Chapter 9. Licensing of medical activities

Chapter 9. Licensing of medical activities

9.1. GENERAL PROVISIONS

In accordance with the legislation in force in the Russian Federation, medical activities carried out by state, municipal, private healthcare organizations and individual entrepreneurs are subject to mandatory licensing.

Licensing- this is the issuance of state permission to a medical organization (individual entrepreneur) to carry out certain types of medical activities and services. Licensing is a legal procedure carried out by executive bodies of state power authorized for this purpose, and includes verification of licensing requirements and conditions that are mandatory for license applicants to comply with. Medical activities subject to licensing include the performance of works (services) for the provision of pre-medical, outpatient, inpatient, high-tech, emergency and sanatorium medical care. The purpose of licensing is to protect the rights of the patient as a consumer of medical goods and services in the provision of medical care to him.

The licensing mechanism, as an element of state regulation in the field of healthcare, is based on legislative and by-laws developed on their basis. Departmental regulations, as a rule, specify the requirements for the implementation of a licensed type of activity.

The main regulatory legal acts regulating the licensing of medical activities:

Federal Law No. 128-FZ of 08.08.2001 “On Licensing Certain Types of Activities”;

Federal Law No. 134-F3 of 08.08.2001 “On the Protection of the Rights of Legal Entities and Individual Entrepreneurs during State Control (Supervision)”;

Decree of the Government of the Russian Federation of January 22, 2007 No. 30 "On approval of the regulation on licensing medical activities";

Code of the Russian Federation on Administrative Offenses, etc.

Despite the large legislative work carried out in recent years by the Ministry of Health and Social Development of the Russian Federation, the existing legal framework for licensing medical activities in the Russian Federation is far from international standards and requires constant improvement.

The main principles on which the licensing system for medical activities is based include the establishment of a unified licensing procedure, licensing requirements and conditions, transparency, openness and compliance with the law in the implementation of licensing.

Licensing in the healthcare sector has two fundamental features. The criteria determining the licensing of medical activities are primarily related to the state of health of citizens.

Another feature is the pronounced social significance of the types of medical activities for which it is necessary to obtain licenses. Thus, the role of state regulation in this area is significant and multifaceted. Due to the fact that licensing implies some kind of legislative restriction on the implementation of certain actions in the field of providing medical care to the population, the methods and forms of state control in this area should be clear and identical throughout the territory of the Russian Federation.

Licensing is a set of organizational and legal measures, providing for:

Consideration of license applications and issuance of licenses;

Re-issuance of documents confirming the availability of licenses;

Suspension, renewal and termination of licenses, cancellation of licenses;

Control of licensing authorities over compliance by licensees with relevant licensing requirements and conditions;

Maintenance of registers of licenses, provision of information on licensing to interested parties in the prescribed manner.

The procedure for considering the application of a license applicant and obtaining a license for medical activities consists of five organizational stages.

First stage. Examination of documents by employees of the licensing authority, which includes checking the availability (completeness), quality of execution and reliability of the documents required to obtain a license.

Second phase. Making an expert opinion on the submitted package of documents.

Third stage. Expert examination of the facility where medical activities are planned.

Fourth stage. Issuance of an expert opinion based on the results of the survey of the object.

Fifth stage. The decision by the licensing authority to issue or refuse to issue a license.

License(from lat. licentia- freedom, right) is a special permit to carry out a specific type of activity subject to mandatory compliance with licensing requirements and conditions, issued by the licensing authority to a legal entity or individual entrepreneur. Only with such permission, healthcare organizations have the right to provide medical care to the population.

According to the current legislation, licensing of medical activities is carried out by: executive authorities of the subjects of the Russian Federation in terms of activities carried out by municipal and private healthcare organizations, as well as the Federal Service for Supervision in the Sphere of Health and Social Development - in terms of activities carried out by state healthcare organizations, as well as municipal and private healthcare organizations in terms of providing high-tech medical care.

9.2. LICENSE REQUIREMENTS AND CONDITIONS

To ensure the licensing procedure, clause 5 of the Regulation on Licensing Medical Activities, approved by Decree of the Government of the Russian Federation of January 22, 2007 No. 30, the following licensing requirements and conditions are established:

Availability of buildings, premises, equipment and medical equipment owned by the right of ownership or on another legal basis, necessary for the performance of works or services declared for licensing;

The presence of the head, his deputy, the head of the structural unit responsible for the implementation of the licensed activities of the legal entity, as well as the presence of an individual entrepreneur of higher (medium - in the case of performing work / services for first aid) professional (medical) education, postgraduate or additional professional (medical ) education and work experience in the specialty for at least 5 years;

The presence in the state or the involvement on another legal basis of specialists with higher or secondary vocational (medical) education and an appropriate certificate of a specialist;

Advanced training of specialists at least once every 5 years;

Compliance with permitted medical technologies and sanitary rules;

Ensuring control over the compliance of the quality of performed medical work (services) with the established requirements (standards);

Compliance with the rules for the provision of paid medical services;

The presence in the staff of specialists who carry out the maintenance of medical equipment, or the existence of an agreement with an organization licensed to carry out this type of activity;

Maintaining records and reporting medical records.

Only if the healthcare organization complies with the above requirements, it can carry out medical activities.

9.3. PROCEDURE FOR ISSUING LICENSES

Obtaining a license

To obtain a license, a healthcare organization (individual entrepreneur) submits the following documents to the licensing authority:

Application for a license indicating the types of work

(services);

Copies of constituent documents;

A document confirming the payment of the state fee for consideration by the licensing authority of an application for a license;

Copies of documents confirming the existence of buildings, premises, equipment and other material and technical equipment on the basis of ownership or other legal grounds;

Copies of documents on education (postgraduate professional education, advanced training) and documents confirming the work experience of the head of the legal entity or his deputy (individual entrepreneur);

Copies of documents on education (postgraduate, additional professional education, advanced training) of specialists who are on the staff of the license applicant or legally attracted by him to carry out works (services);

Copies of registration certificates and certificates of conformity for the medical equipment used;

Copies of documents on the education and qualifications of the license applicant's employees engaged in the maintenance of medical equipment, or an agreement with an organization licensed to carry out this type of activity;

A copy of the sanitary and epidemiological conclusion issued in accordance with the established procedure on compliance with the sanitary rules of the medical activities carried out.

The procedure for granting a license provides for checking the compliance of healthcare organizations (individual entrepreneur) with licensing requirements and conditions, including the availability of premises, equipment and medical equipment necessary for the implementation of the declared activities, the appropriate level of personnel qualification, sanitary and technical condition, fire safety, etc.

Consideration of documents, carrying out the necessary checks and making a decision on granting a license to carry out medical activities is carried out within 45 days from the date of receipt of the application by the licensing authority.

In case of a positive decision, the license is issued for a period of 5 years.

The license to carry out medical activities is refused on the following grounds:

If there are inaccurate or distorted information in the documents submitted by the license applicant;

If the license applicant, the objects belonging to him or the objects used by him do not comply with the license requirements and conditions.

The practice of recent years shows that the main reasons for refusals to issue license documents are the licensee's failure to provide documents confirming the ownership (or other legal basis) of the premises, and documents indicating the qualifications of employees. So, up to 80% of refusals occur due to the lack of documents confirming the right to own the premises.

License renewal

Re-issuance of a document confirming the existence of a license is carried out in the following cases:

Reorganization of a legal entity;

Changes in its name or location or change in the name or place of residence of an individual entrepreneur;

Changes in the addresses of places where a legal entity or an individual entrepreneur carries out medical activities and in other cases provided for by law.

In this case, the licensee is obliged to submit an application for reissuing a document confirming the existence of a license. The application shall contain new information about the licensee (his successor) and the data of the document confirming the fact that the relevant changes have been made to the unified state register of legal entities or the unified state register of individual entrepreneurs.

An application for reissuing a document confirming the existence of a license is submitted by the licensee no later than 15 days from the date of making the relevant changes in the unified state register of legal entities or individual entrepreneurs or from the date of changing the addresses of the places of implementation of the licensed type of activity.

Re-issuance of a document confirming the availability of a license to carry out medical activities is carried out within 10 days from the date of receipt by the licensing authority of the relevant application.

9.4. CONTROL OVER COMPLIANCE

LICENSE REQUIREMENTS AND CONDITIONS

Control over the implementation by a health care organization (individual entrepreneur) of medical activities in accordance with the obtained license is carried out by the Federal Service for Supervision in the Sphere of Health Care and Social Development, as well as by authorized executive authorities of the constituent entities of the Russian Federation. This control is carried out in the form of scheduled and unscheduled inspections.

Planned measures to monitor compliance by a healthcare organization (individual entrepreneur) with license requirements and conditions for medical activities are carried out no more than once every 2 years.

Unscheduled measures to control compliance by licensees with license requirements and conditions of medical activity are carried out in the following cases:

In order to control the execution of orders to eliminate violations identified in the course of planned activities;

Upon receipt of information about the occurrence of emergencies, changes or violations of technological processes, failure of structures, equipment that can directly cause harm to life, health, property of citizens, the environment;

When citizens, legal entities and individual entrepreneurs apply with complaints about violations of their rights and legitimate interests by actions (inaction) of other legal entities and (or) individual entrepreneurs.

The duration of scheduled and unscheduled control measures should not exceed 1 month. In exceptional cases, related to the need to conduct special studies (tests), examinations with a significant amount of control measures, the head of the licensing authority may extend the period for carrying out control measures, but not more than 1 month.

Based on the results of the control measure, the official of the licensing body carrying out the inspection draws up an act of the established form in two copies, one copy of which is handed over to the health care organization (individual entrepreneur) being inspected.

If gross violations of licensing requirements and conditions, as well as other circumstances that may harm the life, health, property of citizens, the environment, are detected during the control measures, an official of the licensing authority draws up a protocol on an administrative offense.

9.5. LIABILITY FOR VIOLATION OF LICENSE REQUIREMENTS AND CONDITIONS

Responsibility for violation of license requirements and conditions is established by the Code of Administrative Offenses of the Russian Federation and the Criminal Code of the Russian Federation.

When carrying out medical activities, the most common violations of licensing requirements and conditions associated with non-compliance with the maintenance regulations for existing medical equipment, poor-quality maintenance of primary medical records, lack of documents on the professional (medical) education of employees.

The Code of Administrative Offenses of the Russian Federation provides for various sanctions for violations in the field of legislation on licensing medical activities.

So, paragraph 2 of Art. 14.1 of the Code of Administrative Legal Violations (CAO) of the Russian Federation provides for liability for carrying out entrepreneurial activities without a license. This offense entails the imposition of an administrative fine (possibly with

confiscation of manufactured medical goods, production tools and raw materials) in the amount of:

2000-2500 rubles - for citizens;

4000-5000 rubles - for officials;

40-50 thousand rubles - for legal entities.

In accordance with paragraph 3 of Art. 14.1 of the Code of Administrative Offenses of the Russian Federation, carrying out entrepreneurial activities in violation of the conditions stipulated by the license, entails the imposition of an administrative fine on citizens in the amount of 1500-2000 rubles; for officials - 3000-4000 rubles; for legal entities - 30-40 thousand rubles.

Carrying out entrepreneurial activity with a gross violation of the conditions stipulated by the license entails:

Imposition of an administrative fine in the amount of 4,000-5,000 rubles or an administrative suspension of activities for up to 90 days for persons engaged in entrepreneurial activities without forming a legal entity;

Imposition of an administrative fine in the amount of 4000-5000 rubles for officials;

Imposition of an administrative fine in the amount of 40-50 thousand rubles or administrative suspension of activities for up to 90 days for legal entities (clause 4, article 14.1 of the Code of Administrative Offenses of the Russian Federation).

A medical organization (individual entrepreneur) may be held criminally liable on the basis of Art. 171 of the Criminal Code of the Russian Federation, according to which the implementation of entrepreneurial activities without a license or in violation of license requirements and conditions, if such a violation caused major damage to citizens, organizations or the state, or is associated with the extraction of income on a large scale. This offense is punishable by a fine in the amount of up to 300,000 rubles, or in the amount of the wage or other income of the convicted person for a period of up to 2 years, or by compulsory work for a term of 180 to 240 hours, or by arrest for a term of 4 to 6 months.

The same act committed by an organized group of persons or involving the derivation of income on an especially large scale is punishable by a fine in the amount of 100,000 to 500,000 rubles or in the amount of the wage or other income of the convicted person for a period of 1 to 3 years, or by deprivation of liberty for a term up to 5 years with or without a fine in the amount of up to 80 thousand rubles or in the amount of the wage or other income of the convicted person for a period of up to 6 months.

9.6. SUSPENSION PROCEDURE

AND LICENSE TERMINATION

The issue of administrative suspension of the activities of a healthcare organization is resolved in court after the relevant procedures have been carried out by the licensing authority. The algorithm for suspension and termination of a license is shown in Fig. 9.1.

Rice. 9.1. Algorithm for suspension and termination of a license

Administrative suspension of the activities of a healthcare organization (individual entrepreneur) should be based on a court decision, as a rule, on facts proving the inability of the licensee to comply with licensing requirements and conditions that entail a direct threat to the life and health of citizens.

If the court makes a decision on the administrative suspension of activities for violation of license requirements and conditions, the license is suspended, about which a healthcare organization (individual entrepreneur) is notified accordingly.

A health care organization (individual entrepreneur) that has received a notification is obliged to eliminate its violations of licensing requirements and conditions within the prescribed period.

When violations are eliminated, the license is renewed from the day following the day of expiration of the term of administrative suspension of activity, or from the day following the day of its early termination. The validity period of the license for the period of suspension of its validity is not extended.

If the health care organization has not eliminated the violation of licensing requirements and conditions within the prescribed period, the licensing authority is obliged to apply to the court with an application to cancel the license. The license is canceled by a court decision.

Grounds for license termination:

Liquidation of a legal entity;

Termination of the activities of a legal entity as a result of reorganization, with the exception of reorganization in the form of transformation or merger;

Termination by an individual of activity as an individual entrepreneur;

Expiration of the license or adoption by the licensing authority of a decision on early termination of the license on the basis of an application submitted to the licensing authority;

Entry into force of the court decision on the annulment of the license.

Further development of the organizational and legal mechanism for licensing medical activities should go, first of all,

along the way of improving the standardization system, which provides for the development and establishment of modern standards, rules, requirements, conditions, technologies in the production and sale of medical goods and services. An important direction in improving the efficiency of licensing is the further improvement of the regulatory legal framework that defines uniform principles and approaches to the use of the licensing procedure throughout the Russian Federation, as well as judicial practice in dealing with cases of violation of license requirements and conditions.

Public health and health care: a textbook / O. P. Shchepin, V. A. Medic. - 2011. - 592 p.: ill. - (Postgraduate education).

In accordance with paragraph 3 of Art. 81 of the Labor Code of the Russian Federation, termination at the initiative of the employer is possible if the employee does not comply with the position held or the work performed due to insufficient, confirmed by the results of certification. For dismissal on this basis, it is necessary to carry out certification and the presence of a conclusion made as a result of it on the professional incompatibility of the employee with the position held.

Problems of certification

At first glance, it may seem that certification is a convenient tool in the hands of the employer to improve overall labor efficiency. However, case law shows that this is not the case at all. The lion's share of claims from employees dismissed in this way are eventually satisfied in courts with the onset of the maximum number of adverse consequences for the employer.

This happens not least due to the fact that the legislator, although it recognizes the right of an economic entity to verify the compliance of its employees with their positions, nevertheless, proceeds from the interests of the weaker side of labor relations.

In this particular case, they "forgot" to prescribe a clear one for the vast majority of employers. Here is a quote from the law: “The certification procedure is established by labor legislation and other local regulations containing labor law norms adopted taking into account the opinion of the representative body of workers” (part 2 of article 81 of the Labor Code of the Russian Federation).

Other regulations establish the procedure and conditions for certification of certain categories of employees, for example, heads of federal state unitary enterprises, federal civil servants, teachers and some others. The list is negligible and medical workers do not appear in it either.

Features of certification in medicine

First of all, it is necessary to distinguish between the certification conducted by the employer on the compliance of the employee with the position held within the framework of the Labor Code of the Russian Federation.

Certification for qualification categories

In accordance with clause 4 of part 1 of Article 72 Federal Law of November 21, 2011 N 323-FZ "On the basics of protecting the health of citizens in the Russian Federation" everything is in order and within the time limits determined by the authorized federal executive body, as well as the differentiation of wages based on the results of certification. The procedure and terms for medical workers to pass certification to obtain a qualification category are approved Order of the Ministry of Health of Russia dated April 23, 2013 N 240n.

At first glance, it seems that the certification of medical personnel for qualification categories, coupled with a diploma and a doctor (Orders of the Ministry of Health No. 541n and No. 707n (previously valid Order of the Ministry of Health and Social Development No. 415n, which lost its legal force on November 6, 2015)) exhaust the list of documents certifying the qualifications of a medical worker and any other certification is redundant, if not illegal. It is important to understand here that the above documents are the legal basis for the admission and legality of the occupation of workers in medical activities, and the mechanism for internal certification by the employer of the employee’s compliance with the position held has other goals and is completely legal, since it is not aimed at determining or belittling the legal status of a medical worker.

Naturally, the basis for allowing an employee to occupy a certain position is to receive the latest professional medical education, improve professional knowledge and skills throughout life and regularly.

What is the feature of internal certification

Internal certification within the framework of the Labor Code is nothing more than an attempt by the employer to constantly keep a "hand on the pulse", control the work process and respond in the right way when there are signals about the insufficiency or decrease in the qualifications of an employee.

In addition, this is an understandable and convenient mechanism for all parties to labor relations to make informed personnel decisions, for example, about reshuffles in the state, promotion to higher positions, etc.

Grounds for certification

Is each employee of a medical and preventive organization (TPO) subject to certification in accordance with the established procedure?

The Labor Code of the Russian Federation does not contain an unambiguous answer to this question. But the Labor Code of the Russian Federation also does not establish a direct ban on employers to conduct certification of all their employees. The appraisal mechanism can be launched for objective reasons, that is, independent of the employee, such as: staff reductions, personnel reshuffles, scheduled appraisal to assess the quality of work.

Signs of non-compliance of a medical worker with his position

In addition, there are a number of subjective reasons that are directly dependent on the specific actions of the employee, guilty or innocent, the nature and consequences of which indicate official mismatch. For example, complaints from patients, poor evaluation of the doctor's performance according to the criteria, violations of labor discipline, i.e. actions in which the employer may see signs of negligence, negligence, low level of professional training.

Additional reasons to conduct staff appraisal

Certification can also be carried out after paid by the employer, the funds for which were allocated by the employer of their own free will, in excess of the mandatory amount provided for in Art. 196 TK. When investing in staff qualifications, it is wise to make sure that employees receive the required amount of knowledge.

An employee of a medical organization himself may be interested in certification, for example, if he wants to be promoted to a certain position.

• Formation of professional personnel;
• Improving the quality and efficiency of medical care;
• Reduction of defects in the provision of medical care;
• Increasing the satisfaction of consumers and other interested parties;
• Performance in the provision of medical activities, namely the presence of internal quality control and safety of medical activities;
• Determination of the compliance of the services provided with the requirements of the current regulatory legal acts, licensing requirements, including the criteria for the quality and safety of medical activities;
• Establishing the compliance of employees with their position;
• Application of measures of responsibility and incentives to employees in order to increase the discipline and motivation of medical personnel, including measures.

Internal certification in the KKMP system

To achieve the above goals, internal certification of personnel can also be provided as part of the CMMP system of a medical organization (Chapter 12 of the Federal Law of November 21, 2011 No. 323-FZ “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”).

Article 90 of the Federal Law No. 323 gives the right to bodies, organizations of the state, municipal and private healthcare systems to carry out internal quality and safety control of core activities in the manner established by the heads of these bodies, organizations.

Checking compliance with the positions held within the framework of paragraph 3 of Art. 81 of the Labor Code of the Russian Federation, the employer has every right to correlate the results of the work of medical personnel with the existing criteria for the quality of medical care, the discrepancy with which must be stopped.

The quality of medical care is a set of characteristics that reflect the timeliness of the provision of medical care, the correct choice of methods for prevention, diagnosis, treatment and rehabilitation in the provision of medical care, the degree of achievement of the planned result (clause 21, article 2 of Federal Law-323).

As can be seen from the definition, the inclusion of internal certification of medical personnel in the CCMP system is completely justified and even expedient, including in order to avoid possible liability for poor-quality treatment of a medical organization as a whole.

In a word, the criteria for evaluating the CCMP can be used as the basis for assessing the qualifications of medical personnel. For example, a regular unsatisfactory assessment of a doctor's work, revealed at the internal CMMP, complaints from patients, regular unfavorable treatment may become grounds for sending him to an internal certification, based on the results of which the employer will make a decision.

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Medical institutions and individuals must be accredited and have a certificate to engage in relevant activities.

Accreditation (from Latin accredo - I trust) of institutions and individuals is the determination of the compliance of their activities with established standards for the provision of medical care and services in accordance with the order of the Ministry of Health of Russia dated 02.03.99 No. 70 "On licensing and accreditation of medical institutions".

Accreditation is carried out by accreditation commissions created from representatives of health authorities, professional medical associations and insurance medical organizations at the republican (for republics within the Russian Federation), territorial (territorial, regional or autonomous entities) and city (Moscow and St. Petersburg) levels.

Financing of accreditation commissions is carried out at the expense of payment for accreditation procedures, dispute resolution or from other sources not prohibited by the laws of the Russian Federation.

Control over the activities of the accreditation commission is vested in the state administration bodies. The accreditation commissions consist of administration, commission members and contracted experts. The general management of the commission is carried out by the chairman, who is elected at a meeting of the commission for a period of 3 years (no more than two terms in a row) from among the members of the commission by secret ballot by a simple majority of votes and approved by the government body. Experts are highly qualified specialists in various types of medical activities.

Accreditation of institutions and persons is carried out by accreditation commissions, which are provided with a list of documents in the prescribed manner. Terms of accreditation and tariffs are established by regional government bodies. The validity of the certificate should not exceed 5 years, but at the initiative of a medical institution or association or by a court decision, accreditation can be carried out earlier.

Accredited institutions and persons receive a certificate that confirms the degree of compliance of the declared types of medical care or services in full. The experts involved by the commission are guided by the legislation of the Russian Federation and, first of all, by Decree of the Government of the Russian Federation of May 21, 2001 No. 402 "On Approval of the Regulations on Licensing Medical Activities" (as amended on August 10, 1998). The result of their examination is the conclusion.

The above Regulation sets out the rights and obligations of accredited institutions and persons.

Accredited institutions and individuals are entitled to:-

receive information about the procedure and terms of accreditation; -

change the terms of accreditation; -

invite independent experts; -

re-accreditation; -

in case of disagreement with the decision of the commission, appeal it through the court.

Institutions and individuals are required to:-

submit an application for accreditation in a timely manner; -

be responsible for the information provided in the documents; -

pay for accreditation and submit a payment receipt; -

provide conditions for the examination; -

provide representation at the meeting of the accreditation commission.

For accreditation by a medical institution, the following documents are submitted: -

statement; -

registered charter of a medical enterprise (institution); -

constituent agreement (copy) or an agreement on joint activities with a government body (for institutions with state ownership); -

a copy of the order or contract for the lease of premises; -

copies of certificates and licenses previously issued to the institution; -

copies of certificates of employees ensuring the performance of the declared types of activities; -

certificate of premises, equipment (separately by type of activity and for the entire enterprise as a whole); -

the number of employees, their qualification characteristics; -

indicators of the volume of activities performed at the time of application; -

financial report for the last year (balance sheet); -

the presence of administrative and disciplinary sanctions for any types of activities for the last year; -

documents on participation in the implementation of territorial medical programs; -

materials on the analysis of the quality of medical care in accordance with the territorial quality control system; -

documents on the scientific activity of the enterprise (institution); -

documents confirming pedagogical activity.

The following documents are submitted for accreditation by a doctor or other healthcare professional: -

statement; -

a copy of the diploma of graduation from a medical school; -

a copy of the certificate of advanced training and specialization (including in the workplace); -

a copy of the diploma of a candidate, doctor of medical sciences, associate professor, professor; -

a report on the activities of the doctor indicating the list, volumes and types of medical work performed (not certified); -

types of medical activity declared for accreditation; -

a copy of previously issued certificates; -

the presence of disciplinary and administrative penalties for any types of medical activities for the last year; -

participation in the implementation of territorial medical programs; -

scientific activity (list of works, speeches at scientific conferences, participation in the work of scientific societies, etc.);

pedagogical activity (including part-time work and on-the-job training); -

extract from the work book.

Licensing of medical institutions is necessary, as it is one of the conditions for the legal functioning of a medical institution, organization or enterprise, regardless of the healthcare system.

In accordance with Art. 15 Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens and Decree of the Government of the Russian Federation dated May 21, 2001 No. 402 "On Approval of the Regulations on Licensing Medical Activities" licensing of medical activities is carried out by the executive authority of the subject of the Russian Federation located on the territory of this subject. If it is necessary to operate in other regions, registration of such a license is obligatory by the executive authority of the constituent entity of the Russian Federation. This applies to healthcare facilities, university clinics and research institutes. The licensing commission of the state administration body of a constituent entity of the Russian Federation includes its representatives or local administration, health authorities, professional medical pharmaceutical associations.

The commission determines the period of validity of the license, but not more than 5 years for state institutions and no more than 3 years for institutions with non-state forms of ownership. Licensing provides for the study of the documents submitted by the institution, the conduct of an examination on the ground and the issuance of a license for the right to provide medical care in the declared volume, with restrictions, or a justified refusal to issue a license.

Health authorities, medical and pharmaceutical institutions, organizations, professional associations may apply to the licensing commission for extraordinary licensing, as well as for the withdrawal or suspension of a license if non-compliance with the requirements of the quality standard of medical care is revealed. As for licenses for the activities of medical educational institutions, higher and secondary educational institutions, as well as postgraduate education, they are issued by the Ministry of Education of the Russian Federation.

Medical institutions submit the following documents to the licensing commission: -

statement; -

a copy of the charter or regulation of the licensed institution, approved in the prescribed manner; -

a copy of the order or agreement on the lease of premises, documents confirming the availability or the possibility of legal use of premises, tools, equipment corresponding to the requested types of activities; -

types of medical activities, services, insurance programs declared for licensing; -

copies of certificates previously issued to the institution; -

the conclusion of the state sanitary supervision; -

the conclusion of the state fire supervision; -

safety report; -

conclusion on the operation of the building; -

financial report of the institution for the last year; -

annual report of the institution for the last 3 years.

The licensed institution has the right to:-

receive all necessary information and documents on the procedure for licensing; -

re-licensing; -

increase the terms of licensing; -

challenge the decision of the territorial licensing commissions in the republican commission; -

accept for licensing independent experts with advisory voting rights.

The licensed institution is required to:-

timely submit an application and documents for licensing; -

be responsible for the truthfulness of the information contained in the submitted documents; -

confirm payment and provide conditions for licensing; -

ensure the attendance of representatives of institutions at the meeting of the licensing commission.

The certificate confirms the certification of a specialist. It is issued on the basis of postgraduate professional education (internship, clinical internship, postgraduate studies), as well as doctors with experience - additional education in advanced training courses and faculties with a subsequent verification test.

As you know, a certificate is issued for the declared types of activities (and in this it is similar to a license) for certain types of medical or pharmaceutical activities in accordance with the Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens. This is noted in the letter of the Ministry of Health of Russia "On clarification of the order of the Ministry of Health of Russia dated 07.08.95 No. 15-00 "On approval of the Regulations on the procedure for admission to the implementation of professional (medical or pharmaceutical) activities."

The procedure for admission to the implementation of medical activities is set out in a number of documents. These include the Regulations on the final state certification of graduates of higher educational institutions in the Russian Federation, approved. Decree of the State Committee of the Russian Federation for Higher Education dated 05.25.94 No. 3, Order of the Ministry of Health of Russia dated 31.03.97 No. 3 "On the phased introduction since 1997 of the final state certification of graduates of higher medical and pharmaceutical educational institutions", as well as a letter from the Ministry of Health of Russia dated 15.06 .00 No. 2510-6646 "On the final state certification of graduates of higher medical and pharmaceutical educational institutions."

The mentioned letter gives the certification stages, the list and form of examinations and, importantly, the qualification characteristics, the list of knowledge and skills for graduate doctors in the specialties: "General Medicine" (040100), "Pediatrics" (040200), "medical and preventive work" (040300), compiled on the basis of the state standard.

After passing the mandatory primary one-year postgraduate training (internship), the doctor must prove that his professional education complies with the state standard, the official certificate of which is a specialist certificate. For higher medical education, state standards were approved by the State Committee for Higher Education of Russia on the basis of Decree of the Government of the Russian Federation of August 12, 1994 No. 940 "On Approval of the State Educational Standard of Higher Professional Education" in accordance with standard plans and programs reviewed every 5 years.

To obtain a certificate, a doctor, after completing an internship, residency or postgraduate course, takes a qualifying exam, for which the Ministry of Health of Russia has specially developed test programs for specialties, and receives a certificate or certificate. The specialist certificate is renewed every 5 years. Documents on the completion of internship, residency and postgraduate studies issued before 5 years have equal legal force with the certificate.

According to Art. 60 "Doctor's Oath" of the Basic Laws of the Russian Federation on the protection of the health of citizens, persons who have graduated from higher medical educational institutions in Russia take an oath before receiving a doctor's diploma. In Federal Law No. 214-FZ of 20.12.99 "On Amendments to Article 60 of the Fundamentals of Legislation of the Russian Federation on the Protection of Citizens' Health", for the first time after the adoption of the new Constitution of the Russian Federation, the text that is given above was published.

Doctors for violation of the doctor's oath are liable under the legislation of the Russian Federation.

Certification of doctors, pharmacists, and other specialists with higher education is carried out in accordance with the order of the Ministry of Health and Medical Industry of Russia dated February 16, 1995 No. 33 "On approval of the Regulations on the certification of doctors, pharmacists and other specialists with higher education in the healthcare system of the Russian Federation" (as amended on September 28. 99) and the order of the regional health department, which form the composition of the certification commission. The commission is headed by the chairman, he determines the rules of its work (Appendix 1 to the mentioned order). The commission consists of a secretary and members from among highly qualified specialists, scientists and medical practitioners. The form of work of the commission is meetings held according to the schedule approved by the head of the health management body. Members of the commission get acquainted with the submitted materials 10 days before the meeting. The decision is taken by open voting by an absolute majority of votes and is valid throughout Russia. The chairman of the profile subcommittee takes part in the meeting of the commission.

A preliminary test of theoretical knowledge and practical skills is carried out by computer testing, taking into account the assimilation of practical skills, solving situational problems and the results of an interview in a subcommittee. The head of the health management body approves the number and composition of the subcommittee, its chairman and the secretary who manages office work. The subcommittee meets as cases accumulate. A decision of a recommendatory nature is made by open voting by an absolute majority of those present on the basis of the results of computer testing and an interview that determines the level of theoretical knowledge and the amount of practical skills, the quality and reliability of the submitted report.

A specialist who has expressed a desire to undergo certification submits a personal statement; when confirming a previously assigned category - no later than three months before the expiration of its term; certification sheet and report on work for the last 3 years. The report should cover the nature of the doctor's activities, the performance of the department or health facility, its characteristics, the dynamics of indicators for 3 years and an assessment of existing trends compared to the corresponding indicators of the city or district. The report is accompanied by published articles, certificates for rationalization proposals, inventions, programs of conferences, congresses, improvement cycles in which the person being certified took part. The report is signed by the applicant and certified by the head of the institution.

The second category is assigned to doctors who have at least 5 years of experience in this specialty, the first - at least 7, the highest - at least 10 years. Work experience includes training in internship, clinical residency and postgraduate studies in the same specialty. In some cases, with high practical and theoretical training, a higher category can be assigned without established requirements for length of service. Specialists with the degree of Doctor of Medical Sciences, the highest category is assigned in absentia. In case of refusal of a specialist from the next recertification, the previously assigned category is lost. Attestation is carried out for a fee at the expense of the assessed person, trade union, scientific society or association at officially established rates.

Certification is one of the mechanisms of state control over the quality of training of specialists, which is voluntary procedure and aims to stimulate the growth of staff qualifications.

Part attestation commission includes leading specialists of medical and preventive, research institutions, higher medical educational institutions, chief specialists of the health management body, representatives of professional medical associations.

The Ministry of Health of the Russian Federation, by its Order dated 09.08.2001, approved the Regulations defining the procedure for obtaining qualification categories by specialists working in the healthcare system of the Russian Federation. In accordance with this Regulation, when obtaining a qualification category, professional qualifications, competence, as well as the ability of a specialist to perform official duties in accordance with the position held are evaluated.

The qualification of a specialist is determined by three qualification categories: second, first and highest.

To certification are allowed specialists with work experience in the certified specialty:

for the assignment of the highest category - 10 years, of which 3 years in one place

To pass certification (re-certification) for a qualification category, a specialist submits the following documentation:

1. Application

2. Attestation sheet

3. Report on work for the last three years, approved by the head of the medical institution

Attestation procedure represents the passing by a specialist of a qualification exam for the assignment of a qualification category. The attestation exam can take place both in the form of testing and in the form of an interview and is conducted by examination boards in specialties. Practical skills are assessed based on the submission of a work report from the main place of work for the last 3 years.

Assessment of qualifications and recommendations for further professional training of a specialist are adopted by voting in the presence of at least 2/3 of the number of members of the approved composition of the certification commission. The results are determined by a majority of votes, and in case of equality of votes, the decision is considered adopted in favor of the specialist.

The decision of the attestation commission is drawn up in a protocol, which is signed by the chairman, secretary and members of the commission who took part in the meeting. Then, the body under which the attestation commission is established, within one month, issues an order on the assignment of a qualification category, which is brought to the attention of the specialist and the head of the healthcare institution.

Recertification to confirm the existing category is carried out every 5 years. In case of refusal of a specialist from the next recertification, the previously assigned qualification category is lost from the moment of the expiration of the five-year term for its assignment.

Certification- a mandatory procedure for all categories of medical workers, since a specialist certificate is required to engage in professional (medical and pharmaceutical) activities.

Specialist Certificate- This is a document of a single sample, confirming the compliance of the training of a specialist with state educational standards. The result of obtaining a specialist certificate is the admission of a specialist to the implementation of professional medical activities. Persons who do not have a certificate can only work as trainees under the supervision of a certified specialist.

Personnel certification is carried out qualification commissions, which are created at state universities and scientific research institutes of a medical profile, as well as at professional medical associations.

Certification procedure is the process of passing a qualifying examination to obtain a specialist certificate. The qualification exam is conducted by examination commissions in specialties approved by the Ministry of Health of the Russian Federation.

To pass the qualifying exam, the medical worker provides the following documents:

1. Application

2. Copy of medical school diploma

3. Copies of state documents on the passage of various forms of postgraduate or additional professional education

4. Copies of previously issued certificates

5. Copy of work book

Exam includes three parts: test control, determination of practical skills, final interview.

The following medical workers are allowed to take the qualification exam for a specialist certificate:

1. Of the inexperienced professional activity - persons who have completed internship, residency, postgraduate studies in clinical disciplines

2. Of those with experience- specialists who have improved their qualifications in cycles of improvement in their specialty in licensed institutions over the past 5 years or who have completed doctoral studies in a clinical discipline.