Regulation (2012:346) Concerning Quality And Safety Standards For The Handling Of Human Organs

Original Language Title: Förordning (2012:346) om kvalitets- och säkerhetsnormer vid hantering av mänskliga organ

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2012:346

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).