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Published 1 January 2024.

At FSHS, self-supervision is conducted by following instructions of action and procedure. This self-supervision plan describes these instructions in detail. The plan’s aim is to prevent and rectify any risks, dangerous situations and inadequate quality of service within our operations, as well as to ensure the professional capabilities of our care personnel.

Our general self-supervision plan is monitored yearly and updated when necessary, as are self-supervision plans of individual service points.

1 Information about service provider
1.1 Values and operational strategy
1.2 Operating principle and mission
1.3 Service regions and service units
2 Self-supervision: organisation and leadership
3 Personnel
4 Facilities, devices, equipment and hygiene practices
4.1 Cleaning, waste management and handling of hazardous waste
4.2 Medical devices and equipment
4.3 Use of radiation in healthcare
4.4 Laboratories
4.5 Hygiene practices
5 Patient ombudsperson
6 Pharmacotherapy
7 Identifying risks and shortcomings, and corrective measures
8 Patient documents and handling of personal data
8.1 Names and contact details of persons responsible for data protection
9 Strengthening patient participation and handling objections
9.1 Processing objections, complaints, and suspected patient injuries
10 Monitoring and assessing self-supervision

Information about service provider

Service provider
Finnish Student Health Service (FSHS)

Service provider’s business ID
Y-0202637-8

Location name
Finnish Student Health Service (FSHS)

Postal address
Töölönkatu 37 A
00260
Helsinki
FINLAND

Directors responsible for services
Director responsible for healthcare services, Medical Director Teija Kulmala
Director responsible for oral healthcare services, Medical Director of Dentistry Krista Brander-Aalto

Phone numbers of directors responsible
+35841 7319 420
+35841 7322 165

Postal address of directors responsible
Töölönkatu 37 A
00260
Helsinki
FINLAND

Email addresses of directors responsible
teija.kulmala(at)ths.fi
krista.brander-aalto(at)yths.fi

Values and strategy

Our guiding values are equality, courage and caring.

The operational strategy consists of:
• targeted services to promote health, wellbeing and fitness to study
• positive client experience and active collaboration with stakeholders
• community of competent and motivated professionals
• responsible and efficient use of resources.

The mission of the FSHS is to promote student health, wellbeing and fitness to study. The FSHS provides statutory student health services for those studying for a Bachelor’s or Master’s degree at a university or other institute of higher education as approved by the National Supervisory Authority for Welfare and Health. Information about those entitled to use FSHS services can be found elsewere on our website yths.fi.

The services provided by the FSHS are set out in the Act on Student Healthcare for Higher Education Students (695/2019) and in section 17 of the Health Care Act. The content of health and medical services is described in detail in the Guide on Student Healthcare (STM 2021) published by the Ministry of Social Affairs and Health and in Government Decree 338/2011 on maternity and child health clinic services, school and student health services and preventive oral health services for children and youth. 

Under section 17 of the Health Care Act, FSHS student healthcare services are required:

  1. to promote and to monitor (every three years) the health, safety and wellbeing of the study environment in educational institution
  2. to monitor and promote student health, wellbeing and fitness to study, which includes individual health check-ups
  3. to provide students with healthcare and medical care services, mental health and substance abuse services, sexual health services and oral healthcare
  4. to identify as early as possible the need for any special support/examinations, to provide support and, if necessary, to issue a referral for further tests or treatment.

In accordance with the FSHS rules, the FSHS Board of Trustees makes decisions concerning the foundation level annual plan of operations and the budget. The Board of Trustees also ratifies the FSHS rules of procedure, which are currently being updated.

In accordance with its rules of procedure the foundation’s activities are conducted in five service regions and through its nationwide digital services. Each service region has its own Regional Director, who is responsible for operations and finances, and who reports to the Managing Director.

Each Regional Director is responsible for reaching the goals set for the region by the foundation’s management, and for the effectiveness and development of regional activities in collaboration with regional supervisors.

Each region also has a Regional Management Group appointed by the FSHS Board of Trustees. It is the responsibility of each Regional Management Group to monitor activities and changes in its region, as well as study community work and health promotion activities in its region. The Regional Management Groups work together with universities and other institutes of higher education, student unions, student associations, public health services and other bodies concerned with student healthcare in their region.

The Finnish Patent and Registration Office has approved the FSHS’s rules and monitors how the FSHS operates as a foundation.

The FSHS’s service network is divided into five service regions based on the public healthcare specific catchment areas. The locations of the FSHS’s service partners can be found on the FSHS website.

The FSHS provides its services in rental facilities in all regions. These facilities have been purpose designed and renovated to ensure patient safety. All facilities have been inspected by the Regional State Administrative Agencies. Any shortcomings found by occupational safety and health officials or another party are rectified together with the lessor.

Inspection reports for facilities and equipment, signed by the chief medical officer or the chief dental officer of the local health centre, have been included in notifications relating to the commencement of activities as required under section 4 of the decree on private healthcare (1647/2009).

Self-supervision: organisation and leadership

Managers responsible for healthcare services are in charge of activities in accordance with sections 5 and 6 of the Private Health Care Act and section 3 of government decree 744/1990. They are also responsible for steering, planning, development and harmonisation of services for the entire FSHS. The Medical Director is in charge of health promotion and research for the FSHS.

Responsibility for the FSHS’s self-supervision activities rests with the foundation’s management and with the service region management working under the regional managers: Regional Medical Directors, Regional Medical Directors of Dentistry, Regional Head Nurses and supervisors. In practice, self-supervision has been organized in such a way that those directors responsible for healthcare services have appointed Regional Medical Directors and/or Regional Medical Directors of Dentistry for FSHS service units, who are responsible for the quality of medical care and patient safety as set out in this self-supervision plan in the respective service regions and service units.

The FSHS service and development team is in charge of updating and coordinating the self-supervision plan, with the manager or director of operations in each area of responsibility updating their own part of the plan. The HR manager provides the text for the HR section and the HR statement. The service development team scrutinises and approves the self-supervision plan, which is published on the FSHS website and on the intranet, to which everyone has access. Service units update their own self-supervision plans, which are publicly available in the service units.

Personnel

On the last day of 2022, the FSHS had 984 (960) employees in total. Most of them, 889 (870), worked on a permanent contract and 95 (78) on a fixed-term contract. In the HR statement the numbers in parenthesis are the corresponding numbers for 2021.

The majority of FSHS personnel are female, which is typical in healthcare organizations. In December 2022, 90% of the employees were women. Most of the rest were male. A minority were non-binary.

Amount of personnel 31.12.2022

FSHS regionPermanentFixed-termTotal
YTHS Southern296 (297)27 (24)323 (321)
YTHS Eastern130 (159)18 (20)148 (179)
YTHS Northern91 (103)13 (8)104 (111)
YTHS Central119 (138)13 (19)132 (157)
YTHS Western132 (144)13 (16)145 (160)
YTHS digital89 ()9 ()98 ()
Foundation management32 (29)2 (3)34 (32)
Total889 (870)95 (90)984 (960)

28.68% (27.6%) of the foundation’s personnel worked part-time in 2022. Working part-time was most common among general practitioners, dentists and psychologists.

Occupational groups and working hours 31.12.2022

OccupationFull-timePart-timeOn-callTotal
General practitioner25 (30)76 (89)8 (5)109 (124)
Public health nurse, nurse182 (176)18 (11)(1)200 (188)
Psychiatric
nurse
85 (79)5 (4)1 ()91 (83)
Physiotherapist28 (25)11 (9) 39 (34)
Dentist19 (28)91 (78)8 (7)118 (113)
Dental nurse123 (113)12 (11)1 (1)136 (125)
Oral hygienist33 (36)7 (6)(1)40 (42)
Other assisting personnel51 (52)14 (12)1 (1)66 (65)
Psychologist43 (51)44 (43) 87 (95)
Administration, management58 (57)4 (2) 62 (59)
Administration36 (31) (1)36 (32)
Total683 (678)282 (265)19 (17)984 (960)

Under section 18a of the Act on Health Care Professionals, healthcare professionals must have sufficient language proficiency to perform their duties. Employers are required to assess whether a person has sufficient language proficiency. Before hiring a new employee, the FSHS assesses the person’s professional competence by checking their academic qualifications and their data in the register of healthcare professionals and assesses their language proficiency for the task concerned. Healthcare professionals must speak Finnish or Swedish fluently enough to be able to perform their duties. A knowledge of English and/or Sami is a bonus.

Read more about FSHS language strategy

It is the responsibility of the recruiting supervisor to check the person’s right to work in social welfare or healthcare with the National Supervisory Authority for Welfare and Health (Valvira) register JulkiTerhikki before signing an employment contract. The supervisor enters the person’s register number provided by Valvira in the HR system Sympa. If the person’s right to practise a social welfare or healthcare profession has been restricted, the issue should be resolved by contacting Valvira.

The FSHS provides workplace orientation for all new employees. Orientation takes place via an online training platform (FSHS Academy) and is arranged by the person’s immediate supervisor. The purpose of workplace orientation is to familiarise new employees with their work and help them adapt to their new working environment. New employees are introduced to the foundation’s organization, goals and operations and given guidance on their duties and the equipment they will use.

Employees are also given guidance after long leaves of absence and when their duties change. New managers are provided with guidance in their managerial duties. The purpose of the guidance is to strengthen the managerial skills and knowledge of employment relationships of those responsible for managing personnel.

All FSHS healthcare professionals who practise pharmacotherapy are required to obtain Laatupassi certification in the FSHS Academy as part of the FSHS orientation programme, which includes getting acquainted with pharmacotherapy plans and the basic range of medicines. A list of orientation issues is available for use by the manager and the employee. Orientation also includes getting acquainted with the FSHS’s pharmacotherapy plan and the service unit’s own pharmacotherapy plan. All employees who have had an extended time off work are required to undergo orientation. Employees who have been off work for longer than three years are also required to complete the theoretical training for a pharmacotherapy licence and possibly also to demonstrate their competence, even if it is less than 5 years since they obtained their pharmacotherapy licence.

Skills are developed in line with the FSHS’s competence needs and an assessment of the person’s current competence. Personal competence assessments and training plans are made during development discussions. The progress of these development discussions is monitored, and employees apply for training based on the training plan.

Personnel training refers to short-term and long-term continuing training offered to employees by the foundation in its role as employer. Continuing training includes all training used to support the employee’s competence and development as a professional and as a member of the working community. Continuing training is carried out either as foundation in-house training or as outsourced training.

The creation of a training plan is part of the foundation’s plan of activities and budget. It includes the general goals for personnel training and the personnel training plan based on these goals for the next budget period.

The annual training plan includes an assessment of the training needs of the entire workforce to achieve the goals set. Planning personnel training ensures that the training provided corresponds with changes in the operating environment and the financial resources available. The annual training rates per occupational group are shown in the HR statement.

At the FSHS, healthcare professionals (new employees, employees who have been off work for a long time, fixed-term employees and trainees) are required to complete the fourth section of Laatupassi certification as part of their FSHS workplace orientation programme. The section includes the key documents governing patient care quality, patient safety and self-supervision. Laatupassi certification is obtained through the FSHS Academy.

Licenced healthcare professionals (excluding physicians and dentists) and healthcare professionals with a protected occupational title are required to complete the online pharmacotherapy training course every 5 years and to provide proof of their competence.

Facilities, devices, equipment and hygiene practices

The FSHS is responsible for ensuring that its facilities are suitable for their intended use and, if necessary, suitably renovated. Access control and protection against intruders and fire are the FSHS’s own responsibilities. The FSHS operates in rental facilities in all its regions. Service facilities are designed and renovated to be appropriate for their intended use with respect to patient safety.

Any shortcomings found by occupational health and safety officials, or by another party, are rectified together with the lessor. All facilities have been inspected by the local Regional State Administrative Agency. Inspection reports for facilities and equipment, signed by the chief medical officer or the chief dental officer of the local health centre, have been included in notifications relating to the commencement of activities as required under section 4 of the decree on private healthcare (1647/2009).

The waste arising from healthcare is managed in compliance with the relevant legislation. The Health Protection Act (763/1994) requires waste to be stored, transported and handled in such a way that it does not constitute a risk to health. Waste produced in patient care, especially risk waste and hazardous waste, is handled appropriately according to the general waste management guidelines and the waste management instructions of the service unit concerned. Cleaning is performed according to the cleaning instructions for the activity concerned, as stated in service descriptions. Instructions regarding cleaning, waste management and waste handling are presented in FSHS hygiene practices. The instructions will be updated in 2024).

FSHS complies with the requirements and obligations for medical devices and equipment set out in the Medical Devices Act (629/2010) and the Medical Devices Regulation (EU 2017/745).

FSHS managers responsible for healthcare services make sure that the devices used comply with the legal requirements and that they are maintained and used as instructed by the relevant manufacturers. FSHS service units have designated persons (Regional Medical Director and Regional Medical Director of Dentistry) whose job it is to report incidents and ensure compliance with the regulations governing devices and equipment. Supervisors are responsible for fulfilling the obligations of professional users at FSHS service units.

In compliance with the Act (629/2010) the FSHS has in place a monitoring system (IDR Device Register), into which all legally required information about the devices in use at the service units is documented. The Regional Head Nurses of the service units are in charge of the device register. To ensure the safety of devices and their use, the persons in charge track the devices and collect traceability data in the tracking system, which they also constantly keep up to date. Employees regularly check the condition of the devices in everyday use and report any issues as instructed. Scheduled maintenance is carried out to ensure all devices and equipment remain in good condition.

Users are trained in the use of new devices. Managers are responsible for organizing appropriate training and for recording this information in the FSHS device register for each particular device. Installations and services are documented in the service unit device register.

Hazardous incidents are reported via a reporting form in Majakka and are dealt with by the service unit concerned and approved by the FSHS. The necessary measures are taken based on the incident in question. In accordance with the Medical Devices Act (629/2010) the FSHS complies with the obligation to report incidents caused by medical devices or equipment to Fimea. The report is made using the incident report form on the Fimea website. Incidents can occur because of the type of the device or equipment concerned, the malfunction or deterioration in performance of the device or equipment, inadequate labelling, inadequate or incorrect operating instructions or incorrect use. Incident reports are submitted to the manufacturer of the device or equipment or to an authorised representative of the manufacturer, because primary responsibility for compliance lies with the manufacturer.

As an organization whose activities require a safety licence, the FSHS provides a written description of the management system for a radiation practice. The managers in charge of services, i.e. the Medical Director of Dentistry for oral health services and the Medical Director for other services, are responsible for the radiation safety licences and guidelines for the FSHS. In accordance with the Radiation Act (859/2018) the FSHS has appointed a radiation safety expert to be in charge of the use of radiation and who also serves as an expert on medical physics at the FSHS. In addition, the FSHS has designated persons in charge of radiation safety: a radiology nurse at the Töölö imaging examination unit and the Regional Medical Directors of Dentistry responsible for regional oral health services. Persons in charge of radiation safety have designated deputies.

An assessment of the safety of imaging practices at the FSHS was made on 6 March 2020 in line with the requirements of the Radiation Act. The assessment identifies the ways in which the practices can cause radiation exposure to employees and patients taking into account potential radiation safety issues. Under the Radiation Act, all exceptional situations and incidents associated with the use of radiation sources together with corrective measures are reported to the Radiation and Nuclear Safety Authority (STUK). Guidelines on preparing for exceptional situations in X-ray practices and on reporting radiation safety issues can be found on the FSHS intranet. Under the Radiation Act 859/2018, all issues and incidents associated with the use of radiation sources must also be reported to the Radiation and Nuclear Safety Authority (STUK) immediately in accordance with STUK guidelines. The Radiation Act requires that all incidents associated with the use of radiation sources must also be reported to the device manufacturer and to Fimea.

The regulations issued by the Radiation and Nuclear Safety Authority concerning the In-service Radiation Safety of Radiation Sources and the Decommissioning of Radiation Sources and Places of Use (STUK S/5/2019) have been taken into account in the FSHS’s oral health radiation practices. The compliance requirements for dental X-ray machines during use and the dental X-ray quality control programme for technical and operational quality control are met as stated in these regulations. In addition, quality control assessments are periodically conducted for individual employees and devices as part of the quality control programme. The findings regarding individual employees and devices are documented at each service unit. The condition of dental X-ray machines is checked during the annual maintenance procedures.

Procedures and past inspections at the Töölö imaging unit:
• Annual self-assessments
• Annual inspection by a physicist (previous in April 2022)
• Periodic STUK inspection (previous in September 2022)
• Internal audit every four years (previous in December 2022)
• External audit every eight years (next in 2024)
• Devices are serviced according to the annual maintenance contract.

The Radiation and Nuclear Safety Authority granted radiation safety licences as stipulated in the Radiation Act (859/2018) for the use of ionising radiation in healthcare to the FSHS service units in Kuopio, Lappeenranta, Oulu, Vaasa, Helsinki Töölö, Tampere Hervanta, Turku, Jyväskylä, Rovaniemi, Joensuu, Lahti, Mikkeli and Pori in 2020. In 2021 safety licences were granted to the service units in Hämeenlinna and Seinäjoki. Oral health services have been closed down in Mikkeli, and the safety licence was terminated in 2023.

The FSHS joined the National Archive of Imaging Data (Kvarkki) in 2022. All cone beam computed tomography images, panoramic images, cephalometric images, temporomandibular images, native X-ray images, sonograms and imaging consultations (referrals and opinions) are recorded in Kvarkki.

Laboratory operations have been outsourced to Synlab.

To meet the requirements of the Communicable Diseases Act (1227/2016), the Medical Director is responsible for infection prevention at the FSHS as the director in charge of healthcare services. The Medical Director of Dentistry is responsible for oral health hygiene practices as the director in charge of oral health services. The Regional Medical Directors and Regional Medical Directors of Dentistry are responsible for infection prevention at the service units. Supervisors are responsible for familiarization training for their personnel and for ensuring their professional competence. Healthcare professionals are responsible for their own actions and for maintaining their professional competence.

The relevant legislation, guidelines and responsibilities and hygiene plans for oral and other healthcare are set out in the FSHS’s hygiene plan, hygiene practice. Additionally, hygiene practice contains information about the procedures to be adopted in the case of accidents involving exposure to blood and for the prevention of such accidents, the usual precautions (hand hygiene, use of workwear and protective equipment, hygiene practices at work), daily procedures at the workplace, the use of surface disinfection agents, risk assessment for chemical agents, instrument cleaning processes and instructions, device validation practices, cleaning and waste management. Hygiene practices are designed to ensure the safety of all patient care situations. The FSHS’s operating and hygiene practices for exceptional situations are based on the current guidelines issued by the Ministry of Social Affairs and Health and the Finnish Institute for Health and Welfare for the protection of patients and personnel and the provision of services.

The FSHS has drawn up hygiene plans for patient work and instrument cleaning for each service unit. The persons in charge of daily infection prevention and their duties, including monitoring the implementation of practices, are documented in the hygiene plan. Instrument cleaning practices and processes and quality measures for oral healthcare are also documented and are in use at all units. They are assessed by each individual unit and/or through internal audits at all units. Self-assessment forms can be found in the FSHS’s hygiene and patient care practice: hygiene and care practice.

Patient ombudsperson

Wellbeing services counties are responsible for arranging the services of a patient ombudsperson. The wellbeing services county responsible for this is determined by the wellbeing services county in the area where the FSHS service is offered.


The duties of the patient ombudsperson include:

  • advising patients about issues governed by the Act on the Status and Rights of Patients (785/1992), later Patient Act
  • advising and, when needed, assisting the patient or their legal representative, family member or other close friend or relative on filing an objection as stated in section 10 of the Patient Act
  • advising the patient on how to make a complaint, request a correction, lodge an appeal, bring an action for damages, bring an action for damages regarding patient injury or pharmaceutical injury, or other issue related to the patient’s legal protection in healthcare with the competent authority
  • advising patients about their rights
  • collecting information about patient contacts and monitoring changes in the rights and status of patients
  • promoting and implementing patients’ rights in ways not mentioned in sections 1–5 above.


Each patient ombudsperson’s contact details are available from every service unit and on the FSHS website.

Pharmacotherapy

The FSHS has in place a pharmacotherapy plan and service unit pharmacotherapy plans (internal link) in accordance with the requirements set by the Ministry of Social Affairs and Health: Turvallinen lääkehoito -opas 2021:6 [”Safe Medicinal Treatment – A Guide”]. The directors responsible for healthcare services approve the pharmacotherapy plan for the FSHS and those for the service units. They are in charge of the foundation’s processes relating to pharmacotherapy and pharmaceutical services, ensuring they are up to date and compliant with the legal requirements. The service units’ pharmacotherapy plans are based on the FSHS’s pharmacotherapy plan. The Regional Medical Director or Regional Medical Director of Dentistry, who are the doctors responsible for pharmacotherapy, is in charge of planning, organization, allocation of duties and the proper functioning of pharmaceutical services in the service unit in accordance with the service unit’s pharmacotherapy plan. Supervisors guide and monitor pharmacotherapy, ensuring it is provided according to the pharmacotherapy plan. The foundation’s pharmacotherapy plan and the service units’ pharmacotherapy plans are updated when necessary, at least once a year. The medicines used within the FSHS are described in FSHS basic medicines.

The dentists, oral hygienists, and dental nurses/practical nurses who provide oral health services are involved in pharmacotherapy. This includes prescribing, dosing and administering medicines to patients, as well as guidance and monitoring of the effects of medication. The most common form of pharmacotherapy in oral health services is the injection of medicinal agents (anaesthetics), which is carried out by dentists and those oral hygienists who have completed additional training. Medicines which are administered via natural routes (tablets and solutions) are also used. In other healthcare services, general practitioners, nurses, public health nurses and practical nurses are involved in pharmacotherapy. Pharmacotherapy includes prescribing, dosing and administering medicines to patients, as well as guidance and monitoring of the effects of medication. Forms of pharmacotherapy include vaccines (PO, IM, SC, ID), injections (IM, SC, ventrogluteal) and medicines which are administered via natural routes: tablets, eye drops, creams, solutions and analgesics.
Employees are required to undergo both basic and further training to ensure their pharmacotherapy competence. Nursing staff complete further training in pharmacotherapy and are required to demonstrate their professional competence once every five years. Pharmacotherapy licences are approved by the doctor responsible for pharmacotherapy (Regional Medical Director/Regional Medical Director of Dentistry). The licence is valid at the FSHS.

Employees are required to undergo both basic and further training to ensure their pharmacotherapy competence. Nursing staff complete further training in pharmacotherapy and are required to demonstrate their professional competence once every five years. Pharmacotherapy licences are approved by the doctor responsible for pharmacotherapy (Regional Medical Director/Regional Medical Director of Dentistry). The licence is valid at the FSHS.

Incidents relating to pharmacotherapy may be near misses or adverse events. Service units make every effort to identify and anticipate the possibility of errors or such incidents in pharmacotherapy. Service units have operating models for different situations and incident prevention. These operating models are regularly reviewed with the personnel and included in workplace orientation. All service units are fully prepared for situations requiring first aid. The first aid preparedness and competence of the personnel are maintained on a regular basis. Immediate action is always taken to secure patient safety when an error or an incident occurs. Clear instructions for dealing with first aid situations and incidents, together with emergency medicines, are always readily available at all service units.

An employee reports any pharmacotherapy-related incident or error that has occurred by filing an incident report in the FSHS system Majakka. Incidents are also reported to the patient and to the supervisor. Supervisors are responsible for processing incident reports with the Regional Director or at a management meeting and, where necessary, procedures are improved to avoid similar incidents in the future. All incidents are regularly processed by the quality control team and operations are improved as a result. Summaries of incidents are presented twice a year in a quality review by the management and administration. Any adverse effects attributable to medication are reported to the Finnish Medicines Agency (Fimea); this also applies to vaccines and vaccinations.

The consumption and expenditure on medicines are monitored for each unit and for the FSHS as a whole. The use of CNS agents is monitored by the FSHS using package-specific consumption cards on which the information needed for monitoring is marked. Consumption cards for CNS agents are archived in the service unit for six years after the calendar year in question. When a medicine has been used up, any measuring losses are marked on the consumption card. Medicine consumption is monitored monthly from the CNS agent consumption cards by the nurse responsible and the Regional Head Nurse or the oral hygienist responsible at the service unit. When the medicine has been used up, the Regional Medical Director/Regional Medical Director of Dentistry responsible for pharmacotherapy signs the consumption card. Any issues are reported to the Medical Director or the Medical Director of Dentistry.

Identifying risks and shortcomings, and corrective measures

The management of the FSHS is in charge of the overall organization of risk management and safety. Directors in charge of services, Regional Directors and supervisors are charged, in line with their responsibilities, with ensuring that conditions in the service units enable safe working and customer service and safe, good quality patient care. Risk management is practised at all levels of the organization by all employees in their designated roles. The management and personnel are familiar with the key legislation, guidelines, rules, and policies regarding their work. Key processes are described in the Majakka system.

The FSHS complies with the requirements stated in the Government Decree on Chemical Agents at Work (715/2001). Possible hazards caused by chemical agents at work and the related health and safety risks for employees have been identified by the FSHS. Chemical risk assessment is carried out at FSHS units annually as part of other work-related risk assessment. Based on these assessments, improvement plans are made, and actions taken accordingly. Safety data sheets for the chemical agents used are available for the personnel either in digital format or in written format at the service units. Suppliers are required to provide safety data sheets when chemical agents are purchased. The chemical agents contained in the products used are listed in FSHS chemical agents list. Lists of chemical agents were updated at the service units during 2023. An assessment form has been introduced for the assessment of biological hazards. Biological hazards are categorised on the form according to the classification by the Ministry of Social Affairs and Health (decree on the classification of biological agents, 748/2020).

All employees and trainees at FSHS can make an incident report about any safety issue they have noticed that has caused or could have caused harm to a patient or an employee. The primary goal in the processing of incident reports is to improve operations and to learn from mistakes in order to avoid similar incidents in the future.

Reports on near misses and incidents regarding patient safety and employee safety, as well as suggestions for improvements are submitted using the near miss and adverse event notification form in Majakka. Issues relating to data protection are reported via the data protection notification form in Majakka.

Regional supervisors or the Regional Medical Director process the reports and make improvements wherever necessary. Reports on near misses and adverse events are approved by the FSHS administration, and guidelines are updated when necessary. The number of issues relating to quality and patient safety, objections, complaints and data protection issues is monitored monthly and submitted to Kela (the Social Insurance Institution of Finland). They are also discussed regularly at quality team meetings and actions are taken whenever necessary. This information is presented in the quality review to the foundation’s management and administration twice a year.

Patient documents and handling of personal data

The FSHS is obliged to keep patient documents in accordance with section 16 of the Act on Health Care Professionals, and section 12 of the Act on the Status and Rights of Patients (785/1992, Patient Act). In compliance with the legislation, FSHS professionals document the information needed to organize, plan, implement and monitor patient care.

The FSHS keeps digital patient documents using Acute-WinHit, a system provided by Vitec Acute Oy and InNet Oy. The FSHS is regularly in contact with the system providers. Patient documents are transferred to the Kanta archive from all services.

The director responsible for healthcare services has produced written instructions regarding the processing of information included in patient documents and related policies in accordance with the Decree on Patient Documents (298/2009). Patient documents constitute a single, shared, and up-to-date patient document register as specified in the European General Data Protection Regulation, GDPR (2016/679).

The obligation to inform, which is required in the GDPR, is met using the Data protection statements on the FSHS website. The FSHS carries out technical and organizational measures to comply with the regulation. These measures are documented, and also apply to outsourced processing of personal data.

The data security team appointed by the Managing Director produces the data security and data protection principles and guidelines for the FSHS. The data security team ensures that the different areas of data security are up to date and processes data security principles and guidelines before they are processed by the management team. Data security team meetings are held every two weeks.

The person responsible for data security at the FSHS is IT Manager Sauli Kleemola, who is also chairman of the data security team. As required in the The Act on the Processing of Client Data in Healthcare and Social Welfare (703/2023) and the European General Data Protection Regulation (2016/679, article 37) persons responsible for data protection are Chief Medical Officer of Digital Health Services Aleksi Schrey and dentist Marjo Tipuri. Persons responsible for data protection can be contacted via email YTHS.tietosuojavastaava@yths.fi or by using the ’Contact the person responsible for data protection’ form, which requires strong identification.

Information regarding data security and data protection at FSHS is documented in a separate data security plan (according to Act 703/2023), which is updated by the data security team annually and when important changes have been made. A list of systems containing patient data and currently in use is attached to the data security plan. Information management is responsible for updating the list.

The data security plan is designed to ensure that the service provider’s personnel master the use of the data processing systems being used and know how to take account of the requirements regarding client and patient data confidentiality and data protection. Matters relating to the operating environment, maintenance and updates of the patient information system are also considered in the data security plan.

All information produced by or stored in the FSHS’s data systems must comply with the basic requirements for secure data systems. These requirements include the reliability, availability, constancy and indisputability of data. The foundation’s main systems have been built in such a way that the data generated is stored on servers. Critical patient or administrative information is not permanently stored on workstations.

In problem situations, such as data communication failures or device malfunctions, users are provided with instructions for the particular system concerned. The main principle is that operations are not interrupted by error situations and that work can continue with temporary arrangements. Once the issue is resolved, data from the interruption is stored in the main systems in accordance with the guidelines for the system concerned. The FSHS has specific instructions for processes and communication in error situations.

There is a specified response time for all systems and technical devices during which they should be back up and running. Systems and devices are classified according to how critical they are to the foundation’s operations, and the response times for device maintenance are set accordingly.

To ensure the safety of the FSHS’s internal network, servers, systems and workstations, communications between facilities is outsourced, the operator being contracted to take charge of maintenance, service and monitoring. Devices should not be connected to the internal network without permission from the data management unit. The foundation servers are located in locked facilities, and the locations and data security of the outsourced servers are based on specific agreements. The right to access the operating system is limited to the administrative personnel. Servers and systems are checked regularly. In addition to hard disk encryption, all workstations have data protection software against viruses and spyware.

System administration rights are limited to the main users, who have the professional expertise required to maintain, install and update the data systems. The data systems are maintained and updated according to the manufacturer’s instructions. Integration interfaces and software connected to the data systems are audited to ensure that they do not compromise the data systems’ performance or data security and data protection. Usernames and passwords are required for the use of all foundation data systems and workstations. The interface between the foundation’s internal network and all external networks (e.g. Internet) is controlled by outsourced services like firewalls and by monitoring communications, scanning communications for viruses, spam filtering and strong digital identification. The operating environment is suitable for using the data systems in an appropriate way that ensures data security and data protection.

The supervisor is responsible for taking care of the access rights for data systems at the beginning or at the end of the employment contract, as well as when changes are needed. The access rights to the patient data systems for each user group are defined according to the basic principles approved by the directors responsible for healthcare services. At the beginning of an employment contract, the regional director can, if necessary, ask the head of data management to grant extended system access rights. The extended access rights granted at the request of the manager are cancelled when no longer needed. Usernames for data systems are granted for the applications needed for specific tasks with an access form approved and signed by the supervisor. The contracting partner is responsible for keeping usernames.

Data in the patient data systems and administrative systems is backed up daily by means of separate verification systems. The procedures involved include a separately agreed securing cycle and instructions. The backup data is copied into permanent storage at regular intervals. The verification principles are the same for both outsourced and internally maintained systems. The content produced by users outside the systems is stored in the users’ own file directories, which are backed up daily by means of a safety system. Users’ workstations are not secured. Workstation security is the user’s responsibility if they store data on the workstation. Data systems are acquired and introduced in conjunction with the data management unit. All data systems in which centralised personal data is collected require administration of the registry.

Since the implementation of GDPR, the FSHS has kept a privacy notice for handling personal data. The notice includes the protocols for sharing and deleting data, and the technical and organizational safety protocols for protecting the registry.

All persons using a workstation must familiarise themselves with the FSHS data safety policy and sign a user and confidentiality agreement. Computers and all individual systems containing personal data require usernames and passwords.

The FSHS offers workplace orientation and additional training to ensure that system users have the training and skills required to use the systems, and that the systems are used according to the manufacturer’s instructions. Instructions needed for the use of data systems can be found in the patient data system and in the FSHS Academy guidelines. FSHS operating instructions are available for the personnel in the intranet. The data security team updates the FSHS data security guidelines regularly.

The persons responsible for data protection are Aleksi Schrey (Chief Medical Officer, Digital Services, Kirkkotie 13, 20540 Turku) and Marjo Tipuri (dentist, Korkeakoulunkatu 6, 33720 Tampere). The persons responsible for data protection can be contacted via e-mail at YTHS.tietosuojavastaava[at]yths.fi or by using the Contact the person responsible for data protection form, which requires strong identification.

Strengthening patient paticipation and handling objections

It is the policy of the FSHS to care for patients in an atmosphere of mutual understanding. Patients are given comprehensible information about their health, treatment and the related risks. Patients are involved in planning and implementing their treatment.

Patients have an opportunity to give immediate feedback during their contact with the service. They can also contact the person responsible for their treatment through the Self service. FSHS clients can use a feedback form available at yths.fi either using their ID or anonymously. The feedback is directed to the respective service unit and there will be a response if the contact details are included. Feedback that meets the criteria for objection will be dealt with as such.

In addition to giving feedback, patients have the right to file an objection addressed to the directors responsible for healthcare services in accordance with section 10 of the Act on the Status and Rights of Patients (785/1992). The instructions and form for filing an objection are available on the FSHS website. The form should be printed out, signed and sent to the directors responsible for healthcare services. They will then request a written report regarding the objection from the doctor or dentist in charge at the respective service unit. The patient will receive a written response to their objection, usually within a month of filing the objection. Objections and responses are archived. The partners providing services under subcontracts have clear internal procedures for monitoring issues and for processing objections, complaints and patient injuries.

Complaints regarding the work of healthcare professionals and service providers will be processed by that level of the FSHS organization concerned. In cases of patient injury or suspected patient injury, the patient will be instructed to make an official notice of patient injury to the Patient Insurance Centre. Patients will also be instructed to contact the Patient ombudsperson if they need further advice or help. FSHS personnel will also assist the patient if necessary. All filed objections, complaints and suspected patient injuries are handled at meetings of the quality team.

Operations are improved based on the feedback, objections and complaints received. All feedback is dealt with regularly by the regional management team for the service unit concerned. Once a year, all feedback is dealt with by the service regions’ management teams and management groups, and by the FSHS Management Team, Board of Trustees and Council. If needed, the feedback will also be discussed with the employee in question and/or at the respective service unit. If necessary, immediate action will be taken and improvements made based on the feedback. More wide-ranging issues needing improvement are incorporated in the annual plans for the FSHS and the service units, and the implementation of these improvements is monitored regularly and systematically.

Monitoring and assessing self-supervision

Self-supervision is a means of improving the quality of patient care and the legal protection of the patients. At the FSHS, the purpose of self-supervision is to ensure that the patient gets safe, good quality healthcare services. Self-supervision at the FSHS is implemented according to specific operational and procedural guidelines. The self-supervision procedures for preventing and correcting risks, incidents, and quality-related issues and for ensuring the professional competence of healthcare professionals are described in the FSHS self-supervision plan. Our operations are guided by self-supervision and its monitoring, assessment, and improvement.

The directors responsible for FSHS healthcare services will ensure that the self-supervision plan is kept up to date. The self-supervision plans for both the FSHS and its service units are revised and updated annually. The self-supervision plans are approved annually, even if there are no changes. Any changes in the guidelines for FSHS operations will be incorporated in the self-supervision plan with immediate effect and the personnel informed of this.

15.12.2023 Helsinki
Place and date

The self-supervision plan is approved and ratified by the director responsible for healthcare services.

Teija Kulmala