Introduction

Pathology testing involves many people working together to achieve an end result. Your sample can go to one or more specialist labs and be seen by specialist pathologists and scientists working with different types of sophisticated lab instruments. Often results are required as a matter of urgency. It goes without saying that safety and quality control procedures are critical.

It’s perhaps no surprise that pathology is one of the most regulated areas of medicine with multiple processes in place to ensure that laboratories produce sustainably reliable and accurate results. The federal government, professional organisations and individual laboratories themselves all play a part in ensuring quality standards are maintained.

Accreditation

What is laboratory accreditation?

For many years the critical role that pathology testing plays in diagnosis of disease has been recognised by government and strict controls and monitoring processes have evolved to ensure that the laboratories that produce these results meet the highest standards of quality and probity.

In fact it is perhaps no surprise that pathology is one of the most regulated areas of medicine with multiple processes in place to ensure that laboratories produce sustainably reliable and accurate results. The federal government, professional organisations and individual laboratories themselves all play a part in ensuring quality standards are maintainedAccreditation of Australian Pathology Laboratories is run jointly by the National Association of Testing Authorities, Australia (NATA) and the Royal College of Pathologists of Australasia (RCPA). NATA has a formal agreement with the Commonwealth Government to assess laboratories for the Health Insurance Commission (HIC).

Accreditation of Australian Pathology Laboratories is overseen by the National Pathology Accreditation Advisory Council (NPAAC) a body representing all key stakeholders in the Pathology testing including consumer representatives and all State and Territory jurisdictions.  NPAAC is appointed by and report directly to the federal minister of health and produces the Standards that all laboratories must meet to ensure Australian pathology laboratories are using the best international practices. NPAAC delegates the auditing of laboratories against these standards to the  National Association of Testing Authorities, Australia (NATA) and the Royal College of Pathologists of Australasia (RCPA). NATA has a formal agreement with the Commonwealth Government to assess laboratories for the Health Insurance Commission (HIC).

Laboratory accreditation is mandatory; laboratories must be accredited to access Medicare rebates. Assessment is to a series of standards developed by the International Standards Organisation (ISO) and the National Pathology Accreditation Advisory Council (NPAAC) in association with the various professional bodies including the:

  • Royal College of Pathologists of Australasia (RCPA)
  • Australian Medical Association (AMA)
  • Australian Institute of Medical Scientists (AIMS)
  • Australasian Association of Clinical Biochemists (AACB)
  • Australian Society for Microbiology (ASM)
  • Human Genetics Society of Australasia (HGSA)
  • Pathology Australia
  • Public Pathology Australia

Assessment for accreditation is by regular on-site audits by NATA and peer assessors. These audits are conducted by specialist technical assessors (a peer review process) and a lead NATA auditor. Accreditation is supported by the pathology community; specialist technical assessors are drawn from public and private pathology services and provide this service on a voluntary no-fee basis.

Audits

Laboratory accreditation audits

Accreditation audits examine all aspects of laboratory performance in detail.

Key areas included in audits are:

Staff qualifications, education and training
There are many different roles in laboratories, and the professional organisations and statutory bodies define the requirements for education and training of laboratory personnel. Pathologists must be registered medical practitioners with specialist qualifications in pathology. Medical scientists must have a degree in medical laboratory science or a related specialist discipline.

All staff must adhere to strict codes of conduct and ethics. Laboratory personnel must participate in continuing professional development and laboratories must demonstrate proof of on-going staff competency.

Documented procedures
To ensure that pathology results are accurate and consistent, staff must follow detailed standard procedures for each test. These standard procedures help ensure that each test is performed consistently each time, no matter which staff member performs the testing. Any change to these procedures is scrutinised during the accreditation audits.

Internal quality control
Laboratories have complex quality control processes and monitor the performance of laboratory equipment and procedures carefully. For example, laboratories test standard control samples as well as samples from patients. These control samples contain known concentrations of particular analytes, so the samples act as a built-in check that the testing process and equipment are operating correctly. Patient results are not released until these internal quality control samples have been assessed. Records of internal quality control are examined as part of the accreditation process.

External quality assurance
Laboratories are required to participate in external quality assurance programs for each type of test performed. In these programs, an independent external body sends samples to laboratories for testing. The external body knows the levels of the particular analytes in the samples – e.g. cholesterol level – but the laboratory does not. The laboratory tests the samples in the same way as patient samples and then submits the results to the external body for review.

The external body provides composite reports to all participating laboratories comparing their results to results of other laboratories in Australia. These reports are reviewed by technical assessors at accreditation audits. 

Performance monitoring and improvement
Laboratories proactively monitor the quality and effectiveness of their internal processes and seek to continually improve the service they provide to patients and doctors.

This is done by a variety of means including internal auditing, risk identification and management, incident reporting and investigation, introduction and validation of new methods and analysers, assessment of customer satisfaction, encouraging staff suggestions for improvement, internal quality assurance programs, and providing a wide variety of publications and information for both patients and doctors. The success of this internal monitoring is assessed at accreditation audits.

Your Role

Your Role

Laboratory accreditation means that accredited laboratories meet specified standards, and gives you confidence that your tests are being processed by a reputable laboratory. What can you do as a patient to make sure you are receiving quality service?

  • Ask where your tests are going to be performed. If you wish your tests to be performed at another laboratory, talk to your doctor about this. Although recent legislative changes mean that you may now present a pathology request form to any pathology provider, the choice of pathology provider is best made in consultation with your doctor before the pathology request form is generated. Your doctor may prefer or require a specific pathology provider to perform a pathology test for various reasons e.g. test availability, quality of service, preference for a particular test method or reporting format. (Please also be aware that not all pathology laboratories conduct all tests and that not all tests attract Medicare rebates, even if the laboratory is accredited to perform the test.)
  • Comply with instructions from pathology staff in relation to pre- and post-testing requirements.
  • Provide accurate and complete information to your referring doctor about your health and all your current treatment and medication.

Related links

Related links

National Association of Testing Authorities (NATA) - to check the accreditation status of a laboratory, or to find out more about laboratory accreditation.

Royal College of Pathologists of Australasia (RCPA) - to find out more about pathology in general. There are also links to other pathology and medical organisations at this site.

National Pathology Accreditation Advisory Council – to find out more about accreditation standards for laboratories.