Replies to LegCo questions

LCQ10: Regulation of private medical laboratories

Following is a question by the Ir Dr Hon Ho Chung-tai and a written reply by the Secretary for Health, Welfare and Food, Dr Yeoh Eng-kiong, in the Legislative Council today (December 17):

Question:

It has been reported that, currently, the Government does not regulate private medical laboratories. As quite a number of private medical laboratories are housed in commercial buildings, they may endanger residents in the neighbourhood in the event of any mistakes made by such laboratories in handling high-risk tests. In this connection, will the Government inform this Council:

(a) of the total number of accidents involving private medical laboratories in the conduct of laboratory tests over the past three years;

(b) whether it knows if the United States and Canada have legislation for regulating private medical laboratories; if so, of the details; and

(c) whether there is legislation regulating private medical laboratories; if so, of the details; if not, whether such legislation will be enacted?

Reply:

(a) Neither the Department of Health nor the Medical Laboratory Technologists Board is aware of any accidents involving private medical laboratories in the conduct of laboratory tests in the past three years. The Medical Laboratory Technologists Board is a statutory body established under the Supplementary Medical Professions Ordinance (Cap. 359) and its subsidiary legislation to regulate the professional practice and conduct among medical laboratory technologists. In the past three years, the Board has not received any complaints relating to accidents in medical laboratories.

(b) Regulatory control on medical laboratory or medical laboratory personnel varies among overseas countries. Based on the information available to us, in the United States, all laboratory testing for human health are regulated through certification and quality assurance programme having regard to the complexity of the tests performed. Some states also require laboratory personnel to be licensed or registered. The situation in Canada differs in that mandatory licensing of medical laboratories or registration of medical laboratory technologists is only practised in certain provinces.

(c) In Hong Kong, the standard of medical laboratory service is ensured through the professional regulation of medical laboratory technologists under the Supplementary Medical Professions Ordinance. Under the Ordinance, the medical laboratory technology profession can only be practised by persons registered in respect of that profession. Moreover, any company carrying on the business of medical laboratory service is required to have at least one director who is a registered medical laboratory technologist. Any medical laboratory technologist who breaches any condition of his registration may be subject to inquiries and liable to disciplinary actions, including receipt of warning letter and removal of his name from the register. We will continue to monitor the standard of laboratory practice and review the adequacy of our present regulatory framework if this is found to be necessary.


Ends/Wednesday, December 17, 2003
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