Laboratory accreditation

11.5 Laboratory accreditation is the formal recognition of an organisation’s competency to perform certain specific tests, classes or types of tests or instrument calibrations. In Australia, the technical competency of medical testing (of which genetic testing is a component) and forensic testing (of which parentage and other kinship testing is a component) is ensured by the accreditation scheme operated by the National Association of Testing Authorities, Australia (NATA).[3] NATA is an independent, private, not-for-profit company, which operates as an association.

11.6 The Commonwealth government recognises NATA as the sole national accreditation body for establishing competent laboratory practice.[4] According to a memorandum of understanding entered into in 1998, the Commonwealth has agreed to:

  • use NATA accredited laboratories to meet its own testing needs wherever possible;
  • encourage state governments and other instrumentalities to adopt a similar approach; and
  • commit Commonwealth government laboratories to obtain and maintain NATA accreditation.[5]

Pathology laboratory accreditation

11.7 The medical testing accreditation scheme is run jointly with the Royal College of Pathologists of Australasia (RCPA) based on policy guidance provided by the National Pathology Accreditation Advisory Council (NPAAC). The policy guidance takes the form of standards and guidelines which pathology laboratories must adopt in order to be accredited by NATA.[6]

11.8 Individual laboratories apply to NATA for accreditation in one or more categories of medical testing, and then undergo an inspection by NATA-selected assessors. Once accredited, laboratories become members of NATA.[7] Ongoing accreditation requires periodic assessment by NATA assessors.

11.9 The NATA/RCPA accreditation scheme is also used by the Minister of Health and Ageing as a way of ensuring that laboratories wishing to obtain Medicare payment for medical services are suitably accredited.[8] Laboratories wishing to access Medicare payments must comply with standards and guidelines developed or endorsed by NPAAC, gain accreditation from NATA, and be designated as an Approved Pathology Laboratory by the Health Insurance Commission.[9]

11.10 The current Australian pathology laboratory accreditation arrangements were reviewed by Corrs Chambers Westgarth Lawyers, at the request of the Department of Health and Ageing (the Commonwealth pathology services review). The July 2002 report of the review found that present arrangements were fundamentally sound and should be maintained.[10]

[C]urrent Australian pathology laboratory accreditation arrangements efficiently and effectively regulate the vast majority of pathology services provided in Australia. There is substantial qualitative evidence that the quality of pathology services has improved since the present arrangements were introduced.[11]

11.11 The minimum standards for pathology laboratory practice in Australia are set out in NPAAC’s Standards for Pathology Laboratories.[12] There are two other relevant NPAAC standards—Quality Systems for Medical Laboratories and Requirements for Supervision of Pathology Laboratories.[13] A range of specific standards and guidelines supports these three key standards,[14] including those relevant to genetic testing.[15]

11.12 NPAAC standards are supplemented by NATA field application documents specific to different areas of laboratory testing.[16] Accreditation criteria for cytogenetic and molecular genetic testing specify the management and technical requirements that each laboratory must maintain, including:

  • quality systems that should provide laboratory management with continuing confidence that results and conclusions are accurate and reliable;
  • records to show that staff members have been properly trained and proof of qualifications and membership of professional societies;
  • documented test and calibration methods and method validation;
  • instructions, safety precautions and requirements for specimen collection; and
  • test reports and calibration certificates.[17]

Forensic laboratory accreditation

11.13 Accreditation criteria for forensic identification testing cover the level of training of personnel, accommodation and environmental conditions in the laboratory, test and calibration methods and method of validation used, and quality assurance protocols and procedures.[18]

11.14 Standards applicable to parentage testing provide, among other things, that laboratories must have documented policies for the interpretation of data for each method of DNA analysis,[19] and that parentage test reports must comply with the Family Law Regulations 1984 (Cth).[20]

Non-accredited genetic testing

11.15 Non-accredited genetic testing occurs in Australia in two situations—when a non-accredited laboratory carries out genetic testing or when an accredited laboratory carries out genetic testing that does not comply with genetic testing accreditation criteria. The latter is possible because NATA permits accredited laboratories to conduct testing that does not comply with NATA requirements, provided that the laboratories do not claim to be accredited for the purposes of that particular test.[21] Overseas laboratories that market genetic testing services via the Internet may also fail to be accredited by NATA or an equivalent international accreditation organisation.

11.16 Submissions and consultations highlighted a range of concerns about non-accredited testing. As discussed above, accreditation standards impose a wide range of general and specific management and technical requirements. Accredited laboratories are required, among other things, to employ quality management systems, comply with laboratory design and fitting standards, properly document test requests and specimens, and to be enrolled and participate in external proficiency testing programs.[22]

11.17 The fundamental concern about non-accredited genetic testing is that there may be no independent assessment about the quality of the testing process, the proficiency of the personnel carrying out the test, or the reliability of the results. Under-performing laboratories outside the accreditation system may not be identifiable.[23]

11.18 Other submissions expressed concerns that non-accredited testing may not comply with important ethical standards, particularly in relation to the adequacy of consent to testing, privacy and confidentiality, and ensuring that individuals are tested only in circumstances where they will be provided with proper information and advice in interpreting the test results, and access to genetic counselling, where necessary.[24] Accreditation standards were also seen as important in ensuring that some sensitive or complex tests are only ordered through medical practitioners.[25]

11.19 As discussed in Chapter 35, in the interests of accurate, reliable and ethical parentage testing, the Inquiry recommends that NATA accreditation should be mandatory for all Australian laboratories that conduct DNA parentage testing.[26] However, concerns have also been expressed about non-accredited medical testing, including by companies offering genetic testing services directly to the public.

Recommendation of the Commonwealth pathology services review

11.20 The Commonwealth pathology services review recognised that most laboratories seek NATA accreditation as a means of accessing Medicare payments and that pathology laboratories that are not interested in reimbursement for services remain unregulated. The review noted that complementary state-based legislation may be appropriate to regulate these laboratories and enforce compliance with national pathology standards.[27]

11.21 At present, Victoria is the only State with its own statutory accreditation scheme.[28] In Victoria, pathology services accreditation legislation, administered by the Pathology Services Accreditation Board on behalf of the State Minister for Health, governs the conduct of pathology testing.[29]

11.22 As with the Commonwealth legislation, the assessment of Victorian pathology services uses the NATA/RCPA scheme and the NPAAC standards. However, enforcement of the Victorian scheme extends not only to pathology services that are eligible for Medicare payments, but also to those services that are either ineligible or do not seek access to such payments.[30]

11.23 The Commonwealth pathology services review concluded that state legislation to complement existing Commonwealth legislation could assure the public about the quality of the relatively small number of pathology services that are currently unregulated because they do not seek Medicare payment.[31] The review recommended:

That the [Department of Health and Ageing], in partnership with State and Territory health authorities, undertakes a detailed evaluation of the need for, and potential costs and benefits of, additional legislation in all jurisdictions to complement the Australian pathology laboratory accreditation arrangements.[32]

11.24 In August 2002, the Government expressed agreement with this recommendation and announced measures to enhance standards of pathology laboratory testing and identify laboratories that pose a risk to public health and safety.[33] The Commonwealth Department of Health and Ageing has confirmed that the establishment and implementation of a nationally consistent quality assurance and accreditation scheme is under consideration by the Australian Health Ministers’ Advisory Council Advisory Group on Human Gene Patents and Genetic Testing.[34]

New legislation to require accreditation

11.25 In DP 66, the Inquiry asked whether legislation should be enacted to require laboratories that conduct genetic testing to be accredited by NATA and to comply with accreditation standards in respect of all genetic testing.[35]In response, there was support for the principle that laboratories conducting medical genetic testing should be accredited and that additional regulation may be required to enforce accreditation requirements.[36]

11.26 However, the New South Wales Health Department submitted that it would prefer to see improvements to existing accreditation processes and flexible policies rather than the introduction of new legislation.[37]

[A]ny policy will need to be flexible to enable genetic testing for often rare disorders for diagnostic purposes, where the test is still under development or part of a research study, to be undertaken by unaccredited research laboratories. Sometimes these laboratories are the only facility to offer a valuable test, and may be the patient's only hope.[38]

11.27 It was also suggested that the enactment of legislation to prohibit genetic testing by non-accredited laboratories may have unforeseen consequences in relation to some forms of genetic testing.[39] The Department of Health Western Australia submitted that:

Careful consideration should be given to any statutory requirement that a provider of a genetic testing service must be accredited. Such criteria could be seen as anti-competitive and should only be introduced where it is justified on the basis of protecting consumers against identified harm.[40]

11.28 The Cancer Council Victoria Cancer Genetics Advisory Council noted that new accreditation requirements could set a precedent for all forms of diagnostic testing with widespread implications across the entire pathology industry.

The cost and effort in achieving [NATA accreditation standards] would be prohibitive for many smaller laboratories which would cease testing. Many of these would be likely to be non-accredited but nonetheless highly capable research laboratories that perform diagnostic tests, often at no cost, for rare or esoteric genetic diseases (eg MEN1) that are not available elsewhere. Somehow these tests will need to be incorporated into an accredited laboratory setting without disrupting a valued clinical service and research activity.[41]

11.29 Most research laboratories are not NATA accredited, notwithstanding that they may perform diagnostic tests from time to time. This does not mean that research laboratories fail to meet stringent standards of technical competence and quality assurance, but rather that there has been no need for research laboratories to obtain accreditation, since they do not receive payment under Medicare. The Children’s Cancer Institute Australia submitted:

We maintain that NATA accreditation should not be required during the development phase of genetic tests, including clinical trials for new tests being undertaken with research funding, and at no cost to either individuals or the health care system. Genetic tests are often developed in research laboratories, under appropriate approval by an institutional Human Research Ethics Committee, where such accreditation would not already be in place. So long as the gene test is in the research phase, it should not require NATA accreditation: the accreditation could be deemed to become essential at the point when the testing procedure attracts a fee or Medicare rebate.[42]

11.30 The Human Genetics Society of Australasia (HGSA) stated that:

the consequence of requiring NATA accreditation for laboratories that provide clinical genetic testing is that many tests, currently provided by non-accredited research laboratories, would no longer be available, or there would need to be technology transfer to an accredited laboratory which can then perform the test. This issue will require addressing by the proposed HGCA in consultation with the NHMRC.[43]

11.31 There is a recognised continuum between research and clinical practice.[44] It is not always clear when a genetic test performed by a pathologist is diagnostic, rather than for the purposes of research into causes of disease.[45] Genetic testing often starts in a research setting before entering the mainstream. It is important, therefore, to ensure that basic research is not impeded by imposing a requirement of NATA accreditation to the research context.[46]Another issue is whether or not an Australian laboratory that receives samples within Australia for dispatch and testing overseas needs to be accredited, even if no testing is performed on site.[47]

11.32 Submissions and consultations confirmed that the NATA laboratory accreditation system is widely recognised as an effective means of ensuring minimum standards of technical proficiency in laboratory testing. The role of the pathology accreditation system has been highlighted by recent events involving pap smear testing,[48] and is seen as a critical factor in the effective operation of national screening programs for breast, cervical and bowel cancer.[49]

11.33 Subject to the qualifications noted below, the Inquiry considers that accreditation requirements should be extended to all laboratories that conduct genetic tests for medical, diagnostic or treatment purposes. The Inquiry recognises, however, that further consideration of these issues should take place within a broader health policy context. In particular, the implications of any new accreditation legislation for research testing, and testing performed in research laboratories, would have to be carefully considered and exemptions developed in appropriate cases.[50]

Recommendation 11–1 In order to complement existing pathology laboratory accreditation arrangements, the Commonwealth, States and Territories should enact legislation to require laboratories to: (a) be accredited for any genetic test that they conduct for medical, diagnostic or treatment purposes; and (b) comply with the relevant accreditation standards. The legislation should make provision for exemptions in appropriate circumstances, such as for genetic tests performed by research laboratories.

[3] There are currently 506 accredited laboratories in the field of medical testing and 30 laboratories in the field of forensic science. Of these, 55 laboratories are accredited for genetic testing, nine for forensic DNA typing, and nine for parentage testing: National Association of Testing Authorities, Consultation, Sydney, 19 November 2002.

[4] National Association of Testing Authorities, Memorandum of Understanding between the Commonwealth of Australia and the National Association of Testing Authorities, Australia, <www.nata.asn.au/
downloads/moa3-98.pdf>, 20 February 2003.

[5] NATA website: National Association of Testing Authorities Australia, Government Requirement for NATA, <www.nata.asn.au/govt_reg/govreq2.htm>, 20 February 2003.

[6] NPAAC was established to make recommendations to the Commonwealth, States and Territories on matters relating to the accreditation of pathology laboratories and the maintenance of uniform standards of practice in pathology laboratories throughout Australia. See National Pathology Accreditation Advisory Council, Functions, <www.health.gov.au/npaac/functions.htm>, 20 February 2003.

[7] Corrs Chambers Westgarth, Evaluation of the Australian Pathology Laboratory Accreditation Arrangements (2002), Department of Health and Ageing, Canberra, 3.

[8] Health Insurance Act 1973 (Cth) s 16A(2).

[9] See Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999 (Cth). The Principles are determined by the Minister for Health and Ageing under the Health Insurance Act 1973 (Cth) s 23DNA.

[10] Corrs Chambers Westgarth, Evaluation of the Australian Pathology Laboratory Accreditation Arrangements (2002), Department of Health and Ageing, Canberra, Rec 2.1. Some problems were identified, including difficulties associated with efforts by the HIC to enforce compliance with NPAAC standards and the fact that the Commonwealth can only indirectly regulate pathology services through its administration of the Medicare Benefits Scheme, leaving unregulated some services that operate outside this framework. A number of strategies addressing all aspects of the accreditation system were recommended to strengthen the system.

[11] Ibid, 5.

[12] National Pathology Accreditation Advisory Council, Standards for Pathology Laboratories (2002), Department of Health and Ageing, Canberra.

[13] National Pathology Accreditation Advisory Council, Quality Systems for Medical Laboratories (2001), Department of Health and Aged Care, Canberra; National Pathology Accreditation Advisory Council, Requirements for Supervision of Pathology Laboratories (1999), Department of Health and Aged Care, Canberra.

[14] See Corrs Chambers Westgarth, Evaluation of the Australian Pathology Laboratory Accreditation Arrangements (2002), Department of Health and Ageing, Canberra, 6. These standards have been developed with reference to current Australian and other international standards including National Association of Testing Authorities (Australia), AS ISO/IEC 17025: 1999 Australian Standard: General Requirements for the Competence of Testing and Calibration Laboratories (1999), NATA, Sydney.

[15] For example, National Pathology Accreditation Advisory Council, Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques (2000), Commonwealth of Australia, Canberra; National Pathology Accreditation Advisory Council, Guidelines for Cytogenetics Laboratories (2001), Department of Health and Aged Care, Canberra.

[16] In relation to medical testing: National Association of Testing Authorities Australia, ISO/IEC 17025 Application Document: Supplementary Requirements for Accreditation in the Field of Medical Testing (2000), National Association of Testing Authorities, Australia.

[17] Ibid.

[18] National Association of Testing Authorities Australia, ISO/IEC 17025 Application Document: Supplementary Requirements for Accreditation in the Field of Forensic Science (2000), National Association of Testing Authorities, Australia.

[19] Ibid [5.4.1]. See B Atchison and N Redman, ‘Interpreting DNA Evidence in Paternity Cases’ (2000) 32 Australian Journal of Forensic Sciences 75.

[20] National Association of Testing Authorities Australia, ISO/IEC 17025 Application Document: Supplementary Requirements for Accreditation in the Field of Forensic Science (2000), National Association of Testing Authorities, Australia, Sec 3, Pt B Supplementary Requirements for Accreditation: Parentage Testing [5.10.2(a)].

[21] National Association of Testing Authorities Australia, Correspondence, 12 April 2002.

[22] See National Pathology Accreditation Advisory Council, Standards for Pathology Laboratories (2002), Department of Health and Ageing, Canberra.

[23] Cancer Council Victoria Cancer Genetics Advisory Committee, Submission G195, 27 November 2002; Australian Medical Association, Submission G212, 29 November 2002; D Ackermann and others, Submission G220, 3 December 2002; National Legal Aid, Submission G314, 19 February 2003; Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Submission G281, 24 December 2002.

[24] Centre for Genetics Education, Submission G232, 18 December 2002; Centre for Law and Genetics, Submission G255, 21 December 2002; Royal College of Pathologists of Australasia, Submission G287, 23 December 2002.

[25] Human Genetics Society of Australasia, Submission G050, 14 January 2002.

[26] Recommendation 35–1. The Inquiry also recommends that forensic analysis of genetic samples should be conducted only by laboratories accredited by NATA in the field of forensic science (Recommendation 41–7).

[27] Corrs Chambers Westgarth, Evaluation of the Australian Pathology Laboratory Accreditation Arrangements (2002), Department of Health and Ageing, Canberra, i.

[28] See Pathology Services Accreditation Legislation Review, Review of the Pathology Services Accreditation Act 1984: Discussion Paper (2002), Department of Health and Human Services (Vic), Melbourne, 15.

[29]Pathology Services Accreditation Act 1984 (Vic). The Board’s functions include accrediting and registering pathology services; making recommendations to the Minister on proposals for regulations pertaining to matters such as minimum qualifications required for the person in charge of each category of accredited pathology service and any person conducting tests, minimum standards required for the conduct of tests; and making recommendations to the Minister about which tests should be prescribed as exempted tests and non-regulated tests: s 9.

[30] Pathology Services Accreditation Legislation Review, Review of the Pathology Services Accreditation Act 1984: Discussion Paper (2002), Department of Health and Human Services (Vic), Melbourne, 17.

[31] Corrs Chambers Westgarth, Evaluation of the Australian Pathology Laboratory Accreditation Arrangements (2002), Department of Health and Ageing, Canberra, 5.

[32] Ibid, Rec 2.2.

[33] Senator the Hon Kay Patterson, ‘Enhanced Pathology Laboratory Testing Standards to Protect Public Health and Safety’, 29 August 2002.

[34] Commonwealth Department of Health and Ageing, Submission G313, 6 February 2003.

[35] Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, DP 66 (2002), ALRC, Sydney, Question 5–1.

[36] Cancer Council Victoria Cancer Genetics Advisory Committee, Submission G195, 27 November 2002; Australian Medical Association, Submission G212, 29 November 2002; D Ackermann and others, Submission G220, 3 December 2002; Centre for Genetics Education, Submission G232, 18 December 2002; Centre for Law and Genetics, Submission G255, 21 December 2002; Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Submission G281, 24 December 2002; Genetic Support Council WA, Submission G243, 19 December 2002; Anglican Diocese of Sydney, Submission G256, 20 December 2002; Royal College of Pathologists of Australasia, Submission G287, 23 December 2002; Association of Genetic Support of Australasia, Submission G284, 25 December 2002; Law Institute of Victoria, Submission G275, 19 December 2002. The HGSA did not consider that specific legislation was necessary to enforce accreditation requirements: Human Genetics Society of Australasia, Submission G267, 20 December 2002; National Legal Aid, Submission G314, 19 February 2003.

[37] NSW Health Department, Submission G303, 13 January 2003.

[38] Ibid.

[39] Cancer Council Victoria Cancer Genetics Advisory Committee, Submission G195, 27 November 2002; Children's Cancer Institute Australia, Submission G221, 29 November 2002; Victorian Breast Cancer Laboratory — Walter and Eliza Hall Institute of Medical Research, Submission G258, 20 December 2002; Human Genetics Society of Australasia, Submission G267, 20 December 2002; Department of Health Western Australia, Submission G271, 23 December 2002.

[40] Department of Health Western Australia, Submission G271, 23 December 2002.

[41] Cancer Council Victoria Cancer Genetics Advisory Committee, Submission G195, 27 November 2002. Similar concerns about the accreditation of research testing were also expressed in consultations: Children’s Hospital at Westmead, Consultation, Sydney, 19 November 2002; Royal College of Pathologists of Australasia, Consultation, Sydney, 18 November 2002.

[42] Children's Cancer Institute Australia, Submission G221, 29 November 2002.

[43] Human Genetics Society of Australasia, Submission G267, 20 December 2002.

[44] Royal College of Pathologists of Australasia, Consultation, Sydney, 18 November 2002. See also Australian Academy of Science, Submission G097, 21 January 2002; Australian Society for Medical Research, Submission G124, 18 March 2002.

[45] Royal College of Pathologists of Australasia, Consultation, Sydney, 18 November 2002.

[46] Victorian Breast Cancer Laboratory — Walter and Eliza Hall Institute of Medical Research, Submission G258, 20 December 2002; Department of Human Services South Australia, Submission G288, 23 December 2002.

[47] Cancer Council Victoria Cancer Genetics Advisory Committee, Submission G195, 27 November 2002.

[48] Senator the Hon Kay Patterson, ‘Press Release: Victorian Women Can Have Confidence in Checks for Cervical Cancer’, 7 March 2002.

[49] Senator the Hon Kay Patterson, ‘Enhanced Pathology Laboratory Testing Standards to Protect Public Health and Safety’, 29 August 2002.

[50] For example, the Pathology Services Accreditation Act 1984 (Vic) allows the Pathology Services Accreditation Board (PSAB) to exempt certain tests performed by medical practitioners from accreditation requirements and for pathologists (or other specialist medical practitioners) to perform tests which are not exempted, provided that the tests and the laboratory in which the tests are performed have been approved by the PSAB: Pathology Services Accreditation Act 1984 (Vic) s 30(2)(a); s 30(4). The Victorian legislation defines a ‘pathology service’ as ‘a service in which human tissue, human fluids or human body products are subjected to analysis for the purposes of prevention, diagnosis or treatment of disease in human beings and includes any premises from which a service is conducted’: Pathology Services Accreditation Act 1984 (Vic) s 3. This definition would include a research laboratory that performs medical testing on an ad hoc basis.