C.7.2 Common Study IE Modules

The following Study IE Modules are common to all Composite Image IODs that reference the Study IE. These Modules contain Attributes of the patient and study that are needed for diagnostic interpretation of the image. They contain Attributes that are also in the Patient Modules in Section C.2 and Study Modules in Section C.4.

C.7.2.1 General Study Module

Table C.7-3 specifies the Attributes that describe and identify the Study performed upon the Patient.

Table C.7-3GENERAL STUDY MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Study Instance UID (0020,000D) 1 Unique identifier for the Study.
Study Date (0008,0020) 2 Date the Study started.
Study Time (0008,0030) 2 Time the Study started.
Referring Physician's Name (0008,0090) 2 Name of the patient's referring physician
Referring Physician Identification Sequence (0008,0096) 3 Identification of the patient's referring physician. Only a single item is permitted in this sequence.
>Include ‘Person Identification Macro’ Table 10-1
Study ID (0020,0010) 2 User or equipment generated Study identifier.
Accession Number (0008,0050) 2 A RIS generated number that identifies the order for the Study.
Issuer of Accession Number Sequence (0008,0051) 3 Identifier of the Assigning Authority that issued the Accession Number. Only a single Item is permitted in this sequence.
>Include HL7v2 Hierarchic Designator Macro Table 10-17
Study Description (0008,1030) 3 Institution-generated description or classification of the Study (component) performed.
Physician(s) of Record (0008,1048) 3 Names of the physician(s) who are responsible for overall patient care at time of Study (see Section C.7.3.1 for Performing Physician)
Physician(s) of Record Identification Sequence (0008,1049) 3 Identification of the physician(s) who are responsible for overall patient care at time of Study. One or more items are permitted in this sequence.If more than one Item, the number and order shall correspond to the value of Physician(s) of Record (0008,1048), if present.
>Include ‘Person Identification Macro’ Table 10-1
Name of Physician(s) Reading Study (0008,1060) 3 Names of the physician(s) reading the Study.
Physician(s) Reading Study Identification Sequence (0008,1062) 3 Identification of the physician(s) reading the Study. One or more items are permitted in this sequence. If more than one Item, the number and order shall correspond to the value of Name of Physician(s) Reading Study (0008,1060), if present.
>Include ‘Person Identification Macro’ Table 10-1
Requesting Service Code Sequence (0032,1034) 3 Institutional department where the request initiated. Only a single item is permitted in this sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 Defined CID 7030.
Referenced Study Sequence (0008,1110) 3 A sequence that provides reference to a Study SOP Class/Instance pair. One or more Items are permitted in this Sequence.
>Include SOP Instance Reference Macro Table 10-11
Procedure Code Sequence (0008,1032) 3 A Sequence that conveys the type of procedure performed. One or more Items are permitted in this Sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 No Baseline Context ID is defined.
Reason For Performed Procedure Code Sequence (0040,1012) 3 Coded reason(s) for performing this procedure. Note: May differ from the values in Reason for the Requested Procedure (0040,100A) in Request Attribute Sequence (0040,0275), for example if what was performed differs from what was requested. One or more Items are permitted in this Sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 No Baseline Context ID is defined.

C.7.2.1.1 General Study Attribute Descriptions

C.7.2.1.1.1 Referring Physician, Physician of Record, Physician Reading Study

The model used for application of attributes related to different functions of Physicians involved in the care of a patient is shown in Figure C.7.2-1. The figure shows some of the relationships and information flows between physician roles that might be present in some healthcare business models.

[pic]

Figure C.7.2-1Functions of Physicians

There can be an overlap of functions provided by any given physician. In this case, the various attributes specifying the different roles would convey the same physician name.

C.7.2.2 Patient Study Module

Table C.7-4a defines Attributes that provide information about the Patient at the time the Study started.

Table C.7-4aPATIENT STUDY MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Admitting Diagnoses Description (0008,1080) 3 Description of the admitting diagnosis (diagnoses)
Admitting Diagnoses Code Sequence (0008,1084) 3 A sequence that conveys the admitting diagnosis (diagnoses). One or more Items are permitted in this Sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 No Baseline Context ID is defined.
Patient's Age (0010,1010) 3 Age of the Patient.
Patient's Size (0010,1020) 3 Length or size of the Patient, in meters.
Patient's Weight (0010,1030) 3 Weight of the Patient, in kilograms.
Patient's Size Code Sequence (0010,1021) 3 Patient's size category code One or more Items are permitted in this sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is CID 7040 for pediatric patients Baseline Context ID is CID 7042 for CT calcium scoring
Occupation (0010,2180) 3 Occupation of the Patient.
Additional Patient History (0010,21B0) 3 Additional information about the Patient's medical history.
Admission ID (0038,0010) 3 Identifier of the visit as assigned by the healthcare provider
Issuer of Admission ID Sequence (0038,0014) 3 Identifier of the Assigning Authority that issued the Admission ID (0038,0010). Only a single Item is permitted in this sequence.
>Include HL7v2 Hierarchic Designator Macro Table 10-17
Service Episode ID (0038,0060) 3 Identifier of the Service Episode as assigned by the healthcare provider
Issuer of Service Episode ID Sequence (0038,0064) 3 Identifier of the Assigning Authority that issued the Service Episode ID (0038,0060). Only a single Item is permitted in this sequence.
>Include HL7v2 Hierarchic Designator Macro Table 10-17
Service Episode Description (0038,0062) 3 Description of the type of service episode.
Patient’s Sex Neutered (0010,2203) 2C Whether or not a procedure has been performed in an effort to render the patient sterile. Enumerated value: ALTERED = Altered/Neutered UNALTERED = Unaltered/intact Note: If this Attribute is present but has no value then the status is unknown. Required if patient is an animal. May be present otherwise.

C.7.2.3 Clinical Trial Study Module

Table C.7-4b contains attributes that identify a Study in the context of a clinical trial.

Table C.7-4b CLINICAL TRIAL STUDY MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Clinical Trial Time Point ID (0012,0050) 2 An identifier specifying the one or more studies that are grouped together as a clinical time point or submission in a clinical trial. See C.7.2.3.1.1.
Clinical Trial Time Point Description (0012,0051) 3 A description of a set of one or more studies that are grouped together to represent a clinical time point or submission in a clinical trial. See C.7.2.3.1.1.
Consent for Clinical Trial Use Sequence (0012,0083) 3 A Sequence that conveys information about consent for Clinical Trial use of the composite instances within this Study. One or more Items are permitted in this sequence. See C.7.2.3.1.2.
>Distribution Type (0012,0084) 1C The type of distribution for which consent to distribute has been granted. Defined Terms: NAMED_PROTOCOL RESTRICTED_REUSE PUBLIC_RELEASE See C.7.2.3.1.2. Required if Consent for Distribution Flag (0012,0085) equals YES or WITHDRAWN.
>Clinical Trial Protocol ID (0012,0020) 1C The identifier of the protocol for which consent to distribute has been granted. Required if Distribution Type (0012,0084) is NAMED_PROTOCOL and the protocol is not that which is specified in Clinical Trial Protocol ID (0012,0020) in the Clinical Trial Subject Module.
>Consent for Distribution Flag (0012,0085) 1 Whether or not consent to distribute has been granted for the purpose described in Distribution Type (0012,0084). Enumerated Values: NO YES WITHDRAWN See C.7.2.3.1.2. Note: Under some circumstances, consent may be withdrawn. The purpose of encoding this is to warn receiving systems that further distribution may not be appropriate, but no semantics are defined by the Standard for what action is appropriate under such circumstances, such as what to do with previously received images that had a value of YES.

C.7.2.3.1 Clinical Trial Study Attribute Descriptions

C.7.2.3.1.1 Clinical Trial Time Point

The Clinical Trial Time Point ID (0012,0050) attribute identifies an imaging study within the context of an investigational protocol. This attribute is used to define a set of studies that are grouped together as a clinical time point or data submission in a clinical trial. The Clinical Trial Time Point Description (0012,0051) attribute can be used to give a description of the Clinical Trial Time Point to which the set of studies belongs.

C.7.2.3.1.2 Consent for Clinical Trial Use Sequence

For applications such as clinical trials, the distribution of composite instances in Studies, whether containing identifying information or partially or completely de-identified, may need to be controlled. Permission for distribution is usually granted under the control of the patient (through informed consent), the ethics committee or institutional review board responsible for the study, and the sponsor of the study through contractual means. The Consent for Clinical Trial Use Sequence (0012,0083) is intended to encode the result of the consent process to allow appropriate subsequent handling of the instances.

The defined terms for Distribution Type (0012,0084) mean that consent has been issued to distribute for the purpose of:

NAMED_PROTOCOL - conducting the protocol named in Clinical Trial Protocol ID (0012,0020)

RESTRICTED_REUSE - re-use for restricted purposes (not specified here) other than those for which the instances were originally created

PUBLIC_RELEASE - release to the general public for re-use without restriction

Notes: 1. There is no intent to convey in this sequence further details of the often complex consent and approval process. Further information about the protocol and ethics committee may be found in the Clinical Trials modules, if present.

2. There is no identification of an individual responsible for the approval or granting consent, since in the case of a clinical trial subject granting informed consent, the presence of this information would breach de-identification requirements.

3. Multiple sequence items may be present; for example a Study may be approved for distribution for conducting multiple explicitly named protocols.

4. Whether or not the instances have been adequately de-identified for any particular purpose of distribution is not defined by the Attributes in the Consent for Clinical Trial Use Sequence (0012,0083). Other Attributes address this, such as Patient Identity Removed (0012,0062), De-identification Method (0012,0063), De-identification Method Code Sequence (0012,0064) and Burned In Annotation (0028,0301). See also PS 3.15 Application Level Confidentiality Profiles.

5. It is possible that the list of Defined Terms for Distribution Type (0012,0084) may be extended in future for other purposes, not necessarily related to the conduct of clinical trials.