Ensuring safety and suitability of donors and quality and traceability of plasma

A donation centre’s Quality Assurance (QA) team ensures a standardised plasma collection environment for staff, donors and patients.

Our daily work includes observing and instructing staff, reviewing records and documentation, and supporting internal audits that check systems in place at each centre. QA ensures a standardised plasma collection environment for staff, donors and patients.

Our donor management system (DMS) supports centre systems in place for quality, safety and traceability, and when standard operating procedures change, DMS also updates with current processes.

When we register a potential donor in DMS, we record their full name, address, social security number, allergies, distinguishing characteristics, medical history and more. Each potential donor is given an in-depth health screening and medical questionnaire to assure suitability. If any of a donor’s responses indicate a concern, a medical professional questions the donor further, which may result in deferring the donor if his or her answers do not meet strict donor eligibility requirements. To become qualified, a donor must donate two times and have acceptable test results for each donation. All donors undergo a screening before each donation to ensure they meet safety requirements defined by the Food and Drug Administration (FDA) and other regulatory agencies.

For me, getting to know donors on a first-name basis is important in order to give great customer service and ensure donor wellbeing.

In QA, we stress the importance of accurately entering data and recording results in DMS. For example, it is important to enter a donor’s temperature, blood pressure and weight correctly during the donor registration. This is for donor safety. If a donor is not within acceptable limits, a temporary deferral will be applied for a minimum of 24 hours. Accuracy in data entry is vital for donor safety, and ensures deferrals are applied appropriately.

People in the USA can donate twice within a seven-day period, with at least 48 hours in between donations. The Plasma Protein Therapeutics Association created a nationwide cross donation check system (CDCS) to protect donors’ health by minimising the risk of cross donations. Each time a donor attempts to donate at an Octapharma Plasma location, the system confirms they have not donated at another centre within the last seven days.

After a donor completes his or her donation, plasma samples are collected and frozen in an on-site freezer. Our technicians collect a minimum of three samples, including viral marker testing samples. Every day, samples are collected and sent to a laboratory for viral marker testing. Sample testing time can range from five to 14 days. Once test results confirm donor health and plasma safety, we ship the plasma donation to our production sites. If plasma is not deemed suitable for manufacture, it is pulled and destroyed as medical waste.

Donors who receive an unsuitable test result, e.g. a positive viral marker, are entered into the National Donor Deferral Registry, which is a database of permanently deferred US plasma donors. The donor’s name and social security number are flagged, preventing donation at any US plasma centre.

I have a bachelor’s degree in social work and studied psychology, which gives me a good understanding of all different types of staff and donors. My background helps me relate to others, because I appreciate that everyone is different. For me, getting to know donors on a first-name basis is important in order to give great customer service and ensure donor wellbeing while they are in our centre. There are still some stigmas attached to the plasma industry, but we’re educating our community to show that plasma donors are regular people – they are moms and dads, workers and students. Donors have multiple reasons for donating – everything from supplementing their income to helping save lives. Without our loyal donors, we cannot complete our job, which is to provide safe, quality plasma for life-saving medications used by patients.

I moved to Texas to help open the Houston centre in 2016. Opening a new centre is a very demanding process that requires dedication and commitment to your job. Once you see it all come together, it is very rewarding. I am now starting a new role as Centre Director in our donation centre in Garland, Texas and am looking forward to continuing my good work with Octapharma Plasma.