In 2010 the FDA guidance for Industry Electronic Source Documentation in Clinical Investigations, put forth the suggestion to promote the capture of source data in electronic form. Source documentation is an original document. It is to be credible, accurate and a real-time entry of electronic data during client visits. The FDA encouraged the recording of source data in an electronic format to eliminate duplication of data, reduce opportunity for transcription errors, promote real-time entry of electronic source data during client visits, and ensure the accuracy and completeness of data.
Ideally a source document should be a part of the patient’s medical record but in reality things can be different. Applications used as part of the EHR often are stand alone systems that are interfaced together through standardized coding, HL7 (Hospital level 7).
At Cancer Treatment Centers of America Midwestern Regional Medical Center (MRMC), our increased investment in Health Informatics is part of our commitment to an integrated health model. Over one hundred applications are currently used to create the patient’s EHR.
MRMC quest for FACT (Foundation for the Accreditation of Cellular Therapy), posed another facet whereby, three departments were providing the necessary reporting, but each in their respective applications.
To bridge this gap and create an effective documentation process, a team of Stem Cell Physicians and Coordinators, Cancer Registry, Laboratory and IT, formed to search for a solution that would meet three objectives: provide a comprehensive medical record, streamline existing processes for reporting to regulating agencies, and to provide data for Business Intelligence analysis to improve outcomes, trending and validation.
As the solution, the team outlined three projects to meet our objectives: create a multi-discipline source document; implement Comprehensive BMT application from Remedy Informatics to interface the source data and electronically submit forms to CIBMTR; implement interfaces into our warehouse where data can be modeled for increased analysis, outcomes and trending.
This venture is a combined quality initiative, guided by our hospital’s strategic plan and our program expectations. Implementation of the process using Lean Six Sigma methodology will result in efficiency, decrease chance for error, collaborate information and process, quality monitoring, and constant process improvement. It may one day be used as an example for other transplant programs.