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From: TSS ()
Subject: SEAC EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD POSITION STATEMENT
Date: November 7, 2006 at 9:38 am PST

© SEAC 2006

1

POSITION STATEMENT

EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS

FOR SUBCLINICAL vCJD

Issue

1. The Department of Health and the UK blood services requested

SEAC’s advice on the scientific criteria by which ante mortem

diagnostic tests for subclinical vCJD could be evaluated and

validated1.

Background

2. The development of an accurate and sensitive ante mortem blood

test to identify asymptomatic individuals infected with vCJD could

substantially reduce the potential for transmission of vCJD via

blood transfusion and other medical interventions. It could also be

valuable in confirming the diagnosis of clinical cases and

monitoring the effect of potential therapies. In addition, such a test

could provide an important tool to ascertain better the prevalence

of vCJD infections.

3. The safety, quality and performance requirements for diagnostic

tests for many infectious diseases are laid down in the In Vitro

Diagnostic Medical Devices (IVD) Directive 98/79/EC. Tests

included in Annex II List A of the Directive must comply with

performance requirements set out in a Common Technical

Specification (CTS) to receive a CE mark2. Currently, diagnostic

tests for subclinical vCJD are not included in Annex IIA of the

Directive and so a CTS with clear performance requirements for

such tests has not yet been defined.

Performance

4. The Committee on Microbiological Safety of Blood Tissue and

Organs (MSBTO) considers that, ideally, tests for subclinical vCJD

1 The papers considered by SEAC are given at:

http://www.seac.gov.uk/agenda/agen210906.htm

2 CE (Conformité Européenne) mark is a declaration by the manufacturer that a product

meets all the necessary requirements of the relevant EU legislation.

© SEAC 2006

2

should be highly sensitive and highly specific. Unless tests have

extremely high specificity, they will generate a large number of

false positive results with unacceptable cost and ethical

consequences. Therefore, a reliable secondary test, to confirm

reactive results in any initial screening test, would be required.

Calculations to ascertain acceptable values for sensitivity and

specificity of both the screening and confirmatory tests should be

taken into account3.

Regulatory position

5. Until diagnostic tests for subclinical vCJD are included in Annex IIA

of the IVD Directive 98/79/EC, the CE mark must not be relied

upon to indicate that a test is fit for purpose. Therefore, it is

strongly recommended that ante mortem tests for subclinical vCJD

are independently evaluated and validated using a clearly defined

protocol prior to implementation.

Prototype Tests

6. A number of prototype ante mortem blood tests for subclinical

vCJD have been developed. Due to commercial sensitivities,

availability of data for these tests is limited and the methodologies

on which they are based are often incompletely specified. The

available information suggests that many, if not all, of these tests

are based on the detection of abnormal prion protein (PrPSc).

7. The relationship between the presence of PrPSc and vCJD

infectivity is not well understood. It is important to emphasise that

the presence of PrPSc is not always correlated with vCJD

infectivity. However, as a better biomarker has not yet been

identified, PrPSc is currently the most appropriate marker against

which any assay should be targeted. Furthermore, it is possible

that tests based on the detection of PrPSc will not identify all

infected individuals and might falsely identify individuals as

infective. As previously stated, calculations to ascertain what

proportion of false positives and false negatives might be

acceptable, are critical to defining test criteria.

Evaluation and validation

8. Preliminary evaluation of the specificity and sensitivity of tests

could be achieved by using human blood spiked with brain or

3 Eglin R and Bennett P (2003). Blood Screening for vCJD: Implications of test results (see

SEAC papers at http://www.seac.gov.uk/agenda/agen210906.htm)

© SEAC 2006

3

spleen homogenate from vCJD cases. However, spiked samples

may not be representative of the form of infectivity naturally

present in blood. Blood of animals infected with transmissible

spongiform encephalopathy strains which, like vCJD are derived

from the BSE strain may also provide a source of material to

conduct preliminary evaluations. However, it is critical to note that

the response of tests when applied to blood from animal models or

spiked human blood, may not accurately reflect the response from

tests when applied to the detection of vCJD infectivity in human

blood. Therefore, the final evaluation of screening and

confirmatory tests must include testing against blood from human

vCJD cases.

9. Blood from clinical cases of vCJD may not provide an indication of

the sensitivity of a test to correctly identify subclinically infected

individuals. This is due to uncertainty in the levels of vCJD

infectivity (and PrPSc) in blood during the incubation period of the

disease. Individuals defined as ‘at risk of vCJD for public health

purposes’ could provide a source of blood from potentially infected

individuals at the preclinical stage of vCJD. Even so, such an

evaluation would not inform on the ability of a test to detect

infection from the point in the incubation period when blood

becomes infectious. Such evaluation would require testing of

blood collected from animal models at a number of time points

through the incubation period, and extrapolation to humans.

10. As relevant human material is extremely difficult to obtain, it is

essential that the quantity of materials required to validate tests is

accurately determined prior to investigations starting. It is also

important that an effective system to collect, manage and distribute

these valuable materials is instituted and to ensure that the

performance criteria that prototype tests must meet are clearly

defined before such valuable materials are provided to evaluate

and validate tests.

Ethical Considerations

11. There are complex ethical issues associated with ante mortem

testing for subclinical vCJD that have yet to be resolved4. These

issues also relate to how many false positives and false negatives

4 The Chief Medical Officer (CMO) asked the Health Protection Agency (HPA) to host a

seminar on the ethical and social aspects of testing for vCJD. This seminar produced a report

with recommendations. At the request of the CMO, the HPA is currently undertaking a

consultation exercise to determine the views of experts, health professionals and members of

the public on the possible impact and implications of a test for vCJD.

http://www.hpa.org.uk/infections/topics_az/cjd/consultation.htm

© SEAC 2006

4

are acceptable and, hence, the test validation criteria. However,

detailed consideration of these issues is not in SEAC’s remit.

Conclusions

12. Until diagnostic tests for subclinical vCJD are included in Annex IIA

of the IVD Directive 98/79/EC, the CE mark cannot be relied upon

to indicate that a test has been properly and fully evaluated and

validated. Therefore, tests should be independently and rigorously

validated using a clearly defined protocol that includes testing of

blood from vCJD cases.

SEAC

November 2006

http://www.seac.gov.uk/pdf/statement-vcjd.pdf

PRODUCT
Source Plasma, Recall # B-0054-7
CODE
Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
CA and Austria


END OF ENFORCEMENT REPORT FOR October 25, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html

PRODUCT
Recovered Plasma, Recall # B-0084-7
CODE
Unit: GR38567
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on May 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

______________________________
PRODUCT
Source Plasma, Recall # B-0085-7
CODE
Units: 03LWID9056 03LWIE0563 03LWIE1438 03LWIE1703 03LWIE2881 03LWIE7822 03LWIF5263 03LWIF5709 03LWIF6162 03LWIF6703 03LWIF7544 03LWIF8839 03LWIG0019 04LWIA0693 04LWIA1413 04LWIA6459 04LWIA7250 04LWIB7909 04LWIC0795 04LWIC2962 04LWIC3881 04LWIC4249 04LWIC5138 04LWIC7988 04LWIC8464 04LWIC9002 04LWIC9487 03LWIS2936 03LWIS3052 03LWIS3082 03LWIS3114 03LWIS3204 03LWIS3554 03LWIS4083 03LWIS4116 03LWIS4147 03LWIS4185 03LWIS4239 03LWIS4334 04LWIS0036 04LWIS0127 04LWIS0262 04LWIS0545 04LWIS0600 04LWIS0616 04LWIS0850 04LWIS1717 04LWIS1784 04LWIS1810 04LWIS1874 04LWIS2074 04LWIS2110 04LWIS2149 04LWIS2179
RECALLING FIRM/MANUFACTURER
BioLife Plasma Service L.P., Onalaska, WI, by facsimile on July 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Austria

END OF ENFORCEMENT REPORT FOR November 1, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00976.html

----- Original Message -----
From: Terry S. Singeltary Sr.

Sent: Monday, October 09, 2006 2:48 PM
Subject: FDA nvCJD MAD COW BLOOD HUMAN RECALL 2006 UPDATE


SCIENTIFIC COMMITTEE ON EMERGING AND NEWLY

IDENTIFIED HEALTH RISKS

(SCENIHR)

Opinion on

The Safety of Human-derived Products with regard to Variant

Creutzfeldt-Jakob Disease

Adopted by the SCENIHR

during the 11th plenary meeting of 11-12 May 2006

after public consultation

Synthesis Report : http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_vcjd_synth.pdf

Stakeholder comments : http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_vcjd_comments.zip

EUROPEAN COMMISSION

HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate C - Public Health and Risk Assessment

C7 - Risk assessment

SCENIHR/003/05

The safety of human-derived products with regard to variant Creutzfeldt-Jakob disease

_______________________________________________________________________

2

TABLE OF CONTENTS

EXECUTIVE SUMMARY ...............................................................................................4

1. BACKGROUND ..........................................................................................................7

2. TERMS OF REFERENCE ...........................................................................................8

3. SCIENTIFIC RATIONALE .........................................................................................9

3.1 Introduction .......................................................................................................9

3.2 Current status of knowledge on vCJD - overview..........................................10

3.2.1 The infectious agent ........................................................................................10

3.2.2 vCJD pathogenesis and the immune system ...................................................11

3.2.3 Distribution of infectivity and PrPSc in CJD ...................................................13

3.2.4 Evidence for the presence of vCJD infectivity in peripheral blood ................15

3.2.5 Conclusions .....................................................................................................15

3.3 Review of the TSE detection methods ............................................................15

3.3.1 Biochemical assay methods for the detection of PrPSc....................................16

3.3.2 Infectivity methods for the detection of TSE agents.......................................18

3.3.3 Surrogate markers of TSE disease...................................................................19

3.3.4 Other methods for the detection of TSE agents ..............................................19

3.3.5 Tests in development for blood .......................................................................20

3.3.6 Conclusions .....................................................................................................21

3.4 Evaluation of current epidemiological data.....................................................21

3.4.1 Surveillance systems and methodologies ........................................................21

3.4.2 Current variant CJD figures ............................................................................24

3.4.3 Modelling and predictions of vCJD figures ....................................................26

3.4.4 Epidemiological approaches to secondary transmission .................................29

3.4.5 Problems & possible deficiencies in current systems .....................................34

3.4.6 Conclusions .....................................................................................................34

3.5 Evaluation of prion decontamination procedures for surgical instruments.....35

3.5.1 Cleaning ...........................................................................................................35

3.5.2 Decontamination and sterilisation....................................................................36

3.5.3 Conclusions......................................................................................................38

3.6 Risk assessment on transmission of vCJD ......................................................38

3.6.1 Risk assessment for transmission of vCJD by blood or blood components ....39

3.6.2 Risk assessment on transmission by surgical instruments or invasive

procedures ........................................................................................................................46

3.6.3 Risk assessment on vertical transmission .......................................................51

3.6.4 Risk assessment on transmission by transplantation of Umbilical Cord Stem

Cells ................................................................................................................................53

3.6.5 Conclusions......................................................................................................53

SCENIHR/003/05

The safety of human-derived products with regard to variant Creutzfeldt-Jakob disease

_______________________________________________________________________

3

3.7 Evaluation of previous opinions of the SCMPMD on human product safety for

vCJD transmission with regard to current scientific knowledge .....................................54

3.7.1 Opinion on Quality and Safety of Blood (Adopted by SCMPMD on 16

February 2000).................................................................................................................54

3.7.2 Opinion on update of the opinion given by SCMPMD on the risk

quantification for CJD transmission via substances of human origin (Adopted by

SCMPMD on 16 February 2000).....................................................................................55

3.7.3 Opinion on The Safety Of Human-Derived Products With Regard To TSE's

(Adopted by SCMPMD on 18 January 2002)..................................................................56

4 COMMITTEE OPINION................................................................................60

5 MINORITY OPINION....................................................................................65

6 REFERENCES......................... 63

7 ACKNOWLEDGEMENTS ............................................................................80

GLOSSARY ....................................................................................................................81

SCENIHR/003/05

The safety of human-derived products with regard to variant Creutzfeldt-Jakob disease

_______________________________________________________________________

4

EXECUTIVE SUMMARY

In 2004 two instances were reported indicating the possible transmission of variant

Creutzfeldt-Jakob disease (vCJD) by blood transfusion. In February 2006 a third

instance of vCJD infection by blood transfusion was reported. This prompted a review

of the current state of knowledge and practice of vCJD infection in relation to the safety

of blood and blood components, including the evaluation of previous scientific Opinions

of the Scientific Committee for Medicinal Products and Medical Devices (SCMPMD).

The general conclusions and recommendations of the previous Opinions on the safety of

human derived products including blood and blood components are still valid. However,

two aspects do need our attention: 1) the possibility of transmission of vCJD by blood

and blood components, and 2), the presence of asymptomatic vCJD infected individuals

in the population who may be responsible for secondary transmission of the disease by

blood/blood components or surgery.

While neither of the three transfusion-related vCJD infections reported is definitively

proven to be caused by the preceding blood transfusion this is the most likely

explanation. These three instances raise serious concern over the possibility of infection

by blood transfusion (or through surgery and dental procedures) from asymptomatic

preclinically or subclinically infected donors. Therefore, it is assumed that vCJD

infectivity is likely to be present in human peripheral blood which is in accord with the

results of recent work in experimental animals on transmission by transfusion. The

present risk assessment of exposure to vCJD infectivity in whole blood and in blood

components allows a rationale to define precautionary measures to reduce vCJD

transmission within the human species by the intravenous or other routes.

While all the clinical cases of vCJD so far have been homozygous for methionine, (MM)

at codon 129 of the prion protein (PRNP) gene, one of the three reported transfusionrelated

instances was heterozygous (MV). In addition, the results of the UK study

evaluating anonymised appendix and tonsil surgical specimens, showed that vCJD

infection might be more common than is suggested by the numbers of actual cases of

vCJD to date. Two of the three positive samples could be evaluated for their genotype at

codon 129 and were found to be of the VV genotype. It is therefore possible that

following exposure to BSE, vCJD infectivity is present in a considerable number of

individuals in the UK in an asymptomatic phase of the disease, including individuals

with MV and VV genotypes. This poses an additional threat to the use of blood and

other products of human origin as a potential source of secondary transmission. The

potential transmission by blood raises concern, especially in view of the fact that routine

screening with respect to vCJD is not (yet) possible. A possible iatrogenic transmission

through surgical instruments used in invasive procedures also has important

implications.

Considerable advances in test methodologies for prion diseases have been made in recent

years. However, no diagnostic system has yet emerged with the level of sensitivity and

specificity required for routine screening of blood or urine. It is essential that

confirmatory assays are available for any assay proposed for large scale screening of

donated blood. In addition, prior to introduction into routine practice, such assays should

be independently assessed and validated for their analytical performance. Validation of

any new methodology should be mandatory prior to introduction, and it is recommended

SCENIHR/003/05

The safety of human-derived products with regard to variant Creutzfeldt-Jakob disease

_______________________________________________________________________

5

that the EU adopts a procedure similar to that used for the BSE testing. For validation,

carefully controlled vCJD reference materials should be used. The issue of false positives

needs especially careful consideration. Even minute percentages of false positives may

actually involve a large number of individuals if the tests are performed on a large scale

in the EU population, with a varying "prevalence" of asymptomatic carriers. The ethical

implications of testing and informing an individual of a positive test result, without

providing any certainty as to the likelihood of progression to clinical disease, should not

be considered lightly.

Based on conservative assumptions made for the purposes of this risk assessment, there

is a considerable risk that an asymptomatic donor infected with vCJD could cause

infective material to be passed on to one or more recipients of blood or blood

components. In the worst case scenario each therapeutic unit of blood from an

asymptomatic infected donor could contain as much as 4500iv ID50. This amount of

infectivity is deemed sufficient to cause transmission of the infection, with or without

development of the disease. Considering that the donor population is much younger than

the recipient population, with only a small overlap in age, preliminary data from one

mathematical model indicate that blood transfusion alone will not be sufficient to

maintain vCJD in the human population at large.

Taking into account the eligible blood donor population, and using the data of the UK

appendix-tonsils study, the number of donations and the percentage of the population

actually donating blood, up to 1250 infected donations may occur per year. As donations

are typically split between 3 recipients, 3750 new infections would occur each year in

the UK as a result of these infected donations in the worst case scenario. Transfusion

statistics show that in general only about 50 % of blood recipients survive more than 3

years. Accordingly half of the blood recipients will not live long enough after

transfusion to develop vCJD. If all the surviving recipients do develop disease, 1875

new individuals per year could develop vCJD in the UK population

The current decline in the onset of clinical vCJD in the UK and the general low number

of cases in the older age groups who comprise the majority of blood recipients, indicate

that this worst case scenario considerably overestimates transfusion-related vCJD

disease development.

There are several possible explanations for this. It is possible that most infections have a

very long incubation period so that the individual dies before disease develops, or that

infections in some groups such as the MV heterozygotes or VV homozygotes are not

associated with blood infectivity, or that different genotypes do not transmit efficiently

to each other even if the unit is infectious. There are analogies in animal models for

these scenarios, and they reflect the difficulty in making realistic estimates of the

number of cases expected from blood transfusion. Taking the lower limit of the

confidence interval of the prevalence from the UK appendix-tonsils study and assuming

that only ten percent of infectious donations actually transmit the infectious agent, the

number of infected donations resulting would be 9 per year in contrast to the 1250

predicted by the worst case scenario. Independent of the method of calculation

transmission by blood transfusion may occur. Based on current data, the frequency

cannot be reliably estimated, but even in the UK it is probably low. The frequency is

largely dependent on the number of asymptomatic vCJD infected individuals in the

general population which is likely to differ from one Member State to another.

SCENIHR/003/05

The safety of human-derived products with regard to variant Creutzfeldt-Jakob disease

_______________________________________________________________________

6

Epidemiological studies, similar to the UK appendix-tonsils study, are needed to collect

data on the presence of infection (PrPRes) in the general population before estimations

can be made on the possible frequency of contaminated blood donations in countries

other than the UK. However, due to the rather low vCJD prevalence in other Member

States there are considerable difficulties in the collection of such data, and alternative

approaches for possible estimations of vCJD prevalence may therefore be used such as

calculations based on BSE exposure.

There is no evidence that individuals working in hospital settings have developed vCJD

by virtue of their profession. Transmission of TSEs during surgical or dental procedures

remains a concern, but to date there is no evidence that it has actually occurred in

relation to vCJD. To minimize the risk of transmission of vCJD by surgical instruments

cleaning and inactivation procedures are recommended based on the probability of the

patient under investigation/treatment being infected with vCJD (or any other TSE).

There are no proven instances of vertical transmission of any human prion disease. The

available animal and human data are inadequate to allow firm conclusions concerning

vertical transmission to be drawn. It is recommended that there is a follow-up for

children that are born to mothers who had or developed clinical vCJD. There are no data

indicating that breast milk transmits human prion disease.

In the absence of evidence on vertical transmission in man, the risk posed by the use of

cord blood which is of fetal origin can be considered to be negligible. However,

contamination with maternal blood during collection remains a possibility.

In conclusion, as long as there is a risk that infectious prion protein is present in blood

and blood components, there will be a risk of transmission of vCJD disease by

transfusion. Blood transfusion appears the most likely route for inter-human

transmission of vCJD, although other routes of transmission should also be considered

like surgery and organ or cell transplants.. The Committee does not consider that

additional specific measures are needed to reduce the risk from vCJD infectivity in

blood. In the UK and some other countries measures have already been taken including

donor exclusion of blood transfusion recipients, leucodepletion, import of fresh frozen

plasma, and reduction of amounts of plasma in blood components for transfusion. When

there is a concern for spreading of vCJD by blood transfusion, donor exclusion of blood

transfusion recipients is the appropriate measure. In addition, there are good practices to

reduce any risk for transmission of infectious diseases such as optimal use of the

transfusion to reduce the number of patients exposed, and optimal blood donation

techniques and blood transfusion practices which minimize the number of blood donors

to which an individual patient is exposed. The Committee recognises that it is important

that Member States maintain the principle of regional blood supply structures, national

surveillance systems and international information exchange at the EU level.

snip...6 of 81 pages, full text ;


http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_004b.pdf


USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________
PRODUCT
Source Plasma, Recall # B-1708-6
CODE
Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,
MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,
MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,
MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,
04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,
05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,
05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,
05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,
05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,
05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,
05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,
05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,
05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.
Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on risk factors for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA, NC, and MD

______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;
b) Fresh Frozen Plasma, Recall # B-1715-6;
c) Platelets, Recall # B-1716-6
CODE
a), b), and c) Unit: 2443732
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by letters dated
November 11, 2003 and December 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and WI

END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html

PRODUCT
Fresh Frozen Plasma, Recall # B-1751-6
CODE
Unit: 4936623
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September
16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk
factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html


Mon Aug 7, 2006 10:24
71.248.132.189

PRODUCT
a) Red Blood Cells, Recall # B-1587-6;
b) Cryoprecipitated AHF, Recall # B-1588-6;
c) Recovered Plasma, Recal # B-1589-6
CODE
a), b) and c) Unit: 2016719
RECALLING FIRM/MANUFACTURER
Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on
March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Germany

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;
b) Fresh Frozen Plasma, Recall # B-1591-6
CODE
a) and b) Unit: 2443595
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June
30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;
b) Fresh Frozen Plasma, Recall # B-1593-6
CODE
a) and b) Unit: 2545596
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
December 14, 2004 and January 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html



PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;
b) Fresh Frozen Plasma, Recall # B-1551-6
CODE
a) and b) Unit 2395371
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;
b) Platelets, Recall # B-1553-6;
c) Fresh Frozen Plasma, Recall # B-1554-6
CODE
a), b) and c) Unit 2438702
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;
b) Fresh Frozen Plasma, Recall # B-1556-6
CODE
a) and b) Unit 2454970
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1494-6
b) Cryoprecipitated AHF, Recall # B-1495-6
CODE
a) and b) Unit 5013100
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
Source Plasma, Recall # B-1450-6
CODE
Unit numbers ST0824313 and ST0824764
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK

______________________________
PRODUCT
Plasma Frozen, Recall # B-1422-6;
Recovered Plasma, Recall # B-1423-6
CODE
a) Unit 03E42218;
b) Unit 03E38153
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and Switzerland

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;
b) Recovered Plasma, Recall # B-1375-6
CODE
a) and b) unit 2453906
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
Source Plasma. Recall # B-1295-6
CODE
Units: NG0046551, NG0045950
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

______________________________
PRODUCT
Source Plasma. Recall # B-1296-6
CODE
Unit: NG 0044520
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

______________________________
PRODUCT
Source Plasma. Recall # B-1297-6
CODE
Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
KY

______________________________
PRODUCT
Source Plasma, Recall # B-1298-6
CODE
Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
KY

______________________________
PRODUCT
Recovered Plasma, Recall # B-1299-6
CODE
Unit: 4357117
RECALLING FIRM/MANUFACTURER
Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany

END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


CJD WATCH MESSAGE BOARD
TSS
FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY
Fri Jul 7, 2006 09:37
70.110.83.160


FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;
b) Platelets, Recall # B-1380-6;
c) Fresh Frozen Plasma, Recall # 1381-6;
d) Recovered Plasma, Recall # B-1382-6
CODE
a) Unit numbers: 2343106, 2377779, and 2403533;
b) and c) Unit numbers: 2377779;
d) Unit numbers: 2343106 and 2403533
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX and Austria
______________________________


PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;
b) Recovered Plasma, Recall # B-1468-6
CODE
a) and b) Unit numbers: 2329380
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland

______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;
b) Cryoprecipitated AHF, Recall # B-1480-6;
c) Recovered Plasma, Recall # B-1481-6
CODE
a), b), and c) Unit numbers: 2383280
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;
b) Fresh Frozen Plasma, Recall # B-1483-6
CODE
a) and b) Unit number: 2501452
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;
b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;
c) Recovered Plasma, Recall # B-1486-6
CODE
a) and c) Unit number: 2554077;
b) Unit number: 2415708
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Austria

_____________________________________

END OF ENFORCEMENT REPORT FOR July 5, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html

with new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. ...

TSS

Prion infections, blood and transfusions

Adriano Aguzzi* and Markus Glatzel

Prion infections lead to invariably fatal diseases of the CNS, including

Creutzfeldt-Jakob disease (CJD) in humans, bovine spongiform

encephalopathy (BSE), and scrapie in sheep. There have been hundreds

of instances in which prions have been transmitted iatrogenically among

humans, usually through neurosurgical procedures or administration of

pituitary tissue extracts. Prions have not generally been regarded as bloodborne

infectious agents, and case-control studies have failed to identify

CJD in transfusion recipients. Previous understanding was, however,

questioned by reports of prion infections in three recipients of blood

donated by individuals who subsequently developed variant CJD. On

reflection, hematogenic prion transmission does not come as a surprise, as

involvement of extracerebral compartments such as lymphoid organs and

skeletal muscle is common in most prion infections, and prions have been

recovered from the blood of rodents and sheep. Novel diagnostic strategies,

which might include the use of surrogate markers of prion infection, along

with prion removal strategies, might help to control the risk of iatrogenic

prion spread through blood transfusions. ...

snip...


Last, despite all epidemiological evidence to

the contrary, patients who are methionine/valine

heterozygous at codon 129 of the PRNP gene are

susceptible to infection with vCJD prions, which

raises several important questions. Is the virulence

of BSE prions enhanced when passaged

from human to human, as opposed to the

original bovine to human situation? Passaging

experiments of scrapie infectivity between mice

and hamsters indicate that this scenario is highly

plausible.6 Even more importantly, can vCJD

infection of heterozygous individuals establish

a permanent subclinical carrier state? Although

this situation might constitute a best-case

scenario for the infected individuals, it could be

disastrous from an epidemiological viewpoint,

as it might lead to an unrecognized and possibly

self-sustaining epidemic. ...

snip... full text ;

JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE CLINICAL PRACTICE NEUROLOGY 329

www.nature.com/clinicalpractice/neuro


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2004. SPORADIC CJD CASES TRIPLED, and that is
with a human TSE surveillance system that is terrible
flawed. in 1997 cases of the _reported_ cases of cjd
were at 54, to 163 _reported_ cases in 2004. see stats
here;

p.s. please note the 47 PENDING CASES to Sept. 2005

p.s. please note the 2005 Prion D. total 120(8)
8=includes 51 type pending, 1 TYPE UNKNOWN ???

p.s. please note sporadic CJD 2002(1) 1=3 TYPE UNKNOWN???

p.s. please note 2004 prion disease (6) 6=7 TYPE
UNKNOWN???


http://www.cjdsurveillance.com/resources-casereport.html

FDA Fines American Red Cross $4.2 Million (BLOOD CJD)
Fri Sep 8, 2006 20:01
71.248.154.242


FDA Statement
FOR IMMEDIATE RELEASE
Statement
September 8, 2006
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Fines American Red Cross $4.2 Million for Failure to Meet Established
Blood Safety Laws

The U.S. Food and Drug Administration (FDA) announced today that the
American Red Cross (ARC) is being fined $4.2 million for failure to comply
with requirements under Federal laws and FDA regulations relating to the
collection of blood products. These fines were assessed under an amended
2003 consent decree that calls for significant financial penalties when ARC
fails to comply with FDA regulations and consent decree provisions designed
to ensure the safety of the nation's blood supply.

The fines stem from a recently completed FDA review of recalls conducted by
ARC between 2003 and 2005 that found these events were preventable by ARC.
The violations include breaches of Good Manufacturing Practice (GMP) such as
a failure to ask appropriate donor screening questions and failure to follow
manufacturer test protocols. We have no evidence that these violations
resulted in serious health consequences.

Because receiving blood products always carries a degree of risk, it is
important that the blood industry complies with the full set of safeguards
in Federal laws and FDA regulations to minimize that risk. However, any
particular breach of the safeguards does not necessarily translate into
unsafe blood products, because the safeguards designed to protect the blood
supply are to some extent overlapping. The FDA continues to advise care
providers and consumers that rigorous protections are in place and that the
blood supply is safe. Patients in need of a transfusion should continue to
follow the advice of their physicians. The risks of receiving a transfusion
are far less than the risk of failing to receive a transfusion when blood
treatment is indicated.

Improvements in donor screening procedures and the use of a variety of new
tests in the last few years have made the national blood supply safer from
infectious diseases and other risks than it has been at any other time.
However, because there is always some degree of risk in receiving blood
products, each individual safeguard is considered critical to minimizing
that risk. Although the failure of an individual safeguard does not
automatically translate into the release of unsafe products, it may increase
the potential for risk. It is the potential risk that FDA insists the Red
Cross Board of Directors prioritize and support its new management's ability
to immediately address and work to improve its approach to quality.

The amended consent decree requires ARC to:

Establish clear lines of managerial control over a newly established
comprehensive quality assurance system in all regions;
To enhance training programs; and
To improve computer systems, records management, and policies for
investigating and reporting problems, including adverse reactions
Since entry of the 2003 consent decree and prior to this action, FDA has
issued the American Red Cross seven similar letters and assessed a total of
$5.7 million in penalties.

While achieving a blood supply with zero risk of transmitting infectious
disease is the ultimate objective, we recognize based on the available
science that this may not be realistic. Therefore, the FDA requires blood
processors to adopt and strictly follow a multi-layered safety program to
protect and enhance the safety of blood products at each stage of their
manufacture. At the blood collection stage, these measures generally
include:

Accurate and complete educational material for donors so that they can
assess their risk and decline to donate if that is appropriate;
Administration of donor screening questions to identify safety risks;
Checking of lists to prevent use of blood from persons known to be
ineligible to donate;
Quality controlled infectious disease testing procedures;
Inventory controls to prevent the release of units that are unsuitable;
Appropriate handling and distribution of blood and blood products for
patient use; and
Investigation and correction of deviations from standards
ARC is responsible for approximately 45% of the nation's blood supply; other
independent community-based blood centers together provide another 45%, and
hospitals collect most of the remaining 10%.

Blood donations are critically needed every day to save lives, and blood
donation is a safe procedure. FDA encourages persons who are in good health
to donate blood and to become regular blood donors.

####

http://www.fda.gov/cber/talkpapers.htm#arc

Red Cross fined $4.2 mln over blood safety

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2
million for failing to ask blood donors proper screening questions and
skipping other steps meant to keep the blood supply safe, officials said on
Friday.

The fine, the largest ever levied by the Food and Drug Administration for a
blood safety violation, follows a multiyear battle between the FDA and the
Red Cross, which collects about 45 percent of the blood donated in the
United States each year for transfusions.

The agency said it had no evidence that any blood collected by the Red Cross
harmed people who got transfusions.


But FDA officials said the failure to follow multiple safeguards increased
the risk that patients could receive blood tainted by an infectious disease.

"It is not acceptable that the quality systems failed in this way," Margaret
O'K. Glavin, FDA associate commissioner for regulatory affairs, told
reporters.

The FDA said its investigation found that several Red Cross recalls of blood
between 2003 and 2005 could have been prevented if it had taken a series of
mandatory steps to ensure donations are free of HIV or other infectious
agents.

One way the Red Cross erred was by failing to ask donors about travel
history that could increase the chances of having malaria or the human
version of mad cow disease, FDA officials said.

The problems involved 12,000 units of blood and blood components, FDA
officials said. None of the units was found to be contaminated after they
were recalled.

The latest fine was issued as part of a legally binding consent decree
reached in 2003 in which the Red Cross promised to improve its blood safety
system. Previously, the FDA had fined the organization a total of $5.7
million.

The 2003 deal revised a 1993 agreement that allowed the FDA to fine the Red
Cross for blood collection lapses.

The Red Cross said it would review the FDA's letter outlining its new
concerns and respond within 20 days.

"American Red Cross's senior management takes (the letter) seriously and is
committed to full compliance with the amended consent decree and all
applicable federal regulations," the organization said in a statement.


The FDA said the blood supply remained very safe.

http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML

http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML&pageNumber=1&imageid=&cap=&sz=13&WTModLoc=NewsArt-C1-ArticlePage1

Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518




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