The CMS Innovation Center held the second in a series of webinars on Wednesday, July 6, 2016 for the Support and Alignment Networks under the Transforming Clinical Practice Initiative (TCPI). This webinar focused on providing information regarding the application process.
- - -
CMS Innovation Center
http://innovation.cms.gov
We accept comments in the spirit of our comment policy:
http://newmedia.hhs.gov/standards/comment_policy.html
CMS Privacy Policy
http://cms.gov/About-CMS/Agency-Information/Aboutwebsite/Privacy-Policy.html
Mutual Fund Modernization and Liquidity Risk ManagementNICSA
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Client Highlight- At Joint Commission: The Progression of a Planning & Foreca...Emtec Inc.
Solving immediate budgeting and forecasting process issues is quite daunting. Learn how one organization achieved budget, planning and forecasting excellence with a phased-in step by step process that lead to success throughout the entire organization.
The CMS Innovation Center held the second in a series of webinars on Wednesday, July 6, 2016 for the Support and Alignment Networks under the Transforming Clinical Practice Initiative (TCPI). This webinar focused on providing information regarding the application process.
- - -
CMS Innovation Center
http://innovation.cms.gov
We accept comments in the spirit of our comment policy:
http://newmedia.hhs.gov/standards/comment_policy.html
CMS Privacy Policy
http://cms.gov/About-CMS/Agency-Information/Aboutwebsite/Privacy-Policy.html
Mutual Fund Modernization and Liquidity Risk ManagementNICSA
Mutual fund sponsors and their service providers are reevaluating their operating models to support compliance with the SEC’s Mutual Fund Modernization reporting requirements and Liquidity Rule. This discussion explores the challenges that fund sponsors and administrators are facing, as well as insights on how they are responding to each of these emerging regulatory requirements.
Client Highlight- At Joint Commission: The Progression of a Planning & Foreca...Emtec Inc.
Solving immediate budgeting and forecasting process issues is quite daunting. Learn how one organization achieved budget, planning and forecasting excellence with a phased-in step by step process that lead to success throughout the entire organization.
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This session provides valuable Meaningful Use information including:
• Recent updates from CMS
• Keys to audit preparation
• How to identify and correct gaps in your Meaningful Use plan
• How to ensure IMO data terminology mapping is completed accurately and on-time
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This Case Study was presented by Henry County Health Center CEO Robb Gardner at National Rural Health Association's Critical Access Conference in October, 2013 then as a webinar for NRHA members in December, 2013.
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During his healthcare career as a clinician and administrator, Robb’s core emphasis has consistently been focused on a patient-centric approach. As the CEO of Henry County Health Center, his role is to remove barriers and provide the necessary tools for associates and providers to succeed in their roles at the health center. Robb has found technology to be essential in achieving these goals.
Through the health center’s portal, associates have access to one central location to find the resources they need. This technology is one example of how HCHC has incorporated the philosophies of Baldrige and LEAN to provide more efficient and effective work processes to help meet the needs of associates and medical staff. Robb’s emphasis on quality patient care and process improvement is the foundation to achieving HCHC’s mission, and the health center’s portal plays a significant role in accomplishing this objective.
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ICD-10 Implementation for Physicians WhitepaperMarie Bunch
Many providers are operating with blinders on, completely unaware of the magnitude of the conversion and potential train wreck ahead for their reimbursement. Support your physicians through the difficult change ahead by helping them take the right steps forward to make their transition as efficient and painless as possible.
Regardless of the size of the practice, training for any implementation – especially for one as complex and far reaching as ICD-10 – can be costly and difficult to deliver. With only a year remaining to complete the transition, providers and their staff must step up to planning, training, software/system upgrades/replacements, as well as other necessary investments. ICD-10 will require a significant education investment in order to ensure accurate coding and minimize productivity loss. While large organizations may have the resources to purchase training materials or send staff to training sessions, smaller organizations may have to depend on special societies or share resources to provide the needed training.
Start the conversation with your physicians now. Help them through the transition with resources designed to get them on board with the transition now. Practice Management Institute® (PMI) is already helping practices adapt to the change with classes especially focused on the transition steps for medical offices, hosted by leading hospitals across the country. PMI’s Professional Services Department and Faculty Team is committed to providing the most up-to-date information on implementation guidelines, coding conversion steps and staff training fulfillment.
About PMI
PMI is the nation’s leading provider of continuing education for medical office professionals, with a broad curriculum of educational workshops that address the office training needs for private practice physicians. Classes are presented in leading hospitals, health care systems, and medical societies. For more than 30 years, physicians have relied on PMI to provide the latest information on managing an efficient and compliant practice.
[WEBINAR] Understanding the 2014 Coverage Gap Discount Program (CGDP) Invoice...Paragon Solutions
Register to watch the recorded webinar: http://goo.gl/YZ6tRT
In January 2014, CMS announced 2014 changes to the Coverage Gap Discount Program (CGDP) related to Negative Invoice Reconciliation and resulting changes to the Quarterly Invoice process. The changes will be in effect for 1Q2014 processing quarter with invoice reports hitting Manufacturers by mid to late April 2014. Quickly reacting to change can cause uncertainty, but with the right awareness, focus, and preparation you can position your organization for a successful transition.
This presentation will enable you to better understand these changes, how they will impact your business process, and what you need to consider and evaluate to prepare for these changes. The change overview and impact considerations will offer insights to companies of all stages.
What you can expect to learn:
- Overview of 2014 CGDP Changes; Negative Invoice Reconciliation and Changes to Quarterly Invoice Process.
- How these changes will impact your business process.
- How to prepare for these changes.
Finance Department COSO Implementation MemoTownofAddison
Finance Department Director and Addison CFO Eric Cannon presented this memo and update to City Council on February 10, 2015 concerning the implementation of COSO standards.
Preparation is the Key to Meaningful Use SuccessIatric Systems
To help hospitals and eligible providers navigate the changing landscape of Meaningful Use, we created an educational webcast.
This session provides valuable Meaningful Use information including:
• Recent updates from CMS
• Keys to audit preparation
• How to identify and correct gaps in your Meaningful Use plan
• How to ensure IMO data terminology mapping is completed accurately and on-time
Transforming Internal Communications with a State of-the-Art IntranetRegan Sonnabend
This Case Study was presented by Henry County Health Center CEO Robb Gardner at National Rural Health Association's Critical Access Conference in October, 2013 then as a webinar for NRHA members in December, 2013.
By all accounts, Henry County Health Center is an innovative CAH. Pioneering vision has led to several state, national, and international awards, which include being named a Gold Intranet Innovation Award recipient, 7-time Most Wired Hospital, Top 100 Hospital of Choice, Web Health Award recipient, HFMA MAP Award Winner, and Baldridge Leadership rating recipient.
Join CEO Robb Gardner to learn firsthand how their intranet has supported and encouraged innovation. Key improvements include process improvement using their Census Board; Policy, Contract, and Forms Management; electronic Board communication; electronic benefits enrollment; and clinician quick links.
During his healthcare career as a clinician and administrator, Robb’s core emphasis has consistently been focused on a patient-centric approach. As the CEO of Henry County Health Center, his role is to remove barriers and provide the necessary tools for associates and providers to succeed in their roles at the health center. Robb has found technology to be essential in achieving these goals.
Through the health center’s portal, associates have access to one central location to find the resources they need. This technology is one example of how HCHC has incorporated the philosophies of Baldrige and LEAN to provide more efficient and effective work processes to help meet the needs of associates and medical staff. Robb’s emphasis on quality patient care and process improvement is the foundation to achieving HCHC’s mission, and the health center’s portal plays a significant role in accomplishing this objective.
This presentation covers the basics of federal grant accounting and compliance (and why you need to know it), state and local tax and corporate tax issues (even if you're not generating revenue), R&D credits, and more for biotech companies.
ICD-10 Implementation for Physicians WhitepaperMarie Bunch
Many providers are operating with blinders on, completely unaware of the magnitude of the conversion and potential train wreck ahead for their reimbursement. Support your physicians through the difficult change ahead by helping them take the right steps forward to make their transition as efficient and painless as possible.
Regardless of the size of the practice, training for any implementation – especially for one as complex and far reaching as ICD-10 – can be costly and difficult to deliver. With only a year remaining to complete the transition, providers and their staff must step up to planning, training, software/system upgrades/replacements, as well as other necessary investments. ICD-10 will require a significant education investment in order to ensure accurate coding and minimize productivity loss. While large organizations may have the resources to purchase training materials or send staff to training sessions, smaller organizations may have to depend on special societies or share resources to provide the needed training.
Start the conversation with your physicians now. Help them through the transition with resources designed to get them on board with the transition now. Practice Management Institute® (PMI) is already helping practices adapt to the change with classes especially focused on the transition steps for medical offices, hosted by leading hospitals across the country. PMI’s Professional Services Department and Faculty Team is committed to providing the most up-to-date information on implementation guidelines, coding conversion steps and staff training fulfillment.
About PMI
PMI is the nation’s leading provider of continuing education for medical office professionals, with a broad curriculum of educational workshops that address the office training needs for private practice physicians. Classes are presented in leading hospitals, health care systems, and medical societies. For more than 30 years, physicians have relied on PMI to provide the latest information on managing an efficient and compliant practice.
[WEBINAR] Understanding the 2014 Coverage Gap Discount Program (CGDP) Invoice...Paragon Solutions
Register to watch the recorded webinar: http://goo.gl/YZ6tRT
In January 2014, CMS announced 2014 changes to the Coverage Gap Discount Program (CGDP) related to Negative Invoice Reconciliation and resulting changes to the Quarterly Invoice process. The changes will be in effect for 1Q2014 processing quarter with invoice reports hitting Manufacturers by mid to late April 2014. Quickly reacting to change can cause uncertainty, but with the right awareness, focus, and preparation you can position your organization for a successful transition.
This presentation will enable you to better understand these changes, how they will impact your business process, and what you need to consider and evaluate to prepare for these changes. The change overview and impact considerations will offer insights to companies of all stages.
What you can expect to learn:
- Overview of 2014 CGDP Changes; Negative Invoice Reconciliation and Changes to Quarterly Invoice Process.
- How these changes will impact your business process.
- How to prepare for these changes.
Finance Department COSO Implementation MemoTownofAddison
Finance Department Director and Addison CFO Eric Cannon presented this memo and update to City Council on February 10, 2015 concerning the implementation of COSO standards.
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4. 4
5/1 Requisition approval enhancements / changes completed
5/17 New user access form launched
6/3 Financial Data Warehouse (FDW) now updated an
additional run per day starting at 4 p.m.
In progress:
1. Focus group
2. Training materials
3. Invoice approval status / details
4. Vendor distribution projects look up
Key Highlights since last meeting
5. 5
Ensuring back end processes that affect patient care work smoothly e.g.
• Requisitions getting processed and approved
• PO’s are issued and sent to vendors for procurement of goods
• Invoices moving through the steps to payment
Access for users
• Ensuring users have access to the systems and information they need
Month-end / Financial information
• Focus on data files as they move through processing
• Addressing any data issues that may become clear or arise e.g., mapping
issues
Focus on refinement of processes that impact the enterprise
• New on-line forms, and information requirements are now being utilized
• With continued experience and evaluation, the need for modification will be
done.
A change management process for prioritization of ongoing work with
governance, scoring, tracking of inventory, estimated level of effort is in the
development process.
Prioritization of work and issues
6. 6
The Change management process scores and prioritizes items accordingly. Highest
scoring items are worked on first. Scores can be spread across entity, department,
software system and/or initiative.
There are several Research items on this list that are in progress, a couple of which
are over 75% complete
Other initiatives in progress that require attention and focus from the team include:
̶ Cornerstone, LLC, a new BMCHS Business requiring a new company setup
̶ Budget season work – System, then hospital and other entities
̶ Strata capital / Infor – making this fully integrated
̶ A/R Accounts Receivable module implementation for the Health Plan
̶ Monthly software critical updates (CU’s)
̶ Pharmacy changing their primary vendor
̶ Continuous changes to related systems, e.g., third party billing being brought in-
house
Prioritization of work and issues continued
7. 7
FIS worked on process improvement of the existing forms based on feedback to:
• Combine the user access and reporting forms into a single form
• Make form more user friendly with guidance on how to complete it
• Launched on 5/17/21, communicated in The Week Ahead
• Replaced within Infor
• To date, this is working well and users are finding it more straightforward
• Will continue to review and update based on user feedback
Reminder: dependencies for access and the steps to follow to assist you in obtaining
access:
1. Need Workday ID and BMC email address to create Infor Access
• If necessary, complete the Visiting Personnel form to obtain a Workday ID
from HRIS @ VisitingPersonnelRegistration@bmc.org
2. Active directory ticket through Service Now to create a network ID and BMC
email address
3. Then create a ticket for Infor access and attach the completed user access form
specifying the access you are requesting
Infor Access Updates and Tips
8. 8
Plan for small, representative group to meet monthly or bi-
monthly
Focus on feedback, pain points, communication, education
Participants identified
• Need replacement in one area
Initial meeting time – target mid to late June
Infor Focus Group
9. 9
Training materials
• Have been focusing on high need information such as
• Navigation & Features
• Finance overview
• BSR Guide – in progress with target completion in next 1.5 weeks
• Other reports intended for department admins – early in the creation
process
Service Now
• Working with ITS to add specific FIS item to the catalog to ensure faster
routing – will help both online and phone-initiated requests
Other Updates
10. 10
Accounts Payable General Update
Added temps and adjusted workload around the team, resulting in smoother
invoice handling
Staff around the organization have a better sense of how to handle requests,
view reports, and submit information
̶ We still get questions on the process but far fewer
̶ We do try to keep the AP pages on the Hub updated, to be a useful resource
Set up DG-Accounts-Payable – every team member is part of the group, to help
catch all incoming questions
̶ External emails should still go to Accounts.Payable@bmc.org
Experiencing ripple effects from earlier Procurement/Receiving system issues
that will take time to resolve
̶ Not atypical for implementations, but researching and working to fix these
takes time
11. 11
Approval Flow Improvements – status
Item Current Update
No level 1 approver
exists
Requisitions and invoices
require manual
intervention
Requisitions now move to and
invoices will move to the next level
approver
Level 1 approver is the
same as the requisitioner
Requisitions require
manual intervention
Requisitions now move to the next
level approver
More than one approval
required
Approvals required more
than once if the same
person approves both
levels
System will validate that the same
person approves at the upper level,
and release the requisition or
invoice – completed for requisitions
Timeout Requisitions take several
days to time out. Invoices
do not escalate
Requisitions will time out sooner
Invoices will escalate to the next
level approver
Changes to the requisition and invoice approval flows:
• Requisition approval updates were programmed, went through extensive user
acceptance testing of 40+ scenarios and were deployed on 5/1/21 per below.
• Invoice approval requirements were identified and signed off 6/4/21. Next is
development and testing with target rollout in late summer.
12. 12
Edited email alerts for invoice approval to make them clearer and provide more
information (e.g., more info on the invoice, link to training in Workday)
BUMG approval flows will be based on the cost center only, not cost center and
project combined
̶ No change to Research/Funds and other company 1 approval flows – project
will determine the approvers
Time outs – more specifically, invoice approvals (other than sub-contractor
invoices) will time out and move up to the next level after a specific number of
business days if the invoice has not been approved or rejected
Other Updates to Invoice Approvals
14. 14
Check AP’s pages on the Hub for current information
• Invoice handling process description
• Form for vendor adds, one-time payments, and recurring payments
• Tip sheets and link to Chrome River
• NEW tip sheet on running the Vendor Distribution report, which is available on the
Infor Management Reports page
• Chrome River reimbursements through AP can be seen on the Vendor Distribution
report
An approval and report access listing and the change request form are available on the
Infor Management Reports page
• Keep approvers for your areas updated – submit changes whenever someone starts,
gets promoted, transfers or leaves
• Review approvers on the listing periodically (quarterly)
Invoice handling
• Request new vendors before sending an invoice whenever possible
• If invoices come to you, forward to BMCHS_Invoices@bmc.org as soon as possible.
Invoices must be approved before they can be paid, so there will be time to review the
invoice after it’s sent for approval
How you can help us
15. 15
Utilize the resources available on line that can assist
• Training SharePoint:
• http://share.bmc.org/InforAndRelatedFinancialSystemsTraining/default.aspx
Service Now Tickets
• If you have issues, please submit a ticket so that these can be tracked, addressed
and resolved.
How you can help us cont.
16. 16
Stephanie Wasserman
̶ NIH bio-sketch update
̶ Shawn, Senior Manager Research Finance
Research Operations Updates
17. 17
Tyler - Space survey gratitude ☺
Research Operations Updates
18. 18
All Milestone projects are being calculated differently in V11:
̶ V9 Budget = Cash Received (open AR is excluded)
̶ V11 Budget = Total Invoiced (Includes both open and collected AR)
Milestone budgets will be updated the 5th business day of each month.
̶ CTO managed milestone projects are up to date
̶ RF managed milestone projects will be updated prior to the end of this month
Research Operations Updates
19. 19
Re-designing the CTO intake form and ancillary service intake forms
New smart forms are being utilized to centralize the flow of documents
Meetings with all Ancillary services have begun, with the first forms to be
modified being Radiology and IPS
Research Operations Updates
20. 20
Chris Sullivan - Staff update, new form will be sent shortly and background- ITS
Research Operations Updates
21. General Clinical
Research Unit
Ridiane Denis
Director of Clinical Research and Operations –GCRU
Email: ridianed@bu.edu and Tel: 617-358-7558
GCRU Main Tel: 617-358-7560
22. Who? What ? & Where?
Who?
Part of the BU Clinical Translational Science Institute(CTSI). We provide a
research area where study protocols are implemented. We also provide services
to BMC inpatient population and outpatient clinics.
What?
We support both clinical trials and socio behavioral studies
Where?
On the 8th floor of the Evans building
23. Protocols
COVID and Non COVID studies
Endocrinology ADAAMS Alzheimer Amyloidosis
Lupus PFIZER PEDI CTE ACTIV4A Gulf war Illness PRESTO
ACTIV 2 HIV PFIZER ADULT Pulmonary NICHE Psychiatry
11+82
GI ACTIV 1M Sickle cell PAH Asthma Genetics
Scleroderma PACT Nephrology Vasculitis
Rheumatoid Arthritis Oncology ACTIV 5 Exercise
training
25. Other Services
On demand extended hours and weekend
services
American Red Cross CPR certification
Phlebotomy training with National
certification
Limited IRB support
Research Job connection
26. LIFE DURING COVID
INCREASE STAFFING
7 24 (14 + 6 MPH + 4WS)
INCREASE DAYS AND HOURS OF OPERATIONS
MON TO FRI 0800-1600 MON TO SUN 0800-TBD
SHIFT IN SERVICES PROVIDED
STRICKLY CLICINAL CLINICAL AND COORDINATOR LIKE
NEW WORLD OF PPE , PRECAUTIONS AND CLEANING
CHANGE IN DAY TO DAY FLOW- SCREENING, MASKS,ENTRANCE, EXIT,
LIMITED NUMBER PEOPLE ON THE UNITCHANGES IN SCHEDULING
PROCESS
27. LIFE DURING COVID (cont.)
CHANGE BILLING STRUCTURE
LEVELS OF INTENSITY A LA CARTE-ITEMIZED
INTRODUCTION TO VELOS AND CLINCARD
CLARIFYING SOME BLURRED LINES/TIES BETWEEN
INSTITUTIONS
APPROXIMATELY 22 PROTOCOLS WERE IMPLEMENTED IN THE
PAST 13 MONTHS
APPROXIMATELY 11 HAVE COMPLETED ALL OF THEIR VISITS
AND/OR NO LONGER NEED GCRU SERVICES
28. CURRENT GCRU STAFF
NON-COVID STAFF
2.5 - REGISTERED NURSE
.20 - PER DIEM NURSE X2
2 - CLINICAL PRACTICE ASSISTANT
1 - LAB MANAGER
1.4 - LAB ASSISTANT
1.5 - FINANCE/BILLING ADMIN
1 - SCHEDULER
1 - UNIT COORDINATOR
COVID STAFF
1.5 - REGISTERED NURSE
1 - SR. CLINICAL PRACTICE ASSISTANT
1 - CLINICAL PRACTICE ASSISTANT
1 - RESEARCH NAVIGATOR
0.6 - ASSISTANT RESEARCH NAVIGATOR
4 - RESEARCH ASSISTANT
30. This Photo by Unknown Author is
licensed under CC BY-NC
31. 31
COVID-19 clinical research summary
and vision for Equity in Research
June 8, 2021
Because research must be inclusive to be
exceptional
32. 32
Presenters
Heather Hsu, MD
Assistant Professor of Pediatrics
Clinical Data Warehouse
Elizabeth Ragan, MPH
Research Program Manager
Biorepository
Johanna Chesley, MPH
Director of the Clinical Trial Office
Melissa Hofman, MSIS
Clinical Research Data Manager
Clinical Data Warehouse
Ryan Schroeder
Director of the Clinical Research Network
33. 33
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
34. 34
Our goal is to embed clinical research into prevention and treatment for all
people, regardless of race or socioeconomic status—without exception
MISSION
To drive and share
world class science
discovery and
innovation through the
conduct of
community-based
participatory clinical
research and clinical
trials that are
responsive to cultural
and linguistic
differences and
inclusive of all
VISION
All people, regardless
of race, ethnicity,
language,
socioeconomic status,
sexual orientation,
gender identification,
insurance coverage,
or national origin, are
provided the
opportunity to
participate in
exceptional clinical
research
36. 36
BMC collaborated with GCRU to successfully develop and run a COVID
research program
16
COVID
interventional
trials completed
enrollment
Apr-May
Participants
Enrolled in
Interventional
Trials
576
1980
PARTICIPANTS
ENROLLED IN
SAMPLE
COLLECTION
PROTOCOLS
269
PARTICIPANTS
ENROLLED IN
VACCINE
TRIAL
686
COVID-RELATED
PUBLICATIONS
Actively
recruiting
COVID
Studies
6
CREATED
Biorepository
TO ADVANCE
COVID
RESEARCH
Compiled
55
data sets for
COVID related
research
Source: internal BMC data updated as of 05/2021
Participants
enrolled in
COVID
ambulatory
research
1844
37. 37
BMC patient voices are being included to advance medical practice
From intervention to market
COVID sped up the process
BMC site for trials proven effective
On average it takes 12 years for
an intervention to go from bench
to FDA approval
5 in 5000 drugs in preclinical
testing progress to human
testing
1 of the 5 drugs tested in
humans receives FDA approval
Chance for a new drug to make it to
market is ONLY 1 in 5,000
Pharma and NIH resources hyper
focused during COVID, most other
research was temporarily stopped
COVID vaccines developed and EUA
approved in less than 1-year
52 repurposed INDs tested to treat
COVID in less than 1-year
BMC selected as a site for 19 repurposed
INDs
Adult Pfizer COVID Vaccine Trial
PI: Dr. Elizabeth Barnett
Enoxaparin Anticoagulant Trial
PI: Dr. Naomi Hamburg
Regeneron Monoclonal Antibody
PI: Dr. Michael Paasche-Orlow
BMC continues to be selected as a site, now
focused on NIH ACTIV and Pfizer COVID
vaccines trials
38. 38
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
39. 39
The Biorepository is comprised of samples from BMC’s COVID-19 patients across
the lifespan and demographic backgrounds, and across the course of disease
A Scientific Review Committee of cross-disciplinary BMC and BU experts
oversees and allocates samples to investigators whose studies are systematically
reviewed and deemed scientifically rigorous
̶ The Biorepository Team is working closely with the CTO and CRN to collaborate on
incorporating community engagement initiatives into Biorepository governance
Close collaboration with the Clinical Data Warehouse (CDW) enables investigators
to link rich medical history and clinical data with patient samples
The Biorepository team is actively building the infrastructure and processes to
enable sample sharing with third-parties, including industry partners
̶ Sharing with third parties may generate new opportunities for collaboration with industry
and other academic centers
̶ Enables inclusion of BMC patients in groundbreaking research on novel diagnostics and
therapeutics
The COVID-19 Biorepository Enables Inclusion of BMC’s Diverse Patient
Population in Innovative COVID-19 Research
40. 40
The COVID-19 Biorepository by the Numbers (as of May 2021)
>4,000
sample
aliquots
collected
from cohort
>48,000
discarded
clinical
aliquots
collected
14
BMC/BU
studies
currently
supported
68%
of cohort
participants
are persons
of color
43%
of cohort
participants
have limited
English
proficiency
>10,000
Individual
BMC
patients
represented
17
unique
sample
requests
evaluated
1,885
samples
allocated or
released to
active
studies
41. 41
COVID-19 Biorepository Sample Sources and the Patient
Population and Disease Course Represented
Prospective Cohort
Participants
Participants enrolled in the COVID cohort study
(H-40047; PIs: Elizabeth Duffy and Jai
Marathe) provide informed consent for future
use of their samples by third parties, including
industry partners
Participants (≥18 yrs old) include:
• Inpatients diagnosed with COVID; samples collected
weekly thought hospital admission
• Outpatients diagnosed in clinic; samples collected 1
week, 1 month, and 2 months after diagnosis
• COVID survivors; samples collected 1, 2, 3, 6, 12, 18,
and 24 months after diagnosis
Samples include: serum, plasma, PBMCs, PAXgene,
saliva, NP/OP swabs, urine, and stool
Discarded Clinical Samples
Clinical samples (respiratory and blood
samples) from BMC patients are obtained at
the end of their clinical utility and banked for
future use through a waiver of informed
consent (H-40115; PI: Stephen Pelton)
• Samples collected from COVID patients of all ages
(including pediatric) from time of diagnosis onwards,
representing acute and convalescent illness
• Both single timepoint and sequential samples from
individuals
• Repeat samples from patients with persistent positive
results or future positive results indicative of persistence
or repeat infection
• Samples from vaccinated and unvaccinated patients
• Samples from COVID negative patients also available
Samples include serum, plasma, and NP/OP swabs
Autopsy Tissue Samples
Tissue samples collected through autopsy of
deceased COVID-19 patients whose families
consented for collection for future use for
research
Research autopsies conducted on 36 patients, 12 of which
were COVID+
Samples include frozen and formalin fixed samples of lung,
kidney, and spleen
42. 42
Learn more about our COVID-19 Biorepository on the web
www.bmc.org/research/covid-biorepository
43. 43
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
44. 44
Developed a virtual COVID repository to expedite data requests and facilitate data
consistency for COVID research in various departments
Collaborated with the prospective biorepository PI & project manager through multiple
iterations of dataset to account for the evolution of COVID data sources and disease
trajectory
Compiled data sets and cohort for 55 COVID-related research projects
Completed daily reviews of COVID data sources to ensure data quality and validation
Supported recruitment for COVID treatment studies with daily reporting of eligible COVID
positive patients meeting various study requirements
Provided a weekly extract for public health reporting to CDC and publication in MMWR
Clinical Data Warehouse Supporting COVID-19 Research
45. 45
• Working towards expanding
data availability through
streamlining access to
Community Health Center
and claims data
• Incorporating common data
models to allow our data to be used
with external data sets
• Integrating external datasets to connect
environmental and social data to clinical
data
COVID Accelerated Existing CDW Initiatives
• Social informatics
• Create definitions and
methods to identify BMC
special populations & health
equity variables
• Household linkages, social
determinants of health, geocoding,
environmental factors
• CDW simultaneously began to focus on foundational
data quality, optimization, & validation efforts
• Certain demographics, diseases and clinical
outcomes are not always straightforward
nor consistent within the EHR
• CDW established the advisory
committee and scientific director for
clinical validation
• Developing standardized
workflows and creating
various resources to ensure
data quality, consistency,
effectiveness and efficiency
• Emphasis on Covid-19 data quality highlighted
infrastructure and optimization hindrances to facilitating
research
• CDW shifted focus to foundational efforts
• Improved internal processes for
requesting data and monitoring
revenue
• Developed a procedure
manual, metrics dashboard
& automated project
management and billing
system
Foundational
Logistics
Foundational
Science
Aspirational
Efforts
Inclusive
Research
46. 46
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
47. 47
CEAL award imbedded into the CRN structure; allows for rapid response
to demanding NIH timeline and milestones
48. 48
CRN Year-one objectives and goals in a phased approach
Phase I Phase II
1. Oversee
financial and
regulatory
lifecycle of ACTIV
trials
2. Define CRN
scope and intake
evaluation
process
Build ACTIV and
CEAL annual
demographic
dashboards for
clinical research
enrollments to
develop baseline
measures
Create a Clinical
Research
Community
Advisory Board
(CAB),
collaborate with
CTSI Community
Engagement
(CE) Core
Sponsor annual
campaign around
clinical research
awareness for
BMC and BU
staff and faculty
1. Co-develops future
PI educational series
with BU/BMC research
administration
2. Hosts clinical
research seminars with
DOM & BU
3. Attend pre-existing
clinical staff meetings
at BMC and CHCs
4. Create website to
host clinical research
material
Assess value in
creating a BMC
Research Registry
to establish a
database for
individuals
interested in
awareness around
research
49. 49
Within 2-months of CRN inception, reporting transparency, and focus is
made clear on how to set clear objectives around inclusive research
metrics, but there is work to be done
50. 50
BMC is well positioned to join the CEAL Alliance
Strong Community
Partnerships
ACTIV COVID
Network Site
6trials
12Community
Health Centers
Leading Edge
Research
7Community
Vaccination
Sites
Coalition of
Physician
Ambassadors
32%
of BMC patients
are Non-English
Speaking
New England’s
Largest Safety Net
Hospital
70%
of BMC patients
are underserved
minorities
856K
Outpatient Clinic
Visits
51. 51
Community-
Engaged
Culture—
rapid mixed methods
assessment of
vaccine, research, &
testing participation
knowledge and
attitudes
Developing guiding principals for BMC’s equitable research goals through
the TRUST/CEAL grant
Analyze Data and
Develop Inclusive
Strategies—
Review mixed
methods, include
community voices,
to design
implementation
strategies around
vaccinations,
research, & testing
Platform for
Dissemination—
Develop candidate
interventions that
can be evaluated
and trialed across
the CEAL network
and internationally
1 2 3
52. 52
Community Partnerships Growth Potential
STEREOTYPES DIVIDE US.
STORIES CONNECT US.
HELPING CHURCHES, MINISTRIES, AND NON-
PROFITS WORK TOGETHER TO ENGAGE OUR
COMMUNITIES
Opening new pathways to opportunity through
individualized, supportive, and multilingual education
that prepares a diverse community of learners to pursue
career advancement and transform their lives.
Engaging BMC’s Community Health Centers in
qualitative formative work and deployment of new CE
interventions.
BHERN
Community Vaccine Clinics
Community Advisory Board &
Patient Advisory Groups
7 community vaccine clinics have been established to
reduce access barriers for residents of Boston.
The TRUST study will benefit from the direct advisory of
a Community Advisory Board/Patient Advisory Group(s).
53. 53
The best science requires diverse voices…. the time has come to include
research equity as a part of our clinical care model
Hospital leadership, GCRU, and Principal Investigators worked tirelessly to offer trial opportunities to BMC patients admitted
Publications reported include: BUSM, BMC, and BUMC
Snapshot of Demographics and research dashboard, many more data to share. Discuss the need for central reporting of participant enrollment into Velos: Clinical Trial Management System.