The Respiratory Function Laboratory Accreditation Manual (referred to as the ‘Program Manual’) contains details of program management and administration, the accreditation process, and most importantly the Standards and key references.
The Program Manual has been re-issued in June 2021, along with updated Application Forms. The re-issued Program Manual contains a variety of clarifications and improvements, and a revision and reorganisation of the Standards. An overview of the changes to the Program is provided here.
Laboratory staff should be advised that there has been a substantial rewrite to the Standards, including a re-organisation of the requirements and amendment of numerous ‘shoulds’ to ‘musts’ in reflection of current standards of best practice within Australian and New Zealand Respiratory Function Laboratories. This will require a significant rewrite of existing laboratory manuals when seeking accreditation against the 2021 Standards.
All Accreditation Applications received from 1st January 2022 must be submitted using the new Forms and meet the standards detailed in the 2021 Program Manual. Prior to the 1st of January 2022, Laboratories may choose to submit their application using the 2016 or the 2021 Program Manual.
The Program Manual and associated forms are available to TSANZ and ANZSRS Members. TSANZ and ANZSRS members can provide proof of TSANZ or ANZSRS membership via email to firstname.lastname@example.org to receive a copy of the Program Manual and associated forms.
What to Expect
From beginning to end the accreditation process should take no longer than 12 months. This starts with the very important self-assessment process conducted by the laboratory and the preparation of their application documentation. Once the application has been accepted by the TSANZ Office, a panel of appropriately qualified volunteer Laboratory Accreditation Assessors is established. The Assessor Panel conducts an initial evaluation of the supplied documentation, and pending an assessment by the Assessor Panel that the laboratory appears likely to meet the required standards, a physical site visit by the Assessor Panel is arranged. However, a combined physical/virtual site visit may be required which will be organised in advance of the assessment. The laboratory is provided with a written feedback report as part of the Initial Evaluation, and then a Final Report following the completion of the Site Visit. In both cases, the Reports may detail Mandatory Requirements that must be addressed by the laboratory before moving to the next stage of the assessment, or before accreditation can be awarded.
An overview of the key tasks and timelines can be downloaded here.
Current fees can be accessed by clicking here
If assistance to access documents is required, including by ANZSRS members, please contact the TSANZ Office on +61 (0)2 9222 6200. Or,