MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER
dated May 31, 2018 No. 298n

ON APPROVAL OF THE PROCEDURE FOR PROVIDING MEDICAL CARE
BY PROFILE “PLASTIC SURGERY”

Registered with the Ministry of Justice of Russia on June 22, 2018 No. 51410

In accordance with Article 37 of the Federal Law of November 21, 2011 No. 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; 2015, No. 10, Art. 1425 ; 2017, No. 31, Art. 4765), I order:

1. Approve the attached Procedure for the provision of medical care in the field of plastic surgery.

2. Recognize the order of the Ministry of Health of the Russian Federation of October 30, 2012 No. 555n “On approval of the Procedure for providing medical care in the field of plastic surgery” (registered by the Ministry of Justice of the Russian Federation on February 18, 2013, registration No. 27150) as invalid.

Minister
V.I.Skvortsova

Approved
by order
dated May 31, 2018 No. 298n

ORDER
PROVISION OF MEDICAL CARE BY PROFILE
"PLASTIC SURGERY"

1. This Procedure establishes the rules for the provision of medical care to adults and children in the field of plastic surgery (hereinafter referred to as medical care) in medical organizations and other organizations engaged in medical activities (hereinafter referred to as medical organizations).

2. Medical care includes a set of measures aimed at maintaining and (or) restoring health and including the provision of medical services, the purpose of which is:

• elimination of anatomical and (or) functional defects of the integumentary and underlying tissues of any localization resulting from hereditary and congenital malformations, injuries and their consequences, diseases and surgical interventions, including iatrogenic defects, as well as traumatic amputations of limbs, their segments and others fragments of the human body of any location using reconstructive plastic surgery methods;
• changing the appearance, shape and relationships of anatomical structures of any areas of the human body in accordance with generally accepted aesthetic standards and ideas of a particular patient, including correction of age-related changes, correction of the consequences of eliminating anatomical and (or) functional defects of the integumentary and underlying tissues of any localization using plastic surgery, leading to improving the quality of life using aesthetic plastic surgery methods.

3. Medical assistance is provided in the form of:

• primary specialized health care;
• specialized, with the exception of high-tech, medical care.

4. Medical care is provided in the following conditions:

• outpatient (in conditions that do not provide round-the-clock medical supervision and treatment);
• inpatient (in conditions that provide round-the-clock medical supervision and treatment).

5. Medical assistance is provided in the following forms:

• emergency - medical care provided for sudden acute diseases, conditions, exacerbation of chronic diseases that pose a threat to the patient’s life;
• emergency - medical care provided for sudden acute diseases, conditions, exacerbation of chronic diseases without obvious signs of a threat to the patient’s life;
• planned - medical care that is provided in the treatment and prevention of diseases and conditions that are not accompanied by a threat to the life of patients, that do not require emergency and emergency care, the delay of which for a certain time will not entail a deterioration in the condition of patients, a threat to their life and health.

6. Primary specialized health care for patients with the specialty “plastic surgery” is provided by plastic surgeons on an outpatient basis (in the plastic surgeon’s office) and includes the following activities:

• to identify anatomical and (or) functional defects of the integumentary and underlying tissues of any localization, resulting from hereditary and congenital malformations, injuries and their consequences, diseases and surgical interventions (iatrogenic defects), as well as traumatic amputations of limbs, their segments and other fragments human body of any localization;
• to identify aesthetic defects in the appearance, shape and relationships of anatomical structures of any areas of the human body, including age-related changes, the consequences of eliminating anatomical and (or) functional defects of the integumentary and underlying tissues of any localization using plastic surgery and associated with the patient’s desire to bring his appearance into line with generally accepted aesthetic standards and one’s own ideas;
• to provide medical care in accordance with clinical guidelines.

If it is impossible to provide medical care within the framework of primary specialized health care and there is availability of specialized medical care in the field of plastic surgery.

7. Specialized, with the exception of high-tech, medical care is provided by plastic surgeons in stationary conditions (in plastic surgery departments or plastic surgery centers) and provides for a set of measures for prevention, diagnosis and provision of medical care, as well as medical rehabilitation in accordance with the procedures for providing medical care and based on standards of care.

8. If there are medical indications, medical care is provided with the involvement of medical specialists in the specialties provided for by the Nomenclature of Specialties of specialists with higher medical and pharmaceutical education<1>.

<1>Order of the Ministry of Health of the Russian Federation dated October 7, 2015 No. 700n “On the nomenclature of specialties of specialists with higher medical and pharmaceutical education” (registered by the Ministry of Justice of the Russian Federation on November 12, 2011, registration No. 39696), as amended by order of the Ministry of Health Russian Federation dated October 11, 2016 No. 771n (registered by the Ministry of Justice of the Russian Federation on December 26, 2016, registration No. 44926).

9. In order to ensure accessibility and quality of medical care, medical organizations use telemedicine technologies<2>.

<2>Order of the Ministry of Health of the Russian Federation dated November 30, 2017 No. 965n “On approval of the procedure for organizing and providing medical care using telemedicine technologies” (registered by the Ministry of Justice of the Russian Federation on January 9, 2018, registration No. 49577).

10. Medical care is provided in accordance with Appendices No. 1 - 9 to this Procedure.

Appendix No. 1

approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

RULES OF ORGANIZATION OF ACTIVITIES

1. These Rules establish the procedure for organizing the activities of a plastic surgeon’s office (hereinafter referred to as the Office), which is a structural unit of a medical organization or other organization engaged in medical activities (hereinafter referred to as medical organizations).

2. The office is organized to provide medical care to the population in the field of plastic surgery.

3. A specialist who meets the Qualification requirements for medical and pharmaceutical workers with higher education in the field of training “Healthcare and Medical Sciences” is appointed to the position of a plastic surgeon in the Cabinet.<1>, specializing in plastic surgery.

<1>

4. The structure and staffing of the Cabinet are established by the head of the medical organization in which the Cabinet is created, based on the volume of medical care provided, taking into account the recommended staffing standards provided for in Appendix No. 2 to the Procedure for providing medical care to the adult population in the field of plastic surgery, approved by this order .

• patient examination room;
• room for medical procedures (dressing room).

6. The Cabinet is equipped in accordance with the standard of equipment provided for in Appendix No. 3 to the Procedure for providing medical care to the adult population in the field of plastic surgery, approved by this order.

7. The main functions of the Cabinet are:

• providing advisory, diagnostic and therapeutic assistance to patients in need of medical care in the field of plastic surgery;
• dispensary observation and medical rehabilitation of patients in need of medical care in the field of plastic surgery;
• carrying out measures for the primary prevention of the development of diseases and conditions related to the profile of “plastic surgery”, as well as secondary prevention of complications and the progressive course of these diseases and conditions;
• solving organizational issues of providing medical care in the field of plastic surgery;
• referral of patients with diseases and conditions requiring medical care in the field of plastic surgery to provide medical care in an inpatient setting of a medical organization;
• development and implementation of sanitary and hygienic education activities;
• introduction into practice of new methods of prevention, diagnosis and treatment of patients with diseases and conditions related to the profile of “plastic surgery”;
• <2> <3>.

<2>

8. In the Office it is allowed to perform postoperative dressings without anesthesia or using application anesthesia. Performing any other types of invasive medical interventions, including infiltrative, conduction and other types of anesthesia is not allowed.

Appendix No. 2
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

RECOMMENDED STATUTORY REGULATIONS
PLASTIC SURGEON'S OFFICE

Appendix No. 3
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

STANDARD OF EQUIPMENT FOR A PLASTIC SURGEON'S OFFICE

No.	Name	Required quantity, pcs.
Medical products
1.	Couch	1
2.	Cabinet for dressings and medicines	1
3.	Medical filing cabinet	1
4.	Height meter	1
5.	Ambu bag	1
6.	Tonometer	1
7.	Container for storing sterile instruments	on demand
8.	Dressing table	1
9.	Tool table	1
10.	Manipulation table	1
11.	Small surgical kit	1
12.	Sterilizer for medical instruments	1
13.	Fridge	1
14.	X-ray viewer	1
15.	Germicidal air irradiator	1
16.	Shadowless lamp	1
17.	Scales	1
18.	Stethoscope	on demand
19.	Portable resuscitation kit	1
20.	Disposable spatula	on demand
21.	Centimeter tape	on demand
22.	Medical thermometer	on demand
23.	Containers for disinfecting instruments	on demand
24.	Containers for collecting household and medical waste	2
25.		1
1.	Safe for storing medicines	on demand
2.	Personal computer with printer, Internet connection	1

Appendix No. 4
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

RULES FOR THE ORGANIZATION OF ACTIVITIES OF THE DEPARTMENT OF PLASTIC SURGERY

1. These rules establish the procedure for organizing the activities of the plastic surgery department (hereinafter referred to as the Department), which is a structural unit of a medical organization or other organization engaged in medical activities (hereinafter referred to as medical organizations).

2. The department is created as a structural unit of a medical organization providing medical care in inpatient settings.

3. The department is organized if the medical organization has the following operating around the clock:

• X-ray department (office), equipped with a stationary X-ray diagnostic apparatus (except for dental ones) and (or) a stationary X-ray computed tomography apparatus (except for dental ones), as well as a mammographic X-ray apparatus and (or) a magnetic resonance imaging apparatus with the ability to perform magnetic resonance imaging tomography of the mammary glands (in the structure of the X-ray service necessary to provide medical care in the field of plastic surgery, dental offices with an X-ray machine are not taken into account);
• <1>
• <2>
• dressing room

<1>

<2>

The X-ray department (office), the department of anesthesiology and resuscitation, the clinical diagnostic laboratory, the transfusion room (blood transfusion room), the operating room (operating block) should be located within the property complex, functionally and technologically combined with the department of plastic surgery. Functional and technological integration means the placement of these units within one building or complex of buildings, connected by warm passages, ensuring the movement and transportation of patients without leaving the premises used by the medical organization.

4. In the medical organization in the structure of which the Department is created, the possibility of providing consultative assistance by medical specialists in the following profiles must be provided: “therapy”, “neurology”, “dermatovenereology”, “pediatrics”, “otolaryngology”, “ophthalmology”, “ obstetrics and gynecology", "surgery", "urology". In the absence of the necessary medical specialists in a medical organization, it is possible to attract specialist doctors from other medical organizations under a contract, provided that such medical organizations have a license for the relevant work (services).

5. The department is headed by a head, appointed and dismissed by the head of the medical organization within which it is organized.

6. A specialist who meets the Qualification requirements for medical and pharmaceutical workers with higher education in the field of training “Healthcare and Medical Sciences” is appointed to the position of Head of the Department.<3>(hereinafter referred to as Qualification Requirements), specializing in plastic surgery.

<3>Order of the Ministry of Health of the Russian Federation dated October 8, 2015 No. 707n “On approval of qualification requirements for medical and pharmaceutical workers with higher education in the field of training “Healthcare and Medical Sciences” (registered by the Ministry of Justice of the Russian Federation on October 23, 2015, registration No. 39438 ), as amended by order of the Ministry of Health of the Russian Federation dated June 15, 2017 No. 328n (registered by the Ministry of Justice of the Russian Federation on July 3, 2017, registration No. 47273).

7. A specialist who meets the Qualification requirements for the specialty “plastic surgery” is appointed to the position of plastic surgeon of the Department.

8. The structure of the Department and its staffing levels are established by the head of the medical organization within which it is organized, based on the volume of diagnostic and treatment work and recommended staffing standards, in accordance with Appendix No. 5 to the Procedure for the provision of medical care in the field of plastic surgery.

9. The Department must ensure the presence of a round-the-clock duty team consisting of a plastic surgeon and a ward nurse for continuous monitoring of patients.

10. During all surgical interventions performed in the provision of medical care in the “plastic surgery” profile, the constant presence of an anesthesiologist-resuscitator in the operating room must be ensured for any type of anesthesia.

11. The duration of a patient’s stay in hospital after surgery is determined by his attending physician, taking into account medical indications.

12. The structure of the Department includes:

• examination room;
• doctors office;
• chambers;
• dressing;
• procedural;
• nursing

13. The equipment of the Department is carried out in accordance with the equipment standard of the plastic surgery department in accordance with Appendix No. 6 to the Procedure for the provision of medical care in the field of plastic surgery, approved by this order.

14. The department carries out the following functions:

• provision of specialized, with the exception of high-tech, medical care by performing reconstructive and (or) aesthetic plastic surgeries using surgical (including microsurgical) methods in accordance with clinical recommendations, based on standards of medical care;
• carrying out measures to prevent diseases and conditions requiring medical care in the field of plastic surgery;
• preparation and conduct of diagnostic procedures in inpatient settings;
• development and implementation of new medical technologies related to the profile of plastic surgery;
• development and implementation of measures aimed at improving the quality of diagnostic and treatment work in the field of plastic surgery;
• carrying out examination of temporary disability;
• improving the professional qualifications of medical workers on specialized medical care in the field of plastic surgery;
• providing advisory assistance to medical specialists from other departments of a medical organization on issues of prevention, diagnosis, treatment and rehabilitation in the provision of medical care in the field of plastic surgery;
• maintaining medical records;
• submission of reports in accordance with the established procedure<4>, collection and provision of primary data on medical activities for health information systems<5>.

<4>Clause 11 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” (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724; 2013, No. 48, Art. 6165; 2014, No. 30, Art. 4257) (hereinafter referred to as Federal Law of November 21, 2011 No. 323-FZ).

15. To ensure its activities, the Department uses the capabilities of the diagnostic, treatment and auxiliary units of the medical organization within which the Department is organized.

16. The department can be used as a clinical base for professional educational organizations, educational organizations of higher education and organizations of additional professional education, as well as scientific organizations.

Appendix No. 5
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

RECOMMENDED STAFF STANDARDS FOR THE DEPARTMENT OF PLASTIC SURGERY

<*>In plastic surgery departments that perform reconstructive plastic surgery on the maxillofacial area, if there is none on staff of the medical organization.

Appendix No. 6
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

EQUIPMENT STANDARD FOR THE DEPARTMENT OF PLASTIC SURGERY

1. Standard of equipment of the plastic surgery department (except for the operating room (operating unit)

No.	Name	Required quantity, pcs.
Medical products
1.	Workplace of the head of the department	1
2.	Doctor's workplace	by number of doctors
3.	Functional bed
4.	Bedside table (bedside table)	by the number of functioning beds
5.	Patient chair	by the number of functioning beds
6.	Distribution system for medical gases, compressed air and vacuum	1 system per department
7.	Medical cabinet	at least 5
8.	X-ray viewer	at least 1
9.	Wall-mounted ultraviolet bactericidal irradiator (for indoors)	at least 1
10.	Shadowless medical mobile lamp	at least 2
11.	Cabinet for sets of surgical linen and instruments	at least 2
12.	Medicine cabinet	at least 1
13.	Dressing table	by the number of dressings
14.	Tool table	at least 2
15.	Manipulation table	at least 2
16.	Blood pressure meter	at least 2
17.	Stethoscope	at least 1
18.	Medical thermometer	at least 2
19.	Sterilization box (biks) for storing sterile instruments and material	at least 2 per dressing room
20.	Medical examination couch	at least 2
21.	Universal examination chair	at least 1
22.	Refrigerator for storing medicines	at least 2
23.	Containers with lids for disinfectants	on demand
24.	Sterilizer for instruments	at least 2
25.	Packing for emergency medical care in case of shock	1
Other equipment (equipment)
1.	Ward alarm system	1 system per department

2. Standard for additional equipment in the operating room (surgical unit) of a medical organization within the structure of which a plastic surgery department is being created (the operating room is retrofitted if the listed equipment items are not available in it)

No.	Name	Required quantity, pcs.
Medical products
1.	Universal operating table	at least 1 per operating room
2.	Shadowless surgical lamp	at least 1
3.	Tool table	at least 3
4.	Surgical aspirator (suction device)	at least 1
5.	Containers for sterile surgical instruments and material	at least 6
6.	Electrocoagulator (coagulator) surgical mono- and bipolar with a set of appropriate instruments
7.	Electrosurgical unit with argon-enhanced coagulation	at least 1
8.	Container (capacity) for pre-sterilization cleaning, disinfection and sterilization of medical devices	at least 4
9.	Electric complex with instruments for traumatology and maxillofacial surgery<*>	at least 2
10.	Intubation kit	at least 3
11.	Single use catheter for anesthesiology and resuscitation	on demand
12.	Disposable epidural anesthesia kit	at least 1
13.	Automatic injector for intravenous infusions	at least 1
14.	Anesthesia-respiratory apparatus with the possibility of ventilation with three gases (O2, No. 2O, air), with evaporators for inhalational anesthetics (isoflurane, sevrflurane) with a gas analysis unit	at least 1 per operating table
15.		at least 1
16.	Device for intraoperative monitoring of the facial nerve	on demand
17.	Operating monitor, including: non-invasive blood pressure measurement (with an interval of 1 to 15 minutes); heart rate control; electrocardiogram monitoring; control of hemoglobin oxygen saturation (pulse oximetry); control of CO2 in the final exhaled gas; control of O2 in the breathing circuit; thermometry control; breathing rate control	at least 1 per operating table
18.	Stand (tripod) for infusion systems	at least 2
19.	Defibrillator	at least 1
20.	Operating room furniture set	at least 1
21.		at least 1
22.	Operating nurse's table	at least 2
23.	Table with drawers for consumables	at least 2
24.	Backless swivel chair with washable cover	at least 4
25.		at least 1
26.	Mobile X-ray unit with electro-optical converter or mobile X-ray C-arm with fluoroscopy capability, equipped with monitor and printer<*>	at least 1
27.	Thermal mattress for operating table	at least 1
28.	Stand for dispensers and infusion pumps	at least 3
29.	Large set of surgical instruments	at least 3
30.	Instruments and kits for combined anesthesia	at least 4
31.	Laying emergency prevention of parenteral infections	on demand
32.	Operating microscope<*****>	at least 1
33.	Operating loupes with headlight x 2x magnification	at least 2
34.		on demand
35.		on demand
36.	Headlights	on demand
37.		on demand
38.	Instrumental vascular set	at least 1
39.	Set of microsurgical instruments<****>	at least 2
40.	Set of tools for working on tendons<***>	at least 1
41.	Set of tools for working on bones<*>	at least 1
42.	Apparatus for external osteosynthesis with consumables<*>	on demand
43.		on demand
44.	Dermabrasion kit	on demand
45.		on demand

<*>In plastic surgery departments where reconstructive plastic surgery on bones is performed.

<**>In plastic surgery departments where reconstructive plastic surgeries are performed.

<***>In plastic surgery departments where reconstructive plastic surgery on the hand is performed.

<****>In plastic surgery departments where reconstructive plastic surgeries are performed using microsurgical techniques.

Appendix No. 7
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

ORGANIZATION RULES OF THE PLASTIC SURGERY CENTER

1. These rules determine the procedure for organizing the activities of the Plastic Surgery Center (hereinafter referred to as the Center).

2. The center is created as an independent medical organization or as a structural unit of a medical organization or other organization carrying out medical activities (hereinafter referred to as medical organizations), or on a functional basis.

3. The center is organized if the medical organization has the following operating around the clock:

• X-ray department (office), equipped with a stationary X-ray diagnostic apparatus (except for dental ones) and (or) a stationary X-ray computed tomography apparatus (except for dental ones), as well as a mammographic X-ray apparatus and (or) a magnetic resonance imaging apparatus with the ability to perform magnetic resonance imaging tomography of the mammary glands (in the structure of the X-ray service necessary for the provision of medical care in the plastic surgery profile, dental offices with an X-ray machine are not taken into account);
• anesthesiology-resuscitation department for the adult population or anesthesiology-resuscitation department with resuscitation and intensive care wards for the adult population, organized in accordance with the Procedure for the provision of medical care to the adult population in the profile of "anaesthesiology and resuscitation"<1>(when providing medical care to adults);
• department of anesthesiology-resuscitation or center of anesthesiology-resuscitation, organized in accordance with the Procedure for providing medical care to children in the field of "anesthesiology and resuscitation"<2>(when providing medical care to children);
• clinical diagnostic laboratory;
• transfusion room (blood transfusion room);
• operating room (operating unit);
• dressing room

<1>Order of the Ministry of Health of the Russian Federation dated November 15, 2012 No. 919n “On approval of the Procedure for providing medical care to the adult population in the field of anesthesiology and resuscitation” (registered by the Ministry of Justice of the Russian Federation on December 29, 2012, registration No. 26512).

<2>Order of the Ministry of Health of the Russian Federation of November 12, 2012 No. 909n “On approval of the Procedure for providing medical care to children in the field of anesthesiology and resuscitation” (registered by the Ministry of Justice of the Russian Federation on December 29, 2012, registration No. 26514), as amended by the order Ministry of Health of the Russian Federation dated July 9, 2013 No. 434n (registered by the Ministry of Justice of the Russian Federation on August 2, 2013, registration No. 29236).

The X-ray department (office), the anesthesiology-reanimation department, the clinical diagnostic laboratory, the transfusion room (blood transfusion room), the operating room (operating block) must be located within the property complex, functionally and technologically combined with the plastic surgery department(s) of the Center. Functional and technological integration means the placement of these units within one building or complex of buildings, connected by warm passages, ensuring the movement and transportation of patients without leaving the premises used by the medical organization.

4. In the medical organization in whose structure the Center was created, it must be possible to provide consultative assistance by medical specialists in the following profiles: “therapy”, “neurology”, “dermatovenereology”, “pediatrics”, “otolaryngology”, “ophthalmology”, “ obstetrics and gynecology", "surgery", "urology", "maxillofacial surgery", "traumatology and orthopedics". In the absence of the necessary medical specialists in a medical organization, it is possible to attract specialists from other medical organizations under a contract, provided that these medical organizations have a license for the relevant types of work (services).

5. The Center is headed by a director appointed and dismissed by the founder of a medical organization or the head of a medical organization in the case when the Center is organized as a structural unit.

A specialist who meets the Qualification requirements for medical and pharmaceutical workers with higher education in the field of training “Healthcare and Medical Sciences” is appointed to the position of head of the Center.<3>, majoring in healthcare organization and public health.

<3>Order of the Ministry of Health of the Russian Federation dated October 8, 2015 No. 707n “On approval of the qualification requirements for medical and pharmaceutical workers with higher education in the field of training “Healthcare and Medical Sciences” (registered by the Ministry of Justice of the Russian Federation on October 23, 2015 No. 39438), as amended by order of the Ministry of Health of the Russian Federation dated June 15, 2017 No. 328n (registered by the Ministry of Justice of the Russian Federation on July 3, 2017 No. 47273).

6. The structure of the Center and its staffing levels are established by the founder of a medical organization or the head of a medical organization in cases where it is organized as its structural unit, based on the volume of diagnostic and treatment work and recommended staffing standards, in accordance with Appendix No. 8 to the Procedure for the provision of medical care by profile "plastic surgery".

7. The equipment of the Center is carried out in accordance with the equipment standard of the Plastic Surgery Center, in accordance with Appendix No. 9 to the Procedure for the provision of medical care in the field of plastic surgery, approved by this order.

8. The Center performs the following functions:

• provision of specialized, with the exception of high-tech, medical care, by performing reconstructive plastic and (or) aesthetic plastic surgeries using surgical (including microsurgical) treatment methods in accordance with clinical recommendations, based on standards of medical care;
• mastering and introducing into clinical practice modern methods of prevention, diagnosis, treatment and rehabilitation in the provision of medical care in the field of plastic surgery;
• development and implementation of new medical technologies for the provision of medical care in the field of plastic surgery;
• assessment of new medical technologies developed in other medical organizations;
• development and implementation of measures aimed at improving the quality of medical care;
• implementation of the first stage of medical rehabilitation of patients specializing in plastic surgery in an inpatient setting;
• carrying out examination of temporary disability;
• improving the professional qualifications of medical workers of the Center, as well as other medical organizations on the provision of specialized medical care in the field of plastic surgery;
• providing advisory assistance to medical specialists from other departments of the medical organization within which the Center is organized, as well as other medical organizations on issues of prevention, diagnosis, treatment and rehabilitation in the provision of medical care in the field of plastic surgery;
• participation in the organization and improvement of medical care in the field of plastic surgery;
• maintaining medical records;
• submission of reports in accordance with the established procedure<4>, collection and provision of primary data on medical activities for health information systems<5>.

<4>Clause 11 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” (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724; 2013, No. 48, Art. 6165; 2014, No. 30, Art. 4257) (hereinafter referred to as Federal Law of November 21, 2011 No. 323-FZ).

9. The center can be used as a clinical base for professional educational organizations, educational organizations of higher education and organizations of additional professional education, as well as scientific organizations.

Appendix No. 8
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

Recommended staffing standards for the plastic center
surgery (except for plastic surgery departments,
included in the structure of the plastic surgery center)

Recommended staffing standards for plastic surgery departments,
included in the plastic surgery center

2. To ensure round-the-clock operation of the Department, based on the volume of medical care provided in addition to the positions of plastic surgeons provided for by the recommended staffing standards of the Department of Plastic Surgery, an additional 4.75 positions of a plastic surgeon and 4.75 positions of a nurse are established.

Appendix No. 9
to the Procedure for providing medical care
in the field of plastic surgery,
approved by order
Ministry of Health of the Russian Federation
dated May 31, 2018 No. 298n

STANDARD OF EQUIPMENT FOR A PLASTIC SURGERY CENTER

1. Standard of equipment of the Plastic Surgery Center (with the exception of plastic surgery departments included in the structure of the Plastic Surgery Center)

2. Standard for additional equipment for the operating room (operating unit) of the medical organization, within the structure of which the Plastic Surgery Center is being created (in addition to equipping the operating room (operating unit) of the plastic surgery departments included in the structure of the medical organization)

No.	Name	Required quantity, pcs.
Medical products
1.	Electric complex with instruments for traumatology and maxillofacial surgery	at least 2
2.	Autohemotransfusion system	at least 1
3.	Endoscopic console or stand with equipment and accessories for endovideosurgery and a set of instruments for plastic surgery	at least 1
4.	Ultrasound scanner with sensors for intraoperative diagnostics	at least 1
5.	Mobile X-ray unit with electro-optical converter or mobile X-ray C-arm with fluoroscopy capability, equipped with monitor and printer	at least 1
6.	Operating microscope	at least 1
7.	Operating loupes with headlight x 3.5 - 4x magnification	at least 2
8.	Operating loupes with headlight x 6x magnification	at least 1
9.	Headlights	at least 2
10.	Retractors with built-in light guides and lighting unit	at least 5 different sizes
11.	Set of microsurgical instruments	at least 2
12.	Set of tools for working on tendons	at least 1
13.	Set of tools for working on bones	at least 1
14.	Set of instruments for microsurgical operations	at least 2
15.	Apparatus for external osteosynthesis with consumables	at least 1
16.	Suction drainage systems	quantity on request
17.	Mechanical liposuction kit	at least 1

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How will the new law on plastic surgery, which came into force on May 31, 2018, affect the activities of clinics? What will change for patients and medical staff, according to Order No. 298n? What will need to be changed in the internal structure and comprehensive equipment of the offices?

First, it is worth noting that the Order “On approval of the Procedure for providing medical care in the field of plastic surgery” replaced the old document No. 555n of the Ministry of Health of the Russian Federation dated October 30, 2012 due to the fact that mortality from such operations remains at a fairly high level. Order No. 298n dated May 31, 2018 is intended to protect clients of aesthetic medicine and plastic surgery centers. It is planned that the quality of services will improve significantly with the latest introductions.

Features and changes

The regulations apply to individual offices, blocks and entire plastic surgery centers. Now complex equipment is more strictly regulated, which should oblige the owners of medical centers to comply with certain standards and purchase everything necessary to undergo the licensing procedure.

Activities for the purchase of equipment and medical equipment intended for examinations, surgical operations and maintaining the condition of patients during the rehabilitation period will be strictly controlled. Those clinics that do not introduce the required changes in their work, according to Order No. 298n dated May 31, 2018, will be forced to cease operations.

What points does the new law correct?

The document touches on the most important aspects of the activities of plastic surgery clinics, from the equipment of offices, departments and complex centers to staffing standards and the organization of work of medical personnel. Based on the changes contained in the new law on plastic surgery, MEDMART LLC has streamlined the section of Ready-made solutions for clinics of this career guidance.

Order No. 298n dated May 31, 2018 approves the procedure for providing services. Types of medical care that a modern plastic surgery center should provide:

• urgent, emergency and planned;
• primary specialized and specialized. In this case, health care involves services involving high-tech equipment and technology.

The new law also regulates inpatient and outpatient conditions. The conditions under which assistance should be provided to patients under round-the-clock supervision or staying in a day hospital have been studied in more detail.

The activities of the surgeon, who is allowed to perform surgical interventions, are also regulated. A certified specialist must provide services only in an office that fully complies with this order. The presence of a plastic surgeon on the hospital staff does not mean the ability to conduct full-fledged activities. Operations in the field of “plastic surgery” can and should be carried out exclusively in those premises/offices that comply with the new law in absolutely all respects.

Indications for plastic surgery - a fresh look

What has changed dramatically is the influence of the wishes of the clinic patients themselves. Now ambitions about one’s own appearance and demands for its correction are not the primary impetus for the surgeon’s actions. The new law, which came into force on May 31, 2018 in Russia, limits specialists’ activities if there are no compelling medical indications for carrying out a particular intervention.

All changes compared to the previous document are described in detail in paragraph 2 of the law. Maintaining and restoring human health became a priority. The purpose of the services that aesthetic medicine centers should offer is to return the patient to normal life after an accident, injury, complex illness and the use of potent drugs. The activities of the clinics can be briefly described as follows:

• elimination of functional defects;
• return of primary anatomical data lost for various reasons;
• correction of iatrogenic abnormalities, genetic, congenital or acquired during life;
• adjustment of appearance, as close as possible to generally accepted ideas about a person’s appearance;
• traumatic amputation of various limbs for medical reasons;
• reconstructive plastic surgery, which makes it possible to build up bones and soft parts in places of damage;
• fight against age-related changes. Here it is permissible to touch different parts of the head and body of a person seeking professional help;
• changes in the anatomy of individual structures, underlying and integumentary tissues, which helps the patient return to his usual way of life.

If the desire of any person who turned to a certified specialist was previously placed at the forefront, today such wording has been completely removed from the regulatory document. It will no longer be possible to change your appearance without any need or obvious reasons. The doctor himself will determine the need for a particular operation, based on the positive aspects that his patient will gain after a particular event or procedure.

Plastic surgery will come as close as possible to traditional medicine, aimed at improving and maintaining health and prolonging the normal life of citizens. Changing the shape of your nose or ears, succumbing to fashion trends or your own mood, will not work!

It is the transition of plastic surgery and the aesthetic medicine sector into a purely medical direction that is the most valuable change that should occur with the introduction of a new law into practice in Russia.

Order No.298n dated May 31, 2018 and a new plastic surgeon

Who will the new doctors be, how will they work? The outdated Order was imperfect in many ways. Experts believe that his main mistake was allowing complex operations that could lead to fatal consequences for people’s lives to be carried out by surgeons who had undergone short-term training in performing certain surgical interventions.

With the innovations, the circle of those doctors, even long-term practicing surgeons, who will be allowed to perform specific surgical interventions will sharply narrow. The competence of plastic surgeons remains the entire range of measures to change the anatomical and structural changes in different parts of the patient’s body. And surgeons who specialized in other areas, but have completed courses to change their qualifications, will have to return to conducting activities in their main profile. Full training lasts for several years, and the skills acquired in practice provide the basis for error-free operation.

Thus, the new law with all its amendments will help remove from the segment of providing services in plastic and aesthetic surgery centers those doctors who do not have sufficient competence in this matter.

Given the transition from the patient’s desire to improve his appearance to every possible contribution to maintaining the health of citizens, centers should provide consultations on a variety of areas of medicine. This means that the staff must be increased. And clients of plastic surgery centers will now be able to receive information before any operation from:

• pediatrician and neonatologist (for pediatric surgery), therapist;
• ENT doctor;
• gynecologist;
• neurologist and neuropathologist;
• urologist;
• orthopedist-traumatologist;
• ophthalmologist;
• cosmetologist and dermatovenerologist;
• a surgeon involved in the restoration of the maxillofacial apparatus.

This approach is designed to eliminate mistakes that were made in practice earlier. Patients will be informed in advance about the quality, volume, and types of activities carried out. They will receive advice on possible changes in the functioning of various organs and life support systems, both negative and positive. Every citizen who decides to undergo plastic surgery of his own free will or for medical reasons will be familiar with the possible risks and the consequences arising from them. This is precisely what should reduce the flow of patients who experiment with their appearance and decide to undergo anatomical changes without good reason.

How will the work of clinics change?

Not everything is as confusing and complicated as it seems at first glance! The new law and the Order on plastic surgery do not force centers to significantly increase the costs of training and hiring specialized specialists in various fields. If there is no doctor on the staff, he can be hired to work under a part-time contract. The main thing here is for patients to receive information about the state of their own health, its possible improvement or deterioration as a result of the provision of certain services within the plastic surgery center.

Important points when comprehensively equipping offices

Staff standards do not apply to private clinics. The equipment of the offices is described in Appendix No. 1, which indicates that now such premises should be included in the centers of medical complexes. Surgeons who do not meet the qualification requirements for the plastic surgery profile will not be allowed to practice.

The second appendix to the Order dated May 31, 2018 regulates the joint activities of surgeons and nurses, of whom there must be at least one per doctor. At least 1 sanitary worker must be allocated for every 3 premises. Appendix No. 6 is devoted to the preparation of the plastic surgery department for licensing. At the same time, the operating unit has its own amendments to the list of equipment.

The office should be clearly zoned - a dressing room and a place for conducting primary and routine examinations with all the necessary equipment available. Invasive activities should not be carried out in the general office. Only dressings are allowed after operations when the patient’s condition is stable. Among the types of anesthesia, only application anesthesia is allowed; other types of anesthesia are carried out in the office of a plastic surgeon.

The third appendix of the new Order is devoted to the correct equipment standards. It contains tables with a list of mandatory and additional (recommended) equipment, consumables, etc.

Subsequent applications regulate the work of plastic surgery centers and departments within multidisciplinary hospitals. All premises of the department in which plastic surgery operations are performed must be located in one building or part of a building. When moving a patient, the patient must not be taken out/out of one building; it is allowed to move from building to building along warm, equipped passages.

New rooms in the plastic surgery center:

• X-ray room with a modern apparatus. A tomograph or x-ray is optional only for dental clinics. In general clinical centers where a variety of operations are performed, MRI and mammographs should be installed to examine the mammary glands;
• anesthesiology room/department.;
• resuscitation with PIT for the necessary equipment depending on the focus - children's or adult center;
• laboratory for diagnostic and clinical studies;
• dressing room;
• operating unit;
• office or department of transfusiology with blood transfusion machines.

Conclusions on the implementation of the new law

If previously there was no room for transfusiology and blood transfusion, now it is mandatory. A 24-hour hospital is being introduced, in addition to the operating day hospital and outpatient clinic. The room with X-ray equipment is equipped in strict accordance with the list. You can forget about redirecting patients to third-party centers for such studies.

Surgeons who have undergone advanced training will not be involved in performing plastic surgeries. All serious manipulations can only be performed by specialized specialists who have undergone full training and received a diploma with qualifications in the relevant profile.

Alexey
07/12/2018 at 11:57

Good afternoon Dear Tatyana Alekseevna! You gave an order to inspect plastic surgery clinics based on unfinished order No. 298n. It’s clear that order needs to be restored, but should everyone be treated with the same brush?!!! Clinics that have existed for decades and do not have unnecessary equipment in a clinic under one roof? Absurd! I would like to eradicate charlatans, but in what way? How much money do you now need to spend on purchasing unnecessary equipment (for example, a 24-hour mammograph - ridiculous), which will stand idle, purchase and then throw away blood, given the shortage of donors in the country? There is a laboratory across the road, is it also impossible to work? Although we receive all those examined from head to toe, operating rooms, pit wards, a large hospital, anesthesiologists - resuscitators, our own autoclave, a laboratory nearby if you need blood, x-rays and everything else, but not in the same building, and we refuse dubious patients! And there was no time to prepare! And in accordance with this order, if we do not have double standards in the country, it is necessary to close all dentistry where patients are taken for local anesthesia without any tests at all and the presence of anesthesiologists and resuscitators nearby, just like in any outpatient clinic with a surgeon or urologist, etc. .d. Can he give an order to carry out checks not rashly, but taking into account the experience of the clinic, the presence of complications, and patient reviews? You understand that on the basis of your order, excesses will begin in the localities and they will close everything in a row, regardless of their faces! How many responsible taxpayers will our country lose, as an economist you understand?! The Order and Procedure does not even indicate a list of tests required to carry out operations; you understand that the order has not been finalized. They treated the writing of the order negligently, there was a feeling that they wanted to destroy someone’s business for the sake of others, maybe there is some kind of corruption component? We are respectable and responsible specialists, caring for our country, patients and the rule of law, and appeal to you for a more attentive attitude to this problem! Law enforcement agencies should deal with criminals! And for many years, having repeatedly received licenses from the Ministry of Health and undergoing inspections by Roszdravnadzor, we now find ourselves with nothing, licenses are canceled, on what grounds? Now should we go to court? We ask YOU to look into this and give additional instructions to local inspection authorities. It is clear that the order needs to be redone, and comments should be given to it, but they will shut us down, the flow of patients will be interrupted (700 people a year in our clinic alone), 30 people will end up on the street, only in our clinic, and it may not be possible to find a job, and now it’s a long time until retirement. Please find time for our troubles, figure it out. Otherwise, everything will be as always in our country again......... Thanks in advance!

COMMENTS

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INDRA-M
03.09.2018, 10:48

We sent this letter to the Minister of Health V.I. Skvortsova. August 10, 2018, entry No. 2099006 to the Ministry of Health of the Russian Federation. We are waiting for an answer.

INDRA-M
03.09.2018, 10:42

Plastic surgeons of the Republic of Buryatia, heads of medical organizations where medical care is provided in the field of plastic surgery are contacting you.

Order of the Ministry of Health of the Russian Federation dated May 31, 2018 No. 298n “On approval of the Procedure for the provision of medical care in the field of plastic surgery” (hereinafter referred to as the Order) significantly changes the rules for the provision of medical care in the field of plastic surgery.

We understand that the new requirements of the Order were established as a result of tragic cases involving harm to the health and death of patients during plastic surgery, and we support that the procedure for providing medical care in the field of plastic surgery should be determined by clear regulated rules.

At the same time, in the procedure for providing medical care in the field of plastic surgery, approved by the Order, there is no necessary separation of requirements in the field of reconstructive and aesthetic medicine. Thus, aesthetic medicine, unlike reconstructive medicine, does not require high-tech equipment. Performing “volume” operations, such as a facelift, cruroplasty or gluteoplasty, in most cases, does not require radiographic examination, computed tomography and blood transfusion, not to mention operations on the auricle, tip of the nose, skin of the upper and lower eyelids etc., which can be carried out in a surgical day hospital.

According to the new requirements, these surgical interventions are possible only in a multidisciplinary hospital, where the following must operate around the clock: an X-ray department equipped with a stationary X-ray diagnostic, mammography and (or) magnetic resonance imaging apparatus with the ability to perform magnetic resonance imaging of the mammary glands; departments of anesthesiology and resuscitation, clinical diagnostic laboratory; transfusion room; operating room; dressing room At the same time, all of the listed departments, as well as the office and the operating room, must be located within the same building or complex of buildings, connected by warm passages that ensure the movement and transportation of patients without leaving the premises used by the medical organization.

We believe that the established requirements contribute to an unreasonable increase in the cost of medical care and a significant reduction in its accessibility for the majority of the population, which leads to a violation of Article 10 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation.”

It has now been proven that the provision of surgical care for minor operations in an outpatient setting has some advantages over inpatient treatment. First of all, this increase:

1) medical effectiveness (reduction of complications due to nosocomial infection);

2) economic efficiency (unloading of expensive surgical hospitals, lower cost of outpatient surgical services compared to inpatient ones);

3) social effectiveness (the patient is not cut off from the usual family environment, which reduces the level of stress and promotes faster recovery).

Domestic and foreign experience shows that up to 40-50% of planned surgical operations can be performed in an outpatient setting.

The functions of outpatient plastic surgery centers for performing minor and medium-sized plastic surgery operations have been unreasonably curtailed. These outpatient surgery centers are small businesses, the development of which is advocated by the President of the Russian Federation and the Government of the Russian Federation.

A plastic surgeon who provides primary specialized medical care in an office setting, a qualified specialist who has completed residency training in plastic surgery, becomes not a plastic surgeon, but a theoretician-consultant. He is prohibited from carrying out any manipulations in the office. At the appointment, he can only advise the patient, at most, do a dressing. At the same time, surgeons and obstetricians-gynecologists, within the framework of current regulations, can perform surgical interventions on an outpatient basis. A cosmetologist, whose activities are carried out only in an office setting, in accordance with the current Procedure for the provision of medical care in the cosmetology profile, has the right to perform medical procedures necessary to correct identified disorders and defects, invasive procedures (introduction of injectable tissue fillers; drug injections botulinum toxin; injection correction of scar tissue; mesotherapy; median peeling; The current situation leads to a violation of paragraph 1 of Article 14 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” on the implementation of a unified state policy in the field of health protection.

One gets the impression that the Order does not protect the interests of the patient, but openly lobbies the interests of large plastic surgery clinics. For small and even medium-sized businesses providing medical care in the field of plastic surgery, the road to this area is now closed. The ground is being created for a reduction in the number of legal clinics and the emergence of a “black” market for plastic surgery, and as a result, the risk of an increase in the number of tragic cases associated with harm to the health of citizens as a result of plastic surgery increases.