Your Hospital Is Key

August 2013

About LifeSouth

Who we are Founded in 1974, LifeSouth is a 501(c)(3) non-profit community blood supplier for hospitals in Alabama, Florida and Georgia. LifeSouth employs nearly 800 people throughout our footprint. With more than 1,000 blood drives a month, 32 donor centers and 42 bloodmobiles, LifeSouth supplies over 350,000 blood components to more than 100 community hospitals annually.

Our missionTo provide a safe blood supply that meets or exceeds the needs in each community we serve, and to provide a variety of services in support of ongoing and emerging blood and transfusion-related activities.

LifeCordLifeCord is a program of LifeSouth Community Blood Centers. Established in 1998, it was the first public cord blood bank in the Southeast. LifeCord collects umbilical cord blood from newborns at hospitals in Florida, Georgia and Alabama. As of August 2013, the stem cells from those collections have been used for 111 transplants in 24 states and nine foreign countries (see map).

LifeSouth received FDA licensure for cord blood manufacturing in June 2013, becoming the fifth cord blood bank nationwide that is licensed by the FDA.

“The LifeCord staff has demonstrated a passion for this, and they are tirelessly working to provide a needed service. Receiving the FDA license indicates that we are meeting the highest and most stringent standards for providing high quality products to the patients we serve. This is an example of how the cooperative effort of how our partner hospitals and LifeSouth can work together to promote health.”

- LifeCord Medical Director Dr. John Wingard

Your hospital is key.You are essential.LifeCord’s goal Because of our geographic location, HRSA and the NMDP are encouraging LifeCord to actively recruit African-American and black donors. Our goal is to increase the likelihood of African-American and black patients finding a match by increasing the number of umbilical cord blood units on the registry.

Your hospital can helpWe want to partner with hospitals in the Southeast that have high minority birth rates. Your participation is the only way we can reach our goal.

Hospital partnersLifeCord currently collects umbilical cord blood at eight hospitals in Florida, Georgia and Alabama.

Baptist Medical Center EastMontgomery, Alabama

Baptist Medical Center South Montgomery, Alabama

East Alabama Medical Center Opelika, Alabama

Jackson HospitalMontgomery, Alabama

North Florida Regional Medical CenterGainesville, Florida

UF Health Gainesville, Florida

Northeast Georgia Medical CenterGainesville, Georgia

Henry Medical CenterStockbridge, Georgia

[insert your hospital name here]

We can’t do it without you. August 2013

What is cord blood and how is it used?Cord blood is the blood remaining in the umbilical cord and placenta after a baby is born. It is rich with blood-forming cells. Life-threatening diseases, such as leukemia or sickle cell disease can be treated with a cord blood transplant. Cord blood replaces diseased blood-forming cells with healthy cells. There is no cost for donating cord blood to LifeCord.

National Marrow Donor ProgramLifeCord partners with the National Marrow Donor Program (NMDP) to provide umbilical cord blood units for patients in need of a life-saving transplant. The NMDP operates the Be The Match Registry®, the largest registry of potential bone marrow donors and umbilical cord blood units in the world.

With nearly 185,000 cord blood units available, physicians around the world can search the registry if they have a patient that needs a transplant.

LifeCord’s partnership with the NMDP began in 2000. As of July 2013, LifeCord has listed 4,831 umbilical cord blood units on the Be The Match Registry®.

Ethnic Diversity

Not all patients are able to find a match on the NMDP registry. Patients from racially or ethnically diverse backgrounds often have uncommon tissue types. A patient’s likelihood of finding a match on the Be The Match Registry® is estimated to range from 66% to 93%, depending on race or ethnicity. African American or black patients have an estimated 66% likelihood of finding a match on the registry. What this means is that African-Americans are least likely to find a match. By increasing the number of minority cord blood units on the registry, minority patients will be more likely to find a match.

About Cord Blood Donation

August 2013

Public vs. Private Cord Blood Banks

One of the most common misconceptions about private cord blood banking is that a child’s own cord blood can be

transplanted if he develops a disease later in life. In many cases, diseases such

as leukemia, are genetic, so the cord blood that is banked at birth already carries the same disease. Most people who need transplants use cord blood donated by a sibling or a public cord blood bank. Cord blood recipients have about a 25 percent chance of matching a sibling and a 75 percent chance of finding a match from a public bank.    Only a small percentage of babies (estimated at between 1 in 1,000 to 1 in 200,000) ever use their own, privately banked cord blood. The American Academy of Pediatrics 2007 Policy Statement on Cord Blood Banking states that: “Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood.”

Common Misconceptions about Private Banking

The Cost of Private Cord Blood Banks

Parents who are interested in banking their baby’s cord blood have the opportunity to store it in a private bank for their family’s own use, or donate it to a public bank. Although

public donation is free and makes the cord blood available to anyone in the world who needs it, it is not available in all areas. Private cord blood banking generally costs up to $2,000 in initial collection and storage fees, and about $150 a year in storage fees after that. Public cord blood banks charge an FDA-approved cost recovery fee upon shipment for transplant.Parents who are considering banking their baby’s cord blood should consider how likely they are to need the cord blood, as well as the potential benefits of donating it to a public bank.On a case-by-case basis, the NMDP Be The Match Registry ® (which LifeCord uses) allows the individual public cord blood banks to work with the physicians if a cord blood unit is still available on the registry for use by a sibling.  Each case is unique and policies and procedures for handling them are at the discretion of the medical director of the cord blood bank.

Public or Private Cord Blood Bank: Making the Right Choice

Private cord blood banks charge mothers up front, including registration fees, harvesting and processing fees, and storage fees.If the cord blood unit is requested for transplant, the parents will incur

the cost of transportation, testing, HLA typing, infectious disease testing,

CD34 testing, and any other necessary testing.

Additionally, the costs associated with the transplant itself (hospital fees, doc fees, etc.) will be billed to the patient’s insurance.

Size Plays a Role in Cord BloodAfter birth, the umbilical cord

contains about 3 to 5 oz. of cord blood. While this amount is often sufficient for a cord blood transplant

in a small child, it is generally not enough for a transplant

in a child or adult who weighs more than 90 lbs. Researchers are investigating ways to multiply cord blood cells to make them useful for larger transplants or perform a multi-unit transplants. While public blood banks discard cord blood units that are too small for transplants or use them for research, many private cord blood banks store them anyway, at the family’s expense, even though they may not be usable later.

August 2013

Acute Lymphoblastic Leukemia (ALL)Acute Myelogenous Leukemia (AML)Chronic Myelogenous Leukemia (CML)Histiocytic DisordersFamilial Erythrophagocytic HistiocyosisHistiocytosis-XHemophagocytosisOther Histiocytic DisordersHodgkin’s LymphomaInherited Erythrocyte AbnormalityBeta Thalassemia MajorFanconi Anemia Pure Red Cell AplasiaSickle Cell DiseaseInherited Immune System DisordersAtaxia-TelangiectasiaCombined Immunodeficiency Kostmann SyndromeLeukocyte Adhesion DeficiencyChediak-Higashi SyndromeOmmenn’s SyndromeSevere Combined Immunodeficiency (SCID) SCID with Adenosine Deaminase deficiency Absence of T & B Cells SCID Absence of T Cells, Normal B Cell SCID Other SCIDWiskott-Aldrich SyndromeX-Linked Lymphoproliferative DisorderOther Immune System DisordersInherited Metabolism DisordersAdrenoleukodystrophySly Syndrome, Beta-Glucuronidase DeficiencyGaucher’s DiseaseHunter’s SyndromeHurler’s SyndromeKrabbe DiseaseMaroteaux-Lamy SyndromeMetachromatic LeukodystrophyNeiman-Pick DiseaseOther Mucopolysaccharidosis

OsteopetrosisSanfilippo SyndromeWolman DiseaseOther Inherited Metabolic DisordersInherited Platelet AbnormalitiesAmegakaryocytosis/Congenital ThrombocytopeniaMyelodysplastic Disorder SyndromesAcute MyelofibrosisChronic Myelomonocytic Leukemia (CMML)Essential ThrombocythemiaIdiopathic Sideroblastic AnemiaMyelodysplastic DisorderMyelofibrosis /Myeloid MetaplasiaParoxysmal Nocturnal HemoglobinuriaPolycythemia VeraRefractory AnemiaRefractory Anemia with Excess BlastRefractory Anemia with Excess Blast with TransformationUnknown Myelodysplastic DisorderOther Myelodysplastic DisorderNon-Hodgkin’s LymphomaOther LeukemiaAcute Biphenotypic LeukemiaAcute Undifferentiated LeukemiaChronic Lymphocytic LeukemiaJuvenile Chronic Myelogenous LeukemiaProlymphocytic LeukemiaOther LeukemiaOther MalignancyBreast CancerRenal Cell CarcinomaOther Non- Malignant DiseasesPlasma Cell DisordersMultiple MyelomaPlasma Cell LeukemiaUnknown Plasma Cell DisordersWaldenstrom’s MacroglobulinemiaOther Plasma Cell DisorderSevere Aplastic Anemia

The following diseases may be treated by transplant using hematopoietic stem cells obtained from umbilical cord blood, peripheral blood or bone marrow under appropriately approved research protocols.

Diseases Treatable by Stem Cell Transplantation

August 2013

When Braelyn Scott was born Jan. 30, 2013, she became her family’s youngest blood donor. Just minutes after she was born, her doctor was able to collect the blood from her umbilical cord.

“It was very simple. I didn’t have to do a thing, it was painless for me and the baby, and it was free,” said Tiffany Scott, Braelyn’s mom. “Ask your doctor. Find out if it’s an option at your hospital. Your tiny baby could be someone’s lifesaver.”

Devon Vickers received a cord blood transplant while undergoing treatment for leukemia. Today she’s healthy thanks to a cord blood donor.

“I would love to have the opportunity to thank the mother and child who donated cord blood.”

To hear Devon’s amazing story, visit youtube.com/lifesouthcbc

Josh Ibarrientos received a cord blood transplant after battling leukemia for six years and is now cancer-free.

“Every time I know someone who is pregnant, I tell them your OB/GYN will give you some information on cord blood. Joshua is a living example that it really helps, don’t let them waste it, if you can donate it,” said Gea Ibarrientos ( Josh’s mother). “My friends, my relatives know how Josh was saved.”

Cord blood saves lives.

August 2013

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888-795-2707 www.lifesouthcord.org

June 2013Hospital Cord Collection Report

NFRMC NGMC

Baptist EBaptist S

EAMC

Jackson

Shands HMC

TOTAL 9 10 48 31 103 5621 21 64 21 86 64

7864Monthly Goal

= Monthly Goal

12586

Bankable units include all units that meet initial criteria* to begin processing at LifeCord facility

*Initial Criteria: meeting weight (> 130g), proper ID placement, exclusion criteria signed, PTC form signed and present, tubes collected, no clots, and matching DIN numbers

33%

59%

68%

67%

68%

71%

57%

60%

Bankable UnitsTotal

Collected Bankable

Baptist Medical Center East

Baptist Medical Center South

East Alabama Medical Center

Jackson Hospital

N. Florida Regional Medical Center

Shands at the University of Florida

Henry Medical Center

Northeast Georgia Medical Center

9

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103

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LifeCord is a program of LifeSouth Community Blood Centers. For more information, call Megan Arthur at 352-224-1738 or email mearthur@lifesouth.org.

Thank you for helping us save lives.

20

40

60

80

100

(All collection numbers in this report represent this month's collections only.)

LifeCord Communication on Hospital Collections

August 2013

Top Cord Collectors Best Cord Volume

Gainesville, FloridaDr. Richard Brazzel100% met weight (13 out of 13)

Gainesville, Georgia Dr. Clayton Cox 100% met weight (5 out of 5)

Montgomery, AlabamaDr. Glenn Saucer100% met weight (5 out of 5)

Stockbridge, GeorgiaDr. Deborah Haynes100% met weight (7 out of 7) Opelika, AlabamaDr. William Golden 100% met weight (5 out of 5)Dr. Kerri Hensarling 100% met weight (5 out of 5)

Gainesville, FloridaDr. Anthony Agrios260g

Gainesville, GeorgiaDr. Jacquelyn Stone219g

Montgomery, AlabamaDr. Paula Sullivan208g Stockbridge, GeorgiaDr. Deborah Haynes230.5g

Opelika, AlabamaDr. Gwen Cooper195g

The importance of DINs Each cord blood kit that is created is assigned a DIN number. The DIN is present on the base label for the collection bag, the enclosed paperwork, and on the outside ziplock bag. The collection nurse also attaches a patient addressograph to the bag, as well as the paperwork. It is very important that the DIN numbers and patient addressographs match when the kit is received at LifeCord. It is also very important to return the contents in the same ziplock bag that originally contained the contents. The DIN on the outside of the large ziplock bag contains a DIN that must match the paperwork and the collection bag DINs.

At times, the DIN number or patient addressograph on the collection bag does not match the paperwork. This may happen if two mothers are delivering at the same time and the nurse is preparing both kits at the same time. It is important to only prepare one patient kit at a time to lower the possibility of mixing the DIN numbers or patient addressographs. It is also important to only use the supplies from the current kit you are preparing. This will help to ensure LifeCord can verify the unit collected is attached to the proper maternal information.

Cord Blood Collection Facts and Tips• Allow cord blood to drain into the bag for as long as possible. • Rocking the bag after collection will minimize clots in the bag.• Applying downward pressure (toward the collection bag) while cleaning the cord will

allow for increased blood flow into bag.• To keep cord blood as aseptic as possible, place the collection bag on the chux, then on

the floor to allow gravity to assist with collection.• C-sections contribute more to the TNC level and allow for collection of cord blood in a

greater amount.• Ethnic cord blood units usually have a lower TNC than Caucasian cord blood units. In

these cases, allowing the most time to collect the cord blood unit is essential.• To maintain viability and potency of the unit, minimize the time from collection to the

time placed in the designated pick up area.

Most units collected will not meet the stringent banking eligibility requirements such as sterility testing, IDM testing, weight and TNC levels

Targets for Bankable Unit

Volume: Minimum 45mL

of cord blood

Collection Bag:2/3 full

Babies are Superheroes

Check out our new Super Baby LifeCord PSA at youtube.com/LifeSouthCBC

August 2013

August 2013

Reference Materials

August 2013

LifeCord Gainesville, FL

www.lifesouthcord.org

Jill EvansVice President of QualityOffice: 352-224-1634Cell: 352-538-1957Email: jaevans@lifesouth.org

JB BowlesVice President of OperationsOffice: 352-224-1603Cell: 352-428-0076Email: jbbowles@lifesouth.org

Ed DowneyAdministrative Laboratory ManagerOffice: 352-224-1601Cell: 727-534-1046Email: emdowney@lifesouth.org

Amy LambertCellular Therapy ManagerOffice: 352-224-1737Cell: 863-201-3735Email: allambert@lifesouth.org

Megan ArthurCellular Therapy RecruiterOffice: 352-224-1738Cell: 317-498-5452Email: mearthur@lifesouth.org

Dr. Juan Merayo-RodriguezLifeSouth Medical DirectorOffice: 352-224-1747Cell: 352-682-2076Email: jamerayo-rodriguez@lifesouth.org

August 2013

John Wingard. M.D. LifeCord Medical Director

Price Eminent Scholar University of Florida Shands Cancer Center Director

Office: 352-273-80222033 Mowry Road, Suite 145

Gainesville, FL 32610Email: wingajr@ufl.edu

Educational Materials for Mothers

1. Give the expectant mother a LifeCord folder, either in Spanish or English as applicable, containing materials listed above

2. Discuss, at minimum, the following topics:

a. Cord blood donation helps treat life-threatening diseases, such as leukemia, lymphoma, and sickle

cell disease because cord blood is rich with blood-forming cells that can be collected, stored, and used for patients in need of a transplant.

b. The donation process does not affect labor and delivery, and no blood is taken from the baby. The blood is collected from the umbilical cord and the placenta after the baby is born.

c. After it is collected, the cord blood is stored at LifeCord, a public cord blood bank. If the cord blood is eligible for banking, it is banked and then listed on the worldwide Be the Match Registry ®. If the cord blood is selected as a match for patient, it is transplanted into the patient’s bloodstream so that the healthy cord blood cells can replace the patient’s bone marrow.

d. Cord blood does not need to match a patient’s tissue type as closely as donated marrow. This means that more patients will have the chance to receive a transplant from umbilical cord blood.

e. Racially and ethnically diverse cord blood units are needed because patients are more likely to match blood tissue types with their same race or ethnic background.

f. Donating to a public bank like LifeCord means that the cord blood is available to any patient who needs a transplant; it is not reserved for the donor’s family, as with a private bank. Private banks must charge families a fee; however, donating to a public bank like LifeCord is free.

g. Donations to LifeCord remain confidential.

If an expectant mother asks a question that you cannot answer, consult with the Cellular Therapy Manager or the LifeCord Medical Director to answer the question.

3. Ask the expectant mother to fill out and sign the Permission for Cord Blood Collection form before going into active labor if she is interested in donating her baby’s cord blood.

4. Ask the expectant mother to bring the signed permission form

Materials List

aLifeCord folder, which contains:

• Cord Blood FAQ brochure

• How to Donate brochure

• Cord Blood brochure

• Cord Blood Recipient Stories (available for different races and ethnicities)

• Permission for Cord Blood Collection form (in English or Spanish as appropriate)

Checklist

p Provide the expectant mother with an informational packet in English or Spanish

p Discuss important topics related to cord blood donation

p Ask the mother to sign the Permission Form before going into active labor.

p Instruct the mother to bring the signed form to the hospital when she delivers her baby.

August 2013

Sample Communication to the Mother About Cord Blood Donation

Mother’s Consent to Donate Baby’s Cord Blood

About Cord Blood DonationUmbilical cord is rich in blood stem cells. These cells can be used for life-saving bone marrow transplants in patients with diseases that have been approved for treatment with cord blood, such as leukemia and lymphoma. Cord blood units available and stored in public banks save thousands of patients’ lives every year. Over 20% of transplants done through the National Marrow Donor Program (NMDP) are cord blood transplants. Because the required degree of matching is less for cord blood than for other sources of cells for transplant, ethnic minorities and patients with rare tissue types often can find suitable matches only by using cord blood.

If you consent to have your baby’s cord blood banked and it meets criteria, the cord blood unit along with test samples will be processed, frozen, and stored by LifeCord for 10 years or more. It will be listed for search as a possible transplant unit as part of the National Cord Blood Inventory (NCBI). The NCBI is part of the C.W. Bill Young Cell Transplantation Program.

The cord blood unit may also be used for other purposes, such as personnel training. If your baby’s cord bloodunit may be useful for future research involving patient transplant, LifeCord will contact you. We will discussthe additional research opportunity and obtain your consent separately for the proposed research.

Medical History and TestingWe will need to obtain your medical history and perform testing to determine if your baby’s cord blood is suitable for banking. If you sign this consent:

• We will ask you detailed questions about your own and your family’s medical history. Some questions relate to your current and past lifestyle, including sexual history and drug use. These questions are similar to those asked of blood donors.

• We will request and evaluate the medical records related to your baby’s delivery. • A sample of your blood will be collected near the time of your baby’s birth. If the cord blood unit qualifies for banking,

your blood and your baby’s cord blood will be tested for a variety of genetic conditions and for infectious diseases, including HIV and hepatitis. Your blood may also be tissue typed.

• Samples of your blood and the cord blood will be stored for possible future testing.All of this information is confidential. However, state law requires LifeCord to report the names of people who test positive for some infectious diseases to the State Health Department. Also, the knowledge that you or your baby has an infectious disease or genetic condition will allow you to seek treatment but may make it difficult for you to get health insurance. Your blood may also be tissue typed, and some of your blood and the cord blood may be stored for possible future testing.

Your Confidential Information All donor records are strictly confidential. Donor records may be reviewed by regulatory agencies such as the U.S. Food and Drug Administration (FDA), funding agencies such as the Health Resources and Services Administration (HRSA), the NMDP, and accrediting organizations such as FACT-NetCord or AABB. We will make every effort to protect your and your baby’s confidentiality.

When LifeCord receives the cord blood unit, we will assign it a number. This number will be used for the cord blood during testing and processing. Donor records that link your name with your number will be kept in a locked file cabinet and stored on a computer in restricted areas.

If LifeCord shares cord blood unit information with a potential transplant center, we will not share information that identifies you or your baby. LifeCord will protect your private information. No personal information is shared with research investigators. There is a remote possibility that your privacy could be compromised; however, LifeCord keeps donor information in secure and confidential storage so that only authorized individuals have access.

August 2013

Sample Consent Form for the Mother Permission for Cord Blood Collection

LifeCord Cord Blood BankBeing a cord blood donor means that your baby’s cord blood is collected, held in a public bank, and included in a cord blood matching registry.

Note these points when you consider becoming a cord blood donor: • You must be at least 18 years old to donate your baby’s cord blood. In addition, you must have a normal labor

and delivery. • Cord blood collection will not affect your labor or delivery. After the umbilical cord has been cut between

the baby and the placenta, either your doctor or trained collection personnel will collect the cord blood. • There is no cost to you for participating in this public cord blood banking program. When donating your

baby’s cord blood to LifeCord, the cord blood may be publicly banked, if it qualifies. If it doesn’t qualify, then it may be sent for research, made available for other scientific or technical needs, used as otherwise deemed medically appropriate by the LifeCord program, or discarded.

• You may also elect to privately bank your baby’s cord blood; LifeCord does not provide this service, but other cord blood banks in your area may.

• Complete this form to provide permission for LifeCord to collect your baby’s umbilical cord blood and to collect blood samples from you for disease testing.

• Once you complete this form, leave it with your healthcare provider, and remember to tell your healthcare provider that you are a cord blood donor.

• Call LifeCord at (352) 224-1737 with any questions about this process.

Thank you for your lifesaving donation!

I understand that LifeCord Cord Blood Bank is a public bank that provides my baby’s cord blood to patients for a service fee that covers labor, materials, delivery, and other costs. The cord blood may also be used for research, used for other medically appropriate applications determined by the LifeCord program, made available for other scientific or technical needs, or discarded.

I understand that a representative of LifeCord may contact me to obtain additional information about my personal and family background and collect a sample of my blood for disease testing. At that time, I will also be asked to consent to have my baby’s cord blood included in LifeCord’s public cord blood bank.

I voluntarily consent to the collection of my baby’s cord blood at the time of delivery and to have samples drawn for disease testing.

Print Mother’s Name: Phone Number:

Mother’s Signature: Date:

Mother’s Date of Birth: Doctor’s Name:

Mother’s Race or Ethnicity: Father’s Race or Ethnicity:

Mother’s Address:Baby’s Gender: p Male p Female p Not known

Recruiting Nurse’s Name: Mother’s Due Date:

August 2013

LifeCord forms and educational materials are available in Spanish Permiso para recolectar sangre del cordón

Banco de sangre de cordón LifeCord

Ser donante de sangre de cordón significa que la sangre de cordón de su bebé es recolectada, conservada en un banco público e incluida en un registro de compatibilidad de sangre de cordón.Tome en cuenta estos puntos cuando piense en convertirse en un donante de sangre de cordón: • Debe tener al menos 18 años de edad para donar la sangre del cordón de su bebé. Además, debe tener un

trabajo de parto y un alumbramiento normales. • La recolección de la sangre de cordón no afectará su trabajo de parto ni el alumbramiento. Después de que el cordón umbilical haya sido cortado entre el bebé y la placenta, su médico o el personal de recolección

capacitado recolectará la sangre de cordón. • La participación en este programa público de banco de sangre de cordón no tendrá ningún costo para usted. Cuando done la sangre de cordón de su bebé a LifeCord, es posible que la sangre de cordón se almacene en un banco público, en caso de que califique. Si no califica, entonces puede ser enviada para investigación, puesta a disposición para otras necesidades científicas o técnicas, ser utilizada según se considere médicamente apropiado para el programa LifeCord, o desechada. • También puede elegir un banco privado para la sangre de cordón de su bebé; LifeCord no proporciona este servicio, pero otros bancos de sangre de cordón en su área pueden hacerlo. • Complete este formulario para otorgar permiso para que LifeCord recolecte la sangre de cordón umbilical de su bebé y muestras de sangre de usted para realizar pruebas de enfermedades. • Una vez que complete el formulario, entrégueselo a su proveedor de atención médica, y recuerde decirle a su proveedor que usted es un donante de sangre de cordón. • Llame a LifeCord al (352) 224-1737 si tiene preguntas acerca de este proceso.¡Gracias por su donación que salvará vidas!

Entiendo que el banco de sangre de cordón LifeCord es un banco público que proporciona sangre de cordón de mibebé a pacientes por una tarifa de servicio que cubre el trabajo de parto, los materiales, el alumbramiento y otroscostos. La sangre de cordón también se puede usar para investigación, para otras aplicaciones médicamenteapropiadas según se determine en el programa de LifeCord, se puede utilizar para otras necesidades científicas otécnicas, o se puede desechar.

Entiendo que un representante de LifeCord puede ponerse en contacto conmigo para obtener información adicional acerca de mis antecedentes personales y familiares, y para recolectar una muestra de mi sangre para realizar pruebas de detección de enfermedades. En ese momento, también me pedirán mi consentimiento para que la sangre de cordón de mi bebé sea incluida en el banco público de sangre de cordón de LifeCord.

Voluntariamente doy consentimiento para la recolección de la sangre de cordón de mi bebé al momento del parto y para tomar muestras para realizar pruebas de detección de enfermedades.

Nombre de la madre, en letra de imprenta: Número de teléfono:

Firma de la madre: Fecha:

Fecha de nacimiento de la madre: Nombre del médico:

Raza u origen étnico de la madre: Raza u origen étnico del padre:

Dirección de la madre:Sexo del bebé: p Masculino p Femenino p Desconocido

Nombre de la enfermera que hace el reclutamiento: Fecha estimada para el parto:

August 2013

Post Donation ContactIf we become aware of any results that may be important to your or your baby’s health or that affect your eligibility todonate cord blood, we will notify you. To better interpret and understand the results of some tests, we may need tocontact you for follow-up testing.

If there is a change in your baby’s health, we ask that you contact us, as this information may affect the cord blood unit’ssuitability for transplantation. To contact us about changes in your baby’s health or if you have any questions, please call352-224-1737.

Mother’s Statement of ConsentThe information I have provided about my medical history and HIV-risk factors is accurate and true. I understand that by donating my baby’s cord blood, my child and I will have no right to the cord blood now or in the future. The cord blood unit will be kept by LifeCord, or it may be transferred to another NCBI cord blood bank. However, if in the future my child or other blood relative requires treatment with stem cell transplantation and the cord blood is still available, LifeCord may be able to provide it.

I understand all of the information presented, all of my questions have been answered, and I agree to donate mybaby’s cord blood.

Mother’s Signature: Date:

Mother’s Printed Name:

Mother’s Date of Birth:

Interviewed by (name):

Signature of Interviewer: Date:

August 2013

Cord Blood Donation Consent Procedures for Nurses

Materials Neededp LifeCord Reference Guide binder (provided

by LifeSouth)p Mother’s Consent to Donate Baby’s Cord

Blood formp Medical release formp NMDP questionnaires • Family Medical History• Maternal Demographic Information• Maternal Riskp Unexpected Response Directive Form

Nurse's Consenting Checklistp Meet the mother at the hospitalp Confirm the mother’s identityp Have mother complete consent form, medical

release form, and 3 NMDP questionnairesp Make copy of and deliver medical releasep Bundle documents and place in collection kit

If the mother decides not to donate her baby’s cord blood unit at any point in this process, thank the mother for her time and alert LifeCord staff that the unit must be discarded, if already collected.

Ifyoucannotlocateaconfidentialsetting,give the mother the forms and let her read and complete them. The mother can complete the family medical health questionnaire in the presence of family members.

1. To initiate the consent process, meet the mother in the hospital. The consent documents can be completed at any time during the mother’s hospital stay so far as she is able to concentrate and not be distracted by the aspects of labor.

2. Obtain the three NMDP questionnaires, a medical release form, and the Mother’s Consent to Donate Baby’s Cord Blood form.

3. Verify the mother’s identity by verbally asking her for her name.

4. Have the mother read and sign the Mother’s Consent to Donate Baby’s Cord Blood form.

5. Have the mother read and sign the required medical release form.6. Have the mother complete all three NMDP

Cord Blood Donor questionnaires.a. Explain to the mother that her health

information will help determine the acceptability of her baby’s CBU.

b. In a confidential setting, read the NMDP questionnaires to the mother and record her answers on the forms.

d. Ensure that all unexpected responses are explained and documented thoroughly on the Unexpected Response Assessment; perform the following:(i) Complete top section of form.(ii) Select appropriate questionnaire; recordquestion number.(iii) Record mother’s response; include as muchdetail as possible.(iv) Repeat steps (ii) through (iv) if moreunexpected responses occur.

e. Use the NMDP Action Guides located in the LifeCord Reference Guide binder for the questionnaires to ensure that all questions are answered completely.

f. When the mother has finished completing the forms, review her responses immediately and follow up as needed, using the NMDP action guides as a reference. Look for and address any blank spaces on the forms.

g. Place the mother’s Addressograph on all forms. Refer to the LifeCord Reference Guide binder to ensure all highlighted areas are completed.7. Ensure that the mother’s sample tubes have been

drawn. If necessary, refer to CB.5.1, Pre-Collection Nursing Procedures for Cord Blood.

8. Make a copy of the medical release; hand deliver the medical release to the appropriate department in the hospital.

9. Bundle the consent form, questionnaires, and a copy of the medical release for the cord blood donation. Include the medical records and Unexpected Response Assessment, if applicable.

10. Place document bundle in a resealable plastic bag and include in collection kit to send to LifeCord.

August 2013

c. Explain any unclear areas.

Pre-Collection Nursing Procedures for Cord BloodCall 1-888-795-2707, extension 41737, with any questions about the collection process.

1. Obtain the cord blood collection kit from the designated storage area.

DO NOT open the kit at this time.

2. Review the Exclusion Criteria label on the outside of the kit(s).

4. Obtain 10 patient ID labels (Addressographs) for the mother.

5. Open the collection kit and review its contents to Ensure that all materials are included. Each kit

should include the following:

a. PVP Iodophor Scrubb. Clamp or small clipc. Underpad (chux)d. Large, resealable plastic bage. Small, resealable plastic bag that includes:

(i) CBU Collection Form(ii) Prepared base labelf. A collection bagg. Tubes for sample collection: 3 purple-top tubes,one red-top tube, and one yellow-top tube.

1. If hospital policy permits, draw the mother’s sample tubes at this time. If not, set the tubes

aside until after delivery. Draw tubes as follows:

a. Use the LifeCord-provided tubes to collect the mother’s samples, following the hospital’s standard operating procedure for sample collection.b. Label each tube with the mother’s hospital patient ID label (Addressograph).c. Write the date and time of draw on the tubes.d. Initial the tube labels.

7. Provide the items from the collection kit to the physician as needed.

3. Ensure that the Permission for Cord Blood Collection form has been completed and signed.

If this: Do this:

Mother matches one or more exclusion criteria

Return the unopened kit to the designated storage area

Mother does not meet any exclusion criteria

Proceed to the next step.

If this: Do this:

Form has not been signed

STOP. Do not proceed with collection. If appropriate, refer to CB.2.1, Educate a Cord Blood Donor Mother.

Form has been signed Proceed to the next step.

Nurse’s Pre-Collection Checklist

p Obtain CBU collection kitp Review Exclusion Criteriap Verify that Permission Form is signedp Obtain 10 patient ID labelsp Open kit; review kit contentsp Draw and label mother’s sample tubes,

if hospital policy permitsp Provide physician with items for cord blood collection from the kit.

August 2013

Cord Blood Collection

Call 1-888-795-2707, extension 41737, with any questions about the collection process.

1. After the infant is delivered and before the placenta detaches, double-clamp and cut the umbilical cord between the clamps.

2. Receive the collection kit from the nurse.

3. Cleanse 4 to 6” of umbilical cord with PVP Iodophor Scrub at the intended needle insertion site.

4. Place the 4" x 4" sterile gauze under the umbilical cord. Using the gauze to hold the umbilical cord, puncture the umbilical vein with the needle just above the clamp.

5. If the vein is not initially punctured or collapses before the collection is complete:

a. Re-scrub the cord, as outlined in Step 3. b. Re-puncture the vein at an additional site as

explained in Step 5, working your way up the cord as needed.

6. Place the blood bag below bed level.

If chux is not used, do not place the blood bag on the floor.

If chux is placed on the floor to prevent contamination, the blood bag may be placed on top of the chux.

7. If possible, allow 5 minutes of blood flow by gravity into the collection bag until it is at least 1/3 full.

8. When collection is completed, milk the blood in the tubing down into the bag.

9. Use the clamp provided on the tubing of the bag to clamp the tubing as close to the bag as possible.

10. Secure the needle by using the guard that is attached to the bag so that it covers the needle.

11 Pull on the tubing to ensure that the needle is secured in the protector.

12. Ensure that the clamp remains clamped to the tubing.

13. Hand the collection kit to the nurse for labeling and processing.

August 2013

Post-Collection Procedure for Nurses

Call 1-888-795-2707, extension 41737, with any questions about the collection process.

1. Upon receipt of the filled collection bag from the physician, close the clamp on the tubing and gently invert the bag 180 degrees at least 10 times to thoroughly mix the cord blood and CPD anticoagulant.

2. Place the prepared base label over the blood bag base label; then, write the collection date and time

on the label.

3. Place one hospital patient ID label (Addressograph) for the mother on the back of the bag.

4. Verify that the hospital patient ID label

5. (Addressograph) placed on the collection bag matches the hospital patient ID on the mother’s

arm band.

6. Verify that the DIN on the base label matches the DIN on the CBU Collection Form.

7. Wrap the cord blood bag in the absorbent material (chux) provided and place it in the large, resealable plastic bag.

8. Verify that no exclusion criteria apply to the collection. Then, provide your signature and the date in Step 1 of the CBU Collection Form.

9. Complete Step 2 of the CBU Collection Form according to the example shown in Figure 1. If the mother’s sample tubes were not drawn prior to delivery, arrange to draw tubes as follows:

a. Use the LifeCord-provided tubes to collect the mother’s samples; follow the hospital’s standard procedure for sample collection.

b. Label each tube with the mother’s Addressograph (hospital patient ID label). c. Write the date and time of draw on the tubes. d. Initial the tube labels.

e. Return the collected tubes to the plastic bag in which they were originally stored. Place this

bag in the designated pickup area (in the same secure, temperature-controlled location where the CBUs are stored).

10. Place the Permission for Cord Blood Collection form, the CBU Collection Form and at least 4 hospital patient ID labels (Addressographs)

for the mother in the small, resealable plastic bag. Seal the small bag and place it in the large, resealable plastic bag. Then, seal the large bag (which contains the wrapped CBU).

11. Place the kit in the secure, temperature-controlled, designated storage area of the hospital (either the designated storage device or in the designated container in the room-temperature storage area).

To report a cord blood collection-related donor complaint, contact the LifeSouth LifeCord Department at 1-888-795-2707 x 41737.

Nurse’s Post-Collection Checklist

p Invert the collection bag 180 degrees at least 10 times

p Place the prepared base label over the blood bag base label and record collection date and time

p Place patient ID label for mother on the back of the collection bag

p Verify that the patient ID label on the bag matches the mother’s arm band and DIN on base label matches DIN on the CBU Collection Form

p Wrap the CBU in chuxp Complete Page 1 of collection formp If sample tubes were not drawn prior to

delivery, draw and label sample tubes

p Prepare kit for pickup

p Place the kit and mother’ sample tubes in the designated storage area

August 2013

CBU Collection FormLifeCord Cord Blood Bank

CB.5.3 Apr2013

STEP 1: EVALUATE THE DELIVERY **Exclusion Criteria**

Do not collect a cord blood unit if any of the following conditions exist: Mother is less than 18 years old Mother has positive test results for HIV, HCV, HBV, HTLV or syphilis Mother has scarring or other evidence of illicit needle use Mother is a surrogate; infant resulted from donated egg, sperm or embryo Infant delivered at less than 34 weeks gestation Multiple fetuses Single infant is stillborn or can’t be resuscitated Grossly evident fetal malformations During labor/delivery:

o Excessive maternal bleeding o Mother received a blood component transfusion or >2L of fluidso Placental trauma occurredo Evidence of placental infection- pus, significant tears, foul odoro Clinical suspicion of chorioamnionitiso Evidence of active genital infection (herpes, human papilloma virus, syphilis, etc.)

None of the above exclusion criteria apply. Signature: Date:

Review the exclusion criteria to ensure that the umbilical cord blood is eligible for collection. If no items are checked in the above category, proceed to the next section of the form after collecting the cord blood.

STEP 2: PROVIDE COLLECTION INFORMATION (please print)

Form Completed by:

Mother’s Patient ID Number (Addressograph) Label: Comments:

Collection Facility:

Did mother receive antibiotics? Yes No

Delivery Nurse: CBU Kit Lot #:

Collected by: Kit Expiration Date:

Collection Date and Time: Time Zone: Eastern Central

If any type of adverse event occurs during collection of the cord unit, contact the LifeCord office at (352) 224-1708 to request a copy of the Adverse Event Report form. Complete this form and return it to LifeCord.

1. Place this completed form in the small resealable bag enclosed in the collection kit. 2. Include four Patient ID Number (addressograph) labels. 3. Seal the plastic bag and place into the large resealable bag with the collected cord blood unit.

Ì&f00001236[Î

CBU Collection FormLifeCord Cord Blood Bank

(LifeCord Use Only) Place CBU

DIN Sticker Here

Clear Fields

Sign and date

Step 1 after reviewing the

exclusion criteria.

Print your name

here.

Indicate your collection

facility and whether the mother received

antibiotics.

Include delivery

nurse’s name, physician’s name, time and date of

collection, and the related time

zone.

Place mother’s

addressograph here.

Figure 1, Example of CBU Collection Form, page 1August 2013