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Electronic Laboratory Reporting (ELR)

Federal Regulations

The Office of the National Coordinator for Health Information Technology (ONC) is the principal federal entity coordinating the national efforts to implement and use the most advanced health information technology and the electronic exchange of health information. In order to ensure that eligible EHR systems are secure and capable of performing the required functions, EHR technology must meet ONC standards and qualification criteria External link.

The initial standards for certified electronic health record (EHR) technology are set forth in the ONC Standards & Certification Criteria Final Rule. The ONC regulation regarding Reportable Lab Results is excerpted below.

From 45 CFR Part 170 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule, published July 28, 2010:

Section 170.306(g) – Reportable Lab Results
Stage 1 Objective Stage 1 Measure Certification Criterion
Capability to submit electronic data on reportable (as required by state or local law) lab results to public health agencies and actual submission in accordance with applicable law and practice. Performed at least one test of certified EHR technology's capacity to provide electronic submission of reportable lab results to public health agencies and follow-up submission if the test is successful (unless none of the public health agencies to which eligible hospital or CAH submits such information have the capacity to receive the information electronically). Electronically record, modify, retrieve, and submit reportable clinical lab results in accordance with the standard (and applicable implementation specifications) specified in § 170.205(c) and, at a minimum, the version of the standard specified in § 170.207(c).
Section 170.205(c) – Electronic submission of lab results to public health agencies
Standard Implementation Specifications
HL7 2.5.1 (incorporated by reference in § 170.299) HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (U.S. Realm) (incorporated by reference in § 170.299).

The entire regulation External link can be accessed.