Move to regulate 250 private medical laboratories

The 250 private medical laboratories in the country are being run without any proper regulation or certification by the Health Ministry.
Health director-general Datuk Dr Ismail Merican said all one needed to do to set up a medical laboratory was to register as a business entity.
“Anybody can set up a laboratory because there is no law governing private laboratories. Even if the person sets up a laboratory without the proper qualifications, the ministry cannot take action,” he added.
Dr Ismail said that at present the laboratories were only registered with the Registrar of Companies or Registrar of Business.
One man, who fell victim to a 'defective test' by a laboratory was Jim Kow Chee Meng. The 46-year-old remisier had his blood tested for cancer when he found a lump on the right side of his neck.
The laboratory gave him a clean bill of health. However, just seven days later, he was diagnosed with nasal cancer by a private hospital.
“The lab's so-called cancer marker test did not detect anything,” claimed Kow, who is now recuperating from first-stage chemotherapy.
The Health Ministry, however, has no power to act against such a laboratory but a bill will be tabled in Parliament soon to address this.
“The ministry will table the Pathology Bill to regulate the private medical laboratories in the country,” said Dr Ismail.
Malaysian Medical Association (MMA) president Datuk Dr Teoh Siang Chin lauded the move to table the long-awaited bill.
“MMA has been fighting for 15 years for the bill to be implemented and five years ago, we conducted forums to regulate about 250 private laboratories in the country.
He called for the bill to be tabled urgently. He said all medical laboratories should:
# MEET the required standards and norms of medical practice and be subjected to continuous medical audit;
# PARTICIPATE in quality assurance programmes;
# BE run by well-qualified personnel in each sub-specialty, who are appropriately trained to run tests and give proper interpretation of the result tests carried out in the laboratories; and
# COMPLY with safety regulations and be subjected to regular inspections for compliance.
Dr Teoh said the ministry lacked legislative control, adding that if the bill were to be implemented, it would ensure that private pathology laboratories nationwide were licensed and placed under the ministry's supervision.
The bill, he added, should have stipulations addressing issues on the standards and norms of medical practice, medical audit, quality assurance, qualifications and adequacy of personnel, and other social and ethical matters.
It would also ensure that anyone intending to establish or operate a private laboratory is subjected to stringent provisions in the proposed Act.
This would also pave the way for those who contravened any of the clauses and be imposed harsh penalties.
Dr Teoh also called for a fee schedule to be drawn up so that the laboratories charged their customers a fair and equitable amount.
Source