Identifiers assigned to this report by the performer or other systems.

Need to know what identifier to use when making queries about this report from the source laboratory, and for linking to the report outside FHIR context.

Usually assigned by the Information System of the diagnostic service provider (filler id).

The status of the diagnostic report.

Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports.

Note that FHIR strings SHALL NOT exceed 1MB in size

The status of the diagnostic report.

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

Codes for diagnostic service sections.

A code or name that describes this diagnostic report.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Codes that describe Diagnostic Reports.

The healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport is about.

Links the request to the Encounter context.

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

The date and time that this version of the report was made available to providers, typically after the report was reviewed and verified.

Clinicians need to be able to check the date that the report was released.

May be different from the update time of the resource itself, because that is the status of the record (potentially a secondary copy), not the actual release time of the report.

The diagnostic service that is responsible for issuing the report.

Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

This is not necessarily the source of the atomic data items or the entity that interpreted the results. It is the entity that takes responsibility for the clinical report.

The practitioner or organization that is responsible for the report's conclusions and interpretations.

Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

Might not be the same entity that takes responsibility for the clinical report.

Details about the specimens on which this diagnostic report is based.

Need to be able to report information about the collected specimens on which the report is based.

If the specimen is sufficiently specified with a code in the test result name, then this additional data may be redundant. If there are multiple specimens, these may be represented per observation or group.

One or more links to full details of any imaging performed during the diagnostic investigation. Typically, this is imaging performed by DICOM enabled modalities, but this is not required. A fully enabled PACS viewer can use this information to provide views of the source images.

ImagingStudy and the image element are somewhat overlapping - typically, the list of image references in the image element will also be found in one of the imaging study resources. However, each caters to different types of displays for different types of purposes. Neither, either, or both may be provided.

A comment about the image. Typically, this is used to provide an explanation for why the image is included, or to draw the viewer's attention to important features.

The provider of the report should make a comment about each image included in the report.

The comment should be displayed with the image. It would be common for the report to include additional discussion of the image contents in other sections such as the conclusion.

Reference to the image source.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Concise and clinically contextualized summary conclusion (interpretation/impression) of the diagnostic report.

Need to be able to provide a conclusion that is not lost among the basic result data.

Note that FHIR strings SHALL NOT exceed 1MB in size

One or more codes that represent the summary conclusion (interpretation/impression) of the diagnostic report.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Diagnosis codes provided as adjuncts to the report.

Rich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they SHALL be semantically equivalent.

Gives laboratory the ability to provide its own fully formatted report for clinical fidelity.

"application/pdf" is recommended as the most reliable and interoperable in this context.

A unique identifier assigned to this observation.

Allows observations to be distinguished and referenced.

A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

The status of the result value.

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Codes providing the status of an observation.

Describes what was observed. Sometimes this is called the observation "name".

Knowing what kind of observation is being made is essential to understanding the observation.

All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Codes identifying names of simple observations.

The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

Observations have no value if you don't know who or what they're about.

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

For some observations it may be important to know the link between an observation and a particular encounter.

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

Who was responsible for asserting the observed value as "true".

May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Provides a reason why the expected value in the element Observation.value[x] is missing.

For many results it is necessary to handle exceptional values in measurements.

Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

Codes specifying why the result (Observation.value[x]) is missing.

A categorical assessment of an observation value. For example, high, low, normal.

For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

Codes identifying interpretations of observations.

Comments about the observation or the results.

Need to be able to provide free text additional information.

May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

Indicates the site on the subject's body where the observation was made (i.e. the target site).

Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

Codes describing anatomical locations. May include laterality.

Indicates the mechanism used to perform the observation.

In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

Only used if not implicit in code for Observation.code.

Methods for simple observations.

The specimen that was used when this observation was made.

Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

The device used to generate the observation data.

Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

Code for the meaning of a reference range.

Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

Need to be able to identify the target population for proper interpretation.

This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

Codes identifying the population the reference range applies to.

The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

Some analytes vary greatly over age.

The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.

Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

Note that FHIR strings SHALL NOT exceed 1MB in size

This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

Describes what was observed. Sometimes this is called the observation "code".

Knowing what kind of observation is being made is essential to understanding the observation.

All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Codes identifying names of simple observations.

Provides a reason why the expected value in the element Observation.component.value[x] is missing.

For many results it is necessary to handle exceptional values in measurements.

"Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

Codes specifying why the result (Observation.value[x]) is missing.

A categorical assessment of an observation value. For example, high, low, normal.

For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

Codes identifying interpretations of observations.

Guidance on how to interpret the value by comparison to a normal or recommended range.

Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

A unique identifier assigned to this observation.

Allows observations to be distinguished and referenced.

A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

The status of the result value.

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Codes providing the status of an observation.

A code that classifies the type of fit index: overall fit index, category fit index, or test fit index.

Used for filtering what observations are retrieved and displayed.

In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Codes for high level observation categories.

Describes what was observed. Sometimes this is called the observation "name".

Knowing what kind of observation is being made is essential to understanding the observation.

All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Codes identifying names of simple observations.

The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

Observations have no value if you don't know who or what they're about.

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

For some observations it may be important to know the link between an observation and a particular encounter.

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

Who was responsible for asserting the observed value as "true".

May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.