HISTORY of BLOOD

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HISTORY of BLOOD

• Why We Do What We Do
• Blood Bank Quality Assurance Workshop, 28-30 July
  2009
• Presented by Maj George A. Hestilow
• 
  Deputy Chief QA, AFBP

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Charles F. Kettering

• The future can be anything we want it to be,
  providing we have the faith and that we realize
  that peace, no less than war, required "blood and
  sweat and tears".

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Introduction

• Blood A Historical Timeline
• Evolution of Blood Banking
• Regulatory Mandates
• US Military Blood Program
• Video Clip Red Gold Series by PBS
• Production of Thirteen/WNET NY by Optomen
  Television

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In the Beginning (2500 BCE-999 CE)

• Egyptians (2500 BCE) Bloodletting
• Video
• Hippocrates (460-377 BCE)
• Four Bodily Humors
• phlegm, blood, black bile, yellow bile
• Claudius Galenus (130-200 CE)
• Venouos and Arterial Systems
• Video

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Blood Timeline (1000 1699)

• Egyptian physician Ibn al-Nafis (mid-1200s)
• Describes pulmonary circulation
• Spanish theologist Michael Servetus (1553)
• Blood flows to both sides of heart via lungs
• English physician William Harvey (1628)
• On the Motion of the Heart and Blood in Animals
  description of circulatory system

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Blood Timeline (1000 1699) Cont

• Dutch microscopist Jan Swammerdam (1658)
• First to observe and describe red blood cells
• French physician Jean-Baptiste Denis (1667)
• Transfuses sheep blood into Antoine Mauroy
• Dutch Anton van Leeuwenhoek (1674)
• Provides precise description and size of RBC

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Blood Timeline (1700 1919)

• Bloodletting in American History (1799)
• Video
• British obstetrician James Blundell (1818)
• First recorded human-to-human bld trxnf
• Austrian physician Karl Landsteiner (1901)
• Discovers bld grp A, B, C (later changed grp C to
  grp O)
• video

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Blood Timeline (1700 1919) Cont

• American Dr. Reuben Ottenberg (1907)
• First transfusion using cross-matched blood
• Researchers Albert Hustin-Brussels and Luis
  Agote-Buenos Aires (1914)
• Discover adding sodium citrate prevents clots
• US Army, Dr. Oswald Robertson (1917)
• Stores blood for arrival of casualties first
  depot

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Blood Timeline (1920-1949)

• British physician Percy Lane Oliver (1922)
• First to develop screened donor pool
• Video
• Russian physician Serge Yudin (1930)
• Soviets first to establish network to collect and
  store blood for transfusion in hospitals
• Video

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Blood Timeline (1920-1949) Cont

• Dr. Bernard Fantus coins term Blood Bank
• Opened first BB/BDC in Chicago, IL (1937)
• Rh Bld Grp discovered (1939-1940)
• Collaboration with Army/Navy/ARC (1941)
• Video
• American Association of Blood Banks (1947)

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Blood Timeline (1950-Current)

• Establishment of ASBPO (1962)
• DOD Directive 6480.5
• Regulation of blood under FDA (1971(2))
• Hep B antibody test mandated
• AIDS epidemic (1981-1985)
• Infectious Disease Testing (1987-Current)

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Blood Bank Regulatory History

• HERE WE GO!!!!
• NOTE Tap you neighbor and wake him/her up.
  This is the stuff where all here for.
• ?

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Regulatory History

• 1630, Nicholas Knopp fined for selling
  ineffective cure for scurvy
• Early 1700s, law passed regarding bread
• 1848, First federal drug law enacted
• 1901, Ten children die from contaminated
  diphtheria antitoxin

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Regulatory History Cont

• 1902, Virus, Serum, and Antitoxin Act was passed
• Required biological products and manufacturing
  facilities to be licensed
• Must conform to purity, potency and safety
  standards established by the Public Health System
• Upton Sinclairs book The Jungle is released

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Regulatory History Cont

• 1906, Pure Food and Drug Act passed
• Prohibited the sale of misbranded food/drugs
• 1937, Elixar Sulfanilamide in ethelylen glycol
  caused several deaths
• 1938, Federal Food, Drugs, and Cosmetic Act is
  passed

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Regulatory History Cont

• 1963, FDA issues first GMP requirements
• 1970, blood is classified as a biologic
• 1972, FDA Bureau of Biologics begins regulating
  blood resources
• 1974, cGMPs are extended to blood establishments
  1975, 21 CFR 606

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Regulatory History Cont

• 1977, Formal FDA compliance program
• 1989, FDA issues light weight computer
  requirements (promise of more to come)
• 1993, FDA Draft Guidance for QA in blood bank
  establishments
• FDAs hint that 21 CFR 200 series would be
  enforced guidance become final rule in 1995

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Regulatory History Cont

• Testing History
• 1947, FDA mandates syphilis testing RPR
• 1972, Hepatitis test licensed and mandated
• 1985, HIV test kit licensed and mandated
• 1987, Surrogate tests for AIDs (anti-Hbc, ALT)
• 1989, HTLV test is licensed/mandated by FDA
• 1990, HCV test (1.0)/1992 (2.0) lic/mandated
• 1996, HIV-1, p24 antigen test mandated
• 1999, NAT (HIV HCV) developed/indorsed
• 2002, NAT (HIV HCV) licensed/mandated
• 2005, NAT (WNV) licensed/mandated

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Historical Translation

• FDAs job safe guard the public welfare
• FDA is not your enemy!
• FDA has regulatory and enforcement oversight for
  all interstate commerce involving blood
• GMPs are legal requirements to produce safe,
  pure, potent products found in Chap. 1 of CFR 21.

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US Military Blood

• WWII
• Shipments from CONUS to theater of war
• Blood for Britain (Plasma Program)
• Whole Blood Program (O Neg only)
• 825,000 units collected in support of war
• 1945, return to peacetime posture
• Blood programs phased out
• War support by civilians evolved into the blood
  centers of today (i.e., America Red Cross)

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US Military Blood

• Korean War
• Development of Blood Plan
• Military to sustain it needs
• Civilian blood centers called upon
• Shipments routed from Travis AFB to Japan
• Invent of plastic blood bags
• 50,000 transfusions administered
• Recorded only 4 major hemolytic reactions
  resulting in acute renal failure/death
• Founding of Tri-Service SBB Fellowship (1958)

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US Military Blood

• Vietnam
• 1962, Armed Services Blood Program commissioned
• First deployment of blood plan/distro system
• 100 of blood was from military BDCs
• Blood collected in Japan and Korea prior 1966
• From CONUS (ASWBPL-E) to Vietnam
• By 1966, grp A and O blood used, all blood was
  typed and crossmatched
• 1,800,000 units collected in support of war

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US Military Blood

• Post Vietnam
• Desert Storm
• Proposition of blood used as psychological
  opsover
• ABO, blood available at all level III facilities
• 100,000 units shipped, very little used
• BDC mission continued as Readiness focused
• Frozen Blood research explored units
  prepositioned

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US Military Blood

• OEF/OIF
• Change in transfusion practices
• RBCFFP (11)
• Introduction of Plt apheresis cryoprecipitate
• Fresh Whole Blood usage
• Media challenge
• Bld less than 14 days old
• Bld Report (MOAS)
• MS Excel spreadsheets
• Total transfusions to date

25
Charles F. Kettering

• The future can be anything we want it to be,
  providing we have the faith and that we realize
  that peace, no less than war, required "blood and
  sweat and tears".

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REFERENCES

• Red Gold, the epic story of blood., PBS
  documentary website www.pbs.org/wnet/redgold/
• The History of Blood Transfusion Medicine.,
  Blood Banking. website www.BloodBook.com
• Armed Services Blood Program History tab,
  website www.militaryblood.dod.mil/
• Good Manufacturing Practices Brief,
• Ms Kathy Elder, Army Bld Prgm QA Mngr

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THANK YOU FOR YOUR SERVICE

• Questions?