The Regulatory Environment

The Regulatory Environment

Quality of Services Following the Institute of Medicine (IOM) initial reports on patient safety and medical errors, an increased attention and accountability has been placed on providers to improve the quality of services (2000, 2001). Within the industry, the IOM of the National Academies released a report in 2011 regarding systematic reviews for the promotion of patient safety and related standards.

Potential Risks Implicit within the quality care delivery process is the identification of potential risks, which may ultimately affect patient care. As the delivery of care standards are increasingly refined, cost-related metrics also must be monitored. The U.S. government, insurance companies, and other private payers are carefully watching the evolution of care standards and cost metrics. Health care leaders must be up to speed with quality care standards, identification of potential risks, and compliance with relevant regulations. An example of the integration of these concepts can be found in the launch of the accountable care organization (ACO) concept by the Department of Health and Human Services Center for Medicare and Medicaid Services (CMS). Secretary of Health and Human Services Kathleen Sibelius (2011) conveyed that the HHS “team carefully weighed the interests of hospitals, doctors, patients, and other stakeholders” when formulating the ACO roles and responsibilities. Risk assessment, quality care, and cost considerations are incorporated into the ACO concept (Lee, Casalino, Fisher, & Wilensky, 2011).

Regulatory Requirements It is important to consider the National Center for Healthcare Leadership Competencies (NHCL). Think of what types of skills will be needed to lead your organizations toward the goal of demonstrating quality and balancing costs. You may even wish to assess your own current competency levels relative to the health care industry’s movement toward performance measurement and increased accountability (NHCL, n.d.). Dr. Donald Berwick, who headed the HHS ACO efforts, discusses ACO concepts in his 2011 White House blog entitled Improving Care for People With Medicare. Dr. Berwick relates that:

Thanks to the Affordable Care Act, the Department of Health and Human Services (HHS) today released proposed new rules to help doctors, hospitals, and other health care providers better coordinate care for Medicare patients through Accountable Care Organizations (ACOs). ACOs are designed to create and support a team of health care providers who treat individual patients by working together across care settings.

Dr. Berwick (2011) adds that “ACOs would have to meet high-quality standards in five key areas:

1. Patient/Caregiver Experience of Care. 2. Care Coordination. 3. Patient Safety. 4. Preventive Health. 5. At Risk Population/Frail Elderly Health.”

Assessment 1 Context

2 MHA-FP5014 Assessment 1 Context

Regulatory Bodies In health care settings, there are various levels of oversight for organizations. Health care managers must be aware of the standards required to successfully provide quality care. Health care organizations need to comply with both regulatory standards as well as quality indicators set by accrediting bodies. For example, the Joint Commission is an accrediting body that sets standards for hospitals and other health care organizations. Organizations that are accredited by the Joint Commission are held to a higher standard. Voluntary accreditation allows health care organizations to benchmark themselves to ensure they are in line with national standards.

Benchmarking as a Condition of Participation Most of us have heard about benchmarking and are somewhat familiar with the concept. But, if your supervisor walked into your work setting today and asked you to provide some internal benchmarking data and compare it against national best practices, would you know what action or steps to take? Furthermore, would you know what organizations develop benchmarking standards and provide guidance for quality improvement? Youngberg (2011), a health care patient safety and risk management expert, describes benchmarking as the process of collecting and analyzing data to identify trends in performance and, when compared with other collectors of the same data, identifying best performers and determining if interventions that were introduced to address identified problems yielded the desired results. (p. 24) Benchmarking is not only a quality improvement tool but a condition of participation for some government and other payer sources. An example of this can be found in the requirements for accountable care organizations. Health care leaders must be familiar with the standards provided by both licensing bodies and accrediting organizations. It is important for health care leaders to understand how their organization stands in comparison to its peers as well as what standards it needs to meet for licensure, accreditation, and other regulatory compliance.

References Berwick, D. (2011). Improving care for people with Medicare [Blog post]. Retrieved from

Institute of Medicine. (2000). To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies.

Institute of Medicine. (2001). Crossing the quality chasm: A new health system for the 21st century. Washington, DC: The National Academies.

Lee, T. H., Casalino, L. P., Fisher, E. S., & Wilensky, G. R. (2010). Perspective roundtable: Creating accountable care organizations [Web video]. Retrieved from full/10.1056/NEJMp1009040

National Center for Healthcare Leadership. (n.d.). NCHL Health Leadership Competency Model. Retrieved from,3238

U.S. Department of Health & Human Services. (n.d.). Accountable care organizations. Retrieved from

Youngberg, B. J. (2011). Principles of risk management and patient safety. Sudbury, MA: Jones & Bartlett.

  • The Regulatory Environment
    • Quality of Services
    • Potential Risks
    • Regulatory Requirements
    • Regulatory Bodies
    • Benchmarking as a Condition of Participation

Overview Assessment 1-6.docx

· Overview

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.

Note: The assessments in this course build upon each other, so you are strongly encouraged to complete them in a sequence.

The scope of the regulatory environment and its requirements are ever-changing. Health care leaders need to know where they can find information about the requirements (within the subsector of the industry) to respond appropriately to issues. In addition, health care leaders need to proactively set strategies in place to mitigate future risks to their patients and organizations.

By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria:

· Competency 1: Conduct an environmental assessment to identify quality- and risk-management priorities for a health care organization.

· Conduct a proactive assessment based on the existing regulations and requirements.

· Describe strategies to influence, impact, and monitor the needed changes for quality improvement.

· Develop a value proposition for change management that incorporates quality- and risk-management concepts.

· Create an executive summary of a risk-management issue that describes an organization’s compliance with a regulatory requirement.

· Competency 4: Analyze applicable legal and ethical institution-based values as they relate to quality assessment.

· Integrate legal and ethical principles and also organizational mission, vision, and values into the decision-making process.

· Competency 5: Communicate in a manner that is scholarly, professional, and consistent with expectations for professionals in health care administration.

· Write clearly and concisely, with well-organized communication that is supported by relevant evidence.

· Use correct grammar, punctuation, and mechanics as expected of a graduate learner.


It is an exciting time in health care as all of us experience the implementation of the Patient Protection and Affordable Care Act of 2010. The change will likely affect your current or future health care job. Leaders in our industry are rethinking how business is to be conducted.

Understanding relevant terminology is an important step in addressing the topics of health care quality, risk management, and regulatory environment.

Read further in the Assessment 1 Context (attached) [PDF] document, which contains important information related to the following topics within the regulatory environment:

· Quality of Services.

· Potential Risks.

· Regulatory Requirements.

· Regulatory Bodies.

· Benchmarking as a Condition of Participation.

Questions to Consider

As you prepare to complete this assessment, you may want to think about other related issues to deepen your understanding or broaden your viewpoint. You are encouraged to consider the questions below and discuss them with a fellow learner, a work associate, an interested friend, or a member of your professional community. Note that these questions are for your own development and exploration and do not need to be completed or submitted as a part of your assessment.

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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?

· Toggle Drawer


Required Resources

The following resource is required to complete this assessment.

· Executive Summary Table [DOCX]. (Attached)

Suggested Resources

The resources provided here are optional and support the assessment. They provide helpful information about the topics. You may use other resources of your choice to prepare for this assessment; however, you will need to ensure that they are appropriate, credible, and valid. The MHA-FP5014 – Health Care Quality, Risk, and Regulatory Compliance Library Guide can help direct your research. The Supplemental Resources and Research Resources, both linked from the left navigation menu in your courseroom, provide additional resources to help support you.

· Terminology Drag and Drop | Transcript. (Attached)

Accountable Care Organizations

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

· O’Connor, J. (2016). An ACO success story. McKnight’s Long-Term Care News, 37(1), 27.

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

· Perez, K. (2014). ACOs and the quest to reduce costs. Healthcare Financial Management, 68(9), 118–122.

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.

· Barr, P. (2011). Setting higher standards: Nursing home quality measures offer guide. Modern Healthcare, 41(18), 17–19.

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

· Brandrud, A. S., Nyen, B., Hjortdahl, P., Sandvik, L., Haldorsen, G. S. H., Bergli, M., . . . Bretthauer, M. (2017). Domains associated with successful quality improvement in healthcare – a nationwide case study. BMC Health Services Research, 17.

This article explains the key role that leadership plays in supporting and aligning staff for patient care using the Malcom Baldrige criteria as a path to quality excellence.

· Miller, R. P. (2007). Baldrige as a path to excellence. Modern Healthcare, 37, 23–24.

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

· Savage, C., Parke, L., von Knorring, M., & Mazzocato, P. (2016). Does lean muddy the quality improvement waters? A qualitative study of how a hospital management team understands lean in the context of quality improvement.  BMC Health Services Research, 16.

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

· Silber, J. H., Rosenbaum, P. R., Ross, R. N., Ludwig, J. M., Wang, W., Niknam, B. A., . . . Fleisher, L. A. (2014). A hospital–specific template for benchmarking its cost and quality. Health Services Research, 49(5), 1475–1497.

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

· Storey, J. (2013). Factors affecting the adoption of quality assurance technologies in healthcare. Journal of Health Organization and Management, 27(4), 498–519.

Regulatory and Compliance

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

· Behrman Sherman, R., Woodcock, J., Norden, J., Grandinetti, C., & Temple, R. J. (2011). New FDA regulation to improve safety reporting in clinical trials. The New England Journal of Medicine, 365(1), 3–5.

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.

· APQC. (n.d.). APQC’s glossary of benchmarking terms. Retrieved from

Quality Improvement

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

· Berwick, D. (2011). Improving care for people with Medicare [Blog post]. Retrieved from

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

· (n.d.). Hospital compare. Retrieved from

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

· Infection Control Today. (2011). Up to Up to $500 million in Affordable Care Act funding will help health providers improve care.00 million in Affordable Care Act funding will help health providers improve care. Retrieved from

Patient Safety

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

· Teal, K. (2017). What infection preventionists can do to ensure a culture of safety. Retrieved from

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.

· National Quality Forum. (n.d.). Retrieved from

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

· The Joint Commission. (n.d.). Retrieved from

Regulatory and Compliance

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

· Healthcare Compliance Association. (n.d.). The Healthcare Compliance Association. Retrieved from

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.

· U.S. Department of Health & Human Services. (n.d.). Accountable care organizations. Retrieved from

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

· U.S. Department of Health & Human Services. (n.d.). Laws & regulations. Retrieved from

Risk-Management Text Books

· Kavaler, F., & Alexander, R. S. (2014). Risk management in health care institutions: Limiting liability and enhancing care (3rd ed). Burlington, MA: Jones and Bartlett. Available from the bookstore .

· Chapter 4, “Communications to Reduce Risk,” read the section, “Grading and Ranking Health Care,” pages 111–114.

· Chapter 5, “Financing Risk,” pages 123–125.

· Youngberg, B. J. (2011). Principles of risk management and patient safety. Sudbury, MA: Jones and Bartlett. Available from the bookstore .

· Chapter 1, “Risk Management and Patient Safety: The Synergy and the Tension,” pages 3–12.

· Chapter 2, “Integrating Risk Management, Quality Management and Patient Safety into the Organization,” pages 13–22.

· Chapter 3, “Benchmarking in Risk Management,” pages 23–30.

· Chapter 6, “Patient Safety: The Last Decade,” pages 63–68.

· Chapter 16, “Principles for Strategic Discovery,” pages 203–214.

· Chapter 17, “Full Disclosure as a Risk Management Imperative,” pages 215–224.

· Chapter 24, “Improving Risk Manager Performance and Promoting Patient Safety with High-Reliability Principles,” pages 343–350.

· Chapter 29, “The Impact of Fatigue on Error and Patient Safety,” pages 423–430.

· Assessment Instructions

Note: This assessment should be completed first.

PreparationScenarioAssume 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.InstructionsStep One: Executive Summary TableSelect 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.3. Issue: Write a brief description of the risk-management issue you selected. Explain why this risk-management issue is important to your organization.3. Regulatory Requirements: Compile a list of the applicable regulatory requirements and an explanation of what they mean to your chosen risk-management issue.3. 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.3. 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.3. Resources to Address Issue: Describe any resources or strengths your organization possesses that could aid in addressing the risk-management issue.3. Philosophy or Culture Statement: Summarize your organization’s philosophy or culture as it relates to patient safety and error reporting.3. Measuring and Monitoring:7. Identify metrics for measuring or monitoring the risk-management issue.7. Propose how you will make use of the outcome data for organizational improvement.3. Organizational Improvement: State how you will encourage voluntary reporting.3. 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 SummaryUsing 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.Additional Requirements. Written communication: Written communication should be free from errors that detract from the overall message. (You must include the Executive Summary Table as an appendix to your report.). Length of paper: 3–4 double-spaced pages for the written portion of the assessment.. Number of resources: A minimum of three resources.

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