HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-12-06

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

December 6, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Edward Pec (Abbott Laboratories), Diane Miller(Alpharma), Art Griesser (Promethues), and Josh McDade (Promethues)

• I have sent another e-mail to find out how to get access and/or post information to www.accessdata.fda.gov. There appeared to be some confusion, and I wanted to know how to post to the FDA Data Standards Council internet web page (goes through Lonnie Smith). I re-asked the question "Who controls and how do I get information on the www.accessdata.fda.gov page similar to how SPL has http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl for their stylesheet and http://www.accessdata.fda.gov/spl/schema/spl.xsd for their schema?"
• I asked Mead Walker if there has been any progress with out issues to HL7 Technical Steering Committee (TSC) and he he has not forgotten the topic, and I will put something together soon.
• Update from Josh on the schematron. Made more enhancements to desktop validator. They have put together a download with a zipped file with the source code and desktop validator, it will be ready for release soon. The validation web site is up and running at http://estability.prometheuscomputing.com. You can use the attached example zipped files to try it (http://gforge.hl7.org/gf/download/docmanfileversion/6032/7867/ExampleMessages.zip). If you are using IE 6.0 you will want to use Firefox to get all the functions.
• See the attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6033/7868/PotentialItemsforValidation_MY_NG_KH-N.doc) for potential items for eStability Validation Procedures document.
• There will be no teleconference on December 27.
• I was in error when I stated that RepresentedManufacturer does not have id root. Here is what schema says:

   <xs:complexType name="PORT_MT090002UV01.AssignedEntity2">
       <xs:sequence>
           <xs:group ref="InfrastructureRootElements"/>
           <xs:element name="representedManufacturer" type="PORT_MT090002UV01.Manufacturer"/>
       </xs:sequence>
       <xs:attributeGroup ref="InfrastructureRootAttributes"/>
       <xs:attribute name="nullFlavor" type="NullFlavor" use="optional"/>
       <xs:attribute name="classCode" type="RoleClass" use="optional" fixed="ASSIGNED"/>
   </xs:complexType>

The representedManufacturer has a type of Manufacturer which has the following properties:

   <xs:complexType name="PORT_MT090002UV01.Manufacturer">
       <xs:sequence>
           <xs:group ref="InfrastructureRootElements"/>
           <xs:element name="id" type="II" minOccurs="0" maxOccurs="unbounded"/>
           <xs:element name="name" type="ON"/>
           <xs:element name="addr" type="AD" minOccurs="0"/>
           <xs:element name="assignedEntity" type="PORT_MT090002UV01.AssignedEntity2" nillable="true" minOccurs="0" maxOccurs="unbounded"/>
       </xs:sequence>
       <xs:attributeGroup ref="InfrastructureRootAttributes"/>
       <xs:attribute name="classCode" type="EntityClass" use="optional" fixed="ORG"/>
       <xs:attribute name="determinerCode" type="EntityDeterminer" use="optional" fixed="INSTANCE"/>
   </xs:complexType>

The id tag is optional based on the schema (i.e, minOccurs="0"). However, if we eventually decide that the use of the assigningAuthorityName of DUNS number would trigger a check of Dun & Bradstreet database, then we will need make the id tag mandatory for eStability purpose.

Agenda for December 13, 2010 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Schematron progress update
• eStability Validation Procedures document