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
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