MHA FPX 5014_Stoycoff_Joshua_Assessment 1_Attempt 1

1 Regulatory Environment – Executive Summary Joshua Stoycoff Capella University MHA FPX 5014 Health Care Quality, Risk, and Regulatory Compliance December 2023

2 Regulatory Environment – Executive Summary Healthcare organizations must establish high regulatory standards attributed to patient safety practices to avoid adverse events such as hospital-acquired complications (HACs) and comply with regulatory standards. Regulatory authorities such as The Joint Commission offer accreditation to healthcare organizations should the commission's criteria be met by the healthcare organization. Additionally, other agencies, such as the Agency for Healthcare Research and Quality (AHRQ), offer six domains to assist healthcare organizations in obtaining high standards of patient care. The six domains AHRQ sets include safe, effective, patient- centered, timely, efficient, and equitable. These six domains will assist the healthcare organization in focusing on critical areas of patient care to provide high-quality healthcare and achieve high accreditation standards by the Joint Commission ( Bumpas & Stuart, 2023). Healthcare Issue Hospital Acquired Complications (HACs) and Healthcare-Associated Infections (HAIs) can negatively affect a healthcare organization's reputation and financial well-being. While many contributing factors can cause HACs and HAIs, primary causes include but are not limited to the following. HACs are often after HAIs, typically following admission to the hospital or similar healthcare organization. HAIs can be acquired in the hospital and lead to a HACs, resulting in longer patient stays, adding to the cycle of HACs. HAIs can be subsequent to post-surgical wounds that acquired an infection during or after the surgical procedure. The etiology of these infections can stem from the hygiene practices of the healthcare workers and the antiseptic preparations before the surgical procedure ( Warner, Zhang, Liu, & Alterovitz, 2016).

4 Environmental Assessment Environmental assessments are an opportunity to assess the healthcare organization and reveal positive and negative contributions to the success or failures of the organization inside and out. The internal processes focus on infection prevention and control in all parts of the organization. The Centers for Disease Control (CDC) has established core infection prevention and control practices for safe healthcare delivery in healthcare organizations. The CDC guidelines will be used to assess the organization's internal workings. These guidelines are not suggestions; they are required in all healthcare settings to ensure patient safety, infection prevention, and control. The CDC guidelines also apply to healthcare personnel, which includes all staff members, healthcare providers, and administration. Externally, the healthcare organization focuses on the patient's satisfaction, safety, and education. Additionally, staff members must be well educated to relay key points to patients regarding their healthcare, such as hygiene practices, preventative measures, hand hygiene, proper medication use, and avoiding falls and other similar accidents. While simple, these external practices will help patients take part in preventing HAIs and HACs while in the hospital and upon being discharged (Morantz & Torrey, 2003). Resources to Address Issue The Joint Commission, AHRQ, and the CDC set solid guidelines to establish patient safety practices, infection prevention, and control, and provide educational resources to patients and healthcare staff. The Joint Commission helps healthcare organizations measure, assess, and improve performance. The commission’s standards apply to all aspects of healthcare, including residential care, hospital care, clinical care, and surgical care ( The Joint Commission, 2023).

5 The Agency for Healthcare Research and Quality (AHRQ) establishes six functionalities to assist healthcare organizations in enhancing patient safety, quality control, infection prevention and control, patient education, and optimal healthcare outcomes. As previously stated, the six domains AHRQ sets include safe, effective, patient-centered, timely, efficient, and equitable. These six domains will assist the healthcare organization in focusing on critical areas of patient care to provide high-quality healthcare and achieve high accreditation standards by the Joint Commission ( Bumpas & Stuart, 2023). Philosophy or Culture Statement Based in San Francisco, California, Genentech/Roche is a biotechnology company focused on developing medications and treatments for life-threatening conditions for patients. As dubbed one of the largest biotechnology companies in the world, Genentech/Roche is highly regulated and adheres to multiple safety guidelines and practices. Genentech’s culture prominently focuses on patient safety and regularly reports errors to the FDA and other healthcare authorities. This is due to the transparent character of the organization and the drive to do now what patients need next. Measuring and Monitoring The leading healthcare authority, The Joint Commission (TJC), has established patient safety goals for healthcare organizations to work towards. For 2024, TJC set the following patient safety measures to enhance patient safety in a hospital setting. The first guideline is ensuring the correct patient through at least two patient identifiers, such as name and date of birth. The second guideline focuses on enhancing communication among staff members and patients. For infection prevention, the focus is on hand hygiene guidelines from the CDC and The World Health Organization (WHO). Regarding infection control, procedures for preventing

7 Ethical Considerations Healthcare workers are held under the Hippocratic Oath, “Do no harm.” As such, HACs and HAIs are problematic if they are not rectified. From aseptic technique to proper hand washing, the healthcare organization is highly regulated and scrutinized by patients and healthcare regulatory agencies. Failure to follow regulatory guidelines can result in lawsuits and litigations. Unresolved risks and adverse events can also result in fines and penalties. Ethically, the healthcare organization must provide the highest quality healthcare for community patients and always hold the highest standard. The HACs and HAIs need to be handled quickly; however, finding the causes and mitigating those causes are the main goals to avoid legal ramifications.

8 References Bumpas, J. W., & Stuart, W. P. (2023). Improving Care Transitions from Hospital to Home: Best Practice. Medsurg Nursing, 32 (2), 84-88. http://library.capella.edu/login?qurl=https%3A %2F%2Fwww.proquest.com%2Fscholarly-journals%2Fimproving-care-transitions- hospital-home-best%2Fdocview%2F2801306325%2Fse-2%3Faccountid%3D27965 Cason, Karla, MS,B.S.N., R.N. (2018). Preparing for a Centers for Medicare & Medicaid Services Survey: The Official Voice of Perioperative Nursing. AORN Journal, 107 (4), 498-501. https://doi.org/10.1002/aorn.12122 Morantz, C., & Torrey, B. (2003). CDC Guidelines for Infection Control. American Family Physician, 68 (11), 2280. http://library.capella.edu/login?qurl=https%3A%2F %2Fwww.proquest.com%2Fscholarly-journals%2Fcdc-guidelines-infection-control %2Fdocview%2F234307998%2Fse-2%3Faccountid%3D27965 Mostepaniuk, A., Akalin, T., & Parish, M. R. (2023). Practices Pursuing the Sustainability of A Healthcare Organization: A Systematic Review. Sustainability, 15 (3), 2353. https://doi.org/10.3390/su15032353 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. https://doi.org/10.1186/s12912-023-01376-9 Park, O., Jeon, M., Kim, M., Kim, B., & Jeong, H. (2023). The Effects of a Simulation-Based

10 Appendix - Executive Summary Table Action Step Relevant Data Resource Information 1. Issue. HACs and HAIs are negative factors to healthcare organizations and can prolong patient stays in the hospital and contribute to further issues internally. Externally, HACs/HAIs can also result in penalties and fines if not rectified swiftly. Lastly, long-term HACs/HAIs can dampen the healthcare organization's reputation if not mitigated promptly. (The Joint Commission, 2023) 2. Regulatory Requirements. The Joint Commission (TJC) sets the standard for healthcare organizations in all aspects of patient care. To receive TJC accreditation, healthcare organizations must meet all regulatory requirements set by TJC. CMS determines reimbursement amounts based on the safety profiles of healthcare organizations, such as the amount of HACs and HAIs present annually. The CDC also outlines best practices for infection prevention and control. (The Joint Commission, 2023) (Morantz & Torrey, 2003). 3. Risk Management Implications. HACs and HAIs can negatively impact healthcare organizations financially. Negative impacts include but are not limited to poor ratings, negative reputation, loss of income, and lack of accreditation from TJC and other organizations. (Morantz & Torrey, 2003). 4. Environmental Assessment. Key players in the internal environment include RNs, Techs, Physicians, and others. Staff training is integral to optimizing patient safety and safe aseptic techniques in clinical and surgical environments. Key players to the external environment are consumers such as patients and family members. Patients need to have proper education to mitigate the risk of infection through several components. Such as, hand hygiene, proper medication use, and avoiding fall risks through proper support such as walkers, canes, and wheelchairs. (Warner, Zhang, Liu, & Alterovitz, 2016) 5. Resources to Address Issue. The CDC sets the standard for proper methods of infection prevention and reduction in the healthcare organization. (Morantz & Torrey, 2003). 6. Philosophy or Culture Statement. Genentech’s culture prominently focuses on patient safety and regularly reports errors to the FDA and other healthcare authorities. This is due to the transparent character of the organization and the drive to do now what patients need next. (The Joint Commission, 2023)

11 7. Measurement and Monitoring. The AHRQ has established six focal points for healthcare organizations to strive towards while providing best patient care. The six domains AHRQ sets include safe, effective, patient- centered, timely, efficient, and equitable. These six domains will assist the healthcare organization in focusing on critical areas of patient care to provide high-quality healthcare and achieve high accreditation standards by the Joint Commission (Park, Jeon, Kim, Kim, & Jeong, 2023). ( Bumpas & Stuart, 2023). 8. Organizational Improvement. Many large healthcare organizations have implemented Incident Reporting Systems to capture high-risk situations and document them accordingly. The Incident Reporting System can also name the individuals who made the report. The system is great for benchmarking and outlining high-risk areas in the organization and allows the organization to work towards areas of deficiency. Oweidat, Al-Mugheed, Samira, Mohammed, & Alzoubi, M. M. (2023). 9. Ethics Considerations. Failure to follow regulatory guidelines can result in lawsuits and litigations. Unresolved risks and adverse events can also result in fines and penalties. Ethically, the healthcare organization must provide the highest quality healthcare for community patients and always hold the highest standard. The HACs and HAIs need to be handled quickly; however, finding the causes and mitigating those causes are the main goals to avoid legal ramifications. (Park, Jeon, Kim, Kim, & Jeong, 2023).