The clinical demand and supply of blood in India: A National level estimation study.

Blood transfusion permits increasingly complex medical and surgical interventions to significantly improve the life expectancy and quality of life of patients [ 1 ]. The timely availability of safe blood is essential to address the clinical demand that arises in health care facilities to ensure appropriate treatment and minimise preventable mortality. Clinical demand is the total number of units of whole blood and components required to meet all blood transfusions for emergencies and elective procedures at health facilities over a defined period. The current supply is the actual supply to healthcare facilities against the demand, and utilization is the actual utilization of the supplied blood by the healthcare facilities over a defined period [ 2 ]. Apart from the social, economic, geographical, and cultural factors, clinical demand is dependent on healthcare providers’ training, behavior and blood ordering practice within the health system capacity [ 3 ]. Ideally, a blood transfusion system should be capable of addressing 100% of clinical demand arising in healthcare facilities, within its catchment area. Yet, in many developing and under-developed countries, there is a widespread shortfall between demand and supply of blood due to several barriers. The major factors are increasing requirement for blood and blood products, poor implementation of voluntary donation and blood safety programs in countries, inadequate voluntary non-remunerated blood donation (VNRBD), suboptimal component separation, inadequate infrastructure, equipment and trained human resources, inappropriate use of blood and blood components, poor quality management systems, poor supply chain management systems, lack of cold chain, wastages and expiry of blood [ 1 , 4 , 5 ]. The blood transfusion service in India is fragmented with a network of 2,760 blood banks owned by the public, private and not-for-profit sectors, collecting around 12 million units in a year. Most (77%) blood banks were attached to hospitals and 22% were stand-alone. Around 51% had a component separation facility, separating 53% of the total annual collection in the country [ 6 ]. Despite the significant increase in the availability and use of components, whole blood is still requested and transfused substantially in clinical settings in India. As the majority of the health care facilities do not have blood banks on their premises, they are dependent on nearby blood banks or blood storage centres as available. Moreover, the proportion of voluntary blood donation is still around 80% and the remaining is depending on replacement donation by families or professionals in the guise of replacement donors. The National Blood Transfusion Council (NBTC) has regulated the cost of blood, both at public and private facilities. However, timely access to safe blood is still a challenge in many parts of the country which requires an efficient blood transfusion system. A comprehensive estimation of clinical demand, supply and utilization is critical to inform evidence-based blood donation and safety programs and strategies towards achieving universal access to blood. Challenged with a large population of approximately 1.4 billion, this study aims to estimate disease-specific clinical demand, supply and utilization of whole blood and blood components in India.

The characteristics of healthcare facilities are mentioned in Table 1 . The majority (76·5%) were in urban, around 57% were owned by the private sector, and two-thirds (67%) of the private sector were for-profit facilities. The average bed occupancy rates for primary, secondary and tertiary care facilities were 60·4% (SD: 25.9), 72·9% (SD: 24·7) and 83.9% (SD: 17·3) respectively. A third of the facilities (34%) had an attached blood bank. * Percentage in parenthesis. According to the study, the total clinical demand of 251 health facilities with 51,562 beds was 474,627 whole blood units. Based on this, the total clinical demand was estimated at 14·61 million units (95% CI: 14·59–14·62) of whole blood, which is equivalent to a requirement of 36·3 donations per 1,000 eligible persons, considering the existing blood transfusion practices and the amount of component separation in the facilities in India [ 18 ]. The estimated demand for medical specialty was 6·0 million units (41·2%), followed by surgery 4·1 million (27·9%), obstetrics and gynecology 3·3 million (22·4%) and pediatrics 1·2 million (8·5%) units ( Table 2 ). *Estimated the national demand by extrapolating the study data (demand and beds) to the total number of estimated beds in the country. The crude clinical demand per bed was 9·2 units (95% CI 7·5–9·5) and bed occupancy rate (BOR) adjusted clinical demand per bed was 11·2 (95% CI: 10·7–13·2) units per annum. It was found to be relatively lower in the northern region, rural areas, primary care facilities, public facilities, and in facilities without an attached blood bank ( Table 3 ). 95% CI is based on bootstrap method using institution-level BOR adjusted demand per bed. The diseases or conditions that recorded more than one percent of total specialty demand, medical, surgical, O&G and pediatrics are mentioned in Table 4 . Most of the demand was for nutritional anaemia (32·8%) which is equivalent to 1·97 million units followed by end-stage renal diseases (ESRD) (9·7%), gastrointestinal bleed (5·8%), chronic liver disorder (5·2%) and leukemia (5%). The demand for communicable diseases such as dengue and malaria were 0·45 million units, which is 7·5% of the medical demand. The estimated demand for orthopedic surgeries was 25%, which is equivalent to around one million units. The demand for polytrauma and road traffic accidents was 0·46 million units which is around 11% of surgical demand. The demand for oncology surgery was 0·34 million units which is 8·4% of surgical demand. A greater proportion of demand (34·2%) was for anaemia in pregnancy, which amounts to 1·1 million units for an estimated 27·7 million pregnant women in a year. Maternal and pregnancy-related complications such as ectopic pregnancy, antepartum hemorrhage–abruptio/placenta praevia, placenta accrete, and postpartum hemorrhage contributed around 25·2% which is around 0·8 million units. Whereas, gynecological cancers, accounted for around 4·1% (0·13 million units) of the gynecology demand. Hemolytic anaemia (predominantly thalassemia) is the leading contributor to the demand for pediatrics specialty (23·6%), followed by severe nutritional anaemia (14%) and leukemia (8·2%). Dengue and malaria contribute to 7·4% of clinical demand, which amounts to 91,729 units. Neonatal conditions such as very low birth weight (VLBW), sepsis, birth asphyxia/trauma and neonatal jaundice together account for 11·8% amounting to 0·15 million units. The whole blood demand was estimated at 6·35 million units (95% CI: 6·34–6·36), red cell concentrates 6·61 million units (95% CI: 6·60–6·62), plasma 2·21 million units (95% CI: 2·20–2·22), platelets- 2·0 million units (95% CI: 1·99–2.02) and 0·22 million units (95% CI: 0·21–0·22) cryoprecipitate. The supply against demand was estimated at 92·6% for whole blood, 91·7% for red cells, 86% for plasma, 77·5% for platelets, and 92·1% for cryoprecipitate. Similarly, the utilization against supply was reported at 98·7% for whole blood, 99·2%, 96·8% 97·6% and 94·6% for red cells, plasma, platelets and cryoprecipitate respectively ( Table 5 ).

Our study estimated a national demand of 14·6 million whole blood units, which translates to 36·3 donations per 1,000 eligible persons per year. The estimated BOR adjusted demand per bed was at 11·2 units per year. Although the gap between supply and demand is only 2·5 donations per 1,000 persons, which is around one million units, it requires sustained and concerted efforts from all stakeholders to address the gap. The demand and supply gap emphasizes the need for increasing the awareness about repeat 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.

We assumed that the weights will not have much impact on the estimates, since we had a high precision in the sample size estimation to account for the clustering effect. The study has limitations because it did not focus on analyzing clinician’s requests for each patient to determine the rationality of demand. Our study did not evaluate clinician ordering practices to determine if they were appropriate. The indications for blood transfusions and adherence to guidelines could vary between clinicians, health facilities and regions which could be potential limitations of the study. The facility-wise supply and utilization data for each component were obtained as a percentage. Moreover, the declared official number of hospital beds may not be accurate in the facilities. The study did not factor in the possible disasters and epidemics that would generate demand which depends on their nature and severity.

We conducted a pilot study in Karnataka state, which was not included in the main study, to evaluate the feasibility of conducting the study, test the research protocols, data collection tools, sampling strategies, and estimate a statistically significant sample size for the study. This study was a national level cross-sectional study conducted in five randomly selected states, one state each from five regions of the country, that are north, east, west, south and northeast ( Fig 1 ). We randomly selected the required number of facilities from the list of primary, secondary and tertiary health care facilities representing the public and private sector, from the state specific list of health care facilities. We provisionally estimated the mean demand per bed as 9·6 (Standard deviation (SD: 6) units per annum through a pilot study. We had three strata- primary, secondary and tertiary care facilities. To estimate the demand of 9·6 (SD:6) units per bed with a precision of 0.1 units with 95% Confidence Interval (CI), we needed to study 13,830 units per stratum (primary, secondary and tertiary) which was rounded off to 15,000 units, totalling to 45,000 units of blood. Accounting for a design effect of two, we needed to study 90,000 units of blood per region, for which 9,000 beds were to be studied. We followed the proportional allocation method to allocate the samples to the strata. We considered 10%, 25% and 65% of primary, secondary and tertiary care beds respectively to transfuse blood, based on consensus among experts through four Delphi exercises conducted among 59 health care providers from across the country. We considered the average number of beds in primary, secondary and tertiary care facilities at 35, 120 and 1,000 and the presence of private and public facilities in India at the ratio of 60:40 [ 7 ]. Based on these considerations and to ensure 9,000 beds in each region, we decided to study 50 facilities from each state, of which 29 and 21 facilities were from private (58%) and public (42%) respectively. In total, we included 251 health care facilities in our study ( Fig 2 ). *States— Uttar Pradesh, West Bengal, Maharashtra, Tamil Nadu and Assam . The sampling frame consists of the list of facilities from the selected states from each region. From the public health care system, we included Community Health Centers (CHCs) as primary; sub-divisional (SDH) and district hospitals (DH) as secondary and medical colleges (MC) as tertiary care hospitals. In the private sector, we included facilities providing basic medical, surgical, Obstetrics & Gynecology (O&G) and pediatrics with less than 50 beds as primary facilities providing basic and specialty services with more than 50 beds as secondary, and facilities providing basic, specialty and super specialty services including medical colleges with more than 200 beds as tertiary facilities. We collected the lists of public and private health facilities from multiple sources and triangulated them to arrive at a state-wise list. We collected annual disease-specific demand, supply and utilization of blood and components from the participating health care facilities using a structured data collection form. The data included administrative details such as location, type of facility (public/private), level of care, number of beds, number of outpatients, admissions, bed occupancy rate, the average length of stay, and number of staff. The transfusion-related details included the number of patients with a disease or condition, number of patients requiring transfusion, number of units required per patient, percentage of blood supplied, utilized, discarded and/or returned to the blood bank under medicine, surgery, obstetrics and gynecology and pediatrics. We obtained these data primarily from the hospital and blood bank records manually. We conducted interviews with the heads of the administration and senior clinicians from these departments to validate the data and obtain additional information. The data were entered in REDCap (Research Electronic Data Capture), a secure web application for building and managing surveys [ 8 , 9 ]. It was extracted as SPSS file and analysed using SPSS version 24 (IBM, Armonk, NY) [ 10 ]. As a first step, we computed disease-specific demand for each institution by summing the demand for whole blood and the demand for the highest component among red cells (RBC), plasma (FFP), platelets and cryoprecipitate because one unit of whole blood can provide one unit each of all components. Besides, it is based on 350 ml per donation which is generally practiced in India. Secondly, we computed the institution-wise demand for each department i.e., medical, surgical, obstetrics and gynecology and pediatrics, by calculating all the disease-specific demand of each department. Finally, we summed up the demand of all four departments to calculate the total demand for the institution. We calculated the actual supply and utilization using the percentage of supply and utilization provided by each institution. We estimated the national demand by extrapolating the study data (number of beds and clinical demand in the study) to the total number of estimated beds in the country. As per the National Health Profile (2017) [ 11 ], India had 634,879 beds in the public sector, which is approximately 40% of the total beds. The remaining 60% was computed at 952,319 beds in the private sector. We used the sum of the public and private beds, which is 1,587,198 for extrapolation. The study included 51,562 beds, of which 40·3% were in the medical specialty followed by surgery (30%), obstetrics and gynecology (17·1%) and pediatrics (12·6%). Each of these four categories included general, specialties and sub-specialties beds. As demand for blood can occur only in occupied beds in a health care facility, we determined the bed occupancy rate (BOR) adjusted clinical demand per bed as well. After estimating the total demand in a health care facility, we adjusted for the actual bed occupancy. For this calculation, we used the total number of beds, bed occupancy rate to calculate the occupied beds and the total clinical demand in the health care facilities. Bootstrap method was used to get narrow confidence intervals for the estimation when the number of facilities per stratum was less than 50. After estimating the total demand in a health care facility, it was adjusted for the actual bed occupancy. For this, we used the total number of beds, bed occupancy rate and the total clinical demand in the health care facilities. To estimate the eligible donor population in the country, we considered the inclusion and exclusion criteria defined by the National Blood Transfusion Council (NBTC) and Drug and Cosmetics Act of India (1940), as amended up to 31 st December 2016 [ 12 ]. We included the adult population between the age group of 18 to 65 years, which is 58·6% (745 million) of the total population in 2017 [ 13 ]. We excluded the pregnant women (estimated at 27 million) and people with anaemia, (adult male, 22·7% and adult female, 53%), hypertension (25·3%), diabetes (7·5%) and co-existence of any two or all the three conditions [ 7 , 14 ]. We did not exclude the estimated 2·5 million cancer patients as anaemia coexists in the majority of cancer patients [ 15 – 17 ] Besides, we factored 5% for other temporary deferrals. Applying all these criteria, we conservatively estimated 402 million as eligible donor population in India. The study protocol was reviewed and approved by the Institutional Review Board (IRB) of Christian Medical College and Hospital, Vellore, India. We obtained approval from Technical Resource Group (TRG), Research and Development, National AIDS Control Organization (NACO), Ministry of Health and Family Welfare, Government of India and Associate Director for Science (ADS) and Associate Administrator for Science (ATSDR), the Centers for Disease Control and Prevention (CDC), Atlanta, USA. For data collection from health care facilities, the National AIDS Control Organization (NACO), Ministry of Health and Family Welfare, Government of India, sent a letter of invitation to the medical head/administrator of all selected health care facilities to participate in the study. Following this, the study team approached the heads of the institutions over the phone to obtain their oral consent for the participation and convenient time for data collection. Before the data collection in the facilities, the study investigator obtained informed written consent from the heads of the institutions. For the Delphi exercises, we sent a letter of invite requesting the health care providers (technical experts) to participate in the study and their agreement to participate by a response mail was considered as their consent.