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Plenary Session: Standards & Assessment Within A Quality Framework

Page last updated: 07 November 2011

Quality in Pathology: An Overview

Dr Michael Harrison

Chief Executive Officer and Managing Partner, Sullivan Nicolaides Pathology

Australian pathology has a long history of quality assessment measures and accreditation. Accreditation and standards setting commenced in the 1980s with all Australian pathology laboratories becoming accredited in 1987. Specific standards used in the accreditation process are developed by a legislatively defined professional committee system and the accreditation process for medical testing is undertaken by a joint program of NATA and the Royal College of Pathologists of Australasia. International standards are also used in the process along with highly developed quality assurance programs and quality control measures used in laboratories. In addition, laboratories have quality systems which are also accredited. These processes have ensured the Australian people are serviced by pathology laboratories, both public and private, which provide services at a reliable and good standard.
Radiation Oncology now has the practice standards developed by the Triapartite Committee. What can be learned from other sectors about models for implementation and evaluation? Dr Harrison’s presentation highlighted the following:
  • Pathology has had accreditation in Australia for approximately 26 years.
  • Quality care is getting things right. The challenge is getting everyone to agree what right is.
  • An optimist sees the opportunity in every difficulty. An accreditation process is a difficult process. Instead of focusing on the problems associated with bringing changes to the system, recognise problems with the existing system and how the changes will improve that system.
  • Role of NATA & The Royal College of Pathologists (RCPA) in Pathology Accreditation:
    • They work with NATA, a not for profit organisation, that assesses organisations and accredits them
    • NATA provides secretariat, lead assessors, and infrastructure of the assessment process
    • RCPA provide professional advice and help recruit voluntary assessors and provide mechanisms for review of fellows if necessary.
  • Prior to 1986 pathology accreditation was voluntary. Since then it has become a mandatory scheme linked through the Health Insurance Act to the payment of Medicare Benefits. A laboratory does not have to be accredited, but if a laboratory is not accredited then the pathology services provided are not eligible for Medicare benefits.
  • Medicare Australia has a significant administrative role:
    • Reports are issued to Medicare Australia following each assessment activity
    • Laboratories are responsible for submitting assessment reports to Medicare to get accredited
    • Benefits cannot be paid until an assessment report is provided and Medicare accredits the organisation on the basis of this assessment.
    • Renewal requires successful reaccreditation.
  • National Pathology Accreditation Advisory Council (NPACC) has a philosophy which is that it pitches standards and guidelines at an aspirational level. Elements in the guidelines ask laboratories to stretch themselves to the next level.
  • It focuses on safety, quality, professionalism, medical and scientific excellence.
  • There is a document hierarchy for NPAAC standards:
    • Tier 1, which is the general principles document, are set out in the Health Insurance Act
    • Tier 2 are standards and supervisory requirements for pathology laboratories
    • Tier 3 are requirements for good medical practice in all pathology laboratories
    • Tier 4 are specific requirements for certain types of individual laboratory
    • Tier 5 are supporting documents and endorsed third-party documents
    • Tier 6 are other documents of interest.
  • Pathology accreditation process:
    • Assessments are at least once every three years. Some laboratories will get assessed more than once every three years if they have a poor history or if there are any major changes to technology and senior staff
    • For a full assessment there is a panel of people, which includes peer assessors
    • It is a one-day assessment process for each laboratory. At the end of this process there is an exit interview and an accreditation report is prepared. The reports are intended to be educative as well as advise on compliance.
  • The detailed accreditation report contains:
    • Conditions that must be addressed for accreditation
    • Minor conditions that must be addressed as a condition of accreditation
    • Observations that are suggestions for improvement.
  • Any lab can respond at any point, either by compliance, correction or to argue the case.
  • The Australian pathology accreditation system has produced excellent outcomes at a reasonable cost.

Panel Discussion: What Determines Quality Health Care & How Can We Measure It?

Panel Members included:

Dr Michael Harrison

Chief Executive Officer and Managing Partner, Sullivan Nicolaides Pathology

Associate Professor Rosemary Knight

Principal Adviser, Population Health Division, Department of Health and Ageing

Associate Professor Christopher Milross

Chair of the Tripartite Committee; Dean of The Faculty of Radiation Oncology, RANZCR; Director of Radiation Oncology, Royal Prince Alfred Hospital

Ms Sue Sinclair

General Manager Service Delivery & Clinical Practice, Cancer Australia, Cancer Australia

Professor Margaret Banks

Senior Programs Adviser, Australian Commission on Safety and Quality in Health Care

The purpose of the panel discussion was to draw on the expertise of panel members and facilitate a broader consideration of what is already being done and what could be done to assure the quality of cancer services and in the context of the symposium, the quality of radiation oncology services. The following key points were raised during the panel discussion.
  • Pathology standards have evolved over time from ‘shoulds’ to ‘musts’ and have become more restrictive. They do, however, create a level playing field.
  • The quality standards and a system for measuring the extent to which people meet those standards is only one part of determining quality radiation oncology service (e.g. other examples or regimes include publishing departments clinical trial rates and indirectly by looking at staff turnover rates).
  • If part of accreditation is having robust quality systems and fast responses then a requirement is being responsive to adverse events.
  • Period of consultation of the options paper is to September 16, a quick turn around for such an important topic.
  • Consultation about the options paper is intended be a two phase process:
    • First seek the general opinion of stakeholders
    • Once these come they will consider a number of different models and do analysis on the costs associated with each one.
  • The total cost of accreditation should be commercially feasible.
  • Quality healthcare should occur at the patient, provider and system level.
  • Consider how the standards will be implemented. Will it be mandatory? If it isn’t people will not have a level playing field as the good centres will do it well and the bad centres may not follow suit.
  • It is important to accrue participation in clinical trials for free to ensure you get a quality program.
  • There are minimal standards, but they are not trivial.
  • Need to see measurement at a patient level so the consumer’s experience can be understood.
  • Develop guides in the national standards that include a patient participation standard with a requirement for consumer engagement as part of that.

Release of “Longer Term Conformity Assessment of Radiation Oncology Practice Standards” Option Paper (July 2011)

Mr Leigh Smith

Chief Radiation Therapist, William Buckland Radiotherapy Centre, The Alfred Hospital
Chair, RORIC Quality Working Group

Much has been achieved in radiation oncology in the almost ten years since the Baume Report. Along with the opening of the Australian Clinical Dosimetry1. In this instance, the ACDS is checking doses emitted from linear accelerators. Service (ACDS) this year, the publication of the Standards by the Tripartite Committee is a significant milestone in the development of a quality framework for radiation oncology. The Standards are an important guide to good practice and a valuable quality assurance and quality improvement tool particularly for those involved in establishing, staffing and operating new or expanded regional cancer centres.

Now that the Standards are published it is important to consider how the Standards might be implemented and measured in the long term. These considerations should recognise that many radiation oncology facilities already participate in accreditation, certification and quality improvement processes and it might be possible to incorporate the radiation oncology practice standards into an existing program, or to recognise such a program as part of any assessment of them.

An Options Paper outlining possible approaches to assessing conformity with the radiation oncology practice standards was released in this session for consultation. The paper has been prepared by the Radiation Oncology Reform Implementation Committee’s Quality Working Group which is hosting the Symposium. As outlined in the paper, there is a range of approaches to conformity assessment that vary in their level of prescription, governance and approach to assessment. Conformity assessment can be considered along a spectrum, from voluntary self-assessment overseen by the professional bodies, to formal or legislative compliance obligations with government or regulator oversight.
  • Comments are sought on a self regulation or mandatory regulation model in regards to:
    • Governance
    • Assessment type
    • Participation.
  • Different models come with heavy and light costs.
  • The Options Paper is seeking comment and no model is set in stone. The options paper is available on the department’s website and it is important that people read it and give feedback.


1 The measurement of doses of ionising radiation. In this instance, the ACDS is checking doses emitted from linear accelerators.