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Orders & Observations

San Antonio Working Group Meeting

May 2006

Meeting Minutes

Table of Contents

ATTENDEES.............................................................................................................................................3

MONDAY Q1/Q2, 2.7 PROPOSALS.......................................................................................................5

TUESDAY Q1 – OO/RX/LAB..................................................................................................................6

TUESDAY Q2 – LAB, IHE, O&O, STRUC DOC..................................................................................8

TUESDAY Q3 – OO/PT SAFETY/RX/BTO/PHER..............................................................................9

TUESDAY Q4 – OO/PATHOLOGY.....................................................................................................10

WEDNESDAY, Q1 – OO/DEV..............................................................................................................11

WEDNESDAY – Q2, OO/LAB/BTO.....................................................................................................12

WEDNESDAY - Q3 – GENOMICS/LAB.............................................................................................13

WEDNESDAY – Q4 – II.........................................................................................................................14

THURSDAY Q1, ORDER SET OVERVIEW......................................................................................15

THURSDAY, Q2 – OO/RX – DYNAMIC MODEL.............................................................................16

Thursday, Q3/4 – Clinical Statement.........................................................................................................17

AttendeesAttendee Company/E-Mail Mon

AMMon PM

Tue AM

Tue PM

Wed AM

Wed PM

Thu AM

Thu PM

Fri

Liora Alshuler liora@alschulerassociates.com √Rita Altamore Rita.altamore@doh.wa.gov √Kay Avant kayavant@aol.co √Calvin Beebe cbeebe@mayo.edu √ √Fred Behlen fbehlen@laitek.com √Deb Belcher Deborah.belcher@idx.com √Charlie Bishop Charlie@ccClarion.com √Keith Boone Keith.boone@dictaphone.com √Bill Braithwaite bill@braithwaite.com √Louise Brown Louise.brown@tntglobal.ca √Nicholas Brown Nbrown.mimic@btinternet.comHans Buitendijk Hans.buitendijk@siemens.com √ √ √ √ √ √ √ √Michael van Campen

Michael.vancampen@gpinformatics.com √ √ √

Jim Case Jtcase@ucdavis.edu √Todd Cooper t.cooper@ieee.org √Garry Cruickshank g.cruickshank@sympatico.ca √Richard Dixon-Hughes

Richard@dhx.com.au √

Bob Dolin Robert.h.dolin@kp.org √Dick Donker Dick.donker@philips.com √Kristi Eckerson Kee8@cdc.gov √Dav Eide Edie.d@ghc.org √ √ √ √Brett Esler brett@pencs.com.au √Peter Elkin √Mollie …@harvard.edu √Clive Flashman Clive.flashman@npsa.nhs.uk √Chris Foye Chris.foye@npsa.nhs.uk √Ken Fuchs Ken.fuchs@ieee.org √Marguerite Galloway

Galloway@vips.com

Rick Geimer rick@alschulerassociates.com √Ken Gerlach kgerlach@cdc.gov √ √Gay Giannone Gay.giannone@siemens.com √John Gilbertson gilbertsonjr@gmail.com √ √Sarah Glamm sglamm@epicsystems.com √William Goossen Williamtfgoosen@cs.com √Freida Hall Freida.hall@med.va.gov √Rob Hallowell Robert.hallowell@siemens.com √ √ √Dick Harding Dick_harding@health.gld.gov.au √John Hatem John.hatem@oracle.com √ √ √Peter Haug Peter.haug@intermountainmail.org √ √Rob Hausam Robert.hausam@theradoc.com √ √Masaaki Hinai Masaaki_hirai@mbt.nkc.co.jp √Jim Horton Jim.horton@biotronik.com √Mary Jarquin Mary.jarquin@med.va.com √ √ √Gaby Jewell gjewell@cerner.com √Yaria Jaroch Yarisa.jaroch@biotronik.com √Dave Johnson David.johnson@guidant.com √Jeri Jones Jeri.jones@med.va.gov √Tom de Jong Hl7@tdejong.demon.nl √ √Kyunghee kang puppycat@lct.co.kn √Bertil Keppin bertil@apertiva.nd √Gert Koelewijn koelewijn@nictiz.nl √ √Helmut König Helmut.Koenig@siemens.com √Alexander Krans Alexander.krans@bitronik.com √Austin Kreisler Austin.kreisler@mckesson.com √ √ √Thom Kuhn tkuhn@acponline.org √Yun Sik Kwak yskwak@mail.knu.ac.kr √Sungkee Lee sklee@knu.ac.kr √

Attendee Company/E-Mail Mon AM

Mon PM

Tue AM

Tue PM

Wed AM

Wed PM

Thu AM

Thu PM

Fri

Andrew Lindy √Patrick Loyd Patrick.loyd@oracle.com √ √ √ √ √Chris Lynton-Mell c.lynton-mell@tallarot.edu.au √François Macary francoismacary@gwi-medica.fr √Joginder Madra Joginder.madra@gpinformatics.com √David Markwell david@clinical-info.co.uk √Michael Martin martingmkm@mminformatics.com √ √Brett Marquard bmarquar@epicsys.gov √Jim McCain James.mccain@med.va.gov √Ken McCaslin Kenneth.a.mccaslin@questdiagnostics.com √ √ √Doris McGinnes dmcginn@cap.org √Larry McKnight Larry.mcknight@siemens.com √Gary H. Meyer Gary.h.meyer@gadord.com √ √Patrick Mitchell-Jones

Patrick.mitchell-jones@npfit.nhs.uk √ √ √

Jun Nakaya junnaka@med.kobe-u.ac.jp √Karen Nocera kyn@cbord.com √Thomas Norgall Nor@iis.fraunhofere.de √Wendell Ocasio Wendell_ocasio@chesii.com √Mike Ostler mikeo@mediserve.com √ √ √ √Charles Parisot Charles.parisot@med.ge.comCraig Parker Craig.parker@ihc.com √Jaqui Parker Jaqui.parker@thomson.com √ √Fola Parrish Fola.perrish.ctr@tmg.osd.mil √Chris Peck c.peck@auckland.nc.nz √Diana Perez-Lopez DianaL.Perez@siemens.com √ √ √ √ √Andrew Perry Andrew@clinical-info.co.uk √Backy Reed Rebecca.reed@cgifederal.com √ √Melvin Reynolds melinvr@ams-consulting.co.uk √Scott Robertson Scott.m.robertson@kp.org √ √ √Craig Robinson Craig.robinson@siemens.com √ √Dan Russler Dan.russler@mckesson.com √Tod Ryal trial@cerner.com √Gunther Schadow Schadow@regenstrief.iupui.edu √ √ √ √Barry Schell Barry.schell@fujinet.com √Dave Shute Dave.h.shujte@medtronic.com √Karen Sieber Ksieber@cerner.com √ √ √ √Ioana Singuraehu ioana@eversolve.com √Corey Smith Corey.smith@healthlanguage.com √ √Rik Smithies Rik.smithies@cfh.nhs.uk √Harry Solomon Harry.Solomon@med.ge.com √ √Rene Spronk Rene-spronk@kingholm.com √Helen Stevens Love Helen.stevens@gpinformatics.com √ √Nick Steblay Nicholas.stabley@guidant.com √Lise Stevens stevensl@cber.fda.gov √Jeff Sutherland Jeff.Sutherland@computer.org √ √ √ √ √ √Sadamu Takasaka s-takasaka@cp.jp.nec.com √ √Jack Taylor John.taylor.ctr@tma.osd.mil √Anita Walden Anita.walden@duke.edu √Mead Walker dmead@comcast.net √Jan Wittenber Jan.wittenber@philips.com √Bob Yeneha bob@alschulerassociates.com √

Communication with declared O&O participants can be done through ord@lists.hl7.org. You can sign up through the HL7 website, www.hl7.org. List servers for focused aspects of the O&O domain are: bloodbank@lists.hl7.org, pharmacy@lists.hl7.org, microbiology@lists.hl7.org, lapauto@lists.hl7.org, and dicom@lists.hl7.org.

Monday Q1/Q2, 2.7 ProposalsSee attached document for proposals discussed to date with discussion and disposition.

Microsoft Word Document

Tuesday Q1 – OO/Rx/Lab

Common Order Context Conduction should be mandatory with default values so it can be used based on

exception. ObservationEventCriterion

o Effective Date/Time in ObservationEvent Criterion: Example is where a headache lasts more then an hour. Agreed to add.

o No recursion in the general model. Rx will work on getting it out of Rx model. Only if use case arises will this go back in.

ActDefinitiono Changed to 0..*

ObservationRequest2o Rx to put in Status code.

Entry Point in Rxo Rx considering choice box so it can come into Header, Supply, other.o Agreed to have Common Order have a choice box. Rx would follow suit. Lab will

constrain to a specific entry point. InformationRecipient

o Do we need InformationRecipient for notification to clinical trials?o In V2 we only reference clinical trial identifiers, not the actual recipient.o We should consider to put the identifiers in Common Order. Rx will likely pick it up

immediately, while Lab is contemplating whether it is needed.o Hans to check whether the V2 use case for Orders (CTI) is still relevant.

Consento In ControlAct or focal act. Should o Patrick and Michael to take to I&M.

CallbackContRequestChoiceo Rx agreed to take this on.

DataEntryLocationo Should it be in the main model or just in the Control Act?o Due to reports and queries we agreed to keep DataEntry in the model.

Annotationo Agreed to change R_AssignedPerson to R_AssignedEntity.

Performero Need to be able to point to a person or organization.o We all agree that we need to recognize performing organizations, not a scoper of an

implicit person. Specimen

o Problem that the entity is CE. Consequently cannot support SNOMED.o Propose EntityCode from CE, CD as harmonization proposal.o Against: 0; Abstain: 2; In Favor: 25.

0…*/1…N Participation or Acto Add sequence number to Participation and ActRelationships and priority to

ActRelationships. Where cardinality is greater then 1. Coverage

o Use case indicating special authorization. Requires 3+ attributes.o A_Coverage is too strict. Need to relax to support Identifier, Effective Date, Insurance

Carrier.

o Rx and Lab will check on how much data they need.o Common Order will already include A_CoverageUniversal as a placeholder.o Need to check with some PT knowledge how much they need as minimum as they will

provide likely use cases for this area. SupportingClinicalInfo CMET.

o Does not support previous, cannot support nested. In short, not fit for purpose.o Considering to eliminate SupportingClinicalInfo altogether.o Patrick to check whether SupportingClinicalInfo is indeed a proper subset of Clinical

Statement. o We will forward to Clinical Statement that we’ll drop SupportingClinicalInfo CMET and

get Clinical Statement into CMET form. ReplacementOf

o Old order becomes obsolete. Requested that an obsolete transaction should come before the replace transaction so that the trigger event only works on one focal act.

o Everybody agrees that the orders space should allow for three approaches: Obsolete Replace – Obsolete, New New

o Level of authorization and use case drives which one to use.o Move to agree that the ReplacementOf trigger event should be able to cover both an

obsolete and replace trigger. Against: 0, Abstain: 0; In Favor: Unanimous: 28

Tuesday Q2 – Lab, IHE, O&O, Struc DocObjective: how Lab SIG ballot, Clinical Statement, IHE CDA lab report, and CCD all inter-relate.

Francois provides IHE objective overview. Scope excludes Blood Bank and Pathology. Includes CDA R2. The Lab Report is not part of the Order Fulfillment process, rather AFTER it’s completed,

including historical data. Three use cases:

o Post Dischargeo Ambulatory Labo Physician EHR Lab

Bottom-Up Approach starting with existing paper reports from various sources focusing on lab data.

For Level 2 using Sections while at Level 3 using Organizers for “promised items”. Slide 16

o Problem: CDA does not support R_Specimen and therefore the procedure to collect the specimen cannot be attached to the specimen directly, rather then the organizer. Can be resolved with Level 3, but not Level 2.

o Problem: Unclear which organizer to use for the battery in CDA. Slide 17

o Problem: Unclear which method is used (MIC vs. Kirby) or all susceptibility forced. Probably a rendering question.

Slide 18 – Issues summaryo Two more issues.

Showing previous result tied to current Expressing global comment on a battery

Other Issues:o When to use Lab result message versus CDA Document?o Single document vs. differentiated document type code?o How can we have a Cumulative report that crosses multiple orders? Should there be

many or if there are many just zero? Flow to resolve issues for IHE.

o Lab first (Core Domain First)o Clinical Statement second (for long-term issue resolution) (Pattern resolution)o Structured Document third (for short-term issue resolution and any long-term

implications) Extensions back to Clinical Statement. (If used as the communication vehicle).

Need formalize short-term issue resolution approach. Currently Liora and Glen facilitate reconciliation. Based on best available knowledge where things may be heading.

Need to get the constrained model for Lab (as other domains) for Clinical Statement. Revalidate Clinical Statement. Most burning issue: Are the resolutions short-term acceptable?

o Could consider to go from procedure to specimen or put procedure on top. Criterion can be on choice-box. Problem is that the specimen is the product of the procedure. What if multiple specimens and multiple procedures? Which belongs to what. Use the CDA participant relationship and specialize.

Public Comment to all parties and IHE to package the specific requests.

Tuesday Q3 – OO/Pt Safety/Rx/BTO/PHER

Rx Harmonizationo Need to ensure that Patient Safety is kept up-to-date with changes.o Need to schedule harmonization meeting.o Rx has list of changes.o Circulate ICSR ideas to Rx in between. Exchange documentation on list servers. Rx to

include Patient Safety and Patient Safety joining Rx list serve.o Adverse Reaction and Allergies standing Wednesday Q3 meeting.

BTOo Generating story boards.o Not enough materials yet for Rx and Patient Safety.o Establishing conference calls. Bloodbank@lists.hl7.org will be the vehicle to establish

the timing. Immunization

o PHER took on Immunization as a project. POIZ stays as separate domain. Patient Care and O&O able to absorb meeting time if needed.

o Working on receiving use cases to create HL7 Immunization Landscape.

Tuesday Q4 – OO/PathologyJohn Gilberson - Pathologist - Presented overviewco-Chair Pathology SIG

Identifying a specimen and doing a study on it is key issue.

Need an Anatomic Pathology domain. Lab SIG model can be used.

Want to invert data on multiple reports on the same specimen.

1. Trying to develop an AP domain model in Visio.2. Will map model to Lab model.

Timeline, resources, anyone want to help?

Have 5-6 pathologists interested who will come to next meeting.

1. Will develop coherent model by next meeting.2. Will look at existing specimen model and comment. Need to understand it better.3. Patrick Loyd has a task to determine whether V3 or CDA is best for AP domain.4. Will begin developing an implementation guide for CDA.

Could do an AP domain model in V3 and then describe how this would be used in CDA.

DICOM Pathology Working Group must use HL7 specification model. They have story boards.

Lab SIG has initial specimen model. Patrick and Gunther have it.

Tissue banking needs more detail in the specimen model than traditional pathology documentation needed for cancer registries, etc. Newer systems support this while older systems do not.

Specimen model in current ballot was reviewed.

Block, level, and ordering of slice of speciment not in model. Speciment treatment needs a time stamp.

When you get a specimen of prostate, for example, you describe physically where the block came from in a specimen. In a big specimen, some tissue will get thrown out. Every block gets a letter or number and free text description (currently). Should be coded better.

A good system will describe site, block number, slide number from block and describe procedure done on it.

Action items: (John Gilbertson)

1. Look at Lab specimen model carefully.2. Come back at next meeting with issues.3. Determine how to represent model in traditional pathology report.

Wednesday, Q1 – OO/Dev

Reviewing various device questions covering their modeling activities.

Recursive Act Relationshipo Use Lab as example for recursive construct of Component on Act. Objective is to insert

into a new ballot round in September.o The IHE implementation guide will need to put this back into V2. Can either use

Parent/Child or OBX Sub-ID using the “.” approach. Null Value

o Various null flavors. Appear to be insufficient.o Examples are in V3 data type. If anything is missing, will work with Gunther/Patrick for

a harmonization proposal.o We need a V2 proposal for OBX to allow to accept null code values. Gunther and Hans

to check what needs to be changed in V2. MedicalDeviceAct.code

o If IEEE has a list, use that, otherwise further work with Vocab to establish. Filter Mechanism – What should we use?

o Year 1 has three profiles for Point of Care Devices.o Primary profile is the inter-enterprise communication of device data.o Third is PCD broker enabling requests for certain data, e.g., o Check with Chapter 5 for V2.

Unsolicited Observations against Standing Orderso Check R30, R31, R32

Personal Health Record Updateso See Clin Statement for relationship with “non-clinicians” as authors/informants to deal

with patients or persons on their behalf providing results.o In V2 check out the Role Segment and utilize the role code for participation/role

definitions. Message vs. Document

o Key differentiation is the readable/formatted aspect of a document versus message. Next is that attestation is more likely on a document then on a message. Beyond that characteristics could be applied to either message or document.

o Critical that to the extent that data can be structured by the source, the same structure is used. Clinical Statement is a good example of a pattern that conveys the core data as part of a message or a document. The packaging around it varies.

Risk Management Paradigmso See slides by Jan Wittenber

Wednesday – Q2, OO/Lab/BTO

Strange problem occurred with BTO content impacting Lab while no known changes had occurred. Diana to check with Woody what happened and determine what BTO may need to do to ensure it does not happen again.

BTO (definitely) and Lab (likely) will skip the next ballot round. Lab needs SupportingClinicalInfo to be extended to meet their needs. We also want to pursue

turning ClinicalStatement pattern into a CMET. Prefer to not change SupportingClinicalInfo for backwards compatibility. Agreed to pursue SupportingClinicalStatement CMET that can be serialized (current tooling

restriction) as replacement to SupportingClinicalInformation CMET. Patrick Loyd and Patrick Mitchell-Jones will pursue.

Need to know what can be added to a Clinical Statement without being non-compliant. Rules need to be documented.

Wednesday - Q3 – Genomics/Lab Update

o Updated the approved DSTU documentation Genotype Topic now contains two models.

GeneticLocus – appears as CMET GeneticLoci

Can get to all core classes from the entry point. Associated properties/observation classes consolidated Phenotype choice box replaced Observed Phenotype class to be replaced by SupportingClinicalInformation

CMET Haplotype class removed and replaced with place holder. tagSNP and translocation classes removed and re-inserted as codes

o Family History Added new class – FamilyHistory Family History is entry point Added classes to hold results of risk assessment Various other changes Question about sensitivity and specificity as input parameters. Suggestion to use

control variable instead. To be reviewed.

Family History Issueso Suggest to use observation construct to carry clinically relevant ethnicity/race, rather then

attempting to extend the more administrative/government defined ethnic group and/or race code.

o Harmonization required with CDA and CCD/CCR.o Provided guidance that the fact that the family history references a Genotype CMET that

is still in DSTU state should not be a limitation on the Family History to go normative, as long as the CMET reference is optional.

V2o Various ideas how to use OBX.

Clinical Statement/Genomics

Wednesday – Q4 – II

Common Order Statuso Motion to put Common Order in Draft for Comments

Against: 0; Abstain: 1; In Favor 8 Ballot Feedback

o Resolved negatives and comments and is ready for Membership.o Challenge is that a CMET is using the Clinical Statement DMIM as the parent. That may

cause a problem when Imaging is normative while Clinical Statement is still on its way there.

o Clarification required on extension guidelines to Workflow Model – Recursive relationship

o There are two alternative ways to model workflow process steps. One is to have ProcedureRequest relate directly to the ScheduledProcessStep and PerformedProcessStep, or through a ScheduledProcedure and Performed Procedure respectively.

o II does not need the middle layer while others do. The choice is therefore to accept two different modeling techniques, leading to similar data being sent in two different ways and requiring clear guidelines when to use one or the other.

Infoway Proposalo Need registry query (list of studies for individual), order, and detailed observation request

involving images

Thursday Q1, Order Set OverviewCraig Parker provided an overview of the approach to Order Sets. Attached are the materials used.

Various questions/discussions were conducted during the review. The primary conclusion we reached is that we need to continue to discuss the approach to ensure we end up with a consistent approach based on O&O order patterns.

Thursday, Q2 – OO/Rx – Dynamic Model

Topics Project Team

o We seem not to be able to get a project team going to focus on the Dynamic Model that cuts across the different areas.

o Should we consider an out-of-cycle, e.g., Sunday prior, or Friday, on Dynamic Model?o Should we focus on creating documentation rather then just making decisions?o Hans to send out request for interest to meet on Sunday prior or Friday for a full day.

Objectiveso Initially focus on common set of rules on how to deal with order management state

transitions after the creation of an order. Covers lab, Rx, Rad, PT, Dietary, NRS, Procedures, etc.

o Subsequently: Create set of rules on how to deal with observation state transitions Synchronize with referrals and appointments.

Referral is patient care provision in order mood. Wiki

o We agreed to use the wiki site to channel discussions.o Hans to populate raw data. Notes and initial seed of the documentationo Copy-n-paste the general act state machine as well.

Documentationo We should take current state machine of act and elaborate under the common order

model.o Alternatively, we can use storyboards as starting point.o We need to provide both the storyboards and state machine.

Approacho Should we use the HDF approach to generate the artifacts necessary?o Should we go back to the topics discussed to date and start to go for each one of them and

start to produce these artifacts and refine our approach?o We agreed to address Storyboard (wiki/pub db), Activity Diagram (visio), Interaction

(pub db), Trigger Events (wiki/pub db), Application Roles, State Transition Definition. (those in bold are needed for ballot).

Left to Right or Right to Left? Do they all end up in the ballot and therefore, do we need to do them?

o Consider listing/prioritizing all topics, or take 1-2 storyboards and flesh them out completely. The latter would not touch all topics, but complete all necessary steps.

o Tom and Rob to provide initial story boards.o Michael/Garry C initial “pub drivers”o Wendell initial “visio driver”

“Combined State Transitions” Examples:

o Suspend/Resume – one focal act, two state transitionso Replace – one focal act and non-focal act, each with their own state transition

Do not want to send two messages for the Replace. MnM must support, or we’ll ignore them. Suspend/Resume – two messages are consistent with V2. Until clear use case to combine,

suggest to stay with two messages. Tom moved, Rob second.o Against: 0; Abstain: 0; In Favor: 15

Thursday, Q3/4 – Clinical Statement

Agenda:1. Ballot Comment Reconciliation2. Current Model status and Issues (Charlie)

a. Attributes missing. 3. Revisit scope, restriction, extension and boundary cases.

a. CSCR -055 add participation for ParticipationInformationRecipientb. CSCR -058 add reasonCode for non clinical Reasonsc. Extension class constraint rules are not clear Patrick Loydd. HDF Synchronization- Ioanae. ConditionClass –Patient Care William

4. Intent for Ballot for September 2006

1. Ballot Comment Reconciliationa. An issue is raised with not wanting to spend too much time on ballot comment reconciliation

to ensure we touch on various modeling issues. We agreed to check at 2:30 PMb. Motion: Move to accept all typo related comments for the editors to address.

i. Against: 0; Abstain: 0; In Favor: 31c. Ballot item 16: Defer all Negative Major from Ioana until she can join and as part of the

Pattern discussion.d. Ballot item 18: The concern raised indicates that CS is an amalgamation of patterns, which

does not have methodology on what that really is in HL7. Lab is using the CS pattern extending it where are appropriate. Other areas are finding the existence very useful and promoting consistency. Submitter will not withdraw.

i. Motion: CS determined it is a pattern and is seen as very useful and therefore the ballot item should be considered Not Persuasive.

1. Against: 0; Abstain: 9; In Favor: 25e. Motion: Defer all artifacts referencing REPC to Patient Care, except ballot item 18.

i. Against: 0; Abstain: 5; In Favor: 29f. Ballot item 21: withdrawng. Ballot item 22: withdrawnh. Ballot item 28: There are two issues in play: use of the word “should” and the issue of what

is being identified.i. Motion: Change wording in identifier from “should” to “may”

1. Against: 0 , Abstain: 9, In Favor: 25 ii. The bigger issue is what is being be identified. This needs to be raised as a separate

issue through a Change Request.i. Motion: All Suggestions will be moved forward as Change Requests. David/Patrick.

i. Discussion: Coordinators putting the agendas together for the Thursday conference calls should attempt to ensure submitters are notified when their topics are most likely to come up.

ii. Against: 0; Abstain: 3; In Favor: 31

2. Current Model status and Issues (Charlie)a. Charlie summarized updates since version in the Ballot.

i. CSCR -047 Cardinality of allContextControlCodes adjusted across the board. If somebody feels the assigned values do not work, please submit a change request on specific topics.

ii. CSCR -056 Overlap of Component on inner and outer-box possible. Requires an additional change request to address how ot fix it. Charlie will prepare

iii. If any issues exists with applying change requests the topic will return back to the CS conference calls for discussion and resolution.

b. Attributes disappeared – William Goosseni. Related Entity needs to be able to enable observations against the feutus. There were

attributes in earlier CS versions to deal with this, but somehow disappeared (Multiple birth and birth order). William will submit a change request.

c. Cardiology gap identification – Harry Salomoni. Participation on procedure used to be able to be done with a generic construct. Harry will

submit a change request.ii. Question when to use procedure vs. substance administration. This will require a separate

discussion.d. CSCR-046 – The Specimen CMET was not added to the pattern since the language was not

specific enough to understand where/how to add it. Patrick Loyd will work with Lab to clarify where it should go and provide the update to enable Charlie to put it in the right place.

3. Revisit scope, restriction, extension and boundary cases.a. Extension class constraint rules are not clear - Patrick Loyd

i. II added DGIMG class and attribute.ii. The text in the domain model give the impression that anything can be added, but not until

later it strongly indicates a change request to CS should be provided as well to provide common support.

iii. We concluded that re-sequencing the text with a few other flow modifications would help.1. Patrick L. will rewrite and submit a change request.2. The re-write will include a discussion on what to do if TC/SIG added and CS rejected.3. Clarify that the CS binds PC/StrucDoc/OO (TC + SIGs) and other areas that claim to

be Clin Statement compliant.b. Boundaries

i. We should create a better definition for Clinical Statement what is included and excluded so it is easier to address questions/ballot comments that indicate some form of non-compliance.

ii. Examples of boundary topics are:1. CSCR-055 Add participation for ParticipationInformationRecipient2. CSCR-058 Add reasonCode for non-clinical reasons3. Encounter Change Request – Lab

iii. We need to clarify that the clinical aspect of a TC domain model can be tied to the SC, but nothing else.

iv. We should use the term Conformance instead Compliant. Compliant = somewhat like. Conformance = stronger.

v. Check with CMET to follow same reference pattern.vi. Suggestion that if there is a negative ballot then there are two cases:

1. If previous CR exists on the same topic, then use that to justify disposition.2. If no previous CR exists, then pursue with a CR as appropriate and then go to

previous step.vii. Motion: We need a voting approach on CRs as Reject, Accept, or Out-of-Scope and keep

running list of what was agreed to as “out-of-scope”. Patrick, Charlie1. Against: 0; Abstain: 1; In Favor: 232. Clarification: This motion/approach does not preclude re-visiting a topic as new

knowledge may require adjustment of a previous CR disposition.c. Encounter Change request

i. Motion : The Administrative and Financial aspects of A_Encounter CMET out of Clinical Statement Scope, while keeping the Encounter Act in the Clinical Statement. David/Charlie

1. Discussion: Out of Scope means that the TC can do what they need to and not subject to the Clinical Statement.

2. Reason to Put a A_Encounter out of scope is that CMET is addressing admin/Financial which, is not relevant within Clinical Statement.

3. Against 0, Abstain 2, In Favor 21.d. If the implementation of a CR runs into problems, then it needs to be brought back for discussion

and updated resolutions.

e. HDF Synchronization - Ioanai. There is no methodology in place to support patterns.

1. What is a pattern?2. How does it work?3. What is the process within the Clinical Statement?4. How is another group going approach?

ii. That makes conformance for other areas challenging. There is a need to document this.

iii. Motion: Clinical Statement team to jointly create with M&M (HDF) own creating the appropriate methodology for defining, developing and adopting patterns. Ioana/William

1. 0 Against, 0 Abstain. 23 In favoriv. Motion: Document the decision making process we follow and forward to PIC/BoD as a best

practice suggestion as input into further organizational/process improvements. Harry/David.1. Discussion: Double check on joint-TC work.2. Against: 0; Abstain: 0; In Favor: 23

f. ConditionClass –Patient Care William Goosseni. Patient Care had Neg-Mi on the use of this class.

ii. How do we handle cross committee resolutions and how to follow up with the submitter?

iii. Actual Case: Charlie and William to double check the at the solution to deal with neg probably does not impact Clinical Statement

iv. Process Case: If the neg-mj need to be ripple back to Clinical Statement , then used referred and tracked.

g. SupportingClinicalStatement CMET OO . Patricki. Goal is to create new Supporting Clinical Statement CMET to meet the needs.

ii. Motion: Clinical Statement supports the approach and goals. David/Charlie1. Discussion: There is a procedural question on backwards compatibility requirements.

Outcome may determine whether we truly need a separate new CMET, or whether Supporting Clinical Information CMET could be enhanced.

2. Against: 0; Abstain: 2; In Favor: 21.h. Remove xdomains in clinical statements – Patient Care – William

i. CR pending.

4 Intent for Ballot for September 2006Ballot schedule

June 26 Deadline Intent to Ballot announcementJuly 2 Initial contentJuly 9 Preview opensJuly 16 Supporting content deadlineJuly 23 Final content deadlineJuly 30 Ballot opens

Ballot work items and task assignmentIsobel Frean - Publishing FacilatorAndrew - Editing

a. There is a concern with going to ballot in absence of pattern methodology. Agreed that it is not a concern, other areas need this desperately.

b. There is a concern we do not have interactions. Since we have a pattern and A CMET on the way, it is felt that is sufficient to be normative.

c. Motion: Move that Clinical Statement go to Committee ballot in the next cycle. Harry/Austin

i. 2 Against, 9 Abstain. 10 In favor

4. Schedule for Conference Call 1st May 18, 2006 time 16:30 – 18:00 EST, every two weeks.