Tissue Banking Operations and Infrastructure

Mid-Atlantic Pathologists Assistantsand

Pathologists Assistants of New England

June 5th 2009Beacon Hotel, Washington DC

Tissue Banking Initiatives

Herceptin (blocks Her2neu receptor)

• Increasing need for high quality tissue samples for advancement medical research

• Translational research – “Bench to Bedside”

Tissue Banking Initiatives

Outline of today’s presentationOutline of today’s presentation Evolution of the Maine Medical Center Tissue BankEvolution of the Maine Medical Center Tissue Bank Overview of the tasks involvedOverview of the tasks involved OperationsOperations

MMC Tissue Bank

• 2001 - Spring 2004: Ardais Corp, Lexington, MA

• 2004 – 2007: Genomics Collaborative, Boston, MA.

• 2005 – Present: Established Maine Medical Center Tissue Bank

• Allowed us to work with multiple investigators (both internal and external) under the same IRB protocol

• All projects have used the same consent form• MMC Investigators will get preference for tissue requests

MMC Tissue Bank Objectives

• To collect and archive high quality tissue samples for advancement of research

• To support tissue requirements for MMC-MMCRI researchers.

• To collaborate with external investigators to help defray operating costs.

MMC Tissue Bank:Current Collaborators

• Two large pharmaceutical companies

• Two “Tissue Broker” companies

• Internal research projects at MMC-Research Institute

• Currently in discussion with two New England Academic centers

• 2011: Future Participant in the National Children's Study (NCS)

Banking Data– ARDAIS

• 2001 to 2004: – 2600 Patients– 48000 samples

– MMC TISSUE BANK• Since 2005: 8000 samples from about 1200 patients• Samples presently in inventory: ~ 5000• Samples distributed to investigators: ~3000

“Tasks”• Determine what case types to bank• Review surgical schedule to identify desirable cases• Meeting and consenting patients• Communication with the OR to identify targeted case and to arrange for timely specimen transport• Handling the tissue/blood (Dividing and processing for various sample formats)• Labeling samples and placing them into an inventory• Maintaining the inventory (Update deposits and withdraws)• Processing of histology blocks• Pathology verification (tumor percent, ischemic time, sample weight)• Develop / purchase a searchable database that can hold case information• Data collection (Pathology report and clinical data retrieval)• De-identification of all patient demographics• Shipping or transporting samples to the researcher• Office responsibilities• Billing management for both external accounts.• Equipment and supply needs

Tissue Banking Operations

• Specimen desirability / research need• Approaching and consenting patients• Targeting / Identifying potential cases• Formats of tissue • Specimen tracking• Sample Data • Inventory management • Data Management

Tissue Banking Operations

• Specimen desirability / research need

– Neoplastic disease (mostly malignant)– Inflammatory diseases (IBD, Arthritis)– Normal Tissue

Tissue Banking Operations

• Approaching and consenting patients

– Structuring a consent process– “Generic vs. client specific” consenting– Pre vs. post surgical consenting– Consenting challenges for tissue banking– Linked (consented) vs. Unlinked (non-consented) tissue

Tissue Banking Operations

• Targeting potential cases (OR and PAU Schedules)

Mailing List ScheduleAbout two weeks prior to surgery a mailing is sent to all patients scheduled for surgery. A Tissue Banking Brochure is include in the mailing for select patients based on desirability

Pre-admission Testing ScheduleMany patients will come to the hospital within a week of surgery for initial work up and blood tests. This is a good place to approach the patient and introduce the project

Daily Surgical ScheduleReview the daily surgical schedule and cross reference for patients that have been approached

Alternatives:Partner with physicians offices to identify patients and consent them.