Collaboration Between Compliance and Risk: What is Permissible?

Compliance departments, generally speaking, guide staff and boards of directors to comply with the requirements, laws and regulations that govern the organization’s business. They also monitor for compliance via internal audits.  Risk departments, on the other hand, address ways to mitigate risk to an organization through such activities as the evaluation and purchase of insurance policies.  Given the broad nature of the scope of these two departments within the organization, when is compliance and risk collaboration permissible?

Possible collaborations

  1. Strategic planning: Collaboration here should include not only compliance and risk but the entire organization and the board of directors, if applicable.
  2. Disaster response and business continuity: As with strategic planning, disaster response and business continuity planning should also involve input and collaboration from all departments in the organization.
  3. General security and privacy : Here the compliance/privacy officer, information technology/security officer, and risk management director should all be included in the planning.
  4. Known security threat and/or breach incident: Compliance, information technology (IT), and risk management would all participate in mitigating a security threat or breach incident on the organization. Each would provide input and guidance on their respective areas of knowledge.
  5. Risk assessments, gap analysis and mitigation plans: Again, the development of these plans should include leaders from the entire organization; moreover, compliance and risk would specifically collaborate on the assessment, analysis and mitigation activities.
  6. General policy development: Compliance and risk staff can collaborate and provide feedback and input for all organization policies.
  7. Record and document retention schedule: Here compliance and risk can collaborate with legal counsel to ensure record and document retention policies comply with state and federal laws.
  8. Staff education: This is an area where compliance and risk can collaborate to provide training, whether it is done in person, virtually, by email or via online course.

Collaborations to vet and evaluate permissibility

  1. Security breach: As noted above, compliance, IT, and risk will work together once a security breach has been identified. It is important to ensure compliance addresses HIPAA related information and potential reporting requirements; IT evaluates the technical aspects of the breach; and risk focuses on reporting to the insurance carrier and mitigation strategies in conjunction with compliance and IT. These collaborative activities will usually take place under a breach coach or law firm to protect the confidential nature of the breach.
  2. Shared work areas: Depending on the confidential nature of discussions, say a lawsuit against the organization, it may or may not be appropriate for compliance staff to be privy to such information. So shared work areas should be closely evaluated.
  3. Shared staff: As with shared work areas, if a staff member such as a registered nurse (RN) is shared between the compliance and risk department, both leaders and the RN must remain in the scope of the job role in which they are working at the time.
  4. Reporting to the board: Typically, compliance reports to the organization’s leader (such as a CEO) but also has direct or dotted line reporting to the board of directors. Make sure any collaborations with other departments do not create potential conflicts of interest with reporting up this chain of command.
  5. Committee membership: As with the analysis discussed above, make sure to vet compliance staff member membership on the risk committee and vice versa to avoid any actual or potential conflicts of interest.

Goal

All organizations should work to develop a culture where permissible collaborations between compliance and risk occur. They should also make certain that staff feel comfortable calling the compliance or risk department with potential concerns while ensuring the staff not crossing any lines when it comes to compliance or risk department confidential matters or conflicts of interest.

PRACTICE TIP:

  1. Evaluate opportunities for the compliance department to collaborate with the risk management team, as noted above.
  2. Access youCompli to find resources which address required document and record retention requirements.

Denise Atwood, RN, JD, CPHRM

District Medical Group (DMG), Inc., Chief Risk Officer and Denise Atwood, PLLC

Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.


Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.  


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Manage your healthcare regulatory change process effectively and efficiently

YouCompli enables the compliance officers to assign ownership and oversight of tasks to different department heads, functional leaders, or specialists. The solution prompts users to accept, reject, or reassign the task by a stated deadline. Manage the rollout and accountability of new requirements with the best workflow in the business.

Organization Liability: Impact and Risk Mitigation (Part II)

liability risks in healthcare denise atwood

Impact of Risk Liabilities 

Unmanaged or poorly managed risk can cause devastating effects to the organization from a reputational and financial perspective. 

An extreme example of financial risk, coupled with nationwide reputational risks, was the Tylenol case in the 1980’s. The New York Times describes how, in 1982, Extra-Strength Tylenol capsules were tampered with and laced with potassium cyanide. Seven people in the Chicago area died and copycats caused several more deaths across the U.S. As a result of those incidents, tamper-resistant packaging was created and implemented so over-the-counter products, such as Tylenol, could not unknowingly be laced with a poison which could cause injury or death. 

Despite the fact that the manufacturer had not introduced the poison, this event led to huge financial  and reputational liability for McNeil Consumer Healthcare, the makers of Tylenol. On just the financial side, this cost a considerable amount of money due to decreased sales and increased advertising costs. 

As this example demonstrates, financial and reputational risk for an organization in the healthcare field can have disastrous consequences that threaten to bankrupt or put the organization out of business. If the event or incident is sufficiently egregious, the organization could also face loss of accreditation or state licensure. If this happens, they may also lose Medicare and Medicaid contracts.   

Risk Mitigation 

Proactive risk mitigation strategies include transfer of risk, through such vehicles as contracts and insurance, and early reporting of incidents or events by staff. 

Transfer of risk in contracts in typically done with indemnity or hold harmless clause. Transfer of risk via insurance is done by ensuring the organization has adequate coverages and retentions to meet the organization’s needs.  

The intent of an indemnity clause is to transfer the risk of financial loss from one party to the agreement to another party to the agreement. Generally, this is financial losses or expenses caused by contract breach or default, negligence, or misconduct by one of the parties.  

Hold harmless language in the contract states one party will not hold another party responsible for potential risks or damages. Hold harmless clauses can be unilateral and apply to just one of the parties to the contract or can be bilateral and apply to both parties to the contract. Typically, bilateral hold harmless language is preferred for healthcare organization contracts because each party will assume their own risk and not sue the other party to the contract for the risk which was assumed.   

Early reporting by staff is crucial in order to ensure that appropriate action, discussion, documentation and reporting takes place. Most importantly, this is necessary to ensure that risk mitigation strategies can be implemented to eliminate or decrease risk to the organization.   

PRACTICE TIP 

  1. Develop and conduct risk assessments of insurance policies and large contracts to identify areas for improvement. 
  2. Review contracts to ensure indemnity or hold harmless clauses have been included.  If not, add the clauses on renewal 
  3. Work with Risk Management to conduct a risk assessment to evaluate organization risks and implement mitigation plans.  

Denise Atwood, RN, JD, CPHRM 

District Medical Group (DMG), Inc., Chief Risk Officer and Denise Atwood, PLLC 

Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.  


Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.  


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 Manage your healthcare regulatory change process effectively and efficiently

YouCompli enables the compliance officers to assign ownership and oversight of tasks to different department heads, functional leaders, or specialists. The solution prompts users to accept, reject, or reassign the task by a stated deadline. Manage the rollout and accountability of new requirements with the best workflow in the business.

Organization Liability: Types of Risk (Part I)

liability types of risk denise atwood

Risk is an important concept for compliance professionals working in the healthcare space to understand. After all, there are many times where risk and liability have crossover to compliance.

For example, in response to a suspected email or electronic health record breach, compliance and risk professionals will need to work together. This work will include:

  • Evaluating the breach
  • Reporting to the insurance carrier
  • Collaborating with a breach coach or legal team to ensure the investigation meets legal requirements and timelines
  • Collaborating with the information technology team and a forensics firm to ensure risk mitigation strategies are implemented and effective

And so on.

Generally speaking, healthcare compliance professionals should have a good working knowledge of organization risks and liabilities, as well as risk mitigation strategies.

This raises two important questions:

  1. What areas of risk do healthcare organizations face?
  2. What are the potential liabilities related to unmanaged or poorly managed risk?

Areas of Risk for a Healthcare Organization

Areas of risk for a healthcare organization are vast, and can involve injury to persons, property and reputation. Several areas of risk include:

Patient safety risks

These include near misses, which are mistakes which almost make it to the patient, as well as events or incidents that do make it to the patient, causing the patient to experience an unanticipated outcome such as a longer hospital stay, disability or death.
For example, a nurse may realize before giving a vaccine to a child that the adult vaccine and dose was drawn up in the syringe instead of the pediatric vaccine and dosage. This would be a near-miss. Along those same lines, a mistake occurs if the adult vaccine dose is actually administered to the child and an allergic reaction occurs.

Operational risks

These include such things as business interruption or supply chain issues. Business interruption incidents may include fire, flood, or pandemic. If the electronic medical record system goes down, and staff have to chart by hand on paper, this would be a business interruption. Supply chain issues can occur due to higher than normal demand or decrease in output by the manufacturer. If an organization cannot obtain needed supplies – such as hand sanitizer or surgical masks – that would be an example of a supply chain issue.

Legal risks

These typically involve lawsuits filed against the organization. Most commonly, lawsuits result from allegations of inappropriate employment practices or medical negligence or malpractice. For example, if a child had an allergic reaction after receiving an adult dose of a vaccine and unfortunately passed away, the parents may file a lawsuit alleging medical malpractice or negligence on behalf of the organization, the provider or the nurse who administered the incorrect vaccine.

Insurance risks

Insurance risks generally stem from a lack of adequate or appropriate insurance coverage or failure to transfer risk. Insurance risks can also connect to legal risks, which can stem from contracts with inadequate risk transfer or failure to conduct due diligence to vet the vendor. In the case of a pandemic, healthcare and other organizations may not have realized that pandemics and resulting business closures may be excluded from their business interruption insurance policy.

Human capital risks

These encompass the inability to hire, contract or retain appropriately trained staff. A lack of ICU level nurses causing staffing shortages would be an example. Human capital risks can also include professional board or licensing complaints against the organization’s doctors, nurses, therapists, or other licensed staff.

Reputational risks

Reputational risks are often forgotten or invisible to an organization until a bad event happens and it is announced to the public – at which point it is too late.

Reputational risk used to be limited to bad publicity which was published in print or reported on television. However, with the increased acceptance and use of social media, reputational risks are more far-reaching than the local newspaper or evening news program, and could potentially have national reach and negative impact on the organization . A newspaper may not run a story about a child who received an incorrect vaccine, but the child’s mother could post to Facebook or other social media platforms that the organization and providers are terrible and not to be trusted.

Practice Tips:

  1. Schedule a meeting with your insurance broker to evaluate your insurance policies by product line (i.e., general liability, property, cybersecurity, etc.) to ensure the organization is adequately covered to protect against most business losses.
  2. Educate staff to ensure they know how and where to report near-misses and mistakes that occur in the organization.
  3. Work with Risk Management to conduct a risk assessment to evaluate organization risks and implement mitigation plans.

Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and owner of Denise Atwood, PLLC
Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.


Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.  


Sign-up for the YouCompli Blog to Stay Up to Date on Compliance Related News!


Manage your healthcare regulatory change process effectively and efficiently

YouCompli enables the compliance officers to assign ownership and oversight of tasks to different department heads, functional leaders, or specialists. The solution prompts users to accept, reject, or reassign the task by a stated deadline. Manage the rollout and accountability of new requirements with the best workflow in the business.