The Diagnosis of Risk.

FitBits, Apple Watches, Oura Rings—all are familiar names that indicate the immense popularity of wearable, digital health technology. Health and fitness trackers have become synonymous with wellness, empowering one to continuously monitor aspects of one’s health. Widespread usage means that doctors are more regularly presented with the discoveries from these devices; however, they are not regulated by the FDA and can provide questionable findings.

When it comes to patient safety, hospitals and doctors are required to abide by various laws and meet professional standards. Medical devices that are not FDA-approved raise legal concerns, as they may violate these laws and standards and put clinicians and medical facilities at risk of liability.

Handling Unregulated Devices and Device Results:

It is essential that hospitals and doctors establish clear guidelines for handling data and results from non-FDA approved devices. These protocols may include:

1. Establishing a clear policy on processing data from non-FDA approved devices. This policy should outline the conditions for whether an organization or practice will accept and use data from non-FDA approved devices.

2. Verifying the source and accuracy of the data via cross-referencing data with other tests, sources or experts.

3. Educating patients on how non-regulated device data can or cannot be used. Informed consent is an essential part of medical ethics. Data from non-FDA approved devices may be helpful to one’s medical history and even aid in medical treatments or discoveries; ultimately, however, it cannot replace or substitute for standard procedures, protocols or testing.

4. Collaborating with device manufacturers to verify device accuracy and reliability.

To ensure administration is purchasing FDA-approved products, follow these steps:

1. Check FDA’s Database

2. Verify the Manufacturer

3. Look for the FDA Approval Stamp or Label

4. Request Documentation: This may be a Certificate of Analysis, Compliance or a Drug Establishment Registration Number

Control of Non-FDA Approved Devices in Hospice.

The control and use of non-FDA approved devices in hospice are primarily instated by the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA). While FDA approval is not always required for certain medical devices used in hospice care, regulations set by CMS determine which devices are approved for use in hospice settings.

Procurement and evaluation are extremely important in hospice facilities. Establishment of robust procurement processes for non-FDA approved devices is required. This involves conducting thorough evaluations of non-FDA approved devices. Once the procurement process is completed, staff should record and monitor the device’s usage. Administration must conduct a brief safety overview including best practices and following protocols of newly integrated devices, as well as implementing maintenance schedules and inspections, and asserting the need for staff to address any malfunctions or defects.

Control of Non-FDA Approved Devices in Nursing Homes.

In nursing homes, non-FDA approved devices are controlled through various regulatory guidelines, facility policies, staff training, and quality assurance protocols, similar to those in hospice settings.

Regulatory Guidelines are set forth by federal and state agencies such as the CMS and the Occupational Safety and Health Administration (OSHA). Individual nursing homes develop and implement specific policies regarding the use of medical devices within their facilities. These policies may address the procurement, storage, usage, maintenance and disposal of non-FDA approved devices. They also outline procedures for staff training, documentation and reporting related to these devices.

Stay up-to-date on the latest information regarding healthcare standards, regulations and requirements regarding medical devices and device practices from the CMS, OSHA and the American Health Care Association (AHCA). Both AHCA and OSHA offer guidance and safety standards regarding the use of unregulated devices for long-term care facilities.

January is Human Trafficking Prevention Month, and Napa River has teamed up with Truckers Against Trafficking to help raise awareness of this pervasive issue.

Considering the seriousness of human trafficking, incorporating practices that highlight the importance and risk of human trafficking relative to the transportation landscape is vital to protecting of not only trafficking victims, but also your staff and your business.

THE RISK YOU FACE.

Trafficking is one of the fastest growing crimes of the 21st century, and because of its sometimes blurred nature with a lack of concrete red flags, it is often difficult to identify.

It is an issue that can affect your business both on and off the road, and as data suggests, most shopping or sex-buying transactions occur during or around the workday.

Drivers have the ability to see more on the road than anyone else, which puts them at a higher probability to spot and notify law enforcement of potential trafficking situations, and most importantly, stop active trafficking pursuits. TAT recognizes truckers as critical frontline personnel, placing them alongside those in the medical, service and hospitality fields.

On the contrary, truckers are also exposed to participating in these acts of violence. Research suggests that truckers may be heavy targets for traffickers, utilizing truck stops and rest areas for solicitation because of their convenient vicinity to the highway systems.

TACKLING TRAFFICKING HEAD-ON:

Stay informed, aware and educated on ways to keep your employees safe and bottom line protected. Below are regulations the United States Congress has set in place to enforce awareness and responsibility that directly affect the transportation industry.

Human Trafficking Prevention Act of 2022 More info

This act requires the posting of contact information of the national human trafficking hotline in specific places.

CDL Lifetime Disqualification for Human Trafficking More info

This law permanently bans drivers convicted of human trafficking from operating a CMV for which a commercial driver’s license or a commercial learner’s permit is required.

A CLEAR PATH FOR THE LONG HAUL: WHAT YOU CAN DO.

The corporate sector has an opportunity to leverage industry leadership and economic influence to raise awareness of this issue, empower everyone to take action, and lead by example.

By raising awareness through formal training, adopting explicit company-wide policies, and combining the efforts of anti-trafficking resources, law enforcement agencies and transportation industry stakeholders can facilitate a confidently coordinated response and have a major impact on the lives of everyone involved in human trafficking. Don’t know where to start?

1. Strengthen your business and enforce safe work environments by educating staff with tools and information regarding the impact of and ways to prevent human trafficking.
2. Create company-wide policies to help mitigate risk, while fostering a company culture based on awareness and respect for oneself, the company and vulnerable community members that may otherwise be subjected to the life-altering impacts of trafficking. This includes:

• • Connecting with companies like Truckers Against Trafficking, who work specifically with businesses to fight human tracking.
  • Adopting protocols and trainings that offer ways to minimize risk exposures and take action against human trafficking that fit within your business operations.
  • Implementing a zero-tolerance policy for engaging in commercial sex of any kind.
  • Initiating practices that promote transparency, trust and satisfaction between management and employees.

An anti-demand campaign such as Truckers Against Trafficking’s Man-To-Man Campaign addresses the issue and establishes the act of trafficking as abnormal behavior and one that goes against company policy.

TRUCKERS AGAINST TRAFFICKING.

Truckers Against Trafficking, or TAT, is a nonprofit organization with a mission to “educate, equip, empower and mobilize members of the trucking, bus and energy industries to combat human trafficking.” They understand the unique abilities of frontline personnel within the transportation industry to not only identify and interrupt an in-progress trafficking incident, but to also cultivate a company culture of awareness and personal responsibility that facilitates prevention. These actions go hand in hand with protecting trafficking survivors, your employees and your business.

Click here to go to the Truckers Against Trafficking website to learn more about how your business can benefit from preventing Human Trafficking.

MOVING FORWARD INTO A BETTER TOMORROW.

Recognizing the reality of human trafficking, educating employees at all levels of your organization and creating an explicit anti-trafficking company culture with specific policies in place will empower everyone involved to take action in the prevention and involvement of human trafficking.

To report suspected human trafficking to Federal law enforcement, please call 1.866.347.2423

The concern of workplace violence is one that touches everyone, and healthcare facilities are no exception. A hospital security team equipped with firearms has the potential to deter an imminent threat or completely interrupt an already-in-progress situation; however, careful consideration must be taken by multiple levels within the organization when it comes to the weighty decision of whether to arm its security staff.

Even with enhanced security protocols, many challenges persevere. A multitude of perspectives, including those of experts from security, law enforcement, administrative leadership, human resources and risk management services should be considered before deciding if firearms should be included in your healthcare facility’s security program. Our team understands this sensitive issue from a risk management perspective; we are here to offer several factors regarding healthcare facility safety for you to consider, as well as direct industry experience to help you move forward fearlessly in protecting your patients, employees and establishments.

MODERN HEALTHCARE

According to the International Association for Healthcare Security and Safety, responsibility for the introduction of firearms in the security program falls onto healthcare facility administration. The development of policies, standards for use and storage of equipment, commitment to current training programs, and application of enhanced screening protocols for all levels of staff involved are required prior to official implementation.

Be thorough. Proper operations analysis is a big component when considering armed security and its associated protocols. Evaluate how firearms implementation impacts all facets within your business or organization. As a result, that information will provide insights to help guide and determine appropriate next steps during the decision-making process. We encourage administration to seek advice and counsel from law enforcement, legal/risk management and human resources. For more insights, consider addressing the following factors:

• The environmental profile and crime index of both the healthcare facility and the community it serves. This includes the difference between crimes against people versus crimes against property, as well as looking specifically at internal security incident data regarding trending levels of violent crime.
• Historical situations in which firearms may have been a deterrent, as well as actual encounters with firearms at a specific healthcare facility or within its community.
• Trends in attitudes, perceptions and expectations on both the local and national levels in regard to armed security.
• Expectations of the role of armed staff (i.e., deterrent value versus engagement with an active assailant).
• Availability of community law enforcement and a general awareness of their response time to an incident.

GIVING YOU CLARITY

So, what are the differences, advantages and drawbacks in using firearms to keep your facilities safe?

Investigating security measures at similar healthcare facilities in terms of their location, size, community and services can be a helpful weigh in when determining the need for additional safety measures. For example, some facilities offer high-risk services that inherently face a higher risk of violence and may require heightened security in order to keep patients and staff safe.

Some advantages to armed healthcare facility security include increased staff confidence, demonstration to the community that patient protection is a priority, potentially deterring or deescalating a dangerous situation or, in extreme cases, completely stopping an active shooter.

Even with the best intentions and implementation, however, there are risks. While attempting to prevent violence, there is always the possibility (and liability) of profiling on behalf of the firearm-bearing individual. In addition, the presence of a gun is not unequivocally proven to de-escalate every situation or deter violent individuals, and the healthcare facility must face the possibility of stolen firearms, increased record keeping and high training costs.

MASTER RISK

The resulting claims that ensue when a security officer discharges his/her gun can be serious; luckily, we can support your need to prevent and move past risk. When considering armed security, we can help you navigate the associated liability and components of risk specific to your institution by considering the following actions:

• Establish strong communication directly with local law enforcement, as well as nearby healthcare facilities.
• Conduct a formal risk assessment specifically tailored to your location(s).
• Hire and train security personnel carefully and offer appropriate compensation.
• Adapt to a “zero incidents” philosophy along with zero tolerance.

FOCUS ON YOUR FUTURE

Untreated risk means costly claims that shift your focus away from your future success. Working together with your expert team of law enforcement, administrative leadership and risk management, the healthcare facility can determine which policies will best serve the location, keeping in mind that a mix of policies may be most effective. You can decide which positions in the security program should be armed, and establish hiring criteria, qualifications and competencies. The facility is then responsible for organizing an appropriate firearms training program, as well as the policies and procedures involving things like management of firearms, personnel background checks, psychological screening and re-evaluation, appropriate licensure, and ongoing training requirements. You may also choose to proactively establish an after-action review process to examine any events involving a security firearm.

In-depth training for your staff will also increase confidence and manage risk. Staff members with and without firearms will benefit from tools to assist with de-escalation and to help recognize both verbal and non-verbal warning signs of violence.

Napa River Insurance Services, Inc.

A Third-Party Administrator

866.407.7060 | https://www.napariverinsurance.com/contact/

¹ IAHSS Handbook: Healthcare Security Industry Guidelines. 13th ed., International Association for Healthcare Security and Safety.

A CHANGING WORLD

A hot topic in U.S. healthcare today is the Supreme Court of the United States (SCOTUS) decision to overturn Roe v. Wade. Since the landmark case formerly had guaranteed the constitutional right to abortion nationwide for nearly 50 years, this significant change in public policy has undeniably impacted healthcare professionals.

Questions of legality, liability and patient responsibility arose in the wake of state trigger laws that changed abortion access overnight. The decision affected healthcare entities in every state – not only those limiting access to the procedure but also those that expect to manage a new influx of out-of-state patients. Conversations began almost immediately about more legislative changes still to come. In the turmoil, many have begun looking ahead toward future policy changes that may potentially include the criminal prosecution of individuals seeking abortions in neighboring states.

THE DIAGNOSIS RISK

The BIG question on everyone’s mind in the healthcare world is: “What can I legally disclose?” The only thing we know for sure is that this situation will continue to evolve over the coming years. That said, it is extremely important, from both healthcare provider and risk management perspectives, to be considering this vital question now. Even though we know circumstances already vary greatly from state to state and will only continue to shift further, it’s a good idea to get re-familiarized with the formal basics of patient privacy. When doing so, it’s also helpful to imagine these applicable questions and possible future scenarios within the context of your unique, field-specific situations, as well as reconsider specific ways in which you might protect yourself, your organization and your patients moving forward.

HIPAA REVISITED

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) deserves some extra attention in a post-Roe America. Most of us feel that our health information should be protected and that we should have both access to our personal records and control over who sees them. In a nutshell, HIPAA gives you rights over your health information, creates national standards to protect sensitive information and sets rules for healthcare providers and insurance companies. The Department of Health and Human Services (HHS) and the Offices for Civil Rights (OCR) administer and enforce the rules, making sure that health information is protected while allowing the proper flow of information needed to provide high-quality healthcare.

One specific rule, known as the Privacy Rule, sets rules and limits on who view and receive protected health information; these are considered “covered entities” and include healthcare providers who use electronic transactions and records, health plans and healthcare clearinghouses. Generally speaking, when it comes to law enforcement, there are some circumstances under HIPAA in which these covered entities are permitted to disclose protected health information, but that does not necessarily mean that they are required to do so.

A good team of resources, ranging from healthcare providers, risk managers and legal entities, will help discern what is needed on a case-by-case basis. While some situations clearly need law enforcement involvement (for instance in the case of a gunshot wound), other circumstances may be more nuanced. From a risk management perspective, this means that professional judgment, policy and ethical principles play a significant role in navigating the realms of both privacy protection and legal compliance.

MOVE FORWARD FEARLESSLY

In the wake of the SCOTUS decision to overturn Roe v. Wade, the HHS provided new guidance for healthcare providers and others in the industry that offers a bit of clarity on what is generally considered permitted versus required under HIPAA, with examples of potential scenarios that helpfully contextualize the information. Considering these scenarios within the framework of your own organization may help you to form new best practices moving forward so that you can keep yourself, your organization, your clients and your patients protected. Click here to read more about the HHS’ new guidance.

A HIPAA infraction can have serious financial, professional, and potentially criminal consequences if someone deliberately obtains and/or discloses someone else’s protected health information. So, where do we go from here? With so many questions looming about the future of healthcare in the U.S., perhaps the best thing we can do right now is to remain vigilant by:

• Asking the right questions to get closer to solutions
• Making HIPAA a priority by training and retraining staff
• Consulting the right experts to help navigate the changing times

This complex situation is still changing day by day, with simple, straightforward solutions feeling out of reach. It is clear to see that attention to detail and subtleties are going to be great tools for determining the best ways to prepare for the future. Whether you are a new or experienced risk manager or a healthcare provider, the Napa River team is here to help you. Contact us to find out how we can offer a clear path to those solutions by offering a personalized plan that will allow your organization to Move Forward Fearlessly.

It comes as no surprise, that for the fifth year in a row, the driver shortage ranked number one in the list of industry concerns, followed closely by driver retention. As supply chain constraints dominate the headlines, even the average consumer is familiar with the issue and likely feels the impact.

WE’RE PAVING NEW ROADS.

With decades of experience in the commercial transportation industry, Napa River understands the complexity involved in not only hiring good drivers but keeping them. To that end, we have built our comprehensive Driver1st® program, based on extensive industry research into the driver shortage to create a new way to think about your organization, transforming it into one that:

• Is proactive and preventative rather than reactionary.
• Uses demographics, support systems and technology/advances to identify, attract and retain successful drivers.
• Better connects your drivers with the whole organization.

We believe that when these goals become standards of practice throughout the organization, drivers will find a “home” with you, despite a career that all too often is transitory by nature.

NEVER A BLIND SPOT.

We are committed to working with you each step of the way as you elevate your organization. To fully understand the issue of driver retention, however, we first need to take a deeper look at the timeline that informs both past and current driver shortages, as this context helps shape our future solutions.

Changing Landscapes

In 1980, the Motor Carrier Act was signed into law deregulating the commercial transportation industry. With fewer limitations and more opportunities, deregulation sparked an increase in demand for drivers and resulted in a rapidly changing landscape for those within the industry.

Moving forward to the 2008 recession and subsequent recovery — many people found truck driving as a second career, spiking both the total number of drivers as well as turnover. Demand for capacity and drivers continued to skyrocket during this time. We witnessed a similar scenario in 2020, and today the commercial auto industry faces a need for drivers unlike ever before. Many companies seek both trainees and experienced drivers, offering many attractive perks (like incentives and signing bonuses). As a result, it is incredibly easy for drivers to leave their current organizations and find a place in a new one. However, some of these deals are not as they appear. Average driver turnover is 100% and can be as high as 300% (meaning that 1-3 people are hired for a single position per year). With the high average cost to hire a driver and the fact that new drivers are much more likely to be involved in an accident, this is less than ideal. Customer service can also suffer from high driver turnover.

SEE AHEAD.

So, other than the evident ease in changing jobs and endless promises for “better” opportunity, what causes drivers to leave?

High Pressure + High Stakes = Higher Likelihood of Losing Your Driver

When it comes to company-related reasons that cause drivers to depart, a single incident is most likely the catalyst (versus long-term, chronic unhappiness). Drivers face difficult situations every day, but a single moment can make or break their experience with a company.

Every Driver Needs a Home

Finding “home” in the workplace can be an especially elusive concept for a person who may feel undervalued. At Napa River, we think it’s not only possible but necessary for a driver to feel safe, valued and respected enough to stay with their company for the long haul.

KNOW THE WAY FORWARD.

Successful transportation organizations have built a culture that recognizes the driver as its most valuable asset. They involve all personnel in the support of the driver. This, in essence, is what Driver1st does. Here’s how we do it:

Before Hiring a Driver:

Consider your organization and safety cultures. Have you created an environment and support system that drivers want to come home to? Research finds that owners who commit to robust and sustained safety and driver support programs usually have better safety and retention performance, leading to higher driver satisfaction.

Ask questions. Once a prospective hire is in sight, the company may look at certain factors that could make a driver’s experience significantly better from the start. Asking simple questions can have a profound impact and better prepare drivers for life on the road.

After a Driver Departs:

Consider what works AND what doesn’t. Napa River knows that better hiring practices lead to improved retention, satisfaction and safety. We analyze past driver input along with demographic data to create a model of the “perfect fit”: a driver that matches the company, and vice versa. Additionally, if a former driver was successful with the company, there could be the potential opportunity to rehire the driver in the future.

A CLEAR PATH FOR THE LONG HAUL.

Let’s say your organization is ready to partner with Napa River and utilize the Driver1st program. What happens next?

How We Can Help You Keep Your Drivers

Driver1st creates a roadmap for success, translating our findings into a personalized action plan and program setup. We facilitate hands-on training complete with ongoing communication and mentoring offered at all levels, including truckers and their families.

We evaluate your company. We begin by evaluating operations with meaningful metrics: where they’re going, what they’re doing, how they’re doing it, etc. We also collect data about former drivers, including contributing factors to dissatisfaction. When the evaluation is complete, the findings are then communicated to management.

We create and introduce a tailored program. Together, we create a tailored Driver1st program that will lead to increased driver hiring and retention, and then introduce it directly to staff through a series of comprehensive seminars. Progress and activities are closely monitored, and ongoing coaching to support personnel, drivers and their families is offered. This continuous mentoring and support structure development ensures that drivers feel heard and valued by the organization

MOVE FORWARD FEARLESSLY.

Napa River understands the concerns facing your industry. We know that higher truck driver turnover results in higher rates of accidents and customer dissatisfaction, and that supporting your frontline personnel will ultimately lead to greater success for everyone. Working towards a measurable goal of fewer claims for your organization is not only possible, but on the horizon, and Driver1st will help get you there. Contact us to find out more about how we can help your organization Move Forward Fearlessly.

The CURES Act was signed into law on December 13, 2016. Statistics show, however, that many healthcare workers are still unaware of this legislation.

KNOW THE WAY FORWARD.

What is the CURES Act? In a nutshell, the CURES Act of 2016 seeks to increase choice and access for both patients and providers. It details “Eight Mandatory Medical Record Categories” of information that must be made available to patients, ranging from things like consultation or visit summaries to lab and imaging reports.

In addition, the Act seeks to ease regulatory burdens associated with use of electronic health record system and health information technology. It includes focus on advancing interoperability and supporting Application Programming Interfaces (API), and details requirements to avoid engaging in “information blocking,” which refers to the prevention of/interference with access, exchange, or use of electronic health information. Since this is a rather generalized definition, the CURES Act provides eight categories of reasonable and necessary activities that do not constitute information blocking, given certain conditions are met, called the Information Blocking Exceptions. These are significant, as they offer a roadmap for healthcare companies to avoid liability while navigating an ever-evolving legislative landscape.

THE DIAGNOSIS FOR RISK.

The law and its subsequent additional rules went into effect in January 2022, and healthcare entities have a grace period through October 2022 to have their new or augmented systems in place. Here are a few of the potential hazards your business may encounter along the way to compliance with the policies of the CURES Act:

1. HIPPA Laws, Data Breach & Patient Confidentiality
2. Back-Up System Failure
3. Misinformation/Management Errors

PREPARE FOR TOMORROW.

With all this in mind, you can manage the obstacles that lie in the way of your success. Here’s what you can do to help your organization manage risk and successfully embrace the CURES Act:

1. Adopt the Right Mindset: The CURES Act presents an opportunity to gain further insight into the health of patients and the individual environmental factors that shape it. This information is integral to the evolution and future innovation of healthcare and healthcare companies.
2. Develop a Business Plan: A formal business plan will guide steady and consistent implementation of compliance efforts, especially when tailored to your organization’s specific goals and challenges.
3. Conduct a Risk Assessment: Various privacy, security, and safety risks can emerge when sharing and accessing patient data from consumer applications. Risk assessment considerations include an organization’s insufficient security standards, as well as risk of harm to patients when third-party apps act inappropriately. From a compliance standpoint, organizations face risks as they aim to preserve data privacy without conflicting with information-blocking regulations. Consultations about risk management and patient safety help mitigate these day-to-day liabilities.
4. Establish an API Governance Policy: Apply Governance Unilaterally: A well-crafted governance policy can enable efficient API integration without putting the organization at risk. Consistently applying the governance policy/vetting process to all third-party apps significantly limits the likelihood of unauthorized access to or use of private information through an app, and simultaneously serves to justify the instances where the organization must deny third-party access due to risk concerns.
5. Educate. Educate: Moving forward, stakeholders, staff and patients need to be informed and continually reminded of the new policies, especially in terms of the “Eight Mandatory Medical Record Categories” and the Information Blocking Exceptions.

MOVE FORWARD FEARLESSLY.

Risk is a reality, and our Napa River experts are here to help. Contact us so, together, we can move your business forward.