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RFC 009 Add Ready-to-Ship structrue

XSD schema changes

(Impact XML format) Add POST_THAW items

Following items are added: postThawBaseType, postThawCbuType, postThawAdcuType

Code Block
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titleVersion 2.4 basicTypes.xsd
linenumberstrue
	<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>
Code Block
languagexml
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titleVersion 2.4 basicTypes.xsd
linenumberstrue
		<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

Code Block
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titleVersion 2.4 Inventories.xsd
linenumberstrue
					<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 

Code Block
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linenumberstrue
	<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

Code Block
languagexml
linenumberstrue
            ...
            <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>

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