InfoCard #: STCL-GEN-009 FRM2 Rev. 04 Effective Date: 16 Aug 2019

STEM CELLLABORATORY (STCL)

DOCUMENT NUMBER: STCL-GEN-009 FRM2

DOCUMENT TITLE:

Cellular Product-Sample Chain of Custody FRM2

DOCUMENT NOTES:

Document Information

Revision: 04 Vault: STCL-General-rel

Status: Release Document Type: STCL

Date Information

Creation Date: 08 Aug 2019 Release Date: 16 Aug 2019

Effective Date: 16 Aug 2019 Expiration Date:

Control Information

Author: WATE02

Previous Number: STCL-GEN-009 FRM2 Rev Ka

Owner:

Change

WATE02

Number: STCL-CCR-463

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:02:55 am

InfoCard #: STCL-GEN-009 FRM2 Rev. 04 Effective Date: 16 Aug 2019

Cooler #

STCL-GEN-009 FRM2Cellular Product/Sample Chain of Custody Form

ISBT 128 Barcode # (if applicable}:

NOTE: For cellular products distributed by the STCL and transported on public roads; thetemperature upon receipt must be recorded at the bottom of the form

1. Patient Name:

Patient History #:

2. Donor Name:

Donor History #:

DOB:(Affix Patient Demographic Label)

DOB:(Affix Patient Demographic Label, if applicable)

3. Collection date:

4. Cellular Product issued by the Stem Cell Laboratory (STCL)Date: Time:

Signature ofSTCL Employee issuing product

5. Cellular Product issued to :

Date: Time:Signature of person transporting product

EST

EST

Serial # _ (Select ONE) D Thermometer D Data Logger

Temperature of the container upon receipt is between 20°C - 24°C*? (CheckONE) D Yes D No

Date: Time: ESTPerson checking temperature upon receipt

PRINT and SIGN

* If the temperature upon receipt is out of range (20"C - 24°Q, please notify the Medical Director / AttendingPhysician immediately and provide dociimentation regarding the disposition of the product (via e-mail).

Date: Time: ESTName ofMD notified of temperature excursion

*If temperature is out of range, a Non-Con forming Product (NCP) form and/or DeviationNCP # assigned: _ or DEVIATION # assigned:

Return Completed Form to the Stem Cell Laboratory

STCL-GEN-009 FRM2 Cellular Product/Sample Chain of Custody FonnStem Cell Laboratory, DUMCDurham, NC Page 1 of 1

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:02:55 am

InfoCard #: STCL-GEN-009 FRM2 Rev. 04 Effective Date: 16 Aug 2019

STCL-GEN-009 FRM2Cellular Product/SampIe Chain of Custody Form

Instructions for Completins the Cellular Product Chain-of-Custodv Form

In the field...Cooler #ISBT 128 barcode (if applicable)Cellular products that are distributed bythe STCL and transported on publicroads, the temperature upon receipt isrequired; must complete Section at thebottom of the form

1. Recipient # Name

Recipient History #2. Donor Name (if applicable)

Donor's History # (if applicable)3. Collection Date

4. Cellular product issued by

5. Cellular product issued to

Serial # of Thermometer or Data Logger

11. Time CP / sample accepted fromSTCL employeeSerial # of thermometer or data loggerused

Signature of person recording thetemperature of container upon receiptIf temperature upon receipt is out of range

If temperature upon receipt exceeds therange of20-24°C, a NCP and/or DEVmust be initiated to investigate the issue.

Record...

Enter cooler number using to transport productPlace ISBT unique barcode (if applicable)If products are transported on public roads, thetemperature must be recorded upon receipt(atthe bottom of the form)

Name of the Recipient whose product or sampleis being distributed.Enter Recipient's Duke HistoryName of Donor whose cellular product orsample is being distributed (if applicable)Donor's History # (if applicable)Date cellular product or sample was collectedEnter the signature of the STCL employeeissuing the CP or sample, Date, and Time(EST).Enter signature of the person accepting the CP,Date, and Time (EST)Record the serial # of the thermometer or data

logger used for this shipment. Select whetherthermometer or data logger was used.Time designated courier accepted the CP /sample from the STCL employee (ET).Record the serial # of the temperaturemonitoring device used in the transportcontainer. If not used, select N/A

Record signature of person reading thetemperature, date, and time (EST).Contact medical director or attending physicianto get instructions regarding disposition of theproduct, date, time (EST). Providedocumentation regarding the disposition of theproduct (via e-mail)Record the NCP# and/or DEV# assigned orenter N/A in these fields, if applicable.

STCL-GEN-009 FRM2 Cellular Product/Sample Chain of Custody FormInstructions

Stem Cell Laboratory, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:02:55 am

Page 1 of 1

InfoCard #: STCL-GEN-009 FRM2 Rev. 04 Effective Date: 16 Aug 2019

Signature Manifest

Document Number: STCL-GEN-009 FRM2

Title: Cellular Product-Sample Chain of Custody FRM2

Revision: 04

All dates and (lines are in Eastern Time.

STCL-GEN-009 FRM2 Cellular Product-Sample Chain of Custody

Author

^Namereignature_ ._Ll!l1^-Barbara Waters-Pick

(WATE02)

Management

Date I Meaning/Reason

13 Aug 2019, 11:23:52 AM Approved

Name/Signature Title

Barbara Waters-Pick

(WATE02)

Medical Director

Date Meaning/Reason

13 Aug 2019, 11:24:00 AM Approved

Name/Signature

Joanne Kurtzberg(KURTZ001)

Quality

Title Jj3ate Meaning/Reason

13 Aug 2019, 11:54:41 AM Approved

Name/Signature | Title

(RB232 ) for Bing Shen (BS76)

Lisa Eddinger (LE42)

Richard Bryant (RB232)

Taylor Orr (TS04)Isabel Storch(IMS19)

Document Release

Date I Meaning/Reason

13 Aug 2019, 12:09:45 PM Approved

Name/Signature J T^Sandy Mulligan (MULL1026)

I Date13 Aug 2019, 06:13:58 PM

Meaning/Reason

Approved

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:02:55 am