Order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1177n “On approval of the procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention in relation to certain types of medical interventions, forms of informed voluntary consent to medical intervention and forms of refusal of medical intervention” ( with changes and additions)

Appendix No. 1. The procedure for giving informed voluntary consent to medical intervention and refusing medical intervention in relation to certain types of medical interventions Appendix No. 2. Informed voluntary consent to types of medical interventions included in the List of certain types of medical interventions to which citizens give informed voluntary consent when choosing a doctor and medical organization to receive primary health care Appendix No. 3. Refusal of types of medical interventions included in the List of certain types of medical interventions to which citizens give informed voluntary consent when choosing a doctor and medical organization to receive primary health care help

Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1177n
"On approval of the procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention in relation to certain types of medical interventions, forms of informed voluntary consent to medical intervention and forms of refusal of medical intervention"

With changes and additions from:

a form of informed voluntary consent for the types of medical interventions included in the List in Appendix No. 2;

form of refusal of a type of medical intervention included in the List of certain types of medical interventions to which citizens give informed voluntary consent when choosing a doctor and medical organization to receive primary health care, in accordance with Appendix No. 3.

V.I. Skvortsova

Registration N 28924

To receive primary health care, when choosing a doctor and medical organization, citizens (their legal representatives) give informed voluntary consent to medical intervention.

Forms of consent to medical intervention and refusal of it are provided.

Consent is issued upon first contact with a medical organization. Before receiving it, the patient is provided with accessible, complete information about the goals and methods of providing medical care, the risks associated with it, possible options for medical intervention, and its consequences, including the likelihood of complications. The expected results of medical care are also reported.

If a citizen refuses medical intervention, the possible consequences of such a decision are explained to him, including the likelihood of developing complications of the disease (condition).

Informed voluntary consent is filed in the patient’s medical documentation and is valid for the entire period of provision of primary health care in the selected medical organization.

Citizens have the right to refuse one or more types of medical interventions or demand their cessation (with the exception of certain cases: for example, this does not apply to persons suffering from severe mental disorders and criminals).

(IDS) is documentary evidence of the necessary procedure - informing the patient, confirming the consent of the patient or his legal representative to a specific medical intervention.

Before signing the IDS, the medical worker provides in an accessible form information about the goals, methods of providing medical care, associated risks, possible options for medical intervention, its consequences, as well as the expected results of medical care.

Signing the Informed voluntary consent to medical intervention or writing a refusal of medical intervention is regulated by Art. 20 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (hereinafter referred to as the Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation”). Informed voluntary consent must be formalized in writing, signed by a citizen, one from a parent or other legal representative, a medical professional and is contained in the patient’s medical records.

Informed voluntary consent is formalized when:

- receiving primary health care when choosing a doctor and medical organization for the period of their choice;

For certain types of medical intervention, which are included in the list established by the authorized federal executive body.

Currently, this list is determined by Order of the Ministry of Health and Social Development of the Russian Federation dated April 23, 2012 N 390n “On approval of the List of certain types of medical interventions to which citizens give informed voluntary consent when choosing a doctor and medical organization to receive primary health care.”

The IDS can be valid for the entire duration of the contract for the provision of medical services and applies to the medical worker whose signature is reflected in the IDS form.

Part 2 art. 20 of the Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” establishes a restriction under which informed voluntary consent to medical intervention is given by one of the parents or other legal representative of the patient, namely:

For persons under 15 years of age;
- in relation to persons recognized as legally incompetent;
- in relation to minors with drug addiction.

In addition to parents, the legal representatives of a citizen are adoptive parents, guardians and trustees.

For the absence of IDS, liability is provided in accordance with the legislation of the Russian Federation. The absence of a completed IDS may be considered:

- as a violation of licensing requirements when carrying out medical activities (clause 5 a., c. Resolution of the Government of the Russian Federation of April 16, 2012 No. 291 “On licensing of medical activities”), which will entail administrative liability in accordance with parts 3, 4 of Art. 14.1 Code of Administrative Offenses of the Russian Federation.

As a violation of clause 28 of the Government of the Russian Federation of October 4, 2012 No. 1006 “On approval of the Rules for the provision of paid medical services by medical organizations,” which will entail administrative liability in accordance with Art. 14.8 Code of Administrative Offenses of the Russian Federation.

As a violation of the Civil Code of the Russian Federation and the Law of the Russian Federation of 02/07/1992 No. 2300-1 “On the Protection of Consumer Rights”. Due to unreliable or insufficient information about a medical service, regardless of the fault of the medical organization.

However, the Citizen or his legal representative have the right to refuse medical intervention or demand its termination. When refusing medical intervention, the possible consequences of such refusal must be explained to the patient or his legal representative in a form accessible to him.

In accordance with paragraph 8 of Art. 20 Federal Law “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”, the procedure for issuing an IDS for medical intervention and refusal of medical intervention, including in relation to certain types of medical intervention, the IDS form for medical intervention and the form for refusing medical intervention are approved by the authorized federal executive body .

Some forms of IDS for medical intervention, including for various branches of medical care, are approved by orders of the Ministry of Health of the Russian Federation.

For each medical organization (not included in the list of IDS orders presented on the website), it is advisable to develop internal IDS forms for each specific medical intervention, taking into account all the necessary criteria for properly informing the patient about the upcoming medical intervention.

Today, Order of the Ministry of Health of Russia dated December 20, 2012 No. 1177n “On approval of the procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention in relation to certain types of medical interventions, forms of informed voluntary consent to medical intervention and forms of refusal of medical intervention” has come into force intervention”, which approved forms of consent and refusal of medical intervention, mandatory for use by medical organizations only when implementing the state guarantee program.

You can view an example of consent, download the IDS for medical intervention and refusal of medical intervention by clicking on the link.

The registration of the IDS form is necessary:

1) when providing all types of medical care: primary health care; specialized and high-tech medical care; emergency medical care; palliative care.
2) under various conditions of medical care: outside a medical organization (at the place where an ambulance is called, in a vehicle during medical evacuation); outpatient, including when calling a doctor at home; in a day hospital; stationary.
3) for all forms of medical care: emergency medical care (for sudden acute diseases and conditions that pose a threat to the patient’s life); emergency medical care (for sudden acute diseases and conditions without obvious signs of a threat to the patient’s life); planned medical care (for diseases and conditions not accompanied by a threat to the patient’s life).

The IDS or refusal of medical intervention form contains the following information: Name of the medical organization, full name. medical worker; Full name the patient and the patient's legal representative; Legal basis for IDS; Features of legal regulation of medical intervention; Name of medical intervention; Purpose of medical intervention; Methods of providing medical care; Possible options for medical intervention; Consequences of medical intervention; Risks of medical intervention; Expected results of medical care; The right and consequences of refusing medical intervention; Additional specialized information (indicated in accordance with the requirements of the legislation of the Russian Federation for various types of medical services).

Medical intervention without consent is necessary:

- for emergency indications to eliminate a threat to a person’s life and if his condition does not allow him to express his will or there are no legal representatives;
- in relation to persons suffering from diseases that pose a danger to others;
- in relation to persons suffering from severe mental disorders;
- in relation to persons who have committed socially dangerous acts (crimes);
- during a forensic medical examination and forensic psychiatric examination.
The decision is made by a council of doctors.

If it is impossible to hold a consultation, the decision is made directly by the attending physician, followed by notification to the head of the medical organization.

In fact, the IDS form, stored in an outpatient card or medical history, when the information procedure itself is carried out in a timely manner, and not forgery in absentia, is an effective mechanism for protecting the doctor and the medical institution from unfounded claims from the patient.

The difficulty associated with registering an IDS lies in the fact that the legislation provides for the necessary minimum procedures for registering an IDS. At the same time, the number of medical services and interventions is growing every year. And for each or almost each of them, it is desirable to register an IDS in order to comply with the law.

How many of the patients understand the essence and meaning of medical terms, how many understand how and under what conditions manipulations are performed, what will be discussed, who will be present during the examination or manipulation?

The preparation of an IDS form or the development of internal IDS forms for individual manipulations should be carried out on the basis of the recommendations set out in the relevant regulations. An incorrectly completed IDS form containing incomplete information cannot be a tool for protecting medical workers and medical institutions. The development of internal IDS forms is a responsible matter, which our company is also involved in. At the same time, filling out the form and registering it at the reception entrance or sometimes with the reception staff (receptionist, administrators) is an equally responsible process.

Often in practical medical activities the question arises: is it possible to carry out a medical procedure or service without issuing an IDS, if the patient or his relatives are unwilling to sign the document.

The legislation, as always, indicates reasons for providing assistance without IDS in the interests of the patient (for emergency indications) or in the interests of society (dangerous infections, socially dangerous acts or forensic examination), but there is no single conclusion on this issue.

However, the absence of a completed IDS form for the service provided is a violation of licensing requirements, a violation of the rules for the provision of paid medical services and a violation of the rights of the consumer of the service.

Refusal to sign the IDS form by the patient, without clear justification of the reasons, but the desire to receive the service leads to a conflict of interest. The medical institution and the doctor may be interested in providing the service, but without completing the IDS form, both the doctor and the medical institution remain unprotected even from unfounded claims.

The solution is to formalize cases of refusal to sign the IDS by holding an, albeit brief, but still in-person medical commission with members of the VC recording the circumstances of the patient’s refusal to sign the IDS form when informing. Thus, receive protection from unfounded claims and perform the service. Or refuse to provide a service to a patient, possibly losing the patient’s favor and definitely losing the cost of the service provided (under compulsory medical insurance, voluntary medical insurance, or for a fee).

LLC "Med-YurConsult"

The head physician needs to control the document flow in the institution. One of the most important documents is informed voluntary consent. Illiterate registration of the IDS threatens the clinic with serious consequences.

IDS today: design rules and pitfalls

Medical intervention or even a complex of medical interventions are defined as actions on the part of health care facility workers in the provision of a particular medical service. Of course, we are talking about diagnosis, prevention, treatment and rehabilitation. For medical organizations today, it is a mandatory task to obtain IDS (informed voluntary consent) from their patients for medical intervention. And this task is at the legislative level.

Let's remember where the bulk of patients come from. In modern living conditions, it is quite difficult for a person to remain perfectly healthy. Even in the healthiest people, the body sometimes malfunctions. Most people are not able to completely control nutrition, physical activity, sleep and other components of their lifestyle due to certain reasons: lack of time or desire, overwork, compelling circumstances, and more. The change of seasons and other environmental factors, age-related characteristics of the human body have also not been canceled. So, until humanity achieves immortality and gets rid of most diseases forever, doctors will have work. There will be patients, there will be doctors, hospitals, litigation, etc.

In the Russian Federation, the legislation provides for many laws dedicated to the rights of patients. The main provisions are specified in the Federal Law dated November 21, 2011 No. 323. Let's delve a little deeper into the rights of a healthcare facility client to submit an IDS for medical intervention by referring to Article 20 of the above document.

IDS as a concept

Let's look at what constitutes informed voluntary consent of the patient. To begin with, it is necessary to indicate that IDS is the provision of information to the patient by a healthcare facility employee about the purpose for which medical intervention is intended to be applied, what methods of treatment, prevention, and rehabilitation can be used for this, about possible negative consequences and the expected result.

Here is a complete list of information that a doctor should provide to a patient:

The legislation does not establish any restrictions on the amount of information that a health worker must provide to the IDS. Familiarization of the patient with all of the above information from the list is done at the discretion of the doctor. There is a mandatory condition - everything must be completely clear to the patient. Therefore, healthcare workers need to take into account that people who are far from medical practice who come to them for treatment do not always understand medical terminology in the form in which doctors are accustomed to perceive it. Another condition is that the information should not psychologically traumatize the patient. That is, you cannot simply approach the patient with a smile and say:

- Hello! There is a 99.9% chance that you will die tomorrow. But there is a tiny chance of survival if we carry out the operation. Check out...

When conveying information to the client, you need to use the correct form of presentation!

And the most important condition is that medical intervention can begin only after the patient has been familiarized with all the necessary information, unless there are some compelling reasons to provide medical care without the patient’s consent (more on emergency care below). The doctor has the right to consider that the patient’s ID for the provision of medical services has been received after he personally familiarizes the patient with the necessary information, provided that the patient, having understood this information, consents to receiving medical services.

The IDS must be prepared in writing. In order for the IDS to enter into legal force, it must be signed by the medical employee who is going to provide medical care to the client of the healthcare facility and, in fact, by the patient himself or his legal representative. After this, the IDS is filed in the patient’s medical record, which should be stored in the archive. Thus, the IDS becomes a document on which both the patient and the medical organization can legally rely.

Today, the Ministry of Health of the Russian Federation has developed the procedure and requirements for issuing IDS for medical intervention and refusing it. Accordingly, medical organizations must comply with the requirements and norms prescribed by law, and also use forms for compiling an IDS. But these requirements apply only to health care facilities that provide free medical care under the state guarantee program. Other health care facilities may use other forms, but on the condition that they fully contain all the necessary information (a complete list of mandatory information is given above).

IDS form

Sample for filling out the IDS:

The IDS must be signed by the client of the healthcare facility upon first contact. The document becomes legally valid from the moment when both the patient and the health worker sign it, and it will be valid throughout the entire period of provision of the medical service. It often happens that health care facility employees do not fully respect the rights of patients (equivalent to simply not complying), by only partially providing information from its mandatory content. This results in patient complaints and litigation.

Cases in which a legal representative can sign an IDS instead of a patient

There are various circumstances and situations when the patient is not able to independently sign the IDS. For example, physical disability. In such cases, the law provides that the patient’s legal representative can sign this document.

Consent for primary health care

When a patient seeks medical care, he signs an IDS for a specific medical intervention, after which he is provided with primary health care. And this help may contain several different types of medical services. Medical interventions during a patient’s initial visit to a health care facility are divided into groups:

Medical intervention without IDS

In view of the fact that sometimes unpredictable situations occur in which it is impossible to familiarize the patient with the necessary information and obtain his consent to carry out certain medical interventions, but this is necessary to preserve the life or health of the patient, the law provides for situations in which health care facility employees can provide medical care without the patient’s IDS. These situations in modern medicine include cases:

• when there is a threat to a person’s life, immediate medical care is needed, but the physical condition of this person does not allow him to express consent or disagreement to medical care, and the legal representatives of this person are not nearby;
• a serious illness that poses a threat to the health or life of others;
• severe mental illness;
• when medical assistance is required for a person who has committed a crime;
• when a forensic medical and (or) forensic psychiatric examination is carried out;

If we delve deeper into the legislation of the Russian Federation and the practical activities of health care facilities, we can come to the conclusion that the absence of IDS can be regarded as a legal violation of the health care facility in relation to the patient. And even if the diagnosis was established correctly and the treatment methods were chosen correctly, the patient still has the right to file an application with the court about non-compliance with his rights by the medical organization. The absence of IDS may also indicate the commission of illegal medical interventions and harm to human health by a medical organization, which is also illegal.

It is not difficult to guess that if the patient proves that his rights were violated and there is no IDS, then he can claim compensation for moral damages and damages from the medical organization whose employee or employees violated his rights. But according to the law, a patient cannot file a claim in court based solely on the absence of an IDS; such a claim will not be satisfied in full.

Today, many trials are taking place precisely on the grounds of infringement of the rights of patients under IDS, as well as attacks on the mental and physical integrity of an individual. It is not difficult to legally secure a medical organization - its employees just need to act within the law, timely and correctly fill out the IDS for the provision of medical care and store such documents in their archives. Just in case. Necessarily.

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When applying the document, it should be taken into account that Order of the Ministry of Health of Russia dated December 20, 2012 N 1177n approved the Procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention in relation to certain types of medical interventions, as well as document forms.

Order of the FMBA of the Russian Federation dated March 30, 2007 N 88 “On voluntary informed consent to medical intervention” (together with “Instructions for filling out voluntary informed consent forms”)

Appendix No. 3

Approved

By order of the FMBA of Russia

FEDERAL MEDICAL-BIOLOGICAL AGENCY CMSC/MSCh/KB/INSTITUTE _______________________ Informed voluntary consent for surgical intervention, incl. blood transfusion and its components I ________________________________________________________________ (last name, first name, patronymic - in full) ____________ year of birth, living at the address: ___________ ┌────────────────────────────────────────────────────────────────┐ │This section of the form is to be filled out only for persons who have not reached│ │age 15 years, or incapacitated citizens: Me, passport: ______,│ │issued: __________________________________________________________│ │I am the legal representative (mother, father, adoptive parent,│ │guardian, trustee) of a child or person recognized│ │incapacitated: ________________________________________________│ │ (full name of the child or incapacitated citizen -│ │ in full, year of birth) │ └────────────────────────────────────────────────────────────────┘ while undergoing treatment (examination, delivery) in the department __________________________________________________________________ (name of department, room number) __________________________________________________________________ I voluntarily give my consent for me (represented): operations: ______________________________________________________________ __________________________________________________________________ __________________________________________________________________ (name of medical intervention) and ask the staff of the medical institution to carry it out. I confirm that I am familiar with the character the upcoming operation for me (introduced). It was explained to me and I I understand the features and course of the upcoming surgical treatment. - It has been explained to me and I understand that during the operation there may be unforeseen circumstances and complications may arise. In this case, I agree (agree) that the course of the operation may be changed by doctors at their discretion. - I have been warned about the risk factors and understand that The operation is associated with the risk of blood loss, the possibility infectious complications, cardiovascular disorders and other vital systems of the body, unintentional causing harm to health and even adverse outcomes. - I have been warned (warned) that in some cases they may repeat operations will be required, incl. due to possible postoperative complications or course features disease, and I give my consent to this. - I informed the doctor about all the problems, related to health, including allergic manifestations or individual intolerance to drugs, all the injuries I have suffered (represented) and known to me, operations, diseases, incl. carrier of HIV infection, viral hepatitis, tuberculosis, sexually transmitted infections by, about environmental and production factors, physical, chemical or biological nature affecting me (represented) during life, taken medications, previous blood transfusions and its components. Reported (reported) truthful information about heredity, as well as the use of alcohol, drugs and toxic agents. - I know that during the operation there may be loss of blood and ________ I give consent to transfusion of donor or auto (own) blood and its components. - I _______________ agree (agree) to recording the progress of the operation on information media and demonstration to persons with medical education exclusively in medical, scientific or teaching purposes, taking into account the preservation of medical confidentiality. - I was given the opportunity to ask questions about the degree risks and benefits of surgical intervention, incl. transfusions donor or auto (own) blood and/or its components and a doctor gave comprehensive answers that I understood. - I am familiar (acquainted) and agree (agree) with everyone paragraphs of this document, the provisions of which have been explained to me, I understand and voluntarily give my consent to ___________________ __________________________________________________________________ __________________________________________________________________ ---- "__" ___________ 20__ Signature of the patient/legal |X | representative ---- Signed in my presence: ---- Doctor _________________________________________________ (signature) |X | (position, I.O. Last name) ---- SEE THE BACK OF THE FORM NOTE: Consent to medical intervention in relation to persons not who have reached the age of 15 years, and citizens recognized in the established legally incompetent, their legal representatives provide (parents, adoptive parents, guardians or trustees) indicating Full name, passport details, family relationships after the message them information about the results of the examination, the presence of the disease, its diagnosis and prognosis, treatment methods, associated risks, possible options for medical intervention, their consequences and results of the treatment. In the absence of legal representatives, the decision on medical intervention, a consultation takes place, and if it is impossible to gather consultation - directly treating (duty) doctor with subsequent notification of the chief physician/head of the Central Medical Unit/Medical Unit/KB/Institute, and in weekends, holidays, evening and night time - responsible duty doctor and legal representatives.

Appendix No. 2

Russian Federation

Informed voluntary consent

on types of medical interventions included in the List

certain types of medical interventions for which

citizens give informed voluntary consent when choosing

doctor and medical organization for primary health care

I, __________________________ Ivanova Elena Ivanovna ____________________________

______________________________"10" January 1980 year of birth , ______________________

registered at: ___________ 614000 Perm, st. Ivanova 1 sq. 1 _________

(address of the citizen’s place of residence or

legal representative)

I give informed voluntary consent to the types of medical interventions included in the List of certain types of medical interventions to which citizens give informed voluntary consent when choosing a doctor and medical organization to receive primary health care (see overleaf), approved by order of the Ministry of Health and Social Development of the Russian Federation dated April 23, 2012 N 390n (registered by the Ministry of Justice of the Russian Federation on May 5, 2012 N 24082) (hereinafter referred to as the List), for me to receive primary health care / receive primary healthcare - sanitary care for a child whose legal representative I am (cross out what is not necessary)

_________________________Ivanov Alexander Sergeevich, born 05/05/2005 _______________

(child’s full name, date of birth)

at the State Budgetary Healthcare Institution of the Perm Territory “Medical and Physical Education Dispensary”

The goals, methods of providing medical care, the risks associated with them, possible options for medical interventions, their consequences, including the likelihood of complications, as well as the expected results of medical care were explained to me in a clear manner. It was explained to me that I have the right to refuse one or more types of medical interventions included in the List, or to demand its (their) termination, except for the cases provided for in Part 9 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ " On the fundamentals of protecting the health of citizens in the Russian Federation" (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724; 2012, No. 26, Art. 3442, 3446).

Information about the persons I have chosen, to whom, in accordance with paragraph 5 of part 3 of Article 19 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation,” information about the state of my health or the state of health of the child can be transferred , whose legal representative I am (cross out what is not necessary)

_____________________ Ivanov Sergey Yurievich, 89020000001 ________________________

Full name citizen, contact number

Personal signature ____________________Ivanova Elena Ivanovna _____________________

(signature) (full name of the citizen or legal representative of the citizen)

Personal signature ___________________ Petrova Olga Ivanovna _____________________

(signature) (full name of medical worker)

"__20 __" ___April ___2016 G.

(date of registration)

Sample of filling out the IDS by a person over 15 years of age

Appendix No. 2

To the order of the Ministry of Health

Russian Federation

State budgetary healthcare institution of the Perm region

"Medical and physical education clinic"