Future Pathology Information Standards!

Jay Kola, Karen Mitchell,NHS Digital

03/05/2019

Status of on-going work and Next Steps!

WhyPathology/LabMedicineInforma8onStandards?

ClinicalFocus-Scope&Background

•  PartoftheNa+onalCCIOPriori+esforEngland•  ‘Abilitytosharebasicpathologyresults’

– Tosharepathologyresultsseamlessly,weneedinforma+onstandards

•  ‘Basicpathology’definedas•  Clinicalchemistry•  Haematology

•  Workscopedfor1styear,withpossiblefurtherextensionplannedfor3-5years.

Whatarethebenefits?

Standardsareeverywheretomakeinteroperabilitywork,especiallyinthedigitalspace:Someareplanned,someareunplanned–whoisaffectedbytheneedtochange?•  Manufacturers=LIMSsuppliers•  Users=Informa+cians,Coders,BMS,pathologists•  Training=Userawareness

Benefits!•  Building EHR/EPR/LIMS

•  Combining data

•  Sharing common LIMS

•  Centralised reporting of results

Professionals Clinicians

Patients

•  Comparing patient data from multiple sites

•  Identifying different methodologies

•  Understanding results

•  Comparing results

•  Comparing and combining data nationally and internationally

Research

England-Vision&Standardsframework

•  Interoperabilityisthefocus•  SecretaryofStateannouncement

– Vision– DraYNHSDstandardsframework

•  UTL(asubsetofSNOMEDCT)•  FHIR•  UCUM

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Ourapproach

Whatarewetryingtocreate?

•  MessageWrapper

•  UnitsofMeasure

•  Value

•  Codes

HaemoglobinLevelCode

LowQualita+veValueQuan+ta+ve 80

UoM g/dL

g/L

Transferclinicalstatementà Haemogloblinlevelof80g/L

DesignPrinciples•  Labmedicineneeds‘informa+onstandards’

– Morethanjustcodes!•  Codesshouldprovide

–  Clinicalcontext&be+edtoclinicalusage– Unambiguousmeaning

•  Uniqueiden+tyfortest/result– Abilitytosa+sfysecondaryuses

•  Grouping/categorisa+onoftests/results•  Mustworkinconjunc+onwith‘informa+onmodel’

–  Ideallyagnos+cof‘flavouroftheday’

Workstreams1.  UnifiedTestList(UTL)–astandardisedcollec+on

oftestnamesinSNOMEDCTthatcanadoptedacrossNHS

2.  UnitsofMeasure(UoM)–standardisedrepresenta+onofunitsofmeasureassociatedwithresults

3.  Informa+on/DataModel–representa+onoftestrequestsandresults

4.  MessagingSpecifica+on–aFHIRbasedinteroperabilityspecifica+onfortransferofrequests&results

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Anover-simplifiedrepresenta8on

Informa8onFlows

•  Requests– Coun+ng/Accoun+ng

•  Processingwithinlabs–  Internaltolabs– Na+veadop+onofcodes?– Howmuchdoweneedtoknow…?

•  Results– Clinicalinterpreta+on,trends,analysis

Implementa8onApproach

Clinical Standards -

UTL!

Data Standards - FHIR Spec!

Data Standards - Units of Measure!

FHIR Curation - validation!

Approved FHIR profile -

Messaging Spec!

First of Type Testing!Feedback!

Use

cas

es! PRSB,

INTEROPen, PINUG, RCPath

LCHREs - Manchester GDEs - Cambridge

NPEx

Prim

ary

Car

e, S

econ

dary

Car

e,N

HSE

, NH

SI,

Agile - Informatics driven blue print

Planforspecial8es

Haematology/ClinicalChemistry

DataModelsUnitsofMeasureFHIRspecifica+onsCodelists/catalogues

Microbiology

Extend/NewDataModelExtend/NewFHIRspecCodelist/catalogue

Histopathology

Extend/NewDataModelExtend/NewFHIRspecCodelist/catalogue

Buildinforma+csprinciplesfirst,thenextendthemtootherspeciali+es….

Progresstodate?

Unified Test List!

Units of Measure!

Information Model!

UnifiedTestList-Whatisit?

•  AlistofSNOMEDtermsforlabtestreports•  Acodedlisttobeusedinmessagesoronscreenstodescribeameasurementresult

•  SNOMED‘observableen+ty’type•  ‘BloodSciences’content•  Contentfortes+ng:currently350codes•  Forpublica+onasdraYin2018/19

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SNOMED Model + Information Model !

!Test

NameSNOMED Attribute Model (‘observable entity’ type)

Message Model (FHIR) (relative to SNOMED model)

SNO

MED

Ter

m

C

OM

PON

ENT

su

bsta

nce

etc.

be

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mea

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PR

OPE

RTY

Con

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ins

UoM

fiel

d

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IREC

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spec

imen

Sc

ale

Type

cons

train

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sult

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ow

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elat

ive

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nd c

ompo

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atio

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UoM

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Patie

nt/ S

peci

men

Pre

cond

ition

Ref

eren

ce R

ange

Ale

rt

REPORTED RESULT VALUE FROM TEST: n

UnifiedtestList:Whatisit?–(2)

Crea8ninesubstanceconcentra8oninserum(substance+property+specimen)

Crea8ninesubstanceconcentra8oninserumbyenzyma)cmethod’(substance+property+specimen+method)

Aldosteronemassconcentra+oninplasmaNeutrophilpercentcountinbloodLipaseenzymeac+vityinserum

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UnifiedTestList(UTL)-Tac8cal•  Done

–  Builta350SNOMEDCTcodescreated•  Note~3,000alreadyexistinSNOMEDCT(PBCL)

–  BuiltadraYgenericSNOMEDanribute/valuesettomodelthesecodesinawaythatalignswithinforma+on/datamodelsandcurrentcoding

•  Planned–  Formalisedesign&editorialguidance–  Formalpublica+onof350listinJune2019SNOMEDCT

release–  Scaleupthebuild/previewcycleandpublica+onof

expected3-5kfulllist(minimumviableproduct)byOct2019

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Benefits for:!Professionals

Allows interoperability of data for primary (clinical) and secondary uses with less manual intervention

•  Sharing data

•  Comparison of data

•  Building new systems

•  Centralised reporting

25 hydroxy vitamin D!

25 OH Vitamin D!

Vitamin D!

25-OH Vitamin D!

SNOMED ID (draft) SNOMED Term (Preferred Term)!

1110381000000103 Total 25-hydroxyvitamin D (D2 and

D3) substance concentration in serum!

Benefits for:!Clinicians

Comparison of results performed at more than one lab. Part of standards for patient records Easy to view trends in results Single test name

Benefits for:!Patients

Single test name Improves understanding of results and disease Visible on patient portals Encourages patient engagement and involvement in disease management Ability to research condition online

Benefits for:!Secondary uses

•  Activity comparison •  Local / STP •  National

•  Centralised reporting •  Renal Registry •  Cancer outcomes •  Microbiology surveillance

Research

•  National & International collaboration and data sharing

UnifiedTestList-Strategy

•  UKProfessionalendorsement–  PlannedforQ22019

•  On-goingmaintenance–  ToalignwithSNOMEDCTgovernancemodel–  Editorial/Governancegroup–representa+onfromclinicians,professionalbodies,informa+cians,etc

•  Alotofsupportforourworkfrominterna+onalpartners–  Sweden,Denmark,Norway,NewZealand

UnitsofMeasure–Context

•  Why?–  Integralpartofresultsinabloodsciences(&lotofother

disciplines)–  ClinicalsafetyimpactwhenUnitsofMeasurearen’t

comparablebetweentests•  Context

–  LaboratoryStandardisedRepresenta+on(LSR):ApreviousdraY‘collec+on’ofUoMsexisted–basedonworkdone~10yearsago

–  LSRhasnotbeenupdated;gaps,qualityissues–  Primarilyproducedasanartefactfor‘humanconsump+on’.

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x10^9/L! IU/L!

x_10^9/L! iu/L!

_10*9/L! iu/_L!

Current UoM variations!

•  Review of LIMS units of Measure compared with LSR/IUG

•  Some mismatches are NOT computer readable but still human readable

UoM-Tac8calDone

1.  Newversion&representa+oncreated–InterimUnitsGuide(IUG)2.  Externalreview(inprogress):4Trusts,3s/wVendors

1.  Posi+vefeedback&interestfromUKcommunity,includingsuppliers.

Findings

1. UoMsascodes-notalwayssuitableforcomputa+onaluse1.  Conversionofunitsisanissue

2.  Currentsystems(e.g.LIMS)verylimited,andlimita+onsdiffer1.  Valueincrea+ngbotha‘humanreadable’&‘computable’

representa+onofunits.

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UoM-Strategic•  HumanreadabilityvsMachinereadability

–  Ensuringthatunitsarereadablebyhumans(e.g.superscripts)–  Ensuringunitsarecomputable

•  RoleforUCUM•  Governance

–  Notallunitsare‘clinical’–mostarejustscien+ficunits–  ‘Recommendedunits’foragiventest–clinicalinputneeded

•  MakingitworkwithSNOMEDCT-Oneapproach–  BaseunitsandcommonunitsrepresentedinSNOMEDCT–  Otherrepresenta+onsoverlaidonSNOMEDCTasnew

‘descrip+onType’!•  ‘machinecomputable’representa+on•  ‘rendering/display’representa+on

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Information Model

•  A logical representation of the information about a lab request or result. Contains elements and attributes. –  Status of request –  Priority of request –  Date of the result, etc

•  The objective is to ensure the model is generic enough to cater for use across health & care –  covers both primary and secondary care.

•  This allows the model to be ‘mapped’ to corresponding structures (attributes) in messaging models –  e.g HL7 V 2.x, PMIP-EDIFACT, HL7 FHIR, openEHR

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Information Model – (2)

•  The new information model –  Is driven by clinical needs –  Mirrors clinical processes –  Intended to cover the whole cycle from report to action

in the future •  The Information model has validated based on

clinical scenarios, FHIR curation, PRSB review. •  Current work covers results only – acknowledging

a reference to ‘request’ will be part of a result.

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Information models - Result

Information models - Request

Requests are not part of this sprint

Information models – broader context

Model includes context: -  Indication for a Request -  Clinical Recommendation/action based on a Result

MessagingStandards-FHIR•  Cliniciansshouldneverhavetoknowaboutthemessagingstandards…J

•  Butpeopleaskwhy?– Neededforinforma+onflows–interoperability–  CurrentUKlandscape

•  PMIP-EDIFACT(current,ageingstandard)•  HL7V2–usedinsecondarycare

–  FHIRisstrategicdirec+onoftravel•  Beingadoptedbyna+onalprogrammes&interna+onalsuppliers

FHIRSpecifica8on-Tac8cal•  Benefits

–  Ensuresinforma+onis‘interoperable’betweendifferentsystems

–  Futureproof•  Basedonthe‘generic/logicalinforma+onmodel’

–  Sonot+ghtlycoupledtojustFHIR•  FHIRProfiles/Specifica+onspublished•  Interestinadop+onfrom

–  Supplierengagement+FirstofType–  InterestfromNHSSitestouse…

Timelines2018/19Date Milestone

Oct 2018 Early version of the Units of Measure landscape and proposal

Oct 2018 Limited, Alpha version of Unified Test List available for review

Oct 2018 Start of curation process for FHIR Specification

Dec 2018 Share early draft of the Unified Test List

End of Dec 2018 Publish version 0.0.1 of UTL, Units of Measure

March 2019 Publish early draft of v 0.0.1 of FHIR spec

End of April 2019 Publish version 1.0.0 of UTL, FHIR spec, Units of Measure & corresponding APIs

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NextSteps

Whatnext?•  Wewillcon+nueto:

–  Extendworktootherspeciali+es•  Microbiology

–  FirstofTypetest•  Feedsintoimprovementsofcurrentwork

–  RobustSNOMEDCTbasedsubsetforLabmedicine•  Publish&Share

–  ExtendGenericInforma+onModel

–  Publish&Share

Communica8ons&Collabora8on•  NHSDwillco-developspecifica+onswithALBsandthecommunity–you!– NHSDwillunilaterallytellyouwhattodo;–  FHIRcura+onisvalida+on,butweneedmorevalida+onin‘firstoftypetes+ng’!

•  Collabora+vesiteforsharingdraYdocuments,feedback,comments–seelastslide

•  Inputfromcommunity–  Landscapetoocomplicatedtohaveasinglemodelforengaging,implemen+ng,etc

– Weneedvolunteersfromyou

Collabora8ontodate

•  NHSE&NHSIarequitesuppor+veofthestandardsbasedapproach–  Coversaccoun+ngandanaly+csneeds– UsefulforNHSIPathologymodernisa+on

•  RoyalCollegeofPathologists,NPL,etc– Quitesuppor+ve

•  Con+nuetoengagewith‘pilotsites’(growinglist)– NWIS(Wales),Scotland,GreaterManchester,Cambridge,Leeds,…

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Collabora8on-Interna8onal•  Ourexperienceteachesusthatproblemsare‘labdomain’

related–notuniquetocountries–  Clinicalusecases&Businesscasesaresimilarusually

•  Seeourclinicalscenariosbasedapproach–  Opportunitytoadopt/alignapproachesbetweencountries

•  USProposalfor‘interoperablelabOWLrefset’•  Implementa+onpanerns&guidanceseemobvious

•  Presence/absenceof‘X’•  ‘TestGroups’/Panels/Baneries•  Associa+onbetweenrequests(procedures?)andresults(observables?)…

•  UnitsofMeasurearebroaderthanjustLabMedicine

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Ques8ons?

•  Collabora+veworkspace–  hnps://hscic.kahootz.com/connect.+/PathologyandDiagnos+cs/grouphome

•  Genericcontactemail:–  pathologyanddiagnos+cs@nhs.net

•  Mycontactdetails–  jay.kola1@nhs.net–  hnp://uk.linkedin.com/in/jaykola