The regulation is already in force: laboratories have six months to adapt to the new rules

New quality standards for medical laboratories have been in effect since July 22nd. The regulation defines detailed rules for ordering tests, collecting biological material, its transport and storage, and requirements for test reports. Facilities that do not yet meet the new requirements have six months to implement changes.

On Monday, July 22, a regulation introducing new quality standards for medical laboratories came into effect. The document was published in the Journal of Laws the day before. As stated in the explanatory memorandum, the new regulations are intended to ensure an appropriate level of quality in laboratory medicine, including diagnostic evaluation and result interpretation.

The purpose of the regulation is, among other things, to increase the reliability of test results and improve the safety of patients and laboratory staff.

The regulation takes into account the various profiles of laboratories – single- and multi-profile – and the types of tests performed there. Annexes 1–6 define the rules for issuing test results (reports), their format (paper or electronic) and content, including information on so-called critical results.

Annex 7 specifies the maximum storage time for biological material – both before and after testing. The document also includes provisions regarding the preparation and preservation of cytological specimens.

Although immunological testing is a distinct activity of laboratory medicine, it does not receive a separate annex in the new regulation. As the Ministry of Health explained, "immunological laboratory testing is one of the types of tests covered by Annex 1." The exception is the rules for collecting biological material – these are specified in specific sections of the document.

Provisions on immunological transfusion medicine are also not included – the regulation refers in this respect to the provisions on the public blood service.

The new quality standards are based on the international standard ISO 15189, which addresses quality and competence requirements for medical laboratories. This standard covers all stages of laboratory operation—from planning and analysis to waste disposal. Particular emphasis is placed on pre- and post-analytical processes, which are crucial for the reliability of results.

Although the regulation came into force on July 22, it provides for a six-month transition period. During this time, laboratories that do not yet meet the requirements can continue to operate under the current rules. After this time, the new standards will become mandatory for all facilities.

The new regulations are intended to standardize and streamline the quality of laboratory services across the country. Experts hope that their implementation will contribute to greater transparency and better patient protection.