National HL7 Standards for Electronic Pathology Reporting to Cancer Registries

1
National HL7 Standards for Electronic Pathology
Reporting to Cancer Registries

• Eric B. Durbin, MS
• Director of Cancer Informatics
• Markey Cancer Control Program/Kentucky Cancer
  Registry
• University of Kentucky
• APIII, August 18, 2006
• Vancouver, British Columbia

2
Overview

• Value of electronic pathology (E-Path) reporting
  and data standards
• History of North American Association of Central
  Cancer Registries (NAACCR) E-Path standards
• NAACCR Standards Volume V Pathology Laboratory
  Electronic Reporting
• HL7 tutorial
• HL7 E-Path messages
• Alternative delimited layout
• Continuing work (standardized synoptic reporting)

3
Value of E-Path Data Standards

• Facilitate the transmission of electronic data
• Define the structure and meaning of the data for
  senders and recipients
• Reduce costs for path labs and cancer registries
• Allow senders and recipients to build a single
  interface
• Single interface can meet needs of multiple
  senders and receivers

4
E-Path Benefits to Oncology and Pathology Research

• E-Path implementations reduce the time from
  cancer diagnosis until the availability of high
  quality, well defined and structured research
  data
• More timely high quality data offers new
  opportunities to use registry based pathology
  data for research purposes
• Registry data is currently an underutilized
  resource

5
The Gold Standard in Quality Central Cancer
Registry Data

• Central cancer registries are in the business of
  collecting high quality population based data
• Registries routinely collect
• Patient Demographics (current and at diagnosis)
• Race, gender, geography, family history
• Site/Histology
• Staging (TNM, Collaborative Stage, Summary Stage)
• Comprehensive therapy data
• Long-term survival and follow-up (outcomes)
  information (for lifetime of patient)
• Many other standard data elements

6
Professional Data Collection

• Registry data is collected by trained
  professionals
• Certified Tumor Registrars (CTR) - ACoS
• Registry data is highly scrutinized for data
  quality and consistency
• Edit checks during collection
• Edit checks at central registry
• Edit checks prior to submissions to federal and
  national agencies
• CDC, NCI/SEER, NAACCR, ACoS
• Frequent audits of data completeness and quality
• Data standards of quality is required by funding
  agencies

7
Role of Pathology Data in Cancer Registration

• Over 90 of all cancers are microscopically
  confirmed by pathology report
• Pathology reports typically provide
• Demographics (limited)
• Diagnosis dates
• Site/Histology/Grade/Laterality
• TNM staging
• Tumor size
• Identification of sources necessary for
  follow-back for additional registry data
• Physicians, involved institutions, etc.
• Other valuable data elements and text

8
Additional Benefits of E-Path to Cancer Registries

• Rapid case ascertainment for research studies
• Before patient is deceased
• Prior to confounding effects of treatment
• Clinical trials patient identification and
  recruitment
• Central registry audits of reporting hospital
  registries (hospital based E-Path)
• Earlier assessment of incidence rates

9
Benefits of E-Path to Tissue Banking

• Short term
• Automated, near real-time annotation of path
  based data soon after specimen collection
• Targeted specimen identification
• Long term
• Availability of long term outcome data
• Ability to associate specimen data with
  population based data for patients with similar
  or dissimilar characteristics

10
NAACCR, Inc.

• North American Association of Central Cancer
  Registries
• Professional organization established in 1987
• Enhancing quality and use of cancer registry data
  
• Develops and promotes uniform data standards for
  cancer registries
• First data exchange standard published in 1994
• Members include central cancer registries and
  many other govt. agencies, organizations and
  individuals
• Governed by elected board of directors
• Funds an executive office
• Various committees, sub-committees and work
  groups
• http//www.naaccr.org

11
AcknowledgementsE-Path Transmissions Work Group
2005-2006
Jovanka Harrison, PhD New York State Cancer
Registry Keith Laubham, MSArizona Cancer
RegistryJ. A. Magnuson, PhD, RSOregon Health
Services Mark Rudolph (Alternate) Florida Cancer
Data Systems Wendy Scharber, RHIT, CTRMinnesota
Cancer Surveillance System Advisors to Work
Group Mary Hamilton CDC Austin
Kriesler CDC Margaret MarshburnCDC
Eric B. Durbin, MS (Chair) Kentucky Cancer
Registry Lori A. Havener, CTRNAACCR Toshi Abe,
MSW, CTR New Jersey State Cancer Registry Mayra
Alvarez, RHIT, CTR Florida Cancer Data
System Steve Barta IMPAC Victor
Brunka Artificial Intelligence In Medicine,
Inc. Ken Gerlach, MPH, CTR CDC/NPCR Barry
Gordon, PhD California Cancer Registry
12
Brief History of the Quest for E-Path Standards

• NAACCR board commissioned the quest in 2003
• IT Committee
• E-Path Sub-committee
• E-Path Transmission Work Group was formed
• Built on previous work by NAACCR and CDC
• Conducted monthly and bi-weekly teleconferences
  for over two years
• NAACCR Volume V was ratified and published in
  November 2005

13
Alas, the Holy Grail!
14
Typical E-Path Data Flow
15
Path Lab E-Path Transmissions
16
Registry E-Path Receiving
17
Whats In NAACCR Volume V?

• Chapter 1 Introduction
• Chapter 2 Implementation Guide for Transmission
  of Laboratory-Based Reports to Cancer Registries
  Using Version 2.3.1 of the HL7 Standard Protocol
• Chapter 3 Pipe-Delimited Format

18
Two Standard Formats

• Health Level Seven (HL7)
• http//www.hl7.org/
• Flexible and robust protocol widely utilized for
  electronic data transmissions by medical
  facilities and pathology Laboratories
• Pipe-Delimited Format
• Less sophisticated (less technically challenging)
• Retained for legacy e-path reporting systems
• May be used alone or in conjunction with HL7

19
NAACCR Volume V Chapter 2HL7 Implementation
Guide

• Based upon CDCs infection disease reporting HL7
  implementation guide
• Explicitly defines the HL7 format necessary to
  transmit a pathology report to a cancer registry
• Specifies how and where to place each pathology
  report data element
• Defines requirement status for each variable
• Required
• Required when available
• Optional
• Provides examples throughout

20
The HL7 Standard

• NAACCR Standard is for HL7 Version 2.3.1
• American National Standards Institute (ANSI)
  approved in 1999
• HL7 Versions 2.4, 2.5 also approved
• 2.3.1 still most commonly supported version
• HL7 Version 3.x radically different from 2.x
  versions
• Clinical Document Architecture (CDA) is appealing
• XML
• But, not yet widely supported by AP-LIS vendors

21
HL7 Basics ORUR01 Message Type

• Lab result information is reported through
  Observational Results (Unsolicited) (ORU)/Event
  R01 messages
• Unsolicited messages are transmitted at will from
  the sender and do not require an electronic
  request from the recipient
• ORUR01 messages are composed of specifically
  defined HL7 segments

22
HL7 Basics Delimited Data Fields

• HL7 messages are ASCII text
• All data fields in an HL7 message are delimited
  by a specified separator
• The delimiter is defined at the beginning of an
  HL7 message
• Usually the (pipe) character
• Field in each position is defined (MSH-1, MSH-2,
  MSH-3 MSH-21)

MSH\HLSHITECK PATH LAB-ATLANTA3D9328409CLI
ASTJ20031124122230ORUR01200311241222300023
P2.3.12.0 ltCRgt
23
HL7 Basics Segments

• Various HL7 segments carry categories of
  information
• Each segment type is identified by a three
  character id at the beginning of the segment such
  as MSH, PID, OBR, OBX
• Some segments can be repeated in a message
• Repeating segments are sequentially numbered

OBX1TX22637-3FINAL DIAGNOSISLNDIAGNOSISL1
LEFT INGUINAL LYMPH NODE - GRANULOMATOUS
LYMPHADENITISFltCRgt OBX2TX22637-3FINAL
DIAGNOSISLNDIAGNOSISL1/ljm
ltCRgt OBX3TXClinical HistoryL2? lymphoma
Quick SectionFltCRgt
24
NAACCR HL7 E-Path Message Structure
ORU - Unsolicited Observation Message (event R01)
ORUR01 Observational Results (Unsolicited) Section
MSH Message Header segment 2.6.1
PID Patient Identification segment 2.6.2
NK1 Next-Of-Kin segment 2.6.2
PV1 Patient Visit segment 2.6.2

ORC Order common segment 2.6.3
OBR Observations Report ID segment 2.6.3
NTE Notes and comments segment 2.6.4

OBX Observation/Result segment 2.6.4
NTE Notes and comments segment 2.6.4


25
HL7 E-Path MSH, PID, NK1 Segments

• Message Header (MSH) Segment
• Message Control/Routing Information
• Sending facility
• Date and time of transmission
• Patient Identification (PID) Segment
• Patient Identification and Demographics
• Patient name
• SSN
• Gender
• Birth Date
• Next of Kin/Associated Parties (NK1) Segment
  (Optional)
• Next of kin
• Contact information

26
HL7 E-Path PV1, ORC, OBR Segments

• Patient Visit (PV1) Segment
• Provider information
• Attending physician
• Referring physician
• Common Order (ORC) Segment
• Pathology order information
• Ordering facility
• Ordering facility address
• Ordering facility AHA number
• Observation Request (OBR) Segment
• Information specific to the pathology
  request/order
• Type of report (i.e. final diagnosis,
  correction,)
• Date and time specimen received
• Pathologist interpreting the observation

27
HL7 E-Path OBX Segment

• Observation/Result (OBX) Segment
• Specific observation identifier (OBX-3)
• Identified by Logical Observation Identifiers
  Names and Codes (LOINC) or SNOMED CT Codes
• Examples
• Path-Final Diagnosis
• Path-Gross Pathology
• Specific observation (OBX-5)
• Examples
• Text of Gross Pathology
• Text of the Final Diagnosis
• OBX Segment carries the results of the pathology
  report as blocks of text

28
HL7 E-Path NTE, FHS, FTS, BHS, BTS Segments

• Notes and Comments (NTE) Segment (Optional)
• Comments from the laboratory
• When transmitting batches of HL7 messages using a
  file transfer protocol or offline via tape,
  diskettes or other media
• Batch Header (BHS) Segment
• Batch Trailer (BTS) Segment
• File Header (FHS) Segment (Optional)
• File Trailer (FTS) Segment (Optional)

29
Volume V HL7 Implementation Guide Segment
Specifications

• Each segment specification provides
• Attribute table
• An example segment
• Each segment field definition
• NAACCR segments and fields are tightly defined

30
NAACCR OBX Attribute Table
Seq Len DT Opt RP Tbl Item Element Name NAACCR Item NAACCR Opt
1 4 SI O 00569 Set ID-OBX R
2 3 ID C 0125 00570 Value type R
3 80 CE R 00571 Observation identifier 7400, 7410, 7420, 7430, 7440, 7450, 7460, 7470 R
4 20 ST C 00572 Observation sub-ID O
5 655361 C Y2 00573 Observation value R
6 60 CE O 00574 Units R
7 60 ST O 00575 Reference ranges O
8 5 ID O Y/5 0078 00576 Abnormal flags O
9 5 NM O 00577 Probability O
10 2 ID O Y 0080 00578 Nature of abnormal test O
11 1 ID R 0085 00579 Observation result status 7330 R
12 26 TS O 00580 Date last Obs normal values O
13 20 ST O 00581 User defined access checks O
14 26 TS O 00582 Date/time of the observation O
15 60 CE O 00583 Producer's ID O
16 80 XCN O Y 00584 Responsible observer O
17 60 CE O Y 00936 Observation method O
31
Excerpt from NAACCR OBX-3 Field Definition

• OBX-3 Observation identifier (CE-590, Required)
  00571
• Definition This field contains a unique
  identifier for the observation. It identifies
  what is being reported in OBX-5 for example,
  the specific test,
• or observation method, or component of the
  pathology report being reported.
• The CE data type transmits codes and the text
  associated with the code. This type has six
  components arranged in two groups as follows
• ltidentifier (ST)gtlttext (ST)gtltname of coding
  system (ST)gt
• ltalternate identifier (ST)gtltalternate text
  (ST)gt ltname of alternate coding system (ST)gt
• CE data type components are defined as follows
• Identifier (ST). The code that uniquely
  identifies the item being referenced by the
  lttextgt. Different coding schemes
• will have different elements here.
• (2) Text (ST). Name or description of the item
  in question.
• Name of coding system (ST). Identifies the coding
  system used. The combination of the identifier
  and the name of
• the coding system components will be a unique
  code for a data item.
• (4-6) Three components analogous to 1-3 for the
  alternate or local coding system.
• Note This is the field and components that will
  contain the text, LOINC, or SNOMED CT codes for
  the following NAACCR items

NAACCR Item Name LOINC Code
Path-Final Diagnosis 22637-3
Path-Text Diagnosis 33746-9
Path-Clinical History 22636-5
Path-Nature of Specimen 22633-2
Path-Gross Pathology 22634-0
Path-Micro Pathology 22635-7
Path-Comment Section 22638-1
Path-Suppl Reports 22639-9
32
Sample Path Report
33
Sample Path Report Page 2
34
Corresponding NAACCR HL7 Message
MSH\HLSHITECK PATH LAB-ATLANTA3D9328409CLI
ASTJ20031124122230ORUR01200311241222300023
P2.3.1 ltCRgt PID197 810430PIHITECK PATH
LAB-ATLANTA 3D9328409CLIA00466144PTST
JOSEPHS3932CMA3270686987PNUS
HEALTHCARESAMPLE30ALLAN19530621M112
BROAD STREETAPT 10ATLANTAGA30301
ltCRgt PV11ATTENDINGIDATTENDINGDRMANAGINGR
EFERRINGIDREFERRERFOLLOWUPDR
ltCRgt ORCREATLANTA CANCER
SPECIALISTSSTREET ADDRESS 1SUITE
ATLANTAGA30303ltCRgt OBR19781043011529-5SUR
GICAL PATH REPORTLNPATHOLOGY
REPORTL20030922EMLOYEEIDPHLEBOTOMISTPAMEL
A164341SURGEONHANNAHDRF
109772PATHOLOGISTQUINCY ltCRgt OBX1TX22637-3F
INAL DIAGNOSISLNDIAGNOSISL1LEFT INGUINAL
LYMPH NODE - GRANULOMATOUS LYMPHADENITISFltCR
gt OBX2TX22637-3FINAL DIAGNOSISLNDIAGNOSISL
1/ljm ltCRgt OBX3TXClinical HistoryL2?
lymphoma Quick SectionFltCRgt OBX4TX22633-2
Nature of SpecimenNSTissue SubmittedL3Left
inguinal nodeFltCRgt OBX5TX22634-0Gross
PathologyLNGross PathologyL4The specimen is
received fresh labelled lymph node. The specimen
consists of two nodes 2.3 and 2.2. cm each. The
cut surface is bulky tan to pink in colour and
fleshy.FltCRgt OBX6TX22634-0Gross
PathologyLNGross PathologyL4QP/jlmFltCR
gt OBX7TX11529-5SURGICAL PATHLNMicroscopicL
5Sections of left inguinal lymph node
demonstrated an encapsulated node which is
largely replaced by epithelioid granulomata
without necrosis. Special stains do not reveal
the presence of organisms. The background
lymphocytes are both B and T lymphocytes and
include macrophages and occasional neutrophils
and plasma cells. Reed-Sternberg cells are not
demonstrated.FltCRgt OBX8TX22639-9Suppleme
ntal Reports/AddendumLNSupplements/AddendaL6
Material was requested by Dr. D. Consult, Saint
Josephs Hospital for review. CltCRgt OBX9TX
22639-9Supplemental Reports/AddendumLNSupplem
ents/AddendaL6A report from Dr. C. Darwin was
received.CltCRgt OBX10TX22639-9Supplementa
l Reports/AddendumLNSupplements/AddendaL6DIA
GNOSIS Consistent with peripheral T-cell
lymphoma wilh epithelioid histocytes (Lennert's
lymphoma), see description and comment - lymph
node, left inguinal (biopsy from November 24,
1997). (See attached report). /HMBCltCRgt OBX
11TX22639-9Supplemental Reports/AddendumLNS
upplements/AddendaL6Tissue was submitted for
lymph node protocol. A report from Dr. B. Study,
Sunnybrook Health Science Center was
received.CltCRgt OBX12TXSupplements/Add
endaL7DIAGNOSIS (See attached report). LYMPH
NODE INGUINAL REGION, BIOPSY. NON-NECROTIZING
GRANULOMATOUS LYMPHADENITIS. /hmbCltCRgt OBX1
3SN21612-7Reported PatientAgeLNPat_ageL1
050YFltCRgt
35
NAACCR Volume V Chapter 3Pipe-Delimited Format

• ASCII pipe () delimited layout
• Defines 77 key data fields
• Similar look and feel as NAACCR Volume II
  (Registry Data Exchange Standard)
• Dictionary definition for each field
• Name, NAACCR Item , max length, standard, field
  position
• Includes a pipe-delimited/HL7 comparison table
• Can be used alone or in conjunction with HL7
  messages
• Simple but not as robust and flexible as HL7

36
Real World Experience with NAACCR HL7 E-Path
Standard

• Labcorp has been working with CDC to implement
  NAACCR HL7 messages as part of a pilot project in
  2005
• Initial feedback
• They felt it was a piece of cake Wendy
  Scharber, Federal Contractor
• Difficulties encountered with required when
  available (R) fields
• Otherwise, has been largely successful

37
The Next Challenge Encoded Synoptic Pathology
Reports

• College of American Pathologists (CAP) have
  defined standard Cancer Protocols and Checklists
  for pathology reports
• http//www.cap.org/
• Protocols and checklists are provided by Site
• Breast, Colon and Rectum, Lung, Prostate, etc.
• Computerized checklists are being implemented by
  Laboratory Information System vendors
• Computerized, synoptic reports following CAP
  protocols are represented by encoded data
  elements instead of text blobs
• NAACCR HL7 standard is being extended to
  accommodate synoptic pathology reports

38
Progress Towards Synoptic Reporting

• CDC/NPCR has sponsored two pilot projects using
  synoptic reports
• Reporting Pathology Protocols (RPP) Project I
• Colorectal
• RPP II
• Breast, Prostate, Melanoma
• Path reports transmitted with HL7
• E-Path Transmission Work Group is building upon
  efforts of the RPP projects
• Face to face meeting in May began work on Lung

39
Continuing Work

• Revise Volume V with lessons learned from real
  world implementations
• Continue to expand support for synoptic reporting
  to include all CAP Checklist sites
• Support for tissue banking
• Conformance testing tools

40
NAACCR HL7 Standard and HL7 Pathology Special
Interest Group

• HL7 Path SIG chaired by John Madden and John
  Gilbertson
• Plan to recognize NAACCR 2.3.1 standard
• Moving forward with development of a HL7 Version
  3 CDA model to facilitate other immediate needs
• imaging

41
Issues/Challenges with NAACCR HL7 Standard

• Less technical cancer registries may have
  difficulties implementing an HL7 interface
• Path vendors may be slow to implement standard
• Defining a standard does not make it a standard
  that gets used!
• NAACCR needs to market standard
• HL7 Version 3 CDA

42
Conclusions

• E-Path implementations between path labs and
  cancer registries will continue to expand at a
  rapid pace
• NAACCR HL7 standards will facilitate and reduce
  implementation costs
• As a result of standards based E-Path reporting,
  opportunities for collaboration between cancer
  registries and pathology research will grow
• Collaborations between pathology and cancer
  registries has the potential to enhance the data
  necessary for both interests

43
Contact Information

• Eric B. Durbin, MS
• Director of Cancer Informatics
• Markey Cancer Control Program/Kentucky Cancer
  Registry
• University of Kentucky
• 2365 Harrodsburg Rd, Ste A230
• Lexington, KY 40504-3381
• ericd_at_kcr.uky.edu
• [phone] x223
• http//www.kcr.uky.edu