Introductory provision
paragraph 1 of this regulation are given supplementary regulations to the
Act (2012:263) on quality and safety standards for
management of human organs. The terms and expressions that
used in this regulation have the same meaning as in the Act.
Organ and donor characterisation
section 2 of the a body offers a country within the European economic
area (EEA), the health care provider responsible for the
making body shall ensure that the information
shown in section A of the annex to this regulation to
competent authority or delegated institution in that country.
In section B of the annex to this regulation, it is clear from the
information provided by the health care provider responsible for taking into
be body shall ensure that the competent authority
or delegated institution in the country in question when it is
possible having regard to the circumstances of each individual
case.
The information in sections A and B of the annex to this regulation
shall, where appropriate, sent directly to the current
transplant centre. Regulation (2014:373).
Traceability
section 3 If a body is sent to a country within the European
economic area (EEA), the healthcare provider
responsible for protecting the body shall ensure that the competent
authority or delegated institution of that country shall be informed
for information about the
1. the organ specification,
2. the unique code of the donor,
3. date of procurement, and
4. names and contact information for the healthcare provider
responsible for protecting the body. Regulation (2014:373).
3 a of the New designation under section 12 of the Regulation (2014:373).
3 b of the redesignation, section 13 by Regulation (2014:373).
section 4 If the body is received from a country within the European
economic area (EEA), the healthcare provider
responsible for transplanting body shall ensure that the competent
authority or delegated institution of that country shall be informed
for information about the
1. the unique code to the recipient or, if the body is not
transplanted, its eventual use,
2. transplant date, if applicable, and
3. name and contact information to the health care provider who is responsible
to transplant the current body.
Regulation (2014:373).
Reporting of serious adverse events and serious
side effects
paragraph 5 of the report that a health care provider who is responsible for
exercise or transplanting organs should make to the relevant
competent authorities or delegated bodies under paragraph 5 of the
second subparagraph, or to paragraph 5 (a) of the Act (2012:263) if
quality and safety standards for the handling of human
body shall contain the information set out in sections C and D
in the annex to this regulation in so far as they are
available. Furthermore, an initial report and a final
report shall be prepared.
In section C of the annex to this regulation sets out the
data provided by a health care provider who is responsible for safeguarding the
or transplant organs shall ensure that disclose to
competent authorities or delegated bodies in
a first report of suspected or actual serious
adverse events and serious adverse events.
Data are disclosed without undue delay, if they are
available. When additional information becomes available,
These will be forwarded without undue delay.
In section D of the annex to this regulation sets out the
tasks that caregivers who are responsible for protecting the
or transplant organs shall ensure that disclose to
competent authorities or delegated bodies
to draw up and submit a final report on the
suspected or actual serious adverse events
or serious side effects. Regulation (2014:373).
Disclosure of information in certain cases
section 6, A Government agency or health care provider that from another
country has a data in response to an organ donation or
organ transplantation shall immediately forward these
information for interested health care providers. Regulation (2014:373).
Delegated bodies in Sweden
section 7 of The health care provider responsible for safeguarding or
transplant organs is delegated bodies in
accordance with article 3(e) of the implementing directive
2012/25/EC of 9 October 2012 if the information procedures
for the exchange between Member States of human organs intended
for transplantation, in the original wording.
Regulation (2014:373).
§ 8 Inspection for health and social care shall notify the European
the Commission is the contact information for the Swedish health care providers
referred to in article 7 to which information will be forwarded
in accordance with articles 5, 6 and 7 of Directive 25/EU, in the
original wording. Regulation (2014:373).
§ 9 Inspectorate for health and long-term care to provide the caregiver
responsible for safeguarding or transplanting organs with
the list of competent authorities and delegated
institutions in the countries of the European economic
area (EEA) and the European Commission shall provide
Member States in accordance with article 8 of Directive 25/EU,
the original wording. Regulation (2014:373).
Register
section 10 of the Inspectorate for health care may provide
on the obligation of health care providers to provide data to
the inspection of the treatment in the register referred to in section 7 of the
Act (2012:263) on quality and safety standards for
management of human organs. Regulation (2014:373).
section 11 of the Inspectorate for health and social care register pursuant to section 7 of the
Act (2012:263) on quality and safety standards for
management of human organs shall include information on
1. the healthcare provider's name and address,
2. Director's name and address,
3. business and its scope, and
4. contact information for the business.
Regulation (2014:373).
Direct access
section 12 of the National Board may be granted direct access to the
the information contained in the register maintained under section 7 of the Act
(2012:263) on quality and safety standards for the handling of
human body if the information is required by the National Board for
knowledge development, statistics production, monitoring,
evaluation, or epidemiological studies.
Regulation (2014:373).
Obligation to provide data
paragraph 13 of the Inspectorate for health and social care shall, at the request of
The National Board of health to disclose information from the records kept
According to section 7 of the Act (2012:263) on quality and safety standards
When handling the human body if the information is required in
The National Board for knowledge development,
statistics production, monitoring, evaluation or
epidemiological studies.
The National Board has the right to take note of the information contained in the
register kept pursuant to section 7 of the law on the quality and
security standards for the handling of human bodies at the
direct access pursuant to paragraph 3 (a). Regulation (2014:373).
Additional regulations
section 14 of the National Board may announce further provisions to
the protection of life and health of caregivers who promotes or
transplanting organs and on the management of bodies.
Regulation (2014:373).
section 15 of the Inspectorate for health care may provide
on the procedure for notifications under section 6 of the Act (2012:263)
quality and safety standards for the handling of human
bodies. Regulation (2014:373).
Annex, section A
1. The name and contact information to the health care facility where
the body is taken care of,
2. the name and contact information for the healthcare provider
responsible for making body;
3. type of donor,
4. the donor's blood group,
5. the donor's sex,
6. the donor's age,
7. the donor's height and weight,
8. date and time of death,
9. cause of death,
10. previous or current intravenous drug abuse,
11. previous or current cancer disease,
12. ongoing communicable disease,
13. other diseases in the donor of importance for
characterization,
14. laboratory tests for HIV-1, HIV-2, hepatitis B, hepatitis C
and Treponema Pallidum (syphilis), and
15. the basic information for the evaluation of the donated
the Agency's function.
Section B
1. The donor's medical history,
2. the results of the clinical examination or
body inspection,
3. If the donor or his sexual partners or parents will
from högprevalensområden,
4. the donor's travel patterns,
5. the donor's sexual exposure to risk and other risk exposure
relevant to the characterization,
6. the donor's stay in the area with local geographic presence
of communicable diseases,
7. laboratory findings may have significance for the discovery of
potentially infectious diseases or other illnesses,
8. bildt ester and image analysis that shows the body's anatomical
status,
9. previous or current treatment with antibiotics,
10. inotropic support or transfusion therapy (for deceased
donors),
11. other previous or ongoing medical treatment
relevant to the characterization,
12. previous or current cancer disease,
13. past or ongoing disease caused by prions
such as
a) any variant of Creutzfeldt-Jakob disease in the donor's
family,
b) rapidly progressive dementia or degenerative neurological
disease, or
c) hormones that the donor has received from a man's
pituitary, e.g. growth hormones or graft off
cornea, sclera or dura mater or neurosurgical
procedures where dura mater may have been used,
14. ongoing systemic infection such as bacterial diseases,
viral, fungal or parasitic infections, or severe local
infection of the organs to be donated,
15. recent vaccination with a live attenuated
viruses,
16. systemic autoimmune disorder that can impair
the quality of the bodies to be recovered,
17. indication of unreliable results of blood tests on
due to haemodilution (in cases where there is no sample
a time before transfusion) or treatment with
immunosuppressive agents,
18. exposure to or ingestion of a substance such as cyanide, lead,
copper and gold if it can be transferred to the recipient of the
body to such an extent that it may pose a risk of
his health,
19. completion of xenotransplantation, for example. transplantation
including biological heart valves, dura mater at
brain surgery or other preparations for heart surgery, and
20. If the donor's biological mother carries or has carried on a
infectious disease, and the risk of transmission to the baby yet
not definitively have been ruled out, if the donor is a
children under 18 months of age or have been breastfed at some time during the 12
in recent months.
Section C
1. the rapporteur Member State,
2. the identification number for the report: country
(ISO code)/national number,
3. contact details for reporting instance (competent
authority or delegated entity in the reporting
Member State): phone, email, and any fax number,
4. reporting the transplantation Centre/organization
procurement,
5. contact information for coordinators/contact person
(the transplantation Centre/Organization for procurement in
the rapporteur Member State): phone, e-mail, and
any fax number,
6. date and time of reporting (YYYY/MM/DD/hh/mm),
7. the Member State in which the body was taken to be,
8. the unique code of the donor, as notified under paragraph 3 of
This regulation,
9. all Member States of the bodies from the current
donor sent for transplant (if known),
10. the unique code for each recipient, the notified
According to paragraph 4 of this regulation,
11. date and time of serious adverse event
or serious adverse reaction began (yyyy/MM/DD/hh/mm),
12. date and time of serious adverse event
or serious adverse reaction was found
(Yyyy/MM/DD/hh/mm),
13. Description of serious adverse event or
serious adverse reaction, and
14. immediate action taken/proposed.
Section D
1. the rapporteur Member State,
2. the identification number for the report: country
(ISO code)/national number,
3. contact information for the instance:
phone, email and any fax number,
4. date and time of reporting (YYYY/MM/DD/hh/mm),
5. identity number for the first report/reports
(section C),
6. Description of the case,
7. the Member States concerned,
8. results and conclusion of the investigation,
9. preventive and corrective measures taken;
as well as the
10. conclusion/follow-up, if required.
Regulation (2014:373).