0A4F4F9BD490A749D5437F821CF06DF1
Law about Blood and Blood Products (2006)
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Health / Drug Usage
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p.001916: 1916
p.001916: Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby
p.001916: DECISION
p.001916: ON THE DECLARATION OF THE LAW ON BLOOD AND BLOOD PREPARATION
p.001916: I hereby declare the Law on Blood and Blood Products, adopted by the Croatian Parliament at its session of 30 June 2006
p.001916: Class: 011-01 / 06-01 / 30
p.001916: Reg. No: 71-05-03 / 1-06-2
p.001916: Zagreb, 5 July 2006
p.001916: The President
p.001916: Of the Republic of Croatia
p.001916: Stjepan Mesic, v. r.
p.001916: LAW
p.001916: ON BLOOD AND BLOOD PREPARATIONS
p.001916: I. GENERAL PROVISIONS
p.001916: Article 1
p.001916: This Act regulates the supply of blood and blood products to the population of the Republic of Croatia, which includes the system of social,
p.001916: group and individual measures and activities in the field of planning, collecting and testing blood and producing, storing and distributing blood
p.001916: of the preparation.
p.001916: The provisions of this Act shall not apply to the supply of medicinal products from human blood or human plasma.
p.001916: Article 2
p.001916: The terms in this Law have the following meaning:
p.001916: 1. "blood" means blood collected from a blood donor into an anticoagulant solution for processing into blood products for transfusion or for
p.001916: further processing,
p.001916: 2. "blood donor" means a person who donates blood or a blood component,
p.001916: 3. "blood recipient" means a person who receives blood or a blood product for medical purposes,
p.001916: 4. "blood component" means the portion of blood collected from a donor (erythrocytes, leukocytes, platelets, plasma),
p.001916: 5. "blood preparation" means any therapeutic preparation for transfusion treatment produced from human blood or a blood component,
p.001916: 6. "plasma derivative" means a therapeutic composition or drug produced from human plasma,
p.001916: 7. "autologous transfusion" is a form of transfusion treatment in which the blood donor and the recipient are the same person and to whom it is administered
p.001916: previously taken and stored blood or a blood preparation,
p.001916: 8. "Certified health institution" means a health institution / part of a health institution that performs blood and blood collection and testing
p.001916: ingredients, regardless of their purpose and their processing, storage, distribution and dispensing when intended for transfusion
p.001916: treatment,
p.001916: 9. "hospital transfusion unit" means an organizational unit of a hospital healthcare institution that stores and dispenses blood and blood products, and which may
p.001916: to carry out testing of markers of blood transmitted diseases, immunohematological and molecular tests of patients and pregnant women, diagnostics and
p.001916: hemostatic disorders therapy, supervision of transfusion treatment and other hospital transfusion diagnostic and therapeutic
p.001916: procedures,
p.001916: 10. "serious adverse event" means an adverse event related to the collection, testing, treatment, storage, distribution or transport of blood and
p.001916: blood products, which could lead to death or danger of damage to the patient's health, or resulting in hospital
p.001916: the treatment of persons, their morbidity or their extension,
p.001916: 11. "serious adverse reaction" means an unpredictable response from a blood donor or patient related to the collection or transfusion of blood or blood
p.001916: preparations, which are deadly, life-threatening, cause damage to the health of the patient or result in hospital treatment
p.001916: the person, their morbidity or who prolongs them,
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Health / Pregnant
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p.001916: of the preparation.
p.001916: The provisions of this Act shall not apply to the supply of medicinal products from human blood or human plasma.
p.001916: Article 2
p.001916: The terms in this Law have the following meaning:
p.001916: 1. "blood" means blood collected from a blood donor into an anticoagulant solution for processing into blood products for transfusion or for
p.001916: further processing,
p.001916: 2. "blood donor" means a person who donates blood or a blood component,
p.001916: 3. "blood recipient" means a person who receives blood or a blood product for medical purposes,
p.001916: 4. "blood component" means the portion of blood collected from a donor (erythrocytes, leukocytes, platelets, plasma),
p.001916: 5. "blood preparation" means any therapeutic preparation for transfusion treatment produced from human blood or a blood component,
p.001916: 6. "plasma derivative" means a therapeutic composition or drug produced from human plasma,
p.001916: 7. "autologous transfusion" is a form of transfusion treatment in which the blood donor and the recipient are the same person and to whom it is administered
p.001916: previously taken and stored blood or a blood preparation,
p.001916: 8. "Certified health institution" means a health institution / part of a health institution that performs blood and blood collection and testing
p.001916: ingredients, regardless of their purpose and their processing, storage, distribution and dispensing when intended for transfusion
p.001916: treatment,
p.001916: 9. "hospital transfusion unit" means an organizational unit of a hospital healthcare institution that stores and dispenses blood and blood products, and which may
p.001916: to carry out testing of markers of blood transmitted diseases, immunohematological and molecular tests of patients and pregnant women, diagnostics and
p.001916: hemostatic disorders therapy, supervision of transfusion treatment and other hospital transfusion diagnostic and therapeutic
p.001916: procedures,
p.001916: 10. "serious adverse event" means an adverse event related to the collection, testing, treatment, storage, distribution or transport of blood and
p.001916: blood products, which could lead to death or danger of damage to the patient's health, or resulting in hospital
p.001916: the treatment of persons, their morbidity or their extension,
p.001916: 11. "serious adverse reaction" means an unpredictable response from a blood donor or patient related to the collection or transfusion of blood or blood
p.001916: preparations, which are deadly, life-threatening, cause damage to the health of the patient or result in hospital treatment
p.001916: the person, their morbidity or who prolongs them,
p.001916: 12. "release of a blood product" means the withdrawal of a blood product from quarantine status by the use of systems and procedures to ensure
p.001916: that the final product meets the release specification,
p.001916: 13. "distribution" means the distribution of blood products to authorized healthcare institutions, hospital transfusion units and other
p.001916: institutions for manufacturers of blood and plasma drugs,
p.001916: 14. "total blood safety monitoring" means a series of organized surveillance procedures aimed at preventing harmful or unexpected
p.001916: events or reactions of the donor or recipient of blood or minimize it,
p.001916: 15. "health inspection" means supervision over the application and enforcement of this Act and the regulations adopted pursuant to this Law.
p.001916: Of the Act, as well as the supervision of professional work in authorized healthcare institutions in accordance with established standards.
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Health / patients in emergency situations
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p.001916: data exchange.
p.001916: Any serious adverse event and serious adverse reaction shall be mandated in writing by an authorized healthcare institution.
p.001916: report to the Croatian Institute for Transfusion Medicine and the Ministry.
p.001916: Authorized healthcare providers are required to establish an effective and proven system of withdrawal from blood products that are
p.001916: cause or may cause a serious adverse event or a serious adverse reaction.
p.001916: Article 21
p.001916: Healthcare facilities that administer blood products for transfusion treatment are required to establish a system for reporting serious
p.001916: adverse events and serious adverse reactions within the institution.
p.001916: Any serious adverse event and serious adverse reaction referred to in paragraph 1 of this Article shall be obliged by the health institution without
p.001916: to notify the Croatian Institute of Transfusion Medicine and the Ministry in writing.
p.001916: Article 22
p.001916: The register of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Act shall be kept by the Croatian Institute for Transfusion
p.001916: medicine.
p.001916: Article 23
p.001916: Ordinance on the monitoring of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Law, with previously obtained
p.001916: the opinion of the competent chamber, is passed by the Minister.
p.001916: VIII. EXPORTS AND IMPORTS OF BLOOD AND BLOOD PREPARATIONS
p.001916: Article 24
p.001916: Blood and blood products must not be exported from the Republic of Croatia.
p.001916: The Minister may exceptionally, in the case of natural disasters and other emergencies, as well as in cases of emergency,
p.001916: medically justified need to approve the export of blood and blood products.
p.001916: In the case referred to in paragraph 1 of this Article, testing in accordance with Article 15 of this Act shall be ensured.
p.001916: Article 25
p.001916: Blood and blood products must not be imported into the Republic of Croatia.
p.001916: The Minister may exceptionally, in the case of natural and other emergencies, as well as in cases of emergency, medically
p.001916: justify the need to approve the importation of blood and blood products.
p.001916: The imported blood and blood products must meet the conditions prescribed by this Act and testing in accordance with Article 15 must be ensured.
p.001916: of this Act.
p.001916: IX. INSURANCE OF THE QUALITY AND INJURY OF BLOOD AND BLOOD PREPARATIONS
p.001916: Article 26
p.001916: The promotion and organization of the donation of blood and blood components in the Republic of Croatia are based on the principles of voluntary, free,
p.001916: anonymity and solidarity.
p.001916: For the blood or blood component taken, it is forbidden for the donor to provide financial compensation.
p.001916: For a given blood or blood component, the donor may not receive any monetary compensation.
p.001916: Article 27
p.001916: Donors of blood and blood components may only be adults who are identified by the doctor of medicine referred to in Article 29, paragraph 2 of this Act
p.001916: absence of medical reasons that could cause damage to the health of the provider or patient.
p.001916: By way of derogation from paragraph 1 of this Article, in the case of an autologous transfusion, the donor of the blood or blood component does not have to be an adult.
p.001916: Article 28
p.001916: The person who approaches the donation of blood or blood component must be informed about possible reactions during blood collection, the extent of testing
p.001916: blood and protect personal information.
p.001916: The information referred to in paragraph 1 of this Article shall be given by the medical doctor referred to in Article 29, paragraph 2 of this Act, who shall also request the information necessary for the
p.001916: an assessment of the person's suitability for donating blood or a blood component.
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Social / Access to Social Goods
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p.001916: Article 31
p.001916: The Croatian Institute for Transfusion Medicine maintains a register of blood donors.
p.001916: In the register referred to in paragraph 1 of this Article, particulars shall be given of persons who may not temporarily or permanently be blood donors.
p.001916: Article 32
p.001916: The blood donor registry must be part of the national transfusion information system.
p.001916: The registry must be accessible to all health facilities that collect blood.
p.001916: Funds for keeping the register are provided in the state budget.
p.001916: Article 33
p.001916: The blood donation and blood components are promoted in the territory of the Republic of Croatia by the Croatian Institute for Transfusion Medicine and the Croatian
p.001916: Red cross.
p.001916: Promotional activities should be continuous and consistent with the need for sufficient quantities of blood and blood products in the area
p.001916: throughout the Republic of Croatia throughout the year.
p.001916: Article 34
p.001916: A unique annual plan of blood donation actions for the Republic of Croatia is adopted by the Croatian Institute for Transfusion Medicine and the Croatian Red
p.001916: cross based on anticipated blood supply needs of all healthcare facilities.
p.001916: Article 35
p.001916: The Minister shall prescribe the conditions regarding the premises and equipment to be fulfilled by the organizer of blood donation operations.
p.001916: X. DATA PROTECTION
p.001916: Article 36
p.001916: Medical information on the blood donor, including the information referred to in Articles 15 and 28 of this Act shall be confidential and shall be protected from
p.001916: unauthorized access.
p.001916: Article 37
p.001916: Personal information about providers is a professional secret.
p.001916: The personal data referred to in paragraph 1 of this Article shall be kept and communicated in accordance with special regulations governing the protection of professional secrecy and
p.001916: protection of personal data.
p.001916: XI. HEALTH-INSPECTION
p.001916: Article 38
p.001916: Supervision of the implementation and enforcement of this Act and regulations adopted pursuant to this Act, as well as supervision of professional work in
p.001916: authorized health institutions are conducted by the ministry - health inspection.
p.001916: Health inspection activities referred to in paragraph 1 of this Article shall be performed by health inspectors and other civil servants
p.001916: in accordance with a separate law.
p.001916: Article 39
p.001916: Health inspectors shall carry out regular inspections referred to in Article 38 of this Act at least once every two years.
p.001916: In the event of a serious adverse event, the health inspector will carry out an urgent inspection.
p.001916: Article 40
p.001916: In carrying out the inspection supervision referred to in Article 39 of this Law, the health inspector shall have the rights and duties:
p.001916: 1. order the pursuit of the activity in accordance with the conditions laid down in this Act and other regulations,
p.001916: 2. order the elimination of identified irregularities and deficiencies within the specified deadline,
p.001916: 3. prohibit the implementation of actions contrary to this Law and other regulations,
p.001916: 4. temporarily prohibit the work of an authorized health care institution if it does not meet the requirements regarding workers, equipment and premises,
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p.001916: performing a specific activity,
p.001916: 7. order the withdrawal from circulation of blood products that do not meet the conditions prescribed by this Law and other regulations,
p.001916: 8. declare a blood product found not to comply with the prescribed standards for hazardous waste and order it
p.001916: disposal,
p.001916: 9. order the taking of other measures for which it is authorized by this Law and other regulations.
p.001916: XII. PENALTY PROVISIONS
p.001916: Article 41
p.001916: A legal person shall be fined in the amount of HRK 70,000.00 to HRK 100,000.00 for the offense if:
p.001916: 1. plans, collects and tests blood or produces, stores or dispenses blood products without the Minister's approval (Article 7),
p.001916: 2. collects or tests blood or produces blood products without the Minister's permission (Article 10),
p.001916: 3. export blood or blood products from the Republic of Croatia contrary to Article 24 of this Law,
p.001916: 4. import blood or blood products into the Republic of Croatia contrary to Article 25 of this Law.
p.001916: A responsible person in
p.001916: to a legal person.
p.001916: A natural person shall also be fined in the amount of HRK 5,000.00 to HRK 15,000.00 for the offense referred to in paragraph 1 of this Article.
p.001916: The perpetrator shall be punished for attempting the offense referred to in paragraph 1 of this Article.
p.001916: Article 42
p.001916: An authorized health institution will be fined in the amount of HRK 70,000.00 to HRK 100,000.00 if:
p.001916: 1. does not inform the Croatian Institute for Transfusion Medicine and the Ministry of any serious adverse event and serious adverse reaction
p.001916: (Article 20 (3)),
p.001916: 2. fails to protect confidential medical information about the blood donor from unauthorized access (Article 36).
p.001916: A responsible person in
p.001916: to a legal person.
p.001916: Article 43
p.001916: The authorized health institution shall be fined in the amount of HRK 30,000.00 to HRK 50,000.00 if:
p.001916: 1. in the case of changes in the procedures for the collection or testing of blood, or the production of blood products that may affect them
p.001916: Efficiency, quality and harmlessness do not require the approval of the Minister (Article 14, paragraph 1),
p.001916: 2. does not keep the prescribed records when performing the transfusion activity (Article 17, paragraph 1)
p.001916: 3. fails to submit the data from the records within the prescribed deadline to the Croatian Institute for Transfusion Medicine (Article 17, paragraph 2);
p.001916: 4. provides compensation for the blood collected (Article 26, paragraph 2),
p.001916: 5. take blood from a minor or adult contrary to Article 27 of this Law,
p.001916: 6. fails to inform the person who approaches the blood or blood component about possible reactions during blood collection, the extent of blood testing and
p.001916: protection of personal data (Article 28),
p.001916: 7. fails to perform the prescribed examination of the person who accesses the donation of blood or blood component (Article 29),
p.001916: 8. take blood or blood component without the prescribed consent of the donor (Article 30).
p.001916: A responsible person in
p.001916: to a legal person.
p.001916: A fine in the amount of HRK 3,000.00 to HRK 7,000.00 for a misdemeanor referred to in paragraph 1, points 5, 6, 7 and 8 of this Article shall also be imposed on the doctor.
p.001916: medicine in a licensed healthcare facility.
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Social / Marital Status
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p.001916: The Croatian Institute for Transfusion Medicine is obliged to keep the data from the records referred to in paragraph 1 of this Article for at least 15 years.
p.001916: Article 18
p.001916: The Croatian Institute for Transfusion Medicine submits data from the Ministry responsible for health (hereinafter: the Ministry)
p.001916: the records of authorized health institutions determined by the ordinance issued by the Minister.
p.001916: The manner and deadlines for submission of data from the records of authorized health institutions shall be determined by the ordinance referred to in paragraph 1 of this Article.
p.001916: The Ministry is obliged to establish and maintain a uniform system of data storage referred to in paragraph 2 of this Article.
p.001916: VII. MONITORING HARMFUL EVENTS
p.001916: Article 19
p.001916: Traceability and labeling system for each blood product produced from the donor to the patient and vice versa throughout
p.001916: States is a set of procedures and measures that can be indisputably identified by each individual blood donor, dose taken, produced
p.001916: blood preparation and patient.
p.001916: The traceability and labeling system for blood products should be in line with international traceability and labeling systems
p.001916: ensuring the traceability of blood products internationally.
p.001916: Authorized healthcare institutions are obliged to apply the traceability and labeling system in performing all the activities referred to in Article 7 of this
p.001916: Of the law.
p.001916: The system of traceability and labeling of blood products, with the previously obtained opinion of the competent chamber, shall be prescribed by an ordinance by the Minister.
p.001916: Article 20
p.001916: Croatian Institute for Transfusion Medicine is obliged to establish a single national system for reporting harmful and unexpected
p.001916: events and reactions related to:
p.001916: - collecting and testing blood, and producing, storing and distributing blood products that could affect their blood
p.001916: efficiency, quality and harmlessness,
p.001916: - the use of blood products in case of doubt about their effectiveness, quality and harmlessness.
p.001916: The system of documentation, classification and assessment of the severity of adverse and unexpected events and reactions must allow for international
p.001916: data exchange.
p.001916: Any serious adverse event and serious adverse reaction shall be mandated in writing by an authorized healthcare institution.
p.001916: report to the Croatian Institute for Transfusion Medicine and the Ministry.
p.001916: Authorized healthcare providers are required to establish an effective and proven system of withdrawal from blood products that are
p.001916: cause or may cause a serious adverse event or a serious adverse reaction.
p.001916: Article 21
p.001916: Healthcare facilities that administer blood products for transfusion treatment are required to establish a system for reporting serious
p.001916: adverse events and serious adverse reactions within the institution.
p.001916: Any serious adverse event and serious adverse reaction referred to in paragraph 1 of this Article shall be obliged by the health institution without
p.001916: to notify the Croatian Institute of Transfusion Medicine and the Ministry in writing.
p.001916: Article 22
p.001916: The register of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Act shall be kept by the Croatian Institute for Transfusion
p.001916: medicine.
p.001916: Article 23
p.001916: Ordinance on the monitoring of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Law, with previously obtained
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Social / Women
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p.001916: Article 2
p.001916: The terms in this Law have the following meaning:
p.001916: 1. "blood" means blood collected from a blood donor into an anticoagulant solution for processing into blood products for transfusion or for
p.001916: further processing,
p.001916: 2. "blood donor" means a person who donates blood or a blood component,
p.001916: 3. "blood recipient" means a person who receives blood or a blood product for medical purposes,
p.001916: 4. "blood component" means the portion of blood collected from a donor (erythrocytes, leukocytes, platelets, plasma),
p.001916: 5. "blood preparation" means any therapeutic preparation for transfusion treatment produced from human blood or a blood component,
p.001916: 6. "plasma derivative" means a therapeutic composition or drug produced from human plasma,
p.001916: 7. "autologous transfusion" is a form of transfusion treatment in which the blood donor and the recipient are the same person and to whom it is administered
p.001916: previously taken and stored blood or a blood preparation,
p.001916: 8. "Certified health institution" means a health institution / part of a health institution that performs blood and blood collection and testing
p.001916: ingredients, regardless of their purpose and their processing, storage, distribution and dispensing when intended for transfusion
p.001916: treatment,
p.001916: 9. "hospital transfusion unit" means an organizational unit of a hospital healthcare institution that stores and dispenses blood and blood products, and which may
p.001916: to carry out testing of markers of blood transmitted diseases, immunohematological and molecular tests of patients and pregnant women, diagnostics and
p.001916: hemostatic disorders therapy, supervision of transfusion treatment and other hospital transfusion diagnostic and therapeutic
p.001916: procedures,
p.001916: 10. "serious adverse event" means an adverse event related to the collection, testing, treatment, storage, distribution or transport of blood and
p.001916: blood products, which could lead to death or danger of damage to the patient's health, or resulting in hospital
p.001916: the treatment of persons, their morbidity or their extension,
p.001916: 11. "serious adverse reaction" means an unpredictable response from a blood donor or patient related to the collection or transfusion of blood or blood
p.001916: preparations, which are deadly, life-threatening, cause damage to the health of the patient or result in hospital treatment
p.001916: the person, their morbidity or who prolongs them,
p.001916: 12. "release of a blood product" means the withdrawal of a blood product from quarantine status by the use of systems and procedures to ensure
p.001916: that the final product meets the release specification,
p.001916: 13. "distribution" means the distribution of blood products to authorized healthcare institutions, hospital transfusion units and other
p.001916: institutions for manufacturers of blood and plasma drugs,
p.001916: 14. "total blood safety monitoring" means a series of organized surveillance procedures aimed at preventing harmful or unexpected
p.001916: events or reactions of the donor or recipient of blood or minimize it,
p.001916: 15. "health inspection" means supervision over the application and enforcement of this Act and the regulations adopted pursuant to this Law.
p.001916: Of the Act, as well as the supervision of professional work in authorized healthcare institutions in accordance with established standards.
p.001916: II. SOCIAL CARE FOR INSURANCE OF EFFECTIVE, QUALITATIVE AND INHERENT BLOOD PREPARATIONS
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Social / Youth/Minors
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p.001916: 4. import blood or blood products into the Republic of Croatia contrary to Article 25 of this Law.
p.001916: A responsible person in
p.001916: to a legal person.
p.001916: A natural person shall also be fined in the amount of HRK 5,000.00 to HRK 15,000.00 for the offense referred to in paragraph 1 of this Article.
p.001916: The perpetrator shall be punished for attempting the offense referred to in paragraph 1 of this Article.
p.001916: Article 42
p.001916: An authorized health institution will be fined in the amount of HRK 70,000.00 to HRK 100,000.00 if:
p.001916: 1. does not inform the Croatian Institute for Transfusion Medicine and the Ministry of any serious adverse event and serious adverse reaction
p.001916: (Article 20 (3)),
p.001916: 2. fails to protect confidential medical information about the blood donor from unauthorized access (Article 36).
p.001916: A responsible person in
p.001916: to a legal person.
p.001916: Article 43
p.001916: The authorized health institution shall be fined in the amount of HRK 30,000.00 to HRK 50,000.00 if:
p.001916: 1. in the case of changes in the procedures for the collection or testing of blood, or the production of blood products that may affect them
p.001916: Efficiency, quality and harmlessness do not require the approval of the Minister (Article 14, paragraph 1),
p.001916: 2. does not keep the prescribed records when performing the transfusion activity (Article 17, paragraph 1)
p.001916: 3. fails to submit the data from the records within the prescribed deadline to the Croatian Institute for Transfusion Medicine (Article 17, paragraph 2);
p.001916: 4. provides compensation for the blood collected (Article 26, paragraph 2),
p.001916: 5. take blood from a minor or adult contrary to Article 27 of this Law,
p.001916: 6. fails to inform the person who approaches the blood or blood component about possible reactions during blood collection, the extent of blood testing and
p.001916: protection of personal data (Article 28),
p.001916: 7. fails to perform the prescribed examination of the person who accesses the donation of blood or blood component (Article 29),
p.001916: 8. take blood or blood component without the prescribed consent of the donor (Article 30).
p.001916: A responsible person in
p.001916: to a legal person.
p.001916: A fine in the amount of HRK 3,000.00 to HRK 7,000.00 for a misdemeanor referred to in paragraph 1, points 5, 6, 7 and 8 of this Article shall also be imposed on the doctor.
p.001916: medicine in a licensed healthcare facility.
p.001916: The perpetrator shall be punished for attempting the offense referred to in paragraph 1, items 4, 5 and 8 of this Article.
p.001916: Article 44
p.001916: A fine of HRK 30,000.00 to HRK 50,000.00 shall be imposed on the Croatian Institute of Transfusion Medicine for an offense if
p.001916: does not submit the data from the records of authorized health institutions to the Ministry within the prescribed period (Article 18, paragraph 1).
p.001916: A responsible person in the amount of HRK 3,000.00 to HRK 7,000.00 shall also be fined for the misdemeanor referred to in paragraph 1 of this Article.
p.001916: Croatian Institute for Transfusion Medicine.
p.001916: Article 45
p.001916: A fine in the amount of HRK 1,000,000 to HRK 5,000.00 shall be imposed on an individual if he or she receives blood or a blood component for a given day.
p.001916: financial compensation (Article 26 (3)).
p.001916: XIII. TRANSITIONAL AND FINAL PROVISIONS
p.001916: Article 46
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Social / education
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p.001916: events or reactions of the donor or recipient of blood or minimize it,
p.001916: 15. "health inspection" means supervision over the application and enforcement of this Act and the regulations adopted pursuant to this Law.
p.001916: Of the Act, as well as the supervision of professional work in authorized healthcare institutions in accordance with established standards.
p.001916: II. SOCIAL CARE FOR INSURANCE OF EFFECTIVE, QUALITATIVE AND INHERENT BLOOD PREPARATIONS
p.001916: Article 3
p.001916: The Republic of Croatia, in the provision of social care for the health of its inhabitants throughout its territory, provides the conditions for supply
p.001916: population with effective, quality and harmless blood products.
p.001916: Article 4
p.001916: Republic of Croatia its rights, obligations, tasks and goals in the field of supplying the population with effective, quality and harmless
p.001916: blood products accomplish:
p.001916: - planning of the need to treat patients with medicines produced from human blood,
p.001916: - promoting the principle of self-sufficiency in the supply of blood to the population through voluntary and unpaid donation,
p.001916: - ensuring the conditions for raising public awareness of the need for blood collection and the use of blood products,
p.001916: - providing funds throughout the Republic of Croatia for the harmonization of blood collection and testing procedures; and
p.001916: production, storage and distribution of blood products with scientific and technological development achievements,
p.001916: - establishing and ensuring the development of a health information system for the field of transfusion medicine in the Republic
p.001916: Croatia,
p.001916: - ensuring the development of scientific activity in the field of transfusion medicine,
p.001916: - providing conditions for the education of healthcare professionals in the field of transfusion medicine.
p.001916: III. AVAILABILITY OF BLOOD PREPARATIONS
p.001916: Article 5
p.001916: In order to ensure the availability of blood products for all health care institutions, the required number is determined by the transfusion network
p.001916: authorized health institutions for the territory of the Republic of Croatia, or units of regional (regional) self-government.
p.001916: Article 6
p.001916: The network of transfusion activities is determined by the basic network of healthcare activities in accordance with the Law on Health Care.
p.001916: Article 7
p.001916: The planning, collection and testing of blood and the production, storage, distribution or dispensing of blood products may be performed by
p.001916: a health institution, that is, a part of a health institution that has been approved by the Minister for performing one of these activities
p.001916: competent for health (hereinafter: the Minister) in accordance with the provisions of this Act (authorized health institution).
p.001916: Article 8
p.001916: The approval referred to in Article 7 of this Act, at the request of the health institution, shall be given by the Minister by a decision declaring that the health care
p.001916: the institution is eligible for a particular activity.
p.001916: No appeal shall be allowed against the decision referred to in paragraph 1 of this Article, but an administrative dispute may be instituted against that decision.
p.001916: An authorized healthcare institution operating the blood production business must employ a responsible person -
p.001916: doctor of transfusion medicine specialist with at least five years of work experience in the field of that specialty that is
p.001916: responsible for the collection, testing, processing, storage, distribution and dispensing of blood products in accordance with this Act.
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Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.001916: authorized health institutions for the territory of the Republic of Croatia, or units of regional (regional) self-government.
p.001916: Article 6
p.001916: The network of transfusion activities is determined by the basic network of healthcare activities in accordance with the Law on Health Care.
p.001916: Article 7
p.001916: The planning, collection and testing of blood and the production, storage, distribution or dispensing of blood products may be performed by
p.001916: a health institution, that is, a part of a health institution that has been approved by the Minister for performing one of these activities
p.001916: competent for health (hereinafter: the Minister) in accordance with the provisions of this Act (authorized health institution).
p.001916: Article 8
p.001916: The approval referred to in Article 7 of this Act, at the request of the health institution, shall be given by the Minister by a decision declaring that the health care
p.001916: the institution is eligible for a particular activity.
p.001916: No appeal shall be allowed against the decision referred to in paragraph 1 of this Article, but an administrative dispute may be instituted against that decision.
p.001916: An authorized healthcare institution operating the blood production business must employ a responsible person -
p.001916: doctor of transfusion medicine specialist with at least five years of work experience in the field of that specialty that is
p.001916: responsible for the collection, testing, processing, storage, distribution and dispensing of blood products in accordance with this Act.
p.001916: More detailed conditions regarding premises, professional staff and medical and technical equipment for performing the activities referred to in Article 7 of this Law, with
p.001916: the previously obtained opinion of the competent chamber shall be prescribed by an ordinance by the Minister.
p.001916: Article 9
p.001916: The Minister ex officio issues a decision revoking the authorization referred to in Article 7 of this Act if he determines that the authorized health
p.001916: institution:
p.001916: - no longer fulfills the conditions from Article 8 of this Law,
p.001916: - does not comply with the provisions of this Act and the ordinances adopted pursuant to this Act.
p.001916: IV. PERMITS TO PERFORM TRANSFUSION ACTIVITIES
p.001916: Article 10
p.001916: Blood collection and testing and production of blood products in the Republic of Croatia may only be performed by an authorized health care provider
p.001916: institution authorized to carry out these transfusion activities.
p.001916: The permit referred to in paragraph 1 of this Article shall be given or denied by the Minister by a decision which is not allowed to appeal, but is appealed against.
p.001916: solutions can be initiated by an administrative dispute.
p.001916: Article 11
p.001916: The application for the permit referred to in Article 10 of this Law shall be submitted to the Minister and shall contain:
p.001916: - name and headquarters of the health institution,
p.001916: - personal data of the responsible person in the institution,
p.001916: - personal data of the person responsible for the transfusion activity in the institution,
p.001916: - a list of procedures and activities for which a license is sought,
p.001916: - documentation describing the system of activity and quality with responsible persons,
p.001916: - display of appropriate premises and equipment for the procedures / jobs for which the permit is requested,
p.001916: - the results of external quality control.
p.001916: Article 12
...
p.001916: the deadlines prescribed by the ordinance referred to in paragraph 1 of this Article.
p.001916: The Croatian Institute for Transfusion Medicine is obliged to keep the data from the records referred to in paragraph 1 of this Article for at least 15 years.
p.001916: Article 18
p.001916: The Croatian Institute for Transfusion Medicine submits data from the Ministry responsible for health (hereinafter: the Ministry)
p.001916: the records of authorized health institutions determined by the ordinance issued by the Minister.
p.001916: The manner and deadlines for submission of data from the records of authorized health institutions shall be determined by the ordinance referred to in paragraph 1 of this Article.
p.001916: The Ministry is obliged to establish and maintain a uniform system of data storage referred to in paragraph 2 of this Article.
p.001916: VII. MONITORING HARMFUL EVENTS
p.001916: Article 19
p.001916: Traceability and labeling system for each blood product produced from the donor to the patient and vice versa throughout
p.001916: States is a set of procedures and measures that can be indisputably identified by each individual blood donor, dose taken, produced
p.001916: blood preparation and patient.
p.001916: The traceability and labeling system for blood products should be in line with international traceability and labeling systems
p.001916: ensuring the traceability of blood products internationally.
p.001916: Authorized healthcare institutions are obliged to apply the traceability and labeling system in performing all the activities referred to in Article 7 of this
p.001916: Of the law.
p.001916: The system of traceability and labeling of blood products, with the previously obtained opinion of the competent chamber, shall be prescribed by an ordinance by the Minister.
p.001916: Article 20
p.001916: Croatian Institute for Transfusion Medicine is obliged to establish a single national system for reporting harmful and unexpected
p.001916: events and reactions related to:
p.001916: - collecting and testing blood, and producing, storing and distributing blood products that could affect their blood
p.001916: efficiency, quality and harmlessness,
p.001916: - the use of blood products in case of doubt about their effectiveness, quality and harmlessness.
p.001916: The system of documentation, classification and assessment of the severity of adverse and unexpected events and reactions must allow for international
p.001916: data exchange.
p.001916: Any serious adverse event and serious adverse reaction shall be mandated in writing by an authorized healthcare institution.
p.001916: report to the Croatian Institute for Transfusion Medicine and the Ministry.
p.001916: Authorized healthcare providers are required to establish an effective and proven system of withdrawal from blood products that are
p.001916: cause or may cause a serious adverse event or a serious adverse reaction.
p.001916: Article 21
p.001916: Healthcare facilities that administer blood products for transfusion treatment are required to establish a system for reporting serious
p.001916: adverse events and serious adverse reactions within the institution.
p.001916: Any serious adverse event and serious adverse reaction referred to in paragraph 1 of this Article shall be obliged by the health institution without
p.001916: to notify the Croatian Institute of Transfusion Medicine and the Ministry in writing.
p.001916: Article 22
p.001916: The register of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Act shall be kept by the Croatian Institute for Transfusion
p.001916: medicine.
p.001916: Article 23
p.001916: Ordinance on the monitoring of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Law, with previously obtained
p.001916: the opinion of the competent chamber, is passed by the Minister.
p.001916: VIII. EXPORTS AND IMPORTS OF BLOOD AND BLOOD PREPARATIONS
p.001916: Article 24
p.001916: Blood and blood products must not be exported from the Republic of Croatia.
p.001916: The Minister may exceptionally, in the case of natural disasters and other emergencies, as well as in cases of emergency,
p.001916: medically justified need to approve the export of blood and blood products.
p.001916: In the case referred to in paragraph 1 of this Article, testing in accordance with Article 15 of this Act shall be ensured.
p.001916: Article 25
p.001916: Blood and blood products must not be imported into the Republic of Croatia.
p.001916: The Minister may exceptionally, in the case of natural and other emergencies, as well as in cases of emergency, medically
p.001916: justify the need to approve the importation of blood and blood products.
p.001916: The imported blood and blood products must meet the conditions prescribed by this Act and testing in accordance with Article 15 must be ensured.
p.001916: of this Act.
p.001916: IX. INSURANCE OF THE QUALITY AND INJURY OF BLOOD AND BLOOD PREPARATIONS
p.001916: Article 26
p.001916: The promotion and organization of the donation of blood and blood components in the Republic of Croatia are based on the principles of voluntary, free,
p.001916: anonymity and solidarity.
p.001916: For the blood or blood component taken, it is forbidden for the donor to provide financial compensation.
p.001916: For a given blood or blood component, the donor may not receive any monetary compensation.
p.001916: Article 27
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General/Other / Public Emergency
Searching for indicator emergency:
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p.001916: data exchange.
p.001916: Any serious adverse event and serious adverse reaction shall be mandated in writing by an authorized healthcare institution.
p.001916: report to the Croatian Institute for Transfusion Medicine and the Ministry.
p.001916: Authorized healthcare providers are required to establish an effective and proven system of withdrawal from blood products that are
p.001916: cause or may cause a serious adverse event or a serious adverse reaction.
p.001916: Article 21
p.001916: Healthcare facilities that administer blood products for transfusion treatment are required to establish a system for reporting serious
p.001916: adverse events and serious adverse reactions within the institution.
p.001916: Any serious adverse event and serious adverse reaction referred to in paragraph 1 of this Article shall be obliged by the health institution without
p.001916: to notify the Croatian Institute of Transfusion Medicine and the Ministry in writing.
p.001916: Article 22
p.001916: The register of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Act shall be kept by the Croatian Institute for Transfusion
p.001916: medicine.
p.001916: Article 23
p.001916: Ordinance on the monitoring of serious adverse events and serious adverse reactions referred to in Articles 20 and 21 of this Law, with previously obtained
p.001916: the opinion of the competent chamber, is passed by the Minister.
p.001916: VIII. EXPORTS AND IMPORTS OF BLOOD AND BLOOD PREPARATIONS
p.001916: Article 24
p.001916: Blood and blood products must not be exported from the Republic of Croatia.
p.001916: The Minister may exceptionally, in the case of natural disasters and other emergencies, as well as in cases of emergency,
p.001916: medically justified need to approve the export of blood and blood products.
p.001916: In the case referred to in paragraph 1 of this Article, testing in accordance with Article 15 of this Act shall be ensured.
p.001916: Article 25
p.001916: Blood and blood products must not be imported into the Republic of Croatia.
p.001916: The Minister may exceptionally, in the case of natural and other emergencies, as well as in cases of emergency, medically
p.001916: justify the need to approve the importation of blood and blood products.
p.001916: The imported blood and blood products must meet the conditions prescribed by this Act and testing in accordance with Article 15 must be ensured.
p.001916: of this Act.
p.001916: IX. INSURANCE OF THE QUALITY AND INJURY OF BLOOD AND BLOOD PREPARATIONS
p.001916: Article 26
p.001916: The promotion and organization of the donation of blood and blood components in the Republic of Croatia are based on the principles of voluntary, free,
p.001916: anonymity and solidarity.
p.001916: For the blood or blood component taken, it is forbidden for the donor to provide financial compensation.
p.001916: For a given blood or blood component, the donor may not receive any monetary compensation.
p.001916: Article 27
p.001916: Donors of blood and blood components may only be adults who are identified by the doctor of medicine referred to in Article 29, paragraph 2 of this Act
p.001916: absence of medical reasons that could cause damage to the health of the provider or patient.
p.001916: By way of derogation from paragraph 1 of this Article, in the case of an autologous transfusion, the donor of the blood or blood component does not have to be an adult.
p.001916: Article 28
p.001916: The person who approaches the donation of blood or blood component must be informed about possible reactions during blood collection, the extent of testing
p.001916: blood and protect personal information.
p.001916: The information referred to in paragraph 1 of this Article shall be given by the medical doctor referred to in Article 29, paragraph 2 of this Act, who shall also request the information necessary for the
p.001916: an assessment of the person's suitability for donating blood or a blood component.
p.001916: Article 29
...
Orphaned Trigger Words
p.001916: For a given blood or blood component, the donor may not receive any monetary compensation.
p.001916: Article 27
p.001916: Donors of blood and blood components may only be adults who are identified by the doctor of medicine referred to in Article 29, paragraph 2 of this Act
p.001916: absence of medical reasons that could cause damage to the health of the provider or patient.
p.001916: By way of derogation from paragraph 1 of this Article, in the case of an autologous transfusion, the donor of the blood or blood component does not have to be an adult.
p.001916: Article 28
p.001916: The person who approaches the donation of blood or blood component must be informed about possible reactions during blood collection, the extent of testing
p.001916: blood and protect personal information.
p.001916: The information referred to in paragraph 1 of this Article shall be given by the medical doctor referred to in Article 29, paragraph 2 of this Act, who shall also request the information necessary for the
p.001916: an assessment of the person's suitability for donating blood or a blood component.
p.001916: Article 29
p.001916: Prior to each donation of blood or blood component, the doctor of medicine is obliged to examine the person who approaches the donation.
p.001916: The medical doctor performing the examination of the person accessing the appointment is designated by the responsible person of the authorized health care institution referred to in the article
p.001916: 8, paragraph 3 of this Law.
p.001916: The Minister shall prescribe the scope of the examination referred to in paragraph 1 of this Article and the criteria for selecting the provider.
p.001916: Article 30
p.001916: Prior to each donation of blood or blood component, the person accessing the donation must give consent for the voluntary blood or blood donation
p.001916: ingredients.
p.001916: The consent referred to in paragraph 1 of this Article shall be given in writing and must be an expression of the free will of the provider, based on the appropriate
p.001916: notifications of the purpose of the administration and common risks.
p.001916: The contents of the consent form referred to in paragraph 1 of this Article shall be prescribed by an ordinance by the Minister.
p.001916: Article 31
p.001916: The Croatian Institute for Transfusion Medicine maintains a register of blood donors.
p.001916: In the register referred to in paragraph 1 of this Article, particulars shall be given of persons who may not temporarily or permanently be blood donors.
p.001916: Article 32
p.001916: The blood donor registry must be part of the national transfusion information system.
p.001916: The registry must be accessible to all health facilities that collect blood.
p.001916: Funds for keeping the register are provided in the state budget.
p.001916: Article 33
p.001916: The blood donation and blood components are promoted in the territory of the Republic of Croatia by the Croatian Institute for Transfusion Medicine and the Croatian
p.001916: Red cross.
p.001916: Promotional activities should be continuous and consistent with the need for sufficient quantities of blood and blood products in the area
p.001916: throughout the Republic of Croatia throughout the year.
p.001916: Article 34
p.001916: A unique annual plan of blood donation actions for the Republic of Croatia is adopted by the Croatian Institute for Transfusion Medicine and the Croatian Red
p.001916: cross based on anticipated blood supply needs of all healthcare facilities.
p.001916: Article 35
p.001916: The Minister shall prescribe the conditions regarding the premises and equipment to be fulfilled by the organizer of blood donation operations.
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Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| drug | Drug Usage |
| education | education |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| pregnant | Pregnant |
| single | Marital Status |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
protect
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input