The medical office is such a separate institution, the main focus of which is the provision of a full range of services for both treatment and prevention of various diseases. In order to obtain licenses for the provision of medical care, as well as for opening an appropriate office, it is necessary to collect all documents that will confirm the professional capabilities of its employees within the framework of a specific type of treatment.
What does medical activity require?
The medical office at the school is also subject to licensing.
Medical activity requires documentary certification, as well as compliance with all norms of the premises in which it will be carried out. This includes documentation such as certificates, permits for the use of medical technology, passports, paper on equipment, tools and vehicles. In this article, we will examine in detail how licensing of medical rooms takes place?
Legislation requirements for medical rooms
Legal standards include the following space requirements when creating and equipping examination medical rooms:
- the gynecologist’s workplace should have a total area equal to eighteen square meters (special medical furniture is required);
- the area of the same cabinet without a viewing chair can be six meters less;
- a gynecologist’s office with a procedural area and a gynecological chair suggests sizes equal to 24 square meters. m;
- the therapist's workplace should also be twelve square meters;
- an office of a psychotherapist measuring 18 square meters. m;
- the area of the medical territory of the psychologist and psychotherapist is 12 square meters. m;
- a surgical room with a small operating room require 34 sq. m;
- the ultrasound cabinet should have at its disposal fourteen square meters; Licensing of medical rooms has recently become increasingly popular.
Key provisions for licensing medical facilities
Licensing of a medical office is regulated by the following legislative acts:
- Decree of the Government of the country No. 291 of April 16, 2012, which is called "On the licensing of medical medical activities."
- Federal Law No. 99, published on May 4, 2011, entitled “On the Procedure for Licensing Certain Types of Activities”.
- Decree of the Chief State Medical Doctor No. 58, adopted on May 18, 2010 "On the approval of sanitary and epidemiological requirements for institutions conducting medical activities."
- Order of the Ministry of Health of the Russian Federation No. 121 of April 11, 2013
The main stages of licensing
The process of registering a medical office, as a rule, consists of the following successive steps. The first step is to conduct an examination of the facility that requires licensing in order to determine its compliance with existing regulatory requirements. Medical furniture is also evaluated. This person is required to have such documents as the plan of the bureau of technical inventory, that is, the BTI of the premises for creating a medical office, a certificate of confirmation of ownership of the place and the lease along with the act of receiving and transferring the area to those who require registration. The latter is possible in situations where property is held by licensees on lease. What else involves licensing medical rooms?
Conclusion of an agreement
Formal conclusion of an agreement with an assistant company to carry out comprehensive measures to work and determine the timing of their implementation, as well as clarifying the cost of the services provided.
Room preparation
Carrying out the preparation of the necessary premises, as well as bringing it into proper condition in accordance with all licensing requirements. Cabinet equipment also needs to be purchased.
Sanitary and epidemiological conclusion
Making a sanitary-epidemiological report for medical activities. As part of this phase, the licensee will be required to receive a certified copy of the enterprise’s charter, confirmation of registration with the tax authority in the form of a TIN, an extract from the USRLE, with a date not older than ten days. In addition to the listed documents, you will also need a copy of the certificate of ownership of the premises, a lease agreement with the act of acceptance of the cabinet for the registration person. This contract must be concluded for at least eleven months. You will also need an institution registration certificate (OGRN).
Registration of a medical license to open a medical office
The requirements are quite high. This stage is quite extensive and requires the provision of a wide list of documents, including:
- the charter of the enterprise plus amendments to it, if any;
- certificate of registration with the tax service, i.e. TIN;
- extract from the Unified State Register of Legal Entities, the period of which must not be older than ten days from the moment of its receipt;
- availability of a certificate of direct ownership of the premises;
- a lease agreement and an act on the acceptance and transfer of premises in cases where the property is leased.
- certificate of registration of the organization;
- information letter informing about registration with the statistics authorities;
- a decision on the formation of the enterprise, as well as various protocols on the nuances introduced in the charter documents, if any;
- payment order, which will confirm the payment of the state fee for services for the provision of a license;
- BTI plan in which the pharmacy will be located;
- an extract regarding the fixed assets of the organization that were acquired by the licensee for the purpose of providing medical care;
- an order on the official appointment of a person to his post of manager;
- an employment contract concluded with the manager;
- an order to appoint a person to the position of general director;
- a list of medical equipment available according to the declared types of medical activity ;
- certificates of conformity for medical equipment;
- registration certificates for these instruments;
- sanitary and epidemiological conclusion regarding medical equipment (equipping medical rooms is not a problem now);
- invoices for this technique;
- statement confirming the location of medical instruments on the balance sheet of the organization;
- contracts for the maintenance of medical equipment;
- Warranty agreements for medical equipment.
Among other things, an on-site examination of the licensing object, as well as a submitted list of necessary documents, should be carried out. A field examination is usually carried out by the Federal Service for Supervision of Consumer Rights Protection and Human Welfare or the Department of Health of the Russian Federation. The final document itself is issued to the licensee with a passport, stamp and power of attorney. In cases where the director receives the paper personally, it is necessary to provide an order on his appointment to this position.
We reviewed the licensing of medical rooms. This process is not difficult, but requires some preparation.