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.
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.