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Regulatory Environment-Executive Summary

Regulatory Environment-Executive Summary

Proactive Assessment of the Organization

The organization has invested in electronic health records (EHR) systems and other decision support systems, including an electronic medication administration record (eMAR) system to support medication administration. Currently, due to the observed nurse shortages and an influx of hospitalized patients, the facility has moved some senior nurses to the inpatient care settings to support care provisions. Therefore, the outpatient department has assigned most outpatient care services such as testing, medication administration, and carrying patient follow-up and discharge medication reconciliation to student nurses to cover the shortage.

Despite having the eMAR system, there have been numerous reports of medication errors from post-discharge patients. The current regulations and hospital policies require that student nurses be supervised during their clinical placements and should not be allowed to provide any medication without a senior nurse supervisor. The organization will be proactively assessed to identify risks related to compliance with the regulatory requirement and use current regulations to manage such risks. The assessment will collect data to develop a POAS system (Point of Act System) to efficiently manage the hospital, improve information sharing and interdepartmental collaborations to improve regulatory compliance and reduce medical errors. Do you need urgent assignment help ? Get in touch with us at We endeavor to provide you with excellent service.

Tools and Best Practices to Reduce, Prevent, and Monitor Medication Errors in Outpatient Settings

Medication administration errors occurring in post-discharge care settings due to unsupervised student nurses administering medications are serious risk management issues. Research has pointed out that medication errors involving student nurses in care settings are relatively high (Asensi-Vicente et al., 2018). Medication administration errors are referred to as public health problems of concern that pose great risks to hospitals and patient safety (Hammoudi et al., 2018). Medication errors are potentially costly in terms of patient, doctor, economic, and social outcomes. Patient safety is the major indicator of quality care within healthcare settings. Medication errors can also lead to reputational damage and the inability of the organization to qualify for CMS incentives and HIPAA regulatory requirements. Due to this, the organization should develop and adopt tools and practices that help reduce, prevent, and monitor medication errors in the outpatient department and the safety of post-discharge medication reconciliation, especially those involving student nurses.

The best practice to reduce medication errors would be to have a supervisor review all prescriptions involving a student nurse. It is also important to provide mentoring and training sessions to improve the student nurses’ understanding of the use of the current EHRs and eMAR to improve medication reconciliation, prescription, and administration. It is important to improve communication on medicines to reduce errors during the transition (Wheeler et al., 2018). A majority of patients visit the outpatient department on a daily basis. Therefore, it is important to have sufficient nurses in the department to reduce working pressure, reduce workload, and improve the proportion of nurses to patients. Better hospital management and monitoring to improve the safety of care delivered can be achieved by adopting a healthcare technology that supports interdepartmental collaboration and eases communication during the transition and medication reconciliation.

Recommendations for Quality Improvement in Transition Medication Reconciliation

Medication errors during the post-discharge transition medication reconciliation will always occur irrespective of whether nurse students or senior nurses are involved. The currently reported errors are minor discrepancies, and no errors have resulted in adverse patient experiences and events to actual patient harm. Adopting a technology system that adopts a systems approach is recommended to improve the quality of patient experiences and the safety and efficiency of medication reconciliation during discharge. Therefore, the adoption of a Point of Act System (POA) over the current EHR systems for the management of the hospital is recommended. The POAs system improves the ability of hospital managers to effectively and efficiently manage human and capital resources and the flow of information between departments. This significantly affects the flow of resources and processes within the organization. In addition, the POA system can support the nursing practice by coordinating activities in real time. Nurses can request a patient’s health information, medical records, and other information during discharge. The various departments can collaborate in real-time to ensure an efficient transition during discharge. This coordination and collaboration can help minimize errors while improving patient experiences and quality of care.

Value Proposition

The organization has provided evidence-based care pediatric and family healthcare services since its inception. With services provided in the primary and acute care settings, we provide care services that ensure that the needs and safety of the patient are maintained throughout the continuum of care. We have certified and licensed healthcare professionals to ensure patient-centered and outcome-focused care is provided to our patients. We utilize data to provide cost-effective care and identify, assess, reduce, and prevent risks related to the provision of health care services.

The adoption of the Point of Action system will provide data in real-time that will allow the facility’s management to analyze events as they occur, such as medication prescriptions or administration, and flag errors before they occur. The health care professionals will utilize the data to make transitional care decisions. Due to the systems approach-based POAs, creating a cooperative and collaborative work environment will be easier. Through real-time data and efficient healthcare interprofessional collaboration, the organization guarantees to provide safe and quality transitional care and medication reconciliation to its patients.

Legal, Ethical, and Regulatory Compliance Considerations

Adopting the POA system to support risk management requires consideration of the legal, ethical, and regulatory requirements of adopting such a system. The system is expected to be tested first to ensure that it can support the provision of high-quality, effective, and safe care. The system must also align with the fundamental ethical concepts and the principles of beneficence, nonmaleficence, social justice, autonomy, moral agents, vulnerability, and dignity. Based on regulations, the system in itself is not a substitute for health care workers’ input in patient care. It is a management aid that improves the efficiency of risk management and helps reduce errors in practice. The system aims to ensure the right number of resources are available as required at a particular point in care delivery and improve the efficiency of service delivery. The implementation of the POA system must meet the regulatory requirements set by the HITECH Act and the HIPAA Privacy and Security Rules on the use of electronic health and medical records and other technologies in health care.


Executive Summary Table

Action Step Relevant Data Resource Information
1. Issue.


·         Medication errors in post-discharge medication reconciliation related to nurse students. Medication errors risk the safety of patient care and the perception of the organization.
2. Regulatory Requirements.


·         Medication be carried out by licensed individuals (Registered nurses)

·         Ensure privacy, safety, and confidentiality of patient health information

(American Nurses Association (ANA), 2021)

(Health Insurance Portability and Accountability Act of 1996 (HIPAA), n.d.)

3. Risk Management Implications.


·         Negative business and professional reputation,

·         Inability to achieve meaningful use and CMS incentives.

·         Inability to operate within the organization’s mission, vision, and values.

(Burlea-Schiopoiu & Ferhati, 2020)
4. Environmental Assessment.


·         Environmental distractions,

·         Education and certification status,

·         Efficiency of EHRs usage,

·         Supervisor availability,

·         Clarity of communication.

Risk Matrix

Decision Tree

(Pascarella et al., 2021)

5. Resources to Address Issue. ·         Ease of data sharing,

·         Error identification and flagging,

·         Availability of computer systems,

·         Student nurse mentors.

Computer systems

RFID Technologies

Communication systems

Employee training

6. Philosophy or Culture Statement. Provide safe transitional care Mission statement


7. Measurement and Monitoring.


·         Reduction of medication errors,

·         Reduction of client complains,

·         Ease and accuracy of medication conciliation,

·         Level of communication and support for student nurses.

Patient and client reviews.

Public ratings.

Student nurse interviews.

(Burlea-Schiopoiu & Ferhati, 2020; Trakulsunti & Antony, 2018)

8. Organizational Improvement.


·         Frequent review of operations,

·         Setting expectations,

·         Adopting a stand-alone error reporting system,

·         Incentivizing participation in error reporting,

·         Taking action on reported errors.

(Rodziewicz et al., 2022)
9. Ethics Considerations. ·         Support healthcare accessibility,

·         Provide adequate information to support decisions,

·         Improve the work environment,

·         Promote honest professional practice.

·         Report negative information promptly and accurately.

(American College of Healthcare Executives (ACHE), 2021)


American College of Healthcare Executives (ACHE). (2021). ACHE Code of Ethics.

American Nurses Association (ANA). (2021). Use of Medication Assistants / Aides / Technicians.

Asensi-Vicente, J., Jiménez-Ruiz, I., & Vizcaya-Moreno, M. F. (2018). Medication Errors Involving Nursing Students: A Systematic Review. Nurse Educator, 43(5), E1–E5.

Burlea-Schiopoiu, A., & Ferhati, K. (2020). The Managerial Implications of the Key Performance Indicators in Healthcare Sector: A Cluster Analysis. Healthcare 2021, Vol. 9, Page 19, 9(1), 19.

Hammoudi, B. M., Ismaile, S., & Abu Yahya, O. (2018). Factors associated with medication administration errors and why nurses fail to report them. Scandinavian Journal of Caring Sciences, 32(3), 1038–1046.

Health Insurance Portability and Accountability Act of 1996 (HIPAA). (n.d.). HIPAA Privacy Rule. Retrieved May 31, 2022, from

Pascarella, G., Rossi, M., Montella, E., Capasso, A., de Feo, G., Snr, G. B., Nardone, A., Montuori, P., Triassi, M., D’auria, S., & Morabito, A. (2021). Risk Analysis in Healthcare Organizations: Methodological Framework and Critical Variables. Risk Management and Healthcare Policy, 14, 2897.

Rodziewicz, T. L., Houseman, B., & Hipskind, J. E. (2022). Medical error reduction and prevention. StatPearls [Internet].

Trakulsunti, Y., & Antony, J. (2018). Can Lean Six Sigma be used to reduce medication errors in the healthcare sector? Leadership in Health Services, 31(4), 426–433.

Wheeler, A. J., Scahill, S., Hopcroft, D., & Stapleton, H. (2018). Reducing medication errors at transitions of care is everyone’s business. Australian Prescriber, 41(3), 73.


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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.

Regulatory Environment-Executive Summary

Regulatory Environment-Executive Summary

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.

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.
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?
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?

The following resource is required to complete this assessment.

Executive Summary Table [DOCX].

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 linked above 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.

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.
APA Format: Use appropriate APA format for clear, concise presentation of information. Communicate information and ideas accurately, utilizing peer-reviewed sources, including proper APA reference citations.
Font and font size: Times New Roman, 12 point.
Competencies Measured
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.

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