Lengea Law Medical Spa Compliance Checklist
As the business year comes to a close, it’s a good time to make sure that your medical spa is in compliance for the new year. We put together a free compliance checklist with some of the most common items to check in a medical spa practice.
✔️ OSHA Compliance and Training: Is the medical spa OSHA compliant? Has the relevant OSHA training been conducted? Does the medical spa have the required posters and/or signage?
✔️ HIPAA Compliance and Training: Is the medical spa subject to HIPAA? If so, is the medical spa abiding by HIPAA and/or a relevant set of state laws with respect to privacy, confidentiality, and security of protected health information? Are business associate agreements and notices of privacy practices posted in the places where they need to be? Does the medical spa have policies and practices in place to provide for both the privacy and security of the patient information? Does the medical spa allow timely access to the patient records in accordance with both state and federal law. Does the medical spa provide annual training?
✔️ Practice of Medicine: Is your medical spa in compliance with your state’s stand on the corporate practice of medicine? Do you have or need a Management Services Organization (MSO) structure? We can guide you through the structuring of that if necessary.
✔️ Marketing: How are you marketing your medical spa? Is your professional advertising in compliance with your states’ professional advertising rules?
✔️ Medical Director Compensation: Is your medical director compensation compliant with law? Does your medical director have a detailed job description?
✔️ Consents: Does the medical spa have compliant informed consent from patients? Are the consents updated to reflect known risks and benefits for the different procedures?
✔️ Provider Supervision: Is a physician or nurse practitioner appropriately supervising the physician assistants, nurses, technician or other ancillary staff? Does the physician or nurse practitioner have written, standardized protocols and procedures? Does the physician or nurse practitioner have experience and training in the areas of practice that they are supervising? Is the physician or nurse practitioner compiling with the level of supervision (general, on site, immediately available, in the room)
✔️ Scope of Practice: Are practitioners performing services within the scope of their licensure? Are there clear rules in the state limiting the scope of practice or is it up to the individual to determine their competencies? Has the Board of Medicine or Board of Nursing provided any guidance or opinions on the scope of practice for aesthetic procedures.
✔️ Initial Consultation or Good Faith Exam: Does the MD, NP or PA conduct a good faith exam with every patient? Is the exam documented in the medical record? Is the provider tailoring the treatment to each patient? Does the medical spa rely on standing orders?
✔️ Standard of Care: What does the MD or NP in charge do to ensure that the standard of care is followed for every patient? For example, are they required to sign off on charts or do routine audits? Are treatment protocols in place and compliant with law?
✔️ Are the Medical and Non Medical Service Appropriately Separated: If it’s a MSO/MSA structure, is the management company correctly formed to provide only non-medical services? Does the language of the MSA clearly prohibit the MSO from interfering with the medical judgement of the providers? Does the MSA clearly state the practice shall have final say in the hiring and firing of clinical staff?
✔️ Ownership of Medical Records: If it’s a MSO/MSA structure, are medical records owned by the medical practice (or professional medical corporation), and not by the MSO? What happens to the records on expiration or termination of the agreement?
✔️ Employee Management: If it is a MSO/MSA model, is it clear that all clinical staff report to the professional corporation and the designated medical director? Does the professional corporation have final authority with respect to the hiring and termination of the clinical staff? Is this documented and consistent with the practice’s disciplinary program?
✔️ Regulatory Compliance: Has the spa been under regulatory agency investigation, sanctions or incurred fines? Is the practice under anytype of restrictive agreement with any governmental agency? Does the medical spa have all of the required licenses along with the facility requirements (do you need a sink in the treatment room)?
✔️ Medical Services and Aesthetic Treatments: Is there a clear delineation between medical procedures (such as Botox, the use of ablative lasers, which should be offered by the medical doctor, NP, PA or the professional medical corporation, and relevant clinical staff hired by them), and aesthetic, non-medical procedures (such as facials and massages), which can be offered by other practitioners?
✔️ Telemedicine: Does the spa have policies in place for the use of telemedicine? Is the patient consenting to the use of telemedicine? Is the consent documented in the medical record?
✔️ COVID Precautions: Does the spa have policies in place for patient safety during COVID? Does the spa have policies in the event of exposure? What are the spa’s cleaning and disinfecting plans?
✔️ Malpractice: Does the spa have appropriate malpractice insurance? Are mobile services included? Are all providers who require coverage on the plan or do they have their own malpractice insurance? Is there tail coverage?
✔️ Vendor Contracts: Are vendor contracts current? Are there contracts that need to be terminated? Do they have a BAA if applicable?
✔️ Clinical Training: Is ongoing clinical training provided to staff? How is it documented? Does the clinical training meet your state specific requirements, if any?
✔️ Provider Contracts: Are the provider contracts current? Are they clear as to Independent Contractor versus Employment? Do they include Non-Solicitation, Non-Disparagement and Non-Compete clauses? Is the Non-Compete reasonable in time/scope/geographic location? Does the agreement accurately reflect what the provider is doing?
✔️ Collaborative/Supervision Agreements: Do the nurse practitioners and/or physicians and/or physician assistants have the appropriate collaborative / supervision agreements in place?
✔️ Signage: Does the spa have all the appropriate signage displayed? Local, State, and Federal?
✔️ Licenses and Continuing Education: Are the providers’ licenses in good standing? Are the providers current on their continuing education and licensure requirements? Does the employee file reflect the current licensure and certification?
Regulations change constantly and can be very confusing. No need to worry if you are unsure about any item on the checklist above! Just give us a call or send us an email–we would love to explain the legal requirements and how we can help you get in compliance.
The general checklist is a great place to start when opening a new medical spa. We also offer your medical spa a more specific checklist for your state. The state specific compliance checklist is $1,450.Get My State Checklist
This checklist includes addressing common issues like ownership, who can provide medical direction, supervision, and scope of practice. Also included in our state specific checklist are state specific labor laws, fee splitting restrictions, and other regulatory guidance.
We can also perform a compliance audit of your healthcare practice. Our compliance audit packages start at $7,500.