ASSESSMENT 1: REGULATORY ENVIRONMENT – EXECUTIVE SUMMARY
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.
Context
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 [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.
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?
Benchmarking:
- 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?
Required Resources
The following resource is required to complete this assessment.
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.
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 https://www.apqc.org/knowledge-base/documents/apqc…
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 http://www.whitehouse.gov/blog/2011/03/31/improvin…
This is the home page of Medicare that summarizes measures of quality shown on Hospital Compare.
- Medicare.gov. (n.d.). Hospital compare. Retrieved from https://www.medicare.gov/hospitalcompare/search.ht…
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 http://www.infectioncontroltoday.com/news/2011/06/…
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 http://www.infectioncontroltoday.com/general-hais/…
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 http://www.qualityforum.org/Home.aspx
This is the home page of the Joint Commission on patient safety goals and standards.
- The Joint Commission. (n.d.). Retrieved from http://www.jointcommission.org
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 https://www.hcca-info.org/
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 http://oig.hhs.gov/compliance/accountable-care-org…
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 http://www.hhs.gov/regulations/index.html
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.
Expert Solution Preview
Introduction: As a medical professor, it is important to educate college students about the regulatory environment and the tools and best practices for quality improvement, risk management, and learning guidelines. In this assessment, students are required to create a 3-4 page executive summary and a summary table that outlines an organization’s compliance status with regulatory requirements.
Q: Which regulatory bodies oversee the subsector of the health care industry in which you currently work or would like to work?
A: The regulatory bodies that oversee the subsector of the healthcare industry vary depending on the subsector. For example, in the hospital industry, regulatory bodies such as the Centers for Medicare and Medicaid Services (CMS), The Joint Commission, and the Occupational Safety and Health Administration (OSHA) oversee compliance with regulations. In the pharmaceutical industry, the Food and Drug Administration (FDA) regulates the development and marketing of drugs. It is important to research and identify the regulatory bodies that pertain to the specific subsector of the healthcare industry of interest.
Q: What types of processes exist for collecting and analyzing data to identify trends in the performance of your healthcare setting?
A: There are several processes that exist for collecting and analyzing data to identify trends in the performance of a healthcare setting. These include benchmarking against similar organizations, tracking and analyzing patient outcomes and satisfaction scores, monitoring infection rates, conducting audits, and using data analytics. Using these processes can help healthcare organizations identify areas for improvement and implement strategies for quality improvement and risk management.
Q: What is an example of a best practice for establishing a systems-based culture of patient safety?
A: One example of a best practice for establishing a systems-based culture of patient safety is the use of a “just culture” approach. In a just culture, healthcare organizations encourage openness and transparency about safety-related events and use them as opportunities for learning and improvement rather than punishment. Additionally, healthcare organizations should implement strategies such as standardizing work processes, developing protocols and procedures, and providing training and education to employees to ensure that patient safety is a top priority.
Q: What types of benchmarking data are important to consider?
A: Some examples of benchmarking data that are important to consider include clinical outcomes, patient satisfaction scores, readmission rates, infection rates, and staff turnover rates. By comparing these data points with other healthcare organizations, healthcare leaders can identify areas for improvement and implement strategies for quality improvement and risk management.
Q: What are some critical success factors for the establishment of a systems-based risk-management program?
A: Some critical success factors for the establishment of a systems-based risk-management program include strong leadership and support from senior management, a culture of safety, the use of data and analytics to identify potential risks, the development and implementation of policies and procedures to mitigate risks, and ongoing training and education for employees. Additionally, it is important to have a system in place to track and respond to safety-related events and to use these events as opportunities for learning and improvement.
