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
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
Group: _ Rh: _ D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending D NT
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
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
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
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
InfoCard #: APBMT-COMM-005 Rev. 1 1 Effective Date: 01 Apr 2019
DUKE UNIVERSITY HEALTH SYSTEM
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
InfoCard #: APBMT-COMM-005 Rev. 1 1 Effective Date: 01 Apr 2019
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
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: 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 0 Non-Reactive D Pending
D Reactive Q Non-Reactive D Pending
D Reactive 0 Non-Reactive D Pending
D Reactive E Non-Reactive D Pending
D Reactive 0 Non-Reactive D Pending
D Reactive B Non-Reactive D Pending
D Reactive 0 Non-Reactive D Pending
Group: A Rh: +
D Reactive 0 Non-Reactive D Pending
D Reactive 0 Non-Reactive D Pending
D Reactive D Non-Reactive D Pending 0 NT
D Reactive 0 Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
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
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
D Reactive D Non-Reactive D Pending
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. 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
DUKE UNIVERSITY HEALTH SYSTEM
Product Collection Date: / / Product: Unit ID#;(Bar Code Label)
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
InfoCard #: APBMT-COMM-005 Rev. 1 1 Effective Date: 01 Apr 2019
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
InfoCard #: APBMT-COMM-005 Rev. 1 1 Effective Date: 01 Apr 2019
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