The industry where innvatin saves mre Australian lives Submissin t the AS/NZS 4760:2017 Cnsultatin n behalf f the IVD Industry in Australia, including Wrkplace Drug and Alchl Testing Organisatins In-Vit Diagnstics Industry, where Innvatin saves mre Australian lives Page 1 f 5
Table f Cntents Executive Summary... 3 Recmmendatins... 4 Recmmendatin 1 4 DR AS/NZS 4760:2017 be renamed Off-site prcedure fr specimen cllectin and the detectin and quantitatin f drugs in ral fluid. 4 Recmmendatin 2 4 The scpe f the draft Standard AS/NZS 4760:2017 be refined t include nly ff-site labratry-based detectin and quantitatin f drugs in ral fluid. 4 Recmmendatin 3 4 An Australian, and New Zealand, Standard fr On-site prcedure fr specimen cllectin and screening fr drugs in ral fluid be develped with the develpment cmmittee cmprised f n-site wrkplace drug and alchl testing prviders, users f the services and the IVD Industry, being the equipment suppliers. 4 Rewrking the current DRAFT AS/NZS 4760:2017 t include n-site cllectin and testing... 5 Abut... 2 Abut is the peak bdy representing spnsrs and manufacturers f in vitr diagnstics based in Australia. Australia s leading pathlgy labratry supply cmpanies frmed in July 2009 and we currently represent Australian manufacturers, multi-natinal and lcal distributrs f pathlgy tests, as well as regulatry cnsultants wrking in the IVD sectr. Our members currently supply prducts valued at ver AUD 1.2 billin per annum and emply ver 3,000 staff in multinatinals, lcal distributrs, lcal manufacturers, exprters and regulatry cnsultant cmpanies; many f which are SMEs. is a funding member f Pathlgy Awareness Australia, a grup that represents interests acrss the entire field f pathlgy in Australia. This bdy is cnducting the Knw pathlgy, Knw Healthcare Campaign n behalf f public pathlgy labratries, private pathlgy cmpanies, pathlgy prfessinals and manufacturers and suppliers t industry. In-Vit Diagnstics Industry, where Innvatin saves mre Australian lives Page 2 f 5
Executive Summary On-site specimen cllectin and the qualitative detectin f drugs is the preferred methd f ral fluid testing in Australia. Fr ver eleven years, Australian emplyers have favured n-site testing f their emplyees as a wrkplace safety measure. Initially utilised in remte wrkplaces, n-site testing has grwn t be accepted as the nrm in mst rganisatins undertaking a drug testing prgram, regardless f remte r metrplitan lcatin. On-site specimen cllectin and the qualitative detectin f drugs (including alchl) is a rapidly grwing Australian industry that recgnises the need fr an Australian Standard t prmte a cnsistently high-quality service t a grwing number f Australian wrkplaces. The draft Standard in its current frmat is nt ready fr final public cnsultatin. Key issues identified in the 2006 standard have nt been and cannt be rectified. The key issues remain: The standard was designed t sit within NATA s current standards. NATA was unable t accredit wrkplaces withut an n-site labratry under AS 4760:2006. NATA is the authrity respnsible fr the accreditatin f labratries, inspectin bdies, calibratin services, prducers f certified reference materials and prficiency testing scheme prviders thrughut Australia (Surce: https://www.nata.cm.au/nata/abut-nata). Mdificatins t the current draft under cnsultatin have been an attempt t crrect the design flaws that wuld enable NATA t accredit n-site specimen cllectin and testing facilities as labratries. NATA will be unable t accredit wrkplaces withut an n-site labratry under the current draft standard. A Standard that excluded the verwhelming majrity f its current cnstituents shuld nt be acceptable. Shuld n-site cllectin and testing remain as a cmpnent, cnsiderable rewrk will be required befre it is acceptable t the n-site wrkplace drug and alchl testing and IVD industries. Including but nt limited t: rerganising f the appendices and infrmative and nrmative cntent; remval f incrrect statements; rewrding f inapprpriate statements; and limits/cut-ffs that are applicable t n-site testing. In-Vit Diagnstics Industry, where Innvatin saves mre Australian lives Page 3 f 5
Recmmendatins Recmmendatin 1 DR AS/NZS 4760:2017 be renamed Off-site prcedure fr specimen cllectin and the detectin and quantitatin f drugs in ral fluid. Recmmendatin 2 The scpe f the draft Standard AS/NZS 4760:2017 be refined t include nly ff-site labratrybased detectin and quantitatin f drugs in ral fluid. Recmmendatin 3 An Australian, and New Zealand, Standard fr On-site prcedure fr specimen cllectin and screening fr drugs in ral fluid be develped with the develpment cmmittee cmprised f n-site wrkplace drug and alchl testing prviders, users f the services and the IVD Industry, being the equipment suppliers. In-Vit Diagnstics Industry, where Innvatin saves mre Australian lives Page 4 f 5
Rewrking the current DRAFT AS/NZS 4760:2017 t include n-site cllectin and testing Key Requirements: Mve the current Appendix A On-Site Testing Prcedure t Sectin 3 On-Site Initial Testing Mve the current Sectin 3 General Labratry Requirements t Appendix A General Labratry Requirements, except where it duplicates the requirements f ISO 15189, in which case, these clauses shuld be remved and replaced with reference t the Standard. Remve Appendix C in its entirety; r re-label t remve any reference t n-site / screening tests; r recnsult n Appendix C t prvide a standard apprpriate t n-site / screening tests. If these key issues cannt be rectified by applicatin f Sectin 4 (specifically Clause 4.1.2) in Standardisatin Guide 006: Rules fr the Structure and Drafting f Australian Standards, then recmmends that all substantive standards relevant t n-site wrkplace drug and alchl be remved frm this standard and a separate apprpriate standard be develped. Quality Cntrl The n-site device and the quality cntrls shall be used and stred strictly in accrdance with manufacturer s instructins. The cllectr shall ensure that n aspect f the prcedure causes cntaminatin f the specimens. Where the manufacturer s instructins are nt fllwed, quality cntrl, as set ut in Appendix A3.3, shall be undertaken, and als when the fllwing are applicable: nn-standard cllectin, strage and transprtatin methds are used; in-huse labratry designed r develped methds are used; standard methds are used utside their intended scpe; validated methds are subsequently mdified. The cllectin facility shall have a written prtcl fr ensuring the integrity f specimen results in the event f a prficiency testing failure. Verificatin f Devices It is inapprpriate t apply an evidentiary labratry standard t an n-site (screening). Transprtatin and strage devices shuld be verified as being fit fr the purpse which they are used. The prpsed verificatin prcess is inapprpriately prescriptive fr the range f ptential devices, in terms f dilutin factr and recvery perfrmance. The perfrmance f device shuld be verified against hw they are used in the prcess f n-site testing. Re-verificatin f devices is required and shuld be perfrmed at intervals f n mre than 60 mnths where there have been n changes t prductin r design that may affect perfrmance. Additinal cmments are prvided in the accmpanying tabulated respnse. In-Vit Diagnstics Industry, where Innvatin saves mre Australian lives Page 5 f 5