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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
RCPA Quality Assurance Programs Pty Ltd
Please identify the best term to describe the Organisation: 
Commercial company
Personal Details
Specific Comments

The term Quality Improvement (QI) describes a series of internal processes to improve patient and population outcomes and health service efficiency. The document states that this is also known as 'Quality Assurance'. This use of this alternate name could lead to ambiguity in the area of laboratory medicine, as 'Quality Assurance' is used as an alternative name for External Quality Assessment (EQA), which is a mandatory and critically important component of laboratory accreditation under ISO and NPAAC Standards. It is important to clearly discriminate between the QI activities which are the subject of these draft guidelines, and the process of EQA and the requirements to provide appropriate material to test the proficiency of laboratories.

Research merit and integrity, justice, beneficence and respect

There is a strong rationale for EQA to be differentiated from the processes of research involving humans, and from quality improvement activities. Organizations that provide EQA (sometimes known as Proficiency Testing providers) operate under a specific international standard (ISO/IEC 17043:2010 Conformity Assessment - general requirements for proficiency testing). This international standard to which EQA providers are accredited requires high levels of control and accountability in specimen selection and management.


General Comments

Diagnostic laboratories within Australia are required under Medicare legislation to participate in ongoing EQA activities for all tests for which they reduce results, and the sheer number of such tests performed in the average pathology laboratory makes the acquisition of the range of EQA test materials a constant ongoing challenge. In many cases this material is sourced from pathology laboratories prior to the routine discard of excess specimens taken in the course of routine pathology investigations. It would not be practical or even possible for an EQA provider to obtain individual consent from each individual whose speciment is being used for the purposes of EQA. The identity of the donors of these specimens is never recorded, but on occasions some de-identified demographic data may be recorded for the purposes of providing a clinical scenario similar to what may be found on a pathology request form. The critical importance of EQA and the issues described above were recognised during the drafting of amendments to the NSW Human Tissue Act, where a specific exclusion was created for the use of human tissue and equivalent clinical material. The NSW Director General of Health summarised these in a set of Guidelines for health staff -

Guideline Title: Human Tissue: Requirements of the Human Tissue Act 1983 in Relation to Research and

Use of Tissue



35. Additional amendments to the Human Tissue Act to facilitate the use of

tissue samples for the purpose of carrying out analyses or tests

commenced on 1 January 2006.


36. These changes allow small tissue samples which have been lawfully

removed from living or deceased persons to be used without consent for

the purposes of carrying out analyses or tests:

  • that are part of a program (including any quality assurance program,

quality control program, audit or evaluation) to ensure, or improve, the

quality of services carried out at or by a hospital, a forensic institution,

a laboratory, an educational or research institution or a supplier of

blood or blood products


The special and unique requirements for EQA specimens has been recognised by the NSW Government in their Human Tissue Act, and exempted from the provisions of the Act. The current wording of these NHMRC guidelines runs the risk that if EQA activities are not differentiated from research and internal QI activities, there will be a direct conflict with the NSW Act. If there was a requirement for informed consent to be obtained for every EQA specimen, it would not be possible for an Australian EQA provider to continue to provide EQA Programs for Australian laboratories. These laboratories are required to perform EQA to achieve and maintain accreditation, which is a requirement under Medicare legislation. For these reasons it is logical and important that the NHMRC guidelines treat EQA specimens in a manner consistent with that in the NSW Human Tissue Act, and I recommend that these activities be differentiated  and formally exempted from the guidelines.

Page reviewed: 17 June, 2013