Veronica E. Klepeis, MD, PhD Massachusetts General Hospital, Boston, MA

Pathology Informatics Summit Tuesday, May 23rd, 2017

What’s New in 2017: CAP Cancer Reporting Update

HARVARD MEDICAL SCHOOL

Notice of Faculty Disclosure

In accordance with ACCME guidelines, any individual in a position to influence and/or control the content of this ASCP CME activity has disclosed all relevant financial relationships within the past 12 months with commercial interests that provide products and/or services related to the content of this CME activity. The individual below has disclosed the following financial relationship(s) with commercial interest(s): Veronica Klepeis, MD, PhD Philips Consultant Consulting Fee CancerLinQ Consultant Consulting Fee

Outline

1. AJCC 8th edition and Pathology Cancer Reporting: Process for Review, Rollout and Implementation

2. Moving to Single Source Product for CAP Cancer Protocols and CAP eCC

3. Next-generation CAP eCC: Improved functionality and interoperability in pathology cancer reporting

4. California Cancer Reporting Revolution: Making Population Health Relevant to Everyday Patient Care

CAP Cancer Protocols (CCP)

• Provide guidelines for collecting essential data elements for complete reporting of malignant tumors and optimal patient care

• Utilized in pathology reporting • Required data elements (RDEs) mandated for accreditation

by ACoS-CoC & CAP LAP

• 66 CAP Cancer Protocols (CCP) [83 eCC Case Summaries ] and 13

Biomarker templates • Includes explanatory notes

• Represents a compilation of standards

• AJCC, WHO Blue Books

CAP Electronic Cancer Checklists (eCC) • Electronic version of CAP Cancer Protocols

• Enables pathologists to use CCP directly within their LIS workflow

• Ensures all required elements are completed • Most AP LIS vendors offer a CAP eCC module • CAP eFRM is a standardized software implementation of eCC

(partner with mTuitive)

• Primary Goals of Electronic Structured Reporting • Streamline workflow and decrease errors in data entry • Improve report format (e.g., synoptic patterns) • Enables downstream uses of the standardized, structured

data

CAP Cancer and PERT Committees

Cancer Committee - CCP • Maintains current protocols and produces

new and improved protocol content • Receives and responds to content issues • Coordinated releases with eCC • Process involves protocol author review

of eCC • Pathologist members with registrar and

clinician liaisons • Liaison to AJCC for issues involving

protocols, PERT and CBRC

Pathology Electronic Reporting (PERT) Committee – eCC • Oversees eCC maintenance and development • Guides eCC informatics issue reconciliation • Guide resolution of user questions and issues

regarding eCC • Facilitates interaction between end-user,

vendors, eCC team and Cancer Committee • Aligns eCC with CAP Cancer Protocol content • Includes pathologists, registrar and public

health members • Liaisons to AJCC, ASCO, CDC, NAACCR,

NCI/SEER, ONC, CBRC and Cancer Committee

Part 1 • AJCC 8th edition and Pathology Cancer

Reporting: Process for Review, Rollout and Implementation

AJCC 8th Edition

• Released October 2016 • 18 Expert panels

• 5 continents • 22 countries • 420 individual contributors

• 7 Cores including Data Collection Core & Content Harmonization Core

• Partnerships • UICC • CAP Protocols • NCCN guidelines • Other endeavors

AJCC 8th Edition Major Content Update

• Updates • Updated General Staging Rules • Updated staging systems • Updated histologic classifications and

grading systems • Updated WHO/IARC histology codes • More illustrations

• New paradigms introduced • HPV (oropharyngeal cancer staging

systems based on HPV status) • Separate staging system for patients with

neoadjuvant therapy (yc or yp systems) • Esophagus and Stomach

• Bone and Soft Tissue Sarcoma • Separate staging systems based on

anatomic sites

• New features • Levels of Evidence • Imaging section • Risk Assessment Models for select

cancer sites • Recommendations for Clinical Trial

Stratification • Prognostic factors

• Required for prognostic stage grouping

• Recommended for clinical care • Emerging factors

AJCC 8th Edition Major Content Update

• New chapters/staging systems • Cervical Lymph Nodes and Unknown Primary Tumors of the Head

and Neck • Pharynx - HPV-Mediated Oropharynx Cancer (p16+) • Cutaneous Squamous Cell Carcinoma of the Head and Neck • Thymus • Bone: Appendicular Skeleton/Trunk/Skull/Face, Pelvis, and Spine • Soft Tissue Sarcoma of the Head and Neck • Soft Tissue Sarcoma of the Trunk and Extremities • Soft Tissue Sarcoma of the Abdomen and Thoracic Visceral Organs • Soft Tissue Sarcoma of the Retroperitoneum • Soft Tissue Sarcoma • Unusual Histologies and Sites • Parathyroid • Leukemia

• Deleted chapters

• Cutaneous Squamous Cell Carcinoma and Other Cutaneous Carcinomas

• See cutaneous carcinoma of the head and neck

• Split chapters • p16 negative oropharynx and hypopharynx (previously pharynx) • Nasopharynx (previously pharynx) • Pancreas – exocrine (previously endocrine/exocrine pancreas) • Pancreas – endocrine (previously endocrine/exocrine pancreas) • Neuroendocrine Tumors of the Stomach • Neuroendocrine Tumors of the Duodenum and Ampulla of Vater • Neuroendocrine Tumors of the Jejunum and Ileum • Neuroendocrine Tumors of the Appendix • Neuroendocrine Tumors of the Colon and Rectum • Neuroendocrine Tumors of the Pancreas • Thyroid – Differentiated and Anaplastic • Thyroid – Medullary • Adrenal Cortical Carcinoma • Adrenal – Neuroendocrine

• Merged chapters

• Ovary, Fallopian Tube, and Primary Peritoneal Carcinoma

Specific Challenges with AJCC 8th Edition Implementation Project • Timing between release and expected implementation too short!

• Multiple organizations/downstream users/vendors • Not enough time to develop, test and deploy updates

• Linear process of review rather than parallel • Little to no overlap • Late feedback from CAP to AJCC

• AJCC Errata updates • Weekly updates • Examples: typos, omissions, content disputes with ongoing discussion

(inclusion of ITCs in pN staging for gynecologic cancers)

AJCC 8th Edition Implementation Project

• Significant feedback on lateness of release and short implementation time

• Implementation date moved from January 1, 2017 to January 1, 2018

• CAP will release updated Cancer

Protocols and electronic Cancer Checklists (eCC) by the end of the second quarter of 2017

• Allows for testing period for vendors • Vendors will have typical 8 months to

implement update to remain compliant for accreditation

• Stage using 7th edition until 2018

AJCC Content Transformation Project • AJCC future changes based on user feedback and lessons

learned • Content needs to be available in more efficient and timely

manner • Digitize material and develop an API (application

programming interface) to help users/vendors • Embrace structured data

• Potential Benefits of an AJCC API

• Focus on usability of software rather than accuracy of AJCC content

• Integrate once and maintain connection for all future versions of the AJCC staging system

• Ability to have rolling releases

• API Development

• Will deliver 8th edition cancer staging manual in XML format to allow for direct integration into software and applications

• Currently in testing phase Slide content provided by Martin Madera

CAP eCC Development Tools

• Custom Developed Tools • Template Editor (TE)

• Model content from CCP into question answer sets for eCC

• Includes metadata • Models and metadata stored in SQL

server database • XML Generator

• Custom .NET tool that generates xml from database records

• Additional programs transform xml in to html

• XML Comparator • Visualize changes between old and

new versions of a template • Project Tracker (PT)

• Data stored in Access database • Also incorporates customer feedback

CAP Cancer Protocol

eCC XML Output

eCC Template Editor

Data Entry Form ( DEF )

Data Repository

1 . Cancer Registries 2 . Patient Providers 3 . Cancer Research

Standard HL 7 Data

Transmission

Sent to vendor

Pathology Report CPP / eFRM

Synoptic Report

Figure provided by Richard Moldwin

Current Process for Review and Rollout at CAP

Word Doc (compare template editor, comment) Project Tracker (update status) Template Editor (compare word doc, comments) Send Draft (pre author meet)

Word Doc (edits directed by author, track changes,

comment, action items) Project Tracker (update

status) Send Edits (to authors

with deadline) Send Errors (to AJCC for

8th ed)

Word Doc (review edits,version, track changes, comments) Project Tracker (update status) Template Editor (incorporate changes, eCC modeling rules)

Word Doc (finalize, version, track changes,

comments) Project Tracker (update

status) Template Editor (eCC

modeling rules) eFRM review

AJCC Errata (incorporate) Final QA (SOP)

xML generator tool (transforms TE data into

xml for downstream users) Packaging and final

documentation eCC files uploaded to file

share management system Communication sent to

users

Word Doc (version, track changes, comments)

Project Tracker (pertinent issues, update

status) Template Editor (eCC

modeling rules) AJCC Errata

QA Tool (LOC file)

Author Meeting

Rele

ase PQ

Participants PM = primary modeler PQ = preliminary QAer A = author(s) MPE = meeting protocol editor RM = release manager

Key Features • Pertinent issues arising in past from customer

feedback are reviewed and scoped during the preliminary modeling stage

• AJCC Errata are reviewed during the preliminary modeling stage and again in the final modeling stage, as these updates occur weekly

• Documentation and versioning are key features in every stage

• Status is continually updated in project tracker • QA step occurs both before and after the

author meeting stage • eFRM review/testing occurs during the Final

QA/Model stage

Protocol Draft

Current Process for Review and Rollout at CAP

Word Doc (compare template editor, comment) Project Tracker (update status) Template Editor (compare word doc, comments) Send Draft (pre author meet)

Word Doc (edits directed by author, track changes,

comment, action items) Project Tracker (update

status) Send Edits (to authors

with deadline) Send Errors (to AJCC for

8th ed)

Word Doc (review edits,version, track changes, comments) Project Tracker (update status) Template Editor (incorporate changes, eCC modeling rules)

Word Doc (finalize, version, track changes,

comments) Project Tracker (update

status) Template Editor (eCC

modeling rules) eFRM review

AJCC Errata (incorporate) Final QA (SOP)

xML generator tool (transforms TE data into

xml for downstream users) Packaging and final

documentation eCC files uploaded to file

share management system Communication sent to

users

Word Doc (version, track changes, comments)

Project Tracker (pertinent issues, update

status) Template Editor (eCC

modeling rules) AJCC Errata

QA Tool (LOC file)

Author Meeting

Rele

ase PQ

Participants PM = primary modeler PQ = preliminary QAer A = author(s) MPE = meeting protocol editor RM = release manager

Future Plans for Revisions to Workflow

• Consider removing preliminary QA and preliminary modeling since too much content flux between then and author meeting

• Move eFRM review and testing earlier in the process to identify data entry/reporting output issues before the final modeling stage

• Much of the documentation and edits are contributed by the preliminary modeler rather than authors/reviewers directly single source product

Protocol Draft

Part 2 • Moving to Single Source Product (SSP)

for CAP Cancer Protocols and CAP eCC

Majority of slide content provided by Varsha Parekh

Single Source Product(SSP) for CAP Cancer Protocols and eCC

• Custom tool to help streamline process for review and rollout of CCP and eCC

• Allows for authors to edit, collaborate, save, and produce the CAP Cancer Protocols within a web-based tool

• Both CAP Cancer Protocols and eCC will be created from a single database remove issue of discrepancies between the paper protocols and eCC

Single Source Product Workflow • Authors and reviewers must log in to SSP • Access to specific protocols is specified

by user • All participants on a protocol are clearly

listed by role • Only primary author or designee can edit

protocols • Reviewers can add comments in the SSP

tool but cannot change content • Submission of edits by author/reviewers

automatically triggers notification to downstream participants via a workflow module

• Author integrates feedback and edits into protocol

• Once final version is approved, data gets transferred from temporary tables into the TE for content modeling and QA

Single Source Product Screenshots

Authoring interface presents different sections of report as structured data elements

Reference manager will allow easy incorporation of references into explanatory notes

Single Source Product Timeline

• First version planned for June/July 2018

• SSP can generate an acceptable “paper” protocol using the eCC database

• Currently refining author editing functionality that will be used by authors to revise their protocols

Dec 2015

• Requirements and work plan defined for SSP prototype • SSP Prototype demonstrated virtually for preselected CaCte and PERT Members

Feb 2016

• SSP Prototype demonstrated during joint CaCte and PERT committee meeting & feedback • SSP-Editor design initiated

Mar 2016

• SSP-Editor design approved • SSP-Editor development started

Oct 2016 • SSP Phase 1 demonstrated during CaCte committee meeting & feedback

Mar 2017

• SSP Editor refinement & field testing • Development, evaluation, & feedback on editing tool

Jun 2017 • CaCte F2F SSP UI working session

Summer 2017

• User Testing

Fall/winter 2017

• User Testing

Jul 2018

• Finalize SSP Tooling • Training, release-ready by mid 2018

Part 3 • Next-generation CAP eCC: Improved

functionality and interoperability in pathology cancer reporting

Majority of slide content provided by Richard Moldwin

Next Generation CAP eCC

• eCC is implemented by multiple vendors

• Vendor receives XML version of eCC along with instructions

• How accurately that gets implemented with regard to data entry form and report generation varies greatly among vendors

• Improved interoperability and functionality of the CAP eCC format would benefit implementation

New eCC Features

• Adoption of enhanced eCC format: June 2016 • Adds new XML attributes • Provides better support for conditional reporting, report text formatting, reporting notes,

repeating metadata • Requires vendors to make some moderate changes in the way they implement eCC templates

• Future transition to Structured Data Capture (SDC) format: June 2017

• Complete redesign with many improvements • Requires vendors to make significant changes in the way they implement eCC templates

SDC Overview

• Initiative launched in 2013 by the ONC in partnership with NIH, AHRQ, FDA, CMS, and CDC

• Key area of focus is enabling the collection of structured data within EHRs to supplement data collected for other purposes

• Values and benefits of adopting SDC • Enables patient information to flow more easily between systems • Allows single point data entry that populates multiple systems • Improve comparability of data to better inform research and quality reporting • Contribute to public health, patient safety, adverse event reporting and clinical

research • These values and benefits overlap with the goals of CAP eCC

SDC Scope

• Enhanced existing standards for • Forms (templates) • Data elements in those forms • Pre-population/auto-population of those forms • Transport/exchange of forms between systems

• These are explained in two implementation guides • Two versions based on different content/structure and transport/security standards

• IHE SDC profile • FHIR SDC profile

Advantages and Challenges of Adopting SDC

Advantages • International standard • Vendor support with less CAP

resources • Plug and play for vendors once

supported • ONC oversight and regulation • Future CMS (Meaningful Use)

inclusion/reimbursement

Challenges • More complex • Time and money invested to get

buy-in for change • Limited support for rules….but in

process • Only basic rule functionality currently

exists • Advanced rules for autostaging

calculations are being developed but will require vendor to implement code

Structured Data Capture for Pathology and Beyond

• Richard Moldwin, MD, PhD • Lead Physician Informaticist

• College of American Pathologists

• Wednesday 11:20 am – 12:00 PM

• Kings Garden 2/3

Part 4 • California Cancer Reporting Revolution:

Making Population Health Relevant to Everyday Patient Care

Majority of slide content provided by Mary Edgerton

Current and Future Roles of Cancer Registries

• Currently allows for: • Public Health: Cancer surveillance for incidence and survival

• Potential for future expansion: • Public Health: Cancer surveillance for incidence and survival on a near real-time basis • Resource for quality improvement in treatment outcomes • Resource for access to clinical trials • Patient/consumer access to identifying best source of care for their individual cancer

Traditional Mode of Data Entry for Cancer Registries

Patient diagnosed with cancer

Patient seeks treatment Outcome

Data Goes Into Registry

Health Provider (Person or Hospital)

charges fee for service

Cancer Incidence by Stage & Type,

etc.

Data Goes Into Registry

Cancer Survival by Stage & Type, etc.

8-24 month backlog Limited analytics

Manual Entry

California Data Modernization Project

• Automate transfer of cancer data into registry so that it will be a near real-time resource

• Goals • Improve quality of outcomes • Improve patient access to informed decision making • Improve patient access to clinical trials • Inform payors about quality metrics of importance to

outcomes

Future Model for Cancer Registry Data Flow

Cancer registries could be a rich data source if data could be discretized, vocabularies standardized and basic analytics applied…

Registry

Diagnosis

Treatment Outcome

Structured data into registry

Data analytics enabled Quality metrics returned to providers

Process Improvement at every step & improved analytics for precision medicine

Patients are better informed on treatment options with respect to outcomes

Barriers to high-quality real-time cancer registry data • Volume

• 420,000 cancer pathology reports reviewed each year in California (35,000/month) • 240,000 new cancer case abstracts sent to California Cancer Registry from hospital-based registries • 170,000 new cancer patient/tumor consolidated records • 57,000 cancer deaths a year in California

• Process • Multilayered processing, by mail, fax, electronic transmission • 8-24 month turnaround time

• 5% are scanned and mailed or faxed. • 95% are received as HL7 messages

• 60% are in narrative format • 30% are in synoptic format • 5% are structured eCC’s

• Result: Surveillance reports are released after science and care standards have already changed

Challenges to Automating the Process

• Difficulty aggregating data due to: • Lack of structured data in basic diagnostic reports, e.g., narrative format • Lack of standardization of terminology in narrative and synoptic reports • Time delays due to labor-intensive, manual curation processes • Multiple standards that are not readily interoperable (CAP, NAACCR, FHIR,

ONC) • Version control

• Potential Solutions • Natural Language Processing (NLP) not perfect and requires continuous

training • Discretized Data Capture (DDC) at reporting level requires manual input at

caregiver level and requires widespread buy-in

Changing Pathology Reporting

•Capture “structured” data upfront - CAP Cancer Protocols: structured synoptic rather than narrative format - CAP eCC: truly structured data capture

Phases of the CCR Structured Reporting Initiative • Phase 1 (Pilot): Feb 2013 – July 2013

• 2 sites, de-identified, legacy reports • LIS vendors / software: Cerner CoPathPlus / mTuitive

• Phase 2: Feb 2014 – Dec 2014 • UCSF Benioff Children’s Hospital Oakland (SCC Soft / eCC) • St. Joseph’s Health System (mTuitive/eCC) • Real-time transmission of structured pathology reports • Resections and biopsies (liquid tumors excluded)

CCR Data Analytics Research is Beginning

• Compliance rate over time • How many structured reports received vs. total reports

• Diagnostic latency (timeliness of reporting)

• Measure time from surgery or specimen received date to report received date at CCR

• Lymph node retrieval • Variations with primary site

• Positive prostate margins

• Presented by vendor, facility, hospital, physician

Phases of the CCR Structured Reporting Initiative • Phase 3: 2015 –

• New sites onboarding, maintenance and sustainability • 5 Current Facility Groups approved and reporting to production

• St Joseph’s (10 sites) • Oakland Children’s Hospital (1 site) • Prime Healthcare (15 sites) • Marin General – Pathgroup (1 site) • PSMG (1 site)

• Phase 4: 2016 – • Legislation to require electronic reporting of pathology reports across the

state

California State Assembly Bill (AB) 2325

• On or after January 1, 2019, a pathologist diagnosing cancer is required to report cancer diagnoses to the CCR by electronic means. If a pathologist fails to report this data electronically, the CCR would be authorized to access the information in an alternative format and to bill the pathologists’ office for its cost in obtaining the data.

• The bill also provides for the establishment of a California Cancer Clinical Trials Program to increase patient access to eligible cancer clinical trials in underserved areas. Donations would be solicited from interested parties involved in healthcare.

• The CCR can contribute by creating tools to determine eligibility

California State Assembly Bill (AB) 2325

• CAP eCC is not a requirement of the state to meet the CA pathology reporting requirement. However, use of software which supports discrete data capture, such as CAP eCC, is highly encouraged in order for CCR to efficiently process cancer incidence data and achieve future uses of data envisioned by CCR.

• An Implementation Guide is being developed currently and will be released as of July 1, 2017. Reporting requirement details will be outlined in the Implementation Guide.

• If a pathology department or lab already reports to CCR, reporting should continue until the new reporting requirements are defined and the Implementation Guide is released

Data Elements to be Reported to CCR

• Multiple identifiers and demographics data elements approved • Identifiers for establishing uniqueness of reports • Demographics for epidemiological study • Would be submitted by higher level institution (e.g. hospital) or EMR

associated with institution that submitted tissue to pathologists-i.e. burden not on pathologist

• Vital Statistics • Made optional –too much burden (getting data from the state department of

vital statistics would be impossible) • Cancer Data Elements

• Recommended that the CAP required data elements be adopted as they are defined by CAP

Areas Requiring more Work

• Biopsy data elements • Use CAP data elements for resections as they apply to a biopsy

• Biomarker reporting • Recommendation was to adopt CAP structure for each cancer type

• Molecular results

• Relevance to PERT/CAP • Adoption of SDC help in this project • Formalization of biopsy data elements for cancer protocols • Development of molecular reporting standards

Conclusions

• Implementation of AJCC 8th edition has been challenging due to the vast amount of changes, but updated CAP Cancer protocols and eCC are scheduled for release by July 2017.

• A single source product for CAP Cancer protocol and eCC development, due for release next year, will remove discrepancies between paper and eCC, and streamline the review and release workflow.

• Enhancements to eCC, with recent implementation of enhanced XML and later this year SDC, will improve vendor implementation and interoperability of the eCC.

• CAP continues to participate in the California data modernization project that will allow real-time cancer surveillance and data analytics with the ultimate goal of improving patient care.

Acknowledgements

• The CAP Pathology Electronic Reporting (PERT) Committee M. Berman, P. Foulis, G. Birdsong, M. Edgerton, R. Simpson, D. Divaris, J. Olson, A. Renshaw, J. Pettus, R. Allan, M. Heayn, K. Hill, S. Sirintrapun, P. Adamo, M. Dryden, J. Warner, G. Lee, T. Baker

• CAP Staff & Facilitators S. Spencer, R. Moldwin, J. Mirza, K. Hulkower, W. Scharber, V. Parekh, S. Krejci

• AJCC Martin Madera, Laura Meyer

Questions