Regulatory Environment – Executive Summary-1 of 5

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Create a 3–4-page executive summary of tools and best practices for quality improvement, risk management, and learning guidelines. Include a summary table that describes the status of an organization’s compliance with regulatory requirements.


Questions to Consider:

The Regulatory Environment:

  • Which regulatory bodies oversee the subsector of the health care industry in which you currently work or would like to work?
  • How would you figure out which organizations oversee the subsector?
  • How would you determine which laws apply to your setting and what type of data you need to collect and examine?
  • What are the standards of care?
  • How would you locate these standards?
  • How would you know if your organization exceeded those standards and might be in a position to apply for accreditation?

Establishing a Culture of Patient Safety:

  • What is an example of a best practice for establishing a systems-based culture of patient safety?
  • How will you know if your organization was identified as an example of success when best practices are used?


  • What types of processes exist for collecting and analyzing data to identify trends in the performance of your health care setting?
  • Who are some of the health care industry’s best performers in terms of risk management?
  • What types of benchmarking data are important to consider?
  • What roles within your own organization need to be involved in a proactive risk-management program?
  • What are some critical success factors for the establishment of a systems-based risk-management program?
  • What types of considerations or cautions are important to keep in mind when interpreting internal and external benchmarking data?



Assume you have taken on a new role as the chief operating officer. You are charged with leading system-wide risk-management efforts to identify risk and minimize HACs. Your organization’s financial viability depends on receiving proper reimbursement for services delivered. As the chief operating officer, you must create an executive summary that describes your organization’s compliance with the regulatory requirement, to promptly identify conditions that are POAs and proactively assess and manage risk.


Step One: Executive Summary Table

Select a risk-management issue within a specific health care setting or organization. You will use this issue as a starting point for your work on this assessment. Use the Executive Summary Table from the Required Resources to complete this step.

  • Issue: Write a brief description of the risk-management issue you selected. Explain why this risk-management issue is important to your organization.
  • Regulatory Requirements: Compile a list of the applicable regulatory requirements and an explanation of what they mean to your chosen risk-management issue.
  • Risk-Management Implications: Identify the associated risk-management implications. For example, HACs result in no reimbursement, and poor quality ratings. Also, there is a risk of losing repeat admissions, a risk of losing Joint Commission and Magnet accreditation or excellence, or other negative implications.
  • Environmental Assessment: Assess the internal versus external environment relative to the risks associated with your chosen risk-management issue. You may use strengths, weaknesses, opportunities, and threats (SWOT) analysis or another suitable tool. Be sure to cite the source.
  • Resources to Address Issue: Describe any resources or strengths your organization possesses that could aid in addressing the risk-management issue.
  • Philosophy or Culture Statement: Summarize your organization’s philosophy or culture as it relates to patient safety and error reporting.
  • Measuring and Monitoring:
    • Identify metrics for measuring or monitoring the risk-management issue.
    • Propose how you will make use of the outcome data for organizational improvement.
  • Organizational Improvement: State how you will encourage voluntary reporting.
  • Ethics Considerations: Describe legal and ethical implications related to the handling of this risk-management issue.

Utilize established sources of information. Some sources that may be useful to you include the federal register, statutes, discipline-specific peer-reviewed journals, and government agency references.

Step Two: Executive Summary

Using the information assembled in Step One, prepare a 3–4-page executive summary for a written presentation to the management team. Select a format for your summary based on your chosen organization’s standards for executive summaries. (Examples of these types of documents can also be found using an Internet search.) Include the following:

  • A proactive assessment of your organization’s compliance with the regulatory requirement to promptly identify POAs and proactively assess and manage risk based on existing regulations and requirements.
  • Your identification of tools and best practices for monitoring parameters and reducing risk, including organizational structure needed for risk reeducation, as supported by the literature.
  • Your recommendations for quality improvement and organization-specific risk management and learning guidelines.

You must include the completed table from Step One as an appendix to this executive summary.


Accountable Care Organizations

This article discusses how a health care facility transitioned into an Accountable Care Organization successfully.

This article discusses how ACOs have achieved cost savings while improving care for their patients.

Quality Improvement Strategies

This article examines the revised nursing home quality measures endorsed by the National Quality Forum which could best represent the improving quality of care in nursing homes.

This article examines the various domains associated with quality improvement in healthcare organizations.

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This article explores how hospital managers perceive lean in the context of quality improvement.

This article discusses methods for auditing cost and quality tailored to a hospital’s specific population.

This article focuses on the factors affecting the adoption of innovative assurance technologies in nursing care.

Regulatory and Compliance

This article discusses a new regulation establishing and new safety-reporting for drugs under the investigational new drug applications.

Additional Resources for Further Exploration

You may use the following optional resources to further explore topics related to competencies.

Process and Performance Improvement

This is the home page of the American Productivity and Quality Center that provides best practices and benchmarking tools for designing effective methods for process and performance improvement.

Quality Improvement

This is a blog page on how to improve care for patients with Medicare.

This is the home page of Medicare that summarizes measures of quality shown on Hospital Compare.

This article discusses the Affordable Care Act funding for health providers to improve patient care.

Patient Safety

This article discusses various principles for creating a culture of safety in hospitals.

This is the home page of the National Quality Forum. It focusses on reducing preventable admission and readmissions, reducing adverse health care associated conditions, and reducing harm or unnecessary care.

This is the home page of the Joint Commission on patient safety goals and standards.

Regulatory and Compliance

This is the home page of the Healthcare Compliance Association for compliance professionals in the healthcare provider field.

This is the home page of the OIG U.S. Department of Health and Human Services. It discusses legal issues regarding ACOs participation in Medicare.

This is the home page of the U.S. Department of Health and Human Services laws and regulations.

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