InfoCard #: FLOW-FORM-007 Rev. 03 Effective Date: 01 Nov 2019

STEM CELLLABORATORY (STCL)

DOCUMENT NUMBER: FLOW-FORM-007

DOCUMENT TITLE:

BD FACSCalibur Flow Cytometer Instrument QC Log

DOCUMENT NOTES:

Document Information

Revision: 03 Vault: FLOW-Form-rel

Status: Release Document Type: FORM

Date Information

Creation Date: 14 Oct 2019 Release Date: 01 Nov 2019

Effective Date: 01 Nov 2019 Expiration Date:

Control Information

Author: MGREESE

Previous Number: FLOW-FORM-007 Rev 02

Owner:

Change

MGREESE

Number: STCL-CCR-471

CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2019 10:28:44 am

InfoCard #: FLOW-FORM-007 Rev. 03 Effective Date: 01 Nov 2019

Instrument Serial #

FLOW-FORM-007BD FACSCalibur Flow Cytometer Instrument QC Log

Month/Year

DateNIU=Not in use Op.

Cali-BRITELot #

B^U31

z

3

4

5

6

/

8

9

1011

1213

14151617

18192021

22

2324Z3

26

27

2829

3031

APCLot #

iL

FSCP/F

sscP/F

FLIP/F

FL2P/F

FL3P/F

FL4P/F

TDP/F

PMT voltageAccording to the Call hr ite Bead prodiict insert, da)' to day change in vol/age is normally^_10 volts for any PMT. Im'estigate possible problems and note corrective action in theiiistnimenl troubleshool log if observed change is >10.

ssc PL 1 FL2 FL3 FL4

Monthly voltage ranges: FL1

Reviewed by_Date:

FL2 FL3 FL4

FLOW-FORM-007 BD FACSCalibur Flow Cytometer Instrument QC LogStem Cell Laboratory, DUMCDurham, NC CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2019 10:28:44 am Page 1 of 2

InfoCard #: FLOW-FORM-007 Rev. 03 Effective Date: 01 Nov 2019

If multiple FACSComp assays are performed, record lot change information on only one Form 007.

Calibrite-3 Kit lot #._

Individual bead lot#: U

Date in use:_ Recorded By:

Calibrite-3 Kit lot #._

Individual bead lot#: U

Date in use:_ Recorded By:

_EXP._

F

_EXP._

F

_Date QC:_

_Date QC:_

p

PCP

PCP

Recorded by:

Recorded by:

APC bead lot#

Date in use:

APC bead lot#_

Date in use:

EXP,

Recorded By:

EXP.

Recorded By:

_Date QC:_

_Date QC:_

Recorded by:

Recorded by:

Reviewed by: Date:

FLOW-FORM-007 BD FACSCalibur Flow Cytometer Instrument QC LogStem Cell Laboratory, DUMC

Durham, NC CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2019 10:28:44 am Page 2 of 2

InfoCard #: FLOW-FORM-007 Rev. 03 Effective Date: 01 Nov 2019

Instruction for completing the BD FACSCaIibur Flow Cytometer Instrument QC LogIn the field...Instrument serial #

Month/Year

Date

Operator

Cali-BRITE lot #

APC lot #

FSC p/f

SSC p/f

Fl-1 p/f

Fl-2 p/f

Fl-3 p/f

Fl-4 p/f

TDp/f

PMT voltage

Monthly voltage values.

Reviewed by and date

Calibrite-3 kit lot

#/exp. /Recorded by

Date QC /Recorded by

Date in use/Recorded by

Individual bead lot #/Recorded

byAPC bead lot #/exp./RecordedbyDate QC /Recorded by

Date in use/Recorded by

Reviewed by and date

Record...

Record the serial # of the flow cytometer

Record the month and year that the testing is performed

Record date of instrument qc.

Initials of operator

Record lot # for Calibrite -3 bead kit.

Record lot number from APC beads

Results of pass fail during instrument qc.

Results of pass fail during instrument qc.

Results of pass fail during instrument qc.

Results of pass fail during instrument qc.

Results of pass fail during instrument qc.

Results of pass fail during instrument qc.

Results of pass fail during instrument qc.

Voltage values from FACSComp report.

Range of monthly values for each PMT. (From the LevyJennings software analysis at end of month)

Record the initial of the reviewer and the date

Add lot number for kit and expiration date/Initial of person thatrecorded this info.

Add the date that the new lot was checked against the oldlot. /Initial of the person that recorded QC

Add the date that the lot was placed in use/Initial of person thatplaced the lot in use

Add lot number in space provided for (F)itc, (P)E,(P)er(CP)/Initial of the person that recorded this info.

Add the lot number for the APC beads and expirationdate. /Initial of the person that recorded this info.

Add the date that the new lot was checked against the oldlot. /Initial of the person that recorded QC

Add the date that the lot was placed in use./ initial of person thatplaced the lot in use

Record the initial of the reviewer and the date

FLOW-FORM-007 BD FACSCalibur Flow Cytometer Instrument QC LogInstructions

Stem Cell Laboratory, DUMCDurham. NC

CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2019 10:28:44 am

Page 1 of 1

InfoCard #: FLOW-FORM-007 Rev. 03 Effective Date: 01 Nov 2019

Signature Manifest

Document Number: FLOW-FORM-007

Title: BD FACSCalibur Flow Cytometer Instrument QC LogRevision: 03

All dates and times are in Eastern Time.

FLOW-FORM-007 BD FACSCalibur Flow Cytometer Instrument QC Log

Author

iN3^!s'§n^^_ _, ^^ ^^.̂

jj^_,^^_^ .,,, ^.̂ .. -:. ". "". -.....,,, J..^IS£n!12S/Peas91

Melissa Reese (MGREESE) 16 Oct 2019, 10:07:01 AM Approved

Management

. !me/si9nature. _-_- . __ ^^_^_^Title_ _ I Date i; Meaning/Reason

Barbara Waters-Pick (WATE02) 16 Oct 2019, 01:53:37 PM Approved

Medical Director

JName/Signature [Title | Date IMeaning/ReasonJoanneKurtzberg(KURTZOOI) 16 Oct 2019, 04:05:47 PM Approved

Quality

I Name/Signature | Title S Date |' Meaning/ReasonIsabel Starch (IMS19) 21 Oct 2019, 11:56:30 AM Approved

Document Release

iJ^laijie^Signatyre _ ; Title __^_ ^^ ̂ _i Date ^ __ ^ Meaning/ReasonSandy Mulligan (MULL1026) 22 Oct 2019, 08:26:04 AM Approved

CONFIDENTIAL - Printed by: ACM93 on 01 Nov 2019 10:28:44 am