spia and pitus - aacb

SPIA and PITUSStandards for Pathology Informatics in Australia &

The Pathology Terminology, Information, Terminologyand Units Standardisation Project

Michael LeggPhD FFSc(RCPA) FAICD FIML FACHI

Chair, PITUS Steering Committee

1

2

In the interests of disclosure…

26-May-2017

Contents

7 May, 2019

(Ancient) History of PI in Australia• 1969 Medicheck, ,Shepherd & Preventicare

– Transmission of first pathology reports to GP withIBM Call 360 by Preventicare

• 1973, 1986 RCPA SI Units• 1993 AACB Uluru ’93 Informatics, The Future of

Laboratory Medicine– PIT developed; Internet transfer of report

• 1996 SA IT-14-6-5 established to decide on Edifact,HL7 or PIT

• 1998 AS4700.2, NPAAC Guidelines for DataCommunications

Diagnostic Error• Harm is being done and potential wellness lost because of

medical errors• Efforts to fix this have largely been unsuccessful and have

led to a recent focus on diagnostic error• Diagnostic error is significant but under-appreciated• We can probably go a long way to improving with focus• Pathology and radiology are critical players in diagnosis but

their errors are mostly at the interfaces and informationrelated

12

Real harm is done by information errors

NPAAC• “the breakdown in the transfer of information

or communication has been identified as one ofthe contributing factors in serious adverseevents and is a major preventable cause ofpatient harm”

14

Much harm is done• It is unacceptable to continue to do so much

harm• US Post-mortem examination shows diagnostic

errors contribute to ~10% of patient deaths• In Australia that means 7 times the road toll!

35/100k/yr VS road toll of 5/100k/yr

15

US IoM 2015

• “Without a dedicated focus on improvingdiagnosis, these errors will likely worsen as thedelivery of health care and the diagnosticprocess continue to increase in complexity”

16

Interventions

18

Standardisation

• Is to reduce variation• To be useful it must

• save money,• save time and/or• improve health outcomes.

• It is required for affordable interoperability

19

Why standardise?

Clinica Chimica Acta 15 May 2014 Volume 432

Messaging

Legg M. Standardisation of test requesting and reporting for the electronic health record. Clin ChimActa. 2014 May 15;432:148-56

Standardisation• Standards can come about by:

• Consensus• Defacto• Legislation• Hijacking

22

26-May-2017

19-Nov-2018

Standards for interoperability

• Transmission of data• Identification policies• Information structures• Common terminology• Common understanding• Behavioural agreement

25

26-May-2017

Contents

7 May, 2019

Steering Committee meeting -24 November 2016

Participants

Terminology

• The standardisation of pathology terminology and unitsin Australia is desirable and achievable.

• No single existing terminology will be sufficient.• Having well-developed subsets of terms will improve

conformance, compliance and efficiency.• A high level of knowledge and familiarity with the

practice of pathology is required to develop andmaintain these subsets.

• All standardised pathology terminology and associatedunits should be available in one place.

29

26-May-2017

Requesting• SNOMED is to be used as the preferred terminology for

requesting pathology• SPIA uses the NPAAC format expecting in due course it

will become part of the NPAAC standard set.

31

Requesting

32

SNOMED CT-AU

Synthesis and overviewTumour stageT classification

pTX Waitng on new SNOMED codepT0 Waitng on new SNOMED codepTis Waitng on new SNOMED codepT1 373200003 |pT1: Tumour invades submucosa (colon/rectum)|pT2 395706002 |pT2: Tumour invades muscularis propria (colon/rectum)|pT3 395707006 |pT3: Tumour invades through the muscularis propria into

the subserosa or into non-peritonealized pericolic or perirectal tissues(colon/rectum)|

pT4a 384612007 |pT4a: Tumour directly invades other organs or structures(colon/rectum)|

pT4b 384613002 |pT4b: Tumour penetrates visceral peritoneum(colon/rectum)|

Reporting

• Codes for terms used to report pathology tests at thehighest level (the first question) in Australia must comefrom LOINC.

• Codes for terms used to report the answers to pathologytests should, wherever possible, come from wellmaintained and recognised international terminologies.SNOMED should be the first choice and used where it isadequate.

34

LOINC

http://search.loinc.org/Colorectal Cancer Report Information Model TerminologyRCPA Preferred term RCPA code LOINC Component Property Timing System Scale MethodSynthesis and overview 17.02.28253 70949-3 Pathology report.section heading - Pt XXX NomTumour stage (AJCC 2010) 17.02.28204 70949-3 Pathology report.section heading - Pt XXX Nom

T classification 17.02.28210 21899-0 Primary tumor.pathology Prid Pt Cancer.XXX NomN classification 17.02.28220 21900-6 Regional lymph nodes.pathology Class Pt Cancer.XXX NomM classification 17.02.28552 67211-3 TNM pathologic staging - distant

metastases - MFind Pt ^Patient Ord PhenX

Stage group 17.02.28243 21902-2 Stage group.pathology Class Pt Cancer.XXX NomYear of publication and edition of cancer stagingsystem

17.02.30004 67203-0 AJCC cancer staging manual Find Pt ^Patient Nom PhenX

Residual tumour status 17.02.28317 LN-RCPA-00084

Residual tumour status Find Pt Specimen Nom

Diagnostic summary 17.02.28842 22637-3 Path report.final diagnosis Imp Pt Specimen Nar

New primary cancer or recurrence 17.02.28472 21983-2 Recurrence type Type Episode^frst

Cancer.XXX Nom

Regional (local) recurrence or Distant metastases 17.02.30005 LN-RCPA-00065

Regional recurrence or distantmetastasis description

Find Pt ^Cancer Nar

Overarching comment 17.02.28252 22638-1 Path report.comments Imp Pt Specimen Nar

Tests not to be combined in reports

• Combining data from what appears to be the same test intime series for a subject such as in cumulative reports orgraphs carries with it significant clinical risk and should onlybe done after that risk has been properly assessed

• This can be due to different methods being used, changes toreagents for the same method and/or different clinicalconditions.

• This variation in results means caution is required whengrouping results from different laboratories, differentmethods or over time for research or other statisticalpurposes

36

Tests not to be combined in reports

• Tests that have method-dependent terms and codes in thereport terminology reference sets (Report Set) must havethe appropriate code applied.

• Tests that have a ‘Combining Results Flag’ with the value of‘Red’ or ‘Orange’ must NOT be shown as the same test insequential display whether by graph or cumulative reportingif they come from different laboratories.

• Tests that have different LOINC codes must NOT be shown asas the same test in sequential display whether by graph orcumulative reporting.

37

Preferred Terms

• Australia has its own preferred terms and there are rulesfor their development

• The terms used in Australia should reflect commonusage but be consistent and safe.

• The terms should also be practical and capable of readyimplementation.

38

Units• The standardisation of units of measure used for reporting

pathology in Australia is desirable and achievable• A single, test-specific, standardised unit of measure is preferred

for use in reports from pathology laboratories• Units should be represented in electronic messages in such a way

that receiving systems can readily convert units under the clinicalgovernance of the receivers - The Unified Code for Units ofMeasure (UCUM) is to be used as the logical representation ofunits of measure in electronic messages

• Numeric results should always have the appropriate unitsassociated with them and they should never be displayed withoutthem

39

Units

40

Report rendering• 2013 Survey of laboratories showed wide variation in

reporting (114 responses, 35 reports)• 2014 Survey of report recipients (403)

• More than 90% of respondents supported standardisation of:• Time direction for columns on a cumulative report (left or right)• Highlighting of latest results in cumulative reports• Flagging of results• Time direction for rows (up or down).• A further 80% supported the standardisation of the position of

reference and units columns.

41

Report rendering• 2013 Survey of laboratories showed wide variation in

reporting (114 responses, 35 reports)• 2014 Survey of report recipients (403)

• More than 90% of respondents supported standardisation of:• Time direction for columns on a cumulative report (left or right)• Highlighting of latest results in cumulative reports• Flagging of results• Time direction for rows (up or down).• A further 80% supported the standardisation of the position of

reference and units columns.

42

Report rendering• Missed or misunderstood test results as the consequence of

poor rendering on paper or screen are as dangerous topatients as lost or wrong results.

• The intention is not to stifle innovation in presentationthrough standardisation and so only those aspects ofrendering where there is a concern around safety and broadsupport for standardisation were considered.

43

Report rendering• Numeric results are incomplete without associated units and

guidance for interpretation (eg reference intervals) and sothese must always be shown with the number.

• Guidance values may be reference intervals, healthy limits ortherapeutic ranges depending on the test.

• Guidance values should be in the context (clinical history) ofthe subject of the report where this context is known andrelevant.

• Because errors are known to be made in reading andinterpreting numbers and risk is reduced with consistency itis appropriate to standardise aspects of their presentation.

44

Rendered report features

7 May, 2019

TimeDirection

Headerand

bolding Box

Latestresultsindictor

Result flag“L” or “H”

Adult Reference Intervals

26-May-2017

Australasian Adult Reference Intervals - Chemical Pathology

Analyte Age Reference Interpretation of age(days)

Interpretation ofreference (units)

Sodium

(LN-RCPA: 2951-2)

Potassium (LN-RCPA: 2823-3)

See note 1Chloride

(LN-RCPA: 2075-0)

Bicarbonate

(LN-RCPA: 1963-8)

Creatinine(LN-RCPA: 14682-9) 19y to <60y (60–110) umol/L 6574 ≤ d ≤ 43829 60 ≤ x ≤ 110 umol/L

See note 2

19y to <60y (45–90) umol/L 6574 ≤ d ≤ 43829 45 ≤ x ≤ 90 umol/LCalcium

(LN-RCPA: 2000-8)

Calcium corrected foralbumin

(LN-RCPA: 29265-6)

Phosphate

(LN-RCPA: 14879-1)

Magnesium

(LN-RCPA: 2601-3)

Lactate dehydrogenase

(LN-RCPA: 14804-9)See note 3

Alkaline phosphatase

(LN-RCPA: 6768-6)

Total Protein

(LN-RCPA: 2885-2)18y to <120y (60–80) g/L 6574 ≤ d ≤ 43829 60 ≤ x ≤ 80 g/L

18y to <120y (22–32) mmol/L 6574 ≤ d ≤ 43829 22 ≤ x ≤ 32 mmol/L

22y to <120y (30–110) U/L 6574 ≤ d ≤ 43829 30 ≤ x ≤ 110 U/L

20y to <120y (0.75–1.50) mmol/L 6574 ≤ d ≤ 43829 0.75 ≤ x ≤ 1.50 mmol/L


18y to <120y

18y to <120y (95–110) mmol/L 6574 ≤ d ≤ 43829

135 ≤ x ≤ 145 mmol/L

95 ≤ x ≤ 110 mmol/L

18y to <120y (135–145) mmol/L 6574 ≤ d ≤ 43829

3.5 ≤ x ≤ 5.2 mmol/L6574 ≤ d ≤ 43829(3.5–5.2) mmol/L

Male

Female

18y to <120y (120–250) U/L 6574 ≤ d ≤ 43829 120 ≤ x ≤ 250 U/L



Harmonised adultreference limits for 11analytes

Developed by AACBHarmonisation Committee

Agreed by thepathologists and scientistsattending the AACBHarmonisation workshopon 29-30 April 2014

Paediatric Reference Intervals

7 May, 2019

Harmonised paediatricreference limits for 9analytes

Developed by AACBPaediatric BiochemistrySIG group

Agreed by thepathologists andscientists attending theAACB Harmonisationworkshop on 29-30 April2014

Australasian Paediatric Reference Intervals - Chemical Pathology

Analyte Age Reference Interpretation of age(days)

Interpretation ofreference (units)

Sodium 0d to <1w (132–147) mmol/L 0 ≤ d ≤ 6 132 ≤ x ≤ 147 mmol/L(LN-RCPA: 2951-2) 1w to <18y (133–144) mmol/L 7 ≤ d ≤ 6573 133 ≤ x ≤ 144 mmol/L

18y to <120y (135–145) mmol/L 6574 ≤ d ≤ 43829 135 ≤ x ≤ 145 mmol/LPotassium 0d to <1w (3.8–6.5) mmol/L 0 ≤ d ≤ 6 3.8 ≤ x ≤ 6.5 mmol/L

(LN-RCPA: 2823-3) 1w to <26w (4.2–6.7) mmol/L 7 ≤ d ≤ 181 4.2 ≤ x ≤ 6.7 mmol/LSee note 1 26w to <2y (3.9–5.6) mmol/L 182 ≤ d ≤ 729 3.9 ≤ x ≤ 5.6 mmol/L


18y to <120y (3.5–5.2) mmol/L 6574 ≤ d ≤ 43829 3.5 ≤ x ≤ 5.2 mmol/LChloride 0d to <1w (98–115) mmol/L 0 ≤ d ≤ 6 98 ≤ x ≤ 115 mmol/L

(LN-RCPA: 2075-0) 1w to <18y (97–110) mmol/L 7 ≤ d ≤ 6573 97 ≤ x ≤ 110 mmol/L

18y to <120y (95–110) mmol/L 6574 ≤ d ≤ 43829 95 ≤ x ≤ 110 mmol/LBicarbonate 0d to <1w (15–28) mmol/L 0 ≤ d ≤ 6 15 ≤ x ≤ 28 mmol/L

(LN-RCPA: 1963-8) 1w to <2y (16–29) mmol/L 7 ≤ d ≤ 729 16 ≤ x ≤ 29 mmol/L2y to <10y (17–30) mmol/L 730 ≤ d ≤ 3651 17 ≤ x ≤ 30 mmol/L10y to <18y (20–32) mmol/L 3652 ≤ d ≤ 6573 20 ≤ x ≤ 32 mmol/L

18y to <120y (22–32) mmol/L 6574 ≤ d ≤ 43829 22 ≤ x ≤ 32 mmol/LCreatinine 0d to <1w (22–93) umol/L 0 ≤ d ≤ 6 22 ≤ x ≤ 93 umol/L

(LN-RCPA: 14682-9) 1w to <4w (17–50) umol/L 7 ≤ d ≤ 27 17 ≤ x ≤ 50 umol/LSee note 2 and 3 4w to <2y (11–36) umol/L 28 ≤ d ≤ 729 11 ≤ x ≤ 36 umol/L

2y to <6y (20–44) umol/L 730 ≤ d ≤ 2190 20 ≤ x ≤ 44 umol/L6y to <12y (27–58) umol/L 2191 ≤ d ≤ 4382 27 ≤ x ≤ 58 umol/L

12y to <15y (35–83) umol/L 4383 ≤ d ≤ 5477 35 ≤ x ≤ 83 umol/L15y to <19y (50–100) umol/L 5478 ≤ d ≤ 6938 50 ≤ x ≤ 100 umol/L19y to <60y (60–110) umol/L 6939 ≤ d ≤ 21914 60 ≤ x ≤ 110 umol/L

12y to <15y (35–74) umol/L 4383 ≤ d ≤ 5477 35 ≤ x ≤ 74 umol/L15y to <19y (38–82) umol/L 5478 ≤ d ≤ 6938 38 ≤ x ≤ 82 umol/L

19y to <60y (45–90) umol/L 6939 ≤ d ≤ 21914 45 ≤ x ≤ 90 umol/LCalcium 0d to <1w (1.85–2.80) mmol/L 0 ≤ d ≤ 6 1.85 ≤ x ≤ 2.80 mmol/L

(LN-RCPA: 2000-8) 1w to <26w (2.20–2.80) mmol/L 7 ≤ d ≤ 181 2.20 ≤ x ≤ 2.80 mmol/L26w to <2y (2.20–2.70) mmol/L 182 ≤ d ≤ 729 2.20 ≤ x ≤ 2.70 mmol/L2y to <18y (2.20–2.65) mmol/L 730 ≤ d ≤ 6573 2.20 ≤ x ≤ 2.65 mmol/L

18y to <120y (2.10–2.60) mmol/L 6574 ≤ d ≤ 43829 2.10 ≤ x ≤ 2.60 mmol/LPhosphate 0d to <1w (1.25–2.85) mmol/L 0 ≤ d ≤ 6 1.25 ≤ x ≤ 2.85 mmol/L

(LN-RCPA: 14879-1) 1w to <4w (1.50–2.75) mmol/L 7 ≤ d ≤ 27 1.50 ≤ x ≤ 2.75 mmol/L4w to <26w (1.45–2.50) mmol/L 28 ≤ d ≤ 181 1.45 ≤ x ≤ 2.50 mmol/L26w to <1y (1.30–2.30) mmol/L 182 ≤ d ≤ 364 1.30 ≤ x ≤ 2.30 mmol/L1y to <4y (1.10–2.20) mmol/L 365 ≤ d ≤ 1460 1.10 ≤ x ≤ 2.20 mmol/L4y to <15y (0.90–2.00) mmol/L 1461 ≤ d ≤ 5477 0.90 ≤ x ≤ 2.00 mmol/L15y to <18y (0.80–1.85) mmol/L 5478 ≤ d ≤ 6573 0.80 ≤ x ≤ 1.85 mmol/L18y to <20y (0.75–1.65) mmol/L 6574 ≤ d ≤ 7304 0.75 ≤ x ≤ 1.65 mmol/L

20y to <120y (0.75–1.50) mmol/L 7305 ≤ d ≤ 43829 0.75 ≤ x ≤ 1.50 mmol/LMagnesium 0d to <1w (0.60–1.00) mmol/L 0 ≤ d ≤ 6 0.60 ≤ x ≤ 1.00 mmol/L

(LN-RCPA: 2601-3) 1w to <18y (0.65–1.10) mmol/L 7 ≤ d ≤ 6573 0.65 ≤ x ≤ 1.10 mmol/L

18y to <120y (0.70–1.10) mmol/L 6574 ≤ d ≤ 43829 0.70 ≤ x ≤ 1.10 mmol/LAlkaline phosphatase 0d to <1w (80–380) U/L 0 ≤ d ≤ 6 80 ≤ x ≤ 380 U/L

(LN-RCPA: 6768-6) 1w to <4w (120–550) U/L 7 ≤ d ≤ 27 120 ≤ x ≤ 550 U/L4w to <26w (120–650) U/L 28 ≤ d ≤ 181 120 ≤ x ≤ 650 U/L26w to <2y (120–450) U/L 182 ≤ d ≤ 729 120 ≤ x ≤ 450 U/L2y to <6y (120–370) U/L 730 ≤ d ≤ 2190 120 ≤ x ≤ 370 U/L6y to <10y (120–440) U/L 2191 ≤ d ≤ 3651 120 ≤ x ≤ 440 U/L

10y to <14y (130–530) U/L 3652 ≤ d ≤ 5112 130 ≤ x ≤ 530 U/L14y to <15y (105–480) U/L 5113 ≤ d ≤ 5477 105 ≤ x ≤ 480 U/L15y to <17y (80 - 380) U/L 5478 ≤ d ≤ 6208 80 ≤ x ≤ 380 U/L17y to <19y (50–220) U/L 6209 ≤ d ≤ 6938 50 ≤ x ≤ 220 U/L19y to <22y (45–150) U/L 6939 ≤ d ≤ 8034 45 ≤ x ≤ 150 U/L22y to <120y (30–110) U/L 8035 ≤ d ≤ 43829 30 ≤ x ≤ 110 U/L

10y to <13y (100–460) U/L 3652 ≤ d ≤ 4747 100 ≤ x ≤ 460 U/L13y to <14y (70–330) U/L 4748 ≤ d ≤ 5112 70 ≤ x ≤ 330 U/L14y to <15y (50–280) U/L 5113 ≤ d ≤ 5477 50 ≤ x ≤ 280 U/L15y to <16y (45–170) U/L 5478 ≤ d ≤ 5843 45 ≤ x ≤ 170 U/L16y to <22y (35–140) U/L 5844 ≤ d ≤ 8034 35 ≤ x ≤ 140 U/L

22y to <120y (30–110) U/L 8035 ≤ d ≤ 43829 30 ≤ x ≤ 110 U/L

Male

Male

Female

Female

Report rendering• The rendering of the pathology report as the issuing

laboratory intends it to be read must be sent by thelaboratory in all electronic messages and be able to bedisplayed to the reader on screen or printed out.

• When reports are displayed on screen the latest results mustbe shown on the first display screen to avoid any chance ofmissing a latest result column or row that is off-screen.

• Because around 4.5% of the population are colour blind andbecause some methods of communication remove colour,colour cannot be used as the only method for highlighting.

48

Cancer Structured Reporting Protocol

http://www.rcpa.edu.au/getattachment/3942f934-6d8c-4a84-a43c-476d0e8c3d0e/Protocol-colorectal-cancer.aspx

International Collaboration on Cancer Reporting(ICCR):

EuropeanSociety ofPathology

- development of evidence-based core datasetsfor pathology cancer reporting

S ome of the Na tiona l P rog rams :S ome of the Na tiona l P rog rams :

• US A• United K ing dom• Aus tra la s ia• Ca na da• F ra nce• S pa in• Germa ny• Netherla nds , S witzerla nd, etc . . . . .

• US A• United K ing dom• Aus tra la s ia• Ca na da• F ra nce• S pa in• Germa ny• Netherla nds , S witzerla nd, etc . . . . .

Wha t wa s the s ta te before ICCR ?

StructuredReporting

SynopticReporting

Information modelsStructured gastric cancer report

Information model

Dotted notation – HL7 V2.4 message

OBX|2|CE|70949-3^^LN^CLUSTER^^EN 13606|1.5|70949-3^Synthesis and overview^LN||||||FOBX|3|CE|70949-3^^LN^CLUSTER^^EN 13606|1.5.1|21902-2^Tumour stage (AJCC2010)^LN||||||FOBX|4|CE|21899-0^T classification^LN|1.5.1.1|395707006^pT3^SCT||||||FOBX|5|CE|21900-6^N classification^LN|1.5.1.2|at0295^pN1b^99A-4DD10FEE7661CBF6||||||FOBX|6|CE|67211-3^M classification^LN|1.5.1.3|at0300^cM0^99A-4DD10FEE7661CBF6||||||FOBX|7|CE|21902-2^Stage group^LN|1.5.1.4|261639007^Stage IIIB^SCT||||||FOBX|8|ST|67203-0^Year and/or edition of staging system^LN|1.5.1.5|AJCC 7th Ed||||||FOBX|9|CE|LN-RCPA-00084^Residual tumour status^LN|1.5.2|at0212^R0^99A-4DD10FEE7661CBF6||||||FOBX|10|FT|22637-3^Diagnostic summary^LN|1.5.3|\H\Diagnostic Summary \.br\\N\Low anteriorresection: \H\Rectal adenocarcinoma, excision complete, pT3,pN1b,cM0, Stage IIIB.\.br\\.br\\N\||||||F

Dotted notation – Report (PDF)

FHIR XML document<entry>

<fullUrl value="http://fhir.hl7.org.au/fhir/rcpa/Observation/57"/>

<resource>

<Observation>

<id value="57"/>

<status value="final"/>

<code>

<coding>

<system value="http://snomed.info/sct"/>

<code value="78873005"/>

<display value="Tumour stages"/>

</coding>

</code>

<valueCodeableConcept>

<coding>

<system value="http://snomed.info/sct"/>

<code value="395707006"/>

<display

value="pT3: Tumor invades through the muscularis propria intothe subserosa or into non-peritonealized pericolic or perirectal tissues (colon/rectum) (finding)"/>

</coding>

</valueCodeableConcept>

</Observation>

</resource>

</entry>

SNOMED CTSNOMED CT

Unstructured vs Structured data

Safety• For optimal safety attention needs to be paid to

having:– Safe pathology informatics– Using informatics and pathology IT safely– Monitoring the safety of pathology informatics

61

7 May, 2019

PITUS 18-20• Steering Committee

• Overall governance of the project• Promote adoption and support uptake of the Standards for

Pathology Informatics in Australia• Wg1 – PITUS evaluation and promotion

• Audit SPIA conformance in reports• Educate and promote uptake

• Wg2 – Terminology Development• Audit SPIA conformance in reports• Educate and promote uptake

64

7 May, 2019

PITUS 18-20• Wg3 – Systems design and compliance

• Specify systems for maintenance and publication of SPIA by NCTS• Develop FHIR extension to record terminology related knowledge• Devise linkage to knowledge in Manual and Labtests On-line

• Wg4 - SPRC infostructure and conformance• Develop model and terminology for four protocols• IEQA trial for one protocol

• wg5 - Report standardisation• Develop policy for flagging• Develop policy for grouping tests in reports

66

67

Grieve’s laws of interoperability• It’s all about the people• You can move complexity around but you can’t

get rid of it• You can have any two of ‘cheap’, ‘flexible’ or

‘interoperable’ but NOT all three

• Grieve G. Health Intersections - Roadmap to blog. [Online]. Available from:http://www.healthintersections.com.au/?page_id=208

spia and pitus - aacb

Documents