SPL Implementation Working Group Technical Team

SPL Implementation Working Group Technical Team

SPL Implementation Working Group Technical Team

Minutes Of Teleconference 28 April 2008

Draft 28 April 2008


Berger, Joan ()

Carpenter, Sean ()

Desai, Pooja ()

Fillipps, Mark ()

Finseth, Myron ()

Fontaine, Leander ()

Gormsen, Ed ()

Harvey, Mary C. ()

Mathis, Charles ()

Saner, Gary ()

Shatz, Howard ()

Thomas, Keith ()

Trautman, Craig ()

West, Jennifer ()

Wilusz, Mary Beth ()

Levin , Randy ()

Agenda Items:

1. Minutes Of Previous Meetings

The minutes of the March 31st teleconference were approved (as distributed with Randy Levin’s corrections) without dissent.

2. Matters Arising From Minutes

(1) Joan Berger asked for clarification about the relationship between Registration and Listing, specifically whether the regulations required that listings be submitted at the same time as registration.

Randy Levin, cautioning that he was not an expert in these regulations, observed that there in practice there is no specific synchronization between Registration, which must be submitted in December of each year, and listing which must be submitted in June and December. Organizations will want to submit some changes as soon as they occur and will be encouraged to submit all changes as soon as they occur. The only tie between Registration and Listing is that any establishment referenced in a listings SPL must already be registered.

(2) Keith Thomas raised the issue of having a ‘No Change’ document type again. The idea is that once a labeler or registrant has submitted labeler, registration or listing information in SPL, at any later required reporting time if there is no change to that information they could submit an SPL instance with a document code of ‘No Change’ and a setId indicating which sequence was being referenced as unchanged. This would allow organizations to discharge their regulatory obligations, while reducing the processing load and the opportunities for error.

Some members though this was a good idea, and no objections or concerns were raised. Randy Levin agreed to undertake to work on this from the FDA side.

3. Clarifications Concerning Registration

(1) In response to a question from Keith Thomas, Randy Levin said that every establishment should be registered by one of its owners, and that an owner is expected to register all of their establishments in one SPL instance, and submit updates through the setId of that instance. In some cases, affiliates might be registered by a registrant that used them rather than submitting their own registrations, but in any case an establishment should be registered only once.

(2) There was some discussion of ‘distributed’ registration practices, where a large organization might assign the registration of some establishments to one division, and some to another. While this would work as long as each division had its own DUNS number acted as an owner under the rules stated in 3.(1) above, no one could give an example, and Mary Beth Willis suggested that we ask Michael Fahmy, who is facilitating the ER/DL lifecycle meetings.

(3) Gary Saner raised the example of a large company that requires each of its establishments to submit their own registration information; in SPL this would result in a number of separate instances (with separate setId’s to designate separate update sequences) each with a different establishment but with the same registrant. After some discussion about possible ambiguities, it was concluded that this should not be allowed because of the difficulty of tracking when establishments ceased to exist as opposed to when they were late reporting, and because of the potential confusion caused by one registrant with a unique DUNS number being associated with multiple registration setId’s. There should be a one-one correspondence between a registrant’s DUNS number and the setId of their seuquenc of SPL Registration updates.

(4) It is unknown to us whether an establishment would get a new DUNS number if it changed hands from one registrant to another. However, it was decided that as long as the original owner submitted a registration update dropping the establishment before the new owner submitted a registration update adding the establishment (the order in which it should happen by regulation and the order which will be enforced by the current validation rules), it would not matter if the establishment had the same DUNS number.

(5) In response to questions about whether labelers had to submit updates to their information by means of a sequence of SPL instances of document type “NDC Labeler Code Request”, and whether those who already had labeler numbers would be required to submit an ‘update’ in SPL in order to initialize the validation database, Randy Levin said that such practices are possible under the standard but these questions are really matters of policy not technical issues related to the standard.

4. Proposed Change To SPL RMIM/Schema

Keith Thomas brought forward a proposal that the cardinality of the relationship between <assignedOrganization> and <id> be made 1:M to allow an establishment to carry both its DUNS number as an id and its FDA Establishment Identifier as another id.

The current validation rules document shows in section 1.4.3 an establishment with one id for its DUNS number, and a <additionalLocator> in the address element which carries as free text content the FDA Establishment Identifier. This seems clumsy for implementers, error-prone for users, and not in keeping with the general HL7 practice of communicating controlled identifiers through id elements where the specific identity value is given by the extension attribute and the identification system is given by an OID in the root attribute.

Randy Levin noted that the same should be said for <representedOrganization> and <id> so the labeler code should be carried as a clear and independent id.

Some members thought this was a good idea and no objections or concerns were raised.

Keith Thomas proposed that we recommendation to Gunther Schadow (as RCRIM’s SPL editor that both <representedOrganization> and <assignedOrganization> be allowed to carry multiple <id> elements. This was approved without dissent.

New Business:

(1) Telecom addresses for reporting in Listing SPL

Gary Saner pointed out that section 2.3 of the R4 IG v0.2 shows a pair of telecom addresses for reporting adverse events, one for telephone and one for web site, associated with the Labeler (<representedOrganization>) and another pair associated with the Registrant, while section 1.5 of the Validation Rules v0.2 shows only a pair associated with the Labeler in a Listing SPL.

Randy Levin confirmed that a listing SPL instance should only have one pair of telecom addresses for adverse event reporting and undertook to have the IG corrected.

(2) Terminology

Gary Saner asked if the terminology used in these descriptions ought to conform to the PLR text which is “adverse reactions” rather “adverse events”.

Randy Levin said that he though that it should be “adverse reactions”.

Action Items And Next Steps:

Next teleconference scheduled for May 12.

SPL Implementation Working Group Technical Team Minutes, 28 Apr 2008Page 1 of 3