Donor Hemovigilance Programme in managing Blood Transfusion Needs:Complications of Whole Blood Donation

Correspondence: Dr. Sadhana Mangwana, MD Department of Blood Transfusion Services, Sri Balaji Action Medical Institute, New Delhi, India Email: sadhanamangwana@yahoo.co.in Background: Hemovigilance like quality systems and audits have become an integral part of Blood Transfusion Services in the developed countries and has contributed greatly to its development. Hemovigilance begins with donors and must enable the collection of information on reactions occurring during the donation of blood, selections of donors and to prevent such incidents. The aim of study was to help identify the trends of adverse events , occurring in blood donors at a tertiary-care hospital, to recommend best practices to improve donor care and safety


INTRODUCTION
Hemovigilance like quality systems and audits have become an integral part of Blood Transfusion Service (BTS) in the developed countries and have contributed greatly to the Mangwana S 1 1 Department of Blood Transfusion Services, Sri Balaji Action Medical Institute, New Delhi, India development of Blood Transfusion Services. The goal of hemovigilance is to identify and prevent occurrence / recurrence of transfusion related unwanted events, in order to increase the safety, efficacy and efficiency of blood transfusion, covering all activities of blood transfusion chain from donors to recipients. However, developing countries are still grappling with donor recruitment, retention and efforts towards sufficiency and safety of blood supply. 463 Tools to help improve the safety of blood supply include -1. Clinical (Transfusion) guidelines 2. Audit systems to monitor adherence to the guidelines as well as effects of guidelines. 3. Hemovigilance programme which monitors the entire blood supply chain, develop measures and solutions to the problems anywhere along the chain that can threaten the safety of component supply and monitors the implementation of these corrective actions.
Hemovigilance begins with donors and donations of blood and must enable the collection of information on reactions occurring during the donation of blood, selections of donors and to prevent the occurrence or recurrence of such incidents.
Whole blood donation is generally considered to be safe and uncomplicated procedure but occasionally donors experience adverse reactions of variable severity during or at the end of collection. Despite complications rates of blood donations being relatively low, donor complications are an important problem, not only for donors but also for the transfusion medicine in general, as some complications may negatively affect donor recruitment and retention.
There have been innumerable studies and articles in the literature on the recording and management of adverse events related to transfusion of blood component to the patients, data on donor adverse events is primarily from western studies. [1][2][3][4][5][6][7][8][9][10] In order to estimate the frequency and type of adverse events occurring in whole blood donors at a tertiary-care hospital, to disseminate the findings, to develop evidence-based medicine and to introduce new and/or existing policies for monitoring blood safety and to bring uniformity in hemovigilance system, this recordbased study was conducted.

MATERIALS AND METHODS
Record-based study was conducted on all adverse events related to allogenic whole blood donations performed over 24 months from January 2010 to December 2011. Criteria for the selection of whole blood donors were in accordance with rules laid down in Drugs and Cosmetic Act, Ministry Of Health and Family Welfare, Govt. of India. 11 Blood donors must be 18 to 65 years old and in good health. All donations were performed using 16 gauze needles from vein in the antecubital area after maintaining strict asepsis of venipuncture site.
It is important to react swiftly to initial complaints of giddiness, light headedness, pallor by donor by stopping the donation immediately and raising the legs and lowering of head end of donor couch (Anti-shock position) as pallor, sweating, giddiness are harbingers of severe vasovagal reactions which could be prevented by taking corrective measures right at the onset of symptoms.

Adverse Events (AE)
Donor adverse reactions were classified into local symptoms, generalized symptoms, complications related to Apheresis and others into 13 categories 12 . In order to create database, data was collected on the form designed as per guidelines by American Red Cross Hemovigilance Programme: 1 Presyncopal symptoms included pallor, sweating or lightheadedness without loss of consciousness.
Syncopal type of complications were classified as: Minor -transient loss of consciousness lasting for < 1 minute Major -prolonged loss of consciousness for >1 minute or complicated by loss of bladder/ bowel control, seizures or convulsions Local adverse events-hematomas which can be small (<25.8 mm 2 ) or large (>25.8 mm 2 ), bruises, infiltration, allergic reactions and a tingling / burning sensations.
Once the donor recovered from AE, a detailed report was filled by phlebotomist. For delayed reactions, the donor was advised to be in touch with designated staff of blood transfusion services.
This study was approved by the Institutional Ethics Committee.

Statistical Analysis:
The data has been summarized through frequency distributions and contingency tables along with suitable graphs. Statistical analysis was performed with Mann-Whitney and Chi-square/Fisher's Exact test using SPSS version 15.0 software determining significance at p<0.05.

RESULTS
During the 24 months period, blood centre at a

DISCUSSION
The aim of this study was to estimate the frequency and type of adverse events occurring in whole blood donors so that appropriate actions can be taken through appropriate educational processes to prevent occurrence and recurrences of these incidences and sufficient and safe blood supply can be maintained by ensuring safety and well-being of the donors. Although whole blood donation is considered to be safe, reports in the medical literature about the frequency of adverse events during donation show broad heterogeneity. 6,7,9 Donation-related adverse events were recorded according to standardized criteria. However, a classification of complications has been implemented in accordance with Standards for Surveillance of Complications Related to Blood Donations. 12 In our study, 0.3 % of all whole blood donations were complicated by an adverse event. This is in accordance with various studies conducted all over the world in which the rate of adverse events associated with donations ranged from 0.3% to 3.8% .2-10,13,14 Variations may result due to differences in donor demography, behavior of collection staff and methodology used to obtain information regarding adverse events from donor.
As part of our study, we tried to analyze the various patterns and found that highest adverse events occurred in the age group of 26-35 years (0.37%).Young age, female gender and first time donation status were associated with significantly higher reaction prevalence. 5,14 There was significant drop in reaction prevalence after the age of 36 years. Mean age of donors recording adverse events is 30.23 ± 7.49 years compared with mean age of donors without adverse events 31.14 ± 8.56 years (p value -0.507). A study by France postulated that baroreceptor sensitivity is decreased in healthy young individuals when they are physically or psychologically stressed. 15 With increasing age, body becomes more stable hemodynamically. Also the young donors were more apprehensive to the pain of phlebotomy.
Female donors showed 0.50% incidence of adverse events against 0.29 % incidence in male donors. We found a very low incidence (0.007% of total donations) of vasovagal reaction-immediate with injury but not necessitating hospitalization of the donor or administration of intravenous fluid which is in accordance with results of other authors 2,3,13 who categorized such adverse events as severe reactions (major syncopal reactions).
Donor safety is an essential perquisite to increase voluntary blood donation. One of the key objectives of our national blood policy is to achieve 100% voluntary blood donation, 16 The present national average being 61%.Adverse events analysis helps in identifying the blood donors at risk of donor reactions, applying appropriate motivational strategies, pre-donation counseling, care during and after donation, developing guidelines and hemovigilance programme in countries with limited resources if a step-up approach is used. As per WHO Global Database Report on Blood Safety, 17 the national hemovigilance system is present in 42 (40%) of the 105 reporting countries with 24 countries (23%)being in process of development of such a system. 39(37%) counties do not have a national hemovigilance system. Among the Asian counties a well established hemovigilance system is lacking and there is paucity of data on hemovigilance except in Japan. 18 In India, a national blood system has been launched on December10, 2012. 19 This programme is an integral part of Pharmacovigilance programme of India.

CONCLUSION
In order to have a well organized hemovigilance system Mangwana S et al. in developing countries like India, a comprehensive approach is required. A streamlined mechanism for data collection using standardized tools at hospital level and good coordination at national level can bring up effective hemovigilance system in a country. The data from a well functioning hemovigilance system can be used as quality indicator for monitoring blood safety and also contribute significantly to evidence-based medicine as well as help to introduce new and /or access the existing blood policies.
There is need to strengthen and to bring uniformity in the hemovigilance system globally.