A/Prof Tony Badrick - National Pathology Accreditation Advisory Council (NPAAC) - Accreditation, licensing and standards

National Pathology

Accreditation Advisory

CouncilProviding advice to all levels of government

on pathology accreditation matters

A/Professor Tony Badrick

8 Sept 2014

History and Role

• Ministerial appointed body constituted by an

Order-in-Council in 1979

• Primary role is to advise all levels of

government on pathology accreditation

matters

• Key responsibility is the development and

maintenance of quality standards for

pathology

Role in more detail

• The matters that NPAAC addresses includes -– developing policy for accreditation of pathology laboratories;

– introducing and maintaining uniform standards of practice in pathology laboratories throughout Australia;

– adopting coordinated legislation and administrative action in providing pathology services;

– initiating, promoting and coordinating educational programs in relation to pathology laboratory practice;

– providing advice, at the request of the Minister, a State or a Territory Minister, about accreditation of a particular pathology laboratory.

Role in more detail (cont…)

• NPAAC (or Council) is comprised of representatives from the Commonwealth, States and Territories and nominees from key pathology, scientific professional groups and consumer organisation

• Sets Standards in Laboratory medicine which are used

for laboratory accreditation for access to Medicare

benefits for the provision of pathology services

• Standards are developed in reference to relavant

international standards, such as AS/ISO15189

Structure of NPAAC

• NPAAC undertakes a range of activities and accordingly has the

ability to establish committees to assist it with exercising its

functions

• Two standing committees and technical drafting committees –

– Document Review & Liaison Committee – forum where technical aspects of

accreditation materials is discussed. Liaison forum for pathology and related

professional groups.

– Advisory & Planning Committee – plays a key role in the strategic direction of

NPAAC and is responsible for refining NPAAC’s standard operating procedures.

– Technical Drafting Committees – technical drafting committees that are

established for specific terms to develop and/ or review identified accreditation

standards.

Legislative basis for pathology

accreditation and linkage to the

Medicare Benefits Schedule• 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 the specified quality standards set out in the Health

Insurance (Accredited Pathology Laboratories-Approval)

Principles 2002.

• The accreditation material is developed and maintained by

NPAAC, or is endorsed by NPAAC (ie NATA Field Application

document)

• Currently, NATA is the only endorsed assessing body for

pathology accreditation. The NATA/ RCPA accreditation scheme

assesses laboratories against the accreditation standards

developed by NPAAC that are specified in the legislative

framework.

Categories of Medical Pathology

Laboratories

Categories of Medical Pathology

Laboratories (cont..)

Pathology accreditation and

quality of pathology services

• Currently 20 quality standards that address good

laboratory practice, including supervision and technical

requirements for specific areas of pathology.

• NPAAC standards are based on relevant international

best practice and adopted for the Australian context

• Standards are usually reviewed on a 3 yearly cycle, or

can be considered earlier where necessary.

Quality of pathology

services

• Accreditation framework has been established for

some time, however there continues to be

challenges to ensure that potential areas of risk to

patient safety in pathology services are addressed

• A key focus for NPAAC is the safety of patients and

provision of quality pathology services

• NPAAC has identified a number of key priorities for

addressing in the accreditation framework as well as

through the publication of best practice guidelines

NPAAC Vision

NPAAC promotes:

• the provision of quality pathology services

• collaboration with government, non-government and consumer organisations

• educational programs in relation to pathology laboratory practice

• engagement with national and international standard-setting organisations

• the monitoring and measurement of quality of Australian pathology practice.

Document Hierarchy

Tier 1: Pathology Principles (legislative framework)

Tier 2: Overarching Requirements for all pathology services

Tier 3(a): Supervisory Requirements for pathology laboratories

Tier 3(b): Technical and specific Requirements for good medical practice in all pathology laboratories

Tier 4: Technical publications for specific areas of pathology

Tier 5: Endorsed third-party documents.

Priorities for 2012-2015The key priorities have been considered from the perspectives of the pathology request-test-report cycle.

Pre-Analytical

(Quality and Safety for Patients)

Patient safety

Unique health care identifiers

Pre-analytical incident monitoring

Direct to Consumer (DTC) testing

Analytical(Process/ laboratory process)

Workforce issues

Workforce numbers

Point-of-Care testing

Multi-analyte testing & molecular diagnostics/analysis

Post-Analytical

(Communication)

Electronic health records and the personally controlled electronic health record (PCeHR)

Post-analytical incident monitoring

Priorities for 2012-2015Quality Assurance

(Quality)

Report to Government

Development of quality metrics

Communication of NPAAC activities

Communication of activities to stakeholders

Development of a mechanism for providing early notification of possible reviews and/or

changes

Collaboration with national and international standards-setting bodies in healthcare.

Review of internal processes

Simplifying NPAAC’s documentation framework

Gap Analysis of the accreditation framework

Timelines for the development and review of documents

Monitor implementation of new requirements

Review of Tier 4 technical documents and whether there is a demonstrated need for

minimum best practice standards and/or guidance.

Recent Activity

• A review of the document hierarchy was

completed in 2013 with a simplified

structure under an overarching umbrella

document, the Requirements for Medical

Pathology Services.

• This entailed revision of all existing

documents to remove duplication and

inconsistencies.

Under Review– Requirements for the Supervision of Medical Pathology Laboratories

– Performance Measures for Australian Laboratories Reporting Cervical

Cytology

– Requirements for Information Communication

– Requirements for Procedures related to the Collection, Processing,

Storage and Issue of Human Haemopoietic Progenitor Cells

– Requirements for the Retention of Laboratory Records and Diagnostic

Materials

– Requirements for the Estimation of Measurement Uncertainty

– Requirements for Cytogenetics

Quality of Pathology

Services

• NPAAC has recently published best practice

guidelines titled –

– The provision of Direct-to-Consumer Genetic Testing:

Guiding Principles for Providers (May 2014)

• Working on best practice guidelines for Semen

Analysis and Point-of-Care Testing

Direct to Consumer (DTC) testing

Pathology testing occurring outside the normal doctor patient relationship and even outside the regulated pathology system has the potential to place patients at risk.

NPAAC continues to support the need for strategies to address the risks associated with DTC testing, in particular genetic testing.

The responsibility for accuracy of testing, the efficacy of the test and counselling patients about the significance of results is not clearly defined.

The UK and US experience to date with DTC provides evidence that guiding principles minimise the risks associated with DTC testing, in particular genetic testing.

DTC- Genetic Testing

• Medical testing occurring outside the normal doctor-patient relationship and/or outside the regulated pathology accreditation system has the potential to place patients at risk.

• While many providers may argue that the genetic testing that they are offering is for information only and is not health advice

• The provider’s processes should match the consequences that would reasonably arise from the consumer’s perception of the test result.

• Guiding principles that should be followed by DTC-GT providers in order to ensure the safety of their clients who seek this type of testing.

PoCT Guidelines

• PoCT is a rapid area of growth

• NPAAC established a technical drafting committee

in 2013 to develop guidelines for point-of-care

testing with the view to ensuring the quality and

safety of testing

• The NPAAC PoCT Guidelines outline best practice

for operators within pathology laboratories, but also

provide guidance on best practice for producing safe

and quality test results regardless of where the test

may be performed.

PoCT Guidelines

• The Guidelines sets out minimum best practice for

clinical governance, quality systems, staff training,

specimen and result integrity related to point-of-care

testing

• Broad public consultation was undertaken in June

2014 on a draft document

• Comments from the public consultation submissions

has been considered and the document has been

revised accordingly

• It is anticipated that the document may be finalised for

presentation to the October 2014 NPAAC meeting

Requirements

for

supervision of

Laboratories

Supervision of

Laboratories

• Review commenced in 2007 shortly after

publication of existing document

• Review has been contentious

• Multiple rounds of public consultation

Supervision

Bones of Contention

• NATA/ RCPA found the previous document

difficult to apply in the field.

• Definition of Senior Scientist

• Point of Care testing

• Supervision of category B laboratories

Supervision

Bones of Contention (cont...)

• Category S laboratories, boundaries of testing

• Tension between roles of Scientist and

Pathologist.

• Medical Director and Laboratory Director

Point of Care Testing

• New categories of P labs proposed in earlier

draft

• Reverted to existing laboratory categories

and deferred consideration of supervision

requirements for PoCT as part of the

Guidelines for Point-of-Care Testing

• NPAAC PoCT Guidelines document released

for public consultation in June 2014 (as

mentioned earlier)

Improvement of revised document

for easier use in the field by labs and

assessing body

• Supervision is considered to be a key area of risk to the

operations of a lab and patient safety

• adequacy of supervision difficult to assess

• most adverse findings at assessment are ultimately a

failure of the quality system or supervision

• the revised Supervision document provides clarity on

who is responsible for supervision in each respective

category of lab; what is expected from supervisors and

staff; how to demonstrate compliance with the

supervision requirements

• inclusion of a normative appendix in the revised

document that details supervision activities.

Future Directions

• Gap analysis of accreditation framework

• Quality Metrics Working party

• Streamlining NPAAC processes

Gap analysis of accreditation

framework

• Massively parallel sequencing

• Telepathology

• Internal Quality assurance to be included in

review of the EQA document

• Report content and format to be addressed in

the revised Communications document

Quality Metrics

• To source and collate information about

the performance of the pathology sector

and the performance of the accreditation

system.

• Consider and recommend measures of

performance.

Streamlining NPAAC

processes

• Timeliness of document reviews

• Better communication with stakeholders

• Signalling of likely future developments to

allow sufficient time for the sector to

consider.

Questions?Questions?

Further information

• Further information can be found from the NPAAC

website - http://www.health.gov.au/npaac

or

• Contact the NPAAC Secretariat at

[email protected]

Thank you