AbULT ANb PEbIATRIC BLOOb ANb MARROW TRANSPLANT …spitfire.emmes.com/study/duke/SOP/Donor Selection... · InfoCard #: APBMT-COMM-002 Rev. 12 Effective Date: 01 Oct 2019 DukeMedicine

InfoCard #: APBMT-COMM-002 Rev. 12 Effective Date: 01 Oct 2019

DukeMedicineDivision of Cellular Therapy

^AbULT ANb PEbIATRIC BLOOb ANb

MARROW TRANSPLANT PROGRAM

DOCUMENT NUMBER: APBMT-COMM-002

DOCUMENT TITLE:Adult Donor Health History Questionnaire

DOCUMENT NOTES:

Document Information

Revision: 12 Vault: APBMT-Common-rel

Status: Release Document Type: Common

Date Information

Creation Date: 04 Sep 2019 Release Date: 01 Oct 2019

Effective Date: 01 Oct 2019 Expiration Date:

Control Information

Author: MC363 Owner: JLF29

Previous Number: APBMT-COMM-002 Rev 11 Change Number: APBMT-CCR-169

CONFIDENTIAL - Printed by: ACM93 on 01 Oct 2019 08:16:26 am


Form

MD345

Date: / /

APBMT-COMM-002ADULT DONOR HEALTH HISTORY QUESTIONNAIRE

Name: Date of Birth:

/ /History Number:

Gender: DMale DFemaleHome Phone: Cell Phone:

Pediatrics Only:Height:

cm/inWeight:

kg/lbsTemp:

C/FPulse: HCT:

Instructions:> Read each question as written and answer to the best of your knowledge.> Mark your responses clearly as "yes" or "no" or "NA".> For question #1 and #2, please explain a "no" response in the remarks section.> For all other questions, please explain any "yes" response in the remarks section. Include details such as type/name

of any medication, when event(s) occurred, type of surgery, current status, etc.> If you have any questions, please discuss them with your donor center staff.

Section 1: General Assessment and Donor Safety Yes | No Remarks

Have you read the educational materials provided to you and hadyour questions answered? D a

2. Are you in good health? D D

3. Are you now, or have you EVER, taken any of the medications onthe Medication Deferral List?

(See reference A for the "Medication Deferral List") D D

4. Do you have an infection now, or are you currently takingantibiotics? D D

5. Are you currently taking any other medication, including over thecounter medications, vitamins, or herbal products orinvestigational drugs?Please list medications and reason for taking. D D

6. In the past 1 2 months, have you needed treatment in an emergencyroom, been hospitalized, or had surgery? D D

7. In the past 12 months, have you received a blood transfusion, ortissue transplant such as bone or cornea? D D

Have you ever had a blood transfusion from a source other thanyour own blood? D D

Questions 9-12: FEMALE DONORS ONLY: Male donors check DNA

9. How many times have you been pregnant?(If "O", go to question 12)

10. In tlie past 6 weeks, have you been pregnant or are you nowpregnant?

11. Have you had any health problems associated with or caused bypregnancy?

12. Do you plan to or is there any chance that you will becomepregnant within the next 6 months?

13. Have you ever received an organ, bone marrow, or stem celltransplant or donated an organ, such as a kidney?

14. Have you or any of your blood relatives ever had problems withgeneral or regional anesthesia such as an epidural or spinal block?

15. Do you have any food, drug, latex or environmental allergies?16. Have you ever had neck, back, hip or spine problems?

If yes, describe your current status, treatments, limitations andany related surgeries. Include your current pain level.

17. Have you ever had breathing problems, including asthma, COPD,sleep apnea or shortness of breath?

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APBMT-COMM-002 Adult Donor Health History QuestionnaireAPBMT, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93on01 Oct2019 08:16:26 amPage 1 of 7

Form

M0345


DUKE UNIVERSITY HEALTH SYSTEMHistory #:

Yes No Remarks

18. Have you ever had a heart attack, heart-related chest pains, heartdisease, heart surgery, or been diagnosed with atrial fibrillation orany other abnormal heart rhythm?

19. Have you ever had Sickle Cell Disease or Thalassemia?20. Have you ever had cancer, including leukemia? (If Yes, describe

stage, treatment, and any recurrence.21. Have you ever had a parasitic blood disease such as Chagas'

disease or Babesiosis?

22. Do you have an autoimmune disorder such as diabetes, psoriasis,Crohn's, Hashimoto's, MS, Lupus, Raynaud's, or a conditioncausing inflammation in the eye such as iritis or episcleritis?

23. Have you ever had a brain injuiy or head trauma, such as aconcussion, skull fracture or traumatic brain injury (also calledTBI)? (If Yes, describe each injury, dates, symptoms or any lossof consciousness.)

24. Have you ever had a stroke, a blood clot (also called a deep veinthrombosis or DVT) or do you have a bleeding or clottingdisorder such as Hemophilia or Factor Five Leiden?

25. In the past 4 weeks have you had any vaccinations (other thansmallpox) or any kind of shot?

26. Are you planning to receive any vaccinations (includingsmallpox) or shots?

27. In the past 3 years, have you had malaria?28. In the past 3 years, have you lived (12 months or more) outside

the United States or Canada? Please list where, when, for how

long and if you took anti-malarial medications.29. In the past 1 2 months, have you traveled (less than 12 months)

outside the United States or Canada? Please list where, when, for

how long and if you took anti-malarial medications.30. Is there any other past or present health information that we have

not discussed, such as a past surgery, chronic medical condition,serious injury and mental health diagnosis?

Section 2: Communicable Disease Assessment

31. Have you had a medical diagnosis ofZIKA virus infection in thepast 6 months?

32. Have you resided in, or traveled to, an area with an increased riskfor ZIKA virus transmission within the past 6 months?

Refer to CDC. GOV for Zika risk areas.

33. Have you had sex with a person who is known to have a medicaldiagnosis ofZIKA virus infection within the past 6 months?

34. Have you had sex with a person who has resided in, or traveledto, an area with active ZIKA virus transmission within the past6 months?

35. In the past 120 days (4 months), have you had a positive test forthe West Nile Virus?

36. Have you ever been told by a healthcare professional that you hador might have had West Nile Virus?If Yes, answer #36A. If No, go to #37.36A. When were you told this? Date:

37. In the past 8 weeks, have you received a smallpox vaccine?If Yes, answer #37A-#37C. If No, go to #38.SPA. When did you receive the vaccination? Date:

37B. Has the scab fallen off your skin by itself?

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CONFIDENTIAL - Printed by: ACM93 on 01 Oct 2019 08:16:26 amPage 2 of 7

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DUKE UNIVERSITY HEALTH SYSTEMHistory #:

Yes | No | Remarks

37C. Did you have any illness or complications due to thevaccination such as an eye infection or a rash, an allergicreaction, sores away from the vaccination site?

38. Have you had close contact with a vaccination site (such astouching the vaccination/ scab or bandages, or handling theclothes, towels or bedding) of anyone who has received thesmallpox vaccine in the past 3 months?If Yes, answer #38A-#38C. If No, go to #3938A. When did the person receive the vaccination? Date:38B. When was the close contact? Date:

38C. Have you had any new skin rash or sores or an eye infectionsince the time of the contact?

39. Have you been diagnosed with Creutzfeldt-Jakob disease (CJD)or variant CJD, or do you have a degenerative neurologicalcondition such as dementia where the cause has not beenidentified?

40. Have any of your blood relatives been diagnosed withCreutzfeldt-Jakob disease, or have you been told that your familyhas an increased risk for this disease?

41. Have you ever had a dura mater (or brain covering) transplant fora head or brain injury?

42. Have you ever received growth hoimone made from humanpituitary glands?

43. Do you have AIDS or have you ever tested positive for HIV,including screening tests?

44. Do you have any of the following?. unexplained weight loss, night sweats, or persistent

diarrhea

. unexplained persistent cough or shortness of breath

. unexplained persistent white spots or unusual sores inthe mouth

. unexplained temperature higher than 100. 5°F (38. 0°C)for more than 10 days

. blue or puqile spots on or under the skin or mucusmembranes

. lumps in the neck, annpits, or groin lasting longer thanone (1) month

45. Have you ever tested positive for HTLV (Human T-lymphotropicvirus), including screening tests?

46. Have you ever tested positive for hepatitis, including screeningtests, or have you ever had yellow jaundice, liver disease, orhepatitis since the age of 1 1 years?

47. Have you, any of your sexual partners, or any members of yourhousehold ever had a xenotransplant (tissues from an animal) or amedical procedure that involved being exposed to live cells,tissues, or organs from an animal?

48. In the past 12 months, have you had a tattoo? (If Yes, providedate applied, any signs of infection. Note if performed in alicensed establishment.)

49. In the past 12 months, have you had an ear, skin or body piercingusing shared instruments or needles?

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APBMT-COMM-002 Adult Donor Health History QuestionnaireAPBMT, DUMCDurham, NC Page 3 of 7


Form

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DUKE UNIVERSITY HEALTH SYSTEM

History #:Yes | No Remarks

50. In the past 12 months, have you had an accidental needle stick orcome in contact with someone else's blood through an openwound, non-intact skin (Example: a cut or sore), or mucusmembranes (Example: into your eye or mouth)?

51. In the past 12 months, have you lived with or had sexual contactwith anyone having yellow jaundice, hepatitis, or have youreceived the Hepatitis B Immune Globulin (HBIG)?

52. Have you ever tested positive for syphilis, including screeningtests, or ever been treated for syphilis?

53. In the past 12 months: have you had sex, even once, with anyonewho has used a needle to take drugs, steroids, or anything else notprescribed by a doctor in the past 5 years?

54. In the past 12 months: have you given money, drugs, or otherpayment for sex OR have you had sex, even once, with anyonewho has taken money, drugs, or other payment in exchange forsex in the past 5 years?

55. In the past 12 months, have you had sex, even once, with anyonewho has taken human-derived clotting factors in the past 5 years?

56. In the past 12 months, have you had sex, even once, with anyonewho has AIDS or tested positive for the AIDS virus?

57. In the past 12 months, have you been held in jail, prison, juveniledetention, or lockup for more than 72 continuous hours?

58. FEMALE DONORS ONLY: In the past 12 months, have you hadsex with a male who has had sex, even once, with another male inthe past 5 years? If male, mark NA D

59. MALE DONORS ONLY: In the past 5 years, have you had sex,even once, with another male? If female, mark NA D

60. In the past 5 years, have you taken money, drugs, or otherpayment in exchange for sex?

61. In the past 5 years, have you used a needle, even once, to takedrugs, steroids, or anything else not prescribed by a doctor?

62. Have you been exposed to anyone with the Ebola Virus oranyone that has been exposed to the Ebola Virus?

63. Since 1980, have you ever lived in or traveled to Europe?(See reference B for a list of the countries in Europe)If Yes, answer #63A - #63D. If No, go to #64.63A. From 1980 through 1996, did you spend time that adds up to

three (3) months or more in the United Kingdom (UK)?(England, Northern Ireland, Scotland, Wales, Isle of Man,Channel Islands, Gibraltar, or Falkland Islands)

63B. Since 1980, did you receive a transfusion of blood or bloodcomponents while in the UK or France?

63C. Since 1980, have you spent time that adds up to 5 years ormore in Europe, including time spent in the UK from 1980-1996?

63D. From 1980 through 1996, were you a member of the U. S.military, a civilian military employee, or a dependent of amember of the U. S. military?If Yes, answer #63D. 1 &63D. 2. If No, go to #64.

63D. 1 Did you spend a total of 6 months or more between 1980and 1990 at a military base in any of the followingcountries: Belgium, Germany, Netherlands?

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FormM0345

63D.2 Did you spend a total of 6 months or more between 1980and 1996 at a military base in any of the followingcountries: Greece, Italy, Portugal, Spain or Turkey?

64. For Donors of the Pediatric Patient: Have you eaten any foods inthe past 72 hours (3 days) that the recipient of your cells isallergic to?

Yes

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No

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History #:

Remarks

DNA


DUKE UNIVERSITY HEALTH SYSTEM



Form

M0345


Reference A: Medication Deferral List: for Question #3Medication:

Proscar© (Finasteride)Avodart® (Dutasteride)Propecia® (Finasteride)Accutane®(Amnesteem, Claravis,Sotret, Isotretinoin)Soriatane© (Acitretin)

TegisonO (Etretinate)

Growth Hormone from

Human Pituitary Glands

Insulin from Cows

(Bovine or Beef Insulin)

Hepatitis B ImmuneGlobulin (HBIG)

Unlicensed Vaccine

Given for:

Prostate gland enlargementProstate gland enlargementBaldnessSevere Acne

Severe psoriasisSevere psoriasis

Delayed/impaired growth(used only until 1985)

Diabetes

Following an exposure tohepatitis B.*This is different from the

Hepatitis B vaccine (\vhich is aseries of 3 injections given overa 6 month period to preventfuture infection from exposuresto Hepatitis B)Usually a research protocol.

Why these medications affect your donation:These medications can cause birth defects. Your donated

blood could contain high enough levels to damage the unbornbaby if transfused to a pregnant woman.Once the medication has cleared from your blood, you maydonate again.Following the last dose, the deferral period is:Proscar®, Propecia® and AccutaneO: 1 monthAvodartO: 6 months

Soriatane© : 3 yearsTegison© is a permanent deferral.This was prescribed until 1985 for children with delayed orimpaired growth. The hormone was obtained from humanpituitary glands, which are found in the brain. Some peoplewho took this hormone developed a rare nervous systemcondition called Creutzfeldt-Jakob Disease (CJD, for short).CJD has not been associated with growth hormonepreparations available since 1985. The deferral is permanent.This is an injected material used to treat diabetes. If thisinsulin was imported into the US from countries in which"Mad Cow Disease" has been found, it could contain materialfrom infected cattle. There is concern that "Mad Cow

Disease" may be transmitted by transfusion. The deferral isindefinite.

This is an injected material used to prevent infectionfollowing an exposure to Hepatitis B. FIBIG does notprevent Hepatitis B infection in every case, therefore personswho have received F1BIG must wait twelve months (one year)to donate blood to be sure they were not infected sinceHepatitis B can be transmitted through transfusion to apatient.

Unlicensed vaccines are usually associated with a researchprotocol and the effect on blood transmission is unknown.Deferral is one year unless otherwise indicated by MedicalDirector.

Reference B: for Question #63: Countries defined as EuropeCountry

Albania

Austria

BelgiumBosnia-HerzegovinaBulgariaCroatia

Czech RepublicDenmarkFinland

France

GermanyGreece

Country

HungaryIreland (Republic of)ItalyLiechtenstein

LuxembourgMacedonia

Netherlands (Holland)NorwayPoland

PortugalRomania

Slovak Republic

CountrySlovenia

SpainSwedenSwitzerlandUnited Kingdom:

England, Northern IrelandScotland, Wales, Isle of Man,Channel Islands, Gibraltar,Falkland Islands

Yugoslavia (Federal Republic of)Kosovo, Montenegro, Serbia



Form

MD346


DONOR - PLEASE READ CAREFULLY

Donor Verification and Authorization History #:

^ I have had the opportunity to ask questions about the infomiation requested on this questionnaire.^ I understand that the requested information is important because if I am at risk for infection due to AIDS or other

communicable disease agents or diseases, my donated cells may transmit these diseases to the patient receiving these cells.^ I have truthfully answered all of the questions on this questionnaire.^ I authorize the release of the information on this questionnaire to the transplant center and to the CIBMTR.^ I understand the recipient of my donated cells may be advised of any communicable disease risks.^ I understand that authorizing this release of information is voluntary and that I can refuse to sign this document.

By signing I acknowledge that I have read, understand and agree with the above.

DONOR NAME (please print):

DONOR SIGNATURE: DATE: / /

Donor Center Staff Review

This fonn was completed by the following method:D This form was self-administered by the donor and reviewed for completeness.D I perfonned an oral interview with the donor (including reading the Medication Deferral List, Reference A and Donor

Verification and Authorization) and completed this form.

D An interpreter was required:Interpreter Name

D Ami inspection was performed.

I have reviewed this fonn and verbally verified answers with the donor. I addressed any questions the donor had, and clarifiedhealth information as needed.

/ /

Donor Center Staff Signature Date

Medical Director/Designee Review and Approval:

/ /Medical Director/Designee Signature Date




Signature Manifest

Document Number: APBMT-COMM-002

Title: Adult Donor Health History QuestionnaireRevision: 12

All dates and times are in Eastern Time.

APBMT-COMM-002 Adult Donor Health History Questionnaire

Author

Name/Signature Title Date Meaning/Reason

Mary Beth Christen (MC363)

Management

10 Sep 2019, 10:41:57 AM Approved

Name/Signature Title

Nelson Chao (CHA00002)

Medical Director

Date Meaning/Reason

12 Sep 2019, 09:53:08 AM Approved

Name/Signature Title

Joanne Kurtzberg(KURTZ001)

Betsy Jordan (BJ42)

Date I Meaning/Reason

12 Sep 2019, 10:48:43 AM Approved

Quality

Name/Signature

Bing Shen (BS76)

Document Release

Name/Signature

Title

Title

Date

12 Sep 2019, 04:27:56 PM

Date

Meaning/Reason

Approved

Meaning/Reason

17 Sep 2019, 01:15:13 PM Approved


Documents

AbULT ANb PEbIATRIC BLOOb ANb MARROW TRANSPLANT …spitfire.emmes.com/study/duke/SOP/Donor Selection... · InfoCard #: APBMT-COMM-002 Rev. 12 Effective Date: 01 Oct 2019 DukeMedicine