The purpose of this page is to capture the goals and requirements to enhance ELR reporting in the context of the COVID pandemic, and in that context provide clear guidance to all parties in the communication flow to enhance their contributions to enhance the ELR transaction to a Public Health Authority.
This is meant to be a working document that we rapidly evolve based on latest understanding. Once it is believed to be sufficiently complete and accurate it will be published elsewhere as a guidance document.
Hans Buitendijk - Cerner, HL7 Orders & Observations Co-Chair, EHRA Standards & Interoperability Chair
David Burgess - LabCorp, HL7 Orders & Observations Co-Chair
Freida Hall - Quest Diagnostics
Jason Hall - CDC
Janet Hamilton - CSTE
Riki Merrick - APHL, HL7 Orders & Observations Co-Chair, IHE Pathology and Laboratory Medicine Co-Chair
Craig Newman - Altarum, HL7 Public Health Co-Chair
Andrea Pitkus- University of Wisconsin-Madison
Dan Rutz - Epic, IHE ???
Kathy Walsh - LabCorp
Michael Waters - FDA
When ELRs are sent to PHA at times, they may not contain sufficient demographic, and other data as is necessary required by public health by law. While some of that data could be part of a subsequent eCR, if the data is already available at time of order and ELR transmission before an eCR is available (or the next eCR is available) helps accelerate the process.
Although ELR has been required of all laboratories performing testing for reportable conditions, only Eligible Hospital labs have been required [Andrea: this is inaccurate. EHs are NOT required to use that format. Inclusion as a Certification Criterion did not make it required. CMS MU/PI could have made it required, but did not either. It is one of the CHOICES they have. So, a number of EHRs did certify against it, even a number of LIS systems effectively did (as they are always responsible to send an ELR), but many providers did not make the choice to do so. ] (Hans, which part do you think is inaccurate and can you provide the required format you believe has been in effect? I'm interested in seeing what you are seeing. ELR has been part of MU for EHs since Stage 1 MU. Certification criteria for vendors has been based upon the HL7 v2.51 IG referenced in the federal rules as certification has been handled nationally (in other words, health it vendors have not been certified by each jurisdiction). NIST has ELR certification test tools vendors are tested upon when they get certified. See https://www.cdc.gov/ehrmeaningfuluse/elr.html and https://www.cdc.gov/elr/technicalstandards.html and https://hl7v2-elr-testing.nist.gov/mu-elr/
Furthermore if you search the ONC CHPL website of Certified Health IT Products ( https://chpl.healthit.gov/#/search )and filter for those certified against the criterion for transmission of reportable lab tests and results, you'll see the 108 vendors who have met the certification requirements. Most are LISs, but some are interface engines or other modules/products.
Each jurisdiction indicates their onboarding criteria for ELR, which may be exactly the same as the IG or they may include additional fields or make some optional. It's up to the sender to comply with each jurisdiction's requirements as part of their onboarding process. using a certified vendor system. What drives vendors crazy is there are slight differences for a state and sometimes they need to modify their interfaces to meet some of these criteria. They wish requirements were exactly the same nationally. These requirements (using a certified vendor system, HL7 2.51 messages, LOINC encoded results, SCT encoded qualitative result values. Here's information from NCDPH's ELR page on their requirements: https://epi.dph.ncdhhs.gov/cd/meaningful_use/elr.html You'll note near the bottom of the page they indicate their criteria is "more extensive" than ONC's requirements. Here's Florida Health's criteria for ELR for MU: http://www.floridahealth.gov/diseases-and-conditions/disease-reporting-and-management/florida-meaningful-use.html and http://www.floridahealth.gov/diseases-and-conditions/disease-reporting-and-management/_documents/elr-implementation-guide.pdf They also list how they wish pregnancy status and other info typically collected as AOEs to be sent.
That all said, for non hospital labs, they don't need to meet MU criteria (such as using a certified vendor system) as they have been ineligible for incentives. They do however, need to meet each jurisdiction's criteria still. Often the jurisdiction will require LOINC and SNOMED CT, but may allow either HL7 v2.31 or v2.51 messaging to be sent by the performing lab. Als
Laboratories are the entities that report reportable conditions using ELR. Reportable conditions are reported by providers using electronic Case Reporting (eCR) or other surveillance functionality.
When I was at CAP, I was part of the CDC & ONC funded Laboratory Interoperability Cooperative (LIC) team, which was tasked to assist 500 hospital labs including 100 CAH labs with their ELR for MU. We worked with about half of the public health jurisdictions across the country. About the same time, Riki was on a sister grant assisting public health laboratories with their ELR criteria. I believe they worked with about 11 public health jurisdictions. Riki please correct me if I've recalled incorrectly.)
to send HL7 v 2.51 messages with LOINC and SNOMED CT codes conforming to each PHA jurisdiction's requirements for the past decade using a vendor system certified to provide functionality according to the HL7 ELR Guide in Meaningful Use regulations. For the remainder of laboratories (i.e. blood banks, reference labs, government/DOD labs, independent labs), they need to meet each jurisdictions ELR requirements based upon the HL7 2.51 ELR IG [Andrea: since when do they meet that guide? (See above references. Is your point about the version of the guide? The version cited in federal rules is not the most recent ELR guide so I'd agree with you there.) We are aware of many variations where the intent is to have used the guide perhaps as a starting point; Riki: yes using the ELR R1 guide as a starting point], but may send messages in HL7 2.3.1 format, which may or may not contain LOINC or SNOMED CT codes or other fields If the PHA onboards the lab, they may accept a variety of fields, formats as long as they are receiving key information. Also it's unclear if point of care testing locations like pharmacies, drive up/drive through testing sites or state national guard collection sites for COVID-19 are 1) reporting ELR at all, 2) providing all required information and 3) those reporting on paper requisitions will not be providing LOINC or SNOMED CT codes and are often lacking demographics, specimen source and other required PHA elements.
Riki proposed replacement paragraph: All laboratories performing tests for reportable conditions are required to report to these to Public Health Agencies. Ideally that is accomplished electronically, hence the name Electronic Lab Reporting (ELR). The HL7 ELR Guide cited in Meaningful Use regulations has been used as the basis in all PHAs to accommodate their local reporting requirements and several Eligible Hospital labs have certified systems, however there are several formats in active use at this time and not all contain LOINC and SNOMED codes, nor all of the elements listed in the HHS guidance. Also it's unclear if point of care testing locations like pharmacies, drive up/drive through testing sites or state national guard collection sites for COVID-19 are 1) reporting ELR at all, 2) providing all required information and 3) those reporting on paper requisitions will not be providing LOINC or SNOMED CT codes and are often lacking demographics, specimen source and other required PHA elements.
Through the process from ordering to reporting, there is a need to:
There are numerous challenges along in this flow in terms of data not being able to be collected, not being documented, not using standard vocabulary, not including it in the order, not forwarding certain data, dropping standard vocabulary, not retaining data, not communicating data available to the PHA. The challenges this guidance is looking at is ensuring that the relevant data can be communicated from ordering provider through a potential intermediary lab to the performing lab and on to PHA as an ELR in a complete, standard, consistent format and with vocabulary.
Currently the specific challenges in that area are:
As indicated before, there are many other challenges to ensure that data is fully, accurately, and consistently documented and communicated, including use of encoded standard vocabulary (at least along with any local coding that remains relevant), but that is not addressed here. Our goal is to provide guidance on how to address the above challenges in the necessary implementation guides that can be deployed as quickly as possible and as consistent as possible across ALL jurisdictions.
We understand that there may be a desire/need to send the original order to PHA directly as well to get earlier insight into certain tests ordered including PHI, particularly during an emergency (as that may invade patient privacy unnecessarily during "normal" situations), but when that interest becomes a requirement, the guidance for the ordering flow is sufficient as the starting point and being extended based on local PHA emergency mandates on how much (or not) PHI is to be removed before forwarding it. That guidance should be as consistent as possible as well, but we will address that when an actual requirement in any jurisdiction is raised.
The following data set is desired to be made available as part of an ELR as much is is available upon placing the order and to the extent that the laboratory has access to any additions before the ELR is sent.
|1||Patient age||Required-HHS||For reporting from PHA to CDC/HHS, when DOB may not be included or in ELR, when DOB is not available|
|2||Patient race||Required-HHS||some jurisdictions used to not allow collection of this information - is that still the case? If so, will this superseed those regulations?|
|3||Patient ethnicity||Required-HHS||some jurisdictions used to not allow collection of this information - is that still the case? If so, will this superseed those regulations?|
|5||Patient residence zip code||Required-HHS|
Some jurisdictions consider a combination of age, sex and zipcode PII, because of the population densitiy - need to accommodate that by allowing creation of regions (and that may be better done in the county field)
|6||Patient residence county||Required-HHS|
Some jurisdictions consider a combination of age, sex and county PII, because of the population densitiy - need to accommodate that by allowing creation of regions
ELR requires use of numeric FIPS 5-2 codes
|7||Patient name (Last name, First name, Middle Initial)||Optional-PHA||It is required for PHA, not desired for HHS|
|8||Patient street address||Optional-PHA||It is required for PHA, not desired for HHS|
|9||Patient phone number with area code||Optional-PHA||It is required for PHA, not desired for HHS|
|10||Patient date of birth||Optional-PHA||It is required for PHA, not desired for HHS|
|1||Ordering provider address||Optional-PHA||It is required for PHA, not desired for HHS|
|2||Ordering provider phone number||Optional-PHA||It is required for PHA, not desired for HHS|
|3||Ordering provider name and NPI (as applicable)||Required-HHS||For some testing there may not be a specific ordering provider (e.g. employment related testing) - it is a CLIA requirement so need to ensure that this is provided|
|4||Ordering provider zip||Required-HHS|
For some low density areas, this may provide too much identification in the HHS feeds
Concern has been raised that this may be hard to decide which to pick, for providers, that have more than one practice location
|5||Date test ordered (date format)||Required-HHS|
|6||Test ordered – use harmonized LOINC codes provided by CDC||Required-HHS||Currently no order code look up available - nor guidance on which LOINC to pick for which order|
|2||Employed in healthcare?||Y/N/U|
|3||Symptomatic as defined by CDC?||Y/N/U|
|4||Symptomatic = Y then Date of Symptom Onset||mm/dd/yy|
|7||Resident in a congregate care setting (including nursing homes, residential care |
for people with intellectual and developmental disabilities, psychiatric treatment
facilities, group homes, board and care homes, homeless shelter, foster care or other setting)
|8||Pregnant?||Pregancy status of the patient||There are 2 LOINCs available|
|1||Date specimen collected (date format)||Required-HHS||ELR allows use of 0000, when date is unknown|
|1||Performing facility name and/or CLIA number, if known||Required-HHS|
|2||Performing facility zip code||Required-HHS|
|3||Device Identifier||Required-HHS||Intent is to know which test has been performed where|
|4||Test result – use appropriate LOINC code, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC||Required-HHS||This is refering to the performed test (observation.code in CDA/FHIR)|
|5||Test result (value) – use appropriate SNOMED CT code as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC||Required-HHS||This is referring to the result value (Observation.value in CDA/FHIR)|
Some results can be numeric, and require units of measure, but no SCT code
some results could be longer text, specifically interpretations
SCT is required for qualitative result values
|6||Test Result date (date format)||Required-HHS|
The following updates need to be made in the base implementation guides for a next version to include the short-term Implementation Guidance provided in the next section.
Use this spreadsheet to collect options and comments around the proposed mapping of the HHS elements to various places in Order and result messages.
Open questions on spreadsheet
Do we need multiple test kits? Ed will check if 1 or 2 UDIs
ROMA is a 2 step immunoassay.
If only device identifier, OBX-18 can handle multiple
If UDI Carrier or UDI, multiple PRTs can handle that.