Law (2012:263) On The Quality And Safety Standards When Handling Human Organs

Original Language Title: Lag (2012:263) om kvalitets- och säkerhetsnormer vid hantering av mänskliga organ

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2012:263

General provisions



Content and objectives of the proposal



section 1 of this Act contains provisions on the quality and

safety standards for human organs intended for

transplantation to the human body.



The aim of the Act is to protect human health.



Definitions



paragraph 2 of this law the following definitions below

the specified importance.



"Serious adverse event" event that occurs in some

step in the chain from donation

to transplant and can



1. lead to the transmission of a

contagious disease or to

death,



2. be life-threatening or

Disabling or cause

significant loss of functionality

for the patient, or



3. cause or extend

disease or need

hospital care.



Serious adverse reaction unintended response,

including infectious disease,

of the living donors or

the receiver may be related

with any step in the chain from

donation to transplantation,

and as



1. can result in death or

to a life-threatening or

disabling condition,



2. result in significant

disability, or



3. results in or prolongs

disease or need

hospital care.



The competent authority or

delegated institution the authorities or

establishments referred to in the

list of European

the Commission shall provide

Member States in accordance with

Article 8 of the Commission's

implementing directive 2012/25/EU

of 9 October 2012

information procedures for

Exchange between Member States of

human organs intended for

transplant.



Organ 1. Differentiated part of

the human body consists of

different tissues and

maintains its structure,

vascularisation, and capacity to

develop physiological

features with a significant

degree of autonomy, or



2. part of such bodies

referred to in 1 and which is intended

to be used for the same purpose

as the whole body of the

the human body and which

satisfying the requirements of the structure

and vascularisation.



Health care providers government agency, County

in the case of such

Healthcare

authority, the County Council or

the municipality is responsible for and

other legal entity or

individual traders

engaged in health care.

Law (2014:358).



Scope of the directive



section 3 of the Act apply to the donation, testing, characterization,

procurement, preservation, transport and transplantation of

human organs intended for transplantation.



Relationship to other laws



§ 4 subject to this Act or the regulations

has been notified pursuant to the law, personal data Act

(1998:204) in the treatment of personal data.



Notification of serious adverse events and serious

side effects



5 § The caregivers responsible for safeguarding a body

should immediately to the health care provider responsible for the

Transplant agency notify and stated

serious adverse events and serious adverse events

that could affect the Agency's safety and quality.



In the cases of such adverse events or reactions

referred to in the first paragraph is suspected to be linked with a donor

whose bodies were sent to a country within the European economic

area (EEA), the health care provider responsible for

to protect this donor organs immediately notify these

events or adverse reactions to the competent authority or

delegated institution in the country that received the donor's

bodies. Law (2014:358).



5 a § The caregivers responsible for transplanting a

agencies should immediately to the health care provider responsible for

to protect the Agency notify and stated

serious adverse events and serious adverse events

that could affect the Agency's safety and quality.



In the cases of such adverse events or reactions

referred to in the first paragraph is suspected to be linked with a body

received from a country within the European economic

area (EEA), the health care provider responsible for

to transplant body immediate notification of these events

or adverse reactions to the competent authority or delegated

establishment in the country where the Agency murals.

Law (2014:358).



section 6 If a caregiver reporting suspected or actual

serious adverse event or serious adverse reactions

According to 5 or 5 a § or receive notification of such

events or reactions from the competent authority or

delegated establishment located in a country within the European economic

area (EEA), must immediately notify the health care provider

These events and side effects to the Inspectorate for health

and care. Law (2014:358).



Registry



section 7 of the Inspectorate for health and long-term care will be using

automated data processing, keep a register of

activities of health care providers who serve or

transplanting organs. The registry is intended to provide

publicity activities including procurement and

transplantation of organs.



The registry may also be used for monitoring, research and for

production of statistics.



The register may, in the case of personal data include information

only if the healthcare provider and business manager.



Inspectorate for health and long-term care is responsible for

the registry.



Government Announces rules on which authority should have

direct access to the data in the inspection for health and

care records. Law (2012:960).



§ 8 the provisions of the Swedish personal data Act (1998:204) about

rectification and damages shall apply in the case of treatment of

personal information under this Act.



Appropriations



9 § Government or authority the Government determines may

provide for an obligation for health care providers to provide

information to the Inspectorate for health and long-term care for treatment

in the register referred to in section 7. Law (2012:960).



section 10 of the Government or the authority, as the Government determines

may announce further provisions for the protection of the life and

health care providers who serve or transplanting organs

and on the management of bodies.