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The effectiveness of healthcare regulation: lessons from research. 7 th EPSO conference – Cork, 15 May 2009 Professor Kieran Walshe Manchester Business School [email protected]. Overview. Defining regulation, and the growth of regulation in healthcare - PowerPoint PPT Presentation
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The effectiveness of healthcare regulation: lessons from research7th EPSO conference – Cork, 15 May 2009
Professor Kieran WalsheManchester Business [email protected]
Overview
• Defining regulation, and the growth of regulation in healthcare
• Thinking about regulatory agencies and processes: theories and frameworks
• The impact of regulation: some ideas and a case study
• Responsive regulation and regulation for quality improvement
• Conclusions
Defining regulation
“Sustained and focused control exercised by a public
agency over activities that are valued by a community”
(Selznick 1985)
• Public interest purpose
• Regulatory agency
• Formal regulatory powers and processes
• Economic and/or social regulation
People Technologies
Organisations
General Medical Council
General Dental Council
General Optical Council
Health Professions Council
Nursing and Midwifery Council
Council for Healthcare Regulatory Excellence
Healthcare Commission
Audit Commission
Mental Health Act Commission
National Institute for Clinical Excellence
European Medicines Evaluations Agency
Medicines and Healthcare Products Regulatory Agency
Equality and Human Rights CommissionHealth and
Safety Executive
EnvironmentAgency
The international regulatory landscape
What is regulated?Healthcare 582 NHS organisations, 1,426 independent
healthcare providersSocial care 150 local authorities, 26,000 care providers
School education
23,000 maintained schools; 1,120 independent schools (also 358 FE colleges; 100,000 childcare providers)
Housing 2,000 registered social landlords (housing associations)
Criminal justice 43 police forces; 42 criminal justice boards; 139 prisons
Environment Major pollution risks to air, water and land
Health and safety
Workplace health and safety in mines, factories, farms, hospitals, schools, railways,…
What does it cost?Healthcare Healthcare Commission has 600 staff and costs
£63m paSocial care CSCI has 2,500 staff and costs £159m pa
School education
OFSTED schools inspections cost £73m pa
Housing Housing Corp has 500 staff and costs £42m pa
Criminal justice HMIC £8.2m; HMIP £3.2m; HMIP £2.6m – total of c250 staff
Environment EA has 11,296 staff and costs £470m pa
Health and safety
HSE has 4,000 staff and costs £284m pa; 1,100 enforcement staff in LAs
The growth of regulation: likely causes
• Societal expectations and changing attitudes – to risk, quality and safety in healthcare
• Diminished trust in health professions and organisations – the rise of the “audit society”
• Evidence of poor performance - regulation as a political response to scandals and failures in care
• Changing ownership and structure of healthcare industry – from state to private/corporate, from central planning and direction to market/competition
Questions, questions…• Does regulation work?
• Why and how does it change organisations’ behaviour and performance?
• What are the principles of effective regulation?
• What can we learn from how regulation is done in other countries or other sectors?
• Why regulate in the first place?
• How should we design the “regulatory regime”?
More questions...
• Should we set standards or rules for people to follow? About what? How detailed? How strict?
• How do we decide who can do the business? Do we licence or certify people to operate? How?
• What shall we inspect? How often do we need to inspect or check up on people? How do we do it?
• What do we do when we find people are not performing or are breaking our rules? When should we use sanctions or punishments?
• How do we show that what we are doing is achieving something (and what is it we are trying to achieve?)
Some theoretical perspectives
• Public choice theory
• Public interest or interest group theory
• Institutional theory
• Principal agent theory
• Game theory
Considerations for regulatory regimesPublic choice theory •Burden
•Capture!
•Life cycleInterest group theory •Stakeholder governance
Institutional theory •Organisations and their responses
•Environmental pressures
•Smart/responsivePrincipal agent theory •Regulator/regulated imbalance
Game theory •“Win-Win”
Framework for analysing regulation
• Policy purpose or objectives
• Regulatory body or agency
• Range and scope of regulated activities
• Regulatory regime
Policy purpose or objectives
• Reasons to regulate: market failure, social goals and organisational characteristics/design– Improving performance – efficiency, effectiveness at an
organisational or a system level
– Making regulated organisations accountable – empowering consumers,
– Providing information (“sunshine regulation”) – which others use in making decisions
• But – objectives conflict; must be negotiated; are one among many influences
Regulatory bodies or agencies: autonomy and accountability
• Three basic types of agency:– Part of a government department (eg HMIC, HMIP)– An arms-length agency/NDPB (eg OFSTED, Healthcare
Commission)– An autonomous statutory body (eg GMC)
• What statutory powers and authority does it have?• How is it resourced – from grants/fees/levies?• How is it governed – board/management arrangements?• How and to whom is it accountable?
Regulated organisations and activities
• Scope of regulation – vertical and horizontal
• Number and size of regulated organisations
• Nature of regulated organisations and their environment
• Heterogeneity, and ideas of “amoral calculators” and “good hearted compliers”
Regulatory regime
• Direction – system level actions like publishing standards or directives, setting rates/tariffs, etc
• Measurement – organisational level actions like self-assessments, inspections, permits/authorisations, investigations
• Enforcement – publication of information, recommendations for action, fines/penalties/sanctions, incentives and awards, interventions in management, licensing/delicensing
The impact of regulation: perceptions
Providers’ views• Regulatory
“burden” and overregulation
• Multiple, duplicated oversight by regulators
• Restrictive, rule-driven regime
• Disconnected from improvement
Public views• Close and cosy
relationship between regulator and providers
• Undemanding oversight, feeble sanctions
• Window-dressing for the industry and professions
Regulator’s views• Necessary,
effective and focused oversight
• Key driver for improvement – would not happen otherwise
• Limited regulatory resources constrains what can be achieved
How regulation has an impact
• Direction – regulator issues rules/requirements and organisations comply of their own accord
• Measurement – prospect of being assessed or inspected stimulates change in organisation; results of measurement prompt reflection and change
• Enforcement – recommendations from regulator, sometimes backed by sanctions or incentives
• Indirect effects – other stakeholders pay attention to information from regulator in making their decisions
Positive and negative impacts
• Specific changes
• Organisational reflection
• Priority to important but non-urgent
• Leverage for internal groups
• Ratchet effect of raising standards
• Temporary improvement not sustained
• Pointless conformance• Defensive or minimal
compliance• Creative compliance• Inhibiting innovation• Distorting internal
priorities• Opportunity costs
Common regulatory problems
• Regulatee resistance
• Ritualistic compliance
• Regulatory collusion and capture
• Measurement ambiguity and problems
• Goal displacement
• Regulatory proliferation and growth
• Regulatory rigidity, juridification and inflexibility
Problems knowing what is effective regulation
• Methodological – difficulties of measurement, causation and interpretation
• Practical – regulatory agencies find it hard to experiment and innovate, are often risk averse
• Cultural – regulators and other stakeholders lack an evaluative culture and aren’t necessarily interested in finding out what works
• Political – purpose of regulation is both symbolic and functional, its not just about technical effectiveness
The impact of regulation: evidence from MARQUIS
• Survey of 69 expert informants in 24 of 25 countries of the EU – focused on national policies and strategies for quality improvement
• Survey of 389 hospitals across 8 countries and site visits to some hospitals, gathering data at organisation, department and clinical service level
• Key conclusions – external pressure from regulation, accreditation etc linked to more developed/mature QI systems at organisational level, linked to better quality care at clinical level
The impact of regulation: a case study of the Commission for Health Improvement
• Range, nature and appropriateness of recommendations in CHI reviews
• Appropriateness, resource implications and viability of Trust action plans
• Extent of implementation of action plans, barriers to progress, future expectations
• Impact on trust organisation and patient care
Benson LA, Boyd A, Walshe K. Learning from regulatory interventions in healthcare: The Commission for Health Improvement and its clinical governance review process. Clinical Governance: An International Journal, 2006; 11(3):213-224.
Research methods
• Selected sample of 30 NHS trusts which underwent clinical governance review in 2001 or 2002
• Existing data: review report, action plan, StHA progress review
• New data: questionnaire survey and case study interviews
• Finding, categorising, tracking and following up recommendations – “key areas for action” or KAAs
CHI reports varied greatly in structure, content and presentation
• Variation – from 20 to 80 pages, from 5 to 57 KAAs, differing structures and designs, different focus and emphasis
• Causes of variation
0
10
20
30
40
50
60
11 26 19 8 10 20 9 30 21 1 17 22 13 23 16 18 15 5 25 14 2 6 27 28 7 4 3 12 24 29
NHS trusts
Num
ber o
f KA
As
Unique Duplicate
Widespread acceptance of CHI’s recommendations
• Generally confirmatory – NHS trusts agreed wholly or partly with 92% of KAAs in survey; 77% of issues raised before in trust
• Recommendations “really came from us”. Trust had “no qualms”. Report was “fair and not surprising”. “Report … did not find anything that was previously not known”
Most of CHI’s recommendations focused on systems, processes and management
72%
11%
5%
2%
10%
Strategic/board level
Management/administrative
Patient care system/process
Environment/facilities
Patient experience/outcomes
Most of CHI’s recommendations focused on systems, processes and management
13%
9%
15%8%
8%
13%
16%
11%7%
Patient involvementRisk managementClinical auditStaffing/managementEducation/trainingClinical effectivenessUse of informationUser experienceStrategic capacity
The nature of CHI’s recommendations and how they were expressed varied greatly
• Type, level and measurability of change
• Clarity of purpose (what needs to be achieved) and prescription (what should be done)
46%
37%
3%14%
Clearly measurable Largely measurableMight be measurable Not measurable
NHS trust action plans also variable in structure, content and presentation
• Variation – from 4 to 89 pages, 25 to 247 action points• Some tackled recommendations embedded in report
text, others didn’t• Structure and ordering variable, hard to connect with
KAAs in report, easy to miss some KAAs• Some KAAs reworded or edited
NHS trust action plans also variable in structure, content and presentation
No of action points in action plan
0
50
100
150
200
250
8 19 9 22 20 13 1 11 21 5 15 17 18 30 25 16 7 4 6 23 27 10 14 26 2 24 12 3 28 29
NHS trusts
Num
ber o
f act
ion
poin
ts
NHS trust action plans also variable in structure, content and presentation
No of action points per KAA
0
5
10
15
20
4 7 21 13 1 18 15 22 8 25 14 20 6 24 27 19 23 16 12 17 5 30 9 2 29 28 3 10 11 26
NHS trusts
Mea
n no
of a
ctio
n po
ints
pe
r KA
A
NHS trust action plans also variable in structure, content and presentation
Percent of KAAs not addressed
0
10
20
30
40
50
14 8 19 9 20 1 11 21 17 18 25 4 6 23 27 26 2 24 12 28 29 3 30 22 10 15 7 16 13 5
NHS trusts
% o
f KA
As
Action plans mostly addressed CHI’s recommendations
17%
32%
46%
5%
Not addressed
Partly addressed
Mostly addressed
Completely addressed
Action plans mostly addressed CHI’s recommendations
Action points per KAA
0
50
100
150
200
1 2 3 4 5 6 7 8 9 10 11+
Number of action points
Num
ber o
f key
are
as fo
r ac
tion
Action plans mostly addressed CHI’s recommendations
Timescale for completion of action plans
0
50
100
150
200
1 2 3 4 5 6 7 8 9+
Timescale for completion (in quarters)
Num
ber o
f key
are
as fo
r ac
tion
Most of CHI’s recommendations have been acted upon
Data from stakeholder survey14%
40%
41%
4% 1%
Little or no action
Some implementation
Mostly implemented
Fully implemented
Don't know
Most of CHI’s recommendations have been acted upon
Data from StHA progress reviews
22%
30%15%
31%
2%
Little or no action
Some implementation
Mostly implemented
Fully implemented
Not reported on
Most of CHI’s recommendations have been acted upon
Data from StHA progress reviews, excluding KAAs not reported on
32%
43%
22%3%
Little or no action
Some implementation
Mostly implemented
Fully implemented
Most of CHI’s recommendations have been acted upon
Data from StHA progress reviews
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Patient involvement
Risk management
Clinical audit
Staffing/management
Education/training
Clinical effectiveness
Use of information
User experience
Strategic capacity
Not reported No action Some implementationMostly implemented Fully implemented
Most of CHI’s recommendations have been acted upon
% KAAs not reported on
01020304050607080
8 9 11 18 21 22 25 26 28 3 23 7 17 27 10 16 15 30 20 6 2 29 12 14 24 4 19 13 1
NHS trusts
% o
f KA
As
not r
epor
ted
on
Most of CHI’s recommendations have been acted upon
0102030405060708090
10 19 1 29 12 21 16 24 28 4 2 15 6 5 30 18 14 20 9 13 8 23 17 27 3 7 22 26 11 25
NHS trusts
% o
f KA
As
fully
impl
emen
ted
There are some important factors involved in securing implementation
Correlated:• Measurability of KAA• Whether action plan addresses
KAA• Timescale for action plan• Clinical governance review area• Trust• NHS trust star rating
Not correlated:• Whether KAA is a priority
• Depth, breadth, type of change
• No of action points
• Clarity of timescale
There are some important factors involved in securing implementation
Stakeholder views of what caused change
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
NHS trusts
PCTs
StHAs
All
CHI Don't know Other factors
There are some important factors involved in securing implementation
• “But where they scored (meaning CHI) was things like they said we needed to do a staffing review, in fact, we had done it before we had the CHI review, but they brought it up in the report which enabled us to use it in our SAFF negotiations to get further investment in staffing. So we used it again as a lever for change but also a lever within the SAFF process…”
• “What made a big difference in this organisation was seeing it in black and white in terms of lack of leadership and strategic direction and again once the execs. and board had been on that (development) programme they had a better understanding of what was expected of them and in terms of what the organisation had to do as well. I think that has made a big difference in the review of arrangements for clinical governance in the organisation…”
There are some important factors involved in securing implementation
• “Some new things for the Trust certainly,. The public involvement stuff… without the focus of the CGR they would not have made much progress with that. The concerns about Cardiology were raised by the Deanery before ……but the review did act as a catalyst to the patient and public stuff in particular.”
• “The review and report helped us to win over doubting clinicians, because it was not a “tick box” exercise. This was the biggest impact. Consultants who thought it was a passing fad now realise that CHI, CNST etc are part of the regulatory framework, so we/they need to be consistent about clinical governance – it is fundamental.”
Policy implications from the study
• Invest more regulatory attention and effort across the regulatory cycle
• Make regulatory interventions more consistent in approach
• Ensure all recommendations are constructed, expressed and communicated clearly
• Require detailed, explicit and comprehensive action plans, focus followup on the original review
• Shorten the regulatory cycle of attention, intervention and action
Responsive regulation• Regulatory regime recognises and responds to the
diversity of regulated organisations
• Regulatory interactions and interventions are highly contingent on how individual organisations behave
• “One size fits all” approaches are eschewed in favour of more flexible and graduated approaches
• Regulators and regulatory staff have considerable freedom to exercise judgement
(Ayres and Braithwaite 1992)
Responsive regulation Deterrence Compliance Regulator’s view of regulated
Amoral, out to get all they can, untrustworthy
Mostly good and well intentioned, not always competent
Regulated view of regulator
Policeman, enforcer, feared and disliked
Consultant, supporter, not a threat
Temporal perspective
Retrospective (find problems, punish and deter)
Prospective (prevent problems, promote improvement)
Regulatory methods Detailed written standards, formal inspection, routine use of penalties and sanctions
Standards supported by guidance, developmental approach to inspection, sanctions as a last resort
Relationship Distant, formal and adversarial
Close, friendly and co-operative
(Reiss 1984)
Responsive regulationStyle of regulation
Organisation
Deterrence Compliance
Amoral, out to get what they can
Tough stance pays, but organisations fight back too?
Organisations take regulator for a ride? Or rise to meet expectations?
Good hearted and well intentioned
Organisations bewildered and hurt by punitive stance? Become hard nosed?
Collaboration pays, and improvement results?
Responsive regulation
• Contingency in approach/methods• Hierarchy of regulatory intervention• Flexibility – scope for discretion• Tripartism – co-opting stakeholders• Parsimony – minimising intervention• Empowerment – supporting improvement
Walshe (2003)
A hierarchy of regulatory interventions
Closure or removal of licence; replacement of management
Detailed ongoing supervision or inspection; financial or other penalties;
limitations to activities or areas of work
Formal requirement to remedy problems; repeat or follow-up inspections; disclosure of findings to others;
referral to support or other agencies
Informal intervention to deal with minor problems; limited follow-up inspection; positive feedback on achievements and strengths
Granting of greater autonomy; relaxing of regulatory regime; financial incentives or rewards for good performance; public recognition of achievements; leading role in
transferring good practice to other organisations
Regulating for improvement
• Direction – setting detailed standards or high level principles with scope for interpretation
• Measurement - changing the intensity or nature of oversight (self-assessment, inspection holidays, shorter visits, etc)
• Enforcement - granting (or withholding) greater freedoms/powers, making remuneration partly dependent on regulatory status or performance
• Using successful, high performing organisations or other stakeholders in the regulatory process
Regulating for improvement
• Information – need for high quality and timely data to make responsive regulatory decisions
• Regulatory agency staff – need for content knowledge currency and credibility, plus process skills in interaction and professional judgement
• Regulatory process design – need for discretion and flexibility allowed in its implementation, balanced with need for accountability and fairness
Regulating for improvement
• The extent, motivations and nature of intrinsic regulatory compliance – and the place of extrinsic compliance?
• Longitudinality of relationship and knowledge crucial – its about feedback and interaction
• The setting of high moral expectations in the relationship – appealing to better nature
• The ability to be helpful, supportive, facilitative – and directive, interventionist and punitive
Conclusions
• Regulation works – it drives change in healthcare organisations, but it can have negative as well as positive impacts
• Research has a lot to offer in helping to develop and evaluate effective regulatory strategies – and has been underused to date – much regulation is not “evidence-based”
• Responsive regulatory strategies offer a real opportunity to make more effective use of regulation to support and reinforce organisational quality improvement efforts