National HL7 Standards for Electronic Pathology Reporting to Cancer Registries

National HL7 Standards for Electronic Pathology Reporting to Cancer RegistriesEric B. Durbin, MSDirector of Cancer InformaticsMarkey Cancer Control Program/Kentucky Cancer RegistryUniversity of Kentucky

APIII, August 18, 2006Vancouver, British Columbia

OverviewValue of electronic pathology (E-Path) reporting and data standardsHistory of North American Association of Central Cancer Registries (NAACCR) E-Path standardsNAACCR Standards Volume V: Pathology Laboratory Electronic ReportingHL7 tutorialHL7 E-Path messagesAlternative delimited layoutContinuing work (standardized synoptic reporting)

Value of E-Path Data StandardsFacilitate the transmission of electronic dataDefine the structure and meaning of the data for senders and recipientsReduce costs for path labs and cancer registriesAllow senders and recipients to build a single interfaceSingle interface can meet needs of multiple senders and receivers

E-Path Benefits to Oncology and Pathology ResearchE-Path implementations reduce the time from cancer diagnosis until the availability of high quality, well defined and structured research dataMore timely high quality data offers new opportunities to use registry based pathology data for research purposesRegistry data is currently an underutilized resource

The Gold Standard in Quality: Central Cancer Registry DataCentral cancer registries are in the business of collecting high quality population based dataRegistries routinely collect:Patient Demographics (current and at diagnosis)Race, gender, geography, family historySite/HistologyStaging (TNM, Collaborative Stage, Summary Stage)Comprehensive therapy dataLong-term survival and follow-up (outcomes) information (for lifetime of patient)Many other standard data elements

Professional Data CollectionRegistry data is collected by trained professionals Certified Tumor Registrars (CTR) - ACoSRegistry data is highly scrutinized for data quality and consistencyEdit checks during collectionEdit checks at central registryEdit checks prior to submissions to federal and national agenciesCDC, NCI/SEER, NAACCR, ACoSFrequent audits of data completeness and qualityData standards of quality is required by funding agencies

Role of Pathology Data in Cancer RegistrationOver 90% of all cancers are microscopically confirmed by pathology reportPathology reports typically provide:Demographics (limited)Diagnosis datesSite/Histology/Grade/LateralityTNM stagingTumor sizeIdentification of sources necessary for follow-back for additional registry dataPhysicians, involved institutions, etc.Other valuable data elements and text

Additional Benefits of E-Path to Cancer RegistriesRapid case ascertainment for research studiesBefore patient is deceasedPrior to confounding effects of treatmentClinical trials patient identification and recruitmentCentral registry audits of reporting hospital registries (hospital based E-Path)Earlier assessment of incidence rates

Benefits of E-Path to Tissue BankingShort termAutomated, near real-time annotation of path based data soon after specimen collectionTargeted specimen identificationLong termAvailability of long term outcome dataAbility to associate specimen data with population based data for patients with similar or dissimilar characteristics

NAACCR, Inc.North American Association of Central Cancer RegistriesProfessional organization established in 1987Enhancing quality and use of cancer registry data Develops and promotes uniform data standards for cancer registriesFirst data exchange standard published in 1994Members include central cancer registries and many other govt. agencies, organizations and individualsGoverned by elected board of directorsFunds an executive officeVarious committees, sub-committees and work groupshttp://www.naaccr.org

Acknowledgements:E-Path Transmissions Work Group 2005-2006Eric B. Durbin, MS (Chair)Kentucky Cancer Registry

Lori A. Havener, CTR NAACCR Toshi Abe, MSW, CTRNew Jersey State Cancer Registry

Mayra Alvarez, RHIT, CTRFlorida Cancer Data System

Steve BartaIMPAC

Victor BrunkaArtificial Intelligence In Medicine, Inc.

Ken Gerlach, MPH, CTRCDC/NPCR

Barry Gordon, PhDCalifornia Cancer RegistryJovanka Harrison, PhDNew York State Cancer Registry Keith Laubham, MS Arizona Cancer Registry J. A. Magnuson, PhD, RS Oregon Health Services Mark Rudolph (Alternate)Florida Cancer Data Systems

Wendy Scharber, RHIT, CTR Minnesota Cancer Surveillance System Advisors to Work Group:

Mary HamiltonCDCAustin KrieslerCDC

Margaret Marshburn CDC

Brief History of the Quest for E-Path StandardsNAACCR board commissioned the quest in 2003IT CommitteeE-Path Sub-committeeE-Path Transmission Work Group was formedBuilt on previous work by NAACCR and CDCConducted monthly and bi-weekly teleconferences for over two yearsNAACCR Volume V was ratified and published in November 2005

Alas, the Holy Grail!

Typical E-Path Data Flow

Server

Cloud

Data

Minicomputer

Lab Information System

Internet(Secure/Encrypted)

Path Reports in HL7

HL7 Parser/Translator

Central Registry

HL7 Writer Configured to export NAACCR HL7 Messages

Path Reports in NAACCR Delimited Layout

Optional Simultaneous Transmissionto Hospital Registry

Path Lab E-Path Transmissions

Registry E-Path Receiving

Whats In NAACCR Volume V?

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

Two Standard FormatsHealth Level Seven (HL7)http://www.hl7.org/Flexible and robust protocol widely utilized for electronic data transmissions by medical facilities and pathology LaboratoriesPipe-Delimited FormatLess sophisticated (less technically challenging)Retained for legacy e-path reporting systemsMay be used alone or in conjunction with HL7

NAACCR Volume V: Chapter 2HL7 Implementation GuideBased upon CDCs infection disease reporting HL7 implementation guideExplicitly defines the HL7 format necessary to transmit a pathology report to a cancer registrySpecifies how and where to place each pathology report data elementDefines requirement status for each variableRequiredRequired when availableOptionalProvides examples throughout

The HL7 StandardNAACCR Standard is for HL7 Version 2.3.1American National Standards Institute (ANSI) approved in 1999HL7 Versions 2.4, 2.5 also approved2.3.1 still most commonly supported versionHL7 Version 3.x radically different from 2.x versionsClinical Document Architecture (CDA) is appealingXMLBut, not yet widely supported by AP-LIS vendors

HL7 Basics: ORU^R01 Message TypeLab result information is reported through Observational Results (Unsolicited) (ORU)/Event R01 messagesUnsolicited messages are transmitted at will from the sender and do not require an electronic request from the recipientORU^R01 messages are composed of specifically defined HL7 segments

HL7 Basics: Delimited Data FieldsHL7 messages are ASCII textAll data fields in an HL7 message are delimited by a specified separatorThe delimiter is defined at the beginning of an HL7 messageUsually the | (pipe) characterField in each position is defined (MSH-1, MSH-2, MSH-3 MSH-21) MSH|^~\&|HLS|HITECK PATH LAB-ATLANTA^3D9328409^CLIA||STJ|20031124122230||ORU^R01|200311241222300023|P|2.3.1|||||||||2.0

HL7 Basics: SegmentsVarious HL7 segments carry categories of informationEach segment type is identified by a three character id at the beginning of the segment such as MSH, PID, OBR, OBXSome segments can be repeated in a messageRepeating segments are sequentially numberedOBX|1|TX|22637-3^FINAL DIAGNOSIS^LN^^DIAGNOSIS^L|1|LEFT INGUINAL LYMPH NODE - GRANULOMATOUS LYMPHADENITIS||||||FOBX|2|TX|22637-3^FINAL DIAGNOSIS^LN^^DIAGNOSIS^L|1|/ljm OBX|3|TX|^^^^Clinical History^L|2|? lymphoma Quick Section||||||F

NAACCR HL7 E-Path Message StructureORU - Unsolicited Observation Message (event R01)

ORU^R01Observational Results (Unsolicited) SectionMSHMessage Header segment2.6.1 PIDPatient Identification segment2.6.2 [{NK1}]Next-Of-Kin segment2.6.2 [PV1]Patient Visit segment2.6.2 { [ORC]Order common segment2.6.3 OBRObservations Report ID segment2.6.3 {[NTE] } Notes and comments segment2.6.4 { [OBX]Observation/Result segment2.6.4 { [NTE] }Notes and comments segment2.6.4 } }

HL7 E-Path MSH, PID, NK1 SegmentsMessage Header (MSH) SegmentMessage Control/Routing InformationSending facilityDate and time of transmissionPatient Identification (PID) SegmentPatient Identification and DemographicsPatient nameSSNGenderBirth DateNext of Kin/Associated Parties (NK1) Segment (Optional)Next of kinContact information

HL7 E-Path PV1, ORC, OBR SegmentsPatient Visit (PV1) SegmentProvider informationAttending physicianReferring physicianCommon Order (ORC) SegmentPathology order informationOrdering facilityOrdering facility addressOrdering facility AHA numberObservation Request (OBR) SegmentInformation specific to the pathology request/orderType of report (i.e. final diagnosis, correction,)Date and time specimen receivedPathologist interpreting the observation

HL7 E-Path OBX SegmentObservation/Result (OBX) SegmentSpecific observation identifier (OBX-3)Identified by Logical Observation Identifiers Names and Codes (LOINC) or SNOMED CT CodesExamples:Path-Final DiagnosisPath-Gross PathologySpecific observation (OBX-5)Examples:Text of Gross PathologyText of the Final DiagnosisOBX Segment carries the results of the pathology report as blocks of text

HL7 E-Path NTE, FHS, FTS, BHS, BTS SegmentsNotes and Comments (NTE) Segment (Optional)Comments from the laboratoryWhen transmitting batches of HL7 messages using a file transfer protocol or offline via tape, diskettes or other mediaBatch Header (BHS) SegmentBatch Trailer (BTS) SegmentFile Header (FHS) Segment (Optional)File Trailer (FTS) Segment (Optional)

Volume V HL7 Implementation Guide Segment SpecificationsEach segment specification provides:Attribute tableAn example segmentEach segment field definitionNAACCR segments and fields are tightly defined

NAACCR OBX Attribute Table

Excerpt from NAACCR OBX-3 Field DefinitionOBX-3 Observation identifier (CE-590, Required) 00571Definition: 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: ^^^ ^ ^CE data type components are defined as follows: Identifier (ST). The code that uniquely identifies the item being referenced by the . 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 NameLOINC CodePath-Final Diagnosis22637-3Path-Text Diagnosis33746-9Path-Clinical History22636-5Path-Nature of Specimen22633-2Path-Gross Pathology22634-0Path-Micro Pathology22635-7Path-Comment Section22638-1Path-Suppl Reports22639-9

Sample Path Report

Sample Path Report Page 2

Corresponding NAACCR HL7 MessageMSH|^~\&|HLS|HITECK PATH LAB-ATLANTA^3D9328409^CLIA||STJ|20031124122230||ORU^R01|200311241222300023|P|2.3.1 PID|1||97 810430^^^^PI^HITECK PATH LAB-ATLANTA &3D9328409&CLIA~00466144^^^^PT^ST JOSEPHS&3932&CMA~3270686987^^^^PN^US HEALTHCARE||SAMPLE30^ALLAN||19530621|M|||112 BROAD STREET^APT 10^ATLANTA^GA^30301^ PV1|1||||||ATTENDINGID^ATTENDINGDR^MANAGING|REFERRINGID^REFERRER^FOLLOWUP^^^DR| ORC|RE||||||||||||||||||||ATLANTA CANCER SPECIALISTS|STREET ADDRESS 1^SUITE #^ATLANTA^GA^30303OBR|1||97810430|11529-5^SURGICAL PATH REPORT^LN^^PATHOLOGY REPORT^L|||20030922|||EMLOYEEID^PHLEBOTOMIST^PAMELA|||||164341^SURGEON^HANNAH^^^DR||||||||||F||||||||109772&PATHOLOGIST&QUINCY OBX|1|TX|22637-3^FINAL DIAGNOSIS^LN^^DIAGNOSIS^L|1|LEFT INGUINAL LYMPH NODE - GRANULOMATOUS LYMPHADENITIS||||||FOBX|2|TX|22637-3^FINAL DIAGNOSIS^LN^^DIAGNOSIS^L|1|/ljm OBX|3|TX|^^^^Clinical History^L|2|? lymphoma Quick Section||||||FOBX|4|TX|22633-2^Nature of Specimen^NS^^Tissue Submitted^L|3|Left inguinal node||||||FOBX|5|TX|22634-0^Gross Pathology^LN^^Gross Pathology^L|4|The 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.||||||FOBX|6|TX|22634-0^Gross Pathology^LN^^Gross Pathology^L|4|QP/jlm||||||FOBX|7|TX|11529-5^SURGICAL PATH^LN^^Microscopic^L|5|Sections 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.||||||FOBX|8|TX|22639-9^Supplemental Reports/Addendum^LN^^Supplements/Addenda^L|6| Material was requested by Dr. D. Consult, Saint Josephs Hospital forreview. ||||||COBX|9|TX|22639-9^Supplemental Reports/Addendum^LN^^Supplements/Addenda^L|6|A report from Dr. C. Darwin was received.||||||COBX|10|TX|22639-9^Supplemental Reports/Addendum^LN^^Supplements/Addenda^L|6|DIAGNOSIS: 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). /HMB||||||COBX|11|TX|22639-9^Supplemental Reports/Addendum^LN^^Supplements/Addenda^L|6|Tissue was submitted for lymph node protocol. A report from Dr. B. Study, Sunnybrook Health Science Center was received.||||||COBX|12|TX|^^^^Supplements/Addenda^L|7|DIAGNOSIS: (See attached report). LYMPH NODE; INGUINAL REGION, BIOPSY. NON-NECROTIZING GRANULOMATOUS LYMPHADENITIS. /hmb||||||COBX|13|SN|21612-7^Reported PatientAge^LN^^Pat_age^L|1|^050|Y||||||F

NAACCR Volume V: Chapter 3Pipe-Delimited FormatASCII pipe (|) delimited layoutDefines 77 key data fieldsSimilar look and feel as NAACCR Volume II (Registry Data Exchange Standard)Dictionary definition for each fieldName, NAACCR Item #, max length, standard, field positionIncludes a pipe-delimited/HL7 comparison tableCan be used alone or in conjunction with HL7 messagesSimple but not as robust and flexible as HL7

Real World Experience with NAACCR HL7 E-Path StandardLabcorp has been working with CDC to implement NAACCR HL7 messages as part of a pilot project in 2005Initial feedback: They felt it was a piece of cake Wendy Scharber, Federal ContractorDifficulties encountered with required when available (R*) fieldsOtherwise, has been largely successful

The Next Challenge: Encoded Synoptic Pathology ReportsCollege of American Pathologists (CAP) have defined standard Cancer Protocols and Checklists for pathology reportshttp://www.cap.org/Protocols and checklists are provided by SiteBreast, Colon and Rectum, Lung, Prostate, etc.Computerized checklists are being implemented by Laboratory Information System vendorsComputerized, synoptic reports following CAP protocols are represented by encoded data elements instead of text blobsNAACCR HL7 standard is being extended to accommodate synoptic pathology reports

Progress Towards Synoptic ReportingCDC/NPCR has sponsored two pilot projects using synoptic reportsReporting Pathology Protocols (RPP) Project IColorectalRPP IIBreast, Prostate, MelanomaPath reports transmitted with HL7E-Path Transmission Work Group is building upon efforts of the RPP projectsFace to face meeting in May began work on Lung

Continuing WorkRevise Volume V with lessons learned from real world implementationsContinue to expand support for synoptic reporting to include all CAP Checklist sitesSupport for tissue bankingConformance testing tools

NAACCR HL7 Standard and HL7 Pathology Special Interest GroupHL7 Path SIG chaired by John Madden and John GilbertsonPlan to recognize NAACCR 2.3.1 standardMoving forward with development of a HL7 Version 3 CDA model to facilitate other immediate needsimaging

Issues/Challenges with NAACCR HL7 StandardLess technical cancer registries may have difficulties implementing an HL7 interfacePath vendors may be slow to implement standardDefining a standard does not make it a standard that gets used!NAACCR needs to market standardHL7 Version 3 CDA

ConclusionsE-Path implementations between path labs and cancer registries will continue to expand at a rapid paceNAACCR HL7 standards will facilitate and reduce implementation costsAs a result of standards based E-Path reporting, opportunities for collaboration between cancer registries and pathology research will growCollaborations between pathology and cancer registries has the potential to enhance the data necessary for both interests

Contact InformationEric B. Durbin, MSDirector of Cancer InformaticsMarkey Cancer Control Program/Kentucky Cancer RegistryUniversity of Kentucky2365 Harrodsburg Rd, Ste A230Lexington, KY 40504-3381ericd@kcr.uky.edu(859)219-0773 x223http://www.kcr.uky.edu