Healthcare Quality Act: Consider the Dutch experience | In Principle

The proposed changes in healthcare in Poland would not only impose new obligations of healthcare providers, but also seek to raise the quality and safety of medical services. Periodic external audits and mandatory reporting of adverse events are to be introduced. This represents an organisational change, but also a cultural one. Every hospital employee would have to be aware of their responsibility towards patients, and all processes would be designed to focus on the patient. The idea of a patient-centred system has been discussed in Poland many times, but not even a uniform definition or principles for such an approach have been adopted to date. It is worth taking a look at how others are doing it.

The COVID-19 pandemic has focused attention on medical facilities, medical practitioners, the quality of healthcare, and patient safety. The pandemic has raised questions about whether services of adequate quality are being delivered, and whether the safety to all stakeholders, especially patients, is being protected.

On 22 July 2021, a bill entitled the Act on Healthcare Quality and Patient Safety was published on the website of the Government Legislation Centre. The bill is designed to improve the standards of healthcare services and increase control over situations occurring in medical facilities. The bill would implement legal and organisational solutions aimed at helping achieve established health policy priorities, specifically in the area of quality.

Authorisation of healthcare entities

The main change is to be the introduction of a requirement for authorisation of entities performing medical activity. Authorisation would be obligatory for entities delivering hospital care. Hospitals are to be subject to greater scrutiny in the provision of publicly funded healthcare services.

According to the bill, the directors of the province branches of the National Health Fund would issue authorisation to healthcare entities, upon application, in the form of an administrative decision valid for 5 years. The decision would be administratively final, but in case of issuance of a negative decision or withdrawal of a decision granting authorisation, the hospital could seek review by the administrative court.

The proposed procedure has been met with criticism, as pursuant to Art. 14 of the bill, another application for authorisation could not be submitted until a year after the decision refusing to grant authorisation becomes legally final and non-appealable. That would prolong the period during which a healthcare facility would be ineligible for public funding of healthcare services.

Quality and safety assurance

A quality and safety assurance system consisting of two levels—internal and external—is proposed to help assess whether an entity should obtain authorisation.

The internal system would be run by healthcare entities themselves. The person in charge of a healthcare entity would be responsible for management of the system, with tasks to include:

• Appointment of the person responsible for conducting the internal quality and safety assurance system
• Development of standard operating procedures
• Implementation of solutions to identify and manage health risks
• Monitoring of non-compliance with standard operating procedures.

The list of obligations is longer, and great importance is attached to the monitoring of adverse events. This is intended to reduce the number of adverse events, which should also help in the assessment for purposes of authorisation.

Register of adverse events

Healthcare entities would have to maintain a register of adverse events, identify them and, above all, report such events. The personnel of the healthcare entity would be bound to report non-compliance with standard operating procedures and adverse events to the head of the healthcare entity (reports to be made anonymously). In turn, the manager of the healthcare entity would be responsible for reporting them to the National Health Fund, which would also keep a register of adverse events (the “external” level of the quality and safety assurance system).

Importantly, the reporting of such an event by medical personnel would not be the basis for initiating disciplinary or criminal proceedings, unless the analysis revealed that the act was committed intentionally (lack of sanctions for reporting adverse events cannot be equated with the lack of sanctions for acting to the detriment of the patient).

The register of adverse events kept by the National Health Fund would not be public. The analysis of such incidents is intended to help implement appropriate remedial measures, ultimately aimed at raising the quality of services provided.

Unfortunately, many aspects of the control procedure are not specified in the bill, which may cause confusion and result in the exclusion of hospital entities that, on the merits, deserve subsidies. This may make it difficult to implement self-monitoring, which should follow a model of “measure, analyse, repair and optimise.”

Damages from the Medical Events Compensation Fund

The act would also regulate out-of-court compensation for injury to patients. The occurrence of such events as infection of a patient with a biological pathogen, bodily injury, health disorder or death of a patient would entitle the patient or next of kin to obtain a benefit to be paid from the Medical Events Compensation Fund. Importantly, claimants seeking such benefits would have to waive all other claims for damages and redress arising from the medical event.

Controversy

The proposal has generated a lot of controversy. The lack of specific regulations and executive provisions concerning the rules and procedures for monitoring the quality of services is the main concern of healthcare entities and medical personnel. The draft does not include:

• Guidelines for analysing the main causes of adverse events
• Identification of the institution responsible for monitoring and enforcing implementation of the system
• References to primary healthcare or outpatient specialist care
• A catalogue of adverse events.

How they do it in the Netherlands

In Europe, there are many examples of measuring health outcomes while maintaining high service quality and attention to patient safety. A good example is the Netherlands, where the system is focused on patients. This is precisely an approach that ensures success.

The foundation of quality assurance is the confidence of patients and clients that healthcare is safe. The Dutch government actively encourages healthcare institutions and employers in the healthcare sector to improve the safety of healthcare, for example by granting additional funding for this purpose. Patient safety is one of the priorities of the Dutch Ministry of Health, Welfare and Sport. But unlike in Poland, in the Netherlands healthcare institutions and providers themselves are responsible for ensuring that the healthcare they provide is safe, patient-centred, and of high quality. The national government supports these efforts by ensuring appropriate legislation on measures to improve patient safety. An example would be the obligation of the healthcare entity to enter into an agreement for continuous improvement of safety programmes.

The Dutch system places a great emphasis on design and process implementation. Patients are at the centre, and care processes are built around them. The national government and companies offering health insurance encourage healthcare institutions and employers in the healthcare sector to increase healthcare safety. For example, they finance funds dedicated to innovative healthcare and reward hospitals with better patient outcomes.

A key aspect of the Dutch system is the doctors’ responsibility for safe and effective care. Of course, patients may suffer physical or psychological harm due to inadvertent errors of healthcare providers or due to shortcomings in the healthcare system. But preventing avoidable injury is vital. This is achieved through a safety programme implemented by healthcare professionals, consisting of procedures, quality and safety metrics, and correcting errors.

In the Netherlands, medical staff, patients and facility supervisors report adverse reactions without hesitation. This furthers the overriding goals of:

• Safe care for sick children
• Prevention of nosocomial sepsis and treatment of severe sepsis
• Optimal care in acute coronary syndromes
• Safe administration of high-risk medications, including parenteral medications
• Early recognition and treatment of pain
• Early recognition and treatment of critically endangered patients
• Prevention of postoperative wound infections.

Through adoption of such a policy, the numbers of hospital admissions due to medication errors and preventable incidents and deaths have decreased.

Additionally, experts have developed uniform safety standards for hospitals, which translates into a uniform quality standard for provision of medical services, thanks to which it does not matter which hospital a patient goes to.

Patients themselves can also contribute to improved healthcare safety. This is supported by patient safety cards issued by healthcare professionals and discussed with the patient. Thanks to their safety cards, patients know what to look out for during treatment and what they can do if something goes wrong. Similar solutions are used during medical procedures performed by doctors.

In addition, patients are protected from incompetence or negligence of healthcare providers under the Individual Healthcare Professions Act. Doctors must be entered in the professional register, and anyone can check to see if a healthcare provider is registered.

Management of hospitals and nursing homes is responsible for the quality of care at their facility. The supervisory board ensures that the management performs its duties properly. The Health and Youth Care Inspectorate monitors (randomly) the safety, quality and availability of healthcare in the Netherlands.

Hospitals in the Netherlands maintain the highest level of safety. They have a constant focus on patient safety and avoiding preventable harm.

For example, safety in primary care is provided by general practitioners, dentists or physiotherapists based on standards, guidelines and safety protocols. These are prepared by professional groups, with input from legal advisers and benefit providers. More information can be found on the website for each profession.

The same is true when it comes to ensuring the safety of healthcare workers. To provide good care, healthcare providers have a right to a safe workplace. Increasingly, healthcare workers encounter aggression and violence on the job. An action plan called “Safe Work in Healthcare” contains solutions for creating a safer working climate in healthcare.

Cultural and organisational change needed

The proposed legislative changes in Poland concern quality and safety aspects which are new for the Polish healthcare system. Here there is no culture of “speaking out” about negligence, shortcomings or errors in managing organisations such as hospitals. By contrast, in the Dutch system, transparency, clarity, and explicit standards and procedures in the area of the quality of medical services and patient safety are the norm. There is also a standard of communication with the patient, as evident for example in the use of safety cards.

Clearly, these factors translate into delivery of services at a high level, although they can always be improved and optimised. The reporting of adverse events by medical staff allows events to be discussed in their own environment, with the aim of introducing self-correction and avoiding mistakes in the future.

The culture of “speaking out” allows people to raise not only issues and concerns, but also ideas. Such a culture not only helps prevent adverse events, but also fosters quality and innovation.

Małgorzata Sokołowska, attorney-at-law, Life Science & Healthcare practice, Wardyński & Partners

With cooperation from Prof. Pieter Stepaniak, consultant expert in health operations management