“There is a lot of confusion among providers that is interfering with EHR adoption progress, so we are taking four steps to bring more clarity to the situation,” stated Mark Leavitt, M.D., Ph.D. CCHIT’s chair, in a press release this morning. Specifically, the Commission is taking the following steps:
- Making the CCHIT Certified program fully independent from the Preliminary ARRA program;
- Reopening applications and testing under both programs on April 7;
- Updating its Web site to offer clarity about the objectives and status of both programs, especially regarding their relationship to the still-awaited government accreditation process; and
- Preparing for a prompt conversion of the Preliminary ARRA program into an ONC-accredited ARRA testing and certification program.
Starting April 7, the Commission will once more accept applications, continue its testing and issue two types of EHR certifications. A product may receive one or both of these certifications:
- CCHIT Certified — an independently developed certification that includes inspection of an EHR’s integrated functionality, interoperability and security. Products that are CCHIT Certified are tested against criteria developed by the Commission’s workgroups. “This program is intended to serve healthcare providers looking for maximal assurance that a product will meet their complex needs. As part of this independent evaluation, successful use is verified at live sites and product usability is rated.”
- Preliminary ARRA — a certification program that tests Complete EHRs or EHR Modules against the Meaningful Use Stage 1 certification criteria in the Interim Final Rule (IFR) issued by HHS/ONC in January. The Preliminary ARRA program is designed to demonstrate that a vendor’s product is “extremely well prepared to be certified” once ONC-accredited testing and certification becomes available (but the final criteria and test procedures are not yet available, nor has CCHIT been accredited yet by ONC). “When those events occur, CCHIT will replace the Preliminary ARRA program with a final, ONC-accredited ARRA certification program. Vendors with Preliminary ARRA certification can undergo retesting by CCHIT at no additional cost to receive a fully-accredited certification once it is available.”
Program materials, including revised program policies, applications, criteria, test scripts and other guidance will be available at http://www.cchit.org/get_certified beginning on April 7.
Dale Sanders says
Mark- Accolades to you for staying with this… My worries might be misinformed, but I’ve been concerned that you might leave CCHIT out of frustration or that CCHIT might be disbanded, and that a vital mission would suffer as either result.
Can you share any updates regarding Human Factors and/or Usability becoming a part of the certification process? I’m a *passionate* believer that we could easily create interoperable EHRs that were completely useless to physician efficiency and harmful to patient safety. Some of us would argue that we’re already doing that. Through CCHIT, I believe we can facilitate the adoption of much better user interfaces and standards without detracting from the proprietary advantages of innovation. I have a Northwestern grad student in Medical Informatics who would love to help… cheap labor. :-) Seriously, count me as a volunteer to help lead or support a Usability and Human Factors Workgroup.
Seems that EHR certification around patient safety issues also needs attention in the future, ala 510k in the FDA? I would be interested in your thoughts on that, too. As a Regional Director and CIO in three healthcare organizations now, I can say without a doubt, from firsthand experience: EHRs improve patient safety, but they also introduce new safety risks that we are not addressing formally as a profession. I’ve been involved in four sentinel event investigations that were root-cause attributable to EHRs, and several others where EHRs were a contributor.
Thanks again…
Mark Leavitt says
First, point of clarification: the term “Government-Produced Vacuum” is a clever headline, but not something I said. (If there was a “government-produced vacuum” I’d give it a catchier name like “The Hoover Administration”.)
Dale, don’t worry about CCHIT being disbanded, it’s going strong, and my personal retirement is calendar-driven, not frustration-based.
Your points about Usability are excellent ones and raise a really valid concern about EHRs. CCHIT has taken a pioneering position here by adding usability testing/rating to Ambulatory EHR certifications starting last Fall. It’s all described in this document http://bit.ly/99l2gP
Patient safety is even more important, but it will take a transformation of healthcare culture, not just extra testing of EHRs, to address that problem. CCHIT requires features such as drug-interaction checking, etc, but you can’t address safety issues introduced during implementation, training, and use by only looking at the software product.
Thanks for your support! There will be more volunteer recruitments in the future and I hope CCHIT will see your application among them. Mark
Dale Sanders says
Thanks, Mark. I’ll take a look at the Ambulatory usability references. BTW, I did a lot of the background liaising to introduce UserCentric to this environment. Companies like UserCentric and brains like Gavin Lew and Bob Schumacher bring the formality of human factors engineering that healthcare desperately needs. Our user interfaces are abysmal, across many products, not just EHRs. About an hour ago, I was up on one of our Wards, empathizing with a poor nurse who was trying to change the settings on a bedside monitor… excruciating.
The EHR patient safety issues I’ve witnessed are attributable to: (1) Homegrown EHRs that were developed in the absence of any formal software safety and IV&V context; and (2) Disparate commercial products (EHRs, LIS, RIS) that were interfaced improperly in the same absence of a software safety and IV&V context. Safety should be addressed in the certification of an EHR, but as you say, it is definitely a bigger issue than the stand-alone products. It’s rooted in the general lack of professional software engineering skills and methodologies in healthcare, especially in the provider organizations that do their own development (I’m guilty as charged). We need the sensible equivalent of 510k methods (or IEC 61508, or ISO 12207…) in and around EHRs. Like HIPAA was to security, we need the same for safety. Healthcare IT security wouldn’t have improved on its own… it took HIPAA to force it.
A thought just crossed my mind… No need to reply…What are the implications of CCHIT certification to locally developed EHRs? I never thought about it before.