 trained ISO1589 auditors to date. Upon completion of training, the new auditors wasted no time in commencing audits of their quality system in preparation for ISO15189 accreditation. Training of trainers modules are being developed for the quality audit training course and training is planned for November 2011, which will further embed the sustainability of quality management training in Vietnamese public health laboratories.
Another essential requirement of laboratory quality management is enrolment in an external quality assurance program, in which the laboratory receives blinded specimens and is required to examine them and identify the unknown pathogen and/or cause of disease. These programs provide a rigorous test of the integrity of the quality system and participation is an essential prerequisite for ISO15189 accreditation. Currently, there is no external quality assurance program available in Vietnam. The National Institute in Hanoi has been directed by the Ministry of Health to develop a national quality assurance program over the next three years, but in order to ensure that the two reference laboratories comply with international quality standards in the short-term, the project has funded the provision of the Royal College of Pathologists of Australasia external quality assurance program to both institutes for a
Pasteur Institute of Ho Chi Minh City
period of two years. This will be reviewed in 2013 and the need for an extension addressed.
The introduction and maintenance of laboratory quality management is a complex task requiring good leadership, communication and teamwork. Much of the
workload is carried by designated institutional “Quality Managers,” whose task it is to ensure laboratory and institutional compliance with the quality system and to prepare their institute for accreditation. In order to assist the National Institute of Hygiene and Epidemiology and Pasteur Institute in Ho Chi Minh City in this difficult role, a study tour of several large Australian hospital and public health laboratories was arranged in November 2010. Tour participants were given privileged access to a large amount of confidential information and documentation on how several leading Australian clinical and public health laboratories manage their quality systems and prepare for ISO15189 accreditation. They were also able to network with Australian quality managers which has provided an excellent source of advice and support in preparing for their own accreditation inspections.
In conclusion, the quality management capacity building project has been well received throughout the public health laboratory system in Vietnam, with
12 leading laboratories in Hanoi, Ho Chi Minh and in Tien Giang Province, achieving ISO15189 accreditation to date. Numbers are growing, with 13 more planning accreditation inspections in the coming 12 months. Other than Vietnam, the only countries in the Asia–Pacific region to have ISO15189-accredited public health laboratories are Australia, New Zealand, Japan, Singapore, Korea and Hong Kong. This is a major achievement for a developing country and has placed Vietnam in a unique position to serve as a regional leader in the global surveillance of epidemic and pandemic disease.
Acknowledgments: Quality management projects cannot be successful without good teamwork. The quality management teams at NIHE and PI-HCMC have worked tirelessly and enthusiastically to achieve their goal of institutional accreditation against ISO15189 and have been rewarded with outstanding success. I also wish to thank our translators and interpreters, Drs Tran Phuc Hau, Pham Ngoc Doan Trang and Dang Thu Ha, Mrs Trinh Quynh Mai and Mrs Tran Dieu Linh, whose painstaking work has been critical to our success. Finally, I wish to acknowledge the wonderful USyd team with whom I have worked closely on this project: Dr Monica Lahra and Ms Emily Bek from Infectious Diseases and Immunology, Mrs Jane Cox and Ms Nicola Reade from Learning Solutions and Ms Megan Brewer and Mr Stephen Brancatisano from the Office of the Deputy Vice-Chancellor (International). Without their dedication, creativity, generosity and enthusiasm this project could not have been successful.