Reform of accreditation standards

11.34 A related issue concerns the extent to which accreditation standards should address ethical concerns, as well as the technical proficiency of the testing process. Should accreditation standards seek, for example, to ensure that individuals who are subjected to genetic testing are adequately informed about any risks associated with the test and the implications of the test result and have the opportunity to be referred to genetic counselling? DP 66 noted that accreditation standards do not generally address issues of consent, although in the case of parentage testing for family law proceedings they may do so indirectly.^[51]

11.35 Submissions and consultations raised concerns about whether accreditation standards provide adequate ethical safeguards. Many observed that the current accreditation standards do not address issues such as privacy, informed consent, access to counselling or chain of custody—rather they operate on ‘the purely technical level of laboratory procedures’.^[52] There was broad support in submissions for augmenting accreditation standards to deal better with consent and other ethical concerns.^[53]

Relevant NPAAC Standards

11.36 NPAAC’s Standards for Pathology Laboratories,^[54]which came into effect on 1 January 2003, include general standards on laboratory ethics and informed consent.^[55] In addition, NPAAC accreditation standards applying specifically to genetic medical testing contain sections relating to ethical concerns. As noted above, pathology laboratories must adopt NPAAC standards in order to be accredited by NATA.

11.37 NPAAC’s Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques (the NPAAC Nucleic Acid Detection Standards) contain provisions concerning consent and counselling in genetic testing. These standards draw a distinction between two broad classes of medical genetic testing—‘Class A: Diagnostic Genetic Tests’ and ‘Class B: Predictive, Carrier and Prenatal Genetic Tests’.^[56]

11.38 The NPAAC Nucleic Acid Detection Standards provide that Class A tests

require verbal consent of the individual being tested (or legal guardian) and do not require specific pre-test counselling for genetic disease. Tests in this class are appropriate for access by the health professionals providing patient care.^[57]

11.39 In contrast, Class B tests

would typically be the province of a specialist laboratory working in close association with a number of specialist referrers. The tests in this category … require formal consent, pre- and post-test counselling, confidentiality procedures, and close dialogue between laboratory and clinical services.^[58]

11.40 Under the the NPAAC Nucleic Acid Detection Standards, laboratories have ethical responsibilities where requests for specialised testing (Class B tests) are

initiated by a health professional unlikely to be familiar with the complexities of the diagnosis, or where a person directly seeking genetics advice has initiated a request for testing without consultation with an appropriate health professional.^[59]

11.41 In these circumstances it is the responsibility of the laboratory director to ensure laboratory practice is consistent with accepted ethical guidelines.^[60] Furthermore, where there are reasonable grounds for believing that informed consent may not have been given, appropriate care (which might include counselling) has not been available, or patient confidentiality may have been breached, the laboratory is obliged to contact the referring practitioner ‘to ensure that informed consent is obtained prior to laboratory testing and provide the practitioner with information regarding how to access genetic services in the region’.^[61] The NPAAC Nucleic Acid Detection Standards also provide that laboratories

shall not provide genetic testing for any patient-initiated service, such as mail-order testing or shop-front testing, which does not occur in the context of a clinical service that provides for appropriate genetic counselling.^[62]

11.42 DP 66 proposed that NPAAC should inquire into whether accreditation standards should ensure that laboratories conduct genetic testing only on bodily samples collected with the consent of the individual to whom the sample relates or as approved by a Human Research Ethics Committee.^[63]

11.43 The Cancer Council of Victoria Cancer Genetics Advisory Committee agreed that NPAAC should amend its standards to make it a requirement for laboratories to conduct genetic tests only when consent has been obtained or waived.^[64] However, the Committee noted that, at present, only predictive genetic tests currently require written consent, as well as pre- and post-test counselling. It stated that:

if recommendations are to be made to NPAAC to amend its standards, then further thought needs to be given whether this applies to all genetic tests and if not which tests.^[65]

11.44 The Centre for Genetics Education noted that in the health care setting a patient may often not provide written consent to a diagnostic test but consent will be assumed by the fact of having consulted a health professional.

[I]t will be important in the areas of carrier and predictive testing however that the consent is informed and therefore it may be appropriate for the HGCA to be involved in the development of consent forms developed for national use …^[66]

11.45 Submissions expressed particular concern about the possible scope of obligations placed on laboratories to ensure that proper consent processes have been followed.^[67] HGSA’s view was that the onus for demonstrating that appropriate informed consent has been obtained should ‘rest with the managing clinician, rather than the laboratory’.

From the laboratory’s point of view, it should be sufficient to have evidence, for example as a marked box on the test request form that the clinician considers that appropriate consent has been obtained.^[68]

Inquiry’s views

11.46 While the primary focus of laboratory accreditation should be on technical proficiency and scientific reliability, the Inquiry considers that NPAAC should continue to include ethical considerations within its genetic testing accreditation standards. In this context, the RCPA submitted that:

international laboratory standards appear to be moving in the direction of inclusion of Ethics within Laboratory Standards, and the College is supportive of such moves. The peak body that would need to embrace the inclusion of an Ethics framework within Australian laboratory practice would be NPAAC, and the College would be supportive of any moves in this direction.^[69]

11.47 To this end, NPAAC should promulgate similar policies in other standards that are relevant to genetic testing laboratories, such as the NPAAC Guidelines for Cytogenetics Laboratories.^[70]

11.48 In Chapter 23 the Inquiry recommends that the Human Genetics Commission of Australia (HGCA) develop genetic testing and counselling practice guidelines (see Recommendation 23–3). These guidelines could identify specific genetic tests, or categories of tests, that require special consideration in obtaining informed consent or ensuring access to genetic counselling. In turn, NPAAC could ensure that their accreditation standards reflect the relevant HGCA guidelines. For example, should the HGCA recommend that a certain class of genetic test be conducted only after genetic counselling has been provided, NPAAC could ensure that accreditation standards reflect these obligations. The Inquiry also believes that it would be beneficial for such accreditation standards to be developed in consultation with the National Health and Medical Research Committee (NHMRC).

11.49 In addition, the Inquiry considers that NPAAC, in consultation with NATA and the RCPA, should consider how compliance with ethical accreditation standards should be assessed as part of the NATA/RCPA accreditation process. The means of verifying compliance with these considerations should be emphasised as part of training programs for NATA officers and peer assessors conducting assessments of laboratories.