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:

  1. ONC-ATL Preparation Activities
  2. ONC-ATL Testing Process
  3. 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:

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.

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.

Retesting
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 of $3000 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.

  1. ONC-ACB Certification Process
  2. Certified Heath IT Product List (CHPL)
  3. 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:

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/2020/12/SLI-Compliance-ONC-ACB-Certification-Program-Manual-2.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:

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 and surveillance of the certified product – as required by the Office of the National Coordinator (ONC). To support ONC program, ACB maintenance activities include but not limited to, inquiries relevant to the certified criteria and requirements; reactive and randomized surveillance; quarterly reporting on the certified products; and handling any complaints or concerns by users on a certified product. SLI Compliance’s approach is to treat developers fairly, conduct activities in a transparent manner and respond to developers inquiries.

An annual maintenance fee for year one is charged to the Client once the product is certified and posted to the CPHL. Client shall pay the amount of the invoice upon receipt. Annual maintenance schedule starts on 2015 Edition certification date and is renewed annually on the certification anniversary date.

We recommend all Clients review, please refer to the SLI Compliance ONC-ACB Surveillance Plan: https://www.slicompliance.com/wp-content/uploads/2020/01/SLI-Compliance-ONC-ACB-2020-Surveillance-Plan.pdf

 

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