Drummond Group EHR Blog

Dear EHR Community,

Drummond Group, recently approved to test and certify 2014 Edition criteria by HHS’ Office of the National Coordinator for Health Information Technology  (ONC), is now providing electronic health records (EHR) software developers and vendors a Decision Guide to 2014 Edition that essentially bridges the knowledge gap between the ONC’s 2014 and 2011 Edition criteria. In essence, this new guide will help reduce the complexity of the decision-making process to meet Stage 2 Meaningful Use requirements, potentially leading to more expedient compliance with the 2014 Edition criteria for software vendors and improved readiness for their providers and hospital customers.

The Decision Guide to 2014 Edition includes three components:

• A Framework Document that helps software developers focus on the specific 2014 edition criteria, clinical quality measures (CQMs) and testing options that will best support customers. This document bridges the complexity gap between the ONC criteria and the necessary Meaningful Use measures.
• An optional Wave Testing Approach that enables vendors to incrementally test for various certification criteria in phases, instead of all at once. This approach helps bridge the marketing gap between testing and certification that enhances opportunities for early adopters by offering as many as three certification points.
• A Pre-Test Assessment Tool to gauge testing readiness. The assessment tool bridges the uncertainty gap between development and testing by helping the clients determine their preparedness which can lead to more successful test results.

“The complexity involved with testing and certifying for the ONC criteria with the different Meaningful Use choices is so large that it could easily overwhelm and discourage many vendors.  As a software certification body, we can’t make the requirements less demanding, but we can offer informative tools that make it possible for vendors to quickly gain much-needed insight into their certification needs and testing readiness,” says Kyle Meadors, Drummond Group’s Director of EHR Testing. “And, we can offer a software testing approach that makes the process more palatable for vendors. Having worked with hundreds of software vendors over the years, Drummond Group knows what the vendor is facing in software testing, certification, as well as product development and marketing. As such, we have a genuine understanding of the myriad of challenges that vendors face in preparing their customers for implementing Stage 2. We are confident that the Decision Guide to 2014 Edition can help organizations navigate the new requirements more successfully.”

Delivered as a “self-help” tool, the Decision Guide to 2014 Edition enables vendors to assess their current software development status as well as their customers’ needs to make the best choices for 2014 Edition criteria selection. The document specifically walks software developers through an EHR category decision tree that helps to determine if they should classify their solution as a complete EHR, or a variety of EHR modular options and describes the testing details.

While the Framework Document helps vendors zero in on important criteria, the Drummond Group Pre-Test Assessment Tool, along with access to the experienced Drummond Group test proctors, will allow vendors to gauge their product testing readiness. Once vendors understand where their product stands with respect to the testing requirements, they can consider the optional Wave Testing Approach which enables better test management by seeking certification for certain requirements in phases.  As such, vendors can demonstrate compliance while still working toward comprehensive certification. The approach meshes with typical software development efforts, making it possible for vendors to systematically move toward earning certification. Best of all, vendors can leverage the fact that their products are moving toward full certification in their marketing campaigns.

“With the Wave Testing Approach, we are offering vendors the ability to tackle the job in phases. As such, the whole process is more doable,” Meadors adds. “We know what software vendors are up against and that’s why we are presenting this optional Decision Guide to 2014 Edition that can help vendors easily move from where they are today to where they need to be to offer software solutions that can successfully be used in the government’s EHR adoption program.”

To receive the Decision Guide to 2014 Edition or to get additional information about Drummond Group’s Wave Testing Approach, please contact EHR@drummondgroup.com.

To achieve ONC approval for 2014 Edition testing and certification, Drummond Group was accredited by NIST’s NVLAP (200979-0) for their EHR Test Lab and by ANSI (1045) for their EHR Certification Body.

We appreciate your interest in our programs and look forward to working with you in 2013.

Sincerely,

Drummond Group Team

Dear EHR Community,

Drummond Group recently participated in a workshop sponsored by the Office of the National Coordinator for Health Information Technology (ONC-HIT) for ALL of the Authorized Test Labs (ATL) and Authorized Certification Bodies (ACB) to review the 2014 Edition Criteria, test procedures and test tools. The ONC draft test procedures have all been distributed for review, and ONC is in the process of reviewing the comments. On Nov. 13, ONC provided public webinars for review of the proposed test tools. The test procedures and test tools are expected to be finalized in December before the holiday break, hopefully this week.

The workshop was very informative, and we were very impressed with the detailed work that occurred to create the test procedures and test tools. It is clear that the complexity of testing the new 2014 Edition has significantly increased from the 2011 Edition.

Drummond Group continues to field questions about 2014 Edition testing and certification. We appreciate your continued interest in our upcoming program.  Here are some key points:

• It is anticipated that the opening date to begin testing and certification for 2014 Edition criteria is Jan. 2, 2013, pending accreditation and approval by ONC, ANSI and NVLAP. ATLs and ACBs will receive specific accreditation instructions from ANSI and NVLAP in December, and Drummond Group will be working diligently to attain approvals from both NVLAP and ANSI within the required deadlines to begin testing and certification on Jan. 2, 2013.
• Drummond Group will be announcing 2014 EHR Testing and Certification Program details during the week of Dec. 17.
• Drummond Group has built a series of customer support tools to help calm the complexity of 2014 Edition testing.
• In the ONC-HIT Certification program, companies now have a choice on where to test and/or certify your product. Drummond Group has now reviewed and certified more than 700 EHR products since opening our EHR doors in 2010.  Needless to say, the Drummond Certification Body, which is separate from our EHR Test Lab, has gained insight, knowledge and experience in the understanding of EHR healthcare products over this time.  We look forward to working with you in testing and certification in the new year.

• If you have specific questions on EHR 2014 Edition testing and/or certification, please call Tracy LaRue at 512-826-2938 or email TracyL@drummondgroup.com or EHR@drummondgroup.com.

We appreciate your interest in our programs and look forward to working with you in the new year!

Sincerely,

Drummond Group Team

ONC has now clarified that those two issues are being postponed until the testing and certification of the 2014 Edition criteria begins next year. Therefore, it will not impact any testing or certification for the 2011 Edition criteria.

You may find the ONC FAQ on this matter in Question 10-12-026-1 found on its FAQ site: http://www.healthit.gov/sites/default/files/pdf/onc-regulations-frequently-asked-questions.pdf

Thank you,

Drummond Group Inc.

Recently, the Office of the National Coordinator for Health Information Technology (ONC-HIT) released several waves of draft test procedures for the 2014 Edition criteria. You may find them here. Each wave will have a two-week comment period. We strongly encourage all vendors to review them and post any comments or suggestions to ONC via the ONC.Certification@hhs.gov email address. All submissions should include “Test Procedure” in the subject line.

Please bookmark this webpage and check back often over the next several months as more test procedures are released.

Drummond Certified™ Seals
In the ONC Final Rule for the 2014 Edition Criteria, ONC modified the certification seal text to be issued by certification bodies and displayed by vendors of certified products. It will no longer reference a calendar year; the certification seal text will now reference the specific certification criteria edition. For example, certifications issued after Oct. 4 for the current certification criteria will include the text: “This Complete EHR is 2011 Edition EHR certification criteria compliant…” The Drummond Group certification logo images will also be updated to reflect the new “2011 Edition” reference. However, ONC did clarify that current seals already issued are still valid and do not need to be updated. As ONC has noted, previous certifications remain valid until Dec. 31, 2013.

Although continuing to use the previously issued logos is perfectly acceptable and does not impact your certification standing, Drummond Group is offering any company with a certified product our new logo with the “2011 Edition” text. If your company’s product(s) were certified beginning in 2010 through present, and you would like to utilize the Drummond Certified “2011 Edition” seal in your marketing, including websites, internal pages, brochures, etc., please email Olga Finneran (olga@drummondgroup.com) and you’ll receive this seal in the design format specific to your products’ certification (modular; complete ambulatory or complete inpatient). Please reference your certified product and its ONC certification ID in your request. Please allow four weeks to receive the new logo.

Changes in the Permanent Program
Oct. 4 marked the beginning of the Permanent Program for the ONC HIT Certification Program. For vendors of EHR technology, there are two key changes which do impact the testing and certification of a product.

1)       Test reports will now be publicly viewable. The test reports describe the results, such as the modules a product successfully passed. However, they will NOT indicate any modules which failed.

2)       Marketing new products’ certifications must include language regarding price transparency. These are any additional types of costs that an EP, EH or CAH would pay to implement a complete EHR’s or EHR module’s capabilities in order to attempt to meet meaningful use objectives and measures. EHR technology self-developers are excluded from this requirement. These are the types of additional costs, but the actual dollar amounts will not have to be listed.

For example: An EHR technology is certified to the 304.g Timely Access certification criterion. However, EP must pay an “ongoing” monthly service fee to the EHR technology developer for it to host/administer this capability in order for the EP to meet the correlated MU objective and measure, the existence of this potential “ongoing” cost would need to be disclosed by the EHR technology developer. Therefore, an example of the price transparency language which must be included whenever the vendor markets its ONC certification status could be “This certified product-version may require ongoing monthly costs to support online patient service (170.304.g).”

This affects certifications issued to products for any certification request received ON OR AFTER Oct. 4. This is not required for previously issued certifications in the Temporary Program although we encourage vendors to begin including this language.

Again, Drummond Group plans to continue delivering updates on related critical information as it is released by the ONC. In the meantime, we appreciate your questions and look forward to continuing a relationship that will carry your product(s) successfully to the next phase.

Thank you,

Drummond Group Inc.

ONC’s draft test procedures for the 2014 Edition criteria

Today the Office of the National Coordinator for Health Information Technology (ONC-HIT) released its first wave of draft test procedures for the 2014 Edition criteria. You can find them here: http://www.healthit.gov/policy-researchers-implementers/2014-edition-draft-test-procedures

Each wave will have a two-week comment period. We strongly encourage all vendors to review them and post any comments or suggestions to ONC via the ONC.Certification@hhs.gov email address. All submissions should include “Test Procedure” in the subject line.

Please bookmark this webpage and check back often over the next several months as more test procedures are released.

Thank you,

Drummond Group Inc.

As you may already know, the ONC Final Rule for the 2014 Edition Criteria and the CMS Final Rule for Stage 2 has been released. Drummond Group is currently reading through and studying these rules as is everyone in the health IT industry. With this Stage 2 release, vendors naturally begin thinking about implications for testing and certification, as well as next steps, and we wanted to clarify some important tasks which still must occur before anyone can test and certify.

Before any testing on 2014 Edition may be done, two critical events must occur:

• ONC-approved test procedures have to be released. At the time of this writing, the test procedures have not been released publicly, even in a beta or draft form. If they are released as beta, which we believe is likely, then there will be a time for comments before they are finalized and approved. Only after they are approved, any NVLAP-accredited testing laboratories (such as Drummond Group) may use the test procedures in conjunction with ONC-ACB certification.
• The five current NVLAP-accredited testing laboratories must work with NVLAP to update our scope of accreditation to cover the new 2014 Edition Criteria. As are the other testing labs, Drummond Group is currently authorized by NVLAP for testing only the 2011 Edition Criteria. We will continue to work with them in the coming weeks to update our scope in order to include the 2014 Edition Criteria.

The bottom line is that testing for 2014 Edition is not starting tomorrow or next week. Just as vendors and providers are working to update their products and processes to support Stage 2, those organizations on the testing and certification side are doing the same. Once we have more details and specific timeframes, we will share these updates as soon as possible.

Thank you,

Drummond Group Inc.

Dear EHR Community,

Due to numerous questions Drummond Group has received, we reach out to you today in hopes that we may provide guidance in respect to the ONC Testing and Certification Program.

Regarding the ONC Permanent Testing and Certification program, Drummond Group has now been accredited by both ANSI and NVLAP in their quality assessments of our organization, and we are on track to be part of the ONC Permanent Testing and Certification Program as both a testing and certifying body.

As of this email’s publication, the Final Rule for the 2014 Edition Criteria and the Stage 2 Meaningful Use program has not been released. These rulings are keys to the next certification criteria’s requirements and timing. Like you, we have no exact details on when the rulings, or their content, will be released. The ONC has asked the ATCBs not to speculate on possible criteria or how testing and certification will be conducted. In addition, many vendors have asked how the Gap Certification will affect their product, but until the Final Rule is released, Drummond Group is unable to comment.

It is anticipated that upon the release of the Final Rule, ONC will announce new test procedures for the 2014 Edition criteria. These test procedures will serve as the foundation for our test proctor sheets and describe the specific testing requirements expected from the EHR technology. We just want to confirm with you that these procedures are not yet available, but we will notify you as soon as they are.

In staff news, Drummond Group welcomes Tracy LaRue (Email: TracyL@drummondgroup.com) as our Client Services Coordinator where she assumes the role previously held by Joani Hughes, who is no longer with the company.

Again, although we are all in a “waiting” period, Drummond Group believes it is appropriate to contact our community and provide assurance regarding current status. We plan to continue delivering updates on related critical information as it is released by the ONC. In the meantime, we appreciate your questions and look forward to continuing a relationship that will carry your product(s) successfully to the next phase.

Thank you,

Drummond Group Inc.

EHR@drummondgroup.com

Drummond Group was recently accredited by ACLASS for our electronic health records (EHR) test lab. Using the international standard of ISO 17025, ACLASS reviewed the quality system of our EHR test lab and confirmed it met the stringent requirements of this specification. ISO 17025 requires testing laboratories to implement and utilize procedures and policies, such as standardized training methods, consistent test procedures and the employment of competent technical personnel, to perform their test services. This accreditation ensures our test lab is performing high quality testing work within our EHR testing.

This accreditation is separate from the ONC requirements of accreditation by NVLAP in order to be a testing laboratory within the ONC Permanent Testing Program. Drummond Group submitted an application to NVLAP in early January 2012 for accreditation for the ONC Permanent Testing Program, and we will be in the first round of on-site accreditation assessments.

Drummond Group chose to pursue 17025 accreditation from ACLASS because of our commitment to producing the highest quality work in the area of health IT testing. We do not view accreditation as simply an extra exercise to complete and then move forward. We recognize it is an excellent means to validate our quality systems in our efforts for continuous improvement.

A 17025 accreditation involves submitting a quality manual along with associated documentation to an accreditor. The accreditor then makes an on-site visit to ask questions, review past testing records and observe actual testing events. Any deficiencies or non-conformities are documented and must be successfully addressed before the accreditor reconvenes and makes a final assessment.

Frankly, it was not an easy process due to the detail of documentation necessary, but we ultimately found it a very beneficial endeavor. Drummond Group will continue moving forward toward maintaining a high quality test laboratory, working with NVLAP to receive our accreditation and becoming a part of the ONC Permanent Program.

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.