Office of Clinical Research and Innovative Care Compliance (OCRICC) What You Need To Know About Conducting Research at Froedtert Hospital Roberta Navarro, BSN, RN, Manager of OCRICC Nancy Schallert, Executive Director of Corporate Compliance

Learning Objectives Understand the purpose of OCRICC Understand the scope of the program What research projects need to obtain approval from OCRICC and when How you get started

Purpose - Background Issues… 1.FMLH was the host to research without knowing it. 2.Pricing was variable Results… 1.No opportunity to determine operational feasibility. 2.FMLH had studies that did not cover its cost – funding source without knowing it, and without FMLH approval.

Purpose - Background Issues… 3.Variable assurance that FMLH leaders understood requirements and needs of the project. 4.Party to the CTA, but never reviewed or approved. Results… 3.Project staff did not always have what they needed once they were enrolling – variable commitment from FMLH. 4.Did not have valid contracts with FMLH.

Purpose - Background Issues… 5.FMLH was not consistently meeting regulatory requirements related to the project. HIPAA Medicare Rules Other Hospital Regulations (JCAHO, COP) Results… 5.RISK!!!!

Purpose – Role of OCRICC FMLH operational feasibility and planning FMLH financial feasibility and pricing HIPAA Privacy Rule compliance for research Research billing compliance Hospital contact for research related issues and questions

What research projects require OCRICC involvement/approval? Research projects that use FMLH resources: –FMLH space: including but not limited to- FMLH clinics, inpatient units, operating room, procedure areas and ancillary departments or –FMLH staff: any FMLH staff member that is asked to participate some way or provide a service that is related to a research event/project (even if standard of care) or –FMLH equipment or supplies: includes if the research project requires the use or purchase of hospital equipment or supplies or –Any other use of FMLH ancillary or other hospital service (i.e. hospital billing information, protected health information)

When the project team is in the process of determining feasibility on the research side (MCW) and/or during the design phase. –An OCRICC Project Application Form must be submitted prior to receiving even preliminary pricing. –A Device Checklist must be submitted to OCRICC as early as possible. –A PHI Checklist in addition to project Application form for projects with hospital PHI requests. For projects with IRB approval on 2/1/11 or after What do I need to do?

What happens after I submit the OCRICC Project Application Form? This depends, OCRICC activities are specific to the project …

OCRICC Financial Activities (feasibility / preplanning / in-study activities) Provide standardized research project pricing Complete Coverage analysis Develop research project billing plan Facilitate review and signing of the Clinical Trial Agreement if FMLH is a party to it

OCRICC Financial Activities (feasibility / preplanning / in-study activities) Manage hospital submission to the Fiscal Intermediary (FI) for the hospital claims Develop procedures for FMLH charging activities to make sure FMLH services are charged/billed appropriately Manage hospital claim to assure required billing codes are on hospital claim

OCRICC Financial Activities (feasibility / preplanning / in-study activities) Manage invoicing for hospital research project expenditures On-going project monitoring of hospital services for duration of IRB approval

OCRICC Operational Activities (feasibility / preplanning / in-project activities) Facilitate identification of key hospital stakeholders Collaborate to identify true project hospital resource needs – assure that FMLH can commit to those Define/document roles and responsibilities (study team versus hospital staff)

OCRICC Operational Activities (feasibility / preplanning / in-project activities) Identify hospital staff educational needs Identify potential hospital policy compliance requirements Provide instruction for appropriate and compliant access to FMLH patient information, according to IRB approval

OCRICC Operational Activities (feasibility / preplanning / in-project activities) Monitor FMLH operational plan Answer questions or investigate issues or complaints that may be raised to FMLH hospital about research projects or events

All research projects utilizing FMLH resources must obtain final OCRICC approval prior to enrolling subjects.

Timelines & Turnarounds Pricing –Standard requests = 7 business days –Requests that are not standard clinical care = Variable Device projects –This is different if sponsor funded or billed to insurance CTA review and approval by FMLH Legal = a timeframe is negotiated between MCW and FMLH legal at the time MCW sends CTA to FMLH IDEs must have FI approval prior to enrolling. FI submission requires IRB approval and a fully executed CTA. The FI response to OCRICC for the hospital can vary, generally less than 30 business days.

What you can expect? We want to partner with you The better we coordinate and communicate, the faster & smoother the process will go We will use to the extent possible, but the complex rules related to research on the hospital side will require phone, face to face discussion

What you can expect? Our understanding… we know you have varied levels of experience and competencies related to hospital research compliance requirements, and that you are often short staffed and this is an additional burden Questions…we need to understand your protocol and intended procedures so we can make sure we are assessing/analyzing your project needs against the correct hospital policies and regulations

What do we expect? You to partner with us Planning and open communication Patience – The rules are very complex and ever- changing, your projects are managed at the department level so there is little standardization of how things are done, and few studies are similar so they require analysis and many times further clarification Any questions you have or if you feel you’ve encountered obstacles with OCRICC process, escalate the item through OCRICC leadership.

OCRICC Resources OCRICC Intranet: pusServices/FH+OCRICC/ pusServices/FH+OCRICC/ OCRICC shared OCRICC Main Program Number:

Questions and Answers Thank you for your time today!