In the previous section, we dealt with the issue of supervising the provision of health care; in this section, we will deal with the upcoming amendment to the Criminal Code, which should establish a new crime - the crime of falsification and counterfeiting of health documentation, as well as legislative changes effective from 1 June 2019.

Upcoming amendment to the Criminal Code

The amendment to the Criminal Code, which is currently in the process of evaluating and interdepartmental comment procedure, is intended to introduce a new crime - the crime of falsification and counterfeiting of health documentation.

According to the Explanatory Memorandum to the amending act, the reason for its adoption is the absence of criminal liability for the manipulation of data contained in the medical records (e.g. data on patient's illness, data on the extent of healthcare provided, prescribed and administered human medicines, etc.)

If this amendment is adopted, the falsification of the medical documentation should be understood as being a complete drafting up of health documentation which is supposed to give the impression of what is actually issued – on the one hand, issued by a medical professional and secondly by the prescribed manner.

By counterfeiting/changing the medical documentation should be understood as making a substantial change to the content as well as to remove certain data contained in the medical documentation, while it is irrelevant how the change is made, whether by overwriting, adding, deleting or deleting certain data.

This legislative change can make a positive contribution in ensuring that supervised entities discourage hiding the neglect of healthcare provided and instead help to ensure the proper supervision of healthcare.

Amendment to the Act on Provision of Health Care and Introduction of the so-called "Clinical audit"

On May 13, 2019, the National Council of the Slovak Republic approved an amendment to the Act no. 578/2004 Coll. on Healthcare Providers, Healthcare Professionals, Professional Organizations in Health Care (hereinafter as the “Act”). The effective date of the amendment to the Act on Clinical Audit was set for 1 June 2019.

The most significant changes in the area of neglect prevention include a newly introduced institute – clinical audit (Section 9b of the Act).

What is a clinical audit?

A clinical audit can be understood as a systematic screening and evaluation of compliance with standard prevention practices, standard diagnostic procedures and standard therapeutic procedures, internal patient safety assessment system and minimum requirements for internal patient safety assessment system.

Patient safety, adverse events and internal rating system for patient safety

Patient safety will be understood as preventing the occurrence of an adverse event in the provision of health care, which is understood to mean:

• an event or circumstance that may have caused or caused damage to health in the performance of healthcare; a case where as an injured party acts a provider of healthcare or a healthcare professional is also considered an adverse event;
• unexpected deterioration of the patient's health leading to permanent health damage or patient´s death, which could have been avoided;
• an event or circumstance that may have caused or caused damage to the patient´s health and has been shown to be avoidable, or
• a situation where a procedure has been identified that is incorrect, does not follow standard procedures and could lead to a deterioration of the patient's health.

An internal patient safety assessment system will be understood as a system for identifying, analyzing, managing and preventing adverse events. For a more precise definition of the internal patient safety assessment system, specifically the minimum requirements for this system, we will have to wait some time. The Ministry of Health of the Slovak Republic should soon establish it in the form of a decree.

Who will perform the clinical audit?

The clinical audit will be carried out by the Ministry of Health of the Slovak Republic or by persons who are professionally qualified to perform the medical profession (hereinafter referred to as “invited persons”) based on a written authorization from the Ministry of Health.

Professional competence in the performance of a clinical audit shall be ensured through invited persons, at least two of whom shall have professional competence in supervised work and at least 10 years of professional health practice. In addition, persons who fulfil any of the assumptions of bias will be excluded from performing a clinical audit.

The benefit of a clinical audit for patient

After conducting a clinical audit, the Ministry may decide in two ways: (i) that the healthcare provider follows the clinical audit requirements; or (ii) it’s inconsistent with the clinical audit requirements.

If the Ministry decides on compliance, this means that the healthcare provider provides healthcare in accordance with standard procedures, the internal patient safety assessment system, and with the minimum requirements for an internal patient safety assessment system and for the period for which the clinical audit has been performed, gives to the provider a certificate confirming these facts.

In cases of non-compliance, the Ministry decides that the healthcare provider does not provide health care in accordance with standard procedures, an internal patient safety assessment system, or with minimum requirements for an internal patient safety assessment system. This is followed by a follow-up to eliminate these shortcomings - initiating a health surveillance procedure before the Health Care Authority.

The Ministry will be obliged to publish on its website the results of the clinical audit performed.

To conclude

In answering the initial question of whether the supervision of healthcare performance will be more effective, we can say that the pressure of the media, the injured families and the public shows a positive trend in the regulation of such legislation.

In our opinion, a clinical audit will open the patient's door when deciding which health care provider is best to deal with their health problems.

However, certain questions still remain unanswered such as the direct involvement of injured families in the health care surveillance procedure, albeit thanks to the Prime Minister's promise, there is a presumption that they will be resolved soon.