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1.  Hemovigilance and blood safety 
doi:10.4103/0973-6247.98911
PMCID: PMC3439750  PMID: 22988376
3.  Automation in Immunohematology 
There have been rapid technological advances in blood banking in South Asian region over the past decade with an increasing emphasis on quality and safety of blood products. The conventional test tube technique has given way to newer techniques such as column agglutination technique, solid phase red cell adherence assay, and erythrocyte-magnetized technique. These new technologies are adaptable to automation and major manufacturers in this field have come up with semi and fully automated equipments for immunohematology tests in the blood bank. Automation improves the objectivity and reproducibility of tests. It reduces human errors in patient identification and transcription errors. Documentation and traceability of tests, reagents and processes and archiving of results is another major advantage of automation. Shifting from manual methods to automation is a major undertaking for any transfusion service to provide quality patient care with lesser turnaround time for their ever increasing workload. This article discusses the various issues involved in the process.
doi:10.4103/0973-6247.98914
PMCID: PMC3439752  PMID: 22988378
Automation; immunohematology; serology
4.  Code development of the national hemovigilance system and expansion strategies for hospital blood banks 
Objectives:
The aims of this study were to develop reportable event codes that are applicable to the national hemovigilance systems for hospital blood banks, and to present expansion strategies for the blood banks.
Materials and Methods:
The data were obtained from a literature review and expert consultation, followed by adding to and revising the established hemovigilance code system and guidelines to develop reportable event codes for hospital blood banks. The Medical Error Reporting System-Transfusion Medicine developed in the US and other codes of reportable events were added to the Korean version of the Biologic Products Deviation Report (BPDR) developed by the Korean Red Cross Blood Safety Administration, then using these codes, mapping work was conducted. We deduced outcomes suitable for practice, referred to the results of the advisory councils, and conducted a survey with experts and blood banks practitioners.
Results:
We developed reportable event codes that were applicable to hospital blood banks and could cover blood safety - from blood product safety to blood transfusion safety - and also presented expansion strategies for hospital blood banks.
Conclusion:
It was necessary to add 10 major categories to the blood transfusion safety stage and 97 reportable event codes to the blood safety stage. Contextualized solutions were presented on 9 categories of expansion strategies of hemovigilance system for the hospital blood banks.
doi:10.4103/0973-6247.98916
PMCID: PMC3439753  PMID: 22988379
Biologic products deviation report; hemovigilance; medical error reporting system-transfusion medicine; reportable event code
5.  A prospective study for prevalence and/or development of transfusion-transmitted infections in multiply transfused thalassemia major patients 
Objective:
To evaluate the rate of seropositivity to hepatitis B and C and Human Immunodeficiency Virus (HIV) infections among children with β-thalassemia major receiving multiple transfusions in Ahmedabad, India, compared with healthy controls.
Materials and Methods:
The study was performed during January 2007 to January 2009 on multi-transfused children suffering with β-thalassemia major registered in the Prathama Blood Centre, Ahmedabad; Jeevandeep hospital, Ahmedabad; and Red Cross Blood Centre, Ahmedabad, and investigated for the prevalence and development of transfusion-transmitted infections. Hepatitis B surface Antigen (HBsAg), anti-Hepatitis C Virus (HCV) Antibodies (Ab), and HIV Ab were checked using a fourth-generation Enzyme-Linked Immunosorbent Assay (ELISA). Positive tests were confirmed by western blots. Healthy blood donors were used for the control group.
Results:
Hepatitis B surface antigen, anti-HCV Ab, and HIV Ab were positive in one of 96 (1.04%; 95% Confidence Interval (CI) = 0.17–1.3), 24 of 96 (25%; 95% CI = 11.4–14.2), and one of 96 (1.04%; 95% CI = 0.12–1.3), respectively. The rate of anti-HCV Ab was significantly higher in multi-transfused children suffering with β-thalassemia major. In thalassemia patients, the rate of positive anti-HCV Ab was significantly higher than that for positive HBsAg (P<0.001) and HIV Ab (P<0.001).
Conclusion:
It is concluded that HCV is the current major problem in multi-transfused children with thalassemia major and more careful pretransfusion screening of blood for anti-HCV must be introduced in blood centers.
doi:10.4103/0973-6247.98919
PMCID: PMC3439754  PMID: 22988380
Hepatitis B; hepatitis C; Human immunodeficiency virus; β-thalassemia major; seroprevalence
6.  Analysis of adverse events and predisposing factors in voluntary and replacement whole blood donors: A study from north India 
Background:
Lack of awareness and community motivation, compounded with fragmented blood transfusion services in our country, Often leads to shortage of blood. Donor recruitment and retention are essential for ensuring adequate blood supply. However, adverse events (AEs) in donors have a negative impact on donor return.
Aims and Objectives:
The present study was aimed to assess the frequency of AEs in whole blood donors and analyze the predisposing factors for AEs.
Material and Methods:
The study was conducted on allogeneic whole blood donors over a period of 14 months, i.e., from January 2002 to February 2003. A total of 37,896 donors were monitored for any AEs: 22587 (59.6%) were voluntary donors (VD) and 15,309 (40.4%) were replacement donors (RD).
Results:
Overall reaction rate was 2.5% with vasovagal reactions constituting 63.5% and hematomas 35.0% of all reactions. Vasovagal reactions showed a significant association with young age, lower weight, first time donation status, female gender, and nature of blood donation camps. Amongst male donors, RDs had more reactions (P=0.03) than VDs. Majority of donors (85%) with vasovagal reactions admitted to some fear or anxiety prior to donation. Hematoma formation occurred significantly more when less trained staff performed phlebotomy.
Conclusion:
Donor safety is an essential prerequisite to increase voluntary blood donation. AE analysis helps in identifying the blood donors at risk of donor reactions and adopting appropriate donor motivational strategies, pre-donation counseling, and care during and after donation.
doi:10.4103/0973-6247.98922
PMCID: PMC3439755  PMID: 22988381
Adverse events; donors; vasovagal reactions
7.  Neonatal thrombocytopenia and platelets transfusion 
Background:
Neonates often develop thrombocytopenia at some time during hospital stay. Platelet transfusion are frequently given to them and are likely to result in unnecessary transfusion.
Material and Methods:
Thus, we analyzed thrombocytopenia in neonates, its prevalence, and relationship if any, between clinical condition and platelet transfusion in neonates, which would have been helpful in developing guidelines and/or protocols for platelet transfusion (and reducing the donor exposure) in neonates.
Results:
A total of 870 neonates who were admitted in Neonatal Intensive Care Unit (NICU) with various morbidities had platelets count done; of these, 146 (16.7%) neonate revealed thrombocytopenia.
Discussion:
Low birth weight babies (P 0.009) and babies born with mother having hypertension (P 0.04) showed significant thrombocytopenia. Neonates with intrauterine growth retardation (IUGR) diagnosed during antenatal screening showed lower platelet count (P 0.022). Neonates having associated illness, such as sepsis, gastrointestinal, and respiratory problems, and on vasopressor drugs were found to be associated with low platelet count.
Conclusion:
In our study, 16.40% of thrombocytopenic neonates required platelet transfusion either alone or with other blood component during their stay in NICU.
doi:10.4103/0973-6247.98924
PMCID: PMC3439756  PMID: 22988382
Neonatal transfusion; platelet transfusion; thrombocytopenia
8.  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.
doi:10.4103/0973-6247.98927
PMCID: PMC3439757  PMID: 22988383
Anti-Hepatitis C Virus Enzyme-linked immunosorbent assay; nucleic acid amplification test; recombinant immuno blot assay
9.  Effectiveness of blood donor questionnaire directed at risk factor for transfusion transmitted infections in Pakistani population 
Background:
Deferring blood donors who admit to high-risk behavior on questioning are likely to eliminate those in window period for transfusion transmitted infections (TTI). However, many questions have been implemented in some countries as part of donor history questionnaire, based on precautionary principle and not on evidence, and can result in increased donor losses. This study aims to identify effective risk-directed questions having high predictive value, in local context which can form part of blood donor deferral policies. For this, a case control study in a hospital blood bank having donation services was carried out prospectively over a period of three years.
Materials and Methods:
Two hundred and twenty donors, who were repeatedly reactive for HBsAg, anti-HCV, anti-HIV with EIA, and syphilis with TPHA, were the cases. Eight hundred and eighty four controls were the donors who tested negative for all TTI test. All donors answered seven hepatitis risk directed questions and their responses and reactivity status for TTI were used for statistical analysis with SPSS ver. 15.
Results:
Positive predictive value for history of jaundice at any age for HBsAg was 20%, while PPV for history of surgery in previous six months for both HBsAg and anti-HCVHCV was also around 20%, based on pretest probability of 7%. The post-test probability for these questions was around 30%. Odds ratios with 95% CI did not reveal any significant association of hepatitis with any of seven questions. Donor losses after deferring on basis of two questions were 5.3% per year, while deferral rate after all seven questions was 20%.
Conclusions:
Donors should be permanently deferred if there is history of jaundice at any age, while deferral period after surgery should be one year. Other risk-directed questions should not be used to defer donors. Donor deferral policies should be evidence based and questions with proven efficacy should be made part of donor history questionnaire to minimize donor losses.
doi:10.4103/0973-6247.98929
PMCID: PMC3439758  PMID: 22988384
Blood donor; donor deferral; donor history questionnaire
10.  Seroprevalence of malaria in blood donors and multi-transfused patients in Northern India: Relevance to prevention of transfusion-transmissible malaria 
Background:
Transfusion-transmissible malaria (TTM) is a major concern in malaria endemic countries. A study was therefore conducted to know sero-prevalence of malaria in blood donors and the risk of TTM to multi-transfused patients at our hospital.
Materials and Methods:
Study subjects were: eligible blood donors (n = 1000), donors deferred due to history of fever in the last 3 months (n = 100), and multi-transfused patients (n = 200). Screening for malaria was done by slide microscopy, immunochromatographic rapid diagnostic test (RDT) for malaria antigen, and anti-malaria antibody by enzyme linked immunosorbent assay.
Results:
Malaria antibody prevalence in eligible donors and donors with history of fever, thalassemia patients, and in other multi-transfused patients was 16.9%, 22%, 6%, and 15%, respectively. None of the donors were positive for malaria on microscopic examination. None of the blood donors except one donor with history of fever, tested positive with RDT.
Conclusion:
Malaria antibody prevalence in blood donors at our center is high. As blood units donated by such donors have high-risk potential, special processing may be undertaken to reduce the risk of TTM.
doi:10.4103/0973-6247.98937
PMCID: PMC3439759  PMID: 22988385
Anti-malaria antibody; blood donor; multi-transfused patients; serology; transfusion-transmitted malaria
11.  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.
doi:10.4103/0973-6247.98939
PMCID: PMC3439760  PMID: 22988386
Copper sulphate; digital hemoglobinometer; hemoglobin
12.  Expanding role of a blood center 
Materials and Methods:
The study was performed on prospective donors who reported to the Department of Transfusion Medicine. Individuals deferred due to hypertension contributed the study population. They were compared with age and sex matched donor controls. Demographic details were recorded in a proforma. On identification of a hypertensive individual, consequent two comparable donors were taken as controls with a total of 50 hypertensive subjects. Hypertensive status of the subjects were assessed based on the criteria formulated by the WHO-ISH and US Seventh Joint National Committee report on prevention, detection, evaluation and treatment of high blood pressure.
Results:
About 0.95% of healthy blood donors had undetected hypertension. Mean age at detection of hypertension in the study group was 35.44 ± 7.69 years. Higher BMI was observed in the hypertensive group compared to normotensive control group with P value significant at 0.0001.
Conclusion:
About 1% of healthy individuals were found to have undetected hypertension. Though the study was not designed to determine the prevalence of hypertension in the region, it is a rough estimate of the proportion of undetected hypertension in the local population as donors are considered as representative of healthy population.
doi:10.4103/0973-6247.98945
PMCID: PMC3439761  PMID: 22988387
Blood donation; hypertension; high ferritin and hematocrit
19.  Blood cell MicroRNAs and blood product safety 
doi:10.4103/0973-6247.98957
PMCID: PMC3439768  PMID: 22988394
20.  Role of transfusion medicine in post-crisis nuclear leakage 
doi:10.4103/0973-6247.98958
PMCID: PMC3439769  PMID: 22988395
21.  Rare blood donor program in the country: Right time to start 
doi:10.4103/0973-6247.95041
PMCID: PMC3353620  PMID: 22623833
22.  Hepatitis B core antibody testing in Indian blood donors: A double-edged sword! 
Background:
Until lately, anti-HBc antibodies were considered an effective marker for occult Hepatitis B virus (HBV) infection and have served their role in improving blood safety. But, with the development of advanced tests for HBV DNA detection, the role of anti-HBc in this regard stands uncertain.
Materials and Methods:
Anti-HBc and HBsAg ELISA and ID-NAT tests were run in parallel on donor blood samples between April 1, 2006 and December 31, 2010 at the Department of Transfusion Medicine, Indraprastha Apollo Hospitals, New Delhi. A positive ID-NAT was followed by Discriminatory NAT assay.
Results:
A total of 94 247 samples were tested with a total core positivity rate of 10.22%. We identified nearly 9.17% of donors who were reactive for anti-HBc and negative for HBsAg and HBV DNA. These are the donors who are potentially non-infectious and may be returned to the donor pool.
Conclusion:
Although anti HBc testing has a definite role in improving blood safety, centers that have incorporated NAT testing may not derive any additional benefit by performing anti-HBc testing, especially in resource-limited countries like ours.
doi:10.4103/0973-6247.95043
PMCID: PMC3353621  PMID: 22623835
Anti-HBc; HBsAg; ID-NAT
23.  Recombinant-activated factor VII in patients with uncontrolled bleeding: A retrospective observational analysis 
Background:
Factor VIIa (recombinant) has an off-label use to control life-threatening bleeding that is refractory to other measures and was shown to decrease transfusion requirements.
Objective:
The primary objective of this study was to assess the safety and effectiveness of factor VIIa (recombinant) on blood transfusion requirements and coagulation parameters when used in patients whose bleeding was uncorrected by other means. The pharmacoeconomic impact for any discrepancy from our protocol was evaluated. Secondary outcomes included 4-hour and 28-day mortality, as well as safety of this agent in terms of thromboembolic complications.
Materials and Methods:
We retrospectively evaluated patients who received recombinant-activated factor VII (rFVIIa) for uncontrolled bleeding from June 2008 to April 2011. The medical records of 33 patients were evaluated. Coagulation parameters and blood products were determined 24 hours before and 24 hours after administration of rFVIIa, and the results compared. Patients were also screened for any thromboembolic complications.
Results:
Administration of rFVIIa reduced blood transfusion requirements and improved coagulation parameters significantly (P<0.05). No thromboembolic complications were reported. Most of the dosing was consistent with those recommended in our institutional protocol, with discrepancies resulting in an average cost of $56 058. Moreover, pH was reported in only 67% of patients. All patients treated with rFVIIa survived up to 4 hours after receiving this agent, while the 28-day mortality was 24% (8/33).
Conclusion:
The use of rFVIIa appears to be safe and effective in promoting hemostasis, as evident from reducing transfusion requirements and improving the coagulation variables.
doi:10.4103/0973-6247.95044
PMCID: PMC3353622  PMID: 22623836
Coagulopathy; hemorrhage; recombinant-activated factor VIIa; trauma; uncontrolled bleeding
24.  Quality indicators for discarding blood in the National Blood Center, Kuala Lumpur 
Background and Objective:
The implementation of quality system and continuous evaluation of all activities of the Blood Transfusion Services (BTS) can help to achieve the maximum quantity and quality of safe blood. Optimizing blood collection and processing would reduce the rate of discard and improve the efficiency of the BTS. The objective of this study is to determine the rate of discard of blood and blood component and identify its reasons at the National Blood Centre (NBC), Kuala Lumpur, during the year of 2007 in order to introduce appropriate intervention.
Study Designs and Methods:
Data on the number of discarded whole blood units and its components, reasons for discard, and the number of blood components processed as well as the number of collected blood units were obtained from the Blood Bank Information System - NBC database. These were analyzed.
Results:
The total number of blood units collected in 2007 was 171169 from which 390636 units of components were prepared. The total number of discarded whole blood units and its components was 8968 (2.3%). Platelet concentrate recorded the highest of discard at 6% (3909) followed by whole blood at 3.7% (647), fresh frozen plasma (FFP) at 2.5% (2839), and cryoprecipitate at 2% (620). The rate of discarded packed red blood cells RBCs, plasma aphaeresis, and PLT aphaeresis was less than 1% at 0.6% (902), 0.6% (37), and 0.29% (14), respectively. RBC contamination of PLT and plasma were the major cause of discard at 40% (3558). Other causes include leakage (26% - 2306), lipemia (25% - 2208), and underweight (4% - 353).
Conclusion:
Good donor selection, training and evaluation of the staff, as well as implementation of automation will help to improve processes and output of BTS. This would reduce discard of blood components and wastage caused by non conformance.
doi:10.4103/0973-6247.95045
PMCID: PMC3353623  PMID: 22623837
Discard blood; National Blood Centre Kuala Lumpur; quality indicators
25.  Distinct immunoregulatory cytokine pattern in Egyptian patients with occult Hepatitis C infection and unexplained persistently elevated liver transaminases 
Background/Aim:
The immunopathogenesis of occult Hepatitis C virus (HCV) infection is a matter of great controversy and has been suggested to involve a complex balance between cytokines with pro- and anti-inflammatory activity. This work aimed at studying the serum Th1 and Th2 cytokine production in patients with occult HCV infection.
Materials and Methods:
Serum levels of cytokines of Th1 (interleukin [IL]-2, INF-γ) and Th2 (IL-4) were measured in 27 patients with occult HCV infection and 28 patients with chronic hepatitis C infection.
Results:
The levels of IL-2 and interferon-γ were highly significantly increased in patients with chronic HCV infection (P<0.001). IL-4 was highly significantly increased in occult HCV infection (P<0.001). Significant increases were noted in chronic HCV infection regarding bilirubin (P<0.001), ALT (P = 0.009), AST (P = 0.013), AFP (P<0.001), while serum albumin was significantly higher in occult HCV infection (P<0.001). Necroinflammation (P<0.001), fibrosis (P<0.001), and cirrhosis (P = 0.03) were significantly increased in chronic HCV infection.
Conclusion:
Our data revealed a high prevalence of occult HCV infection (25%) in patients with unexplained persistently abnormal liver function test results. Those patients exhibited a distinct immunoregulatory cytokine pattern, favoring viral persistence and explaining the less aggressive course of this disease entity than chronic HCV infection.
doi:10.4103/0973-6247.95046
PMCID: PMC3353624  PMID: 22623838
Cytokines; Hepatitis C virus; occult

Results 1-25 (42)