Another important update which effect the XML structure is the flat to nested structure change. This change will change and improve fields of post-collection, post-processing and new fields for post-thaw.
For members who have account in share and are interested to check the detail details of the discussion of the changes, you can check the XSD internal meeting notes for XSD 2.4 in the link:
Add "ADCU" related description for the fields that used in ADCU product.
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<xs:element name="BIRTH_DATE" type="bareDateType">
<xs:annotation>
<xs:documentation xml:lang="en">Date of birth of the donor/donor of ADCU/child of CBU</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="SEX" type="sexType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Biological gender of the donor/ADCU/CBU. Mandatory for donors, optional for CBUs.</xs:documentation>
</xs:annotation>
</xs:element>
Add "ADCU" related description for the fields that used in ADCU product.
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<xs:element name="BIRTH_DATE" type="bareDateType">
<xs:annotation>
<xs:documentation xml:lang="en">Date of birth of the donor/CBU</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="SEX" type="sexType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Biological gender of the donor/CBU. Mandatory for donors, optional for CBUs.</xs:documentation>
</xs:annotation>
</xs:element>
Add new item type unitItemBaseType
This item will extend the itemBaseType and include the shared fields of ADCU and CBU.
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<xs:complexTypeelement name="BIRTH_DATE" type="unitItemBaseTypebareDateType">
<xs:annotation>
<xs:documentation>Abstract base type for banked unit items (ADCU, CBU)<:documentation xml:lang="en">Date of birth of the donor/donor of ADCU/child of CBU</xs:documentation>
</xs:annotation>
<xs:complexContent> </xs:element>
<xs:extension base="itemBaseTypeelement name="SEX" type="sexType" minOccurs="0">
<xs:sequence>annotation>
<xs:elementdocumentationnamexml:lang="ID"en">Biological gender of the donor/ADCU/CBU. Mandatory for donors, optional for CBUs.</xs:documentation>
</xs:annotation>
</xs:element>
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>
<xs:annotation>element name="BIRTH_DATE" type="bareDateType"><xs:annotation>
<xs:documentation xml:lang="en">Unique>Date ofidentifierbirth of the unit: For CBUs: The value comprises the EMDIS hub code + donor identification allocated by the associated donor registry, where the sending organisation is an EMDIS member, otherwise the two digit ISO country code of the associated donor registry + donor identification allocated by the associated donor registry. For example: AU600196166, DEGOE-35487, US087013165, SB45. For ADCUs: ISBT 128 DIN without flag and check characters. for example: A999914123456</xs:documentation>
</xs:annotation>
<xs:simpleType>
donor/CBU</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="SEX" type="sexType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Biological gender of the donor/CBU. Mandatory for donors, optional for CBUs.</xs:documentation>
</xs:annotation>
</xs:element>
Add new item type unitItemBaseType
This item will extend the itemBaseType and include the shared fields of ADCU and CBU.
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<xs:complexType name="cbuItemTypeunitItemBaseType">
<xs:annotation>
<xs:documentation xml:lang="en">A CBU (cord blood unit) is a banked, frozen blood product extracted from a newborn baby's umbilical cord.documentation>Abstract base type for banked unit items (ADCU, CBU)</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:extension base="unitItemBaseTypeitemBaseType">
<xs:sequence>
<xs:element name="COLL_DATE" type="bareDateType" minOccurs="0ID">
<xs:annotation>
<xs:documentation xml:lang="en">Date>Unique identifierthatof the unit:wasForcollected</xs:documentation>
</xs:annotation>
</xs:element>
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<xs:complexType name="cbuItemType">
<xs:annotation>
<xs:documentation xml:lang="en">A cord blood unit (CBU) is a banked, frozen blood product extracted from a newborn baby's umbilical cord.</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:extension base="itemBaseType">
<xs:sequence>
<xs:element name="ID" minOccurs="1">
<xs:annotation>
<xs:documentation xml:lang="en">Unique identifier of the CBU: The value comprises the EMDIS hub code + donor identification allocated by the associated donor registry, where the sending organisation is an EMDIS member, otherwise the two digit ISO country code of the associated donor registry + donor identification allocated by the associated donor registry. For example: AU600196166, DEGOE-35487, US087013165, SB45.</xs:documentation>
</xs:annotation>
<xs:simpleType>
<xs:restriction base="xs:string">
<xs:maxLength value="25"/>
</xs:restriction>
</xs:simpleType>
</xs:element>
Add adcuItemType
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<xs:complexType name="adcuItemType">
<xs:annotation>
<xs:documentation xml:lang="en">An ADCU (adult donor cryopreserved unit) is a banked, frozen blood product collected from an adult donor.</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:extension base="unitItemBaseType">
<xs:sequence>
<xs:element name="POST_COLL" type="postCollAdcuType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Post collection (prior processing) data</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="POST_PROC" type="postProcAdcuType" minOccurs="0">
<xs:annotation>
<xs:documentation>Post-processing (prior cryopreservation) data</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="QA_DATE" type="bareDateType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Date of laboratory quality assessment</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="COLL_DATE" type="bareDateType">
<xs:annotation>
<xs:documentation xml:lang="en">Date that the unit was collected</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="COLL_TYPE" type="collTypeType">
<xs:annotation>
<xs:documentation xml:lang="en">Collection type, i.e. the collection method used</xs:documentation>
</xs:annotation>
</xs:element>
<xs:group ref="nmbrFieldsGroup"/>
<xs:element name="GRID">
<xs:annotation>
<xs:documentation xml:lang="en">GRID of the donor of the ADCU.</xs:documentation>
</xs:annotation>
<xs:simpleType>
<xs:restriction base="xs:string">
<xs:length value="19"/>
</xs:restriction>
</xs:simpleType>
</xs:element>
</xs:sequence>
</xs:extension>
</xs:complexContent>
</xs:complexType>
<xs:complexType name="inventoryType">
<xs:annotation>
<xs:documentation xml:lang="en">Type representing an inventory of donors, ADCUs (adult donor unit) and/or CBUs (cord blood units)</xs:documentation>
</xs:annotation>
<xs:sequence>
<xs:element name="DONOR" type="donItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">A donor is an adult person who has consented to donate haematopoietic progenitor cells, that is, HPC(M) or HPC(A) and similar products to an unrelated patient.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="ADCU" type="adcuItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">An ADCU (adult donor cryopreserved unit) is a banked, cryopreserved blood product collected from an adult donor.</xs:documentation>
</xs:annotation>
</xs:element>
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<xs:complexType name="inventoryType">
<xs:annotation>
<xs:documentation xml:lang="en">Type representing an inventory of donors and/or cord blood units (CBUs)</xs:documentation>
</xs:annotation>
<xs:sequence>
<xs:element name="DONOR" type="donItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">A donor is an adult person who has consented to donate haematopoietic progenitor cells, that is, HPC(M) or HPC(A) and similar products to an unrelated patient.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="CBU" type="cbuItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">A cord blood unit (CBU) is a banked, frozen blood product extracted from a newborn baby's umbilical cord.</xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence>
(Impact XML format) Improve some flat structure to nested structure
Improved to use nested structure of POST_COLL (post collection), introduced item type postCollCbuType, postCollAdcuType, postCollBaseType
Improved to use nested structure of POST_PROC (post processing/pre-cryopreservation), introduced item type postProcCbuType, postProcAdcuType, postProcBaseType
Added POST_THAW object. See details in the part for RFC 009 below
<xs:complexType name="postCollBaseType">
<xs:annotation>
<xs:documentation>Post-collection (prior processing) base data</xs:documentation>
</xs:annotation>
<xs:sequence>
<xs:element name="VOL" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Collected volume (without additives) in ml</xs:documentation>
</xs:annotation>
<xs:simpleType>
<xs:restriction base="xs:float">
<xs:minInclusive value="1.0"/>
<xs:maxInclusive value="9999.9"/>
</xs:restriction>
</xs:simpleType>
</xs:element>
<xs:element name="TNC" type="xs:float" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Total number of nucleated cells</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="CD34PC" type="xs:float" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Total number of CD34+ cells</xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence>
</xs:complexType>
<xs:complexType name="postCollCbuType">
<xs:annotation>
<xs:documentation>Post-collection (prior processing) data for CBUs</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:extension base="postCollBaseType"/>
</xs:complexContent>
</xs:complexType>
<xs:complexType name="postCollAdcuType">
<xs:annotation>
<xs:documentation>Post-collection (prior processing) data for ADCUs</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:extension base="postCollBaseType">
<xs:sequence>
<xs:element name="CD3PC" type="xs:float" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Total number of CD3+ cells </xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence>
</xs:extension>
</xs:complexContent>
</xs:complexType>
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Version 2.4 basicTypes.xsd
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<xs:complexType name="postProcBaseType">
<xs:annotation>
<xs:documentation>Post-processing (prior cryopreservation) base data</xs:documentation>
</xs:annotation>
<xs:sequence>
<xs:element name="VOL" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Total volume in ml</xs:documentation>
CBUs: The value comprises the EMDIS hub code + donor identification allocated by the associated donor registry, where the sending organisation is an EMDIS member, otherwise the two digit ISO country code of the associated donor registry + donor identification allocated by the associated donor registry. For example: AU600196166, DEGOE-35487, US087013165, SB45. For ADCUs: ISBT 128 DIN without flag and check characters. for example: A999914123456</xs:documentation>
</xs:annotation>
<xs:simpleType>
<xs:restriction base="xs:float">simpleType> <xs:minInclusive value="1.0"/>
<xs:maxInclusive value="9999.9"/>
</xs:restriction>
</xs:simpleType>
</xs:element>
<xs:element name="CFU" type="xs:float" minOccurs="0">
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<xs:complexType name="cbuItemType">
<xs:annotation>
<xs:documentation xml:lang="en">Total count of colony forming units<>A CBU (cord blood unit) is a banked, frozen blood product extracted from a newborn baby's umbilical cord.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:complexContent>
<xs:extension base="unitItemBaseType">
<xs:sequence>
<xs:element name="MNCCOLL_DATE" type="xs:floatbareDateType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Total>Date thatNumbertheofunitmononucleatedwascells<collected</xs:documentation>
</xs:annotation>
</xs:element>
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<xs:complexType
<xs:element name="TNC" type="xs:float" minOccurs="0cbuItemType">
<xs:annotation>
<xs:documentation xml:lang="en">Total number of nucleated cells<>A cord blood unit (CBU) is a banked, frozen blood product extracted from a newborn baby's umbilical cord.</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:extension base="itemBaseType"></xs:element>
<xs:sequence>
<xs:element name="VIABILITY_TNCID" type="viabilityType" minOccurs="01">
<xs:annotation>
<xs:documentation xml:lang="en">Viability information regarding TNC<:lang="en">Unique identifier of the CBU: The value comprises the EMDIS hub code + donor identification allocated by the associated donor registry, where the sending organisation is an EMDIS member, otherwise the two digit ISO country code of the associated donor registry + donor identification allocated by the associated donor registry. For example: AU600196166, DEGOE-35487, US087013165, SB45.</xs:documentation>
</xs:annotation>
</xs<xs:element>simpleType><xs:element name="CD34PC" typerestriction base="xs:float" minOccurs="0string">
<xs:annotation>
<xs:documentationmaxLengthxml:langvalue="en">Total number of CD34+ cells 25"/>
</xs:documentation>restriction> </xs:annotation>simpleType> </xs:element>
Add adcuItemType
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<xs:elementcomplexType name="VIABILITY_CD34PC" type="viabilityType" minOccurs="0"adcuItemType">
<xs:annotation>
<xs:documentation xml:lang="en">Viability information regarding CD43+ cells<>An ADCU (adult donor cryopreserved unit) is a banked, frozen blood product collected from an adult donor.</xs:documentation>
</xs:annotation>
<xs:complexContent></xs:element>
<xs:extension base="unitItemBaseType">
<xs:sequence>
<xs:element name="VIABILITYCOLL_CD45PCDATE" type="viabilityType" minOccurs="0"bareDateType">
<xs:annotation>
<xs:documentation xml:lang="en">Viability>Date thatinformationtheregardingunitCD45+wascells<collected</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="REDCOLL_BCTYPE" minOccurstype="0collTypeType">
<xs:annotation>
<xs:documentation xml:lang="en">Total>Collectionnumber of nucleated red blood cells<type, i.e. the collection method used</xs:documentation>
</xs:annotation>
<xs</xs:simpleType>element>
<xs:restriction base="xs:floatelement name="POST_COLL" type="postCollAdcuType" minOccurs="0">
<xs:minInclusive value="0.0E0"/>annotation><xs:maxInclusivedocumentationvaluexml:lang="999.9E7"/>
en">Post collection (prior processing) data</xs:documentation>
</xs:restriction>annotation></xs:simpleType>element></xs:element>
</xs:sequence>
</xs:complexType>
<xs:complexType name="postProcCbuType">
<xs:element name="POST_PROC" type="postProcAdcuType" minOccurs="0">
<xs:annotation>
<xs:documentation>Post-processing (prior cryopreservation) data for CBUs<data</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:extension base="postProcBaseType"/>
</xs:complexContent>element> </xs:complexType>
<xs:complexTypeelement name="POST_THAW" type="postProcAdcuTypepostThawAdcuType" minOccurs="0">
<xs:annotation>
<xs:documentation>Post-processing (prior cryopreservation) data for ADCUs<thaw data</xs:documentation>
</xs:annotation>
<xs</xs:complexContent>element> <xs:extensiongroupbaseref="postProcBaseTypenmbrFieldsGroup">
<xs:sequence>/>
<xs:element name="CD3PCQA_DATE" type="xs:floatbareDateType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Total number>Date of CD3+laboratorycellsquality<assessment</xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence> </xs:extension>
</xs:complexContent>
</xs:complexType>
In XSD 2.3 and before, collection and post-processing fields use flat structure and use "_FRZN" to distinguish them.
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<xs:element name="VOL" minOccurs="0GRID">
<xs:annotation>
<xs:documentation xml:lang="en">Collected>GRIDvolumeofbeforetheprocessingdonor(without additives) in ml<of the ADCU.</xs:documentation>
</xs:annotation>
<xs:simpleType>
<xs:restriction base="xs:shortstring">
<xs:minInclusivelength value="119"/>
</xs:restriction>
<xs:maxInclusive value="9999"/>
</xs:simpleType>
</xs:element>
</xs:sequence>
</xs:extension>
</xs:complexContent>
</xs:restriction>
complexType>
<xs:complexType name="inventoryType">
<xs:annotation>
<xs:documentation xml:lang="en">Type representing an inventory of donors, ADCUs (adult donor unit) and/or CBUs (cord blood units)</xs:simpleType>documentation></xs:element>annotation><xs:sequence>
<xs:element name="DONOR" type="VOL_FRZNdonItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">Total volume frozen (post processing, prior to cryopreservation) in ml<>A donor is an adult person who has consented to donate haematopoietic progenitor cells, that is, HPC(M) or HPC(A) and similar products to an unrelated patient.</xs:documentation>
</xs:annotation>
<xs:simpleType>
<xs:restriction base="xs:short"></xs:element>
<xs:minInclusive value="1"/>
element name="ADCU" type="adcuItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:maxInclusivedocumentationvaluexml:lang="9999"/>en">An ADCU (adult donor cryopreserved unit) is a banked, cryopreserved blood product collected from an adult donor.</xs:documentation></xs:annotation>
</xs:restriction>element>
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<xs:complexType name="inventoryType"><xs:annotation>
<xs:documentation xml:lang="en">Type representing an inventory of donors and/or cord blood units (CBUs)</xs:simpleType>documentation> </xs:element>annotation><xs:sequence>
<xs:element name="TNCDONOR" type="xs:floatdonItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">Total number of nucleated cells (before processing)>A donor is an adult person who has consented to donate haematopoietic progenitor cells, that is, HPC(M) or HPC(A) and similar products to an unrelated patient.</xs:documentation>
</xs:annotation>
</xs:element>
<xs:element name="TNC_FRZNCBU" type="xs:floatcbuItemType" minOccurs="0" maxOccurs="unbounded">
<xs:annotation>
<xs:documentation xml:lang="en">Total>A cordnumberbloodofunitnucleated(CBU)cellsis(postaprocessing, prior to cryopreservation)banked, frozen blood product extracted from a newborn baby's umbilical cord.</xs:documentation>
</xs:annotation>
</xs:element>
</xs:element>
Example ADCU XML
expand
xs:sequence>
(Impact XML format) Improve some flat structure to nested structure
Improved to use nested structure of POST_COLL (post collection), introduced item type postCollCbuType, postCollAdcuType, postCollBaseType
Improved to use nested structure of POST_PROC (post processing/pre-cryopreservation), introduced item type postProcCbuType, postProcAdcuType, postProcBaseType
Added POST_THAW object. See details in the part for RFC 009 below
<xs:elementcomplexType name="CD34PC" type="xs:float" minOccurs="0"postThawCbuType">
<xs:annotation>
<xs:documentation>Post-thaw data for CBUs</xs:documentation>
</xs:annotation>
<xs:complexContent>
<xs:documentationextensionxml:langbase="en">Total number of CD34+ cells</xs:documentation>"postThawBaseType"></xs<xs:annotation>sequence></xs:element>
<xs:element name="VIABILITY_CD34PCTNC" type="viabilityType" minOccurs="0">
<xs:annotation>
<xs:documentation xml:lang="en">Viability information regarding CD43+ cells<TNC</xs:documentation>
</xs:annotation>
</xs:element>
</xs:sequence>
</xs:extension></xs:complexContent>
</xs:complexType>
<xs:elementcomplexType name="LAST_TEST_DATE" type="xs:date" minOccurs="0">
postThawAdcuType">
<xs:annotation>
<xs:documentation>last test date<documentation>Post-thaw data for ADCUs</xs:documentation>
</xs:annotation>
<xs:complexContent><xs:extension base="postThawBaseType"/>
</xs:element>complexContent> </xs:sequence>complexType>
(Impact XML format)Add RELEASE_READY field
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Version 2.4 Inventories.xsd
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<xs:element name="RELEASE_READY" type="xs:boolean" minOccurs="0">
<xs:annotation>
<xs:documentation>Identify whether unit is ready for release by the stem cell bank</xs:documentation>
</xs:annotation>
</xs:element>
(Impact XML )Add item cfuMethodType
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<xs:simpleType name="cfuMethodType">
<xs:annotation>
<xs:documentation>Method used for CFU counting</xs:documentation>
</xs:annotation>
<xs:restriction base="xs:string">
<xs:enumeration value="TT"/>
<xs:enumeration value="GM"/>
<xs:enumeration value="OT"/>
</xs:restriction>
</xs:simpleType>
Example of CBU XML for RFC-009
Add POST_THAW, RELEASE_READY, POST_COLL,POST_PROC. The example of viability usage from RFC-010 also included to make the example more complete