ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of January 26, 2012 No. 55

About approval of the State sanitary standards and the rules "Hygienic Requirements to Placement, Arrangement, the Equipment and Operation of the Perinatal Centers"

According to articles 22 and 40 of the Law of Ukraine "About ensuring sanitary and epidemic wellbeing of the population", subitem 7.1 of the subitem 7 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, I ORDER:

1. Approve the State sanitary standards and the rules "Hygienic Requirements to Placement, Arrangement, the Equipment and Operation of the Perinatal Centers" which are attached.

2. To the public sanitary and epidemiologic service of Ukraine:

2.1. Provide provision in accordance with the established procedure of this order on state registration in the Ministry of Justice of Ukraine.

2.2. Bring this order to permission of heads of the ministries, other central executive bodies, Council of Ministers of the Autonomous Republic of Crimea, the regional, Kiev and Sevastopol city public administrations, organizations and institutions of the public, sanitarnoepidemiologichesky service, the public scientific institutions of sanitarnoepidemiologichesky profile for management in work and ensuring accomplishment within competence.

3. This order becomes effective from the date of its official publication.

4. I reserve control over the implementation of the order.

 

Approved by the Order of the Ministry of Health of Ukraine of January 26, 2012 No. 55

State sanitary standards and rules "Hygienic Requirements to Placement, Arrangement, the Equipment and Operation of the Perinatal Centers"

I. General provisions

1.1. The state sanitary standards and the rules "Hygienic Requirements to Placement, Arrangement, the Equipment and Operation of the Perinatal Centers" (further - Rules) establish the main requirements to placement, arrangement, the equipment and operation of the perinatal centers - health care institutions in which it is provided medical care to pregnant women, women in labor, women in childbirth and newborns, and also women with violation of reproductive function who need high intensity of treatment and supervision, on the basis of use of the latest high-technology medical equipment and implementation of modern preventive and medical and diagnostic technologies.

1.2. These rules extend to the perinatal centers which are designed, under construction, reconstructed, are re-equipped and operated.

1.3. Requirements to rules of personal hygiene of patients, medical and service personnel of the perinatal center, and also action of prevention of intrahospital infections are performed according to the order MZ of Ukraine of 10.05.2007 No. 234 "About the organization of prevention of intrahospital infections in obstetric hospitals", registered in the Ministry of Justice of Ukraine 21.06.2007 for No. 694/13961.

1.4. The state sanitary and epidemiological surveillance and control of observance of requirements of these rules are exercised by the Public sanitarnoepidemiologichesky service of Ukraine and its territorial authorities.

ІІ. Hygienic requirements to placement and content of the territory

2.1. The perinatal centers shall be located in selitebny, green or residential suburb according to the approved master plan of the settlement.

2.2. Sites of construction of the perinatal centers shall not adjoin directly to the main streets and industrial warehouse areas and shall be removed from the railroads, the airports, high-speed highways, other powerful sources of impact of physical and other factors.

It is forbidden to place the perinatal centers in sanitary protection zones of industrial, agricultural and other facilities which are sources of environmental pollution by chemical, physical and biological factors.

2.3. In case of placement of the perinatal centers in selitebny zone of the settlement it is necessary to place medical cases not closer than 30 meters from the red line of building and 30 meters from housing buildings.

2.4. The territory of the site of the perinatal center shall be planted trees and shrubs. The area of green plantings and lawns shall constitute at least 60% of total area of the site, and the area of landscape gardening zone - 25 sq.m on one bed in the perinatal center.

The site of the perinatal center located in the territory of housing building of the settlement shall have strip of green plantings at least 15 meters wide of two-row landing of long-boled trees and number of bushes on perimeter.

Trees with wide krone shall land not closer than 10 meters from wall of the building of the perinatal center.

2.5. To the territory of the perinatal center convenient sidings with hard surface shall be equipped. Similar hard surfaces shall have internal drives and walking paths.

Driving of vehicles through the territory of the perinatal center shall not cross with ways of patients which use landscape gardening zone.

2.6. The distance from pathoanatomical department with ritual zone to cases of the perinatal center and catering department shall be at least 30 meters and exclude possibility of hit of ritual zone in zone of windows of medical cases of the perinatal center.

The ritual zone shall have the isolated entrance and departure.

On the parcels of land of the perinatal centers placement functionally not of the related buildings and constructions is not allowed.

2.7. Household waste which are formed in the territory of the perinatal center are subject to removal according to requirements of the State sanitary standards and rules of content of the territories of the inhabited places approved by the order MZ of Ukraine of 17.03.2011 No. 145, registered in the Ministry of Justice of Ukraine 05.04.2011 for No. 457/19195.

2.8. Container areas at least 40 sq.m in size it is necessary to have in the territory of economic zone of the perinatal center at distance at least 25 meters from medical and diagnostic and ward cases and catering departments.

In the territory and in premises of the perinatal center it is necessary to establish exclusively enameled and faience ballot boxes. The number of ballot boxes is determined from calculation at least than one ballot box on each 700 sq.m of the territory of institution. On the main avenues of ballot box shall be established at distance of 10 m one from another.

2.9. The perinatal center carries out daily cleaning of the territory of institution, cleaning, sink and disinfection of collections of ballot boxes, containers and platforms for their placement.

2.10. For removal of surface sewage from the territory of the perinatal center the network of the rain sewerage shall be provided.

ІІІ. Hygienic requirements to planning solutions of buildings, constructions and certain rooms

3.1. Planning solutions of buildings, constructions and certain premises of the perinatal center, shall provide optimum sanitary and hygienic and anti-epidemic regime and comfortable conditions of stay of patients, work and rest of service personnel.

In the perinatal centers conditions for convenient access and comfortable stay of handicapped national groups shall be created.

3.2. The structure of the perinatal center and planning of its rooms shall exclude opportunity crossing or collision of "net" and "dirty" flows.

3.3. The structure and the areas of the main rooms are determined according to requirements of appendix 1 to these rules.

3.4. The department of transfusiology, the remote consulting and diagnostic center with telemedicine technologies, laboratory and diagnostic blocks, the administrative block and others, can be part of institution of health care as a part of which there is perinatal center.

3.5. Placement under windows of chambers of reception and viewing boxes, entrances to reception, loading, expeditionary and other rooms to which there is entrance of cars is not allowed.

3.6. The stationary equipment which is sources of noise and vibration (pumps, conditioners, compressors, elevators, transformers and so forth) is not allowed to be placed near chambers, medical and procedural offices, and also over and under them.

3.7. Placement of x-ray offices and holding radiological procedures are performed according to requirements of the State health regulations and regulations "Hygienic requirements to arrangement and operation of x-ray offices and holding the radiological procedures" approved by the order MZ of Ukraine of 04.06.2007 No. 294, registered in the Ministry of Justice of Ukraine 07.11.2007 for No. 1256/14523.

3.8. Expansion of hospital beds and accommodation of patients in corridors of ward sections or in other rooms is forbidden.

3.9. The structure of the perinatal centers is determined considering the order MZ of Ukraine of 15.08.2011 No. 514 "About approval of the Approximate charter of the Perinatal center with hospital and Approximate regulations on the Perinatal center as a part of health care institution".

3.10. In reception of obstetric hospital of the perinatal centers acceptance, registration and distribution of the patients arriving in institution are performed.

The reception shall be placed on the first floor near entrance on the institution territory. The entrance to reception shall not be located under windows of chambers. The entrance to department shall be performed through the platform.

Acceptance of patients is carried out through the reception and viewing room. For relatives it is necessary to provide the bathroom the room in lobby.

In reception arrangement of the auxiliary viewing room with gynecologic chair, the sanitary inspection room (with the bathroom and shower with flexible hose) and other auxiliary rooms for service personnel and visitors is provided.

In reception depending on the number of bed fund of maternity hospital one or several boxes (chambers) with bathroom with separate entrance for hospitalization of women in labor and women in childbirth with infectious diseases are provided in stage of sharp clinical manifestations where the woman in labor is from the moment of receipt to the statement. In maternity boxing there shall be equipment for provision of the emergency help and carrying out transactions.

3.11. The delivery room of hospital shall be separated other departments of the perinatal center.

3.12. Are delivered in individual delivery rooms which are equipped with lock, by bathroom (the bathroom, shower with flexible hose) and are equipped with transforming bed for acceptance of childbirth and stay of the woman in childbirth on it during the entire period of childbirth, means for conducting childbirth, open resuscitation system or little table with heating, the equipment for primary resuscitation of the newborn.

In the perinatal center individual maternity chambers of the increased comfort at least 30 m-2, which are in addition equipped with bedroom - patrimonial, by the room for heating of food and the place for stay of family members can be provided.

After the delivery in individual delivery rooms mother and the child are transferred to department of joint stay of mother and child. Mother and the child jointly are in individual maternity chambers to the statement from hospital.

Rooms of individual delivery rooms (chambers) after each childbirth or the statement are subject to clear-out and disinfection.

3.13. In department of joint stay of mother and child of obstetric hospital of the perinatal center chambers on 1-2 beds with lock and bathroom, posts of duty nurses, specialized, service, auxiliary and other premises (office of the doctor, medical personnel, procedural and so forth), similar to ward departments of multi-profile hospitals are equipped.

3.14. The department of pathology of pregnancy and ekstragenitalny pathology shall have exit to park zone and conditions for transportation of pregnant women from department of pathology of pregnancy and ekstragenitalny pathology in delivery room.

3.15. In ward departments for observance of the anti-epidemic mode the ward section shall be impassable for patients, personnel and visitors of other departments of hospital. Each ward section shall contain no more than 30 beds.

3.16. Planning solution of section shall provide the shortest communication of chambers with post of the duty midwife.

3.17. Capacity of chambers of department of pathology of pregnancy and ekstragenitalny pathology shall not exceed 4 beds. Beds in chambers shall be placed parallel to windows at distance of at least 0,9 of meter, distance from bed to the wall opposite to wall with windows, there shall be no more 0,8 of meter.

3.18. The operational block - the structural division of delivery room of obstetric hospital is intended for carrying out transactions and consists of operating rooms and complex of auxiliary and service premises.

3.19. Operational blocks are placed in the isolated attached or certain building or the isolated sections connected to hospital warm transitions or corridors. At the same time the operational block shall be as close as possible to chambers with stay of pregnant women and have direct communication with reception. In the operational block there shall be no vertical communications (technical mines, mines of elevators and refuse chutes).

Entrances to operational blocks for personnel shall be organized through sanitary inspection rooms, and for patients - through locks.

The operational block cannot be through passage, it shall be isolated from other divisions of hospital by lock.

Ways of movement of personnel, patients (before transactions) and materials ("net" and "dirty"), in the operational block shall not be crossed or face.

3.20. In basis of planning solution of the operational block zoning of internal space on 4 zones shall be accepted: zone of absolute control access, zone of high security, zone of the limited mode, zone of general rooms.

3.21. The zone of absolute control access includes operating rooms.

Treat zone of high security:

group of rooms of training of personnel for transaction which includes sanitary inspection rooms and preoperative;

group of rooms of training of the patient for transaction which includes the room where translate the patient, narcotic, the room for storage of the sterile equipment for maintenance of life activity of the patient, including the narcotic and respiratory equipment, materials and tools;

group of rooms for preparation of the tools and the equipment necessary for carrying out transaction: disassembly and washing of tools, narcotic and respiratory equipment, room of disinfection of the narcotic and respiratory equipment.

The zone of the limited mode includes group of the storage facilities intended for storage of blood, portable rentgenapparatura, the room for preparation and storage of dezrastvor, temporary storage of couches, the room for storage of medical waste.

The zone of general rooms includes rooms of personnel (office of the manager of department, the room of the senior nurse, bathroom with shower for personnel).

3.22. Departments of anesthesiology and intensive therapy with methods of efferent therapy of stationary department shall be chanceless and separated other divisions by system of locks and sanitary inspection rooms.

3.23. In department of post-intensive observation and nursing of premature newborns chambers of joint stay of mother and the newborn on 1-2 beds with lock and bathroom which can be blocked on two in case of one lock are equipped. Bathrooms in case of lock on 2 chambers can be integrated with shower, the shower shall be obligatory with flexible hose.

In the specified chambers it is necessary to provide glass apertures for possibility of observation of children. The lower height of apertures shall be placed at meter 1,1 height from floor.

Chambers shall be protected from noise and direct sunlight. At windows of the southern and southwest orientation there shall be blinds or other sun-protection devices.

3.24. The ladder, elevators and receivers leaving to departments shall be equipped with locks.

3.25. Rooms for storage of vaccine BTsZh and chamber for handicapped national groups shall be provided in obstetric hospital.

3.26. In ward departments it is necessary to provide the room for disinfection and presterilizing cleaning of tools.

3.27. The room for processing of couveuses and cribs for quality assurance of sterilization is recommended to be placed centralized in structure of the building of the perinatal center.

IV. Hygienic requirements to internal finishing of rooms

4.1. For internal finishing materials according to functional purpose of rooms are used.

4.2. The surface of walls, floors and ceilings of rooms of delivery rooms and operating rooms shall be smooth, free of defects, easily accessible for wet cleaning and resistant to processing washing and disinfectants. When using panels their design also shall provide smooth surface.

4.3. Floor covering shall adjoin to basis densely. Connection of walls and floor shall be rounded off, joints - hermetic.

Floors of lobbies, halls, corridors shall be resistant to mechanical impact.

Floors in operational, narcotic, maternity and other similar rooms shall have the corresponding electric conductance for prevention of accumulating of static electric charges.

4.4. In rooms of classes of purity "especially net" (EN) and "net" (H) the covering of walls on all height of rooms and ceiling shall be smooth, moisture-proof, resistant to application washing and disinfection to means.

4.5. In rooms with the wet mode (shower, bathing halls) and rooms of class of purity "dirty" (B) finishing shall provide moisture resistance on all height of the room. It is necessary to apply waterproof materials to floor covering.

4.6. It is necessary to provide equipment of the last in installation sites of sinks and other sanitary devices, and also the equipment which operation is connected with possible moistening of walls and partitions moisture-proof materials on meter 1,6 height from floor and on width at least 20 centimeters from the equipment and devices from each party.

4.7. Designs and materials of false ceiling which are used in premises of the perinatal centers shall provide possibility of carrying out their cleaning, cleaning, and disinfection, at the same time in rooms of classes of purity "especially net" (EN) and "net" (H) they shall be hermetic.

V. Hygienic requirements to water supply and the sewerage

5.1. The perinatal centers shall be equipped with water supply system, the sewerage, centralized hot water supply. The perinatal center shall be provided with drinking water which meets the requirements of the State sanitary standards and the rules "Hygienic Requirements to the Drinking Water Intended for the Use by the Person" approved by the order MZ of Ukraine of 12.05.2010 No. 400, registered in the Ministry of Justice of Ukraine 01.07.2010 for No. 452/17747.

5.2. Cleaning and disinfecting of sewage of the perinatal centers shall be performed on the city or other sewer treatment facilities guaranteeing effective purification and disinfecting of sewage.

5.3. For purification of production sewage of catering department of the perinatal center zhiroulavlivatel are established.

5.4. For the perinatal centers which are under construction or reconstructed on case of failure or carrying out preventive repair of hot water supply centralized reserve hot water supply shall be provided. For the existing centers as reserve source water-heating devices are established.

5.5. In bathrooms of individual delivery rooms, offices of doctors, rooms of personnel, wardrobe, in locks of boxes, procedural, dressing and auxiliary rooms the wash basins with leading of hot and cold water equipped with mixers and elbow (or foot) shall be established by cranes.

Individual delivery rooms shall be equipped with bowl sink for washing of the child.

5.6. The preoperative, dressing, delivery rooms, procedural offices, posts of nurses and other rooms requiring observance of particular treatment and purity of hands of the servicing medical staff shall be equipped with wash basins with installation of elbow cranes with mixers and dosers with liquid (antiseptic) soap and solutions of antiseptic agents. In bathrooms of female ward sections there shall be shower with flexible hose.

5.7. All bathrooms are provided one-time paper or electrotowels, means for washing of hands and pedal descents for tanks of removers. Doors of cabins of bathrooms shall open outside.

5.8. Sanitary rooms of ward departments shall be equipped with means of small-scale mechanization for processing and drying of courts, oilcloth and so forth.

5.9. Systems of cold and hot water supply shall exclude congestive zones and to be equipped with devices for fight against reproduction of infecting agent of legionaries.

VI. Hygienic requirements to heating, ventilation and conditioning of the air circle of rooms

6.1. Systems of heating, ventilation and air conditioning, shall provide optimal conditions of microclimate and the air circle of premises of the perinatal center.

6.2. Settlement temperature and frequency rate of air exchange of premises of the perinatal center is given in appendix 2 to these rules.

Air temperature in premises of the perinatal center where stay of the newborn is provided, shall be not below 25 °C.

6.3. Water with extreme temperature in heating devices of 85 °C shall be the heat carrier in systems of central heating. Use of other liquids and solutions (antifreeze and so forth) as heat carrier in systems of heating of the perinatal center is not allowed.

6.4. Heating heating devices shall be placed about outside walls under windows and have the smooth surface resistant to daily impact of washing and disinfection solutions. The arrangement of heating devices in chambers about internal walls is not allowed.

6.5. Premises of the perinatal center shall be equipped with systems of supply and exhaust ventilation with the mechanical drive and natural extract without mechanical drive.

6.6. Operation (servicing) of mechanical supply and exhaust ventilation and conditioning are performed by the responsible person of the perinatal center or other specialized organization. At least once a year check of overall performance, running repairs (if necessary), and also cleaning and disinfection of systems of mechanical supply and exhaust ventilation and conditioning are carried out.

6.7. Premises of the perinatal center depending on their functional purpose and levels of the most admissible quantity of particles and microorganisms (WHICH) in air is divided into such classes of purity: "especially net" - OCh, "net" - H, "conditionally net" - UCh, "dirty" - B - according to appendix 3 to these rules.

6.8. Designing and operation of ventilating systems shall exclude overflow of air masses from "dirty" zones to "net" rooms.

6.9. Frequency rate of air exchange is determined, proceeding from calculations of ensuring the set purity and maintenance of gas composition of air. Relative humidity of air indoors which is serviced shall be no more than 60%, air movement speed - is no more than 0,15 of m/s. In operational rooms, in the presence of system of laminar ventilation, air speed on workplaces shall not exceed 0,3 of m/s.

6.10. In premises of the perinatal center, except operational and other rooms with aseptic operating conditions, along with supply and exhaust ventilation with the mechanical drive the possibility of natural airing shall be provided. Windows in chambers and offices of doctors shall be equipped with window leaves or transoms for natural airing of rooms.

6.11. To all rooms air moves in the upper zone of the room. In the "especially E" (EE) the room air moves laminar or slaboturbulentny flows (speed of air of no more 0,3 of m/s).

6.12. Removal of air is provided from the upper zone, except operational, narcotic, resuscitation and maternity rooms in which air is emitted from two zones: 40% - from the upper zone, 60% - from the lower zone.

6.13. In aseptic rooms air flow shall prevail over removal. In rooms of infectious profile removal of air shall prevail over inflow.

6.14. The intake of outside air for systems of ventilation and conditioning is carried out from net zone at the height at least 2 meters from the Earth's surface. Outside air which moves stitched installations is subject to processing by filters of rough and thin cleaning to requirements of degree of purity of air taking into account functional purpose of the room.

Intakes of outside air, and also window and apertures which are used to forced ventilation with the natural drive shall be located outside influence of ventilating emissions.

Air which moves to operational, narcotic, maternity, resuscitation rooms shall be processed by disinfecting devices with ensuring efficiency of inactivation of microorganisms and viruses which are in the processed air, at least 95% (filters of outstanding performance H11-H 14).

6.15. Quality of stitched air (on concentration of CO2) shall provide in the ventilated rooms concentration of CO2 over its concentration in external air:

in ward rooms - Ј400 ppm;

in administratively household rooms - Ј600 ppm.

6.16. Control of extent of pollution of filters and overall performance of devices of disinfecting of air shall be carried out at least once a month. Replacement of filters shall be performed in process of their pollution, but at least, than recommended by the manufacturing company.

6.17. Emissions of air should be designed above building roof on meter 0,7. Emissions of air on building facade after cleaning with filters of the corresponding appointment are allowed.

6.18. The scheme of air exchange in chambers and departments shall limit as much as possible air overflow between ward departments, chambers and adjacent floors.

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