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National registration and accreditation scheme for doctors and other health care workers

CHAIR —Welcome. Do you have any comments on the capacity in which you appear today?

Prof. Burnett —I am also director of one of the member organisations of the National Coalition of Public Pathology.

CHAIR —Thank you very much. Information on parliamentary privilege and the protection of witnesses is available, and you probably have it. We have your submission; thank you very much. I invite all of you or any of you to make opening comments, and then we will go to questions. We keep it fairly informal. As an issue comes up, people jump in to answer it. Have you arranged who is going to start?

Prof. Wilson —Thank you, Madam Chair and senators, for inviting us to attend this hearing. The National Coalition of Public Pathology, known as NCOPP, represents the interests and values of publicly owned pathology services in Australia. We welcome the opportunity to speak to our submission to this inquiry. I am joined by my colleagues here, who have already been introduced.

There are three key points that NCOPP wishes to highlight to the committee. Firstly, public pathology services are part of the health services run by states and territories. We also provide services under the Commonwealth’s Medicare scheme. Pathology plays a central role in our health systems, and some 70 per cent of all medical decisions are based on the results of a pathology test. Pathology provides specimen collection, processing and transport, testing, analysis, interpretation and expert opinion services to public and privately referred patients and their doctors. In summary, pathology is a clinical knowledge service. Public pathology laboratories provide the testing services of last resort for rare and complex diseases and in rural and remote regions to meet community service obligations. Public pathology laboratories also provide the main capacity for the training of future pathologists. We also provide these services across jurisdictional boundaries. NCOPP therefore supports a national registration scheme for doctors and other health workers to facilitate the delivery of services across jurisdictional boundaries as well as to assure public safety and quality of care, promote public confidence and facilitate the movement of healthcare workers across the nation.

Secondly, NCOPP considers that accreditation and registration should be linked, but they should be managed as independent functions. That provides an important check and balance and it simply represents good governance.

Thirdly, most of the discussion about national registration and accreditation of health professionals has focused on those professions that currently fall either fully or partially under the state and territory based registration schemes and those who have direct contact with patients. NCOPP has sought to highlight to this inquiry that there is no statutory registration or licensing scheme in Australia for medical laboratory scientists. Provision of quality pathology services relies on a diverse team of professionals working closely together. That team includes pathologists—many of whom are also treating physicians—medical laboratory scientists, nurses, laboratory technicians, information technology and information management specialists, specimen collectors and other support staff. Medical laboratory scientists are vital team members. In public pathology services they play key roles as scientific directors of specialised laboratories, particularly in the frontier areas of genetics, reproductive technology—IVF—and toxicology. They are often the operational directors of the entire laboratory service.

The lack of a statutory registration or licensing scheme in Australia contrasts with the situation that applies in comparable countries. For example, New Zealand and the United Kingdom have national registration processes. Work is underway through the Pathology Associations Council, PAC, to examine the need for national registration and accreditation for medical laboratory scientists. It is part of a broader body of work aimed at developing a national workforce improvement framework for medical laboratory scientists in Australia. Medical laboratory scientists are largely overlooked when the health workforce is considered in Australia. Education and training is fragmented, there is no clear career structure, there are recruitment and retention problems and, like other pathology and health professions, there are very worrying workforce shortages.

The evolving framework has several elements: better information about the workforce and its activity; defining the occupation, developing competency based standards and accreditation against those standards, better career structure and pathways, improved recruitment, retention and re-entry, improved education and training, as well as examining regulation via registration or other approaches against the requirements of the proposed national registration and accreditation scheme. The various associations that represent medical laboratory scientists are working together under the Pathology Associations Council umbrella to develop a national framework. It is a significant and important work, with many matters for the professional groups to consider and address.

NCOPP supports the continuing development of an effective national approach to the medical laboratory scientist workforce in Australia, and the merit of pursuing registration of medical laboratory scientists is one of the central issues being considered by this group.

Senator HUMPHRIES —Just to pick up a point that you made there, Professor Wilson, that accreditation and registration need to be linked, we have had evidence throughout most of today from other professionals suggesting that they should be separated, so why do you argue that they should be linked or were you referring to linking them in respect of laboratory staff only?

Prof. Wilson —We believe they link in the sense that they are related to each other but the management of them should be separate. Registration should be contingent on an accreditation process focused on standards and competency. The registration should be recognised based on accreditation to those standards, which are managed and assessed by an independent body.

Senator HUMPHRIES —The national scheme effectively proposes, as we understand it at this stage, that the registration and accreditation be done by the one national board in the case of each of these occupational areas. Does that comply with the model that you have just put forward?

Prof. Wilson —I do not believe so. While we support the national registration initiative, that is one aspect which we feel would be better served by those functions being independent, but clearly connected.

Senator HUMPHRIES —You were talking about pathology covering a number of areas, but are you saying the registration should apply to pathologists, the laboratory scientists, their technicians and other support staff or only some of those categories?

Prof. Wilson —No, our proposal is that pathologists are already registered as medical practitioners and specialists. Our interest, in this case, is for medical laboratory scientists—who comprise something like 50 per cent of the expert workforce working inside a laboratory. There are a number of people in the pathology workforce—specimen collectors, administration staff, transportation people—who work outside the laboratory but, of those in a laboratory, roughly 50 per cent are medical laboratory scientists, five per cent are pathologists and then there are a number of people who are either unqualified or who have lesser qualifications acting as laboratory assistants or laboratory technicians. So it is the qualified scientific staff as medical laboratory scientists that we are drawing attention to.

Senator HUMPHRIES —I suppose a case can be made for registration and in a sense, therefore, for standard setting for almost any occupational group, but we do not register all occupational groups because there is, obviously, a cost associated with it. Can you provide a convincing case to us today that of the occupations which have been chosen for registration under this scheme—and I understand that is still being worked out; that in some cases they have not exactly identified which ones are definitely in and definitely out—the cost of registering laboratory scientists is worth the gain that we obtain by doing so?

Prof. Wilson —Perhaps I could make one comment and then my colleagues might like to comment on it. What I would say is that pathology is a critical element in the management of patients. Increasingly, clinical management decisions are either influenced by, or entirely governed by, results or advice provided out of a pathology laboratory. And clearly if that advice is incorrect, treatment may be wrong, patients’ diagnosis may be delayed and there may be adverse consequences as a result. Within a laboratory, pathologists and laboratory medical scientists work closely together as a team. Medical laboratory scientists take a lot of responsibility for the quality and the accuracy of results coming out of a laboratory and, given the importance of the accuracy of results and the need for doctors and the community to have confidence in the quality of those services, we believe there is some justification for considering the case for registration of medical laboratory scientists.

Prof. Burnett —Within pathology, a very large amount of information is generated. It is estimated that about 70 per cent of medical decisions—in fact, about 90 per cent of information in the electronic medical record—is related to pathology. To ensure the quality and safety of pathology, there is a regulatory framework in place in Australia, and arguably it is the best in the world. It hinges on a model of supervision in which the person who has ultimate authority to operate the laboratory and to authorise the release of results is either a pathologist or a most senior scientist with specified qualifications and experience.

Where it is a pathologist, one already has the ability to ensure that through the registration framework. But increasingly there are parts of the laboratory, or even in entire sections of pathology, where the expertise lies not with the pathologist but with a number of expert scientists—areas such as genetics, assisted reproductive technology, toxicology and others. The laboratory community relies on the scientist to have that ultimate supervisory authority. So here you have a senior person, often the scientific director of the laboratory, who may fall outside a registration framework. On the one hand you have the safety and quality framework that usually has a registered person but in cases particularly at the cutting edge of medicine there is a senior health professional who is not registered.

The second subsidiary issue is that these people are soon going to retire. They have reached the pinnacle of their profession and there are not the numbers coming through to replace them. It has been identified yet the work is continuing as to whether registration plays a key component in ensuring that there is a professional framework to ensure that Australia will have appropriately qualified and trained people to fill that oversight and supervisory role. So the element is missing within the framework. We have the standards, the accreditation and the registered pathologists, but we do not have the registered scientists.

Senator HUMPHRIES —How many cases have there been in Australia of a failure in pathology based on a mistake or a failure in professional standards on the part of laboratory scientists?

Prof. Burnett —We have a number of monitoring systems and quality assurance in place. Pathology is very introspective in that it seeks to measure, control and remove the sources of error. Laboratories would have a very well-developed and mature capacity to measure the number of failures of large or small magnitude but one would then have to drill through and work out whether the root cause lay within a medical failure or a scientific failure. Such a scheme is in the process of being launched. It was developed by the profession. It has a quality assurance privilege, it is a registered quality assurance activity and 2009 is the first year of operation. So I can refer to the existence of the scheme but there is probably an insufficient evidence base to provide the information and detail required for your question.

Senator HUMPHRIES —Do you have any anecdotal impressions of how much this is a problem within Australia’s laboratories? In your professional lives—I assume most of you work in this sort of setting—how often do you see people making mistakes or the system breaking down?

Prof. Burnett —Mistakes of varying severity occur all the time and it is part of the systems process of pathology laboratories that these are captured, corrected and adjusted before the final results are released. I do not think we would be able to provide information drilling to the root cause, although New Zealand has a much more mature system. A new registration system was brought into place about eight years ago in New Zealand and it followed a couple of significant errors in two places in New Zealand. Following those errors, registration of medical scientists came in. So we do not have evidence here but there has been evidence in other jurisdictions. The reason we may have no evidence is that we have no measurement system at present. It is only starting this year to drill down and capture that data.

Senator HUMPHRIES —The basis of my question is this. One of the arguments for registration is that you maintain high standards in the area. The consequences of a failure of standards, if you are a physician or a dermatologist or a gerontologist or whatever it might be, are fairly clear. The patient can suffer directly and the consequences are quite immediate and severe. If, as I think I am picking up from you, the systems within our laboratories provide a system of checks and balances and a screening process so that mistakes do not often translate into harm to patients—and you have not been able to point to any cases of it here in Australia anyway—the argument for a further overlay of bureaucracy, registering the scientists, is not convincingly made out. Perhaps if the rate of mistakes is quite high and, as a quality control measure, we need to register people or to reduce that and you could demonstrate the registration would lead to it being reduced then there is a different case there for this. Is it reasonable to suggest that we should wait to see what the evidence of that process you have just described actually produces as to the extent of the problem before we seek to remedy it with a registration scheme?

Prof. Burnett —I think Australia has been well served by having a high degree of professionals within its pathology workforce. If self-actualisers are to improve and capture it is a credit to Australia that this is the first such scheme that has been developed at a nationwide level to generate this data. If you would allow me to, we could take on notice and provide information to you, but I do not have at my fingertips the answer to the question that you are asking.

Senator HUMPHRIES —Let me pursue that. Supposing it was only a small number—you were able to document five cases of mistakes in laboratories in the last five years that lead to an error in pathological evidence given to a practitioner. Would that level be enough to warrant a national registration scheme of laboratory scientists or would we need an error rate of 100 every five years or 500—as I used before—to say that the cost of the scheme warranted the size of the problem?

Prof. Wilson —The answer to that is a policy issue based around the consequences of errors that occur. I know that it is not specifically part of the terms of reference of this inquiry, but one of the points that Professor Burnett was, I think, alluding to is that, while pathology has been well served to date with a high degree of professionalism and a large body of expert scientists within the profession, there are concerns that as time moves on there will not be the same core of people in the laboratories to provide those checks and balances that we currently have. The time frame in which we are concerned that those sorts of problems might emerge is not very far away.

Senator HUMPHRIES —I am not quite clear, though, how registration fixes that. Are you saying that registration makes it more attractive for people to go and work in those settings?

Prof. Wilson —We believe that it will contribute. It certainly will not resolve the problems in the workforce, but it does provide a framework in which standards based around competency can be developed, which is some of the work that Dr Badrick and his colleagues are working on. With that, it makes it easier to define the role of different levels of medical laboratory scientists and what scope of activities they should be permitted to do. At the moment, in the context of checks and balances, it is more a matter of judgment supported by acceptance of the accreditation framework. It certainly is not necessarily consistent between laboratories and across the country. Registration, in this context, is more about being able to establish the standards, competency and scope of practice for medical laboratory scientists. We believe it also has a fringe benefit of creating a more clearly defined career for people as medical laboratory scientists, which, we would like to think would, at least, make it more attractive for young people to consider as a career and for people working within it to remain in the profession because there is a fairly significant loss of people out of the profession at a young age.

Prof. Burnett —I would like to add a supplementary answer to the question you asked me earlier—I have had the benefit of a few minutes to think it through. As I understand it, you are posing a challenge that, assuming that medical registration has ensured that the pathologists’ supervision is adequate, you are asking me to demonstrate the case that the scientists’ lack of registration may represent a risk. I will provide two answers. Let us assume that the medical registration is satisfactory to prevent problems and to ensure quality. The scientific areas are in particular areas of pathology—in genetics, where a wrong diagnosis may have significance not only for the patient but for their entire family and possibly for generations; toxicology; drugs and abuse and workplace screening, where a wrong answer could provide enormous stigmatisation or loss of employment for an individual or a family; or assisted reproductive technology, where again, an error might impact not just on the family but on the unborn children.

The other side would be to ask the impact of a doctor seeing a patient where your typical doctor might see perhaps a dozen patients a day or perhaps 100 patients a week or perhaps even 1,000 patients a year. For a typical laboratory that might be supervised by a scientist, they might see millions or tens of millions, so there is an enormous magnification factor because of the high transactional volume of pathology. The latent risk is there even though I may not be able to provide today an anecdotal case. But by probability calculations you would argue that if there were a gap in the registration framework it would have significant potential for risk in terms of quality and safety.

Senator HUMPHRIES —Isn’t there a difference though between these two cases? Isn’t a laboratory scientist part of a process? The individual scientist does not necessarily make the crucial decision—but perhaps they do—in the laboratory about what this particular specimen means in terms of indicating a disease or something like that. It is part of the process, which passes through several hands, and is checked and so forth by the pathologist, for example. If a GP is inadequately screened and makes a mistake, it has a direct impact on that patient, but if a scientist makes a mistake it may be picked up further down the line. So the need for the individual scientist to be properly accredited is a little bit less in that sense than for the individual doctor who is dealing with the patient.

Prof. Burnett —There are probably three layers you are referring to. There is the medical laboratory scientist—‘at the laboratory bench’ is the terminology—and is as you describe that they would be performing tests under supervision using rigidly controlled protocols. They may often be the one to release the result but there will always be a supervision support and consultation available. Then there is the more senior medical laboratory scientist, who may at certain hours of the day be in operational control of the laboratory, and in certain parts of pathology such as the ones we have described, will be the appropriate person to release the consultation for an authority. Then we have the pathologist, who in most areas of pathology is the responsible individual, but it is not possible for one to be expert in every area. So the pathologist may well have the regulatory or the supervisory responsibility but may not be the relevant expert within those fields. It is in those areas that we would imagine the greatest risk would be in terms of the gap within the current accreditation framework.

Senator HUMPHRIES —What is the minimum qualification that you might expect to find for a person working in a laboratory in Australia?

Prof. Wilson —There are people with no qualifications working in laboratories. Perhaps Dr Badrick could comment.

Senator HUMPHRIES —I will rephrase that—working as a laboratory scientist. Could, for example, a medical student on a part-time basis be working in that kind of role?

Dr Badrick —They could be working in a laboratory but they would not be recognised as a medical laboratory scientist unless they had an appropriate degree in an appropriate area of pathology. Depending on the laboratory specialty they would not be recognised as a laboratory scientist.

Senator HUMPHRIES —But a straight BSc could get you in?

Dr Badrick —Perhaps in a microbiology but they would still undergo some supervised training within that laboratory before they would be allowed to release results, for instance. That is the base qualification for a medical scientist.

Senator BOYCE —Would all the laboratories be NATA registered?

Prof. Wilson —Yes, generally speaking, certainly pathology laboratories that are making claims in the Medicare scheme are required to be and are accredited as part of the regulatory framework that Professor Burnett referred to.

Senator FURNER —Do you have cause to engage international pathologists in any pathology laboratories around the country?

Prof. Wilson —In terms of overseas trained pathologists working in Australia?

Senator FURNER —That is right.

Prof. Wilson —Yes, we do.

Senator FURNER —Can you give us some examples of the numbers and from what areas they come from?

CHAIR —And how their qualifications are assessed in your industry?

Prof. Wilson —I could not give you information on the numbers. In terms of the process, my understanding is that they are assessed through the Australian Medical Council. They are also assessed within their subspecialty by the Royal College of Pathologists of Australasia, who provide an advisory report to the Australian Medical Council as to whether their qualifications and experience are at a level which is acceptable to the standards in Australia, whether they are unacceptable and cannot be accommodated or whether they fall in between, in which case they are deemed to be at a stage where, with up to three years supervised training in an Australian laboratory, they could meet the standard of Australian pathology qualification and may be accepted on that basis—that is, into supervised training prior to recognition as a specialist.

Senator FURNER —So they get accreditation through the NPAAC and if they do not meet that standard there are gateways to allow them further training to reach that requirement?

Prof. Wilson —The NPAAC establishes the standards for laboratories, not for pathologists. The standards for pathologists are managed by the Royal College of Pathologists of Australasia.

CHAIR —I am interested in your title: the National Coalition of Public Pathology. Do you also cover private pathologists? Do they have their own organisation?

Prof. Wilson —Yes, they have their own organisation.

CHAIR —Do you work cooperatively? I imagine the issues around training, accreditation and registration would cover pathology in both areas.

Prof. Wilson —Yes. In this particular context the Australian Association of Pathology Practices, which represents the private pathology sector, is a member of the pathology association’s council.

CHAIR —Right. I was just trying to see where the link was. There are a significant number of pathologists working in private labs, so I would have thought that would be a large area of membership for you and perhaps an area of interaction, working from workplace to workplace.

Prof. Wilson —Yes. In the context of medical laboratory scientists, we do not have good data, which is difficult in the absence of a registration scheme, but we estimate that some 50 per cent of medical laboratory scientists in Australia are working in publicly owned pathology services and 50 per cent in privately owned pathology services.

Senator BOYCE —What about medical indemnity insurance? Are medical laboratory scientists likely to take out indemnity insurance, or would that be covered by their employer?

Prof. Wilson —Those who are working in the public sector are covered by their employer. In relation to privately referred patients coming through public hospitals in Australia, the liability is carried by the pathologist who supervises the work that is done.

Prof. Burnett —I will raise a supplementary piece of information which I think was implied by the question. The ratio of medical laboratory scientists and pathologists in Australia is approximately 10 to 1—that is, there are about 10 times as many medical laboratory scientists as there are pathologists within the pathology sector.

CHAIR —It seems in your submission that one of the major reasons for wanting a national scheme is that there is none operating in the country at the moment, so it would be a way to start to regulate your profession—would that be right?

Prof. Wilson —Yes. Certainly the current situation presents some difficulties for people moving across jurisdictional boundaries where the standards, qualifications and definitions of people working in pathology laboratories differ.

CHAIR —You talk about Australia, New Zealand and Australasia a lot. Is there interaction between the New Zealand industry and the Australian industry?

Prof. Wilson —In respect of pathologists, the Royal College of Pathologists of Australasia trains, examines and receives as fellows pathologists in both countries as well as in other parts of the world, particularly in the neighbouring region and South-East Asia. Perhaps Dr Badrick could comment on the medical laboratory scientists.

Dr Badrick —They are a bit patchy. The biochemists have an Australasian association, so they cover both Australians and New Zealanders. The other associations, as far as I am aware, are mainly Australian-centric, so they cover mainly just Australian members. The genetics association is also Australasian, apparently.

CHAIR —And genetics is one of the growth areas.

Dr Badrick —Yes.

CHAIR —So that is the coverage. And your two organisations have been involved in the consultation processes that have been going on with the IGA?

Ms Rogers —Yes.

CHAIR —And your issues have been picked up in terms of at least being heard in those processes? No-one can be sure about the result—

Ms Rogers —That is right.

CHAIR —but you have raised the issues you have raised with us in the consultation processes through the IGA?

Prof. Burnett —Yes, we have.

CHAIR —Thank you very much. The process is that we are now waiting for the legislation to be made public, whenever that will be, which will give some more detail, then we will be making sure that everyone who has made a submission to this inquiry will have copies of that. There could well be more interaction as a result of that process. Thank you again.

Committee adjourned at 3.31 pm