0A4F4F9BD490A749D5437F821CF06DF1
Ordinance on the Conditions of Space, Professional Workers, Medical-Technical Equipment and Quality Assurance for Collection, Retrieval, Testing, Processing, Preservation, Storage, and Allocation of Human Tissues and Cells (2013)
http://www.propisi.hr/print.php?id=9354
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
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p.(None): 1. have a SOP detailing the circumstances, duties and procedures for tissue distribution for distribution purposes,
p.(None): 2. have records showing that the tissues issued meet all the prescribed specifications, and in particular that the worker assigned to the task
p.(None): authorized by the responsible person of tkvia bank, in accordance with the written procedure, documented all valid forms of statements,
p.(None): relevant medical records, processing records and test results,
p.(None): (2) Where appropriate, the tissue bank must carry out a documented risk assessment approved by the responsible person of the tissue bank in order to
p.(None): decided the fate of all previously stored tissues after the introduction of each new criteria for donor selection or testing or other
p.(None): significant alterations to the processing procedure that increase the safety or quality of the tissue.
p.(None): Article 45
p.(None): The tissue establishment for tissue distribution procedures must meet the following conditions:
p.(None): 1. Have SOPs / SOPs that detail the allocation procedures
p.(None): 2. establish procedures for managing submitted tissue requests. Rules for assigning tissue to specific patients or
p.(None): health facilities must be documented and made available to those parties upon request,
p.(None): 3. determine the critical conditions of transportation, such as temperature and time limit, to maintain the required tissue properties,
p.(None): 4. Have containers / packages that are protected and maintain tissue under specified conditions. All containers and packaging
p.(None): must be validated as suitable for their purpose,
p.(None): 5. have a documented contract ensuring the maintenance of the required conditions, if the distribution is done by a third party,
p.(None): 6. have authorized staff assessing the need for withdrawal and initiating and coordinating the necessary activities,
p.(None): 7. Establish an effective withdrawal process, including a description of the responsibilities and measures to be taken. The process must include
p.(None): report to the competent authority,
p.(None): 8. carry out activities and measures, at predetermined time intervals, which include investigating the traceability of all relevant ones
p.(None): tissues, and, where applicable, trace-back procedures. The purpose of the investigation is to identify all donors who may have contributed to the challenge
p.(None): reactions at the recipient, isolation of all tissues of that donor, and notification of the institutions to which the tissues were distributed as well as the person
p.(None): who received the tissues of that donor about the potential risk to which they are exposed,
p.(None): 9. Establish a documented system for the management of returned tissues, including criteria for their readmission to the bank
p.(None): tissues, if applicable.
p.(None): Article 46
p.(None): (1) There must be a sticker on the primary tissue container containing the following information:
p.(None): a) type of tissue, tissue identification code and, where applicable, lot or batch number,
p.(None): b) identification of the tissue bank,
p.(None): c) the shelf life of the tissue,
p.(None): d) if it is an autologous donation, it must be specifically stated "FOR AUTOLOGICAL USE ONLY" and must be identified
p.(None): recipient,
p.(None): e) on direct donation, the label must identify the intended recipient,
p.(None): f) a container containing tissue confirmed positive for the relevant contagious disease marker shall be labeled: »DANGER
p.(None): TRANSMISSION DISEASE ';
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Health / Drug Usage
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p.(None): - enable the implementation and preparation of the tissue bank for inspection,
p.(None): - submit to the Ministry an annual report on the activity of the tissue bank,
p.(None): - ensure that the Ministry is informed of serious adverse events and reactions,
p.(None): - ensure that the Ministry reports on serious adverse events and reactions with cause and effect analysis,
p.(None): (2) The Tissue Bank is obliged to provide the Ministry with the name and contact details of the named responsible person and the replacement.
p.(None): (3) In case of temporary absence of the named responsible person, the tissue bank shall be obliged to inform in writing without delay.
p.(None): ministry.
p.(None): (4) In the case of the appointment of a new responsible person, the tissue bank shall notify the ministry in writing without delay.
p.(None): Room
p.(None): Article 31
p.(None): The tissue establishment shall meet the following conditions in terms of space:
p.(None): 1. Depending on the tissue, there should be separate spaces or a safety system for separating the tissue in quarantine from the tissues that have been discarded, and
p.(None): from tissues accepted for administration,
p.(None): 2. the area in which the tissues are treated must be designed, organized and maintained in such a way that the risk of pollution is avoided,
p.(None): including cross pollution minimizes it. Performance, organization and maintenance efficiency must also be validated
p.(None): monitor,
p.(None): 3. if tissues are exposed to the environment during processing, they must be treated in an area in which the air quality corresponds to Class A of
p.(None): Principles and guidelines of good manufacturing practice for medicines as well as additional specifics for individual drug processes and forms »The
p.(None): Rules Governing Medicinal Products in the European Union, Volume 4 - Good Manufacturing Practices, Medicinal Products for
p.(None): Human and Veterinary use, 1998 Edition, European Commission, Directorate General III - Industry, Pharmaceutical and
p.(None): Cosmetics «with all amendments (hereinafter: DPP). The ambient air quality of the space in which the tissue is treated must be
p.(None): appropriate to the type of tissue to be treated but must comply at least with Class D DPP. Air quality must be validated and monitored,
p.(None): 4. less stringent air quality conditions than those referred to in subparagraph 3 of this Article may be applied if:
p.(None): a) validated microbiological inactivation or validated end sterilization is applied, or,
p.(None): b) exposure to the conditions necessary to achieve Class A air quality has been shown to adversely affect the required tissue properties or,
p.(None): c) it is demonstrated that the method and course of tissue administration presents a significantly lower risk of transmission of the bacterial or fungal infection to
p.(None): recipients than in the case of non-transplanting tissue,
p.(None): d) it is technically impossible to perform the required processing procedure in a Class A air quality environment (for example, if processing requires
p.(None): equipment which makes it not possible to validate space in Class A),
p.(None): 5. if the tissues are treated in an area with an air quality of less than class A, the air quality class to be prescribed by the procedure
p.(None): demands. It must be validated that the procedure in the prescribed air class meets the quality and safety criteria for its intended purpose,
p.(None): the mode of administration and the immune status of the recipient,
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p.(None): meninx,
p.(None): e) systemic infection that is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or
p.(None): parasitic infections. Significant local infection in donated tissues. For bacteria donors, it can be evaluated
p.(None): acceptability for corneal donation, but only when the corneas are stored in the culture medium to be tested by microbiological testing
p.(None): enable bacterial contamination of tissue to be detected,
p.(None): f) history, clinical picture or laboratory-proven HIV, acute or chronic hepatitis B (with the exception of proven immunized persons),
p.(None): hepatitis C and HTLV I / II, or the existence of transmission risk or risk factors for these infections,
p.(None): g) a history of chronic systemic autoimmune disease that may have had a detrimental effect on the quality of the tissue collected,
p.(None): h) application of procedures and therapies to donors rendering laboratory tests unreliable:
p.(None): - hemodilution greater than 50% in cases where no blood sample has been taken before transfusion / infusion,
p.(None): - treatment with immunosuppressants,
p.(None): i) the presence of other risk factors for communicable diseases, recognized by risk assessment, taking into account
p.(None): information on donor travel, exposure and local prevalence of a particular infectious disease,
p.(None): j) the existence of physical signs on the donor's body indicating the risk of transmissible disease (s),
p.(None): k) ingestion or exposure to a substance (such as cyanide, lead, mercury, gold) that can be transferred to the recipient at a dose that can
p.(None): endanger health,
p.(None): l) a history of recent vaccination with live attenuated virus, in cases where there is a risk of transmission,
p.(None): m) xenograft transplantation.
p.(None): 2. Additional eligibility criteria for deceased child donors:
p.(None): a) children born to mothers with HIV infection, or mothers who meet any of the general eligibility criteria
p.(None): paragraph 1 of this Article, until the risk of transmission is definitely eliminated,
p.(None): b) children under 18 months of age, born to HIV-infected mothers or mothers with Hepatitis B, Hepatitis C or mothers
p.(None): infected with HTLV or mothers at risk for these infections and breastfed by mothers in the previous 12 months are not eligible donors without
p.(None): regardless of the test results,
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Health / HIV/AIDS
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p.(None): The exceptions to this criterion are:
p.(None): - primary basocellular carcinoma,
p.(None): - carcinoma in situ of the cervix,
p.(None): - Some primary tumors of the central nervous system that should be evaluated in accordance with existing scientific evidence.
p.(None): A donor with malignancy may be assessed for acceptability of corneal donation unless the malignancy is indicated
p.(None): disease:
p.(None): - retinoblastoma,
p.(None): - neoplasms of the hematopoietic system,
p.(None): - malignant tumors of the anterior segment of the eye,
p.(None): d) the risk of transmission of diseases caused by prions, such as:
p.(None): - persons diagnosed with Creutzfeldt-Jacob's disease or a variant of Creutzfeldt-Jacob's disease, or persons with familial
p.(None): a history of non-iatrogenic Creutzfeldt-Jacob disease,
p.(None): - persons with a history of rapidly progressive progressive dementia or degenerative nervous system diseases, including diseases
p.(None): of unknown origin,
p.(None): - recipients of hormones produced by the human pituitary gland (growth hormone),
p.(None): - recipients of corneal transplants, scallops and hard brain envelopes,
p.(None): - persons undergoing neurosurgical procedures for which there is no medical record, whereby a hard
p.(None): meninx,
p.(None): e) systemic infection that is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or
p.(None): parasitic infections. Significant local infection in donated tissues. For bacteria donors, it can be evaluated
p.(None): acceptability for corneal donation, but only when the corneas are stored in the culture medium to be tested by microbiological testing
p.(None): enable bacterial contamination of tissue to be detected,
p.(None): f) history, clinical picture or laboratory-proven HIV, acute or chronic hepatitis B (with the exception of proven immunized persons),
p.(None): hepatitis C and HTLV I / II, or the existence of transmission risk or risk factors for these infections,
p.(None): g) a history of chronic systemic autoimmune disease that may have had a detrimental effect on the quality of the tissue collected,
p.(None): h) application of procedures and therapies to donors rendering laboratory tests unreliable:
p.(None): - hemodilution greater than 50% in cases where no blood sample has been taken before transfusion / infusion,
p.(None): - treatment with immunosuppressants,
p.(None): i) the presence of other risk factors for communicable diseases, recognized by risk assessment, taking into account
p.(None): information on donor travel, exposure and local prevalence of a particular infectious disease,
p.(None): j) the existence of physical signs on the donor's body indicating the risk of transmissible disease (s),
p.(None): k) ingestion or exposure to a substance (such as cyanide, lead, mercury, gold) that can be transferred to the recipient at a dose that can
p.(None): endanger health,
p.(None): l) a history of recent vaccination with live attenuated virus, in cases where there is a risk of transmission,
p.(None): m) xenograft transplantation.
p.(None): 2. Additional eligibility criteria for deceased child donors:
p.(None): a) children born to mothers with HIV infection, or mothers who meet any of the general eligibility criteria
p.(None): paragraph 1 of this Article, until the risk of transmission is definitely eliminated,
p.(None): b) children under 18 months of age, born to HIV-infected mothers or mothers with Hepatitis B, Hepatitis C or mothers
p.(None): infected with HTLV or mothers at risk for these infections and breastfed by mothers in the previous 12 months are not eligible donors without
p.(None): regardless of the test results,
p.(None): c) children of mothers infected with HIV, ie mothers suffering from hepatitis B, hepatitis C, or mothers infected with HTLV or at risk for
p.(None): the development of such infections, which have not been nursed by mothers in the previous 12 months, and for which testing, physical examination and insight
p.(None): medical records have not been proven HIV infection, hepatitis B, hepatitis C or HTLV, can be accepted as
p.(None): donors.
p.(None): Article 18
p.(None): (1) The tissue bank shall establish and document the selection criteria for allogeneic living donors. For allogenes, blood donors are blood donors
p.(None): stem cell criteria establishes a registry of voluntary hematopoietic stem cell donors.
p.(None): (2) The selection of an allogeneic living donor shall be made on the basis of an eligibility assessment procedure, which shall include a health
p.(None): condition and anamnestic data collected through questionnaires and through interviews conducted by a qualified and educated physician,
p.(None): in accordance with paragraph 3 of this Article.
p.(None): (3) The assessment of the acceptability of the donor must include factors relevant to the identification and screening of the donor whose tissue donation is for
p.(None): others may present a health risk, such as the transmission of infectious diseases or a donor whose tissue donation may represent
p.(None): health risk for themselves.
p.(None): (4) The tissue collection process must not endanger the health of the donor or jeopardize the health care provided to him.
p.(None): (5) The provisions of paragraphs 3 and 4 of this Article shall apply to both mother and child when collecting blood from the umbilical cord or amniotic envelope.
p.(None): (6) The tissue establishment shall establish and document the selection criteria for allogeneic living donors.
p.(None): (7) The selection criteria referred to in paragraph 6 of this Article must take into account the specific characteristics of the tissue, the physical status of the donor, the anamnesis,
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p.(None): Article 17 of this Ordinance, except for the criteria referred to in subparagraph 1 (a) of this Article.
p.(None): (9) Depending on the tissue to be donated, additional specific criteria may be introduced to exclude unacceptable donors such as
p.(None): are:
p.(None): (a) pregnancy (except in the case of cord blood donors and amniotic donors, and when the donor
p.(None): donates stem cells to his brother or sister),
p.(None): (b) breastfeeding,
p.(None): (c) for hematopoietic stem cells, the possibility of transmission of hereditary diseases.
p.(None): Article 19
p.(None): The responsible person may approve the conclusion of the donor referred to in Article 17 (1) (e) and Article 18 of this Ordinance.
p.(None): considers acceptable, if such conclusion is justified in a documented risk assessment process.
p.(None): Article 20
p.(None): (1) For autologous donation, the minimum conditions for testing for infectious diseases are the same as for allogeneic donation if
p.(None): collected tissue is stored or cultured.
p.(None): (2) Positive test results shall not interfere with the storage, processing or reimplantation of tissue or tissue derived products.
p.(None): (3) Tissues referred to in paragraph 2 of this Article may be stored and processed provided that conditions that completely disable the cross are provided
p.(None): contamination of other grafts and accessory materials and replacement of grafts.
p.(None): Article 21
p.(None): (1) Tissue donors must be tested for blood transmitted infectious diseases in accordance with this Ordinance.
p.(None): (2) All donors must be serologically tested for at least:
p.(None): - HIV 1 and 2 - Anti-HIV-1,2
p.(None): - Hepatitis B - HBsAg iAnti-HBc
p.(None): - Hepatitis C - Anti-HCV
p.(None): - Syphilis - in accordance with paragraph 6 of this Article.
p.(None): (3) Nucleic acid-NAT multiplication testing is mandatory for all tissue donors with at least HIV 1, HBV and HCV.
p.(None): (4) In addition to the tests referred to in paragraph 2 of this Article, donors must also be tested for HTLV-I if they live or come from areas where
p.(None): the frequency of infection with this virus is high, or if their sexual partners or parents originate in such areas.
p.(None): (5) For an anti-HBc-positive and HBsAg-negative donor, a risk assessment is required to assess the acceptability of the donor
p.(None): do Anti-HBs with a titer. Donor tissues with a titre greater than 100 U / l and negative NAT can be dispensed.
p.(None): (6) In order to exclude Treponema pallidum infection, it is necessary to test the donor according to a validated algorithm. If at
p.(None): testing lacks a specific or non-specific reaction, the tissues of the donor tested can be dispensed with. If a non-specific test is performed,
p.(None): the reactive test is not a reason for not accepting the donor, provided that the specific affirmative test on Treponema pallidum is negative. For
p.(None): a donor with a positive specific test needs a risk assessment to determine eligibility for use.
p.(None): (7) In certain circumstances, depending on the history of the donor and the characteristics of the tissue to be donated, additional
p.(None): donor testing such as ABO, RhD, HLA antigens and antibodies, malaria, CMV, toxoplasma, EBV, Trypanosoma cruzi.
p.(None): (8) The provisions of Article 20 of this Ordinance shall apply to the testing of autologous donors.
p.(None): Article 22
p.(None): (1) Testing shall be performed solely on samples of the donor's serum or plasma and shall not be carried out on other body
p.(None): liquids.
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p.(None): a) ante-mortem sample: transfusion or infusion within 48 hours, before sampling, or infusion of crystalloid one hour before
p.(None): sampling,
p.(None): b) post-mortem sample: transfusion or infusion within 48 hours before death, or crystalloid infusion one hour before death.
p.(None): (5) A tissue bank may receive tissues from donors whose plasma has been diluted by more than 50% only if testing has been carried out
p.(None): by a method validated for such plasma samples, or if there are samples taken before transfusion / infusion.
p.(None): (6) Blood samples from a deceased donor must be taken immediately before death or, if this is not possible, no later than 24 hours after death.
p.(None): (7) Live blood donor blood samples (except allogeneic bone marrow and peripheral blood stem cell donors from
p.(None): practical reasons) must be taken at the time of donation or, if this is not possible, within 7 days of donation (the "donation sample").
p.(None): (8) In the case of stem cells from the bone marrow or peripheral blood, blood samples must be taken within 30 days before donation.
p.(None): (9) If, for duly justified and documented reasons, it is not possible to carry out NAT testing and the tissue of an allogeneic living donor
p.(None): can be stored for a long period, it is necessary to repeatedly take samples and test them every 180 days. In the circumstances described
p.(None): The "donation sample" can be taken no longer than 30 days before and 7 days after tissue donation.
p.(None): (10) Where the tissue of an allogeneic living donor cannot be stored for an extended period, the provision of paragraph 8 of this Article shall apply.
p.(None): (11) If a living donor "donation sample" as defined in paragraph 7 of this Article is tested for HIV, HBV and HCV by NAT,
p.(None): no blood test is required. Retesting is also unnecessary when tissue processing involves
p.(None): a validated method of inactivating said viruses.
p.(None): (12) For newborns, the test sample may be taken from the mother.
p.(None): Article 23
p.(None): (1) Tissue collection and collection procedures must be appropriate for the donor and the type of tissue donated. Procedures must be followed
p.(None): that guarantee a living donor security.
p.(None): (2) Tissue collection and collection procedures must preserve the required tissue properties. Collection and collection must be conducted in a manner
p.(None): minimizing the risk of microbial contamination, especially if subsequent sterilization is not possible
p.(None): tissue.
p.(None): (3) In the case of a deceased donor, the tissue collection area must be limited. Tissue must be taken from a local sterile
p.(None): operating field protected by sterile blankets. Professionals participating in the collection must be appropriately dressed
p.(None): collection method. Professionals must perform surgical hand washing, be dressed in sterile bathrobes and wear sterile gloves,
p.(None): protective masks and, where appropriate, face shields.
p.(None): (4) In the case of a deceased donor, a record must be made of the place of collection and the time interval that is
p.(None): elapsed from the time of death to the time of collection to ensure that the donated tissue retained the required biological and / or
p.(None): physical properties.
p.(None): (5) After collection, the reconstruction of the donor body must be performed with the utmost care, following the natural appearance of the body.
p.(None): (6) Any adverse event during collection that harmed or could harm a living donor must be recorded and considered.
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p.(None): months and documented continuing education.
p.(None): Article 55
p.(None): (1) The laboratory must have a designated responsible person and a replacement who meets at least the following conditions:
p.(None): - Doctor of Medicine specialist in clinical microbiology or specialist in medical microbiology with parasitology, or transfusion
p.(None): medicine or mag. medical biochemistry specialist in medical biochemistry and laboratory medicine,
p.(None): - At least 5 years of work experience in the field of blood-borne disease testing in a blood donor and / or tissue and / or organ.
p.(None): (2) The responsible person shall be responsible for ensuring the quality of the results.
p.(None): Article 56
p.(None): The space laboratory must have:
p.(None): - separate space for testing donors of the appropriate size for the smooth operation of automated systems,
p.(None): - adequate and documented monitored microclimate operating conditions for automated systems.
p.(None): Article 57
p.(None): The laboratory with regard to medical and technical equipment must have:
p.(None): - running automated search systems,
p.(None): - Separate donor testing equipment
p.(None): - validation of results according to validation criteria,
p.(None): - automatic data transfer,
p.(None): - archiving data into the IT system.
p.(None): Article 58
p.(None): (1) The laboratory for the quality of the sea:
p.(None): - be accredited according to a valid revision of the ISO 15 189 standard for quality systems in medical laboratories,
p.(None): - Perform at least 100,000 tests annually to test for blood-borne infectious diseases in blood, tissue and cell donors, and
p.(None): organs, performed in automated systems individually for: HIV (HIVAg / At), HBV (HBsAg), HCV (anti-HCV) and anti-TP,
p.(None): - perform blood-borne infectious disease testing according to the current revision of the Council's Tissue and Cell Quality and Safety Guide
p.(None): Europe
p.(None): - perform confirmatory testing to resolve discrepancies between serological and NAT test results.
p.(None): (2) The laboratory shall use tests marked "CE" where applicable.
p.(None): (3) The tests must be validated for the purpose for which they are used in accordance with current scientific knowledge.
p.(None): Article 59
p.(None): The following shall cease to have effect on the date of entry into force of this Ordinance:
p.(None): 1. Ordinance on the conditions regarding premises, professional staff and medical and technical equipment, quality systems and other conditions for
p.(None): performing tissue collection, storage and transplantation activities (Official Gazette 74/09)
p.(None): 2. Ordinance on the conditions in respect of premises, professionals and medical and technical equipment for performing the activities of taking and
p.(None): storage of umbilical cord blood stem cells (Official Gazette 63/07)
p.(None): 3. Ordinance on the conditions relating to premises, professionals and medical and technical equipment for the taking, storage and
p.(None): transplantation of ocular tissue grafts (Official Gazette 44/07)
p.(None): 4. Rulebook on the method of cooperation with related foreign and international organizations for the purpose of exchanging organs or tissues for work
p.(None): transplantation (Official Gazette 141/05, 44/07)
p.(None): 5. Ordinance on the procedure for the collection, storage and use of hematopoietic stem cells (Official Gazette 59/08)
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Health / Motherhood/Family
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p.(None): selection of donors and professionals responsible for tissue collection and collection.
p.(None): (3) The health institution or tissue establishment must provide skilled workers for the reconstruction of the bodies of deceased donors.
p.(None): (4) Where tissues are intended for direct transplantation, the exploration team must be associated with the transplant
p.(None): the blood donor center or registry.
p.(None): Article 6
p.(None): (1) Health facilities must have a designated coordinator for tissue collection in accordance with Article 35 of the Implementation Act
p.(None): of human tissues and cells (hereinafter: the Law).
p.(None): (2) The hospital transplant coordinator appointed in accordance with the Human Organ Transplantation Act for the purpose of treatment may be
p.(None): also appointed as Tissue Collection Coordinator.
p.(None): (3) The tissue collection coordinator must meet at least the following conditions:
p.(None): - a physician approved to work independently,
p.(None): - at least 2 years of work experience in tissue banking and / or transplantation,
p.(None): - have documented education in the field of tissue collection and collection, at least as prescribed in Article 5 (1) (e)
p.(None): of this Ordinance and theoretical and practical knowledge of the selection and eligibility criteria of the donor.
p.(None): Article 7
p.(None): The tissue collection coordinator is required to:
p.(None): - receive notification of a potential tissue donor,
p.(None): - coordinate all actions related to the tissue donation process,
p.(None): - check the status in the register of non-donors,
p.(None): - obtain consent to donate a living donor,
p.(None): - interview the deceased donor's family,
p.(None): - inform exploration teams and coordinate tissue preparation preparations,
p.(None): - cooperate with the hospital transplant coordinator when appropriate,
p.(None): - collect all available information on the health status of the potential donor necessary to assess the acceptability of the donor,
p.(None): including social and medical history,
p.(None): - complete, maintain and submit all medical records of the possible donor and other forms within the prescribed deadlines
p.(None): from the health care quality system related to tissue donation procedures, including any medical information received after
p.(None): performed tissue sampling,
p.(None): - carry out the evaluation of the tissue donor,
p.(None): - ensure that the prescribed blood and / or tissue samples of the potential donor have been collected and delivered in the prescribed manner and within the prescribed time limit,
p.(None): - document and investigate serious adverse events and reactions related to donation and report them in accordance with a special regulation,
p.(None): - when appropriate to cooperate with a tissue bank in investigating a serious adverse event and reaction,
p.(None): - provide the donor and the donor family with information on all aspects of tissue donation.
p.(None): Room
p.(None): Article 8
p.(None): (1) Tissue collection and collection may be performed by a healthcare institution or tissue bank that has adequate space for tissue collection.
p.(None): following procedures that minimize the possibility of bacterial or other contamination of the tissue taken.
p.(None): (2) The taking of tissues by living donors must be carried out in an environment that guarantees health and personal safety and privacy.
p.(None): Medical and technical equipment
p.(None): Article 9
p.(None): Tissue collection and collection may be performed by a health care institution or tissue bank which, with regard to medical and technical equipment,
p.(None): meets the following conditions:
p.(None): - sterile instruments and devices must be used when collecting tissue. The instruments and appliances must be of high quality,
p.(None): qualified or certified for tissue collection and regularly maintained,
p.(None): - for reusable instruments, it is necessary to establish a validated cleaning and sterilization procedure to remove infectious
p.(None): agents. Sterilization procedures must be carried out in accordance with the requirements of the Croatian Pharmacopoeia and the European Pharmacopoeia for sterilization
p.(None): medicines and medical products,
p.(None): - where applicable, medical devices bearing the CE marking must be used and all workers handling them must be
p.(None): appropriately educated.
p.(None): Article 10
p.(None): The health institution or tissue bank must provide equipment and suitable materials for the reconstruction of the bodies of deceased donors.
p.(None): Article 11
p.(None): There must be documented and approved standard operating procedures (hereinafter SOPs) for tissue collection and collection.
p.(None): at least for:
p.(None): - verification of donor identification (identification is verified by an authorized worker, records who identified the donor),
p.(None): - verification of the consent of the living donor (checks and records that the consent was obtained in accordance with the Law,) or interviews with the deceased's family
p.(None): the donor (checks and records),
p.(None): - verification of the entry of the donor in the registry of the non-donor,
p.(None): - donor eligibility criteria,
p.(None): - eligibility criteria for laboratory testing,
p.(None): - taking,
p.(None): - packaging,
p.(None): - marking,
p.(None): - transport.
p.(None): Quality system
p.(None): Article 12
p.(None): The donation, collection and collection of tissue must be carried out in accordance with the conditions laid down in this Ordinance.
p.(None): Article 13
p.(None): (1) The donor, prior to the tissue collection procedure, must be informed about the donation and tissue collection of at least the following:
p.(None): - the purpose and method of collection,
p.(None): - the consequences and risks of collection,
p.(None): - laboratory tests for infectious diseases,
p.(None): - analytical tests, including genetic testing, if carried out,
p.(None): - recording and protecting donor information and medical secrets,
p.(None): - the therapeutic purpose of the gift and the potential well-being for the recipient,
p.(None): - safeguards applied for the safety of the donor,
p.(None): - the obligation to obtain consent for the collection process.
p.(None): (2) The donor shall have the right to be informed of the results of the tests referred to in paragraph 1, subparagraphs 3 and 4 of this Article, with the interpretation of those results.
p.(None): (3) The information referred to in paragraph 1 of this Article must be communicated in a clear manner by a person educated to speak with the donor.
p.(None): easy to understand terms for the donor.
p.(None): (4) The information referred to in paragraph 1 of this Article may also be provided to the donor in writing.
p.(None): Article 14
p.(None): (1) The health institution is obliged to collect and record all important data from the donor's history, including information on
p.(None): behavior and habits in accordance with Article 24 of this Ordinance.
p.(None): (2) For the purpose of obtaining the relevant information referred to in paragraph 1 of this Article, various relevant sources, including:
p.(None): a) the medical records of the donor,
p.(None): b) in the case of a living donor, an interview with the donor,
p.(None): c) in the case of a deceased donor, an interview with a person who knew the donor well,
p.(None): d) interview with the doctor treating the donor, or treating the donor,
p.(None): e) interview with an elected family physician,
p.(None): f) Autopsy report.
p.(None): (3) In the case of a deceased donor, a physical examination of the donor body must be carried out. Physical examination must be required,
p.(None): Observe and record any signs on which the donor must be considered ineligible. The nature of the signs observed are unclear
p.(None): need to be fully clarified using the medical records and any other available donor information.
p.(None): (4) When medically justified, a physical examination of the body of a living donor must also be carried out.
p.(None): (5) For this purpose, an educated physician of a health institution must review the complete written documentation of the donor, assess the eligibility
p.(None): donor and sign evaluation.
p.(None): Article 15
p.(None): Donor assessment procedures do not apply to the collection and collection of tissue for autologous administration.
p.(None): Article 16
p.(None): (1) The criteria for selecting a donor must be respected when collecting and taking tissue.
p.(None): (2) The selection of the donor must be based on an analysis of the risk associated with the application of a particular tissue.
p.(None): (3) Risk indicators must be identified by physical examination, examination of medical records, documentation of behavior
p.(None): and habits, post-mortem examinations (for deceased donors) and other necessary tests.
p.(None): Article 17
p.(None): A deceased donor should not be considered eligible for donation if one of the following criteria is met:
p.(None): 1. General eligibility criteria
p.(None): a) Unknown cause of death. Exceptions to this criterion are cases where, upon collection, the cause of death was determined by autopsy,
p.(None): and no other ineligibility criteria from this article are present,
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.(None): others may present a health risk, such as the transmission of infectious diseases or a donor whose tissue donation may represent
p.(None): health risk for themselves.
p.(None): (4) The tissue collection process must not endanger the health of the donor or jeopardize the health care provided to him.
p.(None): (5) The provisions of paragraphs 3 and 4 of this Article shall apply to both mother and child when collecting blood from the umbilical cord or amniotic envelope.
p.(None): (6) The tissue establishment shall establish and document the selection criteria for allogeneic living donors.
p.(None): (7) The selection criteria referred to in paragraph 6 of this Article must take into account the specific characteristics of the tissue, the physical status of the donor, the anamnesis,
p.(None): behavioral and behavioral data, clinical treatment and laboratory results to determine the donor's health
p.(None): state.
p.(None): (8) A living allogeneic donor may not be considered eligible for donation if one of the following criteria is met
p.(None): Article 17 of this Ordinance, except for the criteria referred to in subparagraph 1 (a) of this Article.
p.(None): (9) Depending on the tissue to be donated, additional specific criteria may be introduced to exclude unacceptable donors such as
p.(None): are:
p.(None): (a) pregnancy (except in the case of cord blood donors and amniotic donors, and when the donor
p.(None): donates stem cells to his brother or sister),
p.(None): (b) breastfeeding,
p.(None): (c) for hematopoietic stem cells, the possibility of transmission of hereditary diseases.
p.(None): Article 19
p.(None): The responsible person may approve the conclusion of the donor referred to in Article 17 (1) (e) and Article 18 of this Ordinance.
p.(None): considers acceptable, if such conclusion is justified in a documented risk assessment process.
p.(None): Article 20
p.(None): (1) For autologous donation, the minimum conditions for testing for infectious diseases are the same as for allogeneic donation if
p.(None): collected tissue is stored or cultured.
p.(None): (2) Positive test results shall not interfere with the storage, processing or reimplantation of tissue or tissue derived products.
p.(None): (3) Tissues referred to in paragraph 2 of this Article may be stored and processed provided that conditions that completely disable the cross are provided
p.(None): contamination of other grafts and accessory materials and replacement of grafts.
p.(None): Article 21
p.(None): (1) Tissue donors must be tested for blood transmitted infectious diseases in accordance with this Ordinance.
p.(None): (2) All donors must be serologically tested for at least:
p.(None): - HIV 1 and 2 - Anti-HIV-1,2
p.(None): - Hepatitis B - HBsAg iAnti-HBc
p.(None): - Hepatitis C - Anti-HCV
p.(None): - Syphilis - in accordance with paragraph 6 of this Article.
p.(None): (3) Nucleic acid-NAT multiplication testing is mandatory for all tissue donors with at least HIV 1, HBV and HCV.
p.(None): (4) In addition to the tests referred to in paragraph 2 of this Article, donors must also be tested for HTLV-I if they live or come from areas where
...
Health / stem cells
Searching for indicator stem cells:
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p.(None): in accordance with paragraph 3 of this Article.
p.(None): (3) The assessment of the acceptability of the donor must include factors relevant to the identification and screening of the donor whose tissue donation is for
p.(None): others may present a health risk, such as the transmission of infectious diseases or a donor whose tissue donation may represent
p.(None): health risk for themselves.
p.(None): (4) The tissue collection process must not endanger the health of the donor or jeopardize the health care provided to him.
p.(None): (5) The provisions of paragraphs 3 and 4 of this Article shall apply to both mother and child when collecting blood from the umbilical cord or amniotic envelope.
p.(None): (6) The tissue establishment shall establish and document the selection criteria for allogeneic living donors.
p.(None): (7) The selection criteria referred to in paragraph 6 of this Article must take into account the specific characteristics of the tissue, the physical status of the donor, the anamnesis,
p.(None): behavioral and behavioral data, clinical treatment and laboratory results to determine the donor's health
p.(None): state.
p.(None): (8) A living allogeneic donor may not be considered eligible for donation if one of the following criteria is met
p.(None): Article 17 of this Ordinance, except for the criteria referred to in subparagraph 1 (a) of this Article.
p.(None): (9) Depending on the tissue to be donated, additional specific criteria may be introduced to exclude unacceptable donors such as
p.(None): are:
p.(None): (a) pregnancy (except in the case of cord blood donors and amniotic donors, and when the donor
p.(None): donates stem cells to his brother or sister),
p.(None): (b) breastfeeding,
p.(None): (c) for hematopoietic stem cells, the possibility of transmission of hereditary diseases.
p.(None): Article 19
p.(None): The responsible person may approve the conclusion of the donor referred to in Article 17 (1) (e) and Article 18 of this Ordinance.
p.(None): considers acceptable, if such conclusion is justified in a documented risk assessment process.
p.(None): Article 20
p.(None): (1) For autologous donation, the minimum conditions for testing for infectious diseases are the same as for allogeneic donation if
p.(None): collected tissue is stored or cultured.
p.(None): (2) Positive test results shall not interfere with the storage, processing or reimplantation of tissue or tissue derived products.
p.(None): (3) Tissues referred to in paragraph 2 of this Article may be stored and processed provided that conditions that completely disable the cross are provided
p.(None): contamination of other grafts and accessory materials and replacement of grafts.
p.(None): Article 21
p.(None): (1) Tissue donors must be tested for blood transmitted infectious diseases in accordance with this Ordinance.
p.(None): (2) All donors must be serologically tested for at least:
p.(None): - HIV 1 and 2 - Anti-HIV-1,2
p.(None): - Hepatitis B - HBsAg iAnti-HBc
p.(None): - Hepatitis C - Anti-HCV
p.(None): - Syphilis - in accordance with paragraph 6 of this Article.
p.(None): (3) Nucleic acid-NAT multiplication testing is mandatory for all tissue donors with at least HIV 1, HBV and HCV.
p.(None): (4) In addition to the tests referred to in paragraph 2 of this Article, donors must also be tested for HTLV-I if they live or come from areas where
...
p.(None): (8) The provisions of Article 20 of this Ordinance shall apply to the testing of autologous donors.
p.(None): Article 22
p.(None): (1) Testing shall be performed solely on samples of the donor's serum or plasma and shall not be carried out on other body
p.(None): liquids.
p.(None): (2) By way of derogation from paragraph 1 of this Article, testing may be carried out on other body fluids only if explicitly
p.(None): justified even if the test is conducted with a test validated for such use.
p.(None): (3) Possible donors who have lost blood and have recently received a blood or blood transfusion, or a colloid infusion, or
p.(None): crystalloids, tests may be invalid due to hemodilution of the sample.
p.(None): (4) The cases in which the hemoldilution estimation algorithm must be applied are:
p.(None): a) ante-mortem sample: transfusion or infusion within 48 hours, before sampling, or infusion of crystalloid one hour before
p.(None): sampling,
p.(None): b) post-mortem sample: transfusion or infusion within 48 hours before death, or crystalloid infusion one hour before death.
p.(None): (5) A tissue bank may receive tissues from donors whose plasma has been diluted by more than 50% only if testing has been carried out
p.(None): by a method validated for such plasma samples, or if there are samples taken before transfusion / infusion.
p.(None): (6) Blood samples from a deceased donor must be taken immediately before death or, if this is not possible, no later than 24 hours after death.
p.(None): (7) Live blood donor blood samples (except allogeneic bone marrow and peripheral blood stem cell donors from
p.(None): practical reasons) must be taken at the time of donation or, if this is not possible, within 7 days of donation (the "donation sample").
p.(None): (8) In the case of stem cells from the bone marrow or peripheral blood, blood samples must be taken within 30 days before donation.
p.(None): (9) If, for duly justified and documented reasons, it is not possible to carry out NAT testing and the tissue of an allogeneic living donor
p.(None): can be stored for a long period, it is necessary to repeatedly take samples and test them every 180 days. In the circumstances described
p.(None): The "donation sample" can be taken no longer than 30 days before and 7 days after tissue donation.
p.(None): (10) Where the tissue of an allogeneic living donor cannot be stored for an extended period, the provision of paragraph 8 of this Article shall apply.
p.(None): (11) If a living donor "donation sample" as defined in paragraph 7 of this Article is tested for HIV, HBV and HCV by NAT,
p.(None): no blood test is required. Retesting is also unnecessary when tissue processing involves
p.(None): a validated method of inactivating said viruses.
p.(None): (12) For newborns, the test sample may be taken from the mother.
p.(None): Article 23
p.(None): (1) Tissue collection and collection procedures must be appropriate for the donor and the type of tissue donated. Procedures must be followed
p.(None): that guarantee a living donor security.
p.(None): (2) Tissue collection and collection procedures must preserve the required tissue properties. Collection and collection must be conducted in a manner
p.(None): minimizing the risk of microbial contamination, especially if subsequent sterilization is not possible
p.(None): tissue.
p.(None): (3) In the case of a deceased donor, the tissue collection area must be limited. Tissue must be taken from a local sterile
p.(None): operating field protected by sterile blankets. Professionals participating in the collection must be appropriately dressed
...
p.(None): by workers potentially infected with transmissible diseases.
p.(None): (8) The tissue donor must be assigned a unique NTM identification number upon collection.
p.(None): (9) Donated tissues must be assigned a unique identification when taken or in a tissue bank in accordance with the standard for
p.(None): identification, labeling and transmission of ISBT 128 information for tissues and cells.
p.(None): (10) Donor information should be entered in the NTM under a unique identification code.
p.(None): Article 24
p.(None): (1) The documentation of each donor must contain the following written information:
p.(None): a) the identity of the donor: name, surname and date of birth and gender,
p.(None): When mother and child are included in the gift: mother's name, date of birth, mother's name, if any, and date
p.(None): birth and gender of the child,
p.(None): b) age, history and data on the behavior and habits of the donor (the data collected must be sufficient to decide on
p.(None): acceptability of the donor),
p.(None): c) findings of the physical examination of the body, where applicable,
p.(None): d) calculation of hemodilution, where applicable,
p.(None): e) the consent / approval form, where applicable or the form from the non-donor registry,
p.(None): f) clinical data, results of laboratory and other tests performed,
p.(None): g) autopsy finding, if done (when tissues with short shelf life are collected, a preliminary oral finding should be recorded),
p.(None): h) for donors of hematopoietic stem cells, the matching of the donor with the selected recipient should be documented. It is necessary
p.(None): substantiate the suitability of the donor for the selected recipient. For an unrelated gift, if the collection institution does not have complete information
p.(None): the recipient must provide the transplant center with the information required to confirm compliance.
p.(None): (2) The collection center must produce a collection report and submit it to the tissue bank.
p.(None): (3) The report referred to in paragraph 2 of this Article must contain at least the following:
p.(None): a) identification, name and address of the tissue bank receiving the tissue,
p.(None): b) the information needed to identify the donor (including information on the way in which the donor is identified and information on the person who made it
p.(None): identified),
p.(None): c) description and identification of the tissues collected, including test specimens,
p.(None): d) identification of the worker who performs the collection process and who signs the documents of the procedure,
p.(None): e) date, time (when relevant, start time and end time for each tissue), location of collection and
p.(None): the procedure applied (SOP identification code),
p.(None): f) adverse events during the collection process,
p.(None): g) information on environmental conditions in the collection area, if relevant,
p.(None): h) for deceased donors, the conditions under which the body was stored (whether cooled, cooling start time, cooling off time), and
p.(None): date and time of death,
p.(None): i) the names of the reagents, transport media and materials bearing the batch and expiry date.
p.(None): (4) All records must be clear and legible and protected from unauthorized amendment.
p.(None): Records must be clear and legible throughout the life of the storage obligation and easily accessible.
...
p.(None): recipient,
p.(None): e) on direct donation, the label must identify the intended recipient,
p.(None): f) a container containing tissue confirmed positive for the relevant contagious disease marker shall be labeled: »DANGER
p.(None): TRANSMISSION DISEASE ';
p.(None): (2) If any of the information referred to in paragraph 1, items a), b), c) and e) of this Article cannot be stated on the label
p.(None): primary container, it is necessary to attach it on a separate form to be attached to the primary container.
p.(None): (3) The following information must be provided on the label or in the supporting documentation:
p.(None): a) description (definition) and, where appropriate, dimensions of tissue products,
p.(None): b) the structure and information of the action, if necessary;
p.(None): c) date of tissue distribution,
p.(None): d) donor tests and their results,
p.(None): e) storage recommendations,
p.(None): f) instructions for opening the container, packaging and handling / reconstitution instructions,
p.(None): g) expiry date after opening / handling,
p.(None): h) instructions for reporting serious adverse reactions and / or occurrences,
p.(None): i) the presence of any harmful residues (eg antibiotics, ethylene oxide, etc.).
p.(None): Article 47
p.(None): When transporting tissue, the primary container must be placed in a transport container with a label containing at least the following
p.(None): files:
p.(None): a) identification of the tissue originating bank with the address and telephone number,
p.(None): b) identification of the institution responsible for tissue application, with address and telephone number,
p.(None): c) a statement that the container contains tissues of human origin and the warning "HANDLE"
p.(None): d) if live cells such as stem cells are required for the effect of the transplant, the label: "DO NOT RADIATE" must be added,
p.(None): e) recommended transport conditions (eg keep cool, upright, etc.),
p.(None): f) Safety instructions / cooling method, where applicable.
p.(None): Import and export of tissue
p.(None): Article 48
p.(None): (1) In order to carry out the activity of import and export of tissues, the tissue bank must have an adequate number of administrative and
p.(None): professional staff in charge of organizing activities, documenting traceability and assessing conformity, in accordance with scope
p.(None): activities.
p.(None): (2) Workers must be appropriately trained.
p.(None): Article 49
p.(None): (1) If in the process of import, the tissue bank stores the tissues it must have adequate space and equipment to secure the required
p.(None): properties of the tissue.
p.(None): (2) The tissue establishment referred to in paragraph 1 of this Article shall, in respect of premises and equipment, comply with the conditions laid down in this Ordinance.
p.(None): (3) The tissue bank must have adequate communication equipment.
p.(None): Article 50
p.(None): (1) A tissue bank must have a contract with an institution outside the Republic of Croatia that performs any activity for a tissue bank.
p.(None): (2) The tissue establishment must have a contract with an institution outside the Republic of Croatia for which the tissue establishment carries out any activity.
p.(None): (3) The tissue bank must have written SOPs to verify compliance with the terms of the Act and the ordinances issued pursuant to the Act.
p.(None): (4) The tissue establishment must have a documented system in place to ensure tissue traceability.
p.(None): (5) If a tissue bank carries out the activity of import / export of tissue for a legal person other than a health institution founded by the Republic
...
p.(None): - running automated search systems,
p.(None): - Separate donor testing equipment
p.(None): - validation of results according to validation criteria,
p.(None): - automatic data transfer,
p.(None): - archiving data into the IT system.
p.(None): Article 58
p.(None): (1) The laboratory for the quality of the sea:
p.(None): - be accredited according to a valid revision of the ISO 15 189 standard for quality systems in medical laboratories,
p.(None): - Perform at least 100,000 tests annually to test for blood-borne infectious diseases in blood, tissue and cell donors, and
p.(None): organs, performed in automated systems individually for: HIV (HIVAg / At), HBV (HBsAg), HCV (anti-HCV) and anti-TP,
p.(None): - perform blood-borne infectious disease testing according to the current revision of the Council's Tissue and Cell Quality and Safety Guide
p.(None): Europe
p.(None): - perform confirmatory testing to resolve discrepancies between serological and NAT test results.
p.(None): (2) The laboratory shall use tests marked "CE" where applicable.
p.(None): (3) The tests must be validated for the purpose for which they are used in accordance with current scientific knowledge.
p.(None): Article 59
p.(None): The following shall cease to have effect on the date of entry into force of this Ordinance:
p.(None): 1. Ordinance on the conditions regarding premises, professional staff and medical and technical equipment, quality systems and other conditions for
p.(None): performing tissue collection, storage and transplantation activities (Official Gazette 74/09)
p.(None): 2. Ordinance on the conditions in respect of premises, professionals and medical and technical equipment for performing the activities of taking and
p.(None): storage of umbilical cord blood stem cells (Official Gazette 63/07)
p.(None): 3. Ordinance on the conditions relating to premises, professionals and medical and technical equipment for the taking, storage and
p.(None): transplantation of ocular tissue grafts (Official Gazette 44/07)
p.(None): 4. Rulebook on the method of cooperation with related foreign and international organizations for the purpose of exchanging organs or tissues for work
p.(None): transplantation (Official Gazette 141/05, 44/07)
p.(None): 5. Ordinance on the procedure for the collection, storage and use of hematopoietic stem cells (Official Gazette 59/08)
p.(None): 6. Order on standard operating procedures for the allocation and transplantation of ocular tissue grafts (Official Gazette 89/10).
p.(None): Article 60
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): 8. an agreement with another tissue bank with a license to perform activities in accordance with the terms of the Act, for tissue acceptance in a case
p.(None): its termination,
p.(None): 9. documented tissue disposal procedures that must include reliable and accurate transfer of all
p.(None): traceability data and materials,
p.(None): 10. a strategy for reorganizing work in emergency situations.
p.(None): Article 38
p.(None): (1) Documentation must be clearly defined and effective, records and registers (registers) correct and SOPs approved. Documents must be
p.(None): regularly reviewed and must comply with the requirements of the Act and the ordinances adopted pursuant to the Act.
p.(None): (2) Materials, equipment and workers must be identified and documented for each critical activity.
p.(None): (3) All document changes must be documented reviewed, approved and dated. There must be a procedure for control
p.(None): documents to keep records of the review and modification of the document. Activities must be carried out immediately in accordance with changes.
p.(None): The use of the correct version of the document is ensured by the employee in charge.
p.(None): (4) Records must be reliable and must give credible results.
p.(None): (5) The records must be legible and indelible. The records can be handwritten or transferred to another validated system such as a computer
p.(None): or microfilm.
p.(None): (6) In addition to the information referred to in Article 24, paragraph 5 of this Ordinance, all records, including raw data, are critical for security and
p.(None): tissue quality, must be stored in such a way that it is accessible for at least 10 years after the clinical expiry date
p.(None): use or disposal of tissue.
p.(None): (7) Records must comply with Article 9 of the Act. Access to records and registers must be restricted to persons authorized by it
p.(None): the responsible person and the competent authority for inspection purposes.
p.(None): Article 39
p.(None): (1) An internal control (audit) system must be in place for all activities of the tissue bank. Supervision is carried out by qualified and trained persons
p.(None): workers at least once every two years to verify compliance with approved procedures and legal provisions. the results
p.(None): supervision and corrective action must be documented.
p.(None): (2) Deviations from the prescribed quality and safety standards must be documented. When appropriate, necessary
p.(None): determine corrective and preventive measures. The fate of non-compliant tissues shall be decided in accordance with written procedures. spending
p.(None): the procedures are monitored and documented by the responsible person. All non-compliant tissues should be identified and their status clarified.
p.(None): (3) Corrective measures must be documented, timely initiated and effectively implemented. The effectiveness of corrective and
p.(None): preventive measures must be evaluated after implementation.
p.(None): (4) The tissue establishment must establish procedures for verifying the performance of the quality management system to ensure its continued and
p.(None): systematic improvement.
p.(None): Article 40
p.(None): (1) When receiving tissue, the tissue bank shall check:
p.(None): - that all tissue donors have been tested in accordance with the requirements of Articles 21 and 22 of this Ordinance, or that they have been submitted
p.(None): appropriate test samples,
p.(None): - the criteria for the selection and acceptance of tissues are complied with in accordance with the requirements of Articles 14, 15, 16, 17, 18, 19 and 20 of this Ordinance,
...
Social / Age
Searching for indicator age:
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p.(None): - hemodilution greater than 50% in cases where no blood sample has been taken before transfusion / infusion,
p.(None): - treatment with immunosuppressants,
p.(None): i) the presence of other risk factors for communicable diseases, recognized by risk assessment, taking into account
p.(None): information on donor travel, exposure and local prevalence of a particular infectious disease,
p.(None): j) the existence of physical signs on the donor's body indicating the risk of transmissible disease (s),
p.(None): k) ingestion or exposure to a substance (such as cyanide, lead, mercury, gold) that can be transferred to the recipient at a dose that can
p.(None): endanger health,
p.(None): l) a history of recent vaccination with live attenuated virus, in cases where there is a risk of transmission,
p.(None): m) xenograft transplantation.
p.(None): 2. Additional eligibility criteria for deceased child donors:
p.(None): a) children born to mothers with HIV infection, or mothers who meet any of the general eligibility criteria
p.(None): paragraph 1 of this Article, until the risk of transmission is definitely eliminated,
p.(None): b) children under 18 months of age, born to HIV-infected mothers or mothers with Hepatitis B, Hepatitis C or mothers
p.(None): infected with HTLV or mothers at risk for these infections and breastfed by mothers in the previous 12 months are not eligible donors without
p.(None): regardless of the test results,
p.(None): c) children of mothers infected with HIV, ie mothers suffering from hepatitis B, hepatitis C, or mothers infected with HTLV or at risk for
p.(None): the development of such infections, which have not been nursed by mothers in the previous 12 months, and for which testing, physical examination and insight
p.(None): medical records have not been proven HIV infection, hepatitis B, hepatitis C or HTLV, can be accepted as
p.(None): donors.
p.(None): Article 18
p.(None): (1) The tissue bank shall establish and document the selection criteria for allogeneic living donors. For allogenes, blood donors are blood donors
p.(None): stem cell criteria establishes a registry of voluntary hematopoietic stem cell donors.
...
p.(None): elapsed from the time of death to the time of collection to ensure that the donated tissue retained the required biological and / or
p.(None): physical properties.
p.(None): (5) After collection, the reconstruction of the donor body must be performed with the utmost care, following the natural appearance of the body.
p.(None): (6) Any adverse event during collection that harmed or could harm a living donor must be recorded and considered.
p.(None): The results of all investigations into the cause of this adverse event must be recorded and considered.
p.(None): (7) It is necessary to establish rules and implement procedures that minimize the possibility of tissue contamination from
p.(None): by workers potentially infected with transmissible diseases.
p.(None): (8) The tissue donor must be assigned a unique NTM identification number upon collection.
p.(None): (9) Donated tissues must be assigned a unique identification when taken or in a tissue bank in accordance with the standard for
p.(None): identification, labeling and transmission of ISBT 128 information for tissues and cells.
p.(None): (10) Donor information should be entered in the NTM under a unique identification code.
p.(None): Article 24
p.(None): (1) The documentation of each donor must contain the following written information:
p.(None): a) the identity of the donor: name, surname and date of birth and gender,
p.(None): When mother and child are included in the gift: mother's name, date of birth, mother's name, if any, and date
p.(None): birth and gender of the child,
p.(None): b) age, history and data on the behavior and habits of the donor (the data collected must be sufficient to decide on
p.(None): acceptability of the donor),
p.(None): c) findings of the physical examination of the body, where applicable,
p.(None): d) calculation of hemodilution, where applicable,
p.(None): e) the consent / approval form, where applicable or the form from the non-donor registry,
p.(None): f) clinical data, results of laboratory and other tests performed,
p.(None): g) autopsy finding, if done (when tissues with short shelf life are collected, a preliminary oral finding should be recorded),
p.(None): h) for donors of hematopoietic stem cells, the matching of the donor with the selected recipient should be documented. It is necessary
p.(None): substantiate the suitability of the donor for the selected recipient. For an unrelated gift, if the collection institution does not have complete information
p.(None): the recipient must provide the transplant center with the information required to confirm compliance.
p.(None): (2) The collection center must produce a collection report and submit it to the tissue bank.
p.(None): (3) The report referred to in paragraph 2 of this Article must contain at least the following:
p.(None): a) identification, name and address of the tissue bank receiving the tissue,
p.(None): b) the information needed to identify the donor (including information on the way in which the donor is identified and information on the person who made it
p.(None): identified),
p.(None): c) description and identification of the tissues collected, including test specimens,
p.(None): d) identification of the worker who performs the collection process and who signs the documents of the procedure,
...
Social / Child
Searching for indicator child:
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p.(None): f) history, clinical picture or laboratory-proven HIV, acute or chronic hepatitis B (with the exception of proven immunized persons),
p.(None): hepatitis C and HTLV I / II, or the existence of transmission risk or risk factors for these infections,
p.(None): g) a history of chronic systemic autoimmune disease that may have had a detrimental effect on the quality of the tissue collected,
p.(None): h) application of procedures and therapies to donors rendering laboratory tests unreliable:
p.(None): - hemodilution greater than 50% in cases where no blood sample has been taken before transfusion / infusion,
p.(None): - treatment with immunosuppressants,
p.(None): i) the presence of other risk factors for communicable diseases, recognized by risk assessment, taking into account
p.(None): information on donor travel, exposure and local prevalence of a particular infectious disease,
p.(None): j) the existence of physical signs on the donor's body indicating the risk of transmissible disease (s),
p.(None): k) ingestion or exposure to a substance (such as cyanide, lead, mercury, gold) that can be transferred to the recipient at a dose that can
p.(None): endanger health,
p.(None): l) a history of recent vaccination with live attenuated virus, in cases where there is a risk of transmission,
p.(None): m) xenograft transplantation.
p.(None): 2. Additional eligibility criteria for deceased child donors:
p.(None): a) children born to mothers with HIV infection, or mothers who meet any of the general eligibility criteria
p.(None): paragraph 1 of this Article, until the risk of transmission is definitely eliminated,
p.(None): b) children under 18 months of age, born to HIV-infected mothers or mothers with Hepatitis B, Hepatitis C or mothers
p.(None): infected with HTLV or mothers at risk for these infections and breastfed by mothers in the previous 12 months are not eligible donors without
p.(None): regardless of the test results,
p.(None): c) children of mothers infected with HIV, ie mothers suffering from hepatitis B, hepatitis C, or mothers infected with HTLV or at risk for
p.(None): the development of such infections, which have not been nursed by mothers in the previous 12 months, and for which testing, physical examination and insight
p.(None): medical records have not been proven HIV infection, hepatitis B, hepatitis C or HTLV, can be accepted as
p.(None): donors.
p.(None): Article 18
p.(None): (1) The tissue bank shall establish and document the selection criteria for allogeneic living donors. For allogenes, blood donors are blood donors
p.(None): stem cell criteria establishes a registry of voluntary hematopoietic stem cell donors.
p.(None): (2) The selection of an allogeneic living donor shall be made on the basis of an eligibility assessment procedure, which shall include a health
p.(None): condition and anamnestic data collected through questionnaires and through interviews conducted by a qualified and educated physician,
p.(None): in accordance with paragraph 3 of this Article.
p.(None): (3) The assessment of the acceptability of the donor must include factors relevant to the identification and screening of the donor whose tissue donation is for
p.(None): others may present a health risk, such as the transmission of infectious diseases or a donor whose tissue donation may represent
p.(None): health risk for themselves.
p.(None): (4) The tissue collection process must not endanger the health of the donor or jeopardize the health care provided to him.
p.(None): (5) The provisions of paragraphs 3 and 4 of this Article shall apply to both mother and child when collecting blood from the umbilical cord or amniotic envelope.
p.(None): (6) The tissue establishment shall establish and document the selection criteria for allogeneic living donors.
p.(None): (7) The selection criteria referred to in paragraph 6 of this Article must take into account the specific characteristics of the tissue, the physical status of the donor, the anamnesis,
p.(None): behavioral and behavioral data, clinical treatment and laboratory results to determine the donor's health
p.(None): state.
p.(None): (8) A living allogeneic donor may not be considered eligible for donation if one of the following criteria is met
p.(None): Article 17 of this Ordinance, except for the criteria referred to in subparagraph 1 (a) of this Article.
p.(None): (9) Depending on the tissue to be donated, additional specific criteria may be introduced to exclude unacceptable donors such as
p.(None): are:
p.(None): (a) pregnancy (except in the case of cord blood donors and amniotic donors, and when the donor
p.(None): donates stem cells to his brother or sister),
p.(None): (b) breastfeeding,
p.(None): (c) for hematopoietic stem cells, the possibility of transmission of hereditary diseases.
p.(None): Article 19
p.(None): The responsible person may approve the conclusion of the donor referred to in Article 17 (1) (e) and Article 18 of this Ordinance.
p.(None): considers acceptable, if such conclusion is justified in a documented risk assessment process.
p.(None): Article 20
p.(None): (1) For autologous donation, the minimum conditions for testing for infectious diseases are the same as for allogeneic donation if
p.(None): collected tissue is stored or cultured.
...
p.(None): collection method. Professionals must perform surgical hand washing, be dressed in sterile bathrobes and wear sterile gloves,
p.(None): protective masks and, where appropriate, face shields.
p.(None): (4) In the case of a deceased donor, a record must be made of the place of collection and the time interval that is
p.(None): elapsed from the time of death to the time of collection to ensure that the donated tissue retained the required biological and / or
p.(None): physical properties.
p.(None): (5) After collection, the reconstruction of the donor body must be performed with the utmost care, following the natural appearance of the body.
p.(None): (6) Any adverse event during collection that harmed or could harm a living donor must be recorded and considered.
p.(None): The results of all investigations into the cause of this adverse event must be recorded and considered.
p.(None): (7) It is necessary to establish rules and implement procedures that minimize the possibility of tissue contamination from
p.(None): by workers potentially infected with transmissible diseases.
p.(None): (8) The tissue donor must be assigned a unique NTM identification number upon collection.
p.(None): (9) Donated tissues must be assigned a unique identification when taken or in a tissue bank in accordance with the standard for
p.(None): identification, labeling and transmission of ISBT 128 information for tissues and cells.
p.(None): (10) Donor information should be entered in the NTM under a unique identification code.
p.(None): Article 24
p.(None): (1) The documentation of each donor must contain the following written information:
p.(None): a) the identity of the donor: name, surname and date of birth and gender,
p.(None): When mother and child are included in the gift: mother's name, date of birth, mother's name, if any, and date
p.(None): birth and gender of the child,
p.(None): b) age, history and data on the behavior and habits of the donor (the data collected must be sufficient to decide on
p.(None): acceptability of the donor),
p.(None): c) findings of the physical examination of the body, where applicable,
p.(None): d) calculation of hemodilution, where applicable,
p.(None): e) the consent / approval form, where applicable or the form from the non-donor registry,
p.(None): f) clinical data, results of laboratory and other tests performed,
p.(None): g) autopsy finding, if done (when tissues with short shelf life are collected, a preliminary oral finding should be recorded),
p.(None): h) for donors of hematopoietic stem cells, the matching of the donor with the selected recipient should be documented. It is necessary
p.(None): substantiate the suitability of the donor for the selected recipient. For an unrelated gift, if the collection institution does not have complete information
p.(None): the recipient must provide the transplant center with the information required to confirm compliance.
p.(None): (2) The collection center must produce a collection report and submit it to the tissue bank.
p.(None): (3) The report referred to in paragraph 2 of this Article must contain at least the following:
p.(None): a) identification, name and address of the tissue bank receiving the tissue,
p.(None): b) the information needed to identify the donor (including information on the way in which the donor is identified and information on the person who made it
p.(None): identified),
p.(None): c) description and identification of the tissues collected, including test specimens,
p.(None): d) identification of the worker who performs the collection process and who signs the documents of the procedure,
...
Searching for indicator children:
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p.(None): hepatitis C and HTLV I / II, or the existence of transmission risk or risk factors for these infections,
p.(None): g) a history of chronic systemic autoimmune disease that may have had a detrimental effect on the quality of the tissue collected,
p.(None): h) application of procedures and therapies to donors rendering laboratory tests unreliable:
p.(None): - hemodilution greater than 50% in cases where no blood sample has been taken before transfusion / infusion,
p.(None): - treatment with immunosuppressants,
p.(None): i) the presence of other risk factors for communicable diseases, recognized by risk assessment, taking into account
p.(None): information on donor travel, exposure and local prevalence of a particular infectious disease,
p.(None): j) the existence of physical signs on the donor's body indicating the risk of transmissible disease (s),
p.(None): k) ingestion or exposure to a substance (such as cyanide, lead, mercury, gold) that can be transferred to the recipient at a dose that can
p.(None): endanger health,
p.(None): l) a history of recent vaccination with live attenuated virus, in cases where there is a risk of transmission,
p.(None): m) xenograft transplantation.
p.(None): 2. Additional eligibility criteria for deceased child donors:
p.(None): a) children born to mothers with HIV infection, or mothers who meet any of the general eligibility criteria
p.(None): paragraph 1 of this Article, until the risk of transmission is definitely eliminated,
p.(None): b) children under 18 months of age, born to HIV-infected mothers or mothers with Hepatitis B, Hepatitis C or mothers
p.(None): infected with HTLV or mothers at risk for these infections and breastfed by mothers in the previous 12 months are not eligible donors without
p.(None): regardless of the test results,
p.(None): c) children of mothers infected with HIV, ie mothers suffering from hepatitis B, hepatitis C, or mothers infected with HTLV or at risk for
p.(None): the development of such infections, which have not been nursed by mothers in the previous 12 months, and for which testing, physical examination and insight
p.(None): medical records have not been proven HIV infection, hepatitis B, hepatitis C or HTLV, can be accepted as
p.(None): donors.
p.(None): Article 18
p.(None): (1) The tissue bank shall establish and document the selection criteria for allogeneic living donors. For allogenes, blood donors are blood donors
p.(None): stem cell criteria establishes a registry of voluntary hematopoietic stem cell donors.
p.(None): (2) The selection of an allogeneic living donor shall be made on the basis of an eligibility assessment procedure, which shall include a health
p.(None): condition and anamnestic data collected through questionnaires and through interviews conducted by a qualified and educated physician,
p.(None): in accordance with paragraph 3 of this Article.
p.(None): (3) The assessment of the acceptability of the donor must include factors relevant to the identification and screening of the donor whose tissue donation is for
p.(None): others may present a health risk, such as the transmission of infectious diseases or a donor whose tissue donation may represent
p.(None): health risk for themselves.
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None): its termination,
p.(None): 9. documented tissue disposal procedures that must include reliable and accurate transfer of all
p.(None): traceability data and materials,
p.(None): 10. a strategy for reorganizing work in emergency situations.
p.(None): Article 38
p.(None): (1) Documentation must be clearly defined and effective, records and registers (registers) correct and SOPs approved. Documents must be
p.(None): regularly reviewed and must comply with the requirements of the Act and the ordinances adopted pursuant to the Act.
p.(None): (2) Materials, equipment and workers must be identified and documented for each critical activity.
p.(None): (3) All document changes must be documented reviewed, approved and dated. There must be a procedure for control
p.(None): documents to keep records of the review and modification of the document. Activities must be carried out immediately in accordance with changes.
p.(None): The use of the correct version of the document is ensured by the employee in charge.
p.(None): (4) Records must be reliable and must give credible results.
p.(None): (5) The records must be legible and indelible. The records can be handwritten or transferred to another validated system such as a computer
p.(None): or microfilm.
p.(None): (6) In addition to the information referred to in Article 24, paragraph 5 of this Ordinance, all records, including raw data, are critical for security and
p.(None): tissue quality, must be stored in such a way that it is accessible for at least 10 years after the clinical expiry date
p.(None): use or disposal of tissue.
p.(None): (7) Records must comply with Article 9 of the Act. Access to records and registers must be restricted to persons authorized by it
p.(None): the responsible person and the competent authority for inspection purposes.
p.(None): Article 39
p.(None): (1) An internal control (audit) system must be in place for all activities of the tissue bank. Supervision is carried out by qualified and trained persons
p.(None): workers at least once every two years to verify compliance with approved procedures and legal provisions. the results
p.(None): supervision and corrective action must be documented.
p.(None): (2) Deviations from the prescribed quality and safety standards must be documented. When appropriate, necessary
p.(None): determine corrective and preventive measures. The fate of non-compliant tissues shall be decided in accordance with written procedures. spending
p.(None): the procedures are monitored and documented by the responsible person. All non-compliant tissues should be identified and their status clarified.
p.(None): (3) Corrective measures must be documented, timely initiated and effectively implemented. The effectiveness of corrective and
p.(None): preventive measures must be evaluated after implementation.
p.(None): (4) The tissue establishment must establish procedures for verifying the performance of the quality management system to ensure its continued and
p.(None): systematic improvement.
p.(None): Article 40
p.(None): (1) When receiving tissue, the tissue bank shall check:
p.(None): - that all tissue donors have been tested in accordance with the requirements of Articles 21 and 22 of this Ordinance, or that they have been submitted
p.(None): appropriate test samples,
p.(None): - the criteria for the selection and acceptance of tissues are complied with in accordance with the requirements of Articles 14, 15, 16, 17, 18, 19 and 20 of this Ordinance,
...
Social / Mothers
Searching for indicator mothers:
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p.(None): hepatitis C and HTLV I / II, or the existence of transmission risk or risk factors for these infections,
p.(None): g) a history of chronic systemic autoimmune disease that may have had a detrimental effect on the quality of the tissue collected,
p.(None): h) application of procedures and therapies to donors rendering laboratory tests unreliable:
p.(None): - hemodilution greater than 50% in cases where no blood sample has been taken before transfusion / infusion,
p.(None): - treatment with immunosuppressants,
p.(None): i) the presence of other risk factors for communicable diseases, recognized by risk assessment, taking into account
p.(None): information on donor travel, exposure and local prevalence of a particular infectious disease,
p.(None): j) the existence of physical signs on the donor's body indicating the risk of transmissible disease (s),
p.(None): k) ingestion or exposure to a substance (such as cyanide, lead, mercury, gold) that can be transferred to the recipient at a dose that can
p.(None): endanger health,
p.(None): l) a history of recent vaccination with live attenuated virus, in cases where there is a risk of transmission,
p.(None): m) xenograft transplantation.
p.(None): 2. Additional eligibility criteria for deceased child donors:
p.(None): a) children born to mothers with HIV infection, or mothers who meet any of the general eligibility criteria
p.(None): paragraph 1 of this Article, until the risk of transmission is definitely eliminated,
p.(None): b) children under 18 months of age, born to HIV-infected mothers or mothers with Hepatitis B, Hepatitis C or mothers
p.(None): infected with HTLV or mothers at risk for these infections and breastfed by mothers in the previous 12 months are not eligible donors without
p.(None): regardless of the test results,
p.(None): c) children of mothers infected with HIV, ie mothers suffering from hepatitis B, hepatitis C, or mothers infected with HTLV or at risk for
p.(None): the development of such infections, which have not been nursed by mothers in the previous 12 months, and for which testing, physical examination and insight
p.(None): medical records have not been proven HIV infection, hepatitis B, hepatitis C or HTLV, can be accepted as
p.(None): donors.
p.(None): Article 18
p.(None): (1) The tissue bank shall establish and document the selection criteria for allogeneic living donors. For allogenes, blood donors are blood donors
p.(None): stem cell criteria establishes a registry of voluntary hematopoietic stem cell donors.
p.(None): (2) The selection of an allogeneic living donor shall be made on the basis of an eligibility assessment procedure, which shall include a health
p.(None): condition and anamnestic data collected through questionnaires and through interviews conducted by a qualified and educated physician,
p.(None): in accordance with paragraph 3 of this Article.
p.(None): (3) The assessment of the acceptability of the donor must include factors relevant to the identification and screening of the donor whose tissue donation is for
p.(None): others may present a health risk, such as the transmission of infectious diseases or a donor whose tissue donation may represent
p.(None): health risk for themselves.
p.(None): (4) The tissue collection process must not endanger the health of the donor or jeopardize the health care provided to him.
p.(None): (5) The provisions of paragraphs 3 and 4 of this Article shall apply to both mother and child when collecting blood from the umbilical cord or amniotic envelope.
p.(None): (6) The tissue establishment shall establish and document the selection criteria for allogeneic living donors.
...
Social / Occupation
Searching for indicator job:
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p.(None): (d) date and time of commencement of transport,
p.(None): (e) specification of transport conditions affecting tissue safety and quality;
p.(None): (f) the container containing the cells must be labeled "DO NOT RADIATE",
p.(None): (g) a container containing tissue positive for the relevant contagious disease marker shall be labeled with: "TRANSMISSION HAZARD
p.(None): INFECTIOUS DISEASES",
p.(None): (h) a container containing tissue for autologous use must be labeled with the words: "FOR AUTOLOGICAL USE ONLY",
p.(None): (i) Specification of storage conditions: "DO NOT FREEZE" and the like.
p.(None): 3. TISSUE BANK
p.(None): Article 27
p.(None): (1) Tissue banking activities may only be performed at a clinical hospital center eligible for a tissue bank
p.(None): prescribed by this Ordinance.
p.(None): (2) The tissue bank shall carry out at least the activity of tissue processing, preservation, storage and distribution.
p.(None): (3) A tissue bank may also carry out the activity of collecting, taking, testing and applying it if it fulfills the conditions for the said activities
p.(None): prescribed by this Ordinance.
p.(None): (4) A tissue bank may also carry out the activity of import and export of tissue if it fulfills the conditions for the said activities prescribed by this
p.(None): Regulations.
p.(None): Workers
p.(None): Article 28
p.(None): (1) In order to carry out the activity of processing, preserving, storing and distributing tissues, the tissue bank shall, in respect of professional workers, fulfill
p.(None): the following conditions:
p.(None): a) have an adequate number of professional staff qualified to carry out the activity for which the license is requested,
p.(None): b) to check the competences of workers, in accordance with the established quality system,
p.(None): c) have a clear, documented and regularly updated job description for each worker. The tasks, responsibilities and responsibilities must be clear
p.(None): documented and understandable,
p.(None): d) Ensure that the professional workers undergo initial basic education.
p.(None): (2) The education referred to in paragraph (1) (d) of this Article shall be carried out each time the procedure is changed. Education should monitor development
p.(None): scientific knowledge and facilitate the professional development of workers.
p.(None): (3) Education must document, for each worker, the following:
p.(None): - competence in performing assigned tasks,
p.(None): - adequate knowledge and understanding of scientific principles and technical procedures related to the tasks assigned,
p.(None): - understanding of organizational structure, quality system, health protection measures,
p.(None): - adequate information on the ethical, legislative and regulatory context of their work.
p.(None): (4) The tissue establishment shall have at its disposal a physician of appropriate specialization for the purposes of professional counseling and supervision
p.(None): Tissue Bank medical activities such as: selecting a donor, evaluating the clinical outcome of the tissue application, and collaborating with
p.(None): to healthcare professionals who apply tissues.
p.(None): Article 29
p.(None): (1) A tissue bank must have a designated responsible person - a head of a tissue bank who meets at least the following conditions:
p.(None): - a specialist in transfusion medicine or other specialization appropriate to the type of activity of the tissue bank,
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): Pursuant to Article 26 (1), Article 29 (2), Article 30 (4) and Article 35 (5) of the Law on the Use of Human Tissues and
p.(None): station (Official Gazette, No. 144/12), the Minister of Health issues
p.(None): REGULATION ON CONDITIONS CONCERNING SPACE, PROFESSIONAL WORKERS, MEDICAL-TECHNICAL EQUIPMENT AND SYSTEMS
p.(None): QUALITIES FOR PERFORMANCE OF COLLECTING, TAKING, TESTING, PROCESSING, CONSERVATION ACTIVITIES,
p.(None): STORAGE AND DISTRIBUTION OF HUMAN TISSUES AND STATIONS
p.(None): (Official Gazette 80/13)
p.(None): 1. GENERAL PROVISIONS
p.(None): Article 1.
p.(None): This Ordinance lays down the conditions regarding premises, skilled workers and medical and technical equipment, quality systems and others.
p.(None): the conditions to be fulfilled by health institutions for the pursuit of the activities of collection, collection, testing, processing, preservation,
p.(None): the storage and distribution of human tissues and cells (hereinafter referred to as: tissues).
p.(None): Article 2
p.(None): Health facilities in which the activities referred to in Article 1 of this Ordinance are performed must comply with the general sanitary-technical,
p.(None): hygiene and other conditions laid down in the Ordinance on minimum conditions for premises, workers and medical-technical equipment
p.(None): for the pursuit of the health care profession and the additional requirements laid down in this Ordinance.
p.(None): Article 3
p.(None): This Ordinance contains provisions in accordance with the following acts of the European Union:
p.(None): - Directive 2004/23 / EC of the European Parliament and of the Council of 31 March 2004 setting standards of quality and safety for
p.(None): the procedures for the donation, procurement, testing, treatment, storage, storage and distribution of tissues and cells of human origin (OJ L 102, 7. 4.
p.(None): 2004),
p.(None): - Commission Directive 2006/17 / EC of 8 February 2006 implementing Directive 2004/23 / EC of the European Parliament and of the Council
p.(None): certain technical requirements for the donation, acquisition and testing of tissues and cells of human origin (OJ L 38, 9.2.2006),
p.(None): - Commission Directive 2006/86 / EC of 24 October 2006 implementing Directive 2004/23 / EC of the European Parliament and of the Council
p.(None): with respect to monitoring requests, reporting serious adverse reactions and occurrences, and certain technical requirements related to
p.(None): the labeling, treatment, storage, storage and distribution of tissues and cells of human origin (OJ L 294, 25.10.2006).
p.(None): 2. TISSUE COLLECTION AND TAKING
p.(None): Article 4
p.(None): (1) Tissue collection and collection may only be performed in hospital health facilities with adequate
p.(None): the specialist activity required to take a specific type of tissue and which meet the conditions laid down in this Ordinance (in
p.(None): hereinafter referred to as the exploration center).
p.(None): (2) Tissue collection and collection may also be performed by a tissue bank authorized to carry out tissue collection and collection activities.
p.(None): (3) The health institution where the tissue is collected and collected must have an organized system of notification of potential donors and
p.(None): is obliged to provide technical and personnel support to the exploration team.
p.(None): Workers
p.(None): Article 5
...
p.(None): - submit to the Ministry an annual report on the activity of the tissue bank,
p.(None): - ensure that the Ministry is informed of serious adverse events and reactions,
p.(None): - ensure that the Ministry reports on serious adverse events and reactions with cause and effect analysis,
p.(None): (2) The Tissue Bank is obliged to provide the Ministry with the name and contact details of the named responsible person and the replacement.
p.(None): (3) In case of temporary absence of the named responsible person, the tissue bank shall be obliged to inform in writing without delay.
p.(None): ministry.
p.(None): (4) In the case of the appointment of a new responsible person, the tissue bank shall notify the ministry in writing without delay.
p.(None): Room
p.(None): Article 31
p.(None): The tissue establishment shall meet the following conditions in terms of space:
p.(None): 1. Depending on the tissue, there should be separate spaces or a safety system for separating the tissue in quarantine from the tissues that have been discarded, and
p.(None): from tissues accepted for administration,
p.(None): 2. the area in which the tissues are treated must be designed, organized and maintained in such a way that the risk of pollution is avoided,
p.(None): including cross pollution minimizes it. Performance, organization and maintenance efficiency must also be validated
p.(None): monitor,
p.(None): 3. if tissues are exposed to the environment during processing, they must be treated in an area in which the air quality corresponds to Class A of
p.(None): Principles and guidelines of good manufacturing practice for medicines as well as additional specifics for individual drug processes and forms »The
p.(None): Rules Governing Medicinal Products in the European Union, Volume 4 - Good Manufacturing Practices, Medicinal Products for
p.(None): Human and Veterinary use, 1998 Edition, European Commission, Directorate General III - Industry, Pharmaceutical and
p.(None): Cosmetics «with all amendments (hereinafter: DPP). The ambient air quality of the space in which the tissue is treated must be
p.(None): appropriate to the type of tissue to be treated but must comply at least with Class D DPP. Air quality must be validated and monitored,
p.(None): 4. less stringent air quality conditions than those referred to in subparagraph 3 of this Article may be applied if:
p.(None): a) validated microbiological inactivation or validated end sterilization is applied, or,
p.(None): b) exposure to the conditions necessary to achieve Class A air quality has been shown to adversely affect the required tissue properties or,
p.(None): c) it is demonstrated that the method and course of tissue administration presents a significantly lower risk of transmission of the bacterial or fungal infection to
p.(None): recipients than in the case of non-transplanting tissue,
p.(None): d) it is technically impossible to perform the required processing procedure in a Class A air quality environment (for example, if processing requires
p.(None): equipment which makes it not possible to validate space in Class A),
p.(None): 5. if the tissues are treated in an area with an air quality of less than class A, the air quality class to be prescribed by the procedure
p.(None): demands. It must be validated that the procedure in the prescribed air class meets the quality and safety criteria for its intended purpose,
p.(None): the mode of administration and the immune status of the recipient,
p.(None): 6. For the storage of tissues, the conditions necessary to maintain the required tissue properties must be prescribed, especially critical parameters such as
...
Social / education
Searching for indicator education:
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p.(None): - become familiar with the organizational structure and operation of the National Transplant Network (hereinafter referred to as NTM),
p.(None): quality system and reporting of serious adverse events and reactions,
p.(None): - have been adequately informed on ethical and legal aspects in the field of tissue acquisition.
p.(None): (2) When the collection and collection of tissue for a tissue bank is performed by another healthcare institution, the tissue bank must have concluded contracts
p.(None): on the collection of each type of tissue with that health institution, which must include the professionals responsible for
p.(None): selection of donors and professionals responsible for tissue collection and collection.
p.(None): (3) The health institution or tissue establishment must provide skilled workers for the reconstruction of the bodies of deceased donors.
p.(None): (4) Where tissues are intended for direct transplantation, the exploration team must be associated with the transplant
p.(None): the blood donor center or registry.
p.(None): Article 6
p.(None): (1) Health facilities must have a designated coordinator for tissue collection in accordance with Article 35 of the Implementation Act
p.(None): of human tissues and cells (hereinafter: the Law).
p.(None): (2) The hospital transplant coordinator appointed in accordance with the Human Organ Transplantation Act for the purpose of treatment may be
p.(None): also appointed as Tissue Collection Coordinator.
p.(None): (3) The tissue collection coordinator must meet at least the following conditions:
p.(None): - a physician approved to work independently,
p.(None): - at least 2 years of work experience in tissue banking and / or transplantation,
p.(None): - have documented education in the field of tissue collection and collection, at least as prescribed in Article 5 (1) (e)
p.(None): of this Ordinance and theoretical and practical knowledge of the selection and eligibility criteria of the donor.
p.(None): Article 7
p.(None): The tissue collection coordinator is required to:
p.(None): - receive notification of a potential tissue donor,
p.(None): - coordinate all actions related to the tissue donation process,
p.(None): - check the status in the register of non-donors,
p.(None): - obtain consent to donate a living donor,
p.(None): - interview the deceased donor's family,
p.(None): - inform exploration teams and coordinate tissue preparation preparations,
p.(None): - cooperate with the hospital transplant coordinator when appropriate,
p.(None): - collect all available information on the health status of the potential donor necessary to assess the acceptability of the donor,
p.(None): including social and medical history,
p.(None): - complete, maintain and submit all medical records of the possible donor and other forms within the prescribed deadlines
p.(None): from the health care quality system related to tissue donation procedures, including any medical information received after
p.(None): performed tissue sampling,
p.(None): - carry out the evaluation of the tissue donor,
p.(None): - ensure that the prescribed blood and / or tissue samples of the potential donor have been collected and delivered in the prescribed manner and within the prescribed time limit,
p.(None): - document and investigate serious adverse events and reactions related to donation and report them in accordance with a special regulation,
p.(None): - when appropriate to cooperate with a tissue bank in investigating a serious adverse event and reaction,
...
p.(None): INFECTIOUS DISEASES",
p.(None): (h) a container containing tissue for autologous use must be labeled with the words: "FOR AUTOLOGICAL USE ONLY",
p.(None): (i) Specification of storage conditions: "DO NOT FREEZE" and the like.
p.(None): 3. TISSUE BANK
p.(None): Article 27
p.(None): (1) Tissue banking activities may only be performed at a clinical hospital center eligible for a tissue bank
p.(None): prescribed by this Ordinance.
p.(None): (2) The tissue bank shall carry out at least the activity of tissue processing, preservation, storage and distribution.
p.(None): (3) A tissue bank may also carry out the activity of collecting, taking, testing and applying it if it fulfills the conditions for the said activities
p.(None): prescribed by this Ordinance.
p.(None): (4) A tissue bank may also carry out the activity of import and export of tissue if it fulfills the conditions for the said activities prescribed by this
p.(None): Regulations.
p.(None): Workers
p.(None): Article 28
p.(None): (1) In order to carry out the activity of processing, preserving, storing and distributing tissues, the tissue bank shall, in respect of professional workers, fulfill
p.(None): the following conditions:
p.(None): a) have an adequate number of professional staff qualified to carry out the activity for which the license is requested,
p.(None): b) to check the competences of workers, in accordance with the established quality system,
p.(None): c) have a clear, documented and regularly updated job description for each worker. The tasks, responsibilities and responsibilities must be clear
p.(None): documented and understandable,
p.(None): d) Ensure that the professional workers undergo initial basic education.
p.(None): (2) The education referred to in paragraph (1) (d) of this Article shall be carried out each time the procedure is changed. Education should monitor development
p.(None): scientific knowledge and facilitate the professional development of workers.
p.(None): (3) Education must document, for each worker, the following:
p.(None): - competence in performing assigned tasks,
p.(None): - adequate knowledge and understanding of scientific principles and technical procedures related to the tasks assigned,
p.(None): - understanding of organizational structure, quality system, health protection measures,
p.(None): - adequate information on the ethical, legislative and regulatory context of their work.
p.(None): (4) The tissue establishment shall have at its disposal a physician of appropriate specialization for the purposes of professional counseling and supervision
p.(None): Tissue Bank medical activities such as: selecting a donor, evaluating the clinical outcome of the tissue application, and collaborating with
p.(None): to healthcare professionals who apply tissues.
p.(None): Article 29
p.(None): (1) A tissue bank must have a designated responsible person - a head of a tissue bank who meets at least the following conditions:
p.(None): - a specialist in transfusion medicine or other specialization appropriate to the type of activity of the tissue bank,
p.(None): - at least five years of practical experience in the field of tissue banking,
p.(None): (2) The tissue bank shall appoint a replacement for the responsible person referred to in paragraph 1 of this Article in the event of its temporary absence.
p.(None): The replacement must meet the same conditions as the responsible person.
p.(None): Article 30
p.(None): (1) The responsible person referred to in Article 29 of this Ordinance shall be obliged to:
p.(None): - ensure that all the activities of the tissue bank are carried out in accordance with the conditions prescribed by the Act and the regulations adopted thereunder
p.(None): law,
p.(None): - ensure the establishment of a quality management system,
...
p.(None): national and / or regional competent authority for tissues and cells and to which the competent authority for tissues and cells gave the Republic of Croatia
p.(None): certificate of conformity.
p.(None): (3) The competent authority of the Republic of Croatia shall provide the certificate of conformity referred to in paragraph 2 of this Article on the basis of the procedure carried out
p.(None): in accordance with the procedure for granting authorization to exercise the activity as prescribed by the Act and the regulations issued on the basis thereof
p.(None): Act.
p.(None): 4. AUTHORIZATION FOR PERFORMANCE
p.(None): Article 52
p.(None): (1) Health care institutions must obtain approval to perform each of the following groups of activities separately for each tissue type:
p.(None): 1. collection and collection,
p.(None): 2. testing,
p.(None): 3. processing, preservation, storage and distribution,
p.(None): 4. tissue import and / or export.
p.(None): (2) the application for authorization to carry out the activities referred to in paragraph 1 of this Article, together with evidence of compliance with the conditions prescribed by the Law,
p.(None): a health institution or a laboratory is obliged to enclose:
p.(None): 1. Decision on appointment of the head of tissue bank - responsible persons,
p.(None): 2. the treatment of the tissue bank in the event of termination of the storage activity, including the fulfillment of commitments and the sending of tissue to another
p.(None): a tissue bank,
p.(None): 3. evidence of the qualifications of the workers and the education provided,
p.(None): 4. written contracts with legal entities in accordance with the provisions of the Act and this Ordinance,
p.(None): 5. report on compliance with the prescribed conditions for the activities for which approval is sought.
p.(None): (3) Any essential modification of the conditions or requirements on the basis of which the approval of the healthcare institution was granted shall be obliged immediately
p.(None): inform the ministry.
p.(None): 5. LABORATORY
p.(None): Article 53
p.(None): (1) The donor blood test laboratory shall be able to perform all serological and NAT tests
p.(None): tissue donors referred to in Articles 21 and 22 of this Ordinance.
p.(None): (2) Only in exceptional cases can a laboratory be approved to carry out testing by another person
p.(None): laboratory / health care institution / legal entity, with the prior approval of the tissue bank. The laboratory is obliged to do so
p.(None): inform the ministry.
p.(None): (3) The laboratory must have an organized service 24 hours a day.
p.(None): Article 54
p.(None): (1) The testing laboratory must have at least:
p.(None): - 1 doctor of medicine, specialist in transfusion medicine,
p.(None): - 1 doctor of medicine specialist in clinical microbiology or specialist in medical microbiology with parasitology,
p.(None): - 1 Master of Medical Biochemistry Specialist in Medical Biochemistry and Laboratory Medicine,
p.(None): - 2 Bachelor of Medical Laboratory Diagnostics.
p.(None): (2) The laboratory is obliged to provide workers with an initial documented internal training in the field of work, lasting at least 3
p.(None): months and documented continuing education.
p.(None): Article 55
p.(None): (1) The laboratory must have a designated responsible person and a replacement who meets at least the following conditions:
p.(None): - Doctor of Medicine specialist in clinical microbiology or specialist in medical microbiology with parasitology, or transfusion
p.(None): medicine or mag. medical biochemistry specialist in medical biochemistry and laboratory medicine,
p.(None): - At least 5 years of work experience in the field of blood-borne disease testing in a blood donor and / or tissue and / or organ.
p.(None): (2) The responsible person shall be responsible for ensuring the quality of the results.
p.(None): Article 56
p.(None): The space laboratory must have:
p.(None): - separate space for testing donors of the appropriate size for the smooth operation of automated systems,
p.(None): - adequate and documented monitored microclimate operating conditions for automated systems.
p.(None): Article 57
p.(None): The laboratory with regard to medical and technical equipment must have:
p.(None): - running automated search systems,
p.(None): - Separate donor testing equipment
p.(None): - validation of results according to validation criteria,
p.(None): - automatic data transfer,
p.(None): - archiving data into the IT system.
p.(None): Article 58
p.(None): (1) The laboratory for the quality of the sea:
p.(None): - be accredited according to a valid revision of the ISO 15 189 standard for quality systems in medical laboratories,
p.(None): - Perform at least 100,000 tests annually to test for blood-borne infectious diseases in blood, tissue and cell donors, and
p.(None): organs, performed in automated systems individually for: HIV (HIVAg / At), HBV (HBsAg), HCV (anti-HCV) and anti-TP,
...
Social / gender
Searching for indicator gender:
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p.(None): collection method. Professionals must perform surgical hand washing, be dressed in sterile bathrobes and wear sterile gloves,
p.(None): protective masks and, where appropriate, face shields.
p.(None): (4) In the case of a deceased donor, a record must be made of the place of collection and the time interval that is
p.(None): elapsed from the time of death to the time of collection to ensure that the donated tissue retained the required biological and / or
p.(None): physical properties.
p.(None): (5) After collection, the reconstruction of the donor body must be performed with the utmost care, following the natural appearance of the body.
p.(None): (6) Any adverse event during collection that harmed or could harm a living donor must be recorded and considered.
p.(None): The results of all investigations into the cause of this adverse event must be recorded and considered.
p.(None): (7) It is necessary to establish rules and implement procedures that minimize the possibility of tissue contamination from
p.(None): by workers potentially infected with transmissible diseases.
p.(None): (8) The tissue donor must be assigned a unique NTM identification number upon collection.
p.(None): (9) Donated tissues must be assigned a unique identification when taken or in a tissue bank in accordance with the standard for
p.(None): identification, labeling and transmission of ISBT 128 information for tissues and cells.
p.(None): (10) Donor information should be entered in the NTM under a unique identification code.
p.(None): Article 24
p.(None): (1) The documentation of each donor must contain the following written information:
p.(None): a) the identity of the donor: name, surname and date of birth and gender,
p.(None): When mother and child are included in the gift: mother's name, date of birth, mother's name, if any, and date
p.(None): birth and gender of the child,
p.(None): b) age, history and data on the behavior and habits of the donor (the data collected must be sufficient to decide on
p.(None): acceptability of the donor),
p.(None): c) findings of the physical examination of the body, where applicable,
p.(None): d) calculation of hemodilution, where applicable,
p.(None): e) the consent / approval form, where applicable or the form from the non-donor registry,
p.(None): f) clinical data, results of laboratory and other tests performed,
p.(None): g) autopsy finding, if done (when tissues with short shelf life are collected, a preliminary oral finding should be recorded),
p.(None): h) for donors of hematopoietic stem cells, the matching of the donor with the selected recipient should be documented. It is necessary
p.(None): substantiate the suitability of the donor for the selected recipient. For an unrelated gift, if the collection institution does not have complete information
p.(None): the recipient must provide the transplant center with the information required to confirm compliance.
p.(None): (2) The collection center must produce a collection report and submit it to the tissue bank.
p.(None): (3) The report referred to in paragraph 2 of this Article must contain at least the following:
p.(None): a) identification, name and address of the tissue bank receiving the tissue,
p.(None): b) the information needed to identify the donor (including information on the way in which the donor is identified and information on the person who made it
p.(None): identified),
p.(None): c) description and identification of the tissues collected, including test specimens,
...
Social / parents
Searching for indicator parents:
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p.(None): Article 19
p.(None): The responsible person may approve the conclusion of the donor referred to in Article 17 (1) (e) and Article 18 of this Ordinance.
p.(None): considers acceptable, if such conclusion is justified in a documented risk assessment process.
p.(None): Article 20
p.(None): (1) For autologous donation, the minimum conditions for testing for infectious diseases are the same as for allogeneic donation if
p.(None): collected tissue is stored or cultured.
p.(None): (2) Positive test results shall not interfere with the storage, processing or reimplantation of tissue or tissue derived products.
p.(None): (3) Tissues referred to in paragraph 2 of this Article may be stored and processed provided that conditions that completely disable the cross are provided
p.(None): contamination of other grafts and accessory materials and replacement of grafts.
p.(None): Article 21
p.(None): (1) Tissue donors must be tested for blood transmitted infectious diseases in accordance with this Ordinance.
p.(None): (2) All donors must be serologically tested for at least:
p.(None): - HIV 1 and 2 - Anti-HIV-1,2
p.(None): - Hepatitis B - HBsAg iAnti-HBc
p.(None): - Hepatitis C - Anti-HCV
p.(None): - Syphilis - in accordance with paragraph 6 of this Article.
p.(None): (3) Nucleic acid-NAT multiplication testing is mandatory for all tissue donors with at least HIV 1, HBV and HCV.
p.(None): (4) In addition to the tests referred to in paragraph 2 of this Article, donors must also be tested for HTLV-I if they live or come from areas where
p.(None): the frequency of infection with this virus is high, or if their sexual partners or parents originate in such areas.
p.(None): (5) For an anti-HBc-positive and HBsAg-negative donor, a risk assessment is required to assess the acceptability of the donor
p.(None): do Anti-HBs with a titer. Donor tissues with a titre greater than 100 U / l and negative NAT can be dispensed.
p.(None): (6) In order to exclude Treponema pallidum infection, it is necessary to test the donor according to a validated algorithm. If at
p.(None): testing lacks a specific or non-specific reaction, the tissues of the donor tested can be dispensed with. If a non-specific test is performed,
p.(None): the reactive test is not a reason for not accepting the donor, provided that the specific affirmative test on Treponema pallidum is negative. For
p.(None): a donor with a positive specific test needs a risk assessment to determine eligibility for use.
p.(None): (7) In certain circumstances, depending on the history of the donor and the characteristics of the tissue to be donated, additional
p.(None): donor testing such as ABO, RhD, HLA antigens and antibodies, malaria, CMV, toxoplasma, EBV, Trypanosoma cruzi.
p.(None): (8) The provisions of Article 20 of this Ordinance shall apply to the testing of autologous donors.
p.(None): Article 22
p.(None): (1) Testing shall be performed solely on samples of the donor's serum or plasma and shall not be carried out on other body
p.(None): liquids.
p.(None): (2) By way of derogation from paragraph 1 of this Article, testing may be carried out on other body fluids only if explicitly
p.(None): justified even if the test is conducted with a test validated for such use.
p.(None): (3) Possible donors who have lost blood and have recently received a blood or blood transfusion, or a colloid infusion, or
p.(None): crystalloids, tests may be invalid due to hemodilution of the sample.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): assigned,
p.(None): b. get to know the organizational structure, how NTM works and the quality system,
p.(None): c. is properly informed of ethical, legal and professional standards of good practice in the field of tissue bank business,
p.(None): 3. established a documented quality management system for the activities performed by the tissue bank,
p.(None): 4. identified and minimized the potential hazards related to the use and handling of biological material, with
p.(None): while maintaining tissue quality and safety in accordance with their intended use. Dangers imply
p.(None): especially those related to the procedures, environment and health status of the tissue bank staff,
p.(None): 5. specify in the contracts with third parties the terms of the relationship and responsibility and the protocols to be followed in order to achieve them
p.(None): the required tissue properties,
p.(None): 6. a documented system has been established under the supervision of a responsible person, confirming that the tissues meet the requirements
p.(None): specifications for safety and quality for their issue and distribution,
p.(None): 7. agreement with the institution / legal entity distributing tissues that least establishes the institution / legal entity's obligation to
p.(None): recording and timely forwarding to the tissue bank information on the final fate of distributed tissues,
p.(None): 8. an agreement with another tissue bank with a license to perform activities in accordance with the terms of the Act, for tissue acceptance in a case
p.(None): its termination,
p.(None): 9. documented tissue disposal procedures that must include reliable and accurate transfer of all
p.(None): traceability data and materials,
p.(None): 10. a strategy for reorganizing work in emergency situations.
p.(None): Article 38
p.(None): (1) Documentation must be clearly defined and effective, records and registers (registers) correct and SOPs approved. Documents must be
p.(None): regularly reviewed and must comply with the requirements of the Act and the ordinances adopted pursuant to the Act.
p.(None): (2) Materials, equipment and workers must be identified and documented for each critical activity.
p.(None): (3) All document changes must be documented reviewed, approved and dated. There must be a procedure for control
p.(None): documents to keep records of the review and modification of the document. Activities must be carried out immediately in accordance with changes.
p.(None): The use of the correct version of the document is ensured by the employee in charge.
p.(None): (4) Records must be reliable and must give credible results.
p.(None): (5) The records must be legible and indelible. The records can be handwritten or transferred to another validated system such as a computer
p.(None): or microfilm.
p.(None): (6) In addition to the information referred to in Article 24, paragraph 5 of this Ordinance, all records, including raw data, are critical for security and
p.(None): tissue quality, must be stored in such a way that it is accessible for at least 10 years after the clinical expiry date
p.(None): use or disposal of tissue.
p.(None): (7) Records must comply with Article 9 of the Act. Access to records and registers must be restricted to persons authorized by it
p.(None): the responsible person and the competent authority for inspection purposes.
p.(None): Article 39
p.(None): (1) An internal control (audit) system must be in place for all activities of the tissue bank. Supervision is carried out by qualified and trained persons
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): traceability data and materials,
p.(None): 10. a strategy for reorganizing work in emergency situations.
p.(None): Article 38
p.(None): (1) Documentation must be clearly defined and effective, records and registers (registers) correct and SOPs approved. Documents must be
p.(None): regularly reviewed and must comply with the requirements of the Act and the ordinances adopted pursuant to the Act.
p.(None): (2) Materials, equipment and workers must be identified and documented for each critical activity.
p.(None): (3) All document changes must be documented reviewed, approved and dated. There must be a procedure for control
p.(None): documents to keep records of the review and modification of the document. Activities must be carried out immediately in accordance with changes.
p.(None): The use of the correct version of the document is ensured by the employee in charge.
p.(None): (4) Records must be reliable and must give credible results.
p.(None): (5) The records must be legible and indelible. The records can be handwritten or transferred to another validated system such as a computer
p.(None): or microfilm.
p.(None): (6) In addition to the information referred to in Article 24, paragraph 5 of this Ordinance, all records, including raw data, are critical for security and
p.(None): tissue quality, must be stored in such a way that it is accessible for at least 10 years after the clinical expiry date
p.(None): use or disposal of tissue.
p.(None): (7) Records must comply with Article 9 of the Act. Access to records and registers must be restricted to persons authorized by it
p.(None): the responsible person and the competent authority for inspection purposes.
p.(None): Article 39
p.(None): (1) An internal control (audit) system must be in place for all activities of the tissue bank. Supervision is carried out by qualified and trained persons
p.(None): workers at least once every two years to verify compliance with approved procedures and legal provisions. the results
p.(None): supervision and corrective action must be documented.
p.(None): (2) Deviations from the prescribed quality and safety standards must be documented. When appropriate, necessary
p.(None): determine corrective and preventive measures. The fate of non-compliant tissues shall be decided in accordance with written procedures. spending
p.(None): the procedures are monitored and documented by the responsible person. All non-compliant tissues should be identified and their status clarified.
p.(None): (3) Corrective measures must be documented, timely initiated and effectively implemented. The effectiveness of corrective and
p.(None): preventive measures must be evaluated after implementation.
p.(None): (4) The tissue establishment must establish procedures for verifying the performance of the quality management system to ensure its continued and
p.(None): systematic improvement.
p.(None): Article 40
p.(None): (1) When receiving tissue, the tissue bank shall check:
p.(None): - that all tissue donors have been tested in accordance with the requirements of Articles 21 and 22 of this Ordinance, or that they have been submitted
p.(None): appropriate test samples,
p.(None): - the criteria for the selection and acceptance of tissues are complied with in accordance with the requirements of Articles 14, 15, 16, 17, 18, 19 and 20 of this Ordinance,
p.(None): - that the documentation in accordance with the requirements referred to in Article 24 of this Ordinance is attached.
...
p.(None): relevant medical records, processing records and test results,
p.(None): (2) Where appropriate, the tissue bank must carry out a documented risk assessment approved by the responsible person of the tissue bank in order to
p.(None): decided the fate of all previously stored tissues after the introduction of each new criteria for donor selection or testing or other
p.(None): significant alterations to the processing procedure that increase the safety or quality of the tissue.
p.(None): Article 45
p.(None): The tissue establishment for tissue distribution procedures must meet the following conditions:
p.(None): 1. Have SOPs / SOPs that detail the allocation procedures
p.(None): 2. establish procedures for managing submitted tissue requests. Rules for assigning tissue to specific patients or
p.(None): health facilities must be documented and made available to those parties upon request,
p.(None): 3. determine the critical conditions of transportation, such as temperature and time limit, to maintain the required tissue properties,
p.(None): 4. Have containers / packages that are protected and maintain tissue under specified conditions. All containers and packaging
p.(None): must be validated as suitable for their purpose,
p.(None): 5. have a documented contract ensuring the maintenance of the required conditions, if the distribution is done by a third party,
p.(None): 6. have authorized staff assessing the need for withdrawal and initiating and coordinating the necessary activities,
p.(None): 7. Establish an effective withdrawal process, including a description of the responsibilities and measures to be taken. The process must include
p.(None): report to the competent authority,
p.(None): 8. carry out activities and measures, at predetermined time intervals, which include investigating the traceability of all relevant ones
p.(None): tissues, and, where applicable, trace-back procedures. The purpose of the investigation is to identify all donors who may have contributed to the challenge
p.(None): reactions at the recipient, isolation of all tissues of that donor, and notification of the institutions to which the tissues were distributed as well as the person
p.(None): who received the tissues of that donor about the potential risk to which they are exposed,
p.(None): 9. Establish a documented system for the management of returned tissues, including criteria for their readmission to the bank
p.(None): tissues, if applicable.
p.(None): Article 46
p.(None): (1) There must be a sticker on the primary tissue container containing the following information:
p.(None): a) type of tissue, tissue identification code and, where applicable, lot or batch number,
p.(None): b) identification of the tissue bank,
p.(None): c) the shelf life of the tissue,
p.(None): d) if it is an autologous donation, it must be specifically stated "FOR AUTOLOGICAL USE ONLY" and must be identified
p.(None): recipient,
p.(None): e) on direct donation, the label must identify the intended recipient,
p.(None): f) a container containing tissue confirmed positive for the relevant contagious disease marker shall be labeled: »DANGER
p.(None): TRANSMISSION DISEASE ';
p.(None): (2) If any of the information referred to in paragraph 1, items a), b), c) and e) of this Article cannot be stated on the label
p.(None): primary container, it is necessary to attach it on a separate form to be attached to the primary container.
p.(None): (3) The following information must be provided on the label or in the supporting documentation:
...
p.(None): Article 49
p.(None): (1) If in the process of import, the tissue bank stores the tissues it must have adequate space and equipment to secure the required
p.(None): properties of the tissue.
p.(None): (2) The tissue establishment referred to in paragraph 1 of this Article shall, in respect of premises and equipment, comply with the conditions laid down in this Ordinance.
p.(None): (3) The tissue bank must have adequate communication equipment.
p.(None): Article 50
p.(None): (1) A tissue bank must have a contract with an institution outside the Republic of Croatia that performs any activity for a tissue bank.
p.(None): (2) The tissue establishment must have a contract with an institution outside the Republic of Croatia for which the tissue establishment carries out any activity.
p.(None): (3) The tissue bank must have written SOPs to verify compliance with the terms of the Act and the ordinances issued pursuant to the Act.
p.(None): (4) The tissue establishment must have a documented system in place to ensure tissue traceability.
p.(None): (5) If a tissue bank carries out the activity of import / export of tissue for a legal person other than a health institution founded by the Republic
p.(None): Croatia or for purposes of application to a person (patient) who is not a insured person of the Croatian Health Insurance Institute, a tissue bank
p.(None): may charge for administrative costs.
p.(None): Article 51
p.(None): (1) In order to carry out the activity of exporting tissues and cells for the purpose of storage for personal needs, the tissue bank must have a contract with
p.(None): the tissue bank into which the tissue is stored.
p.(None): (2) A tissue bank may conclude an agreement referred to in paragraph 1 of this Article only with that foreign tissue bank which is approved
p.(None): national and / or regional competent authority for tissues and cells and to which the competent authority for tissues and cells gave the Republic of Croatia
p.(None): certificate of conformity.
p.(None): (3) The competent authority of the Republic of Croatia shall provide the certificate of conformity referred to in paragraph 2 of this Article on the basis of the procedure carried out
p.(None): in accordance with the procedure for granting authorization to exercise the activity as prescribed by the Act and the regulations issued on the basis thereof
p.(None): Act.
p.(None): 4. AUTHORIZATION FOR PERFORMANCE
p.(None): Article 52
p.(None): (1) Health care institutions must obtain approval to perform each of the following groups of activities separately for each tissue type:
p.(None): 1. collection and collection,
p.(None): 2. testing,
p.(None): 3. processing, preservation, storage and distribution,
p.(None): 4. tissue import and / or export.
p.(None): (2) the application for authorization to carry out the activities referred to in paragraph 1 of this Article, together with evidence of compliance with the conditions prescribed by the Law,
p.(None): a health institution or a laboratory is obliged to enclose:
p.(None): 1. Decision on appointment of the head of tissue bank - responsible persons,
p.(None): 2. the treatment of the tissue bank in the event of termination of the storage activity, including the fulfillment of commitments and the sending of tissue to another
p.(None): a tissue bank,
p.(None): 3. evidence of the qualifications of the workers and the education provided,
p.(None): 4. written contracts with legal entities in accordance with the provisions of the Act and this Ordinance,
p.(None): 5. report on compliance with the prescribed conditions for the activities for which approval is sought.
p.(None): (3) Any essential modification of the conditions or requirements on the basis of which the approval of the healthcare institution was granted shall be obliged immediately
p.(None): inform the ministry.
p.(None): 5. LABORATORY
p.(None): Article 53
...
Orphaned Trigger Words
p.(None): b) the information needed to identify the donor (including information on the way in which the donor is identified and information on the person who made it
p.(None): identified),
p.(None): c) description and identification of the tissues collected, including test specimens,
p.(None): d) identification of the worker who performs the collection process and who signs the documents of the procedure,
p.(None): e) date, time (when relevant, start time and end time for each tissue), location of collection and
p.(None): the procedure applied (SOP identification code),
p.(None): f) adverse events during the collection process,
p.(None): g) information on environmental conditions in the collection area, if relevant,
p.(None): h) for deceased donors, the conditions under which the body was stored (whether cooled, cooling start time, cooling off time), and
p.(None): date and time of death,
p.(None): i) the names of the reagents, transport media and materials bearing the batch and expiry date.
p.(None): (4) All records must be clear and legible and protected from unauthorized amendment.
p.(None): Records must be clear and legible throughout the life of the storage obligation and easily accessible.
p.(None): (5) The donor's documentation required for traceability must be kept for at least 30 years after its application or expiry,
p.(None): for the proper scripture.
p.(None): (6) The contents of the documentation referred to in paragraph 5 of this Article are prescribed by the Ordinance on the manner of monitoring of serious adverse events and serious
p.(None): adverse reactions in the field of human tissue and cell application, record keeping and reporting deadlines, and content and form
p.(None): stationery of the annual report.
p.(None): Article 25
p.(None): (1) After collection, all the tissues taken must be packed individually in such a way that the risk of contamination is reduced to
p.(None): they must, as far as possible, be stored at a temperature at which the required tissue properties are preserved. Packaging must
p.(None): to prevent infections of tissue packers and transporters.
p.(None): (2) The container for sending packed tissue must be suitable for the transport of biological material and must maintain safety and quality
p.(None): stored tissues during transport.
p.(None): (3) Each accompanying tissue or blood sample to be tested must be properly labeled to ensure traceability up to
p.(None): giver. The time and place of sampling must be indicated on the label.
p.(None): Article 26
p.(None): (1) In the tissue collection process, each tissue pack must be labeled. It must be written on the primary container
p.(None): gift identification and tissue type.
p.(None): (2) Where the size of the packaging allows, the following particulars shall also be provided:
p.(None): (a) the date (and preferably the time) of the gift,
p.(None): (b) the name and address of the receiving medical institution,
p.(None): (c) warnings of potential health hazards,
p.(None): (d) the type of accessories and media, if used,
p.(None): (e) tissues for autologous administration must be labeled "FOR AUTOLOGICAL USE ONLY",
p.(None): (f) the tissue packaging for the known recipient on the label must indicate the recipient's identification.
p.(None): (3) If any of the information referred to in paragraph 2 of this Article cannot be provided on the primary packaging, it must be provided
p.(None): on the form that must accompany the primary packaging.
p.(None): (4) The inscription on the transport container must contain the following information:
p.(None): (a) "HUMAN TISSUE FOR TRANSPLANTATION" and "MANAGEMENT CAUTION";
...
p.(None): of this Ordinance.
p.(None): (3) Any tissue received that does not comply with paragraphs 1 and 2 of this Article must be discarded.
p.(None): Acceptance or rejection of received tissue tissues must be documented.
p.(None): (4) The tissue bank must verify that the tissues are correctly identified in each document. Each delivery or batch of tissue is assigned
p.(None): a unique identification number in accordance with Article 23, paragraphs 8 and 9 of this Ordinance.
p.(None): Article 41
p.(None): Tissues must be quarantined until procedures are in place for testing and collecting donor information.
p.(None): Article 42
p.(None): (1) Upon receipt of the collected tissues at the tissue establishment, it must be documented that the conditions of transport, packaging, labeling,
p.(None): the enclosed documentation and samples meet the requirements of this Ordinance and the specific requirements of the tissue establishment receiving the tissues.
p.(None): (2) The tissue received shall be stored, together with supporting documentation, in quarantine, until properly verified.
p.(None): compliance with the conditions referred to in paragraph 1 of this Article. The donor and tissue collection information is reviewed by the person in charge / authorized
p.(None): workers.
p.(None): (3) The tissue establishment must have written rules and specifications for checking the tissues and samples to be received. Rules and specifications must
p.(None): include technical requirements and other criteria that the tissue bank considers crucial to maintaining acceptable tissue quality.
p.(None): (4) The tissue bank must have written procedures for handling and extracting received tissues that are inconsistent or are testing results.
p.(None): incomplete. Procedures must ensure that other tissues are protected from contamination.
p.(None): (5) The tissue establishment must record the following information:
p.(None): - consent / approval; including the purpose of tissue use (i.e., therapeutic or research, or both therapeutic and research) and all specific
p.(None): disposal instructions if the tissues are not used for the purpose for which consent was obtained,
p.(None): - all required records regarding tissue collection and donor history,
p.(None): - physical examination findings, laboratory and other exam results,
p.(None): - for allogeneic donors, appropriately documented verification of the donor assessment process and compliance with eligibility criteria.
p.(None): The audit is performed by a qualified and responsible person,
p.(None): - for tissues for autologous use, documentation of possible allergies of the recipient.
p.(None): Article 43
p.(None): (1) A tissue bank for tissue processing and storage operations must meet the following conditions:
p.(None): 1. Critical tissue treatments must be validated and may not cause clinical tissue inefficiency or tissue damage to the recipient.
p.(None): The validation may be based on studies conducted by the tissue bank itself, data from studies published in the professional literature or, in
p.(None): in the case of widespread and already well-known processing procedures, on a retrospective evaluation of clinical results for the tissues that have distributed
p.(None): tissue bank,
p.(None): 2. Demonstrate that within the tissue establishment space, the staff of the bank can consistently and effectively perform a validated processing procedure,
p.(None): 3. the procedures must be documented in the SOP, which must be in accordance with the validated method,
p.(None): 4. ensure that all procedures are carried out in accordance with the approved SOP,
p.(None): 5. conduct a specified, documented and validated microbiological inactivation procedure, if applied to tissue,
p.(None): 6. Prior to the introduction of any significant change to the processing process, the modified process must be validated and documented,
p.(None): 7. carry out regular critical evaluation of processing operations to ensure that the results are achieved,
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| drug | Drug Usage |
| education | education |
| emergency | Public Emergency |
| family | Motherhood/Family |
| gender | gender |
| job | Occupation |
| mothers | Mothers |
| parents | parents |
| party | political affiliation |
| restricted | Incarcerated |
| stem cells | stem cells |
| substance | Drug Usage |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
consent
harm
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input