Features of the address system for laying out medical records. On the storage periods for medical documentation in the new letter from the Ministry of Health

The storage periods for documents in medical institutions are established by various regulatory documents.

In accordance with Part 1 of Art. 17 of the Federal Law of October 22, 2004 N 125-FZ “On Archiving in the Russian Federation,” organizations are obliged to ensure the safety of archival documents, including documents on personnel, during their storage periods established by federal laws and other regulatory legal acts of the Russian Federation , as well as the following lists of typical archival documents:

1. A list of standard management archival documents generated in the course of the activities of state bodies, local governments and organizations, indicating their storage periods, approved by Order of the Ministry of Culture of the Russian Federation dated August 25, 2010 N 558;
2. A list of standard archival documents generated in the scientific, technical and production activities of organizations, indicating storage periods, approved by Order of the Ministry of Culture of the Russian Federation dated July 31, 2007 N 1182;

These Lists cover the types and varieties of documents generated in all industry systems, regardless of their economic specifics, i.e. management issues, personnel, labor, financing, etc.

Also considered valid List of documents with storage periods of the USSR Ministry of Health, bodies, institutions, organizations, enterprises of the health care system, approved by Order No. 493 of May 30, 1974.

Storage periods for medical documents not mentioned in the Lists are established by other legislative acts of the Russian Federation and are presented in the table.

We will talk in detail about how long a medical record is kept in a clinic, consider the regulatory documentation on this issue, as well as how to organize the work of the archive of a medical institution in which charts and other medical documents will be stored.

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The main thing in the article:

What is included in medical documents?

Before considering the question of how long a medical record is kept in a clinic, it is necessary to consider the definition of medical documentation, as well as the regulatory framework that determines the forms of documents of medical institutions.

The obligation to store medical records for healthcare institutions is established by the Federal Law “On Health Protection of the Russian Federation”. The definition of such documentation is given in Order of the Ministry of Health of the Russian Federation No. 12 dated January 22, 2001.

The rules for storing medical documentation are outdated - the last document approving the list of forms was approved by order of the USSR Ministry of Health No. 1030 dated October 4, 1980.

In 2015, many forms of medical documentation were updated with the adoption of Order No. 834n of the Ministry of Health of the Russian Federation dated December 15, 2014.

In the document you can find not only forms, but also the procedure for filling them out, and answers to questions such as how long medical records are kept in the archive, how many years an outpatient record is stored in a clinic, etc.

Some forms of medical documents are approved by separate orders. For example, by order of the Ministry of Health of the Russian Federation No. 107n dated August 30, 2012, the form of an insert in an outpatient card was approved.

In the help system, the chief physician can find detailed rules for preparing various medical documents, for example:

1. What information should be included in the stationary card.
2. What information is required for an outpatient card?

Storage periods for medical documents

So, how to determine how long a medical record is kept in a clinic? Any documents should be stored for a certain period of time; the main storage rules are approved in the Federal Law “On Archiving in the Russian Federation”.

In addition, the following regulations apply:

• a list of documentation indicating the storage period from the Main Archive of the USSR dated August 15, 1988. The order sets the storage period for outpatient records in the archive at 5 years; for inpatient records it is increased to 25 years.
• Order of the Ministry of Culture of the Russian Federation No. 558 dated August 25, 2010.

Reminder for filling out the primary form

How to correctly fill out various forms of medical documentation is described in detail in our memo.

How long is a medical record kept in a clinic according to the instructions of the Ministry of Health of the Russian Federation? Letter No. 13-2/1538 dated December 07, 2015 provides the time frame during which medical institutions must store some of their documents. The following deadlines have been established for the documents we are interested in:

1. The storage period for an outpatient card is 25 years.
2. The storage period for an outpatient card in a clinic for a child (form 026/y) is 10 years.

The department also established that these deadlines should be used before the adoption of a new document with lists and storage periods for medical documentation.

By analogy with these rules, the same retention periods apply to electronic documents.

Table: How many years to store medical documents

You can find out in detail from the table below how long outpatient cards are stored in the archive, as well as other medical documentation.

How to maintain an archive

We looked at how long a medical record is kept in a clinic. No less important is the question of how exactly medical documents should be stored in the archive.

First of all, it is important to ensure all necessary measures to preserve and protect patients’ personal data, which are provided for by Decree of the Government of the Russian Federation No. 687 of September 15, 2008.

The peculiarities of processing personal data apply to both paper and electronic archives of a medical institution.

Separately, you must comply with the requirements for storing personal data on electronic media.

Regardless of how long medical records and other documentation are stored in the archive, a number of important provisions can be highlighted.

1. Before determining the list of documents that are stored in the archive for a certain period, an examination of the value of the documents should be carried out. This work is carried out by an expert commission of a medical institution.
2. The chairman of this commission can be the chief physician of the medical institution or one of his deputies. The assessment work is also carried out by the head of the archive and his employees, clerks, the head of the office, and an employee of the statistics office.
3. Next, it is important to determine which medical documents are time to destroy. There are two cases for this:
   • the commission of the medical institution recognized the inappropriateness of further storage of certain documents;
   • The storage period for medical records at the clinic has expired.
4. To destroy medical documents, the commission of the medical institution draws up an act containing a list of documents to be destroyed, the date of their destruction and other data.
5. A medical institution must have an order in place that will determine not only how many years medical records are stored in the archive, but also establish the procedure for their further destruction after these periods have expired. The corresponding order should determine the composition of the commission and its powers.

If the storage period for an outpatient medical record has not yet expired, but the medical institution itself is undergoing a liquidation procedure, the documents cannot be destroyed. They are transferred with the corresponding act to the archives of the municipality in which the medical institution is located.

Medical documentation, especially primary documentation, plays a fundamental role in the legal relationship between the patient and the medical organization, since it certifies facts and events that reflect the progress of diagnosis, treatment, and other activities. The responsibility for storing medical documentation in accordance with paragraph 12, part 1, article 79 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” is assigned to a medical organization.

Medical documentation concept

According to Article 1 of the Federal Law of December 24, 1994 No. 77-FZ “On the Mandatory Deposit of Documents”, a document is a tangible medium with information recorded on it in any form in the form of text, sound recording, image and (or) a combination thereof, which has details , allowing it to be identified, and is intended to be transmitted in time and space for the purposes of public use and storage.

Federal Law No. 323-FZ of November 21, 2011 “On the fundamentals of protecting the health of citizens in the Russian Federation” does not disclose the term “medical documentation”.

In accordance with the order of the Ministry of Health of Russia dated January 22, 2001 No. 12 “On the implementation of the industry standard “terms and definitions of the standardization system in healthcare,” medical documents are special forms of documentation maintained by medical personnel, which regulate actions related to the provision of medical services.

Types of medical documentation

Currently, a single regulatory legal act defining the list of medical documentation has not been adopted.

The main act establishing the forms of medical documentation is currently Order of the USSR Ministry of Health dated October 4, 1980 No. 1030, which, however, became invalid in 1988. Today, this Order can be used by medical organizations in accordance with the recommendation of the Ministry of Health and Social Development of Russia (letter dated October 30, 2009 No. 14-6/242888).

On March 9, 2015, a new Order of the Ministry of Health of Russia dated December 15, 2014 No. 834n “On approval of unified forms of medical documentation used in medical organizations providing medical care in outpatient settings and procedures for filling them out” came into force, which updated many forms of medical documentation.

Some forms of medical documentation are strictly regulated not only by the indicated order of the Russian Ministry of Health, but also by other regulations. For example, an insert in the medical record of an outpatient (inpatient) patient when using ART methods (approved by Order of the Ministry of Health of the Russian Federation dated August 30, 2012 No. 107n).

In general, medical records include: the medical record of a patient receiving medical care in an outpatient setting; medical record of an inpatient; medical record of a tuberculosis patient; medical record of a patient with a sexually transmitted disease; birth history; developmental history of the newborn; medical card for termination of pregnancy; individual card of a pregnant woman and woman in labor; donor card; medical card of a university student; child's medical record; child development history; medical record of the dental patient; individual card of a pregnant and postpartum woman; various types of medical certificates, extracts from outpatient records, medical records, referrals to the ITU, etc.

Issues related to the concept, status and type of medical documentation, forms of medical documentation are discussed in detail in the article “Medical documentation: status and types.”

Procedure for storing medical records

In accordance with paragraph 12 of part 1 of Article 79 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation,” a medical organization is obliged to ensure the recording and storage of medical documentation, including strict reporting forms.

There is currently no single regulatory legal act defining the procedure for storing medical records.

The rules on the procedure for storing medical documentation are contained in separate orders on accounting forms. It is interesting to note that the Procedure for filling out registration form No. 025/U “Medical record of a patient receiving medical care on an outpatient basis”, approved by Order of the Ministry of Health of Russia dated December 15, 2014 No. 834n, in contrast to the previously valid Instructions for filling out registration form No. 025/U- 04 “Medical record of an outpatient”, approved by Order of the Ministry of Health and Social Development of Russia dated November 22, 2004 No. 255, contains much less information about the procedure for storing this document (for example, there is no rule on the period of storage of this document after the death of the patient). At the same time, the procedure for filling out registration form No. 025/U contains the provision that Cards in the registry of a medical organization are grouped according to the district principle. Cards of citizens entitled to receive a set of social services are marked with the letter “2L”.

Issuance of medical documentation to the patient

When storing medical documentation, it should be taken into account that in accordance with the provisions of Part 4 of Article 22 and Article 13 of the Federal Law of November 21, 2011 No. 323-FZ:

• the issuance of medical documentation to the patient, which is registered, is carried out upon his or his legal representative’s written application, if there is information in them relating to his health, it is provided to him in copies or for personal review; removal of medical documentation outside the medical organization is not allowed;
• In order to respect the patient’s right to medical confidentiality, medical documentation is issued to other persons in cases provided for by law or with the written consent of the patient.

The procedure for storing medical documentation in the archive

Article 13 of the Federal Law of October 22, 2004 No. 125-FZ “On Archival Affairs in the Russian Federation” enshrines the right of organizations to create archives for the purpose of storing archival documents generated in the process of their activities, including for the purpose of storing and using archival documents that are not related to the state or municipal property.

General requirements for the storage, acquisition, recording and use of archival documents are determined by Articles 17-26 of the Federal Law of October 22, 2004 No. 125-FZ “On Archival Affairs in the Russian Federation”.

By virtue of Part 1 of Article 17 of this Federal Law, organizations are charged with ensuring the safety of archival documents during their storage periods established by federal laws and other regulatory legal acts of the Russian Federation.

When a medical organization is liquidated, archival medical documents are transferred for storage to the municipal archive (Part 10, Article 23 of the Federal Law of October 22, 2004 No. 125-FZ).

Established retention periods for medical records

The general storage periods for medical documentation in the archive are regulated by Order of the Ministry of Culture of the Russian Federation dated August 25, 2010 No. 558 “On approval of the List of standard management archival documents generated in the course of the activities of state bodies, local governments and organizations, indicating storage periods,” as well as the List of standard documents, formed in the activities of state committees, ministries, departments and other institutions, organizations, enterprises, indicating storage periods, approved by the Main Archive of the USSR on August 15, 1988.

The main act that determined the storage periods for medical documentation in a medical organization is Order No. 1030 dated October 4, 1980. However, as mentioned earlier, this order has lost force and is not a normative act.

The storage periods for medical documentation are also regulated by separate regulatory and legal acts in the field of healthcare. For example, the pathological-anatomical autopsy protocol is stored in the archives of the medical organization in which the pathological autopsy is performed, for the period of storage of the medical record of an inpatient patient (medical record of childbirth, medical record of a newborn, history of child development, medical record of an outpatient) (form 013/u ) (clause 35 of the Order of the Ministry of Health of Russia dated 06.06.2013 No. 354n).

In addition, for some types of medical documentation such a period is not established (for example, a medical record of a drug treatment patient), however, based on analogy, it follows that the storage period for this medical document is 25 years.

In general, the following retention periods for medical records are currently established:

Expert commission on working with archival medical documentation

A departmental healthcare act establishing rules for the storage and destruction of archival medical documents has not yet been developed. In this case, one should be guided by some provisions of the Basic Rules for the Operation of Archives of an Organization dated 02/06/2002 and the List of Standard Documents generated by the activities of state committees, ministries, departments and other institutions, organizations, enterprises, indicating storage periods, approved by the Main Archive of the USSR on 08/15/1988.

In order to determine the storage period for documents and select them for inclusion in the medical archive, an examination of the value of the documents is carried out. This issue is dealt with by a permanent expert and verification commission (EPC) created in a medical organization. An examination of the value of medical documents in a medical organization is carried out when compiling a nomenclature of cases (this is a systematized list of the names of cases opened in the organization’s office work, indicating their storage periods, according to the established form), in the process of forming cases and when preparing cases for transfer to the archive, as well as in preparation for the transfer of cases to permanent storage.

Based on the results of the examination of the value of documents, inventories of permanent storage files, inventories of temporary (over 10 years) storage, as well as acts on the allocation for destruction of files that are not subject to storage are drawn up.

The EPC is engaged in the destruction of those forms of medical documents that contain the EPC icon in the regulatory documents governing storage periods. Such regulatory documents were presented in this article.

Destruction of archival medical documentation

Medical documents are destroyed upon expiration of the storage period, as well as on the basis of an examination of the value of the documents, which reveals documents that are not subject to storage. The destruction of medical documents is carried out by a commission (EPC), created on the basis of an order from the head of a medical organization. Based on the results of the destruction of medical documents, an act is drawn up, which must indicate the documents being destroyed, the method of their destruction, as well as the composition of the commission.

Responsibility for violations of the rules for storing medical records

Article 13.20 of the Code of Administrative Offenses of the Russian Federation provides for administrative liability for violation of the rules of storage, acquisition, accounting or use of archival documents, with the exception of cases provided for in Article 13.25 of the Code of Administrative Offenses of the Russian Federation, in the form of a warning or the imposition of an administrative fine on citizens in the amount of 100 - 300 rubles; for officials - from 300 - 500 rubles.

In accordance with Article 13.25 part 2 of the Code of Administrative Offenses of the Russian Federation, for failure to fulfill the obligation to store documents that are provided for by the legislation on limited liability companies and regulations adopted in accordance with it and the storage of which is mandatory, as well as violation of the established procedure and terms of storage of such documents , a limited liability company may be brought to administrative liability in the form of an administrative fine on officials in the amount of 2,500 - 5,000 rubles; for legal entities - from 200,000 - 300,000 rubles.

Also, the Criminal Code of the Russian Federation (Part 1 of Article 325 of the Criminal Code of the Russian Federation) establishes criminal liability for the destruction or damage of official documents committed for mercenary or other personal interest, in the form of a fine in the amount of up to 200,000 rubles or in the amount of wages or other income of the convicted person for the period up to eighteen months, or compulsory labor for up to 480 hours, or correctional labor for up to 2 years, or forced labor for up to 1 year, or arrest for up to 4 months, or imprisonment for up to 1 year.

The patient's medical record (hereinafter referred to as the medical record) is stored in the medical institution that provides treatment to an outpatient or inpatient patient. Maintaining a medical record is mandatory in all cases when a citizen seeks medical help.

It is believed that a medical card is issued only at the request of the patient himself or his authorized representative, acting on the basis of a power of attorney certified in the manner prescribed by law.

However, in reality the patient's situation is not as simple as it seems at first glance. The fact is that currently there is not a single regulatory act that would directly provide for the issuance of such a card to the citizen himself.

So, according to Part 4 of Art. 31 of the Fundamentals of the Legislation of the Russian Federation “On the Protection of the Health of Citizens”, the patient has the right to directly familiarize himself with medical documentation reflecting the state of his health, and to receive advice on it from other specialists. At the request of a citizen, he is provided with copies of medical documents, including the specified card. At the same time, it is extremely difficult to achieve real liability for refusal to issue even a copy of a medical record.

According to the Letter of the Ministry of Health and Social Development of the Russian Federation dated 04.04.2005 N 734/MZ-14 “On the procedure for storing outpatient records,” the issuance of medical records to the patient is generally possible only with the permission of the chief physician of the institution. Thus, the patient's right is placed directly subordinate to the right of the chief physician. The reasons for refusing to issue such a card are most often references to the following:

1) the card must be kept in the medical institution;

3) the danger of its loss and even its falsification while it is in the patient’s arms. At the same time, the fact is completely ignored that the loss of a medical card, if it is handed over, deprives the plaintiff of referring to its data.

With the introduction of electronic medical records, getting a medical card in your hands has become even more difficult. It is technically not possible to pick up an electronic medical record, but you can only get a copy of it. The procedure for maintaining and storing medical records in electronic form is determined by the medical organization independently.

The likelihood of refusal increases many times over if a citizen has reasonable assumptions that the actions of medical personnel are illegal.

In such a situation, the question arises about how to act correctly if you are not given a medical card in your hands, in order to gain full access to medical documentation in the simplest and fastest way for the purpose of assessing the quality of medical care.

There is an opinion that it will be easier to get a medical card in hand through a lawyer’s request. However, as a lawyer’s practice shows, this path is not the most effective. Especially when it comes to obtaining a medical card from a psychiatric clinic. The period for responding to a lawyer’s request is up to 30 days; the medical institution is not liable for violation of this period. In this case, it seems rational to obtain the card through a judicial or other official request.