AUSTIN, TX– Oct. 19, 2011–Drummond Group Inc. (DGI), the trusted interoperability test lab, last week submitted to the DEA its e-Prescribing of Controlled Substances (ePCS) Certification Process documentation. The DEA is currently reviewing this ePCS Certification Process for approval. Upon approval, DGI will be providing ePCS certification to healthcare software companies with the capability of e-Prescribing controlled substances.
Since 2005, Drummond Group has been the lead auditor and certification organization for the DEA’s final rule regulations on the Controlled Substance Ordering System (CSOS). CSOS enables drug manufacturers, distributors and pharmacies to electronically automate the order and fulfillment supply chain of controlled substances. Drummond Group also serves as an Authorized Testing and Certification Body (ATCB) under the Health and Human Services’ (HHS) electronic health records (EHR) certification program and has certified more than 450 software applications, including e-Prescribing solutions, since its inception in 2010.
For complete press release, please click here.
Last month, Steven Posnack, director of the Federal Policy Division within the Office of the National Coordinator for Health (ONC), wrote a very helpful blog on fact and fiction related to the ONC certification program. We have recently had many questions related to Drummond Group’s involvement in the ONC Permanent Certification program and related certification. Here is our own QA session for questions and how that affects certification from the current Temporary Program.
Question: What is difference between the Permanent Certification Program and the Temporary Certification Program? What about ATCBs and ACBs? Is ANSI now involved in certification?
Answer: The Temporary Certification Program and the Permanent Certification Program are ultimately about the governance of the testing and certification program, specifically, the bodies that are testing and certifying, like Drummond Group. Their work and requirements are, in most ways, outside the concern of EHR vendors and HIT users. Meaningful Use measures and ONC certification criteria are completely separate from the Final Rules governing both certification programs.
The requirements within both programs are very similar. The chief difference is the accreditation method. In the Temporary Program, an organization like Drummond Group was required to take comprehensive tests and submit two sets of quality manuals: 1) for testing plans and processes and 2) for our certification processes. These were approved by ONC itself to be accredited as an ONC Authorized Testing and Certification Body (ATCB). In the Permanent Program, ONC is no longer acting as the accreditation body of either testing or certification although they will still oversee the program. Instead, there is a new ONC-Approved Accreditors (ONC-AA), ANSI, who will do the accreditation for the certification bodies as an ONC-Authorized Certification Body (ACB), and NVLAP, a division of NIST, will run the accreditation program for the testing bodies.
Question: Will Drummond Group be a part of the Permanent Certification Program? Will you also do testing?
Answer: Drummond Group’s intention is to be an ACB (Authorized Certification Body), as well as an NVLAP accredited testing body for EHRs. We are currently working on preparations for approval in the Permanent Program.
Question: When will Drummond Group or others be named as ACBs? Do you have a timeframe?
Answer: We are really hesitant to even speculate on a specific date when ACBs will be open for business given there are many unknowns. Here is what we do know: NIST will be releasing the final testing accreditation requirements for testing agencies around December and will begin processing the applications on Jan. 15, 2012. We have no word from ANSI or ONC on details for applying to become an ACB, nor additional certification body accreditation requirements apart from the core ISO Guide 65.
Also, accreditation is just the first step. Only after you are accredited by ANSI for your certification quality procedures can you submit your application to ONC to be a part of the Permanent Certification program. In the Temporary Program, the submission to ONC to be an ATCB until official approval was a process that took approximately two months.
Question: Will there be new criteria to test and certify in the Permanent Program and will certified EHRs have to return and be recertified with an ACB to remain on the CHPL?
Answer: As stated above, the Temporary and Permanent Program Final Rules are ultimately about the governance of the testing and certification program but not about the criteria which the ATCBs or ACBs will certify. The testing requirements and certification criteria come from ONC separate from anything to do with the current state of the certification program.
Even in the Temporary Program, ONC could revise and update the certification criteria requiring products to be retested and recertified. In fact, they actually did make a revision to the public health surveillance criteria (170.302.l) in an interim rule in October 2010 although it did not require recertification. Eventually, the criteria will be updated when new meaningful use stages are introduced, but that is not connected with the timing or availability of the Permanent Program. Also, certified EHRs will not need to be recertified by an ACB simply because the ATCBs are dissolved with the closing of the Temporary Program.
Question: Once we are in the Permanent Program and new criteria are introduced, such as with Meaningful Use Stage 2, will certified EHRs to have to retest everything previously tested and certified in the temporary program?
Answer: On retesting previously certified criteria, the Permanent Program Final Rule does make a reference to allowing for “gap” certification of new or revised criteria added in later stages versus fully recertifying and retesting all criteria, including those unchanged from previous ONC rulings. However, it ultimately leaves this to the decision of the ACB. We (Drummond Group or any other ATCB) cannot speak definitely on this until we are an ACB and receive further guidance from ONC and possibly ANSI, which is the selected ONC-AA who will accredit us.
Question: In his blog, Steven Posnack stated that current CHPL certification will not expire. However, the certification seals issued in the Temporary Program make reference to 2011/2012. What does that mean?
Answer: Those 2011/2012 Certification Seal dates come from the ONC Final Rule on the Temporary Program, but they are not explicit expirations. Rather, they reflect what was anticipated as the timeline of the criteria and associated Stage 1 Meaningful Use measures.
It ultimately depends upon the current module criteria requirements. If they are not updated, then the certification is still valid.
As a testing company with more than a decade’s worth of experience, we’ve certified many software products across multiple industries. In the process, we’ve worked with quite a few certification and standards-setting bodies.
For the past several months, we’ve been busy in the healthcare industry, working under the auspices of the government’s electronic health records incentive program. As a matter of fact, since becoming an Authorized Testing and Certification Body (ATCB), we’ve certified more than 300 electronic health records systems using a testing script developed by National Institute of Standards and Technology (NIST) for the Office of the National Coordinator for Healthcare Information Technology (ONC-HIT).
Although we’ve tested systems for a variety of standards-setting groups, we weren’t quite sure what to expect when we started working as a testing company under the purview of the Health Information Technology for Economic and Clinical Health (HITECH) legislation – a behemoth government program to say the least.
Much to our delight: We’re really happy with the way things are going so far.
Why? First, we think the leaders in the government program got it right. The powers-that-be managed to develop clear technical requirements without imposing restrictive implementation methods, making it possible to ensure that certified EHRs all perform at a certain level, but also leaving enough flexibility for EHRs to meet specific user needs and for developers to continue to innovate. It’s a tricky balance but one that the ONC seems to have mastered quite well.
As a result, there’s plenty of room for developers to come up with products that push the envelope with new features and functions or to tailor systems to meet the very specific needs of certain specialists such as OB-GYNs, chiropractors or plastic surgeons. At the same time, end-users can rest easy, knowing that software systems that have been certified actually live up to the specifications that will make it possible for them to meet the government’s meaningful use requirements and, subsequently, qualify for their share of the federal government’s incentive funds.
We’re also happy with our work in the program. We feel that Drummond Group has been able to add value to the overall process by infusing a healthy dose of neutrality into the testing and certification process. Steadfastly maintaining neutrality has, after all, been a concept that we have built our company on since the beginning.
Although happy to be a member of the healthcare IT community, we purposely shy away from becoming deeply involved in professional coalitions or advocacy efforts. As such, when we test a product, we test a product. We don’t have to worry about the fact that an industry coalition spoke out against one of the ONC test requirements because our neutrality would keep us apart.
In essence, we make sure we don’t attach to anything else, so that the only thing we are attached to is testing. It’s a singular focus that serves software developers and the overall mission of the HITECH program well.
It’s complicated. That’s how many hospital leaders describe their electronic health records initiatives. These hospitals – instead of having a neat all-in-one EHR solution driving their efforts – have moved toward electronic records by cobbling together a variety of off-the-shelf, customized and possibly even home-grown solutions.
If you work at one of these facilities, you are probably all too familiar with the complications. And, when it comes time to get the stamp of approval needed to qualify for incentive funds, you probably don’t know exactly where to start. No worries. Drummond Group is ready to help. We’re taking applications from hospitals that want to achieve ONC-ATCB 2011/2012 certification for their unique EHR solutions. We stand ready to help hospitals in this situation move forward by testing their solutions to gain the certification required to move toward meaningful use.
Best of all, though, we are gearing up to truly offer more than a cursory certification. With more than 10 years of software testing experience, we have the interoperability know-how that you can tap into to truly get your miscellaneous solutions working together as one unified EHR. Having worked in a variety of complicated industries, we have encountered many difficult software and integration testing scenarios – and have had to evaluate a wide variety of software configurations from the simplest, out-of-the-box applications to complicated solutions derived from a variety of cobbled-together software applications.
What’s more, we are truly committed to meeting the specific needs of healthcare providers. We are presently answering inquiries with hospitals and working on setting up certifications for them. And, while we are ready to start working with you today to qualify your customized or home-grown system for certification, we plan on rolling all of our know-how up into a formal service offering early next year.
Remember, though, to achieve ONC-ATCB 2011/2012 certification, EHR software has to be tested based on the official criteria as defined by ONC. Authorized Testing and Certification Bodies (ATCBs) test and certify the software and then HHS approves and lists these certifications on the Certified Health IT Products Listing (CHPL). Customized programs for hospitals or specific specialties – while designed to help meet the unique needs of various classes of HIT vendors — are not required for the certification that will enable your organization to meet meaningful use incentives.
We’re often asked why we jumped into the healthcare industry. Our answer: It’s simple Business 101 logic. We saw a need and we knew we could fill it.
First, we started hearing from healthcare information technology vendors about the need for software testing. We investigated and discovered that the Department of Health and Human Services (HHC) Office of the National Coordinator (ONC) for Health Information Technology was recruiting organizations to serve as Authorized Testing and Certification Bodies (ATCBs) to provide the stamp of approval to electronic health records (EHRs) that would be used by healthcare provider organizations as they seek to qualify for incentive funds under the American Recovery and Reinvestment Act.
All of this opportunity, of course, piqued our interest. Realizing that we really had something special to offer the healthcare industry, however, made us take the plunge.
Most importantly, we felt that we could offer the efficient and effective software testing that the industry needs –as vendors are scrambling to meet the needs of providers with officially certified EHR solutions. Because we have tested complex software products in a plethora of industries for more than a decade, we have what it takes to get the job done. As a result, vendors can quickly and affordably get their EHR solutions listed on the Certified Health IT Products Listing (CHPL) – and providers can use the solutions to qualify for incentive monies.
Our vision extends beyond the short-term, though. We also realized that we could offer healthcare information technology companies the testing services that they will need as meaningful use requirements evolve—and become more complex. Because of our extensive testing experience, we have become experts in interoperability and privacy issues. Also, we feel that we will be able to help healthcare IT vendors with these issues as meaningful use evolves.
Drummond Group’s ONC-ATCB Certified EHR products have now been posted on the HHS Certified Health IT Products Listing.
Problems viewing the HHS Certified Health IT Products Listing?
Home page of healthit.hhs.gov and look under “What’s New”
Questions? Shoot us an email at EHR@drummondgroup.com