Decree no. 233/2001, dated 25 August - Rules for the licensing and supervision of dental clinics and consulting rooms, as private health units.

Law no. 48/90, dated 24 August, or Health Guiding Rules, establishes that private, profit-seeking health units are subject to licensing, regulation and supervision by the State.

Further to this law, several decrees have been approved, also defining the legal framework applicable to the licensing and supervision of health units devoted to essential health care, which are more closely connected with the Health National System through agreements and protocols.

The present decree defines rules for dental clinics and consulting rooms, as health units which, regardless of their name or legal framework, are devoted to the prevention, diagnosis and treatment of disorders and diseases of the teeth, mouth, jaws and adjacent tissues.

In line with the objective of promoting quality and safety, a similar system has been adopted as that already applied to regulated health units, comprising the requirements regarding facilities and equipment, the rules for their organisation and operation, as well as for the licensing procedure, and the creation of the bodies and instruments of practice supervision at national and regional levels.

As stated in the Health Guiding Rules, quality control of health care must conform to the same standards.

The Portuguese Medical Association, the Portuguese Dental Association and the National Association of Portuguese Dentists were consulted.

Therefore, in compliance with no. 1, paragraph a) of article 198 of the Constitution, the Government has approved the following as a general law of the Portuguese Republic:

CHAPTER I - General Regulations

Article 1 - Object

The present decree defines the legal framework for the licensing and supervision of private dental clinics and consulting rooms and describes the requirements that these must meet regarding facilities, organisation and operation.

2. Dental care in the public sector and in the social sector must comply with the quality and safety regulations stated in this decree.

Article 2 - Scope

Dental clinics or consulting rooms are, as defined by the present decree, private units or establishments devoted to the prevention, diagnosis and treatment of disorders and diseases of the teeth, mouth, jaws and adjacent tissues, regardless of the name and legal framework adopted by them, in the ambit of the competences legally granted to each professional class involved.

Article 3 - Freedom of choice

Dental clinics and consulting rooms must respect the principle of the customer's freedom of choice, refraining from any action which may jeopardise it.

Article 4 - Quality and safety

Quality and safety rules shall be observed in every situation mentioned in this decree, in accordance with the rules defined by internationally acknowledged scientific and technical codes, to be adopted by the Ministry of Health upon recommendation by the National Technical Committee (CNT).

Article 5 - Cooperation duty

Dental clinics and consulting rooms shall cooperate with health officials in public health promotional campaigns and programmes.

Article 6 - Quality control and guidebook of fair practice

1. Quality guarantee processes are defined in the guidebook of fair practice, to be approved by the Ministry of Health, after hearing the CNT, the Portuguese Medical Association and the Portuguese Dental Association.

2. The guidebook mentioned in the above paragraph shall be elaborated so as to allow the licensing of clinics and consulting rooms, which shall be integrated within the health quality system.

Article 7 - Guidebook of fair practice

The guidebook of fair practice must include:

• The nomenclature to be used by health professionals;
• The obligations of the person in charge of the clinic or consulting rooms and of his/her assistants;
• The list of specific equipment; Detailed instructions about operational procedure, such as that concerning the staff, transportation and identification of patients, methodologies used, validation and transmission of results, quality guarantee, confidentiality of results and requirements of the necessary reports;
• The identification of essential resuscitation equipment; Instructions about maintenance of the equipment and frequency of check-ups;
• Guidelines about storage and safety;
• Specific rules about organisation, premises and facilities;
• Instructions about the system of waste management and disposal.

Article 8 - Code of ethics

The practice of dental clinics and consulting rooms, together with that of their staff, shall conform to the code of ethics in force in their respective professional associations, paying particular attention to the principle of professional independence of the clinical director.

CHAPTER II - Operating Licence

Article 9 - Operating licence

The operation of dental clinics and consulting rooms depends on a licence granted by the Ministry of Health or by any organization to which the Ministry has delegated these competences.

Article 10 - National Technical Committee

A National Technical Committee shall be created, which, under the jurisdiction of the Ministry of Health, shall give its fair view on the licensing of dental clinics and consulting rooms mentioned in Art. 1, as well as on the issues specifically mentioned in this decree and on others as required by the Ministry. The competences of the CTN include: Giving its fair view concerning the appropriate application of this decree in all the Portuguese territory; Answering the queries that may be raised by the commissions of technical supervision or by the clinics and consulting rooms; Giving a final report about the licensing processes carried out by the health regional authorities (ARS); Writing an annual report about the clinic's operation, especially in what concerns quality and safety rules; Giving its view regarding the processes conducted by the ARS, which may lead to the suspension or revocation of operating licences. The CTN shall function according to the rules defined by the Ministry of Health. The CTN is made up of three members - a health official presiding on behalf of the Ministry of Health, a medical doctor representing the Portuguese Medical Association and a dentist representing the Portuguese Dental Association. Prior to dealing with matters affecting other entities, the CTN shall ask the view of those concerned.

Article 11 - Commissions of Technical Supervision

1. The Commissions of Technical Supervision (CVT) shall depend on each health regional authority, and shall have the following supervision and inspection competences:

a) Verifying that all the requirements are met for the creation, organisation and operation of clinics and consulting rooms;

b) Assessing the implementation of quality control programmes, to be approved by the Ministry after consultation with the CTN, the Portuguese Medical Association and the Portuguese Dental Association;

c) Putting forward actions against infractors, in order to impose the fines defined by law;

d) Suggesting the necessary measures regarding any deficiencies found;

e) Supervising that clinics and consulting rooms observe the instructions contained in the guidebook of fair practice approved by the Ministry;

f) Taking the necessary steps leading to the suspension or revocation of operation licences.

g) Checking on all the equipment;

h) Assessing storage, safety and certification procedures;

i) Verifying the equipment maintenance conditions and that regular inspections are carried out.

2. The CVTs are made up of three members - a health official presiding on behalf of the Ministry of Health, a medical doctor appointed by the Portuguese Medical Association and a dentist chosen by the Portuguese Dental Association.

3. The processes initiated by the CVTs shall be sent, through the respective ARS, to the Health Directorate General, which shall submit them to the CTN, in compliance with Art. 10 no. 2. 4. The CVTs shall function according to the rules defined by the Ministry of Health, after consultation with the CTN.

Article 12 - Licensing process

The licensing of a clinic or consulting room must be requested from the Ministry of Health, via the ARS of the area where the clinic will be located. 2. The application must include: The applicant's name and identification data Address or head office; Tax number; Location and name of the clinic; Identification of the clinical director(s); Type of services offered. The application must enclose the following documents: Copy of the firm's tax identification card or of the applicant's identity card and tax identification card; Up-to-date certificate issued by the Commercial Registrar; Detailed list of the staff and respective positions, including copies of their diplomas and qualifications certificates; Operational programme, description and map of the premises where the clinic or consulting room is located, signed by a qualified technician; Certificate guaranteeing that the premises of the dental clinic comply with the safety rules in force; Certificate, issued by the competent health official, attesting the hygiene and sanitary conditions of the clinic or consulting room, as well as its accessibility; Licence of occupation, issued by the local city council; Official operational licence application form; Draft of the internal regulation.

Article 13 - Instruction of the process

1. The competent ARS shall conduct the process for granting the respective operating licence.

2. In order to do so, the ARS may ask the applicants to provide further information considered relevant, in addition to the documents listed in the previous article.

Article 14 - Licensing requirements

Other requirements for granting an operating licence are:

a) The applicant's proficiency or, in the case of a firm, the proficiency of the directors, managers or members of the board of directors of the clinic or consulting room;

b) The professional competence of the clinical director and other health professionals of the staff;

c) The technical quality of the treatments to be provided as well as of the equipment to be used;

d) The observance of the requirements in force regarding the premises, equipment, organisation and operation, as defined in CHAPTERS III and IV of this decree.

Article 15 - Inspections

Prior to the issue of the operating licence, the local CVT shall conduct an inspection, which must coincide with the inspections mentioned in Art. 64 of Decree no. 555/99 dated 16 December, in case these are carried out. Once the above mentioned inspection has been conducted, the ARS must forward the process, together with all the corresponding documentation, to the Health Directorate General.

Article 16 - Licence revocation

Whenever a clinic or consulting room operates under unmistakable conditions of technical degradation in the care and treatment provided, its operating licence must be revoked by the Ministry of Health, after proposal of the Health Director General and consultation with the CTN. The conditions mentioned above must be confirmed through a process conducted by the CVTs. Once the clinic or consulting room has been notified of the licence revocation, all activity must cease within the indicated period, lest police and administrative officials be requested to shut it down.

Article 17 - Licence suspension

Whenever a clinic or consulting room is not fitted with the material or human resources demanded by current standards, but may acquire them, the Health Director General must propose the suspension of the operating licence to the Ministry of Health, leading to the cessation of activity, in compliance with no. 2 of the previous Article. The edict determining the suspension of the operating licence shall define a period, not beyond 180 days, within which the clinic must correct the deficiencies, obtain the equipment or hire the necessary staff for the normal functioning of its services, lest its licence be revoked. When a clinic or consulting room operates in such a way that it poses a threat to public health, the suspension may be effective immediately by the initiative of the health authorities, regardless of the CVT's report, which must be notified without delay, together with the CTN and the Health Directorate General. Licensing and Supervision of Dental Clinics and Consulting Rooms Next...