ONC ATL-ACB Services Overview

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 assign a dedicated ATL Test Specialist / Proctor for the ATL engagement.

ONC-ATL Vendor Start-up Package
ONC-ATL Vendor Start-up Package materials include:

SLI Compliance Testing Program Guide, which provides information about and guidance through the testing process
Vendor Testing and Certification Information document, including Attestation forms, for completion and signature
Client Test Scripts that can be used to perform practice testing and will be used by the Proctor during the remote interactive test session
Additional Documentation Requirements, outlining all additional documentation required to be submitted, per criterion, as specified in the ONC Test Methods
Guidance documents regarding the Mandatory Disclosures URL

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 that the Client must complete and return the SLI Vendor Testing and Certification Information document and submit any additional required documentation 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.

Throughout the test effort, the client is expected to provide personnel competent in the functions and navigation of the system under test. Prior to testing, SLI Compliance will send the client a remote session invitation for connecting (SLI Compliance utilizes Zoom).
SLI Compliance will act as a ‘proctor’ for any functions that must be demonstrated during remote interactive testing 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 (these steps can also be found in the Client Test Scripts provided with the ONC-ATL Vendor Start-up Package). Please refer to the approved Test Methods for all data 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 should be pre-loaded prior to the day of testing.

Types of Testing

Remote Interactive Testing – Visual Verification: Throughout the testing process, the SLI Compliance Test 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. In many cases, the tools 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 requirements, but also with 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 the SLI Compliance ATL Team offline. This includes documentation review and 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, 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.

Retesting
If a Client conducts testing with the SLI Compliance ATL Team and has failures that cannot be corrected within the initial designated testing days, then 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.

3. ONC-ATL Testing Completion

Upon successful testing, SLI Compliance requires a minimum of 2 days after the completion of 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 Testing Program Guide prior to the their ATL test engagement: https://slicompliance.com/services/testing-certification-health/sli-compliance-health-it-guides-and-manuals/

Estimated ONC-ATL Testing Timeframe and Fees

ONC-ATL engagement takes 2-5 business days dependent on size and complexity of the product scope.

Fees are determined are by size and complexity of the criteria selected as the system scope.

(ONC-ACB) Certification Services

SLI Compliance conducts a review of the test results submitted by the ATL and, upon successful completion, issues 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 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 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/2021/08/SLI-Compliance-ONC-ACB-Certification-Program-Manual-4.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:

Certificate;
SLI and ONC Certification Marks;
SLI and ONC Certified Mark Terms of Use;
Link to SLI Certification Program Manual;
Link to SLI ONC-ACB Surveillance Plan;
Quarterly Attestation Form;
Mandatory Disclosures Information;
Cost disclosure requirements for communications about the certified product; and
Corrective Action Form.

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 for the 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 results reports; review of new and revised criteria and standards updates; and handling any complaints or concerns by users of a certified product.

Annual maintenance schedule starts on the certification date and is renewed annually on the certification anniversary date.

We recommend all Clients review the SLI Compliance ONC-ACB Surveillance Plan, which can be located in the ACB Maintenance Support Services section at https://slicompliance.com/services/testing-certification-health/

Testing and Certification of Health IT