Post on 03-Mar-2020
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
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
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
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