C.7 Common Composite Image IOD Modules

C.7 Common Composite Image IOD Modules
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This Section defines the Modules that are common to all Composite Image IODs.

C.7.1 Common Patient IE Modules

The following Patient IE Module is common to all Composite Image IODs that reference the Patient IE.

C.7.1.1 Patient Module

Table C.7-1 specifies the Attributes of the Patient that describe and identify the Patient who is the subject of a diagnostic Study. This Module contains Attributes of the patient that are needed for diagnostic interpretation of the Image and are common for all studies performed on the patient. It contains Attributes that are also included in the Patient Modules in Section C.2.

Table C.7-1. Patient Module Attributes

Attribute Name	Tag	Type	Attribute Description
Patient's Name	(0010,0010)	2	Patient's full name.
Patient ID	(0010,0020)	2	Primary hospital identification number or code for the patient.
Include Table 10-18 “Issuer of Patient ID Macro Attributes”
Patient's Birth Date	(0010,0030)	2	Birth date of the patient.
Patient's Sex	(0010,0040)	2	Sex of the named patient. Enumerated Values: M male F female O other
Referenced Patient Photo Sequence	(0010,1100)	3	A photo to confirm the identity of a patient. Only a single Item is permitted in this Sequence. See C.2.2.1.1.
>Include Table 10-3b “Referenced Instances and Access Macro Attributes”
Quality Control Subject	(0010,0200)	3	Indicates whether or not the subject is a quality control phantom. Enumerated Values: YES NO If this Attribute is absent, then the subject may or may not be a phantom. This attribute describes a characteristic of the Imaging Subject. It is distinct from Quality Control Image (0028,0300) in the General Image Module, which is used to describe an image acquired.
Referenced Patient Sequence	(0008,1120)	3	A sequence that provides reference to a Patient SOP Class/Instance pair. Only a single Item is permitted in this Sequence.
>Include Table 10-11 “SOP Instance Reference Macro Attributes”
Patient's Birth Time	(0010,0032)	3	Birth time of the Patient.
Other Patient IDs	(0010,1000)	3	Other identification numbers or codes used to identify the patient.
Other Patient IDs Sequence	(0010,1002)	3	A sequence of identification numbers or codes used to identify the patient, which may or may not be human readable, and may or may not have been obtained from an implanted or attached device such as an RFID or barcode. One or more Items are permitted in this Sequence.
>Patient ID	(0010,0020)	1	An identification number or code used to identify the patient.
>Include Table 10-18 “Issuer of Patient ID Macro Attributes”
>Type of Patient ID	(0010,0022)	1	The type of identifier in this item. Defined Terms: TEXT RFID BARCODE Note The identifier is coded as a string regardless of the type, not as a binary value.
Other Patient Names	(0010,1001)	3	Other names used to identify the patient.
Ethnic Group	(0010,2160)	3	Ethnic group or race of the patient.
Patient Comments	(0010,4000)	3	User-defined additional information about the patient.
Patient Species Description	(0010,2201)	1C	The species of the patient. Required if the patient is an animal and if Patient Species Code Sequence (0010,2202) is not present. May be present otherwise.
Patient Species Code Sequence	(0010,2202)	1C	The species of the patient. Only a single Item shall be included in this Sequence. Required if the patient is an animal and if Patient Species Description (0010,2201) is not present. May be present otherwise.
>Include Table 8.8-1 “Code Sequence Macro Attributes”			Defined CID 7454 “Species”.
Patient Breed Description	(0010,2292)	2C	The breed of the patient. See Section C.7.1.1.1.1. Required if the patient is an animal and if Patient Breed Code Sequence (0010,2293) is empty. May be present otherwise.
Patient Breed Code Sequence	(0010,2293)	2C	The breed of the patient. See Section C.7.1.1.1.1. Zero or more Items shall be included in this Sequence. Required if the patient is an animal.
>Include Table 8.8-1 “Code Sequence Macro Attributes”			Defined CID 7480 “Breed”.
Breed Registration Sequence	(0010,2294)	2C	Information identifying an animal within a breed registry. Zero or more Items shall be included in this Sequence. Required if the patient is an animal.
>Breed Registration Number	(0010,2295)	1	Identification number of an animal within the registry.
>Breed Registry Code Sequence	(0010,2296)	1	Identification of the organization with which an animal is registered. Only a single Item shall be included in this Sequence.
>>Include Table 8.8-1 “Code Sequence Macro Attributes”			Defined CID 7481 “Breed Registry”.
Responsible Person	(0010,2297)	2C	Name of person with medical decision making authority for the patient. Required if the patient is an animal. May be present otherwise.
Responsible Person Role	(0010,2298)	1C	Relationship of Responsible Person to the patient. See Section C.7.1.1.1.2 for Defined Terms. Required if Responsible Person is present and has a value.
Responsible Organization	(0010,2299)	2C	Name of organization with medical decision making authority for the patient. Required if patient is an animal. May be present otherwise.
Patient Identity Removed	(0012,0062)	3	The true identity of the patient has been removed from the Attributes and the Pixel Data Enumerated Values: YES NO
De-identification Method	(0012,0063)	1C	A description or label of the mechanism or method use to remove the patient's identity. May be multi-valued if successive de-identification steps have been performed. Note This may be used to describe the extent or thoroughness of the de-identification, for example whether or not the de-identification is for a "Limited Data Set" (as per HIPAA Privacy Rule). The characteristics of the de-identifying equipment and/or the responsible operator of that equipment may be recorded as an additional item of the Contributing Equipment Sequence (0018,A001) in the SOP Common Module. De-identifying equipment may use a Purpose of Reference of (109104, DCM, "De-identifying Equipment"). Required if Patient Identity Removed (0012,0062) is present and has a value of YES and De-identification Method Code Sequence (0012,0064) is not present. May be present otherwise.
De-identification Method Code Sequence	(0012,0064)	1C	A code describing the mechanism or method use to remove the patient's identity. One or more Items shall be included in this Sequence. Multiple items are used if successive de-identification steps have been performed or to describe options of a defined profile. Required if Patient Identity Removed (0012,0062) is present and has a value of YES and De-identification Method (0012,0063) is not present. May be present otherwise.
>Include Table 8.8-1 “Code Sequence Macro Attributes”			Defined CID 7050 “De-identification Method”.

C.7.1.1.1 Patient Module Attributes

C.7.1.1.1.1 Patient Breed Description and Code Sequence

The breed of an animal, if known, shall be encoded in either Patient Breed Description (0010,2292) or Patient Breed Code Sequence (0010,2293) or both.

In the case of a mixed breed, it shall be either:

described in plain text in Patient Breed Description (0010,2292), e.g., "Border Collie American Bulldog mix", or just "Mixed", or
coded as multiple specific breeds by composing the mix as multiple items of Patient Breed Code Sequence (0010,2293), e.g., (L-809A2, SRT, "Border Collie dog breed") followed by (L-80974, SRT, "American Bulldog breed"), or
encoded non-specifically with a code that means "mixed breed" of the appropriate species, as defined in CID 7486 “Mixed Breeds”, which is included in CID 7480 “Breed”, e.g., (L-809DF, SRT, "Mixed breed dog").

Note

The absence of a value for both Patient Breed Description (0010,2292) and Patient Breed Code Sequence (0010,2293) implies that the breed is unknown, not that it is mixed.

C.7.1.1.1.2 Responsible Person Role

Defined Terms:

OWNER
PARENT
CHILD
SPOUSE
SIBLING
RELATIVE
GUARDIAN
CUSTODIAN
AGENT

C.7.1.2 Specimen Identification Module

Retired. See PS3.3-2008.

Note

The functionality of the Specimen Identification Modulehas been replaced by the Specimen Module. See Section C.7.6.22.

C.7.1.3 Clinical Trial Subject Module

Table C.7-2b contains attributes that identify a Patient as a clinical trial Subject.

Table C.7-2b. Clinical Trial Subject Module Attributes

Attribute Name	Tag	Type	Attribute Description
Clinical Trial Sponsor Name	(0012,0010)	1	The name of the clinical trial sponsor. See Section C.7.1.3.1.1.
Clinical Trial Protocol ID	(0012,0020)	1	Identifier for the noted protocol. See Section C.7.1.3.1.2.
Clinical Trial Protocol Name	(0012,0021)	2	The name of the clinical trial protocol. See Section C.7.1.3.1.3.
Clinical Trial Site ID	(0012,0030)	2	The identifier of the site responsible for submitting clinical trial data. See Section C.7.1.3.1.4.
Clinical Trial Site Name	(0012,0031)	2	Name of the site responsible for submitting clinical trial data. See Section C.7.1.3.1.5
Clinical Trial Subject ID	(0012,0040)	1C	The assigned identifier for the clinical trial subject. See Section C.7.1.3.1.6. Shall be present if Clinical Trial Subject Reading ID (0012,0042) is absent. May be present otherwise.
Clinical Trial Subject Reading ID	(0012,0042)	1C	Identifies the subject for blinded evaluations. Shall be present if Clinical Trial Subject ID (0012,0040) is absent. May be present otherwise. See Section C.7.1.3.1.7.
Clinical Trial Protocol Ethics Committee Name	(0012,0081)	1C	Name of the Ethics Committee or Institutional Review Board (IRB) responsible for approval of the Clinical Trial. Required if Clinical Trial Protocol Ethics Committee Approval Number (0012,0082) is present.
Clinical Trial Protocol Ethics Committee Approval Number	(0012,0082)	3	Approval number issued by committee described in Clinical Trial Protocol Ethics Committee Name (0012,0081).

C.7.1.3.1 Clinical Trial Subject Attribute Descriptions

Identification of subjects in clinical trials generally requires a combination of the following four attributes:

Clinical Trial Sponsor Name (0012,0010),
Clinical Trial Protocol ID (0012,0020),
Clinical Trial Subject ID (0012,0040) (or Clinical Trial Subject Reading ID (0012,0042) for blinded evaluations), and
Clinical Trial Site ID (0012,0030).

For trials in which subject identifiers are unique within the scope of the Clinical Trial Protocol (e.g., if subject identifiers are centrally assigned or contain the site identifier) the Clinical Trial Site ID (0012,0030) is not required to identify subjects.

C.7.1.3.1.1 Clinical Trial Sponsor Name

The Clinical Trial Sponsor Name (0012,0010) identifies the entity responsible for conducting the clinical trial and for defining the Clinical Trial Protocol ID (0012,0020).

C.7.1.3.1.2 Clinical Trial Protocol ID

The Clinical Trial Protocol ID (0012,0020) is the number or character sequence used by the Clinical Trial Sponsor to uniquely identify the investigational protocol in which the subject has been enrolled.

C.7.1.3.1.3 Clinical Trial Protocol Name

The Clinical Trial Protocol Name (0012,0021) contains the title of the investigational protocol in which the subject has been enrolled.

Note

It is recommended that the phase of the clinical trial be noted in the Clinical Trial Protocol Name, if applicable.

C.7.1.3.1.4 Clinical Trial Site ID

The Clinical Trial Site ID (0012,0030) is the identification number or character string (issued by the entity identified by the Clinical Trial Sponsor Name (0012,0010)) used to identify the site responsible for submitting clinical trial data.

C.7.1.3.1.5 Clinical Trial Site Name

The Clinical Trial Site Name (0012,0031) is a character string used to identify the site responsible for submitting clinical trial data.

C.7.1.3.1.6 Clinical Trial Subject ID

The Clinical Trial Subject ID (0012,0040) identifies the subject within the investigational protocol specified by Clinical Trial Protocol ID (0012,0020).

C.7.1.3.1.7 Clinical Trial Subject Reading ID

The Clinical Trial Subject Reading ID (0012,0042) identifies the subject in the context of blinded evaluations.

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