A brief analysis of the Healthcare Quality and Patient Safety Act

What quality, how much security?

In July 2021, the Minister of Health sent the long-awaited draft of the Law on quality in health care and patient safety. The draft, together with the explanatory memorandum and the Regulatory Impact Assessment, is available on the website of the Government Legislation Centre. Without prejudging the final shape of the Act, it is worth tracing its key assumptions and proposed solutions.

The aim of the project is to implement legal solutions that address health policy priorities in the area of quality and safety in a comprehensive and coordinated manner.

The law will define the tasks, responsibilities and powers of the various entities in monitoring, evaluating and improving the quality of the provision of health care. The new regulation is intended to ensure that patients, medical professionals and healthcare providers have access to widespread, reliable, objective and comparable information on the quality of care provided.

Main changes

The Act introduces a new concept: "quality system in health care and patient safety"..

This system will consist of elements regulated in detail by law:

• authorisation;
• internal quality and safety assurance system;
• accreditation;
• compensation scheme;
• medical records.

This is a change in the current approach: quality in healthcare is to be defined and measured by indicators relating to the clinical, consumer and management areas. Moreover, data from the healthcare quality system will be able to be used by the National Health Fund to financially motivate the providers of publicly funded healthcare services to improve quality levels. The principles and mode of monitoring the quality of publicly funded healthcare services will be regulated in a regulation.

Quality and safety assurance system

One of the project's key features is the introduction of an obligation for hospitals to maintain an internal quality and safety assurance system. Managers of healthcare entities will therefore be responsible for developing, implementing, maintaining and improving such a system on the basis of an evaluation of its effectiveness and the results of surveys of patients' opinions and experiences.

As part of the above, the hospital will:

• implement solutions to identify and manage risks in the health services provided;
• identify the criteria and methods needed to ensure effective oversight of the quality and safety of services;
• provide the necessary means for proper monitoring of the quality and safety of the services, periodically monitoring and evaluating them and carrying out the necessary actions to improve them;
• develop so-called standard operating procedures, monitor compliance with them and implement the conclusions of non-compliance analyses;
• keep records of adverse events reported by staff, analyse them systematically and implement the resulting conclusions in order to prevent future adverse events;
• identify priority areas for quality and safety improvement and implement the actions needed to improve them;
• provide the training necessary to obtain and improve the quality and safety competence of personnel;
• conduct opinion and experience surveys based on questionnaires completed by patients after hospitalisation;
• produce and publish a quality report on an annual basis, including information on, inter alia, the number of non-compliances and adverse events reported and the lessons learned from the analyses carried out, as well as the results of surveys on patient opinion and experience.

Adverse event reports are to be made through an ICT system developed and provided by the National Health Fund. Personal data from the reports will be anonymised. The Fund will have access to the reports and root cause analyses, on the basis of which it will develop and publish analyses, reports and safety recommendations.

Authorisation

Significant issues included in the bill also include authorisation and accreditation of healthcare entities, granted by the NFZ in the form of an administrative decision. Obligatory authorisation will concern entities providing hospital services financed from public funds. Without its obtaining, the entity will lose the possibility of concluding a contract with the NFZ. The condition for granting the authorisation will be the fulfilment of criteria concerning the internal quality and safety assurance system and the conditions for the provision of healthcare services relating to the scope of treatment activity of the given provider. The authorisation will be valid for a period of 5 years.

Accreditation

On the other hand, accreditation, which is a voluntary system of external assessment of healthcare quality and patient safety, will serve to confirm compliance with accreditation standards, developed by the President of the NFZ in cooperation with the Accreditation Council for individual scopes of medical activity. These standards will refer to such thematic sections as e.g. patient needs, safety, effectiveness and quality of care, medical information or patient rights. The degree to which the accreditation standards are met will be assessed on a point scale. As part of the assessment procedure, an accreditation review will be carried out by an inspector - a person who meets certain knowledge and experience requirements and is included in a list based on an open and competitive call. The Accreditation Council will then make a recommendation to grant or refuse accreditation. In turn, the decision on accreditation will be issued by the President of the NFZ for a period of four years in the form of an accreditation certificate.

Registers

In addition, the draft law provides for the strengthening of supervision over the keeping of medical registers and the clarification of the rules for their creation and financing. This includes the establishment of a Medical Registers Council at the Minister of Health, the possibility of the NFZ providing a targeted subsidy for tasks related to medical registers, extending the scope of entities authorised to maintain registers to include scientific societies, clarifying the material scope of data processed in registers and extending the catalogue of purposes for processing data from registers. In addition, the draft provides for universal access to data from medical registers by obliging the entities maintaining them to make some of the data available and to develop and publish reports based on data from the registers at least once a year.

New damage compensation model

An extremely important element of the proposed regulation is the extensive amendments to the Act on Patients' Rights and Patients' Rights Ombudsman providing for the creation of a new model of extrajudicial compensation of damages resulting from medical incidents occurring in hospitals. In this respect, the provincial commissions for adjudicating medical events, which had been operating since 2012, but which proved ineffective and, unfortunately, did not fulfil the hopes placed in them, will be extinguished.

In light of the project, the following will be created Medical Incident Compensation Fundwhich will be administered by the Patient Ombudsman. This fund will be financed, inter alia, by a levy on health contributions. The fund will be used to provide compensation to injured patients and, in the event of the death of a patient due to a medical event, the next of kin will be entitled to compensation. A medical event is defined as an adverse event resulting in infection of a patient with a biological pathogen, insofar as this could have been avoided, or in bodily injury, disorder of health or death of a patient, insofar as this could have been, with a high degree of probability, the consequence of incorrect or delayed diagnosis, treatment contrary to current medical knowledge or without due diligence, incorrect use of a medicinal product or defect in or incorrect use of a medical device. The amount of the compensation benefit will range from PLN 2,000 to PLN 200,000 for the patient, and from PLN 20,000 to 100,000 for each of the entitled persons closest to the deceased. The detailed scope and conditions for determining the amount of the benefit will be set out in a regulation.

Applications for compensation benefits will be considered by the Patient Ombudsman. They will be subject to a fee of PLN 300, with indigent persons being able to be exempted from this fee. The application will have to be submitted within one year of the date on which the applicant became aware of the medical event, but no later than three years from the date on which the event occurred. The Ombudsman will make a model application for the benefit available on its website and it can be submitted in traditional or electronic form.

The Ombudsman will collect the necessary documentation, including, if necessary, requests for information, explanations and documents in the possession of the healthcare provider concerned. The material will then be forwarded to the Ombudsman's Medical Compensation Fund Compensation Panel, which is composed of experts who are called upon to give medical opinions. The Ombudsman will then issue an administrative decision on whether to grant the compensation benefit and determine its amount or to refuse it within 3 months of receiving a complete application. A patient who has suffered serious health consequences as a result of a medical event will additionally be entitled to use healthcare services and pharmaceutical services out of turn, as well as the assistance of treatment coordinators operating within the NFZ.

The applicant will have the right to appeal against the decision, which will be considered by a special Appeals Board, consisting of 9 members appointed by the Minister of Health from among representatives of various institutions and circles (including two representatives of social organisations for patient rights). A person still dissatisfied with the way the application has been handled will have the right to complain to the administrative court.

We already know that many stakeholders and organisations have prepared and published their comments and positions on the draft law. Now will be the time to analyse them and, if necessary, make changes in relation to the initial draft. The aim of this text, however, is to trace and highlight the most important changes brought about by this important and in many respects revolutionary draft - also in terms of patient rights and safety. There is much to talk about - it is certain that the discussion and analysis will continue. I myself am curious about the final shape of the bill.

Material for the Institute for Patients' Rights and Health Education was prepared by the Jakub Gołąb, Director of Social Dialogue and Communication Department of the Patient Ombudsman, as part of the 'Network for Health' project.

The Network for Health project is implemented with a grant from the Active Citizens Programme - National Fund financed by Iceland, Liechtenstein and Norway through the EEA Funds..