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Compliance Program Implementation and Ethical Decision Making

Background

Vila Health is a Minnesota and Wisconsin-based community-based secondary hospital. While working as entry-level risk management and quality improvement professional under the supervision of a critical compliance proposal, mistakes were discovered. One of the employees made a mistake that could lead to the Health Insurance Portability and Accountability Act (HIPAA) violation. Their boss informed the employee that an upcoming medical procedure required prior approval (De Simone, 2019). Employees give PHI to insurance companies without getting permission first. A health insurance representative called the caregiver and informed her that no further discussion on the subject could be held without the patient’s consent.

Privacy Breach – HIPAA Violation

Several rules and standards can be applied to HIPAA violations at Vila Health. The HIPAA Privacy Policy lays out the rules for preventing the electronic dissemination of patient information without a healthcare provider’s consent (Vanderpool, 2019). Employees at Vila Health do not disclose patient data to third parties (insurance carriers) without their permission, so this regulation applies to them. Since information is transferred using electronic means, the HITECH (Health Information Technology for Economic and Clinical Health) guidelines are also breached. HITECH mandates that healthcare providers submit to a security audit to determine their HIPPA compliance (Catanzaro & Kain, 2019). Patients benefit from HITECH because of EHR (Electronic Health Record) technology requirements (Catanzaro & Kain, 2019). HIPAA, HITECH, and the Privacy Act limit transfer of patients’ PHI using electronic means without their permission.

Another component of HIPAA is security rules, which set national guidelines for maintaining PHI’s confidentiality, integrity, and accessibility (De Simone, 2019). Because the employee failed to provide PHI or confidential information to the patient before sending it to the insurance company, this rule applies to Vila Health. The employee discloses patient information without first obtaining permission or ensuring confidentiality. The information was released in violation of HIPAA’s violation reporting guidelines. HIPAA-registered businesses and their business partners must notify HIPAA-compliant companies and their business partners following a breach of unprotected protected health information, according to (Vanderpool 2019). This rule may apply in the case of Vila Health because the privacy policy prohibits the dissemination of patient information.

The Code of Federal Regulations defines two personnel statutes: 45 CFR 164,504 and 45 CFR 164,506. Under this law, only authorized employees may disclose PHI plans to sponsors if given permission (De Simone, 2019). It is against the law for a Vila Health employee to disclose PHI to an insurance company without obtaining the patient’s consent. Their manager and the Compliance Department must address the matter. Staff ought to likewise be expected to finish compliance education. TJC has created specific patient safety guidelines to ensure that health information technology is used safely, especially when transmitting EHRs. This is one of the accreditations process’ primary goals, and it can be applied in this case because inaccurate data entered the health technology system can cause negative consequences. HIPPA breaches also happen, leading to non-compliance and loss the certification.

Seven Essential Elements of an Effective Compliance Program

Compliance measures should protect patient safety and confidentiality. There are seven critical components of a successful compliance program that must be implemented. All employees in healthcare facilities will always be at risk from leadership. A thorough understanding of this area is required for compliance programs (Vanderpool, 2019). These criteria are the bare minimum that HIPAA-compliant businesses must meet HIPAA confidentiality and security standards.

The initial step is to put recorded rules, cycles, and conduct principles (De Simone, 2019). Additional risks can also be addressed with this range. The Vila Health Compliance office should guarantee that the worker’s head speaks with them and reaffirms its guidelines and techniques for moving PHI to outsiders. The employees in question did not follow the supervisor’s instructions and sought permission from the patient, resulting in non-compliance. To guarantee adherence to administrative prerequisites, all staff should follow the rules and regulations. Regular obedience training makes everyone aware of their responsibilities. The next step is a compliance officer and commission appointment (Vanderpool, 2019). The Compliance board and the head of compliance have set up a compliance program at Vila Health. Finding ways to improve patient care and investigating PHI violations are among the panel’s responsibilities.

Implementing effective education and training, which aligns with the fourth factor, creating effective communication channels, is the third element (Van den Bulcke et al., 2018). To ensure compliance and avoid concerns about non-compliance, all employees must receive annual training. Employees of Vila Health who submit PHI to insurance providers must complete mandatory training to submit PHI securely. Communication pathways should continuously be open, which is essential for the adherence division at the facility. To do so, they must work with the management of the respective department to educate everyone on how to handle PHI and EHR transmission correctly.

Implementing internal monitoring and auditing is the fifth aspect (Vanderpool, 2019). This is the Compliance Committee’s responsibility, and due to the situation at Vila Health, coordination in monitoring compliance violations is required. Section Six, which establishes standards through disciplinary guidelines, also involves compliance officers (Taleghani et al., 2018). The head of compliance guarantees that the organization’s policies and rules are adhered to avoid fines and infringement, such as PHI exposure.

The seventh and final factor, which responds quickly to violations and takes corrective action, is one of the most critical aspects (Vanderpool, 2019). Because the member service representative contacted the manager directly at Villa Health, it is the manager’s responsibility to meet with the employee. Compliance officers should participate in employee discussions to strengthen PIA management rules and procedures.

Privacy Breach Consequences

Depending on the severity of the violation, HIPPA violations can result in legal and financial penalties. A breach by the compliance officer may be determined if the training provided is deemed insufficient in the case at hand. The Office of Civil Rights (OCR) oversees determining whether there has been a violation based on four factors (Taleghani et al., 2018). The suspicion is that the service acted negligently, which is a civil offense if a lack of training results in the unauthorized disclosure of PIA. Fees are based on whether the issue was resolved within the deadline. For violations, the facility could face fines from about $10,000 to $50,000, with a maximum annual fine of $250,000 for multiple violations (Pope, 2020). If the violation is not corrected within the allotted time, the penalty is increased to $50,000, with a maximum annual fine of $1.5 million.

Persons who are asked to provide information and supervisory authorities may face fines. Violations occur unintentionally or unconsciously, such as failing to maintain policies and processes that enable employees to properly understand how to use CPI (De Simone, 2019). This offense carries a lighter penalty than willful negligence, and the violation is automatically corrected for 30 days before the sentence is handed down. HIPAA violations carry fines ranging from $100 to $50,000, with a maximum annual penalty of $25,000 for repeat offenders (De Simone, 2019). HIPPA violations, if not addressed, can result in financial and legal consequences for the Company (Pope, 2020). Disruptions can have several negative implications for businesses like Vila Health, making a recovery difficult, if not impossible. The Company risks losing its excellent reputation, customer/patient trust, and ability to run a business, in addition to the financial consequences.

Evidence-Based Practice (EBP) Recommendations

To address HIPAA infringement of confidentiality violations, including the transfer and disclosure of PHI to third parties, the organization may use some EBP suggestions (Pope, 2020). Human resources will be involved because it is their job to ensure that all rules and procedures are followed and that no business or patient safety is jeopardized. HR will focus on whether this requires additional training or even termination. The investigation will be led by Vila Health Human Resources and include interviews with employees directly involved in the violation and managers. This would be the first step toward correction from a personnel standpoint. There will be a warning for each employee and additional HIPAA compliance training and sanctions for non-compliance. Supervisors should be taught how to communicate effectively and follow up.

If both workers are trained in this area, the chances of the same or similar offenses are reduced. Gap analysis is recommended by the OCR, even though it is not recommended by HIPPA (Pope, 2020). It contrasts with hazard examination since it doesn’t cover all expected dangers to the facility. This analysis will assist Vila Health in ensuring HIPAA compliance and “provide a comprehensive picture of their compliance efforts, which can help them identify areas where they have not complied with HIPAA rules and gaps in them (Taleghani et al., 2018). They can perform risk analysis in addition to gap analysis, which will reveal any vulnerabilities that make them vulnerable. It is advantageous to use both methods of analysis.

Vila Health must ensure that the process is consistent to avoid future fines. Because of their knowledge of how violations can affect an organization, the Chief compliance officer and the risk manager should be involved in both studies. All department heads and employees collaborate with the compliance office to ensure that PHI is safeguarded and that patient consent is obtained before it is disseminated. FEMA is a gap and risk analysis strategy that can be used together.

The Failure Modes and Effects Analysis, also known as FEMA, is a proactive technique for evaluating processes and identifying areas where change is required (Taleghani et al., 2018). The facility can gain from this by figuring out what could turn out badly, why an infringement happened, and the results of every occasion. When trying to change procedures, Vila Health can use FEMA to help analyze the new process and the impact on the current process. You might want to consider adding features to your IT EHR system to prevent PHI from being disclosed without your permission.

Ethical Decision-Making Framework for Health Care Leaders

Leaders in medical care must be good role models, and their actions must reflect the organization’s goals. When faced with ethical challenges, leaders must respect moral concepts such as justice, autonomy, non-maleficence, and beneficence, as well as professional and organizational norms and codes of conduct (Van den Bulcke et al., 2018). understand the importance of having a single approval process. Medical care leaders should address the developing number of perplexing moral difficulties they face. They can’t and ought not to settle on such choices autonomously or without creating options. Head of the department of health, as in the case of Vila Health, there must be mechanisms in place to deal with ethical issues, and the culture must promote an environment where ethical decisions are prioritized. Non-compliance is handled consistently (Van den Bulcke et al., 2018). ACHE suggests several initiatives for Vila Health to consider.

The ACHE has established several phases to help people make ethical decisions (Vanderpool, 2019). The first step is to pinpoint the circumstances that lead to ethical issues. Understanding the consequences of data breaches is critical in recent data breaches. Vila Health staff should hold meetings to develop a cohesive response to assure the insurance company that they have taken the necessary steps to address the issue as soon as possible. After all the data has been gathered, the next step is to seek clarification on a specific ethical issue. The Company’s ethics committee was asked to explain why and how the violation occurred and the financial implications (Pope, 2020). Management should review all past and current Vila Health policies to determine what standards have been applied to EHR and PHI, in addition to addressing violations.

Applying ethical decision-making requires a thorough understanding of the complexities of each stage and how they interact (Van den Bulcke et al., 2018). The subsequent step in the deciding interaction is to think about different choices. Employee and manager training on an ongoing basis is a good start, but organizational responsibility must also be assumed. Notwithstanding the two representatives straightforwardly involved, the facility should guarantee that all workers get yearly adherence education. After exploring possible responses, the next step is to provide an ethical response after weighing all options (Van den Bulcke et al., 2018). Vila Health stakeholders must advise on how to communicate with all parties. If a similar situation arises in the future, this should include a foundation for counseling ethics that will become the standard. Organizations must anticipate what ethical conflicts will look like in the final phase, which is expected (De Simone, 2019). Vila Health Management must devise a strategy to avoid similar issues in the future.

Develop an ethical culture based on the organization’s vision and values that support ethical clinical and administrative practice, policy, and decision-making using a systematic ethical decision-making process. The organization’s commitment to ethical compliance with its mission or values statement should be communicated. Models’ ethical decision-making demonstrates the importance of ethics to organizations through their professional standards of conduct (Ethical decision making for healthcare executives, 2016). Provide training programs on their organization’s ethical standards and the broader global ethical decision-making challenges in today’s healthcare environment for directors, executives, employees, physicians, and others, including the general public. This includes educating patients and their families on cultural sensitivity and avoiding implicit bias when making ethical decisions for them.

Furthermore, healthcare leaders should support educational opportunities provided by professional associations or academic institutions that allow for informed, civic, and open debate on ethical issues. Ensure that the organization has the resources it needs to deal with ethical issues, including employees who are qualified to do so. Clinical and organizational ethical issues must be resolved, which may necessitate the formation of a separate committee to deal with the latter (Ethical decision making for healthcare executives, 2016). Physicians, nurses, managers, administrators, board members, social workers, lawyers, patients, and the general public, as well as pastors, should all be represented on commissions. Health administrators must make a concerted effort to ensure that decision-makers’ diverse skills and experience accurately reflect the communities impacted by recommendations or policies.

Conclusion

At last, the infringement at the facility, in which a staff inappropriately uncovered PHI to an external insurance agency, was severe. This kind of infringement is moral, lawful, monetary, and institutional (Pope, 2020). HIPAA was created to protect patients from these situations, and the rules are particular about what information, organizations, and individuals are protected. Vila Health owes it to its patients to safeguard their PHI, an essential aspect of patient safety. TJC has developed patient safety and HIPAA compliance standards that must be met by all organizations or risk losing their certification. Vila Health should review its policies and procedures to ensure that sharing protected health information does not violate the TJC when best practices are followed. To avoid violations, Vila Health must conduct thorough inspections and make every effort to ensure that all rules and procedures are followed. It is critical to take the necessary precautions ahead of time to prevent violations.

References

Catanzaro, Z. L., & Kain, R. (2019). Patients as Peers: Blockchain Based EHR and Medical Information Commons Models for HITECH Act Compliance. Nova L. Rev.44, 289.

De Simone, D. M. (2019). When is accessing medical records a HIPAA breach?. Journal of Nursing Regulation10(3), 34-36.

Ethical decision making for healthcare executives. (2016, November). American College of

Healthcare Executives. https://www.ache.org/about-ache/our-story/our /commitments/ethics/ache-code-of-ethics/ethical-decision-making-for-healthcare/executives

Pope, J. (2020). Top Five HIPAA Lessons Learned: A Review of HHS Resolution Agreements. Innovations in Clinical Neuroscience17(7-9), 45.

Van den Bulcke, B., Piers, R., Jensen, H. I., Malmgren, J., Metaxa, V., Reyners, A. K., … & Benoit, D. D. (2018). Ethical decision-making climate in the ICU: theoretical framework and validation of a self-assessment tool. BMJ Quality & Safety27(10), 781-789.

Vanderpool, D. (2019). HIPAA Compliance: A common sense approach. Innovations in Clinical Neuroscience16(1-2), 38.

Taleghani, Y. M., Vejdani, M., Vahidi, S., Ghorat, F., & Raeisi, A. R. (2018). Application of prospective approach of healthcare failure mode and effect analysis in the risk assessment of healthcare systems. EurAsian Journal of BioSciences12(1).

 

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