February 7, 2014

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MissionProvide high quality biospecimens, clinical and specimen annotation data, and a registry of patients for clinical trials

In a way that is efficient for investigators and self‐sustaining for the institution

NWBT will be responsible for biospecimens• Prospectively collected• Remnant diagnostic materials, including Pathology archival 

blocks and Lab Medicine discards• Sites include UWMC, HMC, and SCCA

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and consent

Cancer Consortium Biospecimen Resource (CBR)‐ Peggy Porter‐ Life Sciences Discovery Fund

Washington Phenotyped Biospecimen Resource (WPBR)‐ John Slattery‐ Life Sciences Discovery Fund

Recruited to Pathology from Minnesota 10/2010 ‐ 1/2013:‐ Steve Schmechel‐ Sarah Bowell, assistant director of program operations‐ Jonathan Henriksen, digital imaging coordinator‐ Tony Rizzardi, laboratory scientist 

NWBT Services

• System‐wide consenting• Single point of contact and billing service

– Statement of work (SOW), budget, letter of support, IRB assistance, shipping and invoicing details

• Procurement of biospecimens and data– Study‐, patient‐, visit‐, and specimen‐level data input by NWBT 

staff and researchers, and extracted from Amalga• Detailed annotation services

– EMR‐derived data – Pathologist consultation– Digital pathology annotations

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Patient Consenting

• Two questions at the time of check‐in:– May we use your health information and leftover specimens for research?

– May we contact you in the future about participation in research studies?

• Additional pre‐procedure question if needed:– May we collect a research‐specific sample?

• Responses recorded in Epic

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IT Systems• Study Registration system

– Registration of projects, desired patient and specimen characteristics, IRB, SOWs, budgets, shipments and invoices 

• Consent management system• Prospective collection system

– Extracts Amalga data to anticipate patient visits 

• High‐throughput discard system– Queries Amalga data about samples transiting through Lab Medicine 

against desired characteristics to flag “pick lists”

• (Coming soon:  LabMatrix to capture detailed annotations)• Virtual Biospecimen Discovery (VBD)

– Catalogue of patient samples within existing repositories

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IT Solutions Architecture v1.0Live as of August 2013

SampleRequest

SampleSearch

Patient Identification

Patient Consent

SampleOrder

SampleManager

Data Annotation& Delivery

ServiceReporting

•Query Patients•View Eligibility•Build Cohorts

•View Cons. History•Obtain Consent•Manage Forms

•Collect Samples•De‐ID Samples•Annotate Samples

•Notify Investigator•Distribute Samples•Billing (TBD)

•Honest Broker•Pathology Results•Study Results•Patient Outcomes

•Service Reports•Audit Reports•Enable Compliance

•Search Specimens•Contact Repository

Operations:•Triage Requests•Review Feasibility•Faculty Approval

VBD LabKey SR

Biospecimen Shared Resource Staff 

Secure Operations Web Portal (LabKey – Auditable Workflow)

Investigators

Public Web Portal

Secure Web Portal

Investigators:•Pre‐Grant Estimates•Study Feasibility•Research Requests

i2b2/Amalga EPIC

LabKey Main

2. RemnantTissue

3. RemnantBlood

Amalga / NWBT

Database

NWBTDatabase NWBT

Database

Doc Version:  09/23/2013 

Lab Medicine

BSM(OmniTrax / Labmatrix)

NWBTDatabase

1. Prospectiveresearch-onlyspecimens

Specimen Request

Patient Consent

Patient Identification

Specimen Collection

Biospecimen Report

Specimen Distribution

Discarded SpecimenCapture

Lab MedicineAlliance LabUW Path

Prospective Specimen Collection

SCCA outpatientUW radiology and clinics

UW surgery 

https://www.iths.org/sites/www.iths.org/files/eventmedia/The_Systems_and_Services_Tony_Black.pd

Pathology OperationsParallel system for biospecimen procurement

Specimen source (ORs, etc.)

Utilization for research, clinical

PA, trainees, faculty

High‐throughput

Technician

“at the elbow of the bench”

separate processing area

Patient

Clinical Specimens

Oversight:Hospital policy;

Clinical Regulations

(Joint Commission on Accreditationof Healthcare Organizations,

CLIA’88/College of American 

Pathologists

ResearchMaterials

University policies;Institutional Review 

Board Approval; Appropriate Consenting

“Waste” tissue determined by Pathology to be not needed for diagnosis;Consent generally not required

Clinical flow

Specifically consented

research specimens (not examined for

diagnosis by Pathology)

RESEARCH STORAGESpecimens may be physically

transferred to separate biobank when available

**OR**May be held virtually as

separate bank withIn BioNet freezers and IT system anddistributed to researchers

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Internal Internal Repository External Non‐Profit External Commercial

Num

ber o

f Projects

NWBT Projects by Specimen Category(counted by number of projects)

Cancer Non‐Cancer Educational

nwbt@uw.edu