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InfoCard #: ABMT-GEN-025 FRM2 Rev. 10 Effective Date: 09 Aug 2019

DukeMedicine Division of Cellular Therapy

DOCUMENT NUMBER: ABMT-GEN-025 FRM2

DOCUMENT TITLE:

Photopheresis Run Sheet FRM2

DOCUMENT NOTES:

Document Information

Revision: 10 Vault: ABMT-General-rel

Status: Release Document Type: General

Date Information

Creation Date: 02 Aug 2019 Release Date: 09 Aug 2019

Effective Date: 09 Aug 2019 Expiration Date:

Control Information

Author: MC363 Owner: MC363

Previous Number: ABMT-GEN-025 FRM2 Rev C Change Number: ABMT-CCR-270

CONFIDENTIAL - Printed by: ACM93 on 09 Aug 2019 08:47:54 am

FormM0345

I History #:.

Date:

|ABMT-GEN-025 FRM2 Photopheresis Run SheetTHERAKOS CELLEX SN: 40143 #lD SN: 40524 #2D SN: 40670 #3 D

InfoCard #: ABMT-GEN-025 FRM2 Rev. 10 Effectivi

DUKE UNIVERSITY HEALTH SYSTEM

^ Date: 09 Aug 2019

Name:

Supplies Pass Visual Inspection: aYes aNo

Kit lot #: Exp:_ Card #: Treatment #:

Saline 500mL lot #: Exp: Age:

ACD-A500mL lot #: Exp: Access: Lamp hrs.

Required Settings for Both Single and Double Needle Mode:

D Set return minimum pressure to -100 (default is -50)

D Set return bag threshold to 100 (default is 200)

D Single Needle Mode: D Double Needle Mode:

D During air purge change collect rate to 25 mL/min D During air purge change collect rate to 25 mL/min

D During air purge change return rate to 10 mL/min

D Return rate needs to be at least 5 mL/min greater thanthe collect rate.

Current HCT%:

WBC

Estimated Total Blood Volume:

Weight in Kg Body Build Factor TBV mL

Maximum Safe Extracorporeal Volume Range: to

10% of TBV 15% of TBV

CELLEXT Predicted ECV: Reserve Volume: (15%TBV - CELLEXT ECV)

Time Temp. Pulse Resp. B/P 0, a In EMR(Electronic Medical Record)

Notify MD if vital signs, lab results, or % ECV are out ofthese parameters:

Temperature: >38<>CSystolic BP: <80 or >160Hemoglobin: <8WBC: <1,000 or >15,000Hematocrit: <27%

Heart Rate: <50 or >120Diastolic BP: <50 or >90

Platelets: <75, 000%ECV: >15%ABMT Electrolyte ProtocolAbnormality

IF PATIENT IS RECEIVING W CALCIUM, CALCIUM MUST BE DISCONTINUED PRIOR TOPHOTOACTIVATION RETURN PHASE. (Calcium and Methoxsalen are not compatible)

ABMT-GEN-025 FRM2 Photopheresis Run SheetABMT, DUMCDurham, NC Page 1 of 2


Form

M0345

InfoCard #: ABMT-GEN-025 FRM2 Rev. 10 Effectivi

DUKE UNIVERSITY HEALTH SYSTEM

ABMT-GEN-025 FRM2 Photopheresis Run Sheet

^ Date: 09 Aug 2019

Name:

History #:.

Date: /

PHOTOPHERESIS MONITORING (Q 15 minutes)Time Collect

rate

Returnrate

Interface #*during

collect phase

Comments

Room Temp/Humidity: °c/ % Room Temp/Humidity Acceptable? aYes aNo

(Acceptable Ranges for Temperature 1 5"C to 30*'C/Humidity 30%-75%)

Uvadex dose: 3mL syringe lot #: Exp:

Treatment volume (mL) x 0.017= mL IQinL syringe lot #: Exp:

Uvadex (mL) x 20 mcg = . mcg- 20g needle lot #: Exp:

Photoactivation time: min. Fluid balance: mL

Treatment time: hr. mm. Cleaned by:

Time | Temp. | Pulse | Resp. B/P 0, D In EMR (Electronic Medical Record)

Signature: Date:

|ABMT-GEN-025 FRM2 Photopheresis Run SheetIABMT, DUMCIDurham, NC Page 2 of 2



ABMT-GEN-025 FRM2 Photopheresis Run SheetInstructions

Name/History #/Date

Therakos Serial Number (SN)

Supplies Pass Visual InspectionKit Lot #, Exp Date, and Card #Saline 500 mL Lot #

ACD-A 500 mL Lot #Treatment #

AgeAccess

Lamp HoursRequired Settings for Single and Double Mode

Single Needle Mode-Double Needle ModeSingle Needle Mode: During prime change collect rate to25 mL/min

Double Needle Mode: During prime change collect rateto 25 mL/min

Double Needle Mode: During prime change return rateto 10 mL/min

Double Needle Mode: Return rate needs to be at least

5 mL/min higher than collect rate

Current HCT%

WBC countEstimated Total Blood Volume

Maximum Safe Extracorporeal Volume RangeCELLEX Predicted ECV

Reserve Volume

Pre photopheresis vital signsEMR (Electronic medical record)

Notify MD for abnonnal values

Important Infomiation when using IV Calcium

Record patient name, history number, and date. (Youmay use patient supplied label).Check the serial number of the machine being operated.Visually inspect all supplies and check Yes or No.Record kit log#, the exp. date, NS, and write in card #.Record saline lot # and exp. Date.Record ACD-A lot # and exp. Date.Record treatment number.

Record patient's current age.Record type of access being used.Record lamp hours at beginning of procedure.Record adjusting the return minimum pressure to-100 (default is-50)

Record adjusting the return bag threshold to 100 (defaultis 200)Select single needle mode or double needle modeHelp reduce system pressure alarms at beginning oftreatment per manufactures recommendation.Help reduce system pressure alarms at beginning oftreatment per manufactures recommendation.Help reduce system pressure alarms at beginning oftreatment per manufactures recommendation.If using double needle mode, return rate at least 5mL/min to reduce patient's fluid balance duringtreatment.

Record current HCT. Must be cun'ent within 48 hours ofprocedure.WBC count on day 1 of procedureRecord weight in kg and Body build factor . Multiplyresults=TBV. See Quick Reference section, Table 2:Body Build Factors and Safe Extracorporeal BloodVolumes (ECV) Limits.Multiply TBV by 10% and 15% and record.Record the CELLEX ECV. See Quick Referencesection, Table 1: Estimated Extracorporeal Volume(ECV) Relative to %Hematocrit, Access Mode andReturn Bag Threshold Value.Subtract the CELLEX estimated ECV from the 15% ofTBV.Record time and vital signs prior to startingphotopheresis to monitor fluid status.Checking In EMR, patient's information will bedocumented in the electronic medical record.

Contact the physician if any of the values are not withinlimits.

When using IV Calcium, the infusion must bediscontinued prior to photoactivation return phase ofprocedure. (Calcium and Methoxsalen are notcompatible)




ABMT-GEN-025 FRM2 Photopheresis Run SheetInstructions (continued)

Photopheresis monitoring

Room Temp/HumidityRoom Temp/Humidity Acceptable?

Uvadex dose

Lot# and exp. dates

Photoactivation time

Fluid balance

Treatment time

Machine cleaned by

Post photopheresis vital signsEMR (Electronic medical record)

Signature and date

Eveiy 15 minutes, record the time, collect pressures,return pressures, and interface # during collect phase ofprocedure. Note any comments and/or alarms thatoccurred and what relevant actions were taken toeliminate the alarms.

Record the current temp/humidity during the procedure.Check whether or not the room temp/humidity areacceptable. If not notify Apheresis Coordinator/designeeand record on the ABMT-GEN-021 FRM3

Photopheresis Temperature and Humidity LogTemperature/RH Troubleshooting Log.Calculate Uvadex dose by using:Treatment volume (mL) multiplied by 0.017= dose ofUvadex (mL).Multiple dose ofUvadex per MD by 20 mcg to find themicrogram dose.

Record lot # and exp. dates for syringes and needle usedduring procedure.Record photoactivation time when photoactivation startsin minutes.

Record fluid balance at end of procedure in mLs.Record treatment time at end of procedure in hours andminutes.

Record initials when machine cleaned at end of

procedure.Record time and vital signs post photopheresisChecking EMR, if patient's information will bedocumented in the electronic medical record.Record signature and date




Signature Manifest

Document Number: ABMT-GEN-025 FRM2

Title: Photopheresis Run Sheet FRM2Revision: 10

All dates and times are in Eastern Time.

ABMT-GEN-025 FRM2 Photopheresis Run Sheet

Author

Name/Signature Title

Mary Beth Christen (MC363)

Management

J^Date__^^^^^^_^_^^_^Mea^^08 Aug 2019, 08:58:10 AM Approved

Name/Signature Title

Jennifer Frith (JLF29)

Medical Director

Date____. _,..L^?.nin3./El^.s_?IL08 Aug 2019, 10:27:15 AM Approved

[^Name/SignatureNelson Chao (CHA00002)

Quality

Title Date Meaning/Reason

08 Aug 2019, 12:53:47 PM Approved

Name/Signature

Bing Shen (BS76)

Document Release

Title Date [ Meaning/Reason

08 Aug 2019, 02:27:56 PM Approved

Name/Signature _[JweBetsy Jordan (BJ42)

...l£s!l Meaning/Reason

08 Aug 2019, 03:03:37 PM Approved


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