CalREDIE Electronic Lab Reporting (ELR)
California Reportable Disease Information Exchange Electronic Lab Reporting (CalREDIE ELR) allows healthcare/lab facilities to comply with public health reporting requirements for reportable diseases through an automated, secure communication process. Submitting facilities extract reportable laboratory result data from their information systems and construct a standard formatted message to send to the state and local public health agencies through CalREDIE.
CalREDIE ELR will replace traditional methods of reporting for many reportable diseases and conditions in jurisdictions participating in CalREDIE. CalREDIE ELR provides for more rapid reporting to public health and reduces the administrative burden of reporting. Timely reporting via phone may still be required for selected diseases and conditions.
Entities sending laboratory results electronically to CalREDIE jurisdictions may satisfy the ELR measure of Meaningful Use. (Link to CalREDIE map and CalREDIE list).
For information on reporting laboratory results in jurisdictions not using CalREDIE, please consult with the local health department.
According to the Centers for Medicare and Medicaid Services (CMS) Electronic Health Records Incentive Program, submitting electronic reportable lab results to public health is one of several measures that may enable hospitals to meet the requirements of MU. For more information, please see CMS’ EHR Incentive Program website regarding lab reporting at: http://www.cms.gov/EHRIncentivePrograms/Downloads/9_Reportable_Lab_Results_to_Public_Health_Agencies.pdf
Code of Federal Regulations (CFR) Title 45 Part 164 Section 512 addresses the cases in which a covered entity may disclose individually identifiable health information to a public health authority. 45 CFR. Section 164.512 can be found at: http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=45&PART=164&SECTION=512&TYPE=TEXT
California Laws and Regulations
The California Health and Safety Code (HSC) Section 120130 paragraph (g), as modified by AB 2658 (2008), requires laboratories to submit required reports of notifiable diseases electronically to the Local Health Departments (LHDs) in a manner specified by CDPH. HSC Section 120130 can be found at: http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=120001-121000&file=120125-120155
California Code of Regulations (CCR), Title 17, Section 2505, established under HSC 120130 (a), contains the list of reportable conditions and the requirements for notification by laboratories. CCR Title 17, Section 2505 can be found at: http://www.cdph.ca.gov/HealthInfo/Documents/TITLE_17_SECTION_2505.pdf
The CalREDIE ELR2PH Companion Guide establishes the California-specific technical supplement to ELR messaging as described in HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) HL7 Version 2.5.1: ORU^RO1. ELR submitters should use the HL7 US Realm Guide in conjunction with the CalREDIE ELR2PH Companion Guide to properly format ELR messages for submission to CalREDIE.
HIV/AIDS Laboratory Information
At this point, CalREDIE ELR is not accepting Electronic Laboratory Results regarding HIV/AIDS information. Potential ELR submitters should program their information systems to refrain from sending HIV/AIDS laboratory information via ELR until further notice. Reporting entities should continue to report HIV/AIDS information to the local health jurisdiction via traditional reporting methods. Please see the Office of AIDS page for more information: http://www.cdph.ca.gov/programs/aids/Pages/Default.aspx
Getting Started with ELR
Ensure that your information system can produce a message compliant with HL7 ELR version 2.5.1, with additional constraints imposed by the CalREDIE ELR2PH Companion Guide (July 2012 Edition). Please note the July 2012 edition of the CalREDIE ELR2PH Companion Guide is a revision to the February 2012 edition that was previously published. All changes or additions are listed in Appendix C, pg.191 of the guide. You can test messages using the web validator without having to create an account, but do not include PHI data.
Register at the CDPH HIE Gateway and receive all appropriate credentials and instructions necessary for submitting lab reports data electronically to CalREDIE.
- Identify the reportable conditions in your facility’s test catalog.
- Map reportable tests to LOINC and SNOMED codes accepted by CalREDIE.
Phased Approach to ELR Submission
- Enrollment: This phase of ELR consists of the discovery process between CDPH and the submitting facility.
Precertification: This phase of ELR will include the following activities.
- CDPH will need to learn laboratory findings that will be reported (provide a csv or list of LOINC and SNOMED codes that the lab will report).
- CDPH will need to learn expected volume of reports (estimates based on a reporting year are acceptable).
- The submitting facility will enroll for ELR through the CDPH HIE Gateway. A response to the enrollment includes SOAP messaging credentials.
Certification: This phase of ELR consists of dual method reporting, through ELR as well as more traditional means. In this context, “certification” means completion of the dual method reporting validation process, culminating in written authorization to stop submitting lab reports by paper or other traditional means. This is NOT to be confused with EHR “certification” in the Meaningful Use context, which is addressed through the Office of the National Coordinator for Health Information Technology (ONC).
- The submitting facility will construct logical filters so that only reportable laboratory findings are sent to CDPH.
- The submitting facility will also test ELR transmission via test messages.
- The submitting facility will need to demonstrate the ability to construct a properly formatted ELR message which will pass the programmatic CDPH message validator.
- Traditional disease reporting continues during this phase.
Maintenance: During the maintenance phase, submitting facilities will inform CDPH of changes or updates to their ELR messaging, including changes to the test catalog and associated LOINC and SNOMED code lists. Significant changes may require repeating the certification process. CDPH will also publish changes to the list of reportable LOINC and SNOMED codes.
- The submitting facility will report electronically while simultaneously reporting via traditional means.
- CDPH and the submitting facility will work together to ensure that the logical filters are working properly in terms of sending exactly the reportable results—nothing more and nothing less.
- When CDPH and the submitter agree that ELRs and lab reports submitted by traditional methods are matched and synchronized, the submitter may be certified to submit ELR in lieu of traditional reporting as of an agreed upon date.
CalREDIE ELR2PH Companion Guide (July 2012 Edition)
HL7 ELR Implementation Guide
CDPH HIE Gateway
Current ELR Submitters
Frequently Asked Questions (FAQs)
Reportable Condition Mapping Table (RCMT)
CCR Title 17 Section 2505
Health and Safety Code: Section 120130
Meaningful Use Topic: Reportable Lab Results to Public Health Agencies
For questions or concerns, please contact ELR@cdph.ca.gov
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