Orders & Observations

Orders & Observations

September Working Group Meeting

September 15-19, 2014

Meeting Minutes

Table of Contents

Attendees

Monday

Q1 / Q2

Q3 – OO

Agenda Review

Administrivia

Nutrition

Q4 – OO

Specimen Ballot Reconciliation

Tuesday

Q1 – OO

LRI Ballot reconciliation.

Q2 – OO, Rx, RCRIM, PHER

TEP/OASIS mapping

Common Product Model (CPM) and Structured Product Label (SPL) Ballot Reconciliation

Q3 - OO

Nutrition

SDC:

Q4 – OO

DAF

V2.9 Proposals

Wednesday

Q1 – OO

V2.8.2 Proposals

V2.9 Proposals

Q2 – OO, II, AP, CR

Specimen Ballot Reconciliation Summary

Clinical Genomics Sequencing

FHIR specimen resource comments:

Specimen Identity

FHIR Specimen Resources

Specimen Ballot Reconciliation

Q3 – OO

LRI Ballot reconciliation

Q4 – OO, EHR

Lab Functional Model / Requirements

Thursday

Q1 – OO, Pt Care, CDS, Templates

Pt Care Update

Order Service ballot recon:

Patient Care update

Q2 – OO, FHIR

Q3 – OO, CS, Pt Care

CS DMP

Pt Care V2.9 Request

LRI Ballot Reconciliation

Q4 – OO, CIC

SDC Ballot Reconciliation

Friday

Q1 – OO

V2.9 proposals

V2.8.2

LRI ballot reconciliation:

Attendees

Please contact Hans Buitendijk (OO co-chair) in case your name or e-mail is misspelled, or the attendance is not checked appropriately.

Name / Company/E-Mail / Monday / Tuesday / Wednesday / Thursday / Friday
Q1 / Q2 / Q3 / Q4 / Q1 / Q2 / Q3 / Q4 / Q1 / Q2 / Q3 / Q4 / Q1 / Q2 / Q3 / Q4 / Q1 / Q2
Ahmed, Nasceo / / √
Aymorol, Patti / / √
Ayres, Elaine / / √
Bolte, Scott / / √
Brodsky, Victor / / √
Brown, Louise / / √
Buitendijk, Hans / / √ / √ / √ / √ / √ / √ / √ / √
Bunker, Nathan / / √
Burgess, David / / √ / √ / √ / √ / √ / √ / √ / √ / √ / √
Chen, Ken / / √
Chu, Stephen / / √
Cintron, Hector / / √
Constable, Lorraine / / √ / √ / √ / √ / √ / √ / √ / √
Darbouze, Farrah / / √ / √
Daus, Jane / / √ / √ / √ / √
Dieterle, Lori / / √ / √ / √ / √ / √ / √ / √ / √ / √
Dittloff, Margaret / / √ / √ / √ / √ / √
Feikema, John / / √ / √ / √ / √
Fendt, Kaye / / √
Freimuth, Bob / / √
Friggle, William / / √
Fry, Emory / / √
Gallego, Evelyn / / √ / √
Goodnough, Jerry / / √
Gray, Shannon / s.gray@ / √ / √
Gregory, W / / √
Grieve, Grahame / / √ / √ / √
Haas, Eric / / √ / √ / √ / √ / √ / √ / √ / √
Haddorff, Rick / / √
Hall, Freida / / √ / √ / √ / √ / √ / √ / √ / √ / √ / √
Hausam, Rob / / √ / √
Helton, Edward / / √
Hirai, Masaaki / / √
Holt, Erin / / √
Knapik, Carolyn / / √ / √
Knapp, Paul / / √
Larsen, Ed / / √ / √
Lauphear, Daniel / / √
Lindop, Chris / / √
Macary, François / / √ / √ / √ / √ / √ / √ / √
Madra, Joginder / / √
Mandel, Josh / / √
Mar, Perry / / √
McCaslin, Ken / / √ / √ / √ / √
McDonald, Clem / / √ / √
McKenzie, Lloyd / / √
Merrick, Riki / / √ / √ / √ / √ / √ / √ / √ / √ / √ / √ / √ / √
Moldwin, Richard / / √
Mulders, Rob / / √
Nanjo, Claude / / √
Nelson, Dale / / √
Nguyen, Viet / / √
Peyctchev, Vassil / / √
Pitkus, Andrea / / √ / √ / √ / √ / √
Quirk, Donna / / √ / √
Raup, Gordon / / √
Reeves, Dianne /
Ritter, John / / √
Roche, Mark / / √
Savage, Rob / / √
Sen, Atanu / / √
Shabo, Amnon / / √
Shah, Vijay / / √ / √
Shastak, Srita / / √
Siew, Lam / / √
Smithies, Rik / / √
Spears, Corey / / √
Stollings, Crystal / / √ / √ / √ / √
Strausbaugh, Kelly / / √ / √ / √
Swan, Ron / / √
Takasaka, Sadamu / / √
Taylor, Sheryl / / √ / √ / √ / √ / √ / √
Ting, Jeffrey / / √
Unangst, Lee / / √
Velezis, Marti / / √
Vreeman, Daniel / / √ / √ / √
Walden, Anita / / √
Walker, Mead / / √
Ward, Steve / / √
Warner, Jeremy / / √
Warzel, Denise / / √ / √ / √
(Sue) Los Angeles Department of Health / √

Communication with declared O&O participants can be done through . You can sign up through the HL7 website, List servers for focused aspects of the O&O domain are: , , , , , , , , , and .

Monday

Q1 / Q2

No OO meetings due to Plenary Meetings.

Q3 – OO

Chair: Hans Buitendijk; Scribe: Riki Merrick

Agenda:

Agenda Review
Administrivia
Nutrition

Agenda Review

Need a motion to accept Clem’s additional Lab Orders comments that came in after the ballot close due to issues before the LRI and LOI reconciliations can start.
Tue Q1 – need motion to accept additional comment
Tue Q2 – may use overflow for LOI/LRI ballot
This week is last week for v2.9 proposal submission to the V2.x Proposal Database.
Need Hans for v2.8.2 snapshot proposal – may need to find quarter for that.
Thursday Q3 – Riki not available
Friday Q1 Riki can chair

Administrivia

We do have Co-Chair election to re-elect Ken McCaslin – please vote!
Motion to move Food and Medication Preferences, DSTU R1 into Publication. Margaret Dittloff, Ken McCaslin
Against: 0; Abstain: 2; In Favor: 19

Nutrition

Nutrition ballot was January 2014
The ballot passed and we requested voters to withdraw their negatives, but since this was DSTU - motion to publish Margaret Ditloff, Ken McCaslin, no further discussion, against: 0, abstain:2, in favor:19
Nutrition FHIR resource:
Had a subgroup working through the nutrition requirements
We reviewed the following slide deck:
This includes nutrition order (looking for volunteer to put in nightly build) and assessment
Assessment profile Wed Q3 will be discussed with Patient Care
Probably will need to be own resource, doesn’t fit well into existing resources
Used v3 components for work in vMR and QUICK (Quality Improvement and Clinical Knowledge) model
They are also working on FHIR
How do we manage possible collisions/overlap
Profile proposal process should capture that
FHIR FMG to take a closer look (hope QUICK would use nutrition FHIR resource to write their profile on)
How to do an overall modifier to the nutrition
Assertion of what to include in the diet, for example how to state gluten-free.
Most folks do the tube feeding info into supplement segment or using pharmacy message
We classify 3 types
oral diet / nutritional supplement / enteral formula
Use HL7 or use SNOMED CT
have only high level concepts available.
Are the types mutually exclusive?
Oral diets list nutrient modification
Enteral formulas could be part of supplement
Supplement can be added to both oral and enteral diet.
Need to move the item attributes to each of the 3 classes of diet items
In pharmacy resource ordering time is a single entry – do you want multiple nutritional orders or single order with multiple parts. Need to do grouping of these so the doc can assess the interactions between the 3 nutrition types.
How would we interpret multiple schedules for a single item?
Change cardinality to 0..1.
Schedule: which meal period – three times a day / morning snack / Mon / Wed / Fri
Is oral vs enteral different from how pharmacy uses route for medication?
No, because the class implies what attributes we need for each type – required fields vary.
Schedule has start and end available
So use schedule or period (where only start/end time is used).
Can only have one order at a time?
What could Order status be?
Hold – change to suspended;
isInEffect – not needed covered by order status
How do you suspend just a part of the nutritional order?
In practice only at whole order for the (suspend specifically).
Clarifying with pharmacy about boundaries between nutrition and nutrition supplement
Use the medication resource instead?
Consider creating different resources – one for oral / one for enteral and supplement.
Examples of how to represent in the resources.
Supplement = always oral
Enteral needs route, because you can give this as oral as well as enteral
Overall negation – how best to say NO soy, NO gluten, NO meat.
Exclude food type data element and use the substance resource – at order level
Also add include food modifier for kosher / halal – this is at the order item level
Food preference model included attribute about positive or negative preference (include or exclude)
Nutrition calls are Tuesdays 6PM EDT
Nutrition DSTU is topic scheduled for Tuesday Q3
We also reviewed the following spreadsheet:
Time for cookies 

Q4– OO

Chair: Lorraine Constable ; Scribe: Riki Merrick

Agenda:

Specimen Ballot Reconciliation

Specimen Ballot Reconciliation

#78: Expiration date always needs a context – general expiration date – what would that be for – for bloodbanking or genome banking – should include an out of scope section in the document and list the expiration of the specimen for a specific test.

Eric, Lori, further discussion: the general expiration date still has to have context – what you do with the specimen that time – need to be sure the definition states for the general expiration date – still need condition under which the expiration date applies – so is there value to just the expiration date, or need to add conditions for which the expiration date applies – that would mean we need to add expected condition – then we need to consider adding the expiration date on a relationship – and possibly drop the expiration date from the model: Motion withdrawn – action to clarify with original party who suggested the general expiration date for clarification. Riki to check with Phil.

#82: Definition of sourceLocation needs to be updated Motion to accept proposed disposition – Eric Haas, Lori Dieterle, further discussion: should we add a statement that this location could be relative or absolute (GIS coordinates) – don’t think this helps - everything is relative – add individually or relative to another object? No change to motion, against:0, abstain:0, in favor: 6

#83: Add clarifying note between the “is derived” Boolean and the “parent specimen Identifier” are related and is that Lorie Dieterle, Eric Haas, further discussion: possibly wordsmith the reference – note not literal text, against:0, abstain:0, in favor: 6

#85: Motion to accept the proposed wording and move the note Riki Merrick, Lorie Dierterle, no further discussion, against:0, abstain:0, in favor: 6

#87: Comparing the definitions between ContainerTypeCode in Specimen Container Parameter – this is used as a foreign key in specimenContainer – no need to have this in both places in the conceptual model – Motion to remove containerTypeCode and containerMaterialCode from specimen Container – will be addressed using the foreign key and keep the definition in the specimen Container Parameter but drop off “or the holder” and add in which a “specimen can be collected”– Hans Buitendijk – see spreadsheet against:0, abstain:0, in favor: 6

#90: Motion to work with submitter to draft additional introductory section for the use case section, Riki Merrick, Rob Hausam, further discussion: use of the Clarify the context of, against:0, abstain:0, in favor: 6

#92: Reorder these by order of simplicity – could consider providing the same structure and then list “not provided” for each section - disposition – no action Eric Haas, Rob Hausam, no further discussion, against:0, abstain:0, in favor: 6

#95: Simple changes to update the titles to names – Drop project, workgroup, focus on the noun – persuasive Eric Haas, Lori Dieterle, no further discussion, against:0, abstain:0, in favor: 6

#97: Figure is labeled domain model – use case used this model that is intended to be input to our current – make more clear this was provided to us as input for our and also rename the figure to Domain model provided with the use case, Riki Merrick, Rob Hausam, no further discussion, against:0, abstain:0, in favor: 6

Continue ballot reconciliation in Wed Q2

Have clinical genomics use case for FHIR and specimen resource

Adjourned 5:00 PM EDT

We reviewed the specimen ballot and recorded the dispositions in the spreadsheet attached.

Tuesday

Q1– OO

Chair: ; Scribe:

Agenda:

LRI Ballot Reconciliation

LRI Ballot reconciliation.

Motion to approve all A-T at the discretion of editors. Eric Haas, Rob Savage. 9-0-0 ( 10 present
Ballot #59 Persuasive with Mod Rob Savage, David Burgess 11-0-0 ( 12 present)
Ballot #98 Not Related Possible submit for 2.9 change request be submitted so numbering be consistent. To address and clarify. Eric Haas, Rob Savage. 11-0-0.
Ballot #99 Not persuasive with Mod Frieda Hall, Rob Savage 11-0-0.
Motion to apply dispositions for Rob Savage’s LRI comments to LOI reconciliation where the comments are the same 11-0-0.
Ballot #198 Persuasive Frieda Hall, Eric Haas 11-0-0.
Ballot #121 Persuasive with mod Eric Haas, David Burgess 11-0-0.
Ballot #28 Persuasive Frieda Hall, David Burgess 11-0-0.
Motion to fix all broken Hyperlinks in LOI/LRI IGs at discretion of editors. Eric Haas, David Burgess. 12-0-0 reference ballot # 34 and assigned to Bob Yencha.
Ballot # 44 Persuasive Rob Savage, Francois Macary 12-0-0. ( 13 present)
Ballot #47 Persuasive with mod ( refer to LOI) Frieda Hall, Rob Savage 12-0-0.
Ballot #49 Persuasive with mod David Burgess, Eric Haas 12-0-0.

For the full details on the dispositions, see the spreadsheet attached in the Friday Q1 section.

Q2 – OO, Rx, RCRIM, PHER

Chair: ; Scribe:

Agenda:

TEP/OASIS Mapping
Common Product Model and Structured Product Label Ballot Reconciliation

TEP/OASIS mapping

Scope is outside of hospital: transporting patients between hospitals or to deployment
Working on ADT^03 going out, ADT^17 going in
TEP has info on medication given en route
What message should we use to convey this information?
RXA message as follow on to ADT message
What is the best way to connect the supplemental messages to each other?
PID-3 in both messages we think, but we will follow up with Hans – Riki to do
Scope is emergency management (you may not have patient identification, just distinguishing features)
connecting family members to patients
reconnect families
We can create OBX segments for haircolor, distinguishing marks, etc.
LOINC code to describe the overall distinguishing features
using string as answer
Could also get LOINCs for individual distinguishing features, but this may be more than needed (would we ever do analysis on the different features?) – that additional work is only useful, if analysis is performed – suggest to stick to string for starters

Common Product Model (CPM) and Structured Product Label (SPL) Ballot Reconciliation

See spreadsheet for dispositions on the ballot comments.
Comment regarding Risk Evaluation Management Strategy (REMS):
REMS has special sections, specific data element and supports pdf
How to best connect this to the context of listing a required action before a drug is given – examples: From to be filled out / measure blood pressure etc.
REMS can be applies along any step in the ordering process
Protocol can have code that states: order / dispense / administer / permission to prescribe
Seems to be a good idea to add, but there is no traceability between the SPL and the CPM, which is an issue, because currently it is not clear, that there have been no changes made to SPL, except those due to the underlying CPM change [RM1]
So documenting the reference to the SPL CMET would allow for that traceability, especially since SPL used to be a separate document from CPM. There was a v3.1 publishing issue for SPL[RM2]
Overall a good idea to provide references to the respective CMETs for traceability with a little more text for each.
Add the REMS material and add a description of each of the bullets for more clarity and context
Description of business requirement class  CMET
What listserve to monitor for discussions on this?
Every other Monday 2PM ET are meetings between FDA – NCPDP – SPL folks – monitor RCRIM listserve
Discussed PSS in June, had call in August for intro to work, but no other info
CPM covers 95% of SPL
Will set up a discussion in OO on a call
Need to create a project that covers OO and RCRIM to deal with changes to CPM and make a listserve to post issues to
also should find an OO participant for the Monday calls
set up listserve and send to RCRIM and OO primary lists to let folks know about this.
Preface text will be removed in the next release of SPL, but that covers the datatype backwards compatibility issue – that needs to remain in the next release!
CMETs are in R2, so need special thing for R2B
How best to give that guidance? – add a paragraph to explain
RCRIM to send PSS for FDA project to OO for consideration:
Creation of IDPM standard with the idea to use SPL as the vehicle for exchange, so will need to review SPL/CPM and possibly update for needed data elements
This should meet ISO standards as well as the EU requirements
SPL R5 was the result of folks reviewing EU IDPM standards
Create IGs for IDMP, substance, routes, units, packaging – missed several others
Jan 2013 after ICH work item to go to ISO/HL7
Substance document needs to be reviewed, otherwise a few changes are needed
EU EMA for legal considerations to align with ISO <-> HL7
Why use SPL document and not a message?
In EU mostly use documents. Messaging has painful overhead.
Should we consider newer / easier implementations? (assume FHIR?)
If it is really easier, might consider.
Datatype R2B has been given a limited lifespan (5 years past normative publication) by HL7 board / TSC.
Need to consider what to do, when it is retired
Discussion about possibly re-considering that decision
Possibly constrain for newly developed standards
Existing implementations remain as they are, new projects need to evaluate
Revisit when we need to renew ANSI for R2 datatype
Bring project to OO for review as a staged project:
#1 – Review ??
#2 - EMA & EU requirements capture, specifically substance
#3 – Identify gaps and disposition them
#4 – consider implications /options
If there end up being NO changes to the underlying documents, how would you ballot the added traceability statements and references to those new business requirements?
What about lot distribution[RM3]?
Resolve similar to REMS set up
Balloting also provides outreach to stakeholders, so should be done, but how to clarify that there are no changes to the underlying standard, just documentation and use related notes.
In this ballot the only changes are because of CMET changes, which affected a schema change – may be more of a re-publishing issue, but not sure how to deal with, since ballot is the only process we have for re-publication.
Need to look at how best to document the new requirements
IDMP documents to be released Oct 2014 for review as HL7 specification = ballot May 2015 – this PSS was distributed via the RCRIM listserve as a draft – needs to be fleshed out a little more and then shared with OO – needs to implement by June 2016.

Q3 - OO

Chair: Lorraine Constable; Scribe: Riki Merrick

Agenda:

Nutrition
SDC

Nutrition

2 nutrition products in DSTU

DAM: DSTU comments were submitted in error – Move to close the erroneous DSTU comments – Loraine, Margaret , against: 0, abstain: 4, in favor: 5
DSTU comments against the

Created version 1.1 of DMIM to explain some of this.
#477: Specify the oral nutrition item – to supply request – add participation with negation indicator on to product to administrable Material - this is needed at the higher level = Add product participation with a negation indicator Margaret, Jean - persuasive, no further discussion, against:0, abstain: 5, in favor: 12
#478: Food kind entity needs a quantity when not negated – so add constraint to foodKind4 = nutrient type quantity is M when Negation Ind is not true. Jean, Margaret - persuasive, no further discussion, against:0, abstain: 5, in favor: 12
#479: nutrient type order participation was ONLY on the oral diet, so moved up to the choice box of nutrition order – persuasive Jean, Margaret - persuasive, no further discussion, against:0, abstain: 6, in favor: 11
#480: Added negation indicator and effective time as interval TS to all product participation elements – persuasive Jean, Margaret - persuasive, no further discussion, against:0, abstain: 7, in favor: 10
#481: currently have no way to give combination of nutrients via enteral route – use pharmacy mixture as inspiration / QUICK model has base formula plus additive. Add complex pharmacy model to accommodate this – Jean, Margaret - persuasive, no further discussion, against:0, abstain: 8, in favor: 10
#482: need to be able to handle set of administrations – need to change 1..1 to 1..*for enteral substance administration act relationship - as long as you don’t need to handle relationships – deal with that in another comment – Jean, Margaret - persuasive, no further discussion, against:0, abstain: 8, in favor: 10
#484: orders with conditions – model needs to have goals, and preconditions- suggest to duplicate the medication order what they use for pre-condition and goals – Jean, Margaret - persuasive, no further discussion, against:0, abstain: 7, in favor: 12
#485: Add text field to enteral nutrition order to substance administration as 0..1 as ST datatype -– Jean, Margaret - persuasive, no further discussion, against:0, abstain: 5, in favor: 14
#486: differentiating nutritionally complete products – no need to state, when a specific product is identified, but when you give a “kind of” product – should take this back to the nutrition business users to determine the need – mark as considered for future use – Margaret, Donna - persuasive, no further discussion, against:0, abstain: 8, in favor: 12
#483: Complex rate instructions: start tube feeding at 7 ml/hour, increase by 2ml/hour until you get to 70ml, unless the residual … - also different rates based on mealtime, or time of day – need to convey complex rates in structured form, or would we want that at least provided as a common pattern – create 2 attributes as start and target goal and then use text - should take this back to the nutrition business users and possibly ASPEN – no vote yet – should solve this before we do a DSTU update request. DSTU review required prior to publication request – all the changes were driven by the users trying to implement – wait for user input on the handling of complex requirements
Go to for the DAM comments that were entered in error and marked Not Related
Go to for the dispositions to the comments on the v3 models

SDC:

Idea is to create a generic form generator and define the data elements for this
Hard to read FHIR extension
Data element
Questionnaire
QuestionnaireAnswer – very similar to an observation, why created separately?
Other elements
There are a lot of identifiers around, based on trying to be compliant with using ISO 1-1170.
What defines when you have to create a NEW data element – different absolute limits / different units
Allow extensible answerlists
Scores and how to deal with those – add separate field to report in addition to the answer
Incentive to use ISO 1-1170 – create a cross-map between the different models of v2, v3, FHIR, CIMI
Clem does not think ISO is complex enough to allow this cross-map, so then we will have too many data elements, that are not the exact same in the different models, but we know exactly what each data element is.
When clinicians realize they need to harmonize their treatment we may be able to get to a single model
If we can capture the relationships between the data elements and how they are related in specific models we may have a solution
Context is important and should be explicit – SDC is the first step.
Observation – QuestionnaireAnswer– condition
Need to have clear instructions of what we expect to be used for what
LOINC code seemed to fit, but permissible values in answer list didn’t match
how should we deal with this
if example answer list, then ok to expand; normative answerlists are NOT expandable, so then would need to add new code, if that is the case
Next ballot reconciliation is in Q1 Thursday – need to set up a call to resolve remainders after that
Clem will review the ballot comments for the ones that he requests” in person resolution” and let folks know.
For units – bind to UCUM and all units that are canonical are applicable to the same data element.

Q4– OO

Chair: ; Scribe: