the cap electronic cancer checklists (ecc) ci4cc presentation rws... · decision to roll out ecc at...

© College of American Pathologists.

The CAP electronic Cancer Checklists (eCC):

Discrete Data Entry at the Front Line

Ross W. Simpson, MD, FCAPCAP Pathology Electronic Reporting Committee (PERT)Methodist Hospital Park Nicollet

October 2018


Historical review of anatomic pathology reports

• Up until the 1980s: Typed – multi-part formso Library card catalog like broad based indexing systems – many personal

• Manual SNOMED encodingo 1965 SNOP – SNOMED RT – transferred from CAP to IHTSDO in 2007

• Late 1980s- current – Plain text computer storage – HL7 outputo Manual or Natural language processing for SNOMED encoding or assisted encoding

2


Pathology reports: What did we start with?

• Narrative unstructured texto Variation in terminology, order, and sometimes in classification or

grading systems

o User macros – without attached coding/terminology

3


Overview of CAP Cancer Protocols (synoptics)

• 1990s Evolution to synoptic report in the 1990s

• 1998 Minimum data set to define a cancer diagnosis - first release

• 2003 SNOMED CT encoding

• 2007 SNOMED CT encoded MS Access database

• 2009 CAP XML eCC – CAP PERT Committeeo Uses Ckey to identify individual concepts (data elements) paired with Ckey for individual values

such that a composite gives a unique identifier for question and answer

o Ckey to SNOMED CT mapping possible

4


Content consensus and standards

• American Joint Committee on Cancer (AJCC)o Cancer staging

• World Health Organization (WHO)o Tumor classification and nomenclature

• American College of Surgeons – Commission on Cancer (CoC)o Accreditation standards for Cancer Centers

o -------------------------------------------------

• College of American Pathologists Cancer Committee

• International Collaboration on Cancer (ICCR)o Pathology report content

5


CAP electronic Cancer Checklists (eCC)

• XML structure – (CAP format)o Used by multiple AP-LIS vendors – KEY TO INTEROPERABILITY

• Question / Answer / Fill-in

• Ckey identifiers o Mapping capability

6


CAP eCC Cycle

Cancer Committee

PERT

VendorsEnd Users

PERT

7


CAP eCC market assessment: Sept 2018

8

• 44 new CAP eCC/ eFRM licensed sites• 742 new pathologist users this year as of Sept 2018• Number of licensed pathologists has grown from <1000 to >5000 in 5 years

US 4266

Canada 871

Other international 44

Total Pathologists 5181

Number of licensed pathologist users Vendor # of pathologists

EPIC 1574

eFRM/mTuitive 1121

Cerner Copath 750

Provincial Licenses (Ontario & BC) 524

Voicebrook 423

Sunquest-Powerpath 319

SOFT 285

Meditech 54

Independent 40

Psyche Systems 26

Cerner Millennium 22

Orchard 19

Novopath 12

Starlims 9

Dolbey 4

Total 5181


eCC discrete data to central cancer registries

• Cancer Care Ontario o Required for every hospital in the province

o Rolling out to other Canadian cancer centers

• California Cancer Registry pilot

• ? others

• North American Association of Central Cancer Registries (NAACCR) Vol. 5 interface specifications (HL7 2.3.1 and 2.5.1)

9


Colon: Histologic Type

10


CCO - Example dashboard

11

• Colonic serosal penetration rate by facility


Primary structured data entry – How hard is it?

• Small hospital – 4 pathologists - 1 FTE

• Currently using a top tier AP-LIS with voice dictation

• =================

• Project

• Commercial eCC implementation with a database

• Output used as primary pathology report, replacing narrative

12


Primary structured data entry

• OUTCOMEo 4 of 4 pathologists preferred eCC data entry for reporting

o Elimination of missing elements from reports

o Decision to roll out eCC at larger hospital based on pilot experience

oDECISION based on pathologist preference, due to the complexity of the forms, decision support desired. (analogous to tax prep software)

13


Metadata for decision support for data entry

• Required vs Optional

• Conditionally required

• Single entry vs multiple selections

• Mutually exclusive

• Auto-calculation / Rules

• Question parent and child relationships

• Repeating sections

• Validation rules for complete report

14


“Old” Workflow

Text Entry

Encoding

Report

15


Narrative vs Synoptic (current)

• Colonic adenocarcinoma, grade 2, measuring 5.5 cm in greatest dimension, arising in the cecum.

vs.

Tumor

• Tumor Site: Cecum

• Histologic Type: Adenocarcinoma

• Histologic Grade: G2: Moderately differentiated

• Tumor Size: 5.5 Centimeters (cm)

16


Report: Narrative vs Synoptic - One or both?

• Variable preference

• Traditional: Narrative followed by synoptico Opportunity for discrepancies

• Modified traditional: Top line summary followed by synoptic

• Latest project: Constructing a summary narrative automatically from the synoptic data

17


New Workflow

Encoded discrete content

Structured Data Entry

Human Readable

Report

18


Structured Data Capture (SDC) - What is it?

• The SDC project was initiated by the Office of the National Coordinator for Health Information Technology (ONC) in early 2013 through its Standards and Interoperability (S&I) Framework initiative.

• The SDC project was developed in cooperation with Integrating the Healthcare Enterprise (IHE) , a standards organization which focuses on the interoperability of healthcare IT systems, with a focus on combining constrained standards into profiles for interoperable data transmission.

19


• SDC is technically more capable than the original eCC XML modelo Expanded metadata set (computer instructions)

o More compliant with modern healthcare informatics and general programming approaches

o Standards development process (ONC, IHE)

o Covers the entire data ecosystem, including standardized content design, data-entry, transmission, storage, aggregation and querying

o Open source tools, not proprietary to the CAP

20

Why SDC?

HL7: CDA, V2…SOAP (RFD)REST (FHIR)REST (SDC)

SDC Workflow

SDC XML Output

Data Entry Form

Cancer Registries

Patient Providers

Research

Vendor

HL7 Message

Data Repository

Template Editor

CAP Cancer Protocol

Synoptic Report

© 2018 College of American Pathologists. All rights reserved


SDC XML schema files

23

Base Types

Form Design

Resources

Data Types

Retrieve Form

Mappings

Submit Form

Template Admin

XHTML

Expressions (rules)


SDC XML DEFXSLT



ID



Where do the answers go?*

26

This model is particularly well suited to eCC data representation and transmission.

Optional to transmit


CAP synoptic to SNOMED CT mapping

• W. Scott Campbell PhD and James Campbell M.D.

• UNMC, CAPCollege of American Pathologists, IHTSDO and the Regenstreif Institute, Inc.

• The terminology is based on the harmonized concept model arising from the LOINC/SNOMED International Collaborative agreement and addresses histopathology, biomarkers and molecular pathology.

• All content is contained in the Nebraska Lexicon© may be freely downloaded with a valid UMLS login.

27

Identifiers can be Mapped to DEs(this is external to the Form Template and optional)

Form Design Template (ID-T1)

Section (ID-S29)

QAS:DE (ID-Q92)

QAS:DE (ID-Q11)

QAS (ID-Q5)

QAS:DE (ID-Q39)

QAS (ID-Q30)

Section (ID-S23)

Q92DE123Map

DE123

Answer Items = a (SNOMED =…)b(SNOMED = …)c(SNOMED = …)

SNOMED = …LOINC = …

Note: The map usually travels with the form in an SDC Package. The DEs live in a DE repository, and can be looked up on demand via a web service. DEs may be maintained independently of forms. Maps, if used, are maintained with the form, but do not need to travel with it.



• Formo One SDC FormDesign XML file

• Packageo One or more SDC FormDesign templates (XML)

o One Demographic FormDesign template (optional)

o Maps to terminologies, data elements etc.

o Transforms and/or other formatting / styling artifacts

o Administrative data

29

Forms and packages


• Goal categories:

oWorkflow

oDEF Content

oReporting

oSecondary Use

o Implementation

30

eCC / SDC improvement goals


Reporting instructions for preferred report layoutRight

1 2 4 8 9 10 11…Examined 0 2 3 2 4 2 3

Involved 1

Central3a 3p 7 Other

Examined 4Involved

Left1 2 4 5 5 6 8…

Examined 0 + + + + + +

Involved

© Memorial Sloan-Kettering Cancer Center, 2009


• Site-Specific Data Items (SSDI)o 390 pages of cancer registry data elements

o Harmonized with eCC data elements for the first time

o Permits direct mapping of eCC responses to NAACCR data items for CDC (NPCR) and NCI (SEER)

32

Secondary use: Cancer registries


Secondary use: Cancer registries

A related project with CAP and CDC allows eCC SDC data to flow directly to registry software: WebPlus and eMaRC Plus.

https://apps.naaccr.org/ssdi/list/https://www.naaccr.org/SSDI/SSDI-Manual.pdf

KRAS mutations

“Anti-EGFR antibody therapy is not recommended for patients whose tumors show mutations in KRAS codon 12, 13, or 61, but data on codon 146 are currently insufficient.”

https://apps.naaccr.org/ssdi/list/

https://www.naaccr.org/SSDI/SSDI-Manual.pdf


Barriers

• Vendor implementation variation

• User interface preferences

• Immature synoptic templates for some organ systems

• Inflexibility / Local customization maintenance

• Reporting not optimized

• Template Author tools not readily available yet

• Biopsy templates needed

34


• Cancer Care Ontario – Thoracic surgery synoptic template pilot

• Cancer Care Ontario - Radiology pilot

35

Other clinical areas of SDC development

Demos

• CAP: Conformance Testing (Browser)– Form Filler, Form Manager, Form Receiver– PT, TE, Schemas, XDT Generator, QA Tool, XML Comparator, SSP

• CAP Cancer Protocols www.cap.org• GitHub: • Google Drive• IHE SDC Page• IHE SDC Profile• NLM: Form and CDE library• ONC:

– https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/SDC+Home– https://www.healthit.gov/techlab/ipg/

© 2018 College of American Pathologists. All rights reserved36

https://sdt.cap.org/SDCApp/Index.aspx

http://www.cap.org/cancerprotocols

https://github.com/IHE-SDC-WG

https://drive.google.com/drive/folders/0B6NQrRuWFCvIb3QyaGlxTF9mVHM

http://wiki.ihe.net/index.php/Structured_Data_Capture

https://ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_SDC.pdf

https://cde.nlm.nih.gov/home

https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/SDC+Home

https://www.healthit.gov/techlab/ipg/


Q&A

37


END

38


CAP/CDC SDC Collaborative Agreement Team (2018)

• CAPo Sanjeev Baral

o Richard Moldwin

o Varsha Parekh

o Ross Simpson

o Joe Sirintrapun

• CDCo Sanjeev Baral

o Shailendra Bajracharya

o Wendy Blumenthal

o Sandy Jones

o Jennifer Seiffert

39


Other SDC Contributors (not a complete list)

• ONC: Farrah Darbouze, Doug Fridsma, Evelyn Gallego, Ed Hammond, Steve Posnack, Jon White

o Accenture: Elvino Saldanha, Perri Smith, Kelly Zeng

o ESAC: Elizabeth So, Michal Kotelba, Matt Tiller, Lamáh Asadullah, Jenny Brush, Lauren Caruso

o JBS: Vijay Shah

o Mark Roche, Bob Dieterle

• Allscripts: George Cole

• CCO: Gemma Lee, Dave Kwan, Alex Goel, Jon Zammit

• CCR: Tim Davison, Steve Fuchslin, Jeremy Pine…

• DCG / AHRQ: Matthew Chudy

• Epic: John Stamm, Keith Simmons, Andrew Wu…

• FDA: Mitra Rocca

• IHE: Wash U: Steve Moore

• JBS: Vijay Shah

• mTuitive: Colin Murphy, Peter O’Toole, Peter Mello

• NCI: Denise Warzel

• NHDS: Steve Beller

• NLM: Lisa Lang, Christophe Ludet, Clem McDonald, Kelly Zeng

• OZ Systems: Ken Pool, MD (deceased),

• UCSF: Sue Dubman, Tom Bechtold

• Blue signifies a major technical contributor (100+ hours) to SDC development and/or ONC pilot

40


PERT Committee members and CAP Staff• Andrew A. Renshaw MD

• Deven L Smith MD

• Dimitrios Divaris MD

• Elizabeth Dellers MD

• Eric Daley

• Gemma Lee

• George G Birdsong, MD

• Jaleh Mirza, MD

• Jason R Pettus MD

• Jeffery Karp Jeremy Warner MD,MS

• Jordan E Olson MD

• Joshua Mazuryk BSc

• Kalisha Ashara Hill MD, MBA

• Keren Hulkower, PhD

• Mary Elizabeth Edgerton MD,PhD

• Michael A. Berman MD

• Michelle Heayn MD,PhD

• Peggy Adamo BS, RHIT, CTR, AAS

• Richard Moldwin, MD, PhD

• Robert William Allan MD

• Ross W Simpson MD

• Sabrina Krejci

• Sahussapont Joseph Sirintrapun MD

• Samantha Spencer, MD

• Sandra F Jones

• Shaheena Mukhi, PhD,MHA,BScN,RN

• Ted Carithers

• Thomas Patrick Baker MD

• Vanda Torous MD

• Varsha Parekh

• Veronica Klepeis MD,PhD

41