The Provisions On Reference Laboratory Status And Accreditation Procedures, Roles And Responsibilities, As Well As Reference Laboratory Facilities And Equipment Requirements

Original Language Title: Noteikumi par references laboratorijas statusa piešķiršanas un akreditācijas kārtību, funkcijām un pienākumiem, kā arī par references laboratoriju iekārtām un aprīkojumam noteiktajām prasībām

Read the untranslated law here: https://www.vestnesis.lv/ta/id/167643

Cabinet of Ministers Regulations No. 834 in Riga in 2007 (4 December. No 68 32) the provisions on reference laboratory status and accreditation procedures, roles and responsibilities, as well as reference laboratory facilities and equipment requirements are Issued in accordance with article 11.1 of law veterinary and food supervisory law, article 21 of the sixth part i. General questions 1. determines the procedure for attributing the status of laboratory reference laboratories that diagnose animal diseases, food, life stuff feed , residues, including pesticides, disease control, and the sinātāj of antimicrobial resistance passenger identification (hereinafter referred to as the reference area), reference laboratory accreditation procedures, functions, and responsibilities, as well as the requirements of the reference laboratory facilities and equipment. 2. The reference function to monitor and control the food and veterinary service. Ministry of agriculture monitors the financial spending you reference fields. 3. the functions of the reference laboratory referred to in the annex to these provisions the reference in the performance of assigned field laboratory: 3.1 correspond to the European Parliament and of the Council of 29 April 2004, Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (hereinafter referred to as the European Parliament and Council Regulation (EC) No 882/2004) 33. the requirements laid down in that article and in article 33 provides reference laboratory tasks;
3.2. accredited in accordance with European Parliament and Council Regulation (EC) No 882/2004 article 12 paragraphs 2 and 3;
3.3. implementation of the requirements laid down in the European Commission's March 4, 2005, Regulation (EC) No 378/2005 on detailed rules for the application of the European Parliament and Council Regulation (EC) no 1831/2003 as regards the Community reference laboratory duties and responsibilities in connection with applications for authorisation of food additives;
3.4. with food and veterinary service has concluded the contract. 4. food and veterinary service national diagnostic Center performs the function of a reference laboratory in the following reference: 4.1 animal infectious disease diagnostics: 4.1.1. classical swine fever;
4.1.2. avian influenza;
4.1.3. Newcastle disease;
4.1.4. foot-and-mouth disease;
4.1.5. viral haemorrhagic septicaemia;
4.1.6. infectious haematopoietic necrosis;
4.1.7. salmon anaemia;
4.1.8. rabies (vaccination efficiency);
4.1.9. brucellosis;
4.1.10. enzootic bovine leukosis;
4.1.11. tuberculosis;
4.1.12. Aujeszky's disease;
4.2. the food, feed, genetically modified organisms, substances, including residues of pesticides, control and disease agent antimikr the biāl resistance: 4.2.1. milk and milk products control;
4.2.2. salmonella (all the isolated causative agents) control;
4.2.3. Control Listeria monocytogenes;
4.2.4. coagulase-positive staphylococci (including s. aureus) control;
4.2.5. E. coli (including e. coli in verotoksigēn);
4.2.6. Campylobacter (all the isolated causative agents) control;
4.2.7. parasitic condition in (Trichinella, Echinococcus, Anisak);
4.2.8. the antimicrobial agent resistance;
4.2.9. determination of animal proteins in animal feed;
4.2.10. the veterinary medicinal product and contaminant residues in animal foods: celsm iz 4.2.10.1. of resorcilikskāb lactones including zeranol control, steroid, antitiroīd, of stilbenes, stilbene derivatives, their salts and esters, the sedative features and control of mycotoxins;
4.2.10.2. antibacterial substances, including the sulfonamide, kvinolon, Carbadox and olaquindox dyes, control;
4.2.10.3. beta-agonists, antihelmintisk, antikokcidiāl, including not steroid and nitroimidazole anti-inflammatory products control;
4.2.10.4. carbamate and pyrethroid control;
4.2.10.5., Chloramphenicol and nitrofurans Dapsone control;
4.2.11 involving. transmissible spongiform encephalopathies;
4.2.12. additives used in animal nutrition;
4.2.13. the control of materials intended to come into contact with food;
4.2.14. determination of pesticide residues: cereals and feedingstuffs 4.2.14.1.;
4.2.14.2. in food of animal origin and products with high fat content;
4.2.14.3. fruit and vegetables, including products with high water and plants bring the acid content;
4.2.14.4. one method of determining residues;
4.2.15. determination of heavy metals in feed and food;
4.2.16. determination of mycotoxins;
4.2.17. polycyclic aromatic hydrocarbons (PAHs);
4.2.18. levels of dioxins and dioxin-like PCBs (PHD) in feed and food. 5. food and veterinary service contracts with other European Union Member State laboratory or the European Free Trade Association (EFTA) Member State laboratory for a separate reference area, if this area is not included in the national reference and Latvia is not nominated for the reference laboratory, which performs the following activities and functions of the reference laboratory. 6. Agreement on reference functions with other laboratories in the Member States of the European Union or the European Free Trade Association (EFTA) Member State laboratories in the food and veterinary service switch, if the laboratory meets this rule 3.1, 3.2 or 3.3. the requirements referred to in point. 7. food and veterinary service reference laboratory name, ad res and it reference area shall notify the Ministry of agriculture. 8. the Ministry of agriculture in accordance with European Parliament and Council Regulation (EC) No 882/2004 article 33, paragraph 4 of the order on the right of the reference ratorij nosa Kuma, address and its reference areas notified to the European Commission. 9. Reference Laboratory each year up to 7 January submitted to the food and veterinary service of the message (in paper form) on the use of the previous financial year. Report on the activities of the previous year's reference laboratory to the food and veterinary service shall submit each year to 31 March. The report indicates the following information (for the previous year): 9.1 reference function, results;
9.2. the budget allocation and utilization, as well as off-budget income and expenditure;
9.3. the number and composition of staff;
9.4. information on and discussed between the comparative testing laboratory. 10. food and veterinary service and developed each year to 31 March in the State Ministry of Agriculture presented a reference program for next year. The food and veterinary service calculates the don't the overwhelming financing from the State budget to the national reference program as well sets the reference function delegated to another Member State of the European Union or the European Free Trade Association (EFTA) Member State reference laboratory as well as the function of the required funding. II. the diagnosis of infectious animal disease reference laboratories for general functions, duties, and requirements of the facilities and equipment 11. Reference Laboratory, which diagnosed infectious animal diseases, have the following functions: 11.1 develop, optimize and validate laboratory methods of investigation;
11.2. to coordinate the activities of official laboratories assigned reference area, as well as to define and coordinate laboratory diagnostic methods (laboratory competent infectious animal disease control authority (Latvia-food and veterinary service) has contracted for an individual State to the surveillance and control of infectious animal diseases subject to the diagnosis);
11.3. to train laboratory work will go in the clouded personnel;
11.4. the food and veterinary service request to make scientific and technical expertise;
11.5. establish and maintain a strains of the agent and the bank, the sinātāj of antigen bank trainee, diagnostic reagents the kit item, specific immunoglobulins and serum bank;
11.6. to control analytical reagents and diagnostic tests;
7.3. to evaluate disinfectants and analytical reagent efficiency;
11.8. the epizootiological surveillance network to participate in building the labor seen in the diagnostic field;
7.4. to carry out laboratory investigations in the field and in the reference in case of dispute, approve or reject the other official or accredited laboratory results obtained in the reference area. 12. in paragraph 11 of these rules that reference laboratory has the following responsibilities: 12.1 to buy laboratory equipment and equipment to ensure the ref function in the competition in its field of competence;
12.2. the composition of the staff of the laboratory include the qualified personnel who perform given tasks qualitatively in the reference area;
12.3. ensure confidentiality of laboratory tests, objectivity and independence;
12.4. ensure prompt and rapid action in an emergency, to receive and investigate samples in a given period;

12.5. provide quality work and operational tasks. III. diagnosis of an epizootic disease reference laboratories for general functions, duties, and requirements for facilities and equipment for 13. Reference Laboratory diagnosed epizootic diseases, follow that rule 11 and 12 of the type referred to in paragraph 1 and is equipped with facilities and equipment to perform a sudden outbreak of disease diagnostic super-power duals. 14. in paragraph 13 of these rules reference laboratories referred to in the personnel are trained to identify the diseases epizootic viruses in the reference area. 15. the reference laboratory diagnosed diseases: epizootic 15.1. cooperate with the European Community reference laboratory and other Member States of the European Union reference laboratories-develop improved diagnostic methods, Exchange information and materials related to the infectious animal disease Diagnostics;
15.2. the European Community reference laboratory in the external quality assurance programs and tasks, which are being tested in a reference laboratory staff skills and knowledge in the exercise of its tasks;
15.3. to immediately provide the European Commission with the requested information, as well as inform the laboratory equipment and laboratory methods used in compliance with the International Office of Epizootics approved standards "Into the nostisk test and the vaccine Guide for wild and aquatic animals";
9.6. provide data in its possession on the epizootic disease food and veterinary service and the European Community reference laboratory. 16. Reference Laboratory carrying out the epizootic disease diagnosis (foot-and-mouth disease, classical swine fever, African swine fever, African horse sickness, avian influenza, Newcastle disease, bovine plague, plague in small ruminants, Rift Valley fever, blue tongue disease, epizootic haemorrhagic disease of deer, swine vesicular disease, sheep and goat pox, vesicular stomatitis, lumpy skin dermatitis), scored the other authorised laboratories diagnostic methods to be used by the individual in the determination of the disease , as well as its. The reference laboratory shall be responsible for the use of reagents and for the testing of the vaccine, and it has the following rights: 16.1. deliver diagnostic reagents to other state mandated right ratorij (upon request);
16.2. to control the quality of all diagnostic reagents;
16.3. periodically organise interlaboratory comparative tests;
16.4. to store the material containing the virus of the disease, if the diagnosis is confirmed;
16.5. to evaluate and give a final opinion on other State authorized laboratories the results obtained. IV. Office of epizootic diseases reference laboratory for diagnosis of specific functions and responsibilities 17. Reference Laboratory carrying out the diagnosis of African swine fever, from secure laboratory testing the presence of African swine fever virus detection and the identification of the genetic type are carried out in accordance with the African swine fever diagnostic manual. 18. the reference laboratory for classical swine fever carried out diagnostics of secure laboratory testing the presence of classical swine fever and the identification of the genetic type of virus isolated for identification of happen according to the classical swine fever diagnostic manual. 19. the reference laboratory handling live foot-and-mouth disease virus and carrying out foot-and-mouth disease diagnosis, work conditions, security around the European Union legislation on minimum conditions in laboratories working with the foot-and-mouth disease virus in the laboratory and in living organisms. 20. Antigenic and genomic characteristics determined all the viruses that caused the secondary foot-and-mouth disease outbreaks. If the reference la boratorij is not fitted with suitable facilities, antigenic and genomic characteristics determined by the European Community reference laboratory-transmit of authorisations requested and send the details for the determination of the characteristics (including advice on the relationship between the field of antigens of the strains and vaccine strain) European Community antigen and vaccine bank. This procedure also applies to virus Antigen type and determination of the characteristics of the genome, what reference laboratory receives from third countries. 21. The reference laboratory, which carries out foot-and-mouth disease diagnosis, in addition to providing vesicular virus disease diagnosis services. 22. The reference laboratory shall maintain all foot-and-mouth disease virus serotype inaktivēto for reference and Antisera against these viruses, as well as all other reagents necessary for rapid diagnosis. Negative diagnosis is prepared for approval by the appropriate cell cultures. 23. The reference laboratory, which carries out foot-and-mouth disease diagnosis by serological test and other tests, if not handling live foot-and-mouth disease virus, cooperate with other State authorized laboratories. The official laboratories do not emit the foot-and-mouth disease virus from the samples taken to check the animals infected with any of the cancer in the kulār virus. This laboratory can not implement biosecurity measures, but the internal order of the laboratory shall determine the procedures that ensure effective limitation and elimination of the infection, if have spread foot-and-mouth disease virus. Samples with the results obtained on the existence of infectious agents are not convincing, transferred to the reference laboratory for the final result. 24. The reference laboratory that performs diagnostics of avian influenza: 24.1. is equipped with facilities providing isolated avian influenza virus pathogenicity detection, especially in type A viruses H5 or H7 subtype;
24.2. laboratory investigations of avian influenza agent detection and identification of the genetic type of virus shall be carried out in accordance with the diagnostic manual for avian influenza;
24.3. the European Community reference laboratory isolates of avian influenza virus full characterisation: 24.3.1. from all primary outbreaks of avian influenza;
24.3.2. from secondary outbreaks of avian influenza, taking into account their number;
24.3.3. from poultry, other captive birds or mammals isolates of avian influenza virus, which poses a serious threat to human or animal health;
15.2. cooperate with the State Agency "Infektoloģij Center" Exchange of information on the use of the laboratory diagnostic methods, as well as the isolation of avian influenza virus type. 25. Reference Laboratory carrying out the diagnosis of Newcastle disease, Newcastle disease virus provides full antigenic and biological. 26. Reference Laboratory, which carries out rinderpest, small ruminants, Rift Valley fever, blue tongue disease, epizootic haemorrhagic disease of deer, swine vesicular disease, sheep and goat pox, vesicular stomatitis, lumpy skin dermatitis Diagnostics, equipped with equipment that allows at any time, the type, sub-type and variant of the relevant virus. V. closing question 27. Be declared unenforceable in the Cabinet of 4 October 2005, Regulation No 753 "rules on requirements for food business concerned, reference laboratories and their authorization procedures" (Latvian journal, 2005, nr. 160). Informative reference to European Union directives, the regulations include provisions resulting from: 1) the Council on 29 April 1992 by Directive 92/35/EEC laying down control rules and measures to combat African horse sickness;
2) Council on 14 July 1992 Directive 92/66/EEC introducing Community measures for the control of Newcastle disease;
3) 1992 of the Council of 17 December Directive 92/119/EEC introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease;
4) Council of 20 November 2000 Directive 2000/75/EC laying down specific provisions for the Bluetongue control and eradication;
5) Council of 23 October 2001 directive 2001/89/EC on Community measures for the control of classical swine fever;
6) Council of 27 June 2002 Directive 2002/60/EC laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever;
7) Council of 29 September 2003 of Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC;
8) Council of 20 December 2005 Directive 2005/94/EC on Community measures for the control of avian influenza and repealing Directive 92/40/EEC. Prime Minister a. Halloween Minister of Agriculture m. Roze attachment Cabinet 4 December 2007 regulations No 774 reference areas i. infectious animal disease diagnostic reference areas no p.k. infectious animal disease name infectious animal disease agent 1. Classical swine fever in Flavivirida family, Pestivir to 2. Avian influenza Orthomyxovirida in A Influenzavir family, 3. Newcastle disease Is a family of 4, Rubulavir foot-and-mouth disease, the Picornavirida family Aphthovir, 5. African horse sickness in the family, Reovirida Orbivir 6. Rinderpest Is a native of Morbillivir, 7. Small ruminants plague Is a native of Morbillivir, 8. Swine vesicular disease in the family, Enterovir Picornavirida 9.

EHD-Reovirida family, Orbivir of 10. African swine fever Iridovir, Poxvir-11. Sheep and goat pox the Poxvirida family, Capripoxvir to 12. Vesicular stomatitis-Rhabdovirida family, Vesiculovir-13. Rift Valley fever-Bunyavirida family, Phlebovir of 14. Lumpy skin dermatitis Poxvirida of family, of Capripoxvir 15. Deer epizootic haemorrhagic disease of Reovirida family, Orbivir of All the 16 brucellosis isolated proponents 17. Rabies (rabies vaccination effectiveness monitoring) of Lyssavir of the Rhabdovirida family, Ephemerovir, Vesiculovir, at 18. Tuberculosis, Mycobacterium bovis, Mycobacterium Avium 19. Enzootic Bovine Leukosis retrovirus 20. Aujeszky's disease in the family, Herpesvirida Varicellovir 21. Viral haemorrhagic septicaemia in Rhabdovirida family, Novirhabdovir-22. Infectious haematopoietic necrosis of the Rhabdovirida family, Novirhabdovir in 23. Salmon anaemia-Orthomyxovirida family, Isavir of Haplosporidi of Haplosporidioz of 24. Nelson, Haplosporidi Perkinsoz of the costal 25. Perkins, Perkins of Marinus olsen 26. Mikrocitoz Mikrocytos mackini of Abalon 27 White syndrome of Xenohaliot the californiens the 28 Candidate. Marteill of Marteiliosis refringens 29. Sydney, Marteilia Bonamioz of Bonamia ostreae, Mikrocytos exitios, Bonamia roughley II. Reference areas for food, animal feed, residues, including pesticides, control and disease resistance in antimicrobial agents in determining the reference area PO box no name 1. Milk and milk products control 2. monitoring marine biotoxins in bivalve molluscs bakterovirusāl 3 pollution monitoring of Antimicrobial Agents 4 determination of resistance 5. determination of animal proteins in animal feed 6. Veterinary medicines and residues of pollutants in food of animal origin 6.1. resorcilikskāb control of lactones including zeranol, steroid, antitiroīd, of stilbenes, stilbene derivatives, their salts and esters, the sedative features and control of mycotoxins 6.2. antibacterial substances, including the sulfonamide, kvinolon, Carbadox and olaquindox colouring control 6.3. beta-agonists, antihelmintisk, antikokcidiāl features, including steroids and nitroimidazole, non-inflammatory means control 6.4. carbamate and pyrethroid controls 6.5. chloramphenicol and nitrofurans, Dapsone control 7. Animal nutrition additives used in determination 8. Material Control intended to come into contact with food 9. determination of pesticide residues in cereals and feedingstuffs 9.1 9.2 in food of animal origin and products with high fat content of fruit and vegetables 9.3, including products with high water and high acid content of 9.4. residues of one detection method 10 determination of heavy metals in feed and food 11. determination of mycotoxins 12. Polycyclic aromatic hydrocarbons (PAHs) 13. determination of levels of dioxins and dioxin-like PCBs (PHD) in feed and food 14. Salmonella (all the isolated causative agents) controls 15. Listeriosis (Listeria monocytogenes) control of coagulase-positive staphylococci 16 (including s. aureus) control 17. Intestinal wand (e. coli, including verotoksigēn in e. coli) control 18. Kampilobaktērij (Campylobacter isolated by all proponents) control Parasitic condition in 19 (Trichinella, Echinococcus, Anisak) controls 20. Transmissible spongiform encephalopathies, the determination of the Minister of Agriculture m. rose