Decree No. 335 / 2024 Coll.
Decree amending Decree No. 389 / 2023 Coll., on an epidemiological vigilance system for selected infectious diseases
Valid
Order
Effective from 15.11.2024
Text versions:
15.11.2024
14.11.2024
335
DECLARATION
of 1 November 2024
amending Decree No. 389 / 2023 Coll., on an epidemiological vigilance system for selected infectious diseases
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. 320 / 2002 Coll., Act No. 274 / 2003 Coll., Act No. 392 / 2005 Coll., Act No. 222 / 2006 Coll., Act No. 110 / 2007 Coll. and Act No. 267 / 2015 Coll., ("the Act ') for the implementation of Sections 16 (2), 62 (1) and (2) and § 75a (1) and (4) of the Act:
Decree No 389 / 2023 Coll., on the epidemiological vigilance system for selected infectious diseases, is amended as follows:
1. Annex No 1, including footnotes 4 to 6, reads:
"Annex No 1
Specific procedures
Dispensary care is carried out for infectious and parasitic diseases within the scope of the Dispensary Care Regulation (4).
1. For persons who have been injured by a used needle and for persons who have had an extraordinary exposure to another person's blood during injury and severe contamination of the skin and mucous membranes (hereinafter "injured person '), the care provider shall provide the examination according to the table.
Scope and time intervals of testing to detect viral hepatitis and HIV agents in injured persons
| Infekční onemocnění, na které je vyšetření zaměřeno | Časový interval vyšetření po expozici | |||
|---|---|---|---|---|
| Co nejdříve, maximálně do 72 hodinI | Za 30 dnů | Za 90 dnů | Za 180 dnů | |
| VHB | HBsAgII anti-HBsII anti-HBc totalII | NE | HBsAgII | HBsAgII |
| VHC | anti-HCVIII | anti-HCVIII, IV | anti-HCVIII, IV | anti-HCVIII, IV |
| HIV | anti-HIV + p24V | NE | anti-HIV + p24V | anti-HIV + p24V |
Procedure for testing markers according to the table:
| I | První vyšetření na markery VHB se provádí před aplikací vakcíny, případně hyperimunního globulinu. |
| II | V případě, kdy je prvním odběrem prokázána negativita HBsAg a současně pozitivita anti-HBc total nebo přítomnost ochranného množství anti-HBs protilátek, za které se považuje minimálně 10 IU/l, se další vyšetření neprovádějí. |
| III | V případě pozitivity anti-HCV vyšetřující laboratoř na základě konzultace s ošetřujícím lékařem provede nebo zajistí provedení testu PCR HCV RNA z téhož vzorku. |
| IV | V případě pozitivity anti-HCV v některém předchozím vyšetření se tento test již neprovádí, ale vzorek se vyšetřuje metodou PCR HCV RNA. |
| V | Pozitivitu vyhledávacího testu anti-HIV + p24 potvrzuje Národní referenční laboratoř pro HIV/AIDS. |
2. In case subjective problems or clinical signs leading to possible liver disease, the range of markers may be extended by testing for aminotransferase activity.
3.
(a) PCR HBV DNA, HCV RNA PCR or HIV RNA PCR testing based on a risk assessment in situations where, from an epidemiological point of view, it is desirable to shorten the diagnostic window to the potential formation of antibodies, respectively HBsAg,
(b) in the case of a known source of potentially contaminated material, supplement the HBsAg, anti-HBs, anti-HBc total, anti-HCV, anti-HIV + p24 PCR testing based on epidemiological reasons if these PCR tests are available,
(c) taking into account the epidemiological link, or clinical signs, the end of the investigation of the injured person if the potential source is known and the results of his examination for evidence of VHB, VHC and HIV / AIDS infection are negative.
Registration and reporting
The care provider shall:
(a) a record of the event in the medical file of the injured person; where the injured person is a health professional or other employee of the health service provider or, where appropriate, a student in practical preparation for the exercise of the medical profession or a person handling waste and laundry with the care provider, it is necessary that any case of parenteral exposure to biological material be immediately reported to the nearest superior injured person; ensure verification of the circumstances in which the exposure occurred, the necessary documentation of the accident and the implementation of adequate measures to prevent recurrence of the emergency exposure;
(b) reporting to the local competent public health authority;
(c) notification of injury to the HIV centre if the potential source of HIV is positive, HIV reactive or its HIV status is unknown, to ensure post-exposure prophylaxis of HIV infection within 72 hours at the latest.
Quarantine measures
Based on the assessment of the event and the outcome of the risk assessment, the local competent public health authority shall decide on the regulation of medical supervision.
Immunisation
Prevention of immune disease is possible in the case of VHA and VHB.
A. Immunisation against VHA
For exposure to the blood of a patient with VHA, the care provider shall recommend to the exposed person, who has a negative result of anti-HAV IgG or total antibodies, active immunisation with the vaccine against VHA, which is applied ideally within 24 hours but no longer than 7 days after exposure.
B. Procedure for decisions on immunisation against VHB
When exposure to blood of a person with proven positive HBsAg or a person who cannot be examined, the following procedure is followed:
1. specific passive or active prophylaxis is not necessary in the contamination of intact skin and mucous membranes;
2. for penetrating skin and mucous membranes injury or severe skin and mucous membranes contamination, follow the immune status of the injured person;
(a) no passive or active immunisation against VHB shall be carried out for the injured person who has experienced VHB with a positive overall antiHBc antibody;
(b) in the case of an injured person duly vaccinated with three doses of VHB vaccine, at least a minimum protective amount of anti-HBs antibodies, which is considered to be 10 IU / l, shall not be carried out after completion of the vaccination or at the time of the injury, passive or active immunisation against VHB;
(c) a single dose of a specific hyperimmune globulin against VHB is administered to an injured person, unvaccinated or incompletely vaccinated, and an active immunisation against VHB is initiated or completed with subsequent dose intervals according to the Summary of Product Characteristics of the vaccine used; The dose should be administered ideally within 24 hours, but not more than 7 days after exposure; the dose and method of administration shall be determined in accordance with the Summary of Product Characteristics; the first dose of vaccine is given at the same time at another injection site;
(d) in the case of an injured person known to be unable to produce anti-HBs in a protective quantity, which means a person vaccinated with a basic schedule, or up to six doses, who, 6 to 8 weeks after completion of vaccination, has not achieved at least a minimum protective amount of anti-HBs of antibodies, which is considered to be 10 IU / l, a specific VHB hyperimmune globulin is applied, namely 1 to 2 doses per month; the first dose is ideally administered within 24 hours, but not more than 7 days after exposure; the dose and method of administration shall be determined using the SPC.
Diagram of the procedure for decision on passive and active immunisation against VHB at exposure from a person with proven HBsAg positivity or from a person in whom HBsAg cannot be investigated
| Stav imunity a očkovací status exponované osoby | Pasivní imunizace | Aktivní imunizace |
|---|---|---|
| Prodělala VHB (pozitivní celkové anti-HBc a anti-HBs) | NE | NE |
| Řádně očkovaná třemi dávkami vakcíny proti VHB a dosáhla anti-HBs ≥ 10 IU/l | NE | NE |
| Neočkovaná nebo neúplně očkovaná | Jedna dávka HBIG do 7 dnů od poranění | Zahájí / dokončí se aktivní imunizace s intervaly podle souhrnu údajů o přípravku |
| Neschopná tvorby anti-HBs protilátek v ochranném množství | Dvě dávky HBIG, první do 7 dnů od poranění, druhá za měsíc po první dávce | NE |
For a person suspected of being the victim of a rape offence, the care provider shall immediately ensure:
(a) the withdrawal of a history and examination to the extent and frequency specified in the tables in Article 2 (1) and in this Article; if he is a person suspected of being the victim of a rape crime, a woman, a vaginal swab for a microbial examination shall be carried out,
(b) vaccination against VHB within 14 days of contact if a person suspected to have been the victim of a rape offence has not been properly vaccinated against VHB or if his vaccination data are unknown or has not experienced VHB disease in the past;
(c) medical surveillance for 180 days after possible exposure;
(d) prophylactic measures to prevent STDs consisting of preventive administration of antibiotics, without waiting for the results of laboratory tests;
(e) other post-exposure prophylactic measures in cooperation with a specialist in infectious diseases.
Scope and time intervals of examinations for persons suspected to have been the victim of a rape crime
| Infekční onemocnění, na které je vyšetření zaměřeno | Časový interval vyšetření po expozici | |||
|---|---|---|---|---|
| Co nejdříve, maximálně do 72 hodinI | Za 30 dnů | Za 90 dnů | Za 180 dnů | |
| VHA | anti-HAV IgM a IgG nebo totalII | NE | anti-HAV IgM a IgG nebo totalII | NE |
| Syfilis | RPR + TPHA | RPR + TPHA | RPR + TPHA | NE |
In view of the epidemiological link, or clinical signs, in addition to the examination provided for in the tables in Article 2 (1) and in this Article, testing for infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae may be indicated. In such cases, a PCR test shall be used to test the swabs from the site of the potential disease.
| I | První vyšetření na markery VHA se provádí před aplikací vakcíny. |
| II | V případě pozitivity anti-HAV IgG nebo total v prvním vzorku se další vyšetření neprovádí. |
For infections belonging to the group of highly contagious diseases, for infections subject to reporting to the World Health Organisation, and for the manifestations of diseases or events which constitute the possibility of an outbreak of disease under the International Health Regulations (2005), the procedure shall be followed in accordance with the relevant Directive5.
Following the detection, management and reporting of diseases caused by high-risk and high-risk biological agents and toxins, the legislation governing the list of high-risk and risk biological agents and toxins (6) shall be followed.
4) Decree No. 39 / 2012 Coll., on Dispensary Care, as amended.
5) Government Resolution of 11 January 2019 No 33 on the updated Directive on the Single Emergency Procedure subject to International Health Regulations (2005) concerning the occurrence of highly contagious disease. This Decision is addressed to the Member States. This Decision is addressed to the Member States.
6) Act No. 281 / 2002 Coll., on certain measures related to the prohibition of bacteriological (biological) and toxin weapons and on the amendment of the Trade Act, as amended. Decree No. 474 / 2002 Coll., implementing Act No. 281 / 2002 Coll., on certain measures related to the prohibition of bacteriological (biological) and toxin weapons and on the amendment of the Trade Act, as amended. '
2. In Annex 4, Article 7 (A), point 6 is deleted.
Points 7 and 8 shall become points 6 and 7.
3. In Annex 4, Article 7, Part In point 7, "medical surveillance 'is replaced by" quarantine measures';
4. In Annex 4, Article 7 (B) (2), the words "medical supervision 'are replaced by the words" duration of quarantine measures'.
5. In Annex No 18, Article 7, Part In point 5, "paragraph 'is replaced by" point';
Efficacy
This Decree shall take effect on the day following that of its publication.
Minister:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
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Regulation Information
| Citation | Decree No. 335 / 2024 Coll., amending Decree No. 389 / 2023 Coll., on an epidemiological vigilance system for selected infectious diseases |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.11.2024 |
|---|---|
| Effective from | 15.11.2024 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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