Text consolidated by Valsts valodas centrs (State Language Centre) with amending regulations of: 9 March 2010 [shall come into force on 13 March 2010]; 21 December 2010 [shall come into force on 1 January 2011]; 29 May 2012 [shall come into force on 1 June 2012]; 10 December 2013 [shall come into force on 1 January 2014]; 15 July 2014 [shall come into force on 18 July 2014]. If a whole or part of a paragraph has been amended, the date of the amending regulation appears in square brackets at the end of the paragraph. If a whole paragraph or sub-paragraph has been deleted, the date of the deletion appears in square brackets beside the deleted paragraph or sub-paragraph.

Republic of Latvia Cabinet Regulation No. 60 Adopted 20 January 2009

Regulations Regarding Mandatory Requirements for Medical Treatment Institutions and Their Structural Units

Issued pursuant to
Chapter 55, Paragraph two of
the Medical Treatment Law

1. General Provisions

[10 December 2013]

1. This Regulation prescribes the mandatory requirements for medical treatment institutions and their structural units.

2. [10 December 2013]

2. General requirements for medical treatment institutions

3. Medical treatment institution in accordance with the requirements laid down in the laws and regulations governing the field of construction and this Regulation:

3.1. is located in the building designed or corresponding to its activity;

3.2. provides the availability of environment to persons with functional disorders.

[10 December 2013]

4. In medical treatment institutions that do not provide environmental availability to persons with functional disorders in accordance with Sub-paragraph 3.2 of this Regulation:

4.1. persons with functional disorders are provided with the possibility to receive healthcare services in accordance with the approved medical technologies;

4.2. there is the information approved by the head of medical treatment institution regarding the possibility of persons with functional disorders to receive health care services provided by medical treatment institution. The information includes a brief and understandable explanation regarding the possibility, place and way to receive health care services provided by medical treatment institution to persons with functional disorders, contacts for further information and the list of medical treatment institutions, which provide the possibility to receive health care services that are not available in the appropriate medical treatment institution to persons with functional disorders;

4.3. persons with functional disorders are provided with the possibility of access to medical treatment institution independently if it is a health centre or inpatient hospital. At least one WC to persons with functional disorders is available in health centre that provides health care services, but at least one WC to persons with functional disorders is available on every floor in inpatient hospital, where health care services are provided to persons with functional disorders.

[10 December 2013]

4.¹ Medical treatment institution on its website includes the information on health care services and environmental availability. Medical treatment institutions that do not provide environmental availability to persons with functional disorders in accordance with Sub-paragraph 3.2 of this Regulation on their website include also the information approved by the head of medical treatment institution regarding the procedures for providing the possibility to receive health care services provided by medical treatment institution to persons with functional disorders.

[10 December 2013]

5. Medical treatment institution has a right to include the words "university" or "clinical" in its name if it complies with the requirements referred to in Sub-chapter 3.9 and 5.3 of this Regulation.

6. In medical treatment institution the access to the following information is provided:

6.1. certificates of conformity issued to medical treatment institution and confirming its compliance with mandatory requirements for medical treatment institutions laid down in the laws and regulations or their copies;

6.2. medical practitioners and medical treatment support persons who provide outpatient health care services to patients (name, surname, profession, specialty, working hours and place);

6.3. health care services available in medical treatment institution.

7. In advertising for health care services offered, medical treatment institution laid down the registration code of medical treatment institution and its suitability to provide health care services to persons with functional disorders.

[10 December 2013]

8. Medical treatment institution uses medical technologies approved in accordance with the laws and regulations regarding the procedures for approving medical technologies used in medical treatment and introduction of new medical technologies.

9. Medical treatment institution in operation and technical supervision of medical devices observes the laws and regulations regarding the procedures for registration, conformity assessment, distribution, operation and technical supervision of medical devices.

10. Medical treatment institution has the list of existing measuring instruments that are subject to the State metrological control, as well as ensures metrological control of these instruments in accordance with the laws and regulations regarding the acts on re-verification of measuring instruments, verification certificates and verification marks.

11. Medical treatment institution carrying out medical radiological procedures or medical exposure to radiation, has a special permit (license) or a permit for the activities with sources of ionizing radiation issued in accordance with the laws and regulations regarding the procedures for issuing special permits (licenses) and permits for the activities with sources of ionizing radiation and the procedure, in which the establishment of ionizing radiation facilities of national significance or the performance of essential changes therein are publicly discussed.

12. Medical treatment institution uses disinfectants registered in accordance with in the laws and regulations regarding the requirements on the activities with biocides. Disinfection and sterilization measures are carried out in accordance with the requirements for hygienic and anti-epidemic measures approved by the head of medical treatment institution.

13. Layout of premises and work organization in medical treatment institution complies with the laws and regulations on the basic requirements for hygienic and anti-epidemic measures of medical treatment institution.

14. The procedure of emergency medical care approved by the head of medical treatment institution is available in medical treatment institution. Medicinal products and medical devices necessary to provide emergency medical care are ensured in medical treatment institution (except technic dental laboratory and clinical diagnostic laboratory).

15. The head of medical treatment institution lays down the names and number of medicinal products necessary to provide emergency medical care in accordance with general load in medical treatment institution and existing and planned number of cases of providing emergency medical care. The head of medical treatment institution approves the list of minimal medicinal products necessary to provide emergency medical care (in medical treatment institution and its structural units), establishing the procedures for the use, storage and accounting of medicinal products, as well as laying down the official responsible for the replenishment of minimal medicinal product stock.

16. Duties, authority and responsibility of medical treatment institution employees (including medical practitioners and medical treatment support persons) laid down in external and internal laws and regulations, employment contract and instructions of the head of medical treatment institution. Medical treatment institution employees` (including medical practitioners and medical treatment support persons) education and qualification complies with the requirements laid down in the laws and regulations governing the field of education.

17. In order to ensure quality management of medical services provided, quality management system is developed, approved by the head and introduced in medical treatment institution. Quality management system includes at least the following measures:

17.1. regular quality control of medical services provided;

17.2. consideration of patients` claims and recommendations;

17.3. analysis of treatment results;

17.4. improving the quality of medical services.

(Paragraph shall come into force from 1 January 2012, see Paragraph 183)

18. Information technologies connected to the Internet and software that provides patient data storage and processing, observing the limitations of availability of information, are available in medical treatment institution.

(Paragraph shall come into force from 1 January 2011, see Paragraph 182)

19. If medical treatment institution uses a computer program related to e-health care information systems, information protection provisions and provisions regarding the procedures for medical information processing are developed in medical treatment institution and approved by the head of medical treatment institution.

(Paragraph shall come into force from 1 January 2011, see Paragraph 182)

20. Blood component preparation departments and blood banks comply with the requirements laid down in the laws and regulations regarding quality and safety standards regarding collection, testing, processing, storage and distribution of human blood and blood components, as well as compensation costs of restoring lost blood volume.

21. [10 December 2013]

22. Medical treatment institutions, which provide health care services to children and pregnant women, ensure:

22.1. the availability of medical treatment institution environment to persons with baby carriages, as well as the possibility to leave baby carriage in a safe place;

22.2. changing table pad or equivalent adjusted place in waiting room or patient room;

22.3. seats for patients if patients have to wait in line for health care services.

(Paragraph shall come into force from 1 January 2014, see Paragraph 184)

3. Requirements for outpatient medical treatment institutions

3.1. General requirements

23. Outpatient medical treatment institution provides primary health care or outpatient secondary health care to patients, including inpatient care.

24. Outpatient medical treatment institution has:

24.1. waiting room for patients with cloakroom;

24.2. patient registration room or place;

24.3. patient reception area;

24.4. non-invasive manipulation, invasive manipulation or procedure room (in accordance with the area of medical treatment institution activity);

24.5. WC for patients and staff. If out-patient medical treatment institution is located in a residential building, sanitary facilities is equipped separately;

24.6. WC for patients and staff suitable for use by persons with functional disorders.

[10 December 2013]

25. Outpatient medical treatment institution that has three or more medical or diagnostic offices in addition to the requirements referred to in Paragraph 24 of this Regulation has:

25.1. room for storage of patient-care equipment;

25.2. staff cloakroom or place.

26. Outpatient medical treatment institution in order to provide emergency medical care has:

26.1. phonendoscope;

26.2. device for indirect measurement of arterial blood pressure. If medical treatment institution provides medical services also to children, a device has to have cuff sizes for all age groups;

26.3. equipment used for parenteral medicinal product and solution administration;

26.4. equipment used to stop external bleeding and dressing wounds;

26.5. artificial lung ventilation device in manual mode and transparent or semi-transparent respiratory masks available at least in three sizes;

26.6. equipment used to relieve airway obstruction (tracheal tubes available at least in three sizes);

26.7. stomach pumping and gastric lavage devices (except dental office);

26.8. lightning devices (in accordance with the area of services provided);

26.9. medical couch, procedure table, chairs, functional bed or functional chair (in accordance with the area of services provided);

26.10. immobilisation devices and devices used for patient movement (except dental office);

26.11. equipment providing the basic requirements for hygienic and anti-epidemic measures, including personal protective equipment.

27. Outpatient medical treatment institution (except dental office), which has three or more medical or diagnostic offices to provide emergency medical care in addition to the requirements referred to in Paragraph 26 of this Regulation, has:

27.1. oxygen-delivery device;

27.2. sterile maternity kit;

27.3. devices used to prevent delaying bowel movement;

27.4. devices used to prevent urinary retention or incontinence.

[10 December 2013]

3.2. Requirements for specialist office (physician, including family physician, functional specialist, physician assistant (surgeon assistant), midwife, nurse)

28. Specialist office is outpatient medical treatment institution, which provides outpatient care to a patient, including medical, preventive and health promotion procedures or manipulations.

29. Specialist office complies with general requirements for outpatient medical treatment institutions referred to in this Regulation.

30. Specialist office using invasive medical technologies in addition to the requirements referred to in Paragraph 29 of this Regulation ensures a separate room for use of invasive medical technologies. There is a separate place to carry out aseptic manipulations and place to carry out septic manipulations or there is a separate room to carry out aseptic manipulations and room to carry out septic manipulations.

3.3. Requirements for dental office and technic dental laboratory

31. Dental office is a medical treatment institution or its structural unit where the diagnosis and treatment of the patient's mouth, jaws and facial diseases is made, as well as the prevention of the diseases mentioned above.

32. Technic dental laboratory is a medical treatment institution or its structural unit where dental prostheses are made.

33. Dental office complies with general requirements for outpatient medical treatment institutions referred to in this Regulation.

34. If there is more than one unit of dental equipment in dental office, dental equipment shall be bounded.

35. Dental office has:

35.1. dental chair where it is possible to place the patient horizontally;

35.2. dental equipment connected to electrical wiring and communications with the following equipment:

35.2.1. water/ air gun;

35.2.2. turbine (high-speed nozzle with air and water cooling);

35.2.3. micro motor with adjustable speed and nozzle with air and water cooling;

35.2.4. saliva ejector system;

35.3. dental X-ray diagnostic equipment, except as follows:

35.3.1. dental office is located in a medical treatment institution where it is possible to receive dental X-ray diagnostic services;

35.3.2. dental office is located in an educational institution and provides an educational institution children`s dental care - professional dental hygiene and treatment of caries;

35.4. equipment used to provide increased oxygen level in the inhaled air;

35.5. medical personnel protective equipment (safety gloves, plastic face mask or disposable masks, safety glasses);

35.6. place for patient card register;

35.7. sterilization place or room equipped with:

35.7.1. sink equipped with water supply (tap), which is connected to sewage system;

35.7.2. containers for processing of medical instruments before sterilization;

35.7.3. autoclave or hot air sterilizer, or container for transport of instruments;

35.8. the number of dental instruments appropriate to the amount of services provided by dental office;

35.9. storage of medical materials and tools provided in accordance with the laws and regulations regarding the procedures for registration, conformity assessment, distribution, operation and technical supervision of medical devices.

36. Surplus of dental amalgam seals are collected and transferred to merchants who have the permit for hazardous waste management in accordance with the laws and regulations regarding the procedures for issuing, extension, review and cancellation of waste management permits. In order to prevent the penetration of mercury in sewage, dental equipment outlets are equipped with dental amalgam separators.

37. In order to be able to use general anaesthesia dental office has:

37.1. device used for parenteral medicinal product administration;

37.2. device used for parenteral solution administration;

37.3. device used for long-term precise dosed parenteral medicinal product and solution administration (perfusor, injectomat);

37.4. devices used to perform catheterization of a central vein;

37.5. device used for maintenance of infusion solution at a suitable temperature;

37.6. oxygen inhalation device with the oxygen flow not less than 10 liters per minute and a flowmeter;

37.7. device used for artificial pulmonary ventilation in automatic and manual mode;

37.8. respiratory masks (for infants, children, and adults);

37.9. laryngeal masks;

37.10. esophageal tracheal combitube;

37.11. devices used to relieve airway obstruction (tracheal tubes available at least in three sizes);

37.12. cricothyrotomy kit;

37.13. laryngoscope with straight and curved mirrors available at least in three different sizes;

37.14. orotracheal and nasotracheal intubation tubes available in all sizes;

37.15. oral airway dilator;

37.16. aspiration system;

37.17. gastric probe available at least in three sizes;

37.18. apparatus for general anaesthesia if inhalation anaesthesia is used;

37.19. defibrillator;

37.20. medicinal products used for general anaesthesia;

37.21. equipment for monitoring the following patient parameters during general anaesthesia:

37.21.1. heart rate and blood flow (electrocardioscopy, electrocardiography and arterial blood pressure measurement using non-invasive methods);

37.21.2. breathing and ventilation;

37.21.3. oxygen-saturated haemoglobin (pulse oximetry);

37.21.4. body temperature;

37.22. continuous patient monitoring, oxygen inhalation, pulmonary artificial ventilation and aspiration prevention shall be provided during general anaesthesia.

38. Technic dental laboratory has:

38.1. working room equipped with natural and combined artificial lighting system;

38.2. place or room used to receive orders;

38.3. sanitary facilities.

39. Technic dental laboratory working room has:

39.1. workplace equipped with gas supply, laboratory burner or spirit lamp and electric grinding machine with autonomous dust collector;

39.2. water sink with special deposition container used to provide efficient collection and retention of particles of plaster;

39.3. locked laboratory polishing machine with autonomous dust collector;

39.4. laboratory plaster table with plaster container;

39.5. casting machine;

39.6. gas-stove;

39.7. soldering equipment.

40. Technic dental laboratory over casting machines, gas stoves, soldering equipment and polymerization workplaces has local exhaust devices that suck in dust or mercury vapor and equipped with appropriate filters in accordance with their user`s manual.

41. Working room in technic dental laboratory for work with mineral acids (no more than 200 ml of each nominal value is allowed in the room) and soldering of metal parts has a fume hood with the following characteristics:

41.1. size not be less than 1.5 m x 0.7 m;

41.2. inlet hole not less than 1 m x 0.5 m;

41.3. autonomous, mechanical exhaust air flow rate not less than 0.7 m/ s.

3.4. Requirements for physician office

42. Physician`s office complies with general requirements for outpatient medical treatment institutions referred to in this Regulation.

3.5. Requirements for Health Centre

43. Health centre is a medical treatment institution, which provides primary and secondary outpatient health care to a patient at least in three medical specialties.

44. Health centre complies with general requirements for outpatient medical treatment institutions referred to in this Regulation.

45. Health centre has:

45.1. at least one family physician office (workplace of family physician office);

45.2. at least two medical specialist offices;

45.3. at least two such structural units:

45.3.1. rehabilitation outpatient unit, which provides rehabilitation physician office and at least two different functional specialist offices;

45.3.2. dental office;

45.3.3. day hospital;

45.3.4. diagnostic structural unit.

3.6. Requirements for outpatient rehabilitation institution

46. Outpatient rehabilitation institution is a medical treatment institution or its structural unit, which provides rehabilitation services as various comprehensive or specialized (including technical orthopaedics) rehabilitation programmes.

47. Outpatient rehabilitation institution complies with general requirements for outpatient medical treatment institutions referred to in this Regulation.

48. Outpatient rehabilitation institution has:

48.1. rehabilitation rooms for therapeutic recreation specialist and at least one functional specialist;

48.2. medical devices for diagnosis, patient's physical examination and assessment of functional ability (functional laboratory);

48.3. patient WC suitable for persons with functional disorders, including equipped with a nurse call button.

[10 December 2013]

3.7. Requirements for day hospital

49. Day hospital is a medical treatment institution or its structural unit, which provides diagnostic and medical care, as well as bed to a patient who does not require medical care and supervision outside working hours.

50. Day hospital complies with general requirements for outpatient medical treatment institutions referred to in this Regulation.

51. Day hospital in accordance with the amount of treatment activities has:

51.1. diagnosis, treatment, rehabilitation and care structural unit;

51.2. outpatient operating room.

52. Day hospital, which provides outpatient surgery to a patient, has:

52.1. medical devices used to carry out the following treatment activities:

52.1.1. physical examination of a patient;

52.1.2. electrocardiography, if there is no electrocardiographic room in medical treatment institution;

52.1.3. parenteral medicinal product and solution administration;

52.1.4. maintenance of infusion solution at a suitable temperature;

52.1.5. to stop external bleeding;

52.1.6. artificial lung ventilation in manual mode (transparent or semi-transparent respiratory masks available at least in three sizes in medical device kit);

52.1.7. to relieve airway obstruction (tracheal tubes available at least in three sizes);

52.1.8. stomach pumping and gastric lavage;

52.1.9. to prevent delaying bowel movement;

52.1.10. to prevent urinary retention or incontinence;

52.1.11. movement of patients;

52.2. to provide continuous oxygen inhalation;

52.3. aspiration system.

53. Outpatient operating room is equipped with medical devices used to monitor the following parameters during general and local anaesthesia:

53.1. heart rate and blood flow (electrocardioscopy, electrocardiography and arterial blood pressure measurement using non-invasive methods);

53.2. breathing function and ventilation;

53.3. oxygen-saturated haemoglobin (pulse oximetry);

53.4. body temperature.

54. If during general anaesthesia volatile anaesthetics are used, an outlet opening for the passage of the air exhaled by the patient is provided.

3.8. Requirements for orthopaedic technology institution

55. Orthopaedic technology institution is a specialized outpatient rehabilitation institution, which provides production and adaptation of individual or reusable assistive technology devices in accordance with a patient diagnosis, functional disorders and social situation. Orthopaedic technology institution complies with general requirements for outpatient medical treatment institutions referred to in this Regulation. There are the following orthopaedic technology institutions:

55.1. orthopaedic technology offices;

55.2. orthopaedic technology centres;

55.3. hearing prosthetic centres.

56. Orthopaedic technology institution ensures:

56.1. compliance of the layout of the premises with the technological processes for production and adaptation of assistive technology devices;

56.2. patient rooms separately from workshop premises, including patient WC suitable for persons with functional disorders;

56.3. choice of assistive technology devices in accordance with a patient diagnosis, functional disorders and social situation;

56.4. production and adaptation of assistive technology devices;

56.5. disinfection, washing and drying of leased and returned assistive technology devices (if assistive technology devices have been leased);

56.6. patient training for use of assistive technology devices and necessary quantity and quality of exercises;

56.7. control of further results.

[10 December 2013]

57. Orthopaedic technology centre provides services related to industrial and individual production of assistive technology devices, as well as rehabilitation services to train patients for their use.

58. Orthopaedic technology office provides adaptation of industrially produced assistive technology devices to the patient or production of individual assistive technology devices.

59. Hearing prosthetic centre provides production of individual ear insert appropriate to the patient or provides adaptation of hearing prosthesis in accordance with a patient`s hearing functions (hearing aid, cochlear implant), the appropriate verification, adjustment or programming.

60. Hearing prosthetic centre has:

60.1. otoplasty office;

60.2. hearing aid programming and adjustment office;

60.3. cochlear implant verification and programming office.

3.9. Requirements for university outpatient clinic

61. University outpatient clinic is outpatient medical treatment institution, which carries out treatment activities, as well as in accordance with the agreement concluded between the University and outpatient medical treatment institution in accordance with state accredited educational programs trains students and carries out research in medicine.

62. University outpatient clinic complies with general requirements for outpatient medical treatment institutions referred to in this Regulation.

63. The head of University outpatient clinic is medical practitioner who has Doctor of medicine degree and not less than three-year academic work experience. The head of University outpatient clinic is appointed or dismissed in accordance with the procedures laid down in the university`s rules.

3.10. Requirements for medical laboratories

[21 December 2010]

63.¹ Medical laboratory is a medical treatment institution or its structural unit, which carries out biological, microbiological, immunological, chemical, imunohaematological, haematological, biophysical, cytological, pathological, or other examination of materials derived from the human body.

63.² Organization of the laboratory work provides necessary resources and procedures in order to provide required and appropriate quality of the laboratory services, including the examination outside the laboratory at a patient's bed and express diagnostics.

63.³ The laboratory develops personnel management policy and the organizational structure of the laboratory, lays down the duties, responsibilities and powers of employees, as well as personnel resources and competence necessary for planned work.

63.⁴ Personnel resources comply with the execution of tasks laid down and quality requirements:

63.⁴1. the laboratory management personnel has the appropriate qualification for services provided in the area of organizational, administrative, educational, consultative and technical activities and quality system management;

63.⁴2. the laboratory technical personnel has the appropriate qualification in the area related to the purpose of certain examination procedures, action, assessment of results and providing professional opinion.

63.⁵ The laboratory has the following information about personnel compliance with the execution of tasks laid down:

63.⁵1. copies of documents confirming education;

63.⁵2. copies of documents confirming specialization or improvement of professional qualification in a certain specialization;

63.⁵3. copies of documents confirming education, experience and skills;

63.⁵4. job descriptions;

63.⁵5. training plan or program;

63.⁵6. copies of documents confirming occupational safety training.

63.⁶ The laboratory or its structural units is located in the premises where laboratory examinations can be carried out without affecting the quality of examination results, quality control procedures, personnel safety and patient care services. These conditions are observed in the rooms of primary sample collection and testing also outside usual working premises of the laboratory, at medical centres where samples are taken and collected.

63.⁷ Requirements for microclimate of the premises and the environmental conditions are laid down and maintained, taking into consideration activities carried out in the premises and the corresponding specifications, if it can affect the quality of the examination results.

63.⁸ Surrounding working areas, where incompatible activities take place, are separated in order to prevent contamination.

63.⁹ The laboratory documents and controls the availability of the premises and working areas, as well as their use in order to prevent unauthorized access to laboratory technical resources, documents and materials.

63.¹⁰ The laboratory is equipped with the appropriate communications systems necessary for efficient message transmission depending on the amount and specifics of the executed work.

63.¹¹ The laboratory has devices, which provide the execution of laboratory services:

63.¹¹1. medical examination devices and measuring instruments (hereinafter - equipment);

63.¹¹2. reagents, reference materials, calibration materials (hereinafter - reagents);

63.¹¹3. medical examination systems, laboratory equipment and test samples accessories.

63.¹² Equipment (after installing and using daily) ensure the ability to achieve the required test results. In accordance with the manufacturers` instructions the laboratory develops and documents the following programmes:

63.¹²1. equipment technical monitoring program;

63.¹²2. equipment metrological control program;

63.¹²3. equipment maintenance program.

63.¹³ Analytical equipment used in the laboratory is included in the list of laboratory equipment, and the following documentation formulated in an understandable way is provided to personnel who use the appropriate equipment in the areas of their use:

63.¹³1. operating manuals for laboratory equipment;

63.¹³2. occupational safety provisions for work with laboratory equipment;

63.¹³3. instructions for laboratory equipment maintenance.

63.¹⁴ Each item of equipment used to carry out tests has the original of technical documentation and registration card that contains the following information:

63.¹⁴1. equipment name;

63.¹⁴2. equipment manufacturer, identification type and serial number;

63.¹⁴3. manufacturer's representative or supplier's contact person and phone number;

63.¹⁴ 4. start date of equipment use;

63.¹⁴5. current place of location;

63.¹⁴6. state at the moment of receiving (new, used, restored);

63.¹⁴7. calibration or verification data;

63.¹⁴8. technical monitoring data;

63.¹⁴9. equipment damage, improper operation, modification or repair.

63.¹⁵ Reagents card-file includes the following information on their compliance with the intended use:

63.¹⁵1. name, code, serial number, quantity;

63.¹⁵2. supplier;

63.¹⁵3. period of use;

63.¹⁵4. storage provisions;

63.¹⁵5. provisions of use;

63.¹⁵6. start and end date of use.

63.¹⁶ Equipment is used by personnel trained to use and maintain the equipment and who has the power approved by the head of the laboratory to operate the equipment.

63.¹⁷ The laboratory documents the procedures and activities in case of detection non-compliant laboratory equipment, appointing the persons responsible for the following areas:

63.¹⁷1. labelling and isolating;

63.¹⁷2. damage assessment and further activities;

63.¹⁷3. determination and carrying out mandatory tests;

63.¹⁷4. decision-making on resumption of operation;

63.¹⁷5. impact assessment on the carried out tests and patient information, if necessary.

63.¹⁸ If laboratory information systems or automated medical examination devices are used for test data collection, processing, record-keeping, notification, storage or correction, the laboratory ensures that:

63.¹⁸1. software and patient databases are protected in order to prevent any unauthorized access, modifying or deleting programmes;

63.¹⁸2. computers and automated medical examination devices are maintained under the appropriate environmental conditions, providing their proper functioning.

63.¹⁹ In accordance with the services provided by the laboratory, the laboratory documents information material for collection of test samples and carrying out tests. The laboratory ensures the availability of the latest version of information material for patients and laboratory personnel. Information material contains the following information:

63.¹⁹1. examination methods used in the laboratory;

63.¹⁹2. requirements for patient preparation before collecting test samples and factors that can significantly affect testing results;

63.¹⁹3. the term within which laboratory examinations have been performed;

63.¹⁹4. the period within which it is possible to request repeated and additional tests;

63.¹⁹5. test sample collection, taking, labelling, storage conditions and choice and use of laboratory equipment for taking samples;

63.¹⁹6. test sample rejection criteria and the procedure if it has been rejected;

63.¹⁹7. specific activity and conditions of test sample transport;

63.¹⁹8. use of test request form;

63.¹⁹9. use of test consent form, if necessary.

63.²⁰ The laboratory develops a test request form that includes the following information:

63.²⁰1. identification of the patient;

63.²⁰2. identification of the physician or other person authorized to request test and to use information obtained;

63.²⁰3. test report delivery address;

63.²⁰4. type of test sample and anatomical site of origin (if necessary);

63.²⁰5. requested tests;

63.²⁰6. the patient clinical information;

63.²⁰7. test sample collection date and time;

63.²⁰8. blood group in the ABO blood group system for imunhematology testing;

63.²⁰9. date and time of test sample receipt in the laboratory;

63.²⁰10. conformity assessment of sample received.

63.²¹ The laboratory uses test methods that satisfy the needs of the users of laboratory services and are suited to perform tests. Test procedures, including sampling, are documented and available to the appropriate personnel at their workplaces. Operation manuals issued by the manufacturer (user manual, reagent user manual) can be used as part of the procedure, if these instructions are understandable to laboratory personnel. Description of test method contains the following mandatory information:

63.²¹1. the objective of test;

63.²¹2. the principle of used test method;

63.²¹3. performance specification for test method;

63.²¹4. type of test sample suited to test;

63.²¹5. necessary equipment and reagents or accessories;

63.²¹6. calibration procedures;

63.²¹7. process of test procedure;

63.²¹8. quality control procedures;

63.²¹9. factors affecting test results;

63.²¹10. calculation principle of test results;

63.²¹11. biological reference intervals of test results;

63.²¹12. critical values of test results (where it is necessary);

63.²¹13. interpretation of test results.

63.²² If the laboratory foresees to change test method and therefore test results or their interpretation may significantly differ, possible consequences of these changes are explained to patients before to change a test method.

63.²³ The laboratory documents the procedures to ensure quality of test process:

63.²³1. internal quality control;

63.²³2. external quality control.

63.²⁴ The laboratory in accordance with its area of activity documents internal quality control system, specifying:

63.²⁴1. program;

63.²⁴2. responsible persons;

63.²⁴3. criteria of control;

63.²⁴4. assessment of control results;

63.²⁴5. corrective and preventive actions, assessment of their implementation and efficiency.

63.²⁵ The laboratory in accordance with its area of activity takes part in external quality control programs, documenting:

63.²⁵1. plan;

63.²⁵2. assessment of control results;

63.²⁵3. corrective and preventive actions, assessment of their implementation and efficiency.

63.²⁶ If external quality control programs are not available, the laboratory develops and uses other external quality control mechanisms, implementing the exchange of samples with other laboratories.

63.²⁷ The laboratory documents the confirmations for the comparability of test results (correlation) within clinically acceptable range for tests carried out using different test methods, implementing activity at different places or with different technical support.

63.²⁸ The laboratory documents the following post-test procedures:

63.²⁸1. the procedures regarding the work with test results protocols, which determines drawing up, changes in protocol and personnel responsibilities. Protocols contain test and patient identification, all measurements, original observations, calculations and test results obtained in the calculations, test date, as well as identification of the person who carried out the test;

63.²⁸2. the procedures regarding the control of test results, which determines systematic review of test results by the authorized and competent personnel, evaluating their compliance with available clinical data on the patient, as well as test results approval and notification, type of test results notification, including test results notification by telephone, and the term within which test results are notified;

63.²⁸3. the procedures regarding the work with vital capacity test results obtained within critical range, and the procedure of their notification.

63.²⁹ Test results reports contain the following information:

63.²⁹1. identification of the laboratory where report has been prepared;

63.²⁹2. test identification;

63.²⁹3. patient identification;

63.²⁹4. identification and address of test customer;

63.²⁹5. sample collection date and time, if it is relevant;

63.²⁹6. type of test sample;

63.²⁹7. test results;

63.²⁹8. biological reference intervals;

63.²⁹9. interpretation of test results, if necessary;

63.²⁹10. identification and signature of responsible person;

63.²⁹11. date of preparation of report;

63.²⁹12. notes on non-compliance of test sample with test.

63.³⁰ The laboratory documents biological, chemical and other hazards of procedures. Laboratory management lays down the identification of hazards, identification of hazardous zones and use of marking signs, as well as is responsible for regular review of hazard identification system, updating and notifying personnel. The laboratory determines the procedures and activities in case of accidents and unfavourable incidents, and documentation procedures (detailed description of accident, evaluation of causes, corrective and preventive actions).

63.³¹ All personal protective equipment is the appropriate and used in accordance with the specifics of work.

63.³² The laboratory lays down the procedures for working with the laboratory patients, including consideration of complaints.

63.³³ The laboratory ensures the following consulting services:

63.³³1. participation in educational meetings for laboratory patients;

63.³³2. consultation on tests and their choice in the laboratory;

63.³³3. develops the procedures for visiting the laboratory and to get necessary information, and provides it.

63.³⁴ The laboratory documents corrective action procedure, determining:

63.³⁴1. person responsible for choice and carrying out corrective actions;

63.³⁴2. procedures for carrying out the analysis of reasons for non-compliance;

63.³⁴3. choice of corrective actions depending on importance of the problem and potential risk;

63.³⁴4. corrective action plan;

63.³⁴5. monitoring of corrective actions, assessment of their efficiency to prevent identified problems.

63.³⁵ Requirements referred to in Sub-chapter 3.10 of this Regulation do not apply to medical laboratories accredited in accordance with the standard LVS EN ISO 15189:2013 "Medical laboratories. Particular requirements for quality and competence".

[10 December 2013]

3.11. Requirements for long-term social care and social rehabilitation institution health centre

[10 December 2013]

63.³⁶ Long-term social care and social rehabilitation institution (hereinafter - social care institution) health centre is a social care institution structural unit, which provides health care to the patient (client) in cases of long-term or chronic illness. Night-watch is not required in a health centre.

63.³⁷ In addition to the requirements regarding social services providers in the laws and regulations governing social services, as well as hygiene requirements regarding social care institutions, the following requirements are applied to social care institution health centre:

63.³⁷1. social care institution health centre has the premises to ensure:

63.³⁷1.1. examination of a patient and medical examination;

63.³⁷1.2. medical procedures and manipulations;

63.³⁷1.3. lockable medicine cabinet used for storage of patient care products;

63.³⁷1.4. observation of patients in case of uncertain diagnosis and isolation in case of infectious diseases;

63.³⁷1.5. observation and isolation of dangerous and aggressive patients, and the appropriate rooms are equipped with special window and door latches;

63.³⁷1.6. medical rehabilitation, if such service is provided;

63.³⁷2. Social care institution health centre has a room or top-container used for storage of dirty linen.

63.³⁸ Social care institution health centre shall have:

63.³⁸1. equipment for patient physical examination;

63.³⁸2. equipment providing the basic requirements for hygienic and anti-epidemic measures, including personal protective equipment;

63.³⁸3. equipment used for parenteral medicinal product and solution administration;

63.³⁸4. equipment used to stop external bleeding, treatment and dressing wounds.

3.12. Requirements for Mobile medical unit

[10 December 2013]

63.³⁹ Mobile medical unit (vehicle) is an outpatient medical institution or its structural unit where premises and medical devices necessary for treatment are located and installed in accordance with the area of services provided.

63.⁴⁰ Mobile medical unit complies with general requirements for medical treatment institutions referred to in this Regulation, except the requirements referred to in Paragraphs 3, 4, 5 and 22 of this Regulation.

63.⁴¹ Mobile medical unit complies with general requirements for outpatient medical institutions referred to in Paragraph 23, in Sub-paragraph 24.4 and Paragraph 26 of this Regulation.

3.13. Requirements for medical treatment institution, which provides health care services at patient`s home

[10 December 2013]

63.⁴² Medical treatment institution, which provides health care services at patient's home (hereinafter - home health care), complies with general requirements regarding outpatient medical institutions in this Regulation.

63.⁴³ Medical treatment institution, which provides only home health care, complies with general requirements regarding medical treatment institutions in Sub-paragraph 6.1, in Paragraphs 7, 8, 9, 10, 12, 13, 15, 16, 17, 18 and 19 of this Regulation, as well as general requirements regarding outpatient medical institutions in Sub-paragraph 24.2 of this Regulation.

63.⁴⁴ Providing home health care, nurse or physician's assistant has in a bag:

63.⁴⁴1. device for indirect measurement of arterial blood pressure;

63.⁴⁴2. phonendoscope;

63.⁴⁴3. thermometer;

63.⁴⁴4. lighting equipment;

63.⁴⁴5. medicinal products to provide emergency medical care (in accordance with the procedures laid down by the head of medical treatment institution);

63.⁴⁴6. tools and devices that provide the basic requirements for hygienic and anti-epidemic measures;

63.⁴⁴7. disinfectants for hand, skin and surfaces;

63.⁴⁴8. container for the collection of used sharp items;

63.⁴⁴9. garbage bag for medical waste;

63.⁴⁴10. Personal protective equipment - disposable sterile and non-sterile gloves, aprons, muffs, hats, masks, surgical boots - selected in accordance with performed care procedure before it is started, making risk assessment for possible infectious diseases, as well as the level of risk of medical devices and environmental objects contamination;

63.⁴⁴11. work clothes;

63.⁴⁴12. personnel identification sign.

63.⁴⁵ Providing home health care, nurse or physician's assistant in accordance with medical manipulation prescribed to the appropriate person has in a bag:

63.⁴⁵1. device for determining the blood glucose level;

63.⁴⁵2. devices used for parenteral medicinal product and solution administration - syringes with needles available in different sizes, peripheral venous catheters, self-retained needles, intravenous drip systems, venous constrictor, infusion stand;

63.⁴⁵3. sterile wound dressing kit and non-sterile wound dressings;

63.⁴⁵4. sterile and non-sterile scalpels, scissors, tweezers;

63.⁴⁵5. sterile urinary catheters available at least in two sizes, urine collection bag;

63.⁴⁵6. adhesive sticking plasters, adhesive bandages;

63.⁴⁵7. devices used to prevent delaying bowel movement - enema kit;

63.⁴⁵8. Tracheostomy vacuum suction system if home health care is provided to the patient with tracheostomy.

63.⁴⁶ Providing medical rehabilitation services at home, physiotherapist, physiotherapist`s assistant, audio-speech therapist, ergo therapist, ergo therapist's assistant in accordance with the type of health care necessary for a patient has the minimum equipment kit required to achieve treatment goal in accordance with the procedures laid down by the head of medical treatment institution and Sub-paragraph 63.44 1, 63.44 2, 63.44 7, 63.44 10, 63.44 11 and 63.44 12 of this Regulation.

[10 December 2013]

4. Requirements for emergency medical assistance institutions

4.1. General Requirements

64. Emergency medical assistance institution is a medical treatment institution or its structural unit, which has dispatch centre and emergency medical assistance teams on duty providing 24-hour emergency medical assistance to population in a critical state of danger to life or health, as well as in emergency medical situations.

65. Emergency medical assistance institution, if it is an independent medical treatment institution, can found emergency medical assistance institution branches, as well as emergency medical assistance centres that are structural units of the appropriate institution.

66. Emergency medical assistance institution has:

66.1. premises for medical, administrative, technical services unit;

66.2. dispatch centre with premises and specially equipped workplaces;

66.3. personnel of emergency medical assistance team;

66.4. ambulance emergency response vehicles;

66.5. medical devices used for emergency medical assistance;

66.6. standby medical devices in accordance with risk assessment for emergency medical situations laid down in medical disaster plan;

66.7. communication tools.

67. To provide the operation of emergency medical teams, emergency medical assistance institution has the following premises:

67.1. staff recreation room;

67.2. room for staff clothing change and storage;

67.3. for staff hygiene needs;

67.4. for storage and exchange of medical devices and other equipment;

67.5. for storage of clean and dirty linen.

68. To provide the operation of dispatch centre, emergency medical assistance institution has:

68.1. telephone lines for emergency calls in accordance with load of emergency medical assistance institution, but not less than two;

68.2. direct telephone lines with multiprofile hospital emergency medical assistance and patient reception, State Fire and Rescue Service, State Police and emergency medical assistance institution structural units;

68.3. radio communications with emergency medical assistance teams, emergency medical assistance institution structural units, multiprofile hospital emergency medical assistance and patient reception, State Fire and Rescue Service and State Police;

68.4. continuous, automatic call recording process and recorded calls listening system with the possibility to archive records not less than three months;

68.5. record synchronization using the precise time-scale system;

68.6. registration of emergency medical assistance team emergency status;

68.7. automated data collection, storage and regular statistical analysis of amounts of activity, quality and operational efficiency;

68.8. on-call medical alert system for emergency medical assistance team;

68.9. backup power supply system;

68.10. detailed service area map with marked high-risk objects.

[9 March 2010; Sub-paragraph 68.2 comes into force from 1 January 2012, see Paragraph 183 ]

69. Emergency medical assistance centre is emergency medical assistance team`s (teams`) location area (premises), where emergency medical assistance team is staying outside of time emergency call implementation.

70. Emergency medical assistance centre has the following premises:

70.1. medical staff recreation room;

70.2. drivers` recreation room;

70.3. room for staff clothing change and storage;

70.4. for staff hygiene needs.

71. Personnel and medical resources replacement procedure at emergency medical assistance centre is laid down according to instructions of emergency medical assistance institution head.

4.2. Requirements for emergency medical assistance team

72. Emergency medical assistance team is emergency medical assistance mobile structural unit, which has ambulance emergency response vehicle that complies with the requirements referred to in Sub-paragraph 4.3 of this Regulation, communication facilities and medical equipment.

73. Emergency medical assistance team medical practitioners take theoretical and practical examinations for providing emergency medical assistance annually. Ambulance emergency response vehicle drivers are nursing assistants trained in extended first aid training program for ambulance emergency response vehicle drivers, are re-trained annually and take practical examinations.

74. Emergency medical assistance institution has at least one of the following emergency medical assistance team that consists at least of two medical practitioners:

74.1. physician assistant team;

74.2. intensive therapy team.

75. Emergency medical assistance physician assistant team consists of:

75.1. physician assistant certified in emergency medical assistance who is the head of emergency medical assistance physician assistant team;

75.2. medical practitioner (physician assistant or nurse) who is trained to provide emergency medical assistance;

75.3. ambulance emergency response vehicle driver.

76. Emergency medical assistance intensive therapy team consists of:

76.1. physician certified in emergency medical assistance who is the head of emergency medical assistance intensive therapy team;

76.2. physician assistant certified in emergency medical assistance or nurse certified in emergency medical assistance;

76.3. ambulance emergency response vehicle driver.

77. The head of emergency medical assistance institution to provide the specialized emergency medical assistance can create multiprofile specialized emergency medical assistance physicians teams. In this case, the head of the specialized emergency medical assistance physicians` team is the physician certified in emergency medical assistance or specialty in accordance with the profile of the specialized emergency medical assistance physicians` team. The specialized emergency medical assistance physicians` team consists of:

77.1. physician assistant certified in emergency medical assistance or nurse certified in emergency medical assistance;

77.2. ambulance emergency response vehicle driver.

78. If the specialized emergency medical assistance team provides emergency medical assistance in other medical treatment institution, the head of the appropriate team is the physician certified in the appropriate specialty in accordance with the profile of the team.

79. Nursing assistant can be included in emergency medical assistance teams referred to in Chapter 4 of this Regulation in accordance with the order of the head of the institution or the procedures for performing duties if nursing assistant is not included in the team can be laid down.

80. Medical practitioners prepared for providing emergency medical assistance can be included in emergency medical assistance teams referred to in Chapter 4 of this Regulation in accordance with the order of the head of the institution.

4.3. Requirements for ambulance emergency response vehicle

81. Ambulance emergency response vehicle is vehicle marked and equipped in accordance with the requirements, which is used to respond to calls for emergency medical assistance or to provide the mentioned assistance, as well as to transport such patients who may require emergency medical assistance during transport.

[15 July 2014]

82. Ambulance emergency response vehicle has:

82.1. mobile radio equipment certified and registered in accordance with the laws and regulations regarding the procedures for conformity assessment, distribution and utilization of radio equipment and electronic communications network terminal equipment;

82.2. medical equipment operating manuals, user manuals and guidelines for the maintenance (these documents are in the official language);

82.3. equipment is mounted and fixed so that during transport it will not be damaged and will not expose safety of persons in the cabin to danger;

82.4. flooring is durable and easy to clean;

82.5. a key locked compartment for medicinal products in the cabin;

82.6. all vehicle doors in the "OPEN" position are fixed and equipped with door locks in such a way they could be locked and unlocked without a key from the inside, locked with a key from the outside, as well as unlocked with a key from the outside, if they are locked from the inside. Driver receives acoustic or visual signals showing that one door is not in the fully closed position during movement of the vehicle;

82.7. at least one oxygen cylinder (with capacity not less than 10 l) is located in the rear compartment of the cabin;

82.8. medical infusion bag holders on the ceiling (the minimum infusion capacity is 5 kg) that provide the possibility to hang up two infusion bags separately with a standard infusion system, providing access to the patient's clavicle, elbow and ankle joint zones;

82.9. all seats are equipped with safety belts and headrests.

82.¹ Emergency medical assistance service may have other ambulance emergency response vehicles, which comply with the requirements referred to in Sub-paragraph 82.1 and 82.3 of this Regulation and are used to provide support to emergency medical assistance team.

[15 July 2014]

4.4. Provision of emergency medical assistance team with equipment and the minimum medical devices

83. Patient carrying devices:

83.1. main stretcher;

83.2. cup-shaped stretcher;

83.3. vacuum mattress;

83.4. chair used to carry a patient in a sitting position;

83.5. patient carrying mat;

83.6. long spine immobilization board with head immobilizer and security straps.

84. Injured patient immobilisation devices:

84.1. rigid collar immobilization kit;

84.2. splint kit for limb immobilization;

84.3. short segment spinal fixation device;

84.4. traction splint;

84.5. triangular medical scarves (at least four).

(Sub-paragraph 84.4 shall come into force from 1 January 2012, see Paragraph 183)

85. Pulmonary function equipment:

85.1. stationary oxygen cylinder with gas capacity at least 2000 l, equipped with a flow meter and regulating valve that provides the maximum capacity at least 15 l/min;

85.2. portable oxygen cylinder with gas capacity at least 400 l, equipped with a flow meter and regulating valve that provides the maximum capacity at least 15 l/min with at least two backup oxygen cylinders;

85.3. fixed (attached to the stationary oxygen supply system) portable oxygen inhalation device or stationary (fixed) and portable (portable) oxygen inhalation device;

85.4. fixed (attached to the stationary oxygen supply system) portable artificial lung ventilation system (provides artificial lung ventilation delivering variable oxygen concentration from 40% to 100%), which provides auxiliary ventilation modes, suitable for all age groups, battery powered and powered by electricity (220 V, 12 V);

85.5. fixed portable suction system, which provides the minimum negative pressure not less than 500 mm/Hg and the minimum capacity not less than 1000 ml, battery powered and powered by electricity (220 V, 12 V;

85.6. collection containers for inhaled medicinal products (children and adults);

85.7. positive end-expiratory pressure (PEEP) valve (adjustable or kit).

(Sub-paragraph 85.4 shall come into force from 1 January 2012, see Paragraph 183)

86. Diagnostic devices:

86.1. device for non-invasive measurement of arterial blood pressure (cuffs available in sizes from 10 cm to 60 cm at least);

86.2. phonendoscope;

86.3. thermometer;

86.4. glucometer (with stripes);

86.5. pen-type flashlight.

87. Devices for preventing life-threatening complications:

87.1. defibrillator with monitor, 12-lead electrocardiograph module (or a separate device), external pacemaker, pulse oximeter module (or a separate device), non-invasive blood pressure module, data transmission module and a print device;

87.2. bag with life support devices:

87.2.1. manually operated ventilator with transparent or translucent masks for all age groups, with a reservoir and the possibility of oxygen supply;

87.2.2. oropharyngeal and nasopharyngeal airway kit;

87.2.3. mechanical suction device (pump);

87.2.4. airway suction catheters (rigid, flexible);

87.2.5. coniotomy kit;

87.2.6. laryngoscope (metal, with handle and the appropriate mirrors);

87.2.7. Mulligan`s forceps;

87.2.8. conductor;

87.2.9. endotracheal intubation tubes (for all age groups) with connectors;

87.2.10. cuff inflation syringe;

87.2.11. intubation tube fixing materials;

87.2.12. phonendoscope;

87.2.13. infusion tools, including peripheral venous access catheters (available in different sizes) and their fixing materials, intravenous systems and syringes with needles;

87.3. interosseous access kit;

87.4. kit for puncture the pleural cavity;

87.5. nebuliser;

87.6. perfusor.

(Sub-paragraph 87.6 shall come into force from 1 January 2012, see Paragraph 183)

88. Care equipment:

88.1. wound-dressing materials and materials used to stop external bleeding:

88.1.1. dressings;

88.1.2. tourniquet to stop arterial bleeding;

88.2. materials used for coating of burns and local effects caused by chemicals;

88.3. cooling package;

88.4. blankets (at least two);

88.5. bed linen (one set);

88.6. human corpse covering sheet;

88.7. sickness bag;

88.8. kidney shaped tray;

88.9. urine collection container (unbreakable);

88.10. bladder catheterization kit (disposable, lubricated);

88.11. waste container;

88.12. disposable gastric probes (for all age groups) with a funnel for water intake (lubricated);

88.13. non-sterile disposable gloves;

88.14. emergency childbirth medical kit (disposable);

88.15. replantation container that provides an internal temperature not more than 4 ± 2 °C at least two hours;

88.16. refrigerator;

88.17. medicinal product administration devices (at least two kits):

88.17.1. syringes with needles;

88.17.2. small veins puncture needles;

88.17.3. peripheral venous catheters;

88.17.4. intravenous systems;

88.18. thermal container with support of infusion solution temperature;

88.19. infusion stand.

89. Safety and rescue devices:

89.1. materials used for hand, skin and surfaces cleaning and disinfection;

89.2. victim sorting cards (at least 10);

89.3. safety belts and clothing cutting tool;

89.4. portable projector.

90. Personal protective equipment:

90.1. basic protective clothing with reflective vest and identification sign of staff position;

90.2. protective gloves and safety footwear;

90.3. safety helmet;

90.4. vest with the sign "Head physician".

(Sub-paragraph 90.4 shall come into force from 1 January 2011, see Paragraph 182)

91. The number of equipment units for emergency medical assistance institution intensive therapy team, medical devices and medicinal products necessary for emergency medical assistance, which should be placed in the vehicle, is laid down in accordance with the average daily load of intensive therapy team, current and planned number of cases of the provision of emergency medical assistance.

5. Requirements for in-patient medical treatment institutions

5.1. General Requirements

92. A hospital is a medical treatment institution, where a patient is provided with emergency medical assistance, diagnosis, as well as medical treatment. A patient is under constant and continuous 24-hour care and control of medical practitioners until a certain diagnostics or level of medical treatment is reached.

93. In-patient medical treatment institutions are:

93.1. multiprofile hospital;

93.2. university hospital;

93.3. specialized hospital;

93.4. care hospital.

94. In-patient medical treatment institution has the following structural units:

94.1. in-patient units, where a patient is provided with a bed and is under 24-hour care;

94.2. patient reception area;

94.3. structural units that carry out medical treatment, but do not provide a bed;

94.4. structural units that perform the functions related to medical treatment:

94.4.1. disinfection and sterilization unit;

94.4.2. diagnostic, laboratory and patient functional ability assessment structural units;

94.4.3. pathology unit with a mortuary or storage facilities for human corpses;

94.5. administration;

94.6. technical services units.

95. In-patient medical treatment institution may not have the structural units referred to in Sub-paragraph 94.4.1, 94.4.2 and 94.4.3 of this Regulation. In this case in-patient medical treatment institution concludes the agreements with other institutions that provide the appropriate services.

96. In-patient medical treatment institution in accordance with services provided in addition to the structural units referred to in Paragraph 94 of this Regulation may have the following structural units:

96.1. intensive therapy unit;

96.2. diagnostic radiology unit;

96.3. endoscopy unit;

96.3.1. gastrointestinal endoscopy unit;

96.3.2. respiratory endoscopy unit;

96.4. outpatient department;

96.5. operating suite;

96.6. anaesthesiology service;

96.7. blood bank;

96.8. physical medicine unit;

96.9. rehabilitation unit;

96.10. medical laboratory;

96.11. clinical physiology laboratory;

96.12. day patient department.

97. In medical treatment institution turnover of medicinal products is organized in accordance with the laws and regulations regarding the procedures for purchasing, storage, use, accounting and destruction of medicinal products in medical treatment institutions.

98. In in-patient medical treatment institution patients are provided with:

98.1. 24-hour bed and meal;

98.2. technical possibility to call medical practitioner on duty from any hospital room or WC at any time.

99. In-patient medical treatment institutions provide functional and instrumental diagnostic examinations:

99.1. in case of emergency medical assistance - within one hour;

99.2. in case of urgent medical assistance - within 24 hours;

99.3. in case of planned medical assistance - within 72 hours.

100. In-patient medical treatment institution in accordance with services provided in addition to the structural units referred to in Paragraph 96 of this Regulation may have the following profile-corresponding structural units:

100.1. care unit;

100.2. rehabilitation unit providing the second phase of medical rehabilitation services;

100.3. childbirth unit;

100.4. paediatric units;

100.4.1. common paediatric disease unit;

100.4.2. different profile paediatric diseases unit;

100.4.3. neonatal pathology unit;

100.4.4. neonatal intensive care unit;

100.5. psychiatric profile:

100.5.1. psychiatric unit;

100.5.2. psychiatric rehabilitation unit;

100.5.3. acute mental health unit;

100.6. narcology profile:

100.6.1. emergency narcology treatment unit;

100.6.2. psychotherapy unit;

100.6.3. narcology rehabilitation unit;

100.7. internship profile:

100.7.1. internal disease unit;

100.7.2. cardiology unit;

100.7.3. rheumatology unit;

100.7.4. lung disease and tuberculosis unit;

100.7.5. endocrinology unit;

100.7.6. nephrology unit;

100.7.7. gastroenterology unit;

100.7.8. chemotherapy unit;

100.7.9. haematology unit;

100.7.10. autologous peripheral blood stem cell (bone) marrow transplantation unit;

100.7.11. allogeneic and autologous peripheral blood stem cell (bone) marrow transplantation unit;

100.7.12. neurology unit;

100.7.13. infectious disease unit;

100.7.14. dermatology and venereology unit;

100.7.15. radiation therapy unit with a closed source of ionizing radiation;

100.7.16. radionuclide therapy unit;

100.7.17. palliative care unit;

100.8. surgical profile:

100.8.1. surgical unit;

100.8.2. neurosurgery unit;

100.8.3. thoracic surgery unit;

100.8.4. cardiac surgery unit;

100.8.5. vascular surgery unit;

100.8.6. haemodialysis unit;

100.8.7. urology unit;

100.8.8. plastic surgery unit;

100.8.9. transplantation unit;

100.8.10. traumatology and orthopaedics unit;

100.8.11. thermal tissue damage unit;

100.8.12. gynaecology unit;

100.8.13. ophthalmology unit;

100.8.14. otorynolaringology unit;

100.8.15. oral and maxillofacial surgery unit.

101. In-patient medical treatment institution outpatient department, medical specialist offices, rehabilitation unit and day hospital comply with the requirements for outpatient medical treatment institutions referred to in Chapter 3 of this Regulation.

102. Structural units of in-patient medical treatment institutions referred to in Paragraph 101 of this Regulation in addition to the requirements referred to in Chapter 3 of this Regulation have:

102.1. at least one WC and shower room for persons with functional disorders on every floor;

102.2. one functional bed not less than 2 m in length in every hospital ward.

[10 December 2013]

5.2. Requirements for multiprofile hospital

103. Multiprofile hospital provides comprehensive secondary and selective tertiary inpatient care, professional secondary outpatient care, emergency medical assistance, as well as provides 24-hour availability of specialized secondary health care.

104. Multiprofile hospital provides the following medical specialists to be on duty 24 hours:

104.1. medical internship;

104.2. surgery;

104.3. anaesthesiology and reanimation.

105. Multiprofile hospital emergency medical assistance and patient reception provide the availability of the following functional and instrumental diagnostic examinations:

105.1.rentgenoscopy;

105.2. roentgenography;

105.3. ultrasonography (comprehensive);

105.4. computed tomography;

105.5. monitoring of vital functions in clinical physiology;

105.6. digestive system endoscopy;

105.7. airway endoscopy.

106. Multiprofile hospital provides training of residents. The hospital provides medical practitioners who have rights approved by the Latvian Medical Association to train students and medical practitioners in certain specialties, as well as training rooms suitable for theoretical training of residents and medical literature, access to the Internet and other electronic resources.

107. Multiprofile hospital for continuity and succession of treatment process provides the vehicle to transport patients (including on supine position).

108. Multiprofile hospital is provided with an alternative or autonomous power source - generator - that provides power supply to hospital reception, intensive care unit and surgical unit in case of external power disruption.

(Paragraph shall come into force from 1 January 2011; see Paragraph 182)

109. Closed type pharmacy can be founded in multiprofile hospital. Conformity of closed type pharmacy is assessed in accordance with the laws and regulations governing pharmaceutical activities.

110. Multiprofile hospital has:

110.1. medical laboratory accredited in accordance with the standard LVS EN ISO 15189:2013 "Medical laboratories. Particular requirements for quality and competence";

110.2. diagnostic radiology unit:

110.2.1. roentgen-diagnostic office (with the possibility to perform roentgenoscopy and roentgenography);

110.2.2. ultrasonography office;

110.2.3. computed tomography office;

110.3. clinical physiology laboratory with ECG office;

110.4. endoscopy office:

110.4.1. digestive system endoscopy office;

110.4.2. airway endoscopy office.

[29 May 2012; 10 December 2013]

111. Multiprofile hospital has a separate reception area for patients requiring planned treatment and for patients requiring emergency treatment, or common reception area, in which patient flow is divided in accordance with the type of hospitalization.

112. Multiprofile hospital emergency medical assistance and patient reception have the following premises for:

112.1. waiting and patient registration;

112.2. patient examination;

112.3. stabilization of life-sustaining functions;

112.4. medical procedures and manipulations;

112.5. hygiene needs of patients, including separate shower rooms;

112.6. isolation of patients with infectious diseases;

112.7. control and isolation of dangerous and aggressive patients;

112.8. decontamination of contaminated patients, with separate entrance;

112.9. outpatient examinations;

112.10. storage of immobilization equipment exchange fund;

112.11. staff clothing change and storage;

112.12. staff hygiene needs;

112.13. staff recreation;

112.14. WC and separate shower room for persons with functional disorders.

[10 December 2013]

113. Multiprofile hospital emergency medical care and patient reception equipment exchange fund (it is used for the exchange with emergency medical assistance team equipment) has the following medical devices:

113.1. rigid cervical immobilization collars;

113.2. long spine immobilization boards;

113.3. traction splints to immobilize femoral fractures;

113.4. rigid splints to immobilize limbs;

113.5. vacuum mattresses.

114. Multiprofile hospital emergency medical assistance and patient reception room for stabilization of life-sustaining functions provides:

114.1. control of the following parameters:

114.1.1.patient's heart rate and blood circulation (electrocardiogram, arterial blood pressure), using non-invasive methods;

114.1.2. pulmonary function and ventilation;

114.1.3. haemoglobin oxygen saturation (pulse oximetry);

114.1.4. body temperature;

114.2. at least one movable functional bed with a centralized oxygen supply system;

114.3. medical devices intended for the following medical procedures:

114.3.1. artificial lung ventilation;

114.3.2. to relieve airway obstruction;

114.3.3. long-term precise dosed parenteral medicinal product and solution administration (perfusors, infusion suction systems);

114.3.4. defibrillation;

114.3.5. provision of oxygen during transport of patients.

114.¹ If multiprofile hospital has a separate reception for patients requiring emergency medical treatment and reception for patients requiring planned medical treatment, the requirements referred to in Sub-paragraphs 112.1, 112.2, 112.5, 112.11, 112.12, 112.13 and 112.14 of this Regulation are applied to multiprofile hospital reception for patients requiring planned medical treatment.

[10 December 2013]

5.3. Requirements for university hospital

115. University hospital is a multi-profile hospital, which provides the conditions appropriate for studies and research process, rooms equipped in the accordance with teaching staff, students and researchers` needs, technical support and infrastructure.

116. University hospital complies with the requirements for multiprofile hospital referred to in Sub-paragraph 5.2 of this Regulation.

117. Clinics are founded by university hospital in accordance with the university`s constitution and on the basis of the agreement concluded with medical treatment institution. University hospital implements academic education and research programs and projects, as well as provides medical services at least in three clinics according to their area of activity.

118. University`s lecturers who have an employment relationship with the hospital and their area of activity complies with the profile of medical treatment institution are working in university hospital.

5.4. Requirements for specialized hospital

119. Specialized hospital provides specialized secondary or tertiary health care in one or more profiles and provides secondary outpatient assistance. Specialized hospital provides the availability of at least one physician to be on duty 24 hours.

120. Specialized hospital emergency medical assistance and patient reception have the following rooms for:

120.1. waiting and patient registration;

120.2. patient examination;

120.3. medical procedures and manipulations;

120.4. hygiene needs of patients, including separate shower rooms;

120.5. isolation of patients with infectious diseases and for control of patients, if a diagnosis is uncertain, as well as control and isolation of dangerous and aggressive patients;

120.6. physicians and physician assistants` work;

120.7. nurses` work;

120.8. staff clothing change and storage;

120.9. staff hygiene needs;

120.10. staff recreation;

120.11. WC and separate shower room for persons with functional disorders.

[10 December 2013]

121. Specialized hospital reception of injured patients has equipment exchange fund (it is used for the exchange with emergency medical assistance team equipment) that consists of the following medical devices:

121.1. rigid cervical immobilization collars;

121.2. long spine immobilization boards;

121.3. traction splints to immobilize femoral fractures;

121.4. rigid splints to immobilize limbs;

121.5. vacuum mattresses.

122. Specialized rehabilitation hospital has:

122.1. in-patient unit;

122.2. out-patient department, which has at least:

122.2.1. physical medicine and rehabilitation physician's office;

122.2.2. functional ability assessment laboratory;

122.2.3. functional specialist offices.

123. Specialized rehabilitation hospital provides:

123.1. assessment of the patient`s health status, determining the most appropriate reception time (performs selection of patients), reception and development of individual rehabilitation plan in accordance with patient's diagnosis, limitations in functional ability and social situation;

123.2. use of rehabilitation technologies in the necessary amount and quality in accordance with the rehabilitation plan;

123.3. development of a post-treatment care and social rehabilitation plan for the patient after discharge from a hospital;

123.4. control of further results.

5.5. Requirements for care hospital

124. Care hospital is a medical treatment institution, where a patient is provided with in-patient health care after prevention of exacerbation in disease until a certain level of medical treatment is reached, if he has a long-term or chronic disease. Care hospital does not require a physician to be on duty 24-hours.

125. Care hospital patient reception has the following rooms for:

125.1. waiting and patient registration;

125.2. patient examination (can be combined with room for medical procedures and manipulations);

125.3. medical procedures and manipulations;

125.4. hygiene needs of patients, including separate shower rooms;

125.5. isolation of patients with infectious diseases;

125.6. control of patients, if a diagnosis is uncertain;

125.7. control and isolation of dangerous and aggressive patients;

125.8. WC and separate shower room for persons with functional disorders.

[10 December 2013]

126. Care hospital patient reception has medical devices to carry out the following medical activities:

126.1. physical examination of a patient (phonendoscope and device used for measuring indirect blood pressure);

126.2. providing the basic requirements for hygienic and anti-epidemic measures, including personal protective equipment;

126.3. parenteral medicinal product and solution administration;

126.4. to stop external bleeding;

126.5. to treat and to dress wounds;

126.6. collection, storage and transport of microbiology samples;

126.7. transport of patients.

127. Care hospital inpatient unit has:

127.1. patient wards;

127.2. patient shower or bath room;

127.3. patient WC;

127.4. patient recreation room;

127.5. clean linen warehouse;

127.6. laundry warehouse;

127.7. room for medical procedures;

127.8. rooms for storage of patient care products;

127.9. rooms for physicians and nurses` work;

127.10. rooms for staff clothing change and storage;

127.11. rooms for staff hygiene needs;

127.12. staff recreation rooms;

127.13. rooms for medical and social rehabilitation.

5.6. Requirements for in-patient units

5.6.1. Requirements for intensive care unit

128. In an intensive care unit a patient is under constant care and control of medical practitioners, is provided with intensive treatment, control, maintenance and support of life-sustaining functions, as well as anaesthesia. Basic item of an intensive care unit is one intensive care bed.

129. If necessary, an intensive care unit provides the isolation of a patient. There is an auxiliary room for washing hands and staff clothing change in the isolation ward. Isolation instructions are placed at the entrance to the ward. Contaminated medical equipment and patient care devices are disposed separately.

130. In an intensive care unit:

130.1. staff has free access to a patient's bed headboard and power sockets;

130.2. staff sees a wall clock;

130.3. fluorescent lighting;

130.4. telephone communication within the unit and the hospital and visual alarm system;

130.5. functional beds.

131. Intensive care unit has:

131.1. autonomous centralized power supply system for backup supply to medical devices supporting life-sustaining functions in case of centralized power outage;

131.2. emergency lightning;

131.3. one-level flooring.

(Sub-paragraph 131.1 shall come into force from 1 January 2011, see Paragraph 182)

132. A patient bed in the intensive care unit is provided with the control of the following parameters:

132.1. patient heart rate and blood circulation (electrocardiogram, arterial blood pressure, using non-invasive methods; arterial blood pressure, using invasive methods);

132.2. pulmonary function and ventilation;

132.3. haemoglobin oxygen saturation (pulse oximetry);

132.4. body temperature (peripheral and central).

133. A patient bed in the intensive care unit is provided with the central oxygen supply system and medical devices to carry out the following medical procedures:

133.1. to relieve airway obstruction (tracheal intubation, cricothyrotomy and tracheotomy);

133.2. oxygen inhalation (medical device kit contains a flow meter and humidifier);

133.3. artificial lung ventilation (power-operated);

133.4. long-term precise dosed parenteral medicinal product and solution administration (perfusors, infusion suction systems);

133.5. defibrillation;

133.6. provision of oxygen during transport of patients.

5.6.2. Requirements for operating suite

134. Operating suite has:

134.1. sanitary facilities for staff (with the pass for entrance);

134.2. operating room;

134.3. room for preoperative hand-washing;

134.4. room for sterile medical devices;

134.5. room for non-sterile medical devices;

134.6. room for patient monitoring after general anaesthesia;

134.7. room for storage of surgical equipment (devices, instruments).

135. In operating rooms and room for preoperative hand-washing a complete aseptic technique is observed. In operating rooms outside the operating suite, decreased aseptic technique can be defined, if aseptic level is not significantly affected.

5.6.3. Requirements for Anaesthesiology care service

136. Anaesthesiology care service provides anaesthesia and support of life-sustaining functions to patients:

136.1. during surgical actions and manipulations;

136.2. pre-anaesthesia and post-anaesthesia care;

136.3. pain management;

136.4. intensive care and reanimation, if Anaesthesiology unit and intensive care unit are combined;

136.5. using detoxification methods, if Anaesthesiology unit and intensive care unit are combined.

137. Volatile anaesthetics for general anaesthesia are used in rooms where the patient`s exhaled air output is provided.

138. In multi-profile hospitals, specialized hospitals and university hospitals` operating room for general and local anaesthesia Anaesthesiology care service provides the possibility to monitor the following parameters:

138.1. patient's heart rate and blood circulation (electrocardiogram, arterial blood pressure, using non-invasive methods; arterial blood pressure using invasive methods);

138.2. pulmonary function and ventilation (respiratory volume, minute ventilation volume, airway pressure, concentration of carbon dioxide in exhaled air);

138.3. haemoglobin oxygen saturation (pulse oximetry);

138.4. body temperature;

138.5. neuromuscular control, using muscle relaxants.

5.6.4. Requirements for Childbirth Unit

139. Activity of Childbirth Unit is provided by Surgical Unit, Anaesthesiology Unit and Blood Bank.

140. Childbirth Unit has Childbirth Section that consists of:

140.1. reception;

140.2. prenatal examination room;

140.3. at least two prenatal wards;

140.4. operating room for Labour and delivery;

140.5. patient shower room;

140.6. patient WC;

140.7. WC and shower room for patients with functional disorders.

[10 December 2013]

141. Childbirth Unit has Postnatal Section that consists of:

141.1. neonatal care room;

141.2. postnatal examination room;

141.3. wards for mother with baby;

141.4. patient shower room;

141.5. patient WC;

141.6. room for storage of clean linen;

141.7. room for storage of dirty linen;

141.8. WC and shower room for patients with functional disorders.

[10 December 2013]

142. Neonatal care room has:

142.1. thermal medical table;

142.2. staff has free access to a patient's bed headboard;

142.3. lighting devices;

142.4. staff sees a clock with time fixation;

142.5. neonatal physiological care is provided and, if necessary - reanimation, as well as the possibility to monitor the following parameters:

142.5.1. patient's pulmonary function, heart rate and blood circulation (pulmonary function, electrocardiogram, arterial blood pressure, using non-invasive methods);

142.5.2. haemoglobin oxygen saturation (pulse oximetry).

143. A patient bed in neonatal care room is provided with the central oxygen supply system with the possibility to regulate oxygen concentration, Oxygen heater and humidifier and equipment intended:

143.1. for provision of normothermia;

143.2. to relieve airway obstruction and aspiration;

143.3. positive pressure breathing;

143.4. long-term precise dosed parenteral medicinal product and solution administration (perfusors);

145.5. provision of oxygen during transport of patients.

5.6.5. Requirements for Neonatal intensive care unit

144. A ward in Neonatal intensive care unit has:

144.1. staff has free access to a patient's bed headboard and power sockets;

144.2. staff sees a clock with time fixation;

144.3. fluorescent lighting;

144.4. telephone communication;

144.5. visual alarm system within the Unit;

144.6. the central oxygen supply system with the possibility to regulate oxygen concentration and Oxygen heater and humidifier;

144.7. compressed air supply system;

144.8. medical devices to carry out the following treatment activities:

144.8.1. power-operated artificial lung ventilation;

144.8.2. to relieve airway obstruction and aspiration;

144.8.3. for provision of normothermia;

144.8.4. maintenance of infusion solution at a suitable temperature and lightning;

144.8.5. long-term precise dosed parenteral medicinal product and solution administration (perfusors, infusion suction systems);

144.8.6. provision of normothermia and oxygen during transport of patients.

145. A patient bed in a ward in Neonatal intensive care unit is provided with the possibility to monitor the following parameters:

145.1. patient's heart rate and blood circulation (electrocardiogram and arterial blood pressure, using non-invasive methods);

145.2. pulmonary function and ventilation;

145.3. haemoglobin oxygen saturation (pulse oximetry);

145.4. body temperature (peripheral and central).

146. Neonatal intensive care unit has:

146.1. autonomous centralized power supply system for backup supply to medical devices supporting life-sustaining functions in case of centralized power outage;

146.2. emergency lightning;

146.3. one-level flooring.

(Sub-paragraph 146.1 shall come into force from 1 January 2011, see Paragraph 182)

147. If necessary, Neonatal intensive care unit provides the isolation of a patient. Individual isolation instruction is placed at the entrance to the ward, which lays down the disposal of medical products and patient care equipment. Contaminated medical equipment and patient care devices are disposed separately.

5.6.6. Requirements for Neonatal pathology unit

148. A patient bed in a room for stabilization of vital functions in Neonatal pathology unit

148.1. is provided with the possibility to monitor the following parameters:

148.1.1. patient's heart rate and blood circulation (electrocardiogram, arterial blood pressure, using non-invasive methods);

148.1.2. pulmonary function and ventilation;

148.1.3. haemoglobin oxygen saturation (pulse oximetry);

148.1.4. central and peripheral body temperature;

148.2. is provided with the central oxygen supply system with the possibility to regulate oxygen concentration and Oxygen heater and humidifier;

148.3. medical devices to carry out the following treatment activities:

148.3.1. to relieve airway obstruction and aspiration;

148.3.2. for provision of normothermia;

148.3.3. long-term precise dosed parenteral medicinal product and solution administration (perfusors, infusion suction systems);

148.3.4. maintenance of infusion solution at a suitable temperature and lightning;

148.3.5. provision of normothermia and oxygen during transport of patients.

5.6.6.¹ Requirements for Perinatal Care Centre

[10 December 2013]

148.¹ Perinatal Care Centre is a medical treatment institution structural unit, which provides diagnostic and medical treatment to the patient in case of complications during pregnancy (diagnosis and treatment of pregnancy pathology in cases of fetal anomaly, as well as necessity of invasive procedures), during childbirth and neonatal perinatal period (from 22 full weeks pregnant till 7 full days after baby`s birth).

148.² Perinatal care centre has:

148.²1. prenatal diagnostics unit;

148.²2. childbirth Unit;

148.²3. neonatal intensive care unit.

148.³ Perinatal Care Centre Prenatal Diagnostics Unit has:

148.³1. ultrasound Unit (ultrasonography) with ultrasound device (not older than seven years) with:

148.³1.1. abdominal probe with a frequency not less than 5 MHz;

148.³1.2. vaginal probe with a frequency not less than 7 MHz;

148.³1.3. the zoom option;

148.³1.4. the possibility to repeat the last action (cineloop function) with the smallest measurement step, not more than 0.1 mm;

148.³1.5. colour or power Doppler function;

148.³1.6. obstetrics and gynaecology and First Trimester Screening Program and Fetal Echocardioscopy Program;

148.³2. invasive manipulations room.

148.⁴ Perinatal Care Centre Childbirth Unit provides the following physicians to be on duty 24-hours:

148.⁴1. gynaecologist, maternal - fetal medicine specialist;

148.⁴2. obstetrician;

148.⁴3. neonatologist;

148.⁴4. anaesthetist, reanimatologist;

148.⁴5. operating room nurse;

148.⁴6. children's nurse.

148.⁵ In Perinatal Care Centre Childbirth Unit 24 hours a day are available:

148.⁵1. devices and human resources to carry out epidural analgesia, spinal anaesthesia and general anaesthesia, as well as anaesthesia equipment used for the provision of anaesthesia;

148.⁵2. medical laboratory.

148.⁶ Perinatal Care Centre Childbirth Unit in addition to the requirements specified for Childbirth Unit has:

148.⁶1. single maternity rooms with functional delivery beds - tables in every room;

148.⁶2. one cardiotocograph (external) per delivery bed, including at least two with the possibility of twin monitoring;

148.⁶3. at least one invasive fetal monitoring device during delivery, which provides fetal electrocardiogram analysis of the ST segment (STAN) or fetal scalp pH sampling;

148.⁶4. at least one perfusion pump (perfusor) per delivery bed, at least one infusion pump for solution administration, device for heating of administered infusion solution;

148.⁶5. adjustable-flow oxygen supply system not less than 15 l/ min with a flow meter and oxygen humidifier, connected to an adult breathing circuit with disposable mask with reservoir to supply free flow of oxygen (to woman in labour);

148.⁶6. no shadow surgical lamp;

148.⁶7. vital functions monitor (suitable for non-invasive blood pressure, hemoglobin oxygen saturation (pulse oximetry SpO2), pulse frequency measurement) at least one per three delivery beds with cuffs and sensors for adults and neonates;

148.⁶8. adult reanimation devices;

148.⁶9. at least two vacuum systems with adjustable negative pressure for adult and neonates needs, including one suitable for vacuum extraction;

148.⁶10. neonatal warming and resuscitation table, inspiratory and expiratory pressure-controlled ventilation system with adjustable oxygen concentration (built-in or separate);

148.⁶11. at least one endotracheal intubation kit (the laryngoscope`s tongues of sizes 0 and 1) with not less than two intubation tubes of each size suitable for neonates - 2.5 mm, 3 mm, 3.5 mm and 4 mm;

148.⁶12. neonatal transport incubator for transport of infants at a hospital.

(Sub-paragraph 148.6 3 shall come into force from 1 January 2015, see Paragraph 186)

148.⁷ Perinatal Care Centre Neonatal intensive care unit provides the following physicians to be on duty 24-hours:

148.⁷1. neonatologist;

148.⁷2. children's nurse (at least one per three beds).

148.⁸ Perinatal Care Centre Neonatal intensive care unit in addition to the requirements specified for Neonatal intensive care unit has:

148.⁸1. devices for providing optimal new-borns' temperature (the number of devices is equal to the number of beds) (open reanimation systems or incubators);

148.⁸2. at least one resuscitation table or other surface suitable for resuscitation with heat emitter and reanimation devices;

148.⁸3. inspiratory and expiratory pressure-controlled ventilation system with adjustable oxygen concentration (built-in or separate);

148.⁸4. at least one endotracheal intubation kit (the laryngoscope`s tongues of sizes 0 and 1) with at least two intubation tubes of each size suitable for neonates - 2.5 mm, 3 mm, 3.5 mm and 4 mm;

148.⁸5. patient bed in addition to the specified in sub-paragraph 148.1 is provided with at least one invasive blood pressure measuring device;

148.⁸6 one monitor with electroencephalography module or separate electroencephalography device;

148.⁸7. at least three perfusion pumps (perfusors) per one reanimation bed;

148.⁸8 at least one vacuum pump with sphygmomanometer and adjustable vacuum per two beds;

148.⁸9. at least one phototherapy lamp per two patient beds;

148.⁸10. disposable exchange transfusion kit;

148.⁸11. thoracentesis kit;

148.⁸12. movable procedure table with devices and medicinal products for neonatal emergency medical care;

148.⁸13. positioning devices;

148.⁸14. no shadow surgical lamp;

148.⁸15. fume cupboard to prepare medicinal products;

148.⁸16. device for the preparation of parenteral nutrition;

148.⁸17. patient bed is provided with the central oxygen (two sockets) and compressed air supply system (two sockets), which using available devices allows to provide respiratory support with adjustable oxygen concentration:

148.⁸17.1. each patient bed is provided with at least one oxygen outlet with a flowmeter; oxygen flow lower than 10 l/min, additionally 1 low-flow rotameter;

148.⁸17.2. at least two neonatal non-invasive respiratory support devices that provide continuous positive airway pressure (CPAP) per three patient beds;

148.⁸17.3. one artificial lung ventilation apparatus suitable for neonates (including with a low birth weight) per three patient beds;

148.⁸18. each patient bed is provided with at least 12 grounded electrical outlets;

148.⁸19. radiological diagnostic devices (movable equipment, examination is carried out on-site in the Unit):

148.⁸19.1. roentgenography;

148.⁸19.2. ultrasonography with the possibility to carry out neurosonoscopy, abdominal sonography and echocardioscopy.

(Sub-paragraphs 148.8 3, 148.8 15, 148. 8 16 and 148.8 17 shall come into force from 1 January 2015, see Paragraph 186)

5.6.7. Requirements for Psychiatric Unit

149. There are special window and door latches and locks in Psychiatric Unit, as well as more window and door latches and locks in the Patient observation ward.

150. Psychiatric Unit where patients with acute mental illnesses are placed has the electroconvulsive therapy apparatus.

5.6.8. Requirements for Allogeneic and autologous peripheral blood stem-cell and bone marrow transplantation unit

151. To go in the Allogeneic and autologous peripheral blood-stem cell and bone marrow transplant unit staff has to pass through sanitary room, using their passes. In the sanitary room staff has to put on sterile clothing and shoes, but leaving the room staff takes clothing and shoes off.

152. To provide diagnostic, treatment and patient care services, the Allogeneic and autologous peripheral blood-stem cell and bone marrow transplant unit has:

152.1. a room for stabilization of vital functions;

152.2. beds in the Intensive care unit;

152.3. procedure room;

152.4. a room for storage of patient care products;

152.5. rooms for physicians` work;

152.6. rooms for nurses` work;

152.7. rooms for staff clothing change and storage;

152.8. rooms for staff hygiene needs;

152.9. rooms for staff rest breaks.

153. A patient bed in the room for stabilization of vital functions in the Allogeneic and autologous peripheral blood-stem cell and bone marrow transplant unit:

153.1. is provided with the possibility to monitor the following parameters:

153.1.1. patient's heart rate and blood circulation (electrocardiogram and arterial blood pressure, using non-invasive methods);

153.1.2. pulmonary function and ventilation;

153.1.3. haemoglobin oxygen saturation (pulse oximetry);

153.1.4. body temperature;

153.2. is provided with the central adjustable oxygen supply system;

153.3. medical devices to carry out the following medical procedures:

153.3.1. artificial lung ventilation (power-operated);

153.3.2. to relieve airway obstruction;

153.3.3. long-term precise dosed parenteral medicinal product and solution administration (perfusors, infusion suction systems);

153.3.4. defibrillation;

153.3.5. provision of oxygen supply during transport of patients.

5.6.9. Requirements for Infectious Disease Unit

154. Premises layout of the Infectious Disease Unit provides the possibility to place in the Unit patients with at least two various infectious diseases:

154.1. with infectious diseases transmitted in air-drop way;

154.2. with other infectious diseases.

155. Infectious Disease Unit provides:

155.1. complete isolation of patients and staff for work in dangerous infectious diseases conditions;

155.2. processing and disinfection of the infected material;

155.3. special immunobiological prevention and treatment of infectious diseases;

155.4. WC and shower room for patients with functional disorders.

[10 December 2013]

5.6.10. Requirements for Radionuclide Therapy Unit

156. Radionuclide Therapy Unit is closed to general (public) access. Radionuclide Therapy Unit is control and monitoring area.

157. Radionuclide Therapy Unit Control area has the following rooms:

157.1. Patient wards with individual WC and shower rooms with discharge of wastewater into wastewater storage tanks intended for the storage until the decay of radioactive contamination, and nurse call system;

157.2. a room for stabilization of vital functions;

157.3. a room for storage of linen used by patients until the decay of radioactive contamination;

157.4. rooms for storage, packing and administration of radioactive pharmaceuticals;

157.5. rooms for storage of reusable instruments, devices and accessories until the decay of radioactive contamination;

157.6. a room for temporary storage of solid radioactive waste until the transfer to the authorities authorized to carry out disposal of radioactive waste and long-term storage;

157.7. wards for patients with functional disorders, equipped with individual WC and shower rooms, with discharge of wastewater into wastewater storage tanks intended for the storage until the decay of radioactive contamination, and nurse call system.

[10 December 2013]

158. Radionuclide Therapy Unit Monitoring area has the following rooms:

158.1. rooms for staff hygiene needs and a room with storage lockers for work clothes;

158.2. a room for storage of care products.

159. A patient bed in the room for stabilization of vital functions in the Radionuclide Therapy Unit has a monitoring device that provides monitoring of the following parameters:

159.1. patient's heart rate and blood circulation (electrocardiogram and arterial blood pressure, using non-invasive methods);

159.2. pulmonary function and ventilation;

159.3. haemoglobin oxygen saturation (pulse oximetry);

159.4. body temperature.

160. Patient beds in the room for stabilization of vital functions in the Radionuclide Therapy Unit are provided with the central oxygen supply system and devices intended for:

160.1. artificial lung ventilation (power-operated);

160.2. to relieve airway obstruction;

160.3. long-term precise dosed parenteral medicinal product and solution administration (perfusors, infusion suction systems);

160.4. defibrillation;

160.5. provision of oxygen during transport of patients.

5.6.11. Requirements for Radiotherapy Unit with closed sources of ionizing radiation and equipment generating ionizing radiation

161. Radiotherapy Unit with closed sources of ionizing radiation and equipment generating ionizing radiation has:

161.1. waiting room;

161.2. a room for physicians` work;

161.3. patient WC;

161.4. rooms for staff clothing change and storage;

161.5. rooms for staff hygiene needs;

161.6. staff recreation rooms;

161.7. planning workstation (room for dose calculation) for medical physicists and planning technicians work;

161.8. dosimetry service room;

161.9. archive providing personal data security;

161.10. linear particle accelerator office that has:

161.10.1. room for the control panel;

161.10.2. room for irradiation procedures;

161.10.3. rooms or area for technical equipment;

161.11. distance gamma-therapy office that has:

161.11.1. room for the control panel;

161.11.2. room for irradiation procedures;

161.11.3. rooms for technical equipment;

161.12. brachytherapy office that has:

161.12.1. room for the control panel;

161.12.2. room for endostat administration (may be combined with the room for radiation therapy procedures);

161.12.3. room for control of endostat positioning (may be combined with the room for radiation therapy procedures);

161.12.4. room for irradiation procedures;

161.13. short focus (near focus) roentgenotherapy office that has:

161.13.1. room for the control panel;

161.13.2. room for irradiation procedures;

161.14. deep roentgenotherapy office that has:

161.14.1. room for the control panel;

161.14.2. room for irradiation procedures;

161.15. topometry office that has:

161.15.1. room for the control panel;

161.15.2. topometry room;

161.15.3. laboratory (if topometry is carried out);

161.16. simulator office that has:

161.16.1. room for the control panel;

161.16.2. simulator room;

161.16.3. laboratory (if topometry is carried out);

161.17. WC and shower or bath room for patients with functional disorders.

[10 December 2013]

162. Radiotherapy Unit with closed sources of ionizing radiation and equipment generating ionizing radiation has the following devices:

162.1. three-dimensional water phantom;

162.2. calibrated ionization chamber;

162.3. dose planning system (dose distribution atlas) (for a certain apparatus);

162.4. devices in the Linear particle accelerator office:

162.4.1. the control panel;

162.4.2. nurse call system and a monitor for patient observation during irradiation;

162.4.3. linear accelerator;

162.4.4. in vivo dosimetry device;

162.4.5. daily dosimetry device;

162.4.6. optical system for patient positioning;

162.4.7. patient positioning and immobilization devices;

162.5. devices in the Distance gamma-therapy office:

162.5.1. the control panel;

162.5.2. nurse call system and a monitor for patient observation during irradiation;

162.5.3. distance gamma-therapy apparatus with a source of ionizing radiation;

162.5.4. in vivo dosimetry device;

162.5.5. optical system for patient positioning;

162.5.6. patient positioning and immobilization devices;

162.6. devices in the Brachytherapy office:

162.6.1. the control panel (except manual brachytherapy);

162.6.2. nurse call system and a monitor for patient observation during irradiation;

162.6.3. Endostat kit;

162.6.4. roentgenotherapy apparatus or ultrasound equipment (for control of endostat positioning);

162.6.5. independent dosimeter for registration of radioactive pulse, connected to uninterruptible power source (except manual brachytherapy);

162.6.6. brachytherapy apparatus with a source of ionizing radiation;

162.6.7. emergency source container (containers, if some sources are used);

162.6.8. special safe boxes or containers for storage of sources of ionizing radiation (in case of manual brachytherapy);

162.6.9. gynaecological chair with removable leg section or functional bed for brachytherapy;

162.6.10. no shadow surgical lamp;

162.7. devices in the Short focus (near focus) rentgenotherapy office:

162.7.1. the control panel;

162.7.2. nurse call system and a monitor (window with an appropriate thickness of lead glass for patient observation during irradiation);

162.7.3. roentgenotherapy apparatus with applicator kit;

162.8. devices in the Deep roentgenotherapy office:

162.8.1. the control panel;

162.8.2. nurse call system and a monitor (window with an appropriate thickness of lead glass for patient observation during irradiation);

162.8.3. roentgenotherapy apparatus with applicator kit;

162.9. devices in the Topometry office:

162.9.1. the control panel;

162.9.2. nurse call system and a monitor (window with an appropriate thickness of lead glass for patient observation during irradiation);

162.9.3. topometric device;

162.9.4. X-ray equipment and negatoscope (if topometry is carried out);

162.9.5. Kalinichenko ruler for development of patient topometric card (if topometry is carried out);

162.9.6. computed tomography and magnetic resonance imaging augmentation device (if topometry is carried out);

162.9.7. negatoscope;

162.10. devices in the Simulator office:

162.10.1. the control panel;

162.10.2. nurse call system and a monitor (window with an appropriate thickness of lead glass for patient observation during irradiation);

162.10.3. simulator;

162.10.4. X-ray equipment and negatoscope (if topometry is carried out);

162.10.5. optical system for patient positioning;

162.10.6. patient positioning and immobilization devices.

5.6.12. Requirements for Thermal tissue damage unit

163. In the Thermal tissue damage unit not less than 10 percent of the total number of beds are intended for stabilization of vital functions.

164. A patient bed in the room for stabilization of vital functions in the Thermal tissue damage unit:

164.1. is provided with the possibility to monitor the following parameters:

164.1.1. patient's heart rate and blood circulation (electrocardiogram and arterial blood pressure, using non-invasive methods);

164.1.2. pulmonary function and ventilation;

164.1.3. haemoglobin oxygen saturation (pulse oximetry);

164.1.4. body temperature;

164.2. is provided with the central adjustable oxygen supply system;

164.3. medical devices to carry out the following medical procedures:

164.3.1. artificial lung ventilation (power-operated);

164.3.2. to relieve airway obstruction;

164.3.3. long-term precise dosed parenteral medicinal product and solution administration (perfusors, infusion suction systems);

164.3.4. defibrillation;

164.3.5. provision of oxygen supply during transport of patients.

6. Requirements for Diagnostic medical treatment institutions and structural units

165. Diagnostic medical treatment institution complies with general requirements for outpatient medical treatment institutions referred to in this Regulation. Diagnostic unit may be a structural unit of other medical treatment institution.

6.1. Requirements for Diagnostic radiology, clinical physiology and endoscopy institution or its structural unit

166. Diagnostic Radiology, clinical physiology and endoscopy medical treatment institution or its structural unit provides functional and instrumental diagnostic tests to assess the patient`s health status, as well as treatment.

167. Diagnostic radiology, clinical physiology and endoscopy medical treatment institution or its structural units locate electrical installation in such a way that the minimum number of additional cables is used to connect devices, and cables do not pass through the area where patients and medical personnel move.

6.2. Requirements for Radionuclide Diagnostic institution or its structural unit

168. In order to ensure radionuclide diagnostic tests and to assess the patient's health status, Radionuclide Diagnostic medical treatment institution or its structural unit uses special pharmacological preparations labelled with radioactive isotopes.

169. Radionuclide Diagnostic medical treatment institution or its structural unit has Control and Monitoring areas labelled accordingly.

170. Radionuclide Diagnostic medical treatment institution or its structural unit Control Area is equipped in accordance with the requirements laid down for:

170.1. the provision of radiation protection;

170.2. alarm connection security service;

170.3. the provision of air exchange in accordance with the used radioactive pharmaceuticals.

171. Radionuclide Diagnostic Unit Control Area has:

171.1. room for storage of radioactive pharmaceuticals;

171.2. room for packing of radioactive pharmaceuticals and their preparation for administration (can be combined with a room for storage of radioactive pharmaceuticals);

171.3. room or area for administration of radioactive pharmaceuticals;

171.4. diagnostic equipment cabinet;

171.5. room for diagnostic equipment workstation;

171.6. room for storage of radioactive waste.

172. Radionuclide Diagnostic Unit Monitoring Area has:

172.1. patient registration room;

172.2. patient waiting room with the provision of radiation protection and WC;

172.3. physician's office or area for physician's workstation (can be combined with diagnostic equipment cabinet and room for diagnostic equipment workstation);

172.4. room for staff clothing change and storage;

172.5. room for staff hygiene needs.

173. Radionuclide Diagnostic Unit room for storage, packing and preparation of radioactive pharmaceuticals has:

173.1. a separate packing area (room);

173.2. lead containers for storage of finished radioactive pharmaceuticals and for storage of generators;

173.3. dose calibrator for measurement of radioactive pharmaceuticals administered to the patient.

174. Radionuclide Diagnostic Unit room or area for administration of radioactive pharmaceuticals has:

174.1. independent dosimetry equipment;

174.2. injection equipment;

174.3. containers for collection, labelling and storage of solid radioactive waste until their decay.

175. Radionuclide Diagnostic Unit room for diagnostic equipment has:

175.1. radionuclide diagnostic equipment;

175.2. lead containers for storage of solid radioactive waste until their decay.

176. Radionuclide Diagnostic Unit has a physician's workstation, which is equipped in the physician's office or physician's workplace.

177. Radionuclide Diagnostic Unit Control Area has:

177.1. tools for deactivation and liquidation of radiation accident;

177.2. personal staff dosimeters (they should not be placed in the area of ionizing radiation outside working hours).

7. Final Provisions

178. To recognize Cabinet Regulation No. 77 of 19 February 2002 "Regulation Regarding Mandatory Requirements for Medical Treatment Institutions and Their Structural Units" (Latvijas Vēstniesis, 2002, No. 31; 2003, No.167, 180; 2006, No.37; 2008, No.117) is repealed.

179. [10 December 2013]

180. In-patient medical treatment institutions, which have acquired certificates of conformity before the date on which this Regulation comes into force, until 1 June 2009 notify the Register of Medical Treatment Institutions about the compliance of appropriate in-patient medical treatment institution with the requirements referred to in this Regulation in accordance with the profile of activities of the institution.

181. Medical treatment institutions (except in-patient medical treatment institutions), which have acquired certificates of conformity before the date on which this Regulation comes into force, have not to notify the Register of Medical Treatment Institutions about the compliance of appropriate medical treatment institution with the requirements referred to in this Regulation, and the issued certificates of conformity remain valid.

182. Paragraph 18, 19 and 108, Sub-paragraph 87.3, 90.4, 131.1 and 146.1 of this Regulation shall come into force from 1 January 2011.

183. Paragraph 17 and Sub-paragraph 68.2, 84.4, 85.4, 87.6 of this Regulation shall come into force from 1 January 2012.

[29 May 2012]

184. Paragraph 4, 22 and 102 and Sub-paragraph 24.6, 48.3, 112.14, 120.11, 125.8, 140.7, 141.8, 155.4. 157.7 and 161.17 of this Regulation shall come into force from 1 January 2014.

185. Medical treatment institution until 31 December 2015 ensures the accreditation of medical laboratory in accordance with the standard LVS EN ISO 15189:2013 "Medical laboratories. Particular requirements for quality and competence".

[10 December 2013]

186. Sub-paragraph 148.6 3, 148.8 3, 148.8 15, 148.8 16 and 148.8 17 of this Regulation shall come into force from 1 January 2015.

[10 December 2013]

187. Paragraph 4 of this Regulation applies to medical treatment institutions, which are registered in the Register of Medical Treatment Institutions until January 1, 2014.

[10 December 2013]

188. Medical treatment institutions, which have been registered in the Register of Medical Treatment Institutions before 1 January 2014, until 1 July 2014 submit to the Register of Medical Treatment Institutions a notice on the availability of environment in medical treatment institution. If in medical treatment institution the availability of environment is provided in accordance with the requirements referred to in Paragraph 4 of this Regulation or the availability of environment is not provided, the notice contains the following information:

188.1. information about reasons why the availability of environment is not provided and measures planned for the provision of the availability of environment;

188.2. the period within which it is planned to provide the availability of the environment;

188.3. information about the procedure in which persons with functional disabilities will be provided with the possibility to receive health care services provided by medical treatment institution.

[10 December 2013]

Prime Minister I. Godmanis

Health Minister I. Eglītis

 

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Translation © 2015 Valsts valodas centrs (State Language Centre)