CalREDIE Electronic Lab Reporting (ELR)                                  

CalREDIE Electronic Lab Reporting (ELR)

Meaningful Use (MU)

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

Federal Regulations

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

1. Identify the reportable conditions in your facility’s test catalog.
2. Map reportable tests to LOINC and SNOMED codes accepted by CalREDIE.
• These codes are extracted by disease listing from the Reportable Condition Mapping Table (RCMT) available at:  http://www.phconnect.org/group/rcmt/forum/topics/rcmt-download.
3. 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.
4. Complete the ELR Submitter Enrollment Form. Once complete, contact CalREDIEHelp@cdph.ca.gov (866-866-1428) to start the enrollment process.  

   Phased Approach to ELR Submission

1. Enrollment: This phase of ELR consists of the discovery process between CDPH and the submitting facility.
• 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).
• CDPH will work with the facility to set up the Secure File Transfer.
2. Precertification: This phase of ELR will include the following activities.
• 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.
3. 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 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.
4. 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.

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