Blood has been classified under “biopharmaceuticals”. The Drug is manufactured according to the directives of the Drugs and Cosmetics Act and Good Manufacturing Practices are followed.
Blood transfusion services are guided by the Ethical guidelines of the WHO and International Society of Blood Transfusion and regulated by the product standards set by the Drug Controller General of India.
Blood safety begins with the good quality “raw material” i.e. Whole blood donation. Blood donation is an act of altruism and is voluntary and non-remunerated. Our law does not permit “paid donations”.
It is the duty of the transfusion services to safeguard the safety of both the donor and the recipient.
Donor selection begins with the donor answering an exhaustive list of questions about his health and lifestyle and he/she gives the written informed consent for willingness to donate blood and permit the mandatory tests to be performed as per the national regulatory guidelines and processed and used appropriately by the blood services. A pre-donation process allows this information to be provided to the donor and also gives him an opportunity for self-deferral.
The transfusion services on its part ensures proper collection of blood in a safe and hygienic environment using single-use containers and calibrated devices. At the end of the donation, blood samples are collected in test-tube to test for infectious diseases, blood group and compatibility. The entire process is performed and monitored by trained nurses under the supervision of a Medical officer.
Post donation rest and refreshment is provided in a congenial atmosphere under the watchful eyes of the nurses for any immediate post donation reactions and the donor is allowed to leave the premises after post donation instructions are given.
The entire donation process is documented in appropriate registers as per the guidelines of theDrugs and Cosmetics Act.
Blood Component Production and Inventory management
Every unit of collected blood is sent to the Blood Component preparation and storage laboratory for further processing.
Blood is separated into its constituent components viz. red cells, white cells, platelets and plasma by a process of centrifugation.
The Red cells and platelets are filtered to remove the white blood cells (leuco reduced) that have been known to cause untoward effects in the recipient.
The blood products are stored in appropriate temperature controlled storage units that provide the environment to maintain quality and shelf life of the product. All the storage units are monitored in real time and calibrated periodically to ensure safety of the product.
Screening Tests Performed on Blood donations:
Blood Group Determination and Antibody Detection:
ABO and Rh grouping are performed on automated blood group systems .Testing is also done for unexpected red cell antibodies using commercial cell panels. Recipients are also tested similarly and extended testing done to identify the red cell antibody in the recipient so that specific antigen-free red cells can be provided.
Transfusion Transmissible Disease Testing:
In India it is mandatory to test each unit of donated blood for the following infections that are transmissible through blood. The screening tests are performed using licensed diagnostic kits and equipment for HIV, Hepatitis B and Malaria and Syphilis.
Our blood bank provides an additional layer of safety to the recipient by screening the blood for these viruses using the Nucleic Acid Testing (NAT)
We do not perform confirmatory tests on the donor blood. By a
post donation counselling process the donor is informed of his screening test status and is informed of the need for confirmatory tests to be performed. This is very confidential dialogue between the blood bank officer/counsellor with the blood donor.
After completion of the tests on the blood donations blood in quarantine is released into the inventory for use.
The units not suitable for transfusion are disposed safely according to the guidelines of the Pollution Control Board of the country
Hospital Transfusion Services:
We have qualified medical and technical personnel who are responsible for “vein to vein safety”. The request for blood is received in the laboratory. The requisition forms for blood are designed as per the regulatory requirements and duly completed and signed by a Registered Medical Practitioner. The laboratory personnel select the appropriate product and deliver it to the patient after all the necessary pretransfusion tests are performed on the recipient sample accompanying the requisitionform.
All the activities are recorded in appropriate registers before release.
The clinical staff in the hospital where transfusion takes place are responsible for providing the appropriate sample of the properly identified recipient, to the transfusion service, receiving the product ,verifying the product and the recipient and administering the same through suitable administration sets .All recipients have to be carefully monitored for any adverse effects.
Each transfusion record is maintained in the recipient medical records and feedback shared with the transfusion service also.
Any adverse event is notified to the treating physician and appropriate investigations initiated in the transfusion laboratory.
The transfusion process involves the competent and caring professionals working with great commitment to ensure highest level of safety in our hospital.
HEAD OF THE DEPARTMENT
BLOOD BANK AND IMMUNOHEMATOLOGY