Source: https://www.global-regulation.com/translation/denmark/610827/ordinance-on-reporting-of-adverse-events-in-health-care%252c-etc.html
Timestamp: 2019-04-20 14:20:49+00:00

Document:
Ordinance On Reporting Of Adverse Events In Health Care, Etc.
Original Language Title: Bekendtgørelse om rapportering af utilsigtede hændelser i sundhedsvæsenet m.v.
Under section 199 (2) and (3) and § 202, paragraph 1 and 2 in Health Law, see. lovbekendtgørelse nr. 913 of 13. July 2010, fixed: the scope of section 1. The rules of this order shall apply in the health service and other places where performed in professional activities, including emergency medical services health effort and in connection with the supply of or information about medicines.
Definitions section 2. By adverse events for the purposes of this Ordinance in advance known and unknown events and errors, which are not due to the patient's illness, and that is either harmful or could have been harmful, but previously was foiled or otherwise not occurred due to other circumstances. An unintended event includes an event that occurs in connection with healthcare activities, including emergency medical services action or in connection with the supply of and information on medicinal products.
(2). When processing shall mean investigation, diagnosis, medical care, obstetrics, rehabilitation, health care, prevention and health promotion in relation to the individual patient.
(3). By health-care professionals shall mean persons who are authorized in accordance with special legislation to carry out health-care tasks, and persons acting on their responsibility.
(4). By ambulance practitioners shall mean persons who have undergone training in the field in accordance with applicable law.
(5). By pharmacists shall mean persons who have authorization, or has been employed as a pharmacy manager of a hospital pharmacy or a pharmacy at a private hospital in accordance with applicable law.
(6). By pharmacy staff means pharmacists, pharmacist, pharmaconomists students as well as defektricer, which is the staff at pharmacies.
(7). At the end of the reporting persons shall mean persons covered by paragraphs 2 to 6.
(8). By emergency medical services action means an action before arrival at hospital by ambulance, lægebil or transport in air transport, etc. in the face of acute sick, injured and birthing and health professional activity on call centres. Transport of patients between hospitals in the above mentioned means of transport are also covered by this effort in connection with the reporting of adverse events.
(9). By the supply of or information about medicinal products shall mean the services of the pharmacy sector.
Paragraph 10. By patient means a person who receives or has received treatment by a health care professional, receive or have received emergency medical services effort or receives or has received or supply of information on medicines from the pharmacy sector.
Paragraph 11. By caregivers refers to all relatives of a patient, including relatives, who do not have family links to the patient, and who has knowledge of the adverse events, which the patient has been exposed to.
Reporting to regions, municipalities and private hospitals § 3. Reporting obligation includes events, as a reporting person observes in connection with that the events taking place, including both events as they themselves are implicated in which events they observe with other health-care professionals, etc. in question Also include reporting obligation events, as a reporting person subsequently becomes aware of in connection with the exercise of his professional activity.
(2). Reporting pursuant to paragraph 1 shall take place as soon as possible and no later than 7 days after the reporting person has become aware of the events.
§ 4. Adverse events that occurred in the region, in relation to private practice health persons undertaking emergency medical services response and pharmacists and pharmacy staff and supply of information on medicinal products, to be reported to the region in which they have occurred.
(2). Adverse events occurring in the pre-hospital, reported to the region, which has been in charge of the transport of the patient. Adverse events occurring at guard stations in connection with emergency medical services efforts are reported to the region where on-call centre is located.
(3). Adverse events that occurred at a private hospital, must be reported to the concerned private hospital.
(4). Adverse events that occurred in the municipality, must be reported to the municipality in which they have occurred.
(5). Regions and municipalities will receive reports from the institutions, as they have operational responsibilities or regulatory obligation.
(6). Adverse events that occur in the context of the sector crossing points, to be reported to the region or municipality where the adverse event occurred. Health care agreements may, however, stipulate otherwise.
(7). Reporting to the region, municipality or private hospital shall be done electronically via the internet-based reporting system on the website www.dpsd.dk or by filling out and submitting a paper form drawn up by the Danish Medicines Agency.
Reporting access for patients and caregivers section 5. A patient or his relatives may report an unintended event to a region, a municipality or a private hospital, see. § 4.
(2). No time limit for reports from patients or their relatives.
Reporting to the health protection agency § 6. The regions, municipalities and the private hospitals must pass those in sections 3, 4 and 5 reports to the health protection agency.
(2). The transfer must happen as soon as possible after the region, municipality or private hospital has completed proceedings on the occasion of each adverse event, but not later than 90 days after the reporting is received.
§ 7. Transmission of reports to the health protection agency shall be made in anonymous form. The public reports shall not contain names, addresses, social security numbers and other information, which makes it possible to identify the involved health professionals and patients.
§ 8. The regions, municipalities and the privates technical hospital transmission of reports to the National Board of health shall be done electronically by filling in one of the health protection agency prepared template.
§ 9. Where regions, municipalities and private hospitals have prepared analyses, follow-up plans and action plans of reported adverse events, they must, at the request of the National Board of health shall be forwarded.
(2). Drew up theme reports and annual reports must automatically be disclosed to the health protection agency, see. health law § 199 (3) the date of entry into force of § 10. The decree will enter into force on 1 september 2010, see. However, paragraph 3.
(2). At the same time repealed Executive Order No. 451 of 21. may december 2007 on the reporting of adverse events in hospitals.
(3). § 5 shall enter into force on the 1. September 2011.
Guidance section 11. The health protection agency has in relation to this Ordinance prepared a guide that clarifies the reporting obligation, reporting, access and reporting option in more detail.

References: § 202
 § 3

§ 4
 § 4
 § 6

§ 7

§ 8

§ 9
 § 199
 § 10
 § 5