NOTE: HHS has published their implementation guidance table: https://www.hhs.gov/sites/default/files/hhs-guidance-implementation.pdf

Revision Log:

11/3/2020: Updated the SCT code description for fever from 426000000^Fever over 104F^SCT to 426000000^Fever greater than 100.4 Fahrenheit^SCT to match HHS implementation guidance.6000000 | Fever greater than 100.4 Fahrenheit (finding) |

9/21/2020: Added note to NOT send Symptom Onset Date AOE, when unknown (as that creates a change in datatype).

9/14/2020: Updated syntax for the Device Identifier, when using the UDI definition (numeric values accessible via the FDA GUUID database)(section ).


Introduction

The purpose of this page is to capture the goals and requirements to enhance ELR reporting in the context of the COVID pandemic, in light of HHS guidance, 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. 

Contributors

NameOrganization
NameOrganization
Rita AltamoreDepartment of Health Washington State
Janet HamiltonCSTE
Ketty AndreasenEpic
Ed HeiermanAbbott
Nancy BarrettCT DPH
Christi HildebrandtGDIT
Brooke BeaulieuCSTE
Jennifer JohnsonGDIT
Amy BittrichDHS Wisconsin
Riki MerrickAPHL, HL7 Orders & Observations Co-Chair, IHE Pathology and Laboratory Medicine Co-Chair
Laura BleielEpic
Craig NewmanAltarum, HL7 Public Health Co-Chair
Hans BuitendijkCerner, HL7 Orders & Observations Co-Chair, EHRA Standards & Interoperability Chair
Tom OswellSunquest Information Systems
David BurgessLabCorp, HL7 Orders & Observations Co-Chair
Andrea Pitkus, PhD, MLS(ASCP)CMLaboratory LOINC Committee Member, previously of Laboratory Interoperability Cooperative (LIC) focused on ELR
Coutney FitzgeraldCerner Public Health Surveillance
Dan RutzEpic
Freida HallQuest Diagnostics
Kathy WalshLabCorp
Jason HallCDC
Michael WatersFDA



Mary WedigSLH Wisconsin


















 Definitions

Current Challenges

When ELRs are sent to PHA at times, they may not contain sufficient demographic, and other data as required by public health by law.  This guidance aims to facilitate collection and transmission of these vital data at order entry, for transmission to the performing laboratory and on to the respective PHA.  While some of the data may be part of a provider eCR report to public health, eCR is out of scope for this discussion, but ELR data would need to be aligned with eCR reporting.  These data often available at order entry, and their transmission to the performing laboratory and in that lab's ELR report, may be the first notice to PHA and accelerate PHA processes.

Currently, the following are the data flows that would be impacted:  

As certification to HL7 ELR R1 IG is not required for EHRs, nor LISs, and adoption of certified ELR capabilities is voluntary under CMS' Meaningful Use/Promoting Interoperability program for providers, while not addressed in other programs for Laboratory (e.g., CLIA), while states introduce further variations, and lab order transaction formats are not addressed anywhere, implementations across all data flows vary widely and production use of HL7 EHR R1 IG is limited.  Additionally, the ELR reporting enhancements could almost all be addressed with the latest HL7 LRI R1 STU R3 IG, but that has not been adopted by anybody, since it was not included in MU regulation. 

Additionally, as 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. 

Throughout the data collections and flows there are numerous challenges  in terms of data not being able to be collected (even if it could be available), 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. 

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.

In short, 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, with the least amount of effort to meet the deadlines.

Existing Implementation Guides

Considering the existing implementation guides and updates to them in flight, upgrading to the latest versions would support most of the requirements and address the challenges outlined above, but still would require various updates to address all requirements.  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.

We suggest that HHS works with the key stakeholders and HL7 to pursue these updates as quickly as possible to enable adoption.  In the meantime, the following section outlines the specific short-term guidance to make substantive progress that also prepares the industry for future adoption of the guides referenced above.

Implementation Guidance for Immediate Use

As adoption of the latest guides is not an option short term, we recommend to adopt the following specific guidance to enable communication of the data in the HHS guidance.

This guidance is based on the technique of pre-adopting the relevant capabilities from more current HL7 v2 versions in context of the latest applicable implementation guides referenced in the prior section, which is an acceptable approach that is reflected in many HL7 implementation guides already.  Thus this can be added to any existing HL7 v2.x based ELR specification, recognizing that certain software and integration engines may not recognize and therefore fail "mixed" content without further work.

General

The following identifies for each of the data elements called out by the HHS guidance where in a v2 message it should be communicated. 

Mapping Tables

The embedded spreadsheet includes tabs for each of the tables below as an alternative format.

Optionality Legend: O-Optional, R-Required (cannot be blank), RE-Required but can be empty if not available, ND-Not Desired by HHS, NF-Not Forwarded to HHS, C-Conditional

Demographic Data

SeqNameOptionalityDefinitionHL7 MappingImplementation guidanceComments / Open questions
1Patient date of birthRE-PHA, O-HHSThis is the preferred field to populate.PID-7

2Patient raceRE-PHA, RE-HHSUsed for socio-demographic analytics, and as permitted by jurisdiction.  This may be different than the race used for clinical interpretation (e.g., reference range).  If a race is needed for clinical interpretation as well, that must be communicated with an AOE in addition to this field.PID-10

Code using the expanded value set of HL70005 with these additonal values:
PHC1175^Refused to answer^CDCPHINVS

UNK^Inknown^NULLFL 

We can use this existing value set in use in case notification

(PHVS_RaceCategory_CDC_Ref)

UPDATED: instead of using PHC1175 will support ASKU^Asked but unknown^NULLFL, so need a different value set

We will need to define this value set for the LAB_PH_HHS_ELR_Guidance_Component; listing the new values as permitted .

3Patient ethnicityRE-PHA, RE-HHSUsed for socio-demographic analytics, and as permitted by jurisdiction.  PID-22

If there is a desire to include refused to answer we will have to expand the traditional ELR R1 value set of HL70189 (PHVS_EthnicGroup_HL7_2x) to include:

PHC1175^Refused to answer^CDCPHINVS 

UPDATED: instead of using PHC1175 will support ASKU^Asked but unknown^NULLFL, so need a different value set

We will need to define this value set for the LAB_PH_HHS_ELR_Guidance_Component; liting the additional value as permitted.

4Patient sexRE-PHA, RE-HHSUsed for socio-demographic analytics, and as permitted by jurisdiction.  This may be different than the sex used for clinical interpretation (e.g., reference range).  If a sex is needed for clinical interpretation as well, that must be communicated with an AOE in addition to this field.PID-8

Send only the codes from HL70001 table

(PHVS_AdministrativeSex_HL7_2x)


5Patient residence zip codeRE-PHA, RE-HHS
PID-11.5

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)

6Patient residence countyRE-PHA, RE-HHS
PID-11.9ELR R1 requires use of numeric FIPS 6-4 codes (PHVS_County_FIPS_6-4)

Some jurisdictions consider a combination of age, sex and county PII, because of the population density - need to accommodate that by allowing creation of regions


7Patient name (Last name, First name, Middle Initial)R-PHA, NF-HHS
PID-5

8Patient street addressRE-PHA, NF-HHS
PID-11.1

9Patient phone number with area codeRE PHA, NF HHS
PID-13This assumes it is the patient's home phone

Order Data

SeqNameOptionalityDefinitionHL7 MappingImplementation guidanceComments
1Ordering provider addressRE-PHA, NF-HHS
ORC-24.1
The street information is not forwarded and sometimes the city (based on PHA request); state is forwarded (and zip is its own elemetn further down)
2Ordering provider phone numberRE-PHA, NF-HHS
ORC-14/OBR-17

3Ordering provider name and NPI (as applicable)RE-PHA, RE-HHSIf the ordering provider is not known, then the ordering facility should be included.ORC-12 / OBR-16

Ordering Provider Name is in ORC-12.2 / OBR-16.2 and ORC12.3 / OBR-16.3;

NPI would be ORC-12.1 / OBR-16.1; when populating ORC-12.1 / OBR-16.1 also populate ORC-12.9/OBR-16.9 as: "NPI&2.16.840.1.113883.4.6&ISO"
and ORC-12.13/OBR-12.13 as "NPI"

For some testing there may not be a specific ordering provider (e.g. employment related testing, mass screening) - it is a CLIA requirement so need to ensure that this is provided. 

What about ordering provider for home test (is covered through doctor office or on-line doctor who ordered).

For drive-thru it is possibly the Surgeon General or appropriate Medical officer

4Ordering provider zipRE-PHA, C-HHS

The zip code of the location where the ordering provider is located at the time of ordering.  

Condition: If patient is in a low density area this should not be forwarded to HHS.

ORC-24.5


5Date test ordered (date format)RE-PHA, RE-HHS
ORC-15
For the PH_HHS_ELR_Guidance_component this element will be RE
6Test ordered – use harmonized LOINC codes provided by CDCR-PHA, R-HHSThe test currently being reported to PHA as the test orderedOBR-4

LOINC is strongly recommended in ELR R1

Use the code from column "LOINC Order Code" and optionally description from colum "LOINC Order Code Long Name" in the CDC LIVD mapping file

The LIVD document in the link currently does not cover order LOINCs - that needs to be clarified by HHS

Ask at Order Entry

Valueset for Y/N/U - Use PHINVADS valueset (Y/N from HL70136 and UNK from V3 Nullflavor) that is used for Case notifications: https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888.  U is replaced with UNK below, except as noted in the implementation guidance.

Note that the following OBX fields are not usually expected for AOEs:

Note that various AOEs do not have published LOINC codes yet.  These have been created in the 2.69 pre-release and are marked with "2.69-pre".  Once published they should be communicated with the published release number, likely "2.69".

Note that HHS and CDC are working on finalizing wording of the AOEs and associated LOINC coding.  That may result in a different LOINC code and/or a change in questions.  We will update this section as soon as HHS and CDC finalize the wording and associated LOINC coding.

NOTE: July 28th Updates are captured in red font below

SeqNameOptionalityDefinitionAllowable AnswersImplementation GuidanceComments
1

First test

Suggest to HHS to change to: Whether this is the patient's first test for the condition of interest


RE-HHS - changed to optionalPatient's first test for the condition of interest that is being ordered.Y/N/UNKOBX-2 = CWE
OBX-3 = 95417-2^First test for condition of interest^LN
OBX-5 OBX-5 can be one of:
Y^Yes^HL70136
N^No^HL70136
UNK^Unknown^NULLFL
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

LOINC: 95417-2^Whether this is the patient's first test for the condition of interest^LN^^^^2.69-pre

Questions for HHS:

  • What is the intent of its use and does the patient have to answer it?
  • Is this for the exact test code ordered, or the type of order?  If the latter, what types do we need to consider like or different?  E.g. if a provider is ordering a COVID-19 serology test, but the patient has had a PCR test done in the past, would we say Y or N?  
  • Is this only for tests ordered within that organization, or ordered anywhere anytime?  E.g., since it’s possible that the patient has had other tests through other means (e.g. walk-up clinics, or at a separate ED, etc.)?
  • Is it relevant for previous test for diagnostic, screening, or research.
  • Is there clarification between first diagnostic test and first screening test?
1aType of most recent testOptionalCondition: If First Test is N

Molecular

Antigen

Antibody

Unknown


Questions to resolve:

How is this expected to be reported?

How are patients going to know what type of test was performed?

How are providers going to know if the test results are not in their system?

Depending on how this will be reported, how is this result going to be differentiated from the current result, so it is not counted again?

Hasn't this result already been reported?

Why do labs have to report this, when this is clinical data?


1bResult of most recent testOptional

Detected

Not detected

Unknown

1cTest performed dateOptional

YYYY[MM][DD]]
2

Employed in healthcare?

Suggest to HHS to change to: Whether patient is employed in a healthcare setting

RE- HHSThe main focus is on patients who work in a high-risk setting with patients who could be a super spreader. (first responders, front line clinicians, environmental staff, therapists, in direct contact with patients or in their location).

Y/N/UNK


OBX-2 = CWE
OBX-3 =  95418-0^Employed in a healthcare setting^LN
OBX-5 OBX-5 can be one of:
Y^Yes^HL70136
N^No^HL70136
UNK^Unknown^NULLFL
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

LOINC: 95418-0^Whether patient is employed in a healthcare setting^LN^^^^2.69-pre


2aIf Yes - What is your occupation?Optional for Aug 1, 2020Condition: If Employed in Healthcare is Y

OBX-2 = CWE

OBX-3 = 85658-3^Occupation [Type]^LN

OBX-5 = SNOMED CT codes from this list:

223366009 Healthcare Professional

More Detailed Healthcare Professional List

OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

Suggested LOINC: 85658-3^Occupation [Type]^LN^^^^2.68

Comments/Questions:

Has NIOSH weighed in on the use of SNOMED CT codes?

APHL suggests to allow use of OTH^Other^NULLFL, so that other settings can be reported in OBX-5.9

This is really not lab related data and should be available in the case report / case notification.

3

Symptomatic as defined by CDC?

Suggest to HHS to change to: Whether patient has symptoms related to condition of interest

RE-PHA, RE-HHSSymptomatic per current CDC guidance at time of order for the reportable condition/illnessY/N/UNKOBX-2 = CWE
OBX-3 = 95419-8^Has symptoms related to condition of interest^LN
OBX-5 OBX-5 can be one of:
Y^Yes^HL70136
N^No^HL70136
UNK^Unknown^NULLFL
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

LOINC: 95419-8^Whether patient has symptoms related to condition of interest^LN^^^^2.69-pre

(Note that no LOINC is currently listed on the CDC FAQ page but it is expected to be corrected soon)

3a

Date of Symptom Onset

Suggest to HHS to change to: Illness or injury onset date and time  HHS changed the LOINC

C-PHA, C-HHS

Condition: If Symptomatic is Y.mm/dd/yy

OBX-2 = DT
OBX-3 = UPDATED LOINC 65222-2^Date and time of symptom onset^LN

11368-8^Illness or injury onset date and time^LN
OBX-5 = formatted as YYYYMMDD
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

NOTE: Do NOT send Symptom Onset Date AOE, when unknown (as that creates a change in datatype)

UPDATED LOINC 65222-2^Date and time of symptom onset^LN^^^^2.68

LOINC: 11368-8^llness or injury onset date and time^LN^^^^2.68

3bIf Yes - What were the symptoms experienced?Optional for Aug 1, 2020Condition: If Symptomatic is Y.

OBX-2 = CWE
OBX-3 =75325-1^Symptom^LN

OBX-4 = if needed for more than one symptom (suggest to number sequentially starting with "1" for each occurrence)

OBX-5 can be one of:

49727002^Cough^SCT
426000000^Fever over 100.4 Fahrenheit^SCT
267036007^Shortness of Breath^SCT
84229001^Fatigue^SCT
25064002^Headache^SCT
62315008^Diarrhea^SCT
103001002^Feeling feverish^SCT
43724002^Chills^SCT
230145002^Difficulty breathing^SCT
68962001^Muscle pain^SCT
36955009^Loss of sense of taste^SCT
44169009^Loss of sense of smell^SCT
162397003^Sore throat^SCT
68235000^Nasal congestion^SCT
64531003^Nasal Discharge^SCT
422587007^Nausea^SCT
422400008^Vomiting^SCT

OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

When more than one symptom apply send each as a separate OBX segments using OBX-4 to differentiate individual answers - in the future it is anticipated that the LAB_PH_HHS_ELR_Guidance_Component will also support multiple repeats of OBX-5 when OBX-29 is valued 'QST'

Suggested LOINC: 75325-1^Symptom^LN^^^^2.68

Comments:

APHL suggests to allow use of OTH^Other^NULLFL, so that other settings can be reported in OBX-5.9

This is really not lab related data and should be available in the case report / case notification.

5

Hospitalized?

Suggest to HHS to change to: Whether patient was hospitalized because of this condition


RE-PHA, RE-HHS

Patient has been hospitalized for the reportable illness/condition that this order has been placed for (suspected or diagnosed)

When ordered during ER duration, the answer would be N.


OBX-2 = CWE
OBX-3 =  77974-4^Patient was hospitalized because of this condition^LN
OBX-5 can be one of:
Y^Yes^HL70136
N^No^HL70136
UNK^Unknown^NULLFL
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

LOINC: 77974-4^Whether patient was hospitalized because of this condition^LN^^^^2.68


When interested in whether hospitalized at time of order, use PV1-2 (Patient Class).

Comment:

The CDC web page lists a follow up question here with these expected answers:

840544004^Suspected disease caused by 2019 novel coronavirus (situation)
840539006^Disease caused by 2019 novel coronavirus (disorder)

This seems to indicate the case status, which is something that is determined during case investigation, not at time of test order expect this to be removed

6

ICU?

Suggest to HHS to change to: Whether patient was admitted to intensive care unit for condition of interest

RE-PHA, RE-HHS

Patient has been admitted/transferred to the ICU at any time during the encounter for the reportable illness/condition that the order has been placed for (suspected or diagnosed).

Y/N/UNKOBX-2 = CWE
OBX-3 =  95420-6^Admitted to intensive care unit for condition of interest^LN
OBX-5 can be one of:
Y^Yes^HL70136
N^No^HL70136
UNK^Unknown^NULLFL
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

LOINC: 95420-6^Whether patient was admitted to intensive care unit for condition of interest^LN^^^^2.69-pre

When interested in whether in ICU at time of order, use PV1 location/organization providing care.

Comment:

On the CDC page a single SNOMED CT code is listed If ICU is Yes, which is ICU - expect this to be removed, as it does not provide further information.

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)

Suggest to HHS to change to:  Whether patient resides in a congregate care setting

RE-PHA, RE-HHS

This is at time of exposure where they normally live.Y/N/UNKOBX-2 = CWE
OBX-3 =  95421-4^Resides in a congregate care setting^LN
OBX-5 can be one of:
Y^Yes^HL70136
N^No^HL70136
UNK^Unknown^NULLFL
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

LOINC: 95421-4^Whether patient resides in a congregate care setting^LN^^^^2.69-pre

7aIf YES, what type of residence is the congregate care setting?Optional for August 1, 2020Condition: If Congregate Care setting is Yes
OBX-2 = CWE
OBX-3 =  75617-1^Residence type^LN
OBX-5 can be one of:
22232009^Hospital^SCT
2081004^Hospital ship^SCT
32074000^Long term care hospital^SCT
224929004^Secure hospital^SCT
42665001^Nursing home^SCT
30629002^Retirement home^SCT
74056004^Orphanage^SCT
722173008^Prison-based care site^SCT
20078004^Substance abuse treatment center^SCT
257573002^Boarding house^SCT
224683003^Military accommodation^SCT
284546000^Hospice^SCT
257628001^Hostel^SCT
310207003^Sheltered housing^SCT
257656006^Penal institution^SCT
285113009^Religious institutional residence^SCT
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

Suggested LOINC: 75617-1^Residence type^LN^^^^2.68

Comments:

APHL suggests to allow use of OTH^Other^NULLFL, so that other settings can be reported in OBX-5.9

This is really not lab related data and should be available in the case report / case notification.

8Pregnant?C-PHA, C-HHS

Condition: If patient is female

Current pregancy status of the patient

Pregnant, Not pregnant, UnknownOBX-2 = CWE
OBX-3 =   82810-3^Pregnancy status^LN
OBX-5 can be one of:
77386006^Patient currently pregnant^SCT
102874004^Possible pregnancy^SCT
60001007^Not pregnant^SCT
UNK^Unknown^NULLFL (Note: Expect to have 261665006^Unknown^SCT on the CDC page be updated to UNK^Unknown^NULLFL)
OBX-11 = F
OBX-14 = Date question was answered
OBX-29 = QST

LOINC: 82810-3^Pregnancy status^LN^^^^2.68

LOINC from https://loinc.org/sars-cov-2-and-covid-19/

9

Patient age



C-PHA, RE-HHS

For reporting from PHA to HHS (CDC), when DOB may not be included or in ELR, when DOB is not available.

Condition for PHA: If Patient Date of Birth is not available or cannot be calculated correctly to reflect the age at time of order, then include the age at time of specimen collection using the methodless LOINC (30525-0^Age^LN).


Send as AOE OBX:

OBX-2 = NM (can be SN)
OBX-3 = 30525-0^Age^LN^^^^2.68
OBX-5 = numeric value
OBX-6 = age units in UCUM as applicable - expected as years => a^year^UCUM
other options:
months => mo^month^UCUM
days => d^day^UCUM
hours => h^hour^UCUM
OBX-29 = QST

Questions for HHS:

Can HHS accept DoB and figure out the age so we don't need to calculate? 

Specimen Collection

SeqNameOptionalityDefinitionHL7 MappingImplementation guidanceComments
1Date specimen collected (date format)R-PHA, R-HHS

OBR-7

also in SPM-17 (2.5 and up)

OBR-7 is required;ELR allows use of 0000, when date is unknown
2Specimen Source - use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codesR-PHA, R-HHS

SPM-4 (after 2.5)

OBR-15.1



SPM-8 (after 2.5)

OBR-15.4

Code to SNOMED CT codes for SPM-4 as provided in the "Vendor Specimen Description" column of the "LOINC Mapping" tab in the CDC LIVD mapping file; ELR also allows use of both SNOMED CT codes from the speicmen hierarchy (PHVS_Specimen_CDC) and  HL70487 codes (PHVS_SpecimenType_HL7_2x)

Some labs may support the sending of source site information; ELR R1 uses SNOMED CT codes compiled in the HITSP body site value set (PHVS_BodySite_HITSP)


3Accession #/Specimen IDR-PHA, R-HHS

ORC-3/OBR-3

SPM-2 (V2.5 and up)

This is the testing lab's specimen ID or accession number - may also send the submitters specimen ID / accession number
In older versions of HL7 only ORC-3/OBR-3 can be used; for the submitter's accession number use ORC-2/OBR-2.


Test Result

SeqNameOptionalityDefinitionHL7 MappingImplementation guidanceComments
1Performing facility name and/or CLIA number, if knownR-PHA, R-HHS

OBX-23 (V2.5.1 and up)

ORC-15

In older versions of HL7 OBX-15 (Producer's ID can be used for the Performing Lab ID) or it can be conveyed in the NTE following the result OBX, ensuring it is included on the report.


2Performing facility zip codeR-PHA, R-HHS
OBX-24 (V2.5.1 and up)In older versions of HL7 this information can be conveyed in the NTE following the result OBX, ensuring it is included on the report.


3Device IdentifierRE-PHA, RE-HHS

The test kit/reagent(s) used to perform the test, and as necessary the instrument platform(s) when used off-label.  The EUA may be used when used as authorized.


OBX-17




OBX-18 (v2.4 and up)

Use OBX-17 when describing the manufacturer and model of either test kit (reagent) or instrument used; or when referencing the EUA (see more detailed guidance below).
Use OBX-18 when passing the serial number or UDI of the test kit (reagent) or instrument

The model is acceptable.  It is allowed to use the Device Identifier (as defined per FDA's UDI definition) or the UDI Carrier (the full human readable form of the barcode) instead or as well if that can be obtained.

For the PH_HHS_ELR_Guidance_component OBX-18 will be RE

4Test result R-PHA, R-HHSThis is the code of the test being resulted.OBX-3LOINC Is required in LRI and ELR R1, when an appropriate LOINC exists - since this points to LIVD, as long as LOINC is listed there for the manufactueer test kit, MUST use.Include the fully structured test code, name, and code system of the applicable LOINC code in accordance with the CDC guidance for the reportable illness/condition
5Test result valueR-PHA, R-HHSThe result value.OBX-5

For coded results use the appropriate SNOMED CT code for qualitative result values in accordance with the CDC guidance for the reportable illness/condition.

For numeric results include units in OBX-6 when appropriate (code units in UCUM)

Suggest to HHS to clarify, that not all results are coded.

6Test Result dateRE-PHA, R-HHSThe date the test result was obtained and approved for release

OBX-19 (V2.4 and later)

OBR-22 (as proxy in V2.3.1 and earlier)

Must be sent for each result - may not be populated for AOE OBX segments

Note: For v2.3.1 and earlier, OBR-22 should reflect the date/time when OBR-25 was set to F.  Generally, for an OBR including multiple OBX segments it would be equal to or later than the  most recently finalized OBX, but without OBX-19 available OBR-22 is the closest one can get.

Device Identification

There are four components that are potentially of interest for which to include an "identifier":

There is no need to include identification information for calibrators, controls, or collection devices.

These devices can be identified as a kind of using three different approaches:


The device identification information will be captured in either OBX-17 when describing the kind and OBX-18 when describing an instance.

In order to differentiate which of the devices is being described we propose a list of abbreviations to represent each kind (for use in OBX-17)

ElementType of identifierAbbreviation for the type
Emergency Use AuthorizationEUAEUA
Testkit/reagentModelMNT
Testkit/reagentDevice IDDIT
Instrument PlatformModelMNI
Instrument PlatformDevice IDDII
Manual kitModelMNM
Manual kitDevice IDDIM

Sept 14, 2020 update:

In OBX-17 use OBX-17.1 for the device identification information using the format <Model name or Diagnostic (Letter of Authorization)>_<Manufacturer name>_<Abbreviation for the type> and in OBX-17.3 "99ELR". For Device ID omit "_<Manufacturer name>" resulting in <Device ID>_<Abbreviation for the type> in OBX-17.1. 

Best place to obtain these values is the CDC LIVD file (https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html):

<Model name or Diagnostic (Letter of Authorization)>_<Manufacturer name> is provided in the  in Testkit Name ID (column M); the <Abbreviation for the type> in Testkit Name ID Type (column N)  and concatenate: <Testkit Name ID>_<Testkit Name ID Type>.

<Device ID> in Equipment UID (column O); the <Abbreviation for the type> is in Equipment UID Type (column P)

Using Abbotts ID Now as example:

Using the EUA ID = ID NOW COVID-19_Abbott Diagnostics Scarborough, Inc. EUA
Using the Device ID = 10811877011269_DII^^99ELR

Where OBX-17.1 length limits interfere with the full identification use the following approach:

OBX-17: ID NOW COVID-19_Abb#^^99ELR

Full ID for the NTE: ID NOW COVID-19_Abbott Diagnostics Scarborough, Inc._EUA


Alternatively these devices can be identified as the specific instance used in testing by their UDI as defined by FDA (for use in OBX-18).

Since the OBX-17 and OBX-18 fields can repeat, multiple values can be communicated.  While the newer PRT segment can improve on this somewhat, it still would require a new field to maintain these relationships.  Shifting to FHIR where this already can be addressed is not realistic in the timelines needed and given most LIS/LIMS currently lack FHIR functionality.  However, given the likely configurations being used, we do not believe we need to address that yet while data curation in the analtyics phase can address this challenge. 


ScenarioLocation in messageFormat to be usedInstructionsWhere to find the information
Cepheid Xpert Xpress SARS-CoV-2 test used as described in EUAOBX-17Xpert Xpress SARS-CoV-2 test_Cepheid _EUA

OBX-17.1 = <Diagnostic (Letter of Authorization)>_<Manufacturer name>_EUA

OBX-17.3 = "99ELR"

CDC LIVD mapping file in the "Testkit Name ID" column, when identified as EUA in "Testkit Name ID Type" column

Abbott ID now as described in EUAOBX-17ID NOW COVID-19_Abbott Diagnostics Scarborough, Inc. _EUA

OBX-17.1 = <Diagnostic (Letter of Authorization)>_<Manufacturer name>_EUA

OBX-17.3 = "99ELR"

CDC LIVD mapping file in the "Testkit Name ID" column, when identified as EUA in "Testkit Name ID Type" column
LDT listed in Appendix A OBX-17

Cormeum SARS-CoV-2 Assay_Cormeum Laboratory Services_EUA

OBX-17.1 = <Letter Granting Inclusion under EUA>_<Laboratory>_EUA

OBX-17.3 = "99ELR"

CDC LIVD mapping file in the "Testkit Name ID" column, when identified as EUA in "Testkit Name ID Type" column





CDC test run on Abbott m2000 using model namesOBX-17 for test kitCDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel_CDC_MNT

OBX-17.1 = <Test kit name>_<Manufacturer name>_MNT

OBX-17.3 = "99ELR"

Name used in package insert (or "Testkit Name ID" column, when identified as MNT in "Testkit Name ID Type" column in the CDC LIVD mapping file)
CDC test run on Abbott m2000 using model namesOBX-17 for instrumentm2000 RealTime System_Abbott_MNI

OBX-17.1 = <Instrument name>_<Manufacturer name>_MNI

OBX-17.3 = "99ELR"

Name used in package insert (or "Testkit Name ID" column, when identified as MNT in "Testkit Name ID Type" column in the CDC LIVD mapping file)





bioMérieux ARGENE SARS-COV-2 R-GENE test run on ABI 7500 Fast Dx Real-Time PCR Instrument using device IDOBX-17 for test kit423735_bioMérieux_DIT

OBX-17.1 = <Device ID>_<Manufacturer name>_DIT

OBX-17.3 = "99ELR"

CDC LIVD mapping file in the "Testkit Name ID", when identified as DIT in "Testkit Name ID Type" column
bioMérieux ARGENE SARS-COV-2 R-GENE test run on ABI 7500 Fast Dx Real-Time PCR Instrument using device IDOBX-17 for instrument4351106_Applied Biosystems_DII

OBX-17.1 = <Device ID>_<Manufacturer name>_DII

OBX-17.3 = "99ELR"

CDC LIVD mapping file in the "Product UID" column





Manual test kit for AB testing using model nameOBX-17 for manual test kitSARS-CoV-2 IgM/IgG Antibody Test Kit_Biohit Healthcare_MNM

OBX-17.1 = <Manual kit name>_<Manufacturer name>_MNM

OBX-17.3 = "99ELR"

CDC LIVD mapping file in the "Testkit Name ID"  column, when identified as MNT in "Testkit Name ID Type" column





PH Lab developed test kit on Roche Cobas 6800 using model name for bothOBX-17 for test kitSARS-COV-2 rt-PCR_SLOPHL_MNT

OBX-17.1 = <modelname = whatever the lab calls it>_<Labname = manufacturer name>_MNT

OBX-17.3 = "99ELR"

PH lab documentation
PH Lab developed test kit on Roche Cobas 6800 using model name for bothOBX-17 for instrumentcobas® 6800/8800 Systems_Roche_MNI

OBX-17.1 = <IVD platform model name>_<Manufacturer name>_MNI

OBX-17.3 = "99ELR"

LIVD file from Roche in the "Model" column
PH Lab developed test kit on Roche Cobas 6800 using model name for kitOBX-17 for test kitSARS-COV-2 rt-PCR_SLOPHL_MNT

OBX-17.1 = <modelname = whatever the lab calls it>_<Labname = manufacturer name>_MNT

OBX-17.3 = "99ELR"

PH lab documentation
PH Lab developed test kit on Roche Cobas 6800 usingUDI for instrumentOBX-18 for instrument

[udi carrier]^2.16.840.1.113883.3.3719^ISO

OBX-18.1 = [udi carrier]

OBX-18.3 = "2.16.840.1.113883.3.3719"

OBX-18.4 = "ISO"

Device documentation (package insert/label)






Using Roche COBAS INTEGRA 400 plus using Device IdentifierOBX-174015630924592_Roche_DII

OBX-17.1 = <Device ID>_<Manufacturer name>_DII

OBX-17.3 = "99ELR"

LIVD file from Roche "Product Reference UID" provides the identifier; "Product Reference UID Type" was listed as GITN, indicating it is a device ID





UDI carrier scanned on  barcode using OIDOBX-18

OBX-18.1 = [udi carrier]

OBX-18.3 = "2.16.840.1.113883.3.3719"

OBX-18.4 = "ISO"

Device documentation (package insert/label) on instrument, test kit (or box), or manual kit
UDI carrier scanned on barcode using URIOBX-18

OBX-18.1 = [udi carrier]

OBX-18.3 = "http://hl7.org/fhir/NamingSystem/fda-udi"

OBX-18.4 = "URI"

Device documentation (package insert/label) on instrument, test kit (or box), or manual kit

Flat File

ONLY if no HL7 v2.x support then use flat file to HL7 converter excel file - first box on this page: https://preparedness.cste.org/?page_id=136.  But if you have a HL7 v2 feed continue to use and upgrade as quickly as possible.

If you do not have an HL7 v2 feed, work with your PHA to determine when you can put that in place.

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