Circular 12/2014/tt-Byt: Guidelines For The Management Of Vaccines Used In Immunization

Original Language Title: Thông tư 12/2014/TT-BYT: Hướng dẫn việc quản lý sử dụng vắc xin trong tiêm chủng

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MINISTRY OF HEALTH
Number: 12 /2014/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, March 20, 2014

IT ' S SMART

Instruct management to use vaccine in vaccination

__________________

Base. Point 2 Article 30 Laws, Anti-Infectious Disease;

Base of Decree Stain. 63 /2012/NĐ-CP August 31, 2012 by Ch I'm The government rules, functions, powers, and muscles. All The organization of the Ministry of Health;

At the request of the Bureau of Health. There. -

The Ministry of Health issued a private management of the management of vaccines in vaccination,

Chapter I

COMMON RULES

What? 1. The adjustment range

This message is about:

1. Conditions for medical facilities perform the vaccination (later called the injection base); the following:

2. Transport, reception, maintenance and vaccine level;

3. The organization is vaccinated;

4. Monitoring, post-vaccination response;

5. Authority, profile, new level procedure, reorder, suspension, recovery of certificates of qualifying for vaccination.

What? 2. Explain the word

In this Information, the words below are understood as follows:

1. Immuno It ' s about getting the vaccine into the human body with the purpose of giving the body the ability to meet the immune response to the disease.

2. Cold necklace. is the system of equipment to preserve and transport vaccines in accordance with the correct temperature from the manufacturer to the user, including the cold chamber, the cold car, the fridge, the freezer, the cold chest, the vaccine.

3. Reaction t I'm is an unusual phenomenon of health including expressions at the vaccination site or the entire body that occurs after vaccination, not necessarily due to the use of the vaccine, including the common reaction after vaccination and the post-vaccination heavy accident.

4. Post-immuno crash is the unusual reaction after vaccination that can threaten the human life being vaccinated (including symptoms such as shortness of breath, anaphylaze or anaphylaze, toxic shock syndrome, high fever convultuation, prolonged crying, purple, stop breathing) or leaving the cell. You know, the evidence, or the person being vaccinated.

What? 3. The principle of managing the vaccine

1. Only the medical facilities that have been granted sufficient vaccination conditions are allowed to perform vaccination activities.

2. The certificate is sufficient to qualify for a fixed vaccination basis.

3. The medical facility has been granted sufficient vaccination conditions that must regularly maintain the conditions for carrying out the immuno-prescribed activity at this level.

4. State health facilities that have a vaccination function must organize a prescribed vaccination operation. The facilities of the disease, treating the disease, have to perform the immunology for infants according to regulation.

5. Do not use a vaccine under the Open Vaccine Program for service vaccination activities.

Chapter II

THE CONDITION OF THE IMMUNO FACILITY

What? 4. Medical facilities are carried out vaccination.

1. Hospital, polyfacet clinic, family doctor doctor, residence and Medical Station, ward, town (later known as the Medical Station) have been licensed by law on the law of the disease, healing.

2. Medical facilities.

What? 5. Conditions for the fixed vaccination facility

1. Physical basis:

a) The area waiting before the injection has to be positioned enough seats for at least 50 objects in an immunology session, ensuring the covering of rain, sunny, unwind, and ventilation;

b) The area of the advisory body, the classification examination has a minimum area of 8 m 2 ()

c) A minimum area of 8 m. 2 ()

d) The area monitoring and handling post-vaccination response has a minimum area of 15 m 2 .

In particular, a single-dose vaccine for hepatitis B at the medical facilities has a room, b, c, and d this paragraph, which, according to the following regulation: Room layout or a separate vaccine, where the vaccination is warm enough for the disease. young, there is a classification of children, counseling for mothers or homes of children.

Areas of regulation at points a, b, c and d must guarantee sanitary conditions, enough light and layout in one dimension.

2. Equipment page:

a) The method of preserving the vaccine by regulation: refrigeration, temperature monitoring devices at the site of the preservation and during the transport of vaccines. For a medical station that has no refrigeration, there must be a vaccine poster or cold chest to preserve the vaccine prescribed in this Article 9.

b) The injectable injections, tools, chemicals to kill bacteria and other necessary supplies;

c) The anti-shock box and anti-shock regimen at the monitoring site and the post-vaccination response by the Ministry of Health code;

d) The instrument of vaccine casing, medical waste according to the Ministry of Health regulation.

3. Human Resources:

a) Number: There are a minimum of 3 medical staff, including at least 01 employees with a degree of expertise from the doctor; for vaccination facilities in the deep regions, remote regions, particularly difficult zones must have a minimum of 2 medical staff, There are at least 1 employees with a degree of expertise from the doctor.

b) Direct staff perform screening, counseling, vaccination, monitoring, post-vaccination response processing required vaccination training due to regulatory facilities at Article 30, Article 31 This is acute.

4. The basis for immunology is the basis of the disease, treating the disease, but it is also required to meet the conditions of the disease, and to respond to the laws of the disease, the treatment of the disease.

5. The fixed vaccination facility can lead multiple vaccination points, each of which must meet regulatory conditions at 1, 2 and 3 Articles.

What? 6. Conditions for the Fluid Immuno point

1. The condition of applying the flow injection point:

a) The only implementation of the vaccine in the Expanded Vaccination Program when the organisation of the vaccination campaign or in the deep, remote regions, the region is particularly difficult by the decision of the Director of Health Department of the Provinces, the central city of the central city (later called " Department of Health.

b) Being carried out by the township Medical Station has been granted a certificate of sufficient vaccination.

2. minimum conditions on the basis of matter:

a) There is consultation, discovery, vaccination table;

b) There is a monitoring site and post-vaccination response.

The vaccination point must ensure adequate sanitation, rain, sun, ventilation, ventilation, clear light. The specified areas at Point a and this paragraph must be arranged in accordance with the principle of one dimension.

3. Conditions on the device page: a vaccine poster or cold chest and meets regulatory conditions at Points b, c, and d 2 Article 5 This Smart.

4. Human conditions:

a) Number: there are a minimum of 2 medical professionals, of which at least 01 employees have a degree of expertise from the doctor.

b) Meet the stipulation conditions at the point b 3 Article 5 This message.

Chapter III

RECEPTION, TRANSPORTATION, AND VACCINE LEVEL

What? 7. Process adoption, vaccine level

1. When receiving the vaccine, the officer receives the check and saves the following information at the injection facility:

a) Day of adoption;

b) The vaccine;

c) The name of the vaccine;

d) The number of registered registration licenses or the number of imported licenses;

The paper recognizes the workshop of each vaccine issued by a competent authority (copy);

e) The name of the production base, the production water;

g) The name of the unit supplied;

) Functional, packaging process;

i) Number.

n) The limitation of every batch;

l) The number of the batches.

m) The state of the temperature of preservation;

n) The temperature check directive: only the vaccine temperature indicator, which indicates the freezing temperature when receiving (if any); temperature tracking card;

p) If there is an attached recall water then records the information to the back-back water including: production facilities, production water, supply units, batch numbers, batch limitations.

It does not accept the vaccine if there is any abnormal expression of the information, the status above.

2. When the vaccine is issued, the level cadre must check and save the following information at the allocated unit:

a) Date granted;

b) The vaccine;

c) The name of the vaccine;

d) The number of registered registration licenses or the number of imported licenses;

The paper recognizes the workshop of each vaccine issued by a competent authority (copy);

e) The name of the production base, the production water;

g) Functional, packaging process;

) Lot number;

i) The limitation of every batch;

l) The number of the allocated dose of each batch;

l) The unit received;

m) The state of the temperature of preservation;

n) The temperature check indicator: the vaccine temperature indicator, which indicates the freezing temperature (if any); the temperature monitor card at the level.

p) If there is an attached recall water then records the information to the back-back water including: production facilities, production water, supply units, batch numbers, batch limitations.

In the case of abnormal information about the information, the status of the above is required to make a written statement of the actual status and regulations.

What? 8. Vaccine Transportation

The vaccine must be preserved in a regulated cold chain and at the right temperature for each vaccine required by the manufacturer, having the temperature tracking of the vaccine during transport.

What? 9. Vaccine preservation

1. The battery must be properly preserved according to the manufacturer ' s registration with the Ministry of Health.

2. The vaccine must be preserved separately in a regulated cold chain at the immuno facility, not shared with other products.

3. The vaccine must be monitored for information about temperature, daily preservation conditions. Vaccines, the rest of the water, are limited or have unusable signs of inuse, have to be destroyed and have a negative border.

Chapter IV

VACCINATION ORGANIZATION

What? 10. The vaccination organization

1. Before the vaccination:

a) Consulting for the family, who is vaccinated about the effect, the benefits of using the vaccine and the responses that may be met after vaccination;

b) Discovery for the person to be immunated by regulation;

c) Specify whether to vaccate or exclude cases with an anti-designation or vaccination delay;

d) Provide information about the type of vaccine, the dose of use, the restriction to the person vaccinated or the parent, the guardian of the child.

2. While vaccination:

a) Check out the preservation temperature, the restriction, the reference to the designation of the vaccine;

b) Perform the correct vaccination for each type of vaccine and the safety injection regulations;

c) Do the correct procedure of previous steps and during vaccination.

3. After the vaccination:

a) The person who is required to be vaccinated must stay at a minimum vaccination base of 30 minutes to follow;

b) The guide and coordination with the family or person who is vaccinated against child care and care at home at least 24 hours after injection;

c) Full of information about each vaccine case in the vaccination book (save at the immuno basis) and vaccination or individual vaccination returns to the family or people vaccinated;

d) The vaccines that were open too time were not allowed to use;

Xe, the needle pump is not available after the injection has to be prescribed by regulation.

What? 11. The dose, the vaccine

The dose, the path of each vaccine to comply with the manufacturer's use guidelines registered with the Ministry of Health, if there is any change in dose, the line must be authorized by the Ministry of Health and the manufacturer is responsible for the notice of the product. They ' re producing for the vaccination facilities.

What? 12. The vaccination campaign

1. The organization of the vaccination campaign follows the Ministry of Health ' s own guidelines for each campaign.

2. Only the vaccination facilities that are granted sufficient vaccination conditions are allowed to carry out the vaccination campaign.

Chapter V.

IMMUNO RESPONSE MONITORING

What? 13. Detections, severe ear processing after vaccination

1. All the subjects after the vaccination must be monitored for a minimum of 30 minutes at the site of vaccination, then continue to monitor at home for at least 24 hours after vaccination to detect early post-immunologic complications.

2. At the facility of vaccination: when you are deploying the vaccination that occurs in the aftermath of the vaccination, the head of the immuno facility must direct the following:

a) Stop the immuno;

b) The emergency treatment, diagnosis of severe ear causes after vaccination; cases beyond the ability to transfer the severely damaged person after immunology to the nearest hospital;

c) Full logging information:

-They name, age, gender, address, telephone number (if any) of the person being injected. Their name, mother, address, telephone number (if any) for children;

-Day, vaccination time;

-Type of vaccine; the name of the vaccine; the number; the manufacturer; the manufacturer; the supply unit; the registration number or the number of imported licenses;

-Day, hours of severe ear occurrence after vaccination; major symptoms; treatment results; cause conclusions (if any);

d) Statistics all the amount of the vaccine used during the vaccination; the number of people was used in vaccines; the vaccine name, batch number, the restriction of the vaccine; the health status of those who were vaccinated;

The whole number of vaccines, the injection of needles used during the vaccination;

e) The above line report is prescribed at Article 25 and Article 27 of this.

3. At the reception where the case of the crash was heavy after the vaccination, the head of the place received the direction of the execution of the following content:

a) to conduct emergency, processing, and treatment.

b) The above line report is specified at Article 25 and Article 27 of this.

4. Districts, prefectures: report to report, aggregate of information, report on the line as prescribed at Article 25 and Article 27 of this.

What? 14. Investigation of severe crash case after vaccination

1. During the 24-hour period, since the case of the severe crash after the vaccination, the Health Department is responsible for organizing the investigation, evaluating the cause as follows:

a) The establishment of the Advisory Council for the Calamity Assessment in the process of using vaccines, medical students (later called the Specialized Advisory Council) the provincial level by regulation in the Digital Information 21 /2011/TT-BYT June 7, 2011, of the Minister of Health for the establishment, organization, and operation of the Advisory Council of Experts assessed the accident in the course of the use of vaccines, medical students;

b) proceed to investigate in accordance with the guidelines of the Ministry of Health;

2. The specialized advisory council that evaluated the accident during the use of vaccines, the provincial medical delivery process:

a) General, analysis, assessment of the cause of post-vaccination heavy disaster based on the results of investigation, gathering information, test results, tests, forensy in case of death (if any);

b) Heavy ear assessment reports after vaccination to the Department of Health.

3. During the five-day working day, since receiving a severe ear assessment report after vaccination, the Health Department must hold the Provincial Advisory Council meeting to conclude the cause leading to the severe accident following the vaccination and the proposal of the operation. rectify in the case of necessity. The case has a test template, a test or a medical examiner's conduct, but no results have been concluded, and a full complement of conclusions is required when there is a test result, testing or monitoring.

4. The cause case leading to post-vaccination heavy ears that suspected of vaccine quality, Director of the Health Department decided to suspend use on the site of a vaccine management-related site in relation to the post-vaccination heavy accident on the basis of consent of the vaccine. Department of Pharmacology-Ministry of Health. When the conclusion is not linked to the vaccine quality, the Director of the Health Department decides to allow the use of that vaccine and inform the Department of Health Management.

What? 15. Report and announce the results of the investigation

1. During a two-day period of work, since the conclusion of the Provincial Advisory Council's conclusions, the Department of Health formally announces the cause for the relevant authorities and reports the results of the investigation accompanying the Council of the Council to the Ministry of Health (Bureau of Health). Reserve Medical-Permanent Advisory Council for Calamity Assessment in the course of the use of vaccines, Health Ministry health care products.

2. The backup health bureau receives the report of the Provincial Advisory Council, in case of the need to issue a Senior Advisory Council to review the assessment results of the Provincial Advisory Council.

3. The School of Professional Consultated Advisory Council review the results of the Provincial Advisory Council, the Directorate of General Counsel, and the announcement of the following heavy disaster cause of the vaccination to the relevant units and public publication on the issue.

Chapter VI

JURISDICTION, PROFILE, NEW LEVEL PROCEDURE, REORDER, SUSPENSION AND RECOVERY OF CERTIFICATES OF QUALIFIED VACCINATE

What? 16. The new authority, granting the certificate to sufficient vaccination conditions and the duration of the certificate of sufficient vaccination.

1. Director of the new Department of Health, reissued the certificate of sufficient vaccination against the fixed vaccination facilities on the site.

2. The certificate of qualifying for vaccination is valid for 05 years, since the date of the grade.

What? 17. The certificate level forms are eligible for vaccination.

1. The new level of paper certificates are eligible for vaccination in the following cases:

a) The medical basis for the first time recommended granting a certificate of sufficient vaccination;

b) The expiration date of the certificate of sufficient vaccination is specified at the point of paragraph 2 This Article;

c) The certificate of sufficient vaccination conditions is revoked;

d) Changing locations, facilities on facilities, equipment, personnel of the medical facility were granted sufficient vaccination conditions.

2. Level the certificate of sufficient vaccination conditions applicable to the following case:

a) In the period of a delay of 60 days before the certificate of sufficient vaccination expires, the medical facility was granted a certificate of sufficient vaccination to file a proposal for the grant of the certificate. The case is too limited without filing a certificate granting the certificate, which is required to make a new level of certificate that is required to receive sufficient vaccination at the point b 1 This Article.

b) The certificate of sufficient vaccination is still in effect but lost, broken, and duration from 60 days or more;

c) Changing the name of the medical facility has been granted a qualified certificate of vaccination when a certificate of sufficient vaccination is available from 60 days or more in the event of the site, the facilities, the equipment, the character does not change.

What? 18. The filing of a new grant certificate is eligible for immuno

1. The application of the certificate grant certificate is eligible for the number 1 sample prescribed in Annex 1 issued by this message.

2. The prescribed pattern of the prescribed pattern at Annex 2 issued by this message and the copy of the following papers by each employee as a vaccination worker:

a) the recruitment decision or contract contract that stamped the validation of the employer;

b) By a professional level;

c) The certificate for exercise training.

3. Certificate of qualified vaccination against the specified case at Point 1 Article 1 Article 17 This information.

4. List of predefined page equipment at Annex 3 issued by this message.

5. The side diagram of the immuno implementation area includes: waiting areas, counseling and classification; vaccination, tracking, and post-vaccination response.

6. The copy of the certification of documents that demonstrate the establishment and operation of the basis of a certificate of certification of sufficient vaccination including:

a) The operating permit for the facility of the disease, healing according to the regulation of the law on the examination, healing;

b) The established decision or certificate of business registration or certificate of investment in other medical facilities.

What? 19. The record offers to grant a certificate of sufficient vaccination conditions

1. The filing offers to grant a certificate of sufficient vaccination against the specified case at Point A 2 Article 17 including:

a) The application to grant a certificate of sufficient vaccination conditions under the number 2 pattern specified in Appendix 1 issued by this message;

b) The original certificate of the vaccination condition has been granted.

2. The filing of the proposed granting of a certificate of qualifying certificate includes the case of a B-point clause 2 Article 17 consisting of:

a) The application to grant a certificate of sufficient vaccination conditions under the number 2 pattern specified in Appendix 1 issued by this message;

b) The original certificate of the vaccination condition was granted to the case of failure.

3. The filing offers to re-issue a certificate of sufficient vaccination against the case of a paragraph 2 Article 2 Article 17 includes:

a) The application to grant a certificate of sufficient vaccination conditions under the number 2 pattern specified in Appendix 1 issued by this message;

b) The original certificate of sufficient vaccination conditions was granted;

c) The paper ' s proof of changing the name of the medical facility was granted a certificate of sufficient vaccination.

What? 20. New self-order, reissued a certificate of sufficient vaccination condition

1. The basis of a certificate grant certificate is eligible for the injection of the original case file and 1 copy to the Department of Health (Case Room Y).

2. When receiving the file, the Department of Health sent the basis of a certificate granting the certificate to receive the eligible recipient of the prescribed record at Annex 4 issued by this message.

3. The new, valid new level profile case, the Health Department is responsible:

a) Transfer of a new grant of a new grant certificate of immunology to the District Health Chamber, district, town, provincial city (later called the district) where the medical facility recommended that a new level of certification are eligible for vaccination-based vaccination. 5 working days, since the date of the filing for appraisal at the facility.

b) During the 15-day period of work, since the date of receiving a new grant of the certificate of qualifying for vaccination, the District Health Chamber is responsible for the organization of the appraisal and organization of the appraisal under regulation at Article 21 of this. The component of the jury consists of:

-Leader of the District Health Division-Head of the Union;

-Representative of the Medical Center of the District;

-Representative of the district hospital (for districts that have separated the independent district hospital);

-Experts, officers involved, are invited to the Dean's offer.

c) After the appraisal, the appraisal is responsible for establishing a protocol in the prescribed form at Annex 5 issued by this Notice and sent to the Department of Health (Case Room Y) during the period 3 working days, since the date of the end of the appraisal;

d) During the period of 7 working days, since the date of receipt of the appraisal, the Director of the Health Department must grant a certificate of sufficient vaccination to the prescribed sample at Annex 6 issued by this message. The non-acute case has an answer text and specifies the reason.

4. The case of filing a proposal to grant adequate vaccination certificate, valid, Director of the Health Department must grant a certificate of sufficient vaccination conditions according to the prescribed pattern at Annex 6 issued by this Notice during the 15-day period. work, since the date of the filing. The case is not urgent, there must be an answer text and specify a reason.

5. The case case is incomplete, valid, during the 5-day period of work, since the date of the filing, the Health Department must inform the basis of the certification facility to receive sufficient vaccination conditions to complete the profile and specify the necessary content. plugin, the content needs to be modified.

6. When receiving a text of a complete request for a file complete, the basis of a certificate granting a certificate of sufficient vaccination is responsible for the amendment, the addition required and sent to the Department of Health. The date of the revised record, the plugin is written on the Record Reception.

7. The basis of the proposed issuing of the certificate grant is sufficient, but it is not true that the Health Department will notify the facility to continue to complete the prescribed profile at Section 5 This.

8. The case of the revised profile, added to the request, the Health Department must conduct a new level, granting the certificate of sufficient vaccination by regulation at paragraph 3, paragraph 4 This.

What? 21. The process of issuing a certificate granting sufficient vaccination conditions

1. Case appraise: examination of the conditions on the basis of matter, equipment, personnel, specialized documentation of the basis of the certification facility to receive sufficient vaccination conditions.

2. Appraisal at the base and set the appraisal appraisal at Annex 5 issued by this message. The appraisal is made of 3 sets: 01 sets in the Department of Health, 01 sets in the District Health Room, 01 sets at the basis of a certificate granting the certificate granting sufficient vaccination.

What? 22. The suspended cases operate and revoking the certificate of sufficient vaccination conditions.

1. The suspended cases operate:

a) Do not comply with the regulatory conditions at this Article 5;

b) There is an error in technical expertise in specialized guidelines issued by the Minister of Health;

c) Not carrying out the statistics, the report has been prescribed since 05 times or more.

2. The cases of the revoked certificate are eligible for vaccination against a fixed vaccination basis:

a) The basis of receiving sufficient vaccination conditions has an activity beyond the scope of the expertise;

b) The certificate of sufficient vaccination is granted to be uncorrect or have a legal content;

c) The facility is granted a certificate of sufficient vaccination conditions that are bankrupt or dissolved or merged;

d) The base of operation when a certificate of sufficient vaccination is out of force value;

The facility is suspended but does not rectify the violations by regulation.

What? 23. Procedto, the time of suspension of activity and procedure revoked the certificate of sufficient vaccination.

1. Procedre, time of suspension of activity:

a) In the process of testing, if the detection of a vaccination facility has one of the prescribed violations at Article 1 Article 22 This is the agency, the agency that checks the 19-panel prototype attached to the number decision. 1131 /2008/QĐ-TTCP June 18, 2008 by the General Inspector General of the Government on the issuing of the text template in the operation of the inspection, addressing the complaint, denouncing (the following call is Decision No. 1131 /2008/QĐ-TTCP ). During the five-day period of work, since the date of receipt of the Department of Health, the decision to suspend activity on the basis of a permanent vaccination. The absence of a decision to suspend operations only on the basis of the vaccination must have the text of the examination and specify the reason.

b) The case in which the agency has another inspector function, the decision to suspend, must have a written notice to the Health Department that issued a certificate of sufficient vaccination for a suspended vaccination basis.

c) The decision to suspend operations has a maximum minimum of 6 months, since the date of the signing, issued by regulation at the number 6 issued by Decision No. 1131 /2008/QĐ-TTCP and was sent to the suspended immuno facility, the Provincial Medical Center, the District Health Division, to be publicly announced;

d) The case of the suspended immuno facility conducted the remediation of the violations, the slog of 30 days, before the day of the decision to suspend the deadline:

-The suspended vaccination facility must submit a report on the remediation of violations to the District Health Room and the Department of Health;

-The timing of the breach of the breach was calculated according to the medical department's reception.

The case of a suspended vaccination facility has undertaken to rectify the violations and meet the regulations of this private, and during the five-day period of work, since the date of receiving the report of the immunation facility, the Department of Health is considering, deciding the termination. The suspension of the suspension. The decision to end the suspension of operations by regulation at the 7th denominated issued by No. 7 Decision 1131 /2008/QĐ-TTCP was sent to the suspended facility, the Provincial Prefated Medical Center, the District Health Room and publicly announced.

e) The case at all times the suspension of the operation that the vaccination facility suspended does not perform the remediation of the violations or has done the remediation of the violations but still does not meet the regulation of this Information, the Department of Health Department performs the recall. The certificate is eligible for immuno-vaccination in Clause 2.

2. The procedure to revoking the certificate of sufficient vaccination conditions:

When one of the cases of the breach is specified at paragraph 2 Article 22, the recovery procedure is done as follows:

a) In the 10-day period of work, since the day of the breach, the Director of the Department of Health has decided to revoking the certificate of sufficient vaccination conditions;

b) The decision to revoking the certificate of sufficient vaccination of the Director of Health in accordance with the issue of 12 issued by Decision No. 1. 1131 /2008/QĐ-TTCP, was sent to the suspended facility and the Provincial Reserve Medical Center, the city, the District Health Room where the facility is located and publicly announced;

c) During the five-day working day, since the date received the decision to revoking the certificate of sufficient vaccination, the vaccination base must submit a certificate of sufficient vaccination condition to the Department of Health.

Chapter VII.

REPORT MODE AND PROFILE MANAGEMENT

What? 24. Report Mode

1. A periodic report: report of the month, the quarter and the year on the situation to use the vaccine, the usual response cases and the following severe disaster cases;

2. Breakthrough Report: cases of post-vaccination disaster.

What? 25. Form, report content

1. The report form:

a) A periodic report: in writing;

b) A breakthrough report: in the case of an emergency that can be reported via telephone, email, or direct reports and within 24 hours must submit a written report.

2. Content Report:

a) A periodic report:

-Report of the use of the vaccine in the Expanded Immuno Program by the number 1 form of Annex 7 issued by this message;

-Report of the use of the vaccination vaccine under the number 2 sample of Annex 7 issued by this message;

-Report cases of common response after sample vaccination at Annex 8 issued by this message;

-Report cases of post-immunation accidents at Annex 9 issued by this message.

b) The report breaks out: the specified content at Point 2 Article 2 Article 13 This is or at the request of the report recommended body.

What? 26. Process and time of periodic reporting

1. For vaccine in the Open Vaccine Program

a) The vaccination basis: report the district Health Centre before the next 5 of the next month for the monthly report, dated 05 of the first month of the next quarter for the quarterly report, before the January 15 of the next year for the report of the year;

b) The district health center: report the prefated prepreposition Health Centre before the 10th of the next month for the monthly report, the 10th of the first month of the next quarter for the quarterly report, before January 25 of the next year for the report of the year;

c) Provincial Health Centre: Health Department reporting, Regional Open Vaccine Project at the Central Institute of Epidemiology, Institute Pasteur city of Ho Chi Minh City, Institute of Institute Pasteur Nha Trang, Central Institute of Hygiene (later called the Regional Institute) by distribution the management region of the Minister of Health, simultaneously reported the National Expanded Vaccination Project ahead of the next month ' s 15-month report to the report of the month, the 15th of the first month of the next quarter for the quarterly report, prior to 31 January of the next year. with the report of the year;

d) The National Expanded Vaccination Project reported, sending the Department of Reserve Health (the Ministry of Health) before the next month 20 of the next month for the monthly report, the 20th of the first month of the next quarter for the quarterly report, before February 15 of the next year. with the report of the year.

2. For the vaccination vaccine.

a) The vaccination basis: report the district Health Centre before the next 5 of the next month for the monthly report, dated 05 of the first month of the next quarter for the quarterly report, before the January 15 of the next year for the report of the year;

b) The district Health Centre: report the Provincial Prefated Medical Center before October 10 of the next month for the monthly report, the 10th of the first month of the next quarter for the quarterly report, prior to January 25 of the next year for the report of the year;

c) Provincial Health Center: Health Department report, Regional Institutes, Pre-Defense Department of Health-Ministry of Health before the next month 15 of the next month for the report of the month, the 15th of the first month of the next quarter for the quarterly report, prior to 31 January of the next year I mean, the year's report.

What? 27. Process and Time of Mutant Reporting

1. During the 24-hour period, since the time of the post-vaccination heavy accident, the vaccination facility reported the Provincial Medical Center Medical Center, which simultaneously reported the District Medical Center where the vaccination facility was based.

2. During the 24-hour period, since the time of receiving the report of the vaccination facility, the Prefated Medical Center reported the Department of Health, the Department of Preserved Health and the Institute of Regional Health.

3. Every week, after making a specified report at Point a and point b This paragraph:

a) The vaccination facility must carry out the report that takes the course of the investigation, processed within the week on the second day of the next week;

b) The provincial reserve Medical Center must carry out the investigation of the investigation process, processing during the week on the 4th day of the next week.

What? 28. Profile Management

1. The vaccination facilities must store and manage the specialized document and profile including:

a) The regulations, the expert guidelines for the use of the vaccine;

b) The vaccination monitor for the person who is vaccinated;

c) Record, monthly, quarter and year paper on the use of vaccine; the amount of vaccine used and the case of conventional response and severe following vaccination at the facility.

2. The Department of Health, the Provincial Prefated Medical Center must store and manage specialized materials and records including:

a) The regulations, specialized manual documentation for extended vaccinography;

b) The monthly, quarter and year terms of the use of the vaccine; the number of vaccines used and the usual response cases, the following heavy-or-vaccination of the injections of the units on the management table.

3. Regional institutes and Expanded Vaccination Projects must store and manage specialized materials and records including:

a) The regulations, specialized manual documentation of vaccine use, vaccination;

b) Report of the month, quarter and year on the situation of vaccine use; the number of vaccines used and cases of common response, the post-vaccination heavy disaster of the provinces of the area in charge and report of the combined month, quarter and year of the institute, the vaccination project. It's an extension.

4. File, report, full-to-search, search, search, and storage under the law of storage.

Chapter VIII

EXECUTE RESPONSIBILITY

What? 29. Ministry of Health Responsibility

1. The responsibility of the Reserve Health Service:

a) presided over, in coordination with the cases, the relevant Bureau for guidance, guidance, examination of the use of vaccines across the country; the propaganda of vaccination safety, the benefit of the use of vaccines and reactions that may be met after vaccination;

b) presided, in coordination with the related units that built specialized guidelines on vaccine use, monitoring processing, and investigation of the cause of post-vaccination heavyaction cases;

c) Permanent inaction of the Command Restoration incident involving the vaccination of the Ministry of Health;

d) Permanent advisory board of expertise assessment in the course of the use of vaccines, medical students, Ministry of Health.

Organization of the inspection, examination of the law, according to the law.

2. The responsibility of the Department of Pharmacology:

a) appraisold, review, registration of vaccine registration; export management, import of vaccines by regulation;

b) pause and allow for a nationwide vaccine to be used, in coordination with the Health Department considering a temporary vaccine halt at the Article 4 Article 14 of this article;

c) The management of vaccine quality in Vietnam;

d) Coordinate with relevant units in the inspection, examination of the use of vaccine by regulation.

3. The responsibility of the Bureau of Management, healing:

a) Guide to pre-injection screening guidelines, post-vaccination heavy-ear processing, directing units in the training system for training disease, support for vaccination facilities in the screening of pre-injection screening and post-immuning severe ear processing;

b) Directoring and examination, monitoring of vaccination activities in the system of examination, healing, director of emergency treatment, coordination of the cause of the cause of severe ear cases after vaccination;

c) Coordinate with relevant units in the inspection, examination of the use of vaccine by regulation.

4.

Presiding and coordinating with the relevant units in the inspection of the use of vaccines across the country.

What? 30. The responsibility of the National Open Vaccine Project and the Institutes, the Health Ministry Hospital

1. The responsibility of the National Open Vaccine Project:

a) Planning a need for the use of vaccine in the Expanded Vaccination, which proposes vaccines and vaccination schedules in the Enlarged Vaccination;

b) The organization to buy, receive and supply an Open Vaccine vaccine to the units of use;

c) The cause of the cause of post-vaccination-heavy crash cases, timely handling of cases of post-vaccination heavyages;

d) Focus on monitoring, post-vaccination response to the Provincial Advisory Council.

The organization of the propaganda information about vaccination safety, the benefit of the use of vaccines and post-vaccination reactions.

2. The responsibility of the Regional Institutes:

a) Only technical expertise, monitoring using vaccine in localities according to the management of the Department of Health for quality assurance, safety in vaccination work; monitoring of post-vaccination response;

b) The organization of the training of vaccination regulations and issuing a certificate for the training of the immuno-based vaccination in Annex 10 issued by this message;

c) Joining the investigation of the cause of the cause of post-vaccination heavy disaster cases by the Department of Health's management, timely handling of cases of post-immunologic disaster;

3. The responsibility of the National Institute of Vaccine Control, medical delivery:

a) The regulation and level of certificates that receive the workshop for the domestic vaccine and import by regulation prior to use in the market;

b) Building the plan, implement periodic monitoring and quality breakthroughs, the safety of the vaccine across the country;

c) Building the guidelines for the vaccine to be tested in case of severe crash after vaccination;

d) Coordinate with relevant units in the inspection, examination of the use of the vaccine.

4. The responsibility of the Department of Health, children of the Ministry of Health:

a) The organization does the vaccine in accordance with the rules;

b) The training organization for screening discoveries for vaccination facilities;

c) Implemecting the emergency, diagnosis, treatment, and treatment of cases of post-vaccination heavyaction;

d) Coordination of the investigation, which concluded the cause of the following severe disaster cases.

What? 31. The responsibility of the Department of Health, Centre for Provincial Medical Center, District Health Room, District Medical Center

1. The responsibility of the Health Department:

a) Directs the deployment of extended vaccination activities, vaccination of service under the provisions of the Ministry of Health;

b) The adoption of the filing, granting of sufficient vaccination conditions on the provincial table;

c) The organization of the test, the operational inspector using the vaccine on the provincial table;

d) The organization of the assessment of the cause, conclusion and publication of the cause of post-vaccination cases after vaccination of the province;

The organization of the propaganda information about vaccination safety, the benefit of the use of vaccines and post-vaccination reactions.

e) Decide the deployment of the operating vaccination points by regulation at this Article 6;

g) The decision to pause and reuse the vaccine on a regulatory address under the provisions of Article 4 of this Article 14;

2. The responsibility of the Provincial Center Medical Center:

a) Directoring, the implementation guide, in collaboration with the Inspector of Health Inspects, the Inspector of Operations using local vaccine;

b) The organization of the training and granting of the certificate to the training of the immuno-based vaccination in Annex 10 issued by this message;

c) Permanent advisory board of expertise to assess the accident in the process of using vaccines, provincial medical students;

d) Deploy the use, preservation, distribution of quality assurance vaccine, to meet the needs of the people ' s preventable vaccination.

3. Responsibility of the District Health Department:

c) Chair and coordination with the District Health Centre and related units deleking the vaccination facilities on the management site, report the appraisal results for the Department of Health to review the grant, revoking the certificate of sufficient vaccination conditions;

b) Check out the immunologic activity on the administration desk.

4. Responsibility of the District Medical Center:

a) Command the Social Health Station to open up the vaccination, preserve the vaccine by regulation.

b) Join the appraisal of the certificate granting sufficient vaccination conditions on the administration table;

c) Overall, the report of the use of vaccines on the site of management;

d) Coordinate with the Examination District Health Department, inspect the vaccination activities on the management site.

What? 32. The responsibility of the vaccination facility and the person who carried out the vaccination

1. The responsibility of the injection facility:

a) Responde to the law on the implementation of specialized activities in the right function, the mission is delivered;

b) Compliance of technical expertise on vaccine use and vaccination safety; tracking, implementation of the report by regulation;

c) Coordinate with organizations, propaganda unions, advocacy of the people involved in vaccination of the disease;

d) Coordinate with the related units and facilitate the investigation of the severely damaged cause of the accident after vaccination.

2. The responsibility of the person who performs the immuno: adheres to the specialized processes of the Ministry of Health on vaccination.

Chapter IX

EXECUTION CLAUSE

What? 33. Terms of reference

The case where the text that is shown in this text is replaced or modified, supplemated by an alternate text or text that has been modified, added.

What? 34.

This announcement came into effect on 1 June 2014.

Number Decision 23 /2008/QĐ-BYT July 7, 2008, of the Secretary of Health for the promulgation of the regulation of vaccine, medical care in the chamber and the treatment expires since this date is effective.

What? 35. The transition clause

1. For established and operational facilities prior to this date, it is valid to complete the granting of eligible vaccination conditions prior to December 1, 2015.

2. For the establishment and operation facility after this date is effective only to be used in the vaccine after it has been granted a certificate of sufficient vaccination.

What? 36.

Chief of the Department, Secretary of the Department of Health for the Bureau, the Chief, the Director General, General Secretary of the Ministry of Health, Head of the Agency, Unit of the Ministry, Director of the Department of Health of the Provinces, Central City and Chief Medical Unit of the Ministry of Health, Industry and Industry the relevant units responsible for this practice.

In the course of execution, if there are difficulties involved, the agency, the organization, the individual report on the Ministry of Health to study, resolve.

KT. MINISTER.
Chief.

(signed)

Nguyen Thanh Long