There is a draft regulation on POCT organizational standards

The proposed regulation specifies the organization of laboratory tests of critical parameters performed in biological material in a state of health or life-threatening emergency consisting of the sudden or shortly anticipated appearance of symptoms of health deterioration, the immediate consequence of which may be serious damage to bodily functions or bodily injury or loss of life, at the place of providing health services to a patient in a medical institution, hereinafter referred to as "POCT organizational standards."

The organizational standards of the POCT define a list of basic laboratory tests of critical parameters, the critical value of which supports the presence of a life-threatening pathophysiological condition that requires taking, rapid and effective therapeutic measures. In addition, the standards specify the organization of their performance and the medical personnel authorized to perform them and authorize the result. In addition to medical and nursing personnel, authorized to collect biological material is a paramedic under the provisions of the Law of September 8, 2006 on State Emergency Medical Services (Journal of Laws 2022, item 1720, as amended) and a medical analyst technician under Article 5 of the Law of September 15, 2022 on Laboratory Medicine.

The draft regulates the responsibilities and tasks of the laboratory diagnostician, performing, in accordance with the principles of GLP (Good Laboratory Practice), the substantive supervision of tests performed at the place of providing health services to the patient. The tasks of the laboratory diagnostician will include analytical and clinical validation of the testing methods used, measuring devices and reagents used, as well as ensuring that the test results correlate with those obtained in a medical diagnostic laboratory. The laboratory diagnostician, through his/her qualifications, knowledge and skills in the implementation of analytical methods, measurement consistency, will ensure the quality of POCT tests.

The regulations issued pursuant to Article 11 of the Law of September 8, 2006 on State Emergency Medical Services shall apply to POCT examinations performed by a medical rescue team. A medical entity performing POCT examinations shall adjust its activities to the requirements set forth in this regulation within 12 months from the date of entry into force of this regulation. The proposed regulation will facilitate patient access to quality healthcare services in terms of obtaining real-time test results.

Source: RCL