Category Standard Organisation Australian Commission on Safety and Quality in Health Care (ACSQHC) Type Standard Version 1 Access Open Status Active Created 2019 This document sets out the minimum requirements that a laboratory must meet in order to offer testing of self-collected vaginal swabs for human papillomavirus (HPV) as part of the National Cervical Screening Program as an in vitro diagnostic medical device.Main sections:- Risk management- General requirements- Validation performance requirements- Stability- Monitoring- Performance measures- Adverse event reporting- Use of validation assessment material to verify analytical performance (normative)- Evaluation of performance of testing of SCVS by applicant laboratories with clinical specimens (normative)- Evaluation of stability (normative) Access Requirements for validation of self-collected vaginal swabs for use in the National Cervical Screening Program By accessing this content, you are leaving this website. The Agency takes no responsibility for the accuracy of content on the destination page.