Site Accreditation Procedures

Introduction

The quality control (QC) procedures described here reflect the current requirements for PET-CT centres to become accredited by the UK PET Core Lab and the additional QC tests that must be performed for participation in multicentre PET-CT studies.

Please note: most multicentre trials have additional requirements for standardisation of patient preparation, PET-CT acquisition and image reconstruction parameters and therefore centres participating in multicentre PET trials should always refer to the latest copy of the trial protocol and the imaging manual which can be obtained from the Trial Co-ordinator.

Please contact us for any queries regarding site accreditation.

Roles and Responsibilities

This purpose of this procedure is to establish a consistent method for performing site accreditation of PET Centres participating in multi-centre trials with the UK PET Core Lab.

This procedure applies to all PET Centres currently within the NCRI PET Clinical Trials Network and any new applicants. This procedure only covers site accreditation for participation in non- or semi-quantitative clinical oncology studies using PET.

Co-ordination of the site accreditation process is performed through the UK PET Core Lab based at St Thomas' Hospital, London. Staff at the applying PET Centre are responsible for submission of all data required for site accreditation to the Core Lab. Submitted data is reviewed by medical physicists and stored at the UK PET Core Lab.

Site Accreditation Process

No patients should be scanned as part of a trial until written confirmation is received from the UK PET Core Lab indicating that the site is accredited for the trial.

Before a PET Centre can become accredited the following steps should be completed:

  1. The NEMA image quality phantom must be filled and scanned following the procedure in the 18F_Image_Quality_Phantom_SOP_PET or 68Ga_Image_Quality_Phantom_SOP_PET. For the initial scanner testing, this will usually be performed at a pre-arranged site visit by a physicist from the UK PET Core Lab.
  2. The site must complete the PET_QC_FORM_PET and return a copy to the Core Lab.
  3. Two anonymised patient studies acquired and reconstructed using the proposed study protocol should be transferred to the Core Lab for technical and clinical review. All studies sent to the Core Lab must be in DICOM format and include the attenuation corrected PET, CT and non-attenuation corrected PET.
  4. Procedures for pseudo-anonymisation and transferring of patient studies from the scanning PET Centre to the UK PET Core Lab must be established. Validation of these procedures can be performed when transferring the anonymised patient studies in step 3.
  5. The PET Centre must have a documented quality assurance (QA) programme in place including quality control (QC) procedures for the PET-CT scanner, weighing scales and radionuclide calibrator that conform to the manufacturer's recommendations and the latest UK or EU guidance/legislation where applicable. To demonstrate this fulfils the minimum requirements for accreditation sites will need to submit copies of the following:
    1. A copy of the scanner QA schedule and example QC results covering daily/weekly, quarterly and annual QC tests.
    2. A copy of the most recent annual CT QC report (or the acceptance testing report for new systems).
    3. A copy of the most recent calibration certificate or QC report for the patient weighing scales.
    4. 8 weeks of SUV/sensitivity data measured using a uniform 18F or 68Ge cylinder or 68Ge annulus phantom to demonstrate the scanner stability.

Confirmation of Site Accreditation

Once all these steps are complete and the results of the phantom scan are deemed satisfactory by the UK PET Core Lab, the PET Centre will be issued with a letter of accreditation for the trial by the UK PET Core Lab. A copy of the letter will also be sent to the trial coordinator who will inform the PET Centre when they can begin scanning patients as part of the trial.

Annual Renewal

To maintain on-going accreditation by the UK PET Core Lab, sites will be required to submit data for review on an annual basis. This is to ensure continued compliance and that no significant changes have been made to the local protocol. Sites will therefore be required to submit the following to the Core Lab:

Sites may also be required to repeat the site accreditation process in the following situations:

  • After scanner / processing software or hardware changes which may affect the image quality or integrity.
  • If there are any significant changes to the acquisition or reconstruction parameters originally specified in the PET_QC_FORM_PET.
  • Prior to participation in new multicentre trials unless the proposed acquisition and reconstruction parameters are identical to previous trials.
  • Any other circumstances which arise that the medical physicist at the Core Lab deems may alter the image quality, such as QC failures, apparent scanner degradation or poor image quality.

Staff at individual PET centres are responsible for informing the Core Lab of any changes to the scanner or protocols which may affect image quality/integrity. Ideally this should be in advance of the changes to allow time for the Core Lab to assess the possible impact on the trials and issue guidance to the PET Centre and Principal Investigator where necessary.

For any enquiries about the site accreditation process, quality control procedures or data transfer, PET Centres can contact the physicist at the Core Lab.