0A4F4F9BD490A749D5437F821CF06DF1
Law on Safety of Blood (2009)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10011145
http://leaux.net/URLS/ConvertAPI Text Files/F30C93763C963D23B4C15880AE3B74D2.en.txt
Examining the file media/Synopses/F30C93763C963D23B4C15880AE3B74D2.html:
This file was generated: 2020-07-14 06:26:42
| 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 / criminal
Searching for indicator criminal:
(return to top)
p.(None): (3) The organs of the authority responsible for monitoring the blood donation facility and the experts consulted by it
p.(None): 1. to grant access to all premises of the blood donation facility during operating hours,
p.(None): 2. to grant the required inspection of all documents and records upon request, and
p.(None): 3. enable the taking of samples in the amount required for an analysis.
p.(None): (4) The reviews are in default except in the event of danger or if there is a reasonable assumption that the effectiveness of the official act thereby
p.(None): could be affected to announce in advance.
p.(None): (5) Care must be taken to avoid any interference or disruption to the operation of the blood donation facility that is not absolutely necessary
p.(None): becomes.
p.(None): (6) The samples taken, insofar as this is possible by nature and do not prevent their correct assessment from being frustrated, are divided into three equal parts
p.(None): to share. Two parts of it are to be officially closed, one part is to be left to the party for evidence. The head of the
p.(None): Blood donation institution to issue a confirmation.
p.(None): (7) No compensation is due for the samples taken in accordance with Paragraph 3 No. 3 in conjunction with Paragraph 6.
p.(None): § 19. (1) If the locally responsible district administrative authority becomes aware of violations of this federal law or one based on this
p.(None): Federal law enacted regulation, it immediately, without prejudice to the possible initiation of an administrative criminal procedure
p.(None): Governor and the Federal Office for Safety in Health Care to notify.
p.(None): (2) The district administrative authority has to order the blood donation facility to remedy abuses as soon as possible. Will this
p.(None): has not been removed within a period to be set, the district administrative authority must operate the blood donation facility until the
p.(None): Order to remedy the defect with a provisional decision and to do so by the Governor and the Federal Office for Safety in Health Care
p.(None): communicate.
p.(None): (3) In cases of imminent danger to human health, the district administrative authority, after prior notification of the
p.(None): Owner, or if such is not possible, of the medical director, even without previous procedure and before issuing a decision
p.(None): prohibit the blood donation facility on the spot; however, written notification of this must be issued within two weeks, otherwise the
p.(None): measures taken override.
p.(None): (4) If it is known that a blood donation facility is operated without a license according to § 14, the district administrative authority has no
p.(None): previous procedure and before issuing a decision to prohibit the operation of the blood donation facility on the spot. A written one
p.(None): Notification of this must be issued immediately.
p.(None): (5) Notices in accordance with paragraphs 2, 3 and 4 are immediately enforceable. Notices in accordance with paragraph 2 cease to expire after one year, unless they are limited in time
p.(None): the day of enforceability beyond effectiveness. A change in the person of the owner of the facility does not make the decision effective
p.(None): touched.
...
p.(None): Adequate quality assurance system and an organizational plan must be drawn up;
p.(None): 5. What are the minimum personnel requirements of a blood donation facility, what special knowledge and skills does a leader or his or her manager have
p.(None): Have to have deputies as well as the doctors and other staff employed in the collection of blood or blood components and
p.(None): in which schooling, further education and further training measures these persons must take part;
p.(None): 6. how to label the blood and blood components obtained;
p.(None): 7. Which requirements have to be met when donating your own blood;
p.(None): 8. What content the annual activity report of the blood donation facility has to show.
p.(None): Penalties
p.(None): § 22. (1) Who
p.(None): 1. contrary to Section 8 Paragraph 2, Section 3 or Section 5, wins blood or blood components, violates the obligation to provide information under Section 8 Section 7 or violates Section 8 Section 6
p.(None): communicates personal data to other employees,
p.(None): 2. does not comply with the documentation requirement pursuant to Section 11 or Section 12,
p.(None): 2a. as client or contractor does not meet his obligations under § 11a,
p.(None): 3. as legal successor violates the reporting obligation in accordance with § 17,
p.(None): 4. the report pursuant to Section 18 (2) is not made or not made in good time, or
p.(None): 5. contravenes the orders and prohibitions contained in the ordinances issued on the basis of this federal law,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 7,270 euros.
p.(None): (2) Who
p.(None): 1.applies blood or blood components to other persons contrary to Section 2 Paragraph 2 or Paragraph 4,
p.(None): 2. wins blood or blood components contrary to § 6,
p.(None): 3. contrary to Section 7, Paragraph 1, Paragraph 2, Paragraph 5 or Paragraph 6 wins blood or blood components,
p.(None): 4. does not make use of qualified and suitable personnel in the collection of blood or blood components within the meaning of Section 7 (3) or (7),
p.(None): 5. wins blood or blood components contrary to Section 8 Paragraph 1 or Section 9,
p.(None): 6. contrary to Section 8 Paragraph 4, donates or promises a donor or a third party for his donation,
p.(None): 7. violates the duty of confidentiality in accordance with § 13,
p.(None): 8. operates a blood donation facility without a license pursuant to Section 14 or if there is a significant change within the meaning of Section 14 (3)
p.(None): Continues to operate the blood donation facility without the required authorization,
p.(None): 9. a blood donation facility contrary to the license granted to him in accordance with section 14 (1) to (3) or contrary to the conditions and requirements given to him
p.(None): operates in accordance with section 15 subsection 2 or section 16,
p.(None): 10. prevents or impairs an official act pursuant to Section 18 (3),
p.(None): 11. operates a blood donation facility in accordance with section 23 from the entry into force of this federal law and does not operate the instructions in accordance with section 23 (3) first sentence
p.(None): complies with or continues to operate contrary to Section 23 (3) last sentence or (4), or
p.(None): 12. a plasmapheresis position approved in accordance with section 3 of the Plasmapheresis Act, Federal Law Gazette No. 427/1975, contrary to the last sentence issued in accordance with section 24 (3)
p.(None): Operates conditions or conditions or does not follow instructions in accordance with section 24 (5) first sentence or operates contrary to section 24 (5) and (6)
p.(None): continues,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 36 340 euros. The same applies if an act in accordance with paragraph 1 poses a serious risk to the life or health of a person
p.(None): arisen or the perpetrator has already been punished twice in accordance with paragraph 1.
p.(None): (3) The attempt is punishable.
p.(None): Involvement of the organs of the public security service
p.(None): § 22a. The organs of the public security service are responsible for the Federal Office for Security in Health Care and the district administrative authorities
p.(None): their requests to ensure the exercise of powers pursuant to sections 15 subsections 4, 18 and 19 subsections 3 and 4 within the scope of their statutory scope
p.(None): To provide help.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): Transitional and final provisions
p.(None): Section 23. (1) Anyone who, at the time this Federal Act comes into force, a blood donation facility, with the exception of plasmapheresis sites, which according to Section 3 of the
p.(None): Plasmapheresis Act have been approved, operated and would like to continue this operation, this has within six months after the entry into force of this
p.(None): Federal law to notify the district administrative authority and an operating license to the Federal Minister of Labor, Health and Social Affairs in accordance with § 14
p.(None): apply.
p.(None): (2) Existing blood donation facilities may continue to be operated until a decision has been made on the application made pursuant to paragraph 1, provided the protection of the
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None): Testing blood and blood components suspected of having an impact on the quality of the product or the safety of the recipient
p.(None): the Federal Ministry of Health and Women or a body commissioned by the Federal Ministry of Health and Women
p.(None): Report to.
p.(None): § 11a. (1) Awarding or taking over orders that determine the health suitability of the donor through laboratory tests,
p.(None): There must be a written contract between the client and the contractor, which is always in the blood donation facility in the original or in the form of a copy
p.(None): must rest. The Federal Office for Safety in Health Care must be provided with evidence of the existence and content of the agreement upon request.
p.(None): (2) The responsibilities of each side must be clearly defined in the contract. The client has to make sure that the contractor
p.(None): Performs activity according to the given instructions. The client is responsible for ensuring that the contractor is responsible for the
p.(None): performing work has suitable premises and equipment, expertise and experience as well as competent staff.
p.(None): (3) In the contract, the client must also be granted the right with regard to the work to be carried out on his behalf at the contractor
p.(None): Carry out controls.
p.(None): (4) The responsibility of the client for determining the health suitability of the donor is not covered by agreements in accordance with paragraph 1
p.(None): touched.
p.(None): (5) The contractor must have a corresponding operating license in accordance with Section 63 (1) of the Medicinal Products Act or a corresponding license
p.(None): a competent authority of another EEA contracting party and is subject to an inspection in accordance with Section 67 of the Medicinal Products Act or an inspection
p.(None): by a competent authority of another contracting party to the EEA.
p.(None): (6) A contractor may not pass on any contractually assigned work to third parties without the client's written consent.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): donor card
p.(None): § 12. (1) For repeat donors of whole blood, a donor ID can be made to identify the donor.
p.(None): (2) For each donor of blood components, a donor ID card must be prepared as part of the initial donation to identify the donor.
p.(None): (3) In accordance with paragraph 4, each donor may only have a donor card issued for the donation of whole blood or blood components.
p.(None): A change in family or first name or primary residence is the next time blood or is obtained after the change
p.(None): Announce blood components from the donor and document them from the blood donation facility as soon as they become known.
p.(None): (4) If a donor card is illegible or unusable, it must be provided with a reference to it, provided that the blood donation facility is present
p.(None): Invalid and issue a new ID. If the donor card is lost, another one with corresponding documentation is in the
p.(None): To prepare donor data sheet. Such ID cards must be marked accordingly.
p.(None): (5) If a permanent reason for donor exclusion is determined, the donor ID, if it is available to the blood donation facility, is from the
p.(None): Blood donation facility either to withhold or, at the donor's request, provided with a general indication of its invalidity
p.(None): return.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
...
p.(None): (2) Unless the collection of blood or blood components by mobile blood donation facilities is not made public, the head is one
p.(None): Blood donation facility undertakes to inform the locally responsible district administrative authority of the location and time of the planned blood donation campaign
p.(None): Announcement of collective reports for one month in advance, blood donation campaigns not covered by this collective report must be made two days before admission at the latest
p.(None): to announce the extraction. Blood donation campaigns, the urgency of which does not permit such a report, are exempt from the reporting obligation.
p.(None): (3) The organs of the authority responsible for monitoring the blood donation facility and the experts consulted by it
p.(None): 1. to grant access to all premises of the blood donation facility during operating hours,
p.(None): 2. to grant the required inspection of all documents and records upon request, and
p.(None): 3. enable the taking of samples in the amount required for an analysis.
p.(None): (4) The reviews are in default except in the event of danger or if there is a reasonable assumption that the effectiveness of the official act thereby
p.(None): could be affected to announce in advance.
p.(None): (5) Care must be taken to avoid any interference or disruption to the operation of the blood donation facility that is not absolutely necessary
p.(None): becomes.
p.(None): (6) The samples taken, insofar as this is possible by nature and do not prevent their correct assessment from being frustrated, are divided into three equal parts
p.(None): to share. Two parts of it are to be officially closed, one part is to be left to the party for evidence. The head of the
p.(None): Blood donation institution to issue a confirmation.
p.(None): (7) No compensation is due for the samples taken in accordance with Paragraph 3 No. 3 in conjunction with Paragraph 6.
p.(None): § 19. (1) If the locally responsible district administrative authority becomes aware of violations of this federal law or one based on this
p.(None): Federal law enacted regulation, it immediately, without prejudice to the possible initiation of an administrative criminal procedure
p.(None): Governor and the Federal Office for Safety in Health Care to notify.
p.(None): (2) The district administrative authority has to order the blood donation facility to remedy abuses as soon as possible. Will this
p.(None): has not been removed within a period to be set, the district administrative authority must operate the blood donation facility until the
p.(None): Order to remedy the defect with a provisional decision and to do so by the Governor and the Federal Office for Safety in Health Care
p.(None): communicate.
p.(None): (3) In cases of imminent danger to human health, the district administrative authority, after prior notification of the
p.(None): Owner, or if such is not possible, of the medical director, even without previous procedure and before issuing a decision
p.(None): prohibit the blood donation facility on the spot; however, written notification of this must be issued within two weeks, otherwise the
p.(None): measures taken override.
...
p.(None): 8. What content the annual activity report of the blood donation facility has to show.
p.(None): Penalties
p.(None): § 22. (1) Who
p.(None): 1. contrary to Section 8 Paragraph 2, Section 3 or Section 5, wins blood or blood components, violates the obligation to provide information under Section 8 Section 7 or violates Section 8 Section 6
p.(None): communicates personal data to other employees,
p.(None): 2. does not comply with the documentation requirement pursuant to Section 11 or Section 12,
p.(None): 2a. as client or contractor does not meet his obligations under § 11a,
p.(None): 3. as legal successor violates the reporting obligation in accordance with § 17,
p.(None): 4. the report pursuant to Section 18 (2) is not made or not made in good time, or
p.(None): 5. contravenes the orders and prohibitions contained in the ordinances issued on the basis of this federal law,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 7,270 euros.
p.(None): (2) Who
p.(None): 1.applies blood or blood components to other persons contrary to Section 2 Paragraph 2 or Paragraph 4,
p.(None): 2. wins blood or blood components contrary to § 6,
p.(None): 3. contrary to Section 7, Paragraph 1, Paragraph 2, Paragraph 5 or Paragraph 6 wins blood or blood components,
p.(None): 4. does not make use of qualified and suitable personnel in the collection of blood or blood components within the meaning of Section 7 (3) or (7),
p.(None): 5. wins blood or blood components contrary to Section 8 Paragraph 1 or Section 9,
p.(None): 6. contrary to Section 8 Paragraph 4, donates or promises a donor or a third party for his donation,
p.(None): 7. violates the duty of confidentiality in accordance with § 13,
p.(None): 8. operates a blood donation facility without a license pursuant to Section 14 or if there is a significant change within the meaning of Section 14 (3)
p.(None): Continues to operate the blood donation facility without the required authorization,
p.(None): 9. a blood donation facility contrary to the license granted to him in accordance with section 14 (1) to (3) or contrary to the conditions and requirements given to him
p.(None): operates in accordance with section 15 subsection 2 or section 16,
p.(None): 10. prevents or impairs an official act pursuant to Section 18 (3),
p.(None): 11. operates a blood donation facility in accordance with section 23 from the entry into force of this federal law and does not operate the instructions in accordance with section 23 (3) first sentence
p.(None): complies with or continues to operate contrary to Section 23 (3) last sentence or (4), or
p.(None): 12. a plasmapheresis position approved in accordance with section 3 of the Plasmapheresis Act, Federal Law Gazette No. 427/1975, contrary to the last sentence issued in accordance with section 24 (3)
p.(None): Operates conditions or conditions or does not follow instructions in accordance with section 24 (5) first sentence or operates contrary to section 24 (5) and (6)
p.(None): continues,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 36 340 euros. The same applies if an act in accordance with paragraph 1 poses a serious risk to the life or health of a person
p.(None): arisen or the perpetrator has already been punished twice in accordance with paragraph 1.
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.(None): Extraction has to take place voluntarily and without compulsion.
p.(None): (2) Before the first collection of blood or blood components, the donor is familiar with the procedure used and with the donation
p.(None): possible side effects and dangers to his health. This information is given once a year for people who make repeated donations
p.(None): to repeat. The donor must also be informed about the intended purpose of using the donation.
p.(None): (3) The donor must be particularly advised of the possibility at any time to be able to voluntarily exclude himself.
p.(None): (4) It is prohibited to give or promise to donate blood or blood components or to third parties for a donation.
p.(None): If the blood is donated (whole blood) for products for direct transfusion, the donation must be made completely unpaid. In these cases, a reimbursement of expenses is only
p.(None): then permissible if the donor, due to an immediate need in an acute emergency situation, from the blood donation facility to the immediate donation
p.(None): was asked.
p.(None): (5) The protection of sufficient privacy of the donor must be ensured when collecting the medical history and the aptitude test.
p.(None): (6) Employees of the blood donation facility may only disclose personal data of the donor to other employees to the extent that it is allowed to
p.(None): whose fulfillment of tasks is necessary.
p.(None): (7) The donor is to be informed by a notice in the blood donation facility or in another suitable way that a blood donation is none
p.(None): Appropriate method for determining his HIV status is and can have legal consequences for the donor.
p.(None): health aptitude
p.(None): § 9. (1) Donors of blood and blood components must be suitable for health purposes to obtain blood or blood components.
p.(None): (2) The assessment of the health suitability of donors is based on a qualified and independent professional practice in Austria
p.(None): authorized doctor and has both the health protection of the donor and the perfect quality of the blood taken
p.(None): or the blood components taken. Deviating from this, in mobile blood donation facilities instead of assessing health
p.(None): Suitability of donors through admission to whole blood donation based on a standardized medical history and according to the requirements of a qualified one
p.(None): and physicians authorized to practice their profession independently by qualified members of the senior service for health and nursing
p.(None): be decided if this task has been assigned to them in accordance with §§ 12 Paragraph 3 in conjunction with 15 Paragraphs 1 and 2 GuKG and, in cases of doubt, an immediate one
p.(None): Consultation with a suitably trained doctor is possible.
p.(None): quality assurance
p.(None): § 10. (1) Each blood donation facility has to ensure the quality of blood and blood components based on the principles of good manufacturing practice
p.(None): based quality assurance system. The components of the quality assurance system, such as the quality assurance manual, company description
p.(None): (Site Master File), standard operating procedures (SOPs) and training manuals are published at least once a year or at
p.(None): To bring needs up to date.
p.(None): (2) The quality assurance system must in any case specify:
p.(None): 1. the objectives of quality assurance,
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.(None): considered justified by the state of the art.
p.(None): (4) Appropriate measures must be taken to ensure that the blood and blood components withdrawn in accordance with paragraph 3 are only within the scope of the respective
p.(None): clinical trial.
p.(None): definitions
p.(None): § 3. (1) Blood within the meaning of this Federal Act is the body fluid drawn from a blood vessel from a donor, which is made up of and out of blood plasma
p.(None): corpuscular components.
p.(None): (2) Blood components within the meaning of this Federal Act are the plasma obtained by separation and the corpuscular one obtained by separation
p.(None): Shares.
p.(None): (3) Collection within the meaning of this Federal Act is the withdrawal of blood or its separation directly at the donor, including
p.(None): the determination of the health suitability of a donor and the donor protection and quality assurance measures associated with these processes.
p.(None): (4) Withdrawal within the meaning of this Federal Act is the process of taking blood.
p.(None): (5) Separation within the meaning of this federal law is the division of the blood into its corpuscular and liquid components by means of a cell separator
p.(None): directly at the donor.
p.(None): (6) Cell separator in the sense of this federal law is a self-contained apparatus system with an extracorporeal circuit for the separation of the blood
p.(None): directly on the donor (apparative apheresis).
p.(None): (7) Serious incident within the meaning of this federal law is any undesirable event in connection with the collection and testing of blood or
p.(None): Blood components that are fatal or life-threatening, that could result in disability or loss of ability, lead to illness or
p.(None): their duration or extended hospital stay.
p.(None): (8) Serious undesirable reaction is an unintended reaction at the donor or recipient in connection with the extraction, testing or
p.(None): Transfusion of blood or blood components that is fatal or life-threatening, that results in disability or loss of ability
p.(None): Leads to illnesses or extends their duration or hospitalization
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 4. Donors within the meaning of this Federal Act is any person who has the will to donate blood or blood components for use in others
p.(None): Expresses people and for other people to the staff working in the operation of a blood donation facility.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 5. Blood donation facility within the meaning of this Federal Act is any organizational unit for the collection of blood or blood components.
p.(None): Blood establishments
p.(None): Section 6. (1) Blood and blood components may only be obtained in blood donation facilities that have a license in accordance with Section 14 of this Federal Act
p.(None): become.
p.(None): (2) Each blood donation facility has the personal, spatial,
p.(None): to have operational and technical equipment. The staff must take appropriate further training measures regularly and in good time
p.(None): state of the art.
p.(None): (3) The equipment must be designed in such a way that the current state of medical science and technology is trouble-free
p.(None): Organizational process is guaranteed, the necessary hygiene standards are maintained and donors receive emergency medical care at all times
p.(None): can come.
p.(None): (4) Each blood donation facility has adequate medical equipment for any medical technology and technology
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): (3) In the contract, the client must also be granted the right with regard to the work to be carried out on his behalf at the contractor
p.(None): Carry out controls.
p.(None): (4) The responsibility of the client for determining the health suitability of the donor is not covered by agreements in accordance with paragraph 1
p.(None): touched.
p.(None): (5) The contractor must have a corresponding operating license in accordance with Section 63 (1) of the Medicinal Products Act or a corresponding license
p.(None): a competent authority of another EEA contracting party and is subject to an inspection in accordance with Section 67 of the Medicinal Products Act or an inspection
p.(None): by a competent authority of another contracting party to the EEA.
p.(None): (6) A contractor may not pass on any contractually assigned work to third parties without the client's written consent.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): donor card
p.(None): § 12. (1) For repeat donors of whole blood, a donor ID can be made to identify the donor.
p.(None): (2) For each donor of blood components, a donor ID card must be prepared as part of the initial donation to identify the donor.
p.(None): (3) In accordance with paragraph 4, each donor may only have a donor card issued for the donation of whole blood or blood components.
p.(None): A change in family or first name or primary residence is the next time blood or is obtained after the change
p.(None): Announce blood components from the donor and document them from the blood donation facility as soon as they become known.
p.(None): (4) If a donor card is illegible or unusable, it must be provided with a reference to it, provided that the blood donation facility is present
p.(None): Invalid and issue a new ID. If the donor card is lost, another one with corresponding documentation is in the
p.(None): To prepare donor data sheet. Such ID cards must be marked accordingly.
p.(None): (5) If a permanent reason for donor exclusion is determined, the donor ID, if it is available to the blood donation facility, is from the
p.(None): Blood donation facility either to withhold or, at the donor's request, provided with a general indication of its invalidity
p.(None): return.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): confidentiality
p.(None): § 13. (1) Every person working or who has worked in a blood donation facility is entrusted to secrecy about all who are entrusted with the exercise of their duties
p.(None): or secrets that have become known, unless you already have one according to other legal or official regulations
p.(None): Confidentiality is imposed.
p.(None): (2) There is no duty of confidentiality if
p.(None): 1. the person threatened by the disclosure of the secret, the person working or who has worked in the blood donation facility, from maintaining secrecy
p.(None): gave birth or
p.(None): 2. the disclosure of the type and content of the secret in order to protect the higher interests of public health care or the administration of justice
p.(None): is absolutely necessary.
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None): considered justified by the state of the art.
p.(None): (4) Appropriate measures must be taken to ensure that the blood and blood components withdrawn in accordance with paragraph 3 are only within the scope of the respective
p.(None): clinical trial.
p.(None): definitions
p.(None): § 3. (1) Blood within the meaning of this Federal Act is the body fluid drawn from a blood vessel from a donor, which is made up of and out of blood plasma
p.(None): corpuscular components.
p.(None): (2) Blood components within the meaning of this Federal Act are the plasma obtained by separation and the corpuscular one obtained by separation
p.(None): Shares.
p.(None): (3) Collection within the meaning of this Federal Act is the withdrawal of blood or its separation directly at the donor, including
p.(None): the determination of the health suitability of a donor and the donor protection and quality assurance measures associated with these processes.
p.(None): (4) Withdrawal within the meaning of this Federal Act is the process of taking blood.
p.(None): (5) Separation within the meaning of this federal law is the division of the blood into its corpuscular and liquid components by means of a cell separator
p.(None): directly at the donor.
p.(None): (6) Cell separator in the sense of this federal law is a self-contained apparatus system with an extracorporeal circuit for the separation of the blood
p.(None): directly on the donor (apparative apheresis).
p.(None): (7) Serious incident within the meaning of this federal law is any undesirable event in connection with the collection and testing of blood or
p.(None): Blood components that are fatal or life-threatening, that could result in disability or loss of ability, lead to illness or
p.(None): their duration or extended hospital stay.
p.(None): (8) Serious undesirable reaction is an unintended reaction at the donor or recipient in connection with the extraction, testing or
p.(None): Transfusion of blood or blood components that is fatal or life-threatening, that results in disability or loss of ability
p.(None): Leads to illnesses or extends their duration or hospitalization
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 4. Donors within the meaning of this Federal Act is any person who has the will to donate blood or blood components for use in others
p.(None): Expresses people and for other people to the staff working in the operation of a blood donation facility.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 5. Blood donation facility within the meaning of this Federal Act is any organizational unit for the collection of blood or blood components.
p.(None): Blood establishments
p.(None): Section 6. (1) Blood and blood components may only be obtained in blood donation facilities that have a license in accordance with Section 14 of this Federal Act
p.(None): become.
p.(None): (2) Each blood donation facility has the personal, spatial,
p.(None): to have operational and technical equipment. The staff must take appropriate further training measures regularly and in good time
p.(None): state of the art.
p.(None): (3) The equipment must be designed in such a way that the current state of medical science and technology is trouble-free
...
p.(None): § 11. (1) Every blood donation institution is obliged to document every collection of blood or blood components.
p.(None): (2) The documentation has a complete traceability of the transfusion chain according to the state of medical science, insofar as this is in the
p.(None): The area of responsibility of the blood donation facility falls to ensure.
p.(None): (3) The documentation relating to the individual donor must in any case include:
p.(None): 1. the first and last name, date of birth, gender and main place of residence of the donor and any changes to this data
p.(None): Perusal,
p.(None): 2. the donor's written consent to the donation through his own signature,
p.(None): 3. the donor's confirmation of the information provided within the meaning of Section 8 (2) and (3) by his own signature,
p.(None): 4. the medical history,
p.(None): 5. the date of collection and the quantity of blood or blood components as well as an abnormal duration of the collection or separation,
p.(None): 6. the date and the results of the medical aptitude test carried out to determine whether it is fit for health and in good condition
p.(None): The nature of the blood or blood components of the donor,
p.(None): 7. the determination of a permanent or temporary donor exclusion, which, according to medical assessment, is determined to be the expected duration of a
p.(None): temporary donor exclusion, or the existence of voluntary self-exclusion,
p.(None): 8. any incidents during extraction,
p.(None): 9. the date and results of the laboratory tests performed on the donor's blood,
p.(None): 10. the information of the donor about increased or too low values, provided that this indicates the state of medical science
p.(None): Allow the presence of a serious illness,
p.(None): 11. Which medical devices and in-vitro diagnostics were used to obtain blood or blood components, and
p.(None): 12. The first and last name of the personnel performing the extraction.
p.(None): (4) The documentation must be in writing or on a data carrier, provided that it is ensured that the information specified in paragraph 2 during the
p.(None): Duration of the retention period are available.
p.(None): (5) The documentation has been through for at least fifteen years - those parts that are essential for the complete traceability of the transfusion chain
p.(None): at least thirty years - to be available for inspection at any time by the supervisory bodies responsible under this federal law.
p.(None): (6) Every blood donation facility is obligated, every serious incident and every serious undesirable reaction in connection with the collection or
p.(None): Testing blood and blood components suspected of having an impact on the quality of the product or the safety of the recipient
p.(None): the Federal Ministry of Health and Women or a body commissioned by the Federal Ministry of Health and Women
p.(None): Report to.
p.(None): § 11a. (1) Awarding or taking over orders that determine the health suitability of the donor through laboratory tests,
p.(None): There must be a written contract between the client and the contractor, which is always in the blood donation facility in the original or in the form of a copy
p.(None): must rest. The Federal Office for Safety in Health Care must be provided with evidence of the existence and content of the agreement upon request.
p.(None): (2) The responsibilities of each side must be clearly defined in the contract. The client has to make sure that the contractor
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.(None): to keep and keep ready for use at any time.
p.(None): (Note: Paragraph 5 repealed by Federal Law Gazette I No. 168/2004)
p.(None): § 7. (1) A medical director must be appointed for the management of each blood donation facility. The same applies in the case of Section 14 (2).
p.(None): (2) If the medical director is unable to attend, a deputy is to be appointed and the Federal Office for Safety in Health Care immediately
p.(None): to make known.
p.(None): (3) The medical director and his deputy must
p.(None): 1. be authorized to practice the medical profession independently in Austria,
p.(None): 2. have special knowledge and skills appropriate to their tasks and
p.(None): 3. Have completed at least two years of work in a blood donation facility.
p.(None): (4) The medical director and, if he is prevented, the deputy are responsible for all medical, medical-technical and hygienic matters and the
p.(None): Use of the medical staff of the blood donation facility responsible. In the case of Section 14 (2), the responsibility extends to everyone together
p.(None): approved facilities.
p.(None): (5) The medical director and, if he is prevented, the deputy have during the operating hours of the blood donation facility approved in accordance with § 14
p.(None): to be reachable at any time.
p.(None): (6) The operation of a blood donation facility is only possible in the presence of a doctor who is authorized to practice his profession in Austria and who is responsible for this
p.(None): appropriate knowledge and skills. Deviating from this, whole blood donations in mobile blood donation facilities are also without
p.(None): Presence of a doctor in accordance with the requirements of a doctor who is qualified for this and is authorized to practice his profession in Austria
p.(None): of a member of the senior service for health and sick care (health and sick care law - GuKG, BGBl. I
p.(None): 108/1997) is permissible, provided an immediate consultation with a suitably trained doctor is possible.
p.(None): (7) The collection of blood and blood components has been carried out in accordance with the professional laws for health professionals
p.(None): Regulations to be made by a doctor who is authorized to practice his or her profession independently in Austria. Notwithstanding this, the extraction of
p.(None): Whole blood donations in mobile blood donation facilities even without the presence of a doctor according to the guidelines of a qualified and self-employed person
p.(None): Professional practice in Austria authorized doctor by a qualified member of the high-level service for health and nursing
p.(None): respectively.
p.(None): donor
p.(None): § 8. (1) Blood and blood components may only be taken from a donor with his prior written consent. Consent to
p.(None): Extraction has to take place voluntarily and without compulsion.
p.(None): (2) Before the first collection of blood or blood components, the donor is familiar with the procedure used and with the donation
p.(None): possible side effects and dangers to his health. This information is given once a year for people who make repeated donations
p.(None): to repeat. The donor must also be informed about the intended purpose of using the donation.
p.(None): (3) The donor must be particularly advised of the possibility at any time to be able to voluntarily exclude himself.
p.(None): (4) It is prohibited to give or promise to donate blood or blood components or to third parties for a donation.
p.(None): If the blood is donated (whole blood) for products for direct transfusion, the donation must be made completely unpaid. In these cases, a reimbursement of expenses is only
...
Health / patients in emergency situations
Searching for indicator emergency situation:
(return to top)
p.(None): (7) The collection of blood and blood components has been carried out in accordance with the professional laws for health professionals
p.(None): Regulations to be made by a doctor who is authorized to practice his or her profession independently in Austria. Notwithstanding this, the extraction of
p.(None): Whole blood donations in mobile blood donation facilities even without the presence of a doctor according to the guidelines of a qualified and self-employed person
p.(None): Professional practice in Austria authorized doctor by a qualified member of the high-level service for health and nursing
p.(None): respectively.
p.(None): donor
p.(None): § 8. (1) Blood and blood components may only be taken from a donor with his prior written consent. Consent to
p.(None): Extraction has to take place voluntarily and without compulsion.
p.(None): (2) Before the first collection of blood or blood components, the donor is familiar with the procedure used and with the donation
p.(None): possible side effects and dangers to his health. This information is given once a year for people who make repeated donations
p.(None): to repeat. The donor must also be informed about the intended purpose of using the donation.
p.(None): (3) The donor must be particularly advised of the possibility at any time to be able to voluntarily exclude himself.
p.(None): (4) It is prohibited to give or promise to donate blood or blood components or to third parties for a donation.
p.(None): If the blood is donated (whole blood) for products for direct transfusion, the donation must be made completely unpaid. In these cases, a reimbursement of expenses is only
p.(None): then permissible if the donor, due to an immediate need in an acute emergency situation, from the blood donation facility to the immediate donation
p.(None): was asked.
p.(None): (5) The protection of sufficient privacy of the donor must be ensured when collecting the medical history and the aptitude test.
p.(None): (6) Employees of the blood donation facility may only disclose personal data of the donor to other employees to the extent that it is allowed to
p.(None): whose fulfillment of tasks is necessary.
p.(None): (7) The donor is to be informed by a notice in the blood donation facility or in another suitable way that a blood donation is none
p.(None): Appropriate method for determining his HIV status is and can have legal consequences for the donor.
p.(None): health aptitude
p.(None): § 9. (1) Donors of blood and blood components must be suitable for health purposes to obtain blood or blood components.
p.(None): (2) The assessment of the health suitability of donors is based on a qualified and independent professional practice in Austria
p.(None): authorized doctor and has both the health protection of the donor and the perfect quality of the blood taken
p.(None): or the blood components taken. Deviating from this, in mobile blood donation facilities instead of assessing health
p.(None): Suitability of donors through admission to whole blood donation based on a standardized medical history and according to the requirements of a qualified one
p.(None): and physicians authorized to practice their profession independently by qualified members of the senior service for health and nursing
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): can be withdrawn.
p.(None): (2) The operating license is to be tied to conditions and requirements in accordance with the state of medical science and technology, if such
p.(None): to fulfill in particular to protect the health of the donor and to ensure the perfect condition of the blood obtained and the
p.(None): extracted blood components are necessary.
p.(None): (3) The following documents must be attached to the application for the operating license:
p.(None): 1. Name and address of the applicant,
p.(None): 2. a description of the company including a list of essential medical devices and other company facilities,
p.(None): 3. the necessary plans,
p.(None): 4. a list of the envisaged staffing including qualifications and the organizational plan for the
p.(None): Tasks and the area of responsibility of the personnel,
p.(None): 4a. a list of the possible mobile approvals envisaged, in particular with regard to the selection criteria for the necessary premises,
p.(None): as well as a list of the essential medical devices used,
p.(None): 5. The essential information on the quality assurance system to be provided, including standard operating procedures (SOPs) for recruitment
p.(None): of donors, the examination of the donors, the processing and testing of the blood or blood components obtained, their storage and distribution,
p.(None): recalling and reporting blood or blood components, documenting serious incidents and serious adverse reactions, and
p.(None): 6. a list of the hospital blood deposits to be supplied.
p.(None): (4) Organs of the Federal Office for Safety in Health Care, the Federal Ministry for Health and Women and those commissioned by them
p.(None): Expert is
p.(None): 1. Access to all premises of the blood donation facility to be approved and
p.(None): 2. to grant the necessary inspection of all documents and records relating to the facility.
p.(None): § 16. If an operating license is issued, it follows that, despite compliance with the requirements stipulated in the approval notice, the protection of the
p.(None): Health of the donor or the perfect condition of the blood or blood components obtained is not adequately ensured, so
p.(None): the Federal Office for Safety in Health Care must prescribe other or additional requirements to achieve these goals.
p.(None): Section 17. The effectiveness of this approval is not affected by the change in the person of the holder of a blood donation facility approved in accordance with Section 14.
p.(None): The legal successor must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Operations Review
p.(None): § 18. (1) It is the responsibility of the monitoring of compliance with this federal law
p.(None): 1. with regard to mobile blood donation facilities, the locally responsible district administrative authorities with the involvement of a medical officer, and otherwise
p.(None): 2. the Federal Office for Safety in Health Care.
p.(None): In the case of mobile blood donation facilities, local responsibility is based on the location where blood or blood components are obtained. The
p.(None): Checks according to Paragraph 1 must take place at regular intervals of no more than two years.
p.(None): (2) Unless the collection of blood or blood components by mobile blood donation facilities is not made public, the head is one
p.(None): Blood donation facility undertakes to inform the locally responsible district administrative authority of the location and time of the planned blood donation campaign
p.(None): Announcement of collective reports for one month in advance, blood donation campaigns not covered by this collective report must be made two days before admission at the latest
p.(None): to announce the extraction. Blood donation campaigns, the urgency of which does not permit such a report, are exempt from the reporting obligation.
p.(None): (3) The organs of the authority responsible for monitoring the blood donation facility and the experts consulted by it
p.(None): 1. to grant access to all premises of the blood donation facility during operating hours,
p.(None): 2. to grant the required inspection of all documents and records upon request, and
p.(None): 3. enable the taking of samples in the amount required for an analysis.
p.(None): (4) The reviews are in default except in the event of danger or if there is a reasonable assumption that the effectiveness of the official act thereby
p.(None): could be affected to announce in advance.
p.(None): (5) Care must be taken to avoid any interference or disruption to the operation of the blood donation facility that is not absolutely necessary
p.(None): becomes.
p.(None): (6) The samples taken, insofar as this is possible by nature and do not prevent their correct assessment from being frustrated, are divided into three equal parts
p.(None): to share. Two parts of it are to be officially closed, one part is to be left to the party for evidence. The head of the
p.(None): Blood donation institution to issue a confirmation.
p.(None): (7) No compensation is due for the samples taken in accordance with Paragraph 3 No. 3 in conjunction with Paragraph 6.
p.(None): § 19. (1) If the locally responsible district administrative authority becomes aware of violations of this federal law or one based on this
p.(None): Federal law enacted regulation, it immediately, without prejudice to the possible initiation of an administrative criminal procedure
p.(None): Governor and the Federal Office for Safety in Health Care to notify.
p.(None): (2) The district administrative authority has to order the blood donation facility to remedy abuses as soon as possible. Will this
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.(None): of donors, the examination of the donors, the processing and testing of the blood or blood components obtained, their storage and distribution,
p.(None): recalling and reporting blood or blood components, documenting serious incidents and serious adverse reactions, and
p.(None): 6. a list of the hospital blood deposits to be supplied.
p.(None): (4) Organs of the Federal Office for Safety in Health Care, the Federal Ministry for Health and Women and those commissioned by them
p.(None): Expert is
p.(None): 1. Access to all premises of the blood donation facility to be approved and
p.(None): 2. to grant the necessary inspection of all documents and records relating to the facility.
p.(None): § 16. If an operating license is issued, it follows that, despite compliance with the requirements stipulated in the approval notice, the protection of the
p.(None): Health of the donor or the perfect condition of the blood or blood components obtained is not adequately ensured, so
p.(None): the Federal Office for Safety in Health Care must prescribe other or additional requirements to achieve these goals.
p.(None): Section 17. The effectiveness of this approval is not affected by the change in the person of the holder of a blood donation facility approved in accordance with Section 14.
p.(None): The legal successor must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Operations Review
p.(None): § 18. (1) It is the responsibility of the monitoring of compliance with this federal law
p.(None): 1. with regard to mobile blood donation facilities, the locally responsible district administrative authorities with the involvement of a medical officer, and otherwise
p.(None): 2. the Federal Office for Safety in Health Care.
p.(None): In the case of mobile blood donation facilities, local responsibility is based on the location where blood or blood components are obtained. The
p.(None): Checks according to Paragraph 1 must take place at regular intervals of no more than two years.
p.(None): (2) Unless the collection of blood or blood components by mobile blood donation facilities is not made public, the head is one
p.(None): Blood donation facility undertakes to inform the locally responsible district administrative authority of the location and time of the planned blood donation campaign
p.(None): Announcement of collective reports for one month in advance, blood donation campaigns not covered by this collective report must be made two days before admission at the latest
p.(None): to announce the extraction. Blood donation campaigns, the urgency of which does not permit such a report, are exempt from the reporting obligation.
p.(None): (3) The organs of the authority responsible for monitoring the blood donation facility and the experts consulted by it
p.(None): 1. to grant access to all premises of the blood donation facility during operating hours,
p.(None): 2. to grant the required inspection of all documents and records upon request, and
p.(None): 3. enable the taking of samples in the amount required for an analysis.
p.(None): (4) The reviews are in default except in the event of danger or if there is a reasonable assumption that the effectiveness of the official act thereby
p.(None): could be affected to announce in advance.
p.(None): (5) Care must be taken to avoid any interference or disruption to the operation of the blood donation facility that is not absolutely necessary
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.(None): Home Contact Sitemap Imprint Deutsch
p.(None): [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query
p.(None): Federal law consolidated: Entire legal provision for the Blood Safety Act 1999, version of the print version
p.(None): 02/18/2020
p.(None): Other formats:
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): long Title
p.(None): Federal law on the collection of blood and blood components in blood donation facilities (Blood Safety Act 1999 - BSG 1999)
p.(None): StF: BGBl. I No. 44/1999 (NR: GP XX RV 1430 AB 1577 p. 156. BR: AB 5867 p. 650.)
p.(None): modification
p.(None): BGBl. I No. 119/1999 (NR: GP XX IA 1097 / A AB 1986 p. 174. BR: AB 5987 p. 656.)
p.(None): BGBl. I No. 98/2001 (NR: GP XXI RV 621 AB 704 p. 75. BR: 6398 AB 6424 p. 679.)
p.(None): BGBl. I No. 168/2004 (NR: GP XXII RV 676 AB 718 S. 90. BR: AB 7179 S. 717.)
p.(None): [CELEX-No .: 32002L0098, 32004L0033]
p.(None): BGBl. I No. 63/2005 (NR: GP XXII IA 617 / A AB 962 p. 113. BR: AB 7323 p. 723.)
p.(None): BGBl. I No. 107/2005 (NR: GP XXII RV 675 AB 720 p. 90. BR: AB 7180 p. 717.)
p.(None): BGBl. I No. 107/2009 (NR: GP XXIV RV 153 AB 186 S. 26. BR: AB 8125 S. 772.)
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 S. 23. BR: 9967 AB 9970 S. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): BGBl. I No. 92/2019 (NR: GP XXVI IA 927 / A p. 88. BR: 10239 AB 10257 p. 897.)
p.(None): text
p.(None): scope
p.(None): § 1. (1) This federal law regulates the collection and testing of human blood and blood components as well as the related
p.(None): Security measures to offer donors and patients the best possible protection.
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): Federal law on the collection of blood and blood components in blood donation facilities (Blood Safety Act 1999 - BSG 1999)
p.(None): StF: BGBl. I No. 44/1999 (NR: GP XX RV 1430 AB 1577 p. 156. BR: AB 5867 p. 650.)
p.(None): modification
p.(None): BGBl. I No. 119/1999 (NR: GP XX IA 1097 / A AB 1986 p. 174. BR: AB 5987 p. 656.)
p.(None): BGBl. I No. 98/2001 (NR: GP XXI RV 621 AB 704 p. 75. BR: 6398 AB 6424 p. 679.)
p.(None): BGBl. I No. 168/2004 (NR: GP XXII RV 676 AB 718 S. 90. BR: AB 7179 S. 717.)
p.(None): [CELEX-No .: 32002L0098, 32004L0033]
p.(None): BGBl. I No. 63/2005 (NR: GP XXII IA 617 / A AB 962 p. 113. BR: AB 7323 p. 723.)
p.(None): BGBl. I No. 107/2005 (NR: GP XXII RV 675 AB 720 p. 90. BR: AB 7180 p. 717.)
p.(None): BGBl. I No. 107/2009 (NR: GP XXIV RV 153 AB 186 S. 26. BR: AB 8125 S. 772.)
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 S. 23. BR: 9967 AB 9970 S. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): BGBl. I No. 92/2019 (NR: GP XXVI IA 927 / A p. 88. BR: 10239 AB 10257 p. 897.)
p.(None): text
p.(None): scope
p.(None): § 1. (1) This federal law regulates the collection and testing of human blood and blood components as well as the related
p.(None): Security measures to offer donors and patients the best possible protection.
p.(None): (2) The state of medical science must be observed when collecting and testing human blood or blood components.
p.(None): § 2. (1) This Federal Act does not apply to the collection and testing of blood or blood components from persons who have blood or
p.(None): Blood components are taken for diagnostic purposes as part of their medical treatment.
p.(None): (1a) In the case of donated blood, the provisions of this federal law are fi ned in accordance with a regulation of the Federal Minister of Health and
p.(None): Women according to § 21 application.
p.(None): (2) Appropriate measures must be taken to ensure that the blood and blood components withdrawn in accordance with paragraph 1 are not in modified or
p.(None): unchanged form can be applied to other people.
p.(None): (3) This Federal Law does not apply to the collection of blood or blood components that are withdrawn for clinical testing,
p.(None): as the responsible ethics committee (Section 41 of the Medicinal Products Act, Federal Law Gazette No. 185/1983, Section 58 of the Medical Devices Act, Federal Law Gazette No. 657/1996, or those related to Section 8c of the KAKuG,
p.(None): Federal Law Gazette No. 1/1957, implementing regulations) all for the assessment of the necessity of the deviation from the regulations of this federal law
p.(None): necessary documents were made available and the ethics committee made this deviation in the interests of protecting donors and test participants
p.(None): considered justified by the state of the art.
p.(None): (4) Appropriate measures must be taken to ensure that the blood and blood components withdrawn in accordance with paragraph 3 are only within the scope of the respective
p.(None): clinical trial.
p.(None): definitions
p.(None): § 3. (1) Blood within the meaning of this Federal Act is the body fluid drawn from a blood vessel from a donor, which is made up of and out of blood plasma
p.(None): corpuscular components.
p.(None): (2) Blood components within the meaning of this Federal Act are the plasma obtained by separation and the corpuscular one obtained by separation
p.(None): Shares.
p.(None): (3) Collection within the meaning of this Federal Act is the withdrawal of blood or its separation directly at the donor, including
...
p.(None): 6. the date and the results of the medical aptitude test carried out to determine whether it is fit for health and in good condition
p.(None): The nature of the blood or blood components of the donor,
p.(None): 7. the determination of a permanent or temporary donor exclusion, which, according to medical assessment, is determined to be the expected duration of a
p.(None): temporary donor exclusion, or the existence of voluntary self-exclusion,
p.(None): 8. any incidents during extraction,
p.(None): 9. the date and results of the laboratory tests performed on the donor's blood,
p.(None): 10. the information of the donor about increased or too low values, provided that this indicates the state of medical science
p.(None): Allow the presence of a serious illness,
p.(None): 11. Which medical devices and in-vitro diagnostics were used to obtain blood or blood components, and
p.(None): 12. The first and last name of the personnel performing the extraction.
p.(None): (4) The documentation must be in writing or on a data carrier, provided that it is ensured that the information specified in paragraph 2 during the
p.(None): Duration of the retention period are available.
p.(None): (5) The documentation has been through for at least fifteen years - those parts that are essential for the complete traceability of the transfusion chain
p.(None): at least thirty years - to be available for inspection at any time by the supervisory bodies responsible under this federal law.
p.(None): (6) Every blood donation facility is obligated, every serious incident and every serious undesirable reaction in connection with the collection or
p.(None): Testing blood and blood components suspected of having an impact on the quality of the product or the safety of the recipient
p.(None): the Federal Ministry of Health and Women or a body commissioned by the Federal Ministry of Health and Women
p.(None): Report to.
p.(None): § 11a. (1) Awarding or taking over orders that determine the health suitability of the donor through laboratory tests,
p.(None): There must be a written contract between the client and the contractor, which is always in the blood donation facility in the original or in the form of a copy
p.(None): must rest. The Federal Office for Safety in Health Care must be provided with evidence of the existence and content of the agreement upon request.
p.(None): (2) The responsibilities of each side must be clearly defined in the contract. The client has to make sure that the contractor
p.(None): Performs activity according to the given instructions. The client is responsible for ensuring that the contractor is responsible for the
p.(None): performing work has suitable premises and equipment, expertise and experience as well as competent staff.
p.(None): (3) In the contract, the client must also be granted the right with regard to the work to be carried out on his behalf at the contractor
p.(None): Carry out controls.
p.(None): (4) The responsibility of the client for determining the health suitability of the donor is not covered by agreements in accordance with paragraph 1
p.(None): touched.
p.(None): (5) The contractor must have a corresponding operating license in accordance with Section 63 (1) of the Medicinal Products Act or a corresponding license
p.(None): a competent authority of another EEA contracting party and is subject to an inspection in accordance with Section 67 of the Medicinal Products Act or an inspection
p.(None): by a competent authority of another contracting party to the EEA.
...
p.(None): Product or the security of the recipient may have occurred, be effective and verifiably excluded from distribution or
p.(None): can be withdrawn.
p.(None): (2) The operating license is to be tied to conditions and requirements in accordance with the state of medical science and technology, if such
p.(None): to fulfill in particular to protect the health of the donor and to ensure the perfect condition of the blood obtained and the
p.(None): extracted blood components are necessary.
p.(None): (3) The following documents must be attached to the application for the operating license:
p.(None): 1. Name and address of the applicant,
p.(None): 2. a description of the company including a list of essential medical devices and other company facilities,
p.(None): 3. the necessary plans,
p.(None): 4. a list of the envisaged staffing including qualifications and the organizational plan for the
p.(None): Tasks and the area of responsibility of the personnel,
p.(None): 4a. a list of the possible mobile approvals envisaged, in particular with regard to the selection criteria for the necessary premises,
p.(None): as well as a list of the essential medical devices used,
p.(None): 5. The essential information on the quality assurance system to be provided, including standard operating procedures (SOPs) for recruitment
p.(None): of donors, the examination of the donors, the processing and testing of the blood or blood components obtained, their storage and distribution,
p.(None): recalling and reporting blood or blood components, documenting serious incidents and serious adverse reactions, and
p.(None): 6. a list of the hospital blood deposits to be supplied.
p.(None): (4) Organs of the Federal Office for Safety in Health Care, the Federal Ministry for Health and Women and those commissioned by them
p.(None): Expert is
p.(None): 1. Access to all premises of the blood donation facility to be approved and
p.(None): 2. to grant the necessary inspection of all documents and records relating to the facility.
p.(None): § 16. If an operating license is issued, it follows that, despite compliance with the requirements stipulated in the approval notice, the protection of the
p.(None): Health of the donor or the perfect condition of the blood or blood components obtained is not adequately ensured, so
p.(None): the Federal Office for Safety in Health Care must prescribe other or additional requirements to achieve these goals.
p.(None): Section 17. The effectiveness of this approval is not affected by the change in the person of the holder of a blood donation facility approved in accordance with Section 14.
p.(None): The legal successor must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Operations Review
p.(None): § 18. (1) It is the responsibility of the monitoring of compliance with this federal law
p.(None): 1. with regard to mobile blood donation facilities, the locally responsible district administrative authorities with the involvement of a medical officer, and otherwise
p.(None): 2. the Federal Office for Safety in Health Care.
p.(None): In the case of mobile blood donation facilities, local responsibility is based on the location where blood or blood components are obtained. The
p.(None): Checks according to Paragraph 1 must take place at regular intervals of no more than two years.
p.(None): (2) Unless the collection of blood or blood components by mobile blood donation facilities is not made public, the head is one
...
p.(None): Notification of this must be issued immediately.
p.(None): (5) Notices in accordance with paragraphs 2, 3 and 4 are immediately enforceable. Notices in accordance with paragraph 2 cease to expire after one year, unless they are limited in time
p.(None): the day of enforceability beyond effectiveness. A change in the person of the owner of the facility does not make the decision effective
p.(None): touched.
p.(None): (6) If the requirements for issuing notices pursuant to Paragraphs 2 and 3 no longer exist, the district administrative authority shall apply for the
p.(None): to revoke measures taken with the notices. With the issuance of an operating license notice in accordance with § 14, the notice in accordance with paragraph 4 shall expire
p.(None): Force.
p.(None): Withdrawal of permits
p.(None): Section 20. The Federal Office for Safety in Health Care must withdraw the operating license if
p.(None): 1. a prerequisite for the granting of the operating license in accordance with §§ 14 ff has ceased to exist or orders to remedy defects within the meaning of § 19 (2)
p.(None): has not been complied with twice or
p.(None): 2. it emerges that such a prerequisite was not fulfilled when the operating license was issued or
p.(None): 3. the holder of the operating license for a violation of the provisions of this federal law pursuant to Section 22 (1) at least within five years
p.(None): has been punished twice and the fines imposed exceed a total of 7,260 euros or
p.(None): 4. the holder of the operating license due to serious violations of the provisions of this Federal Act pursuant to Section 22 (2) within
p.(None): has been punished at least twice for five years.
p.(None): statutory authorization
p.(None): § 21. The Federal Minister of Health and Women can issue more detailed regulations by ordinance on
p.(None): 1. Which requirements a donor must meet in accordance with § 9, especially with regard to his health protection, with regard to the flawless
p.(None): Condition of the blood obtained and the blood components obtained, which examinations are to be carried out and which
p.(None): Examination results temporarily or permanently exclude the health suitability as donor, in what quantity and in which
p.(None): time intervals blood and blood components may be taken from a donor and what measures to protect privacy and in
p.(None): With regard to the duty of care towards the donor;
p.(None): 2. the form in which the donor is to be given information before the donation;
p.(None): 3. In what form the identity of the donor is to be documented, by whom, in what way and to what extent the processing, in particular
p.(None): Collection, transmission of the data as well as documentation and reporting obligations according to § 11 and § 12 are to be carried out;
p.(None): 4. What are the requirements for the required spatial and technical equipment as well as the hygiene standards to be observed?
p.(None): Adequate quality assurance system and an organizational plan must be drawn up;
p.(None): 5. What are the minimum personnel requirements of a blood donation facility, what special knowledge and skills does a leader or his or her manager have
p.(None): Have to have deputies as well as the doctors and other staff employed in the collection of blood or blood components and
p.(None): in which schooling, further education and further training measures these persons must take part;
p.(None): 6. how to label the blood and blood components obtained;
...
p.(None): appropriate condition of the blood obtained and the blood components are not adequately guaranteed, are appropriate conditions or
p.(None): To prescribe conditions.
p.(None): (4) On the basis of this review and the on-site inspection carried out, an approval procedure within the meaning of Section 14 (3) may be made ex officio
p.(None): with regard to individual parts of the operating system and the medical and technical facilities required for the operation, if the
p.(None): Protection of the health of the donor and the perfect condition of the blood and blood components obtained are otherwise insufficient
p.(None): are guaranteed.
p.(None): (5) The Federal Minister of Labor, Health and Social Affairs must immediately remedy any abuses before a review in accordance with paragraph 3
p.(None): To order a decision that is suitable for the life or health of donors or the perfect condition of the blood or blood components
p.(None): to endanger. In the event of imminent danger, the blood donation facility must be closed by the Federal Minister of Labor, Health and Social Affairs.
p.(None): (6) If the holder of an operating license fails to notify the Federal Minister of Labor, Health and Health in accordance with Section 3 of the Plasmapheresis Act
p.(None): Social affairs within the specified period, or if the instructions pursuant to paragraph 3 or paragraph 5 are not complied with, the Federal Minister of Labor,
p.(None): Health and social affairs to withdraw the operating license.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): Section 25. (1) The personal terms used in this Federal Act include men and women equally.
p.(None): (2) Insofar as other federal laws are referred to in this federal law, these are to be applied in their respectively applicable version.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): Section 26. With the enforcement of this Federal Act, the Federal Minister of Health is in agreement with the Federal Minister of Health with regard to Section 22a
p.(None): Inside, entrusted.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 27. (1) With the entry into force of this federal law, the federal law of July 4, 1975 on the conduct of plasmapheresis
p.(None): (Plasmapheresegesetz), BGBl. № 427/1975 as well as the ordinance of the Federal Minister for Health and Environmental Protection of April 21, 1978 for implementation
p.(None): of the plasmapheresis law (plasmapheresis regulation), Federal Law Gazette No. 231/1978, is no longer valid.
p.(None): (2) The provisions of the Medicinal Products Act, Federal Law Gazette № 185/1983, the Medical Devices Act, Federal Law Gazette № 657/1996, and the 1994 Industrial Code,
p.(None): Federal Law Gazette No. 194 remain unaffected by this federal law.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 28. Already pending applications for the approval of a plasmapheresis office under the Plasmapheresis Act are deemed to be effective when this Federal Act comes into force
...
Social / education
Searching for indicator education:
(return to top)
p.(None): 1. Which requirements a donor must meet in accordance with § 9, especially with regard to his health protection, with regard to the flawless
p.(None): Condition of the blood obtained and the blood components obtained, which examinations are to be carried out and which
p.(None): Examination results temporarily or permanently exclude the health suitability as donor, in what quantity and in which
p.(None): time intervals blood and blood components may be taken from a donor and what measures to protect privacy and in
p.(None): With regard to the duty of care towards the donor;
p.(None): 2. the form in which the donor is to be given information before the donation;
p.(None): 3. In what form the identity of the donor is to be documented, by whom, in what way and to what extent the processing, in particular
p.(None): Collection, transmission of the data as well as documentation and reporting obligations according to § 11 and § 12 are to be carried out;
p.(None): 4. What are the requirements for the required spatial and technical equipment as well as the hygiene standards to be observed?
p.(None): Adequate quality assurance system and an organizational plan must be drawn up;
p.(None): 5. What are the minimum personnel requirements of a blood donation facility, what special knowledge and skills does a leader or his or her manager have
p.(None): Have to have deputies as well as the doctors and other staff employed in the collection of blood or blood components and
p.(None): in which schooling, further education and further training measures these persons must take part;
p.(None): 6. how to label the blood and blood components obtained;
p.(None): 7. Which requirements have to be met when donating your own blood;
p.(None): 8. What content the annual activity report of the blood donation facility has to show.
p.(None): Penalties
p.(None): § 22. (1) Who
p.(None): 1. contrary to Section 8 Paragraph 2, Section 3 or Section 5, wins blood or blood components, violates the obligation to provide information under Section 8 Section 7 or violates Section 8 Section 6
p.(None): communicates personal data to other employees,
p.(None): 2. does not comply with the documentation requirement pursuant to Section 11 or Section 12,
p.(None): 2a. as client or contractor does not meet his obligations under § 11a,
p.(None): 3. as legal successor violates the reporting obligation in accordance with § 17,
p.(None): 4. the report pursuant to Section 18 (2) is not made or not made in good time, or
p.(None): 5. contravenes the orders and prohibitions contained in the ordinances issued on the basis of this federal law,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 7,270 euros.
p.(None): (2) Who
p.(None): 1.applies blood or blood components to other persons contrary to Section 2 Paragraph 2 or Paragraph 4,
p.(None): 2. wins blood or blood components contrary to § 6,
p.(None): 3. contrary to Section 7, Paragraph 1, Paragraph 2, Paragraph 5 or Paragraph 6 wins blood or blood components,
p.(None): 4. does not make use of qualified and suitable personnel in the collection of blood or blood components within the meaning of Section 7 (3) or (7),
...
Searching for indicator schooling:
(return to top)
p.(None): has been punished at least twice for five years.
p.(None): statutory authorization
p.(None): § 21. The Federal Minister of Health and Women can issue more detailed regulations by ordinance on
p.(None): 1. Which requirements a donor must meet in accordance with § 9, especially with regard to his health protection, with regard to the flawless
p.(None): Condition of the blood obtained and the blood components obtained, which examinations are to be carried out and which
p.(None): Examination results temporarily or permanently exclude the health suitability as donor, in what quantity and in which
p.(None): time intervals blood and blood components may be taken from a donor and what measures to protect privacy and in
p.(None): With regard to the duty of care towards the donor;
p.(None): 2. the form in which the donor is to be given information before the donation;
p.(None): 3. In what form the identity of the donor is to be documented, by whom, in what way and to what extent the processing, in particular
p.(None): Collection, transmission of the data as well as documentation and reporting obligations according to § 11 and § 12 are to be carried out;
p.(None): 4. What are the requirements for the required spatial and technical equipment as well as the hygiene standards to be observed?
p.(None): Adequate quality assurance system and an organizational plan must be drawn up;
p.(None): 5. What are the minimum personnel requirements of a blood donation facility, what special knowledge and skills does a leader or his or her manager have
p.(None): Have to have deputies as well as the doctors and other staff employed in the collection of blood or blood components and
p.(None): in which schooling, further education and further training measures these persons must take part;
p.(None): 6. how to label the blood and blood components obtained;
p.(None): 7. Which requirements have to be met when donating your own blood;
p.(None): 8. What content the annual activity report of the blood donation facility has to show.
p.(None): Penalties
p.(None): § 22. (1) Who
p.(None): 1. contrary to Section 8 Paragraph 2, Section 3 or Section 5, wins blood or blood components, violates the obligation to provide information under Section 8 Section 7 or violates Section 8 Section 6
p.(None): communicates personal data to other employees,
p.(None): 2. does not comply with the documentation requirement pursuant to Section 11 or Section 12,
p.(None): 2a. as client or contractor does not meet his obligations under § 11a,
p.(None): 3. as legal successor violates the reporting obligation in accordance with § 17,
p.(None): 4. the report pursuant to Section 18 (2) is not made or not made in good time, or
p.(None): 5. contravenes the orders and prohibitions contained in the ordinances issued on the basis of this federal law,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 7,270 euros.
p.(None): (2) Who
p.(None): 1.applies blood or blood components to other persons contrary to Section 2 Paragraph 2 or Paragraph 4,
p.(None): 2. wins blood or blood components contrary to § 6,
p.(None): 3. contrary to Section 7, Paragraph 1, Paragraph 2, Paragraph 5 or Paragraph 6 wins blood or blood components,
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): Professional practice in Austria authorized doctor by a qualified member of the high-level service for health and nursing
p.(None): respectively.
p.(None): donor
p.(None): § 8. (1) Blood and blood components may only be taken from a donor with his prior written consent. Consent to
p.(None): Extraction has to take place voluntarily and without compulsion.
p.(None): (2) Before the first collection of blood or blood components, the donor is familiar with the procedure used and with the donation
p.(None): possible side effects and dangers to his health. This information is given once a year for people who make repeated donations
p.(None): to repeat. The donor must also be informed about the intended purpose of using the donation.
p.(None): (3) The donor must be particularly advised of the possibility at any time to be able to voluntarily exclude himself.
p.(None): (4) It is prohibited to give or promise to donate blood or blood components or to third parties for a donation.
p.(None): If the blood is donated (whole blood) for products for direct transfusion, the donation must be made completely unpaid. In these cases, a reimbursement of expenses is only
p.(None): then permissible if the donor, due to an immediate need in an acute emergency situation, from the blood donation facility to the immediate donation
p.(None): was asked.
p.(None): (5) The protection of sufficient privacy of the donor must be ensured when collecting the medical history and the aptitude test.
p.(None): (6) Employees of the blood donation facility may only disclose personal data of the donor to other employees to the extent that it is allowed to
p.(None): whose fulfillment of tasks is necessary.
p.(None): (7) The donor is to be informed by a notice in the blood donation facility or in another suitable way that a blood donation is none
p.(None): Appropriate method for determining his HIV status is and can have legal consequences for the donor.
p.(None): health aptitude
p.(None): § 9. (1) Donors of blood and blood components must be suitable for health purposes to obtain blood or blood components.
p.(None): (2) The assessment of the health suitability of donors is based on a qualified and independent professional practice in Austria
p.(None): authorized doctor and has both the health protection of the donor and the perfect quality of the blood taken
p.(None): or the blood components taken. Deviating from this, in mobile blood donation facilities instead of assessing health
p.(None): Suitability of donors through admission to whole blood donation based on a standardized medical history and according to the requirements of a qualified one
p.(None): and physicians authorized to practice their profession independently by qualified members of the senior service for health and nursing
p.(None): be decided if this task has been assigned to them in accordance with §§ 12 Paragraph 3 in conjunction with 15 Paragraphs 1 and 2 GuKG and, in cases of doubt, an immediate one
p.(None): Consultation with a suitably trained doctor is possible.
p.(None): quality assurance
p.(None): § 10. (1) Each blood donation facility has to ensure the quality of blood and blood components based on the principles of good manufacturing practice
p.(None): based quality assurance system. The components of the quality assurance system, such as the quality assurance manual, company description
...
p.(None): With regard to the duty of care towards the donor;
p.(None): 2. the form in which the donor is to be given information before the donation;
p.(None): 3. In what form the identity of the donor is to be documented, by whom, in what way and to what extent the processing, in particular
p.(None): Collection, transmission of the data as well as documentation and reporting obligations according to § 11 and § 12 are to be carried out;
p.(None): 4. What are the requirements for the required spatial and technical equipment as well as the hygiene standards to be observed?
p.(None): Adequate quality assurance system and an organizational plan must be drawn up;
p.(None): 5. What are the minimum personnel requirements of a blood donation facility, what special knowledge and skills does a leader or his or her manager have
p.(None): Have to have deputies as well as the doctors and other staff employed in the collection of blood or blood components and
p.(None): in which schooling, further education and further training measures these persons must take part;
p.(None): 6. how to label the blood and blood components obtained;
p.(None): 7. Which requirements have to be met when donating your own blood;
p.(None): 8. What content the annual activity report of the blood donation facility has to show.
p.(None): Penalties
p.(None): § 22. (1) Who
p.(None): 1. contrary to Section 8 Paragraph 2, Section 3 or Section 5, wins blood or blood components, violates the obligation to provide information under Section 8 Section 7 or violates Section 8 Section 6
p.(None): communicates personal data to other employees,
p.(None): 2. does not comply with the documentation requirement pursuant to Section 11 or Section 12,
p.(None): 2a. as client or contractor does not meet his obligations under § 11a,
p.(None): 3. as legal successor violates the reporting obligation in accordance with § 17,
p.(None): 4. the report pursuant to Section 18 (2) is not made or not made in good time, or
p.(None): 5. contravenes the orders and prohibitions contained in the ordinances issued on the basis of this federal law,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 7,270 euros.
p.(None): (2) Who
p.(None): 1.applies blood or blood components to other persons contrary to Section 2 Paragraph 2 or Paragraph 4,
p.(None): 2. wins blood or blood components contrary to § 6,
p.(None): 3. contrary to Section 7, Paragraph 1, Paragraph 2, Paragraph 5 or Paragraph 6 wins blood or blood components,
p.(None): 4. does not make use of qualified and suitable personnel in the collection of blood or blood components within the meaning of Section 7 (3) or (7),
p.(None): 5. wins blood or blood components contrary to Section 8 Paragraph 1 or Section 9,
p.(None): 6. contrary to Section 8 Paragraph 4, donates or promises a donor or a third party for his donation,
p.(None): 7. violates the duty of confidentiality in accordance with § 13,
p.(None): 8. operates a blood donation facility without a license pursuant to Section 14 or if there is a significant change within the meaning of Section 14 (3)
p.(None): Continues to operate the blood donation facility without the required authorization,
...
Social / gender
Searching for indicator gender:
(return to top)
p.(None): be decided if this task has been assigned to them in accordance with §§ 12 Paragraph 3 in conjunction with 15 Paragraphs 1 and 2 GuKG and, in cases of doubt, an immediate one
p.(None): Consultation with a suitably trained doctor is possible.
p.(None): quality assurance
p.(None): § 10. (1) Each blood donation facility has to ensure the quality of blood and blood components based on the principles of good manufacturing practice
p.(None): based quality assurance system. The components of the quality assurance system, such as the quality assurance manual, company description
p.(None): (Site Master File), standard operating procedures (SOPs) and training manuals are published at least once a year or at
p.(None): To bring needs up to date.
p.(None): (2) The quality assurance system must in any case specify:
p.(None): 1. the objectives of quality assurance,
p.(None): 2. the specific tasks and responsibilities of the people working in a blood donation facility and the organizational plan,
p.(None): 3. the process steps provided for obtaining blood and blood components,
p.(None): 4. the scope of the documentation and
p.(None): 5. the means for ensuring a perfect quality of the blood and the blood components obtained.
p.(None): documentation
p.(None): § 11. (1) Every blood donation institution is obliged to document every collection of blood or blood components.
p.(None): (2) The documentation has a complete traceability of the transfusion chain according to the state of medical science, insofar as this is in the
p.(None): The area of responsibility of the blood donation facility falls to ensure.
p.(None): (3) The documentation relating to the individual donor must in any case include:
p.(None): 1. the first and last name, date of birth, gender and main place of residence of the donor and any changes to this data
p.(None): Perusal,
p.(None): 2. the donor's written consent to the donation through his own signature,
p.(None): 3. the donor's confirmation of the information provided within the meaning of Section 8 (2) and (3) by his own signature,
p.(None): 4. the medical history,
p.(None): 5. the date of collection and the quantity of blood or blood components as well as an abnormal duration of the collection or separation,
p.(None): 6. the date and the results of the medical aptitude test carried out to determine whether it is fit for health and in good condition
p.(None): The nature of the blood or blood components of the donor,
p.(None): 7. the determination of a permanent or temporary donor exclusion, which, according to medical assessment, is determined to be the expected duration of a
p.(None): temporary donor exclusion, or the existence of voluntary self-exclusion,
p.(None): 8. any incidents during extraction,
p.(None): 9. the date and results of the laboratory tests performed on the donor's blood,
p.(None): 10. the information of the donor about increased or too low values, provided that this indicates the state of medical science
p.(None): Allow the presence of a serious illness,
p.(None): 11. Which medical devices and in-vitro diagnostics were used to obtain blood or blood components, and
p.(None): 12. The first and last name of the personnel performing the extraction.
p.(None): (4) The documentation must be in writing or on a data carrier, provided that it is ensured that the information specified in paragraph 2 during the
p.(None): Duration of the retention period are available.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): Transfusion of blood or blood components that is fatal or life-threatening, that results in disability or loss of ability
p.(None): Leads to illnesses or extends their duration or hospitalization
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 4. Donors within the meaning of this Federal Act is any person who has the will to donate blood or blood components for use in others
p.(None): Expresses people and for other people to the staff working in the operation of a blood donation facility.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): § 5. Blood donation facility within the meaning of this Federal Act is any organizational unit for the collection of blood or blood components.
p.(None): Blood establishments
p.(None): Section 6. (1) Blood and blood components may only be obtained in blood donation facilities that have a license in accordance with Section 14 of this Federal Act
p.(None): become.
p.(None): (2) Each blood donation facility has the personal, spatial,
p.(None): to have operational and technical equipment. The staff must take appropriate further training measures regularly and in good time
p.(None): state of the art.
p.(None): (3) The equipment must be designed in such a way that the current state of medical science and technology is trouble-free
p.(None): Organizational process is guaranteed, the necessary hygiene standards are maintained and donors receive emergency medical care at all times
p.(None): can come.
p.(None): (4) Each blood donation facility has adequate medical equipment for any medical technology and technology
p.(None): To have incidents. This equipment is in the immediate vicinity of the reception area during the operation of a blood donation facility
p.(None): to keep and keep ready for use at any time.
p.(None): (Note: Paragraph 5 repealed by Federal Law Gazette I No. 168/2004)
p.(None): § 7. (1) A medical director must be appointed for the management of each blood donation facility. The same applies in the case of Section 14 (2).
p.(None): (2) If the medical director is unable to attend, a deputy is to be appointed and the Federal Office for Safety in Health Care immediately
p.(None): to make known.
p.(None): (3) The medical director and his deputy must
p.(None): 1. be authorized to practice the medical profession independently in Austria,
p.(None): 2. have special knowledge and skills appropriate to their tasks and
p.(None): 3. Have completed at least two years of work in a blood donation facility.
p.(None): (4) The medical director and, if he is prevented, the deputy are responsible for all medical, medical-technical and hygienic matters and the
p.(None): Use of the medical staff of the blood donation facility responsible. In the case of Section 14 (2), the responsibility extends to everyone together
p.(None): approved facilities.
p.(None): (5) The medical director and, if he is prevented, the deputy have during the operating hours of the blood donation facility approved in accordance with § 14
p.(None): to be reachable at any time.
p.(None): (6) The operation of a blood donation facility is only possible in the presence of a doctor who is authorized to practice his profession in Austria and who is responsible for this
p.(None): appropriate knowledge and skills. Deviating from this, whole blood donations in mobile blood donation facilities are also without
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): Testing blood and blood components suspected of having an impact on the quality of the product or the safety of the recipient
p.(None): the Federal Ministry of Health and Women or a body commissioned by the Federal Ministry of Health and Women
p.(None): Report to.
p.(None): § 11a. (1) Awarding or taking over orders that determine the health suitability of the donor through laboratory tests,
p.(None): There must be a written contract between the client and the contractor, which is always in the blood donation facility in the original or in the form of a copy
p.(None): must rest. The Federal Office for Safety in Health Care must be provided with evidence of the existence and content of the agreement upon request.
p.(None): (2) The responsibilities of each side must be clearly defined in the contract. The client has to make sure that the contractor
p.(None): Performs activity according to the given instructions. The client is responsible for ensuring that the contractor is responsible for the
p.(None): performing work has suitable premises and equipment, expertise and experience as well as competent staff.
p.(None): (3) In the contract, the client must also be granted the right with regard to the work to be carried out on his behalf at the contractor
p.(None): Carry out controls.
p.(None): (4) The responsibility of the client for determining the health suitability of the donor is not covered by agreements in accordance with paragraph 1
p.(None): touched.
p.(None): (5) The contractor must have a corresponding operating license in accordance with Section 63 (1) of the Medicinal Products Act or a corresponding license
p.(None): a competent authority of another EEA contracting party and is subject to an inspection in accordance with Section 67 of the Medicinal Products Act or an inspection
p.(None): by a competent authority of another contracting party to the EEA.
p.(None): (6) A contractor may not pass on any contractually assigned work to third parties without the client's written consent.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): donor card
p.(None): § 12. (1) For repeat donors of whole blood, a donor ID can be made to identify the donor.
p.(None): (2) For each donor of blood components, a donor ID card must be prepared as part of the initial donation to identify the donor.
p.(None): (3) In accordance with paragraph 4, each donor may only have a donor card issued for the donation of whole blood or blood components.
p.(None): A change in family or first name or primary residence is the next time blood or is obtained after the change
p.(None): Announce blood components from the donor and document them from the blood donation facility as soon as they become known.
p.(None): (4) If a donor card is illegible or unusable, it must be provided with a reference to it, provided that the blood donation facility is present
p.(None): Invalid and issue a new ID. If the donor card is lost, another one with corresponding documentation is in the
p.(None): To prepare donor data sheet. Such ID cards must be marked accordingly.
p.(None): (5) If a permanent reason for donor exclusion is determined, the donor ID, if it is available to the blood donation facility, is from the
p.(None): Blood donation facility either to withhold or, at the donor's request, provided with a general indication of its invalidity
p.(None): return.
p.(None): Note for the following provision
...
p.(None): or secrets that have become known, unless you already have one according to other legal or official regulations
p.(None): Confidentiality is imposed.
p.(None): (2) There is no duty of confidentiality if
p.(None): 1. the person threatened by the disclosure of the secret, the person working or who has worked in the blood donation facility, from maintaining secrecy
p.(None): gave birth or
p.(None): 2. the disclosure of the type and content of the secret in order to protect the higher interests of public health care or the administration of justice
p.(None): is absolutely necessary.
p.(None): Issuing the operating license
p.(None): § 14. (1) The operation of a blood donation facility requires an operating license from the Federal Office for Safety in Health Care.
p.(None): (2) The authorization according to paragraph 1 can be given jointly for mobile and stationary blood donation facilities, provided that they are functional and organizational
p.(None): are connected.
p.(None): (3) If a change is made to the operation of a blood donation facility after the operating license has been issued, the effects
p.(None): may have on the health protection of the donor or the perfect condition of the blood or blood components obtained, so
p.(None): this change also requires approval from the Federal Office for Safety in Health Care.
p.(None): (4) The approval procedures under this Federal Act are, if possible, at the same time as the approval procedures required under other regulations
p.(None): perform.
p.(None): (5) For each operating license, the responsible governor and the locally responsible district administrative authority are from the Federal Office for Security
p.(None): to inform healthcare.
p.(None): (6) In consideration of the requirements of a prompt and rapid examination of an application for the authorization of a blood donation facility, the
p.(None): Federal Office for Safety in Health Care to issue the decision without unnecessary delay, but at the latest one year after receipt of the application.
p.(None): (7) When approving blood donation facilities, care must be taken to ensure the supply of recipients of blood products of the appropriate quality
p.(None): and quantity and their availability at all times.
p.(None): (8) The relevant blood donation facilities operating in the same local catchment area are to be heard in the approval procedure in accordance with paragraph 1.
p.(None): Requirements for approval
p.(None): § 15. (1) The operating license is to be issued if
p.(None): 1. The permits required by other legal provisions are available and the operating system and all medical equipment required for the operation
p.(None): and technical facilities comply with the applicable regulations in the field of health law,
p.(None): 2. a medical director in accordance with this law has been appointed and made known to the authority,
p.(None): 3. The personnel, spatial, operational requirements for the type and scope of the collection of blood and blood components in the blood donation facility
p.(None): and technical equipment is given,
p.(None): 4. The tasks and responsibilities of the people working in the blood donation facility are specified and in an organizational plan to be presented
p.(None): is shown
p.(None): 5. The necessary facilities for documentation and state-of-the-art medical science and technology
p.(None): Quality assurance is in place,
p.(None): 6. the blood donor facility has a procedure in which blood or blood components with respect to which a serious incident or serious
p.(None): undesirable reactions in connection with the extraction or testing, which are suspected to have an impact on the quality of the
p.(None): Product or the security of the recipient may have occurred, be effective and verifiably excluded from distribution or
p.(None): can be withdrawn.
p.(None): (2) The operating license is to be tied to conditions and requirements in accordance with the state of medical science and technology, if such
p.(None): to fulfill in particular to protect the health of the donor and to ensure the perfect condition of the blood obtained and the
p.(None): extracted blood components are necessary.
p.(None): (3) The following documents must be attached to the application for the operating license:
p.(None): 1. Name and address of the applicant,
p.(None): 2. a description of the company including a list of essential medical devices and other company facilities,
p.(None): 3. the necessary plans,
p.(None): 4. a list of the envisaged staffing including qualifications and the organizational plan for the
p.(None): Tasks and the area of responsibility of the personnel,
...
p.(None): 2. to grant the necessary inspection of all documents and records relating to the facility.
p.(None): § 16. If an operating license is issued, it follows that, despite compliance with the requirements stipulated in the approval notice, the protection of the
p.(None): Health of the donor or the perfect condition of the blood or blood components obtained is not adequately ensured, so
p.(None): the Federal Office for Safety in Health Care must prescribe other or additional requirements to achieve these goals.
p.(None): Section 17. The effectiveness of this approval is not affected by the change in the person of the holder of a blood donation facility approved in accordance with Section 14.
p.(None): The legal successor must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Operations Review
p.(None): § 18. (1) It is the responsibility of the monitoring of compliance with this federal law
p.(None): 1. with regard to mobile blood donation facilities, the locally responsible district administrative authorities with the involvement of a medical officer, and otherwise
p.(None): 2. the Federal Office for Safety in Health Care.
p.(None): In the case of mobile blood donation facilities, local responsibility is based on the location where blood or blood components are obtained. The
p.(None): Checks according to Paragraph 1 must take place at regular intervals of no more than two years.
p.(None): (2) Unless the collection of blood or blood components by mobile blood donation facilities is not made public, the head is one
p.(None): Blood donation facility undertakes to inform the locally responsible district administrative authority of the location and time of the planned blood donation campaign
p.(None): Announcement of collective reports for one month in advance, blood donation campaigns not covered by this collective report must be made two days before admission at the latest
p.(None): to announce the extraction. Blood donation campaigns, the urgency of which does not permit such a report, are exempt from the reporting obligation.
p.(None): (3) The organs of the authority responsible for monitoring the blood donation facility and the experts consulted by it
p.(None): 1. to grant access to all premises of the blood donation facility during operating hours,
p.(None): 2. to grant the required inspection of all documents and records upon request, and
p.(None): 3. enable the taking of samples in the amount required for an analysis.
p.(None): (4) The reviews are in default except in the event of danger or if there is a reasonable assumption that the effectiveness of the official act thereby
p.(None): could be affected to announce in advance.
p.(None): (5) Care must be taken to avoid any interference or disruption to the operation of the blood donation facility that is not absolutely necessary
p.(None): becomes.
p.(None): (6) The samples taken, insofar as this is possible by nature and do not prevent their correct assessment from being frustrated, are divided into three equal parts
p.(None): to share. Two parts of it are to be officially closed, one part is to be left to the party for evidence. The head of the
p.(None): Blood donation institution to issue a confirmation.
p.(None): (7) No compensation is due for the samples taken in accordance with Paragraph 3 No. 3 in conjunction with Paragraph 6.
p.(None): § 19. (1) If the locally responsible district administrative authority becomes aware of violations of this federal law or one based on this
p.(None): Federal law enacted regulation, it immediately, without prejudice to the possible initiation of an administrative criminal procedure
p.(None): Governor and the Federal Office for Safety in Health Care to notify.
p.(None): (2) The district administrative authority has to order the blood donation facility to remedy abuses as soon as possible. Will this
p.(None): has not been removed within a period to be set, the district administrative authority must operate the blood donation facility until the
p.(None): Order to remedy the defect with a provisional decision and to do so by the Governor and the Federal Office for Safety in Health Care
p.(None): communicate.
p.(None): (3) In cases of imminent danger to human health, the district administrative authority, after prior notification of the
p.(None): Owner, or if such is not possible, of the medical director, even without previous procedure and before issuing a decision
p.(None): prohibit the blood donation facility on the spot; however, written notification of this must be issued within two weeks, otherwise the
p.(None): measures taken override.
p.(None): (4) If it is known that a blood donation facility is operated without a license according to § 14, the district administrative authority has no
p.(None): previous procedure and before issuing a decision to prohibit the operation of the blood donation facility on the spot. A written one
p.(None): Notification of this must be issued immediately.
p.(None): (5) Notices in accordance with paragraphs 2, 3 and 4 are immediately enforceable. Notices in accordance with paragraph 2 cease to expire after one year, unless they are limited in time
p.(None): the day of enforceability beyond effectiveness. A change in the person of the owner of the facility does not make the decision effective
p.(None): touched.
p.(None): (6) If the requirements for issuing notices pursuant to Paragraphs 2 and 3 no longer exist, the district administrative authority shall apply for the
p.(None): to revoke measures taken with the notices. With the issuance of an operating license notice in accordance with § 14, the notice in accordance with paragraph 4 shall expire
p.(None): Force.
p.(None): Withdrawal of permits
p.(None): Section 20. The Federal Office for Safety in Health Care must withdraw the operating license if
p.(None): 1. a prerequisite for the granting of the operating license in accordance with §§ 14 ff has ceased to exist or orders to remedy defects within the meaning of § 19 (2)
p.(None): has not been complied with twice or
p.(None): 2. it emerges that such a prerequisite was not fulfilled when the operating license was issued or
p.(None): 3. the holder of the operating license for a violation of the provisions of this federal law pursuant to Section 22 (1) at least within five years
p.(None): has been punished twice and the fines imposed exceed a total of 7,260 euros or
p.(None): 4. the holder of the operating license due to serious violations of the provisions of this Federal Act pursuant to Section 22 (2) within
p.(None): has been punished at least twice for five years.
p.(None): statutory authorization
p.(None): § 21. The Federal Minister of Health and Women can issue more detailed regulations by ordinance on
p.(None): 1. Which requirements a donor must meet in accordance with § 9, especially with regard to his health protection, with regard to the flawless
p.(None): Condition of the blood obtained and the blood components obtained, which examinations are to be carried out and which
p.(None): Examination results temporarily or permanently exclude the health suitability as donor, in what quantity and in which
...
p.(None): Operates conditions or conditions or does not follow instructions in accordance with section 24 (5) first sentence or operates contrary to section 24 (5) and (6)
p.(None): continues,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 36 340 euros. The same applies if an act in accordance with paragraph 1 poses a serious risk to the life or health of a person
p.(None): arisen or the perpetrator has already been punished twice in accordance with paragraph 1.
p.(None): (3) The attempt is punishable.
p.(None): Involvement of the organs of the public security service
p.(None): § 22a. The organs of the public security service are responsible for the Federal Office for Security in Health Care and the district administrative authorities
p.(None): their requests to ensure the exercise of powers pursuant to sections 15 subsections 4, 18 and 19 subsections 3 and 4 within the scope of their statutory scope
p.(None): To provide help.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): Transitional and final provisions
p.(None): Section 23. (1) Anyone who, at the time this Federal Act comes into force, a blood donation facility, with the exception of plasmapheresis sites, which according to Section 3 of the
p.(None): Plasmapheresis Act have been approved, operated and would like to continue this operation, this has within six months after the entry into force of this
p.(None): Federal law to notify the district administrative authority and an operating license to the Federal Minister of Labor, Health and Social Affairs in accordance with § 14
p.(None): apply.
p.(None): (2) Existing blood donation facilities may continue to be operated until a decision has been made on the application made pursuant to paragraph 1, provided the protection of the
p.(None): The health of the donor and the flawless nature of the blood and blood components obtained are guaranteed.
p.(None): (3) The Federal Minister of Labor, Health and Social Affairs shall immediately have the decision on the application made under paragraph 1
p.(None): To remedy maladministration with orders that are suitable for the life or health of donors or the faultless condition of the donor
p.(None): endangered blood or the blood components obtained. In the event of imminent danger, the blood donation facility is operated by the Federal Minister of Labor,
p.(None): Close health and social issues.
p.(None): (4) If the operator of a blood donation facility fails to notify the district administrative authority and apply for an operating license
p.(None): the Federal Minister of Labor, Health and Social Affairs within the specified period, or will be the operator of the blood donation facility
p.(None): The Federal Minister of Labor, Health and Social Affairs has the operation of the blood donation facility with notice by not following orders in accordance with paragraph 3
p.(None): to prohibit.
p.(None): Note for the following provision
p.(None): Is to be applied to situations that take place after March 10, 1999 (cf. § 29 Paragraph 1 of the Federal Law Gazette I No. 119/1999).
p.(None): Section 24. (1) Operating permits in accordance with Section 3 of the Plasmapheresis Act are deemed to be effective when this Federal Act comes into force
p.(None): Operating licenses according to § 14 of this federal law.
p.(None): (2) The holder of an operating license pursuant to Section 3 of the Plasmapheresis Act, who wishes to continue this operation, has to do this within six months
p.(None): Notify the Federal Minister of Labor, Health and Social Affairs of the entry into force of this federal law.
p.(None): (3) The Federal Minister of Labor, Health and Social Affairs has a review of this within three years of the entry into force of this Federal Act
p.(None): Plasmapheresis sites including a site inspection. This review reveals that protecting the health of the donor and the
p.(None): appropriate condition of the blood obtained and the blood components are not adequately guaranteed, are appropriate conditions or
p.(None): To prescribe conditions.
p.(None): (4) On the basis of this review and the on-site inspection carried out, an approval procedure within the meaning of Section 14 (3) may be made ex officio
p.(None): with regard to individual parts of the operating system and the medical and technical facilities required for the operation, if the
...
Orphaned Trigger Words
p.(None): § 28b. Through this federal law, Directive 2002/98 / EC of the European Parliament and of the Council of January 27, 2003, on the definition of
p.(None): Quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components and for
p.(None): Amendment to Directive 2001/83 / EC and Commission Directive 2004/33 / EC implementing Directive 2002/98 / EC of the European Parliament and
p.(None): of the Council with regard to certain technical requirements for blood and blood components.
p.(None): Section 29. (1) This Federal Act comes into force on January 1, 1999. However, this federal law is only applicable to matters that arise after March 10
p.(None): Realize in 1999.
p.(None): (2) On January 1, 2002, the expression "100,000 S" is replaced by the expression "7,270 euros" in Section 22 (1) and the expression "500,000 S" in Section 22 (2) by the
p.(None): Expression "36 340 euros" replaced.
p.(None): (3) Ordinances based on this federal law can be enacted from the day following its announcement, they may
p.(None): earliest at the same time as this federal law comes into force.
p.(None): (4) Section 7 (2), Section 14 (1), (3), (5) and (6), Section 15 (4), Section 16, Section 17, Section 19 (1) and (2) and Section 20 in the version of the Federal Law BGBl. I No. 107/2005 join
p.(None): take effect on January 1st, 2006.
p.(None): (5) Pending proceedings in accordance with the provisions set out in paragraph 4 have been in effect until the end of December 31, 2005
p.(None): Legal position to continue.
p.(None): (6) Sections 11a and 22 (1) 2a in the version of the Federal Law Gazette I No. 107/2009 come three months after the Federal Law BGBl. I has been published
p.(None): No. 107/2009 in force.
p.(None): (7) Section 21 no.3 in the version of the 2nd Material Data Protection Adjustment Act, Federal Law Gazette I No. 37/2018, comes into force on May 25, 2018.
p.(None): (8) Sections 7 (6) and 7 and 9 (2) in the version of the Federal Law Gazette I No. 92/2019 come into force on August 1, 2019. Regulations based on
p.(None): These provisions can be enacted as soon as this federal law is published, but do not come into force with this federal law at the earliest
p.(None): Force.
p.(None): to the top
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| authority | Relationship to Authority |
| criminal | criminal |
| disability | Mentally Disabled |
| education | education |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| employees | employees |
| family | Motherhood/Family |
| gender | gender |
| home | Property Ownership |
| illness | Physically Disabled |
| officer | Police Officer |
| party | political affiliation |
| schooling | education |
| sick | Physically Ill |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| education | ['schooling'] |
| schooling | ['education'] |
Trigger Words
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input