CPI Continuous Process Improvement 9/23/2021

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TRAINING & DEVELOPMENT |1. NEW DM ONBOARDING SEP 2021 |1. 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

TRAINING & DEVELOPMENT |2. NEW DM ONBOARDING SEP 2021 |2.

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

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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 4

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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

• CTA requirement not met Suspension

• < required % of forms and queries completed for 1 trimester, and/or for 3 consecutive trimesters, 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.

Forms Completion 7

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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

of trimester Resolve Queries

Placed During the Previous Trimester

of trimester IRB (minimal change

from prior requirements)

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

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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

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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 16

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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 19

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CPI Report Example Cont.

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How to run a forms due report in FN

Try It Out: Running a Forms Due List in FN3

IRB

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IRB Process Update

• Upon obtaining center IRB approval, the CIBMTR Protocol Coordinator must receive a copy of the center's IRB approval letter, approved protocol and informed consent documents.

These documents should be submitted via email to: [email protected].

• CIBMTR tracks the IRB approval for the Research Database at each participating center. The center's IRB approval for this protocol must be current at all times. Failure to have current IRB approval may affect a center's ability to meet CPI requirements for data submission.

IRB Process Continued:

• More information on IRB can be found here:

– https://www.cibmtr.org/DataManagement/ProtocolConsent/Observationa lData/pages/index.aspx

– https://www.cibmtr.org/DataManagement/ProtocolConsent/ResearchSam ples/pages/index.aspx

– https://www.cibmtr.org/Meetings/Materials/CRPDMC/Documents/2021/0 6%20Consent%20and%20You%20‐%20What%20It%20All%20Means.pdf

• For questions about Repository IRB please contact [email protected]

CTA

Consecutive Transplant Audit

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Reporting Hematopoietic Cell Transplants (HCTs) for Consecutive Transplant Audit (CTA)

• Consecutive reporting of HCTs ensures the continued epidemiological integrity of the CIBMTR outcomes registry.

CIBMTR is obligated to provide the US government with an accurate assessment of transplant activity.

• Beginning in January each year, your center will submit a list of all HCTs that have occurred at your center the year prior between the dates of January 1, 20XX – December 31, 20XX.

• HRSA reports and CIBMTR Studies rely on accurate reporting in FormsNet

• Refer to your center’s medical records when putting your list together

Importance of Accurate Reporting

CTA cont.

• For more information, please refer to your prerecorded CTA slide deck that was sent to you in your pre-work packet

• For detailed instructions on CTA including submitting your HCT list, downloading your CTA discrepancy file form the portal and resolving each type of CTA discrepancy, please review the CTA pages in our DM guide found here:

– https://www.manula.com/manuals/cibmtr/training-and- reference/1/en/topic/cta

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• Thank you for all your work!

• The CIBMTR research program could not be accomplished without your dedicated contributions and hard work. If you have any questions or concerns after the meeting, please reach out via CIBMTR Center Support