A national or regional blood regulatory system is necessary to ensure the monitoring of blood safety
Blood donation is the most selfless act. There is nothing that can replace human blood. Every two seconds, someone somewhere requires safe blood. In addition to blood cancer patients, thalassemia patients, pregnant women, car accident victims, and those undergoing elective surgery, numerous other patient groups require safe blood. Every year, between 10,000 and 15,000 newborns are born with thalassemia major in India. These Thalassemia patients require regular blood transfusions to maintain their haemoglobin levels, and they require the safest blood available that has been checked for transfusion transmissible infections (TTIs). Blood quality should be a consideration for anyone and everyone going through a blood transfusion.
Recently in Hyderabad, a three-year-old thalassemia patient allegedly contracted HIV after receiving blood from the Indian Red Cross Society's blood bank (IRCS). The boy underwent an HIV test a few days back and the results were positive. Such instances set an alarm that we need to proactively raise our voices to strengthen the blood safety laws and regulations of our country. This isn’t the first time such a case has been reported. In the last three months, we have had two cases, including that of the Hyderabad kid. The other case was in Nagpur where four children suffering from thalassemia were infected with HIV while undergoing blood transfusions.
To ensure that every patient receives safe blood, such occurrences demand enhanced blood screening and testing processes. The importance of blood quality cannot be overstated, as unsafe blood can result in transfusion-transmitted illnesses and death. Concerns have been expressed over the absence of testing and poor safety of blood transportation in India. Generally, blood donors' medical histories and prior disease records are not considered. There is little concept of recurrent blood donation that can maintain the continuity of blood bank services, as the vast majority of donors are one-time, voluntary donors. This makes it extremely difficult for thalassemia patients to obtain safe, high-quality blood from banks.
In India, the poor safety of blood and lack of rigorous testing measures have been a growing concern. All collected blood units must undergo serological testing for HBV (Hepatitis B), HIV and HCV (Hepatitis C), syphilis, and malaria. Due to the window time for certain infections, the presence of hidden diseases, and the ongoing creation of novel variants that defy even contemporary screenings, those who receive blood are still at risk of developing TTIs despite the necessary testing. Consequently, there is an urgent need to offer an additional safety net for blood transfusions.
The Nucleic Acid Amplification Test is a cutting-edge screening method for infectious diseases. Important for donor notification and counselling, NAT also uses serological tests to resolve erroneous reactive contributions. Within the current system, blood banks are free to apply whichever testing techniques they want. Companies may charge a processing fee based on the specialised tests or technologies they employ. Consequently, it is vital to commission a study on best practices related to blood safety, supporting blood banks in a particular region with NAT testing for thalassaemic, and supporting technologies for assembling specialised pools of voluntary thalassemia donors. As of now Rajasthan, Uttar Pradesh, Uttarakhand, Jharkhand and Karnataka have implemented NAT testing. If other states choose to include NAT testing in their blood screening, they must submit suggestions to the Centre as part of their programme implementation plan. HIV, HBV, and HCV have a shorter infectious window duration due to the sensitivity and specificity of NAT for viral nucleic acids. Due to its greater sensitivity and capacity to shorten the window time, NAT is a suggested but optional test for screening for TTIs (to reduce the remaining risk of infection), hence making transfusions safer. Blood Centers should not replace the serology screening of TTIs with an alternative test, but instead, use an extra test to ensure better patient safety.
A single blood donation which consists of 300ml of blood can help save four lives, yet people are unwilling/ unaware of this. The blood supply chain has been disrupted since the pandemic, particularly for those who require regular transfusions, as everyone was hesitant to step out, let alone go for a blood donation. These concerns indicate a greater void in the current blood transfusion services regulatory structure. Due to the inherent dangers of blood and the complexity of providing enough, timely, and fair access to safe blood products, a national or regional blood regulatory system is necessary. Within this system, a competent blood product regulating authority ensures the production of blood products and monitoring of blood safety adheres to the relevant criteria.
(The author is Thalassemia Patients Advocacy Group Member Secretary)
