National Pathology Accreditation Advisory

Council

Seat belts and NPAAC’s risk based approach

to Accreditation Standards in Pathology

Bev Rowbotham MD FRACP FRCPA FAICD

Chair National Pathology Accreditation Advisory Council

Life (and healthcare) is a risky

business

History of risk management

• The whim of the gods

• Social conventions that managed risk and non

systematic preventions

• The theory of probability 1654, led to the use of

mathematics as an instrument for organising and

interpreting information.

- insurance

- Liquid capital markets

- Modelling (engineering)

• Risk management industry (C20)

Solutions to risk

• Prevention

• Insurance

• Education and training

• Regulation

• Disaster recovery

• Risk Management process – inherent risks– Ignoring discontinuity

– Attempting to quantify the unquantifiable

– Encourages risk taking.

Seatbelts

• First seat belt law 1970, Victoria, Australia

• Regulation: Harm prevented (deaths from

MVAs) vs civil liberty and costs to manufacturers

• Claimed benefit – significant but overstated (risk

compensation: people drive faster with

seatbelts)

• More interventions. Incremental passive safety

systems –airbags etc, licences,DUI

Pathology

• Self regulation

• Profession led Standards ( RCPA 1956)

• Qualifications, registration

• Regulation: NPAAC 1979 – standards and

advice.

• Voluntary registration NATA/RCPA 1982

• Compulsory laboratory accreditation and

linkage to Medicare Benefits scheme 1986

• 2016 mature compliance based regulatory

process and high reliability industry

Quality systems

• Origin - industrial product production line

• ISO 9000 1987, ISO 15189 2003 for

medical laboratories - processes and

audit to give a consistent and satisfactory

testing performance. 33 countries, 7 years

to develop.

• Affordable Care Act 2010 - Quality

management in service organisations

• Systems are not necessarily

comprehensive

Insights from other

industries with regulatory systems

• Policing

• Environmental protection

• Tax administration

• Customs

• Occupational health and safety

• Fraud control

• Corruption control

• Financial regulation

• Civil air safety

Australian challenges in the provision of

pathology services

Risks to patient safety1986

• Landscape: mix of large laboratories,

some networks, and cottage industry.

• Problems: lack of consistent methods and

processes, some evidence of unreliable

results, turnaround times.

Risks to patient safety

2016Landscape: corporatisation, single model of

hub and spoke, centralisation, aging

workforce

Problems: logistics, turnaround times and

services for regional Australia, unclear

governance arrangements in some

networks, high dependency on IT

Systems: Healthcare a complex

adaptive system. Glouberman and Zimmerman 2002

Risks of Complex Systems

The Biology of Corporate Survival Reeves et al HBR 2016

Features of robust

organisations

• Heterogeneity

• Modularity

• Redundancy

Threats

• Collapse risk

• Contagion risk

• Fat tail risk

Risk management –

the unmet needs• Risks which are not managed by the

existing systems

• Risks that fall between the cracks,

interagency risks

• Novel risks associated with new

technologies

• Emerging risks

• Catastrophic risks

• The risk-based regulator, by focussing on

outcomes, is constantly monitoring

performance, and detecting and assessing

risks, and must be prepared to change

priorities or instrumental choices as needs

arise. The regulatory framework is not

fixed, and will change over time.

Managing the pivot in

regulation• Build upon compliance based (legal)

regulation

• Consult with the sector

• Identify the risk problems it has not solved

• Build the register of risk or “friction points”

that must be addressed

• Build the metrics

• Consult with other industries and their

regulators (Logistics – clinical trial labs)

Data sources

• Seatbelts

• Drug effects

• Pathology ??

Sources of data about laboratory error

• The media – national and international

- IT failure to release results

- IT failure – no update on changes to procedures to notify

results

- Coroner’s case – result not acted upon

- wrong results with delayed action - test assay and

governance issues

• RCPA/NATA accreditation data

• NPAAC Council

Harm from laboratory error

• Leeds 2016 – pathology the electricity grid

of healthcare

• IOM 2015

Diagnostic error

NPAAC work plan 2016-2018

Standards• Medical governance and supervision

• EQA and QC

• Transport

• Human medical genome testing

• The national cervical cancer screening program

A data set to measure risk

text[Discussion] When self-driving cars are ready,

will we need seat belts, air bags, alcohol laws or

drinking age limits? (self.Futurology)

submitted 8 months ago by sotopheavy

What is the next big thing in risk management in

Pathology? What would Elon Musk do?