Generated Narrative: StructureDefinition EHDSLaboratoryReportObligations Language: en Name Flags Card. Type Description & Constraints EHDSLaboratoryReport 0..* EHDSLaboratoryReport Laboratory report model Instances of this logical model can be the target of a Reference #xD; header O 1..1 Base Laboratory Report header Obligations Actor SHALL:able-to-populate Producer SHALL:process Consumer #xD; subject O 1..1 EHDSPatient Patient/subject information Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer SHALL:process Consumer #xD; identifier O 1..* Identifier Unique identifier of the document Obligations Actor SHALL:able-to-populate Producer SHOULD:display Consumer SHALL:process Consumer #xD; author[x] O 1..* EHDSHealthProfessional, EHDSOrganisation, EHDSDevice Author(s) by whom the laboratory result report was authored. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; date O 1..1 dateTime Date of finalising/issuing the document Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; status O 1..1 CodeableConcept Status of the document Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; language O 0..1 CodeableConcept Language in which the resource is written. Language is expressed by the IETF language tag. Obligations Actor SHALL:able-to-populate Producer #xD; documentType O 1..1 CodeableConcept Type of document at hand, e.g. 60591-5 Patient summary document. Obligations Actor SHALL:able-to-populate Producer #xD; documentTitle O 1..1 string Human readable document title that can be displayed in search results, etc. This can be documentType's display name, or it can be assembled from multiple elements. Examples: 'Laboratory Result Report', 'Patient Summary of Jane Green 10.12.2024' Obligations Actor SHALL:able-to-populate Producer #xD; period O 0..1 Period Time of service that is being documented Obligations Actor SHALL:able-to-populate Producer #xD; attestation O 0..* Base Document attestation details Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; attester[x] O 1..1 EHDSHealthProfessional, EHDSDevice Attester who validated the document Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; datetime O 1..1 dateTime Date and time of the approval of the document by Attester Obligations Actor SHALL:able-to-populate Producer #xD; legalAuthentication O 0..* Base Document legal authentication details Obligations Actor SHALL:able-to-populate Producer #xD; legalAuthenticator[x] O 1..1 EHDSHealthProfessional, EHDSOrganisation The person or organisation taking responsibility for the content of the document. Obligations Actor SHALL:able-to-populate Producer #xD; datetime O 1..1 dateTime Date and time when the document was authorised Obligations Actor SHALL:able-to-populate Producer #xD; eventType O 0..* CodeableConcept Categorisation of the event covered by the document (e.g. laboratory study types, imaging study types including modality, etc.). Selection of such tags or labels depends on the use case and agreement between data sharing parties. This meta-data element serves primarily for searching and filtering purposes. Obligations Actor SHALL:able-to-populate Producer #xD; serviceSpecialty O 0..* CodeableConcept Additional details about where the content was created (e.g. clinical specialty) Obligations Actor SHALL:able-to-populate Producer SHOULD:display Consumer #xD; custodian O 0..1 EHDSOrganisation Organisation that is in charge of maintaining the document/report. Obligations Actor SHALL:able-to-populate Producer #xD; presentedForm O 0..* EHDSAttachment A narrative easy-to-read representation of the full data set, e.g. PDF-version of a document Obligations Actor SHALL:able-to-populate Producer SHALL:process Consumer SHALL:display Consumer #xD; body O 0..1 Base Laboratory Report structured body Obligations Actor SHALL:able-to-populate Producer SHALL:process Consumer #xD; orderInformation O 0..* Base Order Information (Laboratory Result Report could respond to multiple test orders) Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; orderId O 1..* Identifier An identifier of the laboratory test order. Laboratory Result Report may respond to multiple orders. Obligations Actor SHALL:able-to-populate Producer SHOULD:process Consumer #xD; orderPlacer[x] O 0..1 EHDSHealthProfessional, EHDSOrganisation, EHDSPatient The person/organisation "authorised" to place the order. Order placer could be either a health professional, health professional organisation or the patient himself. Obligations Actor SHALL:able-to-populate Producer SHOULD:display Consumer #xD; orderReason[x] O 0..* CodeableConcept, EHDSCondition, EHDSObservation, string An explanation or justification for why this service is being requested in coded form. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; clinicalQuestion O 0..1 string Specification of clinical question (goal of the investigation) to be answered by the laboratory investigation. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; supportingInformation O 0..1 Base Additional clinical information about the patient or specimen that may influence the services or their interpretations. This information includes diagnosis, clinical findings and other observations. In laboratory ordering these are typically referred to as 'ask at order entry questions (AOEs).' This includes observations explicitly requested by the producer (filler) to provide context or supporting information needed to complete the order. For example, reporting the amount of inspired oxygen for blood gas measurements. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; observation O 0..* EHDSObservation Clinical findings and other observations. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; condition O 0..* EHDSCondition Condition that may influence the service or result interpretation. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; medicationAdministration O 0..* EHDSMedicationAdministration Medication administered before ordering the service. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; sexForClinicalUse O 0..1 CodeableConcept A Sex Parameter for Clinical Use is a parameter that provides guidance on how a recipient should apply settings or reference ranges that are derived from observable information such as an organ inventory, recent hormone lab tests, genetic testing, menstrual status, obstetric history, etc.. This property is intended for use in clinical decision making, and indicates that treatment or diagnostic tests should consider best practices associated with the relevant reference population Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; vaccination O 0..* EHDSImmunisation Vaccination history of the patient. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; otherSupportingInformation O 0..* Resource Any other type of relevant supporting information Obligations Actor SHOULD:able-to-populate Producer SHOULD:display Consumer #xD; specimen O 0..* EHDSSpecimen Specimen information Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; serviceRequest O 0..* EHDSServiceRequest Specification of requested service or services Obligations Actor SHALL:able-to-populate Producer SHOULD:display Consumer #xD; resultData O 1..1 Base Laboratory report result data Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; commentsInterpretationAndRecommendations O 0..* Narrative Narrative Comments, such as a textual interpretation or advice accompanying the result report, for example. Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; laboratoryTestResults O 0..* EHDSLaboratoryObservation Observation details (report could consist of multiple observations) Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; attachments O 0..* EHDSAttachment Report attachments Obligations Actor SHOULD:able-to-populate Producer SHOULD:process Consumer SHOULD:display Consumer #xD; Documentation for this format
Obligations for the logical model of laboratory report
Each producer of a laboratory report SHALL be able to provide basic information, such as type of the report, authorship, status of the report, title, etc. This information is crucial for safe identification of the report and for searchability of the report using standardized searching parameters.
EHR systems that consume laboratory report SHALL process document header information.
EHR systems SHALL provide information about the subject of care.
EHR system SHALL render information about the subject of care in such a way that unambiguous assignment to the care subject is preserved.
Information about the subject of care SHALL be processed by the EHR system in such a way that the identity of the subject of care cannot be confused.
Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Author(s) by whom the laboratory result report was authored.
Author(s) by whom the laboratory result report was authored. Multiple authors could be provided.
Author of the laboratory report could be either a health professional who authored the report, laboratory itself or laboratory information system. Author information is the only mandatory element of the laboratory report header. As such, each laboratory shall be able to provide at least the author information.
Date and optionally time of authoring/issuing
Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.
Language in which the resource is written. Language is expressed by the IETF language tag.
Type of document at hand, e.g. 60591-5 Patient summary document.
Human readable document title that can be displayed in search results, etc. This can be documentType's display name, or it can be assembled from multiple elements. Examples: 'Laboratory Result Report', 'Patient Summary of Jane Green 10.12.2024'
Time of service that is being documented
Business version of the document. The exact algorithm for versioning is decided by the producer/custodian
Attester who validated laboratory result report. Multiple attesters could be provided.
Attestation (validation) of the laboratory report content is the usual step before legal authentication. Attestation could be provided by e.g. the laboratory specialist or the laboratory information system based on internal rules of the laboratory.
Date and time of the approval of the document by Attester
The person or organisation taking responsibility for the content of the document.
The person or organization taking responsibility for the medical content of the document
Legal authentication of the laboratory report is the usual step after attestation. Legal authentication could be provided by e.g. the head of the laboratory or the laboratory organization itself.
Date and time when the document was authorised
Categorisation of the event covered by the document (e.g. laboratory study types, imaging study types including modality, etc.). Selection of such tags or labels depends on the use case and agreement between data sharing parties. This meta-data element serves primarily for searching and filtering purposes.
Additional details about where the content was created (e.g. clinical specialty)
Organisation that is in charge of maintaining the document/report.
Each EHR system that is a producer of a laboratory report SHALL be able to provide the entire report as issued by the laboratory in a human readable format, e.g. PDF.
EHR systems that consume laboratory report SHALL process the human readable version of the report.
EHR systems that consume laboratory report SHALL render human readable version of the report to the endusers.
A narrative easy-to-read representation of the full data set, e.g. PDF-version of a document
Information recipient (intended recipient or recipients of the report, additional recipients might be identified by the ordering party, e.g. GP, other specialist), if applicable
Each EHR system that is a producer of a laboratory report SHALL be able to provide structured information about the laboratory investigation, such as order information, supporting information, specimen details and result data.
EHR systems that consume laboratory report SHALL process structured body information.
EHR systems SHALL be able to populate information about one or more order which this report is based on.
Consumer EHR systems SHALL display key order information to ensure traceability between order and report.
Order Information (Laboratory Result Report could respond to multiple test orders)
Consumer systems SHOULD use this element to pair result report with laboratory order.
An identifier of the laboratory test order. Laboratory Result Report may respond to multiple orders.
The person/organisation "authorised" to place the order. Order placer could be either a health professional, health professional organisation or the patient himself.
An explanation or justification for why this service is being requested in coded form.
Specification of clinical question (goal of the investigation) to be answered by the laboratory investigation.
Additional clinical information about the patient or specimen that may influence the services or their interpretations. This information includes diagnosis, clinical findings and other observations. In laboratory ordering these are typically referred to as 'ask at order entry questions (AOEs).' This includes observations explicitly requested by the producer (filler) to provide context or supporting information needed to complete the order. For example, reporting the amount of inspired oxygen for blood gas measurements.
Clinical findings and other observations.
Condition that may influence the service or result interpretation.
Medication administered before ordering the service.
A Sex Parameter for Clinical Use is a parameter that provides guidance on how a recipient should apply settings or reference ranges that are derived from observable information such as an organ inventory, recent hormone lab tests, genetic testing, menstrual status, obstetric history, etc.. This property is intended for use in clinical decision making, and indicates that treatment or diagnostic tests should consider best practices associated with the relevant reference population
Any other type of relevant supporting information
Specification of requested service or services
Narrative Comments, such as a textual interpretation or advice accompanying the result report, for example.
Observation details (report could consist of multiple observations)
Each EHR system that is a producer of a laboratory report SHOULD be able to provide attachments related to the report, such as documents, diagrams, images of the results, etc.
EHR systems that consume laboratory report SHOULD process attachments related to the report.
EHR systems that consume laboratory report SHOULD render attachments related to the report to the endusers.