HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-08-08

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

August 8, 2011

Attendees:

Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Mike Yang (ScienTek Software), Art Griesser (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), Howard Shatz (Data Conversion Laboratory, Inc.), Joby Varghese (Elanco), and April Daly (Lab Objects)

• There is a new version of the desktop validator.
• Addition of a separate process from XSLT to make a request from a web server (e.g, can invoke extra functionality to validate DUNs number).
• When and if FDA decides how validator can communicate with FDA DUNs database, it can check with that.
• Better tractability from error message to line in XML. Will add to code for additional support to Saxon XSLT Processer for people that want , it will require licensing.
• New information the validator will need to check based on changes to the IG: 1) For a facility OID, that the format is right for the type on number and that there is a assigningAuthorityName; 2) For ACTCODE and ACTREASON (p. 18 and 19) the code and CodeSystem are mandatory for FDA; 3) For StudySponser (p. 27), Manufacturer (p. 39), and TestingSite (p. 53) the assigningAuthorityName is mandatory; 4) For TestDefinition (p. 31) the code is mandatory; 5) For the Code and MethodCode (p. 32) the originalText is mandatory; and 6) For StudyOnBatch (p. 35) the code is mandatory.
• Deleted the columns and rows for Code, Display Name, and Description form the Code Lists.
• The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6396/8585/eStability_Implementationguide_1_8_draft_8-8-11.zip) is the new version of the IG (1.8 draft (8-8-11)) with the changes (so far) based on the 8/8/11 teleconference, save file and change extension from .piz to .zip. Please take a final look for discussion.

Agenda for August 15, 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