On 22 July 2021, the Ministry of Health published a draft Act on Quality in Healthcare and Patient Safety. The stated purpose of the bill is to implement legal and organisational solutions to improve the quality of healthcare in a comprehensive and coordinated manner. What will change and to what extent?
Revision of authorisation and accreditation rules
Obtaining public funding by a hospital is to be dependent on authorisation issued by the branch director of the Polish National Health Fund (NFZ). The authorisation criteria and evaluation methods are to be set by the Minister of Health in a regulation, while the evaluation itself is to be based on three sets of parameters: clinical, patient, and managerial.
As part of the authorisation, it would be verified whether healthcare entities meet the requirements for the “basket” of guaranteed benefits. Authorisation would also be a condition for the entity to participate in the hospital network.
However, no procedure is provided for administrative appeal against denial of authorisation. Denial would be appealable only to the administrative court.
The rules for granting accreditation to healthcare facilities would also change. The most significant proposed change is in the accrediting entity. The Centre for Quality Monitoring is to be liquidated and replaced by NFZ.
The bill describes the accreditation process in detail, especially:
- The procedure, timing and participants
- Introduction of the possibility of withdrawal of accreditation
- Rules governing admission to the functions of visiting officer and coordinator
- Additional conditions for granting accreditation:
- Meeting mandatory standards
- Scoring a minimum of 50% on each section of the standards.
According to the bill, NFZ would be the competent entity for granting authorisations and accreditations. There will be criticism of this solution. During the Healthcare Forum, part of the 2021 Economic Forum in Karpacz, Jarosław J. Fedorowski, president of the Polish Federation of Hospitals, raised reservations about the payer, NFZ, also conducting accreditation and authorisation of hospitals: “This should be a process carried out by an independent accreditation commission. After all, we have good international institutions that could deal with this.”
System for providing quality and safety
The bill also directs healthcare entities to introduce an internal quality and safety assurance system. This is to be obligatory for all hospitals (healthcare entities conducting medical activity such as hospital services), regardless of whether they use public funds.
According to the guidelines, the quality and safety assurance system will have two tiers:
- Internal, conducted by the healthcare entity running the hospital, including:
- Mandatory monitoring and reporting of adverse events
- Mandatory risk assessment and management
- Preparation of an annual quality report
- Preparation of standard operating procedures
- External—a register of adverse events kept by the National Health Fund. The register would not be public.
Although the idea of strengthening the monitoring of adverse events is sound, assessment of how it would be implemented is difficult due to the lack of implementing regulations, even if only in terms of rules and procedures for monitoring the quality of services. There is also no catalogue of adverse events or indication of the minimum requirements for internal quality and safety assurance systems.
Compensation for injury for medical events
The system of compensation for injury for medical events is also to change. It is planned to implement an out-of-court, two-instance system of compensation for injury suffered by patients as a result of medical events. This system is to replace the current model based on province commissions. The bill also provides for establishment of a Medical Events Compensation Fund.
It is planned to introduce a model for awarding compensation without an adjudication of fault, based on a determination of whether a medical event occurred in the case and an indication of the amount of the benefit payable for the event. The aim is to streamline the whole process, including shortening the time for payment of benefits (the ombudsman would have three months to issue a decision on granting the benefit).
Legal doubts are raised by the lack of implementing provisions concerning the minimum criteria for granting the compensation benefit and the detailed scope and conditions for establishing the amount of the benefit. The bill also does not clarify the standards of treatment which will be the basis for assessing an adverse event, which also seems to be a problematic issue.
Based on the legal solutions of other countries and guidelines of the World Health Organization concerning the development of systems for monitoring adverse events, the “no fault” rule is also to be introduced. In other words, the bill would eliminate sanctions against medical personnel reporting adverse events, with the exception of actions to the detriment of the patient, i.e. adverse events resulting from negligent or intentional acts of the person reporting a given event. The no-fault rule excludes medical professionals’ liability for unintentional errors.
However, the bill does not specify who will assess the relationship between the event and the potentially negligent or intentional act of the person reporting the adverse event. This issue is vital, as a medical entity against which allegations may be made resulting from occurrence of an adverse event would not be exempt from liability.
The personal details of persons reporting adverse events, in connection with data identifying the specific adverse event, as well as any information collected in the analysis of the causes of adverse events, would not be made available.
In addition to the most significant changes discussed above, the following are planned:
- Strengthening supervision over keeping of medical registers
- Clarification of rules for creation and financing of medical registers
- Specification of the data to be included in the patient identification band (name and date of birth).
Law as a signpost
During the recent Healthcare Forum in Karpacz, Minister of Health Adam Niedzielski announced that this bill is the beginning of the road, and more work on quality of healthcare is ongoing. The proposal announced so far already appears far-reaching. The proposed solutions are scheduled to enter into force on 1 January 2022.
Natalia Falęcka-Tyszka, attorney-at-law, Healthcare practice, Wardyński & Partners