Regulations Regarding the Basic Requirements for a Hygienic and Counter-epidemic Regimen in a Medical Treatment Institution
I. General Provisions
1. This Regulation prescribes the basic requirements for a hygienic and counter-epidemic regimen in a medical treatment institution in order to prevent the spread of infectious diseases.
2. The basic requirements shall be determined according to the precautionary principle that any patient may be a carrier of an infectious disease-causing agent and the organs, tissues, biological liquids and secretion thereof directly or indirectly spread live agents of infectious diseases in the environment that therefore may be contaminated.
3. The requirements referred to in Sub-paragraphs 4.2, 4.7, 4.8, 6.8, 6.9, 7.4, 7.5, 7.6 and Chapter VI of this Regulation shall only apply to inpatient medical treatment institutions.
4. The head of a medical treatment institution shall be responsible for the restriction of the outbreak and spread of infectious diseases at the medical treatment institution. The head of the medical treatment institution shall:
4.1. ensure the development and introduction of the plan of a hygienic and counter-epidemic regimen in a medical treatment institution (hereinafter - the plan of a medical treatment institution) in accordance with this Regulation by taking into account the scope of activity and services provided by the medical treatment institution;
4.2. establish the control team for infectious diseases (hereinafter - the control team) at a multi-functional hospital or university hospital that is responsible for the introduction of the plan of a medical treatment institution and internal control, and in the composition of which is one physician per every 500 beds and one nurse per every 250 beds, but not less than one physician and one nurse at a medical treatment institution;
4.3. appoint a person responsible for the introduction of the plan of a medical treatment institution and internal control in other medical treatment institutions (hereinafter - the responsible person);
4.4. ensure administrative support and collaboration between the control team or the responsible person, the management and structural units of a medical treatment institution;
4.5. appoint a person responsible for the treatment of medical devices, organises the treatment of medical devices (also determines control parameters, tests or indicators for the treatment of medical devices in accordance with new scientifically substantiated recommendations and also determines the expiry date of a sterile medical device in accordance with Annex 1 to this Regulation) in accordance with the plan of a medical treatment institution and, if necessary, organises the storage of medical devices;
4.6. ensure the development and, if necessary, updating the descriptions of invasive procedures and methods for the treatment of medical devices and also ensure the availability thereof at the place of work;
4.7. ensure the supervision of antimicrobial agents in order to promote a prudent use of antimicrobial products;
4.8. prescribe the procedures for the performance of screening examinations in order to identify the agents of multi-resistant micro-organisms;
4.9. include in the employment contract, description of the position or order of the head of a medical treatment institution the obligation of an employee to comply with the plan of a medical treatment institution;
4.10. ensure the planning, arrangement and maintenance of the territory and premises of a medical treatment institution in a way as to ensure effective organisation of the patient flow, restrict the pollution of the territory, premises, equipment and medical devices and facilitate the cleaning thereof.
5. The health care of a patient in a medical treatment institution shall be organised in a way as to ensure timely identification of patients with the symptoms of an infectious disease, separation of infected patients from those not infected, prevention of the risk of infection by patients, employees and visitors, and also environmental pollution.
6. The following matters shall be included in the plan of a medical treatment institution:
6.1. division of premises in cleanliness areas, cleaning frequency and sequence of premises, cleaning and disinfection detergents to be used, labelling, storage and washing of cleaning supplies;
6.2. treatment of the hands of employees and visitors (description of the method);
6.3. requirements for employees (including work clothing, hands, jewellery, etc.) taking into account professional duties;
6.4. use of the personal protective equipment in accordance with the procedure determined by the head of a medical treatment institution or the counter-epidemic measure to be taken;
6.5. treatment of medical devices of a medical treatment institution in conformity with the division thereof according to potential infection risk and treatment stages in accordance with Annex 2 to this Regulation, and also documentation of the treatment process and storage of medical devices (including sterile);
6.6. laundry sorting, labelling and change of laundry;
6.7. waste management;
6.8. procedures for epidemiological surveillance of the infectious disease associated with the health care of a patient in a medical treatment institution, including the collection and analysis of the necessary epidemiological data;
6.9. action and circulation of information (scheme) in a medical treatment institution if a patient is diagnosed with an infectious disease associated with health care or there are professionally reasoned suspicions of him or her being infected with an infectious disease associated with health care, including carrying the agents of multi-resistant micro-organisms;
6.10. infection risk of employees with vaccine-preventable infectious diseases, risk assessment and specific prophylactic measures;
6.11. action in the event of diagnosing an infectious disease for an employee of a medical treatment institution which causes the risk of the spread of infection among employees and patients;
6.12. ensuring the internal control with regard to the fulfilment of the plan of a medical treatment institution.
7. The control team or the responsible person shall:
7.1. determine the division of premises in the following cleanliness areas:
7.1.1. the high purity area (including an operating room, intensive care wards, a room for the invasive diagnostic and remedial procedures, a ward for the patients with immunodeficiency, a ward for the patients with burns, a neonatal ward and a nursing room, a room for assembling and packaging of medical devices, storage facilities for sterile medical devices);
7.1.2. the general purity area (including a waiting room for patients, a registration room or place, a room for patient reception, a room for employees (a wardrobe, resting room), hallway, a patient ward, a rehabilitation room, a blood room, a dental office, a diagnostic examination unit, a patient reception unit, a storeroom for clean laundry, and an administration room);
7.1.3. the potentially-contaminated area (including a ward of infectious patients, a room of septic surgeries, shower rooms for patients or employees, lavatory, cleaning supplies room, work rooms of a microbiological laboratory, a room for dirty laundry, a room for the collection of waste, an autopsy room and a room for the storage of a body of a deceased person, a room for the treatment of used medical devices);
7.2. elaborate the procedures by which the hygienic and counter-epidemic regimen is ensured in the premises of the increased cleanliness area;
7.3. if an infectious disease outbreak related to health care (at least two epidemiologically linked cases) is detected:
7.3.1. inform the head of a medical treatment institution thereof;
7.3.2. organise an epidemiological investigation;
7.3.3. coordinate counter-epidemic measures;
7.4. register at least the following epidemiologically significant case of bacteria detection in a medical treatment institution and once a quarter (by the fifteenth date of the first month of the subsequent quarter) submit a report to the Centre for Disease Prevention and Control regarding the accounting of the referred to bacteria in accordance with Annex 3 to this Regulation:
7.4.1. methicillin-resistant Staphylococcus aureus (MRSA);
7.4.2. vancomycin-resistant Staphylococcus aureus (VRSA);
7.4.3. vancomycin-resistant Enterococcus (VRE);
7.4.4. Clostridium difficile;
7.4.5. carbapenem-resistant Acinetobacter spp./Acinetobacter baumannii;
7.4.6. Extended Spectrum Beta-Lactamase (ESBL), including carbapenemase-producing gram-negative bacilli;
7.5. identify and analyse the risk factors of a health care-related infection, and also elaborate proposals for the prevention thereof;
7.6. if, upon admitting a patient in a medical treatment institution, there is professionally substantiated suspicion regarding the infection of a person with epidemiologically significant bacterium or an infectious disease acquired in the previous medical treatment institution or social care institution, inform the respective medical treatment institution or social care institution;
7.7. prior to the provision of a new health care service or purchase of medical devices, assess what hygiene and counter-epidemic measures are necessary to be carried out in a medical treatment institution and provide this information to the head of a medical treatment institution;
7.8. organise the training of employees regarding the requirements of the plan of a medical treatment institution and regarding counter-epidemic measures, and also new epidemiologically significant infectious disease agents and risk factors of the spread thereof, regarding other topicalities in the prophylaxis and restriction of the spread of health care-related infectious diseases and regarding changes in external and internal laws and regulations;
7.9. inform employees if an infectious disease outbreak related to health care has occurred and also inform about the risk factors of the spread thereof, the necessary counter-epidemic measures and epidemiological surveillance results.
8. Detergents to be used for the purpose of cleaning and disinfection and cleaning supplies shall be prepared and used in accordance with the instructions for use or descriptions of methods of the manufacturer.
9. The Centre for Disease Prevention and Control in collaboration with the Health Inspectorate shall elaborate the Hygienic and Counter-epidemic Regimen Sample Plan of Medical Treatment Institutions. The sample plan shall be available on the websites of the Centre for Disease Prevention and Control and the Health Inspectorate. The sample plan shall be updated in accordance with the latest scientific knowledge and best practice samples.
II. Requirements for the Treatment of Hands of Employees
10. The following methods shall be used for the treatment of hands:
10.1. washing of hands with soap and water;
10.2. hand disinfection with an alcohol-based product;
10.3. surgical hand disinfection.
11. The treatment of hands shall be ensured in the following cases:
11.1. before and after direct contact with a patient;
11.2. prior to conducting clean, invasive or surgical procedures regardless of the use of gloves;
11.3. prior to assembling, packaging or use of clean and disinfected medical devices;
11.4. before dispensing food;
11.5. before dispensing medicinal products;
11.6. after contact with biological liquids, secretion of a patient and contaminated medical devices;
11.7. after use of gloves;
11.8. after contact with the environmental objects of a patient (equipment and personal belongings);
11.9. if hands are apparently dirty;
11.10. in cases when, while taking care of a patient, movement from the contaminated body part to a clean body part takes place.
12. Disinfection of hands with an alcohol-based product is a mandatory request prior to the use of aseptic procedures (including wound dressing, catheter treatment) regardless of the use of gloves.
13. Surgical hand disinfection shall be a mandatory request prior to a surgical procedure.
14. There shall be liquid soap and disposable paper towels near the washstands. The use of an electrical hand driers is permitted in the regular and potentially contaminated cleanliness areas.
III. Requirements for the Use of Gloves
15. Clean non-sterile disposable gloves shall be used in the following cases:
15.1. the employee has hand contact with:
15.1.1. mucous membrane, damaged skin, blood and biological liquids of a patient and also potentially infected secretion of a patient (including saliva, pus, contents of the gastrointestinal tract, expectoration, and exudation of damaged skin);
15.1.2. medical devices which are smeared or potentially are smeared with blood, biological liquids, and secretion;
15.2. employee has skin damages on hands;
15.3. employee conducts a blood sampling manipulation.
16. Resistant, reusable gloves or non-sterile disposable gloves shall be used as follows:
16.1. when washing and cleaning medical devices and surfaces (for example, floors, walls, furniture);
16.2. when collecting and relocating (transporting) waste and dirty laundry.
17. Sterile disposable gloves shall be used upon conducting procedures which require sterility or if using a sterile medical device.
18. Gloves shall be changed:
18.1. after care for each patient (where necessary, several times during care for the same patient);
18.2. if gloves are damaged;
18.3. prior to touching clean or sterile surfaces if gloves are contaminated or there are grounds to believe so.
IV. Requirements for the Treatment, Storage and Sterilisation of Medical Devices
19. The treatment of medical devices shall be performed in accordance with the instructions for use of medical devices defined by the manufacturer and treatment stages referred to in Annex 2 to this Regulation.
20. A medical treatment institution shall ensure that there is not contact of non-sterile and sterilised medical devices (principle of one direction "no return"). The sterilisation process shall be separated from the cleaning process.
21. The treatment stages of hollow medical devices with a medium risk of inspection and of medical devices belonging to the group of a high infection risk shall be documented by ensuring traceability of the treatment stages. The treatment stages, which are performed manually or by using washing and disinfection facilities that have no automatic parameter records, shall be documented by indicating the treatment stage, the number of the respective facility (in the event of several facilities), start and end time, and by adding a note on a criterion applicable to the respective treatment:
21.1. active ingredient used and concentration of the active ingredient;
21.3. exposition time.
22. Medical devices belonging to the group of a high infection risk intended for sterilisation shall be packaged according to the sterilisation method so that after sterilisation they could be freely removed from the steriliser without contaminating them. Medical devices necessary for a single manipulation or operation shall be assembled in one packaging.
23. The labelling of the packaging unit of medical devices shall ensure the traceability of the sterilisation process quality also after the use of the sterile medical device and at least the following information shall be specified therein:
23.1. the content of the packaging or name of the set (the number or another designation accepted by a medical treatment institution) if the packaging is not transparent;
23.2. the place of sterilisation if medical devices are sent to another medical treatment institution;
23.3. the number of the sterilisation equipment if several sterilisation equipment units are used in a medical treatment institution;
23.4. the sterilisation method if several sterilisation methods are used in a medical treatment institution;
23.5. the cycle number if several sterilisation cycles are used in a medical treatment institution on the same day;
23.6. expiry date of a sterile medical device which is determined in accordance with Annex 1 to this Regulation;
23.7. indicator attesting that the packaging has been sterilised.
24. The sterile medical devices shall be stored in accordance with the requirements of the plan of a medical treatment institution by ensuring that they are not kept in direct sunlight or near heating devices.
25. The person who is responsible for the treatment of medical devices shall ensure the verification of sterilisation equipment:
25.1. after the installation of the sterilisation equipment;
25.2. after repair or maintenance of the sterilisation equipment that is related to the change of any parameters of the equipment impacting the sterilisation process and quality;
25.3. by organising the efficiency inspection of the sterilisation equipment (every day in each cycle) with physical, chemically physical or biological methods by using indicators of an appropriate class, a process simulation device or autonomous cycle parameter control devices.
V. Laundry and Bedding Requirements
26. A medical treatment institution shall prevent the contamination of laundry during the storage, transportation, washing, and disinfection thereof.
27. A medical couch (including changing table for babies, gynaecological stretchers, dental chairs) before health care of every patient shall be coated with a disposable cover or disinfected. If a medical couch is contaminated with biological liquids or secretion of a patient, it shall be cleaned and disinfected.
28. The mattress and pillow of a patient bed shall be coated with waterproof material covers that are washed or disinfected after the discharge or relocation of each patient.
29. After the patient is discharged or relocated, the blanket shall be disinfected in the disinfection chamber or disinfected and washed in a laundry room by using a technology that ensures disinfection.
30. The laundry shall be washed in a laundry room at a medical treatment institution or outside a medical treatment institution. A laundry room shall be equipped with washing machines having parameters and technologies required for washing and disinfecting laundry that ensure automatic disinfection (temperature, dosage and exposure of a detergent and disinfectant). The flow of the dirty and clean laundry shall be separated in the laundry room.
31. If another person provides the laundry service to a medical treatment institution, the head of a medical treatment institution shall be responsible for ensuring the compliance of the laundry washing with the requirements referred to in Paragraph 30 of this Regulation.
VI. Action in the Case of an Infectious Disease
32. If a patient is diagnosed with an infectious disease or an infectious agent that is spread by air, respiratory droplets or through contact or there is professionally substantiated suspicion that the person has infected with it (hereinafter - an infectious patient), the attending physician shall:
32.1. inform the infectious patient, other patients in the same ward, employees and visitors about the risk of infection and counter-epidemic measures for the prevention of the spread of the infectious disease;
32.2. take measures to ensure the isolation regimen in accordance with the type of the spread of the infectious disease in accordance with Annex 4 to this Regulation.
33. Infectious patients with one and the same cause of an infectious disease if this infectious disease is not recurrent may be placed in the same ward. The grouping of infectious patients shall be coordinated by the control team or the responsible person.
34. It is prohibited to place an infectious patient in the same ward with a patient with an increased risk of infection, including a patient with immunodeficiency, a patient with wounds and a patient with expected long-term treatment in an inpatient medical treatment institution.
VII. Closing Provisions
35. Cabinet Regulation No. 574 of 11 July 2006, Regulations Regarding the Basic Requirements for a Hygienic and Counter-Epidemic Regimen in a Medical Treatment Institution (Latvijas Vēstnesis, 2006, No. 111; 2009, No. 189), is repealed.
36. In accordance with this Regulation the plan of a hygienic and counter-epidemic regimen in a medical treatment institution shall be developed by 1 July 2016.
37. Sub-paragraph 4.2 of this Regulation shall come into force on 1 January 2018. Until the establishment of a control team, a medical treatment institution shall appoint a responsible person.
38. Sub-paragraph 3.1 of Annex 2 to this Regulation with regard to sterilisation in saturated water vapour (autoclaving) in dental practice shall come into force on 1 January 2018.
Prime Minister Māris Kučinskis
Minister for Health Guntis Belēvičs
Determination of the Validity Period of a Sterile Medical Device According to the Method of Points
I. Material of the External Layer of Packaging
II. Internal Layer of the Packaging Material
III. Additional Packaging for the Protection of the Sterile Barrier
IV. Storage Method
V. Storage Place
VI. Number of Points and the Corresponding Period of Validity
VII. Samples of Calculation
Minister for Health Guntis Belēvičs
Classification of Medical Devices by the Potential Risk of Infection and Treatment Stages Thereof
Note. * If necessary.
Minister for Health Guntis Belēvičs
Register Form for Epidemiologically Significant Bacteria in an Inpatient Medical Treatment Institution
1. * First positive sample.
2. ** Examination of patients in a high risk group.
Minister for Health Guntis Belēvičs
Requirements for Ensuring Isolation Regimen if a Patient is Diagnosed with an Infectious Disease or an Agent Thereof Spread by Air, Respiratory Droplets or Through Contact or There is Professionally Substantiated Suspicion that the Person has Infected with it
Minister for Health Guntis Belēvičs
Translation © 2018 Valsts valodas centrs (State Language Centre)