Title: Transfusion Safety in the AIDS Era: Convergence of Medicine, Science and Technology, and Public Perc
1Transfusion 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
2Objectives
- 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
3Blood Transfusion
- Every second, someone in the world needs blood.
- Transfusion only option for survival for many
patients.
4Blood 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
5Blood 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.
6History of HIV and the Blood Supply
7Epidemiologic 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.
8Epidemiologic 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
9Epidemiologic 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
10Joint 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.
11National 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).
12Current 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
14Y
15Stanford 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
16UpdateAcquired 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
17Acquired 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
18Irwin 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
19Surrogate 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.
20Provisional 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
21FDA 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
22The 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
23Collection 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.
24Estimated Risk of Transmission of the Human
Immunodeficiency Virus by Screened Blood in the
United States
N Engl J Med 1995 333 1721-25
25Estimates 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
26Donor 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)
27Donor 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
29Goodnough 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.
30Transfusion LiabilityandPublic Policy
31Theories of blood transfusion liability
- Failure to perform surrogate testing
- Failure to adequately screen blood donors
- Inadequate warning of blood transfusion risks
32Snyder 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.
33Blood 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.
34French 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
35AIDS-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.
36Compensation 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
37French 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
38Ricky 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).
39Paul 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
40Current Donor Screening PracticesTo
MinimizeTransfusion Transmitted Infections
41Monitor 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
42Donor Screening
- Medical history and risk factor assessment
- Infectious disease testing
- ABO and Rh typing
- Tests for antibodies to red cell antigens
43Infectious 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
44Estimates of Known Viral Infectious Disease Risks
of Transfusion
Transfusion 2002 42 975-979, N Engl J Med
2005353451-9.
45Risks of Transfusion-Transmitted HIV, HCV HBC
in the US
Goodnough LT. Risks of blood transfusion.
Anesthesiol Clin North America. 2005
Jun23(2)241-52.
46West 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
47Estimates of Known NON-Viral Infectious Disease
Risks of Transfusion
48Malaria
- 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
49Chagas 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
50Bacterial 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)
51Potential 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
52Transmissible 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
53Emergence of a New Standard for Blood
Transfusion Safety
54Transfusion 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
55Layers of Safety
- Voluntary unpaid donors
- Donor screening
- Blood testing
- Donor lists
- Quarantine of untested blood
- Investigation of problems
56WHO 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.
57WHO 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.
58WHO 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
59WHO 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
60WHO 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
61WHO 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
62WHO, Global Database on Blood Safety, Report
2001-2002.
63WHO, Global Database on Blood Safety, Report
2001-2002.
64WHO 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
65WHO 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
66WHO 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
67WHO 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.
68Progress
- 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.