Source: https://www.healthit.gov/test-method/transmission-public-health-agencies-reportable-laboratory-tests-and-valueresults
Timestamp: 2019-04-26 09:48:06+00:00

Document:
The standard (and applicable implementation specifications) specified in §170.205(g).
At a minimum, the versions of the standards specified in §170.207(a)(3) and (c)(2).
§ 170.207(c)(2) Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, Released July 2012, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc.
The tester verifies that the Health IT Module creates the source Reportable Lab content correctly and without omission through visual inspection of the system under test using the test data specification associated with the selected test case.
The tester imports the ELR message into the test tool for validation and uses the Validation Report produced by the NIST Electronic Laboratory Reporting (ELR) Test Suite to verify the Health IT module passes without error to confirm that the reportable laboratory tests and values/results message is conformant to the § 170.205(g) HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 and the ELR 2.5.1 Clarification Document for EHR Technology Certification.
The reportable laboratory tests and values/results used in the messages created in (f)(3)(i), use, at a minimum, the versions of the standards specified in the named § 170.207(a)(3) SNOMED CT® standard and the named § 170.207(c)(2) LOINC® standard.
Using the Normative Test Description section of the Normative Test Process Document, the tester uses the Test Tool Validation Report from (f)(3)(i) test cases and visual inspection of both the Test Tool Validation Report and the Health IT configuration file to verify laboratory tests and values/results are represented using the named § 170.207(a)(3) standard and the named § 170.207(c)(2) standard.
Revised to indicate this certification criterion is in scope for the CEHRT definition.
Added hyperlinks for the test tool/data, NIST Normative Test Process Document, and 2015 MU Specification Sheet.
Privacy and Security: This certification criterion was adopted at § 170.315(f)(3). 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.
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.
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.
This certification criterion is intended for technology used in the inpatient (including emergency departments) setting.
The NIST Electronic Laboratory Reporting (ELR) Test Tool tests conformance to the requirements in HL7 Version 2.5.1 Implementation Guide (IG): Electronic Laboratory Reporting to Public Health, Release 1 with Errata and Clarifications, and ELR 2.5.1 Clarification Document for EHR Technology Certification. In the Implementation Guide, RE means “Required, but may be empty” and is not an optional requirement. That is, an RE element is required to be implemented in the EHR technology, but operationally the data may or may not be present (depending on business rules and data availability). The Alternate and non-Alternate data elements have been specified as RE in the IG to ensure the technology can support (receive, process, store, send, etc.) both types (whether or not a particular installation site utilizes/needs this capability is irrelevant for certification testing, which is focused on making sure that buyers of certified EHR technology have the capability). Any Text for Patients and Provider are also RE, and therefore not optional for certification. With regard to repeatable fields, Patient Name (PID.5) can have unlimited repeated instances, and the IG indicates that supporting repeatable fields is a requirement. To support this requirement, the ELR Test Tool and Test Data ensure certified technology can support a minimum of two instances of PID.5.
Technical outcome – The Health IT Module can electronically create reportable laboratory tests and values/results messages which can be transmitted to public health agencies according to the HL7 2.5.1 standard, HL7 Version 2.5.1 Implementation Guide for Electronic Laboratory Reporting to Public Health, Release 1 with Errata and Clarifications, and ELR 2.5.1 Clarification Document for EHR Technology Certification.
Technical outcome – The Health IT can represent data in the reportable laboratory test message using, at a minimum, the July 31, 2012 International Release of SNOMED CT® with the March 2012 Release of the US Extension to SNOMED CT® and Version 2.40 of LOINC®.

References: §170
 §170

§ 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170