The quality of medical care and the system of its provision

Fundamentals of standardization in healthcare.

1. General Provisions;

2. Kinds of medical standards;

3. Basic principles and directions of standardization in healthcare

4. General characteristics and components of the quality of medical care;

5. Quality management of medical care;

6. Quality control of medical care;

7. Strategy for continuous improvement of the quality of medical care.

1. General Provisions

Standardization in healthcare should be understood as activities aimed at achieving the optimal degree of streamlining in the healthcare system by developing and establishing requirements, norms, rules, characteristics, conditions, technologies in the production and sale of medical goods and services.

The standardization process is based on the concept of “standard”. In a general sense, a standard is a regulatory document that regulates a set of rules, norms and requirements for an object of standardization and is approved by the competent authority.

In relation to the health care system, this concept can be expanded: a standard is a normative document developed by consensus and approved by the relevant body, which establishes for universal reuse rules, general principles or characteristics regarding various activities or their results, which is aimed at achieving an optimal degree of order in the health care system.

The effectiveness of standardization in the conditions of developed market relations is ensured by its following main functions: economic, social and communicative.

The economic function covers the following aspects:

Providing information about products and their quality, allowing manufacturers and consumers to correctly evaluate, choose a product or service, invest in investment projects and programs with less risk;

· promotion of competition based on the standardization of test methods and the unification of the main parameters of products, which allows for its objective comparison;

ensuring compatibility and interchangeability of certain types of goods or services;

· streamlining the management of technological processes and ensuring a given level of product quality.

The social function of standardization provides for the determination of such a level of parameters and indicators of goods and services that meets the requirements of public health, sanitation and hygiene, ensures the protection of the environment and the safety of people in the production, handling, use and disposal of products.

The communicative function of standardization provides for the creation of a basis for the objectification of various types of human perception of information, as well as the unification of terms and definitions, classifiers, measurement and testing methods, thereby ensuring the necessary mutual understanding, taking into account international regulations.

Priority directions of standardization. In world practice, the generally recognized priority areas of work on standardization are:

safety and ecology;

· information Technology;

resource saving.

2. Types of medical standards

It is customary to distinguish the following types of medical standards :

By administrative-territorial division:

1. International – approved at the international level and binding on the territory of those countries where this standard is in force.

2. National – approved at the federal level and binding throughout the country.

3. Territorial – developed by the subjects of the Russian Federation on the basis of clarification of national standards (if any are adopted). In the absence of national standards, the subject of the Russian Federation may develop standards independently. The standard of an administrative-territorial unit is a standard adopted at the level of a subject of the Russian Federation and accessible to a wide range of consumers.

4. Local – accepted in a particular medical organization. They are developed in the absence of GOST R and OST for the object of standardization, 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 or industry development procedure and is established by this enterprise.

By departmental affiliation:

1. State standard of the Russian Federation – a standard that is being developed for products, works and services, the needs for which are of an intersectoral nature and are accepted by the State Standard of Russia (GOST R).

2. Industry standard (standardization systems in healthcare) – a standard that is developed in the absence of standardization of GOST R, or if it is necessary to establish requirements that expand the established GOST R. The procedure for developing OST is established by the industry government body of the industry (health).

On the objects of standardization:

1. Structural and organizational standards – standards that establish mandatory requirements for the conditions for the provision of medical care.

2. Professional standards – standards that establish mandatory requirements for the professional qualities of medical workers.

3. Technological standards – standards that establish a list of necessary medical and diagnostic manipulations for monitoring patients with a specific nosological form, taking into account gender, age, and a number of other factors.

According to the mechanism of use:

1. Simple – standards that provide for the existence of only one standard. Compliance is determined according to the system: “corresponds – does not correspond”.

2. Group – a set of standards of the same type, hierarchically interconnected. The determination of conformity in this case is carried out according to the system: corresponds to the standard of the highest category (class, category); meets the standard of the first category; meets the standard of the general (basic) category; does not meet any of the standards.

In addition, a preliminary standard is distinguished – a temporary document that is adopted by the standardization body and brought to a wide range of potential consumers. The information obtained in the process of using the preliminary standard, and feedback on this document, serve as the basis for deciding whether it is appropriate to adopt and put the standard into effect.

3. Basic principles and directions of standardization in healthcare

The ideological basis for the formation of a system of standardization in health care are the following basic principles .

The principle of consent (consensuality): all subjects participating in standardization processes should strive for uniformity in the form and content of regulatory documents.

The principle of uniformity: a single procedure for the development, coordination and use of regulatory documents on standardization should be established in the healthcare system.

The principle of expediency: the requirements must be reasonable both from a scientific and practical point of view and comply with federal and international legislation, modern achievements of science and technology.

The principle of complexity and verifiability: the requirements for various objects of standardization must be consistent with each other and be verifiable by objective methods.

To implement these principles in the formation of a system of standardization in health care, the following main tasks should be solved:

· regulatory support for the development and implementation of the Program of state guarantees for the provision of free medical care to citizens of the Russian Federation, and other medical and social programs;

creation of a unified system for assessing the quality of medical care;

· development of the nomenclature of medical goods and services;

Establishment of uniform requirements for the conditions for the provision of medical care;

Establishment of uniform requirements for accounting and reporting documentation;

Establishment of uniform criteria for the effectiveness, safety and compatibility and interchangeability of preventive, diagnostic, therapeutic and rehabilitation procedures;

· regulatory support of metrological control;

Establishment of uniform requirements for licensing and accreditation of healthcare organizations;

· development of educational standards and uniform requirements for attestation and certification of specialists;

· development of unified requirements for information support of health care systems at the federal, regional and municipal levels;

· creation and maintenance of systems of classification, coding and cataloging in health care; regulatory support in the prescribed manner of supervision and control over compliance with the requirements of regulatory legal acts.

Based on the tasks listed above, the main objects of standardization in healthcare are:

· medical services;

production, sales conditions, quality, safety of medicines and medical equipment;

requirements for medical, pharmaceutical, support personnel;

accounting and reporting documentation;

· information Technology.

4. General characteristics and components of the quality of medical care

What is invested in the concept of “quality of medical care”? There are many definitions of this concept in the literature. In many foreign countries, the WHO definition is often used, which puts the following into this concept: “Each patient should receive such medical care that would lead to optimal results for his health in accordance with the level of medical science, the age of the patient, the diagnosis of the disease, the response to treatment ; at the same time, minimal funds should be involved, the risk of additional injury or disability should be minimal, and the result and satisfaction from the process of medical care provided should be maximized.

The most complete and at the same time simple is the definition developed by the Central Research Institute of Health Organization and Informatization of the Ministry of Health of the Russian Federation, which is proposed to be used as the main one:

The quality of medical care is a set of characteristics that confirm the compliance of the provided medical care with the existing needs of the patient (population), his expectations, the current level of medical science and technology.

Based on the above definitions, the following characteristics of the quality of medical care can be distinguished:

professional competence;

· availability;

· efficiency;

interpersonal relationships;

· efficiency;

Continuity

· security;

convenience;

· Satisfaction.

Professional competence refers to the knowledge and skills of health professionals and support staff, as well as how they use them in their work, following clinical guidelines, protocols and standards.

The lack of professional competence can be expressed both in small deviations from existing standards, and in gross errors that reduce the effectiveness of treatment or even endanger the health and life of the patient.

Accessibility of medical care means that it should not depend on geographical, economic, social, cultural, organizational or language barriers.

Efficiency. The quality of healthcare work depends on the efficiency and effectiveness of the medical technologies used. When evaluating performance, the following questions should be answered:

Will the prescribed treatment produce the desired results?

· Will the prescribed treatment lead to the best results in given conditions?

Interpersonal relationships. This characteristic of the quality of care refers to the relationship between health care workers and patients, medical staff and their management, the health care system and the population at large.

Efficiency in this case should be considered as the ratio of the resources spent to the results obtained. Efficiency is always relative, so efficiency analysis is usually done to compare alternative solutions.

Continuity. This characteristic means that the patient receives all the necessary medical care without delay and unjustified interruptions or unreasonable repetitions in the process of diagnosis and treatment.

Security. As one of the characteristics of quality, safety means minimizing the risk of side effects of diagnosis, treatment and other undesirable consequences of medical care. This applies to both healthcare professionals and patients.

Convenience. This characteristic refers to the comfort, cleanliness, confidential environment in medical institutions. It can also be about such things as having pleasant music, television, etc.

Satisfaction. The health care system must meet both the requirements of health professionals and the expectations and needs of patients.

It is generally accepted that the quality of medical care includes three main components, which essentially corresponds to three approaches to its provision and evaluation:

Structural quality (structural approach to assurance and evaluation);

· quality of technology (procedural approach to assurance and evaluation);

the quality of the result (an effective approach to ensuring and evaluating).

Structural quality characterizes the conditions for providing medical care to the population. It is determined in relation to the entire medical institution as a whole and in relation to a specific medical worker separately.

Structural quality, assessed in relation to the entire institution, is characterized by such parameters as the condition of the buildings and premises in which the medical institution is located; staffing, qualification of personnel; availability, condition and rationality of the use of medical equipment; the level of provision with medicines and medical products; service conditions, etc.

The quality of technology characterizes all stages of medical care. The quality of the technology gives an idea of compliance with the standards of medical care, the correct choice of tactics and the quality of the work performed. It characterizes the extent to which the complex of therapeutic and diagnostic measures provided to a particular patient corresponded to the established standards of medical technologies. If more funds were spent on providing medical care to a patient than provided for by the current medical and economic standards, such care will not be recognized as quality. Even if the expected results of treatment are achieved. The quality of technology is assessed only at this level – in relation to a particular patient, taking into account the clinical diagnosis, comorbidity, age of the patient and other factors. One of the parameters characterizing the quality of technology may be the presence or absence of medical errors.

The quality of the result characterizes the outcome of the provision of medical care, i.e. allows you to judge how the actually achieved results correspond to those actually achievable.

Typically, the quality of the result is evaluated at three levels: in relation to a particular patient, to all patients of a medical institution, to the population as a whole.

In hospital treatment, it was previously customary to distinguish three outcomes of hospitalization: “recovery”, “transfer”, “death”. Currently, hospitals have switched to a new, more differentiated system for assessing treatment outcomes, which distinguishes: “recovery”, “improvement”, “no change”, “deterioration”, “transfer”, “death”. Upon completion of the outpatient treatment of the patient, the possible outcomes are: “recovery”, “remission”, “hospitalization”, “transfer to another medical institution”, “disability”, “death”.

The quality of the results in relation to all patients of a medical institution should be assessed for a specific period of time (usually a year): mortality, the frequency of postoperative complications, the discrepancy between clinical and pathoanatomical diagnoses, neglect in oncology, the ratio of cured and extracted teeth, etc.

The quality of outcomes in relation to the population as a whole is characterized by public health indicators.

5. Quality management of medical care

Quality management of medical care is the organization and control of the activities of the health care system to meet the existing and expected needs of the population in medical care and satisfy consumers.

The medical care quality management system is a set of organizational and managerial structures and actions that analyze, evaluate and correct the conditions, the process of providing and the result of medical care to provide the patient with quality medical care in the amounts provided for by the Program of state guarantees for the provision of free medical care to citizens of the Russian Federation.

This system is based on the following principles:

Continuity of quality management;

using the achievements of evidence-based medicine;

· examination of the quality of medical care based on medical standards (protocols);

· the unity of approaches in conducting departmental and non-departmental examination of the quality of medical care to obtain comparable results;

· the use of economic and legal methods for managing the quality of medical care;

monitoring of the quality management system of medical care;

· analysis of the cost-effectiveness of costs to achieve the optimal level of quality of medical care;

study of public opinion on the quality of medical care.

Quality management of medical care consists of four main activities.

Quality design includes: defining who is the consumer of health services; establishing consumer needs; determination of the result that meets the needs of consumers; development of the structure necessary to achieve the desired result; turning the plan into action.

Quality assurance is the activities that are planned and systematically carried out within the framework of a quality management system, subject to their confirmation and with confidence that the object will fulfill the planned quality requirements.

Quality control is the methods and activities of an operational nature used to assess the fulfillment of quality requirements, its measurement and monitoring.

Continuous quality improvement is a set of activities constantly carried out by medical organizations in order to increase the efficiency and effectiveness of their activities, improve all performance indicators of healthcare organizations in general, all departments and individual employees. The process of quality improvement provides benefits for both the medical organization and consumers of medical services.

6. Quality control of medical care

Control (determination of the level) of the quality of medical care is based on a comparison of the real situation with existing standards (protocols) and accepted norms for managing patients. One of the mechanisms for monitoring the quality of medical care, its comparison with accepted standards is an examination.

The quality control system of medical care consists of three elements:

participants in control (who should exercise control);

means of control (with the help of which control is carried out);

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

In accordance with the legislation, the control participants include: medical institutions, public associations of consumers, health authorities, licensing authorities, medical insurance organizations, professional medical associations, compulsory medical insurance funds, state medical educational institutions, medical research institutes providing postgraduate or additional professional education of specialists, insurers, etc.

From the point of view of the commonality of interests pursued in the control process, all control participants can be combined into three links:

control by the provider of medical services;

control by the consumer of medical services;

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

There are other approaches to uniting participants in quality control of medical services:

State control: internal (departmental), external (non-departmental), independent (audit);

public control;

control of the patient.

However, the current legal documents, depending on the participants in the control, provide for only two types of control: departmental and non-departmental quality control of medical care. Departmental control is carried out by medical institutions and healthcare management organizations, non-departmental – by all the others listed above.

Currently, more than ten different methods and their corresponding means of quality control of medical care are used. These include medical standards, performance indicators of the healthcare organization, expert quality assessment, etc.

The mechanisms for quality control of medical care are:

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

· accreditation of institutions of various health care systems;

control of the professional qualities of medical workers;

certification of medicines, medical products, medical equipment;

· Licensing, attestation and accreditation of educational institutions implementing undergraduate and postgraduate training programs for medical workers.

The organization and procedure for conducting departmental and non-departmental quality control of medical care are regulated by orders of the Ministry of Health of the Russian Federation and FFOMS.

Algorithm for departmental/non-departmental expertise of the quality of outpatient medical care.

During the examination of the quality of medical care, the expert evaluates:

Compliance of medical documentation with accepted norms and rules;

correctness and timeliness of diagnosis;

sufficiency and timeliness of the appointment and implementation of diagnostic measures;

The adequacy of therapeutic measures to the diagnosis or the patient’s symptoms;

Correct implementation of instructions on the procedure for issuing a certificate of incapacity for work in cases of temporary disability.

The expert identifies defects, establishes their causes, gives oral or written recommendations to attending physicians or heads of healthcare organizations to eliminate and prevent identified deficiencies. The expert should pay special attention to identifying and preventing the occurrence of systematic errors.

The examination begins with filling in the passport part of the outpatient medical care quality assessment card, which corresponds to the passport part of the outpatient card.

When examining diagnostic measures during the initial visit of the patient, the completeness of complaints collected by the attending physician, anamnesis data, objective data, their impact on the timeliness and correctness of establishing a clinical diagnosis is assessed. The expert evaluates the patient examination plan and each diagnostic procedure (laboratory, instrumental examination, specialist consultations) in terms of the need and timeliness of this procedure, the correct interpretation of its results, their significance for establishing the correct diagnosis, the need to repeat this procedure, its frequency. When establishing the unacceptability of the timing of the implementation or incorrect interpretation of the results of the diagnostic procedure, the expert evaluates how this affected the diagnosis, the choice of treatment tactics, the timing of treatment and the outcome of the disease. An assessment should be given of the final diagnosis, the timeliness of its establishment, validity and compliance with accepted classifications. In the case of an incorrectly established diagnosis, the expert should draw a conclusion about its impact on the choice of tactics, the timing of treatment, and the outcome of the disease.

The assessment of therapeutic measures begins with an assessment of the conservative treatment performed, its adequacy to the established diagnosis, the sufficiency of daily and course doses of the drugs used, and the timing of their appointment. For this purpose, the method of comparison with the current standards (protocols) and accepted norms for the management of patients is used. Insufficiency or redundancy of therapeutic measures are evaluated by an expert in terms of their impact on the duration of treatment and the outcome of the disease.

Evaluation of surgical treatment on an outpatient basis is given based on the validity and timeliness of the surgical intervention, the presence or absence of complications during or after the operation. In case of untimely surgical intervention or the occurrence of complications, their causes are established, as well as the impact on the timing of treatment and the outcome of the disease.

Evaluation of the anesthetic benefit involves determining the adequacy of the chosen method of anesthesia. Inadequate anesthesia or its absence when indicated is evaluated based on its impact on the conduct of surgery and the development of complications during or after it.

The assessment of the completeness of dispensary measures is given in terms of timeliness, regularity of medical examinations of dispensary patients, laboratory and instrumental examinations, and prescription of anti-relapse treatment. The untimeliness and insufficiency of dispensary measures are evaluated based on their impact on the patient’s condition, the frequency of occurrence of relapses of the disease, their severity and duration. Preventive and rehabilitative measures are evaluated taking into account the presence of indications for their implementation, the timeliness of their implementation, sufficiency, and the impact on the outcome of the disease. The outcome of the disease is assessed on the basis of changes in the patient’s state of health as a result of the treatment. With an unfavorable outcome, a causal relationship with the examination and treatment carried out is established, which is reflected in the conclusions.

An expert doctor evaluates the compliance of the quality of medical documentation with the established requirements, its impact on the ability to assess the patient’s condition, establish a diagnosis, the chosen tactics of patient management, the duration of treatment and the outcome of the disease. At the same time, an assessment is given to the examination of temporary disability. The identified defects are summarized by the expert in the conclusions.

The work of the head of the department is evaluated based on the impact of the defects identified in his work on the timely correction during the examination and treatment of the patient, on the outcome of the disease, and the quality of medical records.

The assessment of hospitalization takes into account its validity, timeliness and their impact on the outcome of the disease.

Compliance with the rights of the patient, provided for by the Fundamentals of the Legislation of the Russian Federation on the Protection of the Health of Citizens, is established according to medical records, which must record the voluntary informed consent of a citizen to medical intervention or refusal of it, effective pain relief during medical interventions, etc.

The quality review ends with conclusions – a comprehensive expert opinion on the quality of medical care, the maintenance of medical records and the observance of the rights of the patient. Shortcomings and errors identified during examination and treatment, which affected the correct diagnosis, patient management, treatment time and outcome of the disease, should be summarized. It is indicated with reference to the current standards (protocols), monographs, guidelines and accepted norms for managing patients, which additional diagnostic methods were necessary to establish the diagnosis, what missing treatment should have been carried out.

The assessment of the ILC is given in the sum of points given by the expert: from 0 to 15 points – good quality of medical care; from 16 to 30 points – satisfactory quality; 31 points or more – unsatisfactory ILC.

Algorithm for conducting departmental / non-departmental examination of the quality of inpatient medical care.

During the examination of the quality of medical care, the expert evaluates:

sufficiency and timeliness of the appointment and implementation of diagnostic measures;

correctness and timeliness of diagnosis;

The adequacy of therapeutic measures to the diagnosis or the patient’s symptoms;

Compliance of medical documentation with approved norms and rules;

Correct implementation of instructions on the procedure for issuing a certificate of incapacity for work in cases of temporary disability.

The quality examination ends with conclusions – a comprehensive expert opinion on the quality of medical care provided, including an analysis of the maintenance of medical records, the correctness and timeliness of establishing a diagnosis, prescribing and conducting therapeutic and diagnostic measures, conducting an examination of temporary disability, and observing the rights of the patient.

The assessment of the quality of medical care is given in the sum of points given by the expert: from 0 to 20 points – good quality of medical care; from 21 to 40 points – satisfactory ILC; 41 points or more – unsatisfactory ILC.

7. Strategy for continuous improvement of the quality of medical care

Provisions used for continuous quality improvement:

· systems approach;

focus on the needs of the consumer;

use of scientific methodology;

understanding of the concept of variability;

· work in a team;

taking into account psychological factors in the work;

The role of management in quality improvement.

The whole process of providing medical care can be divided into a number of stages. The consumer is the person who receives the intermediate or final results of the process (final or intermediate return). The consumer can be a person external to the process (patient; person, organization paying for medical care, etc.) or internal to the system (doctors, nurses, technicians, etc.). At different stages of the process (or in different processes), the same person can act as both a consumer and a participant in the process. Consideration of customer requests and continuous improvement of the relationship between internal and external customers are extremely important for quality improvement. When a healthcare provider constantly seeks to understand and meet the needs and needs of the consumer, the process proceeds with minimal complications, waste, cost, and risk.

Having made a decision to improve the quality of processes, it is necessary to use scientific methodology: researching data, identifying and analyzing problems, searching for hidden causes, putting forward a hypothesis, testing it, and widespread implementation.

The continuous quality improvement process includes the following steps: 6 identifying what needs to be improved; selection of a team working on each task; motivation and training of the team, ensuring its work; “pilot” study of the effectiveness of changes; implementation of what has been achieved, maintaining the work of new elements of the process.

The implementation of a continuous quality improvement strategy is carried out according to the following algorithm (Kucherenko V.Z., 2001):

1. Initiative “explanatory” stage. Management communicates to employees the basic principles of activities in the field of continuous quality improvement and discusses goals and objectives for specific areas of work. The management masters and acquaints employees with the implementation of the continuous quality improvement strategy: the choice of goals and objectives in the field of quality improvement, indicators and quality assessment systems; identification and analysis of problems and ways to resolve them; methods and forms of control.

2. Planning stage. Employees in departments develop basic proposals for the formation of a plan for their departments and individual plans. Based on the generalization of plans, the management forms a master plan in the field of quality improvement, coordinating it with the production plan.

3. Stage of organization. The management of the healthcare organization, through the heads of departments, determines the priority problems, evaluation indicators, work methods, deadlines and responsible persons.

4. Stage of implementation. Employees of the healthcare organization, in accordance with the plans, carry out activities aimed at resolving the problem and its causes. Management monitors processes.

5. Stage of control. Management summarizes and evaluates quality improvement activities. The achievement or non-achievement of the goal is stated. Subsequent plans are determined according to the conclusions.

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