MHA FPX 5014 Assessment 1 Regulatory Environment – Executive Summary

MHA FPX 5014 Assessment 1 Regulatory Environment – Executive Summary


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MHA-FPX 5014 Health Care Quality, Risk, and Regulatory Compliance

Prof. Name


Regulatory Environment – Executive Summary

Healthcare organizations must establish stringent regulatory standards to ensure patient safety and avoid adverse events like hospital-acquired complications (HACs) and healthcare-associated infections (HAIs). Compliance with these standards is also essential for regulatory accreditation, such as that provided by The Joint Commission, which grants accreditation to organizations that meet its criteria. Additionally, the Agency for Healthcare Research and Quality (AHRQ) offers six domains to guide organizations toward high standards of patient care: safe, effective, patient-centered, timely, efficient, and equitable. These domains help healthcare providers focus on critical areas of patient care to achieve high accreditation standards (Bumpas & Stuart, 2023).

Healthcare Issue

Hospital-acquired complications (HACs) and healthcare-associated infections (HAIs) can significantly impact a healthcare organization’s reputation and financial status. These issues are often interrelated, as HACs frequently follow HAIs acquired during a hospital stay. HAIs can stem from post-surgical wounds or inadequate hygiene practices among healthcare workers, leading to extended patient stays and a cycle of complications (Warner, Zhang, Liu, & Alterovitz, 2016).

Healthcare Regulatory Requirements

Regulatory compliance is critical not only for patient safety and optimal outcomes but also for healthcare funding and reimbursement. The Centers for Medicare and Medicaid Services (CMS) set guidelines regarding HACs and reimbursement rates. Organizations with high rates of HACs and HAIs face a reduction in reimbursement, losing approximately 1% of reimbursement per reported HAC. Therefore, minimizing these complications is crucial for both financial and reputational reasons (Cason, 2018).

Risk-Management Implications

A healthcare organization’s patient safety profile is a vital component of risk management. Failing to meet guidelines set by regulatory agencies like The Joint Commission can damage the organization’s reputation, leading patients to seek care elsewhere. Non-compliance can result in financial penalties, loss of accreditation, and legal repercussions (Mostepaniuk, Akalin, & Parish, 2023).

Environmental Assessment

Environmental assessments help healthcare organizations identify internal and external factors contributing to their success or failures. Internally, infection prevention and control are paramount, guided by the Centers for Disease Control and Prevention (CDC) core practices. These guidelines apply to all healthcare personnel and are essential for ensuring patient safety. Externally, patient education on hygiene practices, proper medication use, and accident prevention is crucial in reducing HAIs and HACs (Morantz & Torrey, 2003).

Resources to Address Issue

The Joint Commission, AHRQ, and CDC provide guidelines and resources for patient safety, infection prevention, and control. The Joint Commission helps organizations measure and improve performance across various healthcare settings. AHRQ’s six domains—safe, effective, patient-centered, timely, efficient, and equitable—assist organizations in enhancing patient care quality and achieving high accreditation standards (The Joint Commission, 2023; Bumpas & Stuart, 2023).

Philosophy or Culture Statement

Genentech/Roche, based in San Francisco, is a biotechnology company focusing on developing treatments for life-threatening conditions. The company emphasizes patient safety and transparency, regularly reporting errors to the FDA and other authorities, reflecting its commitment to meeting patients’ needs promptly.

Measuring and Monitoring

The Joint Commission has set patient safety goals for 2024, including using at least two patient identifiers, enhancing communication among staff and patients, and adhering to CDC and WHO hand hygiene guidelines. Preventing surgical errors and maintaining aseptic conditions are also crucial to reducing infection risks (The Joint Commission, 2023).

Organizational Improvement

Incident Reporting Systems in large healthcare organizations help capture and document high-risk situations. These systems are valuable for identifying and addressing areas of deficiency, promoting voluntary reporting, and benchmarking safety performance (Oweidat, Al-Mugheed, Samira, Mohammed, & Alzoubi, 2023).

Ethical Considerations

Healthcare workers must adhere to the Hippocratic Oath, “Do no harm,” and manage HACs and HAIs effectively. Non-compliance with regulatory guidelines can lead to lawsuits, fines, and penalties. Ethically, healthcare organizations must provide the highest quality care and address the causes of HACs and HAIs to avoid legal ramifications (Park, Jeon, Kim, Kim, & Jeong, 2023).


Bumpas, J. W., & Stuart, W. P. (2023). Improving Care Transitions from Hospital to Home: Best Practice. Medsurg Nursing, 32(2), 84-88.

Cason, K. (2018). Preparing for a Centers for Medicare & Medicaid Services Survey: The Official Voice of Perioperative Nursing. AORN Journal, 107(4), 498-501.

Morantz, C., & Torrey, B. (2003). CDC Guidelines for Infection Control. American Family Physician, 68(11), 2280.

MHA FPX 5014 Assessment 1 Regulatory Environment – Executive Summary

Mostepaniuk, A., Akalin, T., & Parish, M. R. (2023). Practices Pursuing the Sustainability of a Healthcare Organization: A Systematic Review. Sustainability, 15(3), 2353.

Oweidat, I., Al-Mugheed, K., Samira, A. A., Sally Mohammed, F. A., & Alzoubi, M. M. (2023). Awareness of reporting practices and barriers to incident reporting among nurses. BMC Nursing, 22, 1-10.

Park, O., Jeon, M., Kim, M., Kim, B., & Jeong, H. (2023). The Effects of a Simulation-Based Patient Safety Education Program on Compliance with Patient Safety, Perception of Patient Safety Culture, and Educational Satisfaction of Operating Room Nurses. Healthcare, 11(21), 2824.

MHA FPX 5014 Assessment 1 Regulatory Environment – Executive Summary

The Joint Commission. (2023). Standards. Retrieved from:,providing%20safe%2C%20high%20quality%20care.

Warner, J. L., Zhang, P., Liu, J., & Alterovitz, G. (2016). Classification of hospital-acquired complications using temporal clinical information from a large electronic health record. Journal of Biomedical Informatics, 59, 209-217.

Appendix – Executive Summary Table

Action Step

Relevant Data

Resource Information

1. Issue

Hospital-acquired conditions (HACs) and healthcare-associated infections (HAIs) pose significant challenges to healthcare organizations. They can extend patient hospital stays and create internal issues. Externally, unresolved HACs/HAIs can lead to penalties and fines. Additionally, persistent HACs/HAIs can harm the reputation of healthcare organizations if not promptly addressed. (The Joint Commission, 2023)

2. Regulatory Requirements

The Joint Commission (TJC) sets standards for all aspects of patient care in healthcare organizations. To obtain TJC accreditation, organizations must comply with all regulatory requirements. The Centers for Medicare & Medicaid Services (CMS) base reimbursement rates on safety profiles, including the annual incidence of HACs and HAIs. The Centers for Disease Control and Prevention (CDC) also provide guidelines for infection prevention and control. (The Joint Commission, 2023; Morantz & Torrey, 2003)

3. Risk Management Implications

HACs and HAIs can have significant financial repercussions for healthcare organizations, including poor ratings, reputational damage, income loss, and lack of accreditation from TJC and other bodies. (Morantz & Torrey, 2003)

4. Environmental Assessment

Internally, key players include registered nurses, technicians, physicians, and other staff. Staff training is crucial to ensure patient safety and proper aseptic techniques in clinical and surgical settings. Externally, key stakeholders include patients and their families. Patients need education on hand hygiene, proper medication use, and fall prevention through supportive devices like walkers, canes, and wheelchairs. (Warner, Zhang, Liu, & Alterovitz, 2016)

5. Resources to Address Issue

The CDC provides standards for effective infection prevention and reduction within healthcare organizations. (Morantz & Torrey, 2003)

6. Philosophy or Culture Statement

Genentech prioritizes patient safety and transparently reports errors to the FDA and other healthcare authorities. The organization’s culture emphasizes addressing current patient needs proactively. (The Joint Commission, 2023)

7. Measurement and Monitoring

The Agency for Healthcare Research and Quality (AHRQ) has identified six key domains for healthcare organizations to target: safe, effective, patient-centered, timely, efficient, and equitable care. These domains help organizations focus on critical aspects of patient care, ensuring high-quality service and meeting Joint Commission accreditation standards. (Park, Jeon, Kim, Kim, & Jeong, 2023; Bumpas & Stuart, 2023)

8. Organizational Improvement

Many large healthcare organizations use Incident Reporting Systems to document high-risk situations and identify areas needing improvement. These systems help benchmark performance and highlight deficiencies. (Oweidat, Al-Mugheed, Samira, Mohammed, & Alzoubi, M. M., 2023)

9. Ethics Considerations

Non-compliance with regulatory guidelines can lead to lawsuits and fines. Addressing unresolved risks and adverse events is essential. Ethically, healthcare organizations must provide the highest quality care and adhere to the highest standards. Identifying and mitigating the causes of HACs and HAIs is crucial to avoid legal and ethical repercussions. (Park, Jeon, Kim, Kim, & Jeong, 2023)

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