Act on Patient Safety

The Danish Act on Patient Safety passed in parliament June 2003 and was put into force January 1, 2004.

The Act obligates:

• Frontline personnel to report adverse events to a national reporting system
• Hospital owners are obligated to act on the reports 
• The National Board of Health is obligated to communicate the learning nationally

The purpose of the reporting system is to learn, not punish. Therefore the act contains a paragraph protecting the health care personnel from sanctions:

“A frontline person who reports an adverse event cannot as a result of that report be subjected to investigation or disciplinary action from the employer, the Board of Health or the Court of Justice.”

The Act on Patient Safety was implemented into the Danish Health Care Act January 1st 2007. The Act on Patient Safety was expanded in 2010.

The reporting system is expanded to the primary care sector as well as patients and relatives.

Part 61 is a translated chapter from the Danish Health Care Act (no. 913 of 13/07/2010)

Part 61
Patient safety
198. - (1) The Regional council and the municipal council receive, record and analyse reports on adverse events, cf. subsections (2) and (3) for use in the improvement of patient safety and for reporting pursuant to the rules laid down in Section 199.
(2) A Health care professional who in connection with professional activity becomes aware of an adverse event shall report this event to the region. Events that occur in the municipal health care sector, cf. Title IX, shall, however, be reported to the municipality. Sentences 1 and 2 above similarly apply to paramedics, pharmacists and pharmacy staff.
(3) A patient or a patient’s relatives may report an adverse event to the region or to the municipality according to the rules in subsection (2) sentences 1 and 2.
(4) An adverse event shall mean an event that occurs in connection with health professional activity, including prehospital activity or in connection with supply of and information about medicines. Adverse events comprise known and unknown events and errors that are not caused by the patient’s disease, and which either are harmful or could have been harmful had they not been avoided beforehand or for other reasons did not occur.
199. – (1) The National Agency for Patients’ Rights and Complaints receives reports from regional councils and municipal councils on adverse events and establishes a national register of these reports. The agency analyses reports and communicates knowledge gathered in this way to the health care sector. Furthermore the National Agency for Patients’ Rights and Complaints puts the reports at the disposal of the National Board of Health for use in connection with this institution’s guidance activity, cf. Section 214 (1).
(2) The National Agency for Patients’ Rights and Complaints lays down further rules on what adverse events are to be reported by the regional council and the municipal council to agency, and when and in what format this reporting shall be submitted as well as its content. Moreover the National Agency for Patients’ Rights and Complaints lays down further rules concerning the cases in which individuals covered by Section 198 (2) shall submit reports on adverse events to the regional council and the municipal council and when and in what format this reporting shall be submitted as well as its content. In addition the National Agency for Patients’ Rights and Complaints may lay down further rules as to the format of reporting in accordance with Section 198 (3).
(3) The National Agency for Patients’ Rights and Complaints may lay down rules to the effect that the regional council and the municipal council shall forward further defined information on reported events as well as action plans, professional announcements etc. to the agency for use in connection with the agency’s tasks according to subsection (1) and for use by the National Board of Health in connection with tasks according to Section 214 (1).
(4) Reporting on adverse events from the regional council and the municipal council to the National Agency for Patients’ Rights and Complaints pursuant to subsection (1) and to rules laid down according to subsection (3) shall be anonymised with regard to the patient concerned as well as the reporting individual.
(5)  The National Agency for Patients’ Rights and Complaints shall submit an annual report on the agency’s activity pursuant to Part 61.
200. - (1) Information on individuals that are comprised by a report, cf. Section 198 (1) is confidential.
(2)  Information on the identity of the person that has submitted a given report pursuant to Section 198 (2) may only be shared with the individuals in the same region or municipality that take care of tasks according to Section 198 (1).
201. - (1) The reporting individual may not as a consequence of reporting be submitted to disciplinary investigations and measures by his or her employer, supervisory measures by the National Board of Health or penal sanctions by the courts.
202. - (1) The National Agency for Patients’ Rights and Complaints may lay down further rules concerning what hospitals and other treatment institutions shall be covered by reporting obligations, and the National Agency for Patients’ Rights and Complaints may lay down special rules for the reporting systems used by private hospitals.
(2) Sections 198-201 also apply to privates hospitals.
(3) Sections 198-201 do not apply to other statutory reporting arrangements concerning adverse events and errors that occur in connection with treatment. In cooperation with the authorities involved the National Agency for Patients’ Rights and Complaints may lay down further rules that specify and possibly coordinate reporting conditions, cf. subsection (1).