hipaa, tissue banking, and data aggregation: new tools to solve old problems

HIPAA, Tissue Banking, and Data Aggregation: New Tools to Solve

Old Problems

Rajiv Dhir, M.D.

Director, Health Sciences Tissue Bank

Ashokkumar A. Patel, MD

Data Manager, Health Sciences Tissue Bank

Key Objective

Reveal methods for developing a Collaborative Honest Broker Service in the Informatics environment to support:

Tissue Banking

Research Information Services

Clinical Trials Research

Outcomes Analysis

Agenda

• Introduction – The Need for Collaboration• Define Honest Broker Services• Identify Need for Honest Broker Services• Define the Process for Developing a

Collaborative Honest Broker Service• Review of a Data Request Tracking Tool• Examples of De-Identification Processes• Current Status and Future Direction

IntroductionThe Importance of Tissue

• Tissue Banking: implies banking of tissue and biological specimens

• Pathology: the study of tissue for the presence and nature of disease

• Genomics, tissue engineering, modern biology has generated an unprecedented demand for qualified tissue for research

• Access to qualified tissue is more important than ever before

IntroductionThe Importance of Tissue

• Tissue is rare and coveted, hard (& expensive) to manage, manipulate and store

• Tissue needed in different flavors• Frozen tissue and biological

materials• Paraffin tissue

– TMA construction– New techniques allow tapping

into archival repositories• Pathology should be driving

tissue banking across the entire health system!

The many roles of the tissue bank

• Pro-actively acquiring research samples and banking samples

• Inventory management and sub-sampling tissue

• Managing Consents and IRB

• Honest broker activities

• Annotating information

• Current Workflow of the Tissue Banking

Patient consented. Pt. in OR for surgery.

Tech. paged

Specimenbrought toPathology

Tissue collected for

research & clinical

Tissue labeled, annotated and

stored.

Tissue Bank Workflow

Tissue Bank initiatives and Issues

• Acquire tumor/ normal pairs with minimal warm ischemia

• Donor tissue• Warm Autopsy program• Blood and biological specimen collection• Project focused collection (special consent forms)

– Aberrant crypt foci (EDRN project).– Carinal biopsy (Lung SPORE)

• Freezers

QA Standards and Protocols

• We do not triage tissue for processing of DNA/ RNA/ protein up front– Changing needs every year– Provide fresh tissue

• Do not process tissue for clients– Every investigator has own best practices

• Focus on minimal “warm ischemia” time– Recorded in the Tissue Bank.

Tissue Banking - Role of the Bank

• Specimen Documentation, Pathology examination and Sampling & QA/ QC

• Tissue frozen/ triaged for cell culture

• Macro and Micro-dissection (LCM)

• Tissue Microarrays• Whole Slide Imaging

Inventory/ bar coding

• Provide an efficient system for – Recording specimen acquisition.– Tracking of specimen storage and usage.

• Linked to other systems with additional annotating information.

• Provides tools for an electronic mechanism for setting limits on specimens.– Last specimen/ for specific end user or project

etc.

• De-Id/ HIPAA

Inventory management

• Categorize and flag samples based on perceived value (primary and associated metastatic samples much more valuable)

• Bar coding and Web based Inventory tracking system– Three flagship hospitals and the Cancer Institute

and approximately 20 freezers

• Query capability– Can place restrictions on amount of information an

individual can access

Inventory management

• Currently using system developed in-house.

• Moving to Ca Tissue Core for future management of the inventory

• Submitted a proposal in response to the RFA for “Testing sites”.

The IRB related role of the Bank

• Tissue Bank Director HAS to be very cognizant of issues pertaining to consenting/ IRB/ ethics/ Patient Consent

• The bank should take the lead in developing a uniform consent for banking tissue and fluid

• Specialized consent forms

Policy and Procedures

• Tissue request form with details of specimen and annotating data requirement.

• IRB approval as well as IRB submission needed for complete assessment of protocol.

• Feedback to requesting investigator with anticipated time needs to fulfill request.

Honest Broker• Purpose

– De-identification

– Honest research

• Functioning– Tissue banker has the linkage codes

– Strips identifiers (de-identifies)

– Provides additional clinical/ pathology information

– Should not be a co-investigator on that project

– Maybe invest in a dedicated honest broker (volume dependent)

IRB Issues

• Who has access to identified data– Clinical usage– Research use only after de-identification

• IRB for collection of materials is different from IRB for usage.

• Any research use of collected materials has to have prior IRB approval– New OHRP guidelines

Tissue Bank Issues and initiatives

• IRB initiative

– Eliminate need for IRB submission and approval for most research

– The role and importance of honest brokers

– OHRP memorandum defining human research

• IRB needed for new prospective collection initiatives

Introduction

• Tissue resource IRB approved for tissue collection

• Individual investigators need IRB approval when requesting tissue/ data for research use from the tissue resource collection

• IRB submission currently is generally in the expedited category, since it involves usage of existing resources

“Human Research”

• The Federal Policy defines “human subject” research as a process where an investigator conducting research obtains– data through intervention or

interaction with the individual OR – identifiable private information

New OHRP guidelines

• New guidance from the Office of Human Research Protection (OHRP): August 10, 2004

• Research activity involving "de-identified" specimens and data – Would not be considered as research

involving human subjects – Would not need specific IRB approval

HSTB Current status and relationships

• Tissue/ biological specimens collected in two major categories– Consented– Non-consented

• Impacts amount of annotating information

HSTB Current status and relationships

• HSTB is a certified Honest Broker facility

• This is a collaborative approval with other important facilities– Cancer registry, Outcomes group,

Medical and Radiation Oncology, and Pathology and Oncology Informatics

HSTB New initiative

• Most investigator requests are for de-identified tissue/ data

• Personal identity not needed in almost 100% of cases, in our current experience

• Honest broker entity essentially covers all aspects of biological specimen and data needs for researchers

HSTB New initiative

• Combined capabilities of the HSTB and this honest broker facility should be able to address almost all needs of researchers, in a manner compliant with current legal and ethical considerations, consistent with current OHRP recommendations

New initiative: What it means to the researcher

• Submit request to the HSTB• HSTB triages request to the TUC for

that organ system• Approval should be within a week• Researcher then provided the tissue/

biological specimens/ data with TAT depending on the volume of activity

New initiative: What it means to the researcher

• The researcher has to sign a usage agreement.

• Can not triage material to others (internal/ external collaborations not permissible)

• Submit additional request for internal use

• External collaboration HAS to be IRB approved

When does a researcher need to file an IRB

• External collaboration HAS to be IRB approved

• Specific focused (non-random) prospective collection

• Collection of specimens only for research – The typical specimen in the HSTB

is “excess” tissue

IRB initiative

• Limitation on what is done with the sample – Stays in the Institution

– Can not be forwarded to other investigators

– Tissue resource provides annual update to IRB

• Streamlines research with decreased TAT

Paraffin archive issues

• Paraffin research is considered exempt

• Should involve an honest broker

• Institutional policies on access– COE model at UPMC

• Can have data annotation via an honest broker

De-identification

• Ensure removal of identifiers when providing research material.

• Can be manual or electronic.• Make copy of report that has been blacked out.

– Software tools allow de-identification and enable electronic tracking.

• Pathology LIS systems may have De-ID capabilities.

HIPAA (Research) Summary

• Section 164.514 of HIPAA – “Other requirements relating to the uses & disclosures of protected health information”

• Section (b)(2)(i) lists 18 identifiers of individuals or of relatives, employers, or household members to be removed

• Section(c) provides implementation specifications for re-identification

The 18 are…

1. Names

2. Geographical Locations

3. Dates and Ages

4. Telephone numbers

5. Fax Numbers

6. Email Addresses

7. Social Security numbers

8. Medical Record Numbers

9. Health Plan Numbers

10. Account Numbers

11. Certificate/License Nos.

12. Vehicle Identifiers

13. Device Identifiers

14. URLs

15. IP Numbers

16. Biometric Identifiers

17. Full-Face Images

18. Any Other Identifier

De-identification

• Co-Path does limited De-ID.

• Our own efforts through MARS.

• Use an honest broker.

• Ongoing joint Project of the Office of Clinical Research and the Center for Biomedical Informatics to– Create a HIPAA complaint engine (De-

identification Engine Development).

De-identification Engine Development

• The engine has been certified by the IRB at University of Pittsburgh and University of Pittsburgh Medical Center (UPMC) Security Office as generating de-identified output from a variety of free text medical reports

• Developed in collaboration with Melissa Saul and the Information Services Division

De-identification Engine• When a name is identified it is replaced by a name tag

and some replacement letters.• When the same person is encountered in multiple places

in the same report, the same replacement letters are used for every occurrence.

• Dates are replaced by some offset. This offset is calculated as a function of the patients medical record number.

• Since the dates are not real, they cannot be used for patient identification.

S_O_HCounters Record Type56,38 DSE_O_H[Record de-identified by: de-ID v. 3.25] CONSULTANTS: Dr. **NAME<XXX WWW> and Dr. **NAME<VVV UUU>. REASON FOR ADMISSION:Brief history and physical: Mr. **NAME<AAA> is a **AGE<in 40s>-year-old gentleman,previously healthy, who was working in a cherry picker on a truck hanging banners when he fell from the cherry picker. HOSPITAL COURSE:He presented to the trauma bay at the **ADDRESS of **ADDRESS with complaints of back pain and left leg pain.

De-ID Report ExampleDe-ID Report Example

Linkage File

• Counter created for each patient and each report based on medical record number

• Linkage file contains counter plus medical record number and unique document number as stored in MARS (our EMR).

• Linkage file is stored on IPS server and not publicly available

Text ProcessorAnd

Statistical Engine

Text ProcessorAnd

Statistical Engine

IPS Server

DE-ID Processing

EncryptedLinkage FileTo Reside

On IPS Server

Query to MARS to retrieve document types of interest

MARS Data Repository

Query to MARS to retrieve document types of interest

MARS Data Repository

IPS Client

Request

Data Set #1

IPS Server and Re-linking Architecture

Data Set #2

Model #1Model #1

Model #3Model #3

Model #2Model #2

Model #4Model #4

Data Annotation

• Depends on the consent status• Basic information

– Age/ sex/ race/ diagnosis/ tissue type (normal/ tumor/ other).

– Locator information (freezer/ rack/ box).– Amount of material available.– Any restrictions.

Organ Specific Databases• Store clinical/ pathology/ outcomes information

on particular tissues of interest.• The information collected on consented

patients.• Tissue/ biological specimens in the Tissue Bank.• The data can be provided to researchers in a

de-identified fashion (HIPAA complaint).

Organ Specific Databases• The data elements in OSD defined by the group

with research interests in that particular area. – Important to define these elements based on current

and future research goals and interests.

• Relationship with the cancer registry– Mechanism to tap into institutional clinical

infrastructure.

– Joint IRB submissions by the Tissue Bank/ Cancer registry/ Outcomes group

Organ Specific Databases

• Mechanism for detailed data entry• Informatics enabled data aggregation

from various sources• Sophisticated query tool for this “Virtual

Tissue Resource”• Model adopted by NCI Cooperative

Resources as well as by the PCABC

Networked virtual Tissue Bank

• Necessity in an institution with multiple hospitals.

• Provides a handle on overall ongoing activities.• Great resource for overview of repository

status.• Essential for large scale collaborative efforts.• Provides mechanism to document collection

and utilization on a programmatic basis.

Collaborative honest Collaborative honest broker servicebroker service

Why a Collaborative honest Why a Collaborative honest broker service?broker service?

• Primary requests from researchers generally consist of the following

– Tissue and Biological specimens only

– Annotating data • generally pathology data

– Outcomes information

20%

70%

10%

Tissue and BiologicalsAnnotated TissuesOutcomes

This breakdown reveals the need for a collaborative service between tissue banking, pathology and cancer registry

Growing area of

requests by Honest Brokers

UPMC Tissue/ data requestsUPMC Tissue/ data requests

Defining Honest Broker ServicesDefining Honest Broker ServicesQA vs. Research – QA vs. Research – Questions to AskQuestions to Ask

• Is there an intent to publish results of the study outside of the covered entity?

• Is it true that a corrective plan has NOT been established based on the outcome of the study?

• Is the study being sponsored/funded by an external agency?

• Does the study include randomization of study participants?

• Does the study involve a control group?

Defining Honest Broker ServicesDefining Honest Broker ServicesQA vs. Research – QA vs. Research – Questions to AskQuestions to Ask

• Does the study involve an intervention delivered in a blinded fashion?

• Is the assessment of the outcome blinded to the study intervention for purposes of studying efficacy

• Does the study involve a non-FDA approved drug/device?

• Will the study participants be exposed to additional risks or burdens (other than completion of satisfaction surveys) in order to make the study generalizable?

• Are Patient Identifying Data, or Protected Health Information (PHI), being requested?

UPMC QA Oversight CommitteeUPMC QA Oversight Committee

• This facility-specific committee has an impact on the way we monitor requests for data for the purpose of quality assurance/process improvement. We have incorporated aspects of this committee’s approval process into the data request tracking tool.

– Policies/procedures for this committee

– Burden of approval-process

– Approval/certification process

– Monitoring

– Data Use Agreement

Need for Honest Broker ServicesNeed for Honest Broker ServicesGovernment and Facility RegulationsGovernment and Facility Regulations

• Health Insurance Portability and Accountability Act (HIPAA)

• Institutional Review Board (IRB)

• General Confidentiality of Patient Data

• Facility Specific Restrictions

Need for Honest Broker ServicesNeed for Honest Broker ServicesPolicies and ProceduresPolicies and Procedures

It is the policy of the University of Pittsburgh Medical Center (UPMC) to comply with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule pertaining to the use and disclosure of protected health information (PHI) and the de-identification of PHI for Research and any applicable related state laws that are not preempted by HIPAA. The HIPAA Privacy Regulations can be located at 45 CFR Parts 160 & 164 or at http://aspe.hhs.gov/admnsimp/final/PvcTxt01.htm.

HIPAA Privacy Rule andHIPAA Privacy Rule andDe-IdentificationDe-Identification

• The Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits protected health information (PHI) to be used without patient authorization in a number of limited cases. One such case is where the PHI is de-identified.

• PHI can either be de-identified by an honest broker which is part of the covered entity (as defined by HIPAA) or by an honest broker which is a business associate of the covered entity.

Defining the Honest BrokerDefining the Honest Broker• An honest broker is an individual, organization or system

acting for, or on behalf of, the covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. – A broker acting on behalf of a covered entity must sign a Business

Associate Agreement (BAA)

• The honest broker cannot be one of the investigators.• Honest broker for a project also cannot be funded by the

project (per NIH concern)

Linkage CodesLinkage Codes

• The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a “re-identification code”).

• The information linking this re-identification code to the patient’s identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker.

De-Identification Facilitates De-Identification Facilitates Retrospective ResearchRetrospective Research

• Since neither the Federal Policy nor HIPAA regulations require prior written informed consent/authorization of patients for the research use of their de-identified health information, this approach would address satisfactorily the regulatory requirements associated with the conduct of retrospective research involving existing health information.

Accrual to Clinical TrialsAccrual to Clinical Trials

• This approach can also be used to identify eligible patients for subsequent recruitment into clinical trials. For example, based on defined search criteria, the honest broker would provide a de-identified listing of the health information of potential eligible subjects, to include re-identification code numbers, to the clinical trial investigators.

• The investigators would determine which of these patients appear to meet eligibility criteria and convey the respective re-identification code numbers back to the honest broker. The honest broker would subsequently provide the names of the identified patients to the patients’ personal physicians

Obtaining Interest in Clinical Trial Participation

• Primary Physician Duties:

– introduce the research study– ascertain their interest in study participation– instruct the patients to contact directly the

investigators or obtain their written authorization to share their interest in study participation with the investigators and to be contacted by the investigators.

– Note that direct contact of the patients by the honest broker would constitute “cold-calling”, which is prohibited by the IRB.

Developing a Collaborative Honest Broker Service

• Mission

• Goals and Objectives

• Details of the Services

• Who are the Brokers? How to Add Brokers?

• Business Associate Agreements (BAA)

• Data Use Agreements

• QA Oversight Committee

Collaborative Honest Broker ServiceCollaborative Honest Broker Service

Mission StatementMission Statement

To assure HIPAA compliance for the release of information involving data stored in applications developed, managed and/or utilized by the Center of Pathology and Oncology Informatics, the Center for Pathology Quality and Healthcare Research, the Health Sciences Tissue Bank and/or the UPMC Network Registry.

Collaborative Honest Broker ServiceCollaborative Honest Broker ServiceGoals and ObjectivesGoals and Objectives

• Enhance Collaborative Research Efforts between Centers• Monitor Requests for Information & Data Use Practices

– Quality Assurance and Process Improvement– Preparation for Research– IRB-Approved Research– Marketing– Incidence

• Develop Web-Based data request tracking tool• Centrally approve supporting documentation• Centralize training and management

Collaborative Honest Broker ServiceCollaborative Honest Broker ServiceThe TeamThe Team

• Centers for Pathology and Oncology Informatics

• Center for Pathology Quality and Health Care Research

• Health Sciences Tissue Bank (HSTB)• Cancer Registry/Research Registry• Clinical Outcomes• NEW: Radiation Oncology


Our StatisticsOur Statistics• Pathology – oversee labs in 20 facilities• Oncology Environment

– 4 ‘hub’ academic hospitals– 10 community hospitals, some teaching facilities– 7 regional standalone cancer centers– 28 physician offices

• 180 affiliated oncologists

• Cancer Registry– Cover hospital and practice-based locations– Over 180,000 cases available – Centralized application


Our FundingOur Funding

• The team manages $7.5M of our own research grants per year

• $35M in collaborations between Pathology and Oncology

• Department of Pathology $19.5M per year

• UPCI $141M per year


RationaleRationale

• Multiple Collaborative Projects with External Facilities– PCABC– PAC3– CDC CAP Demonstration Project– SPIN– CDC Mesothelioma Virtual Tissue Bank

• Internal Collaborative Projects with our Centers of Excellence for both research and clinical tissue and data needs


Data SourcesData Sources• Pathology Laboratory Information System

– CoPath Plus– TBIS (Tissue Banking Information System)– TBINV (Tissue Banking Inventory System)

• Cancer Registry Application (IMPAC MRS)• Hospital Information Systems• Outpatient Systems• Other Oncology Related Applications

– Clinical Trials Management Application– Web-based Organ Specific Database– Radiation Oncology

• Paper-based and Electronic Records

Collaborative Honest Broker SystemCollaborative Honest Broker SystemDetails of Application to the IRBDetails of Application to the IRB

• Application submitted April 30, 2003 (copy to be available on APIII website)

• Initial approval received May 8, 2003• UPMC/IRB approval number HB015• Our Application is being used by the IRB as the “gold

standard”• Sponsored by:

– Michael Becich, MD, PhD - Pathology Oncology Informatics

– Stephen Raab, MD - Center for Pathology Quality & Healthcare Research

– Rajiv Dhir, MD - Health Sciences Tissue Bank

– Sharon Winters, MS, RHIA, CTR - UPMC Network Registry

• Managed by Sharon Winters, MS, RHIA, CTR


Highlights of the IRB ProposalHighlights of the IRB Proposal

• Overview of Each Area: Members, De- Identification Processes, Current Filing Practices– Centers for Pathology and Oncology

Informatics– Center for Pathology Quality and Healthcare

Research– Health Sciences Tissue Bank (HSTB)– Clinical Outcomes– Cancer Registry/Research Registry


Honest Broker CertificationHonest Broker Certification• Complete a Business Associate Agreement (Pitt

employees only)• Complete Education Modules 1, 2 and 6• IRB website generates certificates upon

completion of each module

http://rpf.health.pitt.edu/rpf


The MembersThe MembersHealth Sciences

Tissue Bank Clinical Outcomes Cancer Registry &

Other Oncology Team Leader Michelle Bisceglia

Team Leader Dana Gryzbicki

Team Leader Sharon Winters

Brokers Rajiv Dhir

Michelle Bisceglia Ashok Patel Aprell Delo

Jennifer Young Lindsay Mock Mindy Arnold Bunnie Miller

Fang He Amelia Hensler

Kelly Santo Patricia Clark

Brokers Jennifer Condel Colleen Vrbin

Brian Turcsanyi Janel L’Official Stephen Bruno

Beverly Sutkowski Laura Mahood

Brokers Sharon Winters

Susan Urda Jennifer Ridge-Hetrick

Brenda Crocker Louise Mazur Jamie Gola

Lorraine Ickes Heidi Patterson-Orlando

Ann Merkle

Role of Research Registry• Organ/Disease focused Research Registrars providing one-on-one

services for data to the research community.

UPMC Network Cancer RegistryR egistry In form ation Services

D e ce m be r 20 05

Y e llo w = D ire c t re p o rt

B lu e = P o s ted

G re y = P lan n ed

ADM INISTRAT IVE SUPERVISO R (30% )G enine Barto lo tta

Q A / REG ULATO RY CO O RDINAT ORBeverly Ro zan ok , CT R

South S id e.5

Passavan t1.5

M cKeespor t1

Child ren s1

Bedford.5

Northwest (new)1

S t. M argaret1.5

PUH/SHY1 1

Horizo n2

Braddoc k.5

HO SPITAL BASED20.5 F TEs

East1

South1

Hillm an Rad/O n c.5

W est1

North1

M urtha2

CO M M UNIT Y BASED6.5 FTEs

M ANAG ERClinical Registry Service s

Kim b erlie M arks, RHIA, CT R2 7 F T E s

Non-Neo Lun g3

Breast / G yne1

Head & Nec k2

Prostate1

Brain1

G I / Hem e1

Lun g1

M elanom a/Skin1

M age e4

M ANAG ERResearch Reg istry Service s

Susan Urda, CTR1 1 F T E s

DIRECTO RRegistry Inform ation Service s

Sharo n B. W in ters, M S, RHIA, CTR

UPMC Network Cancer RegistryR egistry In form ation Services

D e ce m be r 20 05

Y e llo w = D ire c t re p o rt

B lu e = P o s ted

G re y = P lan n ed

ADM INISTRAT IVE SUPERVISO R (30% )G enine Barto lo tta

Q A / REG ULATO RY CO O RDINAT ORBeverly Ro zan ok , CT R

South S id e.5

Passavan t1.5

M cKeespor t1

Child ren s1

Bedford.5

Northwest (new)1

S t. M argaret1.5

PUH/SHY1 1

Horizo n2

Braddoc k.5

HO SPITAL BASED20.5 F TEs

East1

South1

Hillm an Rad/O n c.5

W est1

North1

M urtha2

CO M M UNIT Y BASED6.5 FTEs

M ANAG ERClinical Registry Service s

Kim b erlie M arks, RHIA, CT R2 7 F T E s

Non-Neo Lun g3

Breast / G yne1

Head & Nec k2

Prostate1

Brain1

G I / Hem e1

Lun g1

M elanom a/Skin1

M age e4

M ANAG ERResearch Reg istry Service s

Susan Urda, CTR1 1 F T E s

DIRECTO RRegistry Inform ation Service s

Sharo n B. W in ters, M S, RHIA, CTR


Adding New BrokersAdding New Brokers• Monthly review of IRB submission, required every

six months• Submit name, contact information, a signed BAA (if

Pitt employee) and copy of honest broker certification to the team leader: Sharon Winters, Dana Grzybicki or Michelle Bisceglia

• Team leaders keep copies of certificates and BAAs• Broker Service manager oversees adjustments to

IRB submission.• It takes up to a week to obtain IRB approval


The Web-Based Tracking ToolThe Web-Based Tracking Tool

• Team: Winters, Grzybicki, Urda, Bisceglia

• Developers: Phillips, Elnyczky• Originally developed for

tracking Network Cancer Registry requests

• Enhanced for use by the entire Honest Broker Service team

• Reporting functions recently added– Track all requests for data,

regardless of purpose (QA/research/other)

– Track IRB details on research requests for PHI

– Required documentation must accompany requests and will be filed by brokers and noted in tracking tool





• Created to electronically track and maintain honest broker data and tissue requests for any purpose

• Internally developed secure intranet web-based application developed in Cold Fusion using an Oracle database


The Web-Based Tracking ToolThe Web-Based Tracking Tool• Elements Included in the tool

– Project title– Due date– Requestor name, contact information – “UPMC

People database”

– Recipient name, contact information - “UPMC People database”

– Description of the request– Variables included in the request



• Elements Included in the tool (cont.)– Purpose (QA, Research, other details)– Principal Investigator - “UPMC People database”

– IRB Information– Honest Broker Identifiation - “UPMC People

database” – Dates submitted, approved/denied, completed– Comments

Collaborative Honest Broker ServiceCollaborative Honest Broker ServiceRequests: Approvals &TrackingRequests: Approvals &Tracking

• Request is received by Broker• Broker enters all necessary information into the

tracking tool• Broker submits request to HBS manager via tool• Approvals team documents approval status and returns

email to broker• Broker can proceed with request when approved• Broker marks tracking tool when request is complete• Summary of requests reviewed quarterly

Collaborative Honest Broker ServicesCollaborative Honest Broker Services

Sample De-id ProcessesSample De-id Processes• Types of requests clinicians/researchers

– Tissue Only– Tissue + Clinical Data– Tissue, Clinical + Outcomes Data– Clinical Data Only

• QI

• Research

The Collaborative Honest Broker The Collaborative Honest Broker ServicesServices

Honest BrokerHonest Broker Tracking ToolTracking Tool

Honest Broker Tracking Tool

Enter New Request


Types of Requests


Submit Request for Approval


Complete Request

148 Total Requests

Tracking Tool: Reports

446 Total Requests


• 446 Total Requests

purpose of the requests:

45% research

15.7% prep for research

14.8% incidence

12.7% clinical

6.8% quality/process improvement

3.3% marketing

1.8% presentation/abstract


View Completed Requests

Submitter can request to viewAll or just the requests they submitted

View all mode displayed

View by Honest Broker

The Collaborative Honest Broker The Collaborative Honest Broker Services: Future DirectionsServices: Future Directions

• Charging for HBS

• Further enhancement of tool

• Close relationship with Tissue Utilization Committees

Tissue Utilization CommitteesTissue Utilization Committees

• Required to provide oversight to tissue and biological material disbursement

• Provides a mechanism for prioritization of scarce resources

• Provides representation to the different interacting groups in decision making (Surgery/ Oncology/ Pathology/ Researchers)

Tissue Utilization Committees Tissue Utilization Committees Organizational Organizational HierarchyHierarchy

• Organ based in areas of high activity

– Lung/ Head & Neck/ GU/ GI/ Women’s Health/ Liver.

• Institutional Oversight Committee constituted above all the TUCs.

– This committee will serve as a final arbitrator in case of conflicts that are not resolved in the organ specific TUCs.

Fee-for-service structure

• The institutional goal is to make research support facilities self sustaining

• The fee structure is stratified according to the complexity of tissue/biological specimen needs, as well as requirements of annotating data

• Researcher is encouraged to incorporate needs for the support facility in initial research budget

• In addition flat fee structure has also been designed


• Researcher incorporates needs for the support facility in initial research budget– Ballpark estimate of research facility needs

communicated by researcher to the facility– Based on volume of work, support needs are

defined. This includes technical as well as supply needs

– Research facility gets indirects– No additional cost to researcher


• Flat fee structure• Three different tiers designed for tissue specimens

a. Specimens easily aggregated from surgical pathologyb. Tumor/normal pairs, as well as biological specimens

needing specific inputc. Specialized collections (organ donors/warm autopsy)

• Data needs are incorporated into pricing for (b) and (c)

– Clinical annotation– Outcomes– De-identification

Fee-for-service structureFee-for-service structure

• Additional data needs– Specific information pertaining to outcome is

also collected and provided to investigators. Cancer registry is used for this. Investigator is charged for hours of technical time.

– Some projects use non-consented samples, but have data needs. Depending on IRB restrictions, de-identified samples may be annotated with information. Investigator is charged for hours of technical time.

In Conclusion

• Over 80% of tissue requests require clinical annotation and/or outcomes data

• Cancer registry was a source for standardized clinical and outcomes data

• Collaboration formed• Data needs are met• Relationship and requests are tracked• HIPAA and IRB compliance is met

ContactsContacts

• Rajiv Dhir, MD– Director, Health Sciences Tissue Bank

(HSTB)– [email protected]– 412-623-1321

• Ashok Patel, MD– [email protected]– (412) 623-7839

hipaa, tissue banking, and data aggregation: new tools to solve old problems

Documents

banking of tissue

tissue bankpro

qualified tissue

tissue engineering

study of tissue

tissue bankingpatient

tissue banking role

subsampling tissue