Adverse Events

1. Scope of the procedure
   1. The procedure applies to BiaVita Polska S.A. in Białystok - Augustów Health Resort Sanatorium, ul. Zdrojowa 3/5/7, 16-300 Augustów.
   2. The procedure concerns reporting adverse events that may occur during the provision of health care services.
2. Purpose of the procedure

The procedure for reporting adverse events occurring during the provision of health care services at BiaVita Polska S.A. in Białystok - Augustów Health Resort Sanatorium is one of the elements of the internal quality and safety management system. The purpose of the procedure is:

1. Monitoring of adverse events.
2. Standardizing the principles of reporting adverse events.
3. Defining the rules for conducting root cause analysis of adverse events.
4. Identifying the risk of occurrence of adverse events and managing this risk within the provided health care services.
5. Preparing recommendations for corrective actions aimed at preventing future recurrence of similar adverse events.

3. Key concepts

Adverse event – an event occurring during or as a result of the provision or omission of a health care service, causing or potentially causing a negative effect on the patient’s health or life, especially death, health impairment or disorder, disease, life threat, need for hospitalization or extension thereof, as well as physical injury or health disorder of the fetus; an event whose effect is a predictable result of correctly provided health care service does not constitute an adverse event. Adverse events should not be confused with the natural progression of disease or predictable therapeutic complications.

Risk - combination of the probability of occurrence of an event and its consequence. Clinical risk management is a key element in the quality management system (PN-EN ISO 15224:2013 – Health care services – Quality management systems).

Risk assessment - ensures that the probability of someone being injured or falling ill due to hazards in the workplace is at the lowest possible level. The most important is determining how significant hazards are present in the workplace and whether they are prevented with appropriate and sufficient remedial measures.

Interface - point of contact between a human and a machine/device. A proper interface should ensure error-free information reception without the possibility of mistake and performing actions in an unequivocally correct manner.

Reporting and Learning System (RLS) - a system for reporting and learning. The reporting system should be voluntary and confidential; it can be an independent system or integrated with systems for complaints, suggestions, or patient claims registration.

Safety Assessment Code (SAC) - safety assessment code matrix.

Root cause analysis - a process of explaining the causes of occurrence of an adverse event and the circumstances that may have influenced its occurrence.

4. Types of adverse events
   1. Concerning medical devices, equipment (informational and operational interfaces):
      1. lack of regular technical inspections,
      2. lack/restriction of equipment availability,
      3. equipment failure,
      4. illegible device panel,
      5. non-ergonomic layout of buttons or handles of medical equipment,
      6. body injury resulting from faulty operation/use of equipment,
      7. others.
   2. Concerning the organization of medical staff work:
      1. improper classification for the procedure,
      2. wrong identification of treatment site or operated limb,
      3. incorrect dose given during physiotherapy procedure,
      4. conducting a series of physiotherapy treatments in the wrong order (not in accordance with the canon of physiotherapy),
      5. body injury due to incorrect or improperly applied physiotherapeutic procedure,
      6. failure to detect venous thromboembolic disease (deep vein thrombosis) before starting physiotherapy treatments and procedures,
      7. others.
   3. Related to treatment and pharmacology:
      1. incorrect diagnosis due to:
         • misinterpretation of laboratory test results,
         • incorrect description of radiological exams,
         • incorrect description of histopathological exam,
      2. ordering an improper procedure,
      3. injury or stabbing of patient or staff with sharp instruments during a procedure, which may lead to bloodborne pathogen infection and subsequently infectious and invasive disease,
      4. incorrect performance of a medical procedure,
      5. body injury resulting from a medical procedure,
      6. medication errors, including:
         • administration of incorrect medication,
         • incorrect drug dosage determination,
         • misidentifying the patient,
         • incorrect timing of medication administration,
         • unjustified delay in medication administration,
         • incorrect route of administration,
         • incorrect drug preparation method (e.g. wrong solvent),
         • events related to medication expiry,
      7. others.
   4. Related to patient care:
      1. incorrect patient identification,
      2. incorrect procedure identification,
      3. failure or delay in providing care,
      4. bedsores caused by neglecting care,
      5. catheter-related bloodstream infection,
      6. sanatorium infection,
      7. sepsis,
      8. food poisoning,
      9. anaphylactic shock related to allergy,
      10. others.
   5. Related to unexpected events:
      1. suicide attempt,
      2. suicide,
      3. patient fall in the facility,
      4. patient unauthorized departure from the Sanatorium,
      5. patient use of intoxicants and narcotics,
      6. patient death,
      7. drowning or near-drowning,
      8. others.
   6. Related to non-compliance with procedures:
      1. performing a procedure without the patient's signed informed consent,
      2. disclosure of medical information to unauthorized persons,
      3. others.
   7. Concerning work organization and management (standardization):
      1. lack of standardization of devices, terminology, procedures, installations,
      2. allowing unqualified persons (without the right to perform a medical profession) to work,
      3. incorrect patient identification, lack of clear identifiers,
      4. insufficient staffing,
      5. low quality of staff selection,
      6. improper work planning (overtime, night shifts, shift work, allowing an employee to work in multiple places without daily rest),
      7. inability to implement teamwork,
      8. inadequate communication,
      9. others.
5. Responsibility:

1. Based on the Act of 16 June 2023 on quality in health care and patient safety Dz.U. 2023 item 1692 (Art. 19.1), the person responsible for conducting the internal system is the Head of the entity performing medical activities within the meaning of Art. 2 sec. 2 point 1 of the Act of 15 April 2011 on medical activity, hereinafter referred to as "person responsible".
2. The responsibilities of the person responsible include:
   1. conducting root cause analysis of adverse events,
   2. providing resources and information necessary for proper monitoring of quality and safety of provided health care services,
   3. developing internal quality and safety management system documents defining: principles, procedures, methods, and job descriptions as referred to in Art. 18 sec. 1 of the Act of 16 June 2023 on quality in health care and patient safety Dz.U. 2023 item 1692.

6. Reporting an adverse event

The purpose of reporting adverse events is to improve the safety of health services through identifying situations and circumstances that pose threats to patients and taking actions aimed at preventing or controlling those threats. Implementing such solutions allows for the elimination or reduction of adverse events occurrence in the future and subjecting them to in-depth analysis.

The personnel of the entity performing medical activities should be aware of the responsibility associated with proper identification and reporting all adverse events that occurred in the entity to the person responsible, regardless of their severity and likelihood of recurrence.

1. An adverse event may be reported by:
   1. medical and non-medical staff immediately after occurrence or detection of an adverse event,
   2. witnesses of the adverse event,
   3. patients, patient’s families, caregivers,
2. Reporting method:
   1. direct verbal report to a person authorized by the Head of the Entity to handle adverse events. The authorized person is obliged to fill out the adverse event report form (attachment no. 1) or provide such form to the reporting person for completion.
   2. on a paper adverse event report form (attachment no. 1) available at the main reception of Augustów Health Resort Sanatorium or downloadable from the website www.sanatorium.augustow.pl
   3. completed paper adverse event report forms (attachment no. 1) are collected in a specially prepared box located at the main reception of Augustów Health Resort Sanatorium or sent by post to the address:

Augustów Health Resort Sanatorium ul. Zdrojowa 3/5/7, 16-300 Augustów

4. sending information about the adverse event to the e-mail address: zn@biavita.pl, the authorized person in response will send the reporting person the adverse event report form (attachment no. 1) asking for its completion.

7. Procedure

Reporting and Learning System (RLS) - reporting and learning system. According to RLS, the approach to safety and quality in health care is based on systemic risk identification (i.e. at every stage of health care provision), which patients are exposed to, risk reduction, and improving patient outcomes through risk management systems implementation.

1. Reporting the adverse event.
2. Registration and collection of detailed data and information about the event.
3. Mapping of data and information about events.
4. Identification and classification of adverse events based on report forms.
5. Root cause analysis.
6. Determining the root causes of the event and drawing conclusions.
7. Recommendations and report.
8. Communication of information to medical staff and other employees.

RLS is not intended for identifying and stigmatizing individuals involved in the event. The system should be confidential and voluntary. Principles of RLS operation:

1. The data of the event reporter should remain exclusively with the person responsible for reporting; the reporter can also remain completely anonymous, without disclosing their data.
2. Reporting adverse events should aim at finding corrective actions, without personalization and blaming individuals.
3. Reporting, root cause analysis, event assessment, and classification cannot be grounds for disciplinary liability, liability for damages caused by reporting, or liability for violation of rights or obligations defined by law.
4. The person authorized by the Head of the Entity, after receiving an adverse event report, registers the report, collects information about its circumstances and participants, conducts a preliminary analysis, formulates conclusions, and notifies the Head of the Entity.
5. Based on the report, conclusions are drawn and recommendations made for specific actions to prevent recurrence of irregularities.
6. Conclusions are drawn without assigning blame. The report is approved by the Head of the Entity.

8. Root cause analysis

Root cause analysis is a process of explaining the causes of an adverse event and the circumstances that could have influenced its occurrence. Root cause analysis does not involve assessing fault or responsibility of persons involved in the adverse event.

The purpose of root cause analysis is to:

1. collect information about identified causes and circumstances of the adverse event, participants in the event, and its consequences for them;
2. analyze the information mentioned in item 1 and formulate conclusions based on it;
3. formulate recommendations for actions to improve the quality and safety of health care services aimed at preventing recurrence of the adverse event.

9. Risk identification

Adverse events are classified into one of the risk categories related to quality and safety based on the Safety Assessment Code (SAC) matrix:

Figure 1 Safety Assessment Code (SAC) matrix

The risk category for a given adverse event is determined according to a point scale:

1. 3 points - high risk - adverse event meeting the criteria of very severe and severe and frequent events according to criteria and probability assessment,
2. 2 points - medium risk - severe and sporadic or rare or very rare adverse events and moderate and frequent events,
3. 1 point - low risk - moderate and sporadic or rare or very rare adverse events and mild events.

Adverse events are assessed in terms of severity according to the following criteria:

1. a very severe event includes:
   1. death or
   2. significant and permanent injury or health disorder resulting in loss or impairment of sensory, motor, physiological, or intellectual function, unrelated to conditions underlying health care provision or patient’s condition;
2. a severe event includes:
   1. significant injury or health disorder causing temporary limitation of sensory, motor, physiological, or intellectual function unrelated to underlying condition or patient’s state or
   2. transfer to intensive care unit, dialysis unit, or intensive monitoring ward, or
   3. necessity of surgical intervention;
3. a moderate event includes:
   1. prolonged stay in the medical facility or
   2. deterioration of patient’s condition requiring transfer to a higher level of care;
4. a mild event includes events other than those specified in points 1-3 that do not cause health impairment.

Adverse events are assessed according to the likelihood of occurrence as:

1. frequent – event likely to occur several times a year,
2. sporadic – event likely to occur once or twice a year,
3. rare – possible the event will occur once every two years,
4. very rare – very low probability of occurrence, less than once every two years.

10. Risk analysis and management

Figure 2 Four-stage risk management procedure

Risk analysis is developed based on root cause analysis using the received adverse event report forms.

Forms may be received at the medical facility:

1. on a paper form placed at the main reception of the Sanatorium or
2. using a form downloaded from the website and sent by post to the address: Sanatorium Augustów Health Resort Sanatorium ul. Zdrojowa 3/5/7, 16-300 Augustów or
3. sent in response to the report by e-mail to zn@biavita.pl.

11. Person responsible for adverse events at Augustów Health Resort Sanatorium

The Head of the Entity authorizes Dr. Paweł Karaś as the person responsible for handling adverse events.

12. Attachments

• Adverse events reporting form - Download file
• Procedure for reporting adverse events - Download file