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 files to try it, save file and change extension from .piz to .zip. If you are using IE 6.0 you will want to use Firefox to get all the functions.
• See the attached file 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