Interoperability, Usability, and the ONC 2015 Edition Certification

"Satisfaction and usability ratings for certified electronic health records (EHRs) have decreased since 2010 among clinicians across a range of indicators.”

This announcement was made 5 years ago the 2013 Healthcare Information and Management Systems Society (HIMSS) Conference & Exhibition by Michael S. Barr, MD, MBA, FACP.

His presentation highlighted “ the need for the Meaningful Use program and EHR manufacturers to focus on improving EHR features and usability."

The Electronic Health Record Association (EHR Association), a non-profit association of more than 40 EHR companies, created an electronic health record (EHR) Developer Code of Conduct, which aims to encourage transparency and collaboration among EHR developers, as well as developers, providers, and industry stakeholders.

On the first page of the EHRA code of conduct, the very first item (after a general statement) is Patient Safety. The code says:

Recognizing that patient safety is a shared responsibility among all stakeholders in an increasingly health IT-enabled, learning healthcare system: We are committed to product design, development, and deployment in support of patient safety. We will utilize such approaches as quality management systems (QMS) and user-centered design methodologies, and use recognized standards and guidelines.

The terms User-centered design (UCD), Usability, and User eXperience (UX) have been used over the years to describe the work of the software professionals that specialize in the human-computer interaction. "Software Human Factors" is the field of study that applies the methodologies of Human performance and ergonomics to software. Instead of trying to design objects that work with the physical attributes of the human body, experts in Usability and User-centered design virtual interactions that work with the mental capabilities of human minds.

Do you remember the HP calculators of the 1970s?
HP Calculators

(from http://www.hpmuseum.org/ )

They were great for mathematicians, but the general public was really confused about how they worked. They were confused because in order to perform even the most basic mathematical functions people had to think differently. They had to think like the mathematicians.

Adding up a series of numbers was simple. All one had to do is key in a number, press , key in the next number, press , and then press the plus key to calculate the sum of all the numbers entered. As Easy as π!

The problem with these calculators was that the design of the user interface focused exclusively on expert users and these experts were a very limited sample size. The answer to fixing the calculators was User-Centered design. UCD is a design philosophy that creates a culture of understanding and enabling end users to perform their tasks using an information architecture and taxonomy that matches their mental model.

After changing the user experience to match a more common understanding of arithmetic, e.g. key in a number, press plus, key in another number, then press equal, the market for desktop calculators exploded.

The HITECH Act

The Health Information Technology for Economic and Clinical Health Act (HITECH Act ) is part of the American Recovery and Reinvestment Act of 2009 (ARRA). ARRA contains incentives related to health care information technology and contains specific incentives designed to accelerate the adoption of electronic health record (EHR) systems among providers. The Office of the National Coordinator for Health Information Technology (ONC) released a set of Safety-enhanced Design §170.314(g)(3) and §170.315(g)(3) certification and meaningful use requirements for Electronic Health Records (EHRs). These certification requirements EHR vendors must include evidence of user-centered design and summative usability test results in their submission.

Summative usability testing for safety-enhanced design involves recruiting targeted users as test participants (Doctors, Nurses, and other medical practitioners) and asking these users to complete a set of pre-defined tasks. An expert test facilitator conducts the testing via an established test protocol while the test sessions are recorded and later analyzed.

The summative usability tests for ONC certified EHRs are all made public on the CHPL site: https://chpl.healthit.gov/ (Yes, we know this site is "usability challenged")

A big problem is that many of the EHR vendors didn't work with medical professionals in their designs. They created what we call Engineering-centric designs, not User-centered Designs. They made HP Calculators. They created systems that are easy to use for engineers and not medical professionals. Complicating matters, a number of EHR vendors took serious end-runs around the regulations and did not conduct nor report on a proper usability test to become certified. It was fairly obvious that some of the Authorized Testing and Certification bodies seem to be rubber-stamping the summative usability reports perhaps without even looking at them.

Think about this: If an EHR vendor took side-steps in preparation of their usability evaluation, what other short-cuts did they take with development of their system? I’m frightened that someone may suffer serious injury because some EHR vendor ignored usability testing so that their clients can get ONC funding.

The U.S. Food and Drug Administration has acknowledged getting hundreds of reports of problems involving health information technology including numerous patient injuries and deaths.

Some examples seen at hospitals across the country:

  • At Marin General Hospital in Northern California, RNs called on the Marin Healthcare District board to delay implementation of their EHR system. "Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," Marin RN Barbara Ryan said in comments reported by the Marin Independent Journal.
  • In Chicago, the Chicago Tribune in 2011 reported on a patient death at Advocate Lutheran General hospital after an automated machine prepared an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by a physician.
  • At Affinity Medical Center RNs in Massillon, Oh. RNs in June raised multiple objections to the hurried introduction of an EHR system. Subsequently, they have cited medication errors, delays in care, problems with documentation, computers crashing, and other concerns.

For another example of why usability in healthcare is so important, see “How Bad UX Killed Jenny” https://medium.com/@designuxui/how-bad-ux-killed-jenny-ef915419879e

The office of Rep. Michael C. Burgess, MD (R-Texas) released a draft bill that is designed to fix some of the issues associated with the HITECH Act. The draft bill completely ignores the problems with usability in healthcare IT and continues the policy of excluding caregivers, patient safety and patient rights organizations, and other healthcare organizations, from playing an active role in ONC.

Rules for Meaningful Use stage 3

On Friday March 20, 2015 the HHS released proposed rules for Stage 3 of the meaningful use program. Contained within these new rules was very significant, but under reported, changes in the meaningful use program: An expansion of the Safety-enhanced Design (aka usability) testing portion.

For the complete text of the changes to the Safety-enhanced Design program see pages 191 to 196 of the proposed 2015 ONC certification document at https://www.federalregister.gov/articles/2015/03/30/2015-06612/health-in...

A Quick summary of the proposed enhancements included:

• ONC will requires 17 instead of 7 functional areas to test
• ONC recommends 15 participants, instead of providing no recommendation (we have seen many certified EHRs that only tested on two people!
• ONC clarifies the User-centered Design reporting requirements.
• ONC provides guidance on when an EHR needs to be retested due to changes in the UI

The final changes to the usability testing portion of the 2015 ONC criteria were not as extensive but were mostly a direct result of suggestions given as public comment on the 2014 certification program by those, including The Usability People, in the usability community.

So what exactly is usability and user-centered design?

According to the ISO 9241-11 standard usability is defined as "The effectiveness, efficiency, and satisfaction with which specified users achieve specified goals in particular environments (ISO 9241-11)."

Effectiveness - The accuracy and completeness with which specified users can achieve specified goals.

Efficiency - The resources expended in relation to the accuracy and completeness of goals achieved.

Satisfaction - The comfort and acceptability of the work system to its users and other people affected by its use.

All within a specific particular environment (context of use).

Usability in healthcare can be difficult to achieve, but it is important to remember that it is not only based upon the aesthetics of the user interface. Good Usability is also not determined by the number of clicks (see The Myth of Too Many Clicks).

A useable healthcare system must be designed to match the mental models and workflow of its users. A usable EHR needs to work (effective), work well (efficient), and not cause any unnecessary frustration (satisfying). The big business interests of the Healthcare industry may cry wolf (and lobby hard) against enhancements to the usability program because they don’t want to spend the extra time and money to provide a healthcare system that truly follows a safety-enhanced design philosophy. They are no better than the automobile industry that fought hard against seatbelts in the late 1960 and against The United States Intermodal Surface Transportation Efficiency Act of 1991 that required airbags in cars.

With Congress working on legislation to fix major healthcare problems caused by the HITECH act, we hope that they will finally address the issue of lack of EHR usability.

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The Usability People conduct and report summative usability evaluations using the NISTIR 7742 Customized Common Industry Format Template for EHR Usability Testing—suitable for satisfying the Safety-enhanced Design criteria portion of your ONC EHR certification.