HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-03-19

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 19, 2012

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), and Sandra Spiewak (Reed Technology and Information Services Inc.)

  • There was a question related to eStability about a HL7 Harmonization Proposal for Storage and Shelf Life for the Common Product Model (CPM). eStability focuses on new products and their storage conditions and does not have shelf life, only expirationTime and the Storage act contains the storage conditions as observations. e Stability would not use shelf life. Include eStability Storage and StorageCondition into CPM model. Change class code to Storage instead of Act on Storage and change mood code to Definition on Storage. Would need to create a future harmonization proposal for a domains space on code in StorageCondition. It will be put in the Product Information choice box.
  • A contract was awarded by FDA to develop the stylesheet and will be available through he FDA web page. The Input Tool is being developed with input from the eStability Working Group and is proprietary information of the developer but will be available free for use through their web page and FDA web page (if possible). It will be available the same way the Global Submit did the download of the X-Form. People will need to provide user information. The tool will always be free for 30 to 45 day time frames even after the FDA mandates the eStability message. If other companies see someone taking the plunge at developing a tool, then maybe they will too and the group will have more tools to review.
  • Catherine did a demo of the VB.NET Form Input Tool she is working on (just screen shots for now). There are some issues running it from her work system and in two weeks if the issues still persist she will run the demo from her home system.
  • VB.NET Form demo: Establishment can be one to many,navigation bar at top shows 1 of x records. Any establishment can have multiple Organization IDs.
  • VB.NET Form demo: Table format is best.
  • VB.NET Form demo: Pull date has calendar and populates the field with our date format (YYYMMDD).
  • VB.NET Form demo: Use a large form so everything can be seen at once, instead of small forms that you would need to move around.
  • VB.NET Form demo: Pick list for Manufacturer or Assigned Manufacturer (AssignedEntity).
  • VB.NET Form demo: Will always use SRS system.
  • VB.NET Form demo: Make BatchIngredient a separate page.
  • VB.NET Form demo: Result will have parent and child table.
  • VB.NET Form demo: Associated Messaged (AssociatedStudy) tab is good the way it is.
  • VB.NET Form demo: Preview will show XML and stylesheet.
  • VB.NET Form demo: The units from specifications will be used for results.
  • There will be no teleconference on March 26, 2012.

Agenda for April 2, 2012 Teleconference: