Source: https://www.healthit.gov/test-method/transmission-immunization-registries
Timestamp: 2018-07-21 15:14:27
Document Index: 556214419

Matched Legal Cases: ['§170', '§170', '§170', '§170', '§170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170', '§ 170']

Transmission to immunization registries | HealthIT.gov
Version 1.1 Updated on 10-06-2016
§170.315 (f)(1) Transmission to immunization registries—
Create immunization information for electronic transmission in accordance with:
The standard and applicable implementation specifications specified in §170.205(e)(4).
At a minimum, the version of the standard specified in §170.207(e)(3) for historical vaccines.
At a minimum, the version of the standard specified in §170.207(e)(4) for administered vaccines.
Enable a user to request, access, and display a patient's evaluated immunization history and the immunization forecast from an immunization registry in accordance with the standard at §170.205(e)(4).
Paragraph (f)(1)(i)
§ 170.205(e)(4) HL7 2.5.1 Implementation Specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5, October 2014 and HL7 Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5)—Addendum, July 2015
§ 170.207(e)(3) HL7 Standard Code Set CVX— Vaccines Administered, updates through August 17, 2015
§ 170.207(e)(4) National Drug Code (NDC) Directory– Vaccine NDC Linker, updates through August 17, 2015
Paragraph (f)(1)(ii)
Paragraphs (f)(1)(i)
The Health IT Module creates immunization content using ONC Supplied Test data for each of the test cases from the Administration Test Group under the ONC 2015 Test Plan on the Context-Based Validation Tab of the NIST HL7 v2 Immunization Test Suite. All test cases are required. Input may be performed using manual or automated processes.
For each test case, the Health IT Module generates the indicated HL7 v2.5.1 Z22 VXU immunization information message.
For each test case, the Health IT Module consumes the associated acknowledgement message using the provided test data and according to the § 170.205(e)(4) HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5.
The vaccines in the historical vaccine records are represented using § 170.207(e)(3) HL7 Standard Code Set CVX— Vaccines Administered.
The vaccines in the administered vaccine records are represented using § 170.207(e)(4) National Drug Code (NDC) Directory– Vaccine NDC Linker.
The tester verifies that the Health IT Module creates the source immunization content correctly through visual inspection of the system under test using the test data specification of the Send Administration Message test step associated with the selected test case.
The tester imports the immunization message into the test tool for validation and uses the Validation Report produced by the test tool to verify that the Health IT Module passes without error to confirm that the immunization information messages are conformant to the HL7 v2.5.1 Z22 VXU Unsolicited Vaccine Update message of the § 170.205(e)(4) standard.
The tester verifies that the Health IT Module is able to receive and process a Return an Acknowledgement Z23 message (in response to a "Send Unsolicited Immunization Update Using a VXU" Z22 message) through visual inspection of the system under test using the Juror Document of the Consume Acknowledgement test step associated with the selected test cases.
The tester uses Test Tool Validation Report from (f)(1)(i)(B) test cases and visual inspection of both the Test Tool Validation Report and the Health IT configuration file to verify the historical vaccine records are represented using § 170.207(e)(3) standard.
The tester uses Test Tool Validation Report from (f)(1)(i)(C) test cases and visual inspection of both the Test Tool Validation Report and the Health IT configuration file to verify administered vaccine records are represented using § 170.207(e)(4) standard.
The Health IT Module creates immunization query content using ONC Supplied Test data for each of the test cases from the Evaluate History and Forecast Test Group under the ONC 2015 Test Plan on the Context-Based Validation Tab of the NIST HL7 v2 Immunization Test Suite. All test cases are required. Input may be performed using manual or automated processes.
For each test case, the Health IT Module generates the indicated HL7 v2.5.1 Z44 QBP query message.
The Health IT Module electronically receives HL7 evaluated immunization history and forecast HL7 v2.5.1 Z42 RSP or HL7 v2.5.1 Z33 RSP response messages returned for each of the test cases from the Evaluated History and Forecast Test Group under the ONC 2015 Test Plan on the Context-Based Validation Tab of the NIST HL7 v2 Immunization Test Suite, which is in the Return response to the HL7 v2.5.1 Z44 QBP query message initiated in (f)(1)(ii) Request above, formatted according to the § 170.205(e)(4) HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5. The Health IT Module displays the response to the user.
The tester verifies that the Health IT Module creates the source immunization query content correctly through visual inspection of the system under test using the test data specification of the Send Query test step associated with the selected test case.
The tester imports the query message into the test tool for validation and uses the Validation Report produced by the test tool to verify that the Health IT Module passes without error to confirm that the query message is conformant to the HL7 v2.5.1 Z44 QBP Query for Evaluated History and Forecast message profile of the § 170.205(e)(4).
The Tester verifies that the Health IT Module can process each of the following Test Case responses through visual inspection of the system under test using the Juror Document of the second test step (the Return response) associated with the selected test case from the NIST HL7 v2 Immunization Test Suite:
The Tester verifies that the Health IT Module is able to display a response that contains evaluated history and forecast information for the test patient, through visual inspection of the system under test using the Juror Document of the Return response test step associated with the selected test case.
The tester verifies that the Health IT Module can process a response with a notification indicating that the query for the Evaluated Immunization History and Immunization Forecast is complete but no matching records were found for the person in the query, through visual inspection of the system under test using the Juror Document of the Return response test step associated with the selected test case.
The tester verifies that the Health IT Module can process a response with a notification indicating that the query for the Evaluated Immunization History and Immunization Forecast is complete but too many matches were found for the patient requested through visual inspection of the system under test using the Juror Document of the Return response test step associated with the selected test case.
Supported by CDC, the Healthcare Information and Management Systems Society Immunization Integration Program (HIMSS-IIP) is a collaborative effort of HIMSS, Drummond Group, and Chickasaw Health Consulting, LLC. HIMSS-IIP was approved as an ONC-Approved Alternate Test Method on October 10, 2017 for testing § 170.315(f)(1).
The ONC–Approved Alternative, HIMSS IIP, has its own set of testing artifacts. For additional information, contact HIMSS IIP.
Version 1.2 Updated on 03-17-2017
Updated the NIST Test Normative Test Process Document Link.
Updated to include clarification to the CCG that compliance with the IG IM Release 1.5 addendum is required for testing and certification.
Certification Companion Guide: Transmission to immunization registries
Privacy and Security: This certification criterion was adopted at § 170.315(f)(1). 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.
Any health IT can be certified to this criterion if it can meet all the requirements of the criterion, which include context exchange and vocabulary standards. There is no specified transport standard or mechanism required for this criterion. Consequently, any additional products used to facilitate immunization data submission in the manner required by the public health agency are not required to be included as part of Certified EHR Technology (CEHRT) implemented by eligible professionals, eligible hospitals, or critical access hospitals for those CMS programs requiring the use of CEHRT. Please consult CMS regulations for more specific requirements for meeting the CEHRT definition. [see also 80 FR 62663]
While no transport standard is required for this criterion, an expert panel convened by the CDC and the American Immunization Registry Association (AIRA) has recommended a SOAP-based standard for transport of immunization data. Developers have the discretion to decide which transport standard(s) to implement. [see also 77 FR 54240]
CDC issued an addendum to the HL7 2.5.1 Implementation Guide (IG) for Immunization Messaging (IM), Release 1.5. The addendum consolidates the IG IM Release 1.5 information that clarifies the conformance requirements, but does not specify additional substantive requirements. The addendum was adopted with the IG IM Release 1.5 for purposes of testing and certification to this criterion. [80 FR 62663]
The criterion is not intended to specify when submissions should be made or the periodicity of the submissions. Consequently, submitting batch files to an immunization registry, provided that they are formatted according to the adopted standards referenced by this certification criterion, is not prohibited by this certification criterion and would be acceptable. [see also FAQ #2]
The process for submitting immunization data often differs between public health agencies. We recommend developers work with the state or local immunization registry for guidance on how to submit the immunization data.
HL7 Standard Code Set CVX – Vaccine Administered OID: 2.16.840.1.113883.12.292
National Drug Code Directory OID: 2.16.840.1.113883.6.69 [80 FR 62612]
Health IT Modules can present for certification to a more recent version of the CVX – Vaccines Administered and National Drug Code Directory – Vaccine Codes code sets than the August 17, 2015 updates per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [80 FR 62620]
Technical outcome – The Health IT Module can create immunization information according to the IG) IM Release 1.5, and the July 2015 Addendum, using CVX codes for historical vaccines and NDC codes for newly administered vaccines.
For the purposes of administered vaccines, when an immunization is reported at the time it is administered and the actual product is known, the NDC code must be sent. We clarify that for when sending historical vaccines and the actual NDC code is not available, CVX codes can be sent as this method would be supported by health IT certified to this criterion. [see also 80 FR 62663-62664]
Technical outcome – The Health IT Module enables a user to request, access and display the evaluated immunization history and forecast from an immunization registry for a patient in accordance with the HL7 2.5.1 standard, the HL7 2.5.1. IG for Immunization Messaging, Release 1.5, and July 2015 Addendum.
Health IT (e.g., EHR products) may sometimes have a version of the immunization history that differs from the history in the immunization registry. Likewise, Health IT (e.g., EHR products) that includes immunization forecasting capabilities may produce a forecast that differs from one produced by the immunization registry. We still believe that it is important for an EHR to receive the history and forecast from the registry. Based on compliance with the Release 1.5 IG, a user would be able to see and compare the history and forecast from the certified health IT (e.g., EHR product) with the history and forecast from the immunization registry. However, we note that this criterion does not prescribe a particular workflow or reconciliation requirements. Providers and health IT developers may reconcile forecast and history information in a manner that best meets their needs for workflow and patient safety. [see also 80 FR 62664]
NIST HL7v2 Immunization Test Suite
Refer to the NIST HL7v2 Immunization Test Suite