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Community Affairs References Committee
20/04/2016
Emerging tick-borne disease

GRIFFIN, Mr Andrew James, Deputy Sector Manager, Legal and Clinical Services, National Association of Testing Authorities, Australia

MITCHELL, Mr John Cameron, Manager, Government Relations, National Association of Testing Authorities, Australia

STYZINSKI, Mr John, General Manager, Operations and Technical, National Association of Testing Authorities, Australia

[14:12]

Evidence was taken via teleconference—

CHAIR: Welcome and thank you. Can I check that you have had information on parliamentary privilege and the protection of witnesses and evidence?

Mr Mitchell : Yes, we have.

CHAIR: I would now like to invite whoever you have designated to make an opening statement or statements to do so, then we will ask you some questions.

Mr Mitchell : We thank the committee for the opportunity to explain NATA's role, our accreditation processes and how we fit with international practice. NATA is a 1946 Commonwealth and state construct that was cooperatively established to serve the national interest. We are, however, a private not-for-profit company limited by guarantee and, as such, have no statutory powers. We do not compel laboratories to seek accreditation, nor do we prescribe what they must be accredited for.

NATA is recognised by the Commonwealth through an MOU—a memorandum of understanding. That is administered through the Department of Industry, Innovation and Science. The relevant recognition for the purposes of this inquiry is as the national authority for laboratory accreditation. NATA accreditation involves processes to determine the collective competence and capability of services that produce test and measurement data that will be used as the basis for decision making. It is not a generic recognition of everything that a laboratory might do—rather, it is for specific technical competencies as defined in a scope of accreditation. The key element of the accreditation process is our on-site peer assessment—that is, the use of assessment teams made up of individuals having scientific and technical expertise that we match to the range of specific activities to be covered by the accreditation. Assessments cover all aspects of laboratory practice that are important in delivering confidence to the end user—the user of those testing services. Reassessments confirm continuing compliance with accreditation criteria, so it is not a set-and-forget process—there is an ongoing surveillance cycle.

The NATA-Royal College of Pathologists Australasia accreditation of medical-testing laboratories commenced around the mid-eighties—before I joined—and became a prerequisite for all pathology services wishing to have their testing eligible for Medicare rebates. It is not, though, just for MBS listed tests, and includes activities such as workplace drug testing and point-of-care testing—that is the sort of testing that might be conducted, perhaps, in a hospital environment but not in a laboratory.

To the best of our knowledge, the NATA-RCPA program is the oldest comprehensive medical testing accreditation system in the world. Indeed, Mater's expertise and experience is key to the development of the international standard for medical testing laboratories, ISO 15189. The current accreditation criteria is a combination of ISO 15189, together with the series of standards that are produced by the Department of Health's National Pathology Accreditation Advisory Council—known as NPAAC. The accreditation criteria are applied to MBS and non-MBS tests, so we have one standard of accreditation across the board. Accreditation for medical testing laboratories is available to all facilities that can meet the accreditation criteria, whether they be public or private or large or small, or whether they offer a very broad range of capabilities or are even those that might only undertake a single test.

We note from the transcripts that there has been some discussion around international recognition. NATA was actually instrumental in the formation of the International Laboratory Accreditation Cooperation, which is a global cooperation of similar accreditation bodies, and it was a leading player in the development of the ILAC Mutual Recognition Arrangement. NATA itself was amongst the first signatories to this Mutual Recognition Arrangement. The ILAC MRA—and there are also associated regional MRAs—is designed to facilitate international recognition of test data and to reduce technical barriers to trade. MRAs are not just based on a handshake, but built on a system of periodic mutual peer evaluations to determine compliance with the international standard for accreditation bodies—we have one ourselves—which is ISO/IEC 17011.

The MRA evaluation process focuses on the equivalence of outcomes, not the detail of how the outcome was achieved nor, for that matter, that all is done identically. The fact is that we do not. It is really a performance based outcome.

While one of the first signatories to the ILAC MRA—something driven by trade imperatives—we did not actually seek mutual recognition for our 15189 medical program. Primarily because it was so highly focused on domestic needs and having been driven around Medicare rebates, we were perhaps a little bit short-sighted. We did not really see that medical testing was a trade-sensitive activity. But the increasing internationalisation of medical diagnostic services finally meant that we needed to seek inclusion of the NATA-RCPA program under the ILAC mutual recognition arrangement. By 'internationalisation', I am referring to practices such as real-time telepathology and teleradiology, where there is online transfer of data to a diagnostician who may indeed reside across international borders. Then of course there is the growing practice—as we have seen in this inquiry—of sending patient samples offshore to foreign laboratories. MRA recognition for our medical program was achieved in January this year.

If I may, I will say a word on what mutual recognition actually means, particularly in this context. It is the testing performed to the same set of requirements and using the same methods can be regarded as being equivalent. I do stress the point 'same set of requirements and methods'. There is no implication that the MRA requires or expects recognition of another country's requirement and their context. So we need to compare apples with apples here. I also point out that the MRA is there to serve the end user. Our role under the MRA is to promote recognition of equivalence. It is the end user, however, who is actually the individual making the final decision on the recognition.

I will not take too much more of your time, but I do want to finish with some brief points to address some specific matters that we are aware of through the last couple of hearings. The simple fact is that NATA, RCPA and MRA are partner-accredited facilities and are not perfect. They will make mistakes. There is no system that we know of that can render them all perfect, and we would happily adopt it if we did identify one. The point is that they have demonstrated competence and they also have systems in place to facilitate the protection of errors that they might make and, more important, initiate appropriate follow-up measures.

With regard to non-accredited laboratories, NATA makes absolutely no judgement whatsoever about their competence, for the simple reason we cannot know. So, if NATA states that the particular laboratory is not accredited, it is not a judgement but a simple statement of fact. Our longstanding commitment to the international accreditation community is not consistent with some suggestions we have heard that we fear international testing systems. With any type of testing, NATA bases its decisions on the soundness of the science and technology. For well-established, standard methods where there is an abundance of peer reviewed evidence, including validation data, the decision is relatively easy provided the laboratory is using that particular method without modification. In other cases, methods might be more of a proprietary nature but, in Australia, they would typically have been through the TGA's conformity assessment processes and are listed on the ARTG. That gives us confidence that the validation is in order.

For new and innovative methods for which the availability of appropriate validation is limited or where standard methods have been modified or, indeed, used outside their design parameters, the threshold of evidence for acceptance naturally becomes higher. The soundness of evidence provided is judged by relevant experts and professional bodies, not by employees of NATA. NATA must seek the best advice from expert sources, peers of the laboratory, before it commits to a precedent that will impact on the health and safety of the Australian population.

Finally, the scientific answers to the question that is the subject of this very inquiry will obviously dictate how testing services and methodologies develop in the future, but NATA's role is to respond appropriately to evidence based and robust science, not to pre-empt the outcome. NATA needs to get its accreditation decisions right.

We are happy to answer any questions from the committee. We do, however, want to point out that NATA has confidentiality requirements, as part of its rules, that preclude us from divulging information about applicant laboratories. If any of you have questions that relate to specific laboratories, we are happy to provide general answers for the record, but, if you wish to ask very laboratory-specific questions, we would prefer that these were dealt with in camera if at all possible.

CHAIR: Thank you very much for that. I will go to Senator Madigan and we will start the process. If we get to specific questions, you can request to go to in camera and we will go through that process.

Mr Mitchell : Okay. Thank you very much.

CHAIR: Let us start, and we will see how far we get.

Senator MADIGAN: Thank you, gentlemen. Say I wanted to get NATA accreditation for my laboratory and I wanted to run tests for classical Lyme Borrelia burgdorferi. I believe there are the ELISA test, the western blot test and the PCR test. What is the process for me to achieve this accreditation from NATA?

Mr Griffin : The process would be as follows. The laboratory would apply for accreditation. First you ring us and say, 'We're a laboratory. We want accreditation for X test.' The initial process would be an advisory visit. We would go out to the laboratory and just discuss, if you like, their readiness for accreditation, discuss the accreditation process and look at their quality system. Many laboratories may not have had anything to do with accreditation previously, so it is a good idea for us to give them some advice on the process. Depending on where they are within that process, at a point of time we might say, 'Our normal process is to go and take a peer team along to the NATA/RCPA program for a microbiology test.' That would normally include a micropathologist and a microscientist. That is the general process. During that process, we would assess the laboratory. It normally takes a day, depending on the size or the scope. The peer assessors ask questions of laboratory staff. They look at records. They look at validation, verification, quality control, training records, competence—all the things that are listed in the relevant standards. They really look at the whole competence of the lab. During that time then, at the end of the day, we provide a report. Oh yes, and, with the assessment team, we take a lead assessor, so a NATA employee goes along with the assessment team, and they act as the liaison between the lab and the assessment team and ensure that each assessment we do is consistent. The technical assessors may only go out once a year—maybe once every two years, sometimes more often—but the lead assessor will go out an awful lot more. So they know the accreditation process better than the technical assessor, if you like.

Senator MADIGAN: Is there a requirement for both the laboratory and specific tests to be accredited?

Mr Griffin : No. The laboratory puts forward the test they want accredited. We have no say in what they put forward. They could have 100 tests and put forward one, or they could put forward all 100 for accreditation. It is completely the laboratory's decision.

Senator MADIGAN: So you accredit the laboratory but then you individually accredit each test for that laboratory. Is that correct?

Mr Griffin : The laboratories are assessed for technical competence in the testing they put forward.

Senator MADIGAN: Okay.

CHAIR: Can I just clarify that. With each test, it is the test that you are accredited for?

Mr Griffin : The test list they put forward falls under a scope of accreditation. So it is about their technical competence to perform that test. We are not a product certification organisation; we do not certify that products meet a certain standard. We assess whether the lab is able to competently perform that test and produce a result.

Senator MADIGAN: Are you aware of a company called Australian Biologics, which has applied for accreditation to NATA?

Mr Styzinski : Yes.

Mr Griffin : According to my colleague, yes, I am!

Senator MADIGAN: Right. You mentioned confidentiality requirements earlier. No names, no pack drill—but do you have strict confidentiality requirements around applications for NATA accreditation?

Mr Mitchell : We do indeed have confidentiality around applicants. The expectation is that anybody who is involved in the accreditation process—obviously, NATA staff but also any technical assessors, the committees and other specialist experts who would have some role in reviewing material from the laboratory—will have signed a confidentiality agreement with NATA and a conflict-of-interest statement.

Senator MADIGAN: In my first question, I mentioned PCR. Is it common practice to ask a laboratory for their primers, their individual intellectual property?

Mr Griffin : It depends on the nature of the assay. If it is a commercial assay, it has been approved, if you like, by the TGA, so we do not need to ask for that; it has already been validated. If the test is a standard method and it has been published and peer reviewed—those primers and probes are normally published anyway—again, we would not need to ask for those; we would just confirm that they are using a standard method without modification. If it is a new method, then we certainly do an assessment, and the assessment team would look at the primers and probes that the laboratory is using.

Senator MADIGAN: How do you ensure that the intellectual property of a laboratory that is applying for NATA accreditation is not disclosed to their competitors?

Mr Griffin : As we have described, the technical assessors sign a confidentiality agreement and a conflict-of-interest statement. They are obliged not to take anything out with them. They do not take things away in their pockets. We do not take things away with us.

The assessor on the day is working for us. They are not working for the organisation that they come from. They are not representing a professional body. They are working as a technical expert on our behalf on that day. So they are actually considered a NATA employee on that day and have signed confidentiality and conflict-of-interest statements.

CHAIR: Can I just jump in there. So they will look at primers that are novel, but if they are standard ones they do not. Is that what you are saying?

Mr Griffin : Yes.

CHAIR: Australian Biologics said that you had asked them about their primers.

Mr Griffin : That is correct, yes.

CHAIR: Is that because they were considered novel?

Mr Griffin : It is an in-house assay and our understanding is that the assay is a modification of the general PCR assay being used. It is claimed to have more sensitivity than the standard PCR assay. Therefore, the assessment team would want to see those primers and probes when they do the assessment.

Senator MADIGAN: If a laboratory applying for accreditation alleges that their intellectual property has been divulged to their competitors, how does NATA assure that laboratory that their primers, for instance, have not been disclosed to their competitors?

Mr Mitchell : At the end of the day, we are reliant on the integrity of the people in the NATA system. We do not just select assessors and committee members and experts on the basis of their technical knowledge. We also need to have confidence that they are individuals of integrity. That might not be bullet proof, but the other side of the coin is that this is a process of peer assessment. That is the way of getting the best outcome, the best evaluation, so we have to work within those parameters.

Senator MADIGAN: What disciplinary action, investigation, is undertaken by NATA in the event of a claim that your intellectual property has been stolen by a competitor?

Mr Styzinski : The number of complaints we have had of that nature have been very limited, so we would—

Senator MADIGAN: How many complaints has NATA received, in relation to disclosure of intellectual property at individual laboratories? Are you able to take that on notice and furnish that to the committee.

Mr Styzinski : We could do that but, off the top of my head, I can say that in the last number of years we have, probably, had one or two complaints only.

Senator MADIGAN: Was one of those complaints to NATA from Australian Biologics?

Mr Styzinski : There was a complaint received, and that was independently investigated by our quality manager.

Senator MADIGAN: So it is independently investigated by NATA's quality manager.

Mr Styzinski : Investigated by individuals who are independent of the assessment process, regarding—

Senator MADIGAN: The point I am making is that the person who investigated the complaint was an employee of NATA. Is that correct?

Mr Styzinski : That is correct, because any organisation that is required to operate a management system, whether it be to an ISO standard—you would be familiar with ISO 9000—requires a complaint handling process, which is normally an internal process.

Senator MADIGAN: What external oversight is available to a person who lodges a complaint with NATA?

Mr Styzinski : If NATA does not provide a satisfactory response to a complaint it receives, the complainant has the right of appeal to follow up with the Asia Pacific Laboratory Accreditation Cooperation. That is the regional body forming part of the ILAC arrangements that oversee our performance. So they have the line or channel for further complaint up the tree.

CHAIR: In terms of complaints, you said you think you have had only one or two on breaching the confidentiality process.

Mr Styzinski : No, it is specifically with regard to IP.

CHAIR: Sorry, with IP. How many complaints, overall, have you had?

Mr Styzinski : We probably receive about 30 or 40 a year.

CHAIR: Could you perhaps take on notice how many you have had and how many have been either not found to be—

Mr Styzinski : Substantiated or otherwise?

CHAIR: Substantiated or otherwise, yes, please.

Mr Styzinski : Yes.

Senator MADIGAN: For a pathology lab to be able to receive payments from Medicare, they must first have NATA accreditation—is that correct?

Mr Mitchell : Yes.

Senator MADIGAN: So—for crystal clarity—a laboratory cannot be paid for its tests unless it has NATA approval?

Mr Mitchell : Yes. There is another step in the process, which actually is a ministerial approval of the laboratory, but that is based on a report from NATA which goes to the Department of Human Services.

Senator WANG: From what I can gather, you guys are in a really wonderful position. It seems like you guys have a really good monopoly. We have heard comments from both sides that, when a patient was tested positive for Lyme, let us say, in pathology in Australia, the other side will quickly dismiss such a test result, and the argument they would always use is: 'That lab was not NATA accredited.' We have also heard comments—it seemed to me, some people are really confident about NATA accreditation. What makes you so special?

Mr Griffin : I think it is fair to say, firstly, that, as John said, we make no judgement on a lab that is not accredited. So that is not our opinion—that the result does get meaningless if they are not accredited. If we have not seen a lab, we make no judgement about their competence. I think that is important to note.

Mr Mitchell : In terms of NATA, you are inviting us, Senator, to blow our own trumpet, which we do not actually like doing, but NATA does have a long history. Our first accreditation, which was not medical testing but it was granted in 1950. We have some 3,300 accredited facilities nationally. We run the oldest medical program in the world. Many accreditation bodies around the world have been actually modelled on the NATA system. The simple fact is: if we were not doing a reasonable job of providing reliable tests and measurement infrastructure in Australia, things would have changed long ago.

In terms of your suggestion that the monopoly status is wonderful, it is swings and roundabouts. Obviously, we are not actually exposed to competitive pressures that, in this instance, for example, might mean that we cut corners. I do not know that competition in accreditation would resolve the science any faster.

In terms of the rest of the world, models around the world vary. The United States is probably the major example of where there is open competition. The European Union, on the other hand—through the European Parliament's decision 765—actually went the other way and mandated that there be only one accreditation body per member state. Competition was actually in conflict with the objectives of accreditation. That is a discussion that perhaps we can have some other time, but I think competition in the accreditation space is not going to resolve the committee's overarching question, which is the existence of Lyme disease and Lyme-like complaints in Australia.

Senator WANG: No, but a really common argument we hear is, 'That lab is not accredited, therefore the results cannot be trustworthy.' How would you describe the dilemma we are in at the moment, where mainstream doctors seem to deny that there is Lyme-like illness in Australia? We have had a number of minority doctors who are acknowledging the fact and also treating patients accordingly, and their patients are recovering. It seems to me that NATA is in a way representing the majority of the pathologists, who are denying Lyme-like illness as well. How can we make sure there is healthy competition—you probably do not really like competition in this area—between the minority and the majority, where both sides are really trying to advance their argument rather than resulting in the simple comment, 'That lab is not accredited, therefore they are rubbish'?

Mr Mitchell : The discussion about being NATA or unaccredited is unfortunate, to say the least. Unfortunately, I also do not think it is stating the problem. There is a sense in which NATA accreditation or accreditation by anyone in this context is a second-order consideration. The question is: is the science robust and valid? If the answer to that is yes, then accreditation follows. If the answer to the question is, 'We're not sure,' that makes it exceedingly difficult for us to make sure that we ourselves are taking decisions that are the best for the Australian public.

Senator MADIGAN: Gentlemen, is there any quality assurance program for Lyme disease tests in Australia such as the ELISA, Western Blot and PCR and, if so, who administers those quality assurance programs?

Mr Griffin : I understand that the Royal College of Pathologists quality assurance program administer a serology and maybe the immunoblot—I am not quite sure about that. I am not aware of an Australian based PCR QAP.

Senator MADIGAN: Finally, what does NATA plan to do about the recently signed a memorandum of understanding with respect to the mutual recognition of international laboratories who test for Lyme disease? How do these overseas international laboratories go about getting the NATA stamp of approval?

Mr Mitchell : They do not have to get our approval. The fact that we are all signatories to the ILAC Mutual Recognition Arrangement means that we are recognising the equivalence of our systems. Our obligation and the obligation of, for example, the German accreditation body, DAkkS, is to promote within our own countries the equivalence of ILAC MRA accreditation bodies and the accredited facilities under those accreditation bodies. As I mentioned in our opening remarks, it is not actually up to us to accept anyone's report. What we say to anyone who inquires is, 'If you use a NATA laboratory or a DAkkS accredited laboratory or maybe an IANZ laboratory in New Zealand or a UKAS laboratory in the United Kingdom, provided they are performing the same tests to the Australian requirements, you can have confidence that they are equivalent.'

One of the things I also mentioned in our opening statement is the issue of common requirements. If our laboratories test for Germany, they have to test to the German requirements. If a German lab tests for Australia, it has to test to the Australian requirements. I mentioned the NPAAC standards. The NPAAC standards are unique to Australia—they are not part of the MRA—but that does not preclude a foreign accreditation body being asked by a laboratory wherever to, as well as assessing them for ISO 15189, also include the NPAAC standards that are applicable to these tests.

Senator MADIGAN: Last week, we had a number of people who gave evidence to the committee who were quite adamant, for want of a better word, that these overseas international laboratories were not a patch on Australian laboratories.

Senator MOORE: Some of them.

Senator MADIGAN: They said that the Australian standards were so much higher—the best in the world. So some doctors and some specialists do not accept the results that come from these overseas international laboratories, yet we are told that there is this MOU, mutual recognition of international laboratories. We are trying to seek clarification here around this whole business of this international recognition and what part you play in it.

Mr Mitchell : I must admit that I am glad that we have people that spruik the national system, but quite frankly we are not in a position to comment on what they are saying, in a way. We stand by the mutual recognition arrangements, provided that we are comparing apples with apples.

CHAIR: Is the point that you are making here the bit that you have said about Australian requirements and standards?

Mr Mitchell : Yes. We have to make sure that in fact we are comparing laboratories that are accredited to the same suite of standards. Yes, while we use 15189, particularly for very specialised testing, some of the NPAAC requirements provide additional guidance and detail on the expectations that we see. We would have confidence that DAkkS or any of our MRA partners are quite capable of assessing laboratories to the NPAAC standards if they are requested to do so. Since they are publicly available documents on the Department of Health's website, access is not an issue, so they are non-discriminatory in that sense. So if a laboratory is accredited to the same suite of standards then you are comparing apples with apples. In the absence of that additional oversight, you may not get exactly what you are expecting.

CHAIR: Thank you. I have one last request that you may need to take on notice. We had evidence last week from Australian Biologics. It will be available on Hansard soon—it is only just going up. They made a number of comments—would you have a look at them, please, and respond to them? We would very much appreciate your response to a number of the points that were made during that evidence. Is that possible?

Mr Mitchell : Yes, most certainly. May I ask if this is for the public record, or would this be provided—

CHAIR: You can do either, or both. You can ask for it to be in confidence and the committee will consider that—

Mr Mitchell : Okay.

Senator MOORE: But Australian Biologic's evidence was in public.

CHAIR: Yes. Their evidence was clearly in public.

Mr Mitchell : Okay.

CHAIR: That would be appreciated. Thank you very much for your time today and for taking on notice the question that I have just asked and the other questions that I asked. The committee will be in contact with you about those questions.

Mr Mitchell : Okay, thank you. And should you actually think of any additional questions, we are happy to provide a written response. They can be sent to me.

CHAIR: Okay, thank you very much. We have run slightly over time, as we have been wont to do. I apologise for that, but it was very useful evidence that we got today. That is the end of the hearing for today. Obviously, we will release publicly when we will hold our next series of inquiries, bearing in mind that there will be an election in the not-too-distant future.

Senator WANG: Can we have a hearing on 2 July?

CHAIR: I think some people may be occupied on 2 July! The committee is now adjourned.

Committee adjourned at 14:56