HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-01-03

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

January 3, 2011


Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), Chuck Warner (Beckloff Associates) and Gary Saner (Reed Technology and Information Services Inc.)

  • SPL uses both DUN's number and FEI number, the Dun's number is mandatory and the FEI number is not. It can capture both numbers. The DUN's number is being checked at the FDA side for SPL when it comes to the gateway against the Duns and Bradstreet database.
  • The schematron (business rules) would only check for the proper format of the DUN's number, that it is nine digits (e.g., 12-345-6789 or 123456789).
  • The validation guide has been the most beneficial for vendors doing SPL, but it does have some shortcomings. A lot of rules about one element, but no information on other elements. Need to pick one place for the instructions.
  • The validation document will only talk about change between schema and schematron and format. We will point back to the IG for no differences in the schema and schematron.
  • The attached two files, elements of the message and the optionality when sending to FDA (http://gforge.hl7.org/gf/download/docmanfileversion/6079/7936/elements.doc), and the validation document (http://gforge.hl7.org/gf/download/docmanfileversion/6059/7899/HL7DrugStabilityReportingValidationProcedures12-13-10.doc). Please take a look at the elements document and using track changes remove what is not changing between the schema and schematron and add format rules and other rules for the elements that need it. The element documents will then be inserted into the validation document.
  • There will be no teleconference next week on January 10, 2011.

Agenda for January 17, 2011 Teleconference:

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