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Title: Transfusion Safety in the AIDS Era: Convergence of Medicine, Science and Technology, and Public Perc


1
Transfusion Safety in the AIDS Era Convergence
of Medicine, Science and Technology, and Public
Perception in Creating a New Clinical Discipline
  • Alyssa Ziman, M.D.
  • Associate Director of Transfusion Medicine
  • David Geffen School of Medicine at UCLA

2
Objectives
  • US History of HIV and Transfusion
  • Transfusion Liability and Public Policy
  • Current donor screening practices to minimize
    transfusion transmitted infections
  • Emergence of a new standard for transfusion
    safety

3
Blood Transfusion
  • Every second, someone in the world needs blood.
  • Transfusion only option for survival for many
    patients.

4
Blood Transfusion Worldwide
  • Estimated about 80 million units of whole blood
    are donated annually
  • Only 38 are collected in the developing world
    where 82 of the world's population live.

WP/FS/HQ 10 June 2004
5
Blood Transfusion in the US
  • About 14 million units of whole blood are donated
    in the United States each year
  • More than 23 million units of blood components
    are prepared and transfused each year
  • Whole blood is processed into components (pRBCs,
    platelets, plasma and cryo)
  • Plasma can be further divided into
  • derivatives (albumin, globulins) for infusion
  • 40,000 units of pRBCs are needed daily
  • Approximately 60 of the US populationcan donate
    blood, but only about 5 ofthem do.

6
History of HIV and the Blood Supply
7
Epidemiologic Notes and ReportsPneumocystis
Pneumonia --- Los Angeles.
  • October 1980-May 1981
  • Reports of 5 young men, all active homosexuals,
    were treated for biopsy-confirmed Pneumocystis
    carinii pneumonia at 3 different hospitals in Los
    Angeles, California.

MMWR 198130409-10.
8
Epidemiologic Notes and ReportsPneumocystis
carinii pneumonia among persons with hemophilia
A.
  • July 1982
  • Reports of 3 cases of Pneumocystis carinii
    pneumonia (PCP) among patients with hemophilia A
    and without other underlying disease.
  • All 3 were heterosexual males without a history
    of injection drug use.
  • All had lymphopenia, and 2 had evidence of
    cellular immune deficiency.
  • No 2 patients were known to have received Factor
    VIII concentrate from the same lots.
  • Editorial note The similarity of the clinical
    and immunologic features of these 3 patients and
    the features observed among homosexual males,
    heterosexual IV drug users, and Haitians who had
    recently entered the United States suggested the
    possible transmission of an agent through blood
    products.

MMWR 198231365367
9
Epidemiologic Notes and ReportsPossible
transfusion-associated acquired immune deficiency
syndrome (AIDS)?California.
  • December 1982
  • 20-month-old infant developed unexplained
    cellular immunodeficiency and opportunistic
    infection after multiple transfusions.
  • WB-derived platelets donated by a male later
    found to have the AIDS.
  • Editorial note The etiology of AIDS was unknown,
    but its reported occurrence among homosexual men,
    injection drug users, and persons with hemophilia
    A suggested that it might be caused by an
    infectious agent transmitted sexually or through
    blood or blood products. If the infants illness
    was AIDS, its occurrence following the receipt of
    blood products from a person known to have AIDS
    added support to the infectious-agent hypothesis.
    Because the donor was in apparent good health at
    the time he donated blood, it was possible that
    the agent was present in the blood of a donor
    before the onset of symptomatic illness. This
    report and continuing reports of AIDS among
    persons with hemophilia A raised serious
    questions about the possible transmission of AIDS
    through blood and blood products.

MMWR 198231652654
10
Joint statement on acquired immune deficiency
syndrome (AIDS) related to transfusion.American
Association of Blood Banks, American Red Cross,
and Council of Community Blood Centers.
  • January 13, 1983
  • Recommendations
  • Educational campaigns to physicians to balance
    the decisions to transfusion blood vs the risks
    of transfusion
  • Autologous transfusions should be considered more
    frequently
  • Screening blood donors for symptoms of, and
    possible exposure to, AIDS (history of night
    sweats, unexplained fevers, unexpected weight
    loss, lymphadenopathy or Kaposis sarcoma)
  • Discourage the recruitment of blood donors from
    groups at high-risk of contracting AIDS
  • Concern regarding limiting voluntary blood
    donation by individuals from groups with a high
    prevalence of AIDS (medical, ethical, legal
    implications)
  • Request that potential donors who were thought to
    be at increased risk of developing AIDS to
    self-defer from blood donation.
  • Surrogate marker testing (lymphopenia, immune
    complexes and anti-HBc)

Transfusion 19832387-88.
11
National Hemophilia Foundation
  • January 1983
  • Issued guidelines asking blood and plasma
    collectors to adopt screening procedures to
    discourage donations from gay men and other
    high-risk groups.
  • The commercial sector complies, but blood banks
    continue to accept blood from all donors.
  • Deferrals were premature.
  • Preservation of the human right to privacy.
  • Concerns about self-deferral.
  • Maintenance of the blood supply (loss of up to
    10 of urban blood donors).

12
Current TrendsPrevention of acquired immune
deficiency syndrome (AIDS) report of
inter-agency recommendations.
  • March 4, 1983
  • Stats since June 1981
  • 1,200 cases of AIDS in 34 states, DC 15
    countries
  • 450 persons with AIDS had died
  • Case-fatality rate gt 60 for cases first
    diagnosed gt 1 year previously.
  • Several high-risk groups in US identified
  • Homosexual men with multiple sexual partners
  • Abusers of intravenous drugs
  • Haitians, especially those who entered the
    country within the few years prior to this
    report.
  • Available data suggested that AIDS was caused by
    a transmissible agent.

MMWR 198332101103
13
  • As a temporary measure, members of increased
    risk for AIDS should refrain from donating plasma
    and/or blood,
  • US Public Health Service
  • March 1983

14
Y
15
Stanford University Blood Bankbegins donor
testing for evidence of AIDS infection.
  • May 1983
  • First and only major medical center in the US to
    start testing blood for evidence of AIDS
  • TA risk not 1 in 1 million, but rather 1 in 10K
    or 1 in 5K in areas like San Francisco.
  • Test of helper-suppressor lymphocyte ratio
  • 6 per test, increase the price of blood by 10.
  • Would not purchase blood from suppliers that did
    not test donors

16
UpdateAcquired Immunodeficiency Syndrome (AIDS)
in Persons with Hemophilia
  • Medical and Scientific Advisory Council of the
    National Hemophilia Foundation recommendations
    for the therapy of hemophilia
  • Cryo be used in factor VIII-deficient newborn
    infants, children lt 4 yrs, and newly identified
    patients never treated with F8 concentrates
  • FFP be used in factor IX-deficient patients in
    the same categories
  • DDAVP be used whenever possible in patients with
    mild/moderate hemophilia A.
  • Strongly consider changing to heat-treated
    products (protection against AIDS yet to be
    proven).
  • Elective surgical procedures be evaluated with
    respect to possible advantages and disadvantages
    of surgical delays.

MMWR 1984 33(42)589-91
17
Acquired immunodeficiency syndrome (AIDS)
associated with transfusionsJW Curran, DN
Lawrence, H Jaffe, JE Kaplan, LD Zyla, M
Chamberland, R Weinstein, KJ Lui, LB Schonberger,
TJ Spira, and et al.
  • Abstract
  • Of 2157 patients with the acquired
    immunodeficiency syndrome (AIDS) whose cases were
    reported to the Centers for Disease Control by
    August 22, 1983, 64 (3 per cent) with AIDS and
    Pneumocystis carinii pneumonia had no recognized
    risk factors for AIDS. Eighteen of these (28 per
    cent) had received blood components within five
    years before the onset of illness. These patients
    with transfusion-associated AIDS were more likely
    to be white (P 0.00008) and older (P 0.0013)
    than other patients with no known risk factors.
    They had received blood 15 to 57 months (median,
    27.5) before the diagnosis of AIDS, from 2 to 48
    donors (median, 14). At least one high-risk donor
    was identified by interview or T-cell-subset
    analysis in each of the seven cases in which
    investigation of the donors was complete five of
    the six high-risk donors identified during
    interview also had low T-cell helper/suppressor
    ratios, and four had generalized lymphadenopathy
    according to history or examination. These
    findings strengthen the evidence that AIDS may be
    transmitted in blood.

N Engl J Med 1984 310 69-75
18
Irwin Memorial Blood Bank in San Francisco
Begins donor testing for anti-HBc.
  • March 1984
  • Donor testing to begin May 1
  • 2 cases with adults proven to have AIDS after
    being transfused with the blood of diagnosed AIDS
    patients
  • Previous cases - donors from high-risk groups,
    not yet diagnosed
  • First TA-AIDS case (1982) also featured donor and
    recipient with AIDS
  • Tracking 22 recipients who had received blood
    from donors diagnosed with AIDS
  • 11 of these patients were have problems with
    their immune system
  • At least 1 had donated after deferral screening
    had begun did not consider himself at high risk
    for the disease even though a sexually active gay
    man.
  • Risk 1 in 500,000

19
Surrogate Testing of the Blood Supply
  • March 6, 1984
  • Industry task force meets on surrogate testing.
  • Blood bankers oppose the procedure commercial
    collectors plan to test.
  • Proposals
  • Hepatitis B Core antibody test
  • Absolute lymphocyte count, helper-suppressor
    ratio procedure
  • Immune complexes
  • Beta 2 micro-globulin
  • Poor testing methodology, inconsistent results
  • Manufacturer improved test in 1985, at the time
    that an HIV test became available.

20
Provisional Public Health Service Inter-Agency
Recommendations for Screening Donated Blood and
Plasma for Antibody to the Virus Causing Acquired
Immunodeficiency Syndrome.
  • January 11, 1985
  • Public Health Service recommendations
  • Sexual contact should be avoided with persons
    known to have, or suspected of having, AIDS.
  • Members of groups at increased risk for AIDS
    should refrain from donating plasma or blood.
  • Studies should be conducted to evaluate screening
    procedures for effectiveness in identifying and
    excluding plasma and blood with a high
    probability of transmitting AIDS.
  • Physicians should adhere strictly to medical
    indications for transfusions, and autologous
    blood transfusions were encouraged.
  • Work should continue toward the development of
    safer blood products for use by hemophilia
    patients.

MMWR 1985 / 34(1)1-5
21
FDA approves first AIDS antibody screening test.
Nationwide testing begins.
  • March 2, 1985
  • Abbott Laboratories
  • Distribution to 2,300 blood banks and plasma
    centers
  • Policy implications
  • Accuracy of test (95 sensitivity 99
    specificity)
  • Window period
  • Blood donation for status
  • Alternative test sites
  • Civil liberties among gay men
  • Access to test results discrimination
  • Bills passed that forbade release of antibody
    test results to anyone, testing required written
    consent, alternative free testing sites
    follow-up counseling (CA)
  • Until testing sites established, blood banks were
    forbidden from disclosing antibody test results

22
The natural history of transfusion-associated
infection with human immunodeficiency virus.
Factors influencing the rate of progression to
diseaseJW Ward, TJ Bush, HA Perkins, LE Lieb, JR
Allen, D Goldfinger, SM Samson, SH Pepkowitz, LP
Fernando, PV Holland, and et al.
  • Abstract
  • Patients infected by the human immunodeficiency
    virus (HIV) as a result of blood transfusions are
    unique in that their dates of infection are well
    defined and their medical conditions before
    infection are known. To characterize the natural
    history of transfusion-associated HIV infection,
    we studied 694 recipients of blood from 112
    donors in whom AIDS later developed and from 31
    donors later found to be positive for HIV
    antibody. Of the recipients tested, 85 were
    seronegative, 116 were seropositive, and 19 had
    AIDS. Of 101 HIV-seropositive recipients followed
    for a median of 55 months after infection, 54 had
    Centers for Disease Control Class IV disease,
    including 43 with AIDS. Life-table analysis
    suggested that AIDS will develop in 49 percent of
    infected recipients (95 percent confidence
    limits, 36 to 62 percent) within seven years
    after infection. As compared with recipients
    without AIDS, the 43 recipients with AIDS had
    received more transfusions at the time of
    infection (median, 21 vs. 7 P 0.01).
    HIV-infected blood donors in whom AIDS developed
    were grouped according to whether AIDS developed
    within 29 months (the median) after donation
    (Group 1) or 29 or more months after donation
    (Group 2). As compared with the 31 recipients of
    blood from Group 2 blood donors, the 31
    recipients of blood from Group 1 donors were more
    likely to have AIDS four years after infection
    (49 percent vs. 4 percent P 0.005) and
    illnesses resembling acute retroviral syndrome
    (14 of 24 vs. 5 of 22 P 0.03). We conclude
    that most recipients of HIV-infected blood become
    seropositive, that AIDS develops in about half
    these recipients within seven years, and that the
    risk may be higher when AIDS develops in the
    blood donor soon after donation.

N Engl J Med 1989 321 947-952
23
Collection and transfusion of blood in the United
States, 1982-1988. Surgenor DM, Wallace EL, Hao
SH, Chapman RH. Center for Blood Research,
Harvard Medical School, Boston, MA 02115.
  • Abstract
  • Widespread concern about the safety of the
    national blood supply, particularly with respect
    to the human immunodeficiency virus (HIV), has
    reportedly affected the use of blood products to
    support patients. To examine these changes, we
    conducted national surveys of blood collection
    and transfusion in the United States in 1982,
    1984, 1986, and 1987 and made a limited survey of
    these activities in 1988. Transfusions of whole
    blood and red cells reached a peak of 12.2
    million units in 1986, then declined to 11.6
    million units in 1987 and continued to decline in
    1988. Transfusions of plasma declined from a peak
    of 2.3 million units in 1984 to 2.1 million units
    in 1987. Growth in the use of platelet
    transfusions (6.4 million units in 1987) also
    slowed however, the proportion of platelets
    transfused as platelets from single donors grew
    from 11 percent in 1980 to 25 percent in 1987.
    Donations of autologous blood increased sharply,
    from less than 30,000 units in 1982 to 397,000
    units in 1987, equivalent to 3 percent of the
    homologous-blood collections. The growth in
    collections of homologous blood slowed after
    1982. The supply of homologous blood reached a
    peak of 13.4 million units in 1986 and did not
    grow between 1986 and 1988. These trends in
    red-cell, plasma, and platelet transfusions
    appear to have continued through 1988. We
    conclude that the unprecedented decline in
    transfusions of whole blood and red cells,
    coupled with the continued importation of packed
    red cells from Western Europe and the offsetting
    effect of autologous predeposits, forestalled
    serious shortages of blood that could have
    resulted from the decline in collections of
    homologous blood. We attribute these changes in
    blood collection and blood transfusion to the
    effects of the epidemic of HIV infection.

N Engl J Med. 1990 Jun 7322(23)1646-51.
24
Estimated Risk of Transmission of the Human
Immunodeficiency Virus by Screened Blood in the
United States
N Engl J Med 1995 333 1721-25
25
Estimates of HIV Risk per Unit Transfusion
  • Effectively controlled transfusion transmitted
    HIV
  • Combination of screening high-risk donors and
    testing
  • Risk reduction gt1 to 1 in 2 million

26
Donor Screening Questions
  • Deferral from 12 months of last potential
    exposure
  • Have you had sex in the past 12 months with
  • A person who has HIV infection or AIDS? A
    prostitute? A person who currently or previously
    used intravenous drugs? A person receiving
    clotting factor concentrates?
  • For women a man who has sex with another man
    (that is, a man who is bisexual)?
  • Have you had syphilis or gonorrhea?
  • Have you received a blood transfusion?
  • Have you experienced an accidental needle stick
    injury or a blood splash to mucous membranes
    (tissues lining the eyes, nose, or mouth) or
    broken skin?
  • Donors will be asked if they have spent at least
    72 hours in a prison in the past 12 months.
    Individuals answering "yes" may not be permitted
    to donate blood for at least 12 months from the
    last day of imprisonment.
  • Donors will also be asked if they were born in
    Cameroon or the surrounding West African
    countries, if they have received a blood
    transfusion or medical treatment in these
    countries, and if they have had sexual contact
    with anyone who was born in or has lived in these
    countries since 1977. (HIV GROUP O)

27
Donor Screening Questions
  • Permanent disqualification from donating blood
    ("yes" to any of the following)
  • Have you ever had clinical or laboratory evidence
    of AIDS or HIV infection?
  • For men have you had sex with another man, even
    once, since 1977?
  • Have you ever injected intravenous drugs?
  • Have you engaged in sex in exchange for money or
    drugs since 1977?
  • Have you ever received clotting factor
    concentrates for hemophilia or other clotting
    disorders?

28
  • Restrictions based on sexual history anger some
  • FDA regulations bar certain members of gay
    community from taking part in drives

Published October 25, 2006
Let gay men donate blood A 1980s-era ban no
longer makes any practical sense.
Published June 15, 2006
Gay Men Not Allowed To Give Blood
Published September 6, 2005
29
Goodnough LT, et al. NEJM 30(6) (Transfusion
risks), Lazrou J. et al., JAMA 279(15) (Adverse
drug reactions), Luadan L. The Book of Risks,
John Wiley, 1994.
30
Transfusion LiabilityandPublic Policy
31
Theories of blood transfusion liability
  • Failure to perform surrogate testing
  • Failure to adequately screen blood donors
  • Inadequate warning of blood transfusion risks

32
Snyder vs AABBBlood bank trade group held
liable for HIV-tainted transfusion.
  • June 1996
  • Plaintiff William Snyder
  • Received HIV-tainted blood during open-heart
    surgery in 1984.
  • Sued several physicians, the AABB, the blood
    bank, and the hospital, alleging negligence.
  • All but AABB settled out of court or obtained
    dismissals.
  • NJ Supreme Court found AABB responsible for
    transmitting HIV through a blood transfusion to a
    surgical patient.
  • 6-1 ruling
  • Court awarded 405,000
  • AABB owed a duty of care to Snyder because AABB
    was established as the principal overseer of
    blood safety and responsible stringent testing
    standards.
  • By the end of 1983, 28 cases of
    transfusion-associated AIDS had been diagnosed,
    but AABB's opposition to surrogate testing
    continued into 1984.

AIDS Policy Law. 1996 Jun 2811(12)1, 10-1.
33
Blood bank association not liable for tainted
transfusion.
  • The American Association of Blood Banks (AABB) is
    not liable for its early 1980s decision not to
    recommend AIDS screening for blood donors. The
    AABB is also not accountable for the HIV
    infection of an infant who received a blood
    transfusion during surgery. The transfusion
    occurred before blood testing for HIV was
    available, and most blood banks at the time did
    not use the existing hepatitis B test to identify
    individuals at risk for HIV. The court also held
    that imposing liability on the blood bank would
    expose all professional medical associations to
    "a significant burden of litigation" because they
    would be held to a standard of "extraordinary
    skill, knowledge, and insight."

AIDS Policy Law. 2000 Jan 2115(1)9.
34
French case of HIV-contaminated blood knowingly
being distributed to hemophiliacs.
  • Summer, 1992
  • Plaintiffs Hemophiliacs dying of AIDS
  • Defendants High officials in the French national
    transfusion service.
  • Charge Infected through the negligence of the
    leading officials of the French national
    transfusion service.
  • Supposed to ensure the safety of blood products
  • Allowed thousands of the nation's hemophiliacs to
    inject blood-derived clotting factors they knew
    to be contaminated.
  • Underlying paternalism, economics, and limits of
    science

35
AIDS-tainted blood scandalOfficials Accused
  • July 1993
  • Jean-Pierre Allain, former head of plasma
    products research and former president at the
    French National Center for Blood Transfusion sent
    to jail in July for not preventing the
    distribution of HIV-infected blood-clotting
    factors to hemophiliacs in 1985.
  • March 1999
  • Former Prime Minister Social Affairs Minister
    acquitted of manslaughter.
  • Former Health Minister convicted, given no
    sentence.
  • Contamination of 3,846 people given transfusions
  • Conspiring to delay the introduction of a U.S.
    test
  • March 1985 Abbott Laboratories to begin
    screening donated blood in France for AIDS with a
    newly developed test. Test is not approved in
    France until July 1985.
  • April 1985 WHO recommends routine blood
    screening.
  • June 1985 Government approves rival screening
    test developed by France's Pasteur Institute.

36
Compensation for bad blood victims
  • June 19, 2001
  • ROME, Italy -- The Italian Health Ministry has
    been ordered to compensate more than 300 people
    who were given contaminated blood.
  • Damages to victims who contracted HIV and
    hepatitis from blood infusions in public
    hospitals.
  • Ministry failed to carry out proper inspections
    of donated blood
  • 351 hemophiliacs exposed to HIV and HAV/HBV
    through infected blood products in 1980s and
    1990s 100 have died.
  • Similar ruling in 1998 Damages paid to 400
    hemophiliacs

37
French High Court Dismisses Case Against Health
Officials Accused of Giving Patients HIV-Tainted
Blood
  • June 3, 2003
  • 30 health care workers accused of giving patients
    HIV-contaminated blood in the mid-1980s
  • Nearly 4,000 people, mostly hemophiliacs,
    infected with HIV 100s have since died of
    AIDS-related causes
  • Defendants charged with involuntary homicide or
    injury and poisoning or complicity in poisoning
  • Delayed introduction of U.S. HIV blood-screening
    tests until a similar French product could be
    developed
  • Delayed taking basic steps to limit
    HIV-contaminated blood from entering transfusion
    stocks
  • Case dismissed No legal basis.
  • Did not act with the "intention of causing death
  • Did not have "knowledge of the necessarily deadly
    character" of the blood products

38
Ricky Ray Hemophilia Relief Fund Act of 1988
  • Compassionate payments to individuals with
    blood-clotting disorders who were treated with
    anti-hemophilic factor between July 1, 1982 and
    December 31, 1987, and contracted HIV, as well as
    to certain persons who contracted HIV from these
    individuals.
  • Excess of 559M paid to more than 7,171
    individuals and survivors
  • NHF Stats
  • Late 70s - mid-80s 50 of people with hemophilia
    infected with HIV through blood products many
    developed AIDS.
  • Currently, 10 -15 infected with HIV.
  • AIDS epidemic placed great health, economic,
    ethical and emotional burdens on affected
    patients and their families
  • Since 1986, no HIV transmission by any factor
    VIII or IX product in US due to viral
    inactivation (heat treatment, solvent-detergent
    cleansing and monoclonal purification).

39
Paul Gann Blood Safety ActHEALTH AND SAFETY CODE
SECTION 1645
  • Introduced by Bill Dolittle in early 1990s
  • Paul Gann died of transfusion transmitted HIV in
    1989 (transfusion during heart surgery in 1982,
    AIDS developed in 1987)
  • BB accused of not accepting autologous/directed
    donations
  • Bill
  • Parental donations
  • Directed donations

40
Current Donor Screening PracticesTo
MinimizeTransfusion Transmitted Infections
41
Monitor Evaluate
Pre-transfusion Evaluation
Recruitment
Issue
Medical Indication for Transfusion
Donor Screening
Administer
Pre-transfusion Testing
Collection Preparation
Infectious Disease Testing
Product Blood Safety
Entire process Blood Transfusion Safety
42
Donor Screening
  • Medical history and risk factor assessment
  • Infectious disease testing
  • ABO and Rh typing
  • Tests for antibodies to red cell antigens

43
Infectious Disease Testing
  • HIV Anti-HIV 1, 2 and Nucleic Acid Testing
    (NAT)
  • Hepatitis B HBsAg and Anti-HBc
  • Hepatitis C Anti-HCV and NAT
  • HTLV I/II Anti-HTLV I/II
  • WNV NAT
  • Serologic Test for Syphilis
  • Bacterial detection (platelet products)
  • CMV Anti-CMV (for select recipients)
  • Chagas Disease - T. cruzi antibodies

44
Estimates of Known Viral Infectious Disease Risks
of Transfusion
Transfusion 2002 42 975-979, N Engl J Med
2005353451-9.
45
Risks of Transfusion-Transmitted HIV, HCV HBC
in the US
Goodnough LT. Risks of blood transfusion.
Anesthesiol Clin North America. 2005
Jun23(2)241-52.
46
West Nile Virus
  • Flavivirus endemic among avian species (also
    cats, horses, squirrels, rabbits)
  • Seasonal infection transmitted by mosquitoes
  • First emerged in the US in 1999
  • First reported case of transmission organ donor
    to four transplant recipients (Aug 2002)
  • 30 recognized transfusion-transmitted cases
    (2002-2004)(post NAT- implementation resulted
    from IgM Ab-neg donations and low titer viremia)
  • Testing - WNV NAT
  • Under IND starting in 2003 (rapid response to
    seasonal increase in WNV infections)
  • FDA approved in 2006
  • Risk
  • Prior to NAT 1 in 1,000 10,000 in endemic
    areas
  • Following mpNAT implementation Approx 1 in
    350,000

47
Estimates of Known NON-Viral Infectious Disease
Risks of Transfusion
48
Malaria
  • Estimate gt120,000 blood donors/yr deferred in US
    for potential exposure to malaria
  • Loss of approx 180,000 donations/yr
  • Current strategy Donor screening for travel to,
    residence in, and infection
  • Reduce transfusion transmission from 3 cases/yr
    in 1995 to 0.6 cases/yr in 2005
  • Pitfalls Accurate travel histories (greatest
    number PDI)
  • Future strategies
  • Testing as pre-donation screening
  • Follow-up testing to permit reduced deferral
    period for at-risk donors

49
Chagas Disease
  • 18M people infected ( 100K in US)
  • Approx 12M Latin American immigrants residing in
    US
  • Acute Chagas 1 of infected people
  • (flu-like illness)
  • Chronic Chagas develops 0-20yrs afteracute
    infection
  • 40-50 have parasitemia with no symptoms
  • Transmission Routes vectorial (insect),
    congenital and iatrogenic (txn, txp)
  • Risk of transfusion transmission
  • Los Angeles 1550 (Shulman, et al.)
  • US - 125,000 (estimate) (Vostal, FDA)
  • Estimate 618 potential infectious components
    from 13.2M donations/year

50
Bacterial contamination of Platelet Products
  • Leading cause of txn-transmitted infection
  • Incidence 1 in 400 - 1 in 3,000 (prior to
    implementation of bacteria detection)
  • Approximately 20 develop clinical sepsis
  • Second leading cause of txn-related deaths
  • 1976 1998 51 fatalities reported to the FDA
    (approximately 17 of transfusion-related deaths)
  • Implementation date for bacterial detection
    March 1, 2004 (AABB)

51
Potential or Theoretical Transfusion-Transmitted
Infectious Agents
  • Prions
  • Transmissible Spongiform Encephalopathies (vCJD,
    CJD)
  • Viruses
  • Human Herpes Virus 6 8
  • TTV, SEN-V and HGV
  • SARS
  • Tick-borne Diseases
  • Parasitic Diseases

52
Transmissible Spongiform EncephalopathiesvCJD
CJD
  • First recognized in 1996 in the UK
  • Donation/transfusion before diagnosis
  • No current test available
  • Prevention - Stringent donor screening
    (Indefinite deferrals)
  • gt 3 months in UK between 1980 and 1996
  • Affiliated with US military, gt 6 months in N.
    Europe between 1980-1996
  • gt 5 years cumulatively in Europe
  • Received a blood transfusion in the UK
  • Exposure to medication produced from bovine
    sources
  • Relative of a person with CJD
  • Recipient of a dura mater graft
  • Current risk
  • 4 cases two cases associated with same donor

53
Emergence of a New Standard for Blood
Transfusion Safety
54
Transfusion Safety Issues
  • Testing
  • Majority of developing nations still do not carry
    out basic mandatory tests for diseases (HIV, HBV,
    HCV).
  • Annually, 6M tests for donor infectious disease
    screening are not done.
  • Nationally coordinated Blood Transfusion Service
  • lt 30 of countries have a well-organized service
    in place.
  • Voluntary donations
  • Reliance on family replacement or paid donors.
  • Argentina Replacement donors, 92
  • Pakistan Replacement donors, 70 paid donors,
    10 (2004)
  • Unnecessary transfusions

55
Layers of Safety
  • Voluntary unpaid donors
  • Donor screening
  • Blood testing
  • Donor lists
  • Quarantine of untested blood
  • Investigation of problems

56
WHO on Transfusion Safety
  • Every country has a common need to ensure
  • Availability of adequate supplies of blood and
    blood products and their accessibility to all
    patients requiring transfusion
  • Safety of blood and blood products
  • Safe and appropriate clinical use of blood and
    blood products.

57
WHO Blood Transfusion Safety Team
  • Supports the establishment of sustainable
    national blood programs that can ensure the
    provision of safe, high quality blood and blood
    products that are accessible to all patients
    requiring transfusion and their safe and
    appropriate use.

58
WHO Blood Transfusion Safety TeamRecommended
Integrated Strategy
  • Nationally coordinated blood transfusion service
  • Collection of blood only from voluntary unpaid
    blood donors
  • Testing of all donated blood for
    transfusion-transmissible infections, blood
    groups and compatibility
  • Production of blood components
  • Appropriate clinical use of blood and the use of
    alternatives
  • Safe transfusion practice at the bedside
  • Comprehensive quality system covering the entire
    transfusion process

59
WHO Blood Transfusion Safety Team Strategy
National Blood Transfusion Services
  • Secure and continuous government commitment and
    support
  • National blood policy and plan
  • Formulation of an organization with
    responsibility and authority for the blood
    transfusion service
  • Appointment of a medical director, a quality
    manager and when necessary, specialist blood
    transfusion service advisory groups
  • Appointment of qualified and trained staff
  • Development and implementation of a budgeting and
    finance system
  • Establishment of a national quality system,
    including standards, guidelines, standard
    operating procedures (SOPs), accurate records,
    monitoring and evaluation
  • Development of necessary legislation and
    regulation for the blood transfusion service

60
WHO Blood Transfusion Safety Team Strategy
Voluntary Unpaid Blood Donors
  • National blood donor program for the education,
    recruitment and retention of low-risk blood
    donors
  • Appointment of an officer responsible for the
    national blood donor program (education,
    motivation, recruitment and retention)
  • Training of donor recruitment and donor care
    staff
  • Development of strategies to promote positive
    attitudes towards voluntary blood donation
  • Development of donor education and recruitment
    materials
  • Educational and media campaigns
  • Establishment and maintenance of a
    database/register of donor records

61
WHO Blood Transfusion Safety Team Strategy
Voluntary Unpaid Blood Donors
  • Guidelines and protocols for donor selection and
    deferral, donor confidentiality and donor care
  • Guidelines on blood collection
  • Monitoring of transfusion-transmitted infections
  • Training of staff in pre- and post-donation
    counseling
  • Donor notification and referral for counseling
  • Monitoring and evaluation of the blood donor
    program

62
WHO, Global Database on Blood Safety, Report
2001-2002.
63
WHO, Global Database on Blood Safety, Report
2001-2002.
64
WHO Blood Transfusion Safety Team Strategy
Testing of all Donated Blood
  • Development and implementation of a national
    strategy for the screening of all donated blood
  • Training of transfusion service laboratory
    technical staff in all aspects of blood screening
    and processing
  • Maintenance of quality assurance systems and good
    laboratory practice
  • Compatibility testing of all whole blood and red
    cells
  • Procurement, supply, central storage and
    distribution of reagents and materials to ensure
    continuity in testing at all sites
  • Maintenance of effective procedures for storage
    and transportation of blood and blood products

65
WHO Blood Transfusion Safety Team Strategy
Production of Blood Components
  • Commitment and support by national health
    authorities for a sustainable, well-organized,
    nationally coordinated transfusion service
  • Centralization of blood processing and testing to
    maximize utilization of personnel and equipment
    and uniform standards
  • Reliable supply of materials and consumables
  • Well-maintained equipment and spares available to
    keep down-time to a minimum
  • Effective and timely testing of all donated blood
    to ensure maximum safety and availability
  • System for appropriate storage and transportation
  • Optimization of the use of plasma for
    fractionation
  • Promotion of appropriate blood component therapy

66
WHO Blood Transfusion Safety Team Strategy
Appropriate Clinical Use of Blood Safe
Transfusion Practice
  • Well-organized blood program, coordinated at
    national level to guarantee safe, adequate and
    timely supply
  • National blood policy to address the clinical use
    of blood
  • National committee on the clinical use of blood
    and hospital transfusion committees at local
    level
  • National guidelines on the clinical use of blood
  • Availability of alternatives for transfusion -
    pharmaceuticals and medical devices to reduce
    blood loss, when clinically indicated
  • Education and training of clinicians, nurses and
    blood transfusion service staff
  • Monitoring and evaluation of the implementation
    of the national policy and guidelines, and the
    use of monitoring data in quality improvement and
    education

67
WHO Blood Transfusion Safety Team Strategy
Quality System
  • Development of regional and national capacity in
    quality management
  • Identification and strengthening of regional
    quality training centers
  • Development of advocacy and training materials on
    quality management
  • Training of facilitators and quality managers
  • Establishment of proficiency testing
  • Development of a monitoring and evaluation system
    for the provision of post-training support and
    follow-up
  • Creation of effective quality networks.

68
Progress
  • Voluntary blood donor organizations have been set
    up in over 50 countries.
  • In China, voluntary blood donation rose - 45 in
    2000 to 91.3 in 2004.
  • Cuba and Suriname have introduced 100 voluntary
    donation since the creation of their national
    blood transfusion service.
  • Bolivias establishment of a national blood
    program and concerted media campaigns have
    brought the rate of voluntary, unpaid donations
    from 10 in 2002 to 50.
  • South Africa has had 100 voluntary, unpaid
    donation since it established a national blood
    service. With HIV prevalence of 23.3 in the
    adult population, only 0.02 of its regular blood
    donors have contracted HIV.
  • The number of tests not being performed for HIV,
    HBV, HCV and syphilis, decreased from 13 million
    in 1998- 99 to just six million in 2000 - 01.
  • Malaysia, China and India reached 100 screening
    for HIV by 2000.
  • By 2001, 123 countries were monitoring the
    prevalence of transfusion-transmissible
    infections among blood donors, compared with 98
    countries in 1998-1999.
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