RESOLUTION – RDC NO. 197, OF DECEMBER 26, 2017
Provides for minimum requirements for the operation of human vaccination services.
The Collegiate Board of the National Health Surveillance Agency, in the use of the attribution conferred by Art. 15, III and IV allied to Art. 7, III, and IV, of Law No. 9,782, of January 26, 1999, Art. 53, V, §§ Paragraph 1 and 3 of the Internal Regulations approved in accordance with Annex I of the Resolution of the Collegiate Board of Directors – RDC No. 61 of February 3, 2016, resolves to adopt the following Resolution of the Collegiate Board of Directors, as resolved at a meeting held on December 12, 2017, and I, the Chief Executive Officer, determine its publication.
From the initial provisions
From the objective
Article 1. This Resolution of the Collegiate Board of Directors (RDC) aims to establish the minimum requirements for the operation of the services that carry out the activity of human vaccination.
Of the comprehensiveness
Article 2 This Resolution applies to all services performing the vaccination activity in the country, be they public, private, philanthropic, civil or military.
From the definitions
Art. 3 For the purpose of this Resolution, the following definitions are adopted:
I – license permit or equivalent: document issued by the competent sanitary body of the States, Federal District or Municipalities, with permission to provide the service under health surveillance;
II – environment: space physically determined and specialized for the development of certain activity(s), characterized by different dimensions and facilities, which may consist of a room or an area;
III – area: open environment, without walls on one or more of the faces;
IV- Public vaccination campaign: constitutes a strategy of vaccination of a certain number of people in a short period of time, with the objective of controlling a disease intensively or the expansion of vaccination coverage to complement routine work, promoted by public health facilities;
V – International Certificate of Vaccination or Prophylaxis (CIVP): an internationally recognized document that proves that a vaccination or prophylaxis is carried out.
VI – Vaccination error: any avoidable event that may lead to inappropriate use of vaccines or cause harm to a patient. It may be related to professional practice and procedures, with the possibility of occurring if the norms and techniques are not fulfilled;
VII. Post-Vaccination Adverse Event (EAPV): Any occurrence after vaccine application and which does not necessarily have a causal relationship with the product;
VIII – legally qualified professional: professional with superior or technical training with his/her competencies attributed by law;
IX – Legal Officer or Legal Representative: Individual who has legal powers to perform acts on behalf of the legal entity;
X- Technical Officer (RT): Legally qualified professional, formally designated by the Legal Officer to maintain the routines and procedures of a service;
XI – Vaccination room: environment surrounded by walls around its perimeter and at least one door, intended for administration of vaccines;
XII- Vaccination Outside of Private Services: an activity linked to a licensed vaccination service, which occurs sporadically, that is, through a seasonal or occupational health program, practiced outside the establishment, intended for a specific population in a given environment and authorized by the competent sanitary facilities of the state or municipal health secretariats;
XIII – vaccines: immunobiological medicinal products containing one or more antigenic substances which, when inoculated, are capable of inducing active specific immunity in order to protect against, reduce the severity or to combat the disease(s) caused by the the agent that gave rise to the antigen(s).
Requirements for the operation of the vaccination service
Art. 4 The establishment that carries out the vaccination service must be duly licensed for this activity by the competent health authority.
Art. 5 The establishment that performs vaccination service must be enrolled and keep its data updated in the National Register of Health Establishments – CNES.
Article 6. The establishment that performs vaccination service must display the National Vaccination Calendar of the SUS, in a place visible to the user, indicating the vaccines made available in this calendar.
Art. 7 The establishment that carries out the vaccination service must have a Technical Officer and a substitute.
Art. 8 The vaccination service must have a legally qualified professional to develop vaccination activities throughout the period in which the service is offered.
Art. 9 The professionals involved in the vaccination processes should be periodically trained by the service in the following topics related to the vaccine:
I – basic concepts of vaccination;
II – conservation, storage and transportation;
III – preparation and safe administration;
IV- waste management;
V- vaccination-related records;
VI- process for investigation and notification of post-vaccination adverse events and vaccination errors;
VII- National Vaccination Calendar of the current SUS;
VIII – the hygiene of hands; and
IX – conduct to be adopted in the face of possible complications related to vaccination.
Single paragraph. Training should be recorded with date, time, hours, content taught, name and the professional training or qualification of the instructor and the professionals involved in the vaccination process.
Article 10 The establishment that carries out the vaccination service must have adequate physical facilities for vaccination activities in accordance with the Resolution of the Collegiate Board of Directors – RDC No. 50 of February 21, 2002, or any regulation that may replace it, and shall be endowed with at least the following mandatory items:
I – reception area scaled according to demand and separated from the vaccination room;
II – bathrooms; and
III – vaccination room, which must contain, at least:
a) washing sink;
e) easy-to-clean thermal box;
f) exclusive refrigeration equipment for storage and conservation of vaccines, with maximum and minimum moment thermometers;
g) place for the storage of vaccine administration materials;
(h) containers for the disposal of puncturing materials and biological waste;
i) handcart; and
j) thermometer of moment, with maximum and minimum, with extension cables for the thermal boxes.
§ Paragraph 1 In urgent situations, emergencies and in case of need, vaccines may be applied at the point of assistance to the patient.
§ Paragraph 2 The refrigeration equipment for storage and storage of vaccines must be approved by Anvisa.
Management of technologies and processes
Art. 11 The vaccination service must carry out the management of its technologies and processes according to the activities developed and that contemplate, minimally:
I- effective means for the storage of vaccines, guaranteeing their conservation, effectiveness and safety, even in the event of a failure in the supply of electricity;
II – daily recording of the maximum temperature and minimum temperature of the equipment
destined for the conservation of the vaccines, using instruments calibrated properly that allow continuous monitoring of the temperature;
III – use of vaccines only registered or authorized by Anvisa; and
IV – other requirements of the management of technologies and processes according to health standards applicable to health services.
Article 12 The vaccination service must adopt procedures to preserve the quality and integrity of vaccines when it is necessary to transport them.
§ Paragraph 1 The vaccines must be transported in thermal boxes that maintain the conditions of conservation indicated by the manufacturer.
§ Paragraph 2 The temperature throughout the transport must be monitored with the minimum and maximum temperatures recorded.
Art. 13 Vaccination services must guarantee immediate care of possible complications related to vaccination.
Single paragraph. The vaccination service should guarantee the service of referral for the continuity of care for cases of greater complexity, if necessary.
Art. 14 The administration of vaccines in private establishments and that are not contemplated in the National Vaccination Calendar of SUS will only be carried out by medical prescription.
Single paragraph. Dispensation must necessarily be linked to administration of the vaccine.
Registration and Notification of Vaccinations
Article 15 Vaccination services are responsible for:
I – record the information regarding the vaccines applied in the vaccination card and in the information system defined by the Ministry of Health;
II – keep individual records, with registration of all vaccines applied, accessible to users and health authorities;
III – keep in the service, accessible to the health authority, documents proving the origin of the vaccines used;
IV- notify the occurrence of post-vaccination adverse events (EAPV) as determined by the Ministry of Health;
V- notify the occurrence of vaccination errors in the Anvisa notification system; and
VI- investigate incidents and failures in the processes that may have contributed to the occurrence of vaccination errors.
Art. 16 – The vaccination card must contain, in a legible way, at least the following information:
I – data of the vaccinated (full name, identification document, date of birth);
II- name of the vaccine;
III- dose applied;
IV- date of vaccination;
V- vaccine lot number;
VI- name of the manufacturer;
VII – identification of the establishment;
VIII – identification of the vaccinator; and
IX – date of next dose, when applicable.
Occurrence of Outside Vaccination by Private Services
Article 17 Private vaccination services may carry out vaccination outside the facilities with the authorization of the competent health authority.
§ Paragraph 1 The vaccination activity outside the facility must comply with all the guidelines of this Resolution related to human resources, technology and process management, and records and notifications.
§ Paragraph 2 The vaccination activity outside the facility should be carried out only by a licensed vaccination establishment.
Issuance of International Certificate of Vaccination or Prophylaxis (CIVP)
Art 18 The vaccination service may issue the CIVP. Single paragraph. The vaccination service must be accredited by Anvisa for the issuance of the CIVP.
Art. 19 The issuance of the CIVP shall follow the standards defined by ANVISA.
§ Paragraph 1 – The issuance of the CIVP shall be performed free of charge.
§ Paragraph 2 – The issuance of the CIVP shall be registered in an information system established by ANVISA.
Of Final or Transitional Provisions
Article 20 Vaccinations carried out by vaccination services shall be considered valid for legal purposes throughout the national territory.
Article 21 Failure to comply with the provisions contained in this resolution and the regulation approved by it is a health infraction, pursuant to Law No. 6,437 of August 20, 1977, without reduction to the applicable civil, administrative and penal liabilities.
Article 22 Vaccination services, which are in force, at the time of publication of this Resolution of the Collegiate Board of Directors, will have a term of 6 (six) months, counted from the date of publication of this Resolution, to attain compliance with the requirements set forth by this standard.
Single paragraph. The deadline for adaptation to the requirement set forth in § Paragraph 2, Art. 10 will be 2 (two years), counted from the date of publication of this Resolution.
Art. 23 This Resolution of the Collegiate Board of Directors shall enter into force on the date of its publication.
JARBAS BARBOSA DA SILVA JR.