Species Attributes conditions should be non-human not animal Status Assigned Date of Last Update 2022/03/21 Person Assigned David Clunie Submitter Name Carlos Anderson Submission Date 2022/02/03 Correction Number CP-2213 Log Summary: Species Attributes conditions should be non-human not animal Name of Standard PS3.3 Rationale for Correction: The description for the "Patient Species Description Attribute" says "Required if the Patient is an animal..." but I think it meant to say "Required if the Patient is non-human..." since humans are animals. Similar issue for the description for the "Patient Species Code Sequence Attribute". Distinguish between requirements for any organism (species), as opposed to non-human animals (responsible people). Correction Wording:

Patient Module Attributes

Attribute Name	Tag	Type	Attribute Description
...
Patient Species Description	(0010,2201)	1C	The taxonomic rank value (e.g., genus, subgenus, species or subspecies) of the Patient. See . 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 taxonomic rank value (e.g., genus, subgenus, species or subspecies) of the Patient. See . Only a single Item shall be included in this Sequence. Required if the Patient is an animalan organism and not human, and if Patient Species Description (0010,2201) is not present. May be present otherwise.
>Include			D.
Patient Breed Description	(0010,2292)	2C	The breed of the Patient. See . Required if the Patient is an animalan organism and not human, 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 . Zero or more Items shall be included in this Sequence. Required if the Patient is an animalan organism and not human.
>Include			D.
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 animalan organism and not human.
>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			D.
Strain Description	(0010,0212)	3	The strain of the Patient. See .
Strain Nomenclature	(0010,0213)	3	The nomenclature used for Strain Description (0010,0212). See .
Strain Code Sequence	(0010,0219)	3	A coded identification of the strain of the Patient. See . One or more Items are permitted in this Sequence. If more than one Item is present, each Item represents the same information but encoded using a different coding scheme (rather than post-coordinated modifiers).
>Include			No Baseline CID is defined.
Strain Additional Information	(0010,0218)	3	Additional information about the strain of the Patient that is not encoded in the formal nomenclature used in Strain Description (0010,0212). See .
Strain Stock Sequence	(0010,0216)	3	Information identifying an animal within a strain stock. Only a single Item is permitted in this Sequence.
>Strain Stock Number	(0010,0214)	1	The stock number of the strain of the Patient issued by the organization identified by Strain Source (0010,0217). See .
>Strain Source	(0010,0217)	1	Identification of the organization that is the source of the animal, issued by the registry identified by Strain Source Registry Code Sequence (0010,0215). See .
>Strain Source Registry Code Sequence	(0010,0215)	1	Identification of the organization that is the registry of sources of animals. See . Only a single Item is permitted in this Sequence.
>>Include			D.
Genetic Modifications Sequence	(0010,0221)	3	The genetic modifications of the Patient. One or more Items are permitted in this Sequence. See .
>Genetic Modifications Description	(0010,0222)	1	The genetic modifications of the Patient described using a specific nomenclature.
>Genetic Modifications Nomenclature	(0010,0223)	1	The nomenclature used for Genetic Modifications Description (0010,0222).
>Genetic Modifications Code Sequence	(0010,0229)	3	A coded identification of the genetic modifications of the Patient. One or more Items are permitted in this Sequence. If more than one Item is present, each Item represents the same information but encoded using a different coding scheme (rather than post-coordinated modifiers).
>>Include			No Baseline CID is defined.
Responsible Person	(0010,2297)	2C	Name of person with medical or welfare decision making authority for the Patient. Required if the Patient is an animal and not human. May be present otherwise.
Responsible Person Role	(0010,2298)	1C	Relationship of Responsible Person to the Patient. See for Defined Terms. Required if Responsible Person is present and has a value.
Responsible Organization	(0010,2299)	2C	Name of organization with medical or welfare decision making authority for the Patient. Required if Patient is an animal and not human. May be present otherwise.
...

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., (132561000, SCT, "Border Collie dog breed") followed by (132534000, SCT, "American Bulldog breed"), or encoded non-specifically with a code that means "mixed breed" of the appropriate species, as defined in , which is included in , e.g., (132619000, SCT, "Mixed breed dog"). 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.

OWNER PARENT CHILD SPOUSE SIBLING RELATIVE GUARDIAN CUSTODIAN AGENT INVESTIGATOR VETERINARIAN

If the species is not known then the Patient Species Description (0010,2201) or Patient Species Code Sequence (0010,2202) may describe a more general taxonomic rank value, such as a genus or subgenus, family or subfamily. E.g., "Mus" rather than "Mus musculus". If the subspecies is known then the Patient Species Description (0010,2201) or Patient Species Code Sequence (0010,2202) may describe the subspecies. E.g., "Canis lupus familiaris" rather than "Canis lupus".

The strain of an animal (group of animals that is genetically uniform), if known, may be encoded in Strain Description (0010,0212). The nomenclature used may be encoded in Strain Nomenclature (0010,0213). A precoordinated code identifying the strain may be encoded in Strain Code Sequence (0010,0219). MGI_2013 International Committee on Standardized Genetic Nomenclature for Mice, Rat Genome and Nomenclature Committee. MGI-Guidelines for Nomenclature of Mouse and Rat Strains. 2013/10. Available from: A pair of text and nomenclature Attributes are used, since standard nomenclatures typically define values that are constructed from multiple components, and do not distinguish between value and meaning. These are distinct from the precoordinated codes used in Strain Code Sequence (0010,0219). Some strain and genetic modification nomenclatures make use of superscripts. To encode these superscripts consistently in an unformatted string, the convention of enclosing the superscript text in "<" and ">" pairs may be used. E.g., "D2.B6-Ahrb-1/J" would be encoded as "D2.B6-Ahr<b-1>/J". Relevant information that is not encoded in the formal description of the strain (i.e., not defined in the nomenclature used), such as the number of transgenes, may be encoded as plain text in Strain Additional Information (0010,0218). The strain of an animal may be more specifically identified by the Attributes within Strain Stock Sequence (0010,0216). The MGI-Guidelines for Nomenclature of Mouse and Rat Strains recommends the use of the laboratory codes assigned by the Institute of Laboratory Animal Research (ILAR). See the International Laboratory Code Registry (ILCR) . Because allele names are closely tied to gene names/symbols it is necessary to have a unique and permanent code for any allele that is part of a genotype of interest. For mice, MGI is the authoritative source of the nomenclature for genes and alleles and maintains unique, permanent codes for these entities. The MGI provides a report of all precoordinated MGI codes that are assigned to specific strains at . These may be used in Strain Code Sequence (0010,0219) and Genetic Modifications Code Sequence (0010,0229) with a coding scheme of "MGI". Another source of pre-coordinated codes for strains is the NCI Thesaurus, which includes a snapshot of strains from the International Mouse Strain Resource (IMSR), as children of (C14421, NCIt, "Inbred Mouse Strains"). See . For example, a C57BL/6J mouse strain from The Jackson Laboratory might be identified as: Strain Description (0010,0212) = "C57BL/6J" Strain Nomenclature (0010,0213) = "MGI_2013" Strain Code Sequence (0010,0219) >Code Value (0008,0100) = "3028467" >Coding Scheme Designator (0008,0102) = "MGI" >Code Meaning (0008,0104) = "C57BL/6J" Strain Stock Sequence (0010,0216) >Strain Stock Number (0010,0214) = "000664" >Strain Source (0010,0217) = "Jrep" >Strain Source Registry Code Sequence (0010,0215) >>Code Value (0008,0100) = 126850 >>Coding Scheme Designator (0008,0102) = "DCM" >>Code Meaning (0008,0104) = "ILCR" For example, a FVB/N mouse with a Tg(MMTV-Erbb2*)NDL2-5Mul transgene might be identified as: Strain Description (0010,0212) = "FVB/N-Tg(MMTV-Erbb2*)NDL2-5Mul" Strain Nomenclature (0010,0213) = "MGI_2013" Genetic Modifications Sequence (0010,0221) >Genetic Modifications Description (0010,0222) = "Tg(MMTV-Erbb2*)NDL2-5Mul" >Genetic Modifications Nomenclature (0010,0223) = "MGI_2013" >Genetic Modifications Code Sequence (0010,0229) >>Code Value (0008,0100) = "3793949" >>Coding Scheme Designator (0008,0102) = "MGI" >>Code Meaning (0008,0104) = "Tg(MMTV-Erbb2*)NDL2-5Mul" In this example, a precoordinated code for the genetic modification is defined in MGI, but not for the mouse strain.