The Federal Service for Surveillance on Consumer Rights Protection and

Human Well-Being or ROSPOTREBNADZOR is the federal service responsible for

Supervision of consumer rights Protection and Human Well-Being in Russia.

This service was founded in 2004 and was included into the structure of the Ministry of
Health Care of Russia till 2012.

Since May 2012 Rospotrebnadzor was excluded from the Ministry of Health and
reports directly to the Russian Government. It functions on the base of the Act of
Federal Service on the base of the Administrative Regulation.

Rospotrebnadzor in the plan of regulating of the state functions connected with the
technical regulation, evaluation of conformity or other kinds of state regulating
performs the following functions:

• Performs the sanitary control, control and issuing some kinds of permissive
documents;
• Performs licensing of certain kinds of activities;
• Performs certification of different objects of evaluating of conformity to Russian
legislation.
• Performs sanitary certification of production according to the requirements of the
Customs Union;
• Performs state registration of production of the RF (excepting medicaments);
• Performs state registration of production of the Customs Union on the territory of
Russia (excepting medicaments).

Permissive documents of Rospotrebnadzor are issued in the form of Permit for

exploitation of buildings and premises. This document testifies about the fact that the
premises conforms to the requirements to performing a certain kind of activity and
providing some kind of service. This document is obligatory for receiving for owners of
restaurants and cafes, food shops and swimming pools, children's preschool, school
institutions, medical cabinets and clinics, by providing hair-dresser, laundry and other
similar institutions.
ROSPOTREBNADZOR STRUCTURE

Central Office

Rospotrebnadzor Centers of Hygiene

Regional Offices and Epidemiology in Research institutions
(in all subjects the subjects of
of Russian Federation) Russian Federation

Antiplague Health and Epidemiology services of

Institutions Russian ministries and Departments

The Russian federation Federal law “On the sanitary and epidemiological
wellbeing of the population” is aimed at sanitary and epidemiological wellbeing of the
population as one of the main conditions of citizens' constitutional rights to health
protection and favorable environment implementation.

SANITARY AND EPIDEMIOLOGICAL WELLBEING OF THE POPULATION

is a state of population health, environment in which deleterious effect of environmental
factors on human being is absent and favorable conditions of his vital activity are
provided.

Sanitary and epidemiological wellbeing of the population is ensured by:

• diseases prophylactics in accordance with sanitary and epidemiological conditions

and prediction of their changing;
• sanitary-and-antiepidemic (preventive) measures implementation and obligatory
observing by citizens, individual entrepreneurs and legal entities sanitary regulations as
a component part of activity performing by them;
• state sanitary and epidemiological normalization;
• federal state sanitary and epidemiological surveillance;
• obligatory confirmation of product compliance with sanitary and epidemiological
requirements in accordance with procedure established by the legislation of the Russian
Federation on technical regulation;
• licensing of activities posing potential hazard to a human being;
• state registration of potentially dangerous for a human being chemical and
biological substances, separate product kinds, radioactive substances, production and
consumption waste, and also importable for the first time to the territory of the Russian
Federation separate product kinds;
• social-hygienic monitoring;
• scientific researches in the sphere of sanitary-and-epidemiological public well-
being;
• forming and conducting of opened and public federal information resources
directed to proper informing of public authorities, institutions of local governing, legal
entities, individual entrepreneurs and citizens about arising of communicable diseases ,
mass non-communicable diseases (poisoning), state of environment and realizing
sanitary and antiepidemic (preventive) measures;
• measures on public hygienic education and training and raising public awareness
of healthy life-style;
• measures on bringing to account for infraction of the legislation of the Russian
Federation in the sphere of sanitary and epidemiological wellbeing of the population.

SANITARY AND EPIDEMIOLOGICAL CONDITIONS is a state of population health

and environment at a certain territory at a specified time.
SOCIAL-HYGIENIC MONITORING is a state system of surveillance of population
and environment state of health, their analysis, assessment and forecast, and also of
determination of cause-and-effect relations between public state of health and influence
of environmental factors.

Tasks of Surveillance service

1. Realization of preventive and current control

2. Study of the public health condition
3. Evaluation of the city sanitary conditions
4. Organization of preventive and health-improving sanitary and anti-epidemic
measures
5. Coordination of different sanitary and anti-epidemic institutions
6. Organization of sanitary and anti-epidemic work in different treatment-and-
prophylaxis institutions
7. Sanitary and anti-epidemic education of the population
8. Organization of special danger diseases control
9. Statistical registration and report

Work assignment of Surveillance service

1) Conduction of state protecting mass-line sanitary-epidemic supervision.

 2) Conduction of for different department on the question of environmental
protection, prophylaxis of infectious diseases, organization of work , way of life, life,
study, rest.
3) Organizationally-methodical work – co-ordination activity of organizations,
enterprises on fulfilling sanitary-hygienic disease quotas, claim, assertion and co-
ordination of instructional-methodical materials.
4) Scientific-practical work is the study of factors influencing on environment
and mode of life on a health with the purpose of development of measures on its
improvement.
5) Normative work is development and claim of sanitary rules, hygienically
norms, conduction of sanitary-hygienic examination.

Main methods of Surveillance service

1. Dynamic sanitary observation and description

2. Laboratory, instrumental examination of different environmental factors
3. Statistical summarizing and analyses of obtained data

Types of sanitary control:

1. Preventive state control – sanitary examination of raw materials, goods,
design estimates, control of building standards
2. Current control – it's a control of sanitary and anti-epidemic rules
maintenance

Duties of Surveillance service and health establishments (HE)

Surveillance system
➢ Registration of infectious diseases
➢ Analyses of infectious morbidity
➢ Epidemiological examination
of infection focus
➢ Control of vaccination
➢ Disinfection
➢ Control of anti-epidemic regime
HE
➢ Early diagnostics of infectious diseases
➢ Isolation of infectious patients
➢ Treatment of patients at home
➢ Timely referral of emergency notification
to Hygiene and Epidemiology Center
➢ Contract people observation
➢ Organization of the current disinfection
➢ Vaccination, Dehelmintization
 Quality of medical care (QMC)

What Is Health Care Quality?

“The degree to which health services for individuals and populations increase the
likelihood of desired health outcomes and are consistent with current professional
knowledge.”
Or ‘’Health care quality’’ is a level of value provided by any health care resources
as determined by some measurement. As with quality in other fields, it is an assessment
of whether something is good enough and whether it is suitable for its purpose.

QMC is a set of medical service characteristics directed to satisfaction of citizen’s

needs in effective prevention and treatment of diseases, improvement of life quality and
increase of its span.
QMC is a set of characteristics confirming the accordance of rendered medical
aid to the patients` (population) needs and modern level of medical science and
technology.

Key characteristics of QMC evaluating:

1. Availability: possibility of necessary medical aid receipt in necessary terms;

2. Adequacy: conformity of the rendered medical aid to a patient to modern
norms;
3. Continuity: coordination in the medical help rendered to a patient at various
times, different experts and medical establishments;
4. Effectiveness: conformity of the rendered medical help to setting purposes;
5. Efficiency: achievement of the planned medical aid results with minimum
expenditures, efforts and costs;
6. Patient-centered: participation of a patient and his relatives in the taking a
decision connected with health, and also satisfaction with medical aid;
7. Safety of treatment: safety guarantees and absence of harmful influences on a
patient in a medical establishment;
8. Timeliness: medical aid must be render when it is necessary for a patient;
9. Professional competence of medical specialists.

Criteria and structure of health care quality

 Structural quality, i.e. conditions medical care granting;
Quality of process includes the decision about optimum set of medical-
diagnostic actions for a concrete patient;
Quality of outcome - when is estimated a parity of actually reached and planned
results (dynamics of the patient health state, results of all patients` treatment for the
accounting period, separate indicators of the population health state of certain
territory).

Medical care quality standards

To measure correctness of medical technologies realization it is necessary to
compare physician`s actions with standards of their realization:
Diagnostic standards,
Medical-preventive standards,
Rehabilitation measures standards.

Medical standard as the ordered sequence, reflects the achievements of

science and practice, diagnostic and medical actions in a combination with medical
aid efficiency estimation on the base of objective criteria and supervision terms.
 Standards classification:
On compulsion of requirements realization:
Recommendatory standards (standards in the form of methodical
recommendations, instructive letters, etc. which performance does not demand
rigid following to one once and for all confirmed technique, in their execution
variants are possible);
Legislative standards (standards in the form of laws, decisions, orders, etc. which
compulsion of performance is equated to force of the law).
On level and the general hierarchy of application system:
Local (the standards applied in one or several medical-preventive establishments
(MPE), or within of public health management of a city, area);
Regional (the standards, which application it is limited by region);
National (the standards applied at level of the state);
International (the standards applied at the international level).
By types are :
Standards on public health resources ( have requirements to basic funds of MPE,
staff, finance, to used medicines, equipment and so forth).
Standards of medical services and establishments organization have
requirements to systems of effective use of public health resources organization).
Technological standards ( regulate process of medical aid rendering).
Standards of medical aid programs ( regulate carrying out of measures for
separate population groups, united on disease character, age, sex, social status,
occupation, working conditions and so forth).
Medical-economic standards ( combine the standard of diagnostics and treatment
with medical services cost).
Complex standards (a set of structurally-organizational, technological and
standards of organizational programs regulating activity of a certain medical
speciality or service).

State accreditation of medical-preventive establishments and licensing of medical

activity kinds in them are realized with aim of the most effective influence on
medical aid quality, to increase state control after consumers interests protection,
to increase level, volume and improvement of medical aid quality.

Accreditation and licensing is effective means to provide medical activity quality

and carrying out public health reforms considered as the major component of the
general concept of public health system development.
 Accreditation provides the estimation of conformity of the accreditation
subject medical activity to established professional standards with certificate
delivery.

Licensing defines the delivery of the state permission to realize certain

corresponding declared kinds of medical activity to the subject of licensing.
Licensing is a delivery of state permission to medical establishment to realize
certain kinds of activity and services according to programs of obligatory and
voluntary medical insurance. All medical establishments are subject to licensing
irrespective of ownership form.
The license is the official document which allows physical or legal person to
realize medical activity. But consumers can choose medical establishments which
render the most qualitative services.