Affect You? Kay Gardner. February 24, Minneapolis Campus. New Slide 1

Transcription

1 CPI: How Does it Affect You? Kay Gardner Minneapolis Campus February 24, 2010 New Slide 1

2 Objectives Knowledge of Continuous Process Improvement (CPI) program and purpose When to submit Institutional Review Board (IRB) documents How liaisons can help 2

3 National Marrow Donor Program (NMDP) Process CPI Phase I search forms CPI Phase II recipient forms * CPI Phase III research samples CPI Phase IV donor forms * CIBMTR CPI replaces Phase II 3

4 Stem Cell Therapeutic Outcomes Database (SCTOD) Data collection is required TED level data Pre-TED Post-TED INF form 4

5 CIBMTR CPI Requirements 90% of Forms (TED and CRF) must be completed by the end of the trimester January Report ECD: May 1 through August 31 May Report ECD: September 1 through December 31 September Report ECD: January 1 through April 30 5

6 CPI Goal: 90% of Forms Completed for Each Trimester Events occurring in this trimester Are expected to be completed And become Past Due if they re not Earliest Complete Date by the end of this trimester completed by the start of this trimester Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Trimester Trimester Trimester Year 1 Earliest Complete Date: January 1 to April 30, Year 1 Form should be error free by August 31 Past Due on September 1, Year 1 Year 1 Earliest Complete Date: May 1 to August 31, Year 1 Form should be error free by December 31 Year 2 Past Due on January 1, Year 2 Year 1 Earliest Complete Date: September 1 to December 31, Year 1 Year 2 Form should be error free by April 30 Past Due on May 1, Year 2 6

7 CIBMTR CPI Requirements (continued) Forms must be error-free Disease inserts and forms associated with the main form must be error-free 7

8 CIBMTR CPI Requirements (continued) IRB approval documents Must be on file with CIBMTR Minneapolis Must submit annual renewal to CIBMTR - Minneapolis Data Transmission Agreement (DTA) 8

9 CIBMTR CPI Requirements (continued) Due Process Good Standing First Warning Probation Warning Probation Suspension 9

10 CPI Due Process GOOD STANDING less than 90% of forms past due FIRST WARNING 90% goal not met for 1 trimester PROBATION WARNING 90% goal not met for 2 consecutive trimesters 10

11 CPI Due Process (continued) PROBATION 90% goal not met for 3 consecutive trimesters SUSPENSION more than 3 trimesters of non-compliance Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Year 1 Earliest Complete Date: January 1 to April 30, Year 1 Due by September 1, Year 1 1 st Warning Year 2 Probation Warning Probation Suspension 11

12 Liaisons Center assigned to a liaison Monitor/track CPI progress Answer questions Clarify form questions Clarify error reports Train center staff 12

13 CIBMTR CPI Benefits Produce high quality studies to advance the field of HCT Receive data that is: Complete Timely Accurate Representative of overall HCT community 13

14 CIBMTR CPI Benefits (continued) Quality observational database All requested forms are needed to maintain the epidemiologic integrity of the database Timely receipt of research data is important to evaluate new trends in HCT HCT outcomes are not biased by under- reporting of events Patient counseling requests Insurance appeals 14

15 CIBMTR CPI Benefits (continued) Eases center burden Center volumes analyses Center specific analyses Fewer CIBMTR study requests for follow-up data 15

16 Frustrated? 16

17 Customer Focus Let Us Help CRC Liaisons i assigned to each center Build rapport to frequently review Status t Issues CIBMTR work with your center How can we help you? 17

18 Thank You! We sincerely appreciate your commitment to the CIBMTR The ability to meet the research agenda of the CIBMTR, an agenda determined by you and others in the HCT community, depends on the willingness of our participating centers to provide data as requested 18

19 Questions? New Slide 19