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§170.315(a)(2) Computerized provider order entry (CPOE) – laboratory

Updated on 03-11-2024
Regulation Text
Regulation Text

§ 170.315 (a)(2) Computerized provider order entry—laboratory— 

  1. Enable a user to record, change, and access laboratory orders.
  2. Optional. Include a “reason for order” field.
Standard(s) Referenced

None

Certification Dependencies

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.

  • Safety-enhanced design (§ 170.315(g)(3)) must be explicitly demonstrated for this criterion.
  • Quality management system (§ 170.315(g)(4)): 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.
  • Accessibility-centered design (§ 170.315(g)(5)): 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.
Privacy & Security Requirements

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.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (a) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated. 
  • § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.

For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG

Revision History
Version # Description of Change Version Date
1.0

Initial publication

03-11-2024

Testing components

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.

 

System Under Test

ONC-ACB Verification

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.

 

 

Archived Version:
Updated on 03-11-2024
Regulation Text
Regulation Text

§ 170.315 (a)(2) Computerized provider order entry—laboratory— 

  1. Enable a user to record, change, and access laboratory orders.
  2. Optional. Include a “reason for order” field.
Standard(s) Referenced

None

Certification Dependencies

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.

  • Safety-enhanced design (§ 170.315(g)(3)) must be explicitly demonstrated for this criterion.
  • Quality management system (§ 170.315(g)(4)): 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.
  • Accessibility-centered design (§ 170.315(g)(5)): 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.
Privacy & Security Requirements

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.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (a) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated. 
  • § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.

For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG

Revision History
Version # Description of Change Version Date
1.0

Initial Publication

03-11-2024

Certification Companion Guide: Computerized provider order entry (CPOE) – laboratory

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.

The below table outlines whether this criterion has additional Maintenance of Certification dependencies, update requirements and/or eligibility for standards updates via SVAP. Review the Certification Dependencies and Required Update Deadline drop-downs above if this table indicates “yes” for any field.

 

Certification Requirements
Technical Explanations and Clarifications

Clarifications:

  • There is no standard required for this certification criterion.
  • To meet the Base electronic health record (EHR) definition, providers must possess technology that has been certified to at least one of the following: § 170.315(a)(1) Computerized provider order entry (CPOE) – medications, § 170.315(a)(2) Computerized provider order entry (CPOE) – laboratory, or § 170.315(a)(3) Computerized provider order entry (CPOE) – diagnostic imaging.

Technical outcome – The health IT permits a user to record, change, and access laboratory orders.

Clarifications:

  • No standard is required for demonstrating the ability to allow a user to record, change, and access laboratory orders.
  • This provision does not focus on the transmission of laboratory orders, only on the ability of a user to record, change, and access the laboratory order. [see also 77 FR 54248] and 75 FR 44624]

Technical outcome – The health IT allows for the user to include a “reason for order.”

Clarifications:

  • It is not mandatory to allow a user to include a “reason for order” field. However it is optional. The health IT developer has the discretion to determine how to implement this optional provision (e.g., free text field or drop-down menu of pre-determined entries).