HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-10-26

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

October 26, 2009

Attendees: Elizabeth Cormier (CVM), David Longstaff (CVM), Amy Malla (CBER), Catherine Hosage-Norman (Sepracor), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Diane Miller (Alpharma) and Edward Pec (Abbott Laboratories),

  • A code review of the style sheet revealed that the Drug Substance Manufacturing Sites and Lot(s)/Batch(es) cell was never written. Mike Yang had also notice this while trying to develop an example xml file with <batchIngredient>. Attempts to code the style sheet to display the batch ingredient data and to create an example found the same problems with the message.
  • First, there is no identifier for the batchIngredient. Specified Ingredient has specifiedIngredient/ingredient/code/@displayName. The batch ingredient only has batchIngredient/ingredient/desc. Desc is optional. The style sheet will link on this, and the IG should tell users to fill it in. There should have been a clear identifier for the batch ingredient.
  • The second issue is the quantity of batchIngredient. The IG states that it is "The actual quantity of referenced material used to produce the product (e.g. the reference material might be used in parts for this product". The design comments in the hierarchical Message description for both Specified Ingredient/quantity and batch Ingredient/quantity is the same - "The quantity indicates the amount of the substance as an igredient within the product. (AKA strength)." (Spelling of ingredient is incorrectly spelled in both descriptions suggesting a cut an paste.) Note that the data type for the quantity in specified ingredient and batchIngredient/quantity is RTO_PQ_PQ which supports the notion of strength as in "15 g/2 mL." The data type for quantity in batchIngredient/ingredient/quantity is PQ only. Catherine suggested that batchIngredient/quantity may be the amount used to make the product and the quantity in batchIngredient/ingredient/quantity is the size of the ingredient batch, since the lot number is at the same level as the quantity.
  • An action item was assigned to Norman Gregory in his absence to find out what was the intent of the batchIngredient/quantity by the original design team.
  • The group started to give descriptions for each of the fields in the Input Tool is ready for testing from the SMIT0942.zip version. Paul Tenaglia had prepared an Excel spread sheet of all the fields and the group attempted to give descriptions or point to the appropriate section of the IG. After a few fields, Mike Yang volunteered to make a first draft, since the group process is very time consuming. The next meeting will review and add to the draft.