STEM CELL LABORATORY (STCL) - Emmespub.emmes.com/study/duke/SOP/Clinical/STCL-SOP-050 Infusion...

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InfoCard #: STCL-SOP-050 Rev. 05 Effective Date: 26 Apr 2019 STEM CELL LABORATORY (STCL) DOCUMENT NUMBER: STCL-SOP-050 DOCUMENT TITLE: Infusion Form DOCUMENT NOTES: Document Information Revision: 05 Vault: STCL-Processing-rel Status: Release Document Type: SOPs Date Information Creation Date: 18Mar2019 Release Date: 26 Apr 2019 Effective Date: 26 Apr 201 9 Expiration Date: Control Information Author: WATE02 Previous Number: STCL-SOP-050 Rev 04 Owner: Change WATE02 Number: STCL-CCR-455 CONFIDENTIAL - Printed by: ACM93 on 26 Apr 2019 08:03:05 am

Transcript of STEM CELL LABORATORY (STCL) - Emmespub.emmes.com/study/duke/SOP/Clinical/STCL-SOP-050 Infusion...

Page 1: STEM CELL LABORATORY (STCL) - Emmespub.emmes.com/study/duke/SOP/Clinical/STCL-SOP-050 Infusion Form.pdf · neutropenia is defined ANC

InfoCard #: STCL-SOP-050 Rev. 05 Effective Date: 26 Apr 2019

STEM CELLLABORATORY (STCL)

DOCUMENT NUMBER: STCL-SOP-050

DOCUMENT TITLE:

Infusion Form

DOCUMENT NOTES:

Document Information

Revision: 05 Vault: STCL-Processing-rel

Status: Release Document Type: SOPs

Date Information

Creation Date: 18Mar2019 Release Date: 26 Apr 2019

Effective Date: 26 Apr 201 9 Expiration Date:

Control Information

Author: WATE02

Previous Number: STCL-SOP-050 Rev 04

Owner:

Change

WATE02

Number: STCL-CCR-455

CONFIDENTIAL - Printed by: ACM93 on 26 Apr 2019 08:03:05 am

Page 2: STEM CELL LABORATORY (STCL) - Emmespub.emmes.com/study/duke/SOP/Clinical/STCL-SOP-050 Infusion Form.pdf · neutropenia is defined ANC

InfoCard #: STCL-SOP-050 Rev. 05 Effective Date: 26 Apr 2019

STCL-SOP-050INFUSION FORM

Stem Cell Laboratory ISBT 128 Barcode:

1. Date of infusion (MONTH/DAY/YEAR)

2. Start Time of infusion End Time of infusion HR: MIN (24 HOUR CLOCK)

Were pre-infusion medications administered within 2 hours of infusion?

1 n Yes

2 D No

^

Continue wifh question 5

Were emergency medications administered during or within 2 hours of infusion?

4. Record Medication:

BenadtylHydrocortisone

MethylprednisoloneMannitol

Other, specify_

1

1

1

1

1

a

a

D

D

D

Yes

Yes

Yes

Yes

Yes

2D

20

2D

2D

2D

NO

NO

NO

NO

NO

1 D Yes

2 n No

^Continue with question 7

6. Record Medication:

BenadrylHydrocortisoneMethylprednisoloneMannitol

Other, specify.

1 D Yes1 D Yes

1 D Yes1 a Yes1 a Yes

2 D NO2 a NO

2 D NO2 a NO2 D NO

7. Record highest grade ofcomplication/toxicity within 24 hours of infusion.

CTCAE v. 5. 0 Grading

ToxicityInfusion related reaction

Sinus bradvcardia

Sinus tachycardia

Fever(In die absence ofNeutropenia, whereneutropenia is defined ANC<1. 0xlO')/L)

(The teniperaturenieastu-enients listed are oral

or t>Tnpaiiic)

0

a none

a none

a none

D none

1

a Mild transient reaction;infusioii inteiTuption not

indicated; intervention not

indicated

a Asymptomatic.intervention not

indicated

D Asymptomatic,intervention not

indicated

D 38. 0 - 39. 0 degrees C(100. 4-102. 2 degrees F)

2

3 Therapy or infusion inten-uptionindicated but responds promptlyto syinptomatic treatment (e. g..

antihistamincs. NSAIDS.

narcotics, IV fluids); prophylacticmedications indicated for <=24

his.

D Symptomatic, inten'entionnot indicated; change in

medication initiated

D Symptomatic; non-urgentmedical inten'ention iiidicated

D >39.0-40.0 degrees C (102.3- 104. 0 degrees F)

3

D Prolonged (e. g., not rapidlyresponsive to symptomatic

medication an(i/or brief

inteiruption ofinfusioii);recutrence of symptoms

following initial iniprovement;hospitalizatioii indicated for

clinical sequelae

D Symptomatic, interventionindicated

a Urgent medical intei'ventionindicated

a >40. 0 degrees C(> 104.0 degrees F)

for <-24 hrs.

4

a Life-tiireateniiigconsequences: urgentinten'ention indicated

a Life-tlireateningconsequences; urgentintervention indicated

D >40. 0 degreesC(> 104.0

degrees F) for>24 lirs.

STCL-SOP-050 Infusion FormStem Cell Laboratoiy. DUMCDurhani, NC Fax BOTH sides of this form to Barbara Waters-Pick (Fax # 919-684-1555) Page I of 2

CONFIDENTIAL - Printed by: ACM93 on 26 Apr 2019 08:03:05 am

Page 3: STEM CELL LABORATORY (STCL) - Emmespub.emmes.com/study/duke/SOP/Clinical/STCL-SOP-050 Infusion Form.pdf · neutropenia is defined ANC

InfoCard #: STCL-SOP-050 Rev. 05 Effective Date: 26 Apr 2019

STCL-SOP-050INFUSION FORM

Stem Cell Laboratory ISBT 128 Barcode:

Toxicih'

Hypotension

0

a none

CTCAE v5. 0 Grading

1

a Asymptomatic,inten'ention not indicated

2

a Non-urgent medicalintervention indicated

3

a Medical intervention

indicated; hospitalizationindicated

4

a Life-threaten ingconsequences and urgent

interventioii indicated

For pediatric patients, sys/olic BP SSmmHg or/ess m mfanlfs up So I year old and 70 mmHg or less m chHdren ofdcr than I year of age, use fwo successive or three mcasw'emenfs m 24 hoursHypertension

*No)e: For peUiatncpaifcnfs, use age and svx

appropriate no/wa/ vahicf,- 95lh percenlile ULN.

Rigors, chills

Nausea

Vomiting

Dyspnea(shoitiiess of breath)

Hypoxia

Hemoglobinuria

D none

a none

a iioiie

a none

D iioiie

D none

a iioiie

] Adult: Systolic BP 120-139 mm Hg or diastolicBP 80 - 89 mm Hg;

]Pediatric:

Svstolic/diastolic BP>90th pereentile but<95th percentile;

] Adolescent: BPS 120/80

eveii if < 95th perceiitile

D Mild sensation of cold;

shivering; chattering ofteeth

a Loss of appetite withoutalteration in eating habits

a Intenrention iiot

indicated

D Shortiiess of breath with

moderate exertion

] Asymptomatic; clinical ordiagnostic obsen'ationsonly; intei-v-enrion not

indicated

3 Adult: Svstolic BP 140 - 159

mm Hg or diastolic BP 90 - 99mm Hg if previously WT^L;cliange in baseline medicalinten'ention indicated; recun-eii;

or persistent (>=24 hrs. );syniptomatic increase by >20null Hg (diastolic) or to> 140/90 mm Hg; monotherapyindicated initiated:

3 Pediatric and adolescent:

Recurrent or persistent (>=24lu-s. ) BP >ULN. monotherapyindicated; systolic and /ordiastolic BP behveen the 95thpercentile and 5 iTuiiHg abovethe 99th perecntile;

^ Adolescent: Systolic between130-139 or diastolic behveen80-89 even if< 95th pereentile

D Moderate treinor of the entirebody; narcotics indicated

a Oral intake

decreased withoutsigiiificant weight

loss, dehydration ornialnutrition

D Outpatient IV hydration:medical inten'ention iiidicated

D Shortness of breath

with minimal exertion;

liiniring instrumentalADL

a Decreased oxygensaturation with exercise

(e. g., pulse oximeter<88%); intennittenl

supplemental oxygen

^ Adult: Systolic BP >-160mm Hg or diastolic BP >=100mm Hg; medical inten'entionindicated; more than one drugor more intensive therapy thai)previously used indicated;

^ Pediatric and adolescent:Systolic and/or diastolic > 5

nimHg above the 99thpercent! Ie

D Severe or prolonged, notresponsive to narcotics

3 Inadequate oral caloric orfluid intake; tube feeding,

TPN, or hospi talization

indicated

a Tube feeding, TPN, orhospitalization indicated

Shoi-tiiess of breath at rest;limiting self-care ADL

D Decreased oxygensaturation at rest (e. g,

pulse oximeter <88% orPa02 <=55 null Hg)

3 Adult and Pediatric:

^ife-threateiiing:onsequences (e. g.,nalignant hypertension.raiisient or permaiient

leurologic deficit,lypertensive crisis); urgentntervention indicated

a Life-threateningcoiisequences

a Life-tlu'eateningcoiiseqiiences; urgentintei-\rention indicated

Life-threatening ainvaycompromise; urgeiit

intei-vention indicated

(e. g., tracheotomy orintubation)

Comments:

Signature

STCL-SOP-050 Infusion FormStem Cell Laboratory, DUMCDurham, NC

Date

Fax BOTH sides of this form to Barbara Waters-Pick (Fax # 919-684-1S55)

CONFIDENTIAL - Printed by: ACM93 on 26 Apr 2019 08:03:05 am

Page 2 of 2

Page 4: STEM CELL LABORATORY (STCL) - Emmespub.emmes.com/study/duke/SOP/Clinical/STCL-SOP-050 Infusion Form.pdf · neutropenia is defined ANC

InfoCard #: STCL-SOP-050 Rev. 05 Effective Date: 26 Apr 2019

Signature Manifest

Document Number: STCL-SOP-050

Title: Infusion Form

Revision: 05

All dates and times are in Eastern Time.

STCL-SOP-050 Infusion Form

Author

Name/Signature

Barbara Waters-Pick(WATE02)

Management

Title i Date Meaning/Reason

11 Apr 2019, 07:51:33PM Approved

I Name/SignatureBarbara Waters-Pick

(WATE02)

Medical Director

Title Date J ..̂S-aI111^?.̂ £S?-[L11 Apr 2019, 07:51:46PM Approved

Joanne Kurtzberg(KURTZ001)

Quality

Title Date Meaning/Reason

12 Apr 2019, 05:25:37 PM Approved

ture

Bing Shen (BS76)

(BS76 ) for Lisa Eddinger(LE42)Taylor Orr (TS04)Richard Bryant (RB232)

Document Release

Title B-^.. -.. . _^. _-_.. _._. J ..̂ -?^ni!^^?-ea. ^n_

15 Apr 2019, 07:41:24 AM Approved

Name/Signature Title Date Meaning/Reason

Sandy Mulligan (MULL1026) 22 Apr 2019, 05:36:09 PM Approved

CONFIDENTIAL - Printed by: ACM93 on 26 Apr 2019 08:03:05 am