The Health Ministry has issued a warning to facilities offering blood testing services without proper licences, stating that violators may face fines of up to RM500,000, imprisonment for up to six years, or both. The ministry emphasized that blood collection is a regulated clinical procedure and must comply with safety standards under the Private Healthcare Facilities and Services Act 1998.
KUALA LUMPUR: The Health Ministry has issued a stern warning to facilities offering blood testing services without the necessary licences and approvals, stating that such operations may face severe penalties.
In a statement released on Thursday, April 30, the ministry emphasized that any premises conducting blood collection or phlebotomy services without proper registration or licensing under existing laws are committing an offence. Violations of these regulations could lead to fines of up to RM500,000, imprisonment for a term of up to six years, or both upon conviction.
The ministry’s statement comes as part of its efforts to clarify the legal framework surrounding health screening services, particularly blood testing, in community pharmacies. While acknowledging the important role that community pharmacies play in the healthcare delivery ecosystem, the ministry stressed that blood collection is a clinical procedure that demands strict adherence to safety standards and proper risk management. These procedures must be carried out in healthcare facilities that comply with existing legal provisions.
The ministry cited Section 2 of the Private Healthcare Facilities and Services Act 1998 (Act 586), which classifies health screening services, including blood testing, as healthcare services. Consequently, any premises involved in blood collection activities are required to register and obtain the necessary licences under Act 586. The ministry underscored the importance of compliance with these licensing and registration requirements, highlighting that they are essential for ensuring the safety, quality, and accountability of the services provided.
Additionally, adherence to these regulations helps protect community pharmacies from potential legal and reputational risks. The ministry’s statement serves as a reminder to all healthcare providers of the legal obligations they must fulfill to maintain public health standards and avoid penalties
Health Ministry Blood Testing Licensing Penalties Healthcare Compliance
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