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OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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Reporting to the Health and Safety Authority (HSA) in respect of employees
Responsible Person
Senior Site Manager/Administrator
Scope
To describe the procedure followed in the reporting of incidents involving employees to the
HSA. By law “where any accident1 occurs at a place of work as a result of which any person
carrying out work at that place of work dies or is prevented from performing his normal work
for more than three consecutive days, excluding the day of the accident but including any
days which would have been working days” the HSA must be notified on form No. IR1 (page
14). This form is available on https://webapps.hsa.ie/CIRW/employerList.php?go=true&
info=emploc
Procedure
1. Fatality In the event of a fatal accident the manager/administrator must notify the HSA immediately
(i.e. by telephone 1890 289 389) giving the name of the deceased, brief particulars and the
location of the accident. The Gardaí should also be notified, and as soon as practicable
thereafter a written report on the approved form i.e. Form no. IR1 is forwarded to the HSA
and a copy forwarded to the local Quality & Risk Management Department or local
designated office responsible for managing incident reporting.
https://webapps.hsa.ie/CIRW/employerList.php?go=true&info=emploc
Where as a result of an accident at work an employee sustains an injury or suffers a condition
which is required to be reported to the HSA, and as a result of that accident the employee dies
within a year of the accident, the manager/administrator shall, as soon as possible after the
death comes to his/her knowledge, inform the HSA in writing of the death, whether or not the
accident had been previously reported to the HSA.
2. Over Three Day Injuries When an injured employee is unable to carry out his/her normal work for three consecutive
days excluding the day of the accident, or
When an injured employee is absent from work for more than three consecutive days
excluding the day of the accident a written report on the approved form i.e. Form no. IR1 is
forwarded to the HSA and a copy forwarded to the designated Quality & Risk Management
Department.
https://webapps.hsa.ie/CIRW/employerList.php?go=true&info=emploc
Note: Weekends and other normal days off are included when calculating the period of
absence. For example if an employee who normally has Saturday and Sunday off work is
injured on Wednesday and returns to work the following Monday, this incident is reportable.
However, if an employee is absent as a result of an accident for three separate days over a
period of time it is not reportable.
1 The term ‘accident’ is in keeping with the Health & Safety Authorities terminology and for the purpose of this
document can be used interchangeably with the term ‘incident’
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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Reporting to the Health & Safety Authority in respect of accidents to persons who are not employees
Responsible Person
Senior Site Manager/Administrator
Scope
To describe the procedure followed in the reporting of incidents to the Health and Safety
Authority (HSA) in respect of accidents1 to persons who are not employees e.g. visitors or
members of the public to include service users.
By law where ‘any person who is not at work but who as a result of an accident related to a
place of work or a work activity dies or suffers any injury or condition as a result of an
accident which results in the person requiring treatment from a registered medical practitioner
or treatment in a hospital as an in-patient or out-patient’, the HSA must be notified on Form
No. IR1 (see page 37).
https://webapps.hsa.ie/CIRW/employerList.php?go=true&info =emploc
Procedure
1. Fatality
In the event of a fatal accident the manager/administrator must notify the HSA immediately
(i.e. by telephone 1890 289 389) giving the name of the deceased, brief particulars and the
location of the accident. The Gardaí should also be notified, and as soon as practicable
thereafter a written report on the approved HSA form i.e. Form no. IR1 is forwarded to the
HSA and a copy forwarded to the designated Quality & Risk Management Department.
Where as a result of an accident at work a self employed person sustains an injury or suffers a
condition which is required to be reported to the HSA, and as a result of that accident the self
employed person dies within a year of the accident, the manager/administrator shall, as soon
as possible after the death comes to his/her knowledge, inform the HSA in writing of the
death, whether or not the accident had previously been reported to the HSA.
https://webapps.hsa.ie/CIRW/employerList.php?go=true&info=emploc
2. Any Accident
Any injury or accident to a member of the public caused by HSE work activities where
medical treatment is received irrespective of its seriousness will be reported to the HSA as
soon as practicable on Form No. IR1 and a copy forwarded to the designated Quality & Risk
Management Department.
Note: The term ‘registered medical practitioner’ includes nurses as well as doctors.
https://webapps.hsa.ie/CIRW/help.php#faq14
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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Reporting Dangerous Occurrences to the Health & Safety Authority (HSA)
Responsible Person
Senior Site Manager/Administrator
Scope
To describe the procedure followed in the reporting of incidents to the Health and Safety
Authority in respect of dangerous occurrences. Incidents which are categorised as dangerous
occurrences are outlined in the Health & Safety Authority IR3 form.
https://webapps.hsa.ie/CIRW/help.php#faq14
Procedure
1. Where a dangerous occurrence occurs the Health and Safety Advisor/other designated
person must be notified through the incident reporting process.
2. It is the responsibility of the senior site/area manager to notify the HSA as soon as
possible using Form No. IR3.
http://www.hsa.ie/eng Publications_and_Forms/Forms/IR3_Form.pdf
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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FORM OF NOTIFICATION OF A DANGEROUS OCCURRENCE
Approved under the Safety, Health and Welfare at Work (General Application) Regulations, 1993
Form No. IR (Before completing this form, please see instruction below) S.I. 44 of 1993
EMPLOYER / SELF-EMPLOYED INFORMATION
Name of business or company name: Phone Number
Address of head office: Date of incident:
Address of establishment where incident tool
place if different from above:
Approximate number
employed at
establishment:
Approximate
number employed
by business:
TYPE OF WORK BEING UNDERTAKEN AND LOCATION OF DANGEROUS OCCURRENCE
What activity was being undertaken
at the time of the incident
(e.g. construction, road transport,
chemical processing etc):
Where did the incident take place
(e.g. inside buildings, underground, field,
public road, shop etc.):
CIRCUMSTANCES FO THE INCIDENT
Description and cause:
DETAILS OF NOTIFIER
Notifier: Employer/Self Employed Person in control of workplace
Person providing training Other
Date:
Address and phone number for acknowledgement / clarification if different from
above:
Signature:
Position
Return to The Health and Safety Authority, Metropolitan Building, James Joyce Street, Dublin 1
Inquiries concerning this form can be made to our Workplace Contact Unit
Tel: 1890 289 389 E-mail: wcu@hsa.ie
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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INSTRUCTIONS
Where a dangerous occurrence of the kind named below which is not reportable by reason of death of injury occurs, an employer / self
employed person must, as soon as practicable, send a written report in the form above to the Health and Safety Authority.
1. The collapse, overturning, or failure of any load-bearing part of:
(a) any lift, hoist, crane, derrick or mobile powered access platform;
(b) any excavator; or
(c) any pile-driving frame or rig having an overall height, when operating, of more than seven meters.
2. The explosion, collapse or bursting of any closed vessel, including a boiler or boiler tube, in which the internal pressure was above or
below atmospheric pressure.
3. Electrical short circuit or overload attended by fire or explosion which results in the stoppage of the plant involved for more than 24
hours.
4. An explosion or fire occurring in any plant or place which resulted in the stoppage of that plant or suspension of normal work in that
place for more than 24 hours, where such explosion or fire was due to the ignition of process materials, their by-products (including
waste) or finished products.
5. The sudden uncontrolled release of one tonne or more of highly flammable liquid, liquidified flammable gas, flammable gas or
flammable liquid above its boiling point from any system plant or pipe-line.
6. The collapse or partial collapse of any scaffold more than five metres high which results in a substantial part of the scaffold falling or
overturning, including, where the scaffold is slung or suspended, a collapse or part collapse of the suspension arrangements (including
an outrigger) which causes a working platform or cradle to fall more than five metres.
7. Any unintended collapse or partial collapse of:
(a) any building or structure under construction, reconstruction alteration or demolition, or of any false-work, involving a fall of
more than five tonnes or material: or
(b) any floor or wall of any building being used as a place of work, not being a building under construction, reconstruction, alteration
or demolition.
8. The uncontrolled or accidental release or the escape of any substance or pathogen form any apparatus, equipment, pipework, pipe-line,
process plant, storage vessel, tank, in-works conveyance tanker, land-fill site, or exploratory land-drilling site, which, having regard to
the nature of the substance or pathogen and the extent and location of the release or escape, might have been liable to cause serious injury to any person.
9. Any unintentional ignition or explosion of explosives.
10. The failure of any container or any load-bearing part thereof while it is being raised, lowered or suspended.
11. Either of the following incidents in relation to a pipe-line:
(a) the bursting, explosion or collapse of a pipe-line or any part thereof:
(b) the unintentional ignition of anything in a pipe-line, or of anything which immediately before it was ignited was in a pipe-line.
12. (1) Any incident in which a container, tank, tank vehicle, tank semi-trailer, tank trailer or tank-container being used for conveying a
dangerous substance by road: (i) overturns: or
(ii) suffers damage to the package or tank in which the dangerous substance is being conveyed.
(2) Any incident involving a vehicle carrying a dangerous substance by road, where there is-
(i) an uncontrolled release or escape from any package or container of the dangerous substance of dangerous preparation
being covered; or (ii) a fire which involves the dangerous substance or dangerous preparation being conveyed.
13. Any incident where breathing apparatus while being used to enable the wearer to breathe independently of the surrounding
environment malfunctions in such a way as to be likely either to deprive the wearer of oxygen or, in the case of used in a contaminated
atmosphere in such a way as to be likely to either to deprive the wearer of oxygen or, in the case of use in a contaminated atmosphere,
to expose the wearer to the contaminant to the extent in either case of posing a danger to his health, but excluding such apparatus while
it is being used in a mine or is being maintained or tested.
14. Any incident in which plant or equipment either comes into contact with an overhead electric line in which the voltage exceeds 200 volts, or causes an electrical discharge from such electric line by coming into close proximity to it, unless in either case the incident
was intentional.
15. Any accidental collision between a locomotive or a train and other vehicle at a factory or at dock premises.
16. The bursting or a revolving vessel, wheel, grindstone, or grinding wheel moved by mechanical power.
Inquiries concerning this form can be made to our Workplace Contact Unit
Tel: 1890 289 389 Email: wcu@hsa.ie
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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Reporting incidents to the Irish Medicines Board (IMB)
Responsible Person
Line Manager in whose area the incident occurred
Scope
To describe the procedure followed by the Line Manager in respect of adverse incidents
involving medical devices e.g.
(a) any malfunction or deterioration in the characteristics and performance of a
device, as well as any inaccuracies in the instruction leaflet which might lead to
or might have led to the death of a patient, or user or of other persons or to a
serious deterioration in their state of health.
(b) any technical or medical reason in relation to the characteristics or performance
of a device for the reasons referred to in subparagraph (a) leading to systematic
recall of devices of the same type by the manufacturer
http://www.imb.ie/images/uploaded/documents/GN13_SURG0003_Incident%20ReportingFo
rGMDs&AIMDs.pdf
Suggestions as to the type of incidents to be reported are provided in the E.C. Guidelines on a
Medical Devices Vigilance System (Section 5 and Appendices 4 & 5 for general medical
devices and Appendix 10 for in-vitro diagnostics medical devices.
http://www.imb.ie/images/uploaded/documents/GN07_SURG0002_TheVigilanceSystemFor
MedicalDevices.pdf
Background The Medical Devices Directive, the Active Medical Devices Directive and the in-vitro
Diagnostics Medical Devices Directive include requirements for medical devices
manufacturers to report certain types of incidents to the Competent Authority. The Irish
Medicine Board as the Competent Authority for medical devices in Ireland has the
responsibility for coordinating and recording details relating to adverse incidents occurring in
Ireland.
To facilitate an understanding of reporting procedures, the Irish Medicine Board issued a
guidance note (GN-13-0) which defines incidents, near adverse incidents and the different
roles and responsibilities in the reporting and handling of such events.
http://www.imb.ie/images/uploaded/documents/GN13_SURG0003_Incident%20ReportingFo
rGMDs&AIMDs.pdf
Currently reporting of incidents by the user is not mandatory in Irish law. Nonetheless, users
are encouraged by the IMB to report any incidents through the incident reporting system.
Procedure
Any employee who identifies an incident or near-miss involving a medical device and in
keeping with the criteria identified by the E.C. Guidelines on a Medical Device Vigilance
System should:
1. Ensure the safety of any staff or patients and minimise potential for further harm.
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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2. Remove the defective or suspect device from use, label, isolate and retain in a safe
manner for examination.
3. Complete an incident report form in respect of the incident.
4. Serious incidents should be reported immediately to Senior Clinical and Administrative
staff and also to the local Quality & Risk Management Department or local designated
office responsible for managing incident reporting.
5. Notify the clinical engineer/service agent of the occurrence.
6. Line Manager to complete and return DSF-4-01-01/4 form and return to the IMB. The
completion and return of this form should be noted on the Incident Report form and a
copy attached.
7. Line manager should notify the designated person responsible for Risk Management so
that a check for similar devices that may also pose a problem in the service may be
made. Notification should also be made to the National Quality and Risk Team so that
if necessary a National Alert can be issued.
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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IRISH MEDICINES BOARD
MEDICAL DEVICE INCIDENT USER REPORT FORM
If you have experiences problems with a medical device, please complete this form and send it to the
Irish Medicines Board, Medical Devices Department, Earlsfort Terrace, Dublin 2 or contact us by
telephone at 01-6764971 or by e-mail vigilance@imb.ie
SECTION 1: CONTACT DETAILS FO REPORTING ORGANISATION
Name of
Organisation:
Fax Number:
Address of
Organisation:
Contact Name
Position:
Telephone
Number:
Address:
Can the Irish Medicines Board provide your contact details to the manufacturer, as they may need to
contact you in order to carry out an investigation Yes No
SECTION 2: DEVICE DETAILS
Name of device and model number:
Kind of device (e.g. pacemaker):
Serial number / batch number / lot number:
Where did you get the device?
Name of the person who supplied the
device:
Name and address of the manufacturer: Name and address of the distributor:
SECTION 3: INCIDENT DETAILS
What went wrong with the device?
Was an injury suffered? Yes No
If yes, specify who and what injuries were suffered?
Have you contacted the manufacturer? Yes No
Signature:
Date of Report:
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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The Irish Medicines Board Investigates all incidents reported to us in order to identify any faults with
medical devices and to prevent similar incidents happening again. Please note that the Irish Medicines
Board may contact the manufacturer of this medical device to request they carry out an investigation.
OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management
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Reporting to the Irish Medicines Board in respect of adverse drug reactions
Responsible Person
Reporting Clinician in association with the Chief Pharmacist
Scope
To describe the procedure followed by clinical staff in the reporting of incidents to the Irish
Medicines Board (IMB) in respect of all suspected adverse drug reactions. In Ireland, the
Irish Medicines Board (IMB) is responsible for the national reporting system of monitoring
adverse drug reactions. Health care professionals (defined as doctors, dentists, pharmacists
and nurses) are requested to report all suspected adverse reactions to the Irish Medicines
Board.
Of particular importance to report are:
• all suspected adverse reactions to new medicinal products,
• serious suspected reactions1 to established medicines,
• any suspected increase in the frequency of minor reactions,
• any suspected teratogenic effects,
• any suspected reactions associated with the use of vaccines or medicines used in
pregnancy.
http://www.imb.ie/EN/Safety-And-Quality/Advisory,-Warning-And-Recall-Notices/Human-
Medicines/ADVERSE-DRUG-REACTION-REPORTING.aspx?page=1¬icetypeid=-
1&year=2005
Definition
An adverse reaction is defined as a 'reaction which is noxious and unintended and which
occurs at doses normally used in man for the prophylaxis, diagnosis or therapy or disease or
for the modification of physiological function'. (This definition excludes accidental or
deliberate excessive dosage or maladministration).
http://www.imb.ie/EN/Safety--Quality/Reporting-Suspected-Product-Problems~.aspx
Procedure
To maximise the value of the adverse drug reactions reporting system in ensuring drug safety,
prescriber vigilance is essential. The possibility of adverse reactions must continually be
borne in mind.
1. If suspected, all adverse drug reactions should be reported firstly to the patient’s doctor
and also by the healthcare professional to the IMB using the Adverse Reactions Report
Form available from Pharmacy Departments. In the absence of a Pharmacy Department
these forms are available on the IMB website. www.imb.ie
2. A copy of the completed form should be held in the Pharmacy Department/Nursing
Administration and an incident form sent to the local Quality & Risk Management
department/other designated department.
1 A serious reaction is defined as one which is fatal, life threatening, and results in persistent or significant disability/incapacity, results in or prolongs hospitalisation. This definition also includes congenital abnormalities or birth defects and serious adverse clinical consequences.
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IMB Adverse Reaction Report Form
ADVERSE REACTION REPORT FORM
IN CONFIDENCE
(FOR COMPLETION BY HEALTHCARE PROFESSIONALS)
PLEASE SEND TO:-
FREEPOST
PHARMACOVIGILANCE UNIT
IRISH MEDICINES BOARD
EARLSFORT CENTRE
EARLSFORT TERRACE
DUBLIN 2
Telephone: 353-1-6764971
Fax: 353-1-6762517
E-mail: imbpharmacovigilance@imb.ie
REPORTER’S NAME & ADDRESS:
AREA OF SPECIALITY:
Patient Initials/Record No: Sex: M F
Age: Weight (if known): Ethnic Origin
Indication for Use:
Suspect Drug/Vaccine Please use brand name where possible
Daily
Dose
Route Batch No. Dates of Treatment
Suspected Reaction: (Brief description of the toxic effects or side effects)
Onset of Reaction: (Date)
Duration of Reaction:
Any other drugs used over this period: (Please state below)
Drug Daily
Dose
Indication for Use:
Recovery from Side Effects: Complete Symptoms Continuing Fatal
(Please circle)
If treatment was required please specify:
Drug Discontinued: Y N Drug Rechallenge: Y N
Improvement on discontinuation: Y N
Supply of Report Cards Required: Y N Manufacturer Notified: Y N
Signature: ___________________________ Date: _________________________
Thank you for taking the time to complete this for
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