Decree No. 233 / 2011 Coll.
Decree amending Decree No. 473 / 2008 Coll., on an epidemiological vigilance system for selected infections, as amended by Decree No. 275 / 2010 Coll.
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19.08.2011
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233
DECLARATION
of 22 July 2011
amending Decree No. 473 / 2008 Coll., on an epidemiological vigilance system for selected infections, as amended by Decree No. 275 / 2010 Coll.
According to Article 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended by Act No. 274 / 2001 Coll., Act No. 274 / 2003 Coll., Act No. 320 / 2002 Coll., Act No. 392 / 2005 Coll., Act No. 222 / 2006 Coll. and Act No. 110 / 2007 Coll., ("the Act ') for the implementation of Section 75a paragraphs 1 and 4 of the Act:
Decree No. 473 / 2008 Coll., on the epidemiological vigilance system for selected infections, as amended by Decree No. 275 / 2010 Coll., is amended as follows:
1. In Article 3, at the end of paragraph 2, the dot is replaced by a comma and the following point (p) is added:
"(p) Viral hepatitis E Annex 30 to this Decree."
2. In Section 4, "29 'is replaced by" 30'.
3. In Annex 1, point 1.3, the words "Hepatitis E 'are added at the end of the text.
4. In Annex No 2, Article 1, the words "incubation period 2 to 5 days' shall be added at the end of point 1 and in point 3 the words" (2-5 days) 'shall be deleted.
5. In Annex 2, at the end of Article 2, the sentence "The investigating laboratory shall send each strain of C. diphtheriae and C. ulcerans to the National Reference Laboratory for Pertussis and Diphtheria for further determination."
6. In Annex 2, Article 5, Annex 3, Article 5, Annex 6, Article 5, Annex 7, Article 5, Annex 12, Article 5, Annex 13, Article 5 and Annex 14, Article 5, the words "public health authorities' shall be inserted after the words" reporting '.
7. In Annex 2, Article 6 and in Annex 4, Article 6, the words "The doctor who has pronounced" shall be replaced by the words "The person providing the care 1) who has pronounced" and at the end of the text the sentence "Epidemiological investigations, including the check for vaccination, shall be provided by the public health authority in particular to identify the source of the infection and the route of transmission."
8. In Annex 3, Article 1, the words "incubation period 7 to 21 days' shall be added at the end of point 1 and the last sentence of point 5 shall be deleted.
9. In Annex 3, Article 2, the following point 7 is inserted after point 6:
'7. The investigating laboratory shall send each isolated strain B. pertussis and B. parapertussis for verification to the National Reference Laboratory for Pertussis and Diphtheria. '.
10. In Annex 3, Article 6, including the title, reads:
Epidemiological investigation when the presence of a gag is suspected
The person providing care (1) who has expressed suspicion of gushing cough disease shall provide for clinical sampling for culture or PCR testing and blood collection for serological examination and transport of biological material to the testing laboratory without delay; carry out further blood sampling in at least 3 weeks. The person providing care (1) and the investigating laboratory shall report to the public health authority the results referred to in Article 4. The investigating laboratory shall send each isolated strain B. pertussis and B. parapertussis for verification to the National Reference Laboratory for Pertussis and Diphtheria. Epidemiological investigations, including vaccination control, shall be carried out by the public health authority in particular in order to identify the source of the infection and the route of transmission. ';
11. In Annex 4, Article 1, the words "incubation period 7 to 18 days' shall be added at the end of the text in point 1.
12. In Annex 4, Article 2, including the title, reads:
Laboratory diagnostics
1. Isolation of measles virus from a clinical specimen.
2. Detection of measles virus nucleic acid in a clinical specimen taken in the acute phase of the disease.
3. The presence of specific antibodies to the measles virus characteristic of acute infection in serum or saliva:
a) Detection of IgM antibodies against measles virus in individuals not vaccinated in the last 6 weeks.
(b) In order to demonstrate low values of fake IDM positive in sporadic rubella cases, possible positive IgM antibodies against rubella virus, parvovirus B19, EBV and HHV6 must be excluded.
4. Evidence of seroconversion or significant, multiple increases in levels of specific measles IgG antibodies by testing a pair of serum (acute and convalescent) individuals who have not been vaccinated in the last 6 weeks.
5. Evidence of increased levels of pre-existing measles IgG antibodies in reinfections.
6. Detection of measles virus antigen by direct immunofluorescence in a clinical specimen taken in the acute phase of the disease using monoclonal measles specific antibodies.
Clinical and epidemiological data, including vaccination status, should also be taken into account for correct interpretation of laboratory results. If vaccination has been carried out during the last 3 to 6 weeks, consideration should be given to testing for non-vaccine virus.
measles virus isolates isolated from clinical material shall be sent to the National Reference Laboratory for measles, mumps, rubella and parvovirus B19 for further identification. ';
13. In Annex 4, Article 4 (C), the words "which have not recently been vaccinated (3 to 6 weeks) and is' shall be inserted after the word" Case '.
14. In Annex 4, Article 5, the words "public health authority 'shall be inserted after the words" reporting' and the words "meeting clinical and laboratory criteria 'shall be added at the end of the first sentence.
15. in Annex 4, Article 7 (6):
"6. The person providing care (1) shall ensure the administration of normal human immunoglobulin (NLIG) to children under 15 months of age (unvaccinated), those with a permanent contraindication, pregnant women and those with immunosuppression who have been in contact with a possible, probable or confirmed case of measles, according to the Summary of Product Characteristics."
16. In Annex 4, point 7 of Article 7, the word "vaccination 'is replaced by the words" Person providing care 1) to ensure vaccination'.
17. In Annex 4, Article 7 (8), the words "medical supervision 'shall be inserted after the words" contact with the sick'.
18. In Annex 4, Article 7 (9), the word "children 'is replaced by the word" impressionable children' and a comma is inserted after the word "measles'.
19. In Annex 5, Article 1, including the title, reads:
Clinical definition of disease
1. The clinical picture of influenza virus infection is in the form of influenza-like illness or acute respiratory infection. Incubation period 1 to 4 days.
1.1. Influenza-like illness (ILI) is characterised by the following clinical symptoms:
(a) sudden onset of disease, while
(b) at least one of the overall symptoms including fever or chills, nausea, headache, muscle pain, and
(c) at least one of the following respiratory symptoms, including cough, throat burning, respiratory insufficiency.
1.2 Acute respiratory infection (ARI) is characterised by the following clinical signs:
(a) sudden onset of disease, while
(b) at least one of the following respiratory symptoms, including cough, throat burning, respiratory insufficiency, rhinitis.
2. The period of infection is the first to fifth day of the disease in adults. In immunosuppressed persons and children, the period of infectivity may be up to the tenth day of the disease. '
20. In Annex 5, Article 6 (1), the words "(e.g. in terms of number of affected, in time or local context, with unusual course) 'are replaced by the words", in particular with unusual course in time and local context'.
21. In Annex 5, Article 6, in point 2, the words "Diagnostic physician, or OOVZ," are replaced by the words "Person providing care 1) in cooperation with the local competent public health authority."
22. In Annex 5, Article 7 (2), the words "diagnostic physician or OOVZ 'are replaced by the words" person providing care (1)'.
23. In Annex 6, Article 1, at the end of point 1, the words "incubation period 2 to 7 days, exceptionally up to 10 days' shall be added.
24. In Annex 6, Article 2 (5), the last sentence is replaced by the following: "Collection for culture testing shall be carried out before the antibiotic therapy is started."
25. In Annex 6, Article 6, the words "The doctor who has pronounced 'shall be replaced by the words" The person providing the care 1), who has pronounced' and the words "which are transmitted to the National Reference Laboratory for Meningococcal Diseases for further identification 'shall be added at the end of the text. The national reference laboratory for antibiotics shall monitor antibiotic resistance. Epidemiological investigations shall be carried out by the public health authority in particular to identify the source of the infection'.
26. In Annex 6, Article 7 (6), the words "immediate initiation of protective chemotherapy 'are replaced by the words" caregiver 1) immediately initiating protective chemotherapy'.
27. In Annex 7, the words "incubation period of 2 to 4 days' shall be added at the end of the text of Article 1.
28. In Annex 7, Article 2, the final part of the provision reads as follows:
"Due to the fact that the above clinical syndromes may be caused by a number of other aetiological agents, laboratory confirmation of the aetiology of H. influenzae up to the level of species H. influenzae and types is necessary. The strains of H. influenzae isolated from clinical material which is sterile under normal conditions or from body fluids obtained from clinical manifestations referred to in Article 1 shall be sent to the National Reference Laboratory for Haemophile Diseases for further identification. The national reference laboratory for antibiotics shall detect antibiotic resistance. The biological material should be collected for culture testing before initiating ATB therapy. '
29. In Annex 7, Article 6, the words "The doctor who has pronounced 'shall be replaced by the words" The person providing the care 1), who has pronounced' and the words "which are transmitted to the national reference laboratory for further identification at the end of the text 'shall be added. The national reference laboratory for antibiotics shall monitor antibiotic resistance. Epidemiological investigations, including checks for vaccination, shall be carried out by the public health authority in particular to identify the source of the infection.';
30. In Annex 7, Article 7, the following point 5 is added:
"5. No susceptible children shall be admitted to pre-school children to the diseases caused by H. influenzae for a maximum incubation period from the disposal of the sick child. ';
31. In Annex 8, Article 6, including the title, reads:
Epidemiological investigation if HIV / AIDS is suspected
A person providing care 1) who has expressed a suspicion of HIV / AIDS infection will carry out a blood sample to investigate the presence of antibodies. Epidemiological investigations shall be carried out by a person providing care (1) or by a public health authority, in particular in order to identify the source of the infection and the route of transmission. ';
32. In Annex 8, Article 7, the following point 3 is added:
'3. The person providing care 1) shall ensure that persons who have been injured by the needle used are examined in accordance with that table.
| VYŠETŘENÍ | Do 72 hodin po poranění | Za 90 dnů po poranění | Za 180 dnů po poranění |
|---|---|---|---|
| Virová hepatitida B | Ano* | Ano | Ano |
| Virová hepatitida C | Ano | Ano | Ano |
| HIV | Ano | Ano | Ne |
* For injured persons with proven protective titre anti HBs after vaccination or infection, further investigation of VHB markers will be terminated.
In case of a negative result of HBsAg, anti-HCV and anti-HIV markers on a potential source, if known, the surveillance of the injured person shall be terminated.
The examination also includes the detection of subjective problems and clinical signs that may be related to viral hepatitis disease and laboratory testing of aminotransferase activity.
The event shall always be recorded in the medical documentation of the injured person. ';
33. In Annex No 9, Article 1 (1), the words "symptoms and / or 'are deleted.
34. In Annex 9, Article 2, introductory provisions, the sentence "For isolated strains of Mycobacterium tuberculosis, the results of susceptibility tests for antituberculosis are confirmed in the National Reference Laboratory for Mycobacteria. In order to exclude or confirm multi-resistant or extensively resistant tuberculosis, mycobacteriological laboratories carry out isolation of M. tuberculosis and susceptibility tests for strains isolated from secular material or strains isolated from samples of clinical material of persons who died during laboratory tests. '
35. in Annex 9, Article 4 (1):
"1. Classification by infectivity.
1.1. Case with infectious form of TB disease:
1.1.1. a person with TB, secreting in a sputum or in other material the bacile complex of M. tuberculosis, proven to be cultivative and especially cultured and microscopic.
1.2. Case with reasonable suspicion of TB infection:
1.2.1. a person with a finding for active pulmonary TB (rtg, histology, etc.) whose results are not yet closed; or
1.2.2. a person with evidence for active pulmonary TB in which a bacteriological test material has not been obtained; or
1.2.3. a person with evidence of active non-pulmonary TB only, who is suspected to be secreting tuberculosis germs in body secretions or excretion into the external environment.
1.3. Case with unproven infectivity:
1.3.1. a person with evidence for active pulmonary TB with closed mycobacteriological examination with negative result.
1.4. Unlikely infectious case:
1.4.1. a person with evidence for active non-pulmonary TB only except for the situation referred to in 1.1.1. and 1.2.3. '.
36. In Annex 9, point 2.1 of Article 4, the words "tracheo-bronchial branches' are replaced by the words" tracheo-bronchial tree '.
37. in Annex 9, Article 4 (2.3), "branch" is replaced by "tree."
38. In Annex 9, Article 5, first sentence, the words "public health authority 'shall be inserted after the words" public health authority', and in the third sentence, the words "medical practitioner or dispenser 'shall be replaced by the words" caregiver'.
39. In Annex 9, point (1) of Article 6, the words "The doctor who has pronounced 'are replaced by the words" The person providing care 1), who has pronounced' and the words "In addition, the epidemiological investigation shall be carried out in particular to identify the source of the infection and the route of transmission. In cases of infectious form of TB disease, in particular microscopic positive, with an outbreak range exceeding family contacts, it shall cooperate closely in the epidemiological investigation with the public health authority. ';
40.
"Annex No 10 to Decree No 473 / 2008 Coll.
Legionelosis epidemiological vigilance system
Clinical definition of legionelosis
1. Legionnaire disease - acute lower respiratory tract disease with symptoms of pneumonia diagnosed clinically, X-ray, laboratory. Incubation period 2 to 10 days.
2. Pontiac fever - acute Legion infection without lower respiratory tract involvement. Incubation period 1 to 2 days.
Laboratory diagnostics
At least one of the following criteria:
1. Direct identification of antigen in the urine.
2. Proof of specific antibodies in serum.
3. Direct detection of microbes in respiratory secretions.
4. Culturing on selective soils.
5. Typing strains sent to the National Reference Laboratory for Legionelles by sequencing.
Epidemiological criteria
Exposure to the same common reservoir as the confirmed case.
Classification of a disease case
A. Possible: Unable to use.
B. Likely: Matches the clinical definition of the disease, the epidemiological criterion and at least one of the following laboratory criteria:
1. a four-fold or higher increase in antibodies to L. pneumophila of serological groups other than sg. 1 or other species confirmed by indirect fluorescence or microagglutination;
2. high antibody titre against L. pneumophila sg. 1 or other serological groups or species;
3. evidence of specific agents in respiratory secretions and lung tissue by direct fluorescence with monoclonal antibodies;
4. evidence of legionel in biological material by molecular biological accredited methods (PCR).
C. Confirmed: Matches the clinical definition of the disease and one or more of the following laboratory criteria:
1. the isolation of the legionel of bronchoalveolar lavage, sputum, pleural fluid, lung tissue, blood or other biological material;
2. a quadruple or higher increase in specific antibody titres against Legionella pneumophila sg. 1 confirmed by indirect fluorescence, microagglutination or ELISA test;
3. evidence of a specific antigen in the urine validated by a diagnostic kit.
Further classification of legionelosis for the purposes of the national epidemiological vigilance system:
a. Nozocomial Legionelosis - the patient has been infected in a medical facility.
b. Travel legionelosis - the patient was infected during one day or more days in a hotel or other mass accommodation facility in the Czech Republic or abroad, where he was staying 2 to 10 days prior to the appearance of clinical signs of the disease.
c. Professional Legionelosis - Diseases that occurred in the performance of work.
d. Community Legionelosis - Diseases from other reserves.
e. Other.
Data collection and reporting
The person providing care 1) who diagnoses the disease of Legionelosis shall immediately report to the public health authority and the death of the disease.
Epidemiological inquiry in suspected presence of Legionella
The person providing care 1) who has expressed suspicion of Legionelosis disease will collect biological material (bronchoalveolar lavage, sputum or pleural effusion, urine, blood, or other bodily fluids, in the event of death, part of the affected lung tissue deposit) to the laboratory evidence of aetiology and ensure that they are transported to the investigating laboratory. The cultured strains, or the biological material collected, shall be transferred by the laboratory to the National Reference Laboratory for Legionelles for identification and characterisation or processing. Epidemiological investigations shall be carried out by the public health authority, in particular with a view to identifying the reservoir of infection and the route of transmission.
Anti-epidemic measures in the outbreak of Legionella disease
1. Reporting of Legionella disease as referred to in Article 5.
2. Ensure the collection of biological material to verify the diagnosis, its transport to the appropriate laboratory.
3. Epidemiological investigation in an outbreak including the definition of other persons at risk, examination of travel history, sampling of water from technical installations, proposal for a technical revision. '
41. In Annex 11, Article 11 (1) (2.3), "domestic" is replaced by "non-imported (domestic)."
42. In Annex 11, at the end of the text of Article 2, the sentence "Polyovirus isolates isolated from clinical material are sent to the National Reference Laboratory for Enteroviruses for further identification."
43. In the last sentence of Article 11 (4), the words "or" domestic "shall be deleted.
44. In Annex 11, Article 5, the words "public health authority 'shall be inserted after the words" reporting', and at the end of the text the sentence "In the context of the epidemiological vigilance system of poliomyelitis, cases of acute weak paresis under 15 years of age shall be reported and investigated. '
45. In Annex 11, Article 6, including the title, reads:
Epidemiological investigation if poliomyelitis is suspected
A person providing care (1) who has expressed suspicion of poliomyelitis disease shall carry out stool sampling and arrange for collection to be sent to the National Reference Laboratory for Enteroviruses. The investigating laboratory shall send the isolated strain of poliovirus to the Regional Reference Laboratory for Enteroviruses in the World Health Organisation for Europe. Epidemiological investigations, including vaccination control, shall be provided by the public health authority, in particular with a view to identifying the source of infection and the route of transmission. ';
46. Article 7 (6) of Annex 11 reads as follows:
'6. Medical supervision for 35 days after the last contact with a confirmed case of paralytic poliomyelitis. Increased medical supervision is required for persons performing epidemiological activity for 6 weeks from the last contact with a confirmed case of paralytic poliomyelitis. '
47. In Annex No 12, Article 1, the words "incubation period 3 to 21 days' shall be added at the end of point 1.
48. In Annex No 12, at the end of Article 2, the sentence "The investigating laboratory shall send each isolated strain of C. tetani to the National Reference Laboratory for tetanus."
49. In Annex No 12, Article 6, the words "The doctor who has pronounced 'shall be replaced by the words" The person providing the care 1) who has pronounced' and the sentence "Epidemiological inquiry, including the check for vaccination, shall be added at the end of the text to ensure that the public health authority is protected, in particular in order to determine the route of transmission. ';
50. In Annex 13, Article 1, the words "incubation period 14 to 21 days' shall be added at the end of point 1 and in point 2, point B, the word" jaundice 'shall be replaced by "jaundice'.
51. In Annex 13, Article 2, including the title, reads:
Laboratory diagnostics
1. Criteria for confirmed rubella case:
a. Isolation of rubella virus in persons who have not been vaccinated in the last 6 weeks, 1 week before and no more than 1 week after the appearance of rash. The material for direct evidence of rubella virus is preferably neck swabs, otherwise blood, urine and cerebrospinal fluid samples, nose swabs. Samples shall be taken as soon as possible.
b. Detection of unvaccinated rubella virus nucleic acid in a clinical specimen taken in the acute phase of the disease.
c. Proof of seroconversion or significant, non-collinable increase in specific rubella IgG antibody levels by testing a pair of serum or saliva samples in persons who have not been vaccinated in the last 6 weeks. Evidence of increased levels of existing rubella IgG antibodies in reinfections.
2. Criteria for probable rubella case:
IgM antibody detection against rubella virus in individuals who have not been vaccinated in the last 6 weeks.
In case rubella is suspected during pregnancy, further confirmation is required with positive IgM test results (e.g. a specific IgG anti-rubella vaccination test).
3. Criteria for congenital rubella syndrome (KZS):
a. Isolation of rubella virus from a clinical specimen.
b. Detection of rubella virus nucleic acid.
c. The presence of specific IgM antibodies against rubella virus.
d. Persistence of IgG antibodies against rubella virus between the sixth and twelfth months (at least 2 samples with similar concentration of IgG antibodies against rubella virus).
The rubella virus isolates isolated from clinical material shall be sent to the National Reference Laboratory for measles, mumps, rubella and parvovirus B19 for further identification. ';
52. In Annex 13, Article 6, the words "The doctor who has pronounced" shall be replaced by the words "The person providing care 1), who has pronounced" and the sentence "Epidemiological investigations, including vaccination control, shall be added at the end of the text, shall be ensured by the public health authority."
53. In Annex No 14, Article 1, the words "incubation period 16 to 18 days' shall be added at the end of point 1.
54. In Annex 14, Article 2, including the title, reads:
Laboratory diagnostics
1. Direct evidence of non-vaccine strain of mumps virus by isolation from a clinical specimen taken in the acute phase of the disease.
2. Detection of unvaccinated mumps virus nucleic acid in a clinical specimen taken in the acute phase of the disease.
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Regulation Information
| Citation | Decree No. 233 / 2011 Coll., amending Decree No. 473 / 2008 Coll., on an epidemiological vigilance system for selected infections, as amended by Decree No. 275 / 2010 Coll. |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.08.2011 |
|---|---|
| Effective from | 03.09.2011 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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