NPAAC Requirements

Laboratories performing cervical screening testing must comply with requirements set by the National Pathology Accreditation Advisory Council (NPAAC).

The NPAAC Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017) - [the Requirements] are accessible on the Australian Government Department of Health website at:
http://www.health.gov.au/internet/main/publishing.nsf/Content/npaac-cervical-screening

The website states:

“The Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017) set out the minimum requirements for best practice in relation to the HPV NAT and operation of gynaecological cytology services by laboratories participating in cervical screening. This document provides guidance for the additional steps laboratories must take when using HPV NAT alone as a primary screening test in a population of both vaccinated and unvaccinated women.”

Pathologists and medical scientists performing cervical screening tests should ensure that they are familiar with and compliant with the Requirements. Non-compliance with the Requirements may mean that the laboratory would not be accredited to perform cervical screening tests.

It is important to use the current version of the Requirements. The current version of the Requirements is the First Edition (2017). This version takes effect from 1 December 2017 and supersedes the Requirements for Gynaecological (Cervical) Cytology and Performance Measures for Australian Laboratories Reporting Cervical Cytology.

The Requirements is a Tier 4 NPAAC document and must be read in conjunction with the Tier 2 document Requirements for Medical Pathology Services and the Tier 4 document Requirements for Medical Testing of Microbial Nucleic Acids.

NPAAC documents, including the Requirements, are available for download on the NPAAC website.

This document sets out the standards for using HPV nucleic acid testing (NAT) as the primary screening method for cervical cancer screening with reflex liquid based cytology (LBC) in cases positive for oncogenic HPV types. Testing of self-collected specimens, of symptomatic women and in the post-treatment setting are also covered.

Laboratory medicine professionals engaged in cervical screening testing should endeavour to become familiar with all facets of the Requirements as failure to meet the minimum standards in any area could affect the quality of a laboratory’s performance and jeopardise its accreditation to continue offering cervical screening testing as a service.

A detailed discussion of the Requirements is outside the scope of this website however the following summary of the Standards outlined in the Requirements is provided as a guide. Click on the links in each section to access more detail of some critical points:

Introduction

Section 1: Personnel

Section 2: Facilities

Section 3: Specimens

Section 4: Equipment

Section 5: Quality Assessment

Section 6: Post-analytical

Section 7: Performance Measures for HPV NAT and LBC in the renewed NCSP

Appendices

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NPAAC Requirements Quiz

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