HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-02-27
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
February 27, 2012
Attendees: Norman Gregory (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), and Howard Shatz (Data Conversion Laboratory, Inc.)
- There was a question related to eStability about a HL7 Harmonization Proposal for Storage and Shelf Life for the Common Product Model (CPM). It looks like they are describing how a product is stored and its shelf life and use a class called STORE, where we use a class called ACT for Storage and a class called OBS for StorageCondition because we are describing the act of storing the sample and observation (testing) at the specified conditions. I will send them an e-mail explaining that these are two different concepts and hopefully there elements will not change ours.
- Questions for VB.NET Form: A ManufacturedMaterial could have many Manufactures (e.g., contract micronization, packaging), This is why AssignedEntity has a 0 to many cardinality. All facilities need to us DUNS # as primary ID, they could also use other IDs (e.g., FEI, OID).
- Questions for VB.NET Form: What is attributed called “desc; ED” in ManufacturedMaterial used for? From the IG “A textual description or/and external reference to a PDF document describing details of this production. This is where the expirationTime can be specified as a retest date, an expiration date and/or a dating period.”
- Questions for VB.NET Form: The Test element will either have a sequenceNumber or a pauseQuanity, but not both.
- Questions forVB.NET Form: All the values for each time point interval will be entered as opposed to separate value per time point interval (e.g., for time point 3 month would have all the test values for it instead of listing each test value and the time point it goes with).
- Questions for VB.NET Form: All the other example input tools we have worked on, level 2 testing has never been dealt with. Some problems need to be worked out.
- XML file example to create empty Components (test interval) to the maximum time to be stored on stability per stability protocol:
<pauseQuantity xsi:type="PQ" value="36" unit="Month"/> <testing> <code code="C96150" codeSystem="2.16.840.1.1138184.108.40.206.1" codeSystemName="NCI Thesaurus - Stability Study Pause Description Terminology" displayName="Immediate"/> <title></title> <text></text> <effectiveTime value="20110315"/> <performer> <assignedEntity> <assignedTestingSite> <id root="D000000000" assigningAuthorityName="Dun and Bradstreet D-U-N-S Number"/> <name>TBD</name> <addr> <country>TBD</country> <city>TBD</city> <postalCode>TBD</postalCode> <streetAddressLine>TBD</streetAddressLine> </addr> </assignedTestingSite> </assignedEntity> </performer> </testing>
code - All displayed attributes must be one of the legal item from the NCI Thesaurus. testing site id must have assigningAuthorityName of "Dun and Bradstreet D-U-N-S Number" to meet the primary organization requirement. A root value must also be assigned. Since this is going to be a fake testing site, I have chosen "D000000000" to satisfy the DUNS id # requirement. country and postalCode must have values - I have chosen TBD (To Be Determined), rather than using an existing testing site. I recommend that we also add TBD to name, city, and streetAddressLine Need to change IG
- There will be no teleconference on March 5, 2012.
Agenda for March 17 2012 Teleconference:
- We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
- VB.NET Forms
- Outstanding issues