Drummond Group Inc. EHR Certification Guide January 9, 2013 Page 1 of 11
Section One. Overview of the Drummond Group EHR Certification Program ONC Authorized Certification Body: Drummond Group Inc. Drummond Group Inc.(DGI), now approved for 2011 Edition and 2014 Edition, has been accredited by Health and Human Services and American National Standards Institute (ANSI) as a certification body for the Office of the National Coordinator (ONC) Health Information Technology (HIT) Certification Program. Also, Drummond Group has been accredited by the National Voluntary Laboratory Accreditation Program (NVLAP, NVLAP Lab Code: 200979-0) of the National Institute of Standards and Technology (NIST) to test electronic health record (EHR) technology under the auspices of the ONC-HIT. Drummond Group s accredited EHR Certification Body has certified over 700 EHR products under the temporary program. Products certified by Drummond Group can be used by eligible providers and hospitals as part of their criteria for qualifying for Center for Medicare and Medicaid Services (CMS) incentive payments. This guide covers information related to Drummond Group s EHR certification services. For more information on Drummond Group s testing services, please see the EHR Testing Guide. Companies now have a choice in the Permanent Program. You have the choice to register for Drummond Group Testing and Certification, Certification only or Testing only. For those choosing Testing and Certification, Drummond Group offers: * continuity of care between the Drummond Test Lab and the Drummond Certification Body *familiarity with the same knowledgeable, customer-friendly people you have worked with over the years *discounts when choosing BOTH to test and certify with us, along with other Drummond certification services such as EPCS certification *and the assurance of The Drummond Difference In the permanent program, companies can now move their certification to another Certification Body. If your product was tested and certified by an ATCB (Authorized Testing and Certification Body) during the temporary program, you can now move your testing to any other ATL (Accredited Test Lab) of your liking. Likewise you can test with one ATL and certify with any ACB that you choose. Drummond Group is ONC approved and ANSI accredited for certifying all 2014 Edition criteria, either as a complete or modular Inpatient or Ambulatory product, for the Office of the National Coordinator HIT Certification Program. Drummond s Decision Guide to 2014 Testing and Certification. Please note that the complexity of certification choices have significantly increased with 2014 Edition. Drummond Group s Decision Guide to 2014 Edition essentially bridges the knowledge gap between the new ONC 2014 Edition criteria and its current 2011 Edition criteria which can reduce the Page 2 of 11
complexity of the decision-making process to meet Stage 2 Meaningful Use. To receive a copy of this Guide which includes pricing, please contact Client Services by sending email to EHR@drummondgroup.com. Section Two. Certification Procedure Roles and Responsibilities Drummond Group is an ANSI-accredited Authorized Certification Body (ONC-ACB) and also serves as an independent certification committee comprised of its employees designated within the corporate structure. The Drummond Certification Body is organizationally structured for impartiality, efficiency and objectivity to be maintained in all matters pertaining to certification criteria adopted by the Secretary at 45 CFR 170 subpart C. This Certification Body is regularly evaluated and audited on its ability to assure impartiality and objectivity in its practices, decision-making and authority in all matters related to certification through its implemented quality system. If your company was tested by the Drummond Group EHR ATL (Accredited Test Lab), and your company has chosen to use Drummond Group certification services, upon test completion your test report will be submitted to Drummond Group s ONC-ACB. If your company was tested by another Accredited Test Lab (ATL) and chooses to certify with Drummond s ACB, your company will need to register for Certification ONLY. Within 10-15 business days of receipt of the registration form for Certification ONLY or completed test report from Drummond EHR Test Lab, the Drummond Group Certification Committee will review the test results. The following decision options include: Passing. The Drummond Group Certification Committee has up to 15 business days to review and approve/fail the test results. In order to receive a Certificate of EHR Compliance from Drummond Group: * company must successfully complete the registered EHR testing * testing is reviewed and approved by Drummond Group Certification Committee * final payment from the test applicant must be received by Drummond Group Upon certification: the now certified product/ company will receive a Letter of Passing from Drummond Group which details the required maintenance of the product certification, the now certified product/ company will receive a Certificate of Compliance which can be utilized in marketing your certification, the now certified product / company will receive a Drummond Certified seal that may be used on the vendor s website home page, internal product description pages, press releases or other marketing materials Drummond Group will notify ONC of the product s certification status. Drummond Group s Marketing Coordinator will schedule an optional phone call and review the responsibilities of certification with the primary contact on the registration form and answer any questions. Page 3 of 11
EHR Certification Guide Final Test Report will be posted in accordance with ONC requirements Please note that the website listings on the ONC website and the Drummond Group website for the specific certified company name with product with version number will also be updated. Please allow up to 10 business days [business days are measured from date of approval by the certification committee] for the product to be listed on both websites. Failure. A product may fail some modules yet still pass and receive certification for the remaining modules. Modifying Certified Products. A previously certified Complete EHR or EHR Module may be updated for routine maintenance or to include new features that affect capabilities both related and unrelated to the certification criteria adopted by the Secretary without its certification becoming invalid. If changes are made to your certified product, you will be required to do the following: 1. Click on this link http://www.drummondgroup.com/html-v2/ehr/ehr-register.html and follow the steps to select Modified Certified Products Attestation 2. complete the contact information section 3. describe the specific changes that were made to the certified product 4. describe the reasons for those changes 5. describe whether your development team believes this affects your previous certification and other such information and include supporting documentation that would be necessary to properly assess the potential effects the new version would have on previously certified capabilities Please note: if there is additional information besides text that needs to be reviewed by our team, please send an email to EHR@drummondgroup.com and we will set up a conference call as well as a website for you to directly upload information. Upon receipt of the information, Drummond Group will determine whether the updates and/or modifications are such that the new version would adversely affect previously certified capabilities and therefore need to be retested and recertified, or whether to grant certified status to the new version derived from the previously certified Complete EHR or EHR Module. Please note that ONE attestation review is free, additional attestation reviews do have a fee. If the attestation results in additional testing, the testing will be done at an additional fee. In such cases where testing is required the attestation fee will be waived and replaced by the normal testing and certification fee. Certified Products Reseller Policy Companies that have certified a product with Drummond Group are allowed to resell that product through resellers by submitting a letter jointly signed by the original manufacturer and the reseller that confirms the relationship, that both agree to maintain the ONC-ACB certification rules, and that changes are not allowed by the reseller. The specific requirements for this letter and the agreement may be obtained by sending an email to EHR@drummondgroup.com. Page 4 of 11
The letter must be jointly signed by the original manufacturer and all resellers and dated and sent in written form to Drummond Group s offices at: Drummond Group Inc. Attn: Reseller Agreement 13359 North Hwy 183, Ste B-406-238 Austin, TX 78750 Section Three. Scheduling Testing, Steps to Apply, and Test Pricing Drummond Group s accredited EHR ONC-ACB has certified over 700 EHR products under the temporary program. Products certified by Drummond Group can be used by eligible providers and hospitals as part of their criteria for qualifying for Center for Medicare and Medicaid Services (CMS) incentive payments. Companies now have a choice in the Permanent Program. You have the choice to register for Drummond Group Testing and Certification, Certification only or Testing only. For those choosing Testing and Certification, Drummond Group offers: * continuity of care between the Drummond Test Lab and the Drummond Certification Body *familiarity with the same knowledgeable, customer-friendly people you have worked with over the years *discounts when choosing BOTH to test and certify with us, along with other Drummond certification services such as EPCS certification *and the assurance of The Drummond Difference In the permanent program, companies can now move their testing and certifications to another ONC approved testing lab/certification body. For instance, if your product was tested and certified by an ATCB (Authorized Testing and Certification Body) during the temporary program, you can now move your testing and/or certification to any other ATL and ACB of your liking. How to Apply and Schedule Certification With all the choices, if you need help with questions along the way, please send an email to EHR@drummondgroup.com or phone: 512-826-2938. For Testing and Certification: If you want to test and certify with Drummond, you can easily register for both on the same form. The details for testing with Drummond are outlined in the EHR Testing Guide. Page 5 of 11
Certification ONLY: Step One. For EHR Modular certification, fill out this EHR registration form. EHR Certification Guide For EHR Complete certification, fill out this EHR registration form. Please remember to include the correct product name with version with release number on the application form. This information will be used in the certification process. Step Two. Confirmation. You will receive a confirmation email from Drummond Group including: the Master Services Agreement, Pre-Certification Survey, Gap Certification Inheritance Form, Pricing Transparency Attestation (For Certifying 2014 Edition ONLY), Product Name Form and a request for an ATL approved Final Test Report, if you are requesting Certification only. Please note that to enter your product for review by the Drummond Group Certification Committee you must submit a completed Master Services Agreement and make arrangements for payment as outlined below. Master Services Agreement [which may also be referred to as the Terms of Agreement]. Also within that email, Drummond Group will provide the applicant the DGI Master Services Agreement for EHR Certification. The applicant must provide a signature on our Master Services Agreement and return the form within 10 business days via email or fax to Bill Smith, CFO. Failure to return the signed Master Services Agreement within the required timeframe will result in losing the original test date you have scheduled. Questions? email: Bill@drummondgroup.com fax: 817-294-7950 Product Name Form. Participants will receive this document in the confirmation of test registration introductory email. You must complete this form with your company name and product name as you would like it listed on our website as well as on the CHPL listing. It is imperative that this information is listed correctly; therefore, we require a signature from a senior management member of your team. This form must be received prior to your product(s) being submitted for review by the certification committee. Price Transparency Attestation. Starting with certifications for products tested under the 2014 Edition criteria, your company will need to submit an attestation. In this attestation, the organization must describe the price transparency language they will use for their productversion. The Drummond Group ONC-ACB must have this information prior to issuing a certification. For more information on Price Transparency see Section Four: Maintaining your Product Certification. Gap Certification Inheritance Form - If you tested and certified your product under the 2011 Edition certification criteria, some of your criteria may be eligible for Gap Certification. Please review the form and fill out accordingly. If you have further questions, please contact Page 6 of 11
Drummond Group at 512-826-2938. If you are currently certified to 2014 Edition criteria, please ignore this form. Step Three. Payment. 50% of Payment must be received at least 2 weeks before the test and the balance must be received immediately after the test event and prior to the scheduled certification committee meeting. Pricing Please contact Client Services for pricing list. Send email to EHR@drummondgroup.com or phone 512-826-2938. EPCS Certification. The U.S. Drug Enforcement Administration (DEA) has approved Drummond Group's e-prescribing of Controlled Substances (EPCS) Certification Process. DGI is now providing EPCS certification to healthcare software companies with the capability of e- Prescribing controlled substances. For customers who test EHR and EPCS and have not integrated an existing EPCS module, please ask about bundled discounts. Remember to ask about these when discussing your registration. Section Four. Maintaining Your Product Certification HHS/ONC Rules for Maintaining Certification and Rules for Surveillance: If testing 2011 Edition, Participant agrees and acknowledges that the Certificate of EHR Compliance for 2011 Edition is active through the end of fiscal year (inpatient) or calendar year (ambulatory) (FY/CY) 2013. If testing 2014 Edition, Participant agrees and acknowledges that the Certificate of EHR Compliance for 2014 Edition is valid until ONC updates the certification criteria. At the end of this period, the participant must certify on the next ONC-approved certification criteria or Participant will no longer be able to satisfy the definition of certified EHR technology because the Secretary of the U.S. Department of Health and Human Services (HHS) has changed the certification requirements. Per the rules set forth by the HHS Secretary, Participant further agrees to furnish periodic attestations signed by an authorized senior executive regarding the status of the certified product and to be subject to unannounced product audits and reviews which may be conducted at the discretion of DGI as directed by ONC. Refer to the DGI EHR Certification Guide for more details. Rules for Modifying Certified Products: Participant agrees and acknowledges that a previously certified Complete EHR or EHR Module may be updated for routine maintenance or to include new features that affect capabilities both related and unrelated to the certification criteria adopted by the HHS Secretary without its certification becoming invalid. If major or minor changes are made to the Drummond Certified EHR product, you must submit to Drummond Group an approved Drummond Group attestation document indicating the changes Page 7 of 11
that were made, the reasons for those changes, and a statement from your development team as to whether these changes do or do not affect your previous certification, and other such information and supporting documentation that would be necessary to properly assess the potential effects the new version would have on previously certified capabilities. Routine software maintenance changes do not require attestation unless the maintenance changes potentially affect the certified criteria. Upon receipt of the attestation, Drummond Group will determine whether the updates and/or modifications are such that the new version would adversely affect previously certified capabilities and therefore need to be retested and recertified, or whether to grant certified status to the new version derived from the previously certified Complete EHR or EHR Module. Attestation. As product changes are attested, the certification committee has the ability to review and randomly audit test those being reviewed per the signed Master Services Agreement. The product is tested using the same test criteria approved for the random audits and documented. Fees for Re-testing: As published in the EHR Testing Guide and this EHR Certification Guide on the DGI website. Price Transparency: Starting with certifications for products tested under the 2014 Edition criteria, your company will need to submit an attestation. In this attestation, the organization must describe the price transparency language they will use for their product-version. The Drummond Group ONC-ACB must have this information prior to issuing a certification. Regulation 170.523(k)(1)(iii) states that a Complete EHR or EHR Module developer must conspicuously include the following on its Web site and in all marketing materials, communications statements, and other assertions related to the Complete EHR or EHR Module s certification: Any additional types of costs that an EP, EH, or CAH would pay to implement the 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. In the Final Rule, ONC clarified that these types of costs are in addition to those costs that an EP, EH, or CAH would pay to purchase (or upgrade to) the EHR technology capabilities for which certification is required. These may be one-time or recurring costs, or both. They also clarified that ONC-ACBs would only be required to ensure that EHR technology developers disclose the types of additional costs, and not the actual dollar amounts of such costs. Certification Adherence: Upon certification, if testing 2011 Edition, Participant agrees and acknowledges that the Certificate of EHR Compliance for 2011 Edition is active through the end of fiscal year (inpatient) or calendar year (ambulatory) (FY/CY) 2013. If testing 2014 Edition, Participant agrees and acknowledges that the Certificate of EHR Compliance for 2014 Edition is valid until ONC updates the certification criteria. The Participant agrees that during their certification period that they must conspicuously include the following text on its website Page 8 of 11
and in all marketing materials, communications statements, and other assertions related to the Complete EHR or EHR Module s certification: This [Complete EHR or EHR Module] is (specify the edition of Certification criteria 2011 Edition or 2014 Edition) compliant and has been certified by an ONC ACB in accordance with the applicable certification criteria adopted by the Secretary of the U.S. Department of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments. And include: Vendor name, Date Certified, Product Version, Criteria Certified, Certification ID Number, Clinical Quality Measures Certified, any additional software relied upon to certify, and list the certification criteria which has been tested and certified. THIS YELLOW HIGHLIGHTED SECTION MUST BE FILLED IN WITH INFO FOUND ON THE CERTIFICATE OF COMPLIANCE.) [IF TESTING 2014 Edition Only] And include Price Transparency: Any additional types of costs that an EP, EH, or CAH would pay to implement the 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. THIS GREEN HIGHLIGHTED SECTION MUST BE USED WITH YOUR ONC MARKETING. *A certification that is issued to an integrated bundle of EHR Modules shall be treated the same as a certification issued to a Complete EHR except that it must also indicate each EHR Module that comprises the bundle; *A certification issued to a Complete EHR or EHR Module based on applicable certification criteria adopted by the Secretary at subpart C of this part must be separate and distinct from any other certification(s) based on other criteria or requirements. Complaints to Suppliers: Drummond Group requires that your company keep a record of all complaints made known to your company that relate to your product s compliance with the criteria set forth by the HHS Secretary and the resulting certification by Drummond Group. We ask that you provide any complaints to us via email as they are received. Send the complaints with customer contact information to EHR@drummondgroup.com. Drummond Certified EHR Surveillance In the Office of the National Coordinator HIT Certification Program, the surveillance effort of Drummond Group s ACB is closely monitored by the ONC and ANSI to ensure that products are maintaining their certification over time. The time and effort for surveillance has significantly increased in the permanent program and therefore the resulting costs to the customer have increased for certification. Surveillance ensures confidence that Drummond Certified products continue to comply with the criteria to which they were certified. Each customer signs a Page 9 of 11
Drummond Group Master Services Agreement that includes a surveillance section which requires a variety of items related to surveillance activities. Marketing Guidelines for Use of Drummond Group's EHR Certificate of Compliance The Certificate of Compliance and the Seal are provided by Drummond Group Inc. (DGI) to software solutions which have been certified by the Drummond Group's ONC-ACB Certified program for Electronic Health Records (EHR). Companies that have certified software solutions are given a Certificate of EHR Compliance and may use the Certificate and Seal in print ads, company communications, sales materials and related promotional items targeted to reach customers. It displays to potential partners, customers and competitors that a company s solutions are compliant with the certification criteria and has been listed on the Office of the National Coordinator (ONC) Certified Health IT Product Listing (CHPL) which ensures that it is eligible for CMS incentives. Please note that public display of the Drummond Certified EHR seal, Drummond Group Logo or Certificate of Compliance does not replace ONC-required marketing language detailed in the Surveillance section above. Please review the Drummond Certificate of Compliance and Marks Guidelines document for more details on rules for usage. This document is issued upon certification and can be requested by sending an email to EHR@drummondgroup.com. Complaints to Suppliers Drummond Group requires that your company keep a record of all complaints made known to your company that relate to your product s compliance with the criteria set forth by the HHS Secretary and the resulting certification by Drummond Group. We require that you provide these complaints to us via email as you receive them. This information is important to us and to ONC. All complaints will become part of our due diligence for continued process improvement and will be forwarded on to ONC to ensure the overall confidence in the ONC-ACB Program. Please forward any said complaints to EHR@drummondgroup.com. Appeals, Complaints and Disputes All appeals, complaints and disputes should be submitted to EHR@drummondgroup.com or discussed with your DGI contact. Please outline the nature and severity of the problem. Appeals 1. DGI shall, independent of the test proctor and through executive management, conduct a complete and thorough investigation of the issue by interviewing all personnel and examining all data relevant to the appeal. 2. The company will receive a formal response summarizing the findings and setting forth the determination with respect to the appeal. Page 10 of 11
3. If the issue is not resolved, they may respond in writing with an additional request for review. This request must stipulate specific objections to the findings and an explanation as to why those findings are deemed to be incorrect. 4. The additional request will be reviewed by executive management and a thorough investigation will be conducted per the new objections. A letter of resolution will be issued. If this letter of resolution does not resolve the issue, the companies, DGI being represented by executive management, shall engage in good faith negotiations for a period of time not to exceed thirty days in order to resolve the issue. If, after that period of time, the issue cannot be resolved to the mutual satisfaction of the parties (unless negotiation period is extended by mutual consent) the issue shall be settled exclusively by mediation as set forth in the Master Services Agreement Complaints 1. DGI shall, independent of the subject of the complaint and through executive management, conduct a complete and thorough investigation of the issue by interviewing all personnel and examining all data relevant to the complaint 2. The company will receive a formal response summarizing the findings and setting forth the determination, or corrective action, with respect to the complaint. 3. If the issue is not resolved, they may respond in writing with an additional request for review. This request must stipulate specific objections to the findings and an explanation as to why those findings are deemed to be unsatisfactory. 4. The additional request will be reviewed by executive management and a thorough investigation will be conducted per the new objections. A letter of resolution will be issued. If this letter of resolution does not resolve the issue, the companies, DGI being represented by executive management, shall engage in good faith negotiations for a period of time not to exceed thirty days in order to resolve the issue. If, after that period of time, the issue cannot be resolved to the mutual satisfaction of the parties (unless negotiation period is extended by mutual consent) the issue shall be settled exclusively by mediation as set forth in the Master Services Agreement Disputes 1. DGI shall, through executive management, conduct a complete and thorough investigation of the issue by interviewing all personnel and examining all data relevant to the dispute. 2. The company will receive a formal response summarizing the findings and setting forth the determination with respect to the dispute. 3. If the issue is not resolved, they may respond in writing with an additional request for review. This request must stipulate specific objections to the findings and an explanation as to why those findings are deemed to be incorrect. 4. The additional request will be reviewed by executive management and a thorough investigation will be conducted per the new objections. A letter of resolution will be issued. If this letter of resolution does not resolve the issue, the companies, DGI being represented by executive management, shall engage in good faith negotiations for a period of time not to exceed thirty days in order to resolve the issue. If, after that period of time, the issue cannot be resolved to the mutual satisfaction of the parties (unless negotiation period is extended by mutual consent) the issue shall be settled exclusively by mediation as set forth in the Master Services Agreement. END OF DOCUMENT Page 11 of 11