LAW
ON BLOOD AND BLOOD INGREDIENTS
BASIC PROVISIONS
Article 1
This law regulates the organization of transfusion activities, the conditions and standards of quality, safety and supervision in the collection, testing,
processing, storage, distribution, dispensing and use of human blood and blood components in the Federation of Bosnia and Herzegovina (hereinafter:
Federation), funding for transfusion services, and other issues related to transfusion medicine.
The provisions of this law do not apply to the supply of medicines obtained from human blood or plasma, or to hematopoietic
cells.
Article 2
The collection, testing, processing, storage, distribution and use of blood and blood components in the Federation is carried out in accordance with directives
European Union, World Health Organization recommendations, Council of Europe recommendations, good laboratory, manufacturer and
clinical practice, as well as other regulations in this field.
The activity referred to in paragraph 1 of this Article shall be performed in accordance with the principle of the general concept of self-sufficiency of blood, voluntary unpaid
blood donation and safe transfusion treatment.
Article 3
The implementation of the provisions of this Law, as well as the by-laws adopted pursuant to this Law, shall be the responsibility of the Canton and the Federation,
health institutions, health insurance institutes and other legal and natural persons.
Article 4
Some terms used in this law have the following meaning:
blood is whole human blood, taken from a blood donor in a bag / bag with anticoagulant solution, prepared for transfusion or for production
blood components,
unit of blood is the prescribed amount of blood that the donor gives at one time,
a blood component is an integral part of the blood (erythrocytes, leukocytes, platelets, plasma, cryoprecipitate), which is prepared using physical methods
(spin, filter, freeze, etc.),
allogeneic transfusion is a form of transfusion treatment in which the donor and recipient of the blood and the blood component are not the same person,
autologous transfusion is a form of transfusion treatment in which the donor and recipient of the blood and the blood component are the same face,
apheresis procedure is the process of extracting one or more constituents of blood through the automatic processing of whole blood in the apparatus, wherein
the unused blood components are returned to the donor bloodstream, during or at the end of the procedure,
haemostasis is a harmonious and balanced set of various reactions that keep the blood flowing within the blood vessels or keep them after injury.
stops bleeding,
transfusion activity is an activity of general interest providing sufficient blood and blood components to treat the diseased and
injured,
serious adverse event is any adverse event related to the collection, testing, processing, storage and distribution of blood and blood
ingredients that could cause death or endanger life and cause disability or inability to work, or result in
hospitalization or illness or extension of hospitalization or illness,
a serious adverse reaction is an adverse response from the donor or recipient, associated with the uptake or transfusion of blood or blood
ingredient, which may cause death or endanger life and cause disability or inability to work, or result in
hospitalization or illness or extension of hospitalization or illness,
donation of blood and blood components is the division of blood and blood components for transfusion, exclusively within a hospital healthcare facility,
distribution of blood and blood components is the delivery of blood and blood components for the transfusion and production of blood and plasma drugs,
good clinical practice in transfusion medicine is the optimal use of blood, blood components and products derived from blood in clinical practice,
blood donation is a humane gesture that takes place in accordance with the principles of voluntariness, gratuity and anonymity,
a blood donor is a person of good health, with a good medical history, who voluntarily donates blood or a blood component for needs
treatment of patients,
refusal is the permanent or temporary refusal of an individual to donate blood or a blood component,
good manufacturing practice is part of a quality assurance system that allows blood and blood components to be continuously produced in form
which meets the existing quality standards and their purpose (quality, safety and efficiency have been built into each product as planned),
good laboratory practice is a quality assurance system designed to consistently conduct and control laboratory activities
in accordance with the quality requirements,
self-sufficiency is the principle of supplying blood and blood components in which the needs of the population are covered by blood from their own sources and
blood components for modern transfusion treatment,
blood recipient is a person who receives blood or a blood ingredient for medical purposes,
transfusion is the transfer of the donor's blood or blood component to the recipient,
quality system implies good organizational structure, defined responsibilities, procedures, procedures and resources for implementation
quality management and includes all activities that contribute to quality directly or indirectly,
quality management means coordinated activities for the management and control of an organization regarding quality at all levels of health
institutions,
quality control is part of a quality system aimed at meeting quality requirements,
quality assurance is a set of measures and activities that need to be implemented to ensure the quality of blood and blood components needed for
their intended use,
standard operating procedure (SOP) is a detailed, accurate and transparent instruction manual for performing work tasks and procedures, written in
standard form in accordance with the principles of good transfusion practice,
transfusion testing includes pre-transfusion testing and all other testing required for safe transfusion.
Article 5
In order to ensure the conditions for supplying the Federation population with safe and quality blood and blood components, it is necessary to:
establish a unique policy and strategy for the advancement of the field of transfusion medicine,
provide conditions for education of healthcare professionals in the field of transfusion medicine,
plan for the treatment of blood and blood components in regular and emergency conditions;
ensure conditions for raising public awareness of the need to collect blood and blood components,
promote the principle of self-sufficiency in supplying the population with blood and blood components,
establish and maintain a register of health care institutions that have the approval of the Federal Minister of Health (hereinafter: the Minister) for
procedures for collecting, testing, processing, storing, distributing, dispensing blood and blood components,
establish oversight of the overall safety and quality of blood and blood components,
to establish and maintain an information system that ensures the accuracy, completeness, timeliness, security and continuity of monitoring all data
necessary for the successful functioning of transfusion establishments in the territory of the Federation.
ORGANIZATION OF TRANSFUSION ACTIVITIES
Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina
Article 6
The Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina (hereinafter: the Federal Institute) is a health institution, of which
founder of the Federation and carrying out transfusion activities in the territory of the Federation in accordance with the regulations governing health care and
by this law.
Article 7
In addition to the tasks it performs on the basis of regulations governing health care, the Federal Institute performs the following tasks:
promote voluntary blood donation,
organizes and carries out continuous education of personnel in the field of transfusion medicine,
research activity in transfusion medicine,
controls the rationality / justification of the use of blood and blood components,
monitor and analyze the effects of transfusion treatment,
donor and therapeutic apheresis procedures,
collection of blood for autologous transfusion,
testing for haemostasis disorders,
immunogenic processing and tests to determine recipient and donor tissue matching,
keep records and documentation in accordance with the provisions of this Law,
establish and maintain a unified information system of data in accordance with this Law,
maintains a unique register of providers who are temporarily or permanently excluded because of an infectious disease, a donor whose blood is in the affirmative
tests have shown the presence of infectious disease agents, the donor whose blood transfusion caused the recipient and donor disease
rare blood groups, as well as a unique registry of hemophilia patients,
maintains a unique register of serious adverse events and serious adverse reactions,
cooperates with international organizations, associations and related transfusion institutions in Bosnia and Herzegovina and in other
countries,
and other business in accordance with the law and the founding act.
Authorized health facilities
Article 8
Healthcare establishments authorized to carry out certain transfusion activities (hereinafter: authorized
health institutions) are:
transfusion centers,
transfusion sections.
Transfusion Center
Article 9
The transfusion center is part of a public health hospital.
The Transfusion Center performs the following tasks and tasks:
collects, tests, manufactures, stores, dispenses and distributes blood and blood components,
laboratory tests in the field of transfusion medicine,
controls the rationality / justification of the use of blood and blood components,
monitor and analyze the effects of transfusion treatment,
donor and therapeutic apheresis procedures,
collects blood for autologous transfusions,
examines hemostasis disorders,
keep records and documentation in accordance with the provisions of this Law,
Submit to the Federal Office data for the unique registers referred to in Article 7 of this Law,
promote voluntary blood donation,
education in transfusion medicine in accordance with the regulation governing health care,
and other affairs for which the Minister has been approved.
Transfusion Department
Article 10
The Department of Transfusion is part of the hospital's healthcare institution, which performs the following tasks and tasks:
requests blood and blood components from the Federal Institute or transfusion centers,
preserves and releases blood and blood components,
pre-transfusion testing,
keep records and documentation in accordance with the provisions of this Law,
monitor the effects of blood transfusion and blood components,
participates in an autologous transfusion program,
and other activities in accordance with the provisions of this Law.
The transfusion department shall perform the activity referred to in paragraph 1 of this Article for the needs of the health care institution in which it operates.
Article 11
Closer conditions of premises, medical and technical equipment and professional staff, which must be fulfilled by authorized health institutions, upon proposal
The expert commission for transfusion medicine shall be determined by the Minister in an ordinance.
APPROVAL FOR TRANSFUSION ACTIVITIES
Article 12
The collection, testing, processing, storage, distribution, and dispensing of blood and blood components are performed by the Federal Institute and authorized
health care institutions.
Authorization by authorized health institutions is given by the Minister by a decision based on the documented request referred to in Article 13 of this Law and
the applicant's immediate insight.
The decision referred to in paragraph 2 of this Article is finally in administrative procedure and an administrative dispute may be instituted against it by the competent court in
in accordance with the law.
Article 13
The application for authorization referred to in Article 12 of this Law must include:
name and headquarters of the health institution,
personal information of the director of the health care institution,
personal data of the person responsible for the transfusion activity in the institution (name and surname, qualifications, contact address and telephone number),
for transfusion centers and a list of transfusion units to supply blood and blood components,
a list of procedures and jobs for which approval is sought.
In addition to the documentation referred to in paragraph 1 of this Article, the request must include:
a description of the quality system,
a list of existing standard operating procedures (for the selection of donors for blood and blood components, for the collection of blood and blood components, for
testing and processing of blood and blood components, for storage, distribution, dispensing, for the withdrawal of blood and blood components, and for
recording and reporting of serious adverse reactions and serious adverse events),
number and qualification of employees,
a view of the premises and equipment for the procedures for which approval is sought,
the results of external quality control in the approval renewal process.
Article 14
The approval referred to in Article 12 of this Law shall be granted for a period of five years.
Article 15
Authorized health care institution will apply for renewal of the permit no later than 90 days before the expiry date.
The provisions of Article 13 of this Law shall apply to the procedure for renewal of an authorization.
Article 16
The Minister, ex officio, issues a decision revoking the authorization referred to in Article 12 of this Law if it is determined in the supervisory procedure that
authorized health institution:
no longer qualifies for approved procedures,
does not comply with the provisions of this Law and the implementing regulations adopted pursuant to this Law.
The decision referred to in paragraph 1 of this Article is finally in administrative procedure and an administrative dispute may be instituted against it by the competent court in
in accordance with the law.
Article 17
The Federal Ministry of Health (hereinafter: the Ministry) maintains a register of authorized health institutions.
QUALITY MANAGEMENT
Article 18
Federal Institute and Authorized Health Institutions to Establish Quality and Safety System in Transfusion Activity
is based on the principles of good laboratory, manufacturing and clinical practice.
The Minister, on the proposal of the Expert Commission on Transfusion Medicine, will adopt the Rulebook on Quality and Safety of Blood and Blood
ingredients that will further define the standards and specifications of the quality and safety system for blood and blood components, in accordance with the requirements
internationally recognized standards in the field of transfusion medicine and scientific and technological development.
Article 19
The Federal Institute and authorized health institutions are obliged to provide, to persons directly involved in the collection, testing,
the processing, storage, dispensing and distribution of blood and blood components, vocational training and continuous training to ensure
the quality and safety of blood and blood components.
Article 20
The Federal Institute and authorized health institutions will appoint a responsible person for the transfusion activity (hereinafter: responsible
face).
The responsible person shall:
ensure that every unit of blood or blood components is collected, tested, processed, stored and distributed in accordance with this Law and others
regulations.
supervise the implementation of the provisions of this law relating to: quality system, record keeping, record keeping, continuity
monitoring blood flow, monitoring adverse reactions and adverse events.
Article 21
The responsible person must have a medical degree and a specialization in transfusion.
In addition to the conditions referred to in paragraph 1 of this Article, the responsible person must have experience in transfusion activities as follows:
to work in the transfusion department for one year,
to work at the transfusion center for three years and
to work at the Federal Institute for five years.
Authorized health institutions are obliged to inform the Federal Institute on the appointment of the responsible person and on the date of commencement of his / her work.
QUALITY AND SAFETY OF BLOOD AND BLOOD INGREDIENTS
Collection of blood and blood components
Article 22
Collection of blood and blood components is a procedure involving the selection of a blood donor or blood component (hereinafter referred to as: donor), determination of
the amount of blood taken and the way blood is taken.
The collection of blood and blood components in the Federation is based on the principles of voluntariness, free of charge, anonymity and solidarity.
For the blood or blood component taken, it is forbidden for the donor to provide financial compensation.
The donor may not receive cash for a given blood or blood component.
Exceptionally, in justified cases where a blood donor is called by the Federal Institute, the transfusion center or the Red Cross / Cross
for the purpose of donating blood, he is provided with one meal and travel expenses, which will be regulated by an ordinance issued by the Minister.
Blood collection must be performed under professional medical supervision.
Article 23
The procedure for taking blood and blood components must be such as to ensure complete asepticism, ie prevention of bacterial and viral
contamination of blood units and blood components intended for therapeutic use as well as blood samples for laboratory testing.
Provider of blood or blood component
Article 24
The donor may be an adult, legal person who has been found by medical, laboratory and epidemiological examinations to be
may give blood or a blood component without danger to its health and that its blood will not endanger the recipient's health.
By way of derogation from paragraph 1 of this Article, the donor may be a minor, but not under the age of 17, with the written consent of the parent or guardian.
The scope and manner of the review referred to in paragraph 1 of this Article and the criteria for selecting a donor shall be determined by the Minister by the Rulebook on Specific Technical Requirements
for blood and blood components, which he / she brings to the proposal of the Expert Commission on Transfusion Medicine.
Article 25
Prior to each donation of blood or blood component, the written consent of the person accessing the blood or blood component must be obtained.
The consent referred to in paragraph 1 of this Article must be an expression of the free will of the donor, based on full notification of the way blood is taken,
possible unintended consequences of taking blood, searches to be performed, use and protection of personal data, or
information on his blood type and test results.
The contents of the form referred to in paragraph 1 of this Article shall be prescribed by an ordinance by the Minister.
The Federal Institute and blood transfusion centers collect and record data from each donor and each blood unit at blood collection
electronic or written, as follows:
first and last name, name of one of the parents, date and place of birth, gender, address of residence, address of employer and occupation, unique
citizens' identification number (JMBG),
provider's anamnestic data,
the results of the medical examination of the donor,
informed consent form (questionnaire and notification for the blood donor),
reason for temporary or permanent refusal,
date and place of blood collection, ie blood component,
health institution that took the blood or blood component,
the identification number of the blood unit as well as the individual blood component,
the volume of blood taken,
test results,
any adverse events observed before, during and after blood collection.
Article 26
The medical doctor who examined the donor confirms with his signature that the donor has been examined and that blood can be taken from him and
the donor who is refused, state the reason for the rejection and the time period for which he was refused, which shall be notified to the donor.
The doctor of medicine should not allow blood or blood component to be taken if it is determined that there is a reason for temporary or permanent refusal
potential donor in accordance with the Rulebook referred to in Article 24, paragraph 3 of this Law.
The Federal Institute and the Authorized Health Institutions are required to enter the blood type, date of blood collection in the booklet of the voluntary blood donor
and provide a certificate of blood collection.
Article 27
The donor, under certain conditions, may also be the recipient of his own blood (autologous transfusion).
When planning surgeries that predict higher blood loss, the medical doctor treating the patient is required to know
patient with the possibility of autologous transfusion.
The person referred to in paragraph 1 of this Article may be under the age of 18, with the written consent of the parent or guardian.
For the pre-operative collection of autologous blood, the consent referred to in Article 25 of this Law is required.
Article 28
If it is determined or reasonably suspected that the blood donor is infected with any of the causes of blood borne diseases, the responsible person shall
call the donor immediately and inform him or her of a possible infection and its health consequences and recommend further steps in medical
treatment and avoidance of risky behavior.
In the case referred to in paragraph 1 of this Article, the responsible person shall:
determine how many times and when the donor has given blood or a blood component by then,
retest the preserved samples of his blood,
determine who received his or her previously given blood or blood component.
The responsible person shall, without delay, notify the recipient of that blood and advise him or her to be tested for an infected infection.
Testing of the recipient referred to in paragraph 3 of this Article may not be carried out without his or her written consent.
Testing of blood and blood components
Article 29
Each unit of blood and blood components collected will be tested for at least:
ABO and Rh D blood type,
the following blood-borne diseases: HIV1 / 2, hepatitis B, hepatitis C and lues,
the presence of antibodies directed against blood group antigens (outside the ABO blood group system).
The results of laboratory testing must be recorded in the record of the donor.
The ordinance referred to in Article 18 of this Law will set out in more detail the manner and conditions for testing blood and blood components.
Labeling of blood and blood components
Article 30
Each unit of blood and blood component must have a label containing:
the name of the healthcare institution that collected the blood or blood component,
unit identification number,
date of blood collection,
term of therapeutic use (end-use date) of blood or blood component,
blood group ABO and Rh (D) systems,
the presence of antibodies directed against blood group antigens (outside the ABO blood group system),
results of serological testing for blood-borne disease,
composition and amount of anticoagulant and preservative solution,
storage conditions and
method of application.
The label of the blood ingredient must also include the name of the preparation and manufacturer, information on the amount of the active substance, the name of the preservative or
stabilizing agent and method of administration.
On the unit of blood intended for autologous transfusion - must have a label with the name of the donor / recipient and the label
"Autologous blood."
Each blood sample for laboratory testing must bear a label containing the name of the healthcare facility, identification number, date
blood sampling and blood type.
Article 31
It is forbidden to distribute and use blood and blood components unless their origin can be proven and there is no evidence that they were
subjected to the testing referred to in Article 29 of this Law.
Article 32
The infected unit of blood is extracted from the refrigerator to store blood, labeled "not for transfusion-infectious", stored on it
certain site and biologically destroys it.
The Federal Institute and the Authorized Health Institution are obliged to submit a report on competent infectious disease to the competent health authorities
institutions, in accordance with the regulation governing the manner of reporting infectious diseases.
Storage, transportation and distribution of blood and blood components
Article 33
The Federal Institute and the Authorized Health Care Institutions must ensure that the blood, blood and blood components are stored, transported, and distributed so that
their quality and safety of application are ensured.
Article 34
Blood and blood components must be stored at a temperature that is optimal for their preservation. Refrigerators where blood is stored must have a system
which records the temperature.
The shelf life of blood or blood components depends on the composition and volume of the anticoagulants and additives.
If blood or blood components come into contact with air during operation, such unit must be dispensed within 24 hours.
Frozen and then dissolved units of blood and blood components should not be frozen again.
Units of blood or blood constituents for which laboratory testing has not been completed or the findings are not within the normal range must be kept
separate from units ready to be issued and be specially marked.
Autologous transfusion units of blood must be stored separately from allogeneic units of blood and blood components.
Article 35
The transport and distribution of blood and blood components must be carried out at all stages under conditions that maintain the quality and safety of blood and blood components.
ingredients.
Containers for the transport of blood and blood components must be marked with a sticker from a healthcare institution that distributes blood and blood components and
labeled "human blood - do not open".
Autologous blood and blood components must be clearly identified as such and transported and distributed separately from allogeneic blood and blood components.
The Federal Institute and authorized health institutions must keep a permanent record of the stocks and distributions of blood and blood components.
Control of blood and blood components
Article 36
Federal Institute and Transfusion Centers are obliged to control the quality of blood and blood components in accordance with the Rulebook on Special Technical
the requirements for blood and blood components referred to in Article 24 of this Law.
The quality of the blood and the blood component must be checked.
Use of blood and blood components
Article 37
The doctor of medicine who uses blood and blood components in the treatment is responsible for the justification of the use and the correctness of the procedure when
their use in accordance with good clinical practice.
The doctor of medicine referred to in paragraph 1 of this Article keeps the prescribed records, identifies serious adverse reactions and undertakes other prescribed actions.
The provisions of Art. 1 and 2 of this Article shall also apply to autotransfusion.
Article 38
The recipient, before receiving blood or a blood component, must confirm in writing that he or she was informed of the reasons for the blood or blood transfusion
ingredient, and the possible undesirable effects of transfusion, and that it is consistent with this treatment.
For the use of blood and blood components in the treatment of a juvenile, incapacitated person, a doctor of medicine is obliged to
paragraph 1 of this Article, to inform his or her parent or guardian in advance and obtain their written consent.
In case of inability to obtain the consent from par. 1 and 2 of this Article, the doctor of medicine shall act for the purpose of saving life, that is, in
the best interests of the patient, in accordance with the principles of the medical profession.
Hospital Transfusion Committee
Article 39
Healthcare institutions that use blood and blood components in their activity are obliged to establish a Hospital Transfusion Committee (hereinafter:
Committee) of at least five members.
The committee referred to in paragraph 1 of this Article shall consist of: doctor of transfusion medicine specialists, doctors of medicine of other specialties and other medical
professionals who use blood and blood components in their work, as well as medicines obtained from blood, taking into account gender representation.
The Committee monitors the justification for the use of blood and blood components, acting in accordance with the modern blood and blood transfusion procedure
ingredients, monitors serious adverse reactions and other work to justify the use of blood and blood components.
Unused blood and blood ingredient
Article 40
Blood and blood components that do not meet the standards of safety and quality in accordance with this law and regulations issued pursuant to this
laws are withdrawn from traffic, labeled with a "Not for transfusion" label, stored in a separate refrigerator and destroyed.
Unused blood units or blood components marked as "Autologous transfusion" should not be used to treat other persons and
they shall be withdrawn, stored and destroyed in accordance with paragraph 1 of this Article.
The manner of withdrawal, storage and destruction shall be regulated by the Regulations referred to in Article 18, paragraph 2 of this Law.
Monitoring of blood and blood components and reporting of serious adverse events and serious adverse reactions
Article 41
The collection, testing, processing, storage, distribution and dispensation of blood and blood components must be monitored and recorded from the donor to
the recipient as well as from recipient to donor.
The Federal Institute and authorized health institutions provide a system of identification measures for each blood and blood unit collected and issued
ingredients.
Data for complete monitoring of blood and blood components shall be kept for at least 30 years from the date of blood collection.
Article 42
A unique system for reporting serious adverse events and serious adverse reactions is being established in the territory of the Federation.
The system referred to in paragraph 1 of this Article shall contain data related to:
serious adverse events related to the collection, testing, processing, storage and distribution of blood and blood components, which could affect
to their quality and safety,
all serious adverse reactions observed during the use of blood and blood components.
The system of documentation, classification and assessment of the severity of adverse and unexpected events and reactions should be consistent with international
standards so that it enables the international exchange of data.
Any serious adverse event and serious adverse reaction shall be mandated in writing by the authorized healthcare institution without delay.
report to the Federal Bureau of Keeping a single register of serious adverse events and serious adverse reactions.
Article 43
Rulebook on the Monitoring System for Blood and Blood Ingredients and Serious Adverse Events and Serious Adverse Reactions, at the proposal of the Expert Commission for
transfusion medicine, brought by the Minister.
PLANNING PLANNING AND NEEDS
Article 44
Blood collection is performed in accordance with pre-planned or suddenly increased blood requirements, in accordance with the principle of self-sufficiency in
the need for blood and blood components.
Regular blood needs are determined by an annual need plan, and sudden needs are met by extraordinary blood donation and
other measures.
The annual plan for the needs of blood and blood components in the Federation, on the proposal of the Expert Commission on Transfusion Medicine, shall be established by the Minister.
Article 45
Pursuant to the plan referred to in Article 44 of this Law, the Federal Institute and Transfusion Centers, in cooperation with the Red Cross / Cross of the Federation of Bosnia and
Herzegovina and the Cantons shall establish an annual plan of voluntary blood donation actions for each calendar year.
The plan referred to in paragraph 1 of this Article shall determine the areas in which blood will be collected.
Article 46
In order to successfully implement the annual plan of action for voluntary blood donation, the Federal Institute for Transfusion Centers and the Red Cross / Cross
The Federations of Bosnia and Herzegovina and the Cantons act uniquely.
Article 47
Ministry, Cantonal Ministries of Health, Red Cross / Cross of the Federation of Bosnia and Herzegovina and Cantons, Federal Institute, Authorized and
other health care institutions, media, ministries of education, educational institutions, civil protection at all levels and other organizations
they are obliged to inform the population of the importance of blood donation and to encourage the population to donate blood for the purpose of self-sufficiency.
Promotional activities should be aligned with the need for sufficient quantities of blood and blood components throughout the Federation and
should take place throughout the year.
REPORTING
Article 48
The Federal Institute and Transfusion Centers are obliged to submit to the Ministry at least once a year reports on the following:
the total number of persons who have accessed blood and blood components,
the total number of blood units and blood components collected,
a description of the transfusion units supplied by the Federal Institute and transfusion centers,
the number and percentage of blood units processed,
the number of blood units and blood components distributed by species,
incidence and frequency of infectious markers of blood-borne diseases in blood donors and blood components,
the number of units of blood and blood components withdrawn from use,
the amount of blood waste by category (expiry date, damage to bags at production / application phase, faulty storage / transport),
the number and type of serious adverse events and serious adverse reactions.
EXPORTS AND IMPORTS OF BLOOD AND BLOOD INGREDIENTS
Article 49
Blood and blood components must not be exported from the Federation or imported into the Federation.
Notwithstanding paragraph 1 of this Article in emergency situations (natural and other disasters, as well as emergency and medical cases
justified need) permission for import / export of blood and blood components is given by the Ministry of Foreign Trade and Economic Relations of Bosnia and
Herzegovina upon the consent of the Ministry.
The export of plasma as a raw material for the production of plasma drugs for the needs of the population of the Federation shall be carried out in accordance with the procedure referred to in paragraph 2 of this
member.
The imported blood and blood components must meet the requirements of this law.
DATA PROTECTION
Article 50
In all procedures for taking blood and blood components, the privacy of the blood donor is ensured.
The identification of the blood donor and the results of laboratory testing shall be performed in accordance with the principles of medical ethics.
Article 51
Data on donors are collected and used only for the purposes established by this law, as well as for the purposes established by the law by which
records are kept in the field of health.
Article 52
The Federal Institute and Transfusion Centers shall keep all records and records maintained in a secure manner.
All information referred to in paragraph 1 of this Article shall be confidential.
Access to the data referred to in paragraph 1 of this Article is allowed only to an authorized person in accordance with the law.
Article 53
Any unauthorized release, deletion or modification of data, as well as the transfer or transfer of information contrary to the provisions of this
of the law.
EXPERT COMMITTEE ON TRANSFUSION MEDICINE
Article 54
An Expert Commission on Transfusion Medicine (hereinafter: the Commission) is established within the Ministry.
The committee is composed of: two transfusiologists with at least five years of professional experience, two experts from other fields of medicine in which it is applied
treatment with blood and blood components, immunologist, representative of the Ministry, representative of the Red Cross / Cross of the Federation of Bosnia and Herzegovina.
Gender equality must be taken into account when appointing the Commission.
The members of the Commission are appointed and dismissed by the Minister.
The Commission provides expert assistance to the Ministry in:
defining a safe blood transfusion policy and strategy,
monitoring the work of healthcare institutions engaged in transfusion,
defining blood collection programs,
drafting legislation in the field of transfusion medicine,
analysis of the results of transfusion treatment, including serious adverse events and serious adverse reactions,
analysis of the reports referred to in Article 48 of this Law,
drawing up plans for the functioning of the Federation Transfusion Service in emergency situations,
development of curriculum for education / training in transfusion medicine,
drafting technical recommendations / instructions, guidelines and standard operating procedures,
research, development and introduction of new technologies in transfusion medicine,
defining a policy and developing a Federation insurance plan for stable blood products / plasma derivatives,
establishment of a single information system in transfusion medicine and other activities of the Ministry in the development of transfusion medicine
medicine.
The Commission submits a report to the Minister once every three months.
The amount of compensation for the work of the members of the Commission shall be determined by a decision of the Minister.
SURVEILLANCE
Article 55
Supervision of the implementation and enforcement of this Law and regulations adopted on the basis of the law, as well as supervision of professional work, include:
internal professional supervision carried out by a health care institution in accordance with health care regulations,
External professional supervision carried out by the Federal Institute in authorized health institutions in accordance with the regulations referred to in paragraph 1 of this Article,
External expert supervision of the work of the Federal Institute shall be performed by an expert commission appointed by the Minister from among the members of the Commission referred to in Article 54.
of this law
inspection conducted by federal health inspectors in accordance with law.
The supervision referred to in paragraph 1, indents 2, 3 and 4 of this Article shall be carried out at least once every two years.
FINANCING
Article 56
The Federal Institute is funded by:
from the Budget of the Federation of Bosnia and Herzegovina,
based on a contract with the Health Insurance and Reinsurance Institute of the Federation of Bosnia and Herzegovina,
based on contracts with cantonal health insurance institutes,
From other sources in accordance with the law.
Authorized healthcare institutions are financed from the income of the healthcare institutions within which they operate.
The methodology for pricing manipulative costs of blood and blood components is determined by the Minister, upon the proposal of the Health Insurance Institute and
reinsurance of the Federation of Bosnia and Herzegovina, with the opinion of the Commission previously obtained.
PENALTY PROVISIONS
Article 57
A fine in the amount of 10,000.00 to 15,000.00 KM will be imposed on a health institution if:
performs transfusion activities without the Minister's approval (Article 12),
fails to perform blood or blood components testing (Article 29),
does not mark every unit of blood and blood component (Article 30),
distributes and uses blood and blood components contrary to Article 31 of this Law,
fails to perform the prescribed actions to detect units of infected blood or blood components and fails to comply with Article 32,
preserves and distributes blood and blood components in a manner contrary to law (Articles 34 and 35),
imports or exports blood and blood components without authorization (Article 49),
without consent, export plasma as a raw material for obtaining plasma medicines (Article 49).
For a misdemeanor referred to in paragraph 1 of this Article, a responsible person in a legal person shall also be fined in the amount from 500,00 KM to 2,000.00.
KM.
Article 58
A fine in the amount of KM 7,000.00 to KM 12,000.00 shall be imposed on a health institution if:
does not keep records or keep documentation contrary to the provisions of the law (Articles 25 and 41),
unused blood and blood components are withdrawn, stored or destroyed in violation of a special regulation (Article 40),
use autologous blood for unintended use or for the treatment of other persons (Article 40),
not notify the Federal Office of any serious adverse event and serious adverse reaction (Article 42),
does not store data in accordance with the law (Article 52).
For a misdemeanor referred to in paragraph 1 of this Article, a responsible person in a legal person shall also be fined in the amount of KM 300.00 to 1.500,00.
KM.
Article 59
A fine in the amount of KM 5,000.00 to KM 10,000.00 shall be imposed on a health institution if:
for the blood taken and the blood ingredient gives a cash benefit (Article 22),
take blood or blood component from the donor without the prior written consent (Article 25),
take blood or blood ingredient from a donor who is found to have a reason for temporary or permanent refusal as donor (Article 26),
does not inform the provider about the detected infection, infectious disease or carrier of the infectious disease and does not advise the provider about further behavior (Article 28),
does not immediately notify the recipient and does not advise the recipient to be tested for an identified infection (Article 28),
tests the recipient without written consent (Article 28),
apply blood or blood component without the written consent of the recipient or apply blood or blood component in the treatment of a minor, business
incapacitated person without the written consent of the parent or guardian (Article 38),
does not report to the Ministry in accordance with Article 48 of this Law.
For a misdemeanor referred to in paragraph 1 of this Article, a responsible person in a legal person shall also be fined in the amount of 200,00 KM to 1,000,00.
KM.
Article 60
A fine in the amount of KM 10,000.00 to KM 15,000.00 shall be imposed on the Federal Institute if:
does not organize and carry out continuous education (Article 7),
fails to establish the unique registers referred to in Article 7 of this Law.
For a misdemeanor referred to in paragraph 1 of this Article, a responsible person in a legal person shall also be fined in the amount of KM 300.00 to 1.500,00.
KM.
Article 61
A fine in the amount of KM 100.00 to KM 500.00 shall be imposed on the natural person for the offense if he receives for a given blood or blood component
financial compensation (Article 22).
TRANSITIONAL AND FINAL PROVISIONS
Article 62
Health care institutions, which, in accordance with the regulations in force until the day this Law enters into force, performed their activities
transfusion activities, are obliged to harmonize their work and business with the provisions of this law and the by-laws adopted on
basis of this law within 18 months from the day this law enters into force.
Article 63
By-laws for the implementation of this Law from Art. 11, 18, 24, 43 and 56 of this Law shall be adopted within 12 months from the day
the entry into force of this law.
Until the date of entry into force of the regulations referred to in paragraph 1 of this Article, the regulations in force until the date of entry into force of this Article shall apply.
laws, if they do not contravene this law.
On the day this Law and the implementing regulations enter into force, the provisions of Article 85, Paragraph 2 and Article 87 of the Law
health care ("Official Gazette of the Federation of BiH", No. 29/97).
Article 64
The expert commission for transfusion medicine referred to in Article 54 of this Law shall be established within three months from the day this Law enters into force.
of the law.
Article 65
The grammatical use of masculine or feminine for the terms in this law includes both genders.
Article 66
This Law shall enter into force on the eighth day after its publication in the Official Gazette of the Federation of Bosnia and Herzegovina.
CHAIRPERSON
REPRESENTATIVE OFFICE
PARLIAMENT OF THE FEDERATION OF BiH
Safet Softić
CHAIRPERSON
HOME OF THE PEOPLE
PARLIAMENT OF THE FEDERATION OF BiH
Stjepan Krešić