| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | |
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1 | Index | Segment | Set | Component | Title | Requirement for anonymous reporting (no PII) | Requirement for fully identified reporting (includes PII) | Removed during de-identification by hub | Comment | FHIR Cardinality | FHIR Optionality | FHIR Profile Path | At-Home Mapping | At-Home element description | FHIR IG Dev Notes | |||||||||||
4 | 3 | MSH | 1 | 3.1 | Sending system namespace | Required | Required | {name of App, <20 char} | 0..1 | MS | MessageHeader.source.name | MessageHeader-at-home-in-vitro-test-results.source.name | Sending system namespace (name of app) | |||||||||||||
5 | 4 | MSH | 1 | 3.2 | Sending system OID | Required | Required | See 'Obtaining App Specific Identifiers' | 0..1 | MS | MessageHeader.source.id | MessageHeader-at-home-in-vitro-test-results.source.id | Sending system OID | |||||||||||||
7 | 6 | MSH | 1 | 4.1 | Sending facility name | Required | Required | See 'Obtaining App Specific Identifiers' | 0…1 | MS | MessageHeader.sender(Organization).name | MessageHeader-at-home-in-vitro-test-results.sender(US Core Organization).name | US Core: Name used for the organization | |||||||||||||
8 | 7 | MSH | 1 | 4.2 | Sending facility ID | Required | Required | See 'Obtaining App Specific Identifiers' | 0..1 | MS | MessageHeader.sender(Organization).identifier.value | MessageHeader-at-home-in-vitro-test-results.sender(US Core Organization).identifier:CLIA.value | US Core: Clinical Laboratory Improvement Amendments (CLIA) Number for laboratories | References US Core Organization profile, no use-case specific description | ||||||||||||
9 | 8 | MSH | 1 | 4.3 | Sending facility ID type | Required | Required | “CLIA” | 0..1 | MS | MessageHeader.sender(Organization).identifier.system | MessageHeader-at-home-in-vitro-test-results.sender(US Core Organization).identifier.system | US Core: The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.4.7 | References US Core Organization profile, no use-case specific description | ||||||||||||
10 | 9 | MSH | 1 | 5.1 | Receiving system namespace | Required | Required | To be provided by receiving system | 0..1 | MS | MessageHeader.destination.name | MessageHeader-at-home-in-vitro-test-results.destination.name | Receiving system namespace (name of destination application) | |||||||||||||
11 | 10 | MSH | 1 | 5.2 | Receiving system OID | Required | Required | To be provided by receiving system | 0..1 | MS | MessageHeader.destination.id | MessageHeader-at-home-in-vitro-test-results.destination.id | Receiving system OID | |||||||||||||
13 | 12 | MSH | 1 | 6.1 | Receiving facility name | Required | Required | To be provided by receiving system | 1…1 | MS | MessageHeader.destination.receiver(Organization).name | MessageHeader-at-home-in-vitro-test-results.receiver(US Core Organization).name | US Core: Name used for the organization | References US Core Organization profile, no use-case specific description | ||||||||||||
14 | 13 | MSH | 1 | 6.2 | Receiving facility ID | Required | Required | To be provided by receiving system | 0..1 | MS | MessageHeader.destination.receiver(Organization).identifier.value | MessageHeader-at-home-in-vitro-test-results.receiver(US Core Organization).identifier.value | US Core: Identifies this organization across multiple systems (the value that is unique) | |||||||||||||
15 | 1..1 | MS | MessageHeader.destination.receiver(Organization).identifier.system | MessageHeader-at-home-in-vitro-test-results.receiver(US Core Organization).identifier.system | US Core: Identifies this organization across multiple systems (the namespace for the identifier value) | NOT IN V2 | ||||||||||||||||||||
17 | 15 | MSH | 1 | 7 | Date and time of message | Required | Required | {"YYYYMMDDHHMMSS+ZZZZ” (where ZZZZ is the time zone offset); For example: |19760704010159-0500| is 1:01:59 on July 4, 1976 in the Eastern Standard Time zone (USA)} | 1..1 | MS | Bundle.timestamp | BundleAtHomeInVitroTest.timestamp | When the bundle was assembled | |||||||||||||
27 | 25 | SFT | 1 | 1 | Software Vendor Organization | Required | Required | 0..1 | MS | MessageHeader.source.extension | MessageHeader-at-home-in-vitro-test-results.source.extension[Extension-at-home-in-vitro-test-source-software-info.vendorOrganization] | Source software vendor organization | ||||||||||||||
28 | 26 | SFT | 1 | 2 | Software Certified Version or Release Number | Required | Required | 0..1 | MS | MessageHeader.source.version | MessageHeader-at-home-in-vitro-test-results.source.version | Software certified version or release number | ||||||||||||||
29 | 27 | SFT | 1 | 3 | Software Product Name | Required | Required | 0..1 | MS | MessageHeader.source.software | MessageHeader-at-home-in-vitro-test-results.source.software | Software product name | ||||||||||||||
30 | 28 | SFT | 1 | 4 | Software Binary ID | Required | Required | 0..1 | MessageHeader.source.extension | MessageHeader-at-home-in-vitro-test-results.source.extension[Extension-at-home-in-vitro-test-source-software-info.softwareBinaryID] | Source software binary ID | |||||||||||||||
31 | 29 | SFT | 1 | 6 | Software Install Date | Required | Required | {YYYYMMDD} | 0..1 | MessageHeader.source.extension | MessageHeader-at-home-in-vitro-test-results.source.extension[Extension-at-home-in-vitro-test-source-software-info.softwareInstallDate] | Source software install date | ||||||||||||||
33 | 31 | PID | 1 | 3.1 | Patient ID | Required | Required | Unique ID assigned to patient by App provider | 1..1 | MS | Patient.identifier.value | US Core Patient.identifier.value | US Core: An identifier for this patient: the value that is unique within the system | |||||||||||||
34 | 32 | PID | 1 | 3.4.2 | Patient ID assigner | Required | Required | See 'Obtaining App Specific Identifiers' (same as MSH-3.2) | 1..1 | MS | Patient.identifier.system | US Core Patient.identifier.system | US Core: An identifier for this patient: namespace for the identifier value | Assuming this is the system: namespace for the identifier value | ||||||||||||
37 | 35 | PID | 1 | 5.1 | Patient last name | Do not include | Required | Yes | 0..1 | MS | Patient.name.family | US Core Patient.name.family | US Core: Family name (often called 'Surname') | |||||||||||||
38 | 36 | PID | 1 | 5.2 | Patient first name | Do not include | Required | Yes | 0..1 | MS | Patient.name.given | US Core Patient.name.given | US Core: Given names (not always 'first'). Includes middle names | |||||||||||||
39 | 37 | PID | 1 | 5.3 | Patient middle name | Do not include | Optional | Yes | 0..1 | MS | Patient.name.given | US Core Patient.name.given | US Core: Given names (not always 'first'). Includes middle names | |||||||||||||
40 | 38 | PID | 1 | 7 | Patient DOB | Do not include | Required | Yes | {YYYYMMDD} | 0..1 | MS | Patient.birthDate | US Core Patient.birthDate | US Core: The date of birth for the individual | ||||||||||||
41 | 39 | PID | 1 | 8 | Patient sex | Optional | Required | https://www.hl7.org/fhir/v2/0001/ | 1..1 | MS | Patient.gender | US Core Patient.gender | US Core: male | female | other | unknown | |||||||||||||
42 | 40 | PID | 1 | 10.1 | Patient race code | Optional | Optional | https://www.hl7.org/fhir/v2/0005/ | 0..1 | MS | Patient.us-core-race | US Core Patient.us-core-race | US Core Race Extension | |||||||||||||
43 | 41 | PID | 1 | 10.2 | Patient race description | Conditional | Conditional | When PID-10.1 is valued: https://www.hl7.org/fhir/v2/0005/ | 0..1 | MS | Patient.us-core-race | US Core Patient.us-core-race | US Core Race Extension | |||||||||||||
44 | 42 | PID | 1 | 10.3 | Patient race code system | Conditional | Conditional | When PID-10.1 is valued: "HL70005" | 0..1 | MS | Patient.us-core-race | US Core Patient.us-core-race | US Core Race Extension | |||||||||||||
45 | 43 | PID | 1 | 10.7 | Patient race code system version | Conditional | Conditional | When PID-10.1 is valued: "2.5.1" | 0..1 | MS | Patient.us-core-race | US Core Patient.us-core-race | US Core Race Extension | |||||||||||||
46 | 44 | PID | 1 | 11.1 | Patient street address | Do not include | Optional | Yes | 0..* | MS | Patient.address.line | US Core Patient.address.line | US Core: Street name, number, direction & P.O. Box etc. | |||||||||||||
47 | 45 | PID | 1 | 11.2 | Patient street address 2 | Do not include | Optional | Yes | 0..* | MS | Patient.address.line | US Core Patient.address.line | US Core: Street name, number, direction & P.O. Box etc. | |||||||||||||
48 | 46 | PID | 1 | 11.4 | Patient city | Do not include | Required | Yes | 0..1 | MS | Patient.address.city | US Core Patient.address.city | US Core: Name of city, town etc. | |||||||||||||
49 | 47 | PID | 1 | 11.5 | Patient zip code | See comment | Required | See comment | For anonymous reporting, only include initial three digits of zip code unless zip code is restricted. See here: https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html#zip | 0..1 | MS | Patient.address.postalCode | US Core Patient.address.postalCode | US Core: US Zip Codes | ||||||||||||
50 | 48 | PID | 1 | 11.9 | Patient County | Do not include | Required | Yes | https://phinvads.cdc.gov/vads/ViewValueSet.action?id=FA221794-C665-E811-98FD-0017A477041A | 0..1 | Patient.address.district | n/a | Base address data element includes disctrict - not specifically called out in US Core Patient but can be used | |||||||||||||
51 | 49 | PID | 1 | 13.3 | Patient phone telecom equipment code | Do not include | Optional | Yes | "PH" for phone number, "Internet" for email address | 1..1 | MS | Patient.telecom.system | US Core Patient.telecom.system | US Core: phone | fax | email | pager | url | sms | other | ||||||||||||
52 | 50 | PID | 1 | 13.4 | Patient email | Do not include | Optional | Yes | 0..1 | MS | Patient.telecom[system='email'].value | US Core Patient.telecom[system=email].value | US Core: The actual contact point details | |||||||||||||
53 | 51 | PID | 1 | 13.6 | Patient phone area code | Do not include | Required | Yes | {nnn} | 0..1 | MS | Patient.telecom[system='phone'].value | US Core Patient.telecom[system=phone].value | US Core: The actual contact point details | ||||||||||||
54 | 52 | PID | 1 | 13.7 | Patient local phone | Do not include | Required | Yes | {NNNNNNN} | 0..1 | MS | Patient.telecom[system='phone'].value | US Core Patient.telecom[system=phone].value | US Core: The actual contact point details | ||||||||||||
55 | 53 | PID | 1 | 22.1 | Patient ethnicity code | Optional | Optional | https://www.hl7.org/fhir/v2/0189/ | 0..1 | Patient.us-core-ethnicity | US Core Patient.us-core-ethnicity | US Core ethnicity Extension | ||||||||||||||
56 | 54 | PID | 1 | 22.2 | Patient ethnicity description | Conditional | Conditional | When PID-22.1 is valued: https://www.hl7.org/fhir/v2/0189/ | 0..1 | Patient.us-core-ethnicity | US Core Patient.us-core-ethnicity | US Core ethnicity Extension | ||||||||||||||
57 | 55 | PID | 1 | 22.3 | Patient ethnicity code system | Conditional | Conditional | When PID-22.1 is valued: "HL70189" | 0..1 | Patient.us-core-ethnicity | US Core Patient.us-core-ethnicity | US Core ethnicity Extension | ||||||||||||||
58 | 56 | PID | 1 | 22.7 | Patient ethnicity code system version | Conditional | Conditional | When PID-22.1 is valued: "2.5.1" | 0..1 | Patient.us-core-ethnicity | US Core Patient.us-core-ethnicity | US Core ethnicity Extension | ||||||||||||||
92 | 90 | OBR | 1 | 7.1 | Observation result date | Required | Required | {Same as SPM-17.1} | 1..1 | MS | Observation.effective[x].dateTime | Observation-at-home-in-vitro-test-result.effective[x].dateTime | The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset | |||||||||||||
99 | 97 | OBR | 1 | 22.1 | Test result date released | Required | Required | {"YYYYMMDDHHMMSS+ZZZZ} | 0..1 | MS | Observation.issued | Observation-at-home-in-vitro-test-result.issued | Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result) - mapped to OBR 22 because it is the required field in the message. | |||||||||||||
100 | 98 | OBR | 1 | 25 | Result status | Required | Required | "F" | 1..1 | MS | Observation.Status (=final) | Observation-at-home-in-vitro-test-result.status=final | ||||||||||||||
103 | 101 | OBX | 1 | 3.1 | Test performed code | Required | Required | https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html; LOINC Mapping Tab - column F | 0..1 | MS | Observation.code.coding.code | Observation-at-home-in-vitro-test-result.code.coding.code | At Home Tests: Symbol in syntax defined by the system | |||||||||||||
104 | 102 | OBX | 1 | 3.2 | Test performed description | Required | Required | https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html; LOINC Mapping Tab - column G | 0..1 | MS | Observation.code.display | Observation-at-home-in-vitro-test-result.code.coding.display | At Home Tests: Representation defined by the system | |||||||||||||
105 | 103 | OBX | 1 | 3.3 | Test performed code system | Required | Required | "LN" | 0..1 | MS | Observation.code.coding.system | Observation-at-home-in-vitro-test-result.code.coding.system | At Home Tests: Identity of the terminology system | |||||||||||||
106 | 104 | OBX | 1 | 3.7 | Test Performed code system version | Required | Required | Use most common LOINC version available (Currently "2.71") | 0..1 | Observation.code.coding.version | Observation-at-home-in-vitro-test-result.code.coding.version | At Home Tests: Version of the system - if relevant | ||||||||||||||
107 | 105 | OBX | 1 | 5.1 | Test result code | Required | Required | "260373001" if positive, "260415000" if negative, "455371000124106" if invalid, "125154007" if unsatisfactory | 0..1 | MS | Observation.value.coding.code | Observation-at-home-in-vitro-test-result.value.coding.code | At-Home Test Result Value | |||||||||||||
108 | 106 | OBX | 1 | 5.2 | Test result description | Required | Required | "Detected" if positive, "Not detected" if negative, "Invalid result" if invalid, “Specimen unsatisfactory for evaluation" if unsatisfactory | 0..1 | MS | Observation.value.coding.display | Observation-at-home-in-vitro-test-result.value.coding.display | At-Home Test Result Value | |||||||||||||
109 | 107 | OBX | 1 | 5.3 | Test result code system | Required | Required | "SCT" | 0..1 | Observation.value.coding.system | Observation-at-home-in-vitro-test-result.value.coding.system | At-Home Test Result Value | ||||||||||||||
110 | 108 | OBX | 1 | 11 | Test result status | Required | Required | "F" | 1..1 | MS | Observation.Status=final | Observation-at-home-in-vitro-test-result.status=final | ||||||||||||||
111 | 109 | OBX | 1 | 15.1 | Test Producer's ID | Required | Required | "00Z0000014" for OTC, "00Z0000015" for Prescription | n/a | |||||||||||||||||
112 | 110 | OBX | 1 | 17.1 | Device identifier | Required | Required | https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html; LOINC Mapping tab - {value from column M}“_”{value from column N} | Observation.device.reference (Device)Device.udiCarrier.deviceIdentifier | |||||||||||||||||
115 | 113 | OBX | 1 | 19 | Test analysis date | Required | Required | {YYYYMMDDHHMMSS[+/-ZZZZ]}, Date of mobile device interpretation | 1..1 | MS | Observation.effective.dateTime | |||||||||||||||
116 | 114 | OBX | 1 | 23.1 | Test Performing organization name | Required | Required | "SA.OverTheCounter" or "SA.Prescription" | n/a | |||||||||||||||||
151 | 149 | OBX | 3 | 3.1 | Symptomatic assessment code | Conditional | Conditional | When OBX-5 (Set 3) is valued: "95419-8" | 1..1 | MS | Observation.code.coding.code | Observation - Patient Question Answer.code.coding.code | This particular question is required - add constraints to IG to enforce this | |||||||||||||
152 | 150 | OBX | 3 | 3.2 | Symptomatic assessment code description | Conditional | Conditional | When OBX-5 (Set 3) is valued: "Whether the patient has symptoms related to condition of interest" | 0..1 | MS | Observation.code.coding.display | Observation - Patient Question Answer.code.coding.display | ||||||||||||||
153 | 151 | OBX | 3 | 3.3 | Symptomatic assessment code system | Conditional | Conditional | When OBX-5 (Set 3) is valued: "LN" | 1..1 | MS | Observation.code.coding.system | Observation - Patient Question Answer.code.coding.system | ||||||||||||||
154 | 152 | OBX | 3 | 3.7 | Symptomatic assessment code system version | Optional | Optional | Use most common LOINC version available (Currently "2.71") | 0..1 | MS | Observation.code.coding.version | Observation - Patient Question Answer.code.coding.version | ||||||||||||||
155 | 153 | OBX | 3 | 5 | Symptomatic assessment result | Optional | Optional | "Y^Yes^HL70136" if yes, "N^no^HL70136" if no, "UNK^Unknown^NULLFL" if unknown | 1..1 | MS | Observation.valueCodeableConcept.coding.code | |||||||||||||||
158 | 156 | OBX | 3 | 23.1 | Symptomatic assessment Performing organization name | Required | Required | "SA.OverTheCounter" or "SA.Prescription" | n/a | |||||||||||||||||
159 | 157 | OBX | 3 | 23.6.2 | Symptomatic assessment Performing Organization ID Assigner OID | Required | Required | "2.16.840.1.113883.4.7" | n/a | |||||||||||||||||
160 | 158 | OBX | 3 | 23.6.3 | Symptomatic assessment Performing Organization Assigner ID type | Required | Required | "ISO" | n/a | |||||||||||||||||
161 | 159 | OBX | 3 | 23.7 | Symptomatic assessment Performing Organization ID Type | Required | Required | "XX" | n/a | |||||||||||||||||
162 | 160 | OBX | 3 | 23.1 | Symptomatic assessment Performing Organization identifier | Required | Required | "00Z0000014" for OTC, "00Z0000015" for Prescription | n/a | |||||||||||||||||
163 | 161 | OBX | 3 | 24.1 | Symptomatic assessment Performing organization street address | Required | Required | "11 Fake AtHome Test Street" for OTC, "12 Fake AtHome Test Street" for Prescription | n/a | |||||||||||||||||
164 | 162 | OBX | 3 | 24.3 | Symptomatic assessment Performing Organization City | Required | Required | "Yakutat" | n/a | |||||||||||||||||
165 | 163 | OBX | 3 | 24.4 | Symptomatic assessment Performing Organization State | Required | Required | "AK" | n/a | |||||||||||||||||
166 | 164 | OBX | 3 | 24.5 | Symptomatic assessment Performing Organization Zip code | Required | Required | "99689" | n/a | |||||||||||||||||
167 | 165 | OBX | 3 | 24.9 | Symptomatic assessment Performing Organization County | Required | Required | "02282" | n/a | |||||||||||||||||
168 | 166 | OBX | 3 | 29 | Symptomatic assessment Observation type | Required | Required | "QST" | n/a | |||||||||||||||||
169 | 167 | OBX | 4 | 1 | Set ID | Conditional | Conditional | When OBX-5 (Set 4) is valued: "4" | ||||||||||||||||||
170 | 168 | OBX | 4 | 2 | Illness onset date value type | Conditional | Conditional | When OBX-5 (Set 4) is valued: "DT" | MS | Extension: Observation.reasonReference.Reference.USCoreCondition.onsetDateTime | ||||||||||||||||
171 | 169 | OBX | 4 | 3.1 | Illness onset date code | Conditional | Conditional | When OBX-5 (Set 4) is valued: "65222-2" | Extension: Observation.reasonReference.Reference.USCoreCondition.onsetDateTime | |||||||||||||||||
172 | 170 | OBX | 4 | 3.2 | Illness onset date code description | Conditional | Conditional | When OBX-5 (Set 4) is valued: "Date and time of symptom onset" | 0..1 | MS | Extension: Observation.reasonReference.Reference.USCoreCondition.code | |||||||||||||||
173 | 171 | OBX | 4 | 3.3 | Illness onset date code system | Conditional | Conditional | When OBX-5 (Set 4) is valued: "LN" | Extension: Observation.reasonReference.Reference.USCoreCondition.code | |||||||||||||||||
174 | 172 | OBX | 4 | 3.7 | Illness onset date code system version | Optional | Optional | Use most common LOINC version available (Currently "2.71") | ||||||||||||||||||
175 | 173 | OBX | 4 | 5 | Illness onset date result | Conditional | Conditional | When OBX-5 (Set 3) is valued: {YYYYMMDDHHMMSS[+/-ZZZZ]} | ||||||||||||||||||
176 | 174 | OBX | 4 | 6.7 | Unit code system version | Optional | Optional | Use most common UCUM version available (currently "2.1") | ||||||||||||||||||
177 | 175 | OBX | 4 | 11 | Illness onset date result status | Conditional | Conditional | When OBX-5 (Set 4) is valued: "F" | ||||||||||||||||||
191 | 189 | SPM | 1 | 2.2.1 | Specimen ID | Required | Required | {Unique ID assigned to every test by app manufacturer} | 0..1 | MS | Observation.specimen.reference(Specimen).Specimenidentifier.Identifier | Specimen-at-home-in-vitro-test.identifier | Is this the same ID as the test? | |||||||||||||
192 | 190 | SPM | 1 | 2.2.3 | Specimen ID Assigner OID | Required | Required | See 'Obtaining App Specific Identifiers' (same as MSH-3.2) | 0..1 | MS | Observation.specimen.reference(Specimen).Specimen.identifier.Identifier.uri | |||||||||||||||
193 | 191 | SPM | 1 | 2.2.4 | Specimen ID assigner ID type | Required | Required | "ISO" | 0..1 | MS | Observation.specimen.reference(Specimen).Specimen.identifier.Identifier.type | |||||||||||||||
194 | 192 | SPM | 1 | 4.1 | Specimen type code | Required | Required | https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html | 0..1 | MS | Observation.specimen.reference(Specimen).Specimen.type.codableConcept | Specimen-at-home-in-vitro-test.type.coding.code | Safe to bind to SNOMED in framework profile? i.e. this will always be a SNOMED code? Or should we just leave it open and it will be bound to a value set at the use case level? (Going with latter option for now). | |||||||||||||
195 | 193 | SPM | 1 | 4.2 | Specimen type description | Optional | Optional | https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html | 0..1 | MS | Observation.specimen.reference(Specimen).Specimen.type.codableConcept | Specimen-at-home-in-vitro-test.type.text | The specimen text description. | Assuming this is a textual description of the specimen type? (Could be a longer description than the SNOMED term or could just be the SNOMED term) | ||||||||||||
196 | 194 | SPM | 1 | 4.3 | Specimen type code system | Required | Required | "SCT" | 0..1 | MS | Observation.specimen.reference(Specimen).Specimen.type.codableConcept | Specimen-at-home-in-vitro-test.type.coding.system | ||||||||||||||
197 | 195 | SPM | 1 | 4.7 | Specimen type code system version | Required | Required | "20210301" | ||||||||||||||||||
198 | 196 | SPM | 1 | 17.1 | Specimen collected date | Required | Required | {YYYYMMDDHHMMSS[+/-ZZZZ]} | 1..1 | MS | Observation.specimen.reference(Specimen).Specimen.collection.collected.dateTime | Specimen-at-home-in-vitro-test.collectedDateTime | ||||||||||||||
200 | Organization that issues the UDI for this test | Not included in V2 IG | Not included in V2 IG | 0..1 | MS | Device.udiCarrier.issuer | ||||||||||||||||||||
201 | Expiration date of the test kit | Not included in V2 IG | Not included in V2 IG | 0..1 | MS | Device.expirationDate | ||||||||||||||||||||
202 | Lot number of the test kit | Not included in V2 IG | Not included in V2 IG | 0..1 | MS | Device.lotNumber | ||||||||||||||||||||
203 | Serial number of the test kit | Not included in V2 IG | Not included in V2 IG | 0..1 | MS | Device.serialNumber | ||||||||||||||||||||
204 | Not included in V2 IG | Not included in V2 IG | 0..1 | DiagnosticReport.media | ||||||||||||||||||||||
205 | Not included in V2 IG | Not included in V2 IG | V2 - could be Responsible Observer (OBX16) | Proctor | ||||||||||||||||||||||
206 | ||||||||||||||||||||||||||
207 | ||||||||||||||||||||||||||
208 | ||||||||||||||||||||||||||
209 | ||||||||||||||||||||||||||
210 |