The Regional Quality Congress

14 Feb 2004

By Dr Balaji Sadasivan

Venue: Fort Canning Lodge

Introduction

I am very honoured today to be invited to the opening of the Regional Quality Congress and I am pleased that we have with us today in the Congress an excellent group of distinguished speakers from many countries to share with us knowledge and information in the field of external quality assurance in laboratories.

2. According to the National Institute of Health Policy, ?quality assurance or quality assessment is the activity that monitors the level of care being provided by any health care vendor in order to ensure that patients are receiving the best care possible.? Many quality assurance programmes feature systematic processes to identify and prevent discrepancies, attempt remedial actions when sub-standards exist and work towards stretch targets to bring all laboratories to higher levels of quality. The ultimate outcome - an effective, efficient and successful improvement in the delivery of quality patient care.

3. Quality assurance is becoming increasingly important, especially in this era where infectious disease outbreaks have prevailed over the last 1 year globally, either in the SARS outbreak last year or the recent Avian influenza outbreak, where detection and prevention of these diseases are heavily dependent on the reliability of analysis done in clinical laboratories.

BIOSAFETY

4. Besides providing accurate and robust laboratory results, it is also important that laboratories ensure highest levels of biosafety at all times. Already, not one but two cases of laboratory-acquired SARS infections - in Singapore last September and in Taiwan last December - have shown us that we cannot afford to lapse in our attention to biosafety standards, procedures and training in laboratories, especially where work on highly infectious diseases is being carried out. We cannot assume that future cases laboratory-acquired SARS would be isolated like these first two. There is always a risk of secondary transmission to the community with potentially disastrous consequences for the public and our economy.

5. The Ministry of Health is the lead agency in the development of a comprehensive integrated framework for biosafety. We will be working closely with the relevant Ministries and government agencies to address all aspects of biosafety ranging from import and transport of biological agents to their storage, handling and disposal.

6. A key part of this framework will be the establishment of appropriate legislation to require all clinical and research laboratories that hold or handle a select group of biological agents to comply with a set of national biosafety standards. These standards are currently being drawn up by a Technical Working Committee appointed by the National Biosafety Committee. The standards will be based closely on the guidelines in biosafety issued by World Health Organisation (WHO) as well as Centers for Disease Control (CDC), Atlanta. Another Technical Working Committee is concurrently drawing up guidelines for competency-based training in biosafety especially for laboratory staff.

7. In the interim, while this framework is being developed, the Ministry has undertaken a series of audits of the clinical and research laboratories that handle SARS specimens, to ensure that these labs have in place the necessary SOPs, guidelines, facilities and equipment to maintain adequate standards of biosafety in the handling and processing of SARS specimens. These audits are currently in progress.

8. Singapore still faces a threat from SARS with some signs of re-emergence in China. In addition, the new threat of Human Avian influenza (H5N1) has also appeared. IN the same way that we have dealt with SARS, MOH has restricted diagnostic and research work on the Human Avian Influenza (H5N1) virus to select labs that have been checked for compliance with biosafety rules and procedures. No other labs are allowed to hold or handle virus stocks or specimens without prior approval from the Ministry.

CONCLUSION

9. My Ministry hopes that through the efforts I have just described that we will be able to ensure the safety not only of those who work in laboratories, but also the general community at large. However, success in this area depends ultimately on the commitment and responsibility of the lab staff.

10. The most comprehensive guidelines and detailed audits will not ensure biosafety unless each member of the lab staff and management comply fully with the standards and requirements every time they enter the lab and for as long as they remain in the lab. This is a professional responsibility of no less importance than maintaining high standards of quality assurance in one?s work.

11. In conclusion, I invite all labs to work hand-in-hand with MOH and their parent organizations to develop and promote a ?safety culture? in their labs to ensure that there will be no lapses and no more cases of laboratory-acquired infections in Singapore.

12. I wish all of you a most fruitful and rewarding Congress.

Thank you.