Monday, January 7, 2013

Electronic Health Record Safety

On December 21, 2012, ONC issued its Health IT Patient Safety Action & Surveillance Plan for public comment

I was interviewed by the Boston Globe about the plan.

Although EHRs address a variety of safety concerns such as unreadable orders/prescriptions, drug/drug interaction checking, and fostering care coordination, they can create new problems that did not exist with paper.   These problems are rare (less than 1% of quality issues reported), but they are important.

For example, a clinician writing a paper prescription for Atenolol, a beta blocker used for cardiovascular diseases, would be  unlikely to accidentally write for Ativan, a benzodiazepine used for anxiety.

However, if an EHR presents medications in a pulldown or an AJAX style lookup list, you can imagine a physician selecting the wrong medication by simple slip of a mouse.


There have been several articles in the literature suggesting that badly designed software (or any software implemented poorly) can cause harm.

At BIDMC, we've used agile development techniques and rapid cycle improvement processes to  enhance usability of systems, especially in response to sentinel events or clinician concerns.    Our systems are developed by clinicians for clinicians.

It is challenging to define usability of applications and software quality, so writing regulation (such as FDA Device registration/approval) is hard.

Since it will take time to learn how to monitor the safety of EHRs and write enforceable regulation, what can we do in the short term?

The ONC report suggests
 *Learn - Make it easier for clinicians to report patient safety events and risks using EHR technology.  Engage health IT developers to embrace their shared responsibility for patient safety and promote reporting of patient safety events and risks.   Provide support to Patient Safety Organizations(PSOs) to identify,aggregate,and analyze health IT safety event and hazard reports.  Incorporate health IT safety in post-market surveillance of certified EHR technology through ONC-Authorized Certification Bodies (ONC-ACBs).  Align CMS health and safety standards with the safety of health IT,and train surveyors.  Collect data on health IT safety events through the Quality & Safety Review System(QSRS).  Monitor health IT adverse event reports to the Manufacturer and User Facility Device Experience (MAUDE) database.

 *Improve - Use Meaningful Use of EHR technology to improve patient safety.  Incorporate safety into certification criteria for health IT products.  Support research and development of testing, user tools, and best practices related to health IT safety and its safe use.  Incorporate health IT safety into medical education and training for all healthcare providers.  Investigate and take corrective action, when necessary, to address serious adverse events or unsafe conditions involving EHR technology.

 *Lead - Develop health IT safety priority areas, measures, and targets.  Publish a report on a strategy and recommendations for an appropriate,risk-based regulatory framework for health IT.   Establish an ONC Safety Program to coordinate the implementation of the Health IT Safety Plan.  Encourage state governments to incorporate health IT into their patient safety oversight programs.  Encourage private sector leadership and shared responsibility for health IT patient safety.

Some have questioned the wisdom of moving forward with EHRs before we are confident that they are 100% safe and secure.   I believe we need to continue our current implementation efforts.   I realize this is a controversial statement for me to make, but let me use an analogy.

When cars were first invented, seat belts, air bags, and anti-lock brakes did not exist.    Manufacturers tried to create very functional cars, learned from experience how to make them better, then innovated to create new safety technologies. many of which are now required by regulation.

Writing regulation to require seat belts depended on experience with early cars.

My grandmother was killed by a medication error caused by lack of an EHR.  My mother was incapacitated by medication issues resulting from lack of health information exchange between professionals and hospitals.   My wife experienced disconnected cancer care because of the lack of incentives to share information.     Meaningful Use Stage 2 requires functionality in EHRs which could have prevented all three events.

I am hopeful that ONC's thoughtful plan, which leverages the experience of EHRs in use, will appropriately accelerate the benefits of today's Certified EHR Technology while minimizing risks of future EHR products still in development.

1 comment:

Anonymous said...

What is really needed here is the Toyota approach to "stopping the production line"

There are lots of surveillance systems on the market that can check for patient safety issues. The problem is getting these to trigger action within the clinical workflow.

It should be a REQUIREMENT of EMR vendors that they include a "safety stop" API / interface so that third-party monitoring tools can send an "HL7 flag" to create a very visible alert on the patient chart that must be cleared.