Addressing gaps in international blood availability and transfusion safety in low- and middle-income countries: a NHLBI workshop.

In April 2017, a workshop sponsored by the National Heart, Lung, and Blood Institute, Division of Blood Diseases and Resources, and the Center for Translation Research and Implementation Science was held to discuss blood availability and transfusion safety in low- and middle-income countries (LMICs). The purpose of the workshop was to identify research opportunities for implementation science (IS) to improve the availability of safe blood and blood components and transfusion practices in LMICs. IS describes the late stages of the translational research spectrum and studies optimal and sustainable strategies to deliver proven-effective interventions. Regional working groups were formed to focus on opportunities and challenges in East Africa, Central/West Africa, Middle East and North Africa, Latin America and the Caribbean, Southeast Asia, Western Pacific Asia, Eastern Europe, and Central Asia. The need for an "adequate supply of safe blood" emerged as the major overriding theme. Among the regional working groups, common cross-cutting themes were evident. The majority of research questions, priorities, and strategies fell into the categories of blood availability, blood transfusion safety, appropriate use of blood, quality systems, health economics and budgeting, and training and education in IS. The workshop also brought into focus inadequate country-level data that can be used as the basis for IS initiatives. A mixed approach of needs assessment and targeted interventions with sufficient evidence base to move toward sustainment is an appropriate next step for blood availability and transfusion safety research in LMICs.

Giant Platelets in Platelet Donors - A Blessing in Disguise?

INTRODUCTION: Inherited thrombocytopenias, including inherited giant platelet disorders (IGPD) are relatively rare, but their prevalence is probably underestimated. Harris platelet syndrome, the most common IGPD reported from Indian subcontinent, mostly from eastern part, is characterised by a low platelet count, high mean platelet volume (MPV) and absence of bleeding. AIM: A short study was conducted to assess the prevalence of giant platelets in voluntary donors of single donor platelets (SDP) and analyse the effect of transfusion of such SDPs in patients. MATERIALS AND METHODS: Voluntary donors of SDPs were screened as per standard guidelines prior to the procedure. A complete blood count (including MPV) along with a peripheral smear was done. A total of 45 donors were screened for plateletpheresis. Following plateletpheresis from these donors, a platelet count from the collection bag was done after one hour. The SDP was transfused as a single unit or divided into two and transfused to the same patient at two different occasions, as per clinical need. Platelet counts on pateints were done after one hour and the platelet recovery was noted. RESULTS: Out of the 45 donors who were screened, 30 (66.67%) were found to have giant platelets. It was observed that the pre procedure platelet counts in donors having giant platelets were relatively low (1.5 -1.7 lacs) and so also the platelet yield (2.7-3x10(11)) compared to donors who did not, but the post transfusion platelet recovery was greater. CONCLUSION: Since presence of giant platelets has been seen to be common in the Eastern part of India, a peripheral smear examination should always be considered during screening of plateletpheresis donors to avoid rejecting donors with giant platelets whose platelet counts are given falsely low by autoanalysers.

Analysis of efforts to maintain safe donor in main donor pool after completion of temporary deferral period.

BACKGROUND: Voluntary blood donation is not satisfactory all over India. In India, about 55% of donation is through voluntary non-remunerated blood donors (VNRBD). However, about one third already motivated blood donors are deferred due to stringent screening criteria, either temporarily or permanently. The temporarily deferred donors could be a good source of blood donation after deferral period. AIMS: The present study is carried out to know retrieval of blood donors those who are deferred temporarily. DESIGN: The present study is carried out in the Regional Blood Transfusion Centre of Western India. All donors screened as per the guideline and deferred donors are categorized as temporary and permanently deferred donors. MATERIALS AND METHODS: From temporarily deferred donors, reason for deferral is considered. As per reason of deferral, time duration for recalling the donor is defined. Based on this, donor is called back to donate again. STATISTICAL ANALYSIS: Chi-square test is applied. RESULT: A total of 33% donors were deferred either temporarily or permanently. In the repeat donors (5.32%) deferral rate was significantly higher than first time (1.32%) donors. Significant female preponderance was observed (15.05% vs 2.51%). Majority of temporarily deferred donors were less than 40 years of age (80.80%), graduate (82.90%), from low income group (62.90%) and profession was service (48.10%). CONCLUSION: Low hemoglobin (78.30%) was the most common reason of temporary deferral, both in first time and repeat donors (71.00%). Efforts to increase the hemoglobin in the repeat donors will improve the donor retention and overall blood safety can be increased.

Blood bank regulations in India.

Successful blood services depend on legally empowered regulatory services. Blood transfusion services are important constituents of national health services. Blood transfusion services in India are regulated by the Drugs and Cosmetics Act, 1940 and its subsequent amendments. The Drugs and Cosmetics Act, 1940 specifies about accommodation, manpower, equipment, supplies and reagents, good manufacturing practices, and process control to be followed in Indian blood transfusion services.Regulatory affairs in the Indian blood banking system are controlled by central and provincial Drug Control authority under Drug Controller General of India. National AIDS Control Organization (NACO) acts as a facilitator to Indian blood transfusion services on behalf of the Ministry of Health and Family Welfare, Government of India,especially to the government sector. The National Blood Policy was published by the Government of India in 2002 and it provides objectives to provide safe, adequate quantity of blood, blood components, and products.

Deferral pattern in voluntary blood donors on basis of low hemoglobin and effect of application of digital hemoglobinometer on this pattern.

BACKGROUND: One of the responsibilities of blood center is to provide safety to blood donors. It is mandatory to screen a blood donor for hemoglobin (Hb) or hematocrit which should not be less than 12.5 g/dl or 38% Hct. Most commonly applied method for hemoglobin estimation is copper sulphate method, but this method has chances of false acceptance as well as false deferral. In order to avoid this chance of error, digital hemoglobinometer is used. This study was planned to analyze effect of application of digital hemoglobinometer for detection of Hb on donors, who are deferred by copper sulphate method. MATERIALS AND METHODS: Total 35,339 voluntary non renumareted altruistic donors were included in this study between the periods of September 2005 to July 2006. Total deferred donors were 8622 (24.39%) and donors deferred due to hemoglobin by copper sulphate method were 4391 (50.92%). Digital hemoglobinometer was applied on 3163 deferred donors (72.03%). Results of digital hemoglobinometer were validated by known controls. RESULT: Digital hemoglobinometer was applied on 3163 donors who were deferred by copper sulphate method. Out of this, donors accepted by digital hemoglobinometer were 1196 (37.01%). Total repeat donors were 629 (52.50%) and first time were 567 (47.40%). Male donors were 891 (74.44%) and females were 305 (25.50%). Donors deferred with digital hemoglobinometer were 2135, out of them 1097 (51.14%) were repeat, 1038 (48.38%) were first time, 1349 (60.79%) were male, 786 (34.47%) donors were female donors. Range of hemoglobin in deferred donors was 7.0 to 12.4 and in accepted donors 12.5 to 16.4. CONCLUSION: By the application of digital hemoglobinometer 37.81% donors were found hemoglobin >12.5 which were deferred with copper sulphate method and unnecessary deferral of donors can be reduced to a great extent. In country like India, where blood supply is always less than the requirement, this new technique may be helpful to increase donor population but cost benefit ratio should be analyzed.

True positivity of anti-Hepatitis C Virus Enzyme-linked immunosorbent assay reactive blood donors: A prospective study done in western India.

BACKGROUND: A significant number of safe donations are removed from the blood supply, because of the reactive anti-HCV screening test results. This study aimed to assess if the HCV (Hepatitis C Virus) seropositive donors were confirmed positive or not. MATERIALS AND METHODS: More than 68,000 blood donors' samples were routinely screened and 140 samples were found to be anti-HCV ELISA reactive. These 140 samples were tested by NAT. The NAT negative samples were tested by RIBA. Analysis of samples reactive in single ELISA kit vs. two ELISA kits was done. RESULTS: Out of 140 anti-HCV ELISA reactive samples, a total of 16 (11.43%) were positive by NAT. The results of 124 RIBA showed 6 (4.84%) positive, 92 (74.19%) negative, and 26 (20.97%) indeterminate results. None of the sample which was reactive in only single ELISA kit was positive by NAT or RIBA. CONCLUSION: Only a minority of blood donors with repeatedly reactive anti-HCV screening test is positive by confirmatory testing, but all these blood units are discarded as per existing legal provisions in India. Efforts should be made to retain these donors and also donor units.

Serological study on parvovirus B19 infection in multitransfused thalassemia major patients and its transmission through donor units.

BACKGROUND: Human parvovirus B19 (B19) virus is a newly recognized agent for transfusion transmitted diseases. Beta-thalassemia major patients receive a hypertransfusion regimen, hence, are prone to acquire B19 infection; moreover, B19 escapes viral inactivation methods and donor units are not tested for B19, but there are just a couple of studies globally and none from the Asian continent. Hence, a study was designed to find the frequency of B19 infection and its transmission in multitransfused thalassemia patients. MATERIALS AND METHODS: Ninety multitransfused beta-thalassemia major (thalassemia) patients, 32 controls (age, sex matched) without any history of transfusion were enrolled. Besides the donor units were tested in B19 un-infected patients. B19 specific IgG and IgM antibodies in the sera were analyzed by ELISA (in-house), using B19 VPI and VP2 recombinant and purified antigens; additionally HBsAg and anti-HIV and anti-HCV antibodies were tested for coexisting infections. RESULTS: Seventy-three (81%) thalassemia patients tested positive for anti-B19 IgG antibodies as compared to seven (21%) in the controls group (P < 0.01), while anti-B19 IgM antibodies were detected in 37 (41.1%) compared to two (6.2%) in the controls (P < 0.01). Mean age of the thalassemia patient was eight years (range 2 - 18 years) and B19 infection was highest in the six-to-ten year range. Seropositivity increased with the number of transfusions. Two of the four HBsAg positive and five of the seven anti-HCV IgM antibody-positive patients also had anti-B19 IgM. After a six-month follow-up, four (25%) of the 16 seronegative patients seroconverted and anti-B19 IgM antibodies were detected in their donor units. CONCLUSIONS: Most of multitransfused thalassemics were B19 seropositive or had anti-B19 IgM; in the remaining uninfected group, B19 got transmitted through infected / IgM-positive donor units.