Circular 54/2015/TT-BYT reporting and declaration of infectious diseases and epidemics

• Official number: 54/2015/TT-BYT
• Legislation Type: Circular
• Organization: The Ministry of Health
• Signer: Nguyen Thanh Long
• Issued Date: 28/12/2015

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------
No.: 54/2015/TT-BYT	Hanoi, December 28, 2015

CIRCULAR

PROVIDING GUIDANCE ON REPORTING AND DECLARATION OF INFECTIOUS DISEASES AND EPIDEMICS

Pursuant to the Law on prevention and control of infectious diseases No. 03/2007/QH12 dated November 21, 2007;

Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director General of the General Department of Preventive Medicine;

The Minister of Health promulgates a Circular providing guidance on reporting and declaration of infectious diseases and epidemics.

Chapter I

REPORTING ON INFECTIOUS DISEASES

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The reporting is required:

1. when any person is founded to be infected with one of the infectious diseases prescribed in Appendix 1 enclosed herewith;

2. when an infectious disease cluster is detected, during it is active and when it is eliminated;

3. when actions are taken to prevent and control infectious diseases; and

4. when reports are required to serve the supervision and administration of regulatory authorities in preventing and controlling infectious diseases.

Article 2. Reporting rules

1. Information on infectious diseases and epidemics must be provided in an authentic, adequate and timely manner. Reporting units shall assume responsibility for their submitted reports.

2. Procedures, authority and document forms enclosed herewith must be adhered when providing information and submitting reports.

3. If online reports have been provided, written reports are not required, provided that all relevant documents must be kept at the reporting units in accordance with Clause 1 Article 3 hereof.

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1. Online reports: Reports shall be submitted to the reporting system through the internet, and medical records, in case of reporting of cases of infectious diseases, or written reports, in other cases of reporting, must be kept at reporting units.

2. Written reports: In cases where reports cannot be sent online, written reports shall be sent as official dispatches, by fax or email.

3. Other reporting forms: In an emergency, reporting may be made by phone or directly and online or written reports must be submitted within 24 hours.

Article 4. Reporting contents

1. The statistical data on infectious disease cases is based on the date of disease onset.

2. Case reports: The lists of infectious diseases subject to the case reporting are provided in Section 1 and Section 2 of Appendix 1 enclosed herewith (including clinically diagnosed cases, laboratory-confirmed cases, inpatient and outpatient cases, and cases detected in communities). Case reports are made according to Form 1 in Appendix 2 enclosed herewith.

3. Weekly reports: Weekly reports are made according to Form 2 in Appendix 2 enclosed herewith. A weekly report contains data collected within 07 days starting on Monday at 00:00 AM to Sunday at 24:00 PM of the reporting week.

4. Monthly reports: Monthly reports are made according to Form 3 and Form 4 in Appendix 2 enclosed herewith. The list of infectious diseases subject to the case reporting is provided in Section 3 of Appendix 1 enclosed herewith. A monthly report contains data collected from 00:00 AM of the first day to 24:00 PM of the last day of the reporting month.

5. Annual reports: Annual reports are made according to Form 5 and Form 6 in Appendix 2 enclosed herewith. An annual report contains data collected from 00:00 AM of the first day to 24:00 PM of the last day of the reporting year.

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7. Ad hoc reports: Contents and data in ad hoc reports must meet reporting requirements set out by regulatory authorities for each specific purpose.

Article 5. Reporting procedure

Reporting procedure shall be carried out according to the flowchart of infectious disease reporting system provided in Appendix 3 enclosed herewith. To be specific:

1. Health offices of regulatory authorities, private clinics, medical diagnosis centers, family doctor clinics and health professionals of hamlets/villages shall notify their local medical stations of communes, wards or commune-level towns (hereinafter referred to as "commune-level medical stations") as soon as possible after they detect a person reasonably suspected of having one of the infectious diseases listed in Section 1, Section 2 or Section 3 of Appendix 1 enclosed herewith for further investigation, verification, reporting and declaration of infectious diseases/epidemics as prescribed.

2. Commune-level medical stations shall receive notifications, investigate and confirm reported cases, and report infectious disease data collected in the commune to the medical centers of rural or urban districts, district-level towns or provincial cities (hereinafter referred to as "district-level medical centers") within the following time limits:

a) Case reports: submitted within 24 hours or 48 hours after receiving diagnosis of any case of the infectious diseases listed in Section 1 and Section 2 of Appendix 1 enclosed herewith;

b) Weekly reports: submitted by 14:00 PM on Tuesday of the week following the reporting week;

c) Monthly reports: submitted by the 05^th of the month following the reporting month;

d) Updates to case reports and monthly reports: When receiving the list of patients living in the commune but receiving medical examination and treatment in other communes from the district-level medical center, the commune-level medical station shall carry out investigation and verification of information. Within 24 hours after information is certified inaccurate or the patient’s address cannot be verified, the commune-level medical station shall report the case to the district-level medical center for updating.

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a) Case reports: submitted within 24 hours or 48 hours after receiving diagnosis of any case of the infectious diseases listed in Section 1 and Section 2 of Appendix 1 enclosed herewith;

b) Monthly reports: submitted by the 05^th of the month following the reporting month. The list of infectious diseases subject to the monthly reporting is provided in Section 3 of Appendix 1 enclosed herewith;

c) Updates to case reports and monthly reports must be made within 24 hours after receiving changes in initial diagnosis or laboratory confirmation, or when a patient is discharged, transferred to another hospital or dies, or when receiving changes in patient’s personal details.

4. General hospitals and specialized hospitals of central-affiliated cities and provinces (hereinafter referred to as “provincial hospitals”), and private hospitals shall report and provided updated information on infectious diseases in their hospitals to preventive medicine centers of central-affiliated cities and provinces (hereinafter referred to as “provincial preventive medicine centers”) and report and provided updated information on malaria and diseases caused by parasites and insects to malaria prevention and control centers central-affiliated cities and provinces (hereinafter referred to as “provincial malaria prevention and control centers”) within the following time limits:

a) Case reports: submitted within 24 hours or 48 hours after receiving diagnosis of any case of the infectious diseases listed in Section 1 and Section 2 of Appendix 1 enclosed herewith;

b) Monthly reports: submitted by the 05^th of the month following the reporting month. The list of infectious diseases subject to the monthly reporting is provided in Section 3 of Appendix 1 enclosed herewith;

c) Updates to case reports and monthly reports must be made within 24 hours after receiving changes in initial diagnosis or laboratory confirmation, or when a patient is discharged, transferred to another hospital or dies, or when receiving changes in patient’s personal details.

5. Central hospitals, hospitals and medical centers affiliated to regulatory ministries shall report and provide updated information on infectious diseases in their hospitals/centers to National Institute of Hygiene and Epidemiology, Pasteur Institute, National Institute of Malariology, Parasitology and Entomology, provincial preventive medicine centers and provincial malaria prevention and control centers within the following time limits:

a) Case reports: submitted within 24 hours or 48 hours after receiving diagnosis of any case of the infectious diseases listed in Section 1 and Section 2 of Appendix 1 enclosed herewith;

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c) Updates to case reports and monthly reports must be made within 24 hours after receiving changes in initial diagnosis or laboratory confirmation, or when a patient is discharged, transferred to another hospital or dies, or when receiving changes in patient’s personal details.

6. District-level medical centers shall aggregate infectious disease reporting data provided by commune-level medical stations and district hospitals and submit consolidated reports to provincial preventive medicine centers and provincial malaria prevention and control centers within the following time limits:

a) Case reports: submitted within 24 hours from receipt of reports from commune-level medical stations and district hospitals;

b) Weekly reports: A weekly report on infectious disease prevention and control activities performed by commune-level medical stations and the district-level medical center shall be submitted by 14:00 PM on Wednesday of the week following the reporting week;

c) Monthly reports: A monthly report shall be prepared based on lists of patients provided by commune-level medical stations, district hospitals and provincial preventive medicine centers, and submitted by the 10^th of the month following the reporting month;

d) Annual reports: submitted by January 10 of the year following the reporting year.

dd) Updates to case reports and monthly reports: Within 24 hours after receiving notification of inaccurate information on disease cases from a commune-level medical station, the district-level medical center shall provide updates on the reporting system. In the case where a patient’s address cannot be verified, the district-level medical center shall cooperate with the relevant district hospital to re-verify the information if such case was reported by that district hospital or report the case to the provincial preventive medicine center if such case was reported by a provincial or central health facility;

e) Cluster reports: A cluster report must be submitted as soon as possible, but no later than 24 hours, after a new cluster is detected. Situation reports providing updates on the cluster shall be submitted daily (by 10:00 AM) until that cluster is certified inactive, and the report on eliminated cluster shall be submitted within 48 hours after the cluster is certified inactive.

g) Information response: By 10:00 AM every day, the district-level medical center shall provide each of commune-level medical stations with the list of patients living in the commune reported on the online reporting system of the Ministry of Health for carrying out investigation, verification of information as well as prevention and control of infectious diseases.

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a) Weekly reports: A weekly report on infectious disease prevention and control activities in their centers shall be submitted by 14:00 PM on Wednesday of the week following the reporting week;

b) Monthly reports: When receiving the lists of patients with infectious diseases subject to monthly reporting from National Institute of Hygiene and Epidemiology, Pasteur Institutes, central hospitals and provincial hospitals, the provincial preventive medicine center shall prepare and send a consolidated report to district-level medical centers by the 08^th of the following month for performing monthly reporting tasks;

c) Annual reports: Provincial preventive medicine centers and provincial malaria prevention and control centers shall consolidate and submit annual reports in writing to the National Institute of Hygiene and Epidemiology, Pasteur Institute or regional office of National Institute of Malariology, Parasitology and Entomology (in respect of malaria and diseases caused by parasites and insects) by January 15 of the following year;

d) Updates to case reports and monthly reports: Within 24 hours after receiving specimen test reports from the National Institute of Hygiene and Epidemiology, Pasteur Institute or National Institute of Malariology, Parasitology and Entomology, provincial preventive medicine centers and provincial malaria prevention and control centers shall play the leading role and cooperate with relevant units to provide updates as prescribed. In the case where a patient’s address cannot be verified, within 24 hours, the provincial preventive medicine center or provincial malaria prevention and control center shall play the leading role and cooperate with relevant units to verify information and provide updates as prescribed.

8. International health quarantine centers and provincial preventive medicine centers performing health quarantine tasks shall report suspected and confirmed cases of infectious diseases detected at border checkpoints to the National Institute of Hygiene and Epidemiology, Pasteur Institute, National Institute of Malariology, Parasitology and Entomology, provincial preventive medicine centers and provincial malaria prevention and control centers.

9. The National Institute of Hygiene and Epidemiology, Pasteur Institute, and National Institute of Malariology, Parasitology and Entomology shall submit reports on infectious diseases to the Ministry of Health (via the General Department of Preventive Medicine) according to the procedure and within the time limits below:

a) Weekly reports: submitted by 14:00 PM on Wednesday of the week following the reporting week;

b) Monthly reports: When receiving the lists of patients with infectious diseases subject to monthly reporting from central hospitals, hospitals and medical centers affiliated to regulatory ministries, the National Institute of Hygiene and Epidemiology and Pasteur Institute shall prepare and send consolidated lists to provincial preventive medicine centers by the 07^th of the following month;

c) Annual reports: The National Institute of Hygiene and Epidemiology, Pasteur Institute, and National Institute of Malariology, Parasitology and Entomology shall cooperate with provincial preventive medicine centers, provincial malaria prevention and control centers and relevant units in reviewing collected data for preparing and submitting annual reports to the Ministry of Health (via the General Department of Preventive Medicine and the Agency of Health Examination and Treatment) by January 31 of the following year;

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10. Departments of Health of rural or urban districts, district-level towns or provincial cities, and Departments of Health of central-affiliated cities and provinces (hereinafter referred to as "provincial Departments of Health”) shall aggregate data on infectious diseases in their districts/provinces from the online reporting system of the Ministry of Health for administering the prevention and control of infectious diseases in their districts/provinces.

Chapter II

DECLARATION AND REPORTING OF INFECTIOUS DISEASE EPIDEMICS

Article 6. Responsibility to declare infectious disease epidemics

In an area where an epidemic occurs, any person suffering from or suspected of having an infectious disease, or the one who detects a case of infectious diseases shall make a health declaration with the health professional of hamlet or village, commune-level medical station or the nearest health agency within 24 hours after detection as prescribed in Clause 1 Article 47 of the Law on prevention and control of infectious diseases.

Article 7. Responsibility to report infectious disease epidemics

Health facilities shall notify preventive medicine agencies within 24 hours after receiving epidemic-related information from people or detecting confirmed or suspected cases of an infectious disease epidemic for further investigation and verification. In case where the received information is certified accurate, the preventive medicine agency shall promptly report the case to the competent health authority at the place where the epidemic occurs as prescribed in Clause 2 Article 47 of the Law on prevention and control of infectious diseases, and also report on the online reporting system of the Ministry of Health in accordance with regulations herein.

Chapter III

IMPLEMENTATION PROVISIONS

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1. Responsibility of units affiliated to the Ministry of Health:

a) The General Department of Preventive Medicine shall:

- plan, direct and provide guidance on the implementation of this Circular, and organize the inspection of the implementation of this Circular nationwide;

- take charge of managing and keeping infectious disease database;

- act as the unique body authorized by the Minister of Health to make international notifications of infectious diseases.

b) The Agency of Health Examination and Treatment shall:

- direct, instruct, inspect and expedite health facilities nationwide in implementing this Circular.

- ensure the operation of data collection systems in health facilities, and consistent use of forms of medical records/electronic medical records in order to facilitate the sufficient and timely declaration and reporting of infectious diseases and epidemics by health facilities as prescribed herein.

c) The National Institute of Hygiene and Epidemiology, Pasteur Institute, and National Institute of Malariology, Parasitology and Entomology shall:

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- provide technical and operational instructions, supervise and assess the declaration and reporting of infectious diseases and epidemics by units under their management.

d) Central hospitals shall: arrange officials, equipment and funding for performing declaration and reporting of infectious diseases and epidemics. closely cooperate with preventive medicine centers in collecting specimens, sharing specimens or pathogens for reaching conclusive diagnosis.

2. Health offices of regulatory ministries and private hospitals shall:

a) arrange officials, equipment and funding for performing declaration and reporting of infectious diseases and epidemics.

b) closely cooperate with local preventive medicine centers in collecting specimens, sharing specimens or pathogens for reaching conclusive diagnosis.

3. Responsibility of provincial Departments of Health and local health agencies:

a) Each Provincial Department of Health shall: direct and organize the implementation of this Circular in their province; assume responsibility to inspect and expedite relevant units in implementation of this Circular; provide advice to provincial People’s Committees about the allocation of funding for performance and maintenance of reporting and declaration of infectious diseases and epidemics.

b) Local health agencies shall arrange officials, equipment and funding for performing declaration and reporting of infectious diseases and epidemics.

Article 9. Transition

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Article 10. Effect

1. This Circular comes into force from July 01, 2016.

2. Circular No. 48/2010/TT-BYT dated December 31, 2010 of the Minister of Health providing guidance on declaration and reporting of infectious diseases shall be null and void from the effective date of this Circular.

Any difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via the General Department of Preventive Medicine) for consideration./.

PP. MINISTER
DEPUTY MINISTER




Nguyen Thanh Long