InfoCard #: STCL-GEN-009 FRM3 Rev. 03 Effective Date: 16 Aug 2019

STEM CELLLABORATORY (STCL)

DOCUMENT NUMBER: STCL-GEN-009 FRM3

DOCUMENT TITLE:

Cellular Product Chain of Custody Form for Products Collected Outside NP FRM3

DOCUMENT NOTES:

Document Information

Revision: 03 Vault: STCL-General-rel

Status: Release Document Type: SOPs

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 FRM3 Rev Ka

Owner:

Change

WATE02

Number: STCL-CCR-463

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:03:46 am

InfoCard #: STCL-GEN-009 FRM3 Rev. 03 Effective Date: 16 Aug 2019

STCL-GEN-009 FRM3Cellular Product Chain of Custody Form for Products Collected Outside NP

Cooler # ISBT 128 Barcode #:

NOTE: For cellular products collected outside the North Pavilion (NP), transported on publicroads, and delivered to the STCL: the temneraturejAnon receipt must be recorded at the bottomof 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. Serial #

Time Container Packed: EST

(Select ONE) D Thermometer D Data Logger

5. Cooler packed and product delivered to the Stem Cell Laboratory (STCL)

Date: Time: ESTSignature of person who packed Container

6. Stem Cell Laboratory employee or designee acceptins cellular product:

Date: Time: ESTSignature of person accepting product

7. Temp of container upon receipt in STCL 20°C -24°C*? (Check ONE) DYesD No* If the temperature upon receipt is out of range (20"C - 24°C), please notify the Medical Director / AttendingPhysician immediately and provide documentation regarding the disposition of the prodiict (via e-mail)

Date: Time: ESTName of the MD notified oftemperatiire excursion

*If temperature is out ofranse, a Non-Conforming Product (NCP) form and/or DeviationNCP # assigned: _ or DEVIATION # assigned:

NOTE: For Instructions of how to download data logger temperature readings (if applicable),refer to STCL-COLL-007 (JA9).

STCL-GEN-009 FRM3 Cellular Product Chain of Custody Form for Products Collected Outside NPStem Cell Laboratory, DUMCDurham, NC Page 1 of 1

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:03:46 am

InfoCard #: STCL-GEN-009 FRM3 Rev. 03 Effective Date: 16 Aug 2019

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

In the field...Cooler #

ISBT128barcode

Form to be used for products collected outsidethe NP (ie. HPC, Apheresis, HPC, Marrow, etc)

1. Patient Name Affix Label

Patient History # Affix Label

2. Donor Name (if applicable) Affix Label

Donor's History # (if applicable) Affix Label

3. Collection Date

Time Container Packed

4. Serial # ot (Circle ONE) Data Logger orThermometer Used

5. Signature of person who packed anddelivered cellular product to the Stem CellLaboratory (STCL)

6. Signature of Stem Cell Laboratory employeeaccepting cellular product

7. Temperature of transport container at the timeof receipt in the STCL between 20°C - 24°C?Yes or No?

If the acceptable transport temperature range of20 °C - 24 "C has been exceeded, a Non-Conforming Product (NCP) form will need to beinitiated and/or Deviation will need to beinitiated in MasterControl. Record the NCP#

or DEV-XXXX that has been assigned (;/applicable).

Instructions for downloading the datalogger.

Record...Record the cooler number used to transport product.

Place ISBT unique barcode here.

Products collected outside the North Pavilion and transportedon public roads to the Stem Cell Laboratory.

Name of Patient donating cells.

Enter Patient's Duke History.

Name of Donor who donated cellular product (if applicable)

Donor's History # (if applicable)

Record the date the product was collected

Time Container was packed for transport to the lab.

Record the serial # of the data logger or thermometer (circleONE) used to monitor temps.

Signature of the person who packed and delivered thecellular product to the lab (ie. Nursing staff, MD, designatedcourier, etc), date and time

Signature of laboratory personnel, or designee, accepting thecellular product in the laboratory, date, and time.

Once the temperature reading(s) from the thermometer ordata logger have been reviewed/downloaded, ensure thetemperature reading(s) is/are within 20°C -24°C. RespondYES or NO.IF the acceptable transport temperature range of 20 - 24°Chas been exceeded, a Non-Conforming Product form willneed to be initiated and/or a deviation will need to beinitiated in MasterControl

IfNCP form and/or deviation was initiated, record the # of

this chain of custody form.

If a data logger was used in the transport container, referto STCL-COLL-007 (JA9) for instructions of how todownload the data, etc.

STCL-GEN-009 FRM3 Cellular Product Chain of Custody Form for Products collected outside the NPInstructions

Stem Cell Laboratory, DUMCDurham, NC Page 1 of 1

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:03:46 am

InfoCard #: STCL-GEN-009 FRM3 Rev. 03 Effective Date: 16 Aug 2019

Signature Manifest

Document Number: STCL-GEN-009 FRM3 Revision: 03

Title: Cellular Product Chain of Custody Form for Products Collected Outside NP FRM3

All dates and times are in Eastern Time.

STCL-GEN-009 FRM3 Cellular Product Chain of Custody Form for Products CollectedOutside NP

Author

Name/Signature

Barbara Waters-Pick(WATE02)

Management

J Title J Date Meaning/Reason

13 Aug 2019, 11:25:57 AM Approved

Name/Signature

Barbara Waters-Pick(WATE02)

Medical Director

Title Date Meaning/Reason

13 Aug 2019, 11:26:08 AM Approved

[Name/SignatureJoanne Kurtzberg(KURTZ001)

Quality

Title Date Meaning/Reason

13 Aug 2019, 11:54:24 AM Approved

I 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, 12:09:05 PM Approved

^Name/Signature__.._....LlJlLe-.Sandy Mulligan (MULL1026)

J. Date.13 Aug 2019, 06:16:27 PM

! Meaning/Reason

Approved

CONFIDENTIAL - Printed by: ACM93 on 16 Aug 2019 08:03:46 am