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The conditions and procedure for the establishment of death of a person and the standard format for statements on the establishment of death

Issuer:Minister of Health and Labour
Type:regulation
In force from:07.03.2015
In force until: In force
Translation published:02.11.2016

The conditions and procedure for the establishment of death of a person and the standard format for statements on the establishment of death

Passed 02.03.2015 No. 6

The Regulation will be established on the basis of subsection 16 (3) of the Procurement, Handling and Transplantation of Cells, Tissues and Organs Act.

§ 1.  Scope of regulation

 (1) The Regulation constitutes the conditions and procedure for the establishment of a person’s death and the format for statement on the establishment of death (Annex).

 (2) The statement on the establishment of death of a person shall be prepared for the establishment of death of a person whose cells, tissues, or organs are intended to be removed and transplanted to a recipient for therapeutic purposes.

§ 2.  The procedure for the establishment of a complete and irreversible cessation of the brain function

 (1) The decision about the complete and irreversible cessation of the brain function is made by a committee of doctors consisting of an anaesthesiologist and a neurologist or a neurosurgeon.

 (2) Members of the committee prepare and sign the statement for the establishment of death in accordance with the provisions of sections 6 and 7 of this Regulation.

 (3) The clinical features of a complete and irreversible cessation of the brain function shall be evaluated twice.

 (4) The length of the monitoring from the occurrence of the illness until the first evaluation and between the two evaluations of the neurological condition depends on the cause for the complete and irreversible cessation of the brain function, the clinical evaluation, and the age of the patient. The length of the monitoring and the length of the interval between the two neurological evaluations is decided upon by the committee specified in subsection 1 of this section.

 (5) If possible, a complete and irreversible cessation of the brain function is established in the presence of the closest people of the deceased person.

 (6) Time of death is the time when the second evaluation of the neurological condition is completed.

§ 3.  Prerequisites for the establishment of a complete and irreversible cessation of the brain function

 (1) The probable cause of a complete and irreversible cessation of the brain function is known and documented.

 (2) The following reasons have been excluded for the loss of consciousness or coma, absence of brain stem reflexes, and of self-sustainable breathing:
 1) hypothermia;
 2) effect of sedative and narcotic substances, and of substances causing muscle relaxation;
 3) metabolic and endocrine disorders;
 4) arterial hypotension.

§ 4.  Establishment of a complete and irreversible cessation of the brain function

 (1) A death is established on the basis of the neurological features specified in subsection 2 of this section. Evaluation of these allows diagnosing the complete and irreversible cessation of the brain function even in circumstances in which the oxygenation of blood is provided artificially, or a breathing apparatus is used on the person and blood is supplied to the cells, or vasoactive and inotropic medicinal products are administered to the person.

 (2) The neurological features of a complete and irreversible cessation of the brain function are:
 1) unconsciousness or coma;
 2) absence of brain cell reflexes;
 3) absence of self-sustainable breathing or apnoea.

 (3) The committee specified in subsection 1 of this section of this Regulation shall decide on the additional studies which will be carried out in addition to the clinical examination. Additional studies may include studies which evaluate the brain’s perfusion and electrical activity.

§ 5.  Establishment of a complete and irreversible cessation of the circulation

 (1) The decision about the complete and irreversible cessation of the circulation is made by a committee consisting of two doctors.

 (2) Members of the committee prepare and sign the statement for the establishment of death in accordance with the provisions established in sections 6 and 7 of this Regulation.

§ 6.  Requirements for statement on the establishment of death of a person

 (1) Upon preparing the statement for the establishment of death of a person, the entries established with this Regulation are compulsory. A specialised medical unit may, if necessary, make additional entries to the statement.

 (2) A specialised medical unit may change the format of the statement established with this Regulation. The logo of the specialised medical unit may be used on the statement.

§ 7.  Necessary data for the statement on the establishment of death of a person

 (1) The following data shall be included in the statement about the specialised medical unit or hospital which established the death of the person:
 1) name;
 2) activity licence number;
 3) address, phone and fax number.

 (2) The following data shall be included in the statement about the deceased person:
 1) given name and surname;
 2) personal identification code or, in the absence thereof, date of birth;
 3) residence;
 4) hospital department in which the person was hospitalised;
 5) number of health file.

 (3) The following data shall be included in the statement about the committee of doctors who established the death of the person:
 1) the given names and surnames of the doctors;
 2) the m edical specialties of the doctors;
 3) number of the certificates of registration of the doctors;
 4) the signatures of the doctors.

 (4) The following data shall be included in the statement about the establishment of time of death:
 1) date, month, and year;
 2) time.

 (5) The statement shall include data about the diagnose for the disease which caused the person’s death.

 (6) The statement shall include data on whether the death of the person was established on the basis of a complete and irreversible cessation of the brain function or the circulation.

 (7) The statements on deaths which were established on the basis of a complete and irreversible cessation of the brain function shall include the following data about the studies carried out:
 1) existence of prerequisites for the studies (1 – whether the condition may be caused by the effect of sedative and narcotic substances, and substances which cause muscle relaxation; 2 – whether the patient’s mean arterial pressure is less than 60 mmHg (in children, under their age-related norm); 3 – whether the patient’s body temperature is below 35 °C; 4 – whether the condition may be caused by metabolic and endocrine disorders);
 2) the date and time when the tests for the studies were taken;
 3) test results (1 – whether the patient expresses physical contact or reactions; 2 – whether there are signs of muscular tone; 3 – whether their pupils react to light; 4 – whether the pupils are very constricted; 5 – whether corneal reflex occurs on either side; 6 – whether conjugate eye deviation occurs in the opposite direction (doll’s eyes phenomenon) when the head is turned sideways; 7 – whether cough reflex occurs when irritating the pharynx and trachea with an aspiration catheter; 8 – whether a motor reaction occurs in the cranial nerves innervation area during a stimulation of a body part (nail bed, earlobe, nasal root, etc.); 9 – arterial blood pressure; 10 – body temperature);
 4) date, time, and result of the test for the absence of self-sustainable breathing or apnoea;
 5) the day, time, and description of results of additional studies if they have been carried out;
 6) the conclusion made on the basis of the study results about the complete and irreversible cessation of the brain function.

 (8) The statements on deaths which were established on the basis of a complete and irreversible cessation of the circulation shall include the following data about the studies carried out:
 1) results of the studies (1 – whether the person is conscious; 2 – whether a pulse is palpable on the large arteries; 3 – whether there is self-sustainable breathing; 4 – whether an active muscular tone is present; 5 – whether less than 10 minutes have passed since the emergence of the state);
 2) the conclusion made on the basis of the results of the studies on the complete and irreversible cessation of the circulation.

§ 8.  Provision

  Associations of medical specialities will put together a code of conduct for the establishment of a complete and irreversible cessation of the brain function and a code of conduct for the establishment of a complete and irreversible cessation of the circulation.

Annex STATEMENT FOR THE ESTABLISHMENT OF DEATH OF A PERSON