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(1)

Enterprise Risk Management

(2)

Agenda

Definition & Risk Response

Environment Scan – news from Insurance

Confusion Reduction – Lessons Learned from

Others with an ERM program

(3)

Enterprise Risk Management

Defined

: Measures to minimize risk of medical or accidental loss or injuries. A risk is an issue yet to be

realized. An unplanned outcome. A continuous, proactive and systematic process to understand, manage,

and communicate risk organization-wide making strategic decisions to achieve overall corporate objectives

Defined: A process affected by Board of Directors & Management, strategically applied, designed to

identify potential events, manage risk (within their risk appetite), and provide reasonable assurance of an

organizations objectives achievement

1

Focus

: Reducing threats & impact.

Risk

: identification of exposure e.g. property, income, liability, personnel, operational, financial, strategic,

legal, regulatory, technological, etc.

Methods

:

Early Identification

Effective Trending

Appropriate Recommendations

Promote Quality and Process Improvements to diminish risk of future incidents or occurrences

How

?

Promotion and education of Incident Reporting system (including protocols & policy for the unexpected)

Risk assessments, consultation, and sharing of information

Integrated critical incident policy and reporting with partners

Facilitation of adverse / unanticipated event disclosure

3

(4)

Risk Assessment Categories

4

Patient

Quality of Care

Outcomes

Satisfaction

Security

People & Projects

Credentialing Labour Relations Staffing

Training / Education

Occ Health / Safety

Operations & Environmental

High Risk Clinical Programs and Activities

Environment of Care

Supply Chain

Finance

Insurance

Contracts

Funding

Budgeting

Purchasing

Investments

Technology

Information Systems Security Continuity

Data Integrity Capacity Failure

Legal/Reg

Statutes, Policies, Standards, Regulations

Compliance and Accreditation

Strategy

Mission, Vision, Values

Leadership

Reputation

New Projects

(5)

Risk Response

Actions

Accept and tolerate the risk

Share and transfer the risk

Reduce the risk: change likelihood. Change consequences.

Avoid and eliminate the risk

Best Practices

Governance: policies, practices

Development: plan for the realization of benefits

Operations: plan for change testing, capacity, security

Acquisition: plan for partner management

Others:

Focus on what is important to control, not what is easy

(6)

INSURANCE PROVIDER INFORMATION

(7)

2010 U.S. Healthcare Enterprise Risk Survey – Top Risks

Financial

Revenue increases consistently below medical inflation

Unfunded mandates for the provision of services

Increasing capital costs and gaps between needed and available

capital

Physician relationships – ability to control the direction and level of

alignment of physicians and institutions

Preparedness for clinical automation: inadequate I.T. requiring

investment in more sophisticated systems – e.g. Inability to develop

a fully operational electronic health record.

Improving performance in the midst of accelerating regulatory and

marketplace change

Employee dissatisfaction – e.g. Nurses strike, resignations

7

(8)

Emerging Risks / Trends / Class Actions

Nosocomial Infections

Pathology and Lab Issues (ID, interpretation, false pos/neg,

result communication)

Sterilization: effectivity of equipment, staff certification

Clinical Trials

Treatment of Foreign Patients: Governing Law and

Jurisdiction Agreement needs to be in place

Disclosure: transparency and communication with patients

and families

Privacy: custody and control

Cyber Risk: personal devices and virtual wards

8

(9)

HIROC Top Risks

(10)

HIROC High Risk Management Factors

1

1. Documented Board approval of the Risk Management program, including a description of formal reporting relationship to the Board. 2. Committee with Patient Safety/Risk Management responsibilities.

3. Committee activity relating to Risk Management activity including: Infection Control, Occupational Health and Safety, Morbidity and Mortality, Pharmacy and Therapeutics, Quality Management, Utilization Review, etc.

4. Health Records policy advising Claims Manager of potential medical-legal issues. 5. Staff and medical staff awareness of Safety Reporting (RMPro)

6. Awareness of staff and medical staff of policy regarding lending and borrowing of equipment.

7. Loss control procedures including guidelines for identifying pertinent personnel/departments and for requesting the identification, location and look-up of records etc. related to an incident.

8. Responsibility for coordination of risk management delegated to one individual.

9. Managers in Patient Safety department possess a level of authority that allows them to influence change in policies and standards which govern potential loss.

10. Patient Safety Dept. receives copies of all reports and any follow-up documentation (incident reports, medication IV therapy reports, complaints)

11. Claims Manager aware of any statement of claim served upon the institution.

12. Patient Safety Manager receives medical device recalls, and alerts, and has a system in place to disseminate the information, and feedback process to ensure recommendations are adhered to.

13. Compliance with universal precautions/body substance precautions is monitored. 14. Procedure for retention of outdated policies and standards.

15. Security issues are addressed by management, medical staff and at all department levels. 16. Any breach of security is reported as a safety report.

17. All staff and medical staff wear identification badges. 18. Initial and annual credentialing systems are in place.

10

(11)

CONFUSION REDUCTION

Lessons Learned

(12)

Lessons Learned

Traditional concerns:

– “we will worry about that if a situation arises”

– “we cannot get people to fulfill normal project tasks”

– “we don’t have time to plan projects as it is without theoretical risks piled on top”

– “risk planning is too theoretical”

– “its like we are planning for failure”

Practical measures

– Risk Management effectiveness and value should be measured

– Focus needs to be specific, realistic, and actionable

– For projects: 10% of resourcing on risks max.

– Regularly review risks to imbed in culture and reduce blame

– Actively manage a fixed number of risks and reprioritize others

– Multi-dimensional impact analysis (cost, schedule, quality, scope, etc.)

General

– Risk assessment cannot be viewed as episodic, and info needs to build vs. becoming stale w same results

– Data & Information gathered needs to be easy to interpret and use. Assess risk adjusted returns.

– Risk follow-up needs to have clarity, accountability, and ownership

– Risk response needs to be balanced to value (e.g. avoiding an excessive cost burden)

– Risk assessment needs to be built into business processes vs. being added to the day-to-day responsibilities

– Risk assessments need to be centrally coordinated vs. performed independently across the organization

– Risk assessment will not prevent a big failure – it reduces the risk and increases the responsiveness

(13)

Risk Identification

Identification:

Incident reports for the unexpected or change in anticipated disease / treatment

process of a patient / client / resident

Managers review and report to Risk Management

Severity is assessed with RM follow-up

Incidents are tracked and trended in a database

De-identified data in aggregate is distributed to managers regularly

Agenda item in staff meetings

Patient and family feedback through client representatives, care providers, etc. to RM

Process

Managers and staff develop strategies for most situations

Sometimes other stakeholders are engaged for action plans (e.g. policy development,

procedural changes, etc.)

Multi-disciplinary reviews in a non-blame environment sponsored by sr. management

(14)

Success Framework

1)

High level framework and communication tool

Single page view of business focus, milestones, activities

2)

Critical Event Trees – highest risk events

3)

Schedule Risk Analysis

Identify method of completion in time and budget

Identify issues, confidence & near critical paths

Engage in an iterative development path

4)

Develop Risk Trees and Risk Action Plans

Assume events will occur (break optimism cult). Develop plan.

Use effective tools: risk register, actions, due dates, mitigations, etc.

A materialized risk is an issue: corrective action & work-effort

5)

Frequent Consultation

6)

Transparency

(15)

Key Principles

1

Clearly established risk assessment governance process

Board and Audit Committee identify and address risk

Risk facilitator owns process to analyze & discuss

Management manages risk & engages process owners

Specific identification of risk assessment objectives

Organizational objectives define the scope of assessment

The appetite for risk assigns risk tolerance (acceptable variation)

Organizational objectives measurements should define the risk rating scales

Risk measure timelines should align with the achievement of objectives

Prioritization of resources / actions are based on assessment ratings

Management makes decisions using a portfolio view of risks

Enterprise Risk Management looks at the inter-relationships between risks

Correlations may expose assessment variations and change systemic response

Insight into potential risks come from leading indicators

Use Key Risk Indicators (KRI) in addition to KPIs.

Use Leading Indicators: measures that signal a change in the environment

E.g.’s: increase in late supply shipments; outbreaks; reduction in funding; etc.

15

(16)

AVAILABLE PROGRAM & TOOLS

How to proceed?

(17)

Risk Assessment Steps

Establish the context of risk

Use Patient / Client and Business objectives as a basis. Use this as a gauge for risk appetite.

Use strategy maps, cause & effect relationships, value assessments, etc.

Identify potential events threatening objectives achievement

Establish an event inventory using internal (survey, process, events, etc.) and external sources (benchmark, tech

breakthroughs, etc.)

Evaluate “risk/reward” in context of volatility affect on key business services

Assess potential impact and risk tolerance

Categorize potential event categories – opportunities (positive) or risks (negative)

Evaluate within a framework (see key principles, etc.) & risk map

Establish risk tolerance – relative importance of objectives with risk limits

Develop and Iteratively Refine the Response Framework

Regularly evaluate risk tolerance, event probabilities & impacts, backup plans, etc.

Actions taken should demonstrably lower risk probabilities and incrementally build

Consider hedging instruments: risk sharing, insurance, outsourcing, etc.

Maintain and Monitor the Program / Metrics / Framework

Aggregate individual residual risks together to a portfolio view (inter-dependencies and inter-connections)

Action plan assignment needs to have capacity, capability, and authority

Communicate, communicate, communicate

17

Risk Context

Identification

Assessment

Response

Maintain & Monitor

Commu

nic

at

(18)

Frameworks

18

Risk Context

Identification

Assessment

Response

Maintain & Monitor

Commu

nic

at

e

Freque

ncy

Th e n u m b er o f lo ss es /e ve n ts / like liho o d . Often- 5

Occurs often, every 1-6 months

Medium 5 High 10-20 Very High 25-35 Very High 40-50 Possible – 3

Likely/known to occur, every 6 months – year Medium 3 Medium 6-12 High 15-21 Very High 24-30 Rare – 2

Could occur, once every 1-10 years Low 2 Medium 4-8 Medium 10-14 High 16-20 Never – 1

Could happen, but likely not, once every 10-100 years

Low 1 Low 2-4 Medium 5-7 Medium 8-10 Insignificant/ Near Miss/ No Harm (1)

No impact, event did not reach patient or staff member

Minor (2-4)

Could have little impact/ effect on organization/patient/ staff

Moderate (5-7)

Could have a moderate impact/effect/

exposure on

organization/ patient/ staff

Major (8-10)

Could lead to serious risk exposure for the organization/patient/ staff

Consequences / Severity

The severity/amount of a loss/event, focus on actual or potential harm

Patient

People

Operations/Env

Finance

Technology

Legal/Reg

Strategy/Rep

(19)

Risk Evaluation & Management Tools

19

Risk Category

Risk Description

Risk Category

Risk Priority

Risk Impact Assessment

Risk Category

Probability

Impact Consequences Weight (Prob * Impact)

(20)

Risk Management Tools

Incident Reporting Solution

Disaster Recovery & Business Continuity Plan

Emergency and Pandemic Plan

Occupational Health and Safety Monitoring, performance & sick management

Strategic Planning

Patient & Staff Safety, Violence, Harrassment Planning

Standing Agenda Item

Preventative Maintenance Program

Credentialing, consent, confidentiality, privacy, release management

Contract, procurement, and supply chain management

Exceptions, abnormals, adverse events management

Audits, inspections, reviews, assessments

Programs: Infection Control; Quality Improvement

Insurance, working capital, management reporting

(21)

KEY QUESTIONS AND NEXT STEPS

Now What?

(22)

Risk Review Key Questions

1)

Are any of our objectives at risk?

2)

Are we in compliance with policies and regulations?

3)

What risk events have been escalated?

4)

What trends require immediate attention?

5)

What risk areas need to be reviewed?

6)

Are these risks within acceptable limits? i.e. what is the frequency,

are there financial consequences, are there patient or staff safety

consequences?

7)

How will the risk be managed/monitored?

8)

What are the controls in place to manage high and medium risks?

9)

How will each unit/program/team be accountable for the

management of this risk?

10) How will the success be measured?

22

(23)

Enterprise Key Questions

Operational

– Do people with risk management accountability have the authority to change process / practices governing the potential loss?

– Are leaders oriented to risk management strategies?

– Are staff, physicians, volunteers, contractors, etc. oriented to safety reporting & policies?

– Is credentialing an ongoing process

– How is safety and security ensured?

High Risk Practices / Areas

– How are high risk practices addressed (meds, falls, specimens, consent, restraints, observation, etc.)?

– What is equipment and medical device prevention and maintenance program?

– What processes control, monitor, and ensure high standards of documentation and communication?

Legal / Regulatory:

– Are the appropriate people immediately notified?

– Are there risks to statutory / regulatory compliance, adherence with legislation, standards, accreditation, etc.

People Resourcing

– Clear and consistent policies re: termination, education, succession planning, recruitment, harassment, system abuse, etc.

– How is monitoring of clinical competency accomplished?

– How is privacy and confidentiality maintained?

Financial

– Is there a consistent process for contract agreement, development, renewal, and archiving, etc.?

Technology

– Are there risks associated with biomedical, IT, data integrity, systems security, disaster recovery & business continuity, etc.

Strategy

– Are there constraints to growth, budget, LHIN funding, quality of care, public relations, etc.

– Are there risks to culture, change response / planning, etc.

(24)

Risk Assessment Methodologies

Qualitative

Categorization of potential risks using nominal or ordinal scales

(ranked comparatively to each other)

External validation mitigates bias

Quantitative

Benchmarking

Probabilistic modeling (e.g. backtesting, loss event assessments,

and “at-risk” modeling) = likelihood and impact

Non-probabilistic modeling (e.g. stress tests, sensitivity analysis,

and scenario analysis) = impact

Used as internal event data builds and can be tracked

Refined through iteration

(25)

Next Steps

Based on our size and available resources, focus on:

Insurance company risk assessment checklists

Published Patient Safety best practice checklists

Standards based industry tools

Divvy the work up to areas of responsibility using a common tool such as

excel

Standardize the assessment tool (such as shown earlier) and rank the risks

according to:

Impact

Probability / Frequency

Order of magnitude costs to resolve

Area / type of risk

Focus resources on the top ten and develop a mitigation strategy for each

(avoid, share, reduce impact or consequence, or accept and move on)

(26)

THANK YOU

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