HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-08-10

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

August 10, 2009

Attendees:

Norman Gregory (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), and Edward Pec (Abbott Laboratories)

• XForm demo next week (8/17).
• Component2 under test has sequanceNumber and pauseQuanity. It appears that pauseQuanity is used if the sample is subjected to some some other condition after pulling at the test interval (e.g., the sample at 36 month is pulled, subjected to another condition for a period of time than test for bacterial growth). This example was fabricated and it has been unclear if anyone is real doing anything like this. There was an example of product being pulled at a test interval at 5ºC then stored at 25ºC for a period of time before testing. It looks like dissolution matches the description for sequenceNumber better (e.g., #1- 5 minutes, #2- 10 minutes, and #3- 20 minutes), personally I think it should listed as three test (e.g., 5 min. dissolution, 10 min. dissolution, and 20 min dissolution).
• When the style sheet displays a mouse over of "Click to list all individual testing results." and there is no information given for Component2 when clicked the table displayed will have the heading "Replicate", if a sequenceNumber is given then the heading will display "Sequence #", if pauseQuanity is given then the heading will display the actual value, and if both are given the heading will display the actual value from pauseQuanity.
• Style sheet items: 1) sorting pauseQuanity, 2) lookup codes for container and closure, 3) pause description code, and 4) use the SPL file structure.
• AssociatedeStudy can have text with it.
• Change to IG: Pause Description Code - move information from "Code" to "Display Name", information for "Description", make the codes 1 through 5.

Agenda for August 17, 2009 Teleconference:

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