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. Acknowledgements:E-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. What’s 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 CDC’s 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: ORU^R01 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 • ORU^R01 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|^~\&|HLS|HITECK PATH LAB-ATLANTA^3D9328409^CLIA||STJ|20031124122230||ORU^R01|200311241222300023|P|2.3.1|||||||||2.0 <CR>

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 OBX|1|TX|22637-3^FINAL DIAGNOSIS^LN^^DIAGNOSIS^L|1|LEFT INGUINAL LYMPH NODE - GRANULOMATOUS LYMPHADENITIS||||||F<CR> OBX|2|TX|22637-3^FINAL DIAGNOSIS^LN^^DIAGNOSIS^L|1|/ljm <CR> OBX|3|TX|^^^^Clinical History^L|2|? lymphoma Quick Section||||||F<CR>

24. NAACCR HL7 E-Path Message Structure ORU - Unsolicited Observation Message (event R01)

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

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: • <identifier (ST)>^<text (ST)>^<name of coding system (ST)>^ • <alternate identifier (ST)>^<alternate text (ST)> ^<name of alternate coding system (ST)> • CE data type components are defined as follows: • Identifier (ST). The code that uniquely identifies the item being referenced by the <text>. 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:

32. Report Identification Patient Information Institution: 3932 Chart/MRN: 00466144 Address 112 Broad Street Pathology ID: 97 810430 SSN/SIN: Apartment 10 Report Date: 2003-11-24 Surname: SAMPLE30 City/Town: ATLANTA Report Type: Correction Given Name: ALLEN State/Prov: GA Requester ID: Sex: M Zip/Post Code: 30301 Requester: Date of Birth: 1953-06-21 Country: Procedure Date: 2003-09-22 Age: 47 (at procedure date) Surgeon ID: 163741 Insurer: USHC Surgeon: CHARLES, HANNAH Insurance No: 3270686987 Pathologist ID: 109771 Race: Pathologist: MARTIN, QUINCY Ethnicity: DIAGNOSIS LEFT INGUINAL LYMPH NODE - GRANULOMATOUS LYMPHADENITIS jlm Clinical History 47-year old white female with (L) UOQ breast mass Tissue Submitted Left inguinal node Gross Pathology: The specimen is received fresh labeled 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. MQ/jlm Sample Path Report

33. Microscopic Sections of left inguinal lymph node demonstrated an encapsulated node which is largely replaced by epithelioid granulomate 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. Supplements/Addenda Material was requested by Dr. D. Bannerly, Saint Joseph’s Hospital for review. A report from Dr. Patterson was received. 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, 2003) (See attached report). /hmb Tissue was submitted for lymph node protocol. A report from Dr. H. Perez, Chandler Health Science Center was received. DIAGNOSIS: (See attached report). LYMPH NODE; INGUINAL REGION, BIOPSY: NON-NECROTIZING GRANULOMATOUS LYMPHADENITIS. /hmb HITECK PATHOLOGY LABORATORY ATLANTA, GA 30303 HTECK LABORATORY SYSTEMS, INC. Sample Path Report Page 2

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

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@kcr.uky.edu (859)219-0773 x223 http://www.kcr.uky.edu