guidance seracell enrolment 1

7/28/2019 Guidance Seracell Enrolment 1

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Guidance Seracell Enrolment 1.0 1/11

Guidance on the completion of the enrolment process

Dear customer,

thank you for enrolling with Seracell. The cryopreservation of cord blood falls under the strict provisions of the German Drug Act. We are therefore obliged to ask for certain

information on your medical conditions. Furthermore, we are obliged to receive your informed consent on the cord blood collection.

Immediately after you have placed your order online we will ask you to log into your secure customer service area. We explain this in STEP 1 of this document.

After the birth of your child you will receive an email from us asking to make a statement on your medical condition again. We explain this in STEP 2 of this document

We very much appreciate your co-operation.

STEP 1 Before the birth of your child

After you have enrolled by telephone or online, we will send you a letter containing your personal log-in to your secure customer service area. Please go to www.seracell.de andclick LOGIN on the upper right hand side of the website. You will see this screen.

Login Seracell Customer Service Area

Benutzer stands for user namePasswort means Password

After the data input is complete, click onAnmelden to log in. You will see the screen on the

nex page of this document.


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Dear Mrs,welcome to your personal customer service area with Seracell. We would like to giveyou some important information on the collection of cord blood and kindly ask youto give a few confirmations. Please note that the confirmations on this page as well asthe following four pages are required in order for the valuable cord blood to be

collected.

1. About my healthI am not aware of having hepatitis B or C, HIV or AIDS (this box is pre-checked)Confirmed online on date .

2. Relevant informationYes, I have been comprehensively informed about the cord blood collection with nounanswered questions remaining. The doctors (at my hospital) are not bound to

maintain confidentiality. (You may click on bitte lesen for more information or callcustomer service)

3. Consent to the collection, preparation and storage

Yes, I consent to the collection of cord blood after my babys cord has been cut. Iallow for the cord blood to be tested to the required extent, to be prepared and stored.A small sample of my own blood may be drawn for testing.

On the following four pages we ask a few questions about your medical history andcurrent conditions. The information obtained from it (anamnesis) form part of theclearance process for the collection of cord blood at your hospital and will bearchived in our files documenting the cord blood collection. All information obtainedis treated as strictly confidential and securely transmitted.

Please note that your cord blood collection kit may only be dispatched once allquestions have been answered completely and truthfully. Please take a few minutes

to answer them now. Thank you.

You may click on Seite drucken to print this page. By clicking on Weiter zurAnamnese you start with the medical questions.


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1. Questions on your medical history (first block)

1.1. Have you been diagnosed with an acute tumor or cancer thatrequires treatment?

1.2. Do you have or did you have a grave acute or chronic disease ofyour bone marrow or lymphatic system?

1.3. Have you ever been diagnosed with syphilis (lues)?

1.4. Do you have or did you ever have an HTLV-I-II-Infection (alsoknown as T-cell-leucaemia virus)?

1.5. Have you ever been diagnosed with a so-called prootozoonose(e.g. babesiosis, trypanosmiasis/Chagas disease orleishmaniasis)?

1.6. Have you ever had brucellosis, typhus, leprosy, relapsing fever,melioidosis or tularemia?

1.7. Did you stay in the United Kingdom of Great Britain andNorthern Ireland for a total of more than six months during1980 and 1996?

1.8. Did you have surgery in the United Kingdom of Great Britainand Northern Ireland or did you receive a blood infusion in thisterritory?

1.9. Do you belong to a high prevalence group for infections withthe hepatitis B or C virus or the HIV virus (e.g. drug addicts,prisoners).

1.10.Are you currently or have you ever been addicted to drugs ormedical substances or are you abusing any of these?

Please click on the left if any of the above questions apply to you.

Please click on the bottom right nein zu allen Fragen if none ofthe above applies and continue.


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2. Questions on your medical history (second block)

2.1. Have you been diagnosed with malaria during the past four years?

2.2. Did you stay in a malaria endemic region for half a year or longerduring the past four years?

2.3. Were you born or did you grow up in a malaria endemic region?

2.4. Do you have or have you ever had tuberculosis or q fever (Balkanfever or desert fever) during the past two years?

2.5. Have you been diagnosed with solmonellosis (eg typhus,paratyphus) or rheumatic fever (streptococcus fever) during the pasttwo years?

2.6. Were you inoculated against rabies following a bite by a fox or adog? Or did you receive a serum of veterinary origin?

2.7. Do you have or did you have a grave infectious disease during yourpregnancy (eg rubella, listeriosis, cytomegalovirus)?

2.8. Have you been diagnosed with hepatitis A during the past fourmonths?

2.9. Did you have any intimate contact with individuals belonging to a highprevalence group for infections with the hepatitis B or C virus or theHIV-virus (e.g. homosexual or bisexual men, drug addicts, prostitutes,prisoners) during the past four months?

2.10. Did you receive blood components (own blood, somebody elseslood) or plasma or any other blood products (eg blood clotting factors,

immune globolines) during the past four months?

Please click on the bottom left if any of the above questions applies toyou.

Please click on the bottom right nein zu allen Fragen if none of theabove applies and continue.


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3. Questions on your medical history (third block)

Please click ja (yes) or nein (no):

3.1. Have you ever been scathed by an injection needle orinstrument contaminated with somebody elses bloodduring the past four months?

3.2. Were you pierced in your ear, nose or other body partsduring the past four months?

3.3. Were you tattooed during the past four months?

3.4. Have you been diagnosed with toxoplasmosis during yourpregnancy?

3.5. Have you ever been inoculated against hepatitis B?

Please click on the bottom right Weiter to continue.


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4. Medication taken to treat serious diseases (fourthblock)

Are you permanently taking medication to treat any gravediseases? If so, please specify the conditions and themedication (one line per condition/medication).

Please click on the bottom right to continue.


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Thank you for your co-operation

Your cord blood collection kit will reach you approx. 6weeks before your planned delivery date or even faster ifdelivery is imminient. The box with your cord blood

collection kit contains a form on which we ask you todeclare your informed consent on the collection of thecord blood. We appreciate your prompt return of thisform.

The collection kit contains all documents and medicaldevices required for the collection of the cord blood.Please take the kit with you for the delivery.

For any questions, please send us an email [email protected] or call 0800 300 444 14 (Mon-Fri from 8:00 through 19:00).

The process is complete now. You may click on Weiterzur bersicht to get to a summary of your enrolmentinside your customer service area.


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If you clicked on Ja, Einlagerung fortsetzen. (Yes, I wouldlike to continue with the cryopreservation of the cord blood)

this screen will appear:

Your personal details

Thank you very much for enrolling with Seracell!

The formal procedure has been completed and will be proceedwith the cryopreservation of the cord blood.

These are the next steps:

The quality testing is going to take three to four weeks. Youwill be notified via email or telephone once this is completed.In the meantime you may always check the status inside yourcustomer service area.

For any questions:

Please call 0800 300 444 14(Mon Fr from 8:00 through 19:00).


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If you clicked on If you wish to go through and check each of thestatements made:

Details on your medical history

Before the collection kit had been sent to you these statements weremade by you regarding your medical history (anamnesis).

Please check if your statements still applied at the time of the birth ofyour child. Please modify in case there has been any change:

A. Have you go hepatitis B or C, HIV or AIDS?B. Have you ever been diagnosed with syphilis (lues)?C. Were you diagnosed with any serious infectious disease (eg

rubella, listeriosis, c ytomegalovirus)?D. Were you diagnosed with an infectious hepatitis A during the

four months prior to the delivery?E. Have you ever been scathed by an injection needle or instrument

contaminated with somebody elses blood during the past fourmonths?

F. Were you pierced in your ear, nose or other body parts duringthe past four months?

G. Were you tattooed during the past four months?H. Have you been diagnosed with toxoplasmosis during your

pregnancy?I. Have you ever been inoculated against the hepatitis B virus?

Please click on the bottom left Ich mchte etwas ndern if youwould like to view and modify the answers previously given to thesequestions.

If you feel that none of the above applied at the time of the delivery,please click on the bottom right Einlagerung fortsetzen for thecryopreservation to be continued. No further information from you isrequired in that case.


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This screen will only appear if you clicked on Ich mchteetwas ndern in the previous screen.

Details on your medical history

Please check if your statements still applied at the time of thebirth of your child. Please modify in case there has been anychange:

Please click on ja for yes or no for nein. Whenfinished, please click on the bottom right Datenaktualisieren und Einlagerung fortsetzen to update yourpersonal data and continue.

A. Have you got hepatitis B or C, HIV or AIDS?B. Have you ever been diagnosed with syphilis (lues)?C. Have you ever been diagnosed with any serious

infectious disease (eg rubella, listeriosis,cytomegalovirus)?D. Were you diagnosed with an infectious hepatitis A

during the four months prior to the delivery?E. Have you ever been scathed by an injection needle or

instrument contaminated with somebody elses bloodduring the past four months?

F. Were you pierced in your ear, nose or other body partsduring the past four months?

G. Were you tattooed during the past four months?H. Have you been diagnosed with toxoplasmosis during

your pregnancy?I. Have you ever been inoculated against the hepatitis B

virus?

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