Recently, the Drug Controller General of India (DCGI) issued guidelines on preserving blood and blood products by storing them at their intended temperatures. The newly introduced guidelines suggest that, from October 2022 onwards, all blood bank cold chain devices need to be medical grade and class B certified. To deliberate on how reliable cold chain infrastructure can ensure efficient blood management in India, B Medical Systems India Pvt Ltd in association with ETHealthworld brought several domain experts together for a webinar. The speakers for the discussion were Dr Rema Menon, Medical Officer, IMA Blood Centre, Kochi, Dr Nidhi Bhatnagar, Head and Professor (IHBT), BJ Medical College, Ahmedabad, Dr Varun Capoor, Consultant and Incharge Transfusion Medicine, Paras Hospitals, Gurgaon, Dr Rajesh Sawant, Consultant, Transfusion Medicine and Histocompatibility and Immunogenetics, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai, Dr Sumathi Hiregoudar, Associate Professor, Department of Transfusion Medicine and Blood Centre, Tata Memorial Centre—Advanced Centre for Treatment, Research, and Education in Cancer, Navi Mumbai, Dr Abhik Banerjee, Zonal Technical Chief, East Zone, Apollo Diagnostic, Unit of Apollo Health & Lifestyle Ltd, Kolkata. The session was moderated by Prabhat Prakash, Senior Digital Content Creator, ETHealthworld.
During the webinar, the experts touched upon a series of pertinent issues that disrupt the cold chain infrastructure in the country, including making the blood management systems in India more efficient with the intervention of innovative technologies, addressing challenges of blood wastage, improving the quality of plasma with specialised instruments like contact shock freezers, and many more.
Responding to the absolute need for an efficient cold chain system and the importance of correct blood storage, Dr Menon said, “Blood transfusion is an essential part of modern medical healthcare. And if used correctly, it improves health and saves lives.”
Dr Menon defined this as a therapeutic intervention. It could result in acute or delayed complications that carry the risk of morbidity and mortality. Transfusion-transmissible infections are one of the most common complications associated with blood transfusions.
“For safe and effective transfusion, we need to look at coding, and we need to have an implementation of certain strategies for blood safety,” Dr Menon went on to mention that the safe blood transfusion strategies have been defined by the World Health Organisation (WHO), which include the establishment of well organised nationally coordinated blood transfusion services with quality systems in all areas. Blood collection has to happen from voluntary, non-remunerated, and repeat blood donors to ensure safety. There is a need to have a testing programme as directed by the regulatory authorities for all units of blood to avoid transmission of transmissible infections and reduce unnecessary transfusions through effective patient blood management protocols available nationally and internationally.
Dr Bhatnagar explained the nuances and the role of training and skill development for multiple stakeholders in cold chain management. She stressed on specialised training of personnel who hail from medical and paramedical backgrounds while handling and storing blood and various blood components.
“It’s critical to train the working personnel, and we’re handling these blood products, maybe from the outdoor blood donation camps, when the blood is coming to every step. At this point, there is a lack of training in the cold chain maintenance, equipment that is required for the cold chain maintenance and monitoring of temperature handling,” Dr Bhatnagar added.
Dr Capoor raised the need to focus on the wastage of blood at the patient’s side. Narrating the incidences where the blood was found lying near the patient’s bedside and the proper conditions were not fully followed, resulting in the wastage of blood, Dr Capoor elaborated, “We need training of nurses in the proper handling of blood and blood products, as well as training of our junior residents and doctors, surgeons, and physicians also. Mainly because many times they are not aware of the proper storage of these blood products.”
Emphasising that the capacity building of the blood transport boxes is the need of the hour, Dr Bhatnagar explained they are a vital part of any blood centre that needs to be lightweight for carrying and shipment purposes. “Ideally, there should be a digital display that shows the temperature inside, and it must be secured and lockable.” She further added that the holdover period of the transport boxes should be a minimum of 12 hours.
Underscoring that maintaining the temperature during storage, transportation, or even routine processing is important, Dr Sawant shared, “The commonest problem is once the blood is collected, waiting for blood components to be separated, the temperature needs to be an air-conditioned room temperature around 22-24 degrees °C. The ambient temperature and humidity may not be monitored at many centres which affects the quality of blood and blood components.”
Dr Sawant highlighted that in India, the temperature during summer could be a challenging factor. It is a well-known problem that during the component separation process, inventory lies outside as the labelling goes on, and as per Dr Sawant, if the product is not kept at the required temperature for more than 30 minutes, then the chances of quality getting affected are higher.
Apart from installing quality management systems for patients to receive safer products in terms of the efficacy of stem cell therapy, Dr Hiregoudar spoke about the comprehensive cold chain solutions, he said cryopreservation acts as biopreservation of cells, enabling them to be used later as per requirement.
“We have temperature-controlled devices where the cells can be transported over distances and wherever the cells are required at the patient’s bedside, and we have temperature loggers that are being used to maintain the cold chain tracking. These containers are very crucial in managing the viability of the cells,” Dr Hiregoudar informed.
Commenting on the importance of an efficient supply chain in diagnostics, Dr Banerjee remarked, “Nowadays more than 70 per cent of therapeutic decisions are taken only on the basis of laboratory reports, so it is very important when patient management is being done, the accuracy and precision of the laboratory matter a lot.
Dr Banerjee raised a major point that historically more than 70 per cent of laboratory errors happen due to pre-analytical mistakes, which means identical variables. And temperature variation or breakdown of the cold chain is one of the major practical challenges that all laboratories throughout the world, including India, face.
“In India, as the diagnostic sector is largely fragmented and unorganised if we consider that more than one lakh laboratories are present, very few labs maintain that kind of quality. Then you can consider that the magnitude of this problem is huge,” Dr Banerjee asserted.
Adding to that, Dr Banerjee elucidated the day-to-day operational challenges faced for proper analysis of blood samples. He raised concerns about delays in sample pickup or logistics service from the initial collection of samples. The results of samples may vary as per Dr Banerjee if proper cold chain processes are not maintained. Speaking about the logistics, Dr Banerjee highlighted the importance of special transportation boxes with intended ice packs, and adequate sample policies or procedures for preservation purposes.
After getting into the lab, the quotient of the samples has to be maintained until it reaches technicians and also preserved as per the quality management system policy of the laboratory. Dr Banerjee said that in his experience, sometimes complaints or concerns about the rechecking of samples arise, which, according to him, can only be possible if the blood samples are preserved properly in a cold room or a particular refrigerator.
The discussion brought out the common issues with the transportation protocols not being in place. The supply chain requires attention and stringent guidelines, awareness and training as it is a neglected area so far. The participants concluded the webinar on an optimistic note. With the rise and prominence with which technological innovations are derived in the Indian healthcare sector, the experts believe that the ramifications of such innovations will be amplified for the blood management and delivery systems as well.
(Brand Connect Initiative)