Decision 4111/QD-BYT 2021 on Guidance for setting up the 3-storey tower COVID-19 treatment establishments

DECISION

On promulgating the Guidance for setting up the 3-storey tower COVID-19 treatment establishments

__________

THE MINISTER OF HEALTH

Pursuant to the 2007 Law on Prevention and Control of Infectious Diseases;

Pursuant to the 2009 Law on Medical Examination and Treatment;

Pursuant to the Government's Decree No. 75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Government's Resolution No. 8/NQ-CP dated August 06, 2021, on urgent COVID-19 pandemic prevention and control measures;

At the proposal of the Director of the Medical Services Administration - the Ministry of Health.

DECIDES:

Article 1. To promulgate together with this Decision the “Guidance for setting up the 3-storey tower COVID-19 treatment establishments”.

Article 2. This Decision takes effect on the date of its signing.

Article 3.  The Director of the Medical Services Administration; Chief of the Ministry Office, Chief Inspector; Director Generals and Directors of Directorates, Authorities, and Departments under the Ministry of Health; Directors of Hospitals and Institutes under the Ministry of Health; Directors of municipal and provincial Departments of Health; Heads of medical units of sectors shall be responsible for implementing this Decision.

GUIDANCE FOR SETTING UP THE 3-STOREY TOWER COVID-19 TREATMENT ESTABLISHMENTS

(Attached to the Minister of Health’s Decision No. 4111/QD-BYT

dated August 26, 2021)

________________

I. General information

COVID-19 is a group-A contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Persons infected with COVID-19 can be grouped into 05 categories of illness severity, including asymptomatic, mild illness, moderate illness, severe illness, and critical illness. COVID-19 patients can experience a range of clinical manifestations, from no symptoms to critical illness, such as severe pneumonia, acute respiratory distress syndrome (ARDS), septic shock, multi-organ dysfunction, and death, especially in the elderly, people with chronic illnesses, or immunocompromised people, people with co-infection or superinfection of other etiologies like bacteria, fungi. In order to limit severe and critical developments, patients should be regularly and closely monitored for disease progression at medical examination and treatment establishments or homes in accordance with regulations and instructions provided by the Ministry of Health.

The COVID-19 pandemic remains complicated and unpredicted in the world, region, and some neighboring countries, and there is currently no specific treatment drug for this disease. Due to the global shortage of COVID-19 vaccines, the COVID-19 vaccination creating herd immunity to effectively prevent and control the COVID-19 pandemic has not been achieved. The pandemic is forecasted to be prolonged and difficult to predict. Therefore, it is very necessary to grasp and forecast the risk of the pandemic in the locality to have a response plan. At localities according to administrative levels from commune to district, provincial and national levels, taking into account inter-communal, inter-district and inter-provincial factors, it is necessary to accurately grasp the situation, assess and risk forecasting according to 4 levels of “Very high risk”, “High risk”, “Moderate risk”, and “New normal” for each area. The appropriate plans for setting up COVID-19 treatment establishments shall be developed in consideration to the local pandemic forecast, specifically: in the state of “New normal”, “Moderate risk”, the “four-on-the-spot” motto may be applied (whereby command, forces, vehicles and supplies, and logistics taking place on the spot). When the forecast changes to a "High risk" or "Very high risk" state, it is necessary to quickly set up COVID-19 treatment establishments using the "3-storey tower" model.

In order to promptly prevent and control the pandemic, timely respond to the COVID-19 development, especially in some provinces and cities with a rapid increase in the number, speed, spread, and severity of the COVID-19 pandemic, the Ministry of Health promulgates the "Guidance for setting up the 3-storey tower COVID-19 treatment establishments”.

II. Objectives

1. To instruct ministries, branches; provincial and municipal Departments of Health to set up and consolidate COVID-19 treatment establishments in accordance with the actual conditions and situation and local pandemic forecast.

2. To improve response capacity, prepare and respond on the spot in an appropriate and effective manner according to the local pandemic level, for quarantine, management, and treatment of COVID-19 patients, minimizing the number of severe cases and deaths, contributing to minimizing the number of severe cases and deaths, contributing to minimizing the impact of the COVID-19 pandemic on economic development, order and safety of the family, community and society in general.

III. Principles

1. Plans for setting up COVID-19 treatment establishments shall be developed in consideration to

The local pandemic risk and development forecast shall be used as a basis for developing plans for setting up COVID-19 treatment establishments, corresponding to the following levels: "Very high risk", "High risk”, “Moderate risk”, and “New normal”; purchasing medical equipment and supplies; reserving, arranging and organizing forces to promptly and effectively serve pandemic prevention and control in the locality;

2. The entire system of medical establishments of the medical sector, medical units of ministries and sectors, medical examination and treatment establishments of universities, private medical establishments, and other social forces shall be mobilized to timely set up adequate COVID-19 treatment establishments and be ready for providing treatment according to the corresponding plan or plan with one level higher than local pandemic level;

3. Hospitals providing treatment for groups of people with moderate, severe, or critical illness shall be set up and consolidated while considering the sustainable and effective use during the COVID-19 pandemic and the possibility of using them after the pandemic is put under control;

4. COVID-19 treatment establishments shall be set up on the basis of assigning a hospital in the area to take professional responsibility;

5. COVID-19 treatment establishments shall operate under the administration of the local Steering Committee for COVID-19 prevention and control, assign relevant units to coordinate in implementation, in which health agencies shall take professional responsibility.

IV. Guidance for setting up the 3-storey tower COVID-19 treatment establishments

1. The 3-storey tower model in COVID-19 treatment

Figure 1: The 3-storey tower model in COVID-19 treatment

2. Functions and tasks of each storey in the 3-storey tower model in COVID-19 treatment

2.1. The first storey COVID-19 treatment establishment:

- To classify patients by their clinical severity in order to receive the right subjects according to the assigned functions and tasks.

- To receive, quarantine, manage, provide medical treatment and examination for suspected cases waiting for the confirmed test, asymptomatic cases, and cases with mild illness.

- To early detect, provide emergency treatment, timely transfer patients to hospitals when patients progress to moderate and severe.

- To maintain treatment of comorbidities and underlying diseases according to outpatient prescriptions of infected people and patients.

- To recognize the patients’ recovery from COVID-19 and allow them to self-monitor at home.

- To control infection, prevent the disease from spreading in the establishment and to the community.

- To ensure facilities, foodstuffs, and necessities for patients, health staff, and relevant staff.

- To provide guidance, encourage, share and provide spiritual support to infected people and patients so that they can feel secure to perform quarantine, management, and treatment.

- To closely monitor the observance of quarantine and medical examination and treatment at the establishment. Mandatory quarantine shall be imposed if patients fail to comply with quarantine requirements.

- Other tasks as assigned by competent management agencies.

2.2. The second storey COVID-19 treatment establishment:

- To receive and provide treatment for moderate and severe cases.

- To implement intensive care interventions according to the severity of illness.

- To closely monitor the patients’ progress and implement a nursing care regimen for the patients.

- To transfer patients to the third storey COVID-19 treatment establishment when the patients have a severe development beyond the establishment's professional capacity.

- To transfer patients to the first storey COVID-19 treatment establishment when they are in stable conditions.

- To ensure nursing care and nutrition for patients.

- To recognize the patients’ recovery from COVID-19 and allow them to self-monitor at home.

- To control infection, prevent the disease from spreading in the establishment and to the community.

- To ensure facilities, foodstuffs, and necessities for patients, health staff, and relevant staff.

- To provide guidance, encourage, share and provide spiritual support to infected people and patients so that they can feel secure to perform quarantine, management, and treatment.

- To closely monitor the observance of quarantine and medical examination and treatment at the establishment. Mandatory quarantine shall be imposed if patients fail to comply with quarantine requirements.

- Other tasks as assigned by competent management agencies.

2.3. The third storey COVID-19 treatment establishment:

- To receive and provide treatment for severe and critical cases.

- To transfer patients to the first storey or second storey COVID-19 treatment establishment when they are in stable conditions.

- To ensure nursing care and nutrition for patients.

- To recognize the patients’ recovery from COVID-19 and allow them to self-monitor at home.

- To control infection, prevent the disease from spreading in the establishment and to the community.

- To ensure facilities, foodstuffs, and necessities for patients, health staff, and relevant staff.

- To provide guidance, encourage, share and provide spiritual support to infected people and patients so that they can feel secure to perform quarantine, management, and treatment.

- To closely monitor the observance of quarantine and medical examination and treatment at the establishment. Mandatory quarantine shall be imposed if patients fail to comply with quarantine requirements.

- Other tasks as assigned by competent management agencies.

3. Types of COVID-19 treatment establishments

3.1. Switching the function from the existing hospitals

a) A part of the medical examination and treatment establishment may be converted into a COVID-19 treatment establishment

b) A medical examination and treatment establishment may be completely converted into an establishment specializing in the receipt and treatment of COVID-19 patients

The above-mentioned establishments may have different names: Hospital or Center or unit, zone or establishment, depending on its size.

3.2. New construction or establishment from an existing establishment other than a medical examination and treatment establishment (the establishment can be named as follows)

a) COVID-19 intensive care unit

b) COVID-19 field hospital

c) COVID-19 treatment zone

d) COVID-19 treatment establishment

4. Organizing and setting up COVID-19 treatment establishments

4.1. When the pandemic situation at the locality (provincial level) is in the state of “New normal” or “Moderate risk”, COVID-19 treatment establishments shall be set up according to the motto of four-on-the-spot treatment.

Figure 2: Model of four-on-the-spot COVID-19 treatment establishment

(*) The hospital must have a central oxygen system, compressed air, and liquid oxygen tanks

4.2. COVID-19 treatment model shall be set up when the pandemic situation at the locality (provincial level) changes from “Moderate risk” to “High risk” state, in such case, the motto of four-on-the-spot treatment shall no longer be used, and a 3-storey tower COVID-19 treatment establishment (figure 1) shall be set up. To be specific:

a) The first storey:

- The motto of four-on-the-spot treatment shall be followed; every district-level hospital must equip at least 50 sickbeds for receipt and treatment of asymptomatic and mild cases. When these establishments are beyond capacity or when confirmed cases appear scatteredly in various districts in the province, it is necessary to set up COVID-19 treatment establishments with at least 100 sickbeds from existing hospitals (select hospitals specializing in traditional medicine, rehabilitation, dermatology, etc.) of the provincial- or district-level hospitals. In case the above-mentioned establishments are beyond capacity, COVID-19 treatment establishments shall be set up from locations with existing infrastructure such as dormitory, stadium, gymnasium, etc. to manage and provide treatment for asymptomatic and mild cases.

- Organizational structure and human resources (Appendix 1)

- The first storey may comprise establishments assigned to manage confirmed cases under the Ministry of Health's Decision No. 4038/QD-BYT dated August 21, 2021, in case local COVID-19 treatment establishments are beyond capacity due to a large number of confirmed cases.

b) The second storey:

- The motto of four-on-the-spot treatment shall be followed; every district-level hospital must equip an intensive care room with at least 50 sickbeds for treatment of severe and critical cases (including patients with indications for oxygen). In case district-level establishments are beyond capacity as mentioned at Point (a) when confirmed cases appear scatteredly in various districts in the province, it is necessary to set up COVID-19 treatment establishments to provide treatment for severe and critical cases from existing hospitals or existing facilities other than medical examination and treatment establishments.

- Organizational structure and human resources (Appendix 2)

c) The third storey:

 - Establishments providing treatment for severe and critical cases shall be set up immediately when the pandemic appears in the community and confirmed cases are managed and treated at medical examination and treatment establishments located in the province. Establishments assigned the task of receiving and providing treatment for severe and critical cases by the locality on the basis of the hospital's capacity, such as provincial or municipal infectious diseases hospitals; provincial general hospitals with infectious diseases departments, provincial and municipal lung hospitals, or private hospitals, university hospitals, specialized hospitals in the area, district-level hospitals, etc. with an intensive care unit that is capable of emergency, rescue, and treatment of severe patients. When a large number of severe cases exceeds the receipt capacity of the above-mentioned hospitals, each locality must set up 1 - 2 hospitals from the existing hospitals of the province to arrange at least 200 intensive care beds for treatment of severe patients of the province in the following forms: COVID-19 intensive care units; COVID-19 intensive care hospitals of provinces, areas and central level (the list of units and hospitals is provided in the Minister of Health’s Decision No. 3616/QD-BYT dated July 29, 2021, approving the Scheme on “Strengthening the emergency and intensive care capacity for hospitals to treat severe COVID-19 patients”).

- Organizational structure and human resources (Appendix 3)

d) Depending on each local condition, pandemic situations, facilities, equipment, and human resources, different establishments with 3 separate storeys or a 3-storey establishment shall be set up to provide treatment for COVID-19 patients.

dd) Grounds for estimating the number of sickbeds corresponding to the number of storeys of the 3-storey tower model in COVID-19 treatment:

- To classify the clinical severity of COVID-19 patients (based on the analysis of COVID-19 development in Vietnam): Asymptomatic and mild cases: 83.6%; moderate cases:  11.2%; severe and critical cases: 5.2%; extracorporeal membrane oxygenation (ECMO) is estimated at 0.05% (this rate may change by time or in each locality).

- To estimate the number of COVID-19 cases by clinical severity in cases where there are 500; 1,000; 3,000; 10,000 and 30,000 confirmed cases, etc., to set up COVID-19 treatment establishment system (the number of sickbeds) for asymptomatic and mild cases; moderate cases; severe and critical cases.

e) Conditions on medical equipment, supplies, and medicines shall comply with general provisions provided by the Ministry of Health in the Decision No. 2626/QD-BYT dated May 28, 2021, on promulgating the List of demands for essential equipment, consumable supplies, and medicines of COVID-19 treatment zones; the Decision No. 1259/QD-BYT dated March 20, 2020, promulgating the List of essential personal protective equipment for a COVID-19 quarantine and treatment zone.

f) Conditions on human resources: COVID-19 treatment establishments must have all the minimum professional titles such as a doctor, nurse, technician, pharmacist, etc., quantity and professional capacity shall be depending on actual conditions of the locality and the person in charge of professional of the COVID-19 treatment establishment shall arrange them an appropriate work.

5.2. Competence to permit setting up of establishments

- Based on the proposal of the Ministry of Health's Steering Committee for COVID-19 Prevention and Control, the Minister of Health shall issue a decision on setting up “COVID-19 treatment establishments” by each level and type, for medical examination and treatment establishments under the Ministry of Health or other ministries and sectors (except for the Ministry of Public Security and the Ministry of National Defence).

- Based on the proposal of the Ministry of National Defence's Steering Committee for COVID-19 Prevention and Control, the Minister of National Defence shall issue a decision on setting up “COVID-19 treatment establishments” by each level and type, for medical examination and treatment establishments under the Ministry of National Defence.

- Based on the proposal of the Ministry of Public Security's Steering Committee for COVID-19 Prevention and Control, the Minister of Public Security shall issue a decision on setting up “COVID-19 treatment establishments” by each level and type, for medical examination and treatment establishments under the Ministry of Public Security.

- Based on the proposal of the Steering Committee for COVID-19 Prevention and Control of the provincial-level Department of Health or province, the Chairperson of provincial-level People’s Committee shall issue a decision on setting up “COVID-19 treatment establishments” by each level and type. (The Form for Decision on setting up of a “COVID-19 treatment establishment” is provided in Appendix 01).

 - The agency issuing the decision to permit setting up of the "COVID-19 treatment establishment" shall assign a hospital to manage and operate such establishment; in this case, such establishment shall be considered the second branch of the assigned hospital.

5.3. Operation license, hospital ranking, treatment establishment code, lists of techniques, medicines, and medical supplies

- The decision on setting up a COVID-19 treatment establishment issued by the competent agency as prescribed in Section 5.2, Part IV of this Guidance shall currently be the operation license of the medical examination and treatment establishment which is organized under the hospital form.

- A “COVID-19 treatment establishment” shall be ranked equivalent to that of the hospital assigned to manage it.

- Grant of establishment code:  The code of a “COVID-19 treatment establishment” shall be granted by the health management agency.

- The "COVID-19 treatment establishment" shall use the list of techniques, medicines, and medical supplies approved by the managing hospital and such list shall be temporarily supplemented with techniques appropriate to the hospital's intensive care capacity.

5.4. Entering into health insurance-covered medical care contracts

The hospital assigned to be in charge of the “COVID-19 treatment establishment” shall take responsibility for signing a contract annex and terminate the contract or entering a health insurance-covered medical care contract with the social security agency under the Government's Decree No. 146/2018/ND-CP dated October 17, 2018, detailing, and guiding measures to implement, a number of articles of the Law on Health Insurance.

5.5. Financial mechanism

The payment of medical examination and treatment expenses for COVID-19 patients at COVID-19 treatment establishments shall be guaranteed by the state budget according to actual costs; expenses for treatment of other diseases during the treatment of COVID-19 shall comply with the law on health insurance, medical examination, and treatment.

5.6. Dissolution of COVID-19 treatment establishments

Upon completing tasks, the Director of the COVID-19 treatment establishment shall:

- Report the provincial-level People's Committee or the Ministry of Health, the Ministry of National Defence, and the Ministry of Public Security of the decision on dissolution of the COVID-19 treatment establishment.

- Carry out procedures for completing tasks under regulations of competent authorities to return the initial status of the establishment; complete finalization books and documents, specialized reports, hand over mobilized assets (if any), hand over grounds, assess staff before transferring them to their units; report and propose the provincial-level Department of Health and the provincial-level People’s Committee or ministries and sectors about issues related to finance, hand over medical equipment, archive patient records and other issues of the COVID-19 treatment establishment after dissolution.

- Collect and treat wastes and take environmental hygiene measures.

- Conduct the final disinfection for the quarantine areas by spraying disinfecting liquid containing 0.1% active chlorine.

-  Draw on experience, summarize and complete the receipt and treatment tasks.

- Summarize and report to the provincial Steering Committee for COVID-19 Prevention and Control, local authorities, and relevant functional agencies of the performance results as prescribed.

V. Implementation organization

a) The provincial-level People’s Committee shall be responsible for

- Based on the local pandemic development, timely directing and permitting the setting up of COVID-19 treatment establishments.

- Directing the provincial-level Department of Health, Provincial Military Command, Provincial Border Guard Command (if any), units affiliated to the Ministry of National Defense located in the area, Provincial Public Security, and relevant agencies and units to organize and operate the COVID-19 treatment establishment.

- Ensuring force resources to carry out the quarantine and provide treatment for patients, creating favorable conditions and supports so that patients can feel secure and comply with quarantine requirements during the follow-up care period.

- Inspecting and supervising closely the performance of quarantine and health care.

- Ensuring policies for health staff, employees at the COVID-19 treatment establishment shall be entitled to policies as same as those applicable to employees of other establishments providing treatment for COVID-19 patients located in the province.

b) The Provincial Steering Committee for COVID-19 prevention and control shall be responsible for

- Directing relevant departments, agencies, and sectors to ensure that employees of COVID-19 treatment establishments shall be entitled to policies and remunerations as same as those applicable to employees of other establishments providing treatment for COVID-19 patients located in the province.

- Directing establishments used as COVID-19 treatment establishments to prepare necessary conditions as prescribed.

- Directing, organizing, and mobilizing forces to operate COVID-19 treatment establishments.

- Advising the provincial-level People’s Committee to direct and unify the price and allocate funding to pay for services for private establishments used as COVID-19 treatment establishments in accordance with applicable regulations.

- Reaching an agreement with the establishment used as the COVID-19 treatment establishment on the temporary change of use purpose during the COVID-19 prevention period.

- Assigning specialized agencies to inspect, ensure food safety at COVID-19 treatment establishments or establishments providing food portions for COVID-19 treatment establishments.

c) The Management Board shall be responsible for

- The medical examination and treatment establishment assigned to be in charge of the COVID-19 treatment establishment shall appoint a person to manage and run the COVID-19 treatment establishment (the Director) under the appointment decision of the managing agency (the Ministry of Health, the Ministry of National Defence or the Ministry of Public Security, for units affiliated to the Ministry; the provincial-level Department of Health for units affiliated to the provincial-level Department of Health).

- The establishment's Director shall be the head who takes responsibility before the immediate superior for all activities of the establishment.

- Organizing the formulation of professional process, internal rules, and regulations to ensure the effective and smooth operation of the establishment, ensure safety for patients and health staff; arranging functional and professional zones according to the actual situation; assigning specific tasks for regions in performing the assigned tasks and responsibilities.

- Taking responsibility for managing human resources, equipment, infrastructure, and issues related to the performance of tasks by the COVID-19 treatment establishment until completing its tasks.

- Implementing daily briefings between the management board and regions to capture, discuss and direct the general operation of the whole establishment by direct and indirect forms through information technology.

- Reporting the daily operation of the COVID-19 treatment establishment, timely reporting the immediate superior for support to remove difficulties arising in the course of operation of the establishment.

- Directing the screening, quarantine, prevention, and control of infection at the COVID-19 treatment establishment according to the Ministry of Health's Guidance (the Ministry of Health's Decision No. 5188/QD-BYT dated December 14, 2021, “on promulgating the guidance on prevention and control of SARS-CoV-2 in medical examination and treatment establishments"). Seriously implementing 5K measures for all health staff, patients, and relevant people at the COVID-19 treatment establishment.  Supplying sufficient standard equipment and personal protective equipment for health staff, and properly using them. Developing plans for organizing the quarantine for health staff after completing tasks at that COVID-19 treatment establishment or hotels or guest houses.

- Implementing the evaluation and assessment of the risk of SARS-CoV-2 infection for health staff under the guidance on prevention and control of SARS-CoV-2 in medical examination and treatment establishments promulgated together with the Minister of Health's Decision No. 5188/QD-BYT dated December 14, 2020.

- Organizing reasonable work shifts, independently operating, minimizing the number of health staff in direct contact with each other during and between work shifts.  Minimizing the movement of health staff between areas. Applying online meetings and briefings instead of face-to-face meetings.

- It is not allowed to arrange pregnant women, and persons suffering chronic diseases (such as bronchial asthma, chronic cardiopulmonary disease, kidney failure, liver failure, heart failure, cancer, diabetes, immunodeficiency, etc.) to work at COVID-19  treatment establishments.

- Upon dissolution, all documents and dossiers related to the COVID-19 treatment establishment’s professional and management operation shall be handed over to the medical examination and treatment establishment assigned to be in charge of management for storage./.

* All Appendices are not translated herein.