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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
33
This submission reflects the views of
Organisation Name: 
ACSQHC
Please identify the best term to describe the Organisation: 
Other
Personal Details
Specific Comments
Comments: 
Institutional governance for QI

Quality improvement activities are an expected routine part of health care delivery within an organisation and a part of the professional responsibilities of health care professionals.  The review and oversight required for these activities is best provided within the clinical governance framework of an organisation rather than being considered as a separate activity that should be considered under a research framework by a Health Research Ethics Commttee.  The National Safety and Quality Health Service Standards, a mandatory requirement for acute health services and day procedure centres from January 2013, require appropriate clinical governance and oversight of health care improvement activities.

It would be useful for health service organisations and professionals to have clear and considered advice about the ethical requirements for the protection of participants in quality improvement activities, about the differentiation between quality improvement and quality improvement research, and about the specific systems and processes that should be established within each health service to ensure an appropriate degree of oversight of quality improvement activities.  The Commission would welcome the opportunity to work with the NHMRC Ethics Committee to develop such guidance.

General Comments
Comments: 

This submission from the Australian Commission on Safety and Quality in Health Care provides comment on the draft consultation document: Using the National Statement: Ethical Review of Quality Improvement Activities in Health Services.

 

The Australian Commission on Safety and Quality in Health Care

The Australian Commission on Safety and Quality in Health Care (the Commission) is an independent, statutory authority established by the Australian, State and Territory governments to lead and coordinate national improvements in safety and quality.  Initially established in 2006, the Commission was made a permanent body in 2011. Section 9 of the National Health Reform Act 2011 specifies the Commission’s functions. These include:

  • promoting, supporting and encouraging the implementation of arrangements, programs and initiatives relating to health care safety and quality matters
  • advising the Minister about health care safety and quality matters
  • formulating standards, guidelines and indicators relating to healthcare safety and quality matters
  • promoting, supporting and encouraging the implementation of these standards and related guidelines and indicators
  • advising the Minister and participating State/territory Health Ministers on which standards should be implemented as national clinical standards
  • formulating model national schemes that provide for the accreditation of organisations that provide healthcare services and relate to healthcare safety and quality matters
  • collecting analysing, interpreting and disseminating information relating to healthcare safety and quality matters
  • promoting, supporting, encouraging, conducting and evaluating research for purposes in connection with the performance of any of the Commission’s functions.

As the consultation document notes, quality improvement processes are a routine part of delivering effective health services.  They require ethical conduct, oversight and review to the same extent that is required of health care delivery and professional practice.  In contrast to research, where the primary goal is the pursuit of knowledge, quality improvement is designed to provide direct and immediate benefit to patients and the community.  Quality improvement projects are generally designed to deliver local improvements to patient care.  They involve interventions, measures and goals which are adjusted over time in response to the data that is gathered and the experience gained when undertaking the project.  Unlike research projects which have set protocols, methods and time frames, quality improvement projects need to be flexible and able to adjust to the normal processes of service delivery.  Ethical oversight of quality improvement activities should be an integral part of the management of health service organisations and of the accountability systems required for normal clinical care.   

 

The consultation document states that there is a great deal of uncertainty about the appropriate levels of governance for quality improvement activities. In 2011 Health Ministers approved a set of National Safety and Quality Health Service Standards (available from http://www.safetyandquality.gov.au/our-work/accreditation/nsqhss/). This set of Standards includes an overarching governance Standard. Acute health services and day procedure centres, both public and private, will be accredited using these Standards from January 2013 onwards.  The governance standard (Standard 1) requires that there are integrated systems of governance to actively manage patient safety and quality risks.  This includes the collection and review of performance data and undertaking regular clinical audits.  The Standard also requires that organisations establish an organisation-wide quality management system that monitors and reports on the safety and quality of patient care and informs changes in practice. There are specific requirements about patient rights and engagement, including the need for procedures that protect the confidentiality of patient clinical records. These Standards should remove any uncertainties that exist about the requirements for overarching governance and responsibility for quality improvement.

Quality improvement should be regarded as a routine part of health care delivery and as a professional and organizational obligation.  Inconvenience associated with the activity, or the burden of collecting information for quality improvement activities should not be viewed as a legitimate reason for failure to participate. 

Quality improvement activity does require sound clinical governance.  It would be helpful to have a nationally agreed set of ethical requirements for protection of participants in quality improvement activities, some guidance for identifying when activities are both quality improvement and human subjects research and some advice for health service organisations that specifically addresses approaches to implement accountability for the ethical conduct of quality improvement.  The Hastings Centre in the United States has produced a comprehensive set of papers that discuss the ethical aspects of health care quality improvement and the regulatory aspects relevant to the United States (1, 2).  This would provide a useful starting point for development of a guidance to improve practice in this area in Australia.  The Commission would welcome the opportunity to work with the NHMRC Ethics Committee to produce practical advice for health care organisations and professionals about the conduct and oversight of quality improvement activities in Australia.

 

1 Jennings B, Baily MA, Bottrell M, Lynn J (eds).  Health Care Quality Improvement: Ethical and Regulatory Issues. The Hastings Center 2007.

2 Lynn J, Baily MA, Bottrell M et al.  The Ethics of Using Quality Improvement Methods in Health Care.  Ann Intern Med 2007; 146: 666-673.

 

Page reviewed: 17 June, 2013