Transcript Eskenazi Health PowerPoint Template

Research at Eskenazi Health:
An EPIC Overview of Research Policies and
Procedures
Version Date: 11.09.16
Outline
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Meet the Team
Eskenazi Health Research Policy
EH Grants
EH Research Application
EH Researcher Credentialing
EH Research Billing
How to Close an EH Study
EPIC EMR
Meet the Team
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Legal
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Research Billing
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Nina Brahm, Grants Director
Shawn Wellman, Grants Administrator
Medical Records - EPIC – Research
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Tammy Shoultz, Medical Staff Affairs Director
Suzanne Maxwell, Medical Staff Affairs Coordinator
Grants Department
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Gail Jenkins, Billing Manager
Kayla Bullock, PFS Receivable Analyst
Medical Staff Affairs
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Phyllis Garrison, JD, Privacy Director
Andrea Heid, Legal Administration & Contracts Manager
John Putz, Clinical Research Manager
Justin Morea, DO, MS, Associate CMIO
Kris Elkins, Senior Clinical Epic Analyst
Jen Hillstrom, Research Principal Trainer
Researcher Consultants
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David Haas, MD, Physician
Nikki Mehdiyoun, Clinical Research Manager
Megan Gaunnac, Operations Specialist
We are Here for You!
• Over the years, we received feedback regarding the process
• Research Compliance Committee was formed in early 2014 to start
tackling researcher concerns. To outline a few:
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Lack of clear policy and procedures
Research billing and invoicing difficulties
Linkages to the correct EH staff members - troubleshooting
Researcher access to EMR
• We hope the updated process will satisfy the needs of research teams, but
it is a work in progress. We are a volunteer group. Be patient!
Materials from Today’s Presentation
• All information/forms from today’s presentation is available on
the IU Clinical Trials Office (CTO) website:
https://indianaclinicaltrialsoffice.iu.edu/investigators-studycoordinators/eskenazi-health/
Eskenazi Health Research Policy
• Institutional Research Protections, 950-87
• Available on the IU Clinical Trials Office (CTO) website:
https://indianaclinicaltrialsoffice.iu.edu/investigators-study-coordinators/eskenazi-health/
• Policy applies to ALL RESEARCH conducted at Eskenazi Health, with Eskenazi
Health patients, or utilizing Eskenazi Health medical records
• Highlights – PRIOR to commencing study procedures:
• All research conducted at Eskenazi must receive EH approval
• Must have IU IRB approval
• If any Eskenazi Health campus (EH, H&H, Midtown, etc) is listed as a performance site, expect that at your
next IRB continuing review or new study submission you will be prompted to obtain EH research approval
• All staff conducting research/reviewing medical records, must be approved by Medical Staff
Affairs
• The policy is to aid research, not obstruct it. EH will approve ongoing research
and grandfather existing research IF all policies and procedures are completed!
EH Research Approval Process
• One stop shop for all required procedures to be in
compliance with the policies
• A new application and approval process is implemented!
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https://redcap.uits.iu.edu/surveys/?s=APYTFHTXML
“Request to Conduct Research at Eskenazi Health”
REDCap survey
Web access
– Anyone can submit application; however it is suggested that the primary
study coordinator submits
• Must submit one application for EACH research study
Oh No! Not another approval!
• Why?
– The previous procedure lacked sufficient information to
determine various research conducted at EH, with EH patients,
or with EH medical records
– The new application will aid in speedier research services
• Have no fear…there is not a complicated review process!
• EH mandates IU IRB approval (or a waiver, if applicable)
EH GRANTS
EH Grants
• Will EH staff effort be used to carry out any aspect of the clinical research?
– If YES, you MUST make the request through the Grants Department
• Instructions for Requesting Use of EH Staff
• Email request to [email protected]
– Letter of Support (if available) previously provided by Eskenazi Health administration.
Include in body of email the name, email and phone for Principal Investigator and Research
Coordinator
– Completed Request to Use Eskenazi Health Staff form
• All requests for Eskenazi Health staff effort in any aspect of clinical research,
and/or grant-funded projects conducted by non-Eskenazi Health entities, MUST
be approved by Eskenazi Health Administration prior to effort being performed
EH RESEARCH APPLICATION
Research Application: Nuts & Bolts
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When does the application need to be completed?
– The application needs to be completed for all human subjects research (including that which is
not intended for public dissemination) conducted on Eskenazi Health property, interventions
with Eskenazi Health patients, or accessing Eskenazi Health patient PHI
– One for each study
Complete the application at: https://redcap.uits.iu.edu/surveys/?s=APYTFHTXML
You do not have to have a REDCap account in order to complete the application
Preference is for the primary study coordinator to complete the application
You are able to save & return if you need to
– Do not just close the browser, click the “save & return” button on the bottom of the page
– This will provide you with a code for returning to the survey (write this down because you will
need it)
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Once you submit your application, the screen will state “Eskenazi Health: Here for You
Thank You!”
If you have any issues with the application, email [email protected]
Research Application: Levels of Research
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If you meet criteria for more than one study level, choose the lowest numbered level,
which is the most inclusive
Levels:
– Level 1. Conducting full study procedures on Eskenazi Health campuses (including providing an
intervention OR completing procedures on Eskenazi Health campuses)
– Level 2. Biospeciman research ONLY (collection of Eskenazi Health patient biospecimans)
– Level 3. Observational/naturalistic study
– Level 4. Medical Record review of Eskenazi Health records ONLY for retrospective or prospective
reviews (no interaction between subject and researcher on Eskenazi Health property [including
epidemiological studies, outcome studies, etc.]
– Level 5. Recruitment ONLY (no study procedures will be completed on Eskenazi Health property, may
include medical record reviews -- Informed consent only is considered in this level)
– Level 6. Student/Resident/Intern project at Eskenazi Health (no publishing, no external presentations,
has an Eskenazi Health Medical Staff mentor and is currently engaged in an Eskenazi Health approved
educational program)
– Level 7. Anonymous or de-identified survey ONLY (no PHI will be collected)
Research Application: Mandatory Info
Prior to starting the application, have the following handy:
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PI Contact Information
Date of Initial IU IRB approval
Most recent IU IRB Approval Letter (upload required)
Current IU IRB approved Protocol (upload required)
Most recent IU IRB Protocol Summary w/ Eskenazi
Health listed as a study site (upload required)
NCT#
Basic study information
Plan for Eskenazi Health specific information including:
• Anticipated number of Eskenazi Health patients (or
medical records) involved in research
• Eskenazi Health locations where research will be
conducted (i.e.. Primary Care, Emergency
Department, etc)
• Recruitment of Eskenazi Health patients/HIPAA
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Basic investigational medications/devices information
All IU IRB approved “Drug & Biological Products” Forms
(if applicable)
All IU IRB approved “Medical Device” Forms
(if applicable)
Research Billing Grid/Separation of Allowable Costs at
Eskenazi Health
Completed “Research Projects Conducted at Eskenazi
Health” spreadsheet (upload required)
All applicable forms for new access/researcher requests
(Research Credentialing Applicant Information Form ,
CIRA, Flu, & TB) (upload required)
Research Application: Timeline
• Complete Research Application
– IU IRB approved documents are required
• EH approval must be received prior to commencing study
procedures conducted on EH property, interventions with EH
patients, or accessing EH patient PHI for research purposes
Approvals: Ongoing & New Studies
• Submit a Research Application for ALL RESEARCH, regardless
whether ongoing or a new research study
• Submit one application for each research study
• Starting today, this new process will replace all existing processes
• Ensure your research staff are trained on the updated policies and
procedures and are aware of the changes
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Note: All research studies will need to be registered in EPIC that are medically relevant or
have research billing.
EH RESEARCH CREDENTIALING
EH Research Credentialing
• All research personnel conducting research at EH are required to
obtain researcher credentials (in addition to medical staff
credentialing)
• Personnel are only required to obtain research credentialing one
time (vs. for each research study)
• To maintain researcher credentialing, all personnel must complete
the annual re-credentialing process (submit annual TST and flu
shot)
• Two types of researchers
• Medical Credentialing plus Researcher
• Researcher only
EH Credentialing (cont.)
• Ongoing access
• Complete the "Research Projects Conducted at Eskenazi Health" spreadsheet
• New access
• Steps for credentialing:
– Submit the following for EACH person requesting research credentialing:
• Eskenazi Health Confidentiality and Information Resource Agreement
• Research Credentialing Applicant Information Form
• Copy of most recent TST (must have been completed within the past year)
• Copy of most recent Flu Shot (if you have not received the flu shot within the
past 12 months, this requirement will be waived until the subsequent fall
when flu shots are offered)
– Complete the "Research Projects Conducted at Eskenazi Health" spreadsheet
– Submit all of the above to the Medical Staff Affairs office:
[email protected]
EH Credentialing (cont.)
Even though multiple studies are listed on
the Master List, a separate application must
be completed and approved for each study
prior to commencement
Anytime someone is added or removed from a study, update the spreadsheet and
submit it to the Medical Staff Affairs office: [email protected]
EH RESEARCH BILLING & EPIC EMR
What Role Does the Epic EMR Play in the
Research Process?
• Improved clinical care for patients involved in research
trials
– EMR notification of research status
– Notification of ADT events and missed appointments
• Streamlined research billing procedures
• Advanced reporting capabilities
• Improved clinical research workflow efficiency
Patients on Research Studies
Patients on Research Studies
What Does an EPIC Research Record Look Like?
EH Research Billing: Research Accounts
Within the Research study record, specify the research billing information:
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Contact information
Address
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Phone number
E-mail
EH Research Billing: Research Accounts
Within the Research study record, specify the research billing information:
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Guarantor Type: ‘Research’
Service Area: ‘Eskenazi Health Service Area [10]’
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Allowed Procedures (HC preface with the CPT)
‘Create Records Necessary for Billing’
EH Research Billing: Patient Linking
Open the patient’s chart in Epic and add them to the research study record.
EH Research: Linking Orders
1. Open the patient’s chart in Epic, Provider places an order.
2. If Patient is active on a Research Study, Research Association Button will be utilized.
3. Link this Order to the Research Study.
EH Research Billing: Quick Reports
EH Research Billing: Encounter Linking
Review all of the appointments for the patients and studies that
you are involved in, specifying only the appropriate
appointments as ‘Linked to Study’.
EH Research Billing: Charge Review
Review all of the patient accounts for patients that are enrolled
to your research study by selecting ‘Billing Review’.
EH Research Billing: Charge Review
HOW TO CLOSE AN EH STUDY
Closing an Active Study
• CLOSE the study at EH when:
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No longer conducting research at EH
No longer completing procedures with EH patients (regardless of location)
No longer accessing medical records for the purposes of research
Regardless of closure w/ IU IRB
• Email “Close” notification to:
• [email protected] – ALL RESEARCH
• [email protected] – To close a Research Billing Account
• CC the Principal Investigator as acknowledged
• Reference the IU IRB Study Number and all applicable EH specific account
numbers
• You will receive a close out letter from EH to file with your study records
Don’t Forget!
• All information/forms from today’s presentation is
available on the IU Clinical Trials Office (CTO)
website:
https://indianaclinicaltrialsoffice.iu.edu/investigators
-study-coordinators/eskenazi-health/
Contact Information
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If you have questions regarding the overall process for the Eskenazi Health Research
Application or any other general research questions, contact:
[email protected]
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If you have questions regarding Epic training and access, contact:
[email protected]
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If you have questions regarding the Eskenazi Health credentialing process, contact:
[email protected]
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If you have any questions regarding Billing, contact:
[email protected]
Many Thanks!
• Many thanks to all Research Compliance Committee
Members!
•Bill Barnett
•Kenneth Carlson
•Kimberly Curry
•Bob Davis
•Kris Elkins
•Debra Fawcett
•Phyllis Garrison
•Megan Gaunnac
•Chanda Halderman
•David Hass
•Andrea Heid
•Kim Howland
•Colette Jackson
•Gail Jenkins
•Amy Little
•Suzanne Maxwell
•Melissa Materson
•Lenora Maze
•Nikki Mehdiyoun
•Justin Morea
•Margie Payne
•Christopher Scott
•Tammy Shoultz
•Brian Smith
•Amy Waltz
•Shawn Wellman
•Sylvia Wilcox
•John Putz
•Jennifer Hillstrom
Questions?