DPH Licensure
Department of Public Health (DPH) approval of a mobile unit requires compliance with all relevant regulations under 105 CMR 140.000: Licensure of Clinics and the provision of quality care in accordance with applicable standards of practice, state and federal regulations and the conditions detailed therein. In order to request DPH licensure approval for a mobile unit, the following steps must be followed/documents must be submitted to DPH:
Choice of entity for licensee
An entity must be selected to hold the mobile unit clinic license issued by DPH as the “licensee.” This entity and its leadership will operate and be responsible for the mobile unit clinic’s activities. It can be an entity that already has a clinic or hospital license (in which case the mobile unit can be added as a “satellite” service to the existing clinic or hospital license), or an entity that is not currently licensed to operate a clinic by DPH.
Licensure application and suitability review
Prior to operating a mobile unit, an applicant must submit a licensure application. DPH has specific forms for this purpose which allow DPH to assess a new applicant’s suitability for licensure and request basic information related to operation, administration, staff and the nature of the services to be provided on the mobile unit (e.g., laboratory, mental health, substance abuse, etc.). Please note that certain supporting documentation listed on these forms as required to be submitted with the forms do not apply to mobile units and therefore, do not need to be submitted to DPH (e.g., Fire Safety Inspection Certificate and Certificate of Occupancy)
If the proposed licensee entity does not already hold a DPH clinic license, it will be considered a new applicant for a new clinic license. Accordingly, DPH must conduct a suitability review of the proposed licensee before licensure approval can be issued. As an overview, the suitability application requests such information as corporate ownership, other health care entity ownership, compliance history, background checks, resumes, financial capacity, etc. This suitability process is not required if the licensee entity already holds a clinic license from DPH and chooses to add the mobile unit as a satellite under that license.
In addition, the applicant must submit a project narrative that describes the services to be provided along with an attestation form. Compliance with all applicable requirements must be attested to by an authorized officer, such as the responsible physician (e.g. chief medical officer). On the attestation form, the clinic must either mark yes if the mobile unit is compliant or provide a waiver request if it is not compliant. To this point, certain physical requirements that the state typically requires may be waived for mobile health services.
For example, although the attestation form requires that a clinic attest to providing a toilet room with hand washing facilities on the mobile unit, as appropriate tothe services provided by the mobile unit, such clinic may remain in substantial compliance with the requirement by delivering services in areas nearby public restrooms, ensuring that patients have convenient access to such toilet facilities and submitting a waiver request to DPH to this effect.
Upon receipt of a complete application, DPH reserves the right to schedule and conduct a survey of the mobile unit to ensure compliance with all applicable regulatory requirements. During this survey, a tour of the mobile unit will be conducted to verify compliance with the regulations and waivers, as applicable. Additionally, DPH surveyors may request review of documentation, such as contracts and agreements, applicable certificates/registrations, emergency protocols, staff credentials and schedules, clinical records and written policies and procedures that define the practices of the mobile unit. Once it has been determined that the mobile unit meets all regulatory requirements, a license to operate will be issued