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caTissue 2.0 Enhanced Specimen Event Tracking and Standard Operating Procedures
Use Cases and UI Mockups
Assumptions• SOPs are a series of defined procedures that dictate
how to procure or process biospecimens• As a result of performing an SOP, a biospecimen
experiences “events” in its “lifecycle”• A specimen may experience events that either
deviate from the intended SOP or are completely unanticipated
• In the process of performing an SOP on a specimen, a new (derivative) specimen may be created
• Some events or SOPs may occur on a ‘specimen’ before it is instantiated in the system
Assumptions• For purposes of quality assurance, tracking a
collective set of specimen events is more relevant than the SOP that they compose
• SOPs and events are not required• By default, every CP should have a minimal SOP
which includes a single collection event and received event (as is currently true in caTissue 1.2)
Assumptions• At the level of the SCG, an SOP may define how one
primary parent specimen is collected and processed to create all derivative and aliquot specimens, and may also specify how such derivatives are processed by their own SOPs.
SOP ExampleBlood processing SOP
Lab Implementation
CP #1
CP #2
CP #2
PT 1
PT 2
PT 3
Centrifuge Lyse Freeze
SOP A
Aliquot Freeze
SOP B
Collection Event A
Collection Event A
Collection Event B
CP Based View (Specimen Entry)
SOP Based View (Event Entry)
Centrifuge Freeze
SOP C
Proposed Functionality• Two major use cases are supported:
– Create an SOP consisting of a series of specimen events and associate the SOP with an individual specimen requirement or collection protocol event.
– Use defined SOPs to record associated events after specimen collection/creation.
Admin SOP Use CasesAdd/Edit
Event Templates
Add/Edit SOPs having
series of Events
Associate SOP to Specimen
Requirements
Super Admin
Site Admin
Associate SOPs to CP
events
Supervisor SOP Use Cases
Enter SOP data based on CP
for SCGs
Enter SOP data based on CP for
Specimens
View SOP data for individual SCGs
Supervisor
Add Events data to many
specimens
View SOP data for individual Specimen
SOP ExampleBlood processing SOP
SOP1: Blood Collection
EVENT : Isolate buffy coat
Description : Remove the plasma and recover buffy ..
EVENT : Spun
Speed - 3000 rpmDuration - 5 minTemperature - Equipment - clinical centrifuge
EVENT : Incubation
Duration - 10 minTemperature - room
EVENT : Lyse RBC
Volume of lysis solution - 5
EVENT : Spun
Speed - 3000 rpmDuration - 5 minTemperature - Equipment - clinical centrifuge
EVENT: Collection
Container - EDTA vacutainer
EVENT : Aliquot
Container - Liquid Biohazard ContainerDescription: Aliquot equal amounts (approximately 1 ml /tube) of the cell suspension into 1.5 ml tubes
SOP2: Cell Pellets Creation
EVENT : Resuspension
Solution - PBSVolume of PBS – 5 mlDescription: Add appropriate volume of PBS to have 10-20 million cells per ml of PBS. Using a disposable pipette, gently resuspend white cells by pipetting up and down several times.
SOP1 & SOP2 split into events
SOP3: Frozen Cell Pellet Processing
EVENT : Remove Supernatant
Description : Completely remove supernatant from cell pellet with a micropipette. Do not disturb cell pellet.
EVENT : Spun
Speed - 3000 rpmDuration - 5 minTemperature – 4 CEquipment - TOMY micro centrifuge
EVENT : Freeze
Medium - LN2
EVENT : Freeze
Freezing medium - LN2 or in a dry ice/alcohol bathDuration – 15Temperature - -20 C Description - Submerge only the bottom half of the tube in liquid nitrogen- DO NOT COMPLETELY IMMERSE THE TUBE.
SOP3
SOP Admin Tasks
Admin -> Add Event Template
Spun Event
UploadUpload
Event Name
Event Template Package File BrowseBrowse
Admin – Add SOP
SaveSave Set Defaults and SaveSet Defaults and Save
Blood Collection SOPSOP Name
Upload XML file BrowseBrowse
Admin – Associate one or more SOPs with a CP event
These are the SOPs that will be expected to be performed on specimens collected at this time point in the CP
Admin – Associate SOP to Specimen Requirement
Isolate BuffyFreeze
Specimen Creation EventEvent under an OP used to create the specimen
SOP for additional processing steps that creates derivatives
Plasma+PBL
Admin – Associate SOP to Specimen Requirement
Specimen Creation Event
SOP Example association within CP
Action: Blood Collection
Collection Protocol
SOP: Frozen Cell Pellet Processing
CP Event
Specimen Requirement: Whole Blood
Specimen Requirement: Derivative – Cell Pellet
Specimen Requirement: Aliquots- Frozen Cell Pellet
SOP: Cell Pellets Creation
Specimen Creation
Processing
SOPs: Blood Collection
Specimen Requirement: Derivative – Plasma
Action: Resuspension
Action: Aliquot plasma
Action: Aliquot
Specimen Creation
Specimen Creation
Specimen Creation
CP Title PPI Participant Name SCG Name Collection Time Point
CP1 123 Smith, John CP1_SCG1 Initial Diagnosis
CP1 124 Smith, Harry CP1_SCG2 Initial Diagnosis
CP1 125 Doe, John CP1_SCG3 Initial Diagnosis
Enter SOP DataEnter SOP Data
Supervisor -> SOP-based specimen event data entry
Dashboard for SCG SOP data entry
SOP Blood Isolation
Specimen Collection Group Specimen
In this view, user selects a specific SOP and then can apply / enter all specimen event data for instantiated specimens associated with that SOP, across any CP, at the level of the SCG
CP Title PPI Participant Name SCG Name Collection Time Point
Specimen Label
Specimen Type
CP1 123 Smith, John CP1_SCG1 Initial Diagnosis 101231_1 Frozen Cell Pellet
CP1 123 Smith, John CP1_SCG1 Initial Diagnosis 101231_2 Frozen Cell Pellet
CP1 123 Smith, John CP1_SCG1 Initial Diagnosis 101231_3 Frozen Cell Pellet
CP2 123 Smith, John CP1_SCG1 Initial Diagnosis 101232_1 Frozen Cell Pellet
Enter SOP DataEnter SOP Data
Specimen
Dashboard for Specimen SOP data entry
SOP Frozen Cell Pellet Processing
Specimen Collection Group
In this view, user selects a specific SOP and then can apply / enter all specimen event data for instantiated specimens associated with that SOP, across any CP, at the level of the individual specimen
Supervisor -> SOP-based specimen event data entry
Supervisor-> Specimen Event data entry for Specimen based on SOP
SaveSave Back to DashboardBack to Dashboard
SOP Label Frozen Cell Pellet Processing
Event performed
Supervisor-> Add SOP/Events data to groups of specimens
Specimen
SaveSave
Event performed
45678900, 45679041, 45679041_2,45679041_3, 45679041_5, 45679041_6, 45679041_6, 45679041_7
Use can add a series of defined events (SOP) or individual events to a group of specimens
Attributes of the single event or (in this case) series of events (SOP) are applied to all specimens in the list
Remove current events from SCG page
Blood Isolation SOPCollection Event
Supervisor-> View SOP Data for individual SCG
Supervisor-> View Events for individual specimens