This issue contains:
- Technical Assessors Honoured
- Technical Assessors Training
- Crime Scientist Nominated
- Are you a biological, chemical or veterinary laboratory?
- NATA Agreements update: Memorandum of Understanding with TGA
- Technical Documents updates
- NATA Office Closure over the Christmas and New Year Period
To provide our services to members and the community, NATA relies on the knowledge and experience of our 3,000 volunteer Technical Assessors.
Each year, we ask staff to nominate Technical Assessors to be profiled in our Annual Report - someone who has made a significant contribution to NATA and whose activities and input deserve to be honoured.
Three of our Technical Assessors – all of whom have carried out well in excess of 100 assessments - were nominated by NATA staff members to feature in this year’s Annual Report.
All were very surprised to have been nominated but pleased to share their backgrounds with us.
Peter Davis began work with Coffey & Hollingsworth (subsequently Coffey & Partners) as a geotechnical engineer in Brisbane in 1968. Much of his work initially involved geotechnical investigation and construction materials testing in PNG, for the establishment of the Bougainville copper mine.
“My initiation with Coffey & Hollingsworth for much of 1969, 1970 and 1971 involved geotechnical investigation work and construction materials testing in PNG, for the establishment of the Bougainville copper mine. Subsequently there was geotechnical work elsewhere in PNG and in Queensland”.
He moved to Mackay in 1976 to head Ullman & Nolan’s geotechnical division and where he established and operated its geomechanical testing laboratory (triaxial, oedometer direct shear testing etc.). He moved back to Brisbane in 1982 and became a Company Principal with Ullman & Nolan, prior to their merger with Cardno Group.
“Work for Ullman & Nolan was located principally in Central Queensland and the Bowen Basin Coalfields, the Whitsundays, and in the Northern Territory. There wouldn’t be many Bowen Basin coal mines or Whitsunday resort islands that I would not have worked on.”
Peter has been an active Technical Assessor for NATA since September 1989 and his extensive range of technical expertise means that he is highly sought after when arranging complex assessment visits.
NATA has further benefited from Peter’s technical insights through his longstanding role as Chairman of NATA’s Construction Materials Testing Accreditation Advisory Committee, a role which he relinquished in March 2016.
Active in establishing the Australian Geotechnical Testing Association, for which he remained a Committee member until recently, Peter is described as ‘an absolute ‘gem’ by our nominees who also expressed the hope that he would wish to remain involved as a Technical Assessor for years to come.
Peter describes himself as ‘mostly retired’ -
“It never ceases to amaze me how I ever found time for work!
Currently I am fully occupied doing all those tasks at home that I conveniently overlooked for the past 30 years, but I still find time for ‘grandad duties’. We endeavour to do a bit of travelling including a trip earlier this year immersing ourselves in rural village life in the Solomon Islands. The next trip? Tasmania, Western Australia and New Zealand are all on the bucket list, as is Europe (again).
Petrol head activities keep my 1972 Holden Torana XU-1 on the road, with a number of interstate trips each year. It will be Canberra in November this year and Phillip Island next year (among others). There is always something to do to keep an old car going; rarely a month goes by when I’m not found with my head buried in the car somewhere and a bunch of tools by my side.”
With a career spanning over four decades, Barry Neville brings a wealth of knowledge and experience to his role as Technical Assessor.
Barry spent 43 years, the last 20 as a Senior Technical Officer, Materials Testing and Force Calibration at the University of Queensland in their Civil Engineering Department. His manager at the time, already a Technical Assessor, nominated Barry and he joined as an Assessor in September 1989. Following early retirement from the University he worked for more than two years in a private calibration laboratory.
Since he has worked as a bench technician and knows how much of the equipment he sees is used through his own experiences, Barry’s approach at assessments is both down-to-earth and practical. Those nominating Barry all mentioned his ability to connect with people and put them at ease.
Barry was an early member of the Metrology Society of Australasia and was on the organising committees for two of their Conferences.
Now a ‘semi-retired’ Consultant, trading as Force Consulting, Barry is kept busy with word-of-mouth referrals – this allows him to remain involved in the industry but gives him time for other activities. This includes the vintage (pre-1930) car movement (he is a foundation member of two clubs), lawn bowls, involvement with the local district historical society, and occasionally dabbling in historical research and family ancestry.
Barry notes that: “It is often said that the assessment process can benefit both parties, and I can certainly vouch for that as over the years I have on occasion found a better way of performing various tests or calibrations than the way I had approached them”.
We look forward to Barry sharing his knowledge with NATA for many years to come.
Dr James Doery has extensive academic and research knowledge and experience in the medical field and he brought this to his role as a NATA Technical Assessor in1991.
“It was a long time ago but as I recall I was invited to become a Technical Assessor and thought it would be an excellent way to gain a deeper understanding of the accreditation requirements and processes of assessments. The motive was probably more about increasing my understanding than any sense of charity work!! It has been fascinating to see the continuing evolution of the process and steadily rising standards of laboratory practice.”
Jim is a Chemical Pathologist and is currently the Unit Head of Biochemistry of Monash Pathology at Monash Health and the Medical Administrator/Deputy Chairman of the Human Research & Ethics Committees.
He is also active in training the next generation of Chemical Pathologists; now an Adjunct Senior Lecturer for the Department of Medicine at Monash University. Jim has held teaching and lecturing roles at Melbourne University (where he graduated in 1971), RMIT and Monash University.
Jim has authored or co-authored over 200 published articles or papers and also acts as a reviewer for the Journal of Clinical Endocrinology & Metabolism. He serves on the AACB/RCPA Paediatric Laboratory Harmonisation Committee, Monash University Pathology Board of Education and is a tutor in Evidence Based Clinical Practice for Year 3 MBBS students.
In addition to his professional activities, Jim undertakes a variety of diverse voluntary community activities ranging from the Chinese Association of Victoria, to the Melbourne String Ensemble and World Youth Day.
Despite his hectic schedule, Jim is always ready to take part in assessments including stepping in at the last minute.
“It is a wonderful model to have the mix of NATA professionals and voluntary scientific and medical assessors from peer laboratories. It is a very rewarding three way interaction where all parties support and feed off each other.”
Of his activities as a Technical Assessor, Jim says:
“I count it as a true privilege to have worked with such a delightful array of NATA staff, scientific and pathologist colleagues. It’s also been fabulous to visit so many laboratories and locations around Australia including trips to Arnhem Land where I met some warm hearted Aussie aboriginals and Broken Hill where I met our famous artist Pro Hart. I look forward to continuing being part of the NATA ‘family’ for some time to come!”
As you are aware, NATA provides face-to-face training for new Technical Assessors on its accreditation process and the important role our Assessors play.
These courses are scheduled throughout the year and although they are aimed primarily at new Technical Assessors, existing Assessors are welcome to attend these as a refresher.
The dates for 2017 are:
6 February 2017
13 February 2017
20 February 2017
9 May 2017
16 May 2017
17 May 2017
31 July 2017
7 August 2017
7 August 2017
26 September 2017
30 October 2017
30 October 2017
14 November 2017
28 November 2017
Although face-to-face training is considered the best option for our Assessors, we do recognise that some may have difficulty getting to a NATA office for a day which is why we developed a webinar training solution.
This webinar approach allows more interaction between the NATA trainer and the trainees than a normal e-learning approach and does so in a time effective manner.
As with our face-to-face training, the content of the webinar is based on the Assessor Information Guide (AIG) which is provided to all Technical Assessors in their Assessor Resource Kit.
Trainees will need to put aside a half a day to attend the two parts of the training but they do not need to leave their facility and should have time to catch up on other matters in between the two sessions.
To be considered to be a trained Technical Assessor both sessions of the training will need to be completed.
NATA Technical Assessor Sharon Neville has been recognised with a nomination for the Pride of Australia Medal, an acknowledgement of the contribution her work has made to the community.
Sharon leads the team of around 80 DNA scientists at the NSW Health Forensic and Analytical Science Service (FASS) who come through with the results which ultimately bring culprits to justice.
Although she received the nomination, Sharon is quick to point out that it’s very much a team effort at FASS.
The full newspaper article will give you an insight to the important work carried out by Sharon and her team.
Do you provide any testing, or aspects of testing, on human samples?
The TGA In vitro Diagnostic (IVD) Medical Device regulatory framework could impact on you!
What is the IVD framework?
The IVD Framework is designed to ensure all IVD medical devices, including in-house IVD medical devices undergo a level of scrutiny commensurate with the risks associated with their use
What is an “in-house” IVD medical device?
'In-house' IVD medical devices are tests that have been developed or modified within a laboratory (or laboratory network) to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or be used in making decisions concerning clinical management.
All diagnostic tests manufactured by a laboratory, regardless of whether or not they attract a Medicare rebate, are still subject to the requirements of the in-house IVD regulatory framework.
IVD medical devices developed in-house but supplied outside of the laboratory or laboratory network, fall outside the definition of 'in-house'. These are considered to be commercially supplied IVDs, and must be included in the Australian Register of Therapeutic Goods (ARTG) prior to being supplied outside of the laboratory or laboratory network.
In-house IVD Regulatory Requirements
The regulations, on which the framework is based, are not limited to medical testing laboratories, but extend to all laboratories that manufacture in-house IVD medical devices in Australia.
In summary, the TGA IVD framework requires that:
- All in-house IVD medical devices must be notified to or registered with the TGA.
- All Class 1-3 in-house IVD medical devices must be accredited by NATA and notified to the TGA.
- Class 4 in-house IVD medical devices must be registered on the ARTG.
Any “in-house” testing conducted on human samples that assists in clinical diagnosis or used to make decisions concerning patient treatment or management, and which have not been assessed by NATA and notified/registered with the TGA by 1 July 2017 can no longer be legally offered from this date.
Further information on the regulatory requirements for in-house IVDs can be found on the TGA website.
NATA accreditation in relation to In-house IVDs
Class 1-3 in-house IVD’s will usually be accredited under ISO 15189, however, where a laboratory’s main area of testing is not human pathology, accreditation under ISO/IEC 17025 will be considered on a case-by-case basis.
In September 2016 NATA and TGA signed a Memorandum of Understanding (MoU) which clarifies each party’s roles and responsibilities under the regulatory framework, with a particular focus on the co-operation and the exchange of information and material on matters relating to the accreditation of laboratories engaged in the manufacture of in-house IVD medical devices.
This MoU is further described in the article “Regulatory updates” in this edition of NATA News.
In Vitro Diagnostic (IVD) Medical Device regulatory framework
The IVD Medical device regulatory framework comes into full effect on 1 July 2017. Administered by the TGA, the framework is designed to ensure all IVD medical devices, including in-house IVD medical devices, are to be notified to, or registered with, the TGA following a level of scrutiny commensurate with the risks associated with their use.
The TGA and NATA, in recognising the complementary nature of their respective responsibilities as regulator and laboratory accreditation authority, have reached an understanding about co-operating and exchanging information and material on matters relating to the accreditation of laboratories engaged in the manufacture of in-house IVD medical devices.
The practical outcome of the IVD Medical device regulatory framework is that post 30 June 2017, unless otherwise exempt, laboratories will not be able to offer testing using Class 1 - 3 in-house IVD medical devices unless that test is NATA/RCPA or NATA accredited and the laboratory has complied with the requirements for notification to the TGA.
Similarly, unless otherwise exempt, laboratories will not be able to offer testing using Class 4 in-house IVD medical devices unless that test is registered on the Australian Register of Therapeutic Goods (ARTG). Laboratories are required to apply to the TGA for registration of their Class 4 in-house IVDs before 1 July 2017.
It should be noted that the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) apply to in-house IVD medical devices which have been developed from first principles, developed or modified from a published source and/or commercially supplied which have undergone modifications.
In addition, commercially supplied products sold as “Research use only” which are used by laboratories to test and report on patient samples are considered in-house IVDs (as they can affect diagnosis, treatment, or management of a patient). In these circumstances the laboratory must validate the assay as an in-house IVD for diagnostic use in line with the NPAAC Requirements. The use of disclaimers does not preclude the need for the laboratory to validate the assay.
In September 2016, NATA and TGA signed a Memorandum of Understanding (MoU) which clarifies each party’s role and responsibilities under the framework in relation to co-operation and the exchange of information.
The MoU recognises that NATA accreditation is available to any laboratory undertaking tests on human samples and that:
- Medical laboratories undertaking pathology tests may obtain NATA accreditation for compliance with the standard ISO 15189, Medical laboratories – particular requirements for quality and competence,
- in conjunction with assessment activities against ISO 15189, NATA undertakes an assessment of the manufacture and use of in-house IVD medical devices against the National Pathology Accreditation Advisory Council (NPAAC) standards including the NPAAC Standard, Requirements for the Development and Use of In-House In Vitro diagnostic Devices,
- in addition, NATA is able to assess laboratories (that are outside of the scope of ISO 15189) that manufacture Class 1-3 in-house IVDs for compliance with ISO/IEC 17025 and the NPAAC standard Requirements for the Development and Use of In-House In Vitro diagnostic Devices. Requests from laboratories for accreditation with NATA to ISO/IEC 17025 will be considered on a case by case basis. (In principle, assessment against ISO/IEC 17025 will only be considered in exceptional cases e.g. Veterinary laboratories primarily performing testing on animals but may also perform the test on human samples if requested).
Under the MoU NATA has agreed to a set of undertakings which include:
- that in the course of any assessment activity undertaken in relation to accreditation, NATA will require the laboratory to identify any in-house IVD medical devices;
- NATA will include all in-house IVD medical devices identified and put forward by the laboratory in the activities to be covered by the assessment;
- NATA will apply all the relevant clauses of ISO 15189 or ISO/IEC 17025;
- NATA will assess compliance of an in-house IVD medical device with the NPAAC standard Requirements for the Development and Use of In-House In Vitro diagnostic Devices. For in-house IVDs not previously assessed, NATA will focus on requirements relating to design, production and technical validation; for all other in-house IVDs NATA will focus on requirements relating to post market monitoring and reporting;
- NATA will assess that the laboratory has implemented a post market system that monitors the performance of that in-house IVD medical device, implements corrective action to address deficiencies in design production and includes a system for notifying the TGA of any adverse events arising from the use of the in-house IVD medical device;
- Upon becoming aware of an issue with a non-conformance by the laboratory with the post market notification requirements for an in-house IVD (eg, a non-conformance relating to the requirements for reporting an adverse event) NATA will provide TGA with any relevant information relating to the problem identified in relation to the in-house IVD;
- Where TGA has raised a concern with the performance or competence of a NATA/RCPA or NATA accredited laboratory, NATA will promptly respond to these concerns and provide feedback on actions taken by NATA or the laboratory to address these concerns;
- If NATA becomes aware that a laboratory has manufactured Class 1-3 in-house IVD medical devices that have not been notified to the TGA, NATA will advise the laboratory of their obligations under the Regulations;
- If NATA becomes aware that a laboratory has manufactured Class 4 in-house IVD medical devices that have not been included in the ARTG (and are not otherwise exempt), NATA will advise the laboratory of their obligations under the Regulations; advise the laboratory that they must desist from manufacturing and using the device; and to immediately notify the TGA. NATA will also notify TGA directly and provide details of the laboratory and of the Class 4 in-house IVD medical device.
Should you have any questions regarding NATAs undertakings with respect to the IVD Medical device regulatory framework please contact Tracy Fleming, Sector Manager or Andrew Griffin, Deputy Sector Manager - Legal and Clinical Services.
NATA’s offices will close during the Christmas and New Year period. All offices will close officially at 3.00 pm on Friday, 23 December 2016 and re-open on Tuesday, 3 January 2017.
NATA would like to warmly thank the Technical Assessors for their efforts, support and professionalism throughout the year. We look forward to working with you all in 2017.