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© 2013 Winton Gibbons
As Health Care Systems Worldwide Evolve, So Do
Sourcing, Testing and Distribution of Blood for Donation
Family
Limited
volunteers
Volunteer,
required,
and paid
Volunteer
Patient history
and ABO
matching
Serology
Homebrew
nucleic acid
testing
Centralized
nucleic acid
testing
At use
Local clinic
| hospital
Mixed site
and
distribution
Broad
distribution
Donor registers
Health history and mini physical
1 pint of blood and several small test
tubes collected
Bag, test tubes and the donor record
labeled with identical bar code
Donation stored in iced coolers until
transported to a center
Donated blood scanned into database,
and test tubes sent for testing in
parallel
Most blood centrifuged into
transfusable components – red cells,
platelets, and plasma
Primary components like plasma, can
be further manufactured into
components such as cryoprecipitate
Red cells leuko-reduced
Single donor platelets leuko-reduced
and bacterially tested
Test tubes received (one of five Red Cross
National Testing Laboratories)
Dozen tests performed on each unit of
blood – establishes blood type, and tests
for infectious diseases
Test results transferred electronically to
manufacturing facility within 24 hours
If test result positive, unit discarded and
donor notified. Results confidential and
shared with donor, except as required by
law
Blood is available to be shipped
to hospitals 24 hours a day, 7
days a week
When test results received, units
suitable for transfusion labeled
and stored
Red Cells stored in at 6º C up to
40 days
Platelets stored room temperature
in agitators up to 3-5 days
Plasma and cryo frozen and
stored in freezers up to 1 year
Even Developed Process has Some Potential Left
$100
$1,000
$10,000
$100,000
$10$100$1,000$10,000
GDP/capita
Healthcare spending / capita
$100
$1,000
$10,000
$100,000
$10$100$1,000$10,000
GDP/Capita
HC Spending/Capita
China-High
China-Medium
India-Medium
India-Low
0.0%
0.1%
1.0%
10.0%
100.0%
$10$100$1,000$10,000
HIVPrevalence
Healthcare Spending / Capita
High-High
How-Mid
High-Low
Medium-High
Medium-Mid
Medum-Low
Low-High
Low-Mid
Low-Low
High
Medium
Low
0%
20%
40%
60%
High Mid Low
PercentofPopulation
High Mid Low
High 1% 0% 19%
Medium 0% 10% 59%
Low 1% 3% 8%
$451
$348
$90
$399
$280
$2,122
$604
Developed-
equivalent low
HC $ / capita
Developed-
equivalent mid
HC $ / capita
Non-tracked
NAT not
adopted
Tracked NAT
not adopted
Other
Roche
Novartis |
HOLX
57,000,000 9,676,437
55,000,000 143,500,659
40,822,904
High
Medium
Low
Donations tested Donations not tested Potential donations
Donation	
  Systems	
  in	
  Developing	
  Countries	
  Show	
  Clinical	
  Need	
  	
  
•  50% of donations in high-income countries with only 15% of the world's
population. This implies a total equivalent, potential market of 310 million
donations at a similar donation rate for all countries.
•  39 countries (of 159 reporting) unable to screen all blood donations for one or
more of these transfusion-transmissible infections: HIV, hepatitis B, hepatitis C
and syphilis.
•  Only 13% of low-income countries have a national hemovigilance system to
monitor and improve safe blood transfusion.
Source: WHO, American Red Cross, AABB, CIA Factbook, various companies public presentations
Donation	
  in	
  US	
  Could	
  still	
  be	
  Increased	
  
•  Donations
–  10.8 million volunteers donate blood each year
–  17 million units of whole blood and red blood cells
–  29 percent of which are first-time donors
•  Who donates blood?
–  Only 38 % of the US population eligible
–  Less than 10 percent do so annually.
–  Patients scheduled for surgery may be eligible to donate blood for
themselves(autologous blood donation)
International	
  Blood	
  Donations	
  Provide	
  Testing	
  Opportunities	
  
•  92 million blood donations every year
•  50% collected in high-income countries with only 15% of the world's population, leading to
a developed-country total equivalent market of 310 million donations.
•  Approximately 8,000 blood centers in 159 countries report on blood donations.
•  Average, annual blood donations per blood center in high-income countries is 30,000
versus 3,700 low-income countries
•  Only 62 countries have national blood supplies entirely from voluntary, unpaid blood
donations.
Neglected	
  Tropical	
  Diseases	
  (NTDs)	
  
•  Babesiosis
•  Buruli ulcer
•  Chagas disease
•  Cysticercosis
•  Dengue fever
•  Dracunculiasis (Guinea Worm
Disease)*
•  Echinococcosis
•  Fascioliasis
•  Human African Trypanosomiasis
(African Sleeping Sickness)
•  Leishmaniasis
•  Leprosy (Hansen's disease)
•  Lymphatic filariasis*
•  Malaria
•  Onchocerciasis*
•  Rabies
•  Schistosomiasis*
•  Soil-transmitted Helminths (STH)
(Ascaris, hookworm, and
whipworm)*
•  Trachoma*
•  Yaws
Targeting	
  Should	
  Occur	
  in	
  Highest	
  Population	
  at	
  the	
  Right	
  Stage	
  of	
  Economic	
  
Development	
  
Example: Target Countries with Medium HC Spending / Capita
and >1% HIV
Obviously other
issues, such as
political and
regulatory
considerations
are also
important
Example: Country Prioritization by HIV Prevalence
China	
  and	
  India	
  Should	
  be	
  Considered	
  by	
  Region,	
  Not	
  in	
  Total	
  
Rough Donations and Testing by Healthcare Spending / Capita
Nucleic	
  Acid	
  Testing	
  Potential	
  Substantial	
  at	
  
Current	
  Equivalent	
  Price	
  of	
  $14	
  per	
  Donor	
  

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  • 1. © 2013 Winton Gibbons As Health Care Systems Worldwide Evolve, So Do Sourcing, Testing and Distribution of Blood for Donation Family Limited volunteers Volunteer, required, and paid Volunteer Patient history and ABO matching Serology Homebrew nucleic acid testing Centralized nucleic acid testing At use Local clinic | hospital Mixed site and distribution Broad distribution Donor registers Health history and mini physical 1 pint of blood and several small test tubes collected Bag, test tubes and the donor record labeled with identical bar code Donation stored in iced coolers until transported to a center Donated blood scanned into database, and test tubes sent for testing in parallel Most blood centrifuged into transfusable components – red cells, platelets, and plasma Primary components like plasma, can be further manufactured into components such as cryoprecipitate Red cells leuko-reduced Single donor platelets leuko-reduced and bacterially tested Test tubes received (one of five Red Cross National Testing Laboratories) Dozen tests performed on each unit of blood – establishes blood type, and tests for infectious diseases Test results transferred electronically to manufacturing facility within 24 hours If test result positive, unit discarded and donor notified. Results confidential and shared with donor, except as required by law Blood is available to be shipped to hospitals 24 hours a day, 7 days a week When test results received, units suitable for transfusion labeled and stored Red Cells stored in at 6º C up to 40 days Platelets stored room temperature in agitators up to 3-5 days Plasma and cryo frozen and stored in freezers up to 1 year Even Developed Process has Some Potential Left $100 $1,000 $10,000 $100,000 $10$100$1,000$10,000 GDP/capita Healthcare spending / capita $100 $1,000 $10,000 $100,000 $10$100$1,000$10,000 GDP/Capita HC Spending/Capita China-High China-Medium India-Medium India-Low 0.0% 0.1% 1.0% 10.0% 100.0% $10$100$1,000$10,000 HIVPrevalence Healthcare Spending / Capita High-High How-Mid High-Low Medium-High Medium-Mid Medum-Low Low-High Low-Mid Low-Low High Medium Low 0% 20% 40% 60% High Mid Low PercentofPopulation High Mid Low High 1% 0% 19% Medium 0% 10% 59% Low 1% 3% 8% $451 $348 $90 $399 $280 $2,122 $604 Developed- equivalent low HC $ / capita Developed- equivalent mid HC $ / capita Non-tracked NAT not adopted Tracked NAT not adopted Other Roche Novartis | HOLX 57,000,000 9,676,437 55,000,000 143,500,659 40,822,904 High Medium Low Donations tested Donations not tested Potential donations Donation  Systems  in  Developing  Countries  Show  Clinical  Need     •  50% of donations in high-income countries with only 15% of the world's population. This implies a total equivalent, potential market of 310 million donations at a similar donation rate for all countries. •  39 countries (of 159 reporting) unable to screen all blood donations for one or more of these transfusion-transmissible infections: HIV, hepatitis B, hepatitis C and syphilis. •  Only 13% of low-income countries have a national hemovigilance system to monitor and improve safe blood transfusion. Source: WHO, American Red Cross, AABB, CIA Factbook, various companies public presentations Donation  in  US  Could  still  be  Increased   •  Donations –  10.8 million volunteers donate blood each year –  17 million units of whole blood and red blood cells –  29 percent of which are first-time donors •  Who donates blood? –  Only 38 % of the US population eligible –  Less than 10 percent do so annually. –  Patients scheduled for surgery may be eligible to donate blood for themselves(autologous blood donation) International  Blood  Donations  Provide  Testing  Opportunities   •  92 million blood donations every year •  50% collected in high-income countries with only 15% of the world's population, leading to a developed-country total equivalent market of 310 million donations. •  Approximately 8,000 blood centers in 159 countries report on blood donations. •  Average, annual blood donations per blood center in high-income countries is 30,000 versus 3,700 low-income countries •  Only 62 countries have national blood supplies entirely from voluntary, unpaid blood donations. Neglected  Tropical  Diseases  (NTDs)   •  Babesiosis •  Buruli ulcer •  Chagas disease •  Cysticercosis •  Dengue fever •  Dracunculiasis (Guinea Worm Disease)* •  Echinococcosis •  Fascioliasis •  Human African Trypanosomiasis (African Sleeping Sickness) •  Leishmaniasis •  Leprosy (Hansen's disease) •  Lymphatic filariasis* •  Malaria •  Onchocerciasis* •  Rabies •  Schistosomiasis* •  Soil-transmitted Helminths (STH) (Ascaris, hookworm, and whipworm)* •  Trachoma* •  Yaws Targeting  Should  Occur  in  Highest  Population  at  the  Right  Stage  of  Economic   Development   Example: Target Countries with Medium HC Spending / Capita and >1% HIV Obviously other issues, such as political and regulatory considerations are also important Example: Country Prioritization by HIV Prevalence China  and  India  Should  be  Considered  by  Region,  Not  in  Total   Rough Donations and Testing by Healthcare Spending / Capita Nucleic  Acid  Testing  Potential  Substantial  at   Current  Equivalent  Price  of  $14  per  Donor