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Perspectives on Paid Blood Donation

Ethical and safety concerns have historically led to a societal reliance on volunteer blood donations. However, the fragility of the blood supply due to demographic change impacting both supply and demand calls for a rethink of the widely held dogma that all blood collection must be non-remunerated. Here we discuss attributes which validate the collection of blood from responsibly compensated donors while at the same time achieving the very high safety standards established by the source plasma industry.   

First, advances in testing have enabled a marked reduction in risk, setting the stage for a consideration of compensated donation. For context, in the 1940s, syphilis was the first blood-borne sexually transmitted pathogen tested as a requirement for marriage licensure. Today, the American Association of Blood Banks (AABB) standards require that collected blood be tested for a wide variety of known pathogenic viruses. To expand further on the topic of infectious disease testing, the “window period” is defined as the time between potential exposure to infection and the point when a diagnostic test provides an accurate result. The window period for HIV based on a serological (antibody based) test ranges from 17-22 days. Nucleic acid testing (NAT), which was FDA cleared in 2002, slashed the window period to 5-6 days using individual samples, with reductions also seen for hepatitis C (2-3 days) and hepatitis B (2-3 weeks) viruses. While blood is very safe based purely on NAT testing (the residual risk today for transfusion related transmission of HCV or HIV, for example, is 1:1,200,000 and 1:1,500,000, respectively), there remains a small window period risk that can be further addressed.

Heightened donor intake procedures provide the first means of reducing window period concerns. For example, source plasma donors become “qualified” by completing two separate collections, with collected plasma only being released for use if both infectious disease screening tests are negative. This practice is not used for non-profit volunteer blood donors where units are collected and released for transfusion on first-time collections. A comparison across infectious disease marker rates from 2013 shows that the volunteer positivity rate was considerably higher than that for paid plasma donors for HIV, HCV and HBV (Table 1). The rates improved for volunteer donors in 2015, bringing them more in line with marker rates for compensated source plasma donors. These data suggest that paid donors, when “qualified” as per the source plasma industry protocols, do not carry a meaningfully higher incidence of transfusion-transmittable diseases as compared to volunteer, non-remunerated donors.

While enhanced donor intake protocols represent a meaningful advance, the penultimate means of safely harnessing responsibly compensated donors is via the 100% use of pathogen reduction, a safety enhancement pioneered by the source plasma industry. Pathogen reduction works by inactivating the ability of viruses and bacteria to multiply, thus increasing safety. The Cerus INTERCEPT system is currently the only FDA cleared means of performing pathogen reduction on transfusable blood components. In addition to enhanced donor intake procedures, the 100% use of pathogen reduction techniques functionally eliminates concerns surrounding window period risk, providing an industry leading standard of safety.

Finally, a real-world example highlights the extent to which blood can be collected safely from compensated donors even without the benefits of pathogen reduction or nucleic acid testing. From 1981 – 2002, the Mayo Clinic utilized a paid donor program for the collection of platelets. Donors were paid $50 per donation and were required to have completed seven non-paid whole blood donations prior to acceptance into the paid platelet program. Mayo operated this program for two decades without any safety or quality adverse events. All paid platelet products were subject to the same infectious disease testing as volunteer donor platelets.  In comparing the anti-HIV incidence in paid versus volunteer donors, there was no meaningful difference in reactive rates between the two groups (Table2). Further, data showed that the incidence of hepatitis B positivity was significantly greater in the volunteer population than that of the paid donor population (Table 3), perhaps indicating that blood components collected from repeat, reliable paid donors could be safer than collections from infrequent or first time volunteer donors.

Secure Transfusion Services (STS) is a specialized blood collection organization focused on supplying hospitals with hard to source transfusable components using the source plasma industry model of responsibly recruiting donors compensated for their time. STS collection facility locations are carefully selected to avoid high-risk areas. The initial screening for STS donors differs from that of the current volunteer model – at STS, first-time donors have no transfusable product collected. Instead, donors at their first visit to an STS facility undergo health, history, and infectious disease screening in accordance with AABB standards. Components are collected from donors on a second appointment, where the collected units are used only if both the initial and subsequent infectious disease screening tests are negative. Further, STS employs 100% use of pathogen reduction allowing its customers to be fully compliant with the FDA’s Bacterial Risk Control Strategies for Blood Collection.

Increasing blood and specifically platelet supply chain disturbances make clear the need for a rethink of dogmas concerning compensated donation. With advances in testing technology, the finely tuned donor selection process for the source plasma industry, and the 100% use of pathogen reduction, STS has the potential to create new standards in safety and component availability.

 

References

Zou S, Dorsey KA, Notari EP, et al. Prevalence, incidence and residual risk of human immunodeficiency virus and hepatitis C virus infections among the United States blood donors since the introduction of nucleic acid testing. Transfusion 2010; 50:1495-504.

Stramer SL, Glynn SA, Kleinman SH, et al. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. N Engl J Med 2004 ; 351:760-8.

Kumar R, Gupta S, Kaur A, Gupta M. Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety. Asian J Transfus Sci 2015. Jul-Dec 9(2) : 199-202.

31st edition Standards for Blood Banks and Transfusion Services

Ellingson KD, Sapiano MR, Haass KA, et al. Continued decline in blood collection and transfusion in the United States–2015. Transfusion 2017;57 (Suppl 2):1588-1598

Mayo Clinic data presented at 2019 San Antonio AABB conference: https://education.aabb.org/aabb/sessions/2622/view 

https://onlinelibrary.wiley.com/doi/full/10.1111/trf.14286

https://www.pptaglobal.org/images/presentations/2017/Source_Plasma_Safety_-_May_2017.pdf

Perspectives on Paid Blood Donation

Ethical and safety concerns have historically led to a societal reliance on volunteer blood donations. However, the fragility of the blood supply due to demographic change impacting both supply and demand calls for a rethink of the widely held dogma that all blood collection must be non-remunerated. Here we discuss attributes which validate the collection of blood from responsibly compensated donors while at the same time achieving the very high safety standards established by the source plasma industry.   

First, advances in testing have enabled a marked reduction in risk, setting the stage for a consideration of compensated donation. For context, in the 1940s, syphilis was the first blood-borne sexually transmitted pathogen tested as a requirement for marriage licensure. Today, the American Association of Blood Banks (AABB) standards require that collected blood be tested for a wide variety of known pathogenic viruses. To expand further on the topic of infectious disease testing, the “window period” is defined as the time between potential exposure to infection and the point when a diagnostic test provides an accurate result. The window period for HIV based on a serological (antibody based) test ranges from 17-22 days. Nucleic acid testing (NAT), which was FDA cleared in 2002, slashed the window period to 5-6 days using individual samples, with reductions also seen for hepatitis C (2-3 days) and hepatitis B (2-3 weeks) viruses. While blood is very safe based purely on NAT testing (the residual risk today for transfusion related transmission of HCV or HIV, for example, is 1:1,200,000 and 1:1,500,000, respectively), there remains a small window period risk that can be further addressed.

Heightened donor intake procedures provide the first means of reducing window period concerns. For example, source plasma donors become “qualified” by completing two separate collections, with collected plasma only being released for use if both infectious disease screening tests are negative. This practice is not used for non-profit volunteer blood donors where units are collected and released for transfusion on first-time collections. A comparison across infectious disease marker rates from 2013 shows that the volunteer positivity rate was considerably higher than that for paid plasma donors for HIV, HCV and HBV (Table 1). The rates improved for volunteer donors in 2015, bringing them more in line with marker rates for compensated source plasma donors. These data suggest that paid donors, when “qualified” as per the source plasma industry protocols, do not carry a meaningfully higher incidence of transfusion-transmittable diseases as compared to volunteer, non-remunerated donors.

While enhanced donor intake protocols represent a meaningful advance, the penultimate means of safely harnessing responsibly compensated donors is via the 100% use of pathogen reduction, a safety enhancement pioneered by the source plasma industry. Pathogen reduction works by inactivating the ability of viruses and bacteria to multiply, thus increasing safety. The Cerus INTERCEPT system is currently the only FDA cleared means of performing pathogen reduction on transfusable blood components. In addition to enhanced donor intake procedures, the 100% use of pathogen reduction techniques functionally eliminates concerns surrounding window period risk, providing an industry leading standard of safety.

Finally, a real-world example highlights the extent to which blood can be collected safely from compensated donors even without the benefits of pathogen reduction or nucleic acid testing. From 1981 – 2002, the Mayo Clinic utilized a paid donor program for the collection of platelets. Donors were paid $50 per donation and were required to have completed seven non-paid whole blood donations prior to acceptance into the paid platelet program. Mayo operated this program for two decades without any safety or quality adverse events. All paid platelet products were subject to the same infectious disease testing as volunteer donor platelets.  In comparing the anti-HIV incidence in paid versus volunteer donors, there was no meaningful difference in reactive rates between the two groups (Table2). Further, data showed that the incidence of hepatitis B positivity was significantly greater in the volunteer population than that of the paid donor population (Table 3), perhaps indicating that blood components collected from repeat, reliable paid donors could be safer than collections from infrequent or first time volunteer donors.

Secure Transfusion Services (STS) is a specialized blood collection organization focused on supplying hospitals with hard to source transfusable components using the source plasma industry model of responsibly recruiting donors compensated for their time. STS collection facility locations are carefully selected to avoid high-risk areas. The initial screening for STS donors differs from that of the current volunteer model – at STS, first-time donors have no transfusable product collected. Instead, donors at their first visit to an STS facility undergo health, history, and infectious disease screening in accordance with AABB standards. Components are collected from donors on a second appointment, where the collected units are used only if both the initial and subsequent infectious disease screening tests are negative. Further, STS employs 100% use of pathogen reduction allowing its customers to be fully compliant with the FDA’s Bacterial Risk Control Strategies for Blood Collection.

Increasing blood and specifically platelet supply chain disturbances make clear the need for a rethink of dogmas concerning compensated donation. With advances in testing technology, the finely tuned donor selection process for the source plasma industry, and the 100% use of pathogen reduction, STS has the potential to create new standards in safety and component availability.

 

References

Zou S, Dorsey KA, Notari EP, et al. Prevalence, incidence and residual risk of human immunodeficiency virus and hepatitis C virus infections among the United States blood donors since the introduction of nucleic acid testing. Transfusion 2010; 50:1495-504.

Stramer SL, Glynn SA, Kleinman SH, et al. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. N Engl J Med 2004 ; 351:760-8.

Kumar R, Gupta S, Kaur A, Gupta M. Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety. Asian J Transfus Sci 2015. Jul-Dec 9(2) : 199-202.

31st edition Standards for Blood Banks and Transfusion Services

Ellingson KD, Sapiano MR, Haass KA, et al. Continued decline in blood collection and transfusion in the United States–2015. Transfusion 2017;57 (Suppl 2):1588-1598

Mayo Clinic data presented at 2019 San Antonio AABB conference: https://education.aabb.org/aabb/sessions/2622/view 

https://onlinelibrary.wiley.com/doi/full/10.1111/trf.14286

https://www.pptaglobal.org/images/presentations/2017/Source_Plasma_Safety_-_May_2017.pdf