IEEE P11073-10101* Updates IHE Patient Care Devices Face-to-Face Boca Raton, FL October 20-22, 2015 Paul Schluter, GE Healthcare

IEEE P11073-10101a Status IEEE P11073-10101a/D5 passed recirculation ballot with a 100% affirmative vote and 85% response rate (corrected six IHE PCD ACM numeric codes). IEEE-SA RevCom review now rescheduled for December 2015, with anticipated approval on December 5th and publication possibly as early as December 9th. Plan to facilitate upload of new terms to NIST RTMMS at the earliest possible date, with wider disclosure when permitted by IEEE-SA (hopefully on or around December 10th). Key question: Will this be early enough to allow testing with the NIST RTMMS, NIST test tools and IHE NA Connectathon during January 25-29, 2016?

IEEE P11073-10101a transfer to RTMMS IEEE Std 11073-10101a Annex A and Annex C will be available as ‘simple and computable’ XML for IEEE distribution. Annex A tables will include html markup <i>, <b>, <s>, <u>, <sub>, <sup> and <br> to show formatting and text changes (and footnotes?). Will also specify discriminator information for each term: [MMM] Statistical Discriminators {2 bits} dOffset dSuffix dDescription   {base measurement} or not specified  1 _MAX  maximum value observed over an interval  2 _MIN  minimum value observed over an interval  3 _MEAN  mean value observed over an interval  Reference ID Disc Part::Code CF_CODE10 MDC_SAT_O2_DELIV_INDEX MMM 2::19596 150668 MDC_PRESS_BLD_VEN_FEMORAL SDM 2::19604 150676 MDC_PRESS_BLD_ART_BRACHIAL 2::19608 150680 MDC_TTHOR_HEART_RATE RCE 2::18482 149554

refid[disc]code 3-tuples Provides unambiguous method for expanding REFIDs with all discriminator variants and numeric codes Essential for automatic REFID and code generation Fully automatic, but aware of existing code blocking conventions Semi-automatic, with editorial oversight regarding conventions Essential for automatic REFID and code conflict detection Can support REFIDs and codes ‘as is’ with or with discriminators! Reference ID Disc Part::Code CF_CODE10 MDC_SAT_O2_DELIV_INDEX MMM 2::19596 150668 MDC_SAT_O2_DELIV_INDEX_MAX 2::19597 150669 MDC_SAT_O2_DELIV_INDEX_MIN 2::19598 150670 MDC_SAT_O2_DELIV_INDEX_MEAN 2::19599 150671

Updating hRTM with 10101a terms The ‘harmonized’ Rosetta (hRTM) terms contains existing terms, terms that require a numeric code, new terms and obsolete and deprecated terms. Their disposition will be documented as shown below and updated hRTM tables will be generated. Existing NIST RTMMS hRTM Terms Action Updated NIST RTMMS hRTM Existing -10101:2004 terms in hRTM RetainedAs Retained with UoM, enum, site info New -10101a terms in hRTM AssignCode New -10101a terms not in hRTM AddNewTerm Added, determine UoM, enums, site info Proposed hRTM 0^PP/Conc terms not in -10101a Obsolete Not transferred (shall not be used) Deprecated -10101:2004 terms (identified by #) Deprecated Not transferred (use strongly discouraged)

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!

Term Management Issues

Term Co-Management Issues with PHD Root cause of term code conflicts was the 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 (apply to PoCD, PHD, IHE PCD and Continua) 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).

Assigning numeric codes ... All parties using RTMMS would like the ability to rapidly assign REFIDs and numeric codes for new terms ... but this should only be done when the new terms (and containment models) are relatively mature (avoid defining numerous junk terms). If a term is not progressed to an IEEE 11073-10101* standard, then the numeric code must be deprecated for several years or possibly forever (the latter is the safest policy). Ideally, all parties (PoCD, PHD, IHE PCD, PCHA/Continua) would benefit from a short period of time to define their content models and nomenclature before assigning numeric codes.

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. 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). This will help significantly align PoCD, PHD, IHE PCD and PCHA/Continua WAN nomenclature definition efforts.

New Terminology Extensions

IEEE P11073-10101b [PAR submitted] Extends ISO/IEEE Std 11073-10101:2004 and IEEE P11073-10101a. PAR accepted for IEEE-SA NesCom review in December 2015. Infusion pumps and infusion events (IHE PCD PIV and IPEC) Ventilator mode, high-frequency ventilation, breath-by-breath annotations NMT Neuro-muscular transmission 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 Additional observation identifiers and settings

IEEE P11073-10103a [PAR submitted] Extends IEEE P11073-10103:2012 Implanted Devices Cardiac PAR accepted for IEEE-SA NesCom review in December 2015. 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