20080326 Conference Call Minutes
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Minutes for Domain Experts Steering Division Conference Call
Participants
- Co-Chair - Jim Case
- Attachments - Mike Cassidy, Robert Root
- Cardiology - Brian McCourt
- Emergency Care - James McClay
- Government Projects - Randy Levin
- Laboratory - Austin Kreisler (co-chair)
- Pharmacy SIG - Gary Cruickshank
- PHER - Rita Altamore, Kristi Eckerson
- RCRIM - Ed Tripp
Agenda
- Role call
- Randy Levin representing Government projects
- Quorum achieved
- Announcements
- All submitted projects approved by TSC
- Call for HL7 Representative Volunteer(s) to HITSP – HITSP has requested HL7 provide HL7 member volunteers to represent the organization in HITSP activities.
- Kevin Coonan’s name brought forward. Additional volunteers? Names will be forwarded to John Quinn.
- There are questions as to what HITSP is looking for with regards to participation. The view from others that have participated is that this is a time consuming process. Co-chairs will try to get more specifics about the time commitment.
- The link sent in the initial request e-mail and a powerpoint presentation circulated added some description of the work it will be doing. HITSP has recently reorganized and not yet posted details on that change.
- John Quinn & the TSC will make final decision on which HL7 representatives are selected. It is not entirely clear the work objectives the volunteers will be fulfilling.
- Group comments - It's hard to find members to be on multiple committees representing their group because they are so many. Note: this is looking for conference call participation only, not travel, and is to represent HL7, not the Steering Division or workgroup itself.
- "Lost" Harmonization proposals - (Email from MnM) As a result of changes in responsibilty, excess demand on time, and other worthy and not-so-worthy reasons, a variety of Harmonization proposals appear to have been "lost." We plan to spend the April 2 morning sessions identifying these, and determining how best to correct them.
- It appears that the vocabulary side of the RIM is in a little larger state of disrepair than the structural side. Submit any missing proposals to MnM via the harmonization list for consideration on April 2.
- Update on how the DAMs being balloted this cycle are being handled – Rita Altamore
- Early discussion on Domain Analyses Models was about if they were ballotable and how. The decision is that they can be balloted, and have been added as a Clinical Domain Analyses Model section on the v3 balloting website as Informative. Brian commented also the appreciation for the effort working through the discussion for these materials and looks forward to feedback on both the domain content and things we can learn for best practices in DAM’s as these are increasingly worked on in HL7.
- Draft agenda for Phoenix WGM – Potential Agenda Items
- Rules for reaching quorum recognizing it has been hard to reach it on conference calls. There are a few groups not meeting in May and we know already won't be present.
- Pediatrics and AP will not be at the WGM
- Discussion of Joint Initiative Council agreed to be agenda item. May want John Quinn or Ed Hammond to participate to give us some more information on that process.
- Report from TSC on Saturday prior to working group to clarify & prioritize issues they need to address.
- Rules for reaching quorum recognizing it has been hard to reach it on conference calls. There are a few groups not meeting in May and we know already won't be present.
- Scope Statement Approvals
- Drug Stability Reporting (eStability) - Ed Helton
- This is an update of existing standard which was balloted prior to process for scope statements, now recognized need for scope statement. The intent is to develop a second release balloted as DSTU. Question: Who’s project facilitator? The new scope statement requires identification of the project facilitator, so we anticipate the question for why new form wasn’t used for this. This is the individual responsible for making sure the project moves forward.
- Norman Gregory is this person, this will be added to the document in the sponsoring group box
- Make sure it is harmonized with SPL.
- New project scope statement format has been approved by TSC and can be found here:[1]
- All new projects being formed are expected to use the new format.
- Moved Kriesler, second Altamore Vote: 0 against, 0 abstain, 8 for
- This is an update of existing standard which was balloted prior to process for scope statements, now recognized need for scope statement. The intent is to develop a second release balloted as DSTU. Question: Who’s project facilitator? The new scope statement requires identification of the project facilitator, so we anticipate the question for why new form wasn’t used for this. This is the individual responsible for making sure the project moves forward.
- Regulated Product Submission Release 2 - Ed Helton
- This is intended for submission of information to a regulated product authority. Release 1 is approved standard and being used in non-pharmaceutical areas of FDA. Modifications are to support larger submissions for pharmaceutical products (including hyperlinked cross references, communications with authority and submitter, scope clarification to be any regulated product, wasn’t clear about regulated devices. The previous version had specifics about the drug industry that were not broad enough and were struck. The scope has been expanded to address any regulated product.
- TSC stated that maintenance releases of normative standards do not have to go through DSTU. This project qualifies for that and the decision to go forward at normative or DSTU. Project facilitator – Peggy Leizear.
- Moved Kriesler, second Altamore Vote: 0 against, 0 abstain, 8 for
- Drug Stability Reporting (eStability) - Ed Helton
- New balloting guidelines (GOM)[1]
- No more committee or membership ballots
- Normative, Informative, DSTU
- Rules for reconciliation around Informative and DSTU have been relaxed to the point of having little impact as there is no need to reconcile negatives. It was suggested that at least for DSTU, negative comments could be used as warnings of possible negative ballot comments when moving to normative.
- Informative documents, thing such as implementation guides used to have to go through the same ballot reconciliation as normative. This makes informative documents easier to get through the ballot process.
- Rules can be found in Section 12 of the GOM
- Additional rules: There will be a cutoff time for joining ballot pools (two weeks prior). Any reballot will go only to original ballot pool. It will be important to join early so you do not get cut off from participation. This information is going out through the ballot announcement.
- Discussion – changes to the ballot process occurred after the WGM and were not communicated to the membership. These types of announced changes should only occur after being announced at a WGM. “Dynamic” changes to key operational manuals are not easy to manage at the committee level.
- Motion: Add to section 17.03.05 of the GOM. - Changes to procedural documents that affect critical issues such as balloting or deadlines should have an effective date following formal announcement at a WGM meeting and general communication to the membership. Moved: Cassidy Second: Eckerson Vote: 0 against, 0 abstain, 8 for
- Discussion – changes to the ballot process occurred after the WGM and were not communicated to the membership. These types of announced changes should only occur after being announced at a WGM. “Dynamic” changes to key operational manuals are not easy to manage at the committee level.
- No more committee or membership ballots
- Status of HL7 web page to refer to new committee structure
- Planned to roll out working group names and process will be posted soon. They will be coming out on the new website and a gradual transition will occur over the next few months.
- Discussion on use of Project Insight, relationship to GForge. – deferred to next call
- Call was adjourned at 11:13ET