This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
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)
)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
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
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-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)
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
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