SLI Compliance has been authorized to perform Conformance Testing and Certification of Health IT by the US Department of Health and Human Services’ Office of the National Coordinator as an Authorized Test Lab (ONC-ATL) and an Authorized Certification Body (ONC-ACB). The following sections detail SLI Compliance ONC ATL-ACB processes for testing and certification.
(ONC-ATL) Testing Services
SLI Compliance conducts testing as an ONC Authorized Testing Laboratory (ONC-ATL) against the approved 2015 & 2015 Cures Update Edition ONC criteria. SLI Compliance’s ONC-ATL Testing steps include:
- ONC-ATL Preparation Activities
- ONC-ATL Testing Process
- ONC-ATL Testing Completion
1. ONC-ATL Preparation Activities
Once the contractual agreement has been executed, the SLI Compliance ATL Team will create an ONC-ATL Vendor Start-up Package based on the Client’s scope; and will be assigned a dedicated ATL Test Specialist / Proctor for their ATL engagement.
ONC-ATL Vendor Start-up Package
ONC-ATL Vendor Start-up Package materials include:
- Vendor Certification Information form.
- Documentation of All ‘Required Vendor Information’ specified in the Test Procedures section of each ONC Test Criterion that will be tested.
- Attestation forms / documentation for completion and signature(s).
- Any additional supporting vendor documentation that may be needed to satisfy the criteria (e.g., system manuals, security implementation, vendor policies).
- Any 3rd party software or tools you will require to demonstrate compliance to the criteria.
ONC-ATL Preparation Support
A dedicated ATL Test Specialist / Proctor is assigned to you for the duration of the ATL engagement. Your ATL Test Specialist / Proctor is available for support on interpretation of testing criteria and requirements, answering vendor questions and feedback on attestation documents. This dedicated ATL team member will also be the official Test Proctor for your ATL test engagement.
Per the rules of the ONC Health IT Program, in NO WAY can SLI Compliance perform consulting to assist a client in obtaining successful testing and certification.
2. ONC-ATL Testing Process
Please note, the Client must complete and return the ATL Vendor Package materials to the SLI Compliance ATL Team for review a minimum of 2 business days prior to their ATL test start date. The scheduled test window with a Client for ATL testing is based on the scope of testing the client has selected. This can vary from system to system and is highly dependent on what criteria the vendor is testing to.
- Throughout the test effort, the client is expected to provide personnel competent in the functions and navigation of the system under test. At the beginning of testing each day, SLI Compliance will send the client a remote session invitation (SLI Compliance utilizes Zoom) for connecting.
- SLI Compliance will act as a ‘proctor’ for any functions that must be manually executed on the system. The SLI Compliance Test Proctor will instruct your staff to follow a prescribed set of steps that demonstrate compliance with the certification criteria requirements.
- Some example patient information and test data are required to be entered on the day of testing with SLI Compliance selecting the data and/or witnessing the data input.
- Other test data may be pre-loaded prior to the day of testing (Please refer to the approved Test Methods for all data requirements).
Types of Testing
Remote Interactive Testing – Visual Verification: Throughout the testing process, the SLI Compliance ATL Test Specialist /Proctor will record the testing session and take screen images as needed. The SLI Compliance test proctors are required to visually inspect and verify specific functionality being demonstrated for compliance to the criteria requirements.
Remote Interactive Testing – Tool Verification: Many of the requirements utilize conformance testing tools. The approved Test Methods provide the tool detail. The tools in many cases contain test
scenarios, test cases, and test data that will be used in the testing process. In addition, the testing tools will provide automated validation and reports where called out in the Test Methods. It is highly encouraged that the client be familiar with not only the Test Methods & criteria required but also all the associated conformance tools.
Offline Verification Testing: All validation testing that does not require remote session interaction between the Client and SLI Compliance will be conducted by SLI Compliance ATL Team offline. This includes documentation review and any test artifact manual validation, such as Self-attest/attestation criteria testing. Upon completion of offline testing, SLI Compliance will communicate the results to the client in a timely manner.
Additional Testing Time
If a Client is unable to complete all of the required testing within the initial test schedule given, any additional testing day(s) will need to be scheduled to complete the remaining test procedures. The client will be allowed to schedule additional testing days dependent on resource availability and open testing days in SLI’s testing schedule. A testing fee of $1000 per day will be assessed and no partial days are allowed.
The requirement for a retest is that if a Client conducts testing with the SLI Compliance ATL Team and during their initial test schedule has failures that cannot be corrected within those designated testing days a retest needs to be scheduled. After the initial testing SLI Compliance will generate a status report to the Client communicating what failures must be retested. A retest consists of additional interactive testing days that will be scheduled on a mutually agreed upon date. The first retest is free (1 day). If failures occur or remain after the free retest day, any additional retest days required to complete testing are subject to the retesting fee. Each retest day is $1000 per day.
3. ONC-ATL Testing Completion
Upon successful testing, SLI Compliance requires a minimum of 2 days in addition to the complete testing for the ATL Team to complete the final ATL Test Report process.
SLI Compliance ATL Team will submit an official test report to the SLI Compliance Authorized-
Certification Body (ONC-ACB), for evaluation and if accepted final certification. As a separate entity, SLI Compliance’s ONC-ACB executes all matters pertaining to certification criteria associated with ISO 17065 that are required for the ONC-Health IT Certification program.
We recommend all Clients read the SLI Compliance: ONC-ATL Test Program Guide prior to the their ATL test engagement: https://slicompliance.com/wp-content/uploads/2020/07/SLI-Compliance-Testing-Program-Guide_2020v4.0.pdf
Estimated ONC-ATL Testing Timeframe and Fees
ONC-ATL engagement takes 2-5 business days dependent on size and complexity of the product scope.
Base Fee: A one-time fee is charged for each engagement.
ONC-ATL Criteria Testing and Attestation Fees: ATL Testing and attestation fees are in addition to the base testing fee; and determined size and complexity of the criteria selected in the 2015 Criteria tables as the system scope.
(ONC-ACB) Certification Services
SLI Compliance conducts a review of the ATL submitted test results and upon successful completion issue official ONC Health IT Certification for the client system under test (SUT). SLI Compliance shall conduct certification as an ONC Authorized Certification Body (ACB) against the approved 2015 Edition ONC criteria.
- ONC-ACB Certification Process
- Certified Heath IT Product List (CHPL)
- ONC-ACB Certificate of Compliance
1. ONC-ACB Certification Process
The SLI Compliance ONC-ACB Team is responsible for implementing certification procedures by evaluating the testing results and supporting documentation and ensuring that all certification requirements have been met. If deficiencies are identified, the customer and the Testing Lab, as appropriate, will have the opportunity to provide clarification or additional information. Certification is granted based on the requirements of ISO/IEC 17065:2012 and the rules and regulations of the ONC Health IT Certification Program. At the conclusion of the certification process:
- SLI Compliance will issue the certification and the certification information is published to the ONC’s Certified Health IT Product List (CHPL), provided there are no deficiencies or other issues.
- SLI Compliance issues a Certificate of Compliance that documents the criteria under which the product is certified. The Client will receive an ACB Certificate Package with the ACB certificate and other documentation for 2015 Edition certification compliance.
We recommend all Clients review the SLI ACB certification process. Please refer to the SLI Compliance ONC-ACB Certification Program manual: https://slicompliance.com/wp-content/uploads/2021/03/SLI-Compliance-ONC-ACB-Certification-Program-Manual-3.pdf
2. Certified Health IT Product List (CHPL)
The product information transmitted to ONC for listing on the CHPL website is taken from the certification information document. The ACB vendor form must be completed by the customer to state the customer name and product name as they are to be listed on the CHPL and SLI Compliance website. A signature from the customer’s senior management is required, and the signed form must be received from the customer prior to commencement of the product certification.
If the customer also engaged SLI Compliance for testing, this information is already supplied during the testing application.
The CHPL ID is created with certification date, this is posted to the CHPL and communicated to the Client.
3. ONC-ACB Certificate of Compliance
SLI Compliance issues a Certificate of Compliance that documents the criteria under which the
product is certified. The Client will receive their ONC-ACB certification package which will include:
- Link to SLI Certification Program Manual:
- Quarterly Attestation Form;
- Customer List requirements;
- Link to SLI ONC-ACB Surveillance Plan;
- Mandatory Disclosures Information; and
- Costs & Limitations requirements for communications about the certified product.
Estimated ONC-ACB Certification Timeframe and Fees
ONC-ACB Certification typically takes 1-3 weeks based on size and complexity of scope.
ONC-ACB Certification Fee: ACB certification fee is based on project size/number of criteria for the 2015 Edition certification review.
4. ONC-ACB Maintenance and Surveillance
Once the product is certified, the ONC-ACB will provide ongoing maintenance of the certified product as required by the ONC. Keeping your certified product current with the ONC Health IT Certification Program requires attention to several key maintenance requirements.
SLI Compliance helps you make sure your certification stays on track with proactive and responsive maintenance services. The ACB maintenance activities include quarterly reporting; ONC bi-annual attestations; review of developer communications; reactive surveillance; review of real world test plans and test reports; and Cures Rule new and revised criteria and standards updates; and handling any complaints or concerns by users on a certified product.
Annual maintenance schedule starts on 2015 Edition certification date and is renewed on annually on the certification anniversary date.
We recommend all Clients review, please refer to the SLI Compliance ONC-ACB Surveillance Plan: https://slicompliance.com/wp-content/uploads/2021/01/SLI-Compliance-ONC-ACB-2021-Surveillance-Plan-1.pdf
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