AACB 51 st NATIONAL SCIENTIFIC CONFERENCE

Transcription

1 AACB 51 st NATIONAL SCIENTIFIC CONFERENCE 2013 Wednesday 18 September THE REGULATORY PROCESS OF PATHOLOGY IN AUSTRALIA Andrew Griffin Deputy Sector Manager Life Sciences

2 THE REGULATORY PROCESS OF PATHOLOGY IN AUSTRALIA Introduction. Describe the key stakeholders involved in the regulatory framework for Pathology Accreditation in Australia and their roles Describe the relationships between these key stakeholders Describe the regulatory framework of Pathology Accreditation

3 THE REGULATORY PROCESS OF PATHOLOGY IN AUSTRALIA The key stakeholders in the process Medical laboratories NATA RCPA NPAAC & DoHA DHS TGA NBA ACQSHC State governments Professional societies and associations Pathology Associations Council - AACB, AAPP, AIMS, ANZSBT ASC, ASCIA, ASM, ESA, HGSA HISA HSANZ IAP, NCOPP, FSA

4 DoHA / NPAAC Responsible for maintenance of accreditation materials and advisory service to DoHA State Governments DoH/MoH DHS Provision of reimbursement for Medicare funded Pathology testing NATA National Accreditation Body recognised by Commonwealth Government as the provider of laboratory accreditation Medical Laboratories RCPA Joint partners in Medical Testing Accreditation programme Prof. Organisation AACB, AIMS etc National Blood Authority TGA Responsible for In-house IVD framework ACQSHC National Healthcare Standards

5 National Association of Testing Authorities Established in 1947 by the Commonwealth Government Authority in the assurance of technical standards Responsible for the accreditation of laboratories, inspection bodies, calibration services, producers of certified reference materials & proficiency testing scheme providers throughout Australia (and overseas) National accreditation body recognised by MOU with Commonwealth Government

6 NATA ensures compliance with relevant International and Australian standards ensures facilities are competent to provide consistently reliable testing, calibration, measurement and inspection data to government, industry and the wider community. ensures transfer of results and information generated in accredited facilities across countries can be trusted e.g. Genetics, Drug Testing, Clinical trials, R&D

7 NATAs role in Summary NATAs primary role is to serve the national and public interest by facilitating the provision of reliable calibration, measurement, testing and inspection infrastructure to government, industry and the wider public To this end NATA accredits facilities offering these services Accreditation is a high level process of recognising, through demonstration, the collective and specific competencies of these service providers NATA accreditation is a third party and objective assurance that service providers possesses all the competencies necessary to deliver sound technical/scientific i tifi data Thus produce reliable outputs on which decisions can be made with confidence

8 FIELDS OF TESTING Acoustic & Vibration Measurement Biological Testing Chemical Testing Construction Materials Testing Electrical Testing Forensic Science Good Laboratory Practice Heat & Temperature Measurement Inspection Mechanical Testing Medical Imaging Medical Testing Metrology Non-destructive Testing Optics & Radiometry Certification of Reference Materials Proficiency Testing Scheme Providers Software Testing Sleep Services Veterinary Testing

9 Royal College of Pathologists of Australasia (RCPA) The Royal College of Pathologists of Australasia (RCPA) is responsible for the training and professional development of pathologists and for the promotion of the science and practice of Pathology The principal object of the College as defined in the Articles of Association is: To promote the study of the science and practice of Pathology in relation to medicine; to encourage research in pathology and ancillary sciences, to bring together e pathologists og for their common o benefit e and for scientific c discussions and demonstrations; and to disseminate knowledge of the principles and practice of pathology in relation to medicine by such means as may be thought fit.

10 Royal College of Pathologists of Australasia (RCPA) The College has been actively involved in assisting with the setting of standards for laboratory practice and providing Fellows with a means to test the quality of their practice. Within Australia, the College was an active participant in working with the Commonwealth Government to establish the National Pathology Accreditation Advisory Council (NPAAC) in While NPAAC provides the standards for laboratory practice, the actual accreditation process is carried out by NATA/RCPA, a joint initiative between RCPA and NATA. The College plays a role in relation to liaising with government, both Federal and State, on issues relating to professional practice, medical, economic and other medico-political issues.

11 NATA/RCPA Medical Testing Accreditation program NATA and RCPA have a Memorandum of Understanding g( (MoU) This MoU describes the roles and responsibilities of each party NATA is responsible for the day-to-day administration and implementation of the Accreditation Process.

12 NATA/RCPA Medical Testing Accreditation program NATA will engage g Fellows of RCPA to participate p as technical assessors in NATA/RCPA assessments of: (a) every laboratory classified as a Category GX or GY laboratory; (b) every laboratory classified as a Category B laboratory unless it is impractical to do so and where: it has been demonstrated at recent assessments of the parent Category GX/GY laboratory and other Category B laboratories that there is a uniform quality management system across all sites; and there is a sound assessment history and stability in senior management/ownership. Where these criteria are met NATA will use reasonable endeavours to ensure that a pathologist will assist in the assessments of a representative sample of Category B laboratories; and (c) category S laboratories where a pathologist's expertise is required.

13 NATA/RCPA Medical Testing Accreditation program Currently there are a total of 725 facilities, as follows: 690 operative Australian facilities; 11 international facilities; 24 applicant laboratories; and The breakdown of operative facilities with NPAAC Categories is as follows: 86 Category GX facilities 49 Category GY facilities 298 Category B facilities 181 Category S facilities 12 Category M facilities

14 NATA/RCPA Medical Testing Accreditation program Year Accredited facilities new accreditations Approx. 20% increase in overall numbers of accredited facilities in 5 ½ years Apheresis collection units PoCT Drug testing organisations However there have also been 159 withdrawn facilities during the same period

15 NATA National Accreditation Body recognised by Commonwealth Government as the provider of laboratory accreditation Provision of Accreditation RCPA Joint partners in Medical Testing Accreditation programme Medical Laboratories

16 Medical Testing Accreditation Advisory Committee (MTAAC) Currently 12 members Members sourced and nominated from Professional Bodies within Australia Professional bodies nominate members for MTAAC Meet regularly MTAAC meet at least annually;

17 Medical Testing Accreditation Advisory Committee (MTAAC) Role of AAC The primary role of the AAC is to provide technical guidance and identify means of improving technical competence; provide guidance on interpretation of the technical requirements included in ISO 15189; develop and review technical criteria and assessment reports specific to the work carried out by accredited organisations in Medical Testing; review technical criteria developed by the Secretariat (AG); keep NATA staff abreast of technical developments and strategic issues in industry; act as a liaison between NATA and relevant industry and professional societies and Standards writing committees.

18 Medical Testing Accreditation Advisory Committee (MTAAC) 50% of members must be FRCPA Chair must be FRCPA Not all disciplines covered by RCPA members RCPA nominees Dr Michael Harrison Chair Dr Raymond Chan (Microbiologist RPAH) RCPA Liaison Officer Prof Yee Khong Deputy RCPA Liaison Officer Dr Pat Hogan (PAC - Immunology) A/Prof Rob Lindeman (PAC Haematology) A/Prof Adrienne Morey (PAC Anatomical Pathology)

19 Other members of MTAAC Dr Gus Koerbin (AACB Nominee) Prof Barney Rudzki (HGSA Nominee) Mr Geoff Coombs (ASM) Mr Kevin Ericksen (AIMS) A/Prof Keith Harrison (FSA/SIRT) A/Prof David Roxby (ANZSBT)

20 AACB nominee RCPA 50% membership of MTAAC ASM nominee ANZSBT nominee Medical Testing Accreditation Advisory Committee HGSA nominee FSA nominee AIMS nominee

21 National Pathology Accreditation Advisory Council (NPAAC) The National Pathology Accreditation Advisory Council (NPAAC) advises the Commonwealth, o,saea state and territory oyhealth ministers seson matters esrelating ea to the accreditation of pathology laboratories. NPAAC plays a key role in ensuring the quality of Australian pathology services and is responsible for the development and maintenance of standards and guidelines for pathology practices. NPAAC is comprised of representatives from all states and territories, nominees from peak professional bodies and the Department of Health and Ageing.

22 National Pathology Accreditation Advisory Council (NPAAC) Legislative basis for pathology accreditation and linkage to the Medicare Benefits e Schedule e NPAAC is a ministerially-appointed Council that was originally established in 1979 by an Order made by the Governor-General (known as an Order in Council), which sets out NPAAC s role, structure and function. In 1986, the Commonwealth introduced a compulsory accreditation system in relation to Medicare benefits for pathology. In order to be accredited, a pathology laboratory must meet specified quality standards.

23 National Pathology Accreditation Advisory Council (NPAAC) The Health Insurance (Accredited Pathology Laboratories Approval) Principles 2002 set out the specifics of pathology accreditation and its requirements. The Principles include a Schedule that lists accreditation materials (or the standards) that relate to the actual process. The accreditation material is developed and maintained by NPAAC. Medicare benefits are only payable for pathology services if: approved services are performed in a laboratory within an appropriate Accredited d Pathology Laboratory (APL) category the service is rendered by or on behalf of an Approved Pathology Practitioner (APP) the proprietor of the laboratory is an Approved Pathology Authority (APA).

24 National Pathology Accreditation Advisory Council (NPAAC) The matters the Council address include: developing policy for accreditation of pathology laboratories; introducing and maintaining uniform standards of practice in pathology laboratories throughout Australia; adopting coordinated d legislation l and administrative i ti action in providing pathology services; initiating, promoting and coordinating educational programs in relation to pathology laboratory practice; at the request of the Minister, a state or a territory Minister, provide advice about accreditation of a particular pathology laboratory.

25 National Pathology Accreditation Advisory Council (NPAAC) Tier 1 The Principles The Health Insurance (Accredited Pathology Laboratories Approval) Principles 2002 HS/11/2002 Principles i as amended. d These Principles have as their subject matter the Minister's power to revoke or approve an application for the use of premises as an accredited pathology laboratory under section 23DN of the Health Insurance Act Administered by: Health and Ageing Tier 2 - Standards and Supervisory Requirements for Pathology Laboratories Requirements for the Supervision of Pathology Laboratories 2007 Requirements for Pathology Laboratories 2007

26 Tier 3 - Requirements for good medical practice in all Pathology Laboratories Requirements for Quality Management in Medical Laboratories 2007 Requirements for the Estimation of Measurement Uncertainty 2007 Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials 2007 Requirements for Participation in External Quality Assessment (Fourth Edition 2009) Requirements for the Retention of Laboratory Records and Diagnostic Material (Fifth Edition 2009) Requirements for Information Communication i 2007 Requirements for the Development and Use of In-house In Vitro Diagnostic Devices 2007 Guidelines for Approved Pathology Collection Centres 2012

27 Tier 4 - Specialised technical publications, intended to specify requirements in Pathology Laboratories undertaking testing in specific areas of pathology Requirements for Procedures Related to the Collection, Processing Storage and Issue of Human Haemopoietic Progenitor Cells (Third Edition 2009) Requirements for Transfusion Laboratory Practice (First Edition 2008) Requirements for Medical Testing of Human Nucleic Acids 2012 Requirements for Medical Testing of Microbial Nucleic Acids 2012 Requirements for Gynaecological (Cervical) Cytology 2006 Performance Measures for Australian Laboratories Reporting Cervical Cytology 2006 Requirements for Cytogenetic Testing 2007 Requirements for the Performance of Anatomical Pathology Cut-up 2012 Requirements for Laboratory Testing of Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (Second Edition 2009) Guidelines for the use of Liquid Based Collection Systems and Semi-Automated Screening Devices in the Practice of Gynaecological (Cervical) Cytology 2006 Requirements for the Facilities and Operations of Mortuaries (Second Edition 2009)

28 NPAAC NPAAC is comprised of representatives from all states and territories, nominees from peak professional bodies and the Department of Health and Ageing AACB AIMS ASM FSA HGSA ANZSBT NCOOP PA All States and Territories NATA National Accreditation Body recognised by Commonwealth Government as the provider of laboratory accreditation NATA/RCPA joint program Medical Laboratories RCPA Comprises Chair of NPAAC Members sit on Standards writing committees

29 Department of Human Services (DHS) Medicare Australia Department of Human Services (formerly Medicare Australia) manages the administration of the pathology laboratory accreditation. This includes tracking the accreditation status of laboratories and managing the arrangements with organisations that conduct accreditation checks. If patients of a laboratory wish to claim Medicare benefits for services rendered, the laboratory must have APL status approved by Department of Human Services The Australian Government subsidises the costs of general practice and medical specialist services (including to pathology) to private patients in the community and in hospitals (private and public) through the Medicare Benefits Scheme (MBS).

30 Public Pathology funding Pathology services are largely publicly subsidised through Australia s Medicare system. Free access to public hospital care, including pathology testing, is a fundamental component of Medicare Public pathology services are funded primarily through the National Healthcare Agreements and, to a lesser extent, through the MBS.

31 Public Pathology funding While the Agreement is primarily a mechanism to manage pathology outlays, it also provides for the development of many other initiatives including: the development of a National Pathology Framework; the development of better decision support for pathology requesting to improve the quality and clinical appropriateness of requesting; the implementation of electronic requesting and reporting of pathology across the sector; the development of appropriate policy and funding mechanisms for genetic services; ensuring a sustainable workforce for pathology;

32 National Healthcare Agreement a commitment to the National Pathology Accreditation Advisory Council, National Association of Testing Authorities/ Royal College of Pathologists of Australasia laboratory accreditation; ongoing funding for the Quality Use of Pathology Program; and a commitment to the Government s broader e-health agenda, including adoption of National e-health Transition Authority standards in relation to the Personally-Controlled Electronic Health Record.

33 DoHA Responsible for maintenance of accreditation materials, including The Principles NATA Provides a Laboratory Report on Premises Deed of Agreement to perform Accreditation activity Assessment/Accreditation/ Report on Premises DoHA National Healthcare Agreements Accreditation Public Pathology funding DHS Provision of reimbursement for Medicare funded pathology testing based on APL APL MBS Funds Medical Laboratories

34 Therapeutic Goods Administration Blood, tissues and biologicals Most laboratories would be aware of the TGA through cgmp licensing related activities Medical devices & IVDs Until 1 July 2010, the level of IVD regulation in Australia was very limited. IVDs for Human Immunodeficiency Virus (HIV) and hepatitis C virus (HCV) were subject to extensive pre-market review a small number of other IVDs received limited review the vast majority of IVDs were exempt from pre-market regulatory scrutiny.

35 Therapeutic Goods Administration Medical devices & IVDs This system has resulted in a high standard of IVDs available for HIV and HCV testing however most IVDs were not subject to appropriate regulatory control A new regulatory framework commenced on 1 July 2010 that ensures all IVDs will undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use The framework adopts the philosophies and recommendations of the Global Harmonization Task Force (GHTF) for IVDs, ensuring that requirements are internationally aligned The legislation incorporates accepted best practice relating to safety, quality and risk management procedures, and provides the flexibility and capacity to regulate new and changing technology and emerging diseases.

36 Therapeutic Goods Administration Under the new framework IVDs are regulated as a subset of medical devices. The Therapeutic Goods Regulations (Medical Devices) 2002 have been amended to include IVDs. In vitro diagnostic medical devices (IVDs) are, in general, pathology tests and related instrumentation used to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management. IVDs are typically used in diagnostic laboratories, at the point of care, and in the home. The TGA IVD Framework will cover both Commercial and In-House IVDs

37 TGA & NATA As the current framework applies TGA will perform a conformity assessment on all Class 4 IVDs Includes Commercial and In-house TGA will accept NATA accreditation as part of the notification process for Class 1 3In-house IVDs NATA will still accredit In-house Class 4 IVDs as part of the accreditation process if requested by the laboratory to do so Potentially any serious adverse finding at assessment will be relayed to TGA by NATA Laboratories are obliged to notify TGA of their own accord

38 TGA Responsible for In-house IVD framework MoU / Deed of Agreement NATA Notification of All In-house IVDs Accreditation Class 1 3 In-house IVDs Medical Laboratories

39 Australian Commission for Quality and Safety in Healthcare (ACQSHC) ACSQHC leads and coordinates improvements in safety and quality in health care across Australia including the promotion, support and encouragement of the implementation of safety and quality initiatives. A collaborative and consultative approach is undertaken in priorities of the health system that benefit from national coordination. Under its legislation ACSQHC has wide raging functions that also include the formulation of safety and quality standards and indicators.

40 Australian Commission for Quality and Safety in Healthcare (ACQSHC) Australian Safety and Quality Framework for Health Care The Australian Safety and Quality Framework for Health Care describes a vision for safe and high quality care for all Australians sets out the actions needed to achieve this vision The Framework specifies three core principles i for safe and high h quality care. care is consumer centred driven by information organised for safety. The Framework was endorsed by Health Ministers as the national safety and quality framework for Australia in November 2010.

41 Australian Commission for Quality and Safety in Healthcare (ACQSHC) The Commission developed 10 National Safety and Quality Health Service (NSQHS) Standards to drive the implementation of safety and quality systems and improve the quality of health care in Australia. The 10 NSQHS Standards d provide a nationally consistent t statement t t about the level l of care consumers can expect from health services. Accreditation In September 2011, Health Ministers took a significant step towards improving Australia s s health system by endorsing the NSQHS Standards and a national accreditation scheme.

42 Standard 1 Governance for Safety and Quality in Health Service Organisations Standard 2 Partnering with Consumers Standard 3 Preventing and Controlling Healthcare Associated Infections Standard 4 Medication Safety Standard 5 Patient Identification and Procedure Matching Standard 6 Clinical Handover Standard 7 Blood and Blood Products Standard 8 Preventing and Managing Pressure Injuries Standard 9 Recognising and Responding to Clinical Deterioration in Acute Health Care Standard 10 Preventing Falls and Harm from Falls

43 State t Governments Approved Accreditors ACHS, Benchmark etc Medical Laboratories Public and Private Hospitals Accreditation

44 National Blood Authority The NBA represents the interests of the Australian and state and territory governments, and sits within the Australian Government s Health and Ageing portfolio. The key role of the NBA is to: provide an adequate, safe, secure and affordable supply of blood products, blood related products and blood related services, and promote safe, high quality management and use of blood products, blood related products and blood related services in Australia.

45 The NBA: works with jurisdictions to determine the clinical requirements for blood and blood products to meet national clinical needs and develop an annual supply plan and budget negotiates and manages national contracts with suppliers of blood and blood products to obtain the products needed assesses blood supply risk and engages g in contingency planning for risks arising in the sector and impacting on the sector supports the work of the jurisdictions to improve the way blood products are used - including developing and facilitating strategies and programs that will improve the safety, quality and effectiveness of blood usage, particularly in the areas of national standards, guidelines and data capture and analysis

46 The NBA provides expert advice to support government policy development, including identification of emerging risks, developments, trends and new opportunities manages the evaluation of proposals for blood sector improvements, including proposals for new products, technologies and system changes provides secretariat support to the Jurisdictional Blood Committee (JBC).

47 Prof. Organisation ANZSBT National Blood Authority NATA Medical Laboratories

48 State Governments»VIC DOH, NSW MoH, SA DoH, NT DoH, WA DoH NATA obliged to inform those State Governments where an MoU exists of any serious accreditation findings and concerns for public safety for testing performed in those states In some cases for any testing performed anywhere on a citizen of fthat tstate t» Referral laboratories» Corporate interstate t t networks where testing ti is rationalised across the network