EHR system poses barriers to biobank consent process

Cincinnati Children's Hospital Medical Center decided to gain patient consent at the time of registration for use of residual clinical samples for research, but found barriers within its electronic health record system for storing those documents. An article published this week in the Journal of the American Medical Informatics Association describes the workarounds required to use its system--from Epic--to allow patients to opt-in as the hospital created a biobank of samples.

The hospital decided to create two levels of participation: The first involved patients' samples becoming part of the repository with no means of re-contact; the second, because patients often wanted to know the results from any testing on their samples, required the patients or their families to be notified of any results.

The hospital reported higher-than-expected participation in its plans. In fact, more than 86 percent of patients provided consent and almost 83 percent requested to be notified of any incidental research findings. It received decisions from more than 18,000 patients in six months and processed 8,000 blood samples for storage in the research biobank.

The original consent form consisted of a single document, with different signature lines to designate the patient's preferred level of participation. But Epic only supports one electronic signature per document, which required the hospital to create five different documents, including one for patients who elect to withdraw.

What's more, because the system allows multiple documents to be active or "effective" at once, staff had no way to know which one was correct. That required manually going through all the consent documents to clear that up.

The researchers also found that Epic's reporting database, Clarity, wasn't showing the most up-to-date information. It relied on its IT team to create several specialized views to more accurately represent the data in the application, according to EHR Intelligence. Even so, manual intervention is still required periodically to cleanse the data.

The team created a 'traffic light' application to quickly show in red or green whether a sample should be kept or discarded. Still, it reports a manual process is required for sample request, though it plans to automate that. Also after launch, it added the ability for patients to refuse consent without a signature.

The authors concluded that commercial EHRs present "significant barriers to the implementation of a registrar-based process," and added that a "more sustainable solution" would be open, service-based EHR architectures that allow for custom interfaces and workflows.

With hospitals under pressure to make better use of their data--but still pay keen attention to patient privacy and consent--increasingly they have turned to vendors for help. The JAMIA research, however, presents further evidence that EHR systems must evolve to fully meet client hospitals' unique needs.

To learn more:
- here's the JAMIA article
- read the EHR Intelligence story

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