Regulatory Excellence Framework
Written by Michele Brennan Director of Policy, Practice & Legislation College of Registered Nurses of Nova ScotiaIntroduction
Regulation in health professions has been changing in recent years and the concepts of “good regulation” and “right touch regulation” have received much interest. Professional organizations and regulators have been under increased scrutiny by government, the public and the media in the last five years and there have been increasing threats to self‐regulation (Lahey, 2011). The College of Registered Nurses of Nova Scotia, (the College, CRNNS), like many health profession regulators has been examining processes and practices to ensure they are appropriate, fair, transparent and accountable to the public. This article describes the development of an integrated regulatory excellence framework for the College of Registered Nurses of Nova Scotia, which addresses the concepts of risk management, quality assurance, quality improvement and the relationships existing between the concepts.
Regulation in the Health Professions
Casey (2008) states that it is no longer a self‐evident truth to those outside of the professions that self‐ regulation of the professions is in the public interest. Self‐regulation is being displaced, restructured and/or more tightly supervised as regulatory rules are consolidated, transferred to new institutions or subjected to new layers of oversight (Lahey, 2011). Even though health profession regulators are in the quality and safety business, quality and safety are not what they should be (Lahey, 2010). Baldwin and Cave (1999) identify criteria for “good regulation” including effectiveness in fulfilling legislative mandate, expertise, efficiency, procedural fairness, openness, accessibility and accountability. Regulatory organizations not only have to be accountable but must also demonstrate their accountability to the public and other stakeholders. “Right touch regulation” refers to the minimal regulatory force required to achieve the desired outcomes (Council of Healthcare Regulatory Excellence, 2010). For some time now, the College has had many of the components of regulatory excellence in place. The College historically has paid significant attention to risk identification and risk management but did not have a formal documented process or reporting structure. In 2011, the College began to develop a formal risk management framework to document all the known and potential risks to the organization and to identify potential gaps. Changes to internal and external quality requirements continue to evolve with changes to legislation, trends in professional regulation, employee support and development programs including health and safety. In the last 10 years, the College has invested
considerable resources in support of improving internal quality processes for employees. The College Council implemented the policy governance model for Board governance in 1999, which clearly separates the roles of governance and management, clarifies the accountability of the Council and the Executive Director, and promotes effective governance.
It became apparent that the College should clearly document an overall structure to describe the major components of the regulatory framework and the linkages among the components. This structure would support an assurance that the requirements of “good regulation” are being met and identify existing gaps.
Figure 1 below describes the umbrella structure that encompasses all of the innovative regulatory and quality initiatives within the College as well as a risk management framework.
The framework defines the structure of the College's approach in delivering excellent regulatory services, managing risk, identifying strengths and areas of excellence and innovation while also identifying areas where programs and services may need to be developed or improved. Quality and risk management are viewed as complementary concepts and together are key components of regulatory governance and excellence. Utilizing effective risk management principles and processes improves ongoing quality assurance as well as internal quality improvement.
Building on the criteria for good regulation, the College identified six principles of regulatory excellence under the broad umbrella structure using the components of risk management, quality assurance and quality improvement. Those principles are:
1. Focus on the public (owners) and customers
2. Emphasis on achieving excellence in regulatory outcomes effectively, efficiently and sustainably
3. Prioritize regulatory activities and resources on an evidence based assessment of risk 4. Provide a supportive organizational culture
5. Emphasize teamwork and effective collaboration across cross functional teams 6. Ensure effective use of resources including people, finances and IT The benefit of this integrated approach enables all programs and services of the College to play their full part in meeting the requirements of good regulation.
Risk‐Based Regulation
Interest in risk‐based regulation has grown significantly in the past three decades (Black and Baldwin, 2010). Focusing on risks rather than prescriptive rules and encouraging regulators to explicitly assess risks enables limited resources to be better targeted to achieve desired policy outcomes (Peterson and Fensling, 2011). The literature on risk‐based regulation defines it as the application of a systematic framework that prioritizes regulatory activities and deployment of resources on an evidence‐based assessment of risk (Peterson and Fensling, 2011). Risk‐based regulation involves steps and components that require complex and strategic choices, different skills and capabilities, and clear governance and accountability arrangements. Since 2011, the College has been working on developing a risk management framework, which is based on “enterprise risk management” (ERM). The College risk management plan situates and integrates risk management processes within the overall governance, management, quality framework, policies, philosophy, and culture of the College. ERM moves the concept of risk from the traditional ‘silo’ approach where each department was responsible for ‘fixing’ its own problems, to an organizational‐ wide commitment to assessing, managing, measuring and monitoring all risks confronting the College. This is totally consistent with the quality assurance and quality improvement approach used at the College, which is based on cooperation, collaboration and cross functional teamwork. The basis of enterprise risk management at the College is that every part of an organization is responsible for managing risks in its own area using processes and guidance provided by a cross functional risk management committee.Quality Assurance
In reviewing the literature on quality, it is apparent there are often different definitions or even conflicting views of the concepts of quality improvement and quality assurance. In the end, the College developed their own definitions for quality assurance and quality improvement. The goal of quality assurance is to meet regulatory standards and ensure protection of the public. Quality assurance (QA) is viewed as a process oriented to support the College in meeting its mandate of regulation of the practice of registered nurses (RNs) in the public interest. In other words, the College promotes the practice of registered nurses in the delivery of safe, competent, ethical and compassionate nursing care to the public. Quality assurance focuses on processes used to monitor and evaluate compliance of members to regulatory requirements as well as evaluating CRNNS programs and services used to meet regulatory standards. College programs and projects under the quality assurance umbrella include, but are notlimited to, the Continuing Competence Program for RNs and nurse practitioners (NPs); the Nurse Practitioner Quality Monitoring Program (NPQNP); Member and Public Surveys; Governance; and the Regulatory Policy Committee.
Quality Improvement
Quality improvement (QI) is defined as a proactive process, which promotes continuous quality improvements by improving internal processes and systems. Quality improvement is thus more internally focussed recognizing that internal improvements ultimately benefit the regulatory work of the College and positively impact the public, members and other stakeholders. The College joined Excellence Canada in 2005 (previously the National Quality Institute), which assists organizations achieve organizational excellence by providing a criterion based assessment framework process similar to that used in hospital accreditation. The College received three gold awards in 2006 (Quality), 2009 (Healthy Workplace) and 2012 (Order of Excellence, Innovation and Wellness). Included under the QI umbrella are the work of Quality Council (QC); Joint Occupational Health and Safety (JOHS); Health and Wellness Program; Service area teams and cross functional ad hoc quality teams.Conclusion
The College of Registered Nurses of Nova Scotia has developed a Regulatory Excellence Framework that encompasses all of the innovative regulatory and quality initiatives within the College as well as a framework for risk management. Customizing the definitions of quality assurance and quality improvement and clearly linking it to risk management allowed the College to clarify and further strengthen its self‐regulation mandate in the public interest. This includes promoting the development of programs and services to support registered nurses in delivering safe, effective nursing care.The umbrella structure of regulatory excellence promotes improved public confidence, a systematic identification of areas for improvement, better decision‐making, better resource planning and utilization for sustainability of the organization and ultimately better regulation.
References
Black, J., & Baldwin, R. (2010, April). Really responsive risk‐based regulation. Law & Policy, 32(2), 181‐ 213. Abstract retrieved from http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1571808 Baldwin, R., & Cave, M. (1999). Understanding regulation: Theory, strategy and practice. Oxford, UK: Oxford University Press. Casey, J. (2008). Key trends in professional regulation. Fieldlaw, 5, 1‐3.Council of Healthcare Regulatory Excellence. (2010, August). Right‐touch regulation. London, UK: Author. Lahey, W. (2011). Is Self regulation under threat. Canadian Nurse, 107(5), 7‐8. Lahey, W. (2013, February). Trends in health regulation. Paper presented at the meeting of the College of Registered Nurses of Nova Scotia, Halifax. Peterson, D., & Fensling, S. (2011, April). Risk‐based regulation: Good practice and lessons for the Victorian context. Paper presented at the Victorian Competition and Efficiency Commission Regulatory Conference, Melbourne.