Is it necessary to obtain medical practice license for an infirmary?

This material is no longer relevant. Read about the peculiarities of the new regulation of obtaining licenses for infirmaries at the enterprises in the publication of our lawyer here.

Often, enterprises, especially those with a large number of employees or a certain type of activities, intend to set up an infirmary to render urgent medical aid to their workers or even to conduct medical examinations and provide other healthcare services.

First of all, it should be noted that the regulation of infirmaries, like many other healthcare facilities, is quite confusing and does not govern all the aspects of their activity.

According to the Order No. 385 of the Ministry of Health of Ukraine of November 28, 2002, which approves the list of healthcare facilities, there is no such facility as an infirmary.

According to the abovementioned Order, a first aid post shall be established at the enterprises as a part of the outpatient clinic or polyclinic.

Such first aid posts are usually established at large industrial enterprises or educational institutions with more than 1,200 employees or pupils. Legal entities with first aid posts must provide and maintain a first aid post for free, ensuring heating, lighting, water supply, security, cleaning and repair of it.

The medical staff of first aid posts (except for state educational institutions and enterprises for disabled persons and enterprises with special working conditions) shall be maintained at the expense of such enterprises.

However, a first aid post may be established not as a part of a polyclinic or outpatient clinic, but as a subdivision of an enterprise and shall be owned by the latter, regardless of the size or number of employees. We will elaborate on this issue in more detail.

The terms “infirmary” and “first aid post” are identical and do not differ in nature.

Having read the letter of the Ministry of Health of Ukraine No. 17/7755 of 24.03.2014, we can conclude that the infarmaries must provide secondary care. However, according to amendments to the Law of Ukraine “Fundamentals of Health Care Legislation”, which relate to the improvement of health care sector, the secondary (specialized) medical care is a type of medical care, which can be provided in hospitals or outpatient clinics according to the planned order or in emergency situations and includes consultations, diagnostics, treatment, rehabilitation and preventive procedures for diseases, injuries, poisoning, etc.; referral of medically eligible patients to other specialists or to use tertiary health care.

Pursuant to Order No. 385, the infirmary is a healthcare facility and shall therefore be regulated in the same way as other medical establishments, but with certain peculiarities.

Perhaps the main problem that future licensees are usually faced with is the lack of understanding of the need to create a position of the head of an infirmary at the enterprise and the difficulty in finding a person who would meet the Licensing Regulations for medical practice.

The abovementioned position is called the head of the infirmary, but this person shall be actually a chief physician (as in other types of health care facilities), and accordingly he/she shall meet the same requirements. Thus, the key requirement for the head of the infirmary is to have the certificate of a specialist in the “Organization and management of health care” specialty.

Infirmaries can be either general or specialized, for example, in ophthalmology.

Most often, infirmaries function on the basis of a separate regulation, which shall be approved by the company’s order. Such a regulation governs, among other things, the rendering of health care service not only to its employees, but also to their family members, other persons who are not employed by the enterprise, the terms and conditions of rendering health care services for different categories of persons.

Like all other health care facilities, informaries, which are structural subdivisions of enterprises, are subject to accreditation.

The establishment of the infirmary, irrespective of the form of ownership, does not relieve the company from the requirement to obtain a Medical License.

According to the State Construction Codes of Ukraine (DBN), which establish requirements to premises of such facilities (В.2.2-10-2001), namely para. 8.194, medical and feldsher’s stations shall be designed as a part of the industrial enterprises and public institutions according to the requirements of the Construction Norms and Regulations 2.09.04, including the list of premises according to the design specification.

It is necessary to remember that the company represented by its director can grant the power of attorney to its representative (for example an in-house lawyer) to submit documents to the licensing authority. However the licence form shall be obtained personally by the company’s director or the head of the infirmary through the Single Window of the Ministry of Health of Ukraine. To learn more about the procedure for submitting documents under a power of attorney, click here.

Today, many enterprises have doctors or junior specialists with medical education working alone or collectively. However, such enterprises often do not set up infirmaries or neglect the requirement of obtaining a Medical License, as it can be a lengthy and costly process.

Current legislation provides for various penalties in this area.

Pursuant to Article 164 of the Code of Ukraine on Administrative Offences (the CAO), unlicensed business activities or activities that violate licensing regulations are subject to penalties. Depending on the situation, the amount of fines may vary from UAH 340 to UAH 8,500 with or without confiscation of funds received as a result of such an offence.

There are also cases for imposing criminal liability, especially in case of a medical error made by a junior specialist with a medical education, such as a nurse or paramedic. Pursuant to Article 138 of the Criminal Code of Ukraine, engaging in an illegal medical practice without a special license by a person who has no proper medical education, where this has caused grave consequences for the patient,, shall be punishable by  correctional labor for a term up to two years, restraint of liberty for a term up to three years, or imprisonment for a term up to three years.

The law of Ukraine provides also for civil liability.

Thus, the activity of doctors at the enterprises shall be licensed within the framework of the activity of infirmaries. The latter must meet the requirements for the material and technical basis and human resources, which are established by the Licensing Regulations and other laws and regulations governing the procedure of rendering health care services by health care facilities.

This material is no longer relevant. Read about the peculiarities of the new regulation of obtaining licenses for infirmaries at the enterprises in the publication of our lawyer here.