LEGE nr. 136 din 18 iulie 2020 privind instituirea unor măsuri în domeniul sănătății publice în situații de risc epidemiologic și biologic – tradusă în limba engleză

În textul de mai jos aveți tradusă în limba engleză legea nr. 136 din 18 iulie 2020 privind instituirea unor măsuri în domeniul sănătății publice în situații de risc epidemiologic și biologic.

LAW 136 of July 18th 2020

On instituting public health measures in epidemiological and biological risk situations

ISSUER           PARLIAMENT

Published in THE OFFICIAL GAZETTE no. 634 of July 18th 2020

The Parliament of Romania passes the present law.

Article 1

The present law regulates certain necessary temporary public health measures in epidemiological and biological risk situations, to prevent entry of and contain infectious and contagious diseases in the Romanian territory.  

Article 2

The measures provided by the present law are ordered and implemented in the situations provided for in Art. 1, exclusively to protect public health, respecting the fundamental rights and liberties of the citizens and the public order. All measures provided for under this law shall be proportional to the situation they are determined by, limited in time thereto and applied indiscriminately.

Article 3

In the context of this law, the terms and notions used have the following meaning:

a) individual quarantine – measure to prevent the spread of infectious and contagious diseases, consisting in the physical separation of individuals suspected of being infected or carrying a highly pathogenic agent from others, in areas specially designated by the authorities, at home or at the location stated by the quarantined individual, measure established by individual motivated decision of the public health department, which shall contain particulars regarding the date and issuer of the document, name and identification data of the individual quarantined, duration of the measure and the remedy provided for by law;

b) zonal quarantine – measure to prevent the spread of infectious and contagious diseases, aiming to physically separate individuals and activities, including limiting traffic in an area affected by an infectious and contagious disease from the surrounding areas, so as to prevent the spread of infection or contamination outside of that area;

c) isolation – measure consisting of the physical separation of individuals affected by an infectious and contagious disease, or of the carriers of the highly pathogenic agent, even if they do not exhibit indicative signs and symptoms, at home, at the location stated by the isolated individual, in a healthcare unit or at an alternative location attached to the healthcare unit, for health monitoring and treatment, as applicable, measure instituted for the purpose of healing and reduction of the contagion degree on the basis of the individuals’ consent, or, in the absence thereof, by individual motivated decision of the public health department, which shall contain particulars regarding the date and issuer of the document, name and identification data of the individual isolated, duration of the measure and the remedy provided for by law;

d) imminent risk – immediate threat or high probability of spread of a highly pathogenic agent within the human population, which can severely impact human health and life;

e) contamination – presence of a highly pathogenic agent on the surface of a human or animal body, in or on a product prepared for consumption or other objects, including means of transport, which can constitute an epidemiological and biological risk;

f) official scientific information – data offering evidence based on scientific methods, established and transmitted by international or national institutions specializing in healthcare, and accepted by the Ministry of Health;

g) infection – penetration and growth or multiplication of an infectious agent in the human or animal body, which can constitute a public health risk;

h) public health measures – specific prevention, limitation and response measures applied in order to stop the spread of disease or contamination;

i) ill person – individual suffering from an infectious and contagious disease exhibiting indicative signs and symptoms specific to the case definition, or individual carrying a highly pathogenic agent, even without exhibiting indicative signs and symptoms upon objective clinical examination, but who is an epidemiological and biological risk

j) epidemiological risk – probability of occurrence of an event generated by a highly pathogenic agent that can affect population health, with the possibility of spreading at local, county, national, European or international level;

k) biological risk – probability of occurrence of an effect on human health caused by the accidental or intentional dissemination of a highly pathogenic agent;

l) suspected person – individual originating from the area where there is an epidemic, epidemiological or biological risk, who is possibly infected with a highly pathogenic agent, in the incubation period, based on scientific evidence, or individual who has come in contact with an infected person or with goods contaminated with the highly pathogenic agent, until the incubation period is over or until exhibiting clinical or paraclinical signs or symptoms of the disease;

m) public health emergency of international significance – an unusual event which, according to the 2005 International health regulations, approved by the General Assembly of the World Health Organization and implemented by Government Decision no. 758/2009, constitutes a public health risk and demands a potential coordinated international response;

n) epidemic – expansion of an infectious and contagious disease through contamination, at an unusual rate, to a large number of people relative to the particular risk of said disease, in a given area;

o) pandemic – expansion of an epidemic on several continents;

p) communicable disease – disease determined by the invasion of the body tissues by highly pathogenic agents, their multiplication and the reaction of the host tissue to them and to the toxins they produce, which can be transmitted from a source/environment to an individual or from one individual to another;

q) population – a group of people presenting one or more common traits;

r) control bodies – bodies established in accordance to applicable legal regulations, with attributes to assess and monitor the compliance of the authorities or individuals concerned with the measures provided for under this law, in situations of epidemiological and biological risk;

s) area designated by the authorities – location that fulfils the minimum accommodation conditions and is established by the authorities for individual quarantine, under the present law;

ș) alternative location attached to the healthcare unit – area which provides healthcare and belongs to a key healthcare unit, used for individual isolation purposes, in accordance with the present law, such as but without limitation to hotel accommodation units or other specially designated areas.

Article 4

The measures provided for in Art. 7 apply to populations deemed susceptible to be an epidemiological and biological risk to public health by the National Committee for Emergency Situations, and, in individual cases, by motivated decision of the public health department, which shall contain  particulars regarding date and issuer of the document, name and identification data of the individual quarantined, duration of the measure and the remedy provided for by law. The measures and populations are established by the National Committee for Emergency Situations, on the basis of the proposal by the Technical and scientific support group regarding the management of highly contagious disease on Romanian territory.

Article 5

(1) The central and local public administration authorities can make available specially designated areas or alternative locations attached to healthcare units, for individuals in quarantine or isolation, as applicable.

(2) The central and local public administration authorities which do not own or manage the areas mentioned in par. (1) can conclude rental agreements for buildings to this end.

(3) Quarantine in areas specially designated by the competent authorities is carried out in the following cases:

a) if the individuals for which the quarantine is established declare at their own risk that they cannot meet the physical separation conditions at home or at the location stated by them;

b) if the individual does not respect the entire quarantine period at home or at the stated location, in spite of having agreed to it at the date of establishment.

(4) The expenses incurred during quarantine in specially designated areas for the situations provided for in par. (3) letter a) are covered by the budget of the Ministry of Health, approved to that end.

(5) The individuals who do not respect the quarantine at home or at the location stated, are required to cover the quarantine expenses in the areas specially designated by the authorities. The expenses incurred for their quarantine are covered by the Ministry of Health from the budged approved to that end, and are recovered from the individuals concerned.

(6) By way of derogation from the provisions of Art. 297 of Emergency Government Ordinance  no. 57/2019 concerning the Administrative Code, as subsequently amended and supplemented, the assets in the public domain of the State and managed by the Ministry of Youth and Sport by means of the county departments for sport and youth can be used to quarantine individuals under the conditions provided for by the present law. The expenses incurred for the quarantine process are covered by the state budget, by means of the Ministry of Youth and Sport budget. The Ministry of Public Finance shall supplement the budget of the Ministry of Youth and Sport accordingly, with the amounts corresponding to the expenses incurred in the quarantine process.

(7) The detailed rules to establish the minimum conditions of the accommodation areas and the cost standards are approved by Government decision within a maximum of 30 days from the entry into force of the present law.

Article 6

The epidemiological and biological risk situations for which the measures provided for in this law are established, are as follows:

a) epidemic declared by order of the ministry of health;

b) public health emergency of international significance, certified by decision of the National Committee for Emergency Situations, on the basis of the statement by the World Health Organization;

c) pandemic declared by the World Health Organization and certified by decision of the National Committee for Emergency Situations;

d) the imminent epidemiological and biological risk identified and ascertained by the institutions under the coordination of the Department for Emergency Situations or by the institutions subordinated to the Ministry of Health.

Article 7

(1) Quarantine is instituted on the basis of the official scientific information and of the case definition, at the individual’s residence, at a location stated by the latter or, if applicable, in an area specially designated by the authorities, with respect to individuals suspected of being infected or carrying a highly pathogenic agent, and who:

a) arrive from areas where the epidemiological risk is high, based on epidemiological data transmitted at national, European and international level by competent bodies in the field

b) have come in direct contact with at least one individual confirmed to have an infectious and contagious disease.

(2) If the individuals mentioned in par. (1) refuse quarantine at home or at the location stated by them, as well as when the individuals concerned breach the quarantine term, in spite of having previously agreed to it, the physician or, if applicable, the control bodies recommend, and the public health department representative decides to quarantine said individuals in the area specially designated by the authorities, should they determine there is a risk of transmission of an infectious and contagious disease with imminent risk of community transmission. The physician or, if applicable, the control bodies, shall inform the county public health department or the Bucharest public health department immediately, who shall confirm or rule out, by individual decision, the quarantine of the individuals in the area specially designated by the authorities. The decision shall contain particulars regarding the date and issuer of the document, name and identification data of the individual quarantined, duration of the measure and the remedy provided for by law. The decision is issued at the latest 8 days after the briefing with the physician or the control bodies, as applicable, and is communicated immediately to the individual concerned. In order to prevent the spread of the infectious and contagious disease, until such time as the decision of the public health department, ruling out the recommended quarantine in the area specially designated by the authorities, has been communicated, or, as applicable, until the decision of the court of first instance has been communicated, the individual concerned cannot leave his/her residence, the location stated by him/her for quarantine or, as applicable, the area specially designated by the authorities, without the consent of the physician or of the public health representative.

(3) The measure provided for in par. (1) and (2) is instituted for the duration of the incubation period specific to the suspected infectious and contagious disease. The measure ends at the expiry of the term corresponding to the incubation period, or before, following a confirmation of the individual as carrier of the highly pathogenic agent, with or without exhibiting indicative signs and symptoms specific to the case definition, in which case the provisions regarding isolation in the present law shall apply thereto.

(4) The list of areas specially designated by the authorities to quarantine individuals are established by Government decision, under the present law.

(5) Zonal quarantine is instituted for individuals and activities carried out in the perimeter affected by epidemiological and biological risk situations provided for in Art. 6.

Article 8

(1) Isolation is instituted for ill persons, with indicative signs and symptoms specific to the case definition, as well as for carriers of the highly pathogenic agent, even if they do not exhibit indicative signs and symptoms.

(2) The list of infectious and contagious diseases for which isolation at home, at the location stated or, if applicable, in healthcare units or in alternative locations attached thereto is instituted, as well as the list of key healthcare institutions treating ill persons are established by Government decision. To ensure correct balance between the need to prevent the spread of an infectious and contagious disease with imminent risk of community transmission and the individuals’ right to freedom, isolation is instituted depending on the infectious and contagious disease, established in accordance to this paragraph, and respecting the following standards, necessary for the exercise of fundamental rights and freedoms:

  1. a) the measure should be ordered for a limited period, indiscriminately and proportionally to the state of affairs that determined it;
  2. b) the measure should aim at preventing the spread of an infectious and contagious disease that threatens the safety of individuals and public health;
  3. c) the measure should be ordered to protect public interest and not to cause an imbalance between the need to protect public health and the necessity to respect individual freedom.

(3) Isolation of the individuals provided for in par. (1) is ordered with the consent of the individuals under examination, and in the absence thereof, under the conditions of par. (6), when the physician determines the risk of transmission of an infectious and contagious disease with imminent risk of community transmission, in a healthcare unit, or, as applicable, in an alternative location attached to the healthcare unit, established according to par. (2), for the purpose of carrying out clinical, paraclinical tests and biological assessments, until the receipt of the results, but for no longer than 48 hours.

(4) No later than upon the expiry of the 48 hour term, based on the clinical and paraclinical tests and if the risk of transmission of the infectious and contagious disease with a risk of community transmission is maintained, the physician recommends extending the isolation in a healthcare unit or in an alternative location attached to the healthcare unit or, if applicable, at the individual’s residence or at the location stated by him/her.

(5) Isolation at home or at the stated location is ordered if the risk of contaminating other people or spreading the infectious and contagious disease is low. Isolation at home or at the stated location cannot be ordered if the scientific information concerning the type of the highly pathogenic agent, the transmission path and the transmission rate require isolation of the individuals exclusively in a healthcare unit or an alternative location attached thereto.

(6) If the individuals provided for in par. (1) refuse the isolation measure ordered in accordance with par. (3), after recording the individual’s refusal, the physician informs the county or Bucharest public health department immediately, and the latter, no later than within two hours, issues the decision confirming or ruling out the isolation measure recommended by the physician, in the healthcare unit, or at an alternative location attached thereto. The decision is individual and is communicated immediately to the individual concerned. The decision shall contain particulars regarding the date and issuer of the document, name and identification data of the isolated individual, duration of the measure and the remedy provided for by law.  In order to prevent the spread of the infectious and contagious disease, until such time as the court of first instance communicates the decision to nullify the contested administrative action, the individual concerned cannot leave the location where he/she is being isolated without the consent of the physician or of the public health department representative.  

(7) If the individuals provided for in par. (1) refuse the isolation measure extended and recommended in accordance with par. (4) or if the individuals breach the isolation period at home or at the stated location, in spite of having previously agreed to it, the physician or the control bodies, as applicable, shall inform the county or Bucharest public health department immediately, which can confirm or rule out the isolation  measure in a healthcare unit or at an alternative location attached thereto, by means of an individual decision. The decision shall be issued no later than two hours after the briefing from the physician or the control bodies, as applicable, and is communicated immediately to the individual concerned. The decision shall contain particulars regarding the date and issuer of the document, name and identification data of the isolated individual, duration of the measure and the remedy provided for by law. In order to prevent the spread of the infectious or contagious disease, until such time as the public health department communicates the decision ruling out the measure to extend the isolation in the healthcare unit or at an alternative location, or, if applicable, until the court of first instance communicates its decision, the individual concerned cannot leave the location where he/she is being isolated without the consent of the physician or of the public health department representative.

(8) The isolation established in accordance with par. (4) ends on the date the individual is confirmed as healed based on clinical and paraclinical examinations or on the physician’s recommendations, who determines that there is no longer any risk of disease transmission.

(9) If the individual mentioned in par. (1) is a minor, isolation is established for the latter in accordance with par. (3) and (4), as appropriate, at the guardian’s residence or at the location stated by the latter. The isolation of the minor in a healthcare unit or at an alternative location attached thereto, is established in accordance with the applicable regulations. The minor’s guardian is submitted to quarantine under the present law if the isolation measure does not apply to him/her.

Article 9

(1) When the quarantine or isolation measure has been taken with respect to an individual who is in charge of a minor, an incapacitated person, a person who has tutorship or trusteeship or a person who is left without care or supervision due to age, illness or other causes, the parent, legal guardian, medical personnel or public health department representative informs social services, for monitoring purposes, and, if required, to take legal measures for the temporary protection of the individuals concerned.

(2) The monitoring and, if applicable, the temporary protection measures for the individuals provided for in par. (1) can only be ordered for as long as they are unsupervised and without care, and shall not have the effect of rightful suspension of the exercise of parental or legal guardianship rights.

(3) The monitoring and, if applicable, the temporary protection measures for the individuals provided for in par. (1) cannot be ordered if the parent or legal guardian has designated another family member or person of reference to supervise and care for the individuals provided for in par. (1), and if the latter has accepted to temporary exercise the supervision and care of the individuals concerned.

(4) The general directorates for social assistance and child protection shall take measures to make available for the individuals provided for in par. (1) appropriate residential locations and specialized personnel, according to the age and state of health of the protected individuals, for the entire time they remain without supervision and care.

Article 10

In the situations provided for in art. 6 and only if there is imminent risk, on a proposal from the National Public Health Institute and respecting the International health regulations, the ministry of health shall order the manner of enforcement of the measures provided for herein, with a view to prevent and contain infections with the highly pathogenic agent.

Article 11

(1) Quarantine for individuals arriving in Romania from areas with high epidemiological risk or for individuals who have come in direct contact with the infected persons, in the situations of epidemiological risk provided for in art. 6, is ordered by decision of the National Committee for Emergency Situations, on a proposal from the Technical and scientific support group regarding the management of highly contagious diseases on Romanian territory, and is implemented by orders of the ministry of health and of the subordinated units.

(2) For situations with high imminent epidemiological and biological risk, the head of the Department for Emergency Situations or the person designated by the latter shall order the measures provided for in Art. 7 par. (1) and (2). These must be validated no later than within 48 hours by the National Committee for Emergency Situations.

(3) The decision of the National Committee for Emergency Situations is administrative action and can be contested under the conditions of the present law.

Article 12

(1) Zonal quarantine is instituted by order of the head of the Department for Emergency Situations or of the person designated by the latter, on the basis of a decision of the county committee for emergency situations, on a proposal from the territorial public health department and with the approval of the National Institute of Public Health.

(2) By way of derogation from the provisions of par. (1), if the measure is aimed at two or more neighboring counties, the zonal quarantine is imposed by order of the head of the Department for Emergency Situations or by the person designated by the latter, on a proposal from the National Institute of Public Health and with the approval of the National Committee for Emergency Situations within a maximum of 48 hours.

(3) The measures provided for in par. (1) and (2) are established when, based on assessment, it is determined that the risk of community spread cannot be controlled by other means, and the percentage of infections exceeds the threshold established by the National Institute of Public Health.

(4) In the case of a biological accident, the zonal quarantine provided for in par. (1) and (2) can be established temporarily, until the impact of the highly pathogenic agent can be established and, if applicable, the effects are eliminated.

(5) Public order in the areas specially designated by the authorities for quarantine, as well as in the healthcare units or in the alternative locations attached thereto designated for isolation, provided for by the present law, is ensured both outside and inside by the local police. If there is no constituted local police or if its effects are insufficient, public order is ensured by the Romanian Military Police or by the Romanian Police, as applicable.

Article 13

The National Institute of Public Health is required to give a daily account of the number of new cases, retested cases and total number of tests for the new and retested cases, reported separately, at national and county level, including on the basis of test subject residence, for the entire duration of the epidemiological and biological risk situation, in order to prevent the entry of and limit the spread of infectious and contagious diseases on national territory.

Article 14

The central or local public authorities are required to ensure food or, if applicable, treatment for the individuals quarantined or isolated at home or at the stated location, based on individual age and state of health, as well as to deliver them, if the individuals are unable to procure food or treatment, as applicable. The maximum limits for these expenses, which shall be covered by the budget of the Ministry of Health, by means of the administrative and territorial units, shall be established by Government decision.

Article 15

(1) The orders of the head of the Department for Emergency Situations or of the person designated by the latter, issued under the present law, shall be implemented immediately by the competent authorities and published on the official websites of the Ministry of Internal Affairs, Department for Emergency Situations and General Inspectorate for Emergency Situations. The central and local public authorities shall ensure that the citizens in the quarantined areas are informed by means of information campaigns.

(2) The regulatory orders of the head of the Department for Emergency Situations or of the person designated by the latter, issued under the present law, are published immediately in the Romanian Official Gazette, Part I.

(3) The orders of the head of the Department for Emergency Situations or of the person designated by the latter can be contested before the competent court, under the present law, by any individual who considers that his/her right or legitimate interest has been violated.

(4) All regulatory administrative actions regarding the establishment, amendment or cessation of the measures in the present law can be contested by any individual who considers that his/her right or legitimate interest has been violated, by applying for annulment before the competent court, on grounds of illegality and lacking factual basis, within 5 days of the administrative action being published in the Romanian Official Gazette or of the individual taking note of the content of said action, if it has not been published.

(5) The petition for annulment shall be formulated in writing and submitted with the competent court of law.

(6) The court with jurisdiction to settle the petition for annulment formulated against the administrative actions shall be the court of appeal, administrative and fiscal disputes department, of the area where the issuing authority is located.

(7) In the resolution of the legal actions brought against the administrative actions in the present law, the provisions of the Law on administrative litigation no. 554/2004, as subsequently amended and supplemented, regarding the requirement of the prior complaint procedure do not apply. The petitions are put on expedited trial and in particular, the provisions of art. 200 of Law 134/2010 regarding the Code of Civil Procedure, republished, as subsequently amended and supplemented, do not apply.

(8) The parties shall be summoned in accordance with the provisions regarding expedited trial summons.

(9) The statement of defense is mandatory. The judge issues a resolution ordering the disclosure of the petition and of the documents filed by the defendant, who is made aware that he/she is required to file a statement of defense, as well as of the file that was the basis for the issuing of the administrative action, under the sanction provided for by law, which shall be expressly indicated within a maximum of two days from the disclosure of the petition. The statement of defense and the aforementioned file shall be disclosed to the claimant at least 3 days before the first trial date.

(10) The petition for annulment is resolved following the expedited trial and in particular, within a maximum of 15 days from the date of initiation of the court proceedings, with panels of at least 3 judges.

(11) The court may order by default that any evidence necessary for the resolution of the case be examined.

(12) The first trial date is no later than 5 days after the date when the petition for annulment was recorded, and the subsequent dates cannot exceed 10 days in total.

(13) If the claimant is subject to an individual action issued in accordance with the provisions of the present law, ordering one of the measures provided for in Art. 7 or 8, as applicable, and if this circumstance arises from the documents submitted, the resolution of the case shall include the hearing of the claimant, except in the case where his/her state of health forbids it. The hearing of the claimant shall be carried out by means of audiovisual telecommunication which allows for the verification of the identities of the parties, and which guarantees the security, integrity, confidentiality and quality of the transmission. In case of technical or material impossibility to use such means for the hearing of the claimant, said hearing shall be carried out by any electronic means of communication, including telephone, which allows for the verification of the identity of the parties and guarantees the security, integrity, confidentiality and quality of the transmission. The summons shall include the appropriate indication to that end. The minutes of the proceedings shall also record the actions thus carried out.

(14) If the claimant is assisted or represented by a lawyer or if it is necessary to use a translator or interpreter, it is not necessary for the latter to be present with the claimant. The costs incurred by the presence of the translator or interpreter are covered by the budget of the Ministry of Justice.

(15) If the claimant hearing cannot be carried out under the conditions provided for in par. (13) and if he/she has no chosen defender, one shall be appointed to him/her by the court.

(16) The court shall ensure that the proceedings provided for in the present article are carried out in good conditions, in order to respect the right to a fair hearing and the contradictory nature of the proceedings.

(17) The judgement can be postponed by no more than 24 hours, and the reason for judgement is given no later than 48 hours after the judgement.

(18) The judgement of the court of first instance can be appealed no later than two days after the notification. In order to resolve the appeal, the file is submitted to the High Court of Cassation and Justice that same day, in writing or electronic format.

(19) The High Court of Cassation and Justice shall adjudicate in panels of 5 judges, within 5 days of the complaint, by final judgement.  

(20) The final judgement to annul the regulatory administrative action is published in the Romanian Official Gazette within 24 hours of the adjudication, in accordance with the procedure provided for in Art. 23 of Law 554/2004, as subsequently amended and supplemented.

(21) The regulatory administrative actions provided for in par. (4) are part of the category of documents provided for in Art. 5 par. (3) of Law 554/2004, as subsequently amended and supplemented, and the provisions of Art. 14 or 15, as applicable, of the aforementioned law shall not apply to the proceedings brought against them.

Article 16

(1) Any individual who considers that his/her right or legitimate interest has been violated by an individual administrative action issued in accordance with Art. 8 par. (3) can lodge a complaint with the court in his/her district of domicile or residence, or with the court in the district where the area or healthcare unit where he/she is being isolated is located, requesting the annulment of the action. The petitions are exempt from the payment of the legal stamp duty.

(2) The judgement on the petitions provided for in par. (1) is passed within a maximum of 24 hours of the complaint being brought before the court, and the provisions of Art. 200 of law 134/2010 regarding the Code of civil procedure, republished, as subsequently amended and supplemented, do not apply.

(3) The parties shall be summoned in accordance with the provisions regarding expedited trial summons, so as to ensure that the trial date provided for in par. (2) is respected, and legal counsel for the individual is mandatory.

(4) The court cannot postpone the judgement, and the ruling shall be written down immediately.

(5) The provisions of Art. 15 par. (13)-(16) apply accordingly.

(6) The court order is final.

(7) The disclosure of the procedural documents, including the recording of the complaint are carried out in electronic format and using electronic means.

Article 17

(1) Any individual who considers that his/her right or legitimate interest has been violated by an individual administrative action issued in accordance with Art. 7 or 8 par. (4) can lodge a complaint, no later than 24 hours after the communication of the decision of the public health department, with the court in his/her district of domicile or residence, or with the court in the district where the area or healthcare unit where he/she is being quarantined or isolated, as applicable, is located, in accordance with Art. 7 or 8 par. (4), requesting the annulment of the contested administrative action, its revision or the cessation of the measure. The petitions are exempt from the payment of the legal stamp duty.

(2) The petitions provided for in par. (1) undergo expedited trial, and particularly, are resolved no later than within 48 hours. The provisions of Art. 200 of Law 134/2010, republished, as subsequently amended and supplemented, do not apply.

(3) The parties shall be summoned in accordance with the provisions regarding expedited trial summons, so as to ensure that the trial date provided for in par. (2) is respected, and legal counsel for the individual is mandatory.

(4) The provisions of Art. 15 par. (13)-(16) apply accordingly.

(5) The court can postpone the judgement by a maximum of 24 hours, and the ruling is written down the same day.

(6) The individual concerned shall be monitored by a physician daily or when the situation demands it, until the court judgement is passed.

(7) The judgement of the court of first instance is enforceable and can be appealed within two days of its notification.

(8) The appeal is resolved no later than 24 hours after the date when the complaint was brought before the court, and the provisions of par. (5) apply accordingly.

(9) If the court of first instance orders the annulment of the administrative action, the contested measure ceases from the moment that the judgement is passed, and the individual concerned has the right to leave the area or unit where he/she had been quarantined or isolated, as applicable, immediately.

(10) The disclosure of the procedural documents, including the recording of the complaint are carried out in electronic format and using electronic means.

Article 18

(1) Until the date of entry into force of the present law, the quarantine or isolation expenses, as well as the social security benefits corresponding to the medical leave established or granted for quarantine or isolation, as applicable, are covered in accordance with the regulatory actions in force on the day they were established or granted, respectively.  

(2) Until the date of entry into force of the Government decision provided for in Art. 8 par. (2), the provisions of the present law are incident to infections with SARS-CoV-2, denominated COVID-19.

Article 19

(1) If the public health department or the county or Bucharest inspectorate for emergency situations determines that there is a shortage of  medical personnel for the duration of the establishment of the public health measure, in epidemiological and biological risk situations, the specialized medical, paramedical and auxiliary personnel in the public system can be reassigned, with the consent of the reassigned individuals, and in the absence thereof, under the conditions of the present law, for at most 30 days, by order of the ministry of health, or of the heads of the Department for Emergency Situations or of the person designated by the latter, or, as applicable, of the head of the employer institution. 

(2) The measure provided for in par. (1) is ordered in case of a personnel shortage, when the establishment plan cannot be completed with the medical personnel that agrees to the reassignment, with volunteers or with military medical personnel and, at the motivated request of the county or Bucharest public health department, of the county or Bucharest inspectorate for emergency situations or of the National center for coordination and management of the intervention.

(3) For the duration of the reassignment ordered in accordance with par. (1), the reassigned individuals are guaranteed, additionally to the salary paid by the employer unit, the payment of the reassignment compensation amounting to 50% of the basic salary, the daily allowance of 2% of the basic salary, accommodation and transport to the reassignment location.

(4) The rights paid to the reassigned individuals are covered by the budget of the Ministry of Health, transport is ensured by the Inspectorate for Emergency Situations and accommodation by the institution that is provided the services by the reassigned individuals or, as applicable, by the administrative-territorial unit.

(5) The reassignment order issued in accordance with par. (1) can be contested within the legal term, with the competent administrative litigation court.

(6) The Ministry of Health together with the Department for Emergency Situations within the Ministry of Internal Affairs shall operationalize a national register of volunteers within the medical personnel for emergency situations.

Article 20

(1) For individuals in quarantine or isolation established until the entry into force of the present law, the medical leave certificates are granted in accordance with the regulatory actions in force at the date of granting.

(2) The medical leave and the quarantine compensation are granted to policyholders who are prohibited from continuing their activity, which cannot be carried out at home, on suspicion of a contagious disease, for the duration established in the certificate issued by the public health department.

(3) The medical leave certificate for quarantine is issued by the attending physician, based on the certificate issued by the specialized bodies within the public health departments.

(4) In case of quarantine or isolation, the medical leave certificates can be issued at a later date, but only for the current or previous month.

(5) The duration of the medical leave for quarantine or isolation is not cumulated with the duration of medical leaves granted to policyholders for other conditions.

(6) If the duration of the quarantine or isolation period established by the specialized bodies within the public health departments exceeds 90 days, the approval of the specialized social security physician is not necessary.

(7) The monthly gross amount of the compensation for quarantine or isolation is 100% of the calculation basis established according to law, and is covered entirely by the budget of the National Health Insurance Fund.

Article 21

(1) The temporary employment, without a recruitment contest, of medical personnel in healthcare units and in the lacking public health departments, and of emergency situation professionals within the General Inspectorate for Emergency situations and its subordinated units, is permitted, to  cover the shortage of medical personnel in the healthcare system as well as of emergency situation professionals within the General Inspectorate for Emergency Situations, for the duration of the establishment of the epidemiological and biological risk situation.

(2) The additional financial requirements corresponding to the personnel expenses caused by the employment provided for in par. (1) shall be covered by the budgets of the line ministries, that is, by direct transfer from the National Health Insurance Fund.

This law was passed by the Parliament of Romania, respecting the provisions or Art. 75 and 76 par. (1) of the Romanian Constitution, republished.

PRESIDENT OF THE CHAMBER OF DEPUTIES

ION-MARCEL CIOLACU

  1. PRESIDENT OF THE SENATE,

ROBERT-MARIUS CAZANCIUC

Bucharest, July 18th 2020.

No. 136.


Metodologia de supraveghere a sindromului respirator acut cu noul coronavirus (COVID-19) – traducere în limba engleză

Methodology for the surveillance of the acute respiratory syndrome caused by the novel coronavirus (COVID-19)

 

The Romanian National Institute of Public Health

 Methodology for the surveillance of the acute respiratory syndrome caused by the novel coronavirus (COVID-19)

Updated on 23.07.2020 

  1. Name and classification of the disease 

The following ICD codes have been assigned for the acute respiratory syndrome caused by the novel coronavirus (COVID-19):

  • 1 – COVID-19, identified virus = valid for CONFIRMED cases
  • 2 – COVID-19, unidentified virus = valid for SUSPECT cases

 

The ICD-10 coding for COVID-19 based on the clinical picture has been communicated to the public health directorates in all counties and Bucharest.

Confirmed cases will be reported to the Register for Communicable Diseases (RUBT, Registrul Unic de Boli Transmisibile) and to CNSISP (The National Center for Statistics and Public Health) as an “unusual / unforeseen event”.

  1. Initial basis

 2019-nCoV (subsequently called SARS-CoV-2) is a new strain of coronavirus that has not been previously identified in humans. Outbreaks of infections caused by new coronaviruses in humans are always a matter of public health importance and a cause of concern.

The first cases in EU/EEA were confirmed in France. ECDC warned of a probable further worldwide spread.

Human-to-human transmission has been confirmed, but more data are needed to assess the scale of this transmission. EU/EEA countries should ensure that timely and rigorous measures are applied for the prevention and control of the infection when dealing with cases identified within the EU/EEA, in order to prevent future sustained human-to-human transmission in the community and healthcare settings.

 

Adapted from ECDC: www.ecdc.europa.eu/en/novel-coronavirus-china

 

In this context, it is imperative to implement in Romania the surveillance system for the human infection with the new coronavirus (2019-nCoV, subsequently called SARS-CoV-2).

 

III. Purpose: 

– To gain a better understanding of the epidemiological situation of the acute respiratory syndrome caused by the novel coronavirus (COVID-19) in Romania and recommend measures / interventions to prevent the occurrence of secondary cases or an epidemic in Romania

  1. Objective:

 – To establish the basic epidemiological parameters of the SARS-CoV-2 infection:

  • Characteristics of the case with respect to the individual, place, and time;
  • Basic clinical picture (signs and symptoms);
  • Pre-existing medical and physiological conditions;
  • Clinical course, outcome, and severity;
  • Exposures and travel history

The information collected from surveillance activities will also be used for the national risk assessment, as well as to guide response decisions.

  1. Case definitions for the acute respiratory syndrome caused by the novel coronavirus (COVID-19)

Suspect case

Any person with acute respiratory infection (sudden onset of at least one of the following symptoms): cough, fever, breathing difficulties (shortness of breath)

 

OR

 

Any person with pneumonia, bronchopneumonia +/- pleurisy

OR

Any person with a severe acute respiratory infection (SARI) (fever or a history of fever AND cough AND breathing difficulties (shortness of breath) AND requiring overnight hospitalisation)

Note:

 For children under the age of 16 years presenting gastrointestinal symptoms (vomiting, diarrhoea) that are not food-related, a SARS-CoV-2 infection may be suspected.

Definitions of community-transmitted COVID-19 and HCAI

 A COVID-19 case may have originated in the community or may be a case of healthcare-associated infection (HCAI), depending on:

– the number of days prior to the onset or laboratory confirmation of the infection, after the date of admission to a medical facility (hospital, dialysis centre) or a long-term residential care centre (day 1);

– evidence obtained from the epidemiological investigation with respect to its origin in the community or as a HCAI (whether the case relates to an outbreak site that has either one of the possible origins)

The following situations may occur:

  • Community-associated COVID-19 case

– symptoms are present at admission or the onset is within 48 hours after admission;

– onset during days 3 to 7 after admission and a strong suspicion of community-transmission (association with a community outbreak site);

  • Healthcare-associated COVID-19 case (HCAI)

– onset later than 48 hours after admission and a strong suspicion of transmission associated to healthcare);

– cases among the medical and auxiliary healthcare staff, if there is no strong evidence in support of community transmission;

Cases with onset within the first 14 days after discharge from a healthcare facility may be:

– HCAI, if the onset occurs within the first 48 hours after discharge;

– of uncertain origin, if the onset occurs 3 to 14 days after discharge and there is no strong evidence in support of either community origin or HCAI

Assignment to a certain category of transmission should be determined only after a careful assessment of each individual case.

Confirmed case

A person that has received laboratory confirmation of the SARS-CoV-2 infection, irrespective of the clinical signs and symptoms.

A close contact is defined as:

– A person who lives in the same household with a COVID-19 patient;

– A person who has had direct physical contact with a case of COVID-19 (e.g., handshake not followed by hand sanitisation);

– A person who has had unprotected direct contact with the infectious secretions of a COVID-19 case (e.g., while coughing, touching used handkerchiefs without wearing protective gloves);

– A person who has had face-to-face contact with a case of COVID-19 at a distance of less than 2 metres and for duration of at least 15 minutes;

– A person who has been in the same room (e.g., classroom, meeting room, hospital waiting room) with a case of COVID-19 for at least 15 minutes and at a distance of less than  2 meters;

– A healthcare professional or other person providing direct assistance to a COVID-19 patient or laboratory personnel handling samples collected from a COVID-19 patient without proper use of personal protection equipment*;

*Healthcare personnel who have observed the proper use of protection equipment as required by the type of assistance provided ARE NOT CONSIDERED A CLOSE CONTACT.

The epidemiological link may have occurred within a period of 14 days prior to the date of onset.

Death of a confirmed COVID-19 patient

A COVID-19 death is defined as the death of a confirmed COVID-19 patient, unless there is another clear cause of death that cannot be related to COVID disease (e.g., trauma, major acute bleeding, etc.) with no period of complete recovery between the illness and death.

A death due to COVID-19 cannot be attributed to another pre-existing condition (e.g., cancer, blood disorders) and COVID-19 should be reported as the cause of death independently of pre-existing medical conditions that are suspected of triggering a severe course of COVID-19.

COVID-19 must be specified on the death certificate as the cause of death for all individuals whose death was caused by COVID-19 or it is assumed that COVID-19 caused or contributed to their death.

It should also be mentioned that, pursuant to the Order of the Minister of Health no. 961/2020 issued to amend and supplement the Order of the Minister of Health no. 555/2020 on the approval of the Action Plan to prepare hospitals in the context of the COVID-19 epidemic, the List of hospitals that provide medical assistance to patients tested positive for the SARS-CoV-2 virus in phase I and in phase II, and the List of support hospitals for patients tested positive or suspected of SARS-CoV-2 virus, confirmed cases of COVID resulting in death for which the  findings of the RT-PCR dynamic profile in sputum / bronchial aspirate are negative (2 tests) may be considered as death due to SARS-CoV-2 infection if the clinician identifies signs and symptoms highly suggestive of this and the death is correlated with the clinical course determined by COVID. If it is necessary to clarify the cause of death, RT-PCR testing of lung tissue collected by a specialist of pathological anatomy / forensic medicine specialist is recommended, and necropsy is not required.

 

Criteria for performing SARS-CoV-2 testing

 

Prompt confirmation of a suspect case is necessary in order to ensure, in a fast and efficient manner, the epidemiological surveillance of contacts, implementation of prevention and control measures, and the collection of epidemiologically and clinically relevant information.

 

Guidelines for COVID-19 priority testing:

 

  1. Symptomatic persons, including medical and auxiliary healthcare personnel, according to the case definition;

 

  1. Symptomatic close contacts of confirmed cases;

 

  1. Asymptomatic patients within 48 hours prior to a transplant procedure and donors of organs, tissues, and of hematopoietic stem cells, prior to the procedure; recipients of transplants of organs, tissues, and of hematopoietic stem cells who are undergoing immunosuppressive therapy, prior to each hospitalisation during the post-transplant monitoring – 2 tests at a 24-hour interval;

 

  1. Medical teams collecting organs for transplant who travel between the transplant centre and the collection centres – once every 2 weeks;

 

  1. Asymptomatic patients with disease or drug-induced immunosuppression, within 48 hours prior to hospitalisation;

 

In this context, immunosuppression refers to: cytotoxic chemotherapy, extended-release biologics, cellular immunotherapy, and high doses of glucocorticoids, according to the guidelines provided by the Infectious Diseases Society of America (6.05.2020), accessed at https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

 

  1. Asymptomatic cancer patients undergoing chemotherapy and/or radiotherapy:

 

– Asymptomatic cancer patients undergoing chemotherapy – within 48 hours prior to each cycle and prior each visit to the hospital for monitoring purposes;

– Asymptomatic cancer patients undergoing radiotherapy – before the first session and afterwards once every 14 days until the therapy regimen is completed;

 

 

  1. Asymptomatic cancer patients before surgery or invasive procedures, within 48 hours prior to the surgical intervention / procedure;

 

Note:

With regard to points 6. and 7., in case of children hospitalised with an adult, the accompanying adult shall also be tested.

 

  1. Asymptomatic patients undergoing haemodialysis – twice a month;

– Asymptomatic patients undergoing haemodialysis who have been in contact with a confirmed case, 2 tests every 6-7 days; throughout this period, these patients will receive haemodialysis separately from other patients;

 

  1. Symptomatic patients undergoing haemodialysis;

 

  1. Institutionalised asymptomatic individuals – twice a month;

 

  1. Personnel providing assistance in long-term residential care centres – twice a month;

 

  1. Asymptomatic pregnant women who are either quarantined / isolated at home or have been in close contact with a confirmed case – on day 14 if still asymptomatic;

 

  1. Asymptomatic medical and auxiliary healthcare personnel who have been in direct contact with a confirmed case, 6-7 days after the last contact with a potential infected patient**;

 

** During the period following contact with a potential infected patient and until the laboratory results are known, healthcare personnel will continue their activity in compliance with standard protection measures.

Positive cases among symptomatic or asymptomatic healthcare personnel will follow the required isolation procedures that apply to other infected individuals.

Changes in the epidemiological circumstances may lead to the revision of these recommendations.

 

Medical facilities may establish testing protocols for the medical personnel and/or patients using RT-PCR techniques, in addition to these recommendations, which can be carried out using their own resources, either in their own laboratories or in other laboratories.

 

The test reports showing positive results shall be reported immediately, scanned and included in the same e-mail message sent by the laboratory that has performed the test to the hospital that requested the test, to the public health directorate that has jurisdiction over the case, and to the National Institute of Public Health (INSP), and then necessary action will be taken to hospitalise / isolate the infected individuals.

In such cases, the medical facilities will conduct their own epidemiological investigation and will undertake measures to limit the infection; these actions fall under direct responsibility of the manager.

The report of the epidemiological investigation will be sent within 24 hours to the public health directorate in the county to which the case belongs.

 

Laboratory investigations

 

Samples must be collected according to Appendix 2 and sent to the laboratory, together with the Form accompanying specimens collected from a suspected COVID-19 case provided in Appendix 3.

Respiratory samples that have been collected shall be sent to the specialised centres that perform RT-PCR testing for the identification of SARS-CoV-2, specified in the Technical standards for the implementation of National Health Programme (PNS).

Laboratory personnel will comply strictly with the precautions required for the prevention of SARS-CoV-2 infection.

 

The method used for testing is the nucleic acid amplification testing (NAAT), which includes RT-PCR. Patients may be tested for other respiratory pathogens as well, but this should not delay the testing for SARS–CoV-2.

Due to the possibility of co-infections, patients who meet the case definition should be tested for SARS-CoV-2 regardless of the presence of another respiratory pathogen.

 

The minimum set of specimens recommended to be collected for diagnostic include:

Upper respiratory specimens (nasopharyngeal and oro-pharyngeal swab or wash) –  it is recommended to use Dacron or polyester swabs, with plastic shafts, and to place both the nasopharyngeal and the pharyngeal swabs in the (same) vial containing the viral transport medium (VTM).

 

and/or

 

Lower respiratory tract specimens: sputum (if expectorated) and/or endotracheal aspirate or bronchoalveolar lavage, collected from patients with severe acute respiratory infection.

 

In case of deceased patients suspected of COVID-19 autopsy lung specimens will be collected and sent to the laboratory for viral diagnosis. The collection of samples is not typically required for cases previously confirmed based on nasopharyngeal swabs or bronchotracheal aspirate, nor in cases with a negative result for SARS-CoV-2 based on these specimens.

Details regarding the collection of pathological specimens and laboratory tests can be found in Appendix 2.

 

  1. Type of surveillance: case-based, passive/active

 

VII. Population: all residents / people visiting Romania

 

VIII. Period: permanent

 

  1. Reporting data:

 

 

  • The minimum set of data to be reported immediately by telephone for a suspected case:

 – Case code, name, first name, Personal Identification Number (CNP), date of onset, symptoms (in correlation with the case definition), epidemiological link (contact with a confirmed case), occupation (e.g., healthcare personnel), date and place of hospitalisation, date and place of death;

 

  • In case of deaths recorded for confirmed cases of COVID-19: case code, Personal Identification Number (CNP), date of onset, symptoms (in correlation with the case definition), epidemiological link (contact with a confirmed case), occupation (e.g., healthcare personnel), date and place of hospitalisation, date and place of collection, date and place of confirmation (laboratory), date and place of death, pre-existing medical conditions;

 

  • In accordance with the Patient Monitoring Chart pertaining to a CONFIRMED case of COVID-19 (Appendix 1), therefore only for a confirmed case;

 

Data from the patient monitoring charts pertaining to confirmed cases are entered into the online application

 

See also X. Information circuit and informational feedback

 

  1. Information circuit and informational feedback

 

Peripheral level: hospitals

  • report to the Public Health Directorate (DSP) immediately, by telephone, the minimum set of data pertaining to the suspected case: name, first name, Personal Identification Number (CNP), date of onset, symptoms (in correlation with the case definition), epidemiological link (contact with a confirmed case), date of death;
  • report to DSP immediately, by telephone, the deaths recorded for confirmed COVID-19 cases;
  • collect and test / send biological specimens to the laboratory, together with the accompanying form that is provided in Appendix 3, which is a mandatory document;

 

Peripheral level: laboratories performing COVID-19 testing using RT-PCR:

 

  • report immediately the test reports with validated results, signed and sealed, scanned, by e-mail, in the same message sent to the DSP that has jurisdiction over the case (the DSP  in the county where the infection occurred) or which has requested preventive testing, according to the testing algorithm, to the hospital that requested the tests, or to the National Institute of Public Health – The National Centre for Communicable Diseases Surveillance and Control (INSP-CNSCBT);
  • report the tests performed for COVID-19 on a daily basis, between 8-9 a.m. for the previous day, on the platform of the Ministry of Health;
  • report the tests performed for COVID-19 on a daily basis, until 10 a.m. for the previous day, to INSP-CNSCBT, using the e-mail address raportare_covid@insp.gov.ro;

 

The number of positive cases will be notified in advance, by telephone, calling the mobile number 0744510640 or 0742031461 or the landline number 021 3179702.

 

The algorithm for reporting suspected COVID-19 cases is posted on CNSCBT website http://www.cnscbt.ro/index.php/informatii-pentru-personalul-medico-sanitar

 

As mentioned in the algorithm provided for testing, admission to hospital and discharge from hospital, all cases of pneumonia and all cases of SARI with no other aetiology (e.g., influenza) for ALL age categories and from ALL hospitals will be tested for COVID-19.

 

For all suspected/confirmed cases of COVID-19 identified as a result of sentinel surveillance for SARI, it shall also be required to fill in the Monitoring chart pertaining to a case of SARI (Severe Acute Respiratory Infection).

 

 

Peripheral level: family medicine practices, other medical practices

 

  • isolate and apply a mask on the nose and mouth of the suspect case;
  • call 112;report to DSP immediately, by telephone, the minimum set of data pertaining to the suspected case: name, first name, Personal Identification Number (CNP), date of onset, symptoms (in correlation with the case definition), epidemiological link (contact with a confirmed case),occupation (e.g., healthcare personnel);
  • refer the suspect case to the hospital, using an ambulance;
  • notify DSP immediately, by telephone the recorded deaths of suspect/confirmed cases of COVID-19;

 

 

Local level: County DSP / Bucharest DSP

 

  • report immediately on the STS platform any positive result;
  • enter the rest of the data required for a newly confirmed case into the STS platform within 24 hours;
  • initiate the epidemiological investigation for the CONFIRMED case within 24 hours;
  • enter the minimum set of data that is required for immediate reporting by telephone of a SUSPECT case into the electronic platform dedicated to the monitoring record;
  • complete and upload on the electronic platform dedicated to the monitoring record of the CONFIRMED case, within 7 days, the data contained in this chart (Appendix 1);
  • report to CNSCBT, immediately after detection, any outbreak site with at least 3 cases, including the measures that have been recommended / implemented;
  • immediately initiate the epidemiological investigation for the clusters;
  • report immediately, by telephone to CNSCBT, the deaths recorded for suspect/confirmed cases of COVID-19, and afterwards the updated monitoring chart including the information related to the death must be sent within 24 hours after death by fax/e-mail to CNSCBT and CRSP, with the specification “Update”;
  • initiate immediately the epidemiological investigation for the deceased case;
  • receive laboratory results from CNSCBT;

 

 

Regional level: CRSP (Regional Centre of Public Health)

 

  • takes action in the epidemiological investigations carried out with respect to clusters / outbreaks and provides technical assistance, upon request made by the DSP in its area of jurisdiction or following a request made by CNSCBT;
  • sends to CNSCBT and DSP, on a quarterly basis, the epidemiological analysis of the cases within its area of jurisdiction;

 

National level: CNSCBT

  • checks the entries made by DPS on the STS concerning the data and information pertaining to the confirmed cases and outbreak sites;
  • checks the minimum sets of data pertaining to SUSPECT cases and the information included in the monitoring charts pertaining to CONFIRMED cases (Appendix 1), uploaded on the online platform dedicated for these records;
  • sends to the Ministry of Health, every day at 12:00, the reports concerning the tests completed in the laboratories and the stocks of testing kits;
  • collects daily the validated, signed and sealed, scanned tests reports sent by laboratories;
  • conducts the epidemiological analysis of the national database and send the results to the Ministry of Health (MS) – DGAMSP (General Directorate for Medical Assistance and Public Health), CRSP, and DSP;
  • reports the confirmed cases in TESSy, case by case;
  • Provides to IHR department within INSP the information requested by WHO-IHR.

 

 

The National Focal Point for RSI (2005):

Provides to CNSCBT information updated daily with regard to the number of cases and participates in the national risk assessment.

 

  1. Control measures

 

 

Are applied immediately after the identification of a suspect case of COVID-19, without waiting for the laboratory test results!

 

1) Conduct with respect to the case:

 

A case is deemed to be infectious 2 days prior to onset and for another 14 days after the onset.

The following actions are required:

  • isolation of the suspect and confirmed cases;
  • implementation of precautionary measures to avoid transmission by droplets, contact and, as the case may be, air-borne transmission, as well as universal precautions throughout the period of hospitalisation;
  • training of the personnel providing assistance to the suspect case / case confirmed by the hospital epidemiologist, conducted for each new shift by the coordinator of the previous team;
  • cohorting of the suspect cases and personnel that provides assistance to them;

 

2) Conduct with respect to close contacts:

 

The definition of a close contact has been provided in section V. Case definitions for the acute respiratory syndrome caused by the novel coronavirus (COVID-19).

The approach taken in this regard shall observe the provisions of the legislation in force.

 

3) Conduct with respect to clusters of at least 3 cases:

 

The epidemiologic investigation by DSP shall be initiated immediately after the cluster has been reported to DSP / identified by DSP and reported, by DSP, to CNSCBT.

The identification of a cluster requires a thorough epidemiological investigation carried out by DSP, possibly with the technical assistance of CRSP, if requested by DSP or CNSCBT.

The information about the cluster (DSP, location of the cluster – town/city, community / hospital, date of onset of the first case and of the most recent case in the cluster), alongside the recommended measures shall be sent to CNSCBT and CRSP, on the date of identification by DSP.

 

4) Conduct with respect to individuals arriving from international travel

In such cases, the approach shall be established by the legislation in force.

 

XII. Recommended epidemiological analysis

  • number of cases identified daily and weekly, broken down by age groups, sex, environments, and geographic area: county / CRSP jurisdiction / national;
  • number of cases identified daily and weekly, based on their classification as suspect / probable / confirmed cases;
  • the weekly fatality rate and the cumulative fatality rate (probable or confirmed cases);
  • the weekly mortality rate and the cumulative mortality rate (probable or confirmed cases);
  • the attack rate in case of epidemics

 

XIII. Assessment indicators of the surveillance system

 

– % of counties that report correctly (in a complete and timely manner) to CRSP and CNSCT;

– % of suspect / probable cases for which the epidemiologic investigation has been initiated immediately by the epidemiologist;

– % of suspect cases that have been confirmed;

– % of confirmed cases with known source of infection (first confirmed case identified)

 

 

Dr. Adriana Pistol

Dr.Odette Popovici

Dr.Teodora Vremeră

 

 

Appendix 1

Monitoring chart for a CONFIRMED case of COVID-19

 

DSP: ____________________ (county abbreviation)

DSP CODE: ­­­­­­­­­­­­­­­­­______________ (county abbreviation / case number / year – e.g. AB/01/2020)

Date of reporting by fax/e-mail to DSP by CNSCBT: _ _ /_ _ /_ _ _ _ (dd/mm/yyyy)

Detected at the entry point: □ NO                      □  YES             □ Unknown

If YES, specify the date:  _ _ /_ _ /_ _ _ _ (dd/mm/yyyy)

 

Section 1: General information about the patient

 

Name, first name:______________________ CNP: | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ |

Date of birth: _ _ /_ _ /_ _ _ _ (dd/mm/yyyy)   or age in years: _____________

If the age is < 1 year: ___________ months;

If the age is < 1 month: ___________days

Sex at birth: □ Male      □ Female

Place of diagnosis: Region (NUTS 2): RO____ County/NUTS 3: ____ / RO____

Legal home address: Region (NUTS 2): RO____ County/NUTS 3: ____ / RO____ City/town____

Was quarantined in: Region (NUTS 2): RO____ County/NUTS 3: ____ / RO____

City/town______________________

 

Section 2: Clinical information

Date of onset of symptoms: _ _ /_ _ /_ _ _ _ (dd/mm/yyyy)         □ Unknown

Asymptomatic person with a positive result (quarantined / contact of a confirmed case) □

Hospitalised: □ NO      □  YES       If YES, date of first admission: _ _ /_ _ /_ _ _ _ (dd/mm/yyyy)

Name of hospital: ___________________________

Date of current admission: _ _ /_ _ /_ _ _ _ (dd/mm/yyyy) Name of hospital: _________________

Admitted to ICU: □ NO            □ YES

Date of reporting to DSP: _ _ /_ _ /_ _ _ _ (dd/mm/yyyy)

Health status (please circle) at the moment of reporting: Cured/Not cured/Deceased/Unknown/Still under treatment

Date of death: _ _ /_ _ /_ _ _ _   (dd/mm/yyyy)

 

Patient’s declared symptoms (check all that apply):

□ History of fever (≥380 C)        □ Difficulty breathing   □ Pain (check all that apply)

                                                                                       ( ) Muscular  ( ) Chest

                                                                                       ( ) Abdominal  ( ) Joint

□ Chills

□ General weakness                  □ Diarrhoea

□ Cough                                   □ Nausea / vomiting

□ Sore throat                            □ Headache

□ Rhinorrhoea                          □ Irritability / confusion

□  Other, specify _________________________________________

 

Signs observed at admission (check all that apply):

□Measured fever ( ≥380 C) ____ degrees Celsius

□ Pharyngeal discharge             □ Coma                        □ Changes of chest X-ray

□ Conjunctival congestion        □ Dyspnea / Tachypnea

□ Convulsions              □ Modified lung auscultation

□  Other, specify_________________________________________

 

Ventilator support:

Has received only oxygen through respiratory                □

Has received invasive ventilation (intubated)                  □

ECMO (Extracorporeal membrane oxygenation)            □

Was not necessary                                                        □

Was not available                                                         □

 

Current and pre-existing physiological and medical conditions (check all that apply):

□ Pregnancy (trimester: __________)                            □ Post-childbirth (< 6 weeks)

□ Cardiovascular disease, including arterial hypertension  □ Immunodeficiency, including HIV/AIDS

□ Diabetes                                                                   □ Renal disease

□ Hepatic disease                                                         □ Chronic lung disease

□ Chronic neurological or neuromuscular disease           □ Cancer

□  Other, specify

 

Section 3: Exposure and information about travelling during the period of 14 days prior to the onset of symptoms

 

  • Occupation (check all that apply):

□ Student                                 □ Healthcare personnel

□ Working with animals            □ Laboratory personnel handling biological specimens

                                                                        □  Other, specify _________________

 

  • Has travelled during the period of 14 days prior to the onset of symptoms?

□ NO     □YES             □ Unknown

 

If YES, please specify the places of travel:

 

COUNTRY                 REGION                     CITY                           PERIOD

  1. ___________ ___________               ___________               ___________
  2. ___________ ___________               ___________               ___________
  3. ___________ ___________               ___________               ___________

 

Has travelled by airplane?                    □ NO      □  YES       If YES, flight no.:________ Seat_____

Airport of departure _____________     Airport of arrival _____________

Has travelled by coach / minibus?         □ NO      □  YES       If YES,  travel company: _____________

Place of departure _____________ Place of arrival _____________

 

  • Has visited healthcare facilities during the period of 14 days prior to the onset of symptoms?

□ NO      □  YES     □  Unknown

If YES, town/city _____________ Healthcare facility _____________

Period _____________

 

  • Has the patient been in close contact1 with a person with acute respiratory infection during the period of 14 days prior to the onset of symptoms?

 

If YES, where did the contact take place (check all that apply):

 □ Medical facility      □  Family     □  Workplace           □  Unknown

 □ Other, specify _______________________________________

 

  • Has the patient had contact with a probable or confirmed case during the period of 4 days prior to the onset of symptoms? □ NO         □  YES             □ Unknown

If YES, please specify the case codes for all probable or confirmed cases:

Case code 1: ____________ Case code 2: _________ Case code 3: ___________

If YES, where did the contact take place? (check all that apply):

□ Healthcare facilities   □ Family          □ Workplace    □ Unknown

□Other, specify

If YES, place / city / country of exposure: ___________________________

 

  • Has the patient visited, during the period of 14 days prior to the onset of symptoms, any live animal fair / market? □ NO               □  YES             □ Unknown

If YES, place / city / country of exposure: ___________________________

 

Section 4: Laboratory information

 

Name of the laboratory that has performed the testing: ________________________

Type of respiratory specimen(s) (please indicate all of them): ___________________________ ______________________________________________________________________

Please specify the test that was used: _________________________________________

Has sequencing been performed?           □ NO   □  YES             □ Unknown

Date of confirmation (validation of the test) in the laboratory: _ _ /_ _ /_ _ _ _     (dd/mm/yyyy)

Result of influenza virus detection (RT-PCR): □ AH1-positive  □ AH2-positive□ A positive □ B Positive

□ Unknown      □ Untested

 

Section 5: Case classification                                     

 

Case classification:                  □ Suspected     □ Confirmed    □ Ruled out

 

Section 6: Identified contacts

 

TOTAL number of identified contacts: ___________, of which

No. of contacts in the family: _________

No. of contacts in the workplace / school: ______

No. of contacts from other settings: _________, specifically _____________________

 

 

Signature and stamp of the attending physician / hospital epidemiologist _____________________

 

Signature and stamp of the DSP epidemiologist _______________________

 

 

1 Person who lives in the same household with a COVID-19 patient;

– A person who has had direct physical contact with a case of COVID-19 (e.g., handshake not followed by hand sanitisation);

– A person who has had unprotected direct contact with the secretions of an infectious case of COVID-19 (e.g., while coughing, touching used handkerchiefs without wearing protective gloves);

– A person who has had direct face-to-face contact with a case of COVID-19 at a distance of less than 2 metres and for duration of at least 15 minutes;

– A person who has been in the same room (e.g., a classroom, meeting room, hospital waiting room) with a case of COVID-19 for at least 15 minutes and at a distance of less than  2 m;

– A healthcare professional or other person providing direct assistance to a COVID-19 patient or laboratory personnel handling samples collected from a COVID-19 patient without proper use of personal protection equipment*;

 

*Healthcare personnel who have observed the proper use of protection equipment as required by the type of assistance provided ARE NOT CONSIDERED A CLOSE CONTACT.

 

The epidemiological link may have occurred within a period of 14 days prior to the date of onset.

 

 

 

Appendix 2

 

 

COLLECTION, TRANSPORT, AND INVESTIGATION OF BIOLOGICAL SPECIMENS FOR THE DIAGNOSIS OF INFECTION WITH SARS-CoV-2

 

Respiratory specimens (Table 1) shall be collected from patients meeting the criteria for the case definition and from all individuals in the categories mentioned “Guidelines for COVID-19 priority testing”, as follows:

– Nasopharyngeal or oropharyngeal swab or wash from patients with mild or moderate clinical forms and from asymptomatic individuals;

– Sputum and/or endotracheal aspirate or bronchoalveolar lavage from patients with severe clinical forms, as applicable;

– Additionally: blood samples, stool samples, autopsy material.

 

It is recommended to collect a sufficient amount a specimens so as to allow multiple tests.

 

According to ECDC, in case of suspicion of infection with the novel coronavirus in hospitalised patients, it is recommended to collect samples repeatedly, every 2-4 days, until two consecutive negative results are obtained at least 24 hours apart (https://www.ecdc.europa.eu/en/european-surveillance-human-infection-novel-coronavirus-2019-ncov ).

 

Table      I. Recommendations for the collection of samples from symptomatic patients and asymptomatic contacts

 

Type of specimen

Collection instrument

Transportation

Preservation

Nasopharyngeal oropharyngeal swab

Dacron or polyester swab*

2-8°C

 

≤5 days: 2-8°C

> 5 days: -70°C

Bronchoalveolar lavage

Sterile container*

 

2-8°C

 

≤2 days: 2-8°C

> 2 days: -70°C

Endotracheal aspirate, nasopharyngeal or nasal aspirate or wash

Sterile container*

 

2-8°C

 

≤2 days: 2-8°C

> 2 days: -70°C

Sputum

Sterile container

 

2-8°C

 

≤ 2 days: 2-8°C

> 2 days: -70°C

Tissue samples obtained by biopsy or necropsy (including lung tissue)

 

Sterile container with saline solution or viral transport medium (VTM)

 

2-8°C

 

≤ 24 hours: 2-8°C

> 24 hours: -70°C

Stool

Stool container

2-8°C

 

≤ 5 days: 2-8°C

> 5 days: -70°C

Whole blood

Blood collection tube

2-8°C

 

≤ 5 days: 2-8°C

> 5 days: -70°C

Urine

Urine collection container

2-8°C

 

≤ 5 days: 2-8°C

> 5 days: -70°C

 

 

 

* The samples for viral detection shall be transported using a viral transport medium (VTM) containing antifungal and antibiotic supplements. Repeated freezing and thawing of specimens shall be avoided. If VTM is not available saline solution may be used instead, but in this case specimen stability at 2-8°C may be different from what is indicated in the table.

 

Biosafety measures during the handling of specimens

The medical personnel responsible for the collection and transport of specimens shall follow the recommendations provided in the Guideline Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected (https://www.who.int/publications-detail/infection-prevention-and-control-during- health-care-when-novel-coronavirus-(ncov)-infection-is-suspected).

All specimens shall be regarded potentially infectious. Additional precautions shall be undertaken during the collection of samples by means that pose a risk of aerosolisation (e.g., bronchoscopy, aspirate).

Specimens that can be transported fast to the laboratory may be kept at 2-8°C. Otherwise, it is recommended to use a viral transport medium, and the samples may be frozen (at minus 20°C or, ideally, at minus 70°C) and transported carbon ice. Avoid repeated freezing/thawing cycles.

Guidelines for the prevention and control of infections shall be strictly observed, as well as national and international regulations concerning the transportation of infectious materials. The personnel transporting the samples must receive proper training on the correct handling of specimens, as well as decontamination procedures. Involved personnel will observe proper use of the personal protection equipment (PPE). The use of pneumatic systems for the transportation of specimens shall be avoided. The samples shall be labelled properly, and the laboratory will be given prior notice. In the request for analysis, full identification details will be provided, together with the date and time of collection, type of specimen, tests requested, clinical symptoms, relevant case history information (vaccinations, antibiotic treatments, epidemiological information, risk factors).

Specimens collected for molecular diagnosis will be handled in compliance with the same biosafety provisions as those that apply for the molecular testing for influenza (BSL2). However, the isolation of the virus requires a higher level of biosafety (at least BSL3). Involved personnel will observe proper use of the personal protection equipment (PPE).

The following shall be observed:

– national guidelines regarding laboratory biosafety

– the recommendations provided in WHO Laboratory Biosafety Manual – Third Edition

(https://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_ 2004_11/en/)

WHO Laboratory biosafety guidance related to coronavirus disease 2019 (COVID-19)

https://apps.who.int/iris/bitstream/handle/10665/331138/WHO-WPE- GIH-2020.1-eng.pdf

WHO Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected, interim guidance, January 2020

 

The transport of specimen to another laboratory must observe the national guidelines, as well as WHO recommendations – Guidance on regulations for the transport of infectious substances 2019–2020

( https://www.who.int/ihr/publications/WHO-WHE-CPI-2019.20/en/ ) and

WHO interim guidance for laboratory biosafety related to 2019-nCoV.

 

Samples are regarded as inadequate in the following circumstances:

– swabs sent without a viral transport medium;

– specimen is sent in improper containers (damaged, cracked tube, open cover);

– failure to observe the requirements for transport or preservation (duration, temperature);

– missing label on the samples to be tested;

– missing request for testing;

– the request for testing is not properly filled in, with patient information either missing, incomplete, erroneous, or illegible.

 

Laboratory diagnosis of SARS-CoV-2 infection:

 

  1. Nucleic acid amplification testing (NAAT)

 

The diagnosis of the infection with SARS-CoV-2 is based on the detection of specific viral RNA sequences based on testing the amplification of nucleic acids, such as Real Time RT-PCR, and confirmation by sequencing whenever it is necessary. The viral gene targets include: N, E, S, and RdRP genes. The extraction of nucleic acids must be performed in a laboratory biosafety hood at level BSL-2. Thermal treatment of samples prior to the extraction of nucleic acids is not recommended.

 

The confirmation of cases in areas where the virus was not previously known to be in circulation:

– a positive result for at least two gene targets, of which at least one target is specific to SARS-CoV-2, using a validated test

or

– a positive result for beta-coronaviruses followed by SARS-CoV-2 sequencing (partial or WGS – the target sequence must be bigger or different than the one identified through the genic amplification  test)

 

In case of inconsistent findings, the following steps are recommended:

– collection of a new sample;

– sequencing of the virus from the original sample or the amplicon generated from a genic amplification testing other than the one used initially.

 

Any unusual result should be confirmed by an international reference laboratory.

Also, it is recommended to send the first 5 positive samples and the first 10 negative samples (tested in a laboratory in countries where the virus was not previously known to be in circulation) to one of WHO’s reference laboratories https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance

 

 

Confirmation of cases in areas where the virus is known to be in circulation

 

In areas where the virus is widely spread, a simplified diagnosis algorithm can be used, in which the screening by Real Time RT-PCR of a single discriminatory target is sufficient.

Each Real Time RT-PCR testing must include internal control, positive control, and negative control. It is recommended that laboratories which perform SARS-CoV-2 testing take part in an external quality control scheme when it becomes available. Also, the quality of reagents must be checked upon reception, in order to confirm the absence of contamination.

It is recommended that laboratories with limited experience collaborate with more experienced laboratories for the confirmation of initial results and improvement of their own performance.

 

  1. Whole genome sequencing provides useful information for understanding the origin of the virus and the way in which it spreads. It is recommended that identified sequences be reported to WHO and the scientific community and made public on platforms such as GISAID, in compliance with WHO Draft code of conduct for handling of Genetic Sequence data related to outbreaks (https://www.who.int/blueprint/what/norms-standards/GSDDraftCodeConduct_forpublicconsultation-v1.pdf?ua=1)

The sequences of the virus can be used for>

– confirmation of diagnosis in certain cases;

– monitoring of the occurrence of mutations that may impair the performance of diagnosis tests (due to the regular sequencing of samples collected from clinical cases);

– epidemiological studies.

 

Interpretation of results:

The possibility of an infection with SARS-CoV-2 is not ruled out by a one or multiple negative results, in particular in case of samples collected from the upper respiratory tract. A false-negative result may be due to:

– inadequate collection of samples, resulting in a reduced quantity of pathologic product

(it is recommended to include a human DNA target in the PCR testing);

– sample collected too early or too late in the course of the infection;

– inadequate handling and transportation of the sample;

– mutations of the virus;

– the presence of PCR inhibitors.

The identification of another pathogen does not rule out an infection with the novel coronavirus, and the role of co-infection in the pathology is not fully known.

In order to certify the clearing of the virus, it is recommended to repeat the sampling until two consecutive negative results are obtained by genic amplification reactions. All test results (positive or negative) must be notified immediately to the national authorities.

 

Source: https://apps.who.int/iris/bitstream/handle/10665/331329/WHO-COVID-19-laboratory-2020.4-eng.pdf?sequence=1&isAllowed=y

 

 

 

 

 

 

 

 

 

 

 

Appendix 3

 

Form accompanying the samples collected from a SUSPECT / CONFIRMED case of COVID-19 or other categories of individuals

 

Hospital / DSP __________________________

 

To, Laboratory __________________________

 

Case code: | _ | _ | _ | _ | _ | _ | _ | _ | _ (county abbreviation / case no./ year – e.g., AB/01/2020)

 

Sample no. __________________________

 

The case code will be kept for future samples collected form the same person.

 

Other categories of individuals: _____________________________

(e.g., cancer patient, resident in a long-term care facility etc.)

 

Name, first name: _____________________________

 

CNP: | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ | _ |

 

Age: (completed years): _________  months (for children under the age of 1 year) ______

                                                        days (for infants under the age of 1 month) _____                 

Mobile phone no. _____________________________

 

Healthcare personnel

_____________________________

 

Date of onset of the disease: _ _ / _ _ / _ _ _ _

 

Type of specimen:

nasal wash or aspirate □   nasal exudate  □    pharyngeal exudate  □

nasopharyngeal exudate □            sputum □          tracheobronchial aspirate □

bronchoalveolar lavage product  □    necroptic lung material

 

Date of specimen(s) collection:

  • nasal wash or aspirate _ _ / _ _ / _ _ _ _
  • nasal exudate / pharyngeal exudate _ _ / _ _ / _ _ _ _
  • nasopharyngeal exudate _ _ / _ _ / _ _ _ _
  • sputum _ _ / _ _ / _ _ _ _
  • tracheobronchial aspirate _ _ / _ _ / _ _ _ _
  • bronchoalveolar lavage product _ _ / _ _ / _ _ _ _
  • other type of specimen, specify ____________ _ _ / _ _ / _ _ _ _
  • necroptic lung material _ _ / _ _ / _ _ _ _

 

Type of investigation requested: Detection of SARS-CoV-2 by RT-PCR

Date when the sample was sent to the laboratory: _ _ / _ _ / _ _ _ _

Referring physician: _________________________

(signature and stamp)

HOTĂRÂRE pentru modificarea și completarea anexelor nr. 2 și 3 la Hotărârea Guvernului nr. 553/2020

În textul de mai jos aveți tradusă în limba engleză Hotărârea pentru modificarea și completarea anexelor nr. 2 și 3 la Hotărârea Guvernului nr. 553/2020.

                   Romanian Government hereby adopts this decision.

Art. 1 – Annexes No. 2 and 3 to Government Decision No. 553/2020 on the extension of the state of alert on the Romanian territory as of 17 July 2020, as well as the establishment of the measures to be applied throughout such period to prevent and combat the effects of the COVID-19 pandemic, published in the Official Gazette of Romania, Part I, No. 627 of 16 July 2020 shall be amended and supplemented as follows:


1. Annex No. 2, after Article 11 shall include a new Article, Art. 12, with the following content:


“Art. 12 – (1) In the application of Art. 5 para. (2) letter d) of Law no. 55/2020 on some measures to prevent and combat the effects of COVID-19 pandemic, as further amended, wearing a protective mask, so as to cover the nose and mouth is mandatory for all persons who have reached the age of 5, present in public open places, such as markets, fairs, waiting areas (bus stations, platforms and the like), sea fronts, areas where public celebrations or pilgrimages take place, outer part of tourist attractions, in certain time intervals, established by the decision of the County Committee / Bucharest Municipal Committee for Emergency Situations. The areas and time intervals shall be determined upon the proposal of the Public Health Division, by taking into account the probability of the simultaneous presence of a large number of people in those areas and within those time intervals, where there are difficulties in ensuring the physical distance necessary for health protection established under the law.

(2) The directors / owners of open public places established under para. (1) shall display in a visible place information regarding the obligation to wear a protective mask in those places, upon the request of the County Committee / Bucharest Municipal Committee for Emergency Situations.”

2. Article 2 of Annex No. 2 shall be amended and read as follows:
“Art. 2 – Compliance with the measures set forth in Art. 1 – 12 shall be monitored by the Ministry of Health and the Ministry of Internal Affairs.”

3. Annex No. 3, after item 3 in Article 5 shall include three new items, items 4 – 6, with the following content:

“4. The economic operators carrying out their activity in the areas referred to in item 3, such as terraces, clubs, bars and the like are required to comply with the opening hours and the restrictions established by the decision of the National Committee for Emergency Situations, upon the proposal of the Technical and Scientific Support Working Group for the management of highly contagious diseases on the Romanian territory or of a County Committee / Bucharest Municipal Committee for Emergency Situations.
5. The measures set forth in item 4 shall be established for the administrative and territorial units where there is an intense community spread of the virus and/or an increasing number of persons infected with the SARS-COV-2 virus.
6. The economic operators carrying out their activity in the areas referred to in item 3 are required to take measures to limit the number of customers to the number of seats and any activities involving physical interaction between the customers.”

4. Annex No. 3, after item 4 in Article 8 shall include a new item, item 41, with the following content:
“4.1. The economic operators carrying out gambling activities are required to comply with the opening hours and the restrictions established by the decision of the National Committee for Emergency Situations, upon the proposal of the Technical and Scientific Support Working Group for the management of highly contagious diseases on the Romanian territory or of a County Committee / Bucharest Municipal Committee for Emergency Situations. The measures shall be established for the administrative and territorial units where there is an intense community spread of the virus and/or an increasing number of persons infected with the SARS-COV-2 virus.”

5. Paragraph (15) of Article 10 in Annex No. 3 shall be amended and read as follows:
“(15) The measures set forth in Art. 8 item 4 shall be applied by the Ministry for Economy, Energy and Business Environment and the Ministry of Health. Compliance with the measures set forth in Art. 8 items 4 and 41 shall be monitored by the Ministry of Labour and Social Protection and the Ministry of Internal Affairs.”
Art. 2 – The measures set forth in Article 1 shall become effective upon the publication with the Official Gazette of Romania, Part I.

PRIME MINISTER

LUDOVIC ORBAN