HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-11-15

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

November 15, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller(Alpharma), Jennifer Rice (Alpharma), Art Griesser (Promethues), Josh McDade (Promethues), and Gary Saner (Reed Technology and Information Services Inc.)

• An XML stability file is either for a "subjectProduct" or a "subjectSubstnace", if it is for a 'subjectSubstnace" then there is no "specifiedIngredient".
• Made a correction to the IG based on the schematron development. On page 26 removed the xPath "/stabilityStudy/Subject/researchSubject/subjectProduct/ specifiedIngredient" and the sentence "As child of "specifiedIngredient" this element describes a substance as part of a formulation". We will hold off sending the revised IG to HL7 and updating web pages until schematron is done in case there are more revisions.
• Attached is the final version of the Stylesheet (http://gforge.hl7.org/gf/download/docmanfileversion/5977/7770/eStabStyleFinal11-14-10.zip) and example XML messages (http://gforge.hl7.org/gf/download/docmanfileversion/5978/7771/ExampleMessages11-14-10.zip). For the style sheet, save to computer, extract to a folder, and read the file “ReleaseNotes[1.6].txt” and follow the directions for the location of the folder (Ex: C:\estability\stylesheet or D:\estability\stylesheet), for changing the file name from “eStabilityWin.js.txt” to “eStabilityWin.js” and for changing the “eStabstyle.css” file to display in the color you want. For the example XML files save to computer, and extract it into a folder. The example messages folder can be saved at any location, it is the location of the style sheet folder that is important. You an also get it from https://www.estability.org then click on wiki at top of page.
• In the example XML stability file in the IG a second level test has a "testDefinition" indented inside another 'testDefinintion" and the ID root is the same up to the last numbers in the sequence.
• Josh will send example of inconsistencies between TestDefinetion components and Component1 components.
• The SPL Validation Procedures document was the most useful of the SPL documents for vendors.
• I will send Mead Walker an e-mail asking about getting our issues to HL7 Technical Steering Committee (TSC).
• I will send an e-mail to one of the co-chairs of the HL7 Orders and Observations Working Group asking about where on the Common Product Model (CPM) wiki page concerns about substance should be posted.
• I got a response back to the question "Can the coreschema and multicacheshemas be on the FDA Data Standards Council web page like SPL (called "FDA SPL Schema for Implementation") or are they HL7 property?" They are HL7 property.

Agenda for November 22, 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