120 Improving Internal CIBMTR Data Audits: Process Improvement and Time Saving

Track: Clinical Research Professionals/Data Management Conference
Wednesday, February 11, 2015, 1:30 PM-2:30 PM
Harbor Ballroom GHI (Manchester Grand Hyatt)
Melissa Yurch , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Sharisa Cross, CCRP , Blood & Marrow Transplant Program, (Former) Cleveland Clinic, Cleveland, OH
Jason D. Sabo, MA , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Andrea Urbanek , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Tanya Rodela , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Joshua Workman , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Patti Baucco, MT (ASCP) , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Donna Abounader, CCRP , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Daniel Nieser , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Navneet S. Majhail, MD, MS , Blood & Marrow Transplant Program, Cleveland Clinic, Cleveland, OH
Background:  Time management and cost reduction is in the forefront for many centers today. Centers need to save time and money, while accurately reporting data to the Center for International Bone Marrow Transplant Research (CIBMTR). Our center has researched and taken steps to address these issues. As a result, our process for completing and auditing forms has been simplified and made more efficient.

Rationale:  We examined our internal form auditing processes as part of a cost reduction measure.  Previously, we were auditing 100% of all research and Transplant Essential Data (TED) forms.  Because of experienced data managers and their continued training, our error rate was low enough that reducing the breadth of the audit was justified.

Best Practices:  Most events occur in the first year after transplant.  Therefore, we placed importance on this time frame and varied the levels of importance on other forms and used stratified sample auditing to cover them. This allowed us to notice any trends in errors and provide training.  By selecting a percentage of all forms, we can efficiently give feedback to data managers and provide targeted training sessions. 

Method:  We are currently auditing 100% of research; post-TEDs through 1 year.  After 1 year we are utilizing the stratified sample method for auditing post TEDs 2-6 years at 50% and over 6 years at 25% per data manager.  A data manager may request a form be audited at any time point.  New employees are audited at 100% for their first year.  We do routine education based on errors found on our audits.

Outcome:  We tracked our error rate over the past year and a half and our calculated error rate was low enough to warrant this change.  Our current average error rate was 0.41 errors per form. Through tracking audited forms, we found that we saved 2.7 weeks or 107.3 hours per year of the auditor’s time.  Revising the auditing process has improved time, efficiency and lowered the cost of auditing, while maintaining high quality work with low error rates.  The time saving of approximately 3 weeks can be utilized in opening more studies and other projects data coordinators are responsible for.

Future:  In phase two of time management, we have streamlined our submission processes for auditing and saving versions of forms.  FormsNet3 (FN3) has proven that we no longer need to do this and will in turn save valuable drive space.  The amount of time used to convert the form to PDF, submit it, and correcting and resaving will also be saved with the new process.  We utilize the audit sheet to track errors, communicate to data managers, and make corrections in FN3 – all without having to PDF a form.  Additionally, errors are sent and seen on a weekly basis and data managers are given a week to make the corrections inFN3.  We found 3.8 weeks per year of data managers’ time can be saved with this change in process.

Disclosures:
Nothing To Disclose
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