2015-05-12 Call - (S&I) Framework

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S&I Framework: Laboratory Orders Interface (LOI) – eDOS WG

Subject LOI eDOS Workgroup

Facilitator Freida Hall, Mark Jones

Location Conf. Call/WebEx

Date /

Time

Scribe

Materials

05/12/2015

2-3 pm Eastern

Mark Jones

Attendees Freida Hall, David Burgess, Cindy Johns, Kathy Walsh, Mark Jones, Bob Yencha, Riki Merrick

Regrets

Agenda

1.

Agenda Review

2.

Announcements

3.

Begin V2.8.2 N2 (2015May ballot) eDOS related reconciliation

4.

Continue eDOS reconciliation (2015Jan ballot)

5.

AOE update; ballot #110 (Riki)

6.

Follow up from discussion with Orchard Software representatives (July 22):

Latest proposal OM4 segment additions at: http://wiki.hl7.org/index.php?title=OO_CR168-818-OM4Addition

Note: 2014-12-16 version of update to Additives Spreadsheet from Kathy Walsh in notes below; file name:

"Aditives20141203.xlsx".

7.

Standing agenda items: Review eDOS DSTU tracker: http://www.hl7.org/dstucomments/showdetail.cfm?dstuid=105

8.

Next Call – May 19, 2015

Page 1 of 14

Key Discussion Points – Quorum is Co-Chair plus 4 (with no preponderance of influence)

1.

Agenda Review:

2.

Announcements:

3.

Begin V2.8.2 N2 (2015May ballot)

2015-05-12 Call:

#11 David B agrees that resolution in #11 will cover his concern we will be replacing the PLR.2 ST data type with - if that is the motion on #11, then David considers this will resolve his in-person comment David B, Riki, no further discussion, against: 0, abstain: 0, in favor: 6

#39: Add CDM segment in M08 and in M10 in order to send CPT code without any financial information. In eDOS we made the CDM.3 R, maybe if we make this one RE, then we can allow folks to use it, but don’t require it every time – Freida will track down what the rationale was to add CDM.3 as R field in eDOS, as it was in the first version – David has already submitted a related eDOS DSTU comment (#603)

#39: withdrawn by submitter, since that is addressed in eDOS DSTU comment #603

#40: withdrawn by submitter, since that is addressed in eDOS DSTU comment #603

#51: related to MCP-4 – ABN is ONLY used for CMS related billing, but other payers might have similar concepts, but could not use that term, so make ABN to example – motion to find persuasive David B, Mark , no further discussion, against: 0, abstain: 0, in favor: 6

#52: related to MCP-5 – same intent different field – motion to find persuasive Riki, David B, no further discussion, against: 0, abstain: 0, in favor: 6

#50: Adjust example for the rule, that if there is ONLY one price MCP-3 is not populated – sounds like a condition, but we usually don’t do a lot of conditions in the base standard, plus that might trigger another re-ballot - motion to find persuasive – update example as proposed – David B, Riki, no further discussion, against: 0, abstain: 0, in favor: 6

#55: fix an agreed to comment that was not applied – Motion to find persuasive Riki, David B, no further discussion, against: 0, abstain: 0, in favor: 6

#41: the CWE datatype in v2.8.2 has 22 elements – need to update CWE (and CNE) where OO added in this chapter (DPS, OMC, MCP, etc) Riki, Mark, no further discussion, against: 0, abstain: 0, in favor: 6

#42: Motion to find persuasive – if we can change the definition for OM7-1 as a technical correction now, without triggering a re-ballot, include that changes as well – Freida to check with OO/publishing Riki, David B, no further discussion, against: 0, abstain: 0, in favor: 6 – does adding the change of OM7-1 make this persuasive with mod? Left as persuasive.

#43: OMC-2 should be conditional, which would undo N1 ballot comment #94 – Motion to find not persuasive Mark, David B, no further discussion, against:

0, abstain: 0, in favor: 6 – Riki to check with Frank for compelling reason.

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#44: CWE and CNE should have tables or code systems associated with the fields – motion to find not persuasive, David, Mark , no further discussion, against: 0, abstain: 0, in favor: 6

#49: MCP-2 was copied from OM1-2, so we could not change the datatype etc. as we want to be consistent across message elements – in order to update this, we would need to deprecate OM1-2, which would cause a chain reaction in all the fields that reference it – motion to find not persuasive, Riki, Mark, no further discussion, against: 0, abstain: 0, in favor: 6

V282_N2_2015MAY_ consolidated 2015-05-12 eDOS WG.xls

**File above from May 12 eDOS WG call

4.

Continue eDOS reconciliation (2015Jan ballot) -

2015-05-12 Call:

#26: Discussed, if v2.8.2 is not published, then add a sentence to the requisite knowledge section that v2.8.2 elements are "best practice" and will be supported in the next release of eDOS. Thought we have to take these out, if V2.8.2 is not published before eDOS IG. Will leave this line item open.

All open negatives are either AOE or v2.8.2 related.

#995: Bob Y to carry over the text to update the convention section in eDOS – still open

#996 CWE display rule was use CWE.2, if only 1 code, if more than one use text from local (CWE.2 or CWE.5), if CWE.9 is used MUST be used for display – we think that was the agreement from the LRI call a few weeks ago. Don’t need CWE.9 here, so leave OMC-11 as CWE also

Motion to leave OMC-6 and OMC-11 as CWE – Mark, Riki, no further discussion, against: 0, abstain: 1, in favor: 5 – mark as persuasive with mod

V2_IG_LTCF_R2_D2

_2015JAN_2015-05-12.xlsx

**File above from May 12, 2015 call

(From 5/5/2015 call) The call was ended at this point due to time. We will pick up with (#996) OMC-6 and -11 on 5/12. If there is quorum for the second hour, we will finish ballot reconciliation, work on the AOEs and then review edits to IG that have been made to that point.

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(Reminder) Should we post the spreadsheet in the notes or post to the wiki – the latter may make it easier to find, since sometimes you don’t remember the date to look at specifically – will post both ways as a starting point.

5.

AOE update; ballot #110 (Riki)

6.

Follow up from discussion with Orchard Software representatives (July 22):

From July 22 minutes: Specimen requirements and container descriptions – should we add coded fields for these to v2.8.2 - or V2.9? Do we have vocabulary we can use for that? LabMCoP will take a look at existing vocab this week

(Thursday); if you have any suggestion/info on this issue, send to Mark, Riki, Cindy, Freida, and Kathy. (Cindy will be out for 2 weeks starting next week).

Follow up email from Riki Merrick:

Re eDOS call notes.msg

Container volume is in OM4-4

Additive in HL70371 – HL7 defined table (already in OM4-7)

Special Handling Code HL70376 - User defined table (already in OM4-15)

LabMCoP is doing homework on possible vocab addition to these existing tables

For fields that are TX may need to have a guidance note to clarify, what the source of truth is if the coded related field has differing information from what is written in the text – consider DSTU comment for eDOS to be that way (Mark will discuss with his team). Can also consider some guiding text on what to include in the text field.

Also Mark may create a v2.9 Change Request for any more coded elements to added – tube top color, container material – in addition red top glass tube code and possibly include a new field CQ data type for time sensitive specimen.

2014-08-12 info from Kathy Walsh:

Email from Kathy Walsh:

Finding a reasonable list has proved to be more difficult than I thought it would be. In our compendium we send text and when I deleted the duplicates I still had over 700 containers because of extra information, container options, and formatting differences. So what I am sending is not an all-inclusive list but is a list of basic containers for our regular test and does not include transport information.

Thanks,

Kathy

Tube Descriptions

Gel Barrier Tube

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Tube Descriptions

Serum Transfer Tube

Lavender-Top (EDTA) Tube

Slide

Urine Bottle

Gray-Top (Sodium Fluoride) Tube

Blue-Top (Sodium Citrate) Tube

Plasma Transfer Tube

Red-Top Tube

Swab (non-micro)

24 Hour Urine Container

Body Fluid

Stool

CSF (Cerebrospinal Fluid)

Green-Top (Heparin) Tube

Amniotic Fluid

Royal Blue-Top (EDTA) Tube

PKU Card or Filter Paper

Yellow-Top (ACD) Tube

Plasma Transfer Tube with Trasylol

QuantiFERON

Tissue

Whole Blood

Urine Monovette

Gastric Fluid

Sputum

NMR LipoTube (Black/Yellow)

Urine Transport Tube

ColoSure

Semen

Cytec Vial

Paraffin Block

Polymedco iFOBT Bottle

Other (Miscellaneous)

Breath Bag

Holter Monitor Kit

Calculi

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Tube Descriptions

Tan Top Lead-Free Tube

Holter Monitor

Percloric Acid (Gray-Top Tube)

Urine with HCL Preservative

Urine with Boric Acid Preservative

Urine with Acetic Acid Preservative

Urine with Sodium Carbonate Preservative

Vacutainer with No Additive

Affirm Transport System

Quantisal

ORASURE

QuickVue iFOB Tube

BD SST Tube

VIAL TriPath Collection Vial

Aptima (Gen-probe) Endocx/ureth swab

Aptima Org

Digene HPV Transport

Aptima (Gen-probe) Urine

Progensa Urine Transport Tube

Kidney Stone Container

PPT (White)

Urinalysis Transport(Red/Yellow)

Previously Prepared Cyto Slide

Urine Culture Transport

Gen-Probe (PACE) endocx/ureth swab

Bacterial Cult Trans Swab w/Media

Bacteral Cult Trans Swab Dry

Sterile Cup

Para Pak - Gray

Para Pak - Pink

Para Pak - Pink & Gray

Para Pak - Orange

Para Pak - White

Blood Culture Bottles

Jembec

Anaerobic Culture Transport

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Tube Descriptions

Bordetella Culture Transport

Viral Transport System

MicroTrak

Organism Isolate

Gray-Top Vacutainer Urin Culture

Attest Vial

Trichomonas Transport

Fecal Occult Blood Card

Pediatric Blood Culture Bottle

Naso-pharyngeal Swab

Millipore Filter

Miscellane Other Micro Transport

Plated Media

Probe Tec

Uniprobe

Plasma from Light Blue Top Tube

Plasma from Lavender Top Tube

Plasma from Green Top Tube

Plasma from Royal Blue Top Tube

Plasma from Yellow Top Tube

Plasma from Gray Top Tube

Plasma from PPT(TM) Tube

Urine 24hr No Preservative

Urine 24hr 6N HCl

8/12/2014: Could add these as common textual descriptions and then request a new field for coded data in future.

Possibly also request an additional field that you can list the time requirement to ship the specimen by (in minutes / hours / days etc.) to identify specimen that cannot be shipped as part of a batch.

8/19/2014: (2014-10-28 Note: This spreadsheet is now outdated, see later version below.)

OM4_related_Vocab ularyKAW20140818v2.xlsx

Discussion on this call:

Need to review the container type list against the additive table to ensure all additives are covered – should include comments with those to indicate when to use some of these, where currently done in the compendium.

Page 7 of 14

For some tests we seem to have to have two different tube types – was this at the analyte level - Kathy will take a look

Cindy suggests: Kryofibrinogen testing compares reaction in two different tubes in plasma and serum tube after refrigeration – create a code that combines two tube types into a single concept

If we want to code container types may need to request that new field – do we want to deprecate the TX field in favor of the new coded field or allow both?

Would need to do that before the Sept WGM.

Add new field for coded container types using CWE – and deprecate the TX field? Mark to draft for next week

In the container field currently also have notes about where to order containers – how to handle that?

9/2/2014: Reviewing the OO proposal (see above under agenda): Add new field to OM4 to codify container type = SPM-27 – should this field be repeating. SPM-

27 does NOT repeat. Add new code to HL70376 for critical time sensitive – deliver to lab within timeframe specified in new field.

Or add new field using Y and N as allowed answers to indicate, if time-critical. Or have just one new field called time critical delivery time – if not populated, then not time critical?

We need to figure out how to message, when 2 containers are required for one test – if you send 2 OM4 segments and if the OM4-17 is not filled in then would that mean and? Not yet. In the notes we have Example for Preferred specimen where OM4-17 is listed as ‘P’. May need more text for this. Would we need an indicator in the OM4 segment that the specimen is required. If both are marked P would that be the indicator for AND? The rule in OM4-16 indicating only one P for each specimen type does not work for Cindy’s example, where she needs blood with two different additives (Yellow top and lavender and both have to be sent).

Preference is for just having the specimen delivery time field. Let’s not add the time critical code to specimen handling.

Do not deprecate the container description – leave for notes about the container, or deprecate and add a new field for all the other information folks currently put into that field.

Currently have no specific code system to draw from for container types – would need to look, if there are appropriate SNOMED codes or there vocab out there

9/9/2014: Mark sent updated proposal (see above) have OM4-19 as CWE for container type; OM4-20 Specimen delivery time as CQ (if populated, the delivery is critical and will be rejected, if not transported in that timeframe). What about OM4-3 – leave or deprecate? Kathy prefers to leave – do we want to have the list of containers as examples?

Folks are using TX fields for all sorts of additional information – so may be add a sentence to point folks to use the coded field to identify the type specifically. To identify container types as coded values use OM4-19 (Container Type).

Kathy looked at the specimen condition or handling table in the ballot value set and saw more codes than she thought were there.

Make table for OM4-19 user defined and propose codes for folks to review in v2.8.2 ballot.

Ken drops off.

Provenance discussion - How do we know who makes changes to the table values? It would be in the OO minutes and ballot reconciliation to be found – but in practice for user defined tables you sit down with the partners and define what will be used.

Need to also include the OM4 segment table etc.

Move all the detail changes to Section 4

Add impact: Implementers will need information from OM4-3 text format to OM4-19 coded format.

Motion to accept the proposal with proposed changes Riki Merrick, Mark Jones, no further discussion, against: 0, abstain: 0, in favor: 7

Frieda and Mark will upload to the OO wiki (seems to have issues with uploading the file)

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2014-09-23 HL7 WGM discussion – OO requested to add segment table to proposal ( CR166-818 ); this raised question of element number and 'reuse' of SPM-27 element in master file. However SPM version uses Table 9999; proposal CR166-818 proposes User Defined table. Also using copyright names in table was questioned; may need to add appropriate copyright/trademark. Publishing recommends using same element # if possible, but still have table issue (9999 vs. new User Defined Table.)

Per HL7 Terminology Authority (HTA) should use 9999 in the underlying standard and then publish the constrained table in eDOS – will have to create a code system for these concepts – also need to review concepts for the actual container types covered rather than referencing the specimen types contained – Kathy to do a little more work on this one (will add a definition for the container types and possibly where they are used)

How to deal with trademark symbol in table / messaging = Action: Freida to check with HQ on how that is handled

Motion to approve using SPM-27 item# and table number in OM4-19 Mark Jones, Riki Merrick, no further discussion, against: 0, abstain: 1, in favor: 7

2014-09-30 Reviewed HQ response. Motion to remove from the table items that are trademarked, and add note that this is not exhaustive list and trademarked items are excluded by Mark Jones, second Les Keepper. Against-0; Abstain-0; Affirmative-8. Kathy will continue work on the table. Action: Review table next call; Freida to post proposal update from eDOS call to OO wiki.

Kathy had comments/questions about containers from her research:

Top colors don't necessarily control additives (OM4-7 Additive)

Do we care if containers are glass or plastic? No

Do we care about stoppers vs. caps? Yes – may impact automated functions.

2014-10-14: Added 2 tabs – basic list of containers – too basic to be useful, second tab – deleted additives and other words – want to check that list of additives against the official table for additives (Kathy to do) – Bob will post to wiki, will discuss on the next call.

Les question: A big push that lab results be available to the patient – there has to be some kind of demarcation that some information must stay with the laboratorian. Final rule for CLIA amendment was released in 2013 that allows patients to get copies of their lab results – at federal level – labs are trying to make that information useful to the patient. There has to be the relationship between the doctor to help translate the lab results to make them meaningful to most patients. People are trying to structure the information useful in many different ways – having the detail at least gives a patient the option to take this to the

2014-10-28: The glass vs plastic may be important for some tests, but in general not needed. Kathy is now reviewing additives to be sure HL70371 has all of them that are needed.

OM4_related_Vocab ulary20141010.xlsx

Please review for next week's call (11/4).

2014-11-04: Base container list is too basic – need to use at least the abridged container type list – which we had to remove all the trademarked terms, reviewing this now:

Additives tab = HL70371 Kathy is still working on this one

HL70396 – not sure what chilled refers to, so don’t add – but add the other two missing terms – do we need to

Chilled is not referenced in Quest, LabCorp, PAML, Mayo – so let’s not have it.

Motion to approve table as listed in the spreadsheet Mark Jones, Riki Merrick, no further discussion, against:0, abstain:0, in favor: 8

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Container type - do we need metal free? Have that as specimen handling, so don’t add specifically

What about differentiation between glass and plastic?

The base standard for the element we are reusing points to an outside code system, so we won’t get an HL7 table number – use an external code system if we want to get a new HL7 table number assigned for user defined table and deprecate the field in SAC that is describing the container type – POSTCALL NOTE: The field is actually SPM027 (HL7 item#01773)

Will pick this back up next week for voting.

Updated spreadsheet at the end of today’s call:

2014-11-04 OM4 related vocabulary.xlsx

2014-11-11 - discussed value of 'master list' for container type; after removing copyright/service marked items, what remains is a very small list; Kathy did not see of a user defined table since every lab will have to add their specific containers. A Coded field does offer benefits. Discussed if we could include as examples values from the spreadsheet, without designating as a table, and suggest use of the example values; Ken thought we'd need to suggested they could not be changed. Recapped prior actions which diminished value of table, for example, HL7 HQ advised to remove trademark, copyright items unless we had permission from the owner. Ken asked if CLSI had a standard list of containers; Mark and Ken looked during the call but could not find. Les commented a master list usually offers value. After discussion, the following motion was voted on:

Motion not to create an HL7 User Defined table, leave table reference as 9999 and let trading partners decide values. Motion by Kathy Walsh, second by

Mark Jones. Vote: Against-0; Abstain-3; Affirmative-3

Freida commented since the vote was close we could vote to reopen on future call if desired.

2014-11-18 Update to Additives Spreadsheet from Kathy Walsh (discussion deferred)

Aditives220141118.x

lsx

2014-12-02: Reviewing the inserted document – there were some she had to add

AMIES liquid/Agar gel always found in combination

Have some of these in SNOMED as well in substance and product hierarchies

The table is an HL7 table - next steps?

LabMCoP can take on the review, then forward to either HL7 Vocab or HCA, whichever deals with additional vocab – steward of this table is OO – so will need to take there 

Aditives20141203.xlsx

2014-12-16: Kathy tried to re-work the additives, but it still has trademarks and copyrights – here is the latest version

This may be more complicated for this one – we may reconsider getting permission… HL70371 is an HL7 table, with OO being the steward, any reason, why this is an HL7 table? May be want to ask OO if this could become a user-defined table – or asking vocab – find out what the process is? In Chapter 13, under SAC-27 the value set can be extended with user-specific values.

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Kathy then will go back and remove the trademarked items and bring back. Action: Freida will contact OO Co-Chairs to ask for agenda time to discuss HL70371 table.

2014-12-16 Freida emailed OO list – request to add to OO agenda January 8 call if not addressed December 18 OO call.

RE HL7 OO

Conference Call - Webex.msg

2015-01-08 OO call – need to research Table 0371 further; table originally added in V2.4 as "Additive" Table used in SAC-27 and OM4-7. Freida to research further (e.g. V2.8 proposals database) to determine when changed to Additive/Preservative.

Minutes 20150108

OO ConCall.docx

2015-02-03 Defer; Freida noted she added addition input on follow up research after January 8, 2015 OO call.

Research

Changed in V2.5 when SPM-6, Specimen Additives added; table name changed and table values extended. See comparison V2.4 and V2.5 below and HL7

V2 change proposal # 39 , which adds values to table.

(Hall) Recommendation – We now understand Table 0371 was initially created as an HL7 table, i.e. to require support of NCCLS codes but with caveat the table could be extended. Since it might be problematic to revert from an HL7 to User Defined table now, recommend leaving as HL7 table and extending in the eDOS IG to include additional values.

Also suggest drafting letter to manufacturers to ask for permission to include their additive names in the table. Minimally, try first with one manufacturer to gauge their response. (Freida will take action item to work with HQ).

From V2.4:

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From V2.5 –

Page 12 of 14

Chapter 13 – Note: table not renamed in Chapter 13

Chapter 8 – Note: table was renamed in Chapter 8

7.

Standing agenda items: Review eDOS DSTU tracker: http://www.hl7.org/dstucomments/showdetail.cfm?dstuid=105 It is legal to submit DSTU comments while a document is undergoing ballot reconciliation – so Eric will post the question about when a CWE field has to match another, which components have to match, or if all do – will then introduce to ballot recon as discovered item.

NOTE TO EDOS WORK GROUP: Please list harmonizing issues in HL7 tracker as DSTU comments to keep in sync with LOI/LRI.

# 571 (new) - From DSTU comments: 2015-05-12 eDOS-36 matches NIST-19. eDOS-31 matches NIST-21.

Also have for MCP, see eDOS-37.

For this conformance statement, all four components must match; .1 identifier, .2 text, .3 name of coding system, and .7 coding system version ID.

Pending further discussion.

# 603 (new) -Effective date time in MFE segment affects just the CPT update; MFE-4 is the linkage key that links to OM1 and MFE also states if addition/deactivation, update…so then can resolve this way in favor of adding CDM to M08 and M10. Motion to Change CDM-2 Charge Description from R to

RE, in lieu of adding CDM segments to M08 and M10 by David Burgess, second by Riki Merrick. Against-0; Abstain-0; Affirmative-6.

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Also eDOS ballot reconciliation line item #993.

8.

Next eDOS call Thursday 3- 5 PM: Bob Y, Freida, Kathy, Mark, most likely Cindy – David B can be on after first 30 min

No need to wait for Riki to complete the AOE topics.

Call adjourned 5:08 PM EDT

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