Timeline | Proposal ready:
| XSD Approval
| XSD public review - | Implementation / testing TBD | Release Date TBD |
---|---|---|---|---|---|
Status |
Download XSD version 2.4
Please notice that XSD 2.3 rule GRID/ID must be implemented as well if upgrade to XSD 2.4 directly from XSD 2.2
All questions regarding this version can be asked here : https://share.wmda.info/questions/topics/403341316/xsdv24
Changes between version 2.4 and 2.3
Updated version number to 2.4
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" elementFormDefault="qualified" attributeFormDefault="unqualified" version="2.4">
- Update version number to 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
<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>
<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>
XML example
RFC 008 Add whole ADCU structure
XSD schema changes
Change the documentation
Add "ADCU" related description for the fields that used in ADCU product.
<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>
<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.
<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>
<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>
<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
<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>
<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: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>
<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: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>
<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.
<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 ADCU XML
RFC 009 Add Ready-to-Ship structrue
XSD schema changes
(Impact XML format) Add POST_THAW object and item postThawType
<xs:element name="POST_THAW" type="postThawType" minOccurs="0"> <xs:annotation> <xs:documentation>Post-thaw data</xs:documentation> </xs:annotation> </xs:element>
<xs:complexType name="postThawType"> <xs:annotation> <xs:documentation>Post-thaw 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="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="LAST_TEST_DATE" type="xs:date" minOccurs="0"> <xs:annotation> <xs:documentation>last test date</xs:documentation> </xs:annotation> </xs:element> </xs:sequence>
(Impact XML format)Add RELEASE_READY field
<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 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
<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
<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:
<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.
<xs:group ref="nmbrFieldsGroup"/>
<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>
<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>