S&I Framework: Laboratory Orders Interface (LOI) – eDOS WG Subject Facilitator Location Attendees LOI eDOS Workgroup Date / 01/27/2015 Time 2-3 pm Eastern Freida Hall, Mark Jones Scribe Riki Merrick Conf. Call/WebEx Materials Cindy Johns, Freida Hall, Mark Jones, Bob Yencha, Kathy Walsh, Sheryl Taylor, Riki Merrick, MariBeth Gagnon, Eric Haas Regrets Agenda 1. 2. 3. 4. 5. Agenda Review Announcements Begin eDOS reconciliation (2015Jan ballot) Continue V2.8.2 Chapter 8 Ballot Reconciliation – 2015-01-27 defer, open items all marked yellow (pending action) Standing agenda items: Review eDOS DSTU tracker: 2015-01-27 Defer, no new items. http://www.hl7.org/dstucomments/showdetail.cfm?dstuid=105 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. Next Call – February 3, 2015 Page 1 of 12 Key Discussion Points – Quorum is Co-Chair plus 4 (with no preponderance of influence) 1. Agenda Review: 2. Announcements: Craig Newman is leaving EPIC to work at Northrup Grumman as contractor to CDC (Immunization IGs) – will have 2 new folks from EPIC taking over his comments – in person can be satisfied by these folks 3. Begin eDOS reconciliation (2015Jan ballot) 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. 2015-01-23: #3: Motion to designate editor to deal with all comments marked “A-T” and bring any questions back to group Mark Jones, Cindy Johns, no further discussion, against: 0, abstain: 0, in favor: 6 #30: these are subtitles so fix accordingly Bob Yencha, Riki Merrick, no further discussion, against: 0, abstain: 0, in favor: 6 #63: see #30 #17: Cross Section numbering needs to get updated to new section Motion to address numbering as part of the typo updates when formatting the document, Bob Yencha, Mark Jones, no further discussion, against: 0, abstain: 0, in favor: 6 #18: see #17 #22: Add M18 to Table 5-1 – Bob Yencha, Riki Merrick, no further discussion, against: 0, abstain: 0, in favor: 6 #33: see #22 #62: see #22 #16: Add description for M18 to table 3-1 – Freida thinks there should be another comment, this is A-S, so will hold on this one #34: Add M18 to the list of messages to use in initial load Riki Merrick, Mark Jones, no further discussion, against: 0, abstain: 0, in favor: 8 #5: See #34 #35: in section 2.3 – do we need to add column for M18? May be of interest to know for which scenario M18 applies – hold till Ken and David can be on the call #65: Add clarification detail what the message is used for from v2.8.2 until that document is published – find persuasive Eric Haas, Mark Jones, no further discussion, against: 0, abstain: 0, in favor: 8 #95: see #65 #2: pilot section disappeared – Motion to add back in Cindy Johns, Mark Jones, no further discussion, against: 0, abstain: 1, in favor: 7 #79: If there is information about limited coverage and approved coverage - think and hold for discussion along with #35 #107: OMC- segment – need to add the v2.8.2 definitions here until that standard is published – This comment suggests to add the OMC-4 field, that identifies the AOE as a place where LOINC can be used – will pick up here next week. V2_IG_LTCF_R2_D2 _2015JAN_2015-01-27.xls 4. Continue V2.8.2 Chapter 8 Ballot Reconciliation – have 71 comments for chapters 8 and 2C 2015-01-27 deferred, open items all marked yellow (pending action) Page 2 of 12 5. Standing agenda items: Review eDOS DSTU tracker: http://www.hl7.org/dstucomments/showdetail.cfm?dstuid=105 2015-01-27 deferred, open items all marked yellow (pending action) 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. 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 Page 3 of 12 Tube Descriptions Gel Barrier Tube 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 Page 4 of 12 Tube Descriptions Calculi 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 Page 5 of 12 Tube Descriptions Anaerobic Culture Transport 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: Page 6 of 12 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. 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. SPM27 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) Page 7 of 12 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. Page 8 of 12 Motion to approve table as listed in the spreadsheet Mark Jones, Riki Merrick, no further discussion, against:0, abstain:0, in favor: 8 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 Page 9 of 12 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. 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. Changed in V2.5 when SPM-6, Specimen Additives added; table name changed and table values extended. Page 10 of 12 From V2.4: Page 11 of 12 7. Next Call – February 3, 2015 Call adjourned 2:59 PM ET Page 12 of 12