IEEE P11073-10101* Update HL7 DEV SIG and IEEE 11073 GC Meetings, Orlando, FL Tuesday Q2, January 12, 2016 Paul Schluter, GE Healthcare

Topics IEEE Std 11073-10101a-2015 – approved and published! Transfer to NIST RTMMS and test tools Plans for -10101b (pumps, vents) and -10101c (events, alarms)

IEEE Std 11073-10101a-2015

IEEE Std 11073-10101a – approved and published! Approved by IEEE-SA Standards Board on December 5, 2015 Published on December 9th and uploaded to NIST RTMMS NIST RTMMS and test tools are being updated to support IHE PCD implementations for pre-Connectathon testing this month and IHE NA Connectathon testing in January 2016.

IEEE Std 11073-10101a – now available at IEEE Xplore http://ieeexplore.ieee.org/search/searchresult.jsp?newsearch=true&queryText=11073-10101a IEEE Standards Store at Techstreet http://www.techstreet.com/ieee/products/1900549 The essential IEEE Std 11073-10101a-2015 terminology content can be downloaded from http://standards.ieee.org/downloads/11073/ (the xml and html files contain the essential tabulated terminology) NIST RTMMS (and fully incorporated in the NIST test tools next week) “The Rosetta Terminology Mapping Management System (aka ‘RTMMS’ located at URL: rtmms.nist.gov) shall reflect all updates meeting the newly approved 10101a on Friday, December 11.  NIST continues to appreciate any and all feedback and reminds users to post pertinent issues to the RTMMS Google Group (group email: rtmms@googlegroups.com) and/or the IHE-PCD Rosetta Terminology Mapping Profile Work Group (group email: ihe-pcd-rtm@googlegroups.com).” Regenstrief Institute (LOINC) A complete mapping of the 660+ “harmonized” IHE PCD Rosetta terms to LOINC will be available in the next LOINC RELMA release (and on RTMMS).

Transfer to NIST RTMMS

Updated hRTM2 with 10101a terms The original ‘harmonized’ Rosetta (hRTM) contained existing terms, terms that required a numeric codes, new terms and obsolete and deprecated terms. The disposition of existing hRTM terms was documented as shown below and an updated hRTM2 table was produced. Action Description AssignedCode Applies to proposed hRTM 0^REFIDs in -10101a that needed a CF_CODE10 assignment. DiscardedGas Discarded hRTM 0^gas_REFIDs not in -10101a. RenamedOther Renamed hRTM 0^other_REFIDs, typically to as a new (but similar) REFID in -10101a. Retained10101 Existing -10101:2004 REFIDs and codes that will be retained in the updated hRTM MapToAWAY Deprecated (#) -10101:2004 MDC_AWAY_ airway gas REFIDs mapped to MDC_CONC_AWAY, according to Table A.7.4.9 in -10101a. MapToGASDLV Deprecated (#) -10101:2004 MDC_VENT_AWAY, MDC_VENT_CONC_AWAY and MDC_VENT_CONC gas delivery REFIDs mapped to MDC_CONC_GASDLV according to Table A.7.4.9 in -10101a. TempPart0a Five (5) proposed hRTM terms with temporary CF_CODE10 assignments in partition 0. UnifiedECG MDC_ECG_AMPL_ST_* REFIDs with temporary CF_CODE10 assignments in partition 0. Attribute Existing -10101:2004 attribute REFIDs and codes that will be retained in the updated hRTM (3) UnaccountedNZ Existing -10101:2004 term (1) – a single term that fell out of rule set used for mapping.   AddNew More than 240 new -10101a terms beyond what was needed for hRTM. View hRTM10101aMapping.1d.2015-11-30T12.xlsx

Updated hRTM2 co-constraints The hRTM2 co-constraints (units, enums, sites) have also been updated. View hRTM2exp.3c.x1c.2016-01-11T14.html 1. Deploy unit, enum and site _groups and verify against NIST hRTM REFID Missing nist nist UOM_MDC exp UOM_MDC MDC_AREA_BODY_SURF_ACTUAL MDC_DIM_SQ_X_M MDC_DIM_SQ_M MDC_EEG_NUM_SPK MDC_DIM_PER_MIN MDC_DIM_DIMLESS MDC_TIME_PD_EXP MDC_DIM_X_SEC MDC_DIM_X_SEC MDC_DIM_MILLI_SEC MDC_DIM_SEC MDC_DIM_MILLI_SEC MDC_TIME_PD_INSP MDC_CONC_MAC MDC_DIM_DIMLESS (allow?) MDC_DIM_PERCENT MDC_VOL_MINUTE_AWAY_EXP MDC_DIM_L MDC_DIM_MILLI_L_PER_MIN MDC_DIM_L_PER_MIN MDC_DIM_L_PER_MIN MDC_DIM_MILLI_L_PER_MIN MDC_CAPAC_VITAL DIM_MILLI_L MDC_DIM_L DIM_MILLI_L MDC_DIM_L MDC_DIM_MILLI_L 2. Add ‘bar’ and ‘mbar’ to UoM _groups and individual terms (verifying)

New Terminology Extensions

IEEE P11073-10101b [PAR approved] Extends ISO/IEEE Std 11073-10101:2004 and -10101a-2015: Infusion pumps and infusion events (IHE PCD PIV and IPEC) Ventilator mode, high-frequency ventilation, annotations NMT Neuromuscular transmission (level of neuromuscular block) Finalize the WCM waveform attributes (or just use aECG) IHE PCD Device Management Control (DMC) IHE PCD Real-Time Location Services (LS) Generalized Signal Quality Index Dialysis Surgical and OR devices Additional observation identifiers and settings Note: Inclusion of content in draft standard is contingent on timely completion.

IEEE P11073-10103a [PAR approved] Extends IEEE P11073-10103:2012 Implanted Devices Cardiac New IDC term codes, extending IEEE P11073-10103:2012 Likely support for EGM waveforms.

IEEE P11073-10101c IHE PCD Rosetta identifiers for Events, Alerts and Alarms

EXTRA SLIDES

IEEE P11073-10101a Annex A Annex A (normative) Nomenclature Semantics 4 A.5 Nomenclature, data dictionary, and code extensions for vital signs devices (Block A) 5 A.6 Terminology and code extensions for units of measurement (Block B) 8 A.7 Nomenclature, data dictionary, and codes for metrics (measurements and enumerations) (Block C) 14 A.7.3 Nomenclature and code extensions for hemodynamic monitoring measurements 14 A.7.4 Nomenclature and code extensions for respiratory, ventilator and anesthesia measurements 17 A.7.4.18 Gas concentration and partial pressure measurements 17 A.7.4.19 Inspiratory breath type classification 19 A.7.4.20 Nomenclature and code table 21 A.7.4.21 Nomenclature and codes for nebulizers 62 A.7.5 Nomenclature, data dictionary, and codes for common blood-gas, blood, urine, and other fluid chemistry measurements 64 A.7.8 Nomenclature, data dictionary, and codes for neurological monitoring measurements 66 A.7.11 Nomenclature and code extensions for miscellaneous measurements 68 A.7.11.7 Body Weight and Surface Area 69 A.7.12 Nomenclature and code extensions for infant incubator and warmer microenvironments 70 A.7.13 Nomenclature and code extensions for personal health devices 72 A.8 Nomenclature, data dictionary, and codes for body sites (Block D) 72 A.8.4 Sites for EEG-electrode placement on the head 76 A.11 Information attributes to support IHE PCD DEC and PCHA Continua WAN 77 A.11.1 Information attributes to support IHE PCD Alert Communication Management 77 A.11.2 Infrastructure attributes to support PCHA/Continua WAN and IHE PCD DEC 77 A.11.3 Information attributes to support PCHA/Continua WAN 78 A.11.4 Information attributes to support IHE PCD DEC and PCHA/Continua WAN timekeeping 79 A.11.5 Information attributes to support semantics defined by this standard 81

IEEE P11073-10101a Annexes C-G Annex C (normative) Terms and Codes 82 C.1 Overview 82 C.2 Discriminator Sets 82 C.3 Terms and Discriminators 84 Annex D (informative) Breaths and Inflations 101 Annex E (informative) Respiratory, Ventilator and Anesthesia Reference ID Naming Conventions 103 Annex F (informative) Anesthesia Ventilation and Breathing Circuits 105 F.1 Bellows driven on expiratory side 107 F.2 Piston driven on inspiratory side 108 F.3 Mapleson circuits 109 Annex G (informative) Bibliography 111

IEEE P11073-10101a/D4 Table A.7.4.8 Respiratory, Ventilator and Anesthesia observation and setting identifiers   Respiratory Rates – method specific Ventilator Respiratory and Inflation Rates Phase and Time Intervals Airway Measured Flow Ventilator Measured Flow and Settings Tidal volume (airway and ventilator) Minute volume (airway and ventilator, units = volume/minute) Minute volume (Adaptive Support Ventilation: Reference, Percentage and Target) Other volumes Airway and other pressures Ventilator and airway pressures Pressure Limits Pressure risetimes Plateau pressure Resistance and compliance PEEP Apnea Patient-ventilator synchronization Metabolics Work of Breathing (WOB) Inspiratory Pressure-time Product (PTP) Tube Compensation Miscellaneous Ventilator Mode Agents and Gases Gas identification and selection Gas concentrations and partial pressures Nebulizer Topics shown with black font were added or augmented during balloting phase

Term Co-Management Issues with PHD Root cause is lack of a single authoritative repository for both PoCD and PHD terms PoCD uses RTMMS, spreadsheets and MS-Word (in draft standard) PHD uses MS-Word, #defines and spreadsheet maintained by co-chairs Difficult to keep synchronized! Six ACM attribute code conflicts with existing PHD caused delay from October to December RevCom; timing is critical for IHE Connectathon! NIST RTMMS would be perfect choice for PoCD and PHD to use Single numeric code generator and repository to guarantee non-overlap Preliminary agreement by PHD co-chairs to use RTMMS (Paul facilitates) Update methods Method 1: Standard RTTMS term entry after initial bulk upload (preferred). Method 2: For an interim period, periodic bulk uploads with term conflict detection with terms already in RTMMS (aligned with current PHD term workflow).

PHD REFIDs and codes alone are insufficient Phase 1: Need other Rosetta co-constraints: units, enumerations, measurement sites and other information: Essential: Reference ID, Disc, Part::Code [CF_CODE10 calculated] also used to create refid[disc]code 3-tuples Source: specifies term source, e.g. 11073-10424-2014-Cor1-D1 Co-constraints: units, enums, sites The Disc and Source attributes would be added to the existing NIST RTMMS as additional columns. Phase 2: PHD device specializations MDC_DEV_SPEC_PROFILE_* and containment/content models would be captured separately, as a computable representation based on Continua WAN Annex J (differences between WAN and PHD would be noted).

Making things easier ... Confirmed that REFIDs have unambiguous mappings to numeric codes (only four exceptions found) facilitating documentation using only Reference IDs. REFIDs are only associated with a single numeric code (by design) whereas a numeric code may have multiple ‘REFID-synonyms’. Allows codes to be filled on an ‘as needed’ basis in documentation. The NIST RTMMS excellently supports REFIDs, codes, units, enumerations, and measurement sites, facilitating transfer of PHD information into RTMMS. This will help significantly align PoCD and PHD efforts. As noted previously, Continua WAN ‘Annex J’ and later have containment tables for many PHD devices as sent over the Continua WAN (which is based on IHE PCD DEC).

IEEE P11073-10101a Collaborations NIST RTMMS, IHE PCD Rosetta and IEEE 11073 working group ISO/TC121/SC4 (ISO/CD 19223 working group) Dr. Norman Jones (Technical chair, ISO 19223) Dr. Steven Dain (Chair ISO 19223, anesthesiologist, editor for IEC 60601-1-8 Ed 1) Dr. John Walsh (anesthesiologist at Partners) HL7 GAS SIG Dr. John Walsh (HL7 GAS SIG chair, anesthesiologist at Partners) NIH/NLM/LHC and Regenstrief (Mapping IEEE 11073 to LOINC) Drs. Clem McDonald, MD, and Swapna Abhankar, MD THANK YOU for your expertise and guidance!

Paul receives IEEE-SA Standards Medallion Award! Paul Schluter receives the IEEE-SA Standards Medallion from Bruce Kraemer, IEEE-SA President Press release: IEEE Standards Association (IEEE-SA) Awards Distinguish Outstanding Contributions in Standards Development For leadership in the creation and support of innovative and internationally recognized medical device informatics methodologies, particularly nomenclature and related development tools.