§ 170.315(a)(2)
Issued Date:
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements outlined in regulation and related ONC final rules. It extracts key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the Certification Regulations page for links to all ONC final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.
None
Technical Explanations and Clarifications
Clarifications:
Technical outcome – The health IT permits a user to record, change, and access laboratory orders.
Clarifications:
Technical outcome – The health IT allows for the user to include a “reason for order.”
Clarifications:
§ 170.315 (a)(2) Computerized provider order entry—laboratory—
The following standards are referenced within the certification criteria for: § 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory
This certification criterion was adopted at § 170.315(a)(2). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(a) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
For more information on the approaches to meet these Privacy and Security requirements, please download the Privacy and Security CCG below:
Privacy and Security CCG
If choosing
If choosing
For each applicable privacy and security certification criterion not certified for Approach 1, the health IT developer may certify using system documentation which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces the Health IT Module to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule at 85 FR 25710 for additional clarification.
The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
The following resources can offer assistance or additional information: § 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory
The following changelog applies to:
§ 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory
Changelog functionality is not available.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 | Initial Publication | 03-11-2024 |
Issued Date:
Attestation: As of September 21, 2017, the testing approach for this criterion is satisfied by attestation. The archived version of the Test Procedure is attached below for reference.
Archived Version: §170.315(a)(2) Test Procedure
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The health IT developer will attest directly to the ONC-ACB to conformance to the § 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory requirements.
The ONC-ACB verifies the health IT developer attests conformance to the § 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory requirements.
§ 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory
§ 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory
Documentation is an approved method to demonstrate conformance. This may include documents from the health IT developer or third-party that demonstrate/attest to the compliance with the criterion.
Visual inspection is an approved method to demonstrate conformance. Most commonly, this will be accomplished via a live demonstration of functionality that meets the criterion.
Testing tools indicate that a test tool(s) exists and must be used to test a portion or all of a Health IT Module's conformance to the criterion.
Indicates that the Standards Version Advancement Process (SVAP) is applicable to the criterion.
The test data for this criterion is provided within the testing tools tab. Click the link below to be directed to the testing tools tab.
The following changelog applies to:
§ 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory
Changelog functionality is not available.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 | Initial publication | 03-11-2024 |
The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
Must be explicitly demonstrated for this criterion.
When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
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The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the "Real World Testing" Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act.
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