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InfoCard #: APBMT-COMM-001 FRM3 Rev. 01 Effective Date: 17 Jul 2019

DukeMedicineDivision of Cellular Therapy ^ADULT AND PEDIATRIC BLOOD AND

MARROW TRANSPLANT PROGRAM

DOCUMENT NUMBER: APBMT-COMM-001 FRM3

DOCUMENT TITLE:

Summary of Donor Eligibility and Infectious Disease Testing (ABMT) FRM3

DOCUMENT NOTES:

Document Information

Revision: 01 Vault: APBMT-Common-rel

Status: Release Document Type: Common

Date Information

Creation Date: 03 Jun 2019 Release Date: 17 Jul 2019

Effective Date: 17 Jul 2019 Expiration Date:

Control Information

Author: MOORE171 Owner: MOORE171

Previous Number: None Change Number: APBMT-CCR-156

CONFIDENTIAL - Printed by: :ACM93 on 01 Nov 2019 12:34:28 pm

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APBMT-COMM-001 FRM3DUKE UNIVERSITY Summary of Donor Eligibility & InfectiousHEALTH SYSTEM Disease Testing (ABMT)

Product Collection Date: / / Product: Unit ID#;

(Bar Code Label)Donor Testing Performed by: D LabCorp Viromed D Other Testing Site

Section A: Donor testing: Panel expires on __1^^_^ Sample collected: ̂ ^^_1_#

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

Donor Screening Test-lepatitis B Surface Antigen (HBs-Ag)*Donor Referral Panel)

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

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

Freponema pallidum (syphilis) Antibody Screennitial screen (Donor Referral Panel)

^ytomegalovirus CMV Total Antibody*Donor Referral Panel)

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

1IV/HCV/HBV NAT *Donor Referral Panel)

1TLV I/II Antibodies (HTLV I/II) *Donor Referral Panel)

'Aka Virus NATDonor Referral Panel)

Vest Nile Virus NAT*Donor Referral Panel)

'rypanosoma cruzi (Chagas) AntibodyDonor Refeiral Panel)

Results (NT= Not Tested)

D Reactive D Non-Reactive D Pending










3 Reactive D Non-Reactive D Pending

'he section below (#12) applies only ifTreponema pallidum (syphilis) Antibody Screen (#4 above) is REACTIVE. Otherwise,nark not applicable.

12. .yphilis confirmatory testing (RPR) D Not Applicablt II Reactive D Non-Reactive D Pendingf testing is not performed for any sample listed in this section below, (#13-#26), mark Not Tested (NT) and provide rationale inSection B comment line.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

'oxoplasma gondii IgG Antibody

'oxoplasma gondii IgM Antibody

;BV IgG

;BV IgM

;BV EBNA

;BV EA IgG

lerpes Simplex IgG Antibody

?aricella Zoster IgG Antibody

'MV DNA (PCR, quantitative; ifCMV +)

[epatitis A IgM Antibody

erum Protein Electrophoresis

[emoglobin Electrophoresis Panel (HEP)

ype and Screen/Blood Type (ABO/Rh)

inti-HLA Antibody Screen oo

3 Reactive D Non-Reactive D Pending D NT

II Reactive D Non-Reactive D Pending D NT

D Reactive D Non-Reactive D Pending D NT



II Reactive D Non-Reactive D Pending D NT




D Reactive D Non-Reactive D Pending D NT



jroup: _ Rh: _ D Pending

II Reactive D Non-Reactive D Pending D NT,ist any other relevant Donor Testing Completed in this section below (#27); otherwise mark Not Applicable.

27. >ther: D Not Applicable 3 Reactive D Non-Reactive D PendingSection A Continued: Table Footnotes: All testing will be performed by a CLIA certified laboratory.It PDA Required testing, so Anti-HLA Antibody screening is required for all mismatched donor/recipients.

APBMT~COMM~001 FRM3, sumITON1fl6CNT ^^t§dtffctlm^9S^ i§^ &(^WTJ^:34:28 pmAPBMT, DUMC, Durham, NC -- -- - ---,.. -... ---.. -... -. -. -. -. -.. -^... page 1 of 2

dInfoCard #: APBMT-COMM-001 FRM3 Rev. 01 Effective Date: 17 Jul 2019

APBMT-COMM-001 FRM3DUKE UNIVERSITY Summary of Donor Eligibility & InfectiousHEALTH SYSTEM Disease Testing (ABMT)

Product Collection Date: / / Product: Unit IDS;

(Bar Code Label)Section B: Donor Elisibility Requirements: Have the donor eligibility requirements been met based on:

1. Infectious Disease Testing:2. Donor History Questionnaire:

D Yes D No (see exceptions in Section A and comment below)D Yes D No (list exceptions below)

Clinician/Physician Signature

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

/ /

Date

/ /Physician notifiedDate

Section C: Emereencv/Exceptional Release:

The physician is responsible for reviewing any exceptions and detemiining if the product is acceptable as an "UrgentMedical Need." The physician is responsible for informing the product recipient (or legal guardian) that the donoreligibility requirements have not been met.

D This product is determined to be an "Urgent Medical Need" (an urgent medical need means that no comparableHCT/P (Human Cell, Tissue, or Cellular or Tissue-Based Product) is available and the recipient is likely to sufferdeath or serious morbidity without the HCT/P).

D The adult patient (product recipient) has been informed that the donor eligibility requirements have not beenmet:

D Product acceptedD Product not accepted

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

Medical Director/Designee Signature Pager #

/ /

Date of Notification

Quality Manager/Designee Signature Pager #

/ /

Date of Notification

APBMT-CO.M.M-001 FRM3. sum'TONlf©eNT^Lgi.bfl^^lrffct^^^^ 6^ 8,(^^Tj^:34:28 pmAPBMT, DUMC, Durham, NC Page 2 of 2

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DUKE UNIVERSITYHEALTH SYSTEM

APBMT-COMM-001 FRM3Summary of Donor Eligibility & Infectious Disease

Testing (ABMT)

Instructions for Completing the Summary of Donor Eligibility FormField

Product collect Date

Product

Unit ID #Section A:

Donor Testing:

Panel Expires On:

Section B:

Have donor eligibilityrequirements been met basedon the Infectious Disease

Testing 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 donor testing.3. Check each test result as Reactive (positive), Non-Reactive

(negative), or Pending (awaiting result).Record date the Donor Referral Panel expires.Review the Donor 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 thelines provided. Sign and date. If there are exceptions, notify thephysician, and record physician notified.

Apheresis donors: If any testing results are pending, file the original ofthis form in the "Pending" folder in apheresis. Send a copy to the labwith the product and place a biohazard label on the product bag. Theapheresis coordinator or designee will monitor for lab results, update theoriginal form and send to lab. If any of the donor screening test forinfectious disease (questions 1 through 12) are reactive (with theexception ofCMV), the physician will be notified.

If an emergency/exceptional release is needed, the physician will reviewthe exception(s) noted. If the product is determined to be an "UrgentMedical Need", check the appropriate box. The physician will informthe product recipient (or legal guardian) that the donor requirements havenot been met, and check "Product Accepted" or "Product Not Accepted."The medical director/designee will sign; provide pager #, and record dateof notification. The Quality Manager/designee will sign and date.

APBMT-COMM-001 FRM3 SummaQ- of Donor Eligibility & Infectious Disease Testing (ABMT)APBMT, DUMC, Durham. NC CONFIDENTIAL - Printed by: :ACM93 on 01 Nov 2019 12:34:28 pm ^e 1 of 1


Signature hflanifest

Document Number: APBMT-COMM-001 FRM3 Revision: 01

Title: Summary of Donor Eligibility and Infectious Disease Testing (ABMT) FRM3All dates and times are in Eastern Time.

APBMT-COMM-001 FRM3 Summary of Donor Eligibility and Infectious Disease Testii(ABMT)

Author

Name/Signature

Sally McCollum (MOORE171)

Management

Title Date

02 Jul 2019, 11:43:12 AM Approvedj Meaning/Reason

Name/Signature | TitleNelson Chao (CHA00002)

[jDate ̂ ^^^^^^^^ ^^^ ̂ _I^Meaning/Reason02Jul2019, 03:51:33PM Approved

Medical Director

[ Name/SignatureJoanne Kurtzberg(KURTZ001)

! Title

Quality

L[^le_... -_-. _. _. _. | Meaning/Reason

02 Jul 2019, 06:20:23 PM Approved

I Name/SignatureBing Shen (BS76)

Document Release

Title Date Meaning/Reason03 Jul 2019, 09:52:51 AM Approved

Name/Signature Title

Sandy Mulligan (MULL1026).?a*e__. -_ _._. _.___ _[ Meaning/Reason03 Jul 2019, 08:26:53 PM Approved

CONFIDENTIAL - Printed by: :ACM93 on 01 Nov 2019 12:34:28 pm

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