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