Section 5: Quality Assessment

This section details the Quality Measures applicable for HPV NAT testing in all testing settings and those additional measure applicable for screening specimens only. It also outlines the Quality Measures for both Screening and Non-screening LBC.

S5.1 Laboratories must participate in an external quality assurance program.

S5.2 Laboratories must investigate all discordances in external quality assurance for HPV and document corrective actions have been taken.

S5.3 Laboratories must have a documented method for monitoring rates of oncogenic HPV not detected, detected, and unsatisfactory specimens.

S5.4 For HPV NAT within the NCSP, externally sourced non-manufacturer supplied control material must be used at least daily when tests are being performed.

S5.5 Laboratories must compare their rates of HPV detection in screening tests with the rates most recently reported by the NCSR.

S5.6 Each laboratory must document its procedures for internal audit which cover all its activities including:

  1. a system of follow-up for correlating the results of LBC with relevant histopathology
  2. a system within the laboratory for monitoring the performance of the laboratory as a whole and also the performance of individual Pathologists and Scientists.

It is important that this section be read in conjunction with Standards 5 and in Requirements for Medical Testing of Microbial Nucleic Acids.
Note that some of the Quality Measures in this section apply in all HPV NAT settings, including screening, test of cure and self-collected specimens, while some apply only to HPV NAT of screening specimens.

Quality measures for HPV NAT which apply in all settings, including screening, test of cure and self-collected specimens

HPV results must be stratified for HPV16/18, and other oncogenic HPV.

The rate of unsatisfactory specimens must be stratified based on “Routine screening”, “Self-collection” or “Other (includes symptomatic women, test of cure etc.)”.

Quality Measures for HPV NAT for screening specimens only

Laboratories must compare their rates of HPV detection in screening tests with the rates most recently reported by the NCSR. The NCSR will use routinely submitted data to produce a quarterly age stratified data set (including mean ± two standard deviations) compiled from data from all HPV testing throughout Australia. If the laboratory’s HPV positivity rate in screening tests is not within the two standard deviations, the laboratory must follow the procedures in Appendix A of the NPAAC Requirements.

The purpose of this measure is to detect partial or total reagent failure, testing platform failure, operator errors, changes in collection media or other factors associated with specimen collection or any other occurrence that results in a significant change in screening detection rates.

To allow timely retesting, comparison of detection rates with the NCSR should occur at least quarterly.

In determining the laboratory’s HPV detection rate in screening specimens, at least 2000 specimens tested in the same laboratory must be reviewed.

The test volume required for the calculation of this measure is dependent on the expiry time of the collection medium beginning from the time of collection. This period is determined by the storage times, as indicated by the manufacturer of the medium, and the type of HPV NAT testing platform. The specimens must be stored until a suitable test batch size has been reached, but this must occur within such a timeframe that both HPV (re)testing and potential reflex LBC testing remain possible. If refrigerated storage is used the specimen must be kept at the refrigerated temperature from collection and during transport and handling.

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