QI-Core Implementation Guide: STU Ballot (v3.3.0 for FHIR 4.0.0)

Quality Improvement Core Framework (v3.3.0: STU 4 Ballot 1). The current version is 3.2.0 based on FHIR R4. See the Directory of published versions

7.17.0 Observations

A number of QDM “datatypes” (i.e., information class with its corresponding context of use) are basically observations. These include:

  • Assessment, Performed
  • Care Experience
  • Diagnostic Study, Performed
  • Physical Exam, Performed
  • Symptom

This section addresses all of these QDM concepts since they use US-Core and FHIR Observation resources. The mapping uses US-Core R4 where US-Core specifically defines a profile to reference the concept (e.g., US Core Laboratory Result Observation Profile). In some cases, US-Core references some aspects of a “QDM datatype,” (e.g., US Core Smoking Status Observation Profile) but no other related observations. In such cases, the QDM mapping table provides a generic mapping to the FHIR Observation resource and a specific reference for relevant profiles defined in US-Core.

Note, when considering use of components for observations, refer to FHIR Observation.component for guidance (section 10.1.4.3.2 https://www.hl7.org/fhir/observation.html):

Observation.component is used for any supporting result that cannot reasonably be interpreted and used outside the scope of the Observation it is a component of. Component observations may make up the separate and individual parts of the observation or may provide qualifying information to Observation.code and may only be able to be understood in relation to the Observation.code (for example, see the $stats operation). Therefore all code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. Components should only be used when there is only one method, one observation, one performer, one device, and one time. Some use cases for using this structure include:

  1. Observations that are commonly produced and interpreted together. For example, systolic and diastolic blood pressure are represented as a single Blood pressure panel.
  2. Assessment tool results that are commonly produced and interpreted together. For example, a newborn Apgar scorethat is a single Observation with five components.
  3. Representing multiple answers to a question (relationship and boundariesbetween Observation and Questionnaire/QuestionnaireResponse). For example, reporting the types of alcohol consumed by a patient

On the other hand, any observations that are clinically relevant outside the context of being a component of another observation should be represented by separate Observation resources. For example a Body Mass Index (BMI) Observation should not contain components for height and weight because they are clinically relevant observations on their own and should be represented by separate Observation resources. 

This QDM to QI-Core Mapping is updated from QDM 5.4 to QDM 5.5.

7.17.1 Observation Data Types

QDM Datatype Description
Assessment, Performed QDM defines Assessment as a resource used to define specific observations that clinicians use to guide treatment of the patient. An assessment can be a single question, or observable entity with an expected response, an organized collection of questions intended to solicit information from patients, providers or other individuals, or a single observable entity that is part of such a collection of questions. US-Core defines a specific resource for smoking status assessment; other observations that meet the QDM definition of assessment use the FHIR Observation resource:
Assessment, Performed: Smoking Status
Care Experience QDM defines Care Experience as the experience a patient has when receiving care or a provider has when providing care. QDM represents two kinds of care experience: Patient Care Experience and Provider Care Experience. While generally interpreted as patient or provider satisfaction, experience may also represent understanding, involvement and other factors about the care received or given. Most often organizations obtain such information using questionnaires. Use cases are welcome to help provide examples for us of this concept. The Care Experience concept best fits with the FHIR Observation resource.
Diagnostic Study, Performed

QDM defines Diagnostic Study as any kind of medical test performed as a specific test or series of steps to aid in diagnosing or detecting disease (e.g., to establish a diagnosis, measure the progress or recovery from disease, confirm that a person is free from disease). The QDM differentiates diagnostic studies from laboratory tests in that diagnostic studies are those that are not performed in organizations that perform testing on samples of human blood, tissue, or other substance from the body. Diagnostic studies may make use of digital images and textual reports. Such studies include but are not limited to imaging studies, cardiology studies (electrocardiogram, treadmill stress testing), pulmonary-function testing, vascular laboratory testing, and others.

Thus far, consensus opinion suggests that the FHIR Observation Resource best fits the diagnostic study use case for querying clinical data to retrieve information about the event and/or the result of the study. Individual studies may use the US-Core DiagnosticReport-note (http://hl7.org/fhir/us/core/StructureDefinition-us-core-diagnosticreport-note.html) to provide information about an individual study (e.g., a cardiac ultrasound, MRI, etc.) although some have considered use of other reporting resources and artifacts. Since new studies regularly become available and the nature of existing studies change over time, a complete list of studies to reference a desired result cannot be assured. Therefore, a quality measure or clinical decision support (CDS) artifacts seeking a specific result value should use the Observation resource to request a retrieve of the result value desired. This practice will enable implementers to determine which is the best source for the desired observation. LOINC observable entities may indicate specific methods for determination of results. Measure and CDS developers can reference direct reference codes or value sets using the such LOINC codes to specify the type of testing considered acceptable to provide sufficient fidelity to their requests.

Laboratory Test, Performed

QDM defines Laboratory Test as a medical procedure that involves testing a sample of blood, urine, or other body fluids or specimens. Tests can help determine a diagnosis, plan treatment, check to see if treatment is working, or monitor the disease over time. This QDM data category for Laboratory Test is only used for information about the subject of record.

Thus far, consensus opinion suggests that the US-Core Observation-Lab Profile best fits the laboratory test use case for querying clinical data to retrieve information about the event and/or the result of the study. Individual studies may use the US-Core DiagnosticReport-lab (http://hl7.org/fhir/us/core/StructureDefinition-us-core-diagnosticreport-lab.html) to provide information about an individual laboratory test although some have considered use of other reporting resources and artifacts. Each laboratory test may be ordered individually or in a panel. Many use panels for convenience for ordering laboratory tests. Since new laboratory panels regularly become available and the myriad of potential laboratory panels available, a complete list cannot be assured. Therefore, a quality measure or clinical decision support (CDS) artifacts seeking a specific result value should use the US-Core Observation-Lab profile to request a retrieve of the result value desired. This practice will enable implementers to determine which is the best source for the desired observation. LOINC observable entities may indicate specific methods for determination of results. Measure and CDS developers can reference direct reference codes or value sets using the such LOINC codes to specify the type of testing considered acceptable to provide sufficient fidelity to their requests.

Physical Exam, Performed: General
Physical Exam, Performed - Pediatric BMI for Age
Physical Exam, Performed - Vital Signs