Compliance Program Implementation and Ethical Decision
BHA FPX4006 Assessment 1 Health Care Regulation and Compliance was a recent issue at Vila healthcare where, under the direction of her supervisor, an employee was trying to get authorization for a procedure for a patient and shared protected health information (PHI) with the insurance company without a release of information (ROI) being obtained from the patient. The insurance company representative reached out to Vila Health department supe
Problem Summary: Privacy Breach—HIPAA Violation
| Briefly Explain the Law, Regulation, Standard, et cetera* | Briefly Explain How the Law, Regulation, Standard, et cetera Applies to the Privacy Breach/HIPAA Violation | |
| Applicable Law(s) | HIPAA Privacy Rule protect a patient’s protected health information. It gives them access to their own health information. Must have agreements with all entities to disclose PHI (Snell, 2020). | Applicable to Vila health situation because, apparently, the patient had not signed a release to discuss/disclose PHI with their insurance company. |
| Applicable Specific Regulation(s) | Omnibus rule states that any breach of PHI must be reported (Cascardo, 2014). | Applicable to Vila health because it identifies a potential process gap in obtaining authorization from patients. |
| Disclosure | Breach Notification Rule requires notification to affected patients and the department of Health and Human Services (HHS). Some cases may require media notification (CMS, 2021). | Applicable to Vila Health because they were notified of the error by the insurance company so they must report to the patient and HHS. |
| Applicable Human Resource Law(s) | Healthcare workers are responsible for adhering to requirements of HIPAA regulations which clearly state the requirements regarding protected health information. | It appears this Vila health worker violated their responsibility to the HIPAA law. Further investigation will determine intent/knowledge. |
| Applicable Industry Accrediting Body Standards | The department of Health and Human Services and the Civil Rights office, both have accrediting standards regarding HIPAA responsibilities. | Violation in this case, would be reported to the departments listed to determine next steps. BHA FPX4006 Assessment 1 Health Care Regulation and Compliance |
CMS. (2021). HIPAA Basics for Providers: Privacy, Security, & Breach Notification Rules. MLN Network.
Snell, E. (2020). What is a HIPAA Business Associate Agreement (BAA)? HealthIT Security.
Seven Essential Elements of an Effective Compliance Program
| Number | Element of an Effective Compliance Program (Federal Register)* | How Does This Element Apply to the Privacy Breach/HIPAA Violation? |
| 1. | Policies, procedures, and standards of conduct | Having a standard written release of information policy and form would be an initial step to ensuring proper process in obtaining appropriate consent from patients. Following up on training and monthly audits would also be appropriate ways to ensure proper compliance. |
| 2. | Oversight/Follow up | Having an auditor or compliance standard in place to inspect policies and their alignment with current laws. Having a compliance officer or team in place may be key to avoiding gaps in processes (Burton, 2014). |
| 3. | Education and Communication | Having a compliance team to lead this process is beneficial. Managers of each department educating and talking to their about necessary processes for compliance is a best practice for health care systems. The supervisor or department manager of the Vila health employee who made the error has responsibility to ensure their staff are knowledgeable of process and are following it (Burton, 2014). |
| 4. | Internal monitoring and auditing | Following up on education and process is vital to any organization. Having a new hire checklist can help ensure processes have been shared and aid with accountability of staff members. Monitoring operations to ensure adherence to the standard of operating procedures can show areas of weakness or gaps in process (Alexio, 2021). Risk assessments can also be a tool to assist leaders in identifying where resources are most beneficial (Burton, 2014). |
| 5. | Reporting | Information is only beneficial if it is known. Knowledge and understanding of compliance processes is necessary to ensure alignment with healthcare laws. Having a plan of how to communicate information through the company is a start but reporting back that the task is complete can be a missed step (Burton, 2014). |
| 6. | Enforcement of Rules | Human resources having clear rules and consequences for behaviors is an asset in any organization. In this case, the department manager and human resource staff should work together to determine appropriate action with this employee/incident. Information or recommendation from the compliance department may be taken into consideration (Burton, 2014). |
| 7. | Quick response to violations or issues | Responding quicky to compliance violations can help avoid issues in the future. Developing and following a standard protocol for when a compliance breach occurs is appropriate to mitigate future errors. Though having a compliance team is advantageous, everyone understanding the expectations and follow through are elemental in managing compliance (Burton, 2014). BHA FPX4006 Assessment 1 Health Care Regulation and Compliance |
Alexio, J. (2021). Healthcare Compliance Auditing and Monitoring.Emptech.com.
Burton, B. (2014). How to lead your organization in compliance, ethics, and costumer service. Journal of AHIMA, 85(8), 22-25.
Privacy Breach Consequences
| Covered Entity | Legal Penalty(ies)* | Additional Consequences |
| Individual Leader Within Health Care Organization | Because this was not a willful violation, the direct supervisor may receive a Tier II penalty with a fine ranging from $1,000-$50,000 (Compliancy Group, 2021). | The direct leader in this case may have to undergo further training and education and official documentation would likely be in the employee’s file. |
| Other Internal Health Care Organization Stakeholders | Other leaders in the organization may also face the same penalty. The compliance department has responsibility to set and implement policies regarding release of information (Compliancy Group, 2021). | Updated education would likely be required by all individuals at Vila Health. |
| Health Care Organization | Depending on severity and circumstances such as response time, the organization could face a Tier III penalty (Compliancy Group, 2021). | Similar to the others in this case, additional education and training would likely be required, as well as, ensuring implementation of new rule enforcement measures. |
Compliancy Group. (2021). HIPAA Violations, Breaches, and Fines/ Full list of HIPAA Violations.
Evidence-Based Recommendations
| Number | Evidence-Based Recommendation | Additional Insights/Salient Points | Source(s)* |
| 1. | Investigate and analyze the error | The compliance department can determine details of the incident and where policy revision or enforcement focus is needed | Amick. (2020) |
| 2. | Regular risk assessment | Regular internal auditing and analysis of risk keeps the company leaders aware of necessary processes adjustments. | Amick. (2020) |
| 3. | Developing and implementing an action plan | Having a response process in place head of a violation allows appropriate protocols are in place. | Amick. (2020) |
| 4. | Reporting any issues to the Office of Civil Rights (OCR) | Vila health should report errors to the OCR and the OCR would determine penalties to be assessed. | Amick. (2020) |
| 5. |
*Amick, C. (2020). Three Key Recommendations to Improve HIPAA Compliance. The Doctor Weighs In.
Ethical Decision-Making Framework for Health Care Leaders
| Number | Ethical Decision-Making Step* | Apply the Ethical Decision-Making Step to the Privacy Breach/HIPAA Violation |
| 1. | Recognize and define the issue | An employee at Vila Health employee released information to the insurance company without a release signed. The compliance committee would determine if the employee were aware they violated HIPAA laws. |
| 2. | Identify factors | It appears there was not a compliance process in place for obtaining proper consent from patients. |
| 3. | Consider ethical principles | Determine whether the employee knowingly violated HIPAA. |
| 4. | Determine response | Responses will depend on the intent – was the organization knowingly/willingly neglectful in this breach. |
| 5. | Recommend a response | Updating procedures for obtaining consent and ensuring training and processes were consistent and audited. |
| 6. | Assess current response and potential future issues | Having annual HIPAA and compliance training for the entire health system to ensure understanding and appropriate practices are being followed. |
Burton, B. (2014). How to lead your organization in compliance, ethics, and customer service. Journal of AHIMA, 85(8), 22-25.
GEt-related BHA FPX4010 Assessment 1
Conclusion
BHA FPX4006 Assessment 1 Health Care Regulation and Compliance is vital to develop and implement accurate HIPAA practices are enforced in the organization. Communicating the responsibility of each person in the health system to this compliance topic is key. Focusing on internal activities such as education, auditing, and process improvement allows an organization to be proactive in compliance violation avoidance and better prepares leaders in the event of future issues.
References
Alexio, J. (2021). Healthcare Compliance Auditing and Monitoring.Emptech.com.
Amick, C. (2020). Three Key Recommendations to Improve HIPAA Compliance. The Doctor Weighs In.
Burton, B. (2014). How to lead your organization in compliance, ethics, and costumer service. Journal of AHIMA, 85(8), 22-25.
Cascardo, D. (2014). HIPAA Investigation Risks are Increasing: Make Sure You Avoid the “Wall of Shame”.The Journal of Medical Practice
Management: 30(2), 119-123.
CMS. (2021). HIPAA Basics for Providers: Privacy, Security, & Breach Notification Rules. MLN Network.
Compliancy Group. (2021). HIPAA Violations, Breaches, and Fines/ Full list of HIPAA Violations.
Snell, E. (2020). What is a HIPAA Business Associate Agreement (BAA)? HealthIT Security.
