HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-09-19

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

September 19, 2011

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (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), Sandra Spiewak (Reed Technology and Information Services Inc.), Howard Shatz (Data Conversion Laboratory, Inc.), and April Daly (Lab Objects)

ACTION ITEMS for Josh and Art

• What substance list is being used?
• In the error message is "Could not find a CodeItem for the code referring to Code, so an example of an error for testDefinition would be "Could not find testDefintionItem for the testDefintion"?
• If a file is uploaded to Promethues for validation, what is done with the file? Are there any confidentiality issues?
• We need the update to the schematron by the end of the week so we can complete the IG.

• We looked at the error message for the example. Example of error message "[Error] Could not find a CodeItem for the code, Is the CodeItem referring to the code? So if there was an error for testDefinituoin it would say testDefintionItem for the testDefintion.
• The schematron needs to look OID for FDA Substance Registration System, 2.16.840.1.113883.4.9 for substance not 2.16.840.1.113883.3.26.1.1. It looks like it is looking at the wrong Code System OID.
• Need to change the rule for subjectProduct and storageCondition. Need to make sure validation document reflects the rule.
• I changed the link on page 62 of IG to go straight to the SRS search page.
• We need to restrict to use the preferred substance name. Need to make sure validation document reflects the rule.

When a UNll for a new substance is requested it takes one to three days if all the information is complete (e.g., complete chemical structure protein sequence etc.).

• If you use the desktop validator, there should be no confidentiality issues.
• I will send Mead Walker an e-mail asking him to be on the call next week to disuse Section 2.1 of the HL7 Drug Stability Reporting Validation Procedures document.

Agenda for September 26, 2011 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
• Final changes to IG
• Schematron progress update
• eStabilty Validation Procedures document
• Outstanding issues