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InfoCard #: APBMT-COMM-005 Rev. 11 Effective Date: 01 Apr 2019

DukeMedicineDivision of Cellular Therapy

^ADULT AND PEbIATRIC BLOOb AND

MARROW TRANSPLANT PROGRAM

DOCUMENT NUMBER: APBMT-COMM-005

DOCUMENT TITLE:

Summary of Donor Eligibility and Infectious Disease Testing

DOCUMENT NOTES:

Document Information

Revision: 11 Vault: APBMT-Common-rel

Status: Release Document Type: Common

Date Information

Creation Date: 15 Feb 2019 Release Date: 01 Apr 2019

Effective Date: 01 Apr 2019 Expiration Date:

Control Information

Author: MOORE171

Previous Number: APBMT-COMM-005 Rev 10

Owner:

Change

MOORE171

Number: APBMT-CCR-140; APBMT-Ca.

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:05 am

Foi-mM0345

InfoCard #: APBMT-COMM-005 Rev. 1 1 Effective Date: 01 Apr 2019

DUKE UNIVERSITY HEALTH SYSTEM

APBMT-COMM-005Summary of Donor Eligibility & Infectious Disease Testing

Product Collection Date: / / Product: Unit ID#:(Bar Code Label)

Donor Testing Performed by: D LabCorp Viromed D Other Testing SiteSection A: Infectious Disease Testing: Donor Sample Test Results Panel expires on / /

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Sample collected: / /

-iepatitis B Surface Antigen (HBs-Ag)#***Donor Referral Panel)

hepatitis C Virus Antibody (HCV-Ab)*Donor Referral Panel)

-liV 1/2 Antibody test (Anti HIV to 1/2/0)* A(Donor Referral Panel)

-iepatitis B Core Antibody (HBc-Ab)*Donor Referral Panel)

^TLV I/II AB Serum (HTLV 1/11) #~A-Donor Referral Panel)

<.ed Blood Cell Antibody ScreenDonor Referral Panel)

antibody to Syphilis-Triponemapallidum (RPR)nitial screen (Donor Referral Panel)

:MV**Donor Referral Panel)

ilood Type (ABO/Rh)Donor Referral Panel)

flV-1/HCV/HBV NAT (HI V-l RNA) (Hep C Virus RNA) * ADonor Referral Panel)

Vest Nile Virus NAT #Donor Referral Panel)

7[ka Virus+

Donor Referral Panel)

Frypanosoma Cruzi (Chagas)Donor Referral Panel)

)ther (list other applicable testing; otherwise, mark not applicablelere): D Not Applicable

Test Results(NT= Not Tested)

D Reactive D Non-Reactive D Pending








Group: _ Rh: _ D Pending



D Reactive D Non-Reactive D Pending D NT



Fhe section below (#15) applies only if Antibody to Syphilis - Triponemapallidum (RPR) (#7 above) is REACTIVE.Dtherwise, mark not applicable here.D Not Applicable

15. Syphilis confirmatory testing (RPR) D Reactive D Non-Reactive D Pending

Fhe section below (#16 - #23) applies to PEDIATRICS only. Otherwise, mark not applicable here.D Not Applicable16.17.18.19.20.21.22.23.

Foxoplasma IgG

Foxoplasma IgM

iBV IgG

iBV IgM

iBV EBNA

lerpes Simplex IgG Ab

/aricella Zoster IgG Ab

:MV DNA (ifCMV +) A








D Reactive D Non-Reactive D Pending*FDA Required testing. +FDA Optional testing for donation ofHSCT products (Required testing for blood products),~*FDA Required for products containing high WBC content (i. e. Mobilized peripheral blood stem cells, DL1, Granulocytes)A FDA recommended. Obtain in all patients < 6 months of age, on IVIG, or unable to make endogenous antibody.

All testing was performed by a CLIA certified laboratory.

APBMT-COMM-005 Summary of Donor Eligibility & Infectious Disease TestingAPBMT, DUMC. Durham, NC CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:05 am Page I of 2



Product Collection Date: / / Product: Unit ID#;(Bar Code Label)

Section B: Donor Eligibility Requirements: Have the donor eligibility requirements been met based on:

1. Infectious Disease Testing: D Yes D No (see exceptions in Section A)2. Donor History Questionnaire: D Yes D No (list exceptions below)

Clinician Signature

If donor eligibility requirements NOT met, record physician notified and date.

Physician notified

Date

/ /Date

Section C: Emergencv/ExceptionaI Release:

The physician is responsible for reviewing any exceptions and determining if the product is acceptable as an"Urgent Medical Need." The physician is responsible for informing the product recipient (or legal guardian)that the donor eligibility requirements have not been met.

D This product is determined to be an "Urgent Medical Need" (an urgent medical need means that nocomparable HCT/P (Human Cell, Tissue, or Cellular or Tissue-Based Product) is available and therecipient is likely to suffer death or serious morbidity without the HCT/P).

D The adult patient (product recipient) has been informed that the donor eligibility requirements have notbeen met:

D Product acceptedD Product not accepted

D The Legal guardian of the pediatric patient (product recipient) has been informed that the donoreligibility requirements have not been met:D Product acceptedD Product not accepted

Medical Director/Designee signature Pager#1_ jL

Date of Notification

Quality Manager/Designee signature Pager# Date

APBMT-COMM-005 Summary of Donor Eligibility & Infectious Disease TestingAPBMT. DUMC. Durham. NC CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:05 am Page 2 of 2


Instructions for Completing the Summary of Donor Eligibility Form

Field

Product collect Date

Product

Unit ID #Section A:

Infectious Disease Testing:

Panel Expires On:

Section B:

Have donor eligibilityrequirements been met basedon the Infectious DiseaseTesting and the DonorHistory Questionnaire?

Section C:

Emergency/ExceptionalRelease

Requirements

Enter the date the product is collected.

Enter the type of product collected: PBSC, Granulocyte, DLI, NK Cell.

Place unique product identifier (bar code label) here.1. Check where infectious testing was performed. If "Other" is checked write

the name lab performing the tests.2. Enter the date that blood samples were collected for infectious disease

testing.3. Check each test result as Reactive (positive), Non-Reactive (negative), or

Pending (awaiting result).4. Adults: only the Donor Referral Panel is required.5. Pediatric: Donor Referral Panel, Toxoplasma IgG/IgM, EBV

IgG/IgM/EBV EBNA, Herpes Simplex IgG Ab, Varicella Zoster IgG Ab isrequired.

Record date the Donor Referral Panel expires.Review the Infectious Disease Testing and Donor History Questionnaire.Check "Yes" if the requirements have been met, check "No" if there are anyexceptions. If there are any donor history exceptions, list them on the linesprovided. Sign and date. If there are exceptions, notify the physician, andrecord physician notified.

If any infectious disease results are pending, file the original of this form in the"Pending" folder in apheresis. Send a copy to the lab with the product. Theapheresis coordinator or designee will monitor for lab results, update theoriginal form and send to lab. If any infectious disease tests are reactive (withthe exception ofCMV), the physician will be notified.

The physician will review the exception(s) noted. If the product is determinedto be an "Urgent Medical Need", check the box. The physician will infonn theproduct recipient (or legal guardian) that the donor requirements have not beenmet, and check "Product Accepted" or "Product Not Accepted. " The medicaldu-ector or designee will sign; provide pager #, and record date of notification.The Quality Manager or Designee will sign and date.

APBMT-COMM-005 Summan' of Donor Eligibility & Infectious Disease TestingAPBMT, DUMC, Durham, NC

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41 :05 amPage 1 of 1

Fonn

M0345



APBMT-COMM-005Summary of Donor Eligibility & Infectious Disease Testing


Donor Testing Performed by: 0 LabCorp Viromed D Other Testing SiteSection A: Infectious Disease Testins: Donor Sample Test Results Panel expires on / /

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Sample collected: / /

Hepatitis B Surface Antigen (HBs-Ag)*A^Donor Referral Panel)

Hepatitis C Virus Antibody (HCV-Ab)*'Donor Referral Panel)

HIV 1/2 Antibody test (Anti HIV to 1/2/0)* A(Donor Referral Panel)

Hepatitis B Core Antibody (HBc-Ab)*'Donor Referral Panel)

HTLV I/II AB Serum (HTLV I/II) *-*-Donor Referral Panel)

Red Blood Cell Antibody ScreenDonor Referral Panel)

antibody to Syphilis-Triponemapallidum (RPR)nitial screen (Donor Referral Panel)

^MV#*Donor Referral Panel)

Blood Type (ABO/Rh)Donor Referral Panel)

fflV-1/HCV/HBV NAT (HIV-1 RNA) (Hep C Virus RNA) *ADonor Referral Panel)

West Nile Virus NAT#Donor Referral Panel)

Zika Virus+Donor Referral Panel)

Frypanosoma Cruzi (Chagas)Donor Referral Panel)

3ther (list other applicable testing; otherwise, mark not applicablelere): El Not Applicable

Test Results(NT= Not Tested)

D Reactive 0 Non-Reactive D Pending


D Reactive Q Non-Reactive D Pending


D Reactive E Non-Reactive D Pending


D Reactive B Non-Reactive D Pending


Group: A Rh: +



D Reactive D Non-Reactive D Pending 0 NT



The section below (#15) applies only if Antibody to Syphilis - Triponemapallidum (RPR) (#7 above) is REACTIVE.Otherwise, mark not applicable here.0 Not Applicable

15. syphilis confirmatory testing (RPR) D Reactive D Non-Reactive D Pending

The section below (#16 - #23) applies to PEDIATRICS only. Otherwise, mark not applicable here.3 Not Applicable16.17.18.19.20.21.22.23.

Foxoplasma IgG

Foxoplasma IgM

iBV IgG

3BV IgM

5BV EBNA

-lerpes Simplex IgG Ab

Varicella Zoster IgG Ab

:MV DNA (if CM V +) A









*FDA Required testing. +FDA Optional testing for donation ofHSCT products (Required testing for blood products).-*-FDA Required for products containing high WBC content (i. e. Mobilized peripheral blood stem cells. DLI, Granulocytes)A FDA recommended. Obtain in all patients < 6 months of age, on IVIG, or unable to make endogenous antibody.

All testing was performed by a CLIA certified laboratory.

APBMT-COMM-005 Summary of Donor Eligibility & Infectious Disease Testing (EXAMPLE)APBMT, DUMC. Durham. NC CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:05 am Page 1 of 2

Form

M0345 wInfoCard #: APBMT-COMM-005 Rev. 11 Effective Date: 01 Apr 2019



Section B: Donor Elieibilifry Requirements: Have the donor eligibility requirements been met based on:

1. Infectious Disease Testing: IZ1 Yes D No (see exceptions in Section A)2. Donor History Questionnaire: D Yes IZI No (list exceptions below)

Q. 29: spent more than 3mos in the UK between 1980-present: lived in London 2 years( 1985-87)

M. Thompson, ANP 1/4/19Clinician Signature

If donor eligibility requirements NOT met, record physician notified and date.

Date

Dr. N. Marco, MD 1/4/19Physician Signature Physician Notified

Section C: Emereency/Exceptional Release:

The physician is responsible for reviewing any exceptions and determining if the product is acceptable as an"Urgent Medical Need". The physician is responsible for informing the product recipient (or legal guardian)that the donor eligibility requirements have not been met.

Q This product is determined to be an "Urgent Medical Need" (an urgent medical need means that nocomparable HCT/P (Human Cell, Tissue, or Cellular or Tissue-Based Product) is available and therecipient is likely to suffer death or serious morbidity without the HCT/P).

[ZlThe adult patient (product recipient) has been informed that the donor eligibility requirements have notbeen met:

E Product acceptedD Product not accepted

D The Legal guardian of the pediatric patient (product recipient) has been informed that the donoreligibility requirements have not been met:D Product acceptedD Product not accepted

Dr. N. Marco, MD 0000

Medical Director/Designee signature

Lucy Little

Quality Manager/Designee signature

Pager#

1111

Pager#

1/4/19

Date of Notification

1/5/19Date

APBMT-COMM-005 Summary of Donor Eligibility & Infectious Disease Testing (EXAMPLE)APBMT, DUMC, Durham. NC CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:05 am Page 2 of 2


Signature Manifest

Document Number: APBMT-COMM-005 Revision: 1 1

Title: Summary of Donor Eligibility and Infectious Disease Testing

All dates and times are in Eastern Time.

APBMT-COMM-005 Summary of Donor Eligibility and Infectious Disease Testing

Author

' Name/Signature 'TitleSally McCollum(MOORE171)

Management

[ Date28 Feb 2019, 09:10:24 AM

j Meaning/ReasonApproved

! Name/Signature

Nelson Chao (CHA00002)

Medical Director

Title ' Date

01 Mar 2019, 03:07:14 PMMeaning/Reason

Approved

; Name/Signature

Joanne Kurtzberg(KURTZ001)

Quality

Title Date | Meaning/Reason

04 Mar 2019, 07:14:13 AM Approved

; Name/Signature

Bing Shen (BS76)

Document Release

Title [ Date

04Mar2019, 02:41:08PM

Meaning/ReasonApproved

i Name/Signature

Betsy Jordan (BJ42)

Title I Date

05 Mar 2019, 09:23:41 AM

\ Meaning/ReasonApproved

APBMT-COMM-005 Summary of Donor Eligibility and Infectious Disease Testing

Author

! Name/Signature : TitleSally McCollum (MOORE171)

Date

18 Mar 2019, 02:34:56 PM

; Meaning/Reason

Approved

Management

! Name/Signature Title Date Meaning/Reason

CONFIDENTIAL - Printed by: ACM93on01 Apr 2019 08:41:05 am


Nelson Chao (CHA00002)

Medical Director

18 Mar 2019, 03:09:31 PM Approved

Name/Signature

Joanne Kurtzberg(KURTZ001)

Quality

Title Date Meaning/Reason

18 Mar 2019, 09:53:10 PM Approved

Name/Signature

Bing Shen (BS76)

Document Release

Title Date

19 Mar 2019, 10:53:43 AMi Meaning/Reason

Approved

: Name/Signature

Betsy Jordan (BJ42)

Title Date

20 Mar 2019, 09:29:24 AMMeaning/Reason

Approved

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:05 am

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