Knowledge assessment of a donor adverse reaction severity grading tool by the National Blood Donor Vigilance Programme of India.

BACKGROUND AND OBJECTIVES: The severity grading tool (SGT) was recently designed by the Association for Advancement of Blood and Biotherapies (AABB) to have more objectivity in severity assignment for an adverse donor reaction after blood donation. A study was performed in India to assess the knowledge (post-training) and determine the degree of agreement of the SGT between participating centres and the subject expert group. MATERIALS AND METHODS: This prospective cross-sectional survey-based study was conducted by the National Coordinating Centre (NCC) of the National Blood Donor Vigilance Programme (NBDVP) of India. Thirty-five real-world case scenarios, validated by seven national and two international experts, were sent to the participating centres, and their responses received (diagnosis and severity grade) were compared and analysed. RESULTS: A total of 50 blood centres participated in the study. The overall agreement between the participating centres and the expert group was 66.4%, with a fair Kendall's coefficient of concordance (W) of 0.271 (p-value < 0.05). The degree of agreement was observed to be more than 80% for 12 centres, 60%-80% for 27 centres and <60% for 11 centres. The overall degree/percentage of agreement for cases with single and multiple types of donor adverse reaction was 71.3% and 42.6%, respectively. CONCLUSION: The SGT will be an efficient mode to have uniform objective reporting of the adverse donor reactions and may be implemented in the NBDVP of India. This study also highlights the need for training of the blood centres on the basic definitions and categorization of the donor's adverse reaction.

Self-ignored onsite adverse donor reaction among whole blood donors: A single center experience from India.

OBJECTIVES: Adverse donor reactions (ADR) may often go unreported due to donor related or blood center related factors. Possible donor related factors are self-ignorance of the adverse reaction, inertia to notify blood centre and non-compliance to follow-up. A better understanding of the self-ignored adverse donor reaction (SIADR) helps in early detection, avoidance of complications, adoption of mitigation strategies, and retention of donors. In the current study, we aim to identify the incidence and reasons for onsite SIADR among whole blood donors. MATERIALS AND METHODS: Prospective single-center observational study where 501 participants who completed whole blood donation were recruited. They were interviewed twice by an experienced investigator to identify any onsite SIADR occurred. First interview was conducted just before leaving the premise and second two days after donation using a peer reviewed and validated questionnaire. Cross-tabulation and Chi-square test were used for bivariate analysis. RESULTS: Twelve participants out of 501 (2.39%) were found to have onsite SIADR which was twice the frequency of reported onsite ADR (1.20%) during the study period in our center. A majority (75%) of them experienced grade I vaso-vagal reactions (VVR). Around 58.3% of the SIADR donors ignored the reaction as they perceived it as mild, while 25% perceived the symptoms but failed to interpret them as a reaction. CONCLUSION: In our center, incidence of onsite SIADR was double the incidence of ADR and majority were VVR grade I. Commonest reason for SIADR was interpretation of reaction as mild. Blood center team shall be proactive and vigilant to identify and report SIADR.

Safety of Plasmapheresis in Donors with Low IgG Levels: Results of a Prospective, Controlled Multicentre Study.

Background and Objectives: Although plasmapheresis is generally considered safe, there are still concerns about the long-term effects of plasma donation on immunoglobulin G (IgG) levels. The aim of the present study was to investigate if there is a need to permanently defer donors who donated three times with an IgG level below 6.0 g/L. Study Design and Methods: From September 2007 to December 2017, adverse events (AEs) including infections were analysed from data of a prospective, controlled multicentre study of healthy volunteer donors, participating in an individualized plasmapheresis programme stratified by initial IgG level and body weight (individualized arm) or in standard plasmapheresis according to national guidelines (control arm). IgG was monitored at every fifth donation, and donors with IgG levels below the threshold were identified and followed up for possible AEs. Results: In total, 97,540 donations in 1,462 donors in the control arm and 1,491,223 donations in 14,281 donors in the individualized arm were included. Donation-based incidences of at least severe AEs and any infections were 0.019% and 0.192% in the control arm, and 0.014% and 0.153% in the individualized arm. Three or more IgG-measurements below the threshold occurred in 38.2% of control arm donors and 20.9% of individualized arm donors. There were no increased incidence rates of at least severe AEs or any infections in donors with ≥3 IgG-measurements below the threshold in either donor's arm. Conclusions: Our data show no signs of compromised donor safety in donors with ≥3 IgG-measurements below the threshold, indicating that plasmapheresis is feasible and safe in these donors.

National blood donor vigilance programme of India: Analysis of donor adverse reactions reported during initial 2 years of implementation (2016 and 2017).

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.

How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project.

BACKGROUND AND OBJECTIVE: Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle. MATERIALS AND METHODS: From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence. RESULTS: The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process. CONCLUSIONS: While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.

Donor vigilance data of a blood transfusion service: A multicenter analysis.

BACKGROUND: Donor vigilance is an important part of the quality management system of blood transfusion services. The evaluation of donor side effects helps to improve the donation process and donor compliance. The aim of the present study was to evaluate donor vigilance data in whole blood and plasmapheresis donors of a blood donor service. MATERIALS AND METHODS: Donors fulfilling current national and European eligibility criteria underwent whole blood and plasmapheresis donation (PCS and MCS+ (Haemonetics, Braintree, USA), A 200 (Fenwal, Round Lake, USA). Whole blood was collected at fixed and mobile sites while plasmaphereses were performed at 8 plasma centers. From 2011 to 2013 donor information was provided for gender, age, body weight, height, first and repeat donation. Donors were monitored for venipuncture and circulatory associated side effects. RESULTS: The total incidences of adverse events were 5004 (0.56%) in repeat donors and 2111 (2.78%) in first time donors for whole blood donation and 3323 (1.01%) and 514 (7.96%) for plasmaphereses, respectively. Circulatory associated events were 2679 (0.30%) for whole blood donation and 1624 (0.49%) for plasmaphereses. CONCLUSION: Our donor vigilance data of a blood transfusion service show that whole blood and plasmapheresis are safe with low incidences of adverse events. Repeat donation and age are predictors for low rates of adverse events. On the other hand, first time donation and female gender were associated with higher incidences of adverse events.

Blood donors--Serious adverse reactions (SAR) 2010-2014 EFS Châteauroux, France.

BACKGROUND: In 2013, the national French incidence of serious adverse reactions (SAR) was 155.7 per 100,000 donations and 82% of SAR were grade 2 (French classification of SAR related to blood donors) AIMS: The purpose of our study was to describe the profile of blood donator candidate which had a SAR in our center. METHODS: The study contains all the SAR superior to grade 1 occurred on the site EFS Châteauroux (site and mobile blood collection) from January 2010 to October 31, 2014. We analyzed 37 parameters from the e-fit files (e-site French blood vigilance) and In-log software. RESULTS: We identified 82 SAR for 72,553 blood donations (incidence: 113.02 SAR per 100,000 donations). Forty-one men and 41 women, middle age 39 years (18-66). Average height: 1.68 m (1.49-1.85); average weight: 68 kg (50-98); body mass index (kg/m(2)): 24,13(18.6-31.9). All donors were Caucasian and 30% unemployed. We found 74 vasovagal syncope (VVS), 5 hematomas, 2 arterial injuries and an adverse reaction to citrate. In 90%, the SAR was immediate and of grade 2 in 85% of cases. Thirty-seven percent of SAR were first donation in connection with whole blood in 87% of cases. Regarding the seniority of donors, the number of average donations (whole blood, plasma, platelets) was 16.5. An SAR determined the stop of blood donation in 65% of cases with nearly 80% stoppage if it was a first donation. Seventy-three percent of SAR as a VVS took place during blood collection or within 5 minutes following the end of the donation. Sixty-one percent were men. Forty-four percent of cases were a first donation and 83% occurred in mobile blood collection. Average age was 36 years. The result was a permanent stop of all type of donations in 76% of cases. Twenty-seven percent of SAR as a VVS took place beyond 5 minutes after the end of the donation. Seventy-five percent were women. Thirty percent of cases were a first donation and 95% of SAR occurred in mobile blood collection. Average age was 42 years. The result was a permanent stop of all type of donations in 40% of cases. CONCLUSIONS: When the SAR as a VVS occurs during or within 5 minutes following the end of the donation, it leads to a permanent stop of any type of donation in 76% of cases.