Analysis of Variation in Blood Donor Deferral Section Statistics as per Drugs and Cosmetics (Second Amendment) Rules, 2020: An Institutional Experience

Abstract

Introduction: The safety of donated blood is of utmost importance for the well-being of the recipient, which requires proper adherence to donor acceptance criteria. In March 2020, new amendments were introduced in the Drugs and Cosmetics Act, which included several new criteria. It is important to explore these changes and their impact on the donor pool to ensure adequate maintenance of whole blood/component inventory in our blood centre. Aim: To study the variation in deferral statistics of blood donors after the introduction of new donor criteria as per the Drugs and Cosmetics (Second Amendment) Rules, 2020. Materials and Methods: The present study was conducted from October 1, 2022, to June 30, 2023, in the Department of Immunohaematology and Blood Transfusion (Blood Centre) of a tertiary care hospital in Punjab, India. Retrospective data for three years was collected from blood donor records and deferral records, divided into two groups: group 1 (October 1, 2018, to March 31, 2020) for the old criteria, and group 2 (April 1, 2020, to September 30, 2021) for the new criteria. Reasons for deferral of donors were categorised into four stages: clinical history, medical examination, investigations (hemoglobin levels), and inadequate collection for both male and female donors. The collected data was entered into a Microsoft Excel sheet. Variables in different categories were represented as frequencies and percentages. Chi-square test was used for comparison between the data of the two groups. Results: In group I, 332 out of 6,588 donors (5.04%) were deferred, and in group II, 345 out of 6,143 donors (5.61%) were deferred. The deferral rate was comparatively higher in females in both groups, with 17.98% (41/228) in group I and 21.65% (21/97) in group II. The percentage of deferred donors was higher in the age group of 18-30 years in both groups, with 50.60% (168/332) in group I and 47.25% (163/345) in group II. The maximum number of donors were deferred at stage I (clinical history), with 270/332 (81.33%) in group I and 296/345 (85.8%) in group II, followed by stage III (investigations), with 34/332 (10.24%) in group I and 33/345 (9.56%) in group II. COVID-19 related history was the third most common cause of deferral in group II, accounting for 43 (12.46%) of the total deferred cases, which was not present in group I. Conclusion: The new guidelines, although comprehensive, only minimally increased the deferral rate and did not have a significant impact on the donor pool of our blood centre. Knowledge about the latest deferral guidelines and donor deferral rates is of utmost significance for the maintenance of inventory and to reduce the loss of a significant donor pool.