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Medical lawyer. Specializes in protecting the rights of doctors and patients, handling medical malpractice and liability cases, supporting disability determination and appeals procedures, and providing legal analysis of medical documentation.
Verification of Medical Practice Licensing Conditions
The Ministry of Health (hereinafter referred to as the Ministry of Health) carries out systematic supervision over compliance with licensing conditions by medical institutions and enterprises that have received the appropriate license. As part of this control, the Ministry of Health checks a wide range of requirements, including organizational aspects, the state of the material and technical base, and staffing.
For the effective implementation of state supervision, the Annual Inspection Plan for 2025 was put into effect, approved by Order of the Ministry of Health No. 1980. This document allows determining, firstly, the frequency of planned events, and secondly, the types of inspections. The main requirements for conducting an inspection of the Licensing Conditions of Medical Practice are defined in a number of regulatory legal acts, in particular in the Law of Ukraine No. 877-V.
Criteria for inspecting the Licensing Conditions of Medical Practice
The inspection criteria may include the following aspects:
- first, organizational criteria. In particular, the presence and compliance of the organizational structure of the institution with the Licensing Conditions, the fact of compliance with internal procedures and protocols, the presence of a quality control system are checked;
- second, criteria for the material and technical base. The Ministry of Health monitors the availability of the necessary premises and their compliance with basic construction and sanitary standards, the level of provision of medical equipment (including high-risk equipment), and conditions for storing medicines;
- third, personnel criteria. The control includes the number of staff, the presence of employees with appropriate education and qualifications, as well as compliance with the requirements for maintaining personnel records at the enterprise or institution, respectively.
Scheduled inspections of the Licensing Conditions for Medical Practice
Terms
Scheduled inspections of the Ministry of Health are carried out at different times for each individual case, taking into account the degree of risk from the institution’s activities. The list of criteria for assessing such risk is given in the Resolution of the Cabinet of Ministers No. 1163 and is as follows:
- the period during which medical practice is carried out (new institutions require more careful attention);
- types of medical care provided (affect the level of responsibility and the scope of the assessment in general);
- compliance by the institution with the requirements of the law during the conduct of medical practice, the absence of violations according to the results of previous inspections;
- the number of medical specialties in which medical practice is carried out (the applicant may initiate an extension of the license for medical practice, while simultaneously engaging in different types of care).
Taking into account the points indicated above, the degree of risk of a medical institution is determined. Depending on it, the very term for conducting systematic inspections is determined: for a high degree of risk – once every 2 years; for an average degree of risk – once every 3 years; for a minor degree of risk – once every 5 years. In order to find out to which degree your institution or enterprise should be assigned, we recommend that you seek professional advice from one of our lawyers.
What documents does the Ministry of Health check?
It is worth noting that the preparation of the necessary documentation is a key stage of preparation. An approximate list of documents that the Ministry of Health checks is as follows:
- organizational and legal documents (Charter, lease agreements, staffing list);
- documents confirming the qualifications of personnel (copies of passports, diplomas, certificates, copies of work books, documents on mandatory medical examinations);
- documents on activities (valid license, approved medical care protocol, plans, and reports of the institution’s work, etc.);
- documents on material and technical support (technical passports for medical equipment, inspection reports, contracts for medical waste disposal, evacuation plans, etc.).
Depending on the specifics of the activities of each individual institution, the Ministry of Health also checks other documents for proper assessment. Experienced lawyers of “Prikhodko & Partners” can help clients by collecting, checking and properly preparing a list of documents for the Ministry of Health. The price of legal support is determined during an introductory consultation with our specialist accordingly.
Typical cases of violation of the Licensing Conditions of Medical Practice and ways to avoid them
Cases of violation of the Licensing Conditions may concern various aspects of activity. To avoid sanctions from regulatory authorities, we advise you to pay attention to the typical ones, the list of which is provided by our qualified lawyer:
- first, violation of personnel requirements. These include an insufficient number of medical workers in accordance with the staffing list (some are officially employed, and some are not), the absence of documents confirming the passage of medical examinations.
- second, violation of requirements for the material and technical base. Typical are the establishment of the fact of non-compliance of premises with sanitary standards, non-compliance with the storage conditions of medicines, lack of free access to premises for low-mobility groups of the population;
- third, violation of organizational requirements. Quite often in practice, there are cases of improper maintenance of medical records, lack of a quality control system at an enterprise or institution, failure to inform regulatory authorities about changes in activities (and at the same time – failure to take steps to extend the license for medical practice).
Engaging qualified lawyers to assist in compliance with licensing conditions and support during inspections by the Ministry of Health can greatly facilitate life and prepare for the assessment in a quality manner.
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