Office for Health Information Technology

Meaningful Use and Notifiable Condition Reporting

Electronic Laboratory Reporting (ELR) has been promoted as a public health priority for the past several years and its inclusion as a meaningful use objective for public health serves as a catalyst to accelerate its adoption. Centers for Medicare and Medicaid Services (CMS) incentives for hospital compliance with meaningful use include the ‘‘Medicare and Medicaid Programs; Electronic Health Record (EHR) Incentive Program’’ “Demonstrate Meaningful Use of Certified EHR technology”. The Stage 1 meaningful use objective and measure for reportable lab results are below:

  • Objective: 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.
  • Measure: Performed at least one test of EHR’s technology’s capacity to provide results electronic submission of reportable lab results to public health agencies and follow–up submission if the test is successful

The Maine Center for Disease Control and Prevention (Maine CDC) has partnered with HealthInfoNet (HIN) which has been designated as the State of Maine’s Health Information Exchange (HIE).  HIE is the transmission of healthcare-related data among hospitals, laboratories and public health agencies according to national standards.  To meet requirements, HIN enables reliable and secure transfer of data among diverse systems and also facilitates access to and retrieval of data.  If you choose to partner with HIN, the steps below are done in collaboration with them.  Maine CDC also has dedicated resources to support implementation of electronic laboratory reporting and can work with clinical labs on the process.


How to Get Started?

  • Identify laboratory findings indicative of Maine reportable infectious diseases for tests performed at your facility.  Laboratory and infection control personnel are usually involved in this step.  See 2011 Laboratory Reporting of Notifiable Conditions guide.
  • Determine whether your lab uses LOINC (test) and SNOMED (result) codes or local codes. Maine CDC will accept local codes, though the preference is to receive LOINC and SNOMED codes and it is expected that all codes will be standardized over time. 
  • Determine whether your lab can send an electronic file in Health Level 7 (HL7) format. 
  • Note that HL7 version 2.5.1 is the standard for compliance with the Centers for Medicare and Medicaid Services, Health and Human Services, meaningful use criteria for electronic submission of lab results to public health agencies.  The most recent version of the HL7 version 2.5.1 Implementation Guide:  Electronic Laboratory Reporting to Public Health, Release 1 should be followed. 
    • Purchase this guide.  In the HL7 Store it can be found in 'HL7 Standard Implementation and Educational Guides.'
  • Determine the secure mechanism by which your lab will send an ELR file. 
  • The National Institute of Standards and Technology (NIST) has provided a guidance document and testing tools for ensuring that certified EHR systems can properly record, modify, retrieve, and submit immunization data to an IIS.

The Process
There is a four-stage process ELR implementation.  Laboratories partnering with HIN to implement ELR will move through this process collaborating with HIN and Maine CDC.

Engage

Laboratories partnering with HIN need to execute a Participant Agreement.  This agreement establishes the terms for both connecting to the statewide health information exchange and connecting to Maine CDC for ELR implementation.  Maine CDC also needs to know which infectious diseases the laboratory will be reporting, the expected volume of reports, and a list of test codes (LOINC or local) that will be reported.  The laboratory and Maine CDC will determine the format of the file to be sent, the frequency of transmission and the method of transmission.

Connect
During pre-validation, the laboratory will create ELR messages using the standard HL7 format.  The purpose of pre-validation is to ensure the HL7 file meets both HL7 and Maine CDC standards.  Traditional disease reporting will continue during this phase.  Note: Once connection has been established, and a test message received by public health in HL7 2.5.1, the laboratory can attest to have met the Meaningful Use Stage 1 requirement for electronic laboratory reporting.

Validate
During validation, the laboratory will transmit production data electronically.  Traditional disease reporting will continue during this phase.  Maine CDC will compare ELR reports with those received via traditional methods, verifying accuracy and completeness of the ELR report.  This will be an iterative process until ELR reports are error-free.  After an agreed-upon length of time of error-free ELR reports, a laboratory will be validated to submit ELR reports in lieu of paper-based reports.  A date will be set for discontinuing traditional disease reporting. 

Operate

During maintenance, the laboratory will inform Maine CDC of any changes or updates to their HL7 message, including updates to their LOINC and SNOMED lists. If the change is significant, validation may need to be repeated. Maine CDC will notify the laboratory of any changes to the list of reportable diseases or reporting rules.  Validation will be assessed annually.