HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-09-17

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

September 17, 2012

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), and Art Griesser (Promethues)

  • Style Sheet will be getting updated.
  • HL7 has a new policy regarding Intellectual Property (IP) http://www.healthcare-informatics.com/news-item/hl7-standards-be-free. They are looking to have a policy in place by January, But have granted immediate exceptions to FDA uses.
  • VB.NET Forms: Changes data value to NCI eStability preferred term (e.g., Conforms to Passed).
  • VB.NET Forms: Child can have a replicate call out box for separate tests (e.g., impurities’ with different RRT), if need the parent can be changed to have this function too.
  • VB.NET Forms: The null flavors will be listed in popularity order, not alphabetical.
  • A list of all the null flavors and their definitions: NI: "no information" - this is the most general and default exceptional value. There is no information which can be inferred from this exceptional value; NA: "not applicable" – There is no proper value for this data item for this patient; for example, the date of the last menstrual period is not applicable for a male; TRC: "trace" – The content is too small to measure but still a non-zero value; NAV: "temporarily not available" - information is not available at this time but it is expected that it will be available later; NASK: "not asked" - the Information was not requested from the patient; MSK: "masked" - this particular item has a known proper value, but it cannot be released in a given context due to security, privacy or other reasons; QS: "sufficient quantity" – The actual quantity is not known but sufficient enough to achieve a specific goal. For example the advice can be: add a sufficient quantity of water to 10 mg of medicine; UNK: "unknown" - a proper value is applicable, but not known (ASKU: "asked but unknown" – information was sought from the source but not known (e.g., patient was asked but didn't know)); and OTH: "other" - there is a value, but it is not an element in the value domain of a variable (NINF: "negative infinity of numbers" and PINF: "positive infinity of numbers"). We need to decide which of these we want to keep.
  • Do we want to combine the IG and the Validation Documents or keep them separate?
  • Do we send IG through the HL7 process (depending on IP policy) or use Federal Register (FR) notice?
  • The next teleconference will be the final demo of the VB.NET Forms In-put Tool, with directions for download for 60 day Beta test. Please try to call in.
  • There will be no teleconference on 9/24/12, next teleconference will be 10/1/12 and will be 1.5 hours (3:00-4:30).

Agenda for October 1, 2012 Teleconference (3:00-4:30):

  • We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
  • Data types discussion and VB.NET Forms In-Put Tool wrap-up
  • Outstanding issues