In the previous article (“Grounds for conducting scheduled inspections as part of state control of the quality and safety of medical activities”), we examined the grounds for conducting scheduled inspections as part of state control of the quality and safety of medical activities. However, based on statistical data, most inspections of medical organizations are unscheduled. Thus, according to some data, the number of control and supervisory activities carried out by Roszdravnadzor in the field of compliance with licensing requirements when carrying out medical activities in 2021 amounted to 6,244 inspections, of which 1,698 were planned, 4,546 were unscheduled.
Regulatory regulation of the grounds for conducting unscheduled inspections of healthcare institutions
To date, there is no general systematized legal act that would include a list of grounds for unscheduled inspections of medical organizations.
It is possible to make some generalizations on this matter only by analyzing various regulatory documents regulating measures for state control of the quality and safety of medical activities.
The general grounds for conducting unscheduled inspections are indicated in Part 2 of Article 10 of the Federal Law “On the protection of the rights of legal entities and individual entrepreneurs in the exercise of state control (supervision) and municipal control.”
In relation to medical organizations, among them it is possible to highlight:
- expiration of the deadline for the execution of a previously issued order to eliminate the identified violation of mandatory requirements (clause 1 of this article);
- motivated representation of the following facts: the emergence of a threat of harm to the life and health of citizens; causing harm to the life, health of citizens, etc. (clause 2 of this article);
- order (instruction) of the head of the state control (supervision) body, issued in accordance with the instructions of the President of the Russian Federation, the Government of the Russian Federation and on the basis of the request of the prosecutor to conduct an unscheduled inspection as part of supervision over the implementation of laws on materials and appeals received by the prosecutor's office (clause 3 specified article), etc.
According to paragraph 8 of the Regulations on State Control of the Quality and Safety of Medical Activities, the Federal Service for Surveillance in Healthcare uses indicators of the risk of violation of mandatory requirements approved by the Ministry of Health of the Russian Federation as the basis for conducting unscheduled inspections.
Currently, these indicators have not been approved by the Ministry of Health, but there is a published draft of the corresponding order.
The grounds for conducting unscheduled inspections of medical organizations in various areas of healthcare are detailed in a number of orders of Roszdravnadzor.
So, for example, in the field of licensing control, unscheduled inspections are organized and carried out on the following grounds (subparagraphs 2 - 6 of paragraph 24 and paragraph 30 of the relevant Administrative Regulations):
- expiration of the deadline for the licensee to fulfill the order previously issued by Roszdravnadzor (territorial body) to eliminate the identified violation of licensing requirements;
- receipt by Roszdravnadzor (territorial body) of appeals and statements from citizens, including individual entrepreneurs, legal entities, information from state authorities, local governments, and the media about facts of gross violations of licensing requirements by the licensee;
- expiration of the period for which the license was suspended in accordance with parts 2 and 3 of Article 20 of the Federal Law “On Licensing of Certain Types of Activities”;
- the presence of a licensee's request to conduct an unscheduled on-site inspection in order to establish the fact of early execution of the order of Roszdravnadzor (territorial body);
- presence of an order from Roszdravnadzor (territorial body), issued in accordance with the instructions of the President of the Russian Federation or the Government of the Russian Federation.
Clause 26 of the Administrative Regulations, approved by Order of the Ministry of Health of Russia dated January 26, 2015 No. 19n, identifies the following grounds for unscheduled inspections:
- expiration of the deadline for execution by the manager, other official or authorized representative of the inspected person of the order to eliminate the identified violation of mandatory requirements;
- receipt by Roszdravnadzor (territorial bodies) of appeals and statements from citizens, individual entrepreneurs, organizations, information from government bodies, local governments, from the media about facts of a threat of harm to the life and health of citizens; causing harm to the life and health of citizens. These facts must be related to non-compliance with mandatory requirements;
- order of the head of Roszdravnadzor (territorial body), issued in accordance with the instructions of the President of the Russian Federation, the Government of the Russian Federation and on the basis of the request of the prosecutor to conduct an unscheduled inspection as part of supervision over the implementation of laws on materials and appeals received by the prosecutor's office.
Thus, when making a decision to conduct an unscheduled inspection, Roszdravnadzor officials can sometimes be guided by criteria that are very vague from a legal point of view (“information about facts of a threat of harm to the life and health of citizens”, etc.).
For example, from the descriptive part of one of the court decisions, “FULL NAME3 approached the defendant with an application to terminate the contract for the provision of paid medical services.
Out of 115,500 rubles, the amount of 46,500 rubles was returned to her, the return of the rest of the money was refused...
Since the requirements of FULL NAME3 were not satisfied, she applied to the territorial body of Roszdravnadzor ... with an application to conduct an inspection in relation to LLC "...".
An inspection on the appeal of FULL NAME3 was carried out, violations were identified in the provision of medical services to her...”
When conducting unscheduled on-site inspections on the basis provided for in subclause 3 of clause 24 of the Administrative Regulations (receipt of appeals and statements from citizens, including individual entrepreneurs, legal entities, information from government bodies, local governments, and the media to Roszdravnadzor (territorial body) about facts of gross violations of licensing requirements by the licensee), an unscheduled on-site inspection is subject to approval in the prescribed manner with the prosecutor's office.
Prosecutor General's Office on the deadlines for providing documents and conducting inspections
In order to improve prosecutorial supervision, taking into account the legal positions set out in the Resolution of the Constitutional Court of the Russian Federation No. 2-P, Order of the Prosecutor General's Office of Russia dated May 28, 2015 No. 265 (hereinafter referred to as Order of the Prosecutor General's Office No. 265) was issued.
Before the amendments provided for by the said Resolution are made to the Law on the Prosecutor's Office, it provides instructions regarding the timing of the inspection and notification of those being inspected about the adoption of the appropriate decision, as well as the establishment of a deadline for fulfilling the prosecutor's request. Let's take a closer look at them.
For your information
In accordance with paragraph 1 of Art. 17 of the Law on the Prosecutor's Office, the Prosecutor General issues that are binding on all employees of bodies and organizations of the prosecutor's office , regulating the organization of the activities of the prosecutor's office system of the Russian Federation.
Deadline for submitting documents
When determining the deadline for the body (organization) to provide statistical and other information, certificates, documents, other materials and copies thereof at the request of the prosecutor, officials of the Prosecutor's Office must be guided by the principle of reasonableness (clause 1.1 of Order of the Prosecutor General's Office No. 265).
Note!
The deadline for fulfilling the prosecutor's request of less than one day can be set in the event of a threat to the life and health of citizens, the environment, state security, property of individuals and legal entities, state or municipal property, natural and man-made emergencies.
Inspection Notice
When organizing inspections of compliance with the Constitution of the Russian Federation and the implementation of laws in force on the territory of the Russian Federation by government bodies at various levels, including governing bodies and heads of commercial and non-profit organizations, the decision to conduct an inspection must be brought to the attention of the head or other authorized representative of the body (organization) being inspected. no later than the day the inspection begins (clause 1.2 of Order of the Prosecutor General’s Office No. 265).
Check period
Should not exceed 20 working days ; it can be extended only by decision of the prosecutor (his deputy) once for no more than 20 working days. The decision on the subsequent extension of the inspection (for a period not exceeding 20 working days) is made by a superior prosecutor or his deputy (clause 1.2 of Order of the Prosecutor General’s Office No. 265).
If the inspected body (organization) operates in the territories of several constituent entities of the Russian Federation, the period for conducting the inspection is established separately for each branch, representative office, separate structural unit, regional office of the body (organization).
If it is necessary to conduct special research, examinations, audits, or obtain additional documents and information that may affect the conclusions of the inspection, by decision of the prosecutor (his deputy), the inspection may be suspended for up to six months. If it is impossible to complete the above-mentioned activities or obtain the necessary documents and materials within this period, the period of suspension of the inspection may be extended by decision of the superior prosecutor or his deputy.
The extension (suspension, resumption) of the inspection period must be notified to the head or authorized representative of the inspected body (organization).
Within ten working days after completion of the inspection, the head or authorized representative of the inspected body (organization) must be given the right to familiarize themselves with the inspection report.
Timely provision of information
Officials have been instructed to consistently seek from bodies (organizations) the timely provision of statistical and other information (not posted on the official website), certificates, documents, other materials and their copies, as well as compliance with the requirements set out in the acts of prosecutorial response (clause 1.3 of the Order of the Prosecutor General's Office No. 265), and in each case of failure to comply with the legal demands of the prosecutor - to bring the perpetrators to responsibility established by law.
Grounds for conducting unscheduled inspections of medical organizations found in judicial practice
In accordance with judicial practice, the palette of factual grounds for conducting unscheduled inspections of medical organizations is quite extensive and diverse.
As stated earlier, in most cases, the basis for an unscheduled inspection of a medical organization is a patient’s request (complaint).
Thus, from the judicial act it is clear that “12/18/2018.... in relation to the State Budgetary Institution of the Republic of Sakha (Yakutia) "... central district hospital" a protocol on an administrative offense was drawn up under Part 3 of Art. 19.20 Code of Administrative Offenses of the Russian Federation.
The basis for drawing up this protocol was that during an unscheduled documentary inspection of Roszdravnadzor on ... based on a complaint FULL NAME7. about the deterioration of her daughter’s health FULL NAME8. after the surgical delivery, inspection report No. 336-vn dated December 13, 2018 revealed in the State Budgetary Institution of the Republic of Sakha (Yakutia) “... Central District Hospital” non-compliance with the procedure for providing medical care in the field of “obstetrics and gynecology”, improper performance of official duties by medical personnel, violation of citizens’ rights for accessible and high-quality medical care, which entailed a threat of harm to the health and life of the patient, FULL NAME 8., requiring emergency surgical treatment and transportation to Yakutsk in serious condition...”
In another court decision about. An inspection on the appeal of FULL NAME3 was carried out, violations were identified in the provision of medical services to her...”
In a number of cases, judicial practice indicates repeated unscheduled inspections of a medical organization based on complaints (appeals) of the same patient.
Thus, according to one of the judicial acts, “Based on the plaintiff’s complaints against Julia LLC, three unscheduled inspections of Roszdravnadzor were carried out, one of them was canceled due to the withdrawal of the complaint. “No violations were identified during the inspections.”
Sometimes the basis for an inspection of a medical organization by regulatory (law enforcement) authorities may be information about illegal actions of its officials (for example, issuing fake documents).
For example, in one of the court decisions about an administrative offense, provided for in Part 1 of Article 19.28 of the Code of Administrative Offenses of the Russian Federation, the courts reasonably took into account and indicated in the decisions as evidence: the resolution to initiate a case on an administrative offense dated March 17, 2016 (l .d.3-6); application FULL NAME5 dated January 13, 2016, sent to the head of the Ministry of Internal Affairs of Russia for the city.... FULL NAME6 about conducting an inspection of a medical organization located at the address: due to the presence of information about the issuance of fake medical certificates by this medical organization...”
Often inspections are carried out based on information received from authorities (controlling authorities).
Thus, in one of the court decisions about Medical LLC, which entailed a threat to the life and health of students and employees of this institution.
