The International Haemovigilance Network (IHN) defines haemovigilance as 'a set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence'. IHN, the International Society of Blood Transfusion and World Health Organization work together to support both developing and established haemovigilance systems. Haemovigilance systems provide valuable data on a range of adverse events related to blood donation and clinical transfusion, from donor syncopal events to transfusion-transmitted infections, immunological complications and the impact of human errors. Harmonised definitions for most adverse reactions have been developed and validated internationally. Definitions of pulmonary complications are again under review. Haemovigilance data have resulted in changes in policy, products and practice, and can complement and inform clinical audit and research, leading to improved blood donor safety, optimised product use and better clinical outcomes after transfusion. However, more work is needed. Not all countries have haemovigilance systems in place. More robust data and careful analysis are required to improve the understanding of the causes, occurrence and clinical outcomes of these events. Wider dissemination of results will facilitate health policy development internationally, and implementation of haemovigilance recommendations will support further important progress in blood safety.

A centralized hemovigilance program to assure patient safety and to promote public health has been launched for the first time in India on Dec 10, 2012 in 60 medical colleges in the first phase along with a well-structured program for monitoring adverse reactions associated with blood transfusion and blood product administration. National Institute of Biologicals (NIB) will be the National Coordinating Centre for Hemovigilance. This program will be implemented under overall ambit of Pharmacovigilance Program of India (PvPI), which is being coordinated by Indian Pharmacopoeia Commission (IPC). All medical colleges of the country will be enrolled in this program by the year 2016 in order to have a National Centre of Excellence for Hemovigilance at NIB, which will act as a global knowledge platform.

No abstract

Background and Objectives Setting up a national haemovigilance programme requires meticulous planning, and the following issues need to be addressed: whether reporting will be voluntary or mandatory, what is to be reported and by whom, reporting formats and resources to sustain the programme. With this in view, it was aimed to set up a national haemovigilance programme in India. Materials and Methods The Ministry of Health and Family Welfare, Govt. of India had launched the national Pharmacovigilance Programme (PvPI) in July 2010, with oversight by the Indian Pharmacopoeia Commission. Adverse Drug Reaction (ADR) Centres were set up in 90 medical institutes in the country, and trained staff was recruited for data collection and submission. After the successful establishment of PvPI, the haemovigilance programme was initiated as a collaborative venture between National Institute of Biologicals (NIB) and Indian Pharmacopoeia Commission with the coordinating centre at NIB. Five expert subgroups with defined responsibilities will analyse and collate data and make evidence‐based recommendations to the regulatory authorities for blood safety initiatives and their compliance. Results The initial focus is on reporting the adverse reactions as defined by the Working Party of the International Society of Blood Transfusion, reporting is voluntary, and a Guidance Document and the TRRF have been made available to the medical institute blood banks. The reporting is online through software, ‘Haemo‐Vigil’. Reporting commenced from February 2013 and till date 731 reports of adverse reaction have been submitted. Conclusion A well‐structured programme of haemovigilance has been initiated in India.

Several studies have warranted the need to explore the relationship between pedagogical agents in the learning environment and the cognitive load on the learners, specifically, to study the influence on learner populations with different learning and motivation needs. The present work investigates the effects of the presence of a pedagogical agent in the learning environment on intrinsic, extraneous, and germane cognitive load for the dyscalculia and non-learner population. The proposed system intelligently investigates the learner, recommends an exclusive learning dyscalculia path and after tutoring assesses learning gain, and retention. Learner experience and effects of the pedagogical agent on types of cognitive loads are discussed on basis of post tutoring analysis. Samples of 82 learners have been studied, experimental findings based on research questions have been reported and conclusions discussed. Our assumption that 'a well-articulated and well-designed instructional design exerts a minimal extraneous cognitive load on learners and facilitates learning gain and retention' is consistent with the obtained results. The result conclude that pedagogical agent does not add to intrinsic and extraneous cognitive load. An improved Germane Cognitive load and good amount of knowledge retention is noticed post learning.

Background and Objectives:This study was conducted to assess the efficacy of Mirasol pathogen reduction system for platelets aimed at preventing bacterial regrowth by spiking buffy coat pooled platelets (BCPP) with clinically relevant load of Staphylococous epidermidis.Materials and Methods:BCPP units were prepared using Teruflex BP-kit with Imugard III-S-PL (Terumo BCT, Tokyo, Japan). Two BCPP units were pooled, of which 40 ml of negative control (NC) was removed. The remaining volume of the platelet unit was inoculated with clinically relevant load of bacteria (total of 30 CFU of S. epidermidis in 1 ml); following this the platelet unit was split into two parts. One part served as positive control (PC) and the other part was subjected to pathogen reduction technique (Mirasol PRT, CaridianBCT Biotechnologies, Lakewood, CO, USA). Bacterial detection was performed using BacT/ALERT system, controls after day 1 and day 7 following inoculation of bacteria and on day 7 for Mirasol-treated unit.Results:Of the 32 treatment cycles, 28 were valid and 4 were invalid. No regrowth was observed in 96.4% (27 of 28) after treatment with Mirasol pathogen reduction system. Of four invalid tests, on two instances the NC showed growth, whereas in other 2 no regrowth was detected in 7th day PC. Bacterial screening of PCs by BacT/ALERT after 24 h of incubation was 28.6%, whereas the effectiveness increased to 100% when incubated for 7 days.Conclusions:Mirasol system was effective in inactivating S. epidermidis when it was deliberately inoculated into BCPP at clinically relevant concentrations. Such systems may significantly improve blood safety by inactivating traditional and emerging transfusion-transmitted pathogens.

INTRODUCTION: The donor vigilance program is intended to collect and assess information on unexpected or undesirable effects or reactions resulting from blood donation. In this report, we discuss the analysis of the blood donor adverse reactions (DARs) reported in the National Blood Donor Vigilance Programme of India during the first 2 years of implementation. MATERIALS AND METHODS: DAR reporting form prepared and approved by the National Executive Committee of the Haemovigilance Programme of India was used to capture the data by the blood centers and submitted to Donor-Vigil software prepared and hosted by the official website of the National Institute of Biologicals. Data reported for the years 2016 and 2017 were reviewed, analyzed, and validated by independent transfusion medicine experts. RESULTS: During this period, a total of 19,98,101 donations denominator data were reported, in which 1,622,600 (80.9%) were valid. A total of 6091 DARs were reported, out of which 3980 (65.35%) were found valid. Only validated numerator and denominator data were included in the analysis. Generalized DARs were the most common type of DARs reported (83.7%), followed by “others” type (7.7%), localized (7.6%), allergic (0.4%), and complications related to apheresis (0.4%). The overall DAR rate was 2.45/1000 blood donations, which was higher in apheresis donations (3.07/1000) as compared to whole blood donations (2.39/1000). The DARs rates were higher in females (3.5/1000) compared to male donors (2.3/1000) and in the first time (2.5/1000) compared to repeat donors (2.15/1000). CONCLUSION: In this report, we concluded that younger age, first time, and female donors are more prone to DARs as compared to older age, repeat, and male donors. During the analysis of the data, we found some limitations, which can be improved by upgrading the reporting form and conducting regular continuing medical education (CMEs) of participant blood centers.

No abstract