Treatment entities that would like to submit an accreditation application cannot currently do so.

On January 1, 2024. The Law on Quality in Health Care and Patient Safety (hereinafter: “the Law”) came intoforce . The law introduced new provisions into the legal order regarding, among other things. Awarding accreditation certificates to medical entities. At the same time, an earlier regulation – the Law on Accreditation in Health Care – ceased to apply.

No implementing regulations on accreditation

At the moment, the implementing regulations of the Law in the field of accreditation, whose obligation is indicated by the delegation in Article. 41 Law. According to this provision, the Minister of Health is to determine by regulation:

1. the detailed manner of conducting the assessment procedure, including the scope of the accreditation review plan, taking into account the need to ensure comprehensiveness and transparency of the assessment of compliance with the conditions for granting accreditation;
2. model of accreditation certificate, taking into account the need to ensure uniformity in the issuance of such certificates;
3. how to calculate the fees for conducting the evaluation procedure, taking into account the workload associated with the size of the entity and the scope and number of services it provides.

The above-mentioned statutory delegation has not yet been implemented, so the it is not currently possible to initiate an evaluation procedure under the new rules.

Lack of accreditation standards – the role of the Accreditation Council

Accreditation standards have also not been established. The role of the Accreditation Council is important in this case. The Council, which is in accordance with Art. 22 para. 1 of the Law, a body under the Minister of Health, is responsible for developing draft accreditation standards, which it submits to the Minister of Health, who then approves them. According to the transitional provisions of Art. 58 para. 7-9 of the Law, existing members of the Council served until December 31, 2023. Instead, new members of the Accreditation Council were to be appointed by the end of last year and as of January 1, 2024. begin to perform their functions. However, this has not happened, and there is currently no body responsible for developing accreditation standards, resulting in the absence of these standards. This state of affairs makes it impossible for medical entities to submit accreditation applications.

Increasing the requirements for accreditation

As indicated in the explanatory memorandum of the introduced Law, its purpose as it relates to accreditation is to clarify and organize the process of accreditation in health care, particularly in terms of its process, deadlines and participants.

In Art. 37 of the Law introduced new, higher requirements that condition the granting of accreditation:

1. Meeting single mandatory accreditation standards;
2. Achieving an accreditation score of at least 75 percent. The maximum possible sum of the total scores of each accreditation standard;
3. Obtaining at least 50 percent. the maximum possible sum of scores of individual accreditation standards for each subject department.

The possibility of revoking accreditation and other changes to organize and seal the accreditation process

The Law also introduced, among other things, the possibility of revoking accreditation (Article 38, paragraphs 4 and 5 of the Law), and rules for admitting and fulfilling the functions of the visiting team and the coordinator of the visiting team that will perform the accreditation review (Article 31 et seq. of the Law).

Also new is the principle of reviewing and updating accreditation standards at least once every 5 years from the date of their promulgation, based on the analysis prepared by the Accreditation Council, particularly with regard to the need to update them in accordance with current medical knowledge (Article 24 et seq. of the Act)

The current state of affairs – a “rash” of last-minute accreditation applications, the Ministry of Health has announced draft regulations

It is worth noting that About 200 hospitals submitted applications for accreditation at the end of the year. They have managed to do so before January 1, 2024 and will consequently be subject to a less restrictive accreditation procedure, based on the transitional provisions of Art. 58 Law.

The Ministry of Health announced two weeks ago that draft regulations for the Law had been prepared and would be sent for further legislative process.

According to experts at Jabłoński Kozminski Law Firm, the changes introduced will have a positive impact and ensure that the quality of health care in medical entities will improve. However, it is worth bearing in mind that the adoption of the required implementing regulations and accreditation standards will still have to wait.