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

Revision Log:

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 ).

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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 104F^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? 

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