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The Legal Significance of IV Hydration Documents

The healthcare industry is heavily regulated and IV Hydration Clinics have their own set of regulatory compliance requirements that they must strictly adhere to or else they risk disciplinary action (i.e. fines and penalties) taken against them by various federal and state agencies. These regulations aim at protecting patient privacy, worker safety, preventing fraud, waste, and abuse while improving operational efficiency. Ultimately regulatory compliance enhances patient outcomes by promoting adherence to best practices across the sector.

 

Proprietors of IV Hydration Clinics must utilize legally compliant Agreements and documents in addition to obtaining the necessary permits and licenses for operating their business. It is important to understand the legal significance of the IV Hydration documents that you will utilize in your clinic as we will discuss below.

 

IV Therapy Informed Consent

IV Hydration Clinics must receive informed consent from clients. Consent can be oral or written but it must be complete to comply with Florida law. This document is intended to serve as confirmation of the client’s agreement to receive IV Hydration treatment by a duly licensed Florida healthcare practitioner. In Florida, the informed consent law requires that the client be advised of three things: 1) the nature of the treatment; 2) the substantial risks and hazards of the treatment; and 3) the reasonable alternatives to the treatment (including, when appropriate, the option of not receiving the treatment). After learning these things, if a client consents to the IV Hydration treatment, then informed consent has taken place. Failure to obtain informed consent in accordance with Florida Statute 766.103, can result in discipline against your license and a medical malpractice action filed against your IV Hydration Clinic. If you are engaging Independent Contractors to provide IV Hydration services on behalf of your clinic you must ensure that they obtain the appropriate consent prior to providing the treatment.

 

Intake Form with Medical History Questionnaire

This form is critical because it provides insight into the client’s past medical history and present medical condition(s). The form collects basic information such as the client’s name, date of birth, sex, contact information, and emergency contact. It also collects information about medical history, current health status, and any medications that the client is currently taking. Certain conditions may render a client ineligible to receive IV Hydration treatments due to pre-existing conditions, medications that they are taking, and other factors. Failure to do a proper assessment may result in patient harm that could have otherwise been avoided if the Intake Form had been completed by the patient. It is the client’s responsibility to accurately complete the Intake Form. If the patient harm can be linked to the IV Hydration treatment that the client received then a potential lawsuit for damages may be filed by the client, assuming that the client properly disclosed relevant medical history information. Liability may attach to the clinic if the IV Hydration Clinic knew or had reason to discover that the patient had certain medical conditions that rendered the client ineligible for the treatment. To reduce exposure to potential lawsuits relating to patient harm, an intake form should be completed by all clients before providing treatment.

 

Medical Director Agreement

A Medical Director Agreement is a legally binding agreement outlining the terms, duties, and responsibilities of the Medical Director role within the IV Hydration Clinic. IV Hydration Clinic’s may not operate or be maintained without the day-to-day supervision of a single medical or clinic director. Failure by a clinic to employ a qualified medical director may result in disciplinary action against the IV Hydration Clinic. Medical Directors that are supervising the services provided at an IV Hydration Clinic must notify the Florida Department of Health. Medical Directors of IV Hydration Clinics should endeavor to comply with the requirements set forth in Florida Statutes 400.9935 and 59A-33.008, F.A.C. The Agreement will also determine whether the IV Hydration Clinic or Medial Director will provide professional liability insurance for the services provided as well as the coverage limits, in accordance with Florida law. The Agreement should also address indemnification requirements for any liability arising out of, incident to, or attributable to the performance or nonperformance of any duty or responsibility under this Agreement by the Medical Director.

 

HIPAA Notice of Privacy Practice

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) is a federal law that required the creation of national standards to protect sensitive protected health information (“PHI”) from being disclosed without the patient’s consent or knowledge. The US Department of Health and Human Services (“HHS”) issued the HIPAA Privacy Rule to implement the requirements of HIPAA. The HIPAA Security Rule requires IV Hydration Clinics to implement appropriate technical, physical, and administrative safeguard to protect PHI. This Notice of Privacy Practices informs the IV Hydration client of: (1) how their PHI may be used and disclosed; (2) the IV Hydration Clinic duties to protect the privacy and confidentiality of the client’s PHI; (3) explain the client’s privacy rights, including their right to complain to HHS and to the IV Hydration Clinic if the client believes that their privacy rights have been violated; and (4) how to contact the IV Hydration Clinic for additional information and how to file a complaint. The Law requires healthcare providers to obtain a signed writing that confirms that you have received the Notice of Privacy Practices. The Notice is typically provided at the client’s first appointment and is also posted to the IV Hydration Clinic’s website with reminders issued to clients every three years. It should be noted that in addition to HIPAA, IV Hydration Clincs must comply with the Florida Information Protection Act of 2014.

 

IV Therapy Independent Contractor Agreement

An Independent Contractor Agreement (1099) is a contract that lists the terms and conditions of the contractor’s work for the IV Hydration Clinic. The Agreement is meant to protect all parties involved and clarifies the relationship between the IV Hydration Clinic and contractor. Specifically, it outlines the contractor’s classification, compensation, compliance requirements, qualifications of contractor, restrictive covenants, tax obligations, insurance and indemnification requirements, liability, and other miscellaneous terms. It is important that the Agreement is compliant with the IRS’s definition of an independent contractor, which is determined in part by the contractor’s ability to make its own independent decisions regarding the scope of the services and when and how they will be performed. The more control the IV Hydration Clinic has over the contractor and its decision making the less it appears to be an independent contractor relationship.

 

Patient Media Release

A patient media release form is a legally binding document that is signed by an IV Hydration client and authorizes the IV Hydration Clinic to utilize that client’s image, likeness, and voice in its marketing materials, which may include videos, pictures, prints, and recordings. Many IV Hydration Clinics utilize social media and other forms of advertising to promote their goods and services. Oftentimes, IV Hydration Clinics post videos or pictures of their clients receiving IV Hydration treatments to their social media accounts. Due to the sensitive nature of the content that is being posted to social media it is important to receive permission from your clients prior to doing so. The patient media release form ensures that the client understands how their media will be used and authorizes the clinic to utilize the media without fear of liability for privacy or copyright infringement.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Can a Licensed Practical Nurse (LPN) administer I.V. Hydration Treatments in Florida?

As the booming world of I.V. Hydration continues to flourish, it has proven to become a reliable source of revenue for many in the healthcare industry. While these therapies were offered well before 2019, the pandemic has skyrocketed their popularity. Many celebrities have since been known to promote the efficacy and benefits to receiving vitamins intravenously.  I.V. Hydration treatments allow vitamins to be delivered directly into the veins. This can deliver almost immediate results and is a quick outpatient procedure. Because of these benefits and the increasing convenience, the world of intravenous drip therapies has grown in popularity. The world is now debatably much more health conscious and pro-active when it comes to individualized care.

Who Can Administer Intravenous Therapies?

There are various I.V. Hydration clinics opening statewide run by medical professional and non-medical professionals alike. There is guidance on who can run these clinics, and who can and cannot administer these such treatments or if specific medical professionals in the nursing field can administer these treatments under limited supervisions. As for licensed practical nurses, Florida law distinguishes their scope of practice when it comes to intravenous procedures. According to Chapter 464, Section 003, subsection (14) a licensed practical nurse is defined as any person licensed in this state or holding an active multistate license under s. 464.0095 to practice practical nursing. Florida Administrative Code 64B9-12.004 states that with the exception of aspects deemed outside of the scope of practice, a licensed practical nurse who meets competency requirements is authorized to administer intravenous therapy under the direction of a registered nurse or other healthcare provider.

What is Considered “Outside of the Scope of Practice”?

Florida’s Administrative Code Rule 64B9-12.003 says that an IV certified LPN should not perform the initiation of administration of cancer chemotherapy, plasma expanders, administration of investigational drugs, or blood and blood products. Although LPN’s are not to perform these duties without direct supervision of a registered nurse or a health care practitioner, they can however, care for patients who have received these procedures under proper care.

What are the ‘Competency Requirements’ to be Met?

In order to meet the Knowledge and Competency requirements outlined by the Florida Administrative code governing IV Hydration, an LPN must take a course with no less than thirty (30) hours of post-graduation level IV Hydration training. The didactic course must contain specific materials listed in rule 64B9-12.005 such as aspects of policies and procedures, psychological preparation and support for patients, and many more. After the course, interested LPN’s must partake in supervised clinical practice to demonstrate capability and proficiency. For a licensed practical nurse to be able to perform intravenous therapy under the direction of a registered nurse or health care practitioner via central and PICC lines, four (4) hours of appropriate education on Central Venous Lines (CVL) and Peripherally Inserted Central Catheter Lines (PICC) should be included within the required thirty (30) post graduate hours.  It is important to note that this I.V. Hydration education must be sponsored by a provider of continuing education courses approved by the Florida Board of Nursing.

For more information on the rules and regulations for Licensed Practical Nurses and IV Hydration, see the full chapter from the Florida Department of State here:

https://www.flrules.org/gateway/ChapterHome.asp?Chapter=64B9-12

If you are interested in learning more about starting your own I.V. Hydration business, schedule a consultation with Jamaal R. Jones via our Calendly app: https://calendly.com/joneshealthlaw/iv-hydration-consultation or sign up for one of our comprehensive Webinars. For more information or direct assistance call our offices at (305) 877 – 5054.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

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Florida House Bill 725 Introduces New Requirements for Administering IV Hydration Therapy under the Stephanie Balais Act

IV Hydration Vitamin treatments have taken the world by storm in recent years. This alternative medicine practice has gained popularity since the COVID-19 pandemic. It promises to boost the immune system in a post-pandemic world where everyone has developed elevated attentiveness to their bodies and wellness. Certain IV therapies are widely promoted to treat conditions such as fatigue, dehydration, fibromyalgia, asthma, migraines, and more. The ‘Myers Cocktail’ has been coined as one of the most popular mixtures claiming to “heal” patients from many ailments such as those listed above. It was named after the pioneer of IV Hydration, John Myers, who founded IV Hydration treatments in the 1960s. This cocktail is only one of countless mixes used for IV Hydration treatments.

Although popularity has spiked in IV Hydration recently, not much progress has been made to regulate procedures and care for those seeking these treatments. These IV treatments are executed in various settings (i.e. home or place of residence) by various providers (e.g. RNs, LPNs, APRNs, M.D.s, etc.). While there are definitive rules about who can administer an IV therapy treatment, there are not many protocols on emergency care. As with any wellness or medical treatment, there is always some level of risk to be considered beforehand. These risks include but are not limited to vitamin toxicity, infection, and nutritional imbalances.

After the unfortunate death of a young, aspiring nursing student in South Florida (Ms. Stephanie Balais) Florida Representatives filed House Bill 725. It is cited as the “Stephanie Balais Act”. In the products liability case of Stephanie Balais it is noted that her untimely passing was due to a Selenium treatment she received in 2018. It is unclear whether the fault lie with the manufacturer and the batch of products; the individual administering the product; or the lack of established procedures in the event of an emergency.  Liability was never determined in this case, and the case was settled out of court. However, this case prompted the introduction of House Bill 725.

The Act defines Intravenous Hydration Therapy as “a procedure in which high concentrations of vitamins and minerals are administered directly into the person’s bloodstream, allowing rapid absorption of higher doses of the vitamins and minerals than if received through food or supplements”. The prospective rule seeks to require the Board of Nursing to clearly define procedures to: (1) safely administer such treatments; (2) educate those administering treatments; and (3) create protocols for emergency situations. The Act also requires the following:

  • Completion of a Florida Department of Health self-screening risk assessment questionnaire from a patient prior to administering IV Hydration treatments;
  • Notifications to the patient’s designated physicians that an IV Hydration treatment has been administered and documentation regarding the process;
  • Enhanced emergency care plans for the facilities offering treatments, which must be written and kept at the location offering IV Hydration treatments;
  • Patients are also to be provided instructions detailing when to seek medical attention and information on the risks and side effects associated with the treatment being performed; and
  • Patients must receive a visit summary.

The purpose of the Act is to ensure the safety of patients considering IV Hydration treatments. Due to the rise in popularity and frequency of these treatments, it has become necessary to create safety guidelines to eliminate or at the very least minimize risks for the healthcare and wellness community. This is why any written emergency plan must at a minimum include: (1) the name and address of the hospital closest to the location where the IV Hydration Treatment is being performed; (2) reasons why an emergency transfer may be obligatory; and (3) the medical services that must be utilized in the event of a medical emergency. Additionally, if a health care provider, upon review of the completed self-screening risk assessment questionnaire determines that a patient can’t safely receive an IV Hydration Treatment the provider must decline administering the treatment to that individual.

We will have to wait to see how the IV Hydration business will be impacted moving forward. Violation of this Act will result in disciplinary action for the physicians and nurses who are providing IV Hydration Treatments to their patients. The act was set to become effective on July 1, 2023 but died in Congress. This Bill is not effective and the proposed requirements do not have to enforced by healthcare practitioners.

For more information on IV Hydration, please read our previous article,  Establishing A Mobile IV Therapy Clinic in Florida. 

IV Hydration Masterclass: Legal Requirements of Starting an IV Hydration Business

 

 

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

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