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Pathology Information, Terminology and Units Standardisation project
(PITUS 15-16)
Final Report to Commonwealth of Australia
Department of Health 30 April 2017 (extended to 15 May 2017)
RCPA | PITUS-15-16 project | Final Report – 30 April 2017 (extended to 15 May 2017)
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Document Control
Date Version Action Owner/Author
15 May 17 1.0 Final report for PITUS 15-16. Donna Moore
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Contents
1. Glossary of terms & acronyms .................................................................................................................... 4
2. Executive summary ..................................................................................................................................... 6
3. Project statement ........................................................................................................................................ 8
3.1 Background ...................................................................................................................................... 8
4. Scope .......................................................................................................................................................... 9
4.1 Purpose ............................................................................................................................................ 9
4.2 Project Objectives ............................................................................................................................ 9
4.3 Exclusions ........................................................................................................................................ 9
5. Project management ................................................................................................................................. 10
5.1 Governance structure .................................................................................................................... 10
5.2 Steering Committee ....................................................................................................................... 11
5.3 Working groups .............................................................................................................................. 11
5.4 Stakeholders .................................................................................................................................. 12
6. Project Activities ........................................................................................................................................ 15
6.1 Reporting requirements ................................................................................................................. 15
6.2 Project accomplishments ............................................................................................................... 15
6.3 Key activity indicators / milestones / (KPIs) ................................................................................... 19
6.4 Status of the Communication strategy ........................................................................................... 21
6.5 Documentation summary ............................................................................................................... 27
7. Project Issues and Challenges ................................................................................................................. 31
7.1 Issues Register .............................................................................................................................. 31
7.2 Project challenges ......................................................................................................................... 32
8. Financials .................................................................................................................................................. 36
9. References ................................................................................................................................................ 37
10. Appendices ............................................................................................................................................ 38
10.1 Appendix A - PITUS 15-16 Project One-page plan ....................................................................... 39
10.2 Appendix B - PITUS 15-16 Working groups - Summary and Key deliverables ............................. 41
10.3 Appendix C - Project Activity Plan (as at 30 April 2017) ............................................................... 48
10.4 Appendix D - Release Note - RCPA - Pathology Terminology and Information Models v1.0 ....... 65
10.5 Appendix E - Release Note - RCPA - Pathology Terminology and Information Models v1.1 ....... 66
10.6 Appendix F - Trial implementation for atomic reporting of cancer to registries ............................. 67
10.7 Appendix G - Trial implementation of an Informatics External Quality Assurance (IEQA) Program 72
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1. Glossary of terms & acronyms
Acronym Detail
AACB Australian Society of Clinical Biochemists
ACHI Australian College of Health Informatics
the Agency Australian Digital Health Agency (formerly NEHTA)
AHML Australian Healthcare Messaging Laboratory
APUTS Australian Pathology Units and Terminology Standardisation (Standards and Guidelines), from now known as Standards for Pathology Informatics in Australia (SPIA).
CIS Clinical Information System
HISA Health Informatics Society of Australia
HL7 Health Level Seven
IFCC International Federation of Clinical Chemistry
IHTSDO International Health Terminology Standards Development Organisation
LIS Laboratory Information System
LOINC Logical Observation Identifiers Names and Codes
MSIA Medical Software Industry Association
MyHR My Health Record, previously known as Personally controlled electronic health record (PCEHR)
NATA National Association of Testing Authorities, Australia
NCOPP National Coalition of Public Pathology
NCTS National Clinical Terminology Service
NPAAC National Pathology Accreditation Advisory Council, Australia
PAC Pathology Associations Council
PCEHR Personally controlled electronic health record (now known as MyHealth record or MyHR)
PITUS Pathology Information, Terminology and Units Standardisation project (current project is PITUS 15-16)
PUTS Pathology Units and Terminology Standardisation (Project)
RACGP The Royal Australian College of General Practitioners
RACP The Royal Australasian College of Physicians
RCPA Royal College of Pathologists of Australasia
RCPAQAP RCPA Quality Assurance Programs Pty Ltd
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Acronym Detail
SNOMED Systematized Nomenclature of Medicine
SPIA Standards for Pathology Informatics in Australia, previously known as Australian Pathology Units and Terminology Standardisation (Standards and Guidelines)
SPRC Structured Pathology Report of Cancer
UCUM Unified Code for Units of Measure
wg PITUS 15-16 Working group
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2. Executive summary The Royal College of Pathologists of Australasia (RCPA), with the support of the Department of Health, have been leading a program to standardise pathology information, terminology and units for safety and quality.
The Pathology Information, Terminology and Units Standardisation (PITUS 15-16) project involved the collective efforts of key stakeholders (Department of Health, the Agency, RACGP, PAC, AACB, HL7 Australia and RCPA Advisory Committees) to develop standards for pathology requesting and reporting, and to facilitate adoption of these by pathology providers and associated stakeholders (clinicians, registries, MyHR).
This Project aligns with the Department of Health’s published national E-Health strategy, including the MyHR, and Quality Use of Pathology Program (QUPP) and focused on activities that support quality consumer services, quality pathology requesting and quality pathology practice. The Project has contributed to a sustainable healthcare system that will improve the health outcomes for all patients through the development of pathology standards required for safe sharing and use of information between pathology providers and associated stakeholders. To this extent, the Project delivered:
• Best practice guidance for safe communication of pathology requests (computer generated requests communicated via paper and electronic messaging) and pathology reports (printed and electronic);
• An updated list of commonly requested pathology tests with 481 new pathology tests assigned a SNOMED CT-AU code to support electronic pathology requesting between pathology referrers (clinicians, physicians, etc.) and providers;
• Comprehensive and current pathology information models and terminology reference sets, required for atomic pathology reporting and support for the implementation of the MyHR through: o Over 900 updates and amendments to the RCPA published pathology reporting
information models and terminology reference sets developed under PITUS-14; o New information models and terminology reference sets for colorectal cancer and
prostate cancer (radical prostatectomy) structured pathology reporting of cancer protocols;
• New harmonised adult reference intervals for six (6) chemical pathology analytes (Bilirubin, Creatine kinase, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyltransferase and Lipase) to aid with the clinical interpretation of the pathology results for these analytes and assist clinicians with diagnosis, treatment and management of a patient.
The Project also worked with a number of external organisations on four separate sub projects to develop standards for atomic pathology reporting and method for compliance: • The Agency: to deliver a secure, efficient and accessible system for publishing the RCPA Board
approved pathology information models and terminology reference sets on the Agency’s National Clinical Terminology Service (NCTS) website, which will provide pathology providers and associated stakeholders with access to the information required for the implementation of safe electronic communication of pathology requesting and reporting.
• HL7 Australia: to draft the Australian Pathology Messaging - Localisation of HL7 v2.4. This involved localisation of the HL7 International messaging that provides the required information for implementers of electronic pathology messaging in one document. This adaptation of
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localised HL7 standards facilitates safe electronic communication of pathology requesting and reporting between pathology providers and associated stakeholders.
• Cancer Institute of NSW, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology: to develop standards for safe atomic pathology reporting and undertook a trial implementation to demonstrate how atomic reporting of RCPA SPRC reports can be shared between sending (pathology providers) and receiving (clinicians, cancer registries, MyHR) organisations’ computer systems. This trial demonstrated that atomic reporting of SPRC reports is possible by using pathology information models and terminology reference sets and the new HL7 Australia’s FHIR standard for SPRC reporting. However the Project concluded that further development of the HL7’s FHIR standards is required before broader implementation can proceed.
• RCPAQAP: to develop and trial an Informatics Quality Assurance (IEQA) program, to assess the compliance of electronic HL7 pathology report messages against the standards published by HL7 Australia and pathology reporting standards published by the RCPA. The success of this trial demonstrated the potential of how an external quality assurance program will be useful for accrediting bodies such as NATA, as part of the accreditation of pathology providers in Australia, and will facilitate the adoption of pathology informatics standards by pathology providers and associated stakeholders.
The structured pathology reporting of cancer protocols developed by the RCPA SPRC Project, and the pathology information models and terminology reference sets developed by this Project enable pathology providers to deliver higher quality, standardised information to their stakeholders by increasing the timeliness and completeness of the pathology report. This level of improvement in pathology reporting will provide benefits in cancer management and planning services as well as improving patient health outcomes.
The Final Report outlines the Project achieving the KPIs and other project deliverables.
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3. Project statement
3.1 Background
Research has highlighted that most pathology related errors occur in the pre-analytical and post-analytical phases1,2 and so interoperability between computer systems for both requesting and reporting pathology offers the most opportunities for quality and safety improvement3. Interoperability is the ability of two parties, either human or machine, to exchange data or information in a manner that preserves shared meaning to make healthcare safer, more efficient and more effective3.
Interoperability requires standardisation of terminology, information and transmission of data; and this was a key reason this Project focussed on improving standards development and publishing of standardised terminology for requesting and reporting of pathology. The importance of standardisation of pathology terminology is addressed in a review entitled ‘Standardisation of test requesting and reporting for the electronic health record’3.
Pathology reports were once produced in isolation by a specific pathology department within a specific hospital/laboratory. However these reports are now distributed more widely within different healthcare settings including hospitals, community medical practices, indigenous health services, aged care institutions, allied health practices and can be used to cover the whole patient diagnosis and treatment. These pathology reports are often synthesised from the results and records of multiple and sometimes unrelated pathology providers. It is routine practice for clinicians to receive reports from multiple pathology providers, and in some cases for these to be further aggregated into state health records.
The Department of Health designed and implemented the MyHR to facilitate the aggregation of health records at a national level, and the PITUS 15-16 Project developed standards for pathology reporting that can be used to assist with sharing data between sending (pathology providers) and receiving (clinicians, MyHR, registries, etc.) organisations’ computer systems, that will facilitate the safe clinical interpretation of pathology results.
The components of a pathology report are frequently used by clinicians in decision support tools, comparative displays and analysis of pathology results; and this wider use has increased the risk of misinterpretation of pathology results if comparisons of terminology and units by the end users differ. For example, Troponin I test results from Point-of-Care testing and laboratory instruments are reported in the same units i.e. ng/L, however the results from different methods may be significantly different and should not be compared. Consensus amongst chemical pathologists is that these results must not be reported on the same line of a cumulative report, displayed or used for comparison because it could lead to misinterpretation of the results. For safe clinical interpretation of these results it is important that the electronic pathology report message contains standardised terminology.
The increased usage of pathology reports within diverse healthcare settings, combined with the growing desire to better utilise pathology result data in other computer systems, including the MyHR, registries, GP Desktop systems, decision support systems, etc. has resulted in a drive to standardise pathology measurement units and terminology3 and the need to develop methods for conformance testing, compliance and accreditation to ensure the integrity of the pathology result data shared between computer systems.
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4. Scope
4.1 Purpose
The aim of the Pathology Information, Terminology and Units Standardisation (PITUS 15-16) project (the Project) was to develop standards for information in pathology requesting and reporting, and to facilitate the adoption of these standards by pathology providers and associated stakeholders to allow safer and improved quality use of pathology. The Project identified with the Department of Health’s Quality use of pathology program (QUPP) objectives and focused on delivering activities that provide quality consumer services, quality pathology requesting and quality pathology practice required for the broader National E-Health program’s success as reinforced by the findings from the Review of the Personally Controlled Electronic Health Record led by Richard Royle.
The work undertaken by the PITUS 15-16 Project focused on the development, promotion and adoption of pathology standards, information models and terminology reference sets for the electronic communication of requesting and reporting pathology by pathology providers. The Project also developed methods for conformance testing, compliance and accreditation to ensure the integrity of the pathology result data that is shared between computer systems.
4.2 Project Objectives
The key objectives of the PITUS 15-16 Project were:
• Develop standards, information model and terminology reference sets for safe atomic reporting of pathology in preparation for the implementation of the My Health Record;
• Improve health outcomes for patients through the provision of improved pathology requesting and reporting by ensuring standards, information model and terminology reference sets are comprehensive, current and accessible;
• Improve the quality of pathology reporting by establishing a compliance and accreditation environment for pathology terminology to be used by accrediting bodies;
• Provide safer and better quality use of pathology services by developing an implementation checklist for best practice in the use of clinical information systems for the requesting of pathology, records management and follow-up of pathology reports;
• Drive adoption, compliance and accreditation of the standards across the pathology industry.
4.3 Exclusions
The following were exclusions for this Project:
• The Project funding did not include payment for pathologists and other working group member’s time.
• The Agency was responsible for any costs associated with setup of the Agency website for the publication of the RCPA Board approved requesting and reporting terminology standards.
• The standards and guidelines published by this Project are not mandatory for pathology providers, registries and other pathology users, but will be reviewed by NPAAC for possible inclusion in a future version of the NPAAC standards.
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5. Project management
5.1 Governance structure
Figure 1 – Governance structure for the PITUS 15-16 Project
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5.2 Steering Committee
The PITUS 15-16 Steering Committee included representatives from the key stakeholder groups (Department of Health, the Agency, RACGP, PAC, AACB, HL7 Australia and the RCPA Advisory Committees) and had linkages to many others; and included representatives from pathology organisations within the public and private sectors. The Project divided the workload amongst 6 working groups and the chairs of each working group were also members of the Steering Committee, the working groups are:
1. Standards development and publishing (wg1) 2. Safety in pathology reporting (wg2) 3. Request and report terminology (wg3) 4. Request modelling (wg4) 5. Report modelling (wg5) 6. Informatics quality assurance (wg6)
See section 5.1 Governance structure for more details.
The Steering Committee was responsible for the co-ordination and oversight of the Project, and for promoting all Project activities at conferences and other related events, newsletters, journal articles and associated networks.
The PITUS 15-16 Project one-page plan summarises the Project vision, key result areas and activities of each working group, see Section 10.1 – Appendix A.
The Steering Committee held 3 meetings, first meeting on 29 July 2015; second meeting on 7 April 2016; and the final meeting was held on 24 November 2016. Copies of the minutes from these meetings are available from the RCPA Project Management Office upon request.
Key deliverables from the PITUS Steering Committee:
- PITUS 15-16 One page plan – see Section 10.1 – Appendix A - PITUS Update Issue 4 newsletter - circulated on 14 September 2015 - PITUS Update Issue 5 newsletter - circulated on 11 April 2016 - PITUS Update Issue 6 newsletter - circulated on 23 September 2016 - PITUS Update Issue 7 newsletter - circulated on 4 April 2017
5.3 Working groups
The PITUS 15-16 Project had 6 working groups:
wg1 Standards development and publishing
Working group 1 (wg1) focused on establishing efficient and safe electronic publishing of pathology information models and terminology reference sets by working with the Agency to publish pathology information models (terminology required when rendering a complex text or structured pathology report) and terminology (standardised preferred term and SNOMED CT-AU code for pathology request tests; and preferred term, units and LOINC code for use in pathology reporting) for pathology tests for requesting and reporting on the NCTS website.
Wg1 also collaborated with HL7 Australia to draft a localised version of the HL7 International pathology report messaging standards v2.4, conformance requirements and references to the completed PITUS 15-16 work, to provide the required information for implementers of electronic pathology messaging in one document.
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wg2 Safety in pathology reporting
Working group 2 (wg2) developed best practice guidelines for the safe communication of pathology requests (computer generated requests communicated via paper and electronic messaging) and pathology reports (printed and electronic).
wg3 Request and report terminology
Working group 3 (wg3) focussed on terminology used for requesting pathology, from the tests listed in the RCPA Manual of Use and Interpretation of Pathology Tests (RCPA Manual), LabTests Online and feedback received from implementations at NSW Health Pathology, ACT Pathology and Sonic Healthcare.
wg4 Request Modelling
Working group 4 (wg4) planned to consult with stakeholders to develop a consensus approach for requesting genomics testing that would improve the quality of genomics testing, and to identify ways to reduce the number of inappropriate pathology test requests.
wg5 Report Modelling
Working group 5 (wg5) collaborated with Cancer Institute NSW and two testing laboratories, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology to complete a trial implementation for the electronic communication of atomic result data for structured reporting of pathology cancer reports to show how data can be shared between sending (pathology providers) and receiving (cancer registries) organisations’ computer systems.
Wg6 Informatics quality assurance
Working group 6 (wg6) collaborated with the RCPAQAP on the trial implementation to test the compliance of pathology reporting against existing HL7 v2.4 pathology report messaging standards and the RCPA’s Standards for Pathology Informatics in Australia.
For more details of the working group’s activities and key deliverables, see Section 10.1 – Appendix B.
5.4 Stakeholders
The key stakeholders associated with the standardisation of pathology information models and terminology reference sets were:
Health consumers (subjects of care)
Health consumers (subjects of care) are the ultimate beneficiaries for improving the quality of use of pathology services under this Project. The best practice guidelines for the safe communication of pathology requesting and reporting provided by this Project will improve clinicians’ s efficiency by optimising requesting and removing waste incurred through follow-up requests and error. These are both direct and indirect benefits for health consumers.
Pathology requesters and pathology report recipients
GP Desktop systems could save clinicians time with the introduction of easier and more accurate requesting of pathology by utilising the preferred list of commonly requested pathology tests developed by this Project.
Receiving clear and unambiguous reporting of pathology results will save the report recipient time, assist clinicians to correctly interpret the pathology report, diagnose the patient and to prescribe the
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most appropriate treatment for the patient. The Project will enable report recipients to use comparative graphical displays and analysis as a result of the standardised coded terminologies implemented in GP Desktop systems and ancillary applications.
Pathology providers
Receiving clear and unambiguous pathology computer generated requests (via paper or electronic messaging) from requesters and utilising the standardised terminology reference sets for requesting pathology tests from this Project, will save pathology providers time, assist pathology providers to interpret the correct pathology tests requested and ensure the correct laboratory tests are performed.
Standardised pathology information models and terminology reference sets for reporting has the potential to reduce maintenance and development costs associated with pathology information systems, in particular the reduced cost of variation in pathology reporting that is a currently the result of different communication requirements from registries and GP/Specialist clinical systems.
Pathologists
Standardisation of pathology reporting terminology reference sets and content can improve the capacity for the reviewing pathologist to add value to the pathology report by providing more specific advice that will assist the clinician to determine the best treatment for a patient.
Medical Software Industry
The medical software industry has consistently called for standard design and implementation of pathology information models and terminology reference sets to enable the sharing of pathology requesting and reporting data between computer systems. Using standardised terminology in an electronic pathology report from a pathology provider allows medical computer systems to use components of the pathology report for comparative graphical displays and analysis, providing valuable information to assist clinician to assist with the diagnosis, treatment and management of the patient.
Australian Digital Health Agency (the Agency)
This Project is responsible for co-ordinating subject matter experts who provide the knowledge to produce the pathology information models and terminology reference sets used for of pathology for publication on the Agency’s NCTS website. The Agency is responsible for the national digital health services and systems, and by publishing and hosting the pathology information models and terminology reference sets developed by this Project provides the necessary data for healthcare professionals to assist with the implementation of pathology in digital health systems.
External Quality assurance
Compliance and standardisation of pathology reporting terminology are critical elements necessary to maintain the integrity of data shared between the sending (pathology providers) and receiving (clinicians, MyHR, registries, etc.) organisations’ computer information systems. The comprehensive compliance report produced by the IEQA program provides pathology providers with information to improve the quality of the HL7 pathology report messages and the appropriate education to implement the electronic HL7 pathology report messaging and pathology reporting standards developed by this Project.
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Registries
There is significant variation between jurisdictions as well as between the types of registries that pathology providers are required to report to.
Standardisation of pathology information models and terminology reference sets to pathology-related registries provides a number of benefits such as:
- improvement in the quality and timeliness of the information disseminated by pathology providers;
- pathology-related registries and researchers could use the standardised pathology reporting for analysis and further study;
- potential reductions in implementation costs incurred by pathology providers for interfacing to pathology-related registries.
The Cancer Institute NSW provided support to the PITUS 15-16 project in the trial implementation for the atomic reporting of RCPA SPRC reports to show how data can between shared between sending (pathology providers) and receiving (cancer registries) organisations’ computer systems.
Governments
GP Desktop systems could provide clinicians with easier and more accurate requesting of pathology by utilising the preferred list of commonly requested pathology tests developed by this Project, and through the use of decision support tools may also provide benefits with more appropriate utilisation of pathology tests and improved management of Medicare Pathology services.
The pathology informatics standards; and pathology information models and terminology reference sets for reporting provided by this Project, are aimed to provide guidance to pathology providers and stakeholders for the safe atomic reporting of pathology across Australia and support the Department of Health’s Quality Use of Pathology Program to provide quality consumer services, requesting and pathology practice; and support the national E-Health strategy, including the implementation of the MyHR, to deliver a safer, high quality and sustainable healthcare system and to improve the health outcomes for all patients.
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6. Project Activities
6.1 Reporting requirements
The agreed reporting requirements are:
1 August 2015 Detailed activity work plan Submitted 1 Aug 2015
1 December 2015 First Performance Report Submitted 1 Dec 2015
1 May 2016 Second Performance Report Submitted 29 Apr 2016
1 November 2016 Third Performance Report Submitted 1 Nov 2016
1 March 2017* Draft Final Report Submitted 15 March 2017
30 April 2017* Final Report Submitted 15 May 2017
*As per Deed of Variation No.1.
Project was completed on 30 April 2017 within the project budget as allocated under the Funding Agreement; see Section 8 Financials for more details. In undertaking the Project deliverables, there were considerable demands placed upon voluntary pathologist time, due in large to conflicting priorities and workloads.
6.2 Project accomplishments
The PITUS 15-16 Project established five objectives and each of these were successfully achieved.
Objective 1 - Develop standards, information model and terminology reference sets for safe atomic reporting of pathology in preparation for the implementation of the My Health Record
The PITUS 15-16 Project achieved this objective by:
1. Development of pathology standards, information models and terminology reference sets to support atomic reporting of RCPA SPRC Colorectal and Prostate (Radical prostatectomy) cancer protocols. See Section 10.1 – Appendix C (Activity 3.5): a. New HL7 Australia FHIR standards for RCPA SPRC reporting for Colorectal and Prostate
(Radical prostatectomy) cancer for safe atomic reporting to registries (e.g. MyHR, cancer registries), available on the Structured Pathology Reporting of Cancer FHIR website;
b. Colorectal and Prostate (Radical prostatectomy) cancer information models:
RCPA - SPIA Colorectal Cancer Report Information Model v1.0;
RCPA - SPIA Prostate Cancer Radical Report Information Model v1.0;
c. Colorectal and Prostate (Radical prostatectomy) cancer terminology reference sets:
RCPA - SPIA Colorectal Cancer Report Information Model Terminology v1.0;
RCPA - SPIA Prostate Cancer Radical Report Information Model Terminology v1.0.
2. Partnering with the Cancer Institute of NSW, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology on a trial implementation to show how atomic reporting of RCPA SPRC Colorectal and Prostate (Radical prostatectomy) cancer reports can be shared between sending (pathology providers) and receiving (cancer registries)
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organisations’ computer systems; see Section 10.1 – Appendix F for a summary report for this trial implementation.
The pathology standards, information models and terminology reference sets developed under this objective are required for the safe electronic communication of atomic reporting of pathology between pathology providers and their stakeholders (clinicians, cancer registries, MyHR) organisations’ computer systems in a manner that preserves shared meaning.
This development work improving pathology reporting focused on the completeness and timeliness of the pathology information shared with clinicians, cancer registries, MyHR, etc. and will provide quality pathology practice and quality consumer service benefits as outlined in the QUPP objectives. Development work of this nature will lead to improved patient health outcomes through the provision of better cancer management and planning services.
Objective 2 - Improve health outcomes for patients through the provision of improved pathology requesting and reporting by ensuring standards, information model and terminology reference sets are comprehensive, current and accessible
The Project undertook a series of activities to ensure the pathology standards, information models and terminology sets are comprehensive, current and accessible by:
1. Collaborated with HL7 Australia to develop a 242-page first version of the Australian Pathology Messaging - Localisation of HL7 Version 2.4, a localisation of the HL7 International report messaging standards, required for the safe electronic communication of atomic reporting of pathology results to external computer systems. This local version provides the required information for the implementation of electronic pathology messaging by pathology providers and associated stakeholders in one document. See Section 10.1 – Appendix C (Activity 3.7).
2. Supporting the adoption of new and existing pathology information model and terminology reference sets by pathology providers; and updating the pathology standards, information models and terminology reference sets to include:
a. New guidelines for the safe communication of pathology requests and reports in Australia, see chapters 9 and 10 of the SPIA (APUTS) Standards for Pathology Informatics in Australia v3.0 and Section 10.1 – Appendix C (Activity 3.8.3);
b. 481 new pathology requested tests assigned a SNOMED CT-AU code and there are now a total of 969 pathology tests that have been assigned a SNOMED CT-AU code for requesting pathology, see RCPA - SPIA Requesting Pathology Terminology Reference Set 3.0 and Section 10.1 – Appendix C (Activity 3.8.2);
c. Over 900 modifications and 80 new pathology tests added to the pathology terminology for reporting for chemical pathology, haematology, microbiology and immunopathology. See Section 10.1 – Appendix C (Activity 3.8.2) and see Section 6.5 for the full list of documents updated by the PITUS 15-16 Project.
d. New harmonised reference intervals for six (6) analytes (Bilirubin, Creatine kinase, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyltransferase and Lipase). See RCPA - SPIA Chemical Pathology Harmonised Reference Intervals tables v2.0 and Section 10.1 – Appendix C (Activity 3.9).
3. Performed an audit on all published pathology information models and terminology reference sets and reported discrepancies against the latest releases from the international standards development organisations (IHTSDO and Regenstrief Institute, Inc.). All discrepancies were
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rectified in the latest release of the pathology information models and terminology reference sets.
4. Improved accessibility to the pathology standards, information models and terminology reference sets by establishing an agreement between the RCPA and the Agency for hosting the pathology standards, information models and terminology reference sets on the NCTS website. The agreement specified the communication process between RCPA and the Agency for handling content requests; acknowledges the RCPA as the source of the information and sets out the responsibility for maintaining the standards and ensuring that the Agency is informed of any updates or changes. See Section 10.1 – Appendix C (Activity 3.2, 3.3, 3.4).
The outcomes of the Project listed above align with the QUPP objectives of quality pathology practice and quality consumer services. The provision of comprehensive, current, accessible pathology standards, information model and terminology reference sets that are specific for pathology in Australia enable safe electronic communication of pathology requesting and reporting between pathology providers and associated stakeholders and supports the safe implementation of the MyHR and ultimately improves patient outcomes by providing clinicians with:
- Standardised preferred list of commonly requested pathology tests that enable easier and more accurate requesting of pathology;
- Clear and unambiguous pathology reports that assists with the clinical interpretation of the pathology report, diagnosing patients and prescribing the most appropriate treatment for patients;
- Standardised coded reporting terminology that can be used in comparative graphical displays and analysis in GP Desktop systems and ancillary applications to diagnose and monitor the treatment of a patient.
Objective 3 - Improve the quality of pathology reporting by establishing a compliance and accreditation environment for pathology terminology to be used by accrediting bodies
Compliance and standardisation of pathology reporting terminology are critical elements necessary to maintain integrity of data shared between the sending (pathology providers) and receiving (clinicians, MyHR, registries, etc.) organisations’ computer information systems. The inclusion of these elements will improve the quality of electronic reporting of pathology and facilitate the implementation of the MyHR by pathology providers.
To achieve this objective, the Project collaborated with RCPAQAP to develop and trial an Informatics Quality Assurance (IEQA) program to assess the compliance of electronic HL7 pathology report messages against the standards published by HL7 Australia and pathology reporting standards published by the RCPA, that could be used by accrediting bodies such as NATA, as part of the accreditation of pathology providers in Australia. See Section 10.1 – Appendix C (Activity 3.10).
The comprehensive compliance report produced by the IEQA program provides pathology providers with information to improve the quality of the HL7 pathology report messages and the appropriate education to implement the published electronic HL7 pathology report messaging and pathology reporting standards.
The success of this trial implementation shows the potential of an external quality assurance program to assist with compliance that can be used by accrediting bodies, such as NATA, and will facilitate the adoption of pathology informatics standards by pathology providers and
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associated stakeholders, in line with the QUPP quality pathology practice and consumer services objectives.
Due to the success of this trial, the RCPAQAP are considering further development of the compliance software tool and may consider a limited trial of the IEQA Program in the future for pathology providers participating in the Serum Liquid Chemistry Program.
A summary report of this trial implementation project is available; see Section 10.1 – Appendix G.
Objective 4 - Provide safer and better quality use of pathology services by developing an implementation checklist for best practice in the use of clinical information systems for the requesting of pathology, records management and follow-up of pathology reports
The best practice guidelines developed by this Project for the safe communication of computer generated pathology requests, (paper or by electronic messaging), support the QUPP objectives of quality referrals and quality consumer services by providing guidelines for standard design and implementation of GP Desktop systems to improve the quality of pathology requests. This includes the use of pathology terminology reference sets to enable sharing of pathology requesting data between computer systems.
This body of work provides clinicians and medical software vendors with guidelines for the safe communication of pathology reports, both printed and electronic pathology reports, including providing guidance on standard design and implementation of GP Desktop systems to ensure the clear and unambiguous display of pathology results. The provision of better quality pathology results for use in comparative graphical displays and analysis supports the QUPP objective of quality pathology practice and quality consumer services.
The best practice guidelines developed by this Project are in chapters 9 and 10 in the Standards for Pathology Informatics in Australia (SPIA) v3.0 and Section 10.1 – Appendix C (Activity 3.8.3).
Objective 5 - Drive adoption, compliance and accreditation through promotion and adoption of the pathology informatics standards across the pathology industry.
The Project aimed to drive the adoption of the pathology standards, information models and terminology reference sets across the pathology industry through:
a. Participation of key stakeholders (RCPA Advisory Committee, DoH, the Agency, RACGP, PAC, AACB, HL7 Australia and) in PITUS 15-16 Steering Committee and/or associated working groups, providing the expertise required for the standardisation of pathology requesting and reporting in Australia and assisted with promoting the activities from this Project across the pathology industry (Activity 3.6).
b. Promotion of the pathology standards, information models and terminology reference sets through (Activity 3.1): a. Pathology Information Standardisation web pages on the RCPA website. Since the start
of this Project in July 2015 there have been a total of 2610 visits to the PITUS 15-16 Download webpage;
b. Distribution of four (4) PITUS Update newsletters throughout the course of the project; c. Poster displayed at Pathology Update 2016 and corresponding abstract published in
Pathology, the journal of the Royal College of Pathologists of Australia [Volume 48, Supplement 1, pS107];
d. Conference presentations, participation and networking, including: - HISA HIC eSafety Workshop (2015);
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- NSW Health State-wide Biobanking Reference Group workshop (2015); - RACGP EHealth forum (2015); - HL7 Australia’s Education Day (2015); - Pathology Update (2016 and 2017); - Australian e-Health Research Centre - Australian e-Health Research Colloquium
(2016); - Agency’s AuCT-UG Meeting (2016); - MyHealth Record Pathology Checkpoint Workshop (2016); - RCPA Pathology Informatics Seminar (2016).
e. Participation on local and international pathology standardisation working groups, including:
- Agency’s Pathology Program Steering Group; - HL7 Australia’s Orders & Observation working group; - National Pathology Accreditation Advisory Council (NPAAC); - International Health Terminology Standards Development Organisation (IHTSDO)
Terminology Committee; - International Council for Standardisation of Haematology (ICSH) working group; - International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Committee for Nomenclatures, Properties and Units.
6.3 Key activity indicators / milestones / (KPIs)
1. Percentage of RCPA Board approved pathology reporting and requesting terminology standards hosted on the RCPA website by 30 June 2016 Target: 100% by 30 June 2016
Status: 100% complete. See Section 10.1 – Appendix C (Activity 3.3.2)
As at 1 December 2015, the RCPA had published 100% of the RCPA Board approved requesting and reporting terminology standards on the RCPA website.
The RCPA website was updated on 31 January 2017 to incorporate the most recent RCPA Board approved pathology requesting and reporting terminology standards from the PITUS-15-16 Project.
2. Percentage of RCPA Board approved pathology reporting and requesting terminology standards hosted on the RCPA website and NEHTA (or NEHTA equivalent) website by 31 July 2016* *As per Deed of Variation No.1.
Target: 100% by 31 July 2016
Status: 100% complete. See Section 10.1 – Appendix C (Activity 3.3.2, 3.4.1)
Wg1 have worked closely with the Agency’s clinical terminology team on an agreement between the RCPA and the Agency for publishing of pathology standards, pathology information models and terminology reference sets, the final agreement was signed on 28 July 2016.
The agreed publishing date was originally planned for 30 June 2016; however this was delayed while NEHTA transitioned to the Agency. The completion date was revised to 31 July 2016 as per Deed of Variation No.1.
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On 29 July 2016 the Agency published 100% of the RCPA Board approved pathology information models and terminology reference sets from the PITUS-14 Project in the RCPA Pathology Terminology and Information Model v1.0 release on the Agency’s website. The release note for the first release is in Section 10.1 – Appendix D.
In December 2016, the RCPA Pathology Terminology and Information Model v1.0 release was transferred to the new NCTS website.
3. Percentage of RCPA Board approved pathology reporting and requesting terminology standards hosted on the RCPA website and NEHTA (or NEHTA equivalent such as Australian Digital Health Agency) website by 1 March 2017* *As per Deed of Variation No.1.
Target: 100% by 1 March 2017 Status: 100% complete. See Section 10.1 – Appendix C (Activity 3.3.2, 3.4.2)
The Standards for Pathology Informatics in Australia and associated pathology information models and terminology reference sets were officially endorsed by the RCPA Board of Directors as policy documents on 24 January 2017. This approval was granted following an internal and public review process.
The RCPA website was updated on 31 January 2017 with these endorsed pathology requesting and reporting terminology standards. See Section 6.5 for the full list of documents.
On 31 March 2017 the Agency published 100% of the RCPA Board approved pathology information models and terminology reference sets from the PITUS 15-16 Project in the RCPA Pathology Terminology and Information Model v1.1 release on the Agency’s NCTS website. The release note is in Section 10.1 – Appendix E.
The completion of this KPI will be reported in the Final Report.
4. Pathology standards, pathology information models and terminology reference sets are comprehensive, current and accessible for SNOMED mapped request tests by December 2016
Target: 800 SNOMED codes mapped request tests by December 2016 Status: 100% complete. See Section 10.1 – Appendix C (Activity 3.8.2)
Wg3 focussed on terminology used for requesting pathology, from the tests listed in the RCPA Manual of Use and Interpretation of Pathology Tests (RCPA Manual), LabTests Online and feedback received from trial implementations of the pathology requesting and reporting terminology undertaken by NSW Health Pathology, ACT Pathology and Sonic Healthcare.
At the completion of this Project, 969 pathology requested tests have been assigned a SNOMED CT-AU code.
The terminology reference set for requesting pathology was subject to internal and public review and subsequently endorsed by the PITUS-15-16 Project’s Steering Committee. The terminology reference set for requesting pathology was endorsed by the RCPA Board of Directors as policy documents on 24 January 2017.
The PDF version of the terminology reference set for requesting pathology was published on the RCPA website on 31 January 2017, see SPIA Requesting Pathology v3.0. The
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spreadsheet version of the terminology reference set for requesting pathology was published on the Agency’s NCTS website on 31 March 2017.
6.4 Status of the Communication strategy
The communication strategy for the Project consisted of activities to promote the need for safe, standardised messaging and terminology for the communication of pathology requesting and reporting between computer systems which included:
PITUS Update Newsletters
The PITUS Update Issue 4 newsletter was published on the RCPA website and distributed to all stakeholders on 14 September 2015. PITUS Update Issue 4 newsletter was circulated to other pathologists via Pathology Today in 24 Sept 2015 issue (Volume 16 Issue No 20).
The PITUS Update Issue 5 newsletter was published on the RCPA website and distributed to all stakeholders on 11 April 2016. PITUS Update Issue 5 newsletter was circulated to other pathologists via Pathology Today in 21 April 2016 issue (Volume 17 Issue No 8).
The PITUS Update Issue 6 newsletter was published on the RCPA website and distributed to all stakeholders on 23 September 2016. PITUS Update Issue 6 newsletter was circulated to other pathologists via Pathology Today in 6 October 2016 issue (Volume 17 Issue No 20).
The PITUS Update Issue 7 newsletter was published on RCPA website on 31 March 2017 and distributed to all stakeholders on 4 April 2017. PITUS Update Issue 7 newsletter was circulated to other pathologists via Pathology Today on 13 April 2017 issue (Volume 18 Issue No 7).
Journal article
An abstract was written for Pathology, The Journal of the Royal College of Pathologists of Australasia [Volume 48 Supplement 1, pS107]. This edition of the Journal was distributed in delegate bags at Pathology Update 2016.
Press articles
Recently there were two press articles related to the PITUS-15-16 Project, these included:
Pulse+IT - 2 March 2016 - Kate McDonald - RCPA extends pathology program to include My Health Record roll-out
Pulse+IT - 2 March 2016 - Kate McDonald - Study to build evidence base for improved pathology test reporting
Conference/Workshop participation
The Steering Committee promoted the standards for pathology informatics; and associated pathology information models and terminology reference sets produced by the PITUS 15-16 Project through publications, conference presentations, participation and networking, and has included:
• The Chair of the PITUS 15-16 Steering Committee - presented at the HISA HIC 2015 eSafety Workshop on 6 August 2015.
• The Chair of the PITUS 15-16 Steering Committee presented at the NSW Health State-wide Biobanking Reference Group workshop on 12 August 2015.
• Dr Rob Hoskings (RACGP representative on wg2 and PITUS 15-16 Steering committee) presented at the RACGP EHealth forum. The event included representatives from Federal
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and State Governments, Medical Software Industry Association (MSIA), the Agency, AMA, Health Informatics Society of Australia (HISA), various other e-Health organisations and the RACGP Expert Committee on e-Health.
• The Chair of the PITUS 15-16 Steering Committee and Director, HL7 Australia presented 'Australian Pathology Standards Update and Terminology: Content and Conformance testing' at the HL7 Australia’s Education Day on 19 Nov 2015.
• Pathology Update 2016 provided an opportunity to promote the PITUS 15-16 activities for standardisation of pathology requesting and reporting. The Chair of the PITUS 15-16 Steering Committee presented to the General and Biochemical Advisory Committees. A poster describing the outcomes and development activities of the project was displayed in the Roche Scientific Poster Display and published a corresponding abstract in Pathology, the journal of the Royal College of Pathologists of Australia [Volume 48, Supplement 1, pS107]. The PDF version of the poster has been published on the RCPA website, click here.
• There were a number of other presentations that were related to the promotion of the standardisation of pathology requesting and reporting at Pathology Update 2016, these included: o The request-report cycle is changing: New technology, decision support and patient
involvement presented by Prof Jonathan Kay (UK) o Information management for point of care testing: What, where and who is responsible?
Presented by Prof Jonathan Kay (UK) o How should we deal with missed test results and pending results at discharge?
Presented by A/Prof Andrew Georgiou • The Chair of the PITUS 15-16 Steering Committee attended the Australian e-Health
Research Centre - 2016 Australian e-Health Research Colloquium which was held 15 March 2016.
• The Chair of the PITUS 15-16 Steering Committee gave a 30 minute presentation on 6 September 2016 to the Agency’s AuCT-UG Meeting 25 to promote the PITUS 15-16 activities.
• The Chair of the PITUS 15-16 Steering Committee and the chairs of wg2, wg3, wg4 and wg5 were speakers at the RCPA Pathology Informatics Seminar 2016 held on 9-10 November 2016. The program for this seminar is available on the RCPA website.
This seminar covered a wide range of pathology informatics topics and where applicable, references were made to promote the PITUS 15-16 Project. Sixty-five (65) registrants attended this seminar, including pathologists, scientists and informaticians.
One session on Day 2 focussed on the standardisation of pathology requesting and reporting work from the RCPA’s PITUS15-16 Project and applying this to the two (2) RCPA SPRC protocols i.e. Colorectal cancer and Prostate (Radical prostatectomy) cancer.
The Agency and HL7 FHIR Product Director discussed the current and future uses of FHIR; and the draft HL7 Australia Implementation Guide for RCPA SPRC reporting that was created for this Project.
Stakeholder communication
A number of key stakeholders are represented on the PITUS 15-16 Steering Committee and participate in one or more of the working groups. The other communication activities of the Project included:
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• RCPA Committees
The PITUS 15-16 Steering Committee and relevant working groups have representatives from the RCPA Board of Directors, RCPA Advisory Committees, and Board of Professional Practice Quality (BPPQ).
Each of the PITUS Update newsletters published by this Project was circulated to RCPA Board of Directors, RCPA Advisory Committees, and Board of Professional Practice Quality (BPPQ) and the broader membership through Pathology Today publications.
The PITUS Update 4 newsletter was circulated to PITUS 15-16 Steering Committee and working groups on 15 September 2015, and reported in Pathology Today on 24 September 2015 issue (Volume 16 Issue No 20).
The PITUS Update 5 newsletter was circulated to PITUS 15-16 Steering Committee and working groups on 15 September 2015, and reported in the Pathology Today on 21 April 2016 issue (Volume 17 Issue No 8).
The PITUS Update Issue 6 newsletter was circulated to PITUS 15-16 Steering Committee and working groups on 23 September 2016, and reported in the Pathology Today on 6 October 2016 issue (Volume 17 Issue No 20).
The PITUS Update Issue 7 newsletter was circulated to PITUS 15-16 Steering Committee and working groups on 4 April 2017, and reported in the Pathology Today on 13 April 2017 issue (Volume 18 Issue No 7).
• Other professional Colleges
There was an RACGP Expert Committee on e-Health representative on the PITUS 15-16 Steering Committee and Safety in pathology reporting working group (wg2).
The PITUS Update newsletters produced by this Project were circulated to RACGP representatives for re-distribution to the RACGP Expert Committee on eHealth.
• PAC members
Each of the PITUS Update newsletters produced by this Project was circulated to the PAC CEO for redistribution to the PAC members.
• RCPA Quality Assurance Programs (RCPAQAP)
PITUS 15-16 Project team and RCPAQAP collaborated on the trial implementation of an IEQA program for the Liquid Serum Chemistry program for electronic reporting of pathology results from laboratories, as part of wg6 activities.
Additionally, disciplinary experts from the RCPAQAP have assisted the Request and report terminology working group (wg3).
Each of the PITUS Update newsletters produced by this Project was circulated directly to the RCPAQAP CEO and Software Manager for redistribution to RCPAQAP participants.
• Cancer Institute NSW
PITUS 15-16 Project team and Cancer Institute NSW collaborated on the trial implementation of atomised RCPA SPRC reports to registries, as part of Report modelling wg5.
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Each of the PITUS Update newsletters produced by this Project was circulated directly to the Cancer Institute NSW via the wg5 Cancer Institute NSW team members.
• MSIA members
Each of the PITUS Update newsletters produced by this Project was circulated to CEO of MSIA for re-distribution to MSIA members.
• Australian Digital Health Agency (the Agency)
There was an Agency representative on the PITUS 15-16 Steering Committee and working groups. The PITUS Update newsletters produced by this Project were circulated to each of the Agency representatives.
The Chair of PITUS 15-16 Steering Committee presented to the Agency’s AuCT-UG Meeting 25 on 6 September 2016 to promote the PITUS 15-16 activities.
The Chair of PITUS 15-16 Steering Committee represented the PITUS 15-16 Project at the Agency’s Pathology Programme Steering Group meeting held on 6 February 2017.
The Agency’s Pathology Program Steering Group is a representative panel of stakeholders whose role is to provide independent advice to the Agency’s Pathology Program. The key objectives of this steering group are to provide strategic direction and advice; and ensure that the Pathology Program is aligned to the National Digital Agenda and the Australian Digital Health Agency Strategic Plan.
• HL7 Australia
The Chair of PITUS 15-16 Steering Committee and the Director, HL7 Australia presented 'Australian Pathology Standards Update and Terminology: Content and Conformance testing' at the HL7 Australia’s Education Day on 19 Nov 2015.
The Chair of PITUS 15-16 wg1 is the co-chair of the HL7 Australia O&O working group, and a number of the members of PITUS 15-16 wg1 have joined the HL7 Australia working group. PITUS Update 6 newsletter was circulated to the Secretary of HL7 Australia on 23 September 2016 for re-distribution to HL7 Australia members.
PITUS Update 7 newsletter was circulated to the Secretary of HL7 Australia on 4 April 2017 for re-distribution to HL7 Australia members.
• Department of Health There was a representative from the Department of Health on the PITUS 15-16 Steering Committee.
PITUS 15-16 Project team members represent the RCPA on the National Pathology Accreditation Advisory Council (NPAAC).
The Chair of PITUS 15-16 Steering Committee and Chair of wg3 joined the Department of Health and the Agency representatives at the MyHealth Record Pathology Checkpoint Workshop on10 March 2016. There is a continued commitment for the PITUS 15-16 Steering Committee participation in any MyHealth record consultations.
Each of the PITUS Update newsletters produced by this Project was circulated to the Department of Health Steering Committee representative.
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Other committee representation
Members of the PITUS 15-16 Steering Committee and working groups provide input from the Project to the following committees:
• National Pathology Accreditation Advisory Council (NPAAC). The PITUS 15-16 Steering Committee provided feedback on the draft NPAAC Requirements for Information Communication and Reporting (Fourth Edition) document.
• International Health Terminology Standards Development Organisation (IHTSDO) Terminology Committee, collaborated with the Project to link SNOMED CT concepts with LOINC codes.
• International Council for Standardisation of Haematology (ICSH) working group. The PITUS 15-16 Project team provided this working group with the APUTS v2.0 documentation and feedback on a draft paper for ICSH General Assembly on Standardisation of reporting units for the Full Blood Count (FBC) pathology test.
• International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee for Nomenclatures, Properties and Units. One of the PITUS 15-16 Steering Committee members is the chair of this committee.
RCPA Website development
The Pathology Information Standardisation web pages on the RCPA website have been improved and expanded to include a PITUS 15-16 webpage. PITUS 15-16 webpage went live on 4 September 2015. The website is continually updated as more Project information becomes available.
Figure-2 Number of visits to the PITUS-15-16 Download webpage from August 2015 to April 2017
The PITUS 15-16 Download webpage is used to monitor the impact of promotional activities from this Project work, and Figure-2 and Figure-3 show the number of visits (or hits) on this page
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between August 2015 and 30 April 2017. During this period the PITUS 15-16 Download webpage contained the approved standards for informatics; and pathology information models and terminology reference sets from the PITUS-14 Project.
Figure-2 indicates there is an increasing trend of visits to the PITUS 15-16 Download webpage and since August 2015 there have been a total of 2610 visits to the PITUS 15-16 Download webpage. The peaks on the graph corresponded to promotional activities undertaken by the PITUS 15-16 Project team.
The first peak from February to May 2016 followed promotion at the Pathology Update 2016 and the follow-up circulation of Pathology, the Journal of the Royal College of Pathologists of Australasia [Volume 48 Supplement 1, pS107]. Also during this period the Chair of the PITUS 15-16 Steering Committee presented at the Australian e-Health Research Centre - 2016 Australian e-Health Research Colloquium on 15 March 2016.
The peak in July and August 2016 followed the publication and promotion of the RCPA Pathology Terminology and Information Model v1.0 release on Agency’s website. The significant peak was seen in November 2016, and this followed the RCPA Pathology Informatics Seminar 2016.
The peak in April 2017 followed the publication and promotion of the RCPA Pathology Terminology and Information Model v1.1 release on Agency’s NCTS website on 31 March 2017 and PITUS Update 7 newsletter circulated on 4 April 2017.
Figure-3 Number of downloads (saves or online views) per discipline from August 2015 to April 2017
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Figure-3 shows the number of times each of the approved standards for pathology informatics; and pathology information models and terminology reference sets were downloaded (i.e. either saved or viewed online) from August 2015 to April 2017 per pathology discipline. Microbiology, Anatomical Pathology and Chemical Pathology disciplines show the highest number of downloads, and the APUTS Standards and Guidelines v2 (now known as the Standards for Pathology Informatics in Australia) was the highest single downloaded document with a total of 1652 downloads.
Login records on the Agency’s NCTS website have indicated that eleven (11) organisations had downloaded the latest RCPA Pathology Terminology and Information Model v1.1 release (RCPA.zip) between 31 March 2017 and 30 April 2017. The organisations that downloaded the latest release covered a wide spectrum of user groups such as pathology providers, universities, medical software vendors and digital health organisations/consultants.
6.5 Documentation summary
Documents distributed for internal and public review
At the 24 November 2016 meeting the PITUS 15-16 Steering Committee reviewed and agreed to circulate the draft pathology standards for informatics; and pathology information models and terminology reference sets for public review. The public review period commenced on 28 November 2016 and closed on 10 January 2017.
Nineteen (19) documents were circulated for public review to RCPA Advisory Committees, all key stakeholder groups (Department of Health, the Agency, RACGP, PAC, AACB and HL7 Australia), Medical Software Industry Australia (MSIA); and pathology organisations (such as Pathology Associations Council, Pathology Australia) via direct email communications or RCPA Pathology Today newsletters.
The PITUS 15-16 Public review webpage received a total of 320 visits during the period 28 November to 10 January 2017, and a total of 553 files were either saved or viewed online.
Figure-4 Number of visits to the PITUS Public review webpage during the public review period
Figure-4 shows the total number of visits to the PITUS 15-16 Public review webpage during the public review period. The first spike in the graph was on 2 December 2016, and this followed the
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initial email communication to all RCPA Advisory Committees and key stakeholder groups. The second spike on the graph was on 9 January 2017 which followed a reminder email sent to all RCPA Advisory Committees and key stakeholder groups.
Figure-5 shows the number of times a single document was downloaded (i.e. either saved or viewed online) from the PITUS 15-16 Public review webpage. The two most popular documents were the Standards and guidelines document with a total of 84 downloads and the Requesting Pathology Terminology reference set with a total of 56 downloads, which is a reflection that pathology providers and their stakeholders are considering implementing PITUS 15-16 terminology for requesting pathology.
Figure-5 Number of downloads per PITUS document during public review period
The PITUS 15-16 Project received 162 comments from 14 organisations/individuals (from both the public and private pathology sectors), and included comments from key stakeholders, in particular RACGP and the Agency. Each of the comments were reviewed and dispositioned by the PITUS 15-16 Project team.
A summary of the breakdown of disposition:
- 67 comments were accepted and the SPIA documents were updated to reflect these comments;
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- 58 comments were accepted and will be considered in the next PITUS phase. Each of these comments will require further multi-disciplinary team discussion;
- 15 comments and proposed changes were rejected, either as a duplicate or the proposed change was not reflective of the PITUS 15-16 intent;
- 22 comments were reviewed and the dispositioned was postponed until a wider group of experts could review further. This is likely to form part of a future PITUS project.
The PITUS 15-16 team received an additional 24 comments from 2 organisations after the public review period closed, and these have been reviewed and the dispositioned was postponed until a wider group of experts could review further and will likely form part of a future PITUS project.
Documents endorsed by RCPA Board of Directors
The Standards for Pathology Informatics in Australia (SPIA) and associated pathology information models and terminology reference sets were officially endorsed by the RCPA Board of Directors as policy documents on 24 January 2017. This approval followed an internal and public review period.
The documents are now available on the RCPA website. On 31 March 2017 the Agency published the RCPA Board approved pathology information models and terminology reference sets from the PITUS 15-16 Project in the RCPA Pathology Terminology and Information Model v1.1 release on the Agency’s NCTS website.
The full list of documents endorsed by the RCPA Board of Directors for this Project includes:
Standards:
SPIA (APUTS) Standards for Pathology Informatics in Australia v3.0
SPIA Requesting Pathology v3.0
SPIA Anatomical Pathology v3.0
SPIA Chemical Pathology v3.0
SPIA Cytopathology v3.0
SPIA Genetic Pathology v3.0
SPIA Haematology v3.0
SPIA Immunopathology v3.0
SPIA Microbiology v3.0
Terminology:
SPIA Preferred Units v1.0
RCPA - SPIA Requesting Pathology Terminology Reference Set 3.0*
RCPA - SPIA Surgical Pathology Report Information Model Terminology v3.0*
RCPA - SPIA Gastric Cancer Report Information Model Terminology v2.0*
RCPA - SPIA Colorectal Cancer Report Information Model Terminology v1.0*
RCPA - SPIA Prostate Cancer Radical Report Information Model Terminology v1.0*
RCPA - SPIA Chemical Pathology Terminology Reference Set v3.0*
RCPA - SPIA Cytopathology Report Information Model Terminology v3.0*
RCPA - SPIA Genetics Report Information Model Terminology v3.0*
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RCPA - SPIA Haematology Terminology Reference Set v3.0*
RCPA - SPIA Immunopathology Terminology Reference Set v3.0*
RCPA - SPIA Microbiology Report Information Model Terminology v3.0*
RCPA - SPIA Microbiology Serology Molecular Pathology Terminology Reference Set v3.0*
RCPA - SPIA Microbiology Subset of Organisms mapped to SNOMED CT v3.0*
Information Models and other information:
RCPA - SPIA Chemical Pathology Harmonised Reference Intervals tables v2.0
RCPA - SPIA Chemical Pathology Harmonised Reference Intervals v2.0
RCPA - SPIA Gastric Cancer Report Information Model v2.0
RCPA - SPIA Colorectal Cancer Report Information Model v1.0
RCPA - SPIA Prostate Cancer Radical Report Information Model v1.0
RCPA - SPIA Surgical Pathology Report Information Model v3.0 * Available on the Agency’s NCTS website
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7. Project Issues and Challenges
7.1 Issues Register
Issue Source Impact Mitigation
Time constraints - stakeholders
Limited availability of key technical personnel within stakeholder groups
Difficulty to adhere to timelines
Clear communication minimised face to face requirements, frequent monitoring of project deliverables and revised schedules where necessary to take advantage of participation by key stakeholders with the least amount of disruption to daily workloads.
Time constraints – collaborators / partners (e.g. RCPA QAP, Cancer Institute NSW, HL7 Australia, Melbourne Genomics Health Alliance)
Limited availability of key technical and testing personnel within collaborating / partner organisations
Difficulty to adhere to timelines
Clear communication minimised face to face requirements, frequent monitoring of project deliverables and revised schedules where necessary to take advantage of participation by Working groups / collaborators with the least amount of disruption to daily workloads.
PITUS 15-16 Project Officer provided project support to collaborators / partners, including assistance with testing and documentation.
Time constraints - discipline specific pathologist
Workforce shortage, limited availability of discipline specific pathologist
Difficulty to adhere to timelines
Clear communication minimised face to face requirements, frequent monitoring of project deliverables and revised schedules where necessary to take advantage of participation by key pathologists with the least amount of disruption to daily workloads.
Difficulty - agreeing - what to include in Standard.
Difference of professional opinion.
Difficulty to adhere to timelines and project may not have been completed.
Key opinion leaders were included on the Project and on the PITUS 15-16 Steering Committee to ensure adequate representation and expertise.
Lack of acceptance by Fellows.
Difference of professional opinion.
Limitation of buy-in from profession without enforced Standards
Transparent communication of objectives, clear reasoning in support of the Standards, included key stakeholders throughout the development process
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Issue Source Impact Mitigation
Change of governance structure at HL7 Australia
Difference of professional opinion and approach to standard development
Fragmented approach to develop Standards
PITUS 15-16 wg1 members joined the HL7 Australia’s O&O working group and collaborated on the standards development to meet the Project timelines. To facilitate the standards development, the Chair of PITUS 15-16 wg1 was appointed as co-chair of the HL7 Australia O&O working group.
AHML’s changes to future ownership
No or limited availability to the AHML’S Test engine to identify any variances between the HL7 v2 pathology report messages in the trial implementations and the HL7 V2 standard
Difficulty to adhere to timelines
The PITUS 15-16 Project team were aware the ownership of AHML may change, and wg6 agreed in advance on a contingency to use the Medical Objects’ HL7 Lint program.
Lack of automated process for checking currency of published terminology codes
International standards development organisations (IHTSDO and Regenstrief Institute, Inc.) updating terminology codes
Time consuming to perform a manual audit on all the RCPA pathology requesting and reporting terminology reference sets
The PITUS 15-16 Project team requested the Agency to perform an audit on the published pathology information models and terminology reference sets, to report discrepancies between these pathology information models and terminology reference sets and the latest releases from the international standards development organisations.
All discrepancies were rectified in the latest release of the pathology information models and terminology reference sets.
7.2 Project challenges
A number of minor challenges were identified which were largely due to the complexity and collaborative nature of some Project deliverables. These challenges included:
- Managing the availability of the key working group members to meet due to conflicting work commitments;
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- Limited availability and loss of key technical personnel from organisations collaborating on the Project ;
- Other business projects undertaken by collaborators that inadvertently impacted the implementations committed under this Project;
- Collaborators on the trial implementation of the electronic communication of atomic pathology result data to registries had to out-source software development work which added an additional level of complexity to this Project.
More complex challenges that impacted the project’s work activities and timelines were:
1. Changes to the governance structure at HL7 Australia (Activities 3.7, 3.7.1, 3.7.2)
The changes to the governance structure at HL7 Australia delayed finalising the HL7Australia Implementation Guide impacted Activity 3.7, 3.7.1, 3.7.2.
Wg1 was to collaborate with HL7 Australia to develop and finalise HL7 Implementation Guide (Activity 3.7.1), and wg1 had been working on developing this implementation guide since late 2015 using Microsoft Word. However, in March 2016 HL7 Australia made a decision for this work to be undertaken by the HL7 Australia’s Orders and Observations working group and requested the Implementation Guide to be developed using the HL7 Australia’s Confluence site.
This decision impacted the format and completion date for this activity as the existing development required reformatting to be compatible with the HL7 Australia Confluence site. In addition, most of the collaborators had no prior experience with Confluence. The seven collaborators working on this Implementation Guide were able to complete the draft document in mid-December 2016, a few months behind the original wg1 schedule.
The change in governance structure at HL7 Australia also impacted Activity 3.7.2. HL7 Australia Board will be the approving body for the HL7 Implementation Guide titled Australian Pathology Messaging - Localisation of HL7 Version 2.4, and the RCPA Board of Directors will no longer have authority for the final approval.
The HL7 Australia Board recently requested their members to provide feedback on the Australian Pathology Messaging - Localisation of HL7 Version 2.4, feedback is required to be submitted by 9 March. This has impacted Activity 3.7.2.
Activity 3.7.2 was been completed on 09 April 2017 the Chairs of HL7 Australia O&O working group submitted the first version of the Australian Pathology Messaging - Localisation of HL7 Version 2.4 to the HL7 Australia Board for approval prior to publication.
2. Shortage of technical resources (including IT staff and software) (Activity 3.5.3)
The shortage of technical resources (including IT staff and software) to undertake the trial implementation for transmitting atomic data for RCPA SPRC reports to a registry impacted Activity 3.5.3.
HL7 Australia’s FHIR standards are new and the shortage of technical resources was identified early in the project as a potential risk, so a contingency was devised by wg5 to use dotted notation, and the PITUS Project Officer prepared archetypes for Colorectal cancer and Prostate cancer (Radical prostatectomy) cancer to produce example HL7 v2 messages using this archetype structure.
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The Project collaborated with two laboratories, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology, to investigate alternative ways to convey atomic data for RCPA SPRC reports to the Cancer Institute NSW.
To participate in the trial Douglas Hanly Moir required a ‘beta release’ of the LIS to enable FHIR testing functionality and additional support from the PITUS Project Officer to produce HL7 v2 messages with dotted notation for the five (5) Colorectal and five (5) Prostate SPRC reports.These HL7 v2 messages with dotted notation were subsequently used in the new FHIR module of the ‘beta release’.
The business forms and workflow engine trialled by NSW Health Pathology required modifications to produce XML/FHIR documents for this trial.
There was a steep learning curve for the technical staff at the two laboratories to become familiar with FHIR, however with the development of the Structured Pathology Reporting of Cancer FHIR website and access to FHIR experts such as HL7 FHIR Product Director to answer any queries, provided the technical staff with the support and knowledge required for this trial.
This is documented in more detail in the summary report for this trial implementation; see Section 10.1 – Appendix F.
3. AHML’s changes to future ownership (Activities 3.10, 3.10.1)
Wg6 intended to use the AHML test engine for testing compliance of HL7 pathology report messages against the HL7 v2.4 pathology report messaging standards. At the time of planning the trial implementation of the Informatics External Quality Assurance program, the future of AHML was not known and the test engine was not available for use, and so the RCPAQAP were forced to consider an alternative.
Medical Objects was the successful respondent to the RFP to develop software for sending and receiving pathology requests and reports, and modified the HL7 Lint program, to cover the needs of this Project and to ensure the trial implementation was completed on schedule.
4. Shortage of testing for the trial implementation of the IEQA (Activities 3.10, 3.10.1)
The shortage of resources to undertake testing for the trial implementation of the quality assurance protocol to be used by accrediting bodies to assist with compliance of pathology report messages impacted Activity 3.10, 3.10.1.
Resource shortages and time constraints for the trial implementations was a challenge, however to mitigate the impact, the RCPAQAP engaged the PITUS 15-16 Project Officer to provide project support to collaborators / partners, including assisting with testing and documentation of compliance of the pathology report messages from the two participating laboratories.
5. Currency of published pathology information models and terminology reference sets (Activity 3.3.2)
Wg3 identified an issue while reviewing the pathology information models terminology reference sets for reporting pathology where terminology codes published from the previous PUTS and PITUS projects were found to be ‘inactive’ and that new codes had been assigned by the international standards development organisations (IHTSDO and Regenstrief Institute, Inc.) in the latest releases.
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This impacted on the timeline, as a manual audit on the Microbiology Subset of Organisms mapped to SNOMED CT reference set was required and uncovered 320 SNOMED codes listed since February 2013 (i.e. PUTS Project) had been replaced with a new code in the current release published by International Health Terminology Standards Development Organisation (IHTSDO).
The PITUS 15-16 Project team requested the Agency perform an audit on all published pathology information models and terminology reference sets, and report any discrepancies against the latest releases from the international standards development organisations.
All discrepancies identified by the Agency were rectified in the latest release of the pathology information models and terminology reference sets.
The international standards development organisations (IHTSDO and Regenstrief Institute, Inc.) produce a number of releases each year, and it would not practical to perform a manual audit on each of the pathology information models and terminology reference sets each time these international organisations produce a new release, as there over 5000 published codes in the pathology information models and terminology reference sets. Therefore, it is important for the long term sustainability of the pathology information models and terminology reference sets, to develop an automated system for cross checking the currency of the current releases against the international standards development organisations. This will be a consideration for inclusion in a future PITUS Project funding application.
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8. Financials The final financial statement and reconciliation for the Project is in Section 10.2.
The Project team had planned to hold face-to-face meetings for the PITUS 15-16 working groups but as the Project progressed, more teleconferences were held in-lieu of face-to face meetings, as other business commitments made it difficult for some key working group representatives to provide the necessary dedicated time required to attend a face-to-face meeting. This has led to an under spend in ‘Steering & Advisory Committee Costs’.
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9. References 1. Lerner, J, et al ECRI Institute’s Top 10 Patient safety concerns for Healthcare organisations 2. Khoury M, Burnett L, Mackay MA. Error rates in Australian chemical pathology laboratories.
Med J Aust 1996; 165:128–30. 3. Legg M. Standardisation of test requesting and reporting for the electronic health record
Clinica Chimica Acta Volume 432, 15 May 2014, Pages 148–156 4. Sabrina Koetsier, Graham Ross Dallas Jones, Tony Badrick, Safe reading of chemical
pathology reports: the RCPAQAP Report Assessment Survey, Pathology (June 2016) 48(4), pp. 357–362
5. Tony Badrick, Stephanie Gay, Euan J. McCaughey, Andrew Georgiou. External Quality Assessment beyond the analytical phase: an Australian perspective, Biochemia Medica 2017;27(1):73-80.
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10. Appendices Appendix A - PITUS 15-16 One-page plan;
Appendix B - PITUS 15-16 Working groups - Summary and Key deliverables
Appendix C - Project Activity Plan (as at 30 April 2017)
Appendix D - Release note - RCPA Pathology Terminology and Information Model v1.0 [KPI # 2 - see section 6.3 Key activity indicators / Milestones /KPIs].
Appendix E - Release note - RCPA Pathology Terminology and Information Model v1.1 [KPI # 3 - see section 6.3 Key activity indicators / Milestones /KPIs].
Appendix F - Trial implementation for atomic reporting of cancer to registries
Appendix G - Trial implementation of an Informatics External Quality Assurance (IEQA) Program
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10.1 Appendix A - PITUS 15-16 Project One-page plan
Stakeholders Vision, Mission, and Values Key Result Areas Projects
RCPA Members • RCPA Board • Fellows • Trainees • Other associates and members
RCPA People • PITUS steering committee and working
groups • Other advisory committee members • Other volunteers & contractors
Partner Organisations • PAC member organisations • RACGP and other Colleges • HL7.au • NEHTA • Cancer Institute NSW • RCPA Quality Assurance Program
(RCPA QAP) • Consumers
Standards Development Organisations • NPAAC • Standards Australia • ISO • HL7.au • IHTSDO, Regenstrief
Regulators and Funders • Government Departments • Australian Information Commissioner • NATA • TGA • Human Research Ethics Committees • eHealth CCA Governance Group
Vision • Australia has access to and uses
standardised pathology information structures and terminologies to optimise systems for recording, decision support communication and analysis so as to improve healthcare for the individual; the population; and the healthcare system for its practitioners and payers.
Mission • To develop College standards and guidelines
related to pathology terminology, units and information
• To promote and drive adoption of the standards across the pathology industry
• To provide leadership and advice on pathology terminology, units and information to the College and pathology industry
• To act as the governance committee for the pathology terminology, units and information
Values • Expert • Open and consultative • Responsive • Relevant
Leadership • Governance • Expertise & knowledge management • Development of standards and guidelines in
pathology terminology, units and information • Promotion of these standards and guidelines • Quality, safety and good practice
Key Objectives • Develop standards, information models and
terminologies for safe atomic reporting to registries
• Ensuring standards, information models and terminologies are comprehensive, current and accessible
• Establishing a compliance and accreditation environment for pathology terminology to be used by accrediting bodies
• Developing an implementation checklist for best practice in the use of clinical information systems for the requesting of pathology, records management and follow-up of pathology reports;
• Drive adoption, compliance and accreditation through promotion and adoption of the standards across the pathology industry.
Key activity indicators / milestones / (KPIs) 1. 100% of RCPA Board approved reporting and
requesting terminology standards hosted on the RCPA website by 30 June 2016
2. 100% of RCPA Board approved reporting and requesting terminology standards hosted on the RCPA website and NEHTA (or NEHTA equivalent) website by 31 July 2016
3. 100% of RCPA Board approved reporting and requesting terminology standards hosted on the RCPA website and NEHTA (or NEHTA equivalent such as Australian Digital Health Agency) website by 1 March 2017
4. Pathology standards, information models and
Steering committee • Promote adoption and support adoption of
new and existing pathology terminology and information standards
Develop and implement a communications strategy
Overall governance of the project
Working groups Standards development and publishing (wg1) • Develop an Implementation Guide for
standardised HL7v2 messaging • Publishing of standards, models and
terminology with NEHTA and HL7.au Safety in pathology reporting (wg2) • Review chemical tests for combination
safety • Develop an implementation checklist for
best practice in the use of clinical information systems
• Develop harmonised reference ranges (where possible)
Request and report terminology (wg3) • Expand terms in APUTS reference set to
increase test coverage Request modelling (wg4) • Develop an information model and
associated terminology for genetic test requesting
Report modelling (wg5) • Develop draft standards for safe atomic
reporting to registries • Progress the implementation of these
reporting standards by partnering with Cancer Institute NSW
Informatics quality assurance (wg6) • Develop and trial a quality assurance
protocol that can be used by accrediting bodies to assist with compliance, by partnering with RCPA QAP
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Stakeholders Vision, Mission, and Values Key Result Areas Projects terminologies are comprehensive, current and accessible for 800 SNOMED mapped request tests by December 2016
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10.2 Appendix B - PITUS 15-16 Working groups - Summary and Key deliverables
The PITUS 15-16 Project had 6 working groups, the summary and key deliverables were:
wg1 Standards development and publishing
Publication of the pathology information models and terminology reference sets
Working group 1 (wg1) focused on establishing efficient and safe electronic publishing of pathology information models and terminology reference sets by working with the Agency to publish pathology information models (terminology required when rendering a complex text or structured pathology report) and terminology (standardised preferred term and SNOMED CT-AU code for pathology request tests; and preferred term, units and LOINC code for use in pathology reporting) for pathology tests for requesting and reporting) on the NCTS website, and working with HL7 Australia to develop a local version of the HL7 v2.4 pathology report messaging standards.
There are many healthcare organisations that directly or indirectly receive pathology reports from pathology providers, and use pathology results for analysis, research, decision support, etc. These healthcare organisations can easily access the NCTS website to download the comprehensive and current set of pathology information models and terminology reference sets for requesting and reporting of pathology, which will assist these organisations to use the pathology result data.
In July 2016, the RCPA and Australian Digital Health Agency (the Agency) signed an agreement for publishing pathology requesting and reporting terminology on the Agency’s website. The agreement included principles for publishing pathology information models and terminology, these are:
1. There should be only one source of truth for the preferred Australian pathology terminology; 2. Terminology must be developed and maintained in a timely, open and collegiate manner; 3. There must be rigorous systems to assure the provenance and quality of the terminology
and its publication; 4. Due regard must be given to intellectual property rights and license agreements; 5. It should be made easy to use the right pathology terminology in the right way by users; 6. There should be no limit to the number of organisations who publish the terminology or the
form of publication of the terminology, provided it meets the documented standards.
The agreement document between the RCPA and the Agency covers:
• Intellectual property ownership, and the roles and responsibilities of each party for maintaining the standards;
• Principles and specific guidelines for managing and publishing pathology terminology, including: o Release schedule; o Communication strategy, including information flow diagram; o Content development process; o Process for handling content requests.
The RCPA Pathology Terminology and Information Model v1.0 release containing terminology from the PITUS-14 Project was published and made available on the Agency’s website in July 2016. In December 2016, this release was transferred to the Agency’s new National Clinical Terminology Service (NCTS) website. The release note is in Section 10.1 – Appendix D.
The Pathology Terminology and Information Models from the PITUS 15-16 Project were approved by the RCPA Board of Directors on the 24 January 2017. These documents are now available on
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the RCPA website. The RCPA - Pathology Terminology and Information Model v1.1 release containing terminology from the PITUS 15-16 Project was published and made available on the Agency’s NCTS website on 31 March 2017. The release note is in Section 10.1 – Appendix E.
Local Australian version of HL7 pathology report messaging standards
The need to develop a local Australian version of HL7 pathology report messaging standards arose as a result of the RCPA PITUS 15-16 Project being unable to publish a revised AS4700.2 and HB262 with Standards Australia. The PITUS 15-16 Project collaborated with HL7 Australia to draft a localised version of the HL7 International pathology report messaging standards v2.4, conformance requirements and references based on the completed PITUS 15-16 work that provided the required information to enable electronic pathology messaging between pathology providers and pathology report recipients (clinicians, registries, MyHR). This local version of the international ‘standard’ will enable all pathology information required to implement a HL7 pathology request and report messaging standards be available to pathology providers and pathology report recipients (clinicians, registries, MyHR).
Wg1 originally had a sub-group working on the HL7 pathology request and report messaging standards v2.4 localisation document, however in March 2016 HL7 Australia moved the standards development to the HL7 Australia Orders and Observations (O&O) working group. The Chair of PITUS 15-16 wg1 is the co-chair of this HL7 Australia O&O working group along with the Director of Research and Development at Medical Objects Pty Ltd.
The HL7 Australia O&O working group used a collaborative software (Atlassian’s Confluence), to assist with the co-development of the draft Australian Pathology Messaging - Localisation of HL7 Version 2.4 document. In December 2016 the final draft was completed, and the co-chairs of the HL7 Australia Orders and Observations (O&O) working group requested HL7 Australia Board review and approve to proceed to invite feedback from HL7 Australia members.
The HL7 Australia Board agreed at the January 2017 meeting to circulate the draft Australian Pathology Messaging - Localisation of HL7 Version 2.4 and invited HL7 Australia members to provide feedback. The HL7 Australia O&O working group received 13 comments and reviewed each comment. Nine (9) comments were resolved and four (4) comments will require wider consultation for a future version of the document. On 9 April 2017 the Chairs of HL7 Australia O&O working group submitted the 242-page first version of the Australian Pathology Messaging - Localisation of HL7 Version 2.4 to the HL7 Australia Board for their approval prior to publication by HL7 Australia.
As at 30 April 2017, wg1 have held seventeen (17) meetings to discuss publishing pathology information models and terminology reference sets, and participated in twenty (21) HL7 Australia O&O working group meetings (last meeting was held on 20 December 2016). Additionally, there have been face-to-face sub-group meetings, these include:
- Face-to face meeting was held on 7 April 2016 between the RCPA and the Agency to finalise the agreement for hosting pathology requesting and reporting terminology standards;
- Face-to-face meeting was held on 11 April 2016 with the HL7 Australia O&O working group; - Face-to-face meeting was held on 5 July 2016 with the HL7 Australia O&O working group.
Key deliverables from wg1:
- First version of the Australian Pathology Messaging - Localisation of HL7 Version 2.4 [this has been submitted to HL7 Australia Board for approval prior to publication by HL7 Australia];
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- RCPA Pathology Terminology and Information Model v1.0 release (Pathology information models and terminology reference sets from PITUS-14 Project) – available on the Agency’s NCTS website. The release note is in Section 10.1 – Appendix D.
- Pathology informatics standards, Information Models and Terminology reference sets from the PITUS 15-16 Project are available on the RCPA website.
- RCPA Pathology Terminology and Information Model v1.1 release (Pathology information models and terminology reference sets from PITUS 15-16 Project) were available on Agency’s NCTS website on 31 March 2017. The release note is in Section 10.1 – Appendix E.
wg2 Safety in pathology reporting
Working group 2 (wg2) developed guidelines for the safe communication of pathology requesting and reporting in Australia. This work was inspired by the USA government’s SAFER Guides.
The best practice guidelines for the safe communication of pathology requesting and reporting provided by this Project will improve efficiency by optimising requesting and reducing waste that can be incurred following-up errors. These are both direct and indirect benefits for health consumers.
Receiving clear and unambiguous reporting of pathology results will save the report recipient time, assist clinicians to correctly interpret the pathology report, diagnose the patient and to prescribe the most appropriate treatment for the patient.
The key deliverable from wg2 is accessible on the RCPA website:
− Standards for Pathology Informatics in Australia (SPIA) v3.0 [chapter 9 and 10]
Chapter 9 provides guidelines for best practice safe communication of pathology requests in Australia focusing on computer generated requests communicated via paper or electronic messaging.
Chapter 10 describes the guidelines for best practice safe communication of pathology reports (printed and electronic) in Australia for senders and receivers.
As at 1 March 2017, wg2 held 25 meetings, the last meeting was held on 22 November 2016.
wg3 Request and report terminology
Working group 3 (wg3) focussed on terminology used for requesting pathology, from the tests listed in the RCPA Manual of Use and Interpretation of Pathology Tests (RCPA Manual), LabTests Online and feedback received from implementations at NSW Health Pathology, ACT Pathology and Sonic Healthcare. Terminology typically used for requesting pathology is SNOMED CT-AU and this standardised coded terminology enables data to be shared between sending (clinicians, etc.) and receiving (pathology providers) organisations’ computer systems.
The pathology requesting terminology reference set produced by this Project, provides a standardised set of codes which can be used to link to common knowledge-bases, such as the RCPA Manual for Use and Interpretation of Pathology Tests (RCPA Manual), to retrieve information about pathology tests. This information can be used within decision support tools to provide timely and valuable information at the time of requesting pathology to the clinician, which will lead to more appropriate utilisation of pathology tests and better management of Medicare Pathology services.
At the completion of this Project, a total of 969 pathology requested tests have been assigned a SNOMED CT-AU code. During this Project, 481 new preferred terms have been added to the 488 preferred terms previously published by PUTS and PITUS-14 projects. The pathology requesting
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terminology reference set was recently available for public review and all issues highlighted were addressed by the Project prior to submitting to the RCPA Board of Directors for endorsement.
The Project KPI for this work is addressed in Section 6.3.
Wg3 also updated the terminology for reporting for chemical pathology, haematology, microbiology and immunopathology, adding over 80 new LOINC codes (common codes and terminologies for clinical and laboratory observations) and making over 900 other modifications to the pathology reporting terminology reference sets.
Wg3 identified an issue with managing the currency of the published pathology information models and terminology reference sets when international terminology organisations (such as International Health Terminology Standards Development Organisation and Regenstrief Institute) make changes to published pathology terminology. This issue and how the Project should address it in the future is discussed in more detail in Section 7.1.
Two submissions were made to the Regenstrief Institute, Inc. for new LOINC codes. The first was the July 2016 release of LOINC codes whereby 26 Microbiology pathology tests were added; and the second was December 2016 release where a further 38 new LOINC codes were added to cover terminology for Colorectal and Prostate (Racial prostatectomy) Cancer.
During the course of the Project, four (4) request submissions were made to the Agency for new SNOMED CT-AU codes, and by the December 2016 SNOMED CT-AU release, over 150 new SNOMED CT-AU codes have been added, including new requesting terminologies; and terminologies for reporting of Colorectal and Prostate cancers.
These submissions for new LOINC and SNOMED CT-AU codes provided new pathology reporting terminology that can be used in the implementation of structured pathology reporting of Colorectal and Prostate (Racial prostatectomy) cancer protocols by pathology providers in Australia. Standardised terminology for RCPA SPRC protocols enables reporting data to be shared between sending (pathology providers) and receiving (clinicians, MyHR, cancer registries, etc.) organisations’ computer systems.
The pathology information models and terminology reference sets for reporting provided by this Project are aimed to provide guidance to pathology laboratories for the safe and consistent atomic reporting of pathology across Australia and to support the implementation of the MyHR in a way that is consistent with the Department of Health Quality Use of Pathology objectives and E-Health Programs.
Key deliverables from wg3:
− RCPA - SPIA Requesting Pathology Terminology Reference Set 3.0 − RCPA - SPIA Chemical Pathology Terminology Reference Set v3.0* − RCPA - SPIA Haematology Terminology Reference Set v3.0* − RCPA - SPIA Immunopathology Terminology Reference Set v3.0* − RCPA - SPIA Microbiology Serology Molecular Pathology Terminology Reference Set v3.0* − RCPA - SPIA Microbiology Report Information Model Terminology v3.0* − RCPA - SPIA Microbiology Subset of Organisms mapped to SNOMED CT v3.0 − RCPA - SPIA Cytopathology Report Information Model Terminology v3.0 − RCPA - SPIA Gastric Cancer Report Information Model Terminology v2.0 − RCPA - SPIA Colorectal Cancer Report Information Model Terminology v1.0 − RCPA - SPIA Prostate Cancer Radical Information Model Terminology v1.0
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− RCPA - SPIA Genetics Report Information Model Terminology v3.0* − RCPA - SPIA Surgical Pathology Report Information Model Terminology v3.0*
The above deliverables were endorsed by the RCPA Board of Directors on 24 January 2017 and the above marked with a ‘*’ were published on the RCPA website on 31 January 2017. All the above listed documents are included in the RCPA Pathology Terminology and Information Model v1.1 release which was published on the Agency’s NCTS website on 31 March 2017.
As at 30 April 2017, wg3 have held 31 meetings, with the last meeting held on 17 November 2016.
wg4 Request Modelling
Working group 4 (wg4) planned to consult with stakeholders to develop a consensus approach for requesting genomics testing that would improve the quality of genomics testing, and to identify ways to reduce the number of inappropriate pathology test requests.
Since the wg4 plan was developed, a number of organisations and/or collaborations specialising in genomic testing have been established around Australia. One such collaboration is the Australian Genomics Health Alliance (AGHA) which has 50 partner organisations who are working towards integrating genomic medicine into healthcare across Australia; see the AGHA website for the list of partners. The genomic alliances were recently formed to address this rapidly growing area of genomics testing. The Project engaged with the AGHA regarding possible collaboration/input on wg4 workshops to assist with the development of pathology information models and terminology reference sets for use in requesting genomic tests.
Wg4 held a workshop with representatives from a number of genomic organisations such as Genome.one, Melbourne Genomics Health Alliance and the CSIRO Lead on the Melbourne Genomics Health Alliance to discuss the initial plan and gain agreement from the genomics alliances for the RCPA PITUS 15-16 Project to lead the work to develop a pathology information model and terminology reference set that clinicians can use for requesting genomic tests.
The Project was unable to leverage the services of the genomics alliances to coincide with the wg4 project plan due to competing business commitments. Previous experience in establishing consensus-based standards requires all parties to participate in the development process so as to create a robust standard and to increase adoption and compliance.
As this was not possible in the given timeframe, the Chair of wg4 and the representatives from the AGHA agreed that a temporary delay to developing the pathology information model and terminology reference sets for genomic requesting was the best approach. The key stakeholders however have expressed a commitment to continue this important development work and have proposed a series of workshops to address the development of the pathology information model and terminology reference set for genomic requesting under a future project.
As at 30 April 2017, wg4 have held 7 meetings. In addition, Melbourne Health Genomics Alliance held an internal workshop on 11 July 2016, and the Chair of PITUS 15-16 and Chair of wg4 attended an all-day face-to-face workshop with Melbourne Health Genomics Alliance on 28 July 2016 to discuss the collaborative approach for developing the pathology information model and terminology reference sets for genomic requesting.
wg5 Report Modelling
Working group 5 (wg5) collaborated with Cancer Institute NSW and two testing laboratories, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology to complete a trial
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implementation for the electronic communication of atomic result data for structured reporting of pathology cancer reports to show how data can be shared between sending (pathology providers) and receiving (cancer registries) organisations’ computer systems.
Standardisation of pathology reporting terminology to pathology-related registries will provide a number of benefits such as:
- improved quality and timeliness of information from laboratories; - registries and researchers could use the standardised information for analysis and further
study; - possible reductions in the implementation costs incurred by pathology providers for
interfacing to pathology-related registries.
Colorectal cancer and Prostate cancer (Radical prostatectomy) SPRC protocols were selected for this trial implementation. The pathology information models and terminology reference sets required for representing the structured pathology reporting of cancer report for colorectal cancer and prostate cancer (radical prostatectomy) have been developed, and are listed in the key deliverables section below.
The Agency and HL7 FHIR Product Director developed the draft HL7 Australia’s Implementation Guide for Structured Pathology Reporting of Cancer using the new HL7 Australia FHIR standards to convey the pathology information model and terminology reference sets for RCPA SPRC reporting of colorectal and prostate cancer. Wg5 selected FHIR to transmit atomic data for structured pathology reporting of cancer reports as FHIR is gaining rapid and wide acceptance by pathology communication experts and is likely to be the preferred option for future electronic delivery of complex pathology reports.
The implementation guide is available on the Structured Pathology Reporting of Cancer FHIR website. This implementation guide describes how to implement the RCPA SPRC protocols for data exchange covering logical models, mappings, FHIR resources and examples to assist pathology providers with the implementation of structured pathology reporting of cancer.
FHIR is still in the early stages of development and the trial implementation uncovered a number of technical issues which required resolution before the trial could begin. This delayed the trial implementation. A summary of the trial implementation including the identified issues are set out in Section 10.1 – Appendix F.
As at 30 April 2017, wg5 have held 22 meetings, with the last working group meeting held on 17 November 2017. A technical sub-group was formed to investigate the use of the new HL7 Australia FHIR standards, and this sub-group held 5 meetings.
Key deliverables from wg5:
− RCPA - SPIA Colorectal Cancer Report Information Model Terminology v1.0 − RCPA - SPIA Colorectal Cancer Report Information Model v1.0* − RCPA - SPIA Prostate Cancer Radical Report Information Model Terminology v1.0 − RCPA - SPIA Prostate Cancer Radical Report Information Model v1.0* − HL7 Australia Implementation Guide for RCPA SPRC reporting, see the Structured
Pathology Reporting of Cancer FHIR website − Summary report for the trial implementation for atomic reporting of cancer to registries, see
Section 10.1 – Appendix F.
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The above deliverables were endorsed by the RCPA Board of Directors on 24 January 2017 and the above marked with a ‘*’ were published on the RCPA website on 31 January 2017. All the above hyperlinked documents are included in the RCPA Pathology Terminology and Information Mode v1.1 release which was published on the Agency’s NCTS website on 31 March 2017
wg6 Informatics quality assurance
In 2015, as part of the RCPAQAP Liquid Serum Chemistry program, laboratories were invited to supply a routine paper report displaying results. The RCPQAP analysed these reports against the RCPA’s Standards for Informatics in Australia (previously known as APUTS Standards and Guidelines). The variation identified4 by the RCPAQAP validated the rationale for the PITUS 15-16 Project to collaborate with RCPAQAP to develop and trial a quality assurance protocol for one quality assurance program that can be used by accrediting bodies to assist with compliance pathology reporting against published HL7 report messaging standards and RCPA’s Standards for Pathology Informatics in Australia.
The PITUS 15-16 Project entered into an agreement with the RCPAQAP to trial the implementation of an Informatics External Quality Assurance (IEQA) program for the Liquid Serum Chemistry program with two pathology laboratories. Working group 6 (wg6) collaborated with the RCPAQAP on the trial implementation to test the compliance of pathology reporting against existing HL7 v2.4 pathology report messaging standards and the RCPA’s Standards for Pathology Informatics in Australia. RCPAQAP do not send electronic request or receive results for any of the external quality assurance programs, so a thorough review of the technical infrastructure was required before this trial could begin.
The development of the compliance tools used in the trial for an informatics external quality assurance program as part of this Project can be offered to pathology providers to test compliance of their electronic report messages in the future. These compliance tools can also be used to promote and educate pathology providers on best practice with respect to compliance to electronic HL7 pathology report messaging standards and standards for pathology informatics developed by this Project.
The summary report of the trial implementation for the IEQA program for Liquid Serum Chemistry program is detailed in Section 10.1 – Appendix G.
As at 30 April 2017, wg6 have held 10 meetings, with the last working group meeting held on 17 November 2016. There have been multiple face-to-face meetings between the RCPAQAP and the PITUS 15-16 wg6 Chair to draft functional specifications and the technical infrastructure required to implement an IEQA program.
Key deliverables from wg6:
− Summary report for the trial implementation of an Informatics External Quality Assurance (IEQA) Program (see Section 10.1 – Appendix G)
A copy of the minutes from the above working group meetings are available from the RCPA Project Management Office upon request.
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10.3 Appendix C - Project Activity Plan (as at 30 April 2017)
Completed [Note: All activities in the table have been completed.]
*This date was changed as per Deed Variation No.1 extension.
Activity Activity Owner Date Due Status
1 Project Kick-off
1.1 Prepare project plan Project team 24-Jul-15 Project plan completed
1.2 Establish Steering committee Project team 24-Jul-15 Steering committee established and met on 29 July 2015
1.3 Face to Face Steering Committee meeting Project team 29-Jul-15 Steering committee met on 29 July 2015. The minutes are available from the RCPA Project Management Office.
1.4 Submit Activity report Project team 01-Aug-15 Activity report submitted to DoH on 1 August 2015, and updated for the DoH on 18 August 2015.
1.5 Assemble working groups Project team 31-Aug-15 All working groups except wg4 (Genetics) have commenced activities. Due to the current limited availability of the genetic specific pathologists, wg 4 plan to start work in February 2016.
2 DOH Performance and Final Reports
2.1 Submit Performance report 1 Program team 01-Dec-15 First progress report submitted on 1 December 2015.
2.2 Submit Performance Report 3 Program team 01-May-16 Second progress report submitted on 29 April 2016.
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Activity Activity Owner Date Due Status
2.3 Submit Performance report 3 Program team 01-Nov-16 Third progress report submitted on 1 November 2016.
2.4 Submit Draft Final report * *Added as per Deed of Variation No.1
Program team 1-Mar-17 Draft final report submitted on 1 March 2017.
2.5 Submit Final report including final statements* *Date changed as per Deed of Variation No.1
Program team 30-Apr-17 Final report submitted on 30 April 2017.
3 Work activities
3.1 Develop and implement a Communications Strategy to support the promotion of the pathology terminology standards
Steering committee
30-Apr-17* Completed.
3.1.1 Develop communications strategy (similar to PITUS-14). The Steering committee will approve and are responsible for all communications.
Steering committee
29-Jul-15 The communication strategy has been developed; see Section 6.4 of this report.
3.1.2 Conference participation Steering committee
Ongoing Refer to below for details.
HSIA HIC 2015 eSafety workshop presentation Steering committee
06-Aug-15 For details see Section 6.4 of this report.
Presentation to Biobanking workshop Steering committee
12-Aug-15 For details see Section 6.4 of this report.
Pathology Update 2016 Steering committee
28-Feb-16 For details see Section 6.4 of this report.
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RCPA Pathology Informatics Seminar 2016* *This was added to the work activities
Steering committee
10-Nov-16 For details see Section 6.4 of this report.
Pathology Update 2017 Steering committee
26-Feb-2017 The Chair of the Safety in pathology reporting presented ‘Traceability’ at the Pathology Update as part of a “safety in pathology initiative”.
Other conference participation - to be discussed and determined
Steering committee
Ongoing For details see Section 6.4 of this report.
3.1.3 PITUS 15-16 Newsletters at least 3 newsletters will be published and placed on website.
Steering committee
Ongoing Refer to below for details.
PITUS 15-16 Newsletter #1 Steering committee
30-Sep-15 The PITUS Update 4 newsletter was published on the RCPA website and distributed to all stakeholders on 14 September 2015.
PITUS 15-16 Newsletter #2 Steering committee
29-Apr-16 The PITUS Update 5 newsletter was published on the RCPA website and distributed to all stakeholders on 11 April 2016.
PITUS 15-16 Newsletter #3
Steering committee
23-Sep-16 The PITUS Update Issue 6 newsletter was published on the RCPA website and distributed to all stakeholders on 23 September 2016.
Note: With the significant progress made by the working groups and with the project extension (Deed of Variation No.1), the PITUS 15-16 Project tem decided to distribute an extra newsletter to report the progress of the project.
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PITUS 15-16 Newsletter #4 Steering committee
Pre-Final report The PITUS Update 7 newsletter was published on the RCPA website and distributed to all stakeholders on 4 April 2017.
3.1.4 RCPA, RCPA QAP, Pathology Australia, Medical Software Industry Australia communications
Steering committee
Ongoing, last newsletter will be published Apr 2017
For details see Section 6.4 of this report.
RCPA QAP - Meeting with CEO (follow up meetings will be scheduled regularly)
Steering committee
25 August 2015 For details see Section 6.4 of this report.
CEO of RCPAQAP participated in wg6 meetings and trial implementation update meetings.
RCPA to distribute notification of PITUS 15-16 newsletters in Pathology Today
Steering committee
Oct 2016, May 2016, Sept 2016, Apr 2017
For details see Section 6.4 of this report.
RCPA to send to Pathology Australia for distribution of PITUS 15-16 newsletters to members.
Steering committee
Oct 2016, May 2016, Sept 2016, Apr 2017
For details see Section 6.4 of this report.
RCPA to send to Medical Software Industry Australia to distribute PITUS 15-16 newsletters to members.
Steering committee
Oct 2016, May 2016, Sept 2016, Apr 2017
For details see Section 6.4 of this report.
3.1.5 Journal article/s Steering committee
Ongoing For details see Section 6.4 of this report.
3.1.6 Press articles e.g. Pulse-IT Steering committee
Ongoing For details see Section 6.4 of this report.
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3.1.7 Industry meetings e.g. HL7 Australia Steering committee
Ongoing until Dec 2016
For details see Section 6.4 of this report.
3.1.8 Participation in Pathology in the PCEHR Consultations
Steering committee
Ongoing For details see Section 6.4 of this report.
3.2 Implement an improved system for hosting pathology requesting and reporting terminology standards.
Steering committee, WG1
May-16 Completed, see Activity 3.2.1 below.
3.2.1 Develop, negotiate and finalise of an agreement between RCPA and the Agency for hosting requesting and reporting terminology standards. Includes establishing agreement and governance model with IP agreements between RCPA, the Agency and other organisations (as required).
Steering committee, WG1
May-16 Wg1 have worked closely with the Agency’s clinical terminology team on an agreement between RCPA and the Agency for publishing pathology information models and terminology reference sets, the final agreement was signed on 28 July 2016.
3.3 The RCPA will have responsibility of maintaining the standards and ensuring that the Agency is informed of any updates or changes.
Steering committee
30-Apr-17*
Completed.
3.3.1 Setup a communication strategy to ensure the Agency is informed when updates or changes are made to published APUTS standards. Note: The communication strategy will be documented as part of the above established agreement between RCPA and the Agency.
Steering committee; WG1
01-May-16 The communication strategy between RCPA and the Agency was detailed in the agreement, including a detailed workflow diagram outlining how the organisations will manage:
3. Bulk submission requests 4. Maintenance requests 5. Content requests for new SNOMED CT-AU codes.
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3.3.2 Establish and agree on an improved mechanism for capturing feedback, currency of information and version control which includes handling version control. Implement improved hosting systems.
WG1 30-Apr-17*
The agreement between RCPA and the Agency covers the mechanism to capture feedback, currency of information and version control. This agreement was signed on 28 July 2016.
RCPA Terminology and Information Model v1.0
As at 1 December 2015, the RCPA had published 100% of the RCPA Board approved requesting and reporting terminology standards on the RCPA website. For more details see Section 6.3 (KPI #1) of this report.
On 23 December 2016 the Agency published the RCPA Terminology and Information Model v1.0 on the NCTS website. The release note is in Section 10.1 – Appendix D. For more details see Section 6.3 (KPI #2) of this report.
RCPA Terminology and Information Model v1.1
The RCPA website was updated on 31 January 2017 to incorporate the most recent RCPA Board approved pathology requesting and reporting terminology standards from the PITUS-15-16 Project.
The Agency published the RCPA Pathology Terminology and Information Model release v1.1 release on the NCTS website on 31 March 2017. The release note is in Section 10.1 – Appendix E. For more details see Section 6.3 (KPI #3) of this report.
3.4 The standards are to be published by the Agency with acknowledgment of the RCPA as the source of the information.
WG1 PITUS -14 – 31- July-16
PITUS 15-16 –
The Agency’s NCTS website has acknowledged the RCPA Pathology Terminology and Information Standardisation publications as the source of information.
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30-Apr-17*
3.4.1 The Agency to publish APUTS terminology reference sets.
WG1 31- July-16 The agreed publishing date was originally planned for 30 June 2016; however this was delayed while NEHTA transitioned to the Agency. The Deed of Variation No.1 revised the completion date to 31 July 2016.
The first release of the RCPA Pathology Terminology and Information Model v1.0 was included in the 29 July release. The release note is in Section 10.1 – Appendix D.
For more details see Section 6.3 (KPI #3) of this report.
3.4.2 Update PITUS download website with all RCPA Board approved requesting and reporting terminology standards from PITUS-15/16.
Steering committee
30-Apr-17*
Completed.
For more details see Section 6.3 (KPI #3) of this report.
3.4.3 RCPA to inform the Agency when PITUS 15-16 documents are approved by board.
Steering committee
3 Feb 2017 The Standards for Pathology Informatics in Australia and associated pathology information models and terminology reference sets created or updated by the PITUS-15-16 Project, and approved by the RCPA Board, were emailed to the Agency on the 31 January 2017.
The Agency published the RCPA Pathology Terminology and Information Model release v1.1 release on the NCTS website on 31 March 2017. The release note is in Section 10.1 – Appendix E.
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3.5 Develop and finalise standards, information models and terminologies for safe atomic reporting to registries including Personally Controlled Electronic Health Record (PCEHR).
WG1, WG2, WG3, WG4, WG5, WG6
01-Dec-16 Completed, see Activity 3.5.1, 3.5.2, 3.5.3 and 3.5.4 below.
3.5.1 Develop a detailed plan for the trial implementation of these reporting standards and information model by partnering with one cancer registry. NOTE: WG5 will contain representatives from Cancer registries to discuss the implementation plan in more detail. The draft plan for the trial implementation will be documented in Performance report 1.
WG1, WG5 01-Nov-15 A trial implementation project was devised in consultation with Cancer Institute NSW and the testing laboratories, and a project document outlining the project activities and timelines was developed. A copy of the project plan is available upon request from the RCPA Project Management Office.
3.5.2 Develop draft standards for safe atomic reporting to registries.
WG1, WG5 01-Dec-16 The pathology information models and terminology reference sets required for representing the structured pathology of cancer report for colorectal cancer and prostate cancer (radical prostatectomy) were developed by wg5, and were officially endorsed by the RCPA Board of Directors as policy documents on 24 January 2017.
The Agency and HL7 FHIR Product Director have developed a model using the new HL7 Australia FHIR standards for structured pathology reporting of cancer. The draft implementation guides are available on the Structured Pathology Reporting of Cancer FHIR website.
3.5.3 Trial implementation by partnering with one cancer registry.
WG1, WG5 01-Dec-16 Wg5 collaborated with Cancer Institute NSW and two testing laboratories, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology to complete a trial implementation of a computer to computer atomic
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reporting of RCPA SPRC reports.
A summary report for this trial implementation is available; see Section 10.1 – Appendix F.
3.5.4 Collate stakeholder feedback and gain RCPA Board of Directors approval of the standard.
Steering committee, WG1
Pre-Draft final report
The pathology information model and terminology reference sets for the Colorectal and Prostate (Radical prostatectomy) cancer were officially endorsed by the RCPA Board of Directors as policy documents on 24 January 2017. This approval followed an internal and public review period.
The Agency has recommended further improvements to the publication of the multi-layered and complex pathology information models and terminology reference sets which will assist pathology providers with the implementation of RCPA SPRC protocols; this new work will form part of the future proposal.
3.6 Maintain a Steering Committee and Working Groups, ensuring representation by key stakeholder groups.
Steering committee
Ongoing until 30 Nov 2016
Key stakeholders (DoH, the Agency, RACGP, PAC, AACB, HL7 Australia and RCPA Advisory Committees) participated in standardising of the pathology requesting and reporting terminology. Representatives from these stakeholder groups are also members of the PITUS 15-16 Steering Committee and/or associated working groups. For more details see section 5.3 Steering Committee details.
3.7 Work with HL7 Australia to develop and finalise a HL7 Implementation Guide to allow for safe communication of atomic reporting
WG1 01-Dec-16 On 9 April 2017 the Chairs of HL7 Australia O&O working group submitted the first version of the Australian Pathology Messaging - Localisation of HL7 Version 2.4 to
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of pathology results to external computer systems.
the HL7 Australia Board for their approval prior to publication. This was delayed, for details see Activity 3.7.2 and 7.2 Project Challenges.
3.7.1 Assist HL7 Australia to develop and finalise HL7 Implementation guide.
WG1, WG5 01-Dec-16 There were 7 collaborators from the HL7 Australia Orders and Observations working group co-developing the draft Australian Pathology Messaging - Localisation of HL7 Version 2.4 document.
3.7.2 Collate stakeholder feedback to finalise and seek RCPA Board of Directors approval of the HL7 Implementation guide.
WG1 Draft final report The HL7 Australia Board agreed at the January 2017 meeting to circulate the draft Australian Pathology Messaging - Localisation of HL7 Version 2.4 and invited HL7 Australia members for their feedback until 10 March 2017.
The HL7 Australia O&O working group received 13 comments and reviewed each comment in a meeting held on 7 April 2017, nine (9) comments were resolved at the meeting and four (4) comments require wider consultation and were dispositioned for a future version of the document.
On 9 April 2017 the Chairs of HL7 Australia O&O working group submitted the first version of the Australian Pathology Messaging - Localisation of HL7 Version 2.4 to the HL7 Australia Board for their approval prior to publication.
The HL7 Australia Board are the approving body as a result of the changes to the HL7 Australia governance
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structure which was effective from March 2016 [refer to Section 5.2]. Therefore the HL7 Australia Board is required to approve this document as the RCPA Board of Directors does not have the authority.
3.8 Promote adoption and support adoption of new and existing pathology terminology standards by pathology providers.
Steering committee
01-Dec-16 Completed, see Activity 3.8.1, 3.8.2, 3.8.3, 3.8.4 and 3.8.5 below.
3.8.1 Identify issues from proof of concept performed in PITUS-14. Feedback from implementation and live sites will be gathered to identify areas for improvements in the implementation of terminology standards. NOTE: Issues analysis will continue until November 2016 to ensure latest feedback is incorporated into PITUS 15-16 version of the standards.
WG3 01-Dec-16 The PITUS 15-16 Project Officer worked closely with a number of pathology organisations in NSW, ACT, QLD and TAS, who have, or are in the process of, implementing SNOMED codes within LIS’s for requesting and LOINC codes for pathology reporting tests.
Feedback provided by these implementation sites resulted in over 80 new terminologies added to the pathology information models and terminology reference sets.
3.8.2 Update pathology standards, information models, terminologies and RCPA protocols.
WG3 01-Dec-16 The Project made a significant number of additions and modifications to the pathology information models and terminology reference sets.
Requesting terminology:
At the completion of this Project there are 969 pathology requested tests with an assigned SNOMED code.
The updated pathology requesting terminology reference set was endorsed by the RCPA Board of Directors on 24 January 2017.
For more details see Section 6.3 (KPI #4) of this report.
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Reporting terminology: Wg3 also updated pathology terminology for reporting for chemical pathology, haematology, microbiology and immunopathology. Over 80 new LOINC codes were added to the pathology reporting terminology reference sets, and over 900 other modifications were made to the pathology reporting terminology reference sets.
See Section 6.5 for the list of new or updated pathology information models and terminology reference sets.
3.8.3 Develop implementation checklist for customers of pathology (e.g. GPs, etc.) using electronic requesting, record keeping and follow-up patient reports.
WG2 01-Dec-16 Wg2 developed guidelines for the safe communication of pathology requests and reports in Australia. These are set out in chapters 9 and 10 of the Standards for Pathology Informatics in Australia (SPIA) v3.0 (previously known as APUTS Standards and Guidelines).
3.8.4 Update Requesting terminology targeting 800 SNOMED mapped request tests in the APUTS Standard.
WG3 01-Dec-16 For more details see section 6.3 of Performance Report 3 - Key activity indicators / milestones / (KPIs).
3.8.5 Collate stakeholder feedback to finalise and seek RCPA Board of Directors approval of the amended standards, information models and terminologies.
Steering committee, WG1, WG3
Pre-Draft Final report
The Standards for Pathology Informatics in Australia including pathology information models and terminology reference sets were officially endorsed by the RCPA Board of Directors as policy documents on 24 January 2017. This approval followed an internal and public review period.
3.9 Identify chemical pathology tests that can be safely combined on a pathology cumulative report.
WG2 01-Dec-16 Completed, see Activity 3.9.1 and 3.9.2 below
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3.9.1 Perform issues analysis (from feedback from live and implementation sites) and determine Chemical pathology tests that can be safely combined on a cumulative report. NOTE: Issues analysis will continue until November 2016 to ensure latest feedback is incorporated into PITUS 15-16 version of the documents.
WG2 01-Dec-16 Wg2 Chair led the analysis and discussion with the working group regarding the rules for combining results on a Chemical Pathology report, and it was agreed that no further changes were required to this coding system.
The AACB Harmonisation Committee developed harmonised adult reference limits for another six (6) analytes (Bilirubin, Creatine kinase, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyltransferase and Lipase). 17 analytes now have harmonised reference intervals.
The 6 new harmonised adult reference intervals were unanimously agreed by the pathologists and scientists attending the AACB Harmonisation workshop in September 2016.
The harmonised adult reference intervals for Bilirubin, Creatine kinase, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyltransferase and Lipase were endorsed by the RCPA Board of Directors as a policy on 24 January 2017.
Reference interval harmonisation is very important for the safe reporting of analytes, in particular when these analytes are combined on a pathology cumulative report.
3.9.2 Collate stakeholder feedback to finalise and seek RCPA Board of Directors approval of chemical pathology test list.
Steering committee, WG2
Pre-Draft Final report
The chemical pathology reporting test list was officially endorsed by the RCPA Board of Directors on 24 January 2017. This approval followed an internal and public review period.
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3.10 In consultation with RCPA Quality Assurance Program (RCPAQAP), develop and trial a quality assurance protocol that can be used by accrediting bodies to assist with compliance.
WG6 01-Dec-16 Completed, see Activity 3.10.1, 3.10.2 and 3.10.3 below.
A trial implementation of an informatics external quality assurance protocol for Liquid Serum Chemistry Program was successfully completed.
A summary report of this trial implementation project is available; see Section 10.1 – Appendix G.
3.10.1 Establish the requirements and plan the framework (including design architecture) to develop a quality assurance protocol for pathology messaging.
WG6 30-Jun-16 The PITUS 15-16 Project Team and RCPAQAP documented the functional requirements for the framework to test the compliance of pathology reporting by implementing a quality assurance protocol for electronic pathology report messaging for the Liquid Serum Chemistry program. An RFP for software and services to support electronic pathology requesting, electronic pathology report receipt and conformance/compliance testing of pathology report messages was released.
Medical Objects was the successful respondent to develop the software for sending and receiving pathology requests and reports, and the analysis software that will form the basis for the laboratory to report ‘Informatics’ performance.
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3.10.2 Develop and trial a draft quality assurance protocol for pathology messaging for one Program, this includes the trial period. Activities: -Select QAP program to use in trial (likely to be Liquid Serum Chemistry program, as patient testing covers male and female sampling). - Develop testing protocol (likely to be similar to proof of concept implementation undertaken in PITUS-14, by using the Australian Healthcare Messaging Laboratory (AHML) test engine to test HL7 pathology report messages and will require demonstration that a comparison of atomic data for the current episode and the rendered pathology report show no significant differences.) - Develop the following infrastructure: · Capacity to send and receive HL7 AS4700.2 messages · Testing engine, likely to be Australian Healthcare Messaging Laboratory (AHML) test engine to test HL7 pathology report messages. · Beta testers (select testing partners, likely to be the 2 consortiums who undertook the PITUS-14 implementation proof of concept testing). · Initiate development of integration to QAP analysis system
WG6 01-Dec-16 RCPAQAP established an Informatics External Quality Assurance (EQA) program for electronic reporting of results from laboratories for the Liquid Serum Chemistry program. Two laboratories assisted RCPAQAP with the trial implementation.
A summary report of this trial implementation project is available; see Section 10.1 – Appendix F.
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3.10.3 Collate feedback from the trial which will then be used to inform future development. Initial feedback from trial will be documented in Final report.
WG6 Ongoing, initial feedback by Feb 2017
A demonstration of the Medical Objects software compliance tool used in the trial implementation was made to wg 6, RCPAQAP Informatics Steering Committee and representatives from the two participating laboratories.
The feedback from the demonstration was that the tool exceeded expectations and there was potential for this tool to be used in an RCPAQAP Informatics External Quality Assurance Program in the near future.
For more details, see the Conclusion of the summary report of the trial implementation project under Section 10.1 –Appendix F.
3.11 Engage in stakeholder consultation to develop an information model and associated terminology for genetic test requesting.
WG4 01-Dec-16 Working group 4 (wg4) planned to consult with stakeholders to develop a consensus approach for requesting genomics testing to improve the quality of the genomics testing, and to identify ways to reduce the number of inappropriate pathology test requests.
The Project engaged with the Australian Genomics Health Alliance (AGHA) regarding possible collaboration/input on wg4 workshops to assist with the development of information and terminology for use in requesting genomic tests. The genomic alliances were recently formed to address this rapidly growing area of genomics testing.
Wg4 held a workshop with representatives from a number of genomic organisations such as Genome.one, Melbourne Genomics Health Alliance and the CSIRO Lead on the Melbourne Genomics Health Alliance to discuss the initial plans and gain agreement from the genomics alliances to
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have the RCPA PITUS 15-16 Project lead the work to develop a pathology information and terminology reference set that clinicians can use for requesting genomic tests.
The Project was unable to leverage the services of the genomics experts to coincide with the wg4 project plan due to competing business commitments. Previous experience in establishing consensus-based standards requires all parties to participate in the development process so as to create a robust standard and to increase adoption and compliance.
As this was not possible in the given timeframe, the Chair of wg4 and the representatives from the AGHA agreed that a temporary delay to developing the pathology information model and terminology reference sets for genomic requesting was the best approach. The key stakeholders however have expressed a commitment to continue this important development work and proposed a series of workshops to address the development of the pathology information model and terminology reference set for genomic requesting in the future project.
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10.4 Appendix D - Release Note - RCPA - Pathology Terminology and Information Models v1.0
July 2016 release note for the RCPA Terminology and Information Model v1.0 release (6 pages). To view the release note, go to NCTS website.
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10.5 Appendix E - Release Note - RCPA - Pathology Terminology and Information Models v1.1
March 2017 release note for the RCPA Terminology and Information Model v1.1 release (5 pages). To view the release note, go to NCTS website.
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10.6 Appendix F - Trial implementation for atomic reporting of cancer to registries
Executive summary
The Pathology Information, Terminology and Units Standardisation 15-16 Project run by the Royal College of Pathologists of Australasia (RCPA) with the support of the Department of Health, have lead the standardisation of pathology informatics standards, information and terminology for safer and better pathology requesting and reporting, and facilitating the adoption of these standards by pathology providers and their stakeholders.
The RCPA SPRC Project run by the RCPA with the support of the Department of Health, have been leading a program to develop a suite of standardised pathology reporting of cancer protocols to improve the safety and completeness of pathology reporting of cancer. Both these RCPA Projects collaborated on this trial implementation for atomic reporting of cancer to registries Project.
The PITUS 15-16 Project undertook to develop draft standards for safe atomic reporting to registries (e.g. MyHealth Record, cancer registries) including the investigation of the use of the new HL7 Australia FHIR standards. PITUS 15-16 Working Group 5 (wg5) worked closely with the SPRC Project to develop pathology information models and terminology reference sets for Colorectal cancer and Prostate cancer (Radical prostatectomy) SPRC protocols.
Wg5 collaborated with the Agency and HL7 Australia FHIR Product Director to develop a model using new HL7 Australia’s FHIR standards to convey the information model and terminology for Colorectal cancer and Prostate cancer (Radical prostatectomy) SPRC protocols. Wg5 selected FHIR to transmit atomic data for SPRC reports as FHIR is gaining rapid and wide acceptance and will possibly represent the preferred option for the future electronic delivery of complex documents.
A trial implementation project was performed using the pathology information models and terminology reference sets developed by wg5 and the new HL7 Australia’s FHIR standards, to demonstrate computer to computer atomic reporting of SPRC reports from two testing laboratories, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology to the Cancer Institute NSW.
Figure-6 provides a diagrammatic overview of the trial implementation for safe atomic reporting to a cancer registry that was agreed by all collaborators for this project.
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Figure-6 Overview of the trial implementation for safe atomic reporting to a cancer registry.
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Currently there are significant variations between jurisdictions and different types of registries such as NSW Cancer Registry, Victorian Cancer Registry, etc., that pathology laboratories are required to report to. The introduction of standardised reporting requirements across Australia would likely lead to a significant reduction in the cost to pathology of interfaces to registries.
The structured cancer reporting protocols developed by the RCPA SPRC Project, and the pathology information models and terminology reference sets developed by the PITUS 15-16 Project will enable pathology laboratories to deliver higher quality, standardised information to cancer registries by increasing the completeness and timeliness of information contained within the pathology report. This level of improvement in pathology reporting will provide benefits in cancer management and planning services as well as improving patient outcomes.
Although further development is required to HL7’s FHIR standards before broader implementation, this trial demonstrated the computer to computer atomic reporting of SPRC reports is possible by using pathology information models and terminology reference sets and the new HL7’s FHIR standard for SPRC reporting.
Trial Implementation project
A trial implementation project was devised by wg5, in consultation with the SPRC Project, the Cancer Institute NSW and two pathology testing laboratories, NSW Health Pathology North (Hunter and Taree) and Douglas Hanly Moir Pathology, to demonstrate computer to computer atomic reporting of SPRC reports.
There were three (3) phases to this trial implementation project:
1. Development of information models and terminology
RCPA Colorectal and Prostate (Radical prostatectomy) SPRC protocols were selected for this trial implementation. The pathology information models and terminology reference sets required for representing the SPRC report for colorectal cancer and prostate cancer (radical prostatectomy) were developed by wg5 and draft versions were used in this trial.
2. Development of the FHIR standards for SPRC reporting
The Agency and HL7 FHIR Product Director developed a model for using the new HL7 Australia’s FHIR standards for SPRC reporting, using colorectal cancer and prostate cancer (Radical prostatectomy) as examples. Wg5 selected FHIR to transmit atomic data for SPRC reports as FHIR is gaining rapid and wide acceptance and will possibly represent the preferred option for the future electronic delivery of complex documents.
The implementation guide is available on the Structured Pathology Reporting of Cancer FHIR website. This implementation guide describes how to implement the RCPA SPRC protocols for data exchange covering logical models, mappings, FHIR resources and examples to assist implementers.
These FHIR standards are new and some are still undergoing development, and a number of technical issues were identified by wg5 which required resolution before the trial could begin. This delayed the trial implementation by 2-3 months.
In addition, the two pathology testing laboratories identified a number of other issues with the FHIR logical model and mappings for Colorectal cancer and Prostate cancer (Radical prostatectomy which fortunately did not impact this trial, however these issues will need to
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be resolved before the FHIR standards are used in implementations at other pathology organisations.
3. Trial implementation of the standardised SPRC protocols
Using the draft FHIR standard and the pathology information models and terminology reference sets developed by wg5, two testing laboratories (NSW Health Pathology’s John Hunter Area Health and Douglas Hanly Moir) implemented the Colorectal and Prostate SPRC protocols.
Each testing laboratory produced five (5) Colorectal and five (5) Prostate SPRC reports for use in the trial and electronically transmitted these reports to the Cancer Institute NSW using HL7 v2 report messages embedded with a XML/FHIR document and a rendered report in PDF format.
The Cancer Institute NSW’s analysis of the HL7 v2 report messages embedded with a XML/FHIR showed a high level of compliance of preferred terminology against the pathology information models and terminology reference sets developed by this Project used in the rendered PDF reports. There was a lower level of compliance to the HL7’s FHIR standards; indicating that further development and education of the HL7’s FHIR standards will be required before broader implementation can proceed.
Challenges and issues identified
A number of issues were identified during the course of this trial implementation:
1. Time constraints by the testing organisations (e.g., Cancer Institute NSW, Douglas Hanly Moir, NSW Health Pathology) due to limited availability of key technical and testing personnel which created difficulties in adhering to the planned timelines.
This trial implementation required a substantial amount of time from key technical personnel from each testing organisation to investigate ways to implement SPRC reporting and relevant terminology into the respective IT systems. Both pathology laboratories encountered system limitations for configuring their LIS to handle the SPRC protocols and terminology, which had to be overcome before this trial could begin.
The PITUS Project team mitigated this risk by frequently monitoring the implementation schedule and revising these schedules where necessary to accommodate conflicting commitments within each testing organisation over the length of the trial implementation.
2. The initial development of the RCPA SPRC implementation guide on the Structured Pathology Reporting of Cancer FHIR website was completed by the HL7 FHIR Product Director and representatives from the Australian Digital Health Agency. Wg5 identified issues with the logical models and mappings for Colorectal and Prostate (Radical Prostatectomy) during the initial review, which required the HL7 FHIR Product Director to resolve.
3. HL7 Australia’s FHIR standards for SPRC were new and both testing laboratories were required to investigate different methods of producing XML/FHIR documents, requiring acquiring new vendor software which added another level of complexity to this trial.
Each laboratory had expressed concerns on implementing FHIR during the feasibility study, and as a result, a contingency to use dotted notation was devised by wg5. The PITUS Project Officer prepared archetypes for Colorectal cancer and Prostate cancer (Radical prostatectomy) cancer to produce example HL7 v2 messages using this archetype.
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To participate in the trial Douglas Hanly Moir required a ‘beta release’ of the LIS to enable FHIR testing functionality and additional support from the PITUS Project Officer to produce HL7 v2 messages with dotted notation for the five (5) Colorectal and five (5) Prostate SPRC reports.
These HL7 v2 messages with dotted notation were subsequently used in the new FHIR module of the ‘beta release’.
The business forms and workflow engine trialled by NSW Health Pathology required modifications to produce XML/FHIR documents for this trial.
4. During the trial implementation some issues were identified by the testing organisations: − a number of broken links on the Structured Pathology Reporting of Cancer FHIR
website; − configuration issues with the FHIR logical model, for example: the FHIR XML
specification for Colorectal cancer provided two options for primary tumour location quadrants and planes, however it is common place that pathologists can report tumour locations across multiple quadrants and multiple planes.
− inconsistent data types i.e. where a data type was defined as ‘Quantity’ in the FHIR standards, however the SPRC protocol was expecting text.
Time did not permit for the above issues with the FHIR standards to be resolved in timely manner for this trial, however the testing laboratories were able to implement a workaround to enable continuation of the trial.
5. During the analysis of the FHIR documents, the Cancer Institute NSW reported the XML documents produced by each laboratory were in different formats and contained different result identification. One laboratory used FHIR field definitions without accompanying LOINC codes, and the other laboratory used LOINC codes to identify fields and did not accompany FHIR field definitions. The XML documents will require further analysis by FHIR experts to determine the source of this issue, however it is likely this was caused by a misinterpretation by the software vendors of how to implement the new HL7 Australia’s FHIR standards.
Next steps
Wg5 agreed that each of the issues identified with the HL7 Australia’s FHIR standards for SPRC reporting need to be resolved before the Structured Pathology Reporting of Cancer FHIR website is promoted to a wider audience. Additionally, the Agency has recommended additional development of the publication system is required to improve the way these complex information models are represented to assist implementers, this will form part of the PITUS 17-19 funding proposal.
Wg5 have established the differences in XML document formats require further analysis by the HL7 FHIR Product Director to determine the source of this issue, and provide feedback to the two testing laboratories and their software vendors.
The testing laboratories made recommendations of other tools that would be helpful to implementers of the HL7’s FHIR standard for reporting SPRC protocols such as a web based validator / JSON authoring and XML conversion tools. This will be discussed and considered by the wg5 technical team and HL7 FHIR Product Director for possible inclusion in a future version of the HL7 Australia’s FHIR standards.
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10.7 Appendix G - Trial implementation of an Informatics External Quality Assurance (IEQA) Program
Executive summary
Pathology reports are distributed widely within healthcare settings and these reports are often issued by different pathology providers. Currently, variations can and do arise from different pathology providers having different reporting policies, and/or the same provider issuing different styles of reports to different customers - depending upon computer system requirements. Variations in pathology reporting formats and styles can add another layer of complexity when interpreting the report, and also the possibility of errors occurring which can pose a risk to patient safety.
One response in investigating these issues was for the Project to collaborate with the RCPAQAP to analyse reporting data. In 2015, as part of the RCPAQAP Liquid Serum Chemistry Program, laboratories were invited to supply a routine paper report displaying results. The RCPQAP analysed the reports against the RCPA APUTS v2.3 standards (now known as SPIA, i.e. Standards for Pathology Informatics for Australia), and the variation identified4, validating the rationale for the development and trial of a quality assurance protocol to test compliance against existing HL7 reporting standards and reporting standards developed by the RCPA5, that can be used by accrediting bodies, such as NATA.
PITUS 15-16 Project entered into an agreement with the RCPAQAP to trial an Informatics External Quality Assurance (IEQA) Program for the Liquid Serum Chemistry Program.
The RCPAQAP used Medical Objects Pty Ltd (Medical Objects), an external medical software vendor, to assist with building a compliance software tool to send standardised electronic request messages and to assess received electronic report messages. In addition, two pathology laboratories agreed to volunteer to send HL7 v2 report messages with atomic pathology results for the RCPAQAP Liquid Serum Chemistry Program.
The trial was carried out over a two-month period, September 2016 to October 2016. The Medical Objects compliance software tool was used to test compliance of the HL7 v2 report messages received from each laboratory against the HL7 Messaging Standard Version 2.4 and AS4700.2:2012 standard; and RCPA APUTS v2.3 standards within the RCPAQAP Liquid Serum Chemistry Program. A compliance report was generated for each participating laboratory as a means of assessing the validity and integrity of the data received.
The trial implementation highlighted several areas where improvement could be made before the compliance software tool can be considered fully functional. The RCPAQAP are considering further development of the compliance software tool and will be proposing a limited trial of the IEQA Program in the next 12 months for laboratories participating in the RCPAQAP Liquid Serum Chemistry Program. Wg6 agreed the next steps would be to perform a similar trial for text-based RCPASPRC protocols, utilising the Colorectal and Prostate cancer information models and terminology developed by PITUS 15-16 Working group (wg5), and this will form part of a funding application for the next PITUS Project.
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Background
The RCPA PITUS 15-16 Project engaged the RCPAQAP to trial the implementation of an IEQA Program for the Liquid Serum Chemistry Program. Wg6 was responsible for collaborating with RCPAQAP on the trial and assisted the RCPAQAP with establishing Informatics Steering Committee (ISC) responsible for overseeing the trial.
Members of the RCPAQAP Informatics Steering Committee (ISC) compiled the minimum system requirements required to implement the trial IEQA Program, and developed a high level architecture diagram to capture these requirements. Using these system requirements a full analysis of the current RCPAQAP infrastructure ( was performed, and it was including hardware, and software)determined that new software and communication services would be required to undertake this trial IEQA program.
In April 2016, RCPAQAP circulated a Request For Proposal (RFP) to medical software companies in Australia who were interested in developing the software that could be used by RCPAQAP for sending pathology requests and receiving pathology reports, and the analysis software that would form the basis for reporting ‘Informatics’ performance. Another important requirement documented in the RFP was for the provision of message services to support Secure Message Delivery (SMD)-based secure messaging to comply with relevant National Pathology Accreditation Advisory Council (NPAAC) standards.
Medical-Objects were the successful respondent. Medical Objects were also required to provide communication services and technical support during the trial implementation. Weekly meetings were held with the Medical Objects development team to review and discuss progress.
Trial Implementation project
Wg 6 and members from the RCPAQAP’s ISC agreed to the project plan for this trial implementation, and Figure-7 provides a diagrammatic overview of the workflow for trial implementation of the IEQA Program. The Liquid Serum Chemistry Program was selected for this trial implementation; see the RCPAQAP Product Catalogue for the full list of tests.
The RCPA PITUS 15-16 project team engaged Diagnostic Services Pty Ltd (Launceston Pathology) and South Eastern Area Laboratory Service (SEALS) to take part in the trial, as each laboratory had previously been part of a trial implementation under the PITUS-14 Project for a select serum chemical pathology analytes and were in the advanced stages of implementing the requesting and reporting terminology developed by the PITUS projects.
The key milestones for this trial implementation project were:
1. Development of the software by Medical Objects; 2. Installation, setup and verification of the system software and communication services; 3. Implementation of the IEQA Program and compliance testing of the received HL7 v2.4 report
messages; 4. Compilation of a draft Informatics Program Survey Report; 5. Review of trial implementation.
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Figure-7 Overview of the workflow for the trial implementation of the Informatics EQA Program.
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1. Development of the software by Medical Objects
Medical Objects developed two new software modules for this trial implementation:
− Bulk Orders - allows data entry of bulk pathology request orders; − Quality Assurance – compliance rule checking module for:
o HL7 v2.4 report messages against HL7 Messaging Standard Version 2.4 and AS4700.2:2012 standard, including compliance to the conformance points documented in the AS4700.2:2012 standard;
o Atomic data in the HL7 v2.4 report messages against the RCPA APUTS v2.3 standards (now known as SPIA, i.e. Standards for Pathology Informatics for Australia), including checking the LOINC code, preferred term, reference interval, and units.
Medical Objects used a phased approach to develop the complex compliance rule checking module and this allowed opportunities for feedback from RCPAQAP on the functionality as it was being developed. Weekly meetings between RCPAQAP and Medical Objects were held during the software development phase to provide ample opportunity for feedback from the RCPQAP Project officer and PITUS-15-16 Project Officer directly to the Medical Object’s development team. This collaboration during the software development phase contributed to the success of this project.
2. Installation, setup and verification of the system software and communication services
Medical Objects “Explorer” software application with the two new software modules developed for the trial (Bulk orders and Quality assurance) was installed on computers that would be used for the compliance testing.
Medical Object’s Eclipse communication services were used during the trial implementation to electronically send HL7 v2.4 request messages to the participating laboratories and receive HL7 v2.4 report messages from the participating laboratories. This communication service did not require any further modification for the trial.
Both participating laboratories were required to make configuration changes to their computer systems to ensure the successful transfer of HL7 v2.4 messages to and from the Eclipse communication service. Medical Objects provided IT support to each laboratory and assisted with verification testing of the electronic transfer of test HL7 v2.4 messages.
There was however some resourcing and time constraints at the RCPAQAP to deliver the outcomes in accordance with the project plan and the PITUS 15-16 Project Officer was able provide additional support the RCPAQAP with the verification of the system software and communication services. Verification testing was performed on the two new software modules (Bulk orders and Quality assurance) to ensure each module performed as per RCPAQAP requirements and in accordance with Medical Objects design prior to implementing the modules during the compliance test phase of the trial.
3. Implementation of the IEQA Program and compliance testing of the received HL7 v2.4 report messages
Using this new Bulk orders module a pathology request for the Liquid Serum Chemistry Program was created and an electronic HL7 v2.4 request message was electronically
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transmitted to the two participating laboratories. The laboratories were also sent a PDF version of the pathology request form via email.
The laboratories electronically transmitted HL7 v2.4 report messages with the results of the Liquid Serum Chemistry Program to the RCPAQAP for analysis.
The new Quality Assurance module performed compliance rule checks on each of the received HL7 v2.4 report messages, assessing:
a. Compliance of the HL7 v2.4 report message against the HL7 Messaging Standard Version 2.4 and AS4700.2:2012 standard, including compliance to the conformance points documented in the AS4700.2:2012 standard (see Figure-8 shows an example of two sections of the compliance rule check).
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Figure-8 Example of two sections of the compliance check for the HL7 v2.4 report messages against the AS4700.2-2012 standard
In Figure-8 above, the report contains hyperlinks labelled ‘HL7 Reference’ and if laboratories have purchased the HL7 International Access database and it is installed on the computer, they will have an interactive link directly to the HL7 standard for the given error.
b. Compliance of the atomic result data reported in the HL7 v2.4 report messages against the terminology standards (preferred term, units and LOINC code) and harmonised reference intervals described within the RCPA APUTS v2.3 standards (see Figure-9 for an example of this compliance rule check against RCPA APUTS v2.3 standards)
Figure-9 Example of the compliance rule check for the atomic result data against the RCPA APUTS v2.3 standards
The new “Quality Assurance” module in the Medical Objects “Explorer” software application also provided software windows for the tester to perform a manual comparison of the rendered pathology report against the expected the format documented in RCPA APUTS
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v2.3 standards. This was crucial as there are some RCPA APUTS v2.3 standards that require manual checking. Figure-10 shows a screenshot of the software windows used for the manual compliance check, with the report format using the APUTS rendered report rules on the left, and the PIT rendered pathology report that was received from one of the laboratories on the right.
Figure-10 Example of the Quality Assurance software windows
The “Quality Assurance” module provides functionality for the tester to add in-line or summary comments to the each section of the Final report. The Final report contained the detailed compliance rule checks and any entered comments, and was able to be saved to the tester’s computer in HTML format.
4. Compilation of a draft Informatics Program Survey Report
The RCPQAP ISC developed a draft template of IEQA Program Survey Report which was used to summarise the results of compliance testing for each laboratory for this trial implementation.
The IEQA Program Survey Reports were provided to each laboratory who participated in this trial, to assist the laboratories to identify compliant areas and areas that require further improvement. These reports are not included in this report however these are available from the RCPA Project Management Office upon request.
Both participating laboratories were at different stages of implementing the RCPA APUTS v2.3 standards, and therefore the detailed compliance rule checks provided valuable feedback to each.
5. Review of trial implementation
A demonstration of the compliance rule checking tool and the draft IEQA Program Survey Report produced from this trial was presented to each of the participating laboratories. Each laboratory was impressed with the reports produced and was very interested in reviewing these reports in more detail to facilitate changes required within the LIS systems.
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The compliance rule checking tool was demonstrated and the results from this trial implementation were discussed in a meeting held with to wg6 and RCPAQAP ISC on 17 November 2016. All meeting participants were impressed with the trial implementation and could see potential for a limited offering of an IEQA Program for laboratories registered for the Liquid Serum Chemistry Program.
Wg6 agreed a similar trial for an IEQA Program should be undertaken for text-based RCPA SPRC protocols by utilising the Colorectal and Prostate cancer information models and terminology developed by wg5. This will form part of a funding application for PITUS 17-19 Project.
Conclusion
The success of this trial implementation shows the potential of an external quality assurance program that can be used by accrediting bodies to assist with compliance that will facilitate the adoption of pathology informatics standards by pathology providers and their stakeholders.
Compliance and accreditation of electronic messages are critical elements necessary to maintain the integrity of the data shared between the sending (laboratories) and receiving (clinicians, MyHealth record, registries, etc.) organisations’ computer systems. Barriers to interoperability exist between computer systems and so the implementation of compliance and accreditation mechanisms such as those used within this trial are essential for safer and improved pathology reporting and will likely assist with facilitating the implementation of the MyHR by pathology providers.
Next steps will be to offer this IEQA Program to a wider group of participants to gain greater insight into the current level of compliance (against the relevant HL7 and RCPA Standards for Pathology Informatics in Australia standards) within the pathology community. This trial will also assist the RCPAQAP to further develop and refine the functionality, reporting and educational aspects of this IEQA Program.
