DIRECTOR-GENERAL OF HEALTH MALAYSIA
SAFETY OF BLOOD DONORS AND RECIPIENTS
- Ministry of Health (Ministry) refers to an article published by The New Straits Times newspaper titled “HIV-contaminated blood transfusion: Medical centre to pay RM896,000 to accident victim” on 4th February 2016 and a few other media agencies on the similar issue.
- Ministry takes note of the recent report in which one of the private hospitals has been asked to pay RM 896,000 to an accident victim for its negligence in providing him with HIV-contaminated blood in 2005. Ministry is very concerned with regards to the safety of blood transfusion services in this country. It is known that blood transfusion services are not only being provided in public healthcare sector but also in the private healthcare facilities. While blood transfusion can be a life-saving intervention that has an essential role in patient management, it is not without risk. Many steps have been taken to ensure the safety and adequacy of the blood supply in Malaysia.
- Safe blood comes from safe donors. In many parts of the world, it has been shown that voluntary non-remunerated blood donors are the safest donors. Each healthcare facility that conducts blood donation must assess prospective donors individually for his/her suitability to donate blood using a well-structured questionnaire during the pre-donation interview. This is to provide an opportunity to defer individuals with high risk of having infections that can be transmitted through blood, thus ensuring the safety of blood supply. At the same time Ministry of Health would like to highlight that HIV cannot be transmitted to a donor through blood donation as the process utilises single use medical devices.
- The HIV test became available in 1985 and since then, screening of all donated blood has become mandatory for HIV together with other infections such as hepatitis B, hepatitis C and syphilis. Blood and blood products that have tested positive for HIV and/or other infections are discarded and are not used for transfusions. Blood donors who test positive for HIV are deferred permanently from future donations and will be interviewed and investigated following notification by blood banks.
- Ministry has published successive guidelines as additional safety measures to be use in facility that conduct blood donation, processing and screening of donated blood. This includes using only licensed assay systems for blood screening; adhering to national and international standards; ensuring the availability of adequate number of trained staff; appropriately resourced in term of equipment and facility as well as the implementation of an effective quality system in the laboratory.
- Ensuring the safety and availability of blood is also the responsibility of the community and individual blood donors. Ministry of Health calls upon prospective blood donors to provide frank and accurate answers in the donor questionnaire and not to use donation sites as a place to test their HIV status.
- Blood donation and transfusion activities in the private healthcare settings are governed through Private Healthcare Facilities and Services Act 1998 [Act 586] and the Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006 [P.U. (A) 138/2006]. These facilities undergo regular inspection for control and licensing purposes by Ministry.
- Based on Section 60 in Act 586, all licensed private healthcare facilities providing emergency services regularly or surgical services shall maintain a minimum blood supply in its premises at all times for its daily use or be in a position to obtain blood quickly from other licensed blood banks or Government facilities for its daily needs. For licensing purposes, it is compulsory and part of the requirements, for such private healthcare facilities to have agreement with blood banks or Government facilities to supply the facilities with blood and blood products when the need arises.
- In relation to this, under Part XXI in the Private Healthcare Facilities and Services Regulations 2006, there are special requirements for blood bank services, blood transfusion services or blood donation programmes which need to be adhered to if these services are being provided by the private healthcare facilities or services. Amongst others the special provisions include requirements on performance of tests and procedures, Standard Operating Procedures (SOP) and administration of blood and blood products.
- A private healthcare facility or service providing blood transfusion services and blood donation programmes shall ensure the safety of donors and recipients and shall draw up criteria and standards for blood donor recruitments, selection and care. Such criteria and standards shall be consistent with the Code of Ethics for Blood Donation and Transfusion, Ministry of Health as stated in the Eleventh Schedule of the Private Healthcare Facilities and Services Regulations 2006.
- The Code focuses on the requirements that need to be followed for the donor, the recipient as well as on the control. It is stated appropriate controls shall be required to verify that blood transfusions practices meet internationally accepted standards and that guidelines issued in accordance with the Code are followed.
- As such Ministry would like to remind all private healthcare facilities especially private hospitals to take extra preventive measures to prevent untoward complications in the blood transfusion processes or services. The private hospitals and other private healthcare facilities are advised to adopt the revised guidelines established by the National Blood Bank (Pusat Darah Negara), Ministry of Health, as it is being part of the requirements under the Regulations.
DATUK DR NOOR HISHAM ABDULLAH
DIRECTOR-GENERAL OF HEALTH MALAYSIA
7 FEBRUARY 2016