1. caTissue 2.0 Enhanced Specimen Event Tracking and Standard Operating Procedures Use Cases and UI Mockups

2. 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

3. 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) 3

4. 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. 4

5. SOP Example
Blood processing SOP

6. Lab Implementation CP Based View (Specimen Entry)
SOP Based View (Event Entry)
SOP A
Collection Event A
PT 1
CP #1
Centrifuge
Lyse
Freeze
Collection Event A
Aliquot
Freeze
PT 2
CP #2
SOP B
Centrifuge
Freeze
Collection Event B
PT 3
CP #2
SOP C 6

7. 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. 7

8. Admin SOP Use Cases Add/Edit Event Templates
Super Admin
Add/Edit SOPs having series of Events
Associate SOP to Specimen Requirements
Site Admin
Associate SOPs to CP events

9. Supervisor SOP Use Cases
Enter SOP data based on CP for SCGs
Enter SOP data based on CP for Specimens
Supervisor
Add Events data to many specimens
View SOP data for individual SCGs
View SOP data for individual Specimen

10. SOP Example
Blood processing SOP 10

11. SOP1 & SOP2 split into events
SOP1: Blood Collection
SOP2: Cell Pellets Creation
EVENT : Spun
Speed rpm
Duration - 5 min
Temperature -
Equipment - clinical centrifuge
EVENT: Collection
Container - EDTA vacutainer
EVENT : Isolate buffy coat
Description : Remove the plasma and recover buffy ..
EVENT : Lyse RBC
Volume of lysis solution - 5
EVENT : Resuspension
Solution - PBS
Volume of PBS – 5 ml
Description: Add appropriate volume of PBS to have million cells per ml of PBS. Using a disposable pipette, gently resuspend white cells by pipetting up and down several times.
EVENT : Incubation
Duration - 10 min
Temperature - room
EVENT : Spun
Speed rpm
Duration - 5 min
Temperature -
Equipment - clinical centrifuge
EVENT : Aliquot
Container - Liquid Biohazard Container
Description: Aliquot equal amounts (approximately 1 ml /tube) of the cell suspension into 1.5 ml tubes

12. SOP3 SOP3: Frozen Cell Pellet Processing EVENT : Spun Speed - 3000 rpm
Duration - 5 min
Temperature – 4 C
Equipment - TOMY micro centrifuge
EVENT : Remove Supernatant
Description : Completely remove supernatant from cell pellet with a micropipette. Do not disturb cell pellet.
EVENT : Freeze
Freezing medium - LN2 or in a dry ice/alcohol bath
Duration – 15
Temperature C
Description - Submerge only the bottom half of the tube in liquid nitrogen- DO NOT COMPLETELY IMMERSE THE TUBE.
EVENT : Freeze
Medium - LN2

13. SOP Admin Tasks

14. Admin -> Add Event Template
Event Name
Event Template Package File
Browse
Spun Event
Upload
Package contains zip of Model XMI, Permissible Value XMLs, and Form XML

15. Admin – Add SOP SOP Name Upload XML file Blood Collection SOP Browse
Save
Set Defaults and Save
Blood Collection SOP
SOP Name
Upload XML file
Browse

16. Admin – Associate one or more SOPs with a CP event
Add all SOPs that result in creation of any specimen (or specimen requirement) collected under this CPE/SCG. Select the SOP (i.e. the event under that SOP) that resulted in the creation of each parent under its specimen requirement.
These are the SOPs that will be expected to be performed on specimens collected at this time point in the CP

17. Admin – Associate SOP to Specimen Requirement
Specimen Creation Event
Event under an OP used to create the specimen
Plasma+PBL
SOP for additional processing steps that creates derivatives
Freeze
Isolate Buffy

18. Admin – Associate SOP to Specimen Requirement
Specimen Creation Event
Creation is always an event. Processing is an SOP.

19. 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

20. Supervisor -> SOP-based specimen event data entry
Dashboard for SCG SOP data entry
Specimen Collection Group
Specimen
SOP
Blood Isolation
CP Title
PPI
Participant Name
SCG Name
Collection Time Point
CP1
123
Smith, John
CP1_SCG1
Initial Diagnosis
124
Smith, Harry
CP1_SCG2
125
Doe, John
CP1_SCG3
Enter SOP Data
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

21. Supervisor -> SOP-based specimen event data entry
Dashboard for Specimen SOP data entry
Specimen Collection Group
Specimen
SOP
Frozen Cell Pellet Processing
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
101231_2
101231_3
CP2
101232_1
Enter SOP Data
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

22. Supervisor-> Specimen Event data entry for Specimen based on SOP
SOP Label
Frozen Cell Pellet Processing
Event performed
Save
Back to Dashboard

23. Supervisor-> Add SOP/Events data to groups of specimens
, , _2, _3, _5, _6, _6, _7
Use can add a series of defined events (SOP) or individual events to a group of specimens
Event performed
Attributes of the single event or (in this case) series of events (SOP) are applied to all specimens in the list
Save

24. Remove current events from SCG page

25. Supervisor-> View SOP Data for individual SCG
Blood Isolation SOP
Collection Event

26. Supervisor-> View Events for individual specimens