Quality control of medical care. licensing and accreditation of medical institutions. Non-departmental quality control of medical care

Introduction

It is obvious that medical services are of great social importance and therefore the importance of maintaining their quality level is difficult to overestimate. Therefore, it is advisable to define the concept of “quality of medical services”.

Doctrinal understanding of the quality of medical services

The doctrinal concept of "quality" was the subject scientific research various sciences and has been studied by many legal theorists since Soviet times.
For example, M.I. Braginsky understood quality as “the set of properties of the legal and material objects of the contract, ensuring the possibility of normal use of the item in accordance with its usual or special purpose, determined by the contract.”
Some Soviet legal scholars (M.B. Emelyanova, B.P. Mezrin, V.M. Ogryzkov, etc.) drew a parallel between the concepts of “quality” and “compliance with quality” and included the concept “quality” as mandatory in the author’s definitions the principle of criteria for the qualitative assessment of goods, work, services by including in the definition a reference to the compliance of product quality with the requirements of regulatory and technical documents and the terms of contracts.
M.N. Semyakin, based on the results of an analysis of scientific approaches to defining the concept of product quality in various scientific disciplines: philosophical, technical, economic, legal, came to the conclusion that the difference in definitions of the concept “quality” is due to the characteristics of the sciences themselves. And a definition that satisfies one science cannot be fully acceptable to another. scientific knowledge with another subject of research. Nevertheless, he proposed taking the economic definition of quality as the initial definition and integrating it into other scientific fields. At the same time, he proposed to understand product quality as inner essence a phenomenon, the external manifestation of which is expressed in the form of use value, which becomes obvious only during its implementation (consumption).
V.S. Belykh emphasized that the concepts of “quality” and “use value” are not identical, since they simultaneously presuppose and deny each other. From the point of view of philosophy, quality is one of the main categories of dialectical logic, since quality is a set of objective properties that characterize the certainty of an object, due to which it is precisely this, and not another object (phenomenon), which manifests itself outwardly through its properties. But all properties can be described and expressed in appropriate indicators, and therefore the initial definition of the concept of “quality” should be formulated, according to V.S. Belykh, economic science.
Modern scientists pay more attention to the philosophical understanding of quality.
For example, A.V. Maslova considers quality as a set of characteristics of an object that define the object as objectively existing, regardless of people’s attitudes towards it. Quality is a certain stable system of internal essential connections of an object, a certainty that is inseparable from its existence and which allows one to distinguish this object from other objects and phenomena. The quality of a thing is revealed through its properties. Moreover, if quality is an integral main characteristic of a thing, then a property characterizes a thing only from one side.
A.V. Gridin understands quality as a set of properties of a product, work, service that meets the reasonable and sufficient needs of the buyer and excludes harm during its proper operation, storage, transportation and consumption. This definition proposes to add to paragraph 1 of Art. 469 of the Civil Code of the Russian Federation in relation to sales and purchase agreements.

Legislative consolidation of the concept quality of medical services

The doctrinal development of the concept of “quality” is reflected in legislation.
The International Organization for Standardization (ISO) adopted in 1986, and in 1994 clarified the following definition of the concept of “quality” - a set of characteristics of an object related to its ability to satisfy needs, established or expected.
In domestic legislation, the definition of “quality” has undergone many changes and is still very vaguely defined.
For example, in Resolution No. 1 of the Plenum of the Supreme Court of the USSR dated April 5, 1985, the court gave the following explanation: products that cannot be used for their intended purpose completely and without significant processing should be recognized as poor quality.
Modern legislation in relation to the quality of goods contains the following definition of quality - this is a product that meets the terms of the purchase and sale agreement (clause 1 of Article 469 of the Civil Code of the Russian Federation) or is suitable for the purposes for which a product of this kind is usually used (clause 2 of Article 469 of the Civil Code RF), or corresponding to the sample (clause 3 of Article 469 of the Civil Code of the Russian Federation), or corresponding to special requirements established by law (clause 4 of Article 469 of the Civil Code of the Russian Federation). At the same time, the understanding of quality given in Chapter 30 (Article 469 of the Civil Code of the Russian Federation) does not apply to the quality of services provided for a fee, since Article 783 of the Civil Code of the Russian Federation does not contain any indication of the possibility of applying the provisions of Chapter 30 (purchase and sale) to legal relations arising from the contract paid provision of services (Chapter 39 of the Civil Code of the Russian Federation).
The Law "On the Protection of Consumer Rights" interprets the concept of "quality" identically to the Civil Code of the Russian Federation, but extends the application of this definition to services (Article 4 of the Law of the Russian Federation "On the Protection of Consumer Rights").
The variety of services provided determines the diversity of understanding of the quality of various types of services, which complicates the formulation of the concept of “service quality”, which would apply equally to all types of services provided.
According to GOST 30335-95/GOST R 50646-94, “service quality” is “a set of service characteristics that determine its ability to satisfy the established or expected needs of the consumer.”
Applied to medical care the concept of “quality” is legal and legally significant, therefore it is defined by the legislator in the Federal Law “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation” as a set of characteristics reflecting the timeliness of medical care, the correct choice of methods of prevention, diagnosis, treatment and rehabilitation in the provision of medical care assistance, the degree of achievement of the planned result.
By the quality of medical activities (care), the legislator also understands a system of criteria that allows determining the quality of medical care both in a certain medical institution, with a certain doctor, in a certain territory, and to an individual patient. This concept is included in the group of requirements for organizational technologies in healthcare and is closely related to the term “assessment of the quality of medical activities (care)”, which is understood as a methodology for assessing the quality of medical services based on approved criteria, and with the concept of “efficiency of medical care”, which is the amount at which the appropriate type of medical care and assistance achieves its goal of improving the patient's condition.

Discussion

In the science of medical law, there is an opinion that legal regulation quality of medical services has three main approaches: based on socio-legal, administrative-legal and civil-legal methods.
The socio-legal approach follows from the social significance of medical care for the population due to special treatment state to protect the health of the population, enshrined in the Constitution of the Russian Federation (Article 41 of the Constitution of the Russian Federation). Essentially, all concepts for the development of domestic healthcare provide for increasing the availability of medical services of adequate volume and quality, since this principle is basic for the healthcare system.
Administrative regulation of the quality of medical services is carried out by checking their compliance with established requirements when licensing medical activities involving government agency comprehensive assessment of the capabilities of a medical institution to provide quality medical care in the future, but does not provide for the possibility of administering the quality of medical services provided during the validity period of the license, since assessment of the quality of medical care can only be carried out in the process practical activities and is carried out by patients within the framework of civil legal relations arising between the medical institution and the patient.
From the point of view of assessing the quality of medical services, the system of medical organizations located in the state and municipal property, since these organizations are in administrative legal relations with healthcare authorities, which makes possible wider use of the administrative resource for managing the quality of medical services of medical institutions operating within the framework of State Guarantee Programs for the provision of free medical care to Russian citizens and guided by the relevant industry legislation, which obliges to provide the quality of medical services in accordance with the requirements of industry standards and the requirements put forward by insurance companies. Failure to comply with the specified standards for the quality of medical services may entail liability of medical institutions, in accordance with the procedure approved by the compulsory health insurance fund, in the form of fines or refusal of the compulsory health insurance fund to pay for low-quality medical services.
Control over the quality of medical services provided by private medical institutions is carried out mainly through civil law methods of influence, carried out within the framework of civil proceedings with reference to consumer protection legislation. This situation can be explained by the fact that in the field of private medicine it is expected to create competitive internal requirements of medical institutions for the quality of the medical services they provide, which should ensure increased efficiency of patient treatment, which in conditions of free competition should contribute to the growth of the competitiveness of the medical institution. But in practice, the process of competitive selection of medical institutions in the medical services market occurs extremely slowly, which is due to the specifics of the field of medical services, the quality of which is difficult to assess for patients without the involvement of special expert organizations.
This situation was complicated by the cancellation of the joint Order of the Ministry of Health of Russia and the Federal Compulsory Medical Insurance Fund dated October 24, 1996 N 363/77 “On improving quality control of medical care for the population of the Russian Federation,” which contained a list of signs of poor-quality medical care and criteria for assessing the quality of medical services to patients:
- patient satisfaction with the results of interaction with the healthcare system;
- compliance of medical care with indicators characterizing its quality and effectiveness (standards);
- presence of defects in medical care and medical errors;
- the state of performance indicators of healthcare institutions and the health status of the population.
In addition, when formulating claims to the quality of medical services provided by private medical institutions, it is controversial whether the patient can use, by analogy, the departmental regulations of the compulsory health insurance fund, which can help consumers of medical services determine the quality of the medical services provided to them and navigate the determination of the presence of defects in the services provided. medical services.
It should be noted separately Negative influence repeal of some regulations that regulated the protection of patient rights, contained definitions and named signs of medical care of inadequate quality:
- in the Methodological Recommendations “Territorial system for ensuring and protecting the rights of citizens in the conditions of compulsory health insurance”, approved by Order of the Federal Compulsory Medical Insurance Fund of September 6, 2000 N 73, under medical care of inadequate quality the occurrence or risk of occurrence of the following is defined: negative consequences as a result of the medical care provided: difficulty in stabilizing or increasing the risk of progression of the patient’s existing disease, increasing the risk of a new pathological process, leading to suboptimal use of the resources of the medical institution, causing dissatisfaction with the patient’s interaction with the medical institution;
- in Order of the Federal Compulsory Medical Insurance Fund dated May 26, 2008 N 111 “On the organization of control over the volume and quality of medical care in the implementation of compulsory health insurance,” defects in the provision of medical services are understood as actions (inaction) of medical personnel that are a violation of the requirements of regulations of authorized executive authorities; violation of business customs, usually imposed requirements in the field of healthcare; suboptimal choice of technology for providing medical services;
- Methodological recommendations for structural units for the protection of the rights of insured territorial compulsory medical insurance funds (CMO) on preparing cases related to the protection of the rights of the insured for trial, approved by Order No. 48 of October 11, 2002, contained the most complete classifier of frequently occurring violations that may serve as a reason for the patient to go to court for protection.
Today, there is no normative definition of “medical care defect” in the legislation, which significantly complicates the determination by the patient and his family of the quality of the medical service provided. The Procedure for organizing and monitoring the volume, timing, quality and conditions of providing medical care under compulsory health insurance, approved by the Compulsory Medical Insurance Order of December 1, 2010 N 230, contains a list of actions that may result in the occurrence of defects in medical care: inconsistency of the medical care provided the health status of the insured person; failure to comply (incorrect implementation) of procedures for the provision of medical care or standards of medical care and medical technologies.
In addition, the cancellation of the Methodological Recommendations for the Protection of the Rights of Insured Territorial Compulsory Medical Insurance Funds (CMOs) on the preparation of cases related to the protection of the rights of the insured for trial has led to the fact that modern medical organizations do not have a guideline for assessing the presence of signs of those problems in the medical services they provide. violations, which in most cases lead to disputes with patients. This circumstance can only be assessed as negative, since it deprives medical organizations and patients the opportunity to objectively assess the quality of medical services received and provided.
The absence of a legally established right of the patient or his relatives to exercise control over the quality of medical services provided during the treatment process and a legal guideline for determining the quality of medical services, in our opinion, is a violation of the constitutionally enshrined principle of accessibility of medical care aimed at protecting and strengthening the health of the population, and contributes to the emergence of various abuses on the part of unscrupulous medical workers.

conclusions

In our opinion, an urgent need is to legislate in the Federal Law of November 21, 2011 N 323-FZ the definition of the concept of “defect of medical care”, which should be understood as the actions or inaction of medical personnel, expressed in a non-optimal choice of technology for providing medical care, violation requirements of regulations of authorized executive authorities and business customs, usually imposed in the field of healthcare, which led to or increased the risk of negative consequences for the patient’s health as a result of the medical care provided, expressed in the difficulty of stabilizing or progression of the patient’s existing disease, increasing the risk of a new pathological process, which led to suboptimal use of the resources of the medical institution, causing the patient's dissatisfaction with his interaction with the medical institution and its staff.

Bibliography

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Quality- is a set of characteristics of an object related to its ability to satisfy established and expected needs.

Health care– a set of therapeutic and preventive measures carried out for diseases, injuries, pregnancy and childbirth, as well as for the purpose of preventing diseases and injuries.

Medical service– this is a set of necessary, sufficient, conscientious, appropriate professional actions of a medical worker aimed at meeting the needs of the patient.

Workmanship– a characteristic that reflects the extent to which a product or service provided by an organization actually satisfies customer needs.

Quality of Compliance– a characteristic that reflects the extent to which the products or services provided by an organization conform to the internal specifications of the product or service.

Quality of medical care- a set of characteristics confirming the compliance of the medical care provided with the patient’s existing needs, his expectations, the modern level of medical science, technologies and standards.

Adequate quality of medical care- this is the compliance of the medical care provided with the modern understanding of its required level and volume for a given type of pathology, taking into account individual characteristics the patient and the capabilities of a particular medical institution.

Inadequate quality of medical care- this is a discrepancy between the medical care provided and the generally accepted modern understanding of its required level and volume for a given type of pathology, taking into account the individual characteristics of the patient and the capabilities of a particular medical institution.

Main characteristics of the quality of medical care.

Quality of medical care- a set of characteristics confirming the compliance of the medical care provided with the patient’s existing needs, his expectations, the modern level of medical science, technologies and standards.

The following characteristics of the quality of medical care are distinguished:

Professional competence;

Availability;

Interpersonal relationships;

Efficiency;

Continuity;

Safety;

Convenience;

Meeting patient expectations.

Professional competence: It refers to the theoretical knowledge and practical skills of healthcare workers, support staff and how they use them in their work, following clinical guidelines, protocols and standards.

Availability of medical care: This characteristic means that health care should not be affected by geographic, economic, social, cultural, organizational or language barriers. All barriers must be removed.

Interpersonal relationships: This dimension of quality of care refers to the relationships between health care providers and patients, health care personnel and their management, the health care system, and the population at large. Correct relationships create an atmosphere of psychological comfort, confidentiality, mutual respect and trust. Important elements of this relationship are the art of listening and responding appropriately. All this contributes to the formation of a positive attitude of the patient towards the treatment.

Efficiency: Efficiency should be considered as the ratio of the achieved economic effect to costs. The importance of this characteristic is determined by the fact that health care resources are usually limited, while an effectively functioning health care system must ensure optimal quality of care through the rational use of available resources.

Continuity: means that the patient receives all necessary medical care without delay, undue interruption or unreasonable repetition in the process of diagnosis and treatment. Typically, compliance with this principle is ensured by the fact that the patient is observed by the same specialist, ensuring continuity in work with colleagues. Failure to comply with this principle negatively affects performance, reduces efficiency and worsens the interpersonal relationship between the doctor and the patient.

Safety: means minimizing the risk of side effects of diagnosis, treatment and other manifestations of iatrogenicity. This applies to both healthcare professionals and patients. Compliance with safety measures is very important when providing not only specialized, but also primary medical care.

Convenience: implies a system of measures aimed at creating an optimal medical and protective regime: ensuring comfort and cleanliness in medical institutions, rational placement of wards and treatment and diagnostic units, equipping them with modern functional medical furniture, organizing the patient’s daily routine, eliminating or maximizing the impact of adverse external factors environment, etc.

Meeting patient expectations: For patients in a particular medical facility, the quality of medical care is determined by the extent to which it meets their needs, expectations and is timely. Patients most often pay attention to convenience, effectiveness, accessibility, continuity of medical care, and the relationship between them and medical staff. Patient satisfaction with medical care depends on the assessment of health-related quality of life.

Efficiency– “external” efficiency, measuring the achievement of the organization’s goals (the ratio of the achieved result to the maximum possible, based on scientific data).

Efficiency- internal efficiency, economy, which measures the most rational use of resources, i.e. the lowest cost of medical care without reducing its effectiveness.

Optimality - optimal ratio costs of healthcare and the results obtained in improving health.

Eligibility- the relationship between the assistance provided and the expectations, wishes and hopes of patients and their relatives.

Legality- compliance with social preferences expressed in ethical principles, laws, norms and rules.

Fairness, impartiality– a principle that determines the reasonable and legal distribution of medical care and benefits among the population.

Basic elements of quality of medical care (Donabedian triad).

Dr. A. Donabedian identified three main areas of work to ensure the quality of medical care: improving the structure, process (technology) and result. The relationship between structure, process and result was called "Donabedian triads".

Quality of technology– a component of medical care that describes how optimal the complex of treatment measures for a particular patient was; technologies of prevention, diagnosis, treatment, rehabilitation - assessed as compliance with the principles of standards.

Quality of the result– the KMP component, which describes the relationship between the actual results achieved and the actually achievable ones; achieving accepted clinical indicators and correlating them with economic ones (result - costs).

Structure quality– describes the conditions for providing assistance, including qualifications of personnel, availability and condition of equipment, condition of premises, drug supply, availability and replenishment of consumables, rational use of resources, etc.

Thus, to improve activities to ensure the quality of medical care it is necessary:

create an appropriate legislative and regulatory framework to regulate mechanisms for ensuring the quality of medical care;

bring structures and resources (human, financial, material and information) into compliance with the legal framework;

create appropriate technology and outcome standards and more effectively monitor the implementation of medical technologies.

The main factors of the internal environment that determine the quality of medical care.

Effective management of the quality of medical services is possible when the leading factors influencing its quality are identified:

- Compliance with honey volume standards. help

The correct choice of honey. technologies and compliance with their quality

Level of organization of personnel work

Personnel qualifications

Material and technical support, its compliance with the standard

Funding level

Level of drug supply

Basic principles of medical care quality management.

The concept of continuous quality improvement, as a new management philosophy, was developed by the American quality specialist Dr. W. E. Deming (W. E. Deming, 1986). The core principle of Deming's philosophy is the pursuit of continuous improvement of products or services. Dr. Deming formulated the main provisions of the new approach as fourteen principles of management. According to the author, it is necessary:

1. Create a continuous goal to improve products and services(innovate, invest resources, continuous improvement). It finds practical embodiment in the implementation of the famous PDCA cycle developed by Deming: plan (Plan) - do (Do) - check (Check) - improve (Act).

2. Embrace a new philosophy. We cannot continue to live with the existing system of delays, delays, and mistakes; defective materials and imperfect labor. Management style needs to change to stop the ongoing economic downturn; constantly improve the quality of all systems, processes, and activities within the company.

3. Stop relying on inspection to achieve high quality.

Eliminate the need for mass testing and inspection as a way to achieve quality, primarily by “building” quality into products. Demand statistical evidence of “embedded” quality in both manufacturing and purchasing functions.

4. Stop judging a business based on price.. Along with the price, demand serious evidence of its quality. When choosing suppliers, it is important to pay attention not only to the price of the purchased product, but also to the total cost of owning this resource throughout its entire service life, which includes the cost of repairs, spare parts, and losses from downtime of cheaply purchased resources. Often, a simple economic calculation shows that it is better to buy more expensive but high-quality products.

5. Constantly and irreversibly improve the production and service system. Constantly improve, today and always, all your planning, production and service processes. Constantly look for problems in order to improve all activities and functions in the company, increase quality and productivity and thus constantly reduce costs.

6. Enter training. Introduce modern approaches to training and retraining for all workers, including managers and managers, in order to better use the capabilities of each of them. Keeping pace with changes in materials, methods, product design, equipment, technology, functions and service methods requires new skills and abilities.

7. Establish leadership. Understand and practice leadership as a way of working to help employees do their best work. Managers at all levels should be responsible not for bare numbers, but for quality. Improved quality automatically leads to increased productivity.

8. Drive out fear. Encourage effective two-way communication and use other means to eliminate fear, apprehension, and hostility within the organization so that everyone can work more effectively and efficiently for the benefit of the company.

9. Break down barriers between departments. People from different functional areas must work in teams to resolve problems that may arise with products or services.

10. Put an end to slogans, appeals and tasks in numbers. Such calls only cause hostility; the bulk of poor quality and productivity problems are system-related and thus beyond the capabilities of ordinary workers to resolve.

11. Abandon quantitative quotas or production standards. Often the priority of quality in work contradicts the quantitative production standards that are set for workers. How to be? Find compromises between quality and quantity, rather than going to one of the extremes.

12. Remove barriers that prevent people from taking pride in their craft.. This involves, among other things, the abandonment of annual certifications (evaluations of employee performance) and management methods by objectives. Methods such as honor boards and awards are still relevant today.

13. Introduce an intensive training program. The source of successful progress in achieving competitiveness is knowledge.

14. Take action to make changes. One of the first tasks of a project manager is to involve all employees in working to improve quality. And make sure that people participate in it voluntarily and with enthusiasm.

The essence of Deming's approach is that the causes of low efficiency and poor quality most often lie in the system, not in the workers. Therefore, to improve operational results, managers must adjust the system itself.

8 principles of quality management:

Customer Focus(the success of any organization depends on consumers, both external and internal, so it is necessary to understand their current needs and predict future needs)

Leadership leadership(health care managers must ensure high IMP; for this it is necessary to create an internal environment of the organization in which employees are actively involved in solving this problem: developing a policy and action plan, tactics, ideology and appropriate microclimate in the team)

Employee Engagement(health workers of all levels

form the basis of the organization of medical care, therefore it is necessary to determine their needs and expectations, job satisfaction, desire for professional growth, which will help ensure their fullest involvement in the production process and increase work motivation)

Process approach(any activity that uses resources to transform inputs into outputs can be considered a process. To function effectively, organizations must manage numerous interrelated and interacting processes)

Systematic approach to management(the process of providing medical care is considered as an open dynamic system, consisting of interconnected parts (subsystems) that influence the higher-level system, and are themselves subject to its influence. If a part of the system functions ineffectively, then this has a negative impact not only on the activity of the system as a whole, but also into components)

Continuous improvement(increasing the IMC is impossible without constant optimization of the process of its provision in response to changes in the external and internal environment of a healthcare institution based on a systematic analysis of incoming data, the development of corrective and preventive actions, the necessary elimination of the causes of emerging problems (inconsistencies) and the prevention of their reoccurrence)

Fact-based decision-making method (Effective decisions are based on an objective analysis of data and their correct interpretation, therefore it is necessary to abstract from the psychological characteristics of perception and processing of information)

Mutually beneficial relationships with suppliers(The organization must ensure that purchased products comply with specified purchasing requirements. It must evaluate and select suppliers based on their ability to supply products in accordance with its requirements).

The main elements of a health care quality management scheme (design, assurance, control, continuous improvement).

Health care quality management consists of four main activities: quality design, quality assurance, quality control, and continuous quality improvement.

Quality design- this is an activity to develop a system for providing the population with quality medical care. Quality design includes:

identification of the target group of consumers of medical services;

studying consumer requests;

determining the result that meets consumer needs;

development of the mechanism necessary to achieve the expected result.

Quality assurance- these are the types of activities planned and implemented within the framework of the quality management system. To improve activities to ensure the quality of medical care, it is necessary to:

development of an appropriate legislative and regulatory framework to regulate mechanisms for ensuring the quality of medical care;

bringing the existing structure and resources (human, financial, material and information) into compliance with the legal framework;

creation of appropriate technological standards and standards for results, effective control of the implementation of medical technologies, etc.

Quality control is a system of operational measures that allow assessing the implementation of the main components of the quality of medical care. Monitoring (determining the level) of the quality of medical care is based on comparison results achieved with existing standards (protocols) for patient management. One of the mechanisms for monitoring the quality of medical care and determining its compliance with accepted standards is examination.

The medical care quality control system consists of three elements:

control participants;

controls;

control mechanisms.

According to the composition of participants in regulatory bodies, quality control of medical care is carried out according to the following directions:

Control by medical service providers;

Control by consumers of medical services;

Control by organizations independent of consumers and producers of medical services.

The quality control mechanism for medical care is quite complex and includes a set of the following basic procedures:

Licensing of medical, pharmaceutical and other types of activities carried out in the field of public health;

Accreditation of medical institutions;

Certification of medical workers;

Certification medicines, medical products, medical equipment;

Licensing, certification and accreditation of educational medical institutions, etc.

Managing the quality of medical care involves continuous increase in its level.

At the same time, in the process of improving the quality of medical care, two interrelated and interdependent components are clearly visible:

the first is a constant increase in the very level of standards (protocols) for patient management

the second is the continuous process of achieving these standards.

Total Quality Management Concept (TQM, "Japanese model").

Total Quality Management Concept(total quality management, TQM) involves a perception of quality that covers the organization as a whole - from the supplier to the buyer.

The Total Quality Control model was proposed by Armand Feigenbaum in the early 50s.

By Total Quality Control, Feigenbaum understood a system that made it possible to solve the problem of product quality and its prices, depending on the benefits of consumers, manufacturers and distributors. Feigenbaum proposed to consider quality not as the final result of the production of a product, but at every stage of its creation. According to this concept, the Total Quality Control model looked like this:

The system of Total Quality Control created by Feigenbaum was introduced into the practice of Japanese enterprises by E. Deming.

The quality strategy should be based on the direct participation of top management, who is familiar with the basic principles of the TQM concept.

The figure shows that the most important elements of TQM are:

focusing all company activities on the needs and wishes of both external and internal consumers;

ensuring the opportunity and real participation of everyone in the process of achieving the main goal - to satisfy consumer needs, the effective participation of each employee;

focusing on processes, considering them as an optimal system for achieving the main goal - maximizing the value of the product for the consumer;

constant and continuous improvement of product quality;

basing all company decisions only on facts, and not on the intuition or experience of its employees.

In Japan, after the end of World War II, quality improvement was elevated to the rank of public policy. The solution to quality problems in this country has been very successful in a fairly short period of time. A quality management system was created in which total quality control is a unified process for ensuring quality throughout enterprises, this process is carried out by all personnel from the president to ordinary workers.

The main approaches to quality management in Japanese models boil down to the following points:

Find out consumer requests

Find out what consumers will buy

Determine the costs required to achieve quality

Warn possible defects and claims

Provide corrective action

Eliminate the need for verification

The Japanese system distinguishes four quality level:

1) compliance with the standard (satisfying the requirements of the standard);

2) compliance with use (satisfying operating requirements);

3) compliance with market requirements;

4) compliance with hidden needs (the consumer does not suspect what he wants)

Distinctive elements Japanese quality management system are:

Focus on improving processes and labor results in all departments;

Focus on process quality control rather than product quality;

Focus on preventing the possibility of defects;

Thorough research and analysis of emerging problems using the ascending flow principle, i.e. “from the next operation to the previous one”;

Cultivating the principle: “Your consumer is the performer of the next production operation”;

Full assignment of responsibility for the quality of work to the direct performer;

Active use of the human factor, development of the creative potential of workers and employees, cultivation of morality: “It’s a shame for a normal person to do a bad job”.

Much attention is paid to the activities of quality circles. These are voluntary associations of workers at various levels and in various fields of activity, meeting outside of working hours in order to search for measures to improve quality. Such circles work under the mottos: “Quality determines the fate of the enterprise,” “Think about quality every minute.”

Basic rules for the work of quality circles: regularity of meetings, voluntary participation, solution of specific problems, identification, research and assessment of quality problems during the discussion.

During the work of the quality circle, cause-and-effect analysis is ensured, self-training of circle members is ensured, connections between workers are strengthened, and measures are identified to reduce costs and production waste. This form of activity requires an understanding of the company’s goals, knowledge of data collection methods, and knowledge of analysis methods.

The “five zeros” program is popular in Japanese enterprises:

Do not create conditions for the appearance of defects;

Do not transfer defective products to the next stage;

Do not accept defective products from the previous stage;

Do not change technological modes;

Don't repeat mistakes.

The most famous Japanese quality management models:

Quality Circle

“FIVE ZEROS” program

JIT (Just-In-Time) system

KANBAN system

European approach to quality management.

The Western model of quality improvement is innovation (as opposed to the Japanese model of “continuous improvement”)

All management is aimed at reducing prices (not at reducing defects); the goal is profit, not quality).

The European approach to quality is focused on creating a unified system of laws for assessing and confirming quality, harmonizing national standards and certification rules, creating a regional structure of organizations and laboratories for product certification and quality systems. Under these conditions, a total quality management system was created. It includes:

incoming inspection of materials;

control of finished products;

product quality assessment;

assessment of the quality of production processes;

control of equipment providing quality information;

use of quality information;

training in quality assurance methods;

warranty service;

creating an atmosphere of interested participation in improving quality.

The activities of medical institutions providing services under the insurance program are constantly monitored by the Insurance Fund. The event allows us to improve the quality of service for insured persons within the framework of the regulated basic program. All business entities whose activities are licensed and located in the healthcare sector can participate in the compulsory insurance system. Insurance supervision of medical institutions is carried out within the framework of compulsory medical insurance, which represents a system of economic, legal and organizational measures aimed at ensuring guarantees of the provision of medical care paid from the funds of the insurance company within the framework of the basic Program.

What are the rules, procedures and features of insurance supervision over the quality of medical care and medical services provided? What regulations regulate such supervision? Which organizations are authorized to carry it out? What forms of supervision are carried out and with what frequency? What is the role of the CMO in monitoring the quality of medical care under compulsory medical insurance? We will answer these questions in this article.

The procedure for interaction and control of insurance program participants

In order to realize the constitutional rights of every citizen of the Russian Federation to health care and to receive free qualified care in any corner of the country, a system of compulsory health insurance was introduced. To implement the program, three parties are required, between whom contractual relations must be formalized. The implementation of activities, as well as the order of relationships between the participants, is determined by the terms of the agreement. Its provisions oblige the insured person to regularly implement mandatory insurance premiums to the Insurance Fund, the medical institution - to provide assistance within the framework of the Program, and the insurance company - to pay for the services provided in accordance with the contract.

In practice, many disputes arise between participants in the insurance system. They mainly relate to the quality and competence of the services provided. The insurance company is interested in ensuring high level medical care, since the financing of services provided to insured persons is carried out from their funds. All problematic situations are resolved through an expert investigation.

Rules, procedure and features of insurance supervision

The specifics of the event regarding insurance in the healthcare sector are reflected in the Federal Law “On Compulsory Health Insurance” No. 326 of October 29, 2010. On its basis, Order No. 230 of December 1, 2010 was issued, which regulates the rules for conducting the control procedure. Insurance supervision over the quality of medical services is carried out on a planned or targeted basis. The planned event is carried out within the time limits established by the authorized body in the inspection plans. Targeted control is carried out in situations where the insured are dissatisfied with the quality of the services received and initiate an action by filing a complaint. It is also carried out in emergency situations involving the death of the patient or the deterioration of his condition.

Scheduled control

Before carrying out a planned event, the medical institution receives notification from the controller about the timing and planned program. The notice may contain recommendations with a list of documentation that needs to be prepared. The inspection is carried out for all medical services classified as insured events provided since the date of the last scheduled inspection.

Target control

Targeted control is carried out spontaneously; there may be no warning about it. The inspection is carried out within the framework of an insured event that has unpleasant features or about which a complaint has been received. Based on the results of the examination, an inspection report is drawn up and an expert opinion is drawn up. The document should reflect all identified service deficiencies, recommendations for their elimination and principles for further work. Depending on the severity of the violations, sanctions or fines may be applied to the medical institution. Sanctions may consist of a reduction in payment for medical services provided by the amount of identified violations or a ban on medical practice carried out under the compulsory health insurance program.

Who is authorized to supervise medical organizations?

Insurance supervision of medical organizations is carried out by the FFOMS, its territorial divisions and insurance companies specializing in the field of healthcare. Any participant in the insurance program can monitor the work of a medical institution. To carry out the procedure, they resort to the services of a representative of the controlling organization - an expert who must be competent in matters of the insured event and meet the regulated requirements. An expert in medical and economic examination must have five years of experience as a practicing physician who has undergone special training in the field expert activities.

An expert specializing in quality control of medical care is subject to more stringent requirements. The specialist must have more than ten years of work experience. His qualifications that meet the requirements must be confirmed by an accreditation certificate or specialist certificate. An authorized representative of the organization must undergo training in an expert activity course, following which he is included in the territorial registers of experts. Information about an accredited specialist is contained on the official website of the Health Insurance Fund.

Forms of supervision and frequency of their conduct

Monitoring of the activities of medical institutions is carried out within the framework of targeted or planned activities aimed at verifying compliance with regulatory requirements of the parameters of treatment and advisory services. The event is carried out using such monitoring elements as:

• Medical and economic control;
• Medical and economic examination;
• Examination of the quality of medical care.

The Compulsory Health Insurance Fund exercises control over medical and advisory institutions located in the country that carry out licensed activities in the field of healthcare. A prerequisite for the implementation of the event in relation to the subject is the existence of contractual relations with the Fund and the insurance company regulating the provision of medical care under insurance programs. During the inspection, the medical institution has no right to interfere with its implementation. Representatives of the institution are obliged to provide the expert with free access to all documents and materials necessary to carry out control.

Medical and economic control

In the process of implementing the event, specialists authorized to carry out the event establish the reliability of the information provided to the insurance company related to the volume of assistance provided. The analysis is carried out on the basis of information data contained in the register of invoices provided for payment by the policyholder. This article also checks the calculation of payment for services, with a focus on contractual terms and regulated tariffs used in the calculation.

Medical and economic examination

Such examination of the provision of medical care contributes to the formation of an effective tariff policy in insurance medicine and strengthens control over the availability and quality of medical care. During the medical and economic examination, authorized persons carry out analytical work to establish the correspondence of actual and normative parameters. A comparison is made of the parameters of the duration and volume of medical care provided to the data reflected in the reporting documents.

Examination of the quality of medical services

The examination allows us to identify violations committed during the provision of medical services. The event helps improve the quality of service for insured persons. The reputation of the medical institution depends on its result, which influences the decision of participants in the compulsory health insurance program to be served in a medical institution.

An example of conducting an examination of the quality of medical services

The Insurance Fund received a complaint against the doctor N.N. Tarasov, whose untimely actions led to complications of the disease of citizen A.A. Ignatov. Based on the complaint against the medical institution, a specialist, MD, was sent to clarify the circumstances and conduct an investigation. Petrovsky I.P. During the control, a number of violations were identified, consisting in the irresponsible attitude of employees to their duties. The expert drew up a conclusion on the basis of which sanctions were applied to the medical organization (City Clinical Hospital No. 2 in the city of B.) in the form of a reduction in funding for payment for medical services in the amount of the specified damage due to the incompetent actions of the medical staff.

It is worth noting that such an examination can only be carried out by a doctor included in the regional or federal register of experts. At the same time, he can carry out supervision only within the framework of the specialization in which he works and has a valid license or accreditation. Thus, a neurologist can conduct an examination of the quality of medical care only in the field of neurology. At the same time, quality control of expert work can be planned or targeted. The initiation procedure and nuances of the event are discussed in the table below.

Table - Types of quality examination and frequency of their conduct

Thus, all forms of supervision are a set of measures aimed at assessing the activities of a medical organization or the services it provides to the requirements of the legislation of the Russian Federation. In accordance with the law, the supervisory authority or expert is obliged to warn the organization about the inspection at least 24 hours before it begins.

Quality of medical care. Components of quality, its assessment, quality management. Medical care quality control system.
In a market economy, it is generally accepted that quality is the property of a product or service (including medical - as a socio-economic category) to satisfy the demand of consumers (in healthcare - patients).

However, medical activities cannot be reduced to traditional production and, accordingly, the usual criteria for the quality of goods, works and services are not fully applicable to healthcare.

What do they consist of? specific socio-economic features of medical activity and its product - medical services, making it difficult to use traditional methods and quality assessment and assurance systems?

Firstly, A medical service is inseparable from the process of its provision. A medical service cannot be considered abstractly, as a phenomenon with independent properties. It cannot be stored and is consumed at the time of production.

Secondly, a medical service has uncertain consumer properties. At the time of providing medical care, the true need and need of the patient is unknown. The most important direction of a doctor’s activity is to identify this need and diagnose the pathological condition present in the patient. Thus, unlike the classical market, in healthcare it is the producer, not the consumer, who determines the volume of services provided. Doctors act in two guises - as agents of patients who determine the extent of the need for the volume of necessary services, and as producers of these services. As a result, there may be a conflict between the medical and economic interests of doctors. They may exaggerate the amount of services needed, choosing the most expensive ones. This information “asymmetry” between the producer and consumer of medical services changes the usual interaction of supply and demand, and, as a consequence, pricing mechanisms.

Third, the production of medical services is carried out within the framework of a deep technological contradiction, since it is carried out on the basis of modern scientific and technical achievements, but in a conservative form of healing. On the one hand, modern medicine uses techniques that have ancient origins, as they were formed throughout the history of the development of medicine. They are based on classical methods of diagnosis and treatment, such as questioning and examining the patient, palpation, auscultation, etc. Qualitative assessment of these medical technologies is extremely difficult due to the lack of clear criteria. This is explained, first of all, by the significant role of the subjective factor, which is determined by the personality and abilities of the doctor using such diagnostic and treatment methods. We are talking about that area of ​​medicine that is akin to art, Objective assessment which is very complex.

On the other hand, medicine carries out its activities on the basis of modern medical technologies using the latest achievements of science and technology, and it is here that they find greatest application modern methods for assessing the quality of medical care (services).

Fourthly, Medical activity is also unique in that the consumer actively participates in its process. A person’s attitude towards his health, the adequacy of his implementation of medical prescriptions and recommendations, to a huge extent determine the medical treatment he receives. The answer to the question about the degree of patient intervention in the treatment and preventive process lies both in the development of the legislative framework and in the development of educational programs for patients and members of their families.

From a philosophical point of view, QUALITY is a category that expresses its essential certainty, inseparable from the existence of an object, due to which it is precisely this and not another object. Quality reflects a sustainable relationship constituent elements object, which characterizes its specificity, making it possible to distinguish one object from others. At the same time, quality also expresses something common that characterizes the entire class of homogeneous objects.

From a general economic point of view, quality, as defined by International (ISO 8402) and national (GOST 15467) standards, is a set of properties and characteristics of services that determine its ability to satisfy established or expected requirements.

Quality of medical care (services) – a characteristic that reflects the degree of adequacy of the technologies chosen to achieve the goal and comply with professional standards.

Based on WHO recommendations, a detailed (complete) definition of the quality of medical care can be formulated as follows: quality of medical care – this is the content of interaction between a doctor and a patient, based on the professional’s qualifications, that is, his ability to reduce the risk of progression of the patient’s existing disease and the emergence of a new pathological process, optimally use medical resources and ensure patient satisfaction from his interaction with the healthcare system.

Sometimes the concept of IMP is identified with indicators characterizing the level of health of the population; this served as the basis for the creation in a number of regulatory documents of “standard models of the final performance results” of medical organizations.

In some cases, the concept of quality standards is correlated with quality standards. In this sense, quality reflects the completeness and adequacy of diagnostic, treatment and preventive measures, and also characterizes the desired state of health of the patient at the time of discharge from the hospital, at the end of the course of treatment, at certain points in time (changes over the year, quarter, month, etc. .).

In the annex to the order of the Ministry of Health of the Russian Federation dated January 22, 2001. No. 12 “On the introduction of the industry standard “Terms and definitions of the standardization system in healthcare” provides the following definition: “The quality of medical care is a system of criteria that allows us to determine the quality of medical care in a certain medical institution, with a certain doctor, in a certain territory , and for the individual patient."

The concept of medical treatment can also be used to characterize the implementation by medical workers of actual medical methods or medical technologies.

The following quality characteristics are currently generally accepted:

• 
  safety;
• 
  adequacy;
• 
  scientific, technical and professional level;
• 
  efficiency;
• 
  availability;
• 
  effectiveness;
• 
  continuity;
• 
  convenience;
• 
  interpersonal relationships;
• 
  patient satisfaction.

SAFETY. The primary principle of medicine is to do no harm. The intervention should not lead to consequences more severe than the suffering for which it is provided.

ADEQUACY means the compliance of the provided medical service with the need (need) of the patient. Adequacy can be considered, firstly, as the possibility of receiving a medical service (availability) and the compliance of the patient’s expectations with the services actually offered to him (satisfaction), and secondly, as the compliance of the pathological condition detected in the patient and the medical treatment carried out in connection with this activities, thirdly, as the degree of achievable objectives of the diagnostic and treatment process (effectiveness). At the same time, adequacy is associated with cost-effectiveness, when conclusions about the quality of the diagnostic and treatment process are made based on an analysis of the volume and structure of costs incurred.

SCIENTIFIC, TECHNICAL AND PROFESSIONAL LEVEL. An important criterion The level of material and technical, scientific and technological, personnel and resource support for medical activities is what makes it possible to adequately judge the IMC. In the minds of the consumer, there is an idea that medical care can be of high quality only if it is materially and technically equipped, if people are involved in its provision the latest devices and devices that only with the help of the latest achievements of scientific and technological progress can truly high-quality medical care be provided.

While paying tribute to the above approaches, one should recognize the limited significance of the described feature. There is something in medical practice that distinguishes it from craft, production and is related to art. A number of methods and evidence systems used to justify diagnostic and treatment options are not always based on traditional information sources. Sometimes a doctor makes absolutely correct decisions, guided not by logic, but by intuition, which is based on an inexplicable specific ability for medical practice. In this case, information is obtained in inexplicable, unconscious ways. Apparently, the activity of a doctor with its specific functions will never be replaced by a machine; the level of human creative capabilities will always be ahead of the level of scientific and technical achievements.

ECONOMICAL. With a limited amount of financial resources spent on healthcare, medical care should be provided in such a way that financial expenses are carried out optimally, taking into account the results obtained and based on the most important areas of medical activity.

In some health care systems, health care providers, with an economic interest in the results of their work, prescribe a large number of indicated and non-indicated medical manipulations and procedures. As a result, there is an inadequate overestimation of the volume of medical services provided, which is not due to the state of health, but to the direct economic interest of doctors in carrying out relevant procedures and operations.

Modern resuscitation and intensive care technology is such that it is able to maintain the biological existence of a patient for an almost unlimited time, with the complete absence of the possibility of recovery. There are examples when both here and in the West the existence of virtually biological objects is maintained for years, despite the fact that they have no chance of returning to human life. This raises a number of questions.

How economically justified are the huge expenses incurred as a result of this? medical institutions? Under what circumstances and to what extent does the doctor have the right to intervene in this process? Who makes the decision to terminate intensive care measures and thereby deprive a living object of life? Thus, economic problems are often intertwined with moral and ethical problems.

A feature of the “quality” category as applied to a medical service is that the examination and treatment of a patient in full compliance with the type of pathology and the specification (category) of a medical institution does not always fully satisfy the patient due to the latter’s lack of an objective idea about the possibilities of correcting the real pathological conditions using modern medicine. Taking this feature into account, the concepts of adequate and inadequate quality of medical care can be formulated as follows.

The appropriate quality of medical services is the compliance of the medical care provided with modern ideas about its required level and volume for a given type of pathology, taking into account the individual characteristics of the patient and the capabilities of a particular medical institution.

Inadequate quality of medical services is a discrepancy between the medical care provided and generally accepted modern ideas about its required level and volume for a given type of pathology, taking into account the individual characteristics of the patient and the capabilities of a particular medical institution.

Quality control of medical care

An analysis of various methods for assessing the IMF showed that the most acceptable is the methodological scheme proposed by A. Donabedian, which is based on the so-called Donabedian triad of indicators

Donabedian Triad distinguishes three groups of indicators:

1. 
   Indicators of resource quality (structure).
2. 
   Process quality indicators,
3. 
   Indicators of the quality of results.

• 
  medical personnel and their qualifications;
• 
  material support;
• 
  financial resources;
• 
  information support, etc.

• 
  technology;
• 
  compliance with standards;
• 
  diagnostics;
• 
  treatment;

• 
  treatment outcomes;
• 
  cost of treatment;
• 
  average duration of treatment;
• 
  access to treatment;
• 
  safety of treatment;
• 
  optimality of treatment;
• 
  patient satisfaction, etc.

The examination of structure indicators is carried out by licensing and accreditation bodies. The purpose of the examination is comprehensive assessment readiness of the medical institution to provide appropriate types of medical care. At the same time, the material and technical base, staffing and resource support are assessed.

PROCESS QUALITY INDICATORS in a medical institution characterize the medical technology itself and organizational technology.

Medical technology itself is a technology that constitutes the essence of the diagnostic and treatment process. Assessment of medical technology involves a detailed study by an expert of a doctor’s actions and their assessment taking into account modern principles of medical care for a specific disease, the individual characteristics of the patient and the capabilities of the medical institution. Organizational technology is a technology related to the organization of this process and the management of a medical institution.

RESULT QUALITY INDICATORS involve the use of absolute and relative indicators, characterizing the ratio of costs incurred and results achieved.

Federal civil legislation that can be used in relation to the problem of ILC is divided into general and special.

The general ones include:

1. 
   Constitution of the Russian Federation (December 12, 1993).
2. 
   Civil Code.
3. 
   Federal Law "On non-profit organizations"(1996)
4. 
   Law "On the Protection of Consumer Rights" (1993, as amended in 1996)

Special legislation includes:

1. 
   “Fundamentals of the legislation of the Russian Federation on protecting the health of citizens” (1993)
2. 
   “Law on health insurance of citizens in the Russian Federation” (1991, as amended in 1993)

With the entry into force of the Russian Federation Law “On Medical Insurance of Citizens in the Russian Federation”, the medical insurance control system acquired the following form:

Rice. 1. System of quality control of medical care in the Russian Federation (schematically)

KMP departmental control system

The activities of the departmental quality control system are regulated, in particular, by order of the Ministry of Health of the Russian Federation No. 5 dated January 13, 1995 “On measures to improve the examination of disability,” which contains the main provisions on the implementation of quality control. Based on this document, a new concept of “clinical expert work” is introduced.

At the level of a medical institution, a three-stage quality assessment is being introduced:

1. 
   stage – control is exercised by the heads of departments and divisions;
2. 
   level – deputy chief physician for medical, clinical and expert work, outpatient care;
3. 
   stage – clinical expert commissions.

This provision establishes the general organizational and methodological principles of departmental quality control of medical care provided to the population in healthcare institutions, regardless of departmental subordination and forms of ownership on the territory of the Russian Federation.

The examination is carried out on individual completed cases, as a rule, according to medical documentation (inpatient or outpatient card).

The following must be examined:

1. 
   Cases of deaths.
2. 
   Cases of nosocomial infection and complications.
3. 
   Cases of primary disability of persons of working age.
4. 
   Cases of re-hospitalization for the same disease during the year.

1. 
   Cases with discrepant diagnoses.
2. 
   Cases involving complaints from the patient or their relatives.

Examination of ILC for a specific patient involves comparison with standards, which, as a rule, contain a unified set and scope of diagnostic and therapeutic measures, as well as requirements for the timing and results of treatment for specific nosological forms of diseases. The leading role in this case belongs to the expert, who, along with the implementation of standards, must take into account the characteristics of this particular individual case.

During the examination, the completeness and timeliness of the diagnostic measures, the adequacy of the choice and adherence to treatment measures, the correctness of the diagnosis, defects are identified and the causes of their occurrence are established.

The information obtained as a result of the examination, containing recommendations for eliminating and preventing identified deficiencies, is brought to the attention of the management of the medical institution and health care authorities.

It must be emphasized that departmental control of the quality and effectiveness of medical care is the main type of control that is closest to the producers of medical services. Its results are compared with data from non-departmental control. Indicators of the quality and efficiency of medical care can and should be used for differentiated remuneration of medical workers.

KMP non-departmental control system

Formed during the implementation of the Law “On Medical Insurance of Citizens in the Russian Federation”, when compulsory medical insurance subjects - insurance companies and territorial compulsory medical insurance funds were given the right to conduct an independent examination of the quality of medical services provided to insured citizens.

Despite the fact that some subjects of non-departmental control existed before, an additional impetus for the formation of the system was given precisely by the introduction of compulsory medical insurance.

Obviously, this is due not only to the emergence of a legislative framework, but also to the emerging economic motivation among individual subjects to effective implementation control.

The main task of the subjects of non-departmental control of the Medical Commission is to organize, within their competence, a medical and medical-economic examination in order to ensure the rights of citizens to receive medical care of a certain quality and check the effectiveness of the use of healthcare resources, compulsory medical insurance and social insurance funds.

Non-departmental control of the KMP is carried out mainly in the following areas:

• 
  checking the fulfillment of contractual obligations between the medical institution and the health insurance company;
• 
  checking the fulfillment of contractual obligations between the insurance company and the policyholder;
• 
  studying patient satisfaction with the level of medical care provided;
• 
  preparation of recommendations for improving the organization of medical care and improving its quality;
• 
  compliance with instructions on the procedure for issuing documents certifying temporary disability of citizens;
• 
  compliance of the invoices submitted to the insurance company with the actual amount of work performed.

• 
  control the result;
• 
  target control;
• 
  planned control.

• 
  medical effectiveness of the service;
• 
  economic efficiency.

• 
  70% is used to eliminate the causes of unsatisfactory performance management (increasing personnel qualifications, purchasing and repairing equipment, introducing new technologies, etc.). These funds are not allowed to be used to pay for medical personnel;
• 
  10% goes to the reserve for payment of medical services of the health insurance company;
• 
  20% is used to pay the costs of conducting the CMO case and, first of all, to organize and conduct the examination of the ILC.

The regulatory documents do not provide a universal, comprehensive definition of the concept of “quality of medical care”, which does not allow the provisions of the Law “On Health Insurance...” and other by-laws to be properly used;

Recent years have been characterized by the emergence of a significant number of entities whose tasks include monitoring the quality of medical care. At the same time, the division of powers between them is not clearly defined, which leads to unjustified duplication of their functions.

In general philosophical terms, quality is understood as a set of characteristics of an object that distinguish it from other objects.

In general terms, quality most often means the degree of superiority of the consumer properties of one object compared to another (for example, different generations of computers). In this case, the terms “quality level”, “better quality”, etc. are more often used.

There are many formulations of the concept of “quality of medical care” in the literature. This is due to the fact that the quality of medical care is a complex, multicomponent category. Most developed countries use the wording of the World Health Organization: “Each patient should receive such a package of diagnostic and therapeutic care that would lead to optimal health outcomes for that patient in accordance with the level of medical science and such biological factors as his age, diseases, concomitant diagnosis, response to the chosen treatment, etc. At the same time, to achieve such a result, minimal resources should be used, the risk of additional injury or disability as a result of treatment should be minimal, the patient should receive maximum satisfaction from the process of care provided, and the patient’s interactions with medical care system, as well as the results obtained.” Based on this formulation, the quality of medical care can be defined as an assessment of medical activity in relation to the patient from 4 positions:

1) availability of medical care;

2) safety of medical care;

3) optimal medical care;

4) patient satisfaction.

As noted, the quality of medical care is a multicomponent category. It is customary to distinguish 3 components of the quality of medical care and, accordingly, three approaches to ensuring and assessing quality:

Structural quality (structural approach);

Quality of technology (process approach);

Quality of the result (effective approach).

Structural quality is a component of the quality of medical care that describes the conditions under which it is provided. The concept of “conditions” includes: personnel qualifications, availability and condition of equipment, rational use of equipment, condition of buildings and premises, drug supply in a medical institution, availability and replenishment of consumables, etc. Structural quality can be defined both in relation to the medical institution as a whole, with its material and technical base, staffing, organization of work, service conditions (in this case they talk about the ability of health care facilities to provide medical services at the required level), and to each medical worker individually. In the latter case, his professional qualities are assessed, i.e. the sum of skills, knowledge, and skills in performing specific therapeutic and diagnostic procedures (Scheme 1).

The quality of technology is a component of medical care that describes how optimal the complex of therapeutic and diagnostic measures provided to a particular patient was.

An important principle underlying the procedural approach to the quality assurance system is the creation of such conditions when the error of a particular performer or random deviation from the normal process of performing medical technology does not lead to a deterioration in the result of medical care.

The quality of the result is a component of the quality of medical care that describes the relationship between the actually achieved results and the actually achievable (planned) results. Depending on the object being assessed, planned results can be understood (Diagram 19.1):

Dynamics of the health status of a particular patient;

Results of treatment of all patients in health care facilities during the reporting period;

The state of health of the population of the territory.

Scheme 19.1.

The main regulatory documents for quality control are:

Law of the Russian Federation dated 02/07/92 No. 2300-1 “On the protection of consumer rights.”

Law of the Russian Federation dated 10.06.93-1 “On standardization”.

Law of the Russian Federation dated June 10, 1994 No. 5151-1 “On certification of products and services”;

Order of the Ministry of Health of the Russian Federation No. 12 of January 22, 2001. “On the introduction of the industry standard “Terms and definitions of the standardization system in healthcare.”

Order of the Ministry of Health of the Russian Federation and the Federal Compulsory Medical Insurance Fund No. 303/77 dated October 24, 1996 “On improving quality control of medical care to the population of the Russian Federation.”

Other legislative acts and orders of the Ministry of Health of the Russian Federation (see section “Licensing”).

The medical care quality assurance system consists of 3 elements. These include:

1) control participants (i.e. those who must exercise control);

2) means (by which control is carried out);

3) control mechanisms (how control is carried out, sequence of actions).

The legislative framework includes the following as participants in quality control of medical care:

1) medical institutions;

2) public associations of consumers;

3) health authorities; 4 ^licensing authorities;

5) medical insurance organizations;

6) professional medical associations;

7) compulsory health insurance funds;

8) state medical educational institutions; medical research institutions providing postgraduate or additional professional education specialists;

9) policyholders;

10) Gosstandart of Russia and its territorial bodies;

11) State Committee for Antimonopoly Policy and its territorial bodies;

12) bodies of the state sanitary and epidemiological service;

13) state fire supervision authorities;

14) state labor protection inspection;

15) committees for state property management;

16) executive bodies of the social insurance fund. The regulatory framework divides all of the listed control participants into 2 links. It is customary to distinguish departmental and non-departmental links in the quality of medical care. At the same time, medical institutions and health care management bodies belong to the departmental level, and all others belong to the non-departmental level.

At the departmental level (at the health care facility level), quality control of medical care is a function of:

Heads of departments (first stage of examination);

Deputy heads of institutions for clinical expert work, medical care, etc. (second stage of examination);

Clinical expert commissions of the institution as a whole (third stage of examination).

At the level of the healthcare management body, quality control is carried out:

Clinical expert commissions of government bodies at all levels;

Chief full-time and freelance specialists of government bodies at all levels.

IN necessary cases To carry out the examination, employees of universities, research institutes and other institutions can be involved on a contractual basis.

Participants at the departmental level monitor all components of the quality of medical care, which follows from the content of the tasks of this level.

The system of departmental quality control of medical care is designed to:

1) assessment of the state and use of human and material and technical resources of health care facilities (i.e. control of the structural quality of care provided to medical institutions as a whole);

2) assessment professional qualities and medical workers through personnel certification;

3) examination of the process of providing medical care to specific patients (i.e. control of the technological component of the quality of medical care);

4) identification and substantiation of defects, medical errors and other factors that had a negative effect and resulted in a decrease in the effectiveness of medical care;

5) preparation of recommendations for managers of medical institutions and health care authorities aimed at preventing medical errors and defects in work and helping to improve the quality and efficiency of medical care;

6) studying patient satisfaction from their interaction with the healthcare system;

7) calculation and analysis of indicators characterizing the quality and effectiveness of medical care;

8) selection of the most rational and management decisions, carrying out operational corrective actions and monitoring the implementation of management decisions.

It should be noted that to unify the procedure for controlling technological quality, especially at the departmental level, “Expert Assessment Cards” can be used, which provide a score for such aspects as the completeness of collecting complaints and anamnesis, the adequacy of the examination (laboratory, instrumental, specialist consultations), validity diagnosis - main and concomitant diseases, treatment, rehabilitation, these recommendations, the correctness of the examination of work capacity, assessment of the continuity of patient management on different stages, the correctness of his observation tactics.

Regulatory documents do not clearly regulate the distribution of objects of control between medical institutions and health authorities. However, in practice, in most cases such a division is formed. Structural formations that form the first, second and third stages of examination in health care facilities focus their attention on monitoring the technological quality and outcome of treatment of specific patients. The control of these same components is carried out by the chief specialists of health authorities.

Heads of treatment and prevention institutions and officials of governing bodies evaluate and control the quality, outcome of treatment, of all patients who applied to health care facilities during the year.

Quality control of the results of medical care for the population is carried out by officials of government bodies at all levels.

The assessment of the structural quality of care provided by health care facilities is also carried out by the chief doctors of institutions and officials of governing bodies. However, to date, effective mechanisms for ensuring this component have not been formulated.

Control of the professional qualities of medical workers is carried out by certification commissions formed by the healthcare management body of the subject of the Federation.

Non-departmental quality control of medical care includes:

Analysis of the results of providing medical care to the population;

Studying patient satisfaction with medical care provided;

Verification of fulfillment of contractual obligations between the policyholder and the insurer;

Verification of fulfillment of contractual obligations between healthcare institutions and medical insurance organizations;

Monitoring compliance with instructions on the procedure for issuing documents certifying temporary disability of citizens;

Assessing the ability of healthcare institutions to guarantee the required level of quality of medical care;

Monitoring the correct application of tariffs and compliance of bills submitted for payment with the volume of medical care provided;

Other types of control carried out by subjects within their competence.

An important problem of ensuring the quality of medical care that requires an immediate solution is the multiplicity of non-departmental entities, the lack of a clear delineation of their functions and, as a consequence, duplication of the latter.

The regulatory framework provides that the competence of licensing authorities is:

Monitoring the safety of medical services for patients and staff and their compliance with established standards during licensing and accreditation of healthcare institutions and certification of specialists;

Monitoring compliance by healthcare institutions and individuals with licensing conditions;

Issuance of licenses and certificates to legal entities and citizens;

Participation in the formation of non-departmental medical examination and a register of experts on the territory of a constituent entity of the Russian Federation.

The competencies of the medical insurance organization are:

Organization and implementation, within the framework of concluded contracts of compulsory and voluntary medical insurance, of monitoring the quality, volume and timing of medical care by in-house experts, as well as by attracting freelance experts included in the register of experts on a contractual basis;

Determining the compliance of bills issued for payment for medical services provided with their true volume and quality, and for compulsory health insurance - with the territorial compulsory medical insurance program, with the right not to partially or completely reimburse the costs of providing medical services;

Submission of claims and lawsuits to medical institutions for compensation of damage caused to insured citizens;

Informed health care authorities, licensing and accreditation commissions about the shortcomings identified during the expert work in the activities of medical institutions;

Concluding agreements for the performance of medical quality assessments with competent organizations and specialists;

Participation in licensing and accreditation of medical institutions and individuals;

Applying in accordance with the established procedure to the licensing and accreditation commission with an application for suspension or termination of the license;

Renewal of an agreement for the provision of treatment and preventive care (medical services) under health insurance in cases of detection of repeated and serious violations in the provision of medical care to the insured. The competencies of the insurer are:

Monitoring compliance with the terms of the health insurance contract;

Obtaining the necessary information about the organizations existing in the territory that are authorized to carry out an examination of the quality of medical care to the population, and the procedure for their activities;

Obtaining information from insurers about the state of medical care for the insured and measures to improve it;

Bringing to the attention of the insured the results of an expert assessment of the quality of medical care and measures taken to improve it;

Renewal of a health insurance contract in cases of repeated and serious violations in the provision of medical care to the insured.

The competence of the executive bodies of the Social Insurance Fund of the Russian Federation is:

Carrying out, within the scope of competence, control over the validity of the issuance, extension, and correct execution of documents confirming the temporary disability of citizens, including when identifying:

A) cases of temporary disability with long-term stay of patients sick leave above average;

B) cases ending in disability;

C) cases of untimely referral for medical and social examination.

The competence of professional medical associations within the limits determined constituent documents and the Charter are:

Organization of an examination of the quality of medical care provided to citizens by medical institutions and persons engaged in private practice who are members of this association;

Participation in the development of quality standards for medical care, programs and criteria for training advanced training of medical personnel, agreements on tariffs for medical services;

Participation in organizing a register of experts;

Participation in the work of commissions for the certification of medical workers, accreditation and licensing of the activities of healthcare institutions, and qualification examination commissions.

Compensation societies (associations) for the protection of consumer rights are:

Studying public opinion about the quality of medical care provided;

Informing subjects of non-departmental quality control and health care authorities about defects in the provision of medical care;

Protecting the rights of patients by representing and protecting their interests in administrative and judicial authorities.

The main reasons for prescribing a non-departmental medical examination:

For medical insurance organizations:

Complaints from patients or insurers about the quality and culture of medical care;

Discrepancy in diagnoses;

Unfavorable outcome of the disease, directly related to deficiencies in medical interventions;

Transfers of patients within one health care facility and between different health care facilities;

Denial of medical care;

Complications that arose during treatment;

Disability of the insured;

Readmission to hospital;

Significant deviation of treatment times from average indicators. For the executive bodies of the Remaining Insurance Fund of the Russian Federation:

Submission for payment of documents certifying the temporary disability of citizens, issued in violation of the established procedure;

Doubts about the validity of issuing documents certifying the temporary disability of citizens, the terms of temporary disability, the terms of referral for medical and social examination.

For licensing authorities:

The need for licensing and accreditation of legal entities and individuals and certification of specialists with the involvement of freelance experts;

Ensuring control over the implementation of licensing conditions with departmental and non-departmental examination.

Thus, medical insurance organizations are called upon to monitor all three components of the quality of medical care provided by health care facilities, and control the professional qualities of medical workers - the scope of activity of licensing authorities and professional medical associations. The latter, in addition, have the right to assess the quality of patient treatment technology among members of associations. At the same time, the competence of insurers and, most importantly, public associations of consumers is unreasonably narrowed and insufficiently specified.

From the point of view of the commonality of interests pursued in the process of monitoring the quality of medical care, all participants in the system can be combined into 3 links:

Control by the manufacturer of medical services (internal quality control);

Control by the consumer of medical services (consumer quality control);

Control by organizations independent of consumers and producers of medical services (external quality control).

And the powers of the external link can be divided as follows (Diagram 19.2).

Currently, more than a dozen different methods and corresponding means of monitoring the quality of medical care are used. The main means of control should be recognized:

Medical standards;

Performance indicators of health care facilities;

Expert assessment.

Scheme 19.2..

Standards are normative and technical documents regulating norms, rules, mandatory requirements for the object of standardization and approved by the competent authority.

In the order of the Ministry of Health of the Russian Federation No. 12 of January 22, 2001? Some definitions in the field of standardization in healthcare are given. Even the term “standard” itself is adapted for processes specific to healthcare.

A "standard" is a normative document, developed by consensus and approved by a recognized body, which sets out rules, general principles or characteristics relating to various activities or their results for universal and repeated use, and which aims to achieve an optimal degree of orderliness in a certain areas.

What is consensus? The order provides a clear explanation of this concept:

“Consensus is a general agreement, characterized by the absence of serious objections on significant issues from the majority of interested parties and achieved as a result of a procedure that seeks to take into account the views of all parties and bring together divergent points of view; consensus does not necessarily imply complete unanimity.”

The order also defines the concept or process of “standardization in healthcare”:

“Standardization in healthcare is an activity aimed at achieving the optimal degree of regulation in healthcare by developing and establishing requirements, norms, rules, characteristics of conditions, products, technologies, works, services used in healthcare.”

Thus, the goal of standardization is to create a regulatory framework for monitoring compliance with the requirements of regulatory documents on standardization in healthcare when managing quality and ensuring the availability of medical care to the population of the Russian Federation.

The conformity assessment procedure by which an organization independent of the manufacturer and consumer of medical products and services certifies in writing that properly identified products or services comply with a specific standard or other regulatory document is called certification (of products and services).

The following types of medical standards should be distinguished.

1. By administrative-territorial division:

International;

National, state;

Territorial;

Local.

2. For standardization objects:

Structural and organizational standards;

Professional standards;

Technological (medical and economic) standards.

3. According to the mechanism of use:

Simple;

Group.

National standards are approved at the federal level and are mandatory throughout the country.

Territorial standards are developed by the subject of the Federation on the basis of clarification of national standards (if any are adopted). In the absence of national standards, a subject of the Federation may develop standards independently.

Local standards are standards adopted in a specific medical institution. They, in turn, complement and clarify territorial requirements.

The order of the Ministry of Health of the Russian Federation No. 12 dated January 22, 2001 provides such clear definitions of these and some other standards that are used or should be used in the healthcare system. By the way, the same order defines the healthcare system from the standpoint of its possible standardization:

“The healthcare system is a set of organizations, institutions, enterprises, associations, scientific societies, specialists and other economic entities, regardless of their departmental affiliation and organizational and legal form of activity, whose activities are related to the production, provision, quality control, sale of medicines, medical equipment, medical services, carrying out work to prevent diseases, organizing and managing processes and finances in the field of protecting the health of citizens, education of medical workers at the undergraduate and postgraduate level.”

“The state standard of the Russian Federation is developed for products, works and services, the needs for which are intersectoral in nature, and is adopted by Gosstandart of Russia (Gosstroy of Russia).”

“An industry standard for a standardization system in health care is developed in the absence of GOST R for the standardization object or if it is necessary to establish requirements that expand those established by GOST R, the procedure for developing OST is established by the industry body of state health care management.”

“The standard of an administrative-territorial unit is a standard adopted at the level of one subject of the Russian Federation and accessible to a wide range of consumers.”

“Enterprise (institution) standard: an enterprise standard is developed in the absence of GOST R and OST for the standardization object or if it is necessary to establish requirements that expand those established by GOST R or OST; the procedure for developing an enterprise standard is harmonized with the state and industry development procedures and is established by this enterprise.”

“A preliminary standard is a temporary document that is adopted by a standardization body and communicated to a wide range of potential consumers; information obtained during the use of the preliminary standard and feedback on this document serve as the basis for deciding whether to adopt and implement the standard.”

“Structural and organizational standards establish mandatory requirements for the conditions for the provision of medical care, professional - for the professional qualities of medical workers, technological - provide a list of necessary therapeutic and diagnostic procedures for monitoring patients with a specific nosological form, taking into account gender, age, and a number of others biological factors. If the need for the formation of structural, organizational and professional standards does not raise any doubts, then in the literature there are different opinions on the advisability of the formation of technological standards. A rational combination of using standards and expert assessment can reconcile supporters and opponents of the need to use standards as a means of monitoring the technological quality of medical care. In this case, non-compliance with the standard to a greater or lesser extent will be the reason for an examination by experts from the insurance medicine organization.

The question of the hierarchical structure of standards remains controversial. In world practice, there are two reasons for their creation and use. The first provides for the existence of only one standard for a product or service (simple standard). Therefore, determining the compliance of a product (service) with a standard is carried out according to the system: “complies - does not comply.” Non-compliance causes a refusal to issue a certificate, which, with mandatory certification, entails a prohibition on the sale of this product or service. The second approach involves the development and use of a set of standards of one type, hierarchically related to each other (group standard). Determining the conformity of the service in this case is carried out according to the system:

Corresponds to the standard of the highest category (class, rank);

Complies with the first category standard;

Meets the standard of the general (basic) category;

Does not meet any of the standards. In this case, a certificate of conformity will be issued indicating the categoricality of the standard. Refusal to issue a certificate occurs only if the object does not comply with one of the standards.

When developing simple or group standards, one should proceed not only from the content of their requirements, but also take into account the types of corrective actions that are taken based on the use of the standard. If the corrective action apparatus is based only on responsibility, simple types of standards should be used. Then compliance with the standard does not entail liability. Group standards should be used when corrective actions are based on a balance of responsibility and rewards. In this case, liability arises if the requirements of the basic standard are not met. There are no different responsibilities or incentives when meeting the basic standard. If any standard of a higher hierarchical level is met, a system of incentives is used (most often in the form of increased tariffs for services or the cost of products). In this regard, it becomes clear that technological standards should be simple, and structural and organizational, professional standards- group.

Comparison of advantages and disadvantages various means quality control of medical care allows us to draw some conclusions:

1. Medical standards are a more objective means of control compared to expert assessment (which is their advantage). In addition, they are characterized by high throughput.

2. The disadvantages of the standards include the following:

The creation and use of standards requires significantly more resources compared to expert assessment. In addition, regular revision of the content of the standards is required;

When forming medical standards, the “feasibility” of the standard’s requirements should be taken into account (i.e., mandatory requirements should not be excessive for the majority of healthcare facilities, medical workers, etc.). On the other hand, the requirements of the standards must take into account modern achievements science and technology.

3. It is not possible to develop standards for all components of the quality of medical care and take into account all the variety of influencing factors.

4. The formation and use of statistical indicators (activity of health care facilities, health of the settlement) as a means of quality control do not require significant costs, and they are also characterized by a certain objectivity. A definite disadvantage is that the scope of application of the indicators is quite narrow.

5. The advantages of peer review as a means of quality control include the fact that its use requires less money (compared to the development of medical standards), as well as its inherent differentiated approach(the ability to take into account its diversity - factors influencing the quality of medical care in each specific case). The disadvantages include a significant degree of subjectivity (compared to both standards and indicators) and “low” throughput.

Table 19.1

Used and optimal controls various components quality

Table 19.1 lists the components of quality of care and levels of assessment. Each of them corresponds to currently used and optimal controls.

An institution's ability to provide medical services of the required quality (one of the levels of structural quality assessment) is currently assessed in the accreditation process based on expert assessment.

Accreditation of medical institutions is the determination of their compliance with established standards.

In St. Petersburg and in a number of other regions, an assessment system is used, based on 3 categories: as a result of accreditation, units of health care facilities can be certified to the highest, first or second categories (or they will be denied certification).

The professional qualities of a medical worker are assessed in the process of personnel certification and personnel certification.

The quality of the treatment outcome of all patients at health care facilities and the results of medical care for the population in a specific territory are assessed based on the use of performance indicators of health care facilities and public health indicators. IN Lately Sociological surveys of patients are becoming more widely used as a means of monitoring the quality of the result, in particular, determining the degree of patient satisfaction.

The main elements of the mechanism for ensuring the quality of medical care are:

Collection and analysis of information;

Making management decisions (corrective actions) aimed at creating favorable conditions for the provision of quality medical care;

Monitoring the implementation of decisions made.

The last element is similar to the first, since it involves the collection and analysis of information.

All the variety of corrective influences can be reduced to 2 types: responsibility and incentives. At the same time, ensuring structural quality and the quality of the result should be based primarily on measures of an incentive nature, technological quality, and on measures of an exacting nature.

Thus, medical insurance organizations, using technological standards and expert assessment as means of control, are called upon to control the quality of the treatment technology for a particular patient and, partly, the quality of the result. First of all, cases of deviation of the performed therapeutic and diagnostic measures from the requirements of technological standards are analyzed. In this case, these cases are subsequently subject to expert assessment, and management decisions possible in the form of liability (penalties).

Territorial licensing and accreditation bodies control the structural quality of medical care. The means of control are structural and organizational standards - group ones for the accreditation of health care facilities included in the compulsory medical insurance system, and simple ones for the accreditation of institutions providing services only at free prices; for the former, management decisions also provide for liability - in the form of refusal of certification in case of non-compliance with the basic standard, and incentives - in the form of increased tariffs for services. For institutions that are not included in the compulsory medical insurance, only liability is provided in case of non-compliance with the standard.

Professional medical associations monitor the professional qualities of specific medical professionals. The latter are an element of structural quality. Group professional standards serve as means of control. Compliance with higher standards and, accordingly, assignment to a higher category entails receiving bonuses to the official salary. In case of compliance with the basic standard, there is no responsibility or incentives; failure to comply will result in denial of certification.

Public associations of consumers - the subject of the consumer link - exercise control over all three components of the quality of medical care. Analysis regulatory framework and the experience of their activities indicates that they will carry out inspections primarily based on statements from specific patients, and not in favor of an indefinite circle of consumers.

Health care management bodies, being an external link, are called upon to monitor the quality of the results of medical care for the population of the territory and all patients treated in each health care facility during the reporting period. The means of control are population health indicators and performance indicators of health care facilities. Analysis of these indicators allows governing bodies to carry out operational management and determine the prospects for the development of healthcare.

The medical institution is the only representative of the internal level; it exercises control over all three components of the quality of medical care (to the greatest extent - technological). To collect information, both a variety of documentation filled out in health care facilities and documents drawn up based on the results of inspection of health care facilities by entities at other levels are used. Main means of control: expert assessment, performance indicators, sociological surveys.

The territorial compulsory health insurance fund forms the rules for interaction between entities in the relevant territory and exercises control over the rational use of funds allocated for compulsory health insurance.

Thus, the existing system of quality control of medical care is important stage its provision and improvement.

Control and licensing mechanisms in healthcare

The state's obligation to guarantee the safety of medical care and the diversity of the health care economy is a prerequisite for the formation of control and licensing mechanisms in health care.

Analysis of the world and domestic experience allows you to highlight the following groups control and licensing mechanisms in healthcare:

Licensing procedures for medical, pharmaceutical and other activities carried out in the field of health protection;

Accreditation of institutions of various healthcare systems;

Monitoring the professional qualities of medical workers;

Certification of medicines, medical products, medical equipment;

Licensing, certification and accreditation of educational institutions implementing diploma and postgraduate training programs for medical workers.

Control and permitting mechanisms should, first of all, include licensing procedures. The following types of activities are licensed in the domestic health care system:

Medical activities;

Pharmaceutical activities;

Production of medicines;

Production of medical equipment;

Activities for the distribution of medicines and medical products;

Maintenance of medical equipment (except for the case if the specified activity is carried out to meet the own needs of a legal entity or individual entrepreneur);

Activities to provide prosthetic and orthopedic care;

Cultivation of plants used for the production of narcotic drugs and psychotropic substances;

Activities related to the circulation of narcotic drugs and psychotropic substances (development, production, manufacture, processing, storage, transportation, release, sale, distribution, acquisition, use, destruction) included in List II in accordance with the Federal Law “On narcotic drugs and psychotropic substances";

Activities related to the circulation of psychotropic substances (development, production, manufacture, processing, storage, transportation, release, sale, distribution, acquisition, use, destruction) included in List III in accordance with the Federal Law “On Narcotic Drugs and Psychotropic Substances” ;

Activities related to the use of infectious disease agents;

Production of disinfectants, pest control and deratization products.

Thus, according to the law, 12 types of activities are subject to licensing, one way or another related to healthcare. The following materials are devoted primarily to licensing of medical activities.

The legal basis for licensing medical activities is:

1. Federal Law “On licensing of certain types of activities” dated 08.08.01 No. 128-FZ.

2. Regulations on licensing of medical activities, approved by Decree of the Government of the Russian Federation of May 21, 2001 No. 402.

3. Regulatory documents of federal executive authorities (orders of the Ministry of Health of the Russian Federation, state and industry standards, decrees of the Government of the Russian Federation, etc.), defining the content of licensing requirements and conditions for each type of medical activity.

4. Territorial legislation.

Federal Law “On licensing of certain types of activities”:

Establishes general principles, rules and licensing procedures;

Gives definitions to basic concepts;

Determines the list of licensed activities According to the Law:

License - a special permit to carry out a specific type of activity subject to mandatory compliance with licensing requirements and conditions, issued by a licensing authority to a legal entity or individual entrepreneur;

Licensing - activities related to

Providing licenses;

Re-issuance of documents confirming the availability of licenses;

Suspension and renewal of licenses;

Cancellation of licenses and control of licensing authorities over compliance by licensees when carrying out licensed types of activities with the relevant licensing requirements and conditions;

Licensing requirements and conditions - a set of requirements and conditions established by the provisions on licensing specific types of activities, the fulfillment of which by the licensee is mandatory when carrying out the licensed type of activity;

A license applicant is a legal entity or individual entrepreneur who has applied to the licensing authority for a license to carry out a specific type of activity;

Licensee - a legal entity or individual entrepreneur who has a license to carry out a specific type of activity;

Licensing authority - federal executive authorities, executive authorities of constituent entities of the Russian Federation, carrying out licensing in accordance with this Federal Law.

Regulations on licensing of medical activities:

Defines a specific mechanism for licensing medical activities, establishes that licensing of medical activities is carried out by the licensing authority of the constituent entity of the Russian Federation.

Type of licensing body of a constituent entity of the Russian Federation, its structure, staffing, etc. are determined by a group of normative documents that make up territorial legislation. All the variety of types of licensing authorities in healthcare can be reduced to 3 main types. The following types of licensing authorities in healthcare should be distinguished:

1. Medical licensing and accreditation commissions (centers for licensing and accreditation of medical activities, etc.) are independent legal entities. The superior governing body for them is either the Government of a constituent entity of the Russian Federation or the healthcare management body of a constituent entity of the Russian Federation. The peculiarity of this type of licensing body in healthcare is that this body:

Deals only with licensing;

Carries out licensing only types of activities related to the system of protecting the health of citizens.

2. Health care management body of a constituent entity of the Russian Federation. In this case, a division has been formed within the structure of the governing body to carry out licensing functions. The peculiarity of this type of licensing body in healthcare is that this body:

Engaged not only in licensing, but also in all functions inherent in the executive body responsible for protecting the health of citizens;

Carries out licensing only types of activities related to the system of protecting the health of citizens (as well as medical licensing and accreditation commissions).

3. The Licensing Chamber (Licensing Committee, etc.) is the single licensing body of a constituent entity of the Russian Federation. This body licenses all types of activities within the competence of a constituent entity of the Russian Federation (operation of gas stations, veterinary activities, operation of engineering infrastructures of cities and other populated areas, public display of audiovisual works carried out in a cinema hall, real estate activities, etc.), including including types of activities related to the system of protecting the health of citizens.

Only deals with licensing.

The advantages of licensing bodies in healthcare, supervised or being healthcare management bodies, include strengthening the role and influence of healthcare management bodies of a constituent entity of the Russian Federation in the health care system. The disadvantages include the removal of the licensing procedure from the system of non-departmental quality control of medical care, which contradicts the regulatory framework.

The advantages and disadvantages of independent licensing bodies in healthcare are the opposite of the disadvantages and advantages of the previous type.

The advantages of this type of single licensing body include:

Ensuring uniform methodological approaches, establishing a unified licensing technology for various types of activities;

Ensuring comprehensive inspections, the possibility of creating a common database of licensees;

Increasing the independence of the licensing authority when making decisions;

Intensification of activities;

Reduction in the number of management personnel.

Regardless of what type of licensing body in healthcare operates on the territory of a constituent entity of the Russian Federation, its structure can be distinguished common elements. One of the elements is the apparatus of the licensing body - civil servants, managers responsible for carrying out the tasks of this executive body. To make a decision on issuing or refusing to issue a license, it is very important to take into account the opinions of freelance medical experts. The totality of these experts is the second element general structure licensing authority in healthcare. There are licensing and joint licensing and accreditation commissions. The licensing commission includes representatives of: the licensing body, the health care management body, professional medical associations and medical institutions. The licensing and accreditation commission also includes representatives of insurers.