Providing safe and adequate blood

Plugging the loopholes in the nation’s blood banking system cannot be overstated, be it in collection, processing, storage, or delivery.

The implementation of advanced technology in blood management systems is reducing blood wastage, improving the quality and availability of blood for patients. The inclusion of class B medical devices under the licensing regime further enhances blood management practices. Embracing these technological advancements helps minimize blood wastage and ensures a reliable supply of safe blood.

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 is an integral part of every country’s national healthcare policy and infrastructure.

There is a marked difference in the level of access to blood between low- and high-income countries. The whole-blood donation rate is an indicator for the general availability of blood in a country. The median blood donation rate in high-income countries is 31.5 donations per 1000 people. This compares with 16.4 donations per 1000 people in upper-middle-income countries, 6.6 donations per 1000 people in lower-middle-income countries, and 5.0 donations per 1000 people in low-income countries.

In India, there is a demand and supply gap of 2.5 donations per 1000 eligible persons, which is around one million units. The clinical demand is estimated at 14·6 million whole-blood units, an equivalent of 36·3 donations per 1000 eligible populations, which will address whole blood and component requirement. The supply is 93 percent, equivalent to 33·8 donations against the demand.

The demand-and-supply gap emphasizes the need for increasing the awareness about repeat voluntary non-remunerated blood donation (VNRBD); optimizing the availability of blood components through efficient blood component separation units; promoting modern principles of patient blood management, and strengthening capacities of human resources in the blood transfusion system, to ensure universal access to blood and components in India.

The accessibility of blood and blood products remains challenging in many countries because of the complex supply chain of short lifetime products, timely access, and demand fluctuation at the hospital level. Drone delivery has arisen as an alternative delivery mechanism for health supplies to remote areas. A case study from Rwanda conducted by The Lancet is very informative. In an effort to improve availability and delivery times, Rwanda launched the use of drones to deliver blood products to remote health facilities. The study of the use of drones for blood and blood products delivery found that this strategy was effective, shortened delivery times, and reduced blood component wastage in Rwanda. Compared with the existing delivery system, products arrived 79–98 minutes earlier than they would have by road. Additionally, the intervention was associated with a 67-percent decrease in blood and blood products expiration after the drone delivery program was put in place. Findings were similar to studies that assessed the effect of similar drone delivery systems of medical supplies in a high-income country as USA.

Blood is considered to be wasted when it cannot be transfused to a patient for technical reasons, which include faults in storage or expiration. This excludes the discarded seropositive blood screened for transfusion-transmitted infection. Many factors lead to wastage of blood and its components in India like broken bags, broken seals, burst packs, contaminated packs, under donations, clotted donations, delays to conduct tests, problems with manufacturing and testing of blood components, lack of proper storage, expired units, over-ordering, improper transport, returned after 30 minutes, etc. Most of them happen due to a lack of proper knowledge and awareness. Care must be taken in storage, transportation, and manufacturing and testing of blood components to reduce blood wastage. Proper additive solutions should be added to enhance shelf life and reduce wastage. The blood bank staff should issue the short expiry blood products first to reduce the expiry rate. Mega blood donation camps should be avoided to minimize blood wastage. A collection of up to 500 units of blood in a camp is acceptable and manageable. It is estimated that 10 to 20 percent of the blood collected in donation camps is wasted because of deficiency in storage facilities. Instead of organizing mega blood donation camps, the blood banks should maintain a list of blood donors and call them to donate blood, when necessary, to fill the gap between demand and supply.

Blood wastage in India is also influenced by various challenges, including unreliable electricity supply, damaged packaging during transportation, contamination risks, insufficient donations, clotting of donated blood, issues with manufacturing and testing processes, improper storage, expired units, over-ordering, suboptimal transport conditions, the return of unused units, limited access to refrigeration, and inadequate healthcare personnel training. These factors contribute to significant blood wastage, leading to both financial and health-related implications and exacerbating blood shortages.

• Blood must be stored and transported at certain temperatures to maintain the quality of the sample, after it has been collected from donors. Around 6.5 million units is estimated to be wasted yearly due to a lack of proper storage facilities. For instance, healthcare professionals can easily use blood bags and red blood cell samples at a temperature between 2°C and 6°C. Similarly, plasma extracted from red blood cells via centrifugation must be stored at a temperature as low as −27°C to maintain its protein VIII component for an extended period. Given the need to store blood and its components at intended low temperatures after extracting from donors, efficient medical-grade cold chain solutions should be in place. This will help reduce the wastage of blood from the collection until the point it is used for a patient.
• The shortage of blood supply is further exacerbated due to wastage in the absence of efficient blood management systems.
• Medical-grade cold chain solutions. New-age medical-grade refrigeration like blood bank refrigerators, plasma storage freezers, and ultra-low freezers are utilized for storing blood and its components at varying low temperatures ranging from 2°C to 6°C, −41°C to −20°C and −86°C to −20°C, respectively. These devices are connected to advanced software for efficient monitoring, including temperature data acquisition, recording, and visualization.
• Contact shock freezers for plasma. Essential for fast freezing of plasma in blood banks and transfusion centers, they ensure plasma reaches a core temperature of −30°C, or below, quickly. Rapid freezing is critical to preserve Factor VIII, an important protein involved in blood clotting.
• RFID technology. Blood banks and blood management systems utilize RFID (radio frequency identification devices) to track blood bags using bar-coded tags. This technology reduces errors, and prevents incidents like incorrect blood transfusions by passively identifying tagged objects through radio waves.
• Automated blood management systems. Blood collection and transfusion centers are embracing automated blood management systems, powered by web technologies, data analytics, ML, cloud computing, and IoT devices. These technologies automate processes like blood sample screening, storage, testing, and donor-recipient cross-matching, reducing human efforts in routine tasks.

New technologies are helping to improve the quality of blood management systems and reducing wastage, thereby increasing the availability of blood for patients in all parts of the country.

Top of Form
Solar-powered refrigerators operate independently of the electricity grid by harnessing solar energy, making them both environmentally friendly and cost-effective for blood storage.

Automated blood bank refrigerators are designed to minimize temperature fluctuations and enable real-time temperature monitoring, ensuring optimal storage conditions for blood. This reduces the risk of blood wastage caused by temperature deviations, ultimately guaranteeing the high quality and safety of blood products.

Blood transport boxes are designed with thermal insulation to maintain a consistent temperature during transportation, ensuring the safe and reliable delivery of blood products without compromising their quality.

Temperature monitoring devices are essential for tracking the temperature of blood products during storage and transportation. Equipped with sensors, they provide real-time readings and trigger alarms if the temperature deviates from the acceptable range.

Cold chain management software optimizes the storage and transportation of blood products by providing real-time tracking, temperature monitoring, and notifications for any deviations. This efficient solution reduces blood wastage and minimizes the risk of temperature variations by optimizing the supply chain.

In a medical environment, blood wastage can be attributed to several factors, such as seropositivity for transfusion-transmissible infections (TTIs) including HIV, HBsAg, HCV, VDRL, and syphilis testing. Other reasons include sterility issues during quality control checks, underweight donors leading to less bleeding, sample expiry, hemolysis, and polycythemia.

The most prevalent cause of wastage is seropositivity for TTIs, with HBsAg being the most common, followed by HIV, HCV, and VDRL. Sterility checks mandated by the Drugs and Cosmetics Act in India also contribute to blood discarding, as compliance with this regulation is necessary in all blood banks, making it unavoidable to prevent wastage in such cases.

A case study
A retrospective study was conducted in the Department of Transfusion Medicine, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh. The required data was collected for two years. The inclusion criterion was all blood and blood components issued during the study period were included in the study. The exclusion criterion was all blood and blood components discarded due to reactivity of transfusion-transmitted infections, outdated, leakage/broken were excluded in the study.

There was no wastage of SDP and CP. Among the various reasons for wastage recorded, 43 (37.39 percent) were due to demise of patients before transfusion was initiated, followed by non requirements by the patients due to no loss/minimal loss blood during surgery 24 (20.87 percent). Among the wastage of PRBC, majority 24 (47.06 percent) were not utilised due to minimal blood loss during surgery. Among the FFP and RDP issues, majority were wasted due to demise of the patients after issuing the blood components. Majority of blood and blood components wasted belong to O positive 43 (37.39 percent) followed by B positive 38 (33.04 percent). Majority of blood and blood components were wasted by the Department of EMD 36 (31.3 percent), followed by the Department of Neurology 20 (17.39 percent), and Orthopedics 12 (10.43 percent).

Most of the reasons of wastage in the present study were preventable. Sensitization of doctors and residents regarding indication and ordering of blood and its components would decrease the wastage. The issue of limited units, particularly in case of FFP, rather than as a bulk of six or more units would decrease the wastage of FFP due to transfusion reaction of the earlier units, so that remaining units can be utilized properly without wastage.

The implementation of operation research methodologies, and correct technical practices in blood inventory management, has shown great potential for improving efficiency. However, their real-world implementation in India is rarely documented. The situation has worsened after the pandemic, with a significant decrease in blood donations and disrupted blood donation drives, resulting in dwindling stocks and a shortage of blood and its components in the country.

There has also been a change in the regulatory landscape in health and pharma. The Central Drugs Standard Control Organization (CDSCO) has made registration of Class B devices for blood management mandatory from October 1, 2022. Regulatory support and raising awareness about blood safety are expected to reduce blood shortage and wastage in India.