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

Version 1.1 Updated on 09-21-2017
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure

01-08-2016
1.1

As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only

09-21-2017
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

Testing components

Gap Eligible
Self-Declaration: As of September 21, 2017, the testing approach for this criterion is satisfied by self-declaration.

The archived version of the Test Procedure is attached below for reference.

 

System Under Test

Test Lab Verification

The health IT developer submits their self-declaration to the ONC-ATL.

The Tester verifies the self-declaration document contains all of the required data elements.

 

 

Archived Version:
Version 1.1 Updated on 12-10-2015
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-22-2015
1.1

Revised to include clarification about developer discretion for implementing the optional provision.

12-10-2015
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 Companion Guide: Computerized provider order entry (CPOE) – laboratory

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
 

 

Certification Requirements

Privacy and Security: This certification criterion was adopted at § 170.315(a)(2). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(a) “paragraph (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) “VDT” and (e)(2) “secure messaging,” which are explicitly stated.

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.
  • 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.
Table for Privacy and Security
Technical Explanations and Clarifications

 

Applies to entire criterion

Clarifications:

  • There is no standard required for this certification criterion.
  • To meet the 2015 Edition Base 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.

Paragraph (a)(2)(i)

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 [see also 75 FR 44624]

Paragraph (a)(2)(ii) Optional

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 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).

Content last reviewed on May 17, 2018
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