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Timeline | Proposal ready:
| XSD Approval
| XSD public review - | Implementation / testing TBD | Release Date TBD |
---|---|---|---|---|---|
Status |
Introduction
XSD 2.4 includes quite a lot of changes for RFCs as below:
For the implementation plan, WMDA will further notify the community when it is clear.
Any question or comments are welcome. You can ask question regarding XSD 2.4 here : https://share.wmda.info/questions/topics/403341316/xsdv24 or send email to support@wmda.info.
For members who have account in share and are interested to check the details of the discussion of the changes, you can check the internal meeting notes for XSD 2.4 in the link: https://share.wmda.info/x/agztFQ.
Please notice that XSD 2.3 change of GRID/ID must be implemented as well if upgrade to XSD 2.4 directly from XSD 2.2
Download XSD schema version 2.4
Below are the example XML files and the .xsd files.
Changes between version 2.4 and 2.3
Inventories.xsd
Updated version number to 2.4
Version 2.4
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" elementFormDefault="qualified" attributeFormDefault="unqualified" version="2.4">
Version 2.3
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" elementFormDefault="qualified" attributeFormDefault="unqualified" version="2.3">
RFC 007 IDM changes
XSD schema doc changes
Add new fields ANTI_HEV, HEV_NAT, CHAGAS_NAT
Rename fields WMV to WNV_NAT, CHAGAS to ANTI_CHAGAS
Update order of fields HCV_NAT and HBV_NAT
v2.4
<xs:element name="ANTI_HBS" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Hepatitis B status (antibody to hepatitis B surface antigen)</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HBV_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HBV NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_HCV" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Hepatitis C status (antibody to hepatitis C virus)</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HCV_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HCV NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_HEV" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Hepatitis E status (antibody to hepatitis E virus)</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HEV_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HEV NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_HIV_12" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Anti-HIV 1/2 status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HIV_1_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HIV-1 NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HIV_P24" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HIV p24 status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_HTLV" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Antibody to HTLV I/II</xs:documentation> </xs:annotation> </xs:element> <xs:element name="SYPHILIS" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Syphilis status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="WNV_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">WNV NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_CHAGAS" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Chagas antibody status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="CHAGAS_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Chagas NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="EBV" type="idmValueExtType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">EBV status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="TOXO" type="idmValueExtType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Toxoplasmosis status</xs:documentation> </xs:annotation> </xs:element>
v2.3
<xs:element name="ANTI_HBS" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Hepatitis B status (antibody to hepatitis B surface antigen)</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_HCV" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Hepatitis C status (antibody to hepatitis C virus)</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_HIV_12" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Anti-HIV 1/2 status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HIV_1_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HIV-1 NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HIV_P24" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HIV p24 status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HCV_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HCV NAT status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="ANTI_HTLV" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Antibody to HTLV I/II</xs:documentation> </xs:annotation> </xs:element> <xs:element name="SYPHILIS" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Syphilis status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="WNV" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">WNV status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="CHAGAS" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Chagas status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="EBV" type="idmValueExtType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">EBV status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="TOXO" type="idmValueExtType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Toxoplasmosis status</xs:documentation> </xs:annotation> </xs:element> <xs:element name="HBV_NAT" type="idmValueType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">HBV NAT status</xs:documentation> </xs:annotation> </xs:element>
Example of IDM XML
<IDM> <ANTI_CMV>P</ANTI_CMV> <ANTI_CMV_DATE>2010-07-04</ANTI_CMV_DATE> <CMV_NAT>N</CMV_NAT> <CMV_NAT_DATE>2010-07-04</CMV_NAT_DATE> <HBS_AG>N</HBS_AG> <ANTI_HBC>N</ANTI_HBC> <ANTI_HBS>N</ANTI_HBS> <HBV_NAT>N</HBV_NAT> <ANTI_HCV>N</ANTI_HCV> <HCV_NAT>N</HCV_NAT> <ANTI_HEV>N</HEV_NAT> <HEV_NAT>N</HEV_NAT> <ANTI_HIV_12>N</ANTI_HIV_12> <HIV_1_NAT>N</HIV_1_NAT> <HIV_P24>N</HIV_P24> <ANTI_HTLV>N</ANTI_HTLV> <SYPHILIS>N</SYPHILIS> <WNV_NAT>N</WNV_NAT> <ANTI_CHAGAS>N</ANTI_CHAGAS> <CHAGAS_NAT>N</CHAGAS_NAT> <EBV>N</EBV> <TOXO>N</TOXO> <PB19_NAT>N</PB19_NAT> <ALT>1</ALT> </IDM>
RFC 008 Add whole ADCU structure
XSD schema changes
Change the documentation
Add "ADCU" related description for the fields that used in ADCU product.
Version 2.4
<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>
Version 2.3
<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.
Version 2.4
<xs:complexType name="unitItemBaseType"> <xs:annotation> <xs:documentation>Abstract base type for banked unit items (ADCU, CBU)</xs:documentation> </xs:annotation> <xs:complexContent> <xs:extension base="itemBaseType"> <xs:sequence> <xs:element name="ID"> <xs:annotation> <xs:documentation xml:lang="en">Unique identifier 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>
Version 2.4
<xs:complexType name="cbuItemType"> <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.</xs:documentation> </xs:annotation> <xs:complexContent> <xs:extension base="unitItemBaseType"> <xs:sequence> <xs:element name="COLL_DATE" type="bareDateType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Date that the unit was collected</xs:documentation> </xs:annotation> </xs:element>
Version 2.3
<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
Version 2.4
<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="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: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="POST_THAW" type="postThawAdcuType" minOccurs="0"> <xs:annotation> <xs:documentation>Post-thaw data</xs:documentation> </xs:annotation> </xs:element> <xs:group ref="nmbrFieldsGroup"/> <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="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>
Version 2.3
<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
Version 2.4 Inventories.xsd
<xs:element name="POST_COLL" type="postCollCbuType" 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="postProcCbuType" minOccurs="0"> <xs:annotation> <xs:documentation>Data of post-processing (prior cryopreservation)</xs:documentation> </xs:annotation> </xs:element>
Version 2.4 Inventories.xsd
<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>
Version 2.4 basicTypes.xsd
<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>
Version 2.4 basicTypes.xsd
<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> </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="CFU" type="xs:float" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Total count of colony forming units</xs:documentation> </xs:annotation> </xs:element> <xs:element name="MNC" type="xs:float" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Total Number of mononucleated cells</xs:documentation> </xs:annotation> </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="VIABILITY_TNC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding TNC</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:element name="VIABILITY_CD34PC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding CD43+ cells</xs:documentation> </xs:annotation> </xs:element> <xs:element name="VIABILITY_CD45PC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding CD45+ cells</xs:documentation> </xs:annotation> </xs:element> <xs:element name="RED_BC" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Total number of nucleated red blood cells</xs:documentation> </xs:annotation> <xs:simpleType> <xs:restriction base="xs:float"> <xs:minInclusive value="0.0E0"/> <xs:maxInclusive value="999.9E7"/> </xs:restriction> </xs:simpleType> </xs:element> </xs:sequence> </xs:complexType> <xs:complexType name="postProcCbuType"> <xs:annotation> <xs:documentation>Post-processing (prior cryopreservation) data for CBUs</xs:documentation> </xs:annotation> <xs:complexContent> <xs:extension base="postProcBaseType"/> </xs:complexContent> </xs:complexType> <xs:complexType name="postProcAdcuType"> <xs:annotation> <xs:documentation>Post-processing (prior cryopreservation) data for ADCUs</xs:documentation> </xs:annotation> <xs:complexContent> <xs:extension base="postProcBaseType"> <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>
In XSD 2.3 and before, collection and post-processing fields use flat structure and use "_FRZN" to distinguish them.
Version 2.3
<xs:element name="VOL" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Collected volume before processing (without additives) in ml</xs:documentation> </xs:annotation> <xs:simpleType> <xs:restriction base="xs:short"> <xs:minInclusive value="1"/> <xs:maxInclusive value="9999"/> </xs:restriction> </xs:simpleType> </xs:element> <xs:element name="VOL_FRZN" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Total volume frozen (post processing, prior to cryopreservation) in ml</xs:documentation> </xs:annotation> <xs:simpleType> <xs:restriction base="xs:short"> <xs:minInclusive value="1"/> <xs:maxInclusive value="9999"/> </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 (before processing)</xs:documentation> </xs:annotation> </xs:element> <xs:element name="TNC_FRZN" type="xs:float" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Total number of nucleated cells (post processing, prior to cryopreservation)</xs:documentation> </xs:annotation> </xs:element>
Example of ADCU XML
RFC 009 Add Ready-to-Ship structrue
XSD schema changes
(Impact XML format) Add POST_THAW items
Following items are added: postThawBaseType, postThawCbuType, postThawAdcuType
Version 2.4 basicTypes.xsd
<xs:complexType name="postThawBaseType"> <xs:annotation> <xs:documentation>Post-thaw base data</xs:documentation> </xs:annotation> <xs:sequence> <xs:element name="CFU" type="xs:float" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Total count of colony forming units</xs:documentation> </xs:annotation> </xs:element> <xs:element name="CFU_GROWTH" type="xs:boolean" minOccurs="0"> <xs:annotation> <xs:documentation>CFU growth or not</xs:documentation> </xs:annotation> </xs:element> <xs:element name="CFU_METHOD" type="cfuMethodType" minOccurs="0"> <xs:annotation> <xs:documentation>CFU count method</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:element name="VIABILITY_CD34PC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding CD43+ cells</xs:documentation> </xs:annotation> </xs:element> <xs:element name="LAST_TEST_DATE" type="xs:date" minOccurs="0"> <xs:annotation> <xs:documentation>last test date</xs:documentation> </xs:annotation> </xs:element> </xs:sequence>
Version 2.4 basicTypes.xsd
<xs:complexType name="postThawCbuType"> <xs:annotation> <xs:documentation>Post-thaw data for CBUs</xs:documentation> </xs:annotation> <xs:complexContent> <xs:extension base="postThawBaseType"> <xs:sequence> <xs:element name="VIABILITY_TNC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding TNC</xs:documentation> </xs:annotation> </xs:element> </xs:sequence> </xs:extension> </xs:complexContent> </xs:complexType> <xs:complexType name="postThawAdcuType"> <xs:annotation> <xs:documentation>Post-thaw data for ADCUs</xs:documentation> </xs:annotation> <xs:complexContent> <xs:extension base="postThawBaseType"/> </xs:complexContent> </xs:complexType>
(Impact XML format)Add RELEASE_READY field
Version 2.4 Inventories.xsd
<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
<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
... <PLA_QUANT>10.0</PLA_QUANT> <POST_THAW> <CFU>2.1E5</CFU> <CFU_GROWTH>true</CFU_GROWTH> <CFU_METHOD>GM</CFU_METHOD> <TNC>250E7</TNC> <VIABILITY_TNC> <VALUE>95</VALUE> <METHOD>7A</METHOD> <DATE>2010-09-02</DATE> </VIABILITY_TNC> <CD34PC>2.1E6</CD34PC> <VIABILITY_CD34PC> <VALUE>91</VALUE> <METHOD>7A</METHOD> <DATE>2009-09-02</DATE> </VIABILITY_CD34PC> <LAST_TEST_DATE>2009-09-02</LAST_TEST_DATE> </POST_THAW> <RELEASE_READY>true</RELEASE_READY> <ID>WMDA0CBU001</ID> <COLL_DATE>2009-09-02</COLL_DATE> <POST_COLL> <VOL>100</VOL> <TNC>1.20E9</TNC> <CD34PC>1.50E6</CD34PC> </POST_COLL> <POST_PROC> <VOL>25</VOL> <CFU>1.23E6</CFU> <MNC>552999973</MNC> <TNC>9.90E8</TNC> <VIABILITY_TNC> <VALUE>95</VALUE> <METHOD>7A</METHOD> <DATE>2009-09-02</DATE> </VIABILITY_TNC> <CD34PC>1.10E6</CD34PC> <VIABILITY_CD34PC> <VALUE>92</VALUE> <METHOD>7A</METHOD> <DATE>2009-09-02</DATE> </VIABILITY_CD34PC> <RED_BC>9.00E7</RED_BC> </POST_PROC> <MAT> ... </MAT>
RFC 010 CBU viability
XSD schema changes
(Impact XML)Add XSD viabilityType to group viability related fields
Version 2.4 basicTypes.xsd
<xs:complexType name="viabilityType"> <xs:annotation> <xs:documentation>Viability fields</xs:documentation> </xs:annotation> <xs:sequence> <xs:element name="VALUE" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability as percentage value</xs:documentation> </xs:annotation> <xs:simpleType> <xs:restriction base="xs:short"> <xs:minInclusive value="0"/> <xs:maxInclusive value="100"/> </xs:restriction> </xs:simpleType> </xs:element> <xs:element name="METHOD" type="viabilityMethodType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Method used to calculate the viability. Note: PI and TB only allowed for TNC!</xs:documentation> </xs:annotation> </xs:element> <xs:element name="DATE" type="bareDateType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Date that viability was tested</xs:documentation> </xs:annotation> </xs:element> </xs:sequence> </xs:complexType>
(Impact XML) Add object VIABILITY_TNC, VIABILITY_CD34PC in POST_PROC object
Version 2.4 basicTypes.xsd
<xs:complexType name="postProcBaseType"> <xs:annotation> <xs:documentation>Post-processing (prior cryopreservation) base data</xs:documentation> </xs:annotation> ... <xs:sequence> ... <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="VIABILITY_TNC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding TNC</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:element name="VIABILITY_CD34PC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding CD43+ cells</xs:documentation> </xs:annotation> </xs:element> <xs:element name="VIABILITY_CD45PC" type="viabilityType" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Viability information regarding CD45+ cells</xs:documentation> </xs:annotation> </xs:element> ...
Example CBU XML for viability
Example usage in POST_THAW and POST_PROC:
XSD 2.4
<POST_THAW> <CFU>2.1E5</CFU> <CFU_GROWTH>true</CFU_GROWTH> <CFU_METHOD>GM</CFU_METHOD> <TNC>250E7</TNC> <VIABILITY_TNC> <VALUE>95</VALUE> <METHOD>7A</METHOD> <DATE>2010-09-02</DATE> </VIABILITY_TNC> <CD34PC>2.1E6</CD34PC> <VIABILITY_CD34PC> <VALUE>91</VALUE> <METHOD>7A</METHOD> <DATE>2009-09-02</DATE> </VIABILITY_CD34PC> <LAST_TEST_DATE>2009-09-02</LAST_TEST_DATE> </POST_THAW>
Example usage in POST_PROC
<POST_PROC> ... <VIABILITY_TNC> <VALUE>95</VALUE> <METHOD>7A</METHOD> <DATE>2009-09-02</DATE> </VIABILITY_TNC> <CD34PC>1.10E6</CD34PC> <VIABILITY_CD34PC> <VALUE>92</VALUE> <METHOD>7A</METHOD> <DATE>2009-09-02</DATE> </VIABILITY_CD34PC> ... </POST_PROC>
Other structure improvements in XSD schema
nmbrFieldsGroup
Group the value for number, this is an update and improvement of the XSD schema, and no change of the XML file.
Version 2.4 Inventories.xsd
<xs:group ref="nmbrFieldsGroup"/>
Version 2.4 basicTypes.xsd
<xs:group name="nmbrFieldsGroup"> <xs:annotation> <xs:documentation>Group of number fields for donors and donors of ADCUs</xs:documentation> </xs:annotation> <xs:sequence> <xs:element name="NMBR_TRANS" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Number of blood transfusions</xs:documentation> </xs:annotation> <xs:simpleType> <xs:restriction base="xs:short"> <xs:minInclusive value="0"/> </xs:restriction> </xs:simpleType> </xs:element>
Version 2.3 Inventories.xsd
<xs:complexType name="donItemType"> <xs:annotation> <xs:documentation xml:lang="en">A donor is an adult person who has consented to donate haematopoietic progenitor cells to an unrelated patient.</xs:documentation> </xs:annotation> <xs:complexContent> <xs:extension base="itemBaseType"> <xs:sequence> <xs:element name="ID" minOccurs="0"> <xs:annotation> ... <xs:element name="NMBR_TRANS" minOccurs="0"> <xs:annotation> <xs:documentation xml:lang="en">Number of blood transfusions</xs:documentation> </xs:annotation> <xs:simpleType> <xs:restriction base="xs:short"> <xs:minInclusive value="0"/> </xs:restriction> </xs:simpleType> </xs:element>