'We might meet certification criteria, but it might interrupt workflow. Intent is not met, but the letter of the law is met.'
What can the U.S. healthcare industry learn from other nations? In the realm of EHR certification, arguably a whole lot, policymakers say. The question arose during health IT policy talks in May, and reemerged this week: Could a Kaizen study of certification -- an end-to-end analysis -- reveal what has been lacking in the EHR certification process?
The Health IT Policy Committee sees enough potential that, in fact, this week it voted unanimously to approve a recommendation for ONC to hold a Kaizen review of the entire end-to-end certification process.
Kaizen, of Sino-Japanese origins, according to multiple reference sources, means "continuous improvement," and pertains to any type of change, whether it be brief or enduring. The word is also referenced when discussing corporate improvement methods, like that of lean manufacturing, for instance.
Kaizen is also considered akin to agile or lean business tactics and, in fact, ONC has deployed them before for clinical quality measure development for Stage 3 meaningful use, and with success enough to streamline the process from as long as five years per measure down to one year or less.
As HIT Policy Committee panel members envisioned it, a Kaizen would involve gathering representatives from policymakers, certification bodies, vendors, providers, privacy advocates and others related to the process to create a total understanding of how meaningful use certified products work and affect the achievement of meaningful use.
The Kaizen technique could help ONC make the certification process more limited in scope.
Indeed, some members of the group said certification should be limited to a "critical few" elements, which these members named as: interoperability; the "right" clinical quality measures and privacy and security. The majority, however said the scope should be limited, but not necessarily to just these three areas.
Earlier this year, due to a barrage of industry complaints over Stage 2 requirements along with vendor difficulty preparing the technology on a stunted timeline, ONC was forced to extend the exception policy to allow for vendor delays in meaningful use Stage 2.
More recently, ONC is considering adding some leeway to the requirements, and will make that decision based on public comments from proposed changes on May 20 and from an all-day ONC certification hearing May 7, with testimony given by panels of providers, vendors, certification bodies and others from the private sector.
The purpose of the hearing was to find what was working and what certification challenges had developed under Stages 1 and 2.
"It was a learning experience," said Paul Tang, MD, chair of the certification hearing and meaningful use workgroup and also the chief innovation and technology officer at the Palo Alto Medical Foundation. "Oftentimes we might meet certification criteria, but it might interrupt workflow. Intent is not met, but the letter of the law is met."
The certification workgroup would like to see ONC increase collaboration between the federal government and the private sector when it comes to certification, creating a sort of "policymaking interoperability," Tang said, as he presented the certification workgroup's ideas to the larger advisory panel.
Most of what Tang proposed went over well.
The HIT Policy Committee endorsed the Kaizen process, in fact, but they said the Kaizen could not take the place of decisions the federal advisory committee should make.
Rather, it should only be used as a learning tool -- a continuous one.