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§170.315(f)(6) Transmission to public health agencies — antimicrobial use and resistance reporting

Version 1.0 Updated on 01-20-2016
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure

01-20-2016
Regulation Text
Regulation Text

§170.315 (f)(6) Transmission to public health agencies – antimicrobial use and resistance reporting

Create antimicrobial use and resistance reporting information for electronic transmission in accordance with the standard specified in §170.205(r)(1).

Standard(s) Referenced

Applies to entire criterion

§ 170.205(r)(1) HL7 Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm, August 2013

Technology is only required to conform to the following sections of the implementation guide:

  1. HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report (Numerator) specific document template in Section 2.1.2.1 (pages 69-72);
  2. Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in Section 2.1.1.1 (pages 54-56); and
  3. Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in Section 2.1.1.2 (pages 56-58)

Please consult the Final Rule entitled: 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications for a detailed description of the certification criterion with which these testing steps are associated. We also encourage developers to consult the Certification Companion Guide in tandem with the test procedure as they provide clarifications that may be useful for product development and testing.

Note: The order in which the test steps are listed reflects the sequence of the certification criterion and does not necessarily prescribe the order in which the test should take place.
 

Testing components

No GAP Icon No Documentation Icon Visual Inspection Icon Test Tool Icon No ONC Supplied Test Data Icon

 

Paragraph (f)(6)

System Under Test Test Lab Verification
  1. The Health IT Module creates Antimicrobial use and resistance reporting information in accordance with the following sections of the standard specified at § 170.205(r)(1) HL7 Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection (HAI) Reports, Release 1:
    • HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option Report (Numerator), document template in Section 2.1.2.1;
    • Antimicrobial Resistance Option (ARO) Summary Report (Denominator), document template in Section 2.1.1.1; and
    • Antimicrobial Use (AUP) Summary Report (Numerator and Denominator), document template in Section 2.1.1.2.
  1. The tester reviews the validation report and verifies that the documents generated are correct and without omission, reflecting the data entered into the Health IT Module, using value sets specified by the HL7 HAI Reports implementation guide.
  2. The tester imports each antimicrobial use and resistance reporting document into the test tool for validation and uses the Validation Report produced by the test tool to verify the report indicates passing without error to confirm that the Antimicrobial use and resistance reporting document is conformant to the specified templates of the § 170.205(r)(1).

Version 1.2 Updated on 02-19-2016
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-29-2015
1.1

Added contact email for CDC support on the testing and/or test tool for this criterion.

12-07-2015
1.2

Updated link to test tool.

02-19-2016
Regulation Text
Regulation Text

§170.315 (f)(6) Transmission to public health agencies – antimicrobial use and resistance reporting

Create antimicrobial use and resistance reporting information for electronic transmission in accordance with the standard specified in §170.205(r)(1).

Standard(s) Referenced

Applies to entire criterion

§ 170.205(r)(1) HL7 Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm, August 2013

Technology is only required to conform to the following sections of the implementation guide:

  1. HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report (Numerator) specific document template in Section 2.1.2.1 (pages 69-72);
  2. Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in Section 2.1.1.1 (pages 54-56); and
  3. Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in Section 2.1.1.2 (pages 56-58)

Certification Companion Guide: Transmission to public health agencies — antimicrobial use and resistance reporting

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(f)(6). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(f) “paragraph (f)” 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 (f) 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 tested 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.

  • 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

Technical outcome – Health IT can create an electronic antimicrobial use and resistance report for the following three sections of the HL7 Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection (HAI) Reports, Release 1, U.S. Realm, August 2013:

  1. HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report (Numerator) specific document template in Section 2.1.2.1 (pages 69-72);
  2. Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in Section 2.1.1.1 (pages 54-56); and
  3. Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in Section 2.1.1.2 (pages 56-58).

Clarifications:

  • For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
  • The antimicrobial use and resistance reporting information for electronic transmission will be collected by CDC only rather than at the jurisdictional level. [see also 80 FR 62668]
  • For support with the testing and/or test tool for this criterion, please contact CDC at NHSNCD@cdc.gov.

Regulation Text
Regulation Text

§170.315 (f)(6) Transmission to public health agencies – antimicrobial use and resistance reporting

Create antimicrobial use and resistance reporting information for electronic transmission in accordance with the standard specified in §170.205(r)(1).

Testing Tool
Criterion Subparagraph Test Data
(f)(6)

None

Content last reviewed on September 21, 2018
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