Quality and supervision of health care services
To ensure the quality of health services provided to patients in situation where health service is only provided by private legal persons, in 2002, the state established quality requirements for health care 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 general level of modern medical science, the resources available, as well as the health status needs and satisfaction of the patient.
Quality requirements for provision of health care services are set out in:
1) Article 762 of the Law of Obligations Act, according to which 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 established requirements on quality of health service and their availability.
Health care quality problems are assessed and solved by:
1) a health care provider, within their internal quality management system. A health care provider shall ensure the organization of work and quality of management, professional quality of patient service and medical care and assesses patient satisfaction;
2) EHIF that orders clinical audits to assess the quality of health care services in the EHIF’s list;
3) the supervisory department of the Health Board which monitors and evaluates the health services' compliance with regulations, i.e. their formal quality;
4) the advisory expert committee on quality of health care providing an independent opinion on the substantive quality of health care services provided to patients.
The role of health care providers in quality assurance
The obligations of health care 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 a health care provider is liable for the quality of health care services provided to a patient. The health care provider 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.
To ensure patient satisfaction and management of risks related to the provision of health care services, a health care provider should:
1) develop criteria for assessing and analysing patient satisfaction, which ensure patient satisfaction and allow to manage the risks associated with the provision of health care services;
2) develop an organizational customer service standard, and notify patients thereof in their place of activity;
3) inform, in their place of activity, on patient's right, upon a complaint concerning the activities of health workers in the course of health care 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 prepare 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 a health care service and to mitigate the risks, a health service provider should:
1)record the transfusion reactions that occurred during the provision of health care service;
2) apply to the expert committee on the quality of medical care for an expert opinion on health care service cases, which caused disputes;
3) use clinical audits, self-assessment, monitoring of medical records;
4) register adverse reactions that occurred during the use of medicinal products and notify the State Agency of Medicines thereof;
5) when providing inpatient care service, to hold regular internal clinical conferences, which would also include relevant medical specialists and family physicians, where appropriate;
6) establish regulations for conducting specialized care councils in order to ensure the quality of inpatient care provided,
To ensure the quality of health care services, a specialized medical care provider shall establish operational guidelines on the following:
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 therapy;
5) assessment of a patient’s pre-operative condition;
6) use of radiation in diagnostic and therapeutic procedures.
The health service providers’ duties on the availability of health care services provided and on waiting lists have been provided by the Social Minister’s Regulation no. 46 of 21 August 2008 "Requirements for the access to health care services and keeping waiting lists".
According to this regulation, a health care service can be provided using waiting lists, if a health care provider is unable to provide the health care service immediately, and if the deferral of health care service to a set deadline does not affect the patient's medical condition, the course of illness or worsen the later prognosis of the illness.
A health care provider shall maintain a waiting list either on paper or in their information system or digital registry.
A health care provider must also display following information in a visible location in their place of operation:
1) reception hours by specialties;
2) contact details of the closest service provider providing required emergency care outside the reception hours and round-the-clock;
3) contact details for authorities to whom to submit complaints and proposals, such as health care service provider, EHIF and the Health Board;
4) maximum lengths of waiting lists approved by the council of EHIF.
The Health Board conducts the supervision on the compliance of the activities of health care providers with established requirements.
The Health Board is a government agency under the governance of the Ministry of Social Affairs which conducts state supervision and enforces powers of a state on the basis and to the extent provided by the law.
The areas of activity of the Health Board are health care, communicable disease surveillance and epidemic control, environmental health, chemical safety and safety of medical devices. The objective of the Health Board is to implement policies aimed at creating a living and learning environment that supports and improves health in these areas. The statutes of the Health Board are available here.
Health care providers must apply to the Health Board for an activity license. An activity license is required for the provision of:
1) ambulance services;
2) primary medical care on the basis of family physicians practice lists;
3) specialized medical care;
4) independent nursing care;
5) independent midwifery care.
To apply for an activity license, a health care provider must meet certain pre-established requirements and before issuing an activity license, the Health Board checks the compliance with those requirements. For example, the license applicant should provide:
- the names and personal identification numbers of health care professionals, and on first application for an activity license, written confirmation from health care professionals agreeing to work for the health care provider applicant;
- when applying for a license 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 a health care provider is already licensed, they are obliged to inform the Health Board:
1) immediately of any changes in 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 license holder's inability to provide health care services listed in activity license.
In addition, the Health Board monitors all health care providers on their compliance with the requirements provided in established legislation.
EHIF is obliged under the Estonian Health Insurance Fund Act to check whether the services provided were reasoned and of required quality. To monitor this, the following are used:
- monitoring of health insurance benefits ;
- clinical audits ;
- methods for measuring activities and outcomes (clinical indicators);
- diagnosis-related groups (DRGs).
To improve the quality of health care services, EHIF also supports the activities of professional associations and medical institutions both in improving the quality of data and in initiating development projects to learn from best international practices.
More information about the role of EHIF can be found here.
Clinical guidelines
EHIF has set up the Guideline Advisory Board with the purpose to improve the quality of health care services provided to patients. In order to achieve this goal, cost-effective and evidence-based Estonian clinical guidelines that take account of local circumstances are prepared, and the process of developing them is led by the Guideline Advisory Board
Clinical guideline is a document which provides recommendations on handling specific health conditions. It provides health workers with evidence-based guidance on various diagnostic and treatment methods and it may also contain recommendations for disease prevention. Information provided in the clinical guideline help make choices between the different intervention methods that affect 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 a health care service, and it is kept in the registry of health care provider. The duties of health care 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 regulation, a health care service can be provided using waiting lists, if a health care provider is unable to provide the health care service immediately, and if the deferral of health care service to a set deadline does not affect the patient's medical condition, the course of illness or worsen the later prognosis of the illness.
The EHIF's supervisory board has set maximum lengths of waiting lists. This is the time period during which a person is entitled to get to a doctor’s appointment. These time limits 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 about waiting lists can be found here.
In cases, where there is doubt about the quality of medical services, it is recommended to contact the advisory expert committee on the quality of health care services working under the Ministry of Social Affairs. The expert committee on the quality of health care services is an advisory committee with the purpose to assess the quality of health care services provided to the patient and to make recommendations to the Health Board, EHIF and health care providers on the basis of such assessment.
The committee’s responsibilities include:
1) assessment of the quality of care provided to patients;
2) making proposals to the Health Board to initiate supervision proceedings as a result of the activities of the health care provider;
3) making proposals to a health care provider to assess health care professionals’ competence and to refer employees to in-service training;
4) making proposals to a health care provider for changes in the organization of work;
5) making proposals to the Health Board to revoke the activity license of a health care provider;
6) making proposals to the Health Board to refuse to issue an activity license to a health care provider;
7) making proposals to EHIF to review funding contracts concluded with a health care provider.
An application must be submitted to the expert committee for the quality of health care services, if there is any doubt as to the appropriateness of the provision of health care, a doctor's decision, a medical error or safety of the service. Please, send the application to:
Expert Committee on Quality of Health Care Services, Ministry of Social Affairs, Gonsiori 29, 15027 Tallinn or by e-mail info [at] sm.ee (info[at]sm[dot]ee) (application must be digitally signed).
Written application must be clear and intelligible, and must include
1) patient's contact information (name and phone number, e-mail address or mailing address);
2) information of health care provider in question (name of the medical institution, name of the physician or other health care professional and place of service);
3) signed consent (permission) to use the patient’s health data, which is necessary to clarify the circumstances of his or her statement.
If the committee has identified a medical error, they will inform the physician responsible and the medical institution and, if necessary, propose to the professional association that the competence of the medical professional who made the mistake be verified. In its decision, the committee may make suggestions, give advice or recommendations, but may not oblige a physician or medical institution to compensate the patient for the damage caused by a medical error. A patient may turn to court to claim financial compensation.
The State Agency of Medicines is a government agency whose ultimate task 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 by supervising veterinary medicinal products. The State Agency of Medicines is under the administration of the Ministry of Social Affairs.
The State Agency of Medicines has various supervisory functions. The agency assesses the quality, safety and efficacy of medicinal products before granting them a marketing authorization, controls the quality of medicinal products in a laboratory, and supervises the various stages of production, import and sale of medicinal products.
The State Agency of Medicines decides on the admissibility of clinical trials of medicinal products, checks the compliance of the advertising of medicinal products, collects and analyses data on the volume and safety of the use of medicinal products. In addition to its national functions, the State Agency of Medicines has international obligations - to represent Estonia in the pharmacovigilance network of European Union and Council of Europe, providing advice and information in the preparation of normative documents and expertise of medicinal products.
Terviseamet on sotsiaalministeeriumi valitsemisalas tegutsev valitsusasutus, kes teeb riiklikku järelevalvet ning kohaldab riiklikku sundi seaduses ettenähtud alustel ja ulatuses.
Terviseameti tegevusvaldkonnad on tervishoid, nakkushaiguste seire ja epideemiatõrje, keskkonnatervis, kemikaaliohutus ja meditsiiniseadmete ohutus. Terviseameti eesmärk on nendes valdkondades tervist toetava ja parendava elu- ja õpikeskkonna kujundamisele suunatud poliitika elluviimine. Terviseameti põhimäärus on kättesaadav siit.
Tervishoiuteenuste osutaja peab Terviseametilt taotlema tegevusloa. Tegevusluba on nõutav:
1) kiirabiteenuse osutamiseks;
2) perearsti nimistu alusel üldarstiabi osutamiseks;
3) eriarstiabi osutamiseks;
4) iseseisvalt õendusabi osutamiseks;
5) iseseisvalt ämmaemandusabi osutamiseks.
Tegevusloa taotlemiseks peab tervishoiuteenuse osutaja vastama teatud nõuetele, mida Terviseamet enne tegevusloa väljastamist kontrollib. Näiteks peab tegevusloa taotleja esitama:
- tervishoiutöötajate nimed ja isikukoodid ning esmasel tegevusloa taotlemisel tervishoiutöötajate kirjalikud nõusolekud tegevusluba taotleva tervishoiuteenuse osutaja juurde tööle asumiseks;
- kiirabiteenuse osutamise loa taotlemise korral taotletavate kiirabibrigaadide arvu, koosseisu ja varustuse;
- ruumide meditsiinitehnoloogia osa projekti, milles on andmed ruumide, sisseseade ja aparatuuri kohta;
- andmed andmekaitse järelevalve asutuses delikaatsete isikuandmete töötlemise registreerimise kohta.
Kui tervishoiuteenuse osutajale on juba tegevusluba väljastatud, siis on ta kohustatud teavitama Terviseametit:
1) viivitamatult kõikidest muudatustest tervishoiutöötajate koosseisus;
2) suurtest tehnilistest riketest ja muudest olulistest muudatustest tervishoiuteenuse osutamiseks vajalikus aparatuuris, kui nimetatud rikete ja muudatuste tulemusena on tegevusloa omajal võimatu osutada tegevusloal märgitud tervishoiuteenuseid.
Lisaks kontrollib Terviseamet kõiki tervishoiuteenuse osutajaid selles suhtes, kas nad täidavad õigusaktidega kehtestatud nõudeid.
Tervisekassal on Tervisekassa seaduse alusel kohustus kontrollida osutatud tervishoiuteenuste põhjendatust ja kvaliteeti. Selle jälgimiseks kasutatakse:
- ravikindlustushüvitiste kontrollimist;
- kliinilisi auditeid;
- tegevuste ja tulemuste mõõtmise meetodeid (kliinilised indikaatorid);
- diagnoosipõhiseid kompleksteenuseid ehk DRG-sid.
Tervishoiuteenuste kvaliteedi parendamiseks toetab Tervisekassa ka erialaühenduste ja raviasutuste tegevusi nii andmekvaliteedi parandamisel kui ka arendusprojektide algatamisel parimatest rahvusvahelistest praktikatest õppimiseks.
Rohkem infot Tervisekassa rollist leiab siit.
Ravijuhendid
Tervisekassa on asutanud Ravijuhendite Nõukoja, mille eesmärk on patsientidele osutatavate tervishoiuteenuste kvaliteedi parendamine. Selle eesmärgi saavutamiseks koostatakse kulutõhusad ja tõenduspõhised, kohalike oludega arvestavad Eesti ravijuhendid, mille väljatöötamise protsessi juhib Ravijuhendite Nõukoda.
Ravijuhend on dokument, mis annab tervishoiutöötajatelesoovitusi konkreetsete haigusseisundite käsitlemiseks Ravijuhendis antakse tõenduspõhiseid juhiseid haiguste diagnoosimise ja ravimise viiside kohta, samuti võib see sisaldada soovitusi haiguste ennetuseks.. Ravijuhendis toodud teave aitab meditsiinitöötajatel teha valikuid sekkumisviiside vahel, mis mõjutavad tervist, ravikvaliteeti ning tervishoiuressursside kasutamist. Ravijuhendi koostamise algatus võib tulla ükskõik milliselt asjakohaselt organisatsioonilt (nt erialaselts, patsientide rühm, õppeasutus jne).
Kõik nõukoja vastuvõetud ravijuhendid on kättesaadavad siit.
Ravijärjekorrad
Ravijärjekord on tervishoiuteenuse saamist ootavate inimeste nimekiri, mida peetakse tervishoiuteenuse osutaja registratuuris. Tervishoiuteenuse osutajate kohustused pakutava tervishoiuteenuse kättesaadavusele ja ravijärjekorra pidamisele on kehtestatud sotsiaalministri 21. augusti 2008. a määruses nr 46 „Tervishoiuteenuste kättesaadavuse ja ravijärjekorra pidamise nõuded".
Selle kohaselt võib tervishoiuteenust osutada ravijärjekorra alusel juhul, kui tervishoiuteenuse osutajal puudub võimalus tervishoiuteenust osutada kohe ning teenuse osutamise edasilükkamine kindlaksmääratud tähtajani ei põhjusta patsiendi terviseseisundi halvenemist, ei mõjuta haiguse kulgu ega halvenda haiguse hilisemat prognoosi.
Tervisekassa nõukogu on kehtestanud ravijärjekordade maksimummäärad. See tähendab aega, mille jooksul inimene peab kindlasti arsti vastuvõtule pääsema. Määrade kehtestamisel on lähtutud põhimõttest, et inimene peaks saama vajamineva tervishoiuteenuse sellise aja jooksul, mil tema tervislik seisund oluliselt ei halvene.
Rohkem infot ravijärjekordade kohta leiab siit.
Kui kaheldakse raviteenuse kvaliteedis, siis peaks pöörduma sotsiaalministeeriumi juures tegutseva nõuandva tervishoiuteenuse kvaliteedi eksperdikomisjoni poole. Tervishoiuteenuse kvaliteedi eksperdikomisjon on nõuandev komisjon, mille eesmärk on patsiendile osutatud tervishoiuteenuse kvaliteedile hinnangu andmine ning hinnangust tulenevalt Terviseametile, Eesti Haigekassale ja tervishoiuteenuse osutajatele ettepanekute tegemine.
Komisjoni pädevuses on:
1) anda hinnang patsiendile osutatud tervishoiuteenuse kvaliteedile;
2) teha ettepanekuid Terviseametile järelevalvemenetluse algatamiseks tervishoiuteenuse osutaja tegevuse üle;
3) teha ettepanekuid tervishoiuteenuse osutajale tervishoiutöötaja pädevuse hindamiseks ja täienduskoolitusele suunamiseks;
4) teha ettepanekuid tervishoiuteenuse osutajale töökorralduse muutmiseks;
5) teha ettepanekuid Terviseametile tervishoiuteenuse osutaja tegevusloa kehtetuks tunnistamiseks;
6) teha ettepanekuid Terviseametile tervishoiuteenuse osutajale tegevusloa väljaandmisest keeldumiseks;
7) teha ettepanekuid Eesti Haigekassale tervishoiuteenuse osutajaga sõlmitud ravi rahastamise lepingute ülevaatamiseks.
Tervishoiuteenuse kvaliteedi eksperdikomisjonile tuleb esitada avaldus, kui on tekkinud kahtlus tervishoiuteenuse osutamise asjakohasuse, arsti otsuse, ravivea või teenuse ohutuse suhtes. Avaldus tuleb saata:
Tervishoiuteenuse kvaliteedi eksperdikomisjon, Sotsiaalministeerium, Suur-Ameerika 1
10122 , Tallinn või e-postiga info [at] sm.ee (info[at]sm[dot]ee) (avaldus peab olema digiallkirjastatud).
Kirjalik avaldus peab olema selgelt ja arusaadavalt sõnastatud ning peab sisaldama:
1) patsiendi kontaktandmeid (nimi ja telefoninumber, e-posti aadress või postiaadress);
2) kõnealuse tervishoiuteenuse osutaja andmeid (raviasutuse nimetus, arsti vm tervishoiutöötaja nimi ja tervishoiuteenuse osutamise koht);
3) patsiendi allkirjaga nõusolekut (kasutada patsiendi terviseandmeid, mis on tema avalduse asjaolude selgitamiseks vajalikud.
Kui komisjon on tuvastanud arstliku vea, teatab ta sellest vea teinud arstile ja raviasutusele ning vajadusel teeb erialaseltsile ettepaneku kontrollida eksinud meditsiinitöötaja pädevust. Komisjon võib oma otsuses teha ettepanekuid, anda nõu või soovitusi, kuid ei saa kohustada arsti või raviasutust kompenseerima patsiendile arstliku vea tagajärjel tekkinud kahju. Rahalise hüvituse saamiseks võib patsient pöörduda kohtusse.
Ravimiamet on valitsusasutus, mille ülesanne on kaitsta rahva tervist Eestis kasutatavate ravimite järelevalve kaudu. Ravimiamet osaleb ka loomade tervise kaitses, tehes järelevalvet veterinaarravimite üle. Ravimiamet on sotsiaalministeeriumi haldusalas.
Ravimiametil on mitmesugused järelevalvefunktsioonid. Amet hindab ravimite kvaliteeti, ohutust ja toimivust enne neile müügiloa andmist, kontrollib laboratoorselt ravimite kvaliteeti, teeb järelevalvet ravimite tootmise, sisseveo ja müügi erinevate etappide üle.
Ravimiamet otsustab kliiniliste ravimiuuringute lubatavuse üle, kontrollib ravimireklaami nõuetelevastavust, kogub ja analüüsib andmeid ravimite kasutamise mahu ja ohutuse kohta. Lisaks riiklikele funktsioonidele on Ravimiametil rahvusvahelised kohustused – esindada Eestit Euroopa Liidu ja Euroopa Nõukogu ravimite järelevalvevõrgustikus, andes nõu ja infot normdokumentide ettevalmistamisel ning ravimiekspertiisides.