Q&A With ICSA Labs on Stage 2 Testing and Certification

There is one consistent question I have received over the past few weeks from many of my EHR vendor clients, “What is the next round of ONC certification testing going to be like?”. Well with the Final Test Procedures due out tomorrow it is probably a good time to ask Michelle Knighton at ICSA Labs what they are expecting in terms of testing complexity and process.

Q. Have you been hearing from vendors that they want to test for certification ASAP like many did during the last round of testing?
While we expect to see competition among some of the vendors to be part of the first wave of 2014 Edition Certified vendors, we don’t anticipate the rush will be as great as it was for the Stage 1 testing. The main reason for this is that eligible hospitals and providers can use Stage 1 certified software until the last 90 days of the 2013 FY reporting period. Additionally, the test tools are continuously being updated and we would imagine that the majority of the vendors would need time with the Final Test Procedures (anticipated 12/14/12) and more final versions of the test tools themselves.

Q: We have heard that 2014 Edition testing will be more complex and time consuming. Is this so?
Absolutely! The ONC has introduced additional rigor into the testing process. In Stage 1, we saw 1 file per interoperability criterion validated. However, in 2014 Edition testing, test labs will be required to validate multiple test files, sometimes as many as 8-10 files per criterion. We’ve spent this week pilot testing the criteria and test tools with a number of vendors, and it is obvious that the bar has been raised significantly. That will be reflected in the overall time and effort it takes to not only to prepare for certification, but to conduct the testing.

Q: What is the tool that will be utilized to test Clinical Quality Measures objectively?
We anticipate that the ONC will name Cypress as the official test tool for testing clinical quality measures. The newest version of the tool has some great features and will help the test labs gain some test efficiencies and help ensure a more robust testing process. However, there are still some scenarios that the ONC will need to provide guidance on, particularly issues surrounding the use of live patient data during a test event. Many hospitals and provider sites use live data for their certification test. Due to the deterministic nature of testing with the Cypress tool, a non-conformant validation result will be returned if there are patient records within the CQM file that Cypress is not expecting. The test labs will need guidance by the ONC on how to handle these types of exceptions.

Q: Do you anticipate that achieving 2014 Edition certification will be much more difficult for some of the vendors who achieved 2011 certification?
While 2014 Edition certification will be more difficult for some vendors to achieve, we do still believe it is attainable for the majority of vendors given time to prepare. However, we expect to see some of the smaller vendors drop out of the pool because the development time and resources needed to bring their system up to the required standards will be cost-prohibitive. That being said, ONC has incorporated certain flexibilities as far as requirements for modules – for better or worse, the most significant being that privacy and security criteria are no longer required for modules.

Q: ICSA Labs made an announcement at this year’s mHealth Summit about a new partnership with IHE-USA and a Certification Track starting at the 2013 North American Connectathon. How does this new IHE-USA Certification program through ICSA Labs compare to the existing ONC 2014 edition program specifically?
It is important to make the distinction that IHE Certification through ICSA Labs is a completely separate and independent certification program that does not result in qualifying for federal incentives in the Meaningful Use Program. The new IHE certification program is voluntary, and is open to vendors who have registered for the 2013 North American Connectathon, and are committed to demonstrating that their products meet a higher bar than the baseline federal requirements. Hundreds of products have been certified to the Meaningful Use requirements to date, and in a way, ONC Certification can be seen as a cost of doing business today in the Health IT arena. This new certification will allow vendors to demonstrate additional and in some cases increased levels of functionality appropriate for the healthcare enterprise, for example using health information registries and repositories. Overall, we feel that this certification is complimentary to the ONC’s program, and builds upon the underpinnings of the standards named in the Final Rule.

Michelle Knighton, Healthcare Testing Manager, provides oversight of the entire healthcare testing division for health information technology at ICSA Labs.  Since 2009, she has focused on the testing and certification of electronic health records, both proprietary programs and those administered under the auspices of the Office of the National Coordinator (ONC) for Meaningful Use.