eSafety Trial Projects – Leading the Way in Canada on Guidelines Use to Mitigate Safety Risks in eHealth

One could say that as a COACH Board member and a foundational leader of the eSafety Program in Canada, I could not “opt out” as a potential volunteer trial user of the eSafety Guidelines – however, I saw it as a way to ensure fewer sleepless nights prior to the launch of our major provincial eHealth application in the months leading up to go-live on Aug. 30, 2013.

For those of us on the front lines of eHealth delivery, the busy planning and testing phase prior to go-live is an intense experience filled with both anticipation and restlessness, mulling over potential issues and risks that may derail the success of the launch.  Therefore, the additional eSafety tools, processes and checklists used by my newly minted eSafety team to ease this burden were welcomed by my organization, stakeholders, clinician users and operations team to ensure we had left no stone unturned that could present any risk.

So how did we use these eSafety Guidelines? What were the benefits and what did we learn from this experience? Perhaps before we delve into the trial use case experience, a quick refresher on eSafety is needed to understand the background and context for the work COACH is doing.

The Premise eSafety: Why the COACH Guidelines are Needed
In a previous article on this topic, co-authored by myself and COACH President Neil Gardner, we emphasized that the promotion of “e” systems, software and solutions as safe reliable tools for enhancing patient safety is a strongly held premise and indeed targeted benefit underlying many of our EHR and related initiatives for the last 10 years.  Yet, in our quest to enhance patient safety through all of our good work in the “e” world, we need to be equally cognizant of the need to protect patients against the risk of harm due to unintended safety risks that we may inadvertently introduce in the development, implementation and use of those same “e” systems, whether those be EHRs, EPRs, EMRs.


This premise is also backed from a November 2011 report published by the Institute of Medicine (IOM) in the US (…).  The IOM report noted that:

“It is widely believed that health IT, when designed, implemented, and used appropriately, can be a positive enabler to transform the way care is delivered.  Designed and applied inappropriately, health IT can add an additional layer of complexity to the already complex delivery of healthcare, which can lead to unintended adverse consequences, for example dosing errors, failing to detect fatal illnesses, and delaying treatment due to poor human–computer interactions or loss of data.”

The report makes a compelling case for increasing our safety “vigilance”, and provides some strong evidence that action is required in ensuring that our systems are not only well-designed, but also well implemented.

So relying on a national team of health informatics (HI) professionals and clinicians, COACH developed a comprehensive set of guidelines as part of an overall eSafety Program, and enlisted the help of eight volunteer organizations from across Canada to trial the guidelines and associated tools and checklists on current eHealth projects to improve on the guidelines and test the effectiveness of the tools.

The eSafety Case – Ask Yourself the Question:  What Could Possibly Go Wrong?
As we launched into our trial use project for our provincial eHealth implementation, our principle deliverable was to create an eSafety Case Summary report that highlighted any potential patient safety risks and how we were going to mitigate them prior to go-live.

The COACH guidelines provided clear tools and checklists and outlined how to use the eSafety Case Method to confirm that the development, deployment and use of our eHealth application would not pose an unacceptable safety risk to patients. Much like a Privacy Impact Assessment, a Safety Case should be completed before the eHealth system is implemented to reduce adverse events or near-misses.

Following the creation of the OntarioMD eSafety Team (comprised of product and change management experts and our physician champion), and the assertion from our CEO that our organization had a “low” tolerance threshold for eSafety risks, we started asking ourselves THE QUESTION: “What can possibly go wrong in the implementation of our eHealth application?”  The safety culture was already well established in our organization – it was just not formalized in an eSafety Summary Case.

Nailing down the scope of your eSafety case is the next step – where the key question is how you deal with those risks outside your control? The eSafety approach enables the identification of safety risks within your initiative (that you can mitigate), as well as risks that are outside the domain of your project that you can work with other stakeholders to mitigate to ensure patient safety throughout the entire lifecycle.

In our case, we already had many existing process and tools in place to ensure our application (Hospital Report Manager or ‘HRM’) had minimal risks. These include standardized specifications, legal agreements, checks and balances within the product, the PIA, stringent operational processes, extensive testing and validation with vendors, data senders and receivers.

As we completed the eSafety trial, we found that the checklists and tools in particular ensured that pertinent questions are asked at the right time and for the right reasons. We included many different stakeholders, including physicians and physician office managers to walk through our processes from end to end, and identify additional processes to build into our ongoing maintenance of the project to ensure that we could specifically identify, track, and communicate any risks that we may not be responsible for, but we needed to ensure our stakeholders were managing effectively. For example, while transcription report errors on the hospital side were not “our responsibility”, we still have processes around managing those errors, and we used the eSafety case as a way to ensure we are aware of the incidents so we can understand the incident volume and deal with it as partners.

eSafety Trial – What Were the Main Lessons Learned?
The entire process to develop the eSafety Case Summary report took less than eight weeks in duration (80-100 hours total), and relied on the existing team and processes to produce a comprehensive summary of how our eHealth application was dealing with eSafety risks.


Was it worth it at a time when the team and organization was poised to go-live? Certainly in our experience it was – and we have taken the additional step to build in ongoing updates on eSafety risk management as part of our Product Roadmap so our clinician users, hospitals and other stakeholders can clearly understand how we are managing any risks.

Our findings on the eSafety Case Method and associated guidelines:
The guidelines were easy to understand and comprehensive; and the tools and checklists provided were easily picked up by the team.

The eSafety leading practice can be easily integrated with existing risk management practices and policies already in place rather than creating net new processes to ensure eSafety.

You can (and indeed should) rely on your existing team to complete the eSafety Case – you do not need to hire external experts to complete it.

Your eHealth system does not exist in a silo environment; apply the guidelines to integrated systems and different implementation models.

The guidelines extend the effectiveness by helping us create an ongoing program for eSafety and a method to maintain it.

In order to ensure eSafety is repeatable and up-to-date – tie it to your operations processes and product roadmap.

Next Steps for eSafety in Canada
COACH and indeed Canada is in the early stages of understanding and formally adopting eHealth safety leading practices.  Building on the patient safety agenda, the engagements already underway with many in our HI community and the collaboration opportunities with the UK, Australia and the IOM leadership in the US, COACH and advisory partners will advance the eSafety agenda.  Important next steps include:

  1. Market and deploy the eSafety Guidelines in Canada and more broadly around the world as leading practice.
  2. Continue to provide education and awareness around how to successfully apply the eSafety Guidelines.
  3. Build adoption, promotion and deployment strategies with key advisors from Ministries of Health, national organizations, clinical professions and key health agency levels through the COACH eSafety Steering Committee and other forums.

Many key stakeholders are embracing and growing the eSafety culture already.  The chart, right highlights a number of those eSafety champions that are participating today or providing the many linkages further necessary to successfully protect patients against the risk of harm due to unintended safety risks in the development, implementation and use of those same “e” systems, software and solutions.



share this article...
Share on FacebookShare on Google+Tweet about this on TwitterShare on LinkedIn