KUALA LUMPUR: Facilities offering blood testing services without the required licence and approvals may face hefty penalties, the Health Ministry says.
The ministry said that premises conducting blood collection or phlebotomy services without proper registration or licensing under existing laws commit an offence.
“Such violations could result in fines of up to RM500,000, imprisonment of up to six years, or both upon conviction,” it said in a statement on Thursday (April 30).
The ministry was clarifying the provision of health screening services, including blood testing, at community pharmacies, acknowledging their important role in the healthcare delivery ecosystem.
“Blood collection is a clinical procedure that requires strict adherence to safety standards and proper risk management, and must be carried out in healthcare facilities that comply with existing legal provisions,” it said.
Citing Section 2 of the Private Healthcare Facilities and Services Act 1998 (Act 586), the ministry said that health screening services, including blood testing, fall within the definition of healthcare services.
“As such, any premises carrying out blood collection activities are deemed to be providing healthcare services and are subject to registration and licensing requirements under Act 586,” it added.
The ministry added that compliance with licensing and registration requirements is crucial to ensure the safety, quality and accountability of services, while also protecting community pharmacies from legal and reputational risks.
