To be compliant with CPI standards, there are three requirements:

  1. Having current IRB documents (renewal letters and consents) on file with NMDP including the following:
    • Current IRB Documents
    • Approval letters
    • Approved consents
  2. Meeting the requirements of consecutive reporting of hematopoietic transplants (HCT) which includes centers submitting their complete list, registering CRIDs for any unregistered patients, resolving invalid CRIDs that do not exist in FormsNet3℠, and resolving data discrepancies (i.e. mismatches) that were found between center-provided lists and FormsNet3℠
  3. Form completion of at least 90% of the required forms for three product types at each of three time periods (January 1 – April 30th, May 1 – August 31st, September 1 – December 31st)
    • Allogeneic Related form completion (for applicable centers)
      • All three time periods
    • Allogeneic Unrelated form completion (for applicable centers)
      • All three time periods
    • Autologous form completion (for applicable centers)
      • All three time periods
    • Cellular Therapy form completion (for applicable centers)
      • All three time periods

Compliance will be enforced according to the following schedule:

A center meets CPI and is considered in “Good Standing” by meeting all of the standards of CPI. A center that fails to meet any of the three CPI standards is given a non-compliance status. Below is the non-compliance schedule:

  • First Warning: First failure
  • Probation: Second consecutive failure
  • Suspension: Third consecutive failure

One successful trimester, in all of the standards, returns the center to Good Standing.

A center that fails to comply with the above during the CPI period will receive a letter from the CIBMTR Senior Manager informing them that they did not meet all the CPI goals. By the next trimester, the center must return all standards to Good Standing or they will be moved to the next stage of non-compliance. While there may not be any direct consequences to being in First Warning or Probation status, CIBMTR encourages centers to return to good standing as soon as possible. This ensures the database is as complete and accurate as possible. Please work with your center’s CRC if you have any questions about how to best return to good standing.

If a center did not meet CPI due to non-compliance in Allogeneic Related form completion one trimester and fails to meet the IRB requirements the next will be moved on to the next level of non-compliance. All standards must be met to return the center to Good Standing.

A center that reaches “Suspension” status could be suspended from initiating new patient searches for a NMDP donor and from participating in CIBMTR leadership activities. Failure to submit the forms may also affect Center Volume reporting and the Center Specific Analysis. Failure to report data to CIMBTR in a timely and accurate manner affects the quality of the database and ultimately could affect published reports.

CIBMTR Management may contact the Medical Director or Primary Data Manager of a center at any time a center has not met all of the CPI standards.

Last modified: 2019/01/17

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