The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).
The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).
CPI
Continuous Process Improvement
Disclaimer
• This presentation is geared towards Domestic CPI
– International CPI will follow the Domestic CPI concepts
• Trimester start date and end date will vary once fully established
Objectives
What is CPI and why do we want this information?
How to read your weekly CPI report
How to use the form toolset in FN3 to run a list of forms due IRB portion of CPI, how to submit data
What is CTA and why do we want this information?
Questions
The CPI program assures timely and accurate submission of data to help CIBMTR achieve its goal of promoting collaborative
research that increases access and improves outcomes of all cellular therapies.
What is Continuous Process Improvement (CPI)
CPI Requirements
To be compliant with CPI standards, there are three requirements:
1. Forms Completion including Query Resolution
2. Current IRB/MHA documents (renewal letters and consents) on file with NMDP
3. Meeting the requirements of consecutive reporting of
hematopoietic cell transplants (HCT CTA)
• On a trimester basis (Domestic)
– January 1
st– April 30
th– May 1
st– August 31
st– September 1
st– December 31
st• Centers are reviewed and held accountable for meeting CPI form completion standards for:
– Critical Forms
– Study Supplemental Forms – All other forms
CPI Overview
CPI Status at End of Trimester
Good Standing
• Required % of forms and queries completed
• IRB up-to-date
• CTA requirement met
1
stWarning
• < required % of forms and queries completed for 1 trimester, and/or
• IRB expired, and/or
• CTA requirement not met
Probation
• < required % of forms and queries completed for 1 trimester, and/or for 2 consecutive trimesters, and/or
• IRB expired, and/or
• CTA requirement not met
Suspension
• < required % of forms and queries completed for 1 trimester, and/or for 3 consecutive trimesters, and/or
• IRB expired, and/or
• CTA requirement not met
• access to NMDP donors may be restricted
CPI exemption request
Example scenarios could be:
Temporary Staffing Shortage (e.g., short
term leave, illness, hiring open position)
Training needs (e.g.,
new staff) Competing CIBMTR Requests
Local Prioritization Issues (other work at
site prioritized over CIBMTR reporting)
Logistics/Infrastructure (e.g., no remote access to EMR, center location
move)
Include what action your center is taking to address the challenges
described?
CIBMTR understands that sometimes a center may have extenuating circumstances that impact their work. Each trimester we will offer an exemption request to be completed by your centers primary DM. These
will be reviewed by CIBMTR leadership on a case-by-case basis.
The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).
The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).
Forms Completion
CPI Requirement Rollout
Requirement Sept-Dec 2021 Jan – Apr 2022* May – Aug 2022* Sept – Dec 2022 (Final) Submit Critical Forms
On-Time ≥ 25% Completed by
Due Date ≥ 50% Completed by
Due Date ≥ 75% Completed by
Due Date ≥ 95% Completed by Due Date
Complete Critical Forms Due During the Previous Trimester
≥ 90% Complete by end
of trimester ≥ 90% Complete by end
of trimester ≥ 90% Complete by end
of trimester ≥ 98% Complete by end of trimester
Complete Study Supplemental Forms Due During the Previous Trimester
100% Complete by end
of trimester 100% Complete by end
of trimester 100% Complete by end
of trimester 100% Complete by end of trimester
Complete All Other Forms Due During the Previous Trimester
≥ 75% Complete by end
of trimester ≥ 90% Complete by end
of trimester ≥ 95% Complete by end
of trimester ≥ 95% Complete by end of trimester
Resolve Queries Placed During the Previous Trimester
≥ 90% Complete by end
of trimester ≥ 95% Complete by end
of trimester ≥ 95% Complete by end
of trimester ≥ 95% Complete by end of trimester
IRB (minimal change from prior
requirements)
No unresolved IRB lapse No
unresolved IRB lapse No
unresolved IRB lapse No
unresolved IRB lapse CTA (no change from
prior requirements) Pass CTA Pass CTA Pass CTA Pass CTA
Critical Forms and Due Dates
• Critical Forms Submission Requirements:
– Previous Trimester – Completion rate of 98% required to achieve CPI standard. Includes all forms that were due in the previous trimester.
– Current Trimester – Completion rate of 95% required to achieve CPI standard. Must be completed by DUE DATE noted in FN3 during the current trimester
– CPI Forms and Due dates can be found here: https://www.manula.com/manuals/cibmtr/training-and- reference/1/en/topic/cpi-forms
Critical Forms Due Date
Indication for CRID Assignment (2814) Form Due 30 days from registration
Pre-TED (2400) Form Due 30 days from infusion
Pre-TED Disease Classification (2402) Form Due 30 days from infusion Hematopoietic Stem Cell Transplant (HCT) Infusion
(2006) Form Due 45 days from infusion
Study Supplemental Forms
• Participation in prospective studies is voluntary and requires a commitment from the
Transplant Center Medical Director. If a center elects to participate in a study that requires additional (supplemental) forms to collect specific study data, CPI requirements will apply to these supplemental forms.
• Study Supplemental Form Submission Requirements:
– 100% completion of study supplemental forms with DUE DATE in previous trimester (allows for an extra trimester to complete all study forms)
– Study forms usually are any form that begin with 25XX
– CPI Forms and Due dates can be found here: https://www.manula.com/manuals/cibmtr/training-
and-reference/1/en/topic/cpi-forms
Non-Critical Form Completion Requirement
• For all other forms not classified as critical or a study supplemental forms, CIBMTR monitors completion rates for two trimesters after the form’s due date.
• Form Submission Requirement:
– 95% completion of all other forms due in previous trimester – CPI Forms and Due dates can be found here:
https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/cpi-forms
Query Resolution
• Query placement process verifies that data used for studies, product quality assurance, Center Volumes Report (CVDR), Transplant Center Specific Analysis (TCSA) or for
Consecutive Transplant Audit (CTA) are submitted accurately. Queries may be placed on
missing or inconsistent data, or when clarification and/or documentation is needed to confirm the reported data. Query resolution should occur within six weeks after placement of the
query.
• Query Resolution Requirement:
– 95% completion of queries placed in the previous trimester
– Please refer to your weekly query report as well as FN home tab/my work landing page – Query eLearning can be found here:
https://www.cibmtr.org/DataManagement/Training/OnlineTraining/Pages/default.aspx
Scroll to Query Functionality
CPI Forms and Due Dates
For a full list of CPI forms and due dates please review our DM guide: https://www.manula.com/manuals/cibmtr/training-and-
reference/1/en/topic/cpi-forms
– Allogenic related and unrelated transplants- Required by SCTOD
– Autologous forms- Starting in 12/3/2007 at CIBMTR
– Cellular Therapy (CT) infusions are included in CPI- if reported to CIBMTR
These forms are currently excluding from CPI:
• Form numbers: 2008, 2800, and 2801
• Form numbers: 5000 – 5002
Form Status for CPI
• Forms considered due for CPI include:
– DUE, QRY, SVD, ERR, and MOD status
• Forms considered complete for CPI include:
– AUD, CMP, LCK, and PND
• You will not see these statuses in your forms due list
• LTF (lost to follow-up), SUR (survival), or NRQ (no longer
required) do not count in the total forms or completion rate
Important things to remember
• The number of forms required to meet your CPI requirement is subject to change until 11:59 pm the close of the trimester.
– Some forms once completed, such as the Pre-TED Form
2400/2402, trigger other forms to be due. The forms that come due
will count for CPI if the due date falls into the applicable time period.
CPI Reports
CPI Reports
To assist centers with their form completion and other CPI requirements, reports are sent out at an increased frequency at the end of each trimester.
The last two weeks of a trimester CPI reports are sent
out daily
The last two days of a
trimester CPI reports are sent out twice/day
One final CPI report is sent out after midnight at the close
of the tri
The Recipient CPI Reports are automatically sent weekly to current Primary
Data Managers and CC-PDC staff
CPI Reports cont.
The summary table includes CPI metrics on:
– form completion and query status – CTA status
– current IRB documentation and expiration date on file
• The top of your report will provide a date and time the report was generated as well as your CCN number and center name.
• If CTA is TBD ( to be determined), that step is not currently due.
• Note: IRB Not Applicable denotes centers that utilize the NMDP IRB for their informed consent
documents or the center does not require submission to their local IRB in compliance with the
revised common rule.
CPI Report Example
CPI Report Example Cont.
CPI Report Example Cont.
CPI Report Example Cont.
The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).
The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).
How to run a forms due report in FN
Try It Out: Running a Forms Due List in FN3
The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).
The CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®(NMDP)/Be The Match®and the Medical College of Wisconsin (MCW).