Are community pharmacies legally required to be licensed for blood tests?

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Community Pharmacies Must Be Licensed for Blood Tests

Community pharmacies offering blood collection services are legally required to be registered and licensed premises in accordance with existing laws. Blood collection, also known as phlebotomy, is classified as a clinical procedure that necessitates adherence to stringent safety protocols and effective risk management.
Legal Framework for Health Screening Services

Under Section 2 of the Private Healthcare Facilities and Services Act 1998 (Act 586), any facility providing health screening services, which explicitly includes blood collection, must obtain registration and a valid license under this Act. This legal provision categorises premises performing blood collection as healthcare service providers, mandating compliance with the licensing requirements stipulated by Act 586.
Penalties for Non-Compliance

Operating a facility that offers blood collection services without the requisite registration or a valid license under Act 586 constitutes a significant offense. Individuals or entities found in violation face severe penalties, including a fine of up to RM500,000, imprisonment for a term not exceeding six years, or a combination of both.
Emphasis on Safety and Accountability

The Health Ministry acknowledges the valuable role community pharmacies play in healthcare delivery. However, the ministry unequivocally prioritises safety, quality, and accountability in the provision of all healthcare services. To this end, the ministry intends to enhance enforcement measures, ensuring that all healthcare services are exclusively delivered at licensed facilities, thereby safeguarding patient well-being and helping community pharmacies mitigate potential legal and reputational hazards.

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Are community pharmacies legally required to be licensed for blood tests?

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