Q: What do I need to do to be a complete certified product?
A: For 2015 Edition Certification, ONC has dropped the ‘complete’ certification designation, so all products certified will be called certified modules. ONC has also dropped the ‘ambulatory’ and ‘inpatient’ domain designations. You will need to identify what scope (ie criteria) you want your product certified to. You can select from the ONC Test Methods at https://www.healthit.gov/policy-researchers-implementers/testing-and-test-methods

Q: How do I know what the minimum is to get certified?
A: The overall testing scope will highly depend on what your customers need in order to attest. Per the ONC Final Rule, 170.315(g)(4) Quality Management System and 170.315(g)(5) Accessibility centered design are required with every certification. There are many other “conditional requirements. We recommend first reaching out to your customers, and secondly, that you let SLI Compliance help you understand what may be in or out of scope for your system.

Q: What do I need to do for the new disclosure requirements?
A: New disclosure requirements have recently gone into effect that require developers of certified Health IT Modules to submit additional information before a product’s certification can be granted. Certified health IT developers must conspicuously disclose in plain language on their website, in all marketing materials, communication statements, and other assertions related to certified health IT all of the ONC required information, for every Certified Product. This will include providing a publicly accessible URL on your web site where other additional information is required to be listed. In addition, on a quarterly basis each calendar year, certified health IT developers must submit a record of all adaptations of the certified module, all updates made that affect safety enhanced design and all complaints related to the certified product functionality to the certification body. SLI Compliance will provide documentation that provides guidance to the vendor.

Q: What is the minimum requirement for CQMs?
A: There are no minimum requirements for number of CQMs as defined in ONC 2015 Edition final rule. It is recommended that you research the incentive program(s) requirements (ie, MU, MIPS, etc.) that may apply to your customers in order to identify any specific CQMs needed for testing.

Q: Does every test procedure have different standards?
A: No. Some test procedures do not have a required standard. Some standards are required across multiple test procedures, i.e. HL7 IG for CDA R 2: Consolidated CDA Templates for Clinical Notes is required for multiple test procedures. See individual sections of each test procedure to review standards required.

Q: What does Gap Certification mean?
A: A product that has been previously certified to certain 2014 test procedures may be eligible for gap certification. The developer may attest through documentation that the software was previously certified to certain 2014 criteria, and the functionality has not changed for the gap eligible functionality since the software was previously certified. The proctor will review the documentation and confirm the certified software id on the CHPL. If no programming changes were made to the software functions covering gap eligible test procedures previously certified, then certain 2015 test procedures will not need to be tested. Only certain criteria are eligible for Gap Certification as outlined in the final rule (see next FAQ).

Q: Which of the 2015 test procedures are Gap Certification eligible?
A: See the below list from the Final Rule of Gap-eligible test procedures.
(a)(1) CPOE-meds
(a)(2) CPOE – laboratory
(a)(3) CPOE – diagnostic imaging (DI)
(a)(4) DDDA
(a)(7) Medication List
(a)(8) Medication Allergy List
(a)(10)Drug Formulary Preferred Drug List checks (DF PDL)
(a)(11) Smoking Status
(d)(1) Authentication, Access Control, Authorization
(d)(4) Amendments
(d)(5) Automatic Access Time-Out
(d)(6) Emergency Access
(d)(7) End-user Device Encryption
(d)(11)Accounting of Disclosures
(f)(3) Transmission to PHA – Reportable Laboratory Tests and values-results

Q: Can I submit documentation prior to testing?
A: Yes. Submitting required documentation prior to beginning the test procedure will give your proctor time to review and return any documents requiring additional information back to you.

Q: What Test Data requirements do I need to have in place for testing 2015 Criteria?
A: On the ONC website, Test Methods page (refer to the ONC links above) each public test procedure has the following logo. It will either have the “ONC Supplied Test Data” ‘x’d out if no test data is require or no ‘x’ present stating there is ONC supplied data you will be required to enter for testing.

In addition there are Companion Guides on the Test Methods page associated with each test procedure. The companion guides also reference if Test data is required for the test procedure with a link to the test data.

Q: Can I pretest test procedures with SLI Compliance proctor?
A: We offes a pretest service for a fee. Contact the Test Manager for details.

Q: How can I most effectively manage my testing time?
A: Careful preparation for each test procedure will help with time management; i.e.

  1. Enter as much test data as allowed for each test procedure in advance.
  2. Prepare patients and/or login accounts as required for each test procedure
  3. Plan & prepare patients and test data for use for test procedures that allow vendor supplied test data
  4. Self-pretest with ONC testing tools prior to your official test date.
  5. During testing; if a step in a procedure fails, make appropriate fixes offline then plan to retest after completing all untested test procedures first, then go back and retest any/all failures.

Q: Can I contact an SLI Compliance testing expert with questions?
A: Yes, support time is part of your contract; you will be assigned a test specialist to assist you with pre-test questions pertaining to the test procedures you are requesting to test. If you wish to purchase additional support time, contact the Test Manager for details.

For Additional FAQs provided by the ONC please visit the official ONC Program FAQ page

ONC FAQs & Resources

https://www.healthit.gov/policy-researchers-implementers/onc-regulations-faqs
https://www.healthit.gov/policy-researchers-implementers/permanent-certification-program-faqs
https://www.healthit.gov/policy-researchers-implementers/resources
https://www.healthit.gov/policy-researchers-implementers/2015-edition-test-method

CMS

https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html?redirect=/ehrincentiveprograms/