REASONS FOR DEFERRAL IN DEFERRED VOLUNTARY BLOOD DONORS IN EASTERN CROATIA

Vladimir Cipek; Marina Ferenac Kiš; Dalibor Ratić; Silvija Piškorjanac; Marko Samardžija; Kristina Kralik; Marina Samardžija

doi:10.20471/acc.2023.62.01.12

. 2023 Apr;62(1):93–105. doi: 10.20471/acc.2023.62.01.12

REASONS FOR DEFERRAL IN DEFERRED VOLUNTARY BLOOD DONORS IN EASTERN CROATIA

Vladimir Cipek ^1,^2,^*, Marina Ferenac Kiš ^2,^3,^*,^✉, Dalibor Ratić ², Silvija Piškorjanac ^2,⁴, Marko Samardžija ⁵, Kristina Kralik ³, Marina Samardžija ^2,³

PMCID: PMC10829957 PMID: 38304378

SUMMARY

When choosing a voluntary blood donor (VBD), it is important to ensure the donor health, and at the same time to produce a quality and safe blood product. The donor selection process leads to donor rejection related to their current health condition. The aim of this study was to determine gender differences in VBDs, to examine the reasons for their rejection, and to determine the share of permanently and temporarily deferred VBD, especially due to low hemoglobin levels. The research was conducted in eastern Croatia in the 2014 to 2018 period. The study included 144,041 blood donations from a total of 80,418 VBDs, of which 83.3% of donations were from male VBDs and 16.7% from female VBDs. There were 11.46% of temporarily deferred and permanently rejected donors. Out of all temporarily deferred donors and possible reasons for deferral, the largest share of deferrals referred to a reduced hemoglobin level, which accounted for 54% in female VBD and 46% in male VBD. Female VBDs made up to one-third of total VBDs and account for one-sixth of total blood donations. Low hemoglobin was the most common reason for VBD deferral. Gender and age are related to blood hemoglobin levels in rejected and accepted donors. Female VBDs represent a potential reservoir for increasing the total number of VBDs.

Key words: Blood donor, Gender differences, Deferral, Hemoglobin

Introduction

A voluntary blood donor (VBD) is a person who donates blood, plasma or cellular components of blood according to the principles of voluntariness, solidarity, anonymity and free of charge (1). Blood is a national treasure of every country, and a VBD is an indirect, active participant in the treatment of patients, or an active link between the healthy part of society and patients. A precondition for donating blood is good health of the person donating blood, but there are situations where donor’s health is impaired, and donor must be temporarily or permanently deferred. According to the Recommendations of the Council of Europe (European Committee, European Directorate for the Quality of Medicines (EDQM), Guide to the Preparation Use and Quality Assurance of Blood Components, 18^th Edition) and Good Manufacturing Practices (Good Manufacturing Practices for Blood Establishment, GMP), basic criteria need to be met so that a person can become a VBD (1).

The selection of VBD is important primarily to protect the health of donors, and consequently to ensure the quality and safety of blood products for transfusion treatment (2-4). The hemovigilance system in transfusion medicine is constantly considering the criteria for selecting VBDs. According to the EDQM guidelines and European Union (EU) Blood Directives that have been transposed into Croatian legislation, the basic criteria in selecting VBD are general condition, body weight (≥55 kg), age, body temperature (<37 °C), pulse (50-100 min), pressure (systolic 100-180 mm Hg, diastolic 60-110 mm Hg) and hemoglobin value (men 135 g/L, women 125 g/L). Men can donate blood every 3 months, and women every 4 months or platelets every month. According to the criteria for selecting VBDs, donors may be temporarily or permanently deferred. Depending on their health condition, temporarily deferred donors are deferred for a certain period depending on the reason of deferral. Permanently deferred donors are those who are prevented from further blood donation to preserve the health of voluntary donors and the health of recipients. Due to the reduced hemoglobin concentration, a significant number of VBDs are temporarily deferred, which may have an impact on self-sufficiency and blood supply (5, 6).

The aim of the study was to determine demographic characteristics and reasons for deferral of VBDs in eastern Croatia in the 2014-2018 period, with emphasis on temporary deferrals due to low hemoglobin levels. Our goal was to review hemoglobin concentrations among temporary deferred blood donors and determine their distribution in the predefined age groups. The purpose was to identify which age groups of donors were affected most by the low levels of hemoglobin and, therefore, should be monitored and further tested to determine their iron levels or potential anemia. It is known that hemoglobin concentration is related to iron levels and regular blood donors may develop anemia after blood donation despite the acceptable hemoglobin concentration during donor selection (7-11). In order to safeguard donor’s health, it is important to analyze such data and systematically monitor donors at the national level (12, 13).

Subjects and Methods

The study population included all VBDs, those who donated whole blood units, and those who did not donate blood due to temporary or permanent deferral in the 2014-2018 period. Department of Transfusion Medicine in Osijek collected blood in the eastern Croatia region that consists of 4 counties: Osijek-Baranja County, Vukovar-Srijem County, Virovitica-Podravina County and Brod-Posavina County. Data were collected prospectively and obtained from the national e-Delphyn IT transfusion program. Data on the number of donors, whole blood donations, and reasons for temporary and permanent deferral of VBDs were extracted from the database. The research was designed as a retrospective study.

During the study period, a validated quantitative method for determination of hemoglobin concentration from capillary blood on a Hemo Control analyzer (EKF, Barleben, Germany) was used, as described in the literature (14). The devices are calibrated and regularly preventively maintained according to the manufacturer’s recommendations.

Ethics

All the procedures in the study were in accordance with ethical standards of the institutional or regional board on human experimentation and Helsinki Declaration from 1975, as revised in 1983. Ethical approval for this study was obtained from Ethics Committee of Osijek University Hospital Center, Osijek, Croatia (R1-1954-412020).

Statistical methods

Statistical analysis was done with SPSS software package for Windows (version 9.0, Carry, New York, USA). The following tests were used: t-test, Pearson’s χ²-test, simple analysis of variance (ANOVA, Bonferroni post-hoc test), Fisher exact test, and Spearman’s correlation coefficient.

Results

During the 2014-2018 study period, a total of 80,418 donors, 60,423 (66.91%) males and 19,995 (33.09%) females, donated 144,041 blood donations. Annual data showed a higher participation of females in 2017 and 2018, and of males in 2014, 2015 and 2016. These differences were statistically nonsignificant (χ²-test, p<0.001). The highest number of males were in the 26-55 age group, while the highest number of females were in the ≤25 age group (χ²-test, p<0.001) (Table 1). Males donated 119,920 (83.3%) donations and females 24,121 (16.7%) donations. Although females constituted one-third of the overall donor pool, they accounted for only one-sixth of all blood donations (Table 2).