reporting to the health and safety authority (hsa) in ... 20090330 v7 toolkit of documentation to...

OQR008 20090330 v7 Toolkit of Documentation to Support HSE Incident Management

1

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.


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’


2

Reporting to the Health & Safety Authority in respect of accidents to persons who are not employees

Responsible Person


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.


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


3


4

Reporting Dangerous Occurrences to the Health & Safety Authority (HSA)

Responsible Person


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


5

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: [email protected]


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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: [email protected]


7

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.


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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.


9

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 [email protected]

SECTION 1: CONTACT DETAILS FO REPORTING ORGANISATION

Name of

Organisation:

Fax Number:

Address of

Organisation:

Contact Name

Position:

Telephone

Number:

E-mail

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:


10

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.


11

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&noticetypeid=-

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: [email protected]

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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