Table of content:

The quality and supervision of health services
The role of health care service providers in quality assurance
The role of Health Board in quality assurance


The quality and supervision of health services

To ensure the quality of health services provided to the patient in situation where health service is only provided by private legal persons, in 2002, the state established quality requirements for health service and established surveillance system for monitoring the activities of health care providers.

High-quality health care services must meet the applicable requirements at time of service, including vocational and professional requirements and the general level of the modern medical science the resources available and the health status needs and satisfaction of the patient.

Quality requirements for provision of health service are provided in: 
1) Law of Obligations Act § 762, according to which the Health care services shall at the very least conform to the general level of medical science at the time the services are provided and the services shall be provided with the care which can normally be expected of providers of health care services. If necessary, a provider of health care services shall refer a patient to a specialist or involve a specialist in the treatment of the patient;
 2) pursuant to the Health Services Organisation Act, the Minister of Social Affairs has establishedrequirements on quality of health service and their availability.

Health care quality problems are assessed and solved by:
1. health care provider, within their internal quality management system, shall ensure the organization of work and quality of management, professional quality of patient service and medical care and assesses patient satisfaction;
2. the health insurance fund orders clinical audits to assess the quality of health services in health insurance fund's list;
3. The supervisory department of the Health Board monitors and evaluates the health services' compliance with regulations, i.e. their formal quality;
4. The advisory expert committee on quality of health care provides an independent opinion on the substantive quality of provided patient care.


The role of health care service providers in quality assurance

The duties of health care service providers for the assurance of the quality of service provided have been set by the Social Minister’s Regulation no. 128 of 15 December 2004 on Health Care Services Quality Assurance . 

According to this the health service provider is liable for the quality of health services provided to the patient and is required to develop and implement a quality management system to ensure and develop the quality of health care service and to reduce risks related to the provision of health care services. 

Health care quality management system must include:
1) service quality assurance;
2) patient satisfaction evaluation;
3) professional quality assurance;
4) assuring the quality of institution's organization of work and management.

In assurance of patient satisfaction and management of health-service provision-related risks, a health service provider should:
1) to develop criteria for assessing and analysing patient satisfaction, which ensure patient satisfaction and allow to manage the risks associated with the provision of health services;
2) to develop an organizational customer service standard, and to notify patients in their place of activity;
3) to inform, in their place of activity, on patient's right, upon a complaint concerning the activities of health workers in the course of health service provision, to turn to the management of health care service provider, the regional department of health insurance fund or Health Board, and their contact details;
4) at least once a year to make a patient satisfaction and complaint review, analysis and discussion, and record the results. The results of patient satisfaction analysis shall be published on the public service provider's place of activity, and on their website if such exists.

To assess the quality of health care service and to mitigate the risks, the health service provider should:
1) record the transfusion reactions that occurred during the provision of health service;
2) apply for the expert committee on the quality of medical care for an expert opinion on health service cases, which caused disputes;
3) use clinical audits, self-assessment, monitoring of medical records;
4) register adverse effects that occurred during the use medicinal products and notify the State Agency of Medicines;
5) when providing hospital service, to hold regular internal clinical conferences, which would also include relevant medical specialists and family physicians, where appropriate;
6) in order to ensure the quality of hospital service provided, to establish regulations for conducting specialized care councils.

To ensure the quality of health care services, specialist care provider shall establish following operational guidelines:
1) control and prevention of hospital infections;
2) prescription of medicinal products, including antibiotics with hospital's medicinal product form;
3) prevention and treatment of pressure ulcers;
4) organization of transfusion treatment;
5) assessment of patient's pre-operative status;
6) the use of radiation in diagnostic and therapeutic procedures.

The health service providers’ duties on the availability of health services provided and on waiting lists have been provided by the Social Minister’s Regulation no. 46 of 12 August 2008 "Tervishoiuteenuste kättesaadavuse ja ravijärjekorra pidamise nõuded" (Estonian only).

Under this, the health service can be provided using waiting lists, if the health service provider is unable to provide immediate health care, and if the deferral of health service to a set deadline does not affect the patient's medical condition, the course of the illness or worsen the later prognosis of the illness.

Health service provider shall maintain the waiting list either on paper or in their information system or digital registry.

The health care provider must also display following information in a visible location in their place of operation:

1) the office hours by specialty;
2) the contact details of the closest service provider providing required emergency care outside the reception hours and round-the-clock;
3) in case of grievances concerning the availability of health care and for proposals, the health care service provider must list the contact details for authorities to whom to submit complaints and proposals, such as health care service provider, the regional department of the health insurance fund and the county governor and the Health Board;
4) the maximum length of waiting list approved by the council of the health insurance fund.

The Health Board conducts the state supervision on the compliance of the activities of health service providers with established requirements.


The role of Health Board in quality assurance

Health Board is a government agency under the governance of the Ministry of Social Affairs, which has a management function and conducts state supervision and enforces powers of a state on the basis and to the extent provided by the law.
The objective of Health Board is to implement policies aimed at shaping the living and learning environment supporting and improving health and population health policies aimed at quality health protection and health care in the field of health care, health protection, chemical safety and medical devices.
Health Board Statues can be accessed here.

Health care services can be provided under activity licence requested from the Health Board. A licence is required for provision of:
 1) emergency care;
 2) general health care according to practice lists of family physicians;
 3) specialized medical care;
 4) independent nursing care;
 5) independent midwife care.

To apply for a license, a health care provider must meet certain pre-established requirements, compliance with which the Health Board shall check prior to the issuance of activity licence. For example, the license applicant:
 - provide the names and personal identification numbers of health workers and on first application for activity licence, must provide written confirmation from health workers agreeing to work for the health service provider applicant;
 - when applying for a licence to provide emergency care, the number, staff and equipment of ambulance crews;
- when applying for the medical technology part of facilities, a project, which includes the details of facilities, installations and equipment;
- data on the registration of sensitive personal data in data protection supervision authority.

If the health care service provider is already licensed, it is obliged to inform the Health Board on continuous basis:
1) immediately of all changes in the health care staff;
2) of major technical malfunctions, and other significant changes in the provision of health care equipment, if such failures and changes result in the activity licence holder's inability to provide health care services listed in activity licence.

Additionally, the Health Board monitors all the health care providers on their compliance with the requirements provided in established legislation.


The role of Estonian Health Insurance Fund in ensuring the quality

According to the Estonian Health Insurance Fund Act, Estonian Health Insurance Fund (hereinafter health insurance fund) is required to monitor the quality of services, and determine whether the provision of services has been justified. Means of monitoring are:
 - monitoring of health insurance benefits,
 - clinical audits,
 - methods for measuring activities and results (clinical indicators according to health insurance fund),
 - DRG-s.

To improve the quality of health care services, the health insurance fund also supports the activities of a number of professional associations and medical institutions, such as:
 - improving the quality of data, 
 - support and initiation of various development projects, in order to study the best international practices.

Treatment Instructions

The health insurance fund has set up Guideline Advisory Board with the purpose to improve the quality of health care services provided to patients, by guiding development process of cost-effective and evidence-based Estonian treatment guidelines, which take local conditions into account.

Clinical guideline is a document which provides recommendations on actions that effect health. It provides health workers with evidence-based guidance on various diagnostic and treatment methods and it may also contain recommendations for disease prevention and patient education strategies, etc. Information provided in the clinical guideline shall help to make choices between the different intervention methods that affect the health, quality of care, and the use of health care resources.
Initiative for clinical guideline development may come from any organization (e.g. professional association, a group of patients, educational institution, etc.)

All clinical guidelines adopted by the Guideline Advisory Board can be found here.

Waiting lists

Waiting list is a list of persons waiting for the receipt of health care service, kept in the registry of health care service provider. The duties of health care service providers concerning the availability of health care service and the keeping of waiting lists have been provided in Regulation No. 46 of Minister of Social Affairs of 21 August 2008 “Tervishoiuteenuste kättesaadavuse ja ravijärjekorra pidamise nõuded“ (The requirements for the availability of health care services and waiting lists).
According to this, the health care service can be provided on waiting list basis, if the health care service provider is unable to provide health care service immediately and the deferral of a health care service does not affect the health status of the patient, the course of the illness or worsen the later prognosis of the illness.

The health insurance council has established maximum values for waiting lists. This means the time period during which a person must get to the doctor's appointment. Values were set on the principle that a person should be able to receive health care within a time frame, during which their health would not deteriorate significantly.

More information on waiting lists can be found here.


The role of expert committee on quality of health services in the quality assurance

In cases, where there is doubt about the quality of medical services, it is recommended to contactthe advisory expert committee on quality of health services working under the Ministry of Social Affairs. The expert committee on quality of health services is an advisory committee with the purpose to assess the quality of health services provided to the patient and to make recommendations to the Health Board, the health insurance fund and the provider of health services on the basis of such assessment.

It is in the competency of the committee to:
1) to assess the quality of care provided to patients;
2) to make proposals to the Health Board to initiate supervision proceedings as a result of the activities of the health care provider;
3) to propose the health care provider to assess health worker's competence and to refer employees to in-service training;
4) to make proposals for health care providers to change their organization of work;
5) make proposals to the Health Board to revoke the activity licence of a health care provider;
6) make proposals to the Health Board to refuse to issue an activity licence to a health care provider;
7) make proposals to the Estonian Health Insurance Fund to review funding contracts concluded with a health care provider.

Application should be sent to:
Expert committee on quality of health services
Ministry of Social Affairs 
Gonsiori 29 
15027 Tallinn 
or by e-mail at info|ä| (application must be digitally signed)

The written application must be clear and intelligible, and must include:
1) the patient's contact information (name and phone number, e-mail address or mailing address);
2) the information of health care provider in question (name of the medical institution, name of the physician or other health worker and place of service);
3) the signature of the patient's consent (permission) to use health data, which is necessary to clarify the circumstances of his or her statement.

If the committee has identified a medical error, it shall inform the doctor and medical institution that made a mistake, and, where appropriate, makes a proposal to professional association to control the competency of the health worker who made a mistake. The committee may, in its decision, make suggestions, give advice or recommendations, but it cannot require a doctor or a medical institution to compensate the patient for the medical error which caused damage. The patient may file a lawsuit, in order to receive financial compensation.


The role of State Agency of Medicines in quality assurance

The State Agency of Medicines is a government agency whose mission is to protect public health through surveillance of medicinal products used in Estonia. The State Agency of Medicines also participates in the protection of animal health, through the monitoring of veterinary drugs. The State Agency of Medicines is under the administration of the Ministry of Social Affairs.

The State Agency of Medicines:
•controls the efficacy, quality and safety of medicinal products and issues marketing authorizations for medicinal products;
•monitors the admissibility of clinical trials of medicinal products and monitors the safety of trial participants;
•issues the activity licences for handling medicinal products, monitors pharmacies, pharmaceutical wholesale and manufacturing companies for compliance with the regulation on the handling of medicinal products, also the handling of narcotic and psychotropic substances;
•monitors the movement of narcotic and psychotropic substances across borders of Estonia;
•determines, whether a medicinal product is classified under narcotic, psychotropic, non-prescription or prescription medicines;
•collects and analyses data on trends in drug consumption;
•collects and evaluates information on adverse drug reactions, organizes the communication of related information to international organizations;
•monitors the handling of cells, tissues and organs (except their removal);
•oversees the compliance with the requirements on advertising of medicinal products;
•provides opinions on the applications for entering medicinal products to lists of medicinal products issued by pharmacies under discount;
•organizes the participation of Estonian representatives in European Medicines Agency and European Pharmacopoeia committees and other assemblies;
•helps citizens to receive information on all medication-related issues.