HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-08-03

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

August 3, 2009

Attendees:

Norman Gregory (CVM), Mai Huynh (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), and Maje Nazim (Genzyme)

• Component2 under test has sequanceNumber and pauseQuanity, The IG indicates that either sequanceNumber or pauseQuanity is used but not both. The IG states "If a test has parameters (e.g. Assay and ingredients) this structure is used to store the parameters and document their order (“sequenceNumber”) or Use this structure to indicate any special handling after the sample was drawn from the chamber before the real testing took place (pauseQuantity)".
• When the style sheet displays a mouse over of "Click to list all individual testing results." when clicked the table displayed will have the heading of "Sequence #" or "Replicate", not "Trial".
• For expirationTime, a high value will denote "approved", a low value will denote "proposed", and width value of zero (0) will denote "not established".
• Need to make a spreadsheet with columns for IG, Message, How to document, and any other documentation we think we need and the changes we have talked about making to the said documents and/or information said documents should contain.
• The latest style sheets can be found at: http://gforge.hl7.org/gf/project/rcrim/scmsvn/?action=browse&path=%2Ftrunk%2FProject%2520Related%2520Documents%2FStability%2F

Agenda for August 3, 2009 Teleconference:

• We will continue to use Adobe connect (to join the meeting:https://collaboration.fda.gov/hl7/).
• Discuss the style sheet example.
• Input Tool documents.