The Role of Medical Records During On-Site Clinical Program Inspections
Last year, FACT and CIBMTR announced their collaborative data assessment program, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited Clinical Programs. Not only has this program intensified support and improvement of Clinical Programs’ data management and reporting processes, it saves time for programs audited by CIBMTR by reducing the need to make Transplant Essential Data (TED) forms and source documentation available to FACT inspectors during the on-site inspection.
Despite the reduction in records to produce for the data audit, there is still a critical need for access to medical records during on-site inspections. Compliance with many standards can be verified through medical records including:
- Donor and recipient informed consent;
- Donor eligibility evaluation and determination;
- Compliance with established policies, procedures, and guidelines;
- Verification of preparative regimens and recipient identity against protocols;
- Detection, evaluation, reporting, correction, and prevention of adverse events and other occurrences; and
- Verification of corrective action plan implementation.
Pre-selected and organized medical records facilitate inspector review. Pre-select records that represent a variety of situations applicable to your program, including:
- Allogeneic, autologous, and haploidentical transplants;
- Transplants using cells derived from peripheral blood, bone marrow, and cord blood;
- Cellular therapy using novel products such as immune effector cells (IECs);
- Adult and pediatric patients; and
- Adverse events, positive microbial cultures, and ineligible donors. (Yes! Showing inspectors medical records that represent less than ideal, but inevitable, circumstances will improve the results of your inspection by allowing inspectors to verify compliance with all standards.)
(A note about electronic medical records (EMR): Because it takes time to navigate electronic systems, it will also take time for the inspector to become familiar with your EMR. Create printed shadow charts and/or plan to navigate the system for your inspector. It is a good idea to communicate with your inspector in advance regarding his/her preferences.)
With the time saved by eliminating the need to produce accessible copies of TED forms, spend time selecting medical records from a variety of situations, evaluate your processes and make improvements where necessary. Use this opportunity to show your inspector how you continuously improve your program. That is, after all, the real purpose of FACT accreditation.