Pathology - 2011

The AMA has developed this Position Statement as a vision for pathology practice.

Summary

Pathology services in Australia are amongst the highest quality and the most accessible in the world. However, Government funding cuts to pathology services have had an impact on the quality, accessibility, affordability and safety of pathology services. Government funding changes can also have a significant impact on the sustainability of the pathology sector including the ability to support ongoing training, research and development.

Government policies and funding arrangements for pathology services should therefore:

• ensure access and affordability for patients;
• ensure safety and quality;
• facilitate patient care and convenience;
• support sustainability of the pathology sector including the ongoing provision of training for pathologists, research and development;
• acknowledge that timely pathology services deliver savings to the healthcare system from early diagnosis and intervention and monitoring of chronic disease which are facilitated through pathology services; and
• appropriately reimburse the patient for the full cost of providing pathology services.

The AMA supports:

• fee-for-service payments which encourage competition within the sector while maintaining quality services;
• annual indexation of Medicare Benefits Schedule (MBS) fees for pathology services at rates that reflect increases in the CPI and LPI;
• abolishing current coning restrictions – each service provided should attract an appropriate MBS rebate;
• an appropriate geographic spread of pathology services sufficient to provide affordable and timely access to results for all patients in Australia;
• workforce planning and investment in training and development to ensure an ongoing high quality and diverse pathologist and pathology-related workforce;
• the current systems of accreditation (NATA/RCPA) as an essential part of ensuring consistent, reliable and high quality services are provided across Australia;
• the use of shared electronic health records by medical practitioners;
• interoperable software linking pathology services to other medical practices to enable the sharing of electronic health records;
• point of care testing when services are conducted within an appropriate quality framework to ensure patient safety;
• the right of patients to participate in their choice of pathology provider in consultation with their treating doctor; and
• medical genetic testing requested on behalf of a patient by a medical practitioner in the context of providing health care.

Principles for the provision of pathology services in Australia

Pathology services are a vital and integral part of health care in Australia and contribute to the good health of all Australians.

About seventy per cent of medical diagnoses are confirmed by pathology investigations . Pathology tests are ordered in relation to one in every five encounters between patients and general practitioners and one in every two encounters between patients and specialists. Sixty per cent of Australians will have at least one pathology-testing episode each year, and many with chronic disease will have far more.

Australians currently enjoy amongst the highest quality and most accessible pathology services in the world. Pathologists are highly trained medical specialists who contribute to the health of communities as well as the health of individual patients.

The following principles should underpin pathology services in Australia so this high standard of quality and professionalism continues into the future.

Pathologists should be supported to continue to:

• provide accessible, safe and high quality services for patients and treating doctors;
• provide contemporary patient care and personalised medicine through the full range of predictive and preventive pathology services as well as diagnostic and management services;
• promote broad health interests through research and contributing to accurate diagnoses and treatment;
• work in a diverse range of practices, including public, private, comprehensive or single subdiscipline; and
• be offered a dynamic career path to attract and retain junior doctors.

Government policies and funding arrangements for pathology services should therefore:

• place primary importance on safety, quality, access and affordability;
• facilitate patient care and convenience, including in regional and rural areas;
• support sustainability of the pathology sector including the sector’s ability to support ongoing training, research and development;
• recognise the savings to the healthcare system and the general economy from early diagnosis and intervention and monitoring of chronic disease which are facilitated through pathology services; and
• appropriately reimburse the patient for the full cost of providing pathology services.

These principles are expanded in more detail in this position statement.

Role of the pathologist

Pathologists are medical specialists who lead teams of scientists and technicians in providing high quality pathology services in a laboratory setting. Pathologists are legally and ethically responsible and accountable for all services provided in their laboratories.

Pathology plays a vital medical role in best practice patient care. Pathologists provide crucial information to enable doctors to assess and diagnose a patient’s condition and to determine the best approach for treatment. Early diagnosis increases the likelihood of cost effective treatment and improved patient outcomes.

Pathology services underpin the concept of personalised medicine, in which treatment and management of disease is tailored to the individual and avoids the trial and error of a treatment designed for a broad population. This concept has been proven over many decades in microbiology where antibiotic sensitivity is routinely reported when bacterial infections are identified, and is now being extended, by means of genomic testing, to other diseases, such as cancer and autoimmune diseases. As well as saving patients from undergoing therapy that will not be effective, it also allows targeting of expenditure so that expensive new therapies are directed to those who are most likely to benefit.

Once a treatment plan is implemented, many medical conditions require follow-up pathology to determine when treatment has successfully alleviated the condition, or to guide the ongoing treatment and management of the condition.

Pathologists work as part of a medical team providing care for patients. They regard a request for a pathology service as a medical consultation on a particular patient and all tissue samples are considered within a medical ethical context. Although the term ‘pathology test’ is frequently taken to mean a measurement, pathologists regard this as a narrow and inaccurate definition. The term is better understood as an examination of tissue, which may include measurement, from which one can make inferences about health and disease. This wider definition includes the morphological disciplines of pathology such as anatomical pathology and haematology, flow cytometry and genetic testing. Regardless of their discipline, pathologists will consider the findings of the range of pathology tests, from one episode or over a time course, in conjunction with the patient’s clinical history to provide a medical opinion.

The pathologist’s professional input is vital throughout the testing procedures, including:

• consultation with the requesting doctor prior to pathology requesting, where appropriate, to determine the best type of test for the patient;
• quality assurance for test processes and interpretation to ensure pathology services are carried out according to the highest standard and results are reported accurately;
• performing tests and examining tissue biopsies;
• providing interpretation and professional advice on test results and diagnostic procedures;
• conferring with the requesting doctor on treatment and management of the patient; and
• advocating for the patient’s best care.

Pathologists maintain long-standing professional relationships with treating doctors. This ensures high quality medical care, which is informed by expert medical opinion, is provided to patients. Pathologists and treating doctors regularly confer on the interpretation of results of tests and diagnostic biopsies. This interaction ensures optimal patient care and facilitates quality pathology referrals. This professional engagement does not attract a Medicare rebate for either doctor.

Pathologists, like other medical practitioners, have embraced technology wherever it has been shown to contribute to the accuracy and efficiency of service provision. The contribution of technology and automation in pathology, however, varies dramatically across the many types of pathology tests and the different types of laboratories and falls into four broad categories:

• tests in which there is no technology relevant to the one-to-one interaction between the pathologist or scientist and the test specimen, for example, morphology, cytogenetics;
• a small number of common tests in which technology has played a major role in allowing laboratories to provide more rapid turnaround times in the face of growing demand so that treating doctors can make timely clinical decisions, for example, electrolytes;
• the vast majority of tests, in which technology has contributed to some segments only of the testing sequence; and
• tests which have only been made possible by advances in technology, for example, gene sequencing.

The role that technology plays in any pathology test does not alter the fact that pathology testing is a clinical knowledge service that provides information to doctors to assist them in treating patients. Pathologists must supervise all aspects of testing undertaken within their laboratories. They are responsible for the quality framework, all quality assurance activities of all testing, the clinical interpretation of all abnormal results and the notification of critical results to the treating doctor or the patient. It is not possible, nor is it clinically appropriate, for the pathologist’s professional input to be extricated from the purely technical aspects of a pathology test without compromising the safety and quality of the service.

Pathologists also have an important role in communicating with patients. Pathologists’ direct contact with patients is increasing because of growing demand from patients for their results.

Pathologists have a responsibility to explain services provided to patients including the details of the procedure and any out-of-pocket costs involved. New policies supporting greater consumer choice in pathology service provision will further increase a direct relationship between pathologists and patients.

Quality and safety

Pathologists play a critical role in the provision of safe, high quality pathology services. The quality of pathology in Australia is currently amongst the best in the world. Policies and funding arrangements should underpin a continuing emphasis on high standards of patient safety and high quality pathology services.

The AMA supports the current system of accreditation (NATA/RCPA) as an essential part of ensuring quality standards across the industry. The system ensures consistent, reliable and high quality services are provided across Australia.

Pathologists also have a vital role in contributing to research to improve the knowledge base about best practice and cost effective pathology for providers and requestors. Funding support is essential for research to ensure pathology continues to develop and evolve. More studies need to be conducted to evaluate the contribution of pathology to clinical pathways and to develop the evidence to support best practice guidelines. This should be done in close consultation with the medical profession and the medical colleges.

The AMA supports the development and use of shared electronic health records by medical practitioners to improve the safety and quality of medical care in Australia. A shared electronic medical record that links reliable and relevant medical information across health care settings will help provide treating doctors with the information required to make the best clinical decisions. It will also reduce unnecessary ordering of pathology tests by making results available to all treating doctors.

Pathologists expect that relevant patient information generated in the course of completing pathology services would generally be provided to the requestor to add to the patient’s summary record. However, the pathology sector must be consulted in the design of electronic health record including the type and standard of information included in the patient’s summary record. This is important to ensure that summary records contain information that might be required to interpret results correctly, for example, the kind of assay used in testing.

In addition, it is important that software linking pathology services to other medical practices is interoperable so that pathologists can communicate results quickly, effectively and equitably.

Access to pathology services

The current balance and mix of public and private services ensures Australia has a diversity of pathology providers with different areas of expertise that can provide a wide range of services. Neither the public nor private sectors have sufficient capacity to meet demand alone. Policies need to continue to support this diversity.

The critical role that comprehensive laboratories play in underpinning medical practice in Australia needs to recognised, and pathologists need also to be able to practice in a single discipline laboratory should they choose to do so. Laboratories that act as reference laboratories for specific rare or complex tests need to be supported so that Australians are not denied access to this testing. Consideration needs to be given during workforce planning to ensure that there are sufficient experts amongst pathologists and senior scientists in all areas of pathological diagnosis who can provide a second opinion in difficult diagnoses.

There must be an appropriate geographic spread of pathology services sufficient to provide affordable and timely access to results for all patients in Australia.

It is sometimes possible to send some tissue specimens to more distant locations to take advantage of particular expertise or decreased costs while still meeting adequate access and timeliness requirements. However there are also clinical circumstances when it is necessary to have laboratories nearby.

Funding arrangement should recognise the clinical importance of access to local services, and subsequently local services may need additional funding to be viable.

The community and treating doctors expects pathology services to be available to respond to urgent requirements 24 hours a day, 7 days a week. These services underpin the care of critically ill patients, surgical emergencies and emergency obstetrics.

A responsive after-hours service has flow-on benefits for the whole health care system. Without this service, emergency department waiting times and access block would be worse and patient bed days would be longer. This responsiveness also allows the treating doctor to provide his/her own timely service. However, responsiveness comes at an increased cost that must be recognised by the funding arrangements.

The vast majority of medical practitioners and patients now requires rapid turnaround times for pathology investigations, so that they can make decisions about the next step in a clinical pathway. This increases the productivity of the healthcare sector and minimises the impact of illness on a patient’s life.

Point of care testing

POCT has a role to better support general practice in the front-line management of patients with some chronic conditions, and is consistent with the aim of the AMA to improve primary care services.

These services must be conducted within an appropriate quality framework to ensure patient safety.

Pathology requests

The AMA supports the right of patients to participate in the choice of their pathology provider in the majority of cases.

There are situations where a treating medical practitioner requires, for valid clinical or practical reasons, that a specific pathology provider performs a pathology test. For example, the treating practitioner may need to specify a specific pathology service to undertake a particular test due to:

• the particular expertise of a specific pathology provider;
• confidence in the quality of the service;
• familiarity with the way in which results are reported;
• a preference for the testing methodology used by the pathology provider;
• knowledge that a specific test can be done by a specific provider, or that they are the only provider of that test in the area; and
• a preference to refer the patient to a pathology provider who maintains a longitudinal test result history for the patient.

Patients should therefore not make decisions about choice of a pathology provider without discussing potential selections with their treating doctor.

The Medicare benefits arrangements should always provide for a treating practitioner to be able to make a request to a specific approved pathology provider if clinically necessary.

Advocacy

Where new tests become available, particularly for rare diseases, it is the role of the pathologists to inform the medical community and patient support groups of the evidence for the use of these tests and to advocate on behalf of the patient and the treating doctor for access to, and funding for, useful testing that would improve patients’ lives.

Genetic testing

Direct to consumer marketing of pathology tests, and in particular genetic tests, carries real risks for patients because test results can be inaccurate, contradictory, misleading, taken out of context, and open to misinterpretation.

Medical genetic testing should only be available if requested on behalf of a patient by a medical practitioner in the context of providing health care. The decision to proceed with testing and the provision of results should be accompanied by appropriate genetic counselling and patient education.

Prevention of disease

The AMA supports preventative health and recognises the important role of appropriate pathology testing for at-risk groups of patients. Testing may allow treatment to be offered that could ameliorate or prevent full-blown disease in affected individuals through early identification and/or effective management. 

Infectious disease

Rapid and accurate pathology testing is critical to the management of infectious disease. While it is clearly important to individual patients to be diagnosed and treated promptly, pathology testing for infectious disease also plays a major role in protecting public health more broadly. Infection control, which includes surveillance by pathology testing, also underpins our defenses against healthcare associated infections. Control of pandemics depends on rapid turnaround of high volumes of pathology tests.

Investment in modern technologies is required in the front line clinical laboratories in both private and public sectors so that Australia’s healthcare system is ready and able respond to seasonal influenza activity, as well as uncommon but high-risk infectious disease outbreaks.

Autopsy and forensic pathology

High quality autopsy services are critical to the understanding of disease in individual patients, provide a final audit of clinical decision making, and are an invaluable tool for the education of medical practitioners and other healthcare practitioners. Forensic pathology services also play a critical role in the response to disasters.

Strategic national investment in new technologies and in training members of the forensic pathology workforce is required.

Funding and sustainability

Pathology services are integral to cost-effective medical treatment as well as ongoing patient management.

Funding for pathology services should not be considered in isolation to its inter-relationship with other health care costs. Pathology plays an important role in disease prevention and health care maintenance, and therefore reduces potential higher costs in acute cate and the management of chronic disease.

It is inevitable that the demand for pathology services will increase: not just because of an ageing population, but also because a focus on preventative health will increase the demand for pathology services.

Government funding arrangements for pathology services should:

• be based on evidence of enhanced management of patients and improved patient outcomes;
• provide long-term certainty for pathology providers;
• support continuing high levels of access and quality services for patients and treating doctors, including in rural and remote areas; and
• support ongoing high quality training, research and development activities.

MBS rebates

The current Australian fee-for-service model for pathology services provides the best balance of incentives to encourage quality services and competition within the sector.

A viable, sustainable and diverse pathology sector is essential to ensure there is sufficient capacity to meet demand. Medicare rebates must reflect the true cost of providing the service and be indexed annually to ensure that this continues to be the case.

The pathology sector has achieved some dramatic efficiencies over the last twenty years that have contributed to containing health care costs. However, while MBS fees have remained stagnant, all the costs associated with providing services have increased, for example, salaries, rent, electricity, computers and professional indemnity insurance. Pathologists must also make significant, ongoing investments in up-to-date equipment.

At the same time pathology providers must offer quick and efficient services. Many providers operate 24 hours a day, 7 days a week, to respond to urgent service requirements. This responsive service comes at an increased cost, which must be covered through fee-for-service arrangements that are not dependent on the volume of services provided.

The viability of services in small centres is particularly vulnerable to changes in funding arrangements and structures. Additional financial support is necessary for services located in rural and remote areas in the form of special grants or additional loadings.

It is the level of the MBS rebate that impacts on patient access and affordability. Any funding arrangement must ensure the gap between MBS rebates and the real cost of providing these services does not grow. It is vital that those less well off and in areas of social disadvantage remain able to access private pathology services.

Coning

Current coning restrictions should be abolished. Patient episode coning was introduced in 1995 to address concerns about inducement of referrals for unnecessary tests. Funding should support each and every service provided by a pathologists. Not only does the coning system expect pathologists to carry the cost of additional services, but it does not allow utilisation statistics to be accurately collected and analysed. This has implications for epidemiological research and wider health policies.

Workforce

The current workforce of pathologists is primarily made up of salaried pathologists – approximately 98% – employed in either the public or private sector. There are significant cost barriers for pathologists to start their own practice.

To ensure that there are attractive career paths with opportunities to train further and undertake research, it is essential that appropriate and comprehensive training opportunities are available to junior pathologists to ensure the current high level of quality and professionalism throughout the workforce can be maintained, and sufficient pathologists can be attracted and retained to meet future demand.

Furthermore there is still an overall shortage of appropriately qualified and accredited people working in the pathology sector, such as medical scientists, technical staff and people trained to collect specimens.

It is important that a high quality pathologist and pathology-related workforce is supported by appropriate government policies and funding arrangements, and included as part of wider health workforce planning. Ongoing training and development of the existing workforce, and investment in a future workforce, are vital to sustaining high quality and diverse pathology services.

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1. Department of Health, UK. Report of the review of NHS pathology services in England. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4137606