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InfoCard #: STCL-SOP-052 FRM2 Rev. 01 Effective Date: 01 Nov 2018

STEM CELLLABORATORY (STCL)

DOCUMENT NUMBER: STCL-SOP-052 FRM2

DOCUMENT TITLE:

Hematopoietic Progenitor Cell (HPCA) CCBB Samples Repeat Analysis FRM2

DOCUMENT NOTES:

Document Information

Revision: 01 Vault: STCL-General-rel

Status: Release Document Type: SOPs

Date Information

Creation Date: 18 Oct 2018 Release Date: 01 Nov 2018

Effective Date: 01 Nov 2018 Expiration Date:

Control Information

Author: WATE02 Owner: WATE02

Previous Number: None Change Number: STCL-CCR-434

CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2018 08:14:50 am

InfoCard #: STCL-SOP-052 FRM2 Rev. 01 Effective Date: 01 Nov 2018

STCL-SOP-052 FRM2

HEMATOPOIETIC PROGENITOR CELL ASSAY (HPCA) CCBB SAMPLESREPEAT ANALYSIS

Month / Year: N/A = Not ApplicableSpecimens reflecting "no growth" or contamination will be repeated (if sample is available and/or if repeal testing is ordered) to rule out technical errors.

SpecimenType

Specimen ID DatePlated/Tech ID

DateRead/

Tech ID

RepeatedY/N?

Date

Replated/Tech ID

Reason for

RepeatRepeat Result(Growth/ No

Growth)

Comments:

Total # ofCCBB Samples Plated/Month:Total # of Contaminated CCBB Samples/Month:Total # of "No Growth" CCBB Samples/Month:

% Contaminated:% No Growth:

Monthly Review by Lab Manager or QA Designee: Date:

STCL-SOP-052 FRM2 Hematopoietic Progenitor Cell (HPCA) CCBB Samples Repeat AnalysisStem Cell Laboratory, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2018 08:14:50 am

InfoCard #: STCL-SOP-052 FRM2 Rev. 01 Effective Date: 01 Nov 2018

Signature Manifest

Document Number: STCL-SOP-052 FRM2 Revision: 01

Title: Hematopoietic Progenitor Cell (HPCA) CCBB Samples Repeat Analysis FRM2All dates and times are in Eastern Time.

STCL-SOP-052 FRM2 Hematopoietic Progenitor Cell (HPCA) CCBB Samples RepeatAnalysis

Author

Name/SignatureBarbara Waters-Pick

(WATE02)

Manager

Title Date

18 Oct 2018, 06:35:11 PM

I Meaning/Reason

Approved

Name/Signature

Barbara Waters-Pick(WATE02)

Medical Director

Date Meaning/Reason

18 Oct 2018, 06:35:23 PM Approved

Name/Signature

Joanne Kurtzberg(KURTZ001)

Title Date I Meaning/Reason

18 Oct 2018, 09:21:57PM Approved

Quality

Name/Signature

Richard Bryant (RB232)

Document Release

Name/Signature

Title

Title

Date

19 Oct 2018, 07:45:19 AM

Date

Meaning/Reason

Approved

Meaning/Reason

Sandy Mulligan(MULL1026) 23 Oct 2018, 04:30:40 PM Approved

CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2018 08:14:50 am