Mumbai: In a world where medical emergencies and critical conditions are an unfortunate reality, blood donation plays a pivotal role in saving countless lives. The act of donating blood is an act of selflessness and compassion that can make a significant difference in the lives of those in need. Recent developments in the healthcare sector have highlighted the pressing need for blood donations, as hospitals and medical facilities face shortages that put patients’ lives at risk.
As medical advancements continue to evolve, blood transfusions remain an integral part of various treatments, including surgeries, cancer therapies, organ transplants, and emergency care. However, the demand for blood often surpasses the available supply, leaving medical professionals with limited resources to adequately respond to emergencies and provide necessary treatments.
Recent studies indicate that blood shortages persist in many regions, underscoring the ongoing importance of blood donations. These shortages are felt most acutely during crises such as natural disasters, pandemics, and accidents when the demand for blood surges.
According to the National Blood Transfusion Council (NBTC) in 2019–20, India reported around 12.5 million donations, of which around 11.8 million units would have been available for transfusion. The actual demand could be estimated at 14.8 million units. Over the years, the government has taken several steps towards modernising blood banks in the country by providing critical inputs under the blood safety programme.
Ethealthworld interacted with some experts on the importance of blood safety regulations, accurate donor screening, and the critical need for nucleic acid testing (NAT)-tested blood.
Ensuring quality, safety of donated blood
In recent years, the government and health authorities have also taken steps to improve blood safety and quality. Stringent screening and testing protocols have been implemented to minimise the risk of transfusion-transmitted infections. The emphasis is on ensuring that donated blood is safe for recipients.
Several organisations and blood banks are actively working towards increasing voluntary blood donations across the country. These organisations conduct awareness drives, mobile blood donation camps, and community-based initiatives to reach out to potential donors. The Indian Red Cross Society, State Blood Transfusion Councils, and non-governmental organisations (NGOs) play crucial roles in coordinating and facilitating blood donation efforts.
Despite these efforts, challenges such as misconceptions, cultural beliefs, and lack of awareness still exist, hindering the growth of voluntary blood donation in India. Overcoming these barriers requires sustained awareness campaigns, active community participation, and collaboration between healthcare providers, NGOs, and governmental organisations.
Blood transfusion service is an extremely vital part of the healthcare system, leukaemia patients, thalassemia patients, pregnant women, accident victims, and those undergoing elective surgery, all depend on blood transfusions. “Over the years, the government has taken several steps towards modernising blood banks in the country by providing critical inputs under the blood safety programme. However, India still needs to adopt a comprehensive, efficient, total quality management approach. The good news is that in the recently concluded NBTC governing body meeting, a few recommendations have been considered,” expressed Dr Rema Menon, Medical Officer, IMA Blood Centre, Kochi.
NBTC recommendations:
- HIV, HBV and HCV are transfusion-transmitted infections and so high-risk populations should not be allowed to donate blood.
- Nucleic Acid Amplification Testing (NAT) plays a vital role as an additional layer of safety thereby enhancing patient care.
- A Metro/Capital Blood Bank will be established in the Capital City of each State/UT. Such Blood Centres will be high-volume blood centres having all advanced facilities including Human Leukocyte Antigens (HLA) typing. The processing and testing of blood will be done centrally in the Metro Blood Centre which will be connected to the smaller blood centres/blood storage units. Blood Transfusion Services should also be part of Emergency Medical Services under the Disaster Management Plan.
- A health economics study may be carried out for assessment of NAT vs NON-NAT through a suitable institution.
- NAT testing may be introduced in a phased manner as a centralised facility in high volume Blood Centers and collection & storage may be done in the smaller volume blood centres.
Dr Varun Capoor, Consultant and Incharge Transfusion Medicine, Paras Hospitals, Gurgaon, emphasised mandatory screening of donated blood for HIV, hepatitis B and C, syphilis, and malaria using serological methods (rapid/ELISA or newer ECI) and nucleic acid amplification technique (optional). “Blood centres in India require licenses from state regulatory authorities, involving inspections, quality standards, and adherence to good manufacturing practices. Accreditation bodies like National Accreditation Board for Hospitals & Healthcare Providers (NABH) provide accreditation based on stringent criteria, said Dr Capoor.
He further added, “Blood centres must report adverse events or reactions related to transfusions to regulatory authorities, aiding risk identification, investigation, and preventive measures. Blood centres should establish quality control and assurance programmes, including internal audits, proficiency testing, and external quality assessment schemes, ensuring reliable testing, proper storage, and adherence to procedures.”
Healthcare providers improving accuracy, effectiveness of blood donation
Shortage of blood supply is frequently encountered in healthcare settings and this can be attributed to a gap in the demand and supply for safe blood products, lack of voluntary donations and low awareness about safe blood practices.
Commenting on important parameters for a successful blood donation system, Dr Menon highlighted some crucial aspects; Donor education: Educating people about the dos and don’ts of blood donation; encouraging people for repeat donations; and sustained efforts to educate people on the benefits of blood donation. Effective and efficient blood collection process: Blood collection needs to be done in a way that ensures the health and safety of blood donors before, during and after collection. This will also include the use of minimum haemoglobin requirements and safety considerations for nonbinary donors, information on blood donation and iron health and limiting donation frequency. The donor screening process must protect the safety of the transfusion recipient by identifying eligible donors who meet specific criteria to help ensure blood safety.
Adding to Dr Menon’s viewpoints, Dr Capoor shared, “Actively participating in collaborations and networks with other blood centres, regulatory authorities, and relevant organisations can share best practices, exchange knowledge, and stay updated on advancements in blood safety protocols. Having a quality assurance programme in place and having dedicated standard operating procedures (SOPs) for each process increases the accuracy, safety and effectiveness of the donation process.”
“Securing a safe and sufficient blood supply is vital for saving lives and improving healthcare outcomes. Effective blood screening programs have significantly lowered the risk of transfusion-transmitted infections (TTIs) and instilled public confidence in the healthcare system. However, in India, only a small percentage of the millions of blood donations received annually undergo thorough infection screening,” commented, Dr Sandeep Sewlikar, Head – Medical & Scientific Affairs, India and Neighbouring countries (Bangladesh, Sri Lanka, Nepal and Bhutan), Roche Diagnostics India.
Implementing comprehensive donor screening programmes challenges
Implementing comprehensive donor screening programmes for blood donations presents various challenges. First, raising awareness and educating the public about the importance of screening is crucial, as many individuals may not fully understand its significance. Encouraging voluntary donors to participate can be difficult due to concerns about eligibility, cultural and socio-economic factors or invasive procedures. Adequate allocation of resources, including trained personnel, laboratory facilities, and infrastructure, is essential but can be a challenge, particularly in resource-constrained settings. Standardization and quality assurance across multiple donation centres require clear guidelines, training programmes, and monitoring. The cost of implementing screening programmes can be a barrier, necessitating sustainable funding sources and partnerships. Managing donor data securely and maintaining confidentiality are critical considerations that require proper IT systems and protocols. Overcoming these challenges requires collaboration between stakeholders, public awareness campaigns, and supportive policies and funding
“Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process. Effective screening, therefore, can reduce the risk of transmission to very low levels, mentioned Dr Menon.
The implementation of advanced testing methodologies for accurate and timely detection of infectious diseases may be constrained by cost, availability, and the need for trained laboratory personnel. Dr Capoor voiced, “Ensuring compliance with regulatory requirements, including licensing, inspections, and adherence to quality standards, poses challenges, particularly for smaller blood centres with limited resources. Properly screening potential donors based on eligibility criteria can be challenging, as it requires comprehensive medical history assessments and adherence to deferral guidelines for individuals with specific risk factors.”
The provision of safe blood and blood components for transfusion involves several processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and its administration to the patient. There is a risk of error in each of the processes and a failure at any point in time can have serious implications for the recipients. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Implementation of advanced testing techniques
India receives around 12.4 million blood donations each year out of which around 10-12 per cent of blood is screened for infections. Largely blood screening for HBV, HIV and HCV is done by serological tests for HBsAg and antibodies to HIV 1/2 and HCV. However, screened seronegative donations are still at risk for TTIs and thus, the need for a sensitive screening test arises. Nucleic acid testing (NAT), a molecular technique for screening blood donations to reduce the risk of TTIs in recipients provides an additional layer of blood safety. NAT is a highly sensitive technology that can detect early-stage infectious agents in donated blood, such as HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV). NAT helps prevent the spread of infectious diseases by identifying infected donations and maximising blood safety and availability for patients.
Dr Capoor explained, “Nucleic acid amplification technique of NAT detect viral DNA or RNA in donors blood against HIV 1 & 2 Hepatitis B & C hile traditional & serological tests like ELISA & Chemiluminescence (ECI) detect antigen &/or antibody against these infections. The window period (the period where the infection is present in the blood but is not detectable by the screening tests) is shorter with NAT testing. Hence, NAT testing provides an additional layer of safety & security to transfusion services.”
Dr Menon added, “We all know that blood transfusion saves lives and improves health, but many patients requiring transfusion do not have timely access to safe blood. Providing safe and adequate blood should be an integral part of every country’s national healthcare policy and infrastructure. In countries where effective blood screening programmes have been implemented, the risk of transmission of TTIs has been reduced dramatically. This results in a better health trajectory and eventually public trust in the healthcare system.”
“To enhance blood safety, NAT, a gold standard method, provides an additional layer of protection by identifying early-stage infectious agents such as HIV, HBV, and HCV. NAT’s high sensitivity helps prevent the spread of diseases, maximising blood safety and availability for patients in need, particularly those with conditions like leukaemia, and thalassemia, and requiring emergency surgeries or maternity care. Although the government has made strides in modernising blood banks, a comprehensive and efficient approach to blood safety remains essential,” stated Dr Sewlikar.
“States like Odisha, Jammu and Kashmir, and Madhya Pradesh have demonstrated commendable initiatives by mandating NAT testing in blood banks, elevating blood safety standards. To ensure safe and cost-effective blood, laboratories must be equipped for infection testing and storage. Adopting models like centralized NAT testing, as seen in Odisha and Madhya Pradesh, is crucial. The Odisha government’s implementation of NAT in government-run blood banks through a public-private partnership (PPP) exemplifies a state-of-the-art project. NAT is not a luxury but a necessity, reducing the risk of TTIs by detecting infections at an early stage. Compliance with global standards is imperative, as NAT has proven to minimise infection window periods. It is crucial for India to prioritise blood safety, align with international norms, and safeguard the well-being of its citizens,” added Dr Sewlikar.
NAT tests are also able to detect occult infections which would otherwise remain undetected by routine screening tests and pose serious risks to transfusion recipients. Implementing NAT testing also contributes to public health protection by preventing the spread of infectious diseases through blood transfusions. It helps control the transmission of blood-borne pathogens within the population.
Partnerships, collaborations promoting blood safety
Partnerships and collaborations enable the exchange of best practices, research findings, and expertise among different stakeholders, including blood centres, regulatory authorities, healthcare providers, and donor organisations. The sharing of knowledge can help improve screening protocols, enhance quality assurance measures, and stay updated on emerging trends and technologies.
Collaborations also allow for the pooling of resources, including funding, infrastructure, and testing equipment. This would enable the establishment of comprehensive screening programmes, especially in regions or organisations with limited resources individually.
“Collaborations and partnerships are instrumental in ensuring access to safe healthcare. Public-private partnership (PPP) model can help in implementing NAT centralisation across the nation. An example of a successful partnership or collaboration is the Orissa State NAT PPP model. The government in addition, to providing equal access to NAT-tested blood for all patients irrespective of their socioeconomic status, subsidises 100 per cent of the additional cost of NAT testing to the patients. This has not only served the purpose of providing quality medical care to the people of Odisha but has also contributed toward the prevention of transmission of viral infections to recipients of transfusion and saved significant financial resources in the management of the infections. The PPP could potentially be a significant step towards providing access to safe blood across the country,” concluded Dr Menon.
Collaborative initiatives provide opportunities for training and capacity-building programmes. This includes workshops, seminars, and educational materials aimed at enhancing the skills and knowledge of healthcare professionals involved in donor screening. By improving the competencies of personnel, partnerships contribute to more accurate and reliable screening practices,” voiced Dr Capoor. “By joining forces, organisations can amplify their voice, raise awareness among policymakers, and advocate for policies and regulations that prioritise and support effective screening practices. In summary, partnerships and collaborations foster knowledge sharing, resource pooling, coordination, and advocacy, ultimately promoting blood safety and accurate donor screening.”
Implementing comprehensive donor screening programmes for blood donations is a complex endeavour that comes with several challenges. However, overcoming these challenges is essential to ensure the safety and reliability of donated blood. Raising public awareness, addressing misconceptions, and educating potential donors about the screening process are vital steps in encouraging voluntary participation. Allocating sufficient resources and maintaining standardised protocols across donation centres are necessary to uphold quality control. Finding sustainable funding sources and forging partnerships can help overcome financial barriers.
Additionally, safeguarding donor data and ensuring confidentiality is crucial for maintaining trust. By addressing these challenges through collaborative efforts, public awareness campaigns, and supportive policies, comprehensive donor screening programmes can be effectively implemented, ultimately ensuring the safety and availability of life-saving blood donations. In the words of Dr Nidhi Bhatnagar, Head and Professor (IHBT), BJ Medical College, Ahmedabad, “Blood donors need to be thanked each day of the year.”