National Ethics Advisory Committee
Kāhui Matatika o te Motu
Quality improvement (QI) is an umbrella term that refers to a range of activities. Quality improvement activities involve cycles of change that are linked to measurable assessment, with the goal of improving the experience, process, safety and efficiency of health care. For an activity to be considered quality improvement, it must not be conducted to generate evidence to support an intervention’s efficacy, but it can involve evaluating and changing practice (Provost and Murray 2011).
In QI, generally the focus is on system functioning rather than the individual. These standards supplement guidance provided by regulatory bodies, which take precedence. Researchers, health and disability care providers and health care institutions should consider the ethical dimensions of quality improvement because:
18.1 Service providers should inform the public that quality assurance and improvement activities are essential for the high-quality delivery of health or disability services, and that consumers’ information may be used for such activities.
18.2 Privacy and confidentiality need to be protected except in circumstances of overriding concern, where release of information is required for reasons relating to public health or the safety of an individual.[1]
18.2.a Any identifiable information pertaining to individuals should always be stored securely, and accessible only to the defined project team.
18.3 The potential gains from a quality improvement activity should justify the resources spent and the risks imposed on participants
18.4 A quality improvement activity should be methodologically sound (ie use improvement science and methodology).
18.5 A quality improvement activity should be designed to limit risks while maximising potential benefits.
18.6 QI activities should be transparent, and the results shared appropriately within the organisation.
18.7 Quality improvement results should be freely shared with others in the health care system, but participant confidentiality should be protected by putting results into non-identifiable form.
18.8 Each quality improvement activity should receive consideration of ethics and or supervision that is appropriate to its level of risk.
18.8.a Service providers should periodically review risk control measures to ascertain whether the implemented quality management activities remain effective and relevant, taking into account emerging knowledge and experience.
| QI ethical risk factor |
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QI activities are generally low risk. Some factors that may increase ethical risk are when:
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It is critical to consider whether a quality improvement project is going to involve a significant change in the standard or nature of clinical care and, if so, how firm the grounds are for expecting that this change will constitute an improvement, or at least not cause harm, from the participant’s perspective.
Where proposed changes or other quality improvement activities are based on national and internationally recognised best practice standards (e.g. they use a recognised quality improvement methodology), ethical considerations still apply, but it is likely that implementation may proceed as part of quality improvement, as opposed to research.
When an activity tests a new, modified or previously untested intervention, service, process or programme on participants, and there is insufficient evidence to determine whether this untested aspect is safe or effective, the activity may be defined as research involving humans, and ethical Standards for research processes apply.
18.9 Where standard of care is changed based on national and international best practice, and this change is made at a system level (e.g. changing a standard practice across a district health board) to improve outcomes, specific individual consent is not required for the specific change, but routine patient consent will still be required to treat individuals.
18.9.a Prior to implementing a full system level change, best practice involves multiple Plan Do Study Act (PDSAs) small scale tests first. The end could result in a significant change, however the PDSAs are conducted to test amongst other things make sure that the change is not detrimental from the patient’s perspective and staff too.
18.10 Increased ethical oversight and specific informed consent for the QI activity is required where there is a change in the standard of care for the purposes of piloting a new approach that does not have clear evidence of benefit in a similar population, or if the change is being made solely to improve efficiency or otherwise benefit the health care provider, with potential adverse effects for consumers.
When a particular quality improvement activity poses risk, patients must be provided with sufficient information in an environment free of undue pressure in order to enable them to decide whether they wish to be involved – that is, to give their informed consent (Code of Health and Disability Services Consumers’ Rights 1996) – just as they do in the context of clinical care or research. See ‘Informed consent’ for more information.
18.11 Participants should be asked for their informed consent if a quality improvement activity imposes more than minimal risk, as defined by categories of risk in these Standards. See Categories of Risk for more information.
18.11.a See Identifying risk factors in QI for features that may increase risk in quality improvement.
18.12 Informed consent should be obtained where practicable prior to commencing QI activities, preferably in writing. Verbal consent and discussions related to written consent should be documented.
18.13 Information provided about quality improvement activities must be clear and understandable.
18.14 Consumers should have an opportunity to ask questions, and to reflect on their potential involvement and what it would mean for them.
18.15 QI activities should always be conducted with transparency to patients, regardless of whether consent is obtained.
Quality Improvement activities should be determined using improvement science to ensure a strong evidence base. Tools for quality improvement include Shewhart Charts, driver diagrams, Quality Improvement Cycles (Plan, Do, Study, Act-PDSA), Clinical Audit, Evaluation and Programme evaluation studies, Experience Capture tools i.e. interviews and focus groups. Many of these tools are commonly used across both Research and Quality Improvement, which again illustrates the importance of ensuring good ethical practice when using these tools regardless of the context in which they are being applied.
Some recent examples of quality improvement activities are:
Clinical audit is a common tool for both Quality Assurance and Quality Improvement activities. Clinical audit is defined as the systematic peer evaluation of an aspect of patient care. The process may be multidisciplinary, and involves a cycle of continuous improvement of care based on explicit and measurable indicators of quality that include a service user perspective.
Clinical audit involves investigating whether an activity meets explicit standards, as defined from national or international standards, policies, guidelines, or best practice reviews, for the purpose of checking and improving the activity audited. An audit generates knowledge for the situation in which it was undertaken, rather than generalisable knowledge. It should provide feedback primarily to the local setting or particular service involved, although it may also involve a wider dissemination by way of publication or presentation of its findings.
Healthcare providers should restrict access to personal health information to those who the healthcare provider employs or contracts, the funder of the service and agencies responsible for overseeing the safety and quality of the service. Such information should be used solely for the purpose of auditing a service.
In addition, clinical audit is often used interchangeably with other non-research activities such as service evaluation and outcome analysis. Briefly, clinical audit measures practice against a standard, service evaluation measures current practice of ‘how much, how many and how well’ of the service, while outcome analysis looks at outcomes of practice focussing often on management and complication rates. Specifically, outcome analyses are conducted on activities already being undertaken and does not provide new knowledge for an intervention where no knowledge exists in that area[4].
Some examples of audits and related activities are:
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Audits may present more than minimal risk if:
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18.16 Health service providers should ensure that the audit and audit-related activities they undertake have the potential to improve health outcomes.
18.17 People conducting audits or related activities must operate under professional standards or employment requirements that oblige them to maintain the confidentiality of patient data.
18.18 Audits should be conducted by people under a professional or an employment obligation, or student candidates, to maintain patient confidentiality. Such activity may be initiated from outside the organisation or by the organisation itself, and may be conducted by the organisation (an internal audit or related activity) or by a contracted party external to it (an external audit or related activity). Services should restrict access to confidential medical and personal information to those individuals the service provider employs or contracts, the funder of the service and agencies responsible for overseeing the safety and quality of the service. Such information should be used solely for the purpose of auditing a service.
18.19 It may be ethical to use health information without additional or specific consent for the purpose of audits and related activities, as these activities are sometimes an essential part of high-quality health care delivery and may be one of the reasons why the data were collected.
18.20 In the case of audits and related activities, the use of record linkages within organisations without specific or additional consent is ethically justifiable when these activities are part of high-quality health care delivery[5].
18.21 When the activity involves disclosure, it must be part of a professionally recognised external quality assurance programme in order to permit the disclosure of the person’s health information[6].
18.22 Health service providers should ensure that they comply with internal organisational requirements in respect of all audits and related activities that they conduct in or through the organisation.
18.22.a The appropriate approach will vary from organisation to organisation; as such, organisations might also specify their own processes regarding notification or approval of audits and related quality activities.
18.23 An audit requires ethical review if it involves the use, collection or storage of human tissue without consent, other than in accordance with a statutory exception (set out at section 20(f) of the Human Tissue Act 2008(external link) and Right 7(10)(c) of the Code of Health and Disability Services Consumers’ Rights 1996(external link)).
Evaluation studies aim to determine the relevance, effectiveness and impact of activities in the light of their objectives. They may evaluate the structure, process or outcome of an activity.
Programme evaluation focuses on a whole programme, rather than specific interventions, where the sole purpose of the exercise is to refine and improve the programme or monitoring. At a minimum, the description of a programme evaluation should convey the idea that evaluation assesses the value of a programme as a whole in order to refine, improve or possibly cease it.
If a programme was not originally designed based on robust evidence,[7] there are often significant uncertainties as to the benefits and harms posed by its active components (specific interventions).
18.24In this case, programmes and subsequent programme evaluations may be considered as research.
Health care organisations that conduct quality assurance and improvement activities are accountable for the ethical conduct of those activities and must ensure there is appropriate ethical oversight for activities in relation to their risk (Lynn et al 2007). Organisations should consider the following, alongside the obligations of individual practitioners:
18.25 Practices that ensure accountability for the ethical conduct of quality improvement should be integrated into practices that ensure accountability for clinical care.
18.26 Regulatory institutions[8] should inform members about their professional responsibility to improve quality, identify the basic quality improvement skills members should have, educate members about standards for ethical conduct of quality improvement and incorporate quality improvement into professional codes of ethics.
18.27 Health service providers should inform members about their responsibility to improve quality, the need to ensure that their employees have basic quality improvement skills and the standards for ethical conduct of quality improvement.
18.28 Leaders in professional education should press for greater emphasis on the responsibility of health professionals to improve the quality of care and the development of quality improvement skills in educational curricula, including management of the ethical dimensions of quality improvement.
18.29 Service providers should tell people seeking health care why quality improvement activities are important to the quality of their care, and how to obtain more information about quality improvement programmes if they want it.
18.30 Health care organisations should develop patient education materials about patient rights and responsibilities with respect to quality improvement and the conduct of quality improvement within the organisation.
18.31 Arrangements for deciding which quality improvement projects qualify as human research, and should therefore have increased ethical oversight, should be tested in practical application, aiming to implement clear definitions and accepted procedures.
[1] See Health Information Privacy Code for relevant circumstances.
[2] These Standards have been developed on the basis of Lynn et al 2007.
[3] Code of Rights right 7(10).
[4] For more information please see Towards Clinical Excellence – Ministry of Health(external link) (2002).
[5] Quality audits, including those activities that involve linking data, must fall under a directly related purpose of the information collected. See Health Information Privacy Code(external link) for more information.
[6] See Rule 11 of the Health Information Privacy Code(external link).
[7] For example, evidence that is generated from studies that have a priori criteria, an objective process, transparent, reproducible, using validated methods to distinguish high vs. low quality evidence and draws conclusions based on the body of evidence and its limitations.
[8] See the Medical Council of New Zealand website(external link) for examples
