HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-08-09

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

August 9, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), JoAnn Ziyad (CFSAN), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Jennifer Rice (Alpharma), and Diane Miller (Alpharma)

• The IG is complete except for example in appendix.
• The following are some issues with the validation: I am unable to validate the message I created. I have been able to validate an old message by altering PORT_IN090004UV01. PORT_IN090004UV01 does not have a stability message in it. That means when they did the validation, the entire PORT_MT090001UV02 was never validated. This explains why PORT_IN090004UV01 includes the wrong file. I had to delete the sender and receiver all together because they now require more info than before, and I just do not know what. There are little changes all over the place.
• There are problems with specified ingredient, now requires an expiration time because substance changed (all ingredient are treated as "IngredientSubstance"):

NEW

<xs:complexType name="PORT_MT090002UV01.Substance">
 <xs:sequence>
  <xs:group ref="InfrastructureRootElements"/>
  <xs:element name="code" type="CE"/>
  <xs:element name="desc" type="ED" minOccurs="0"/>
  <xs:element name="expirationTime" type="IVL_TS"/>
 </xs:sequence>
 <xs:attributeGroup ref="InfrastructureRootAttributes"/>
 <xs:attribute name="classCode" type="EntityClass" use="optional" fixed="MMAT"/>
 <xs:attribute name="determinerCode" type="EntityDeterminer" use="optional" fixed="INSTANCE"/>
</xs:complexType>

OLD

<xs:complexType name="PORT_MT090001UV02.Substance">
 <xs:sequence>
  <xs:group ref="InfrastructureRootElements"/>
  <xs:element name="code" type="CE"/>
  <xs:element name="desc" type="ED" minOccurs="0"/>
 </xs:sequence>
 <xs:attributeGroup ref="InfrastructureRootAttributes"/>
 <xs:attribute name="nullFlavor" type="NullFlavor" use="optional"/>
 <xs:attribute name="classCode" type="EntityClassMaterial" use="optional" fixed="MAT"/>
 <xs:attribute name="determinerCode" type="EntityDeterminer" use="required"/>
</xs:complexType>

• A value can be "PQ" data type for a number value or can be "ST" data type for non number value (e.g., ND, < LOD, ect.)
• There is not preference if the IG has a watermark or not for ballot, I will leave the DRAFT watermark on the document.
• There will be no teleconference on August 16th and 23rd.

Agenda for August 30, 2010 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Next steps.
• Discuss responses to IG.