POLICY FOR THE DONATION AND LOAN OF EQUIPMENT

Transcription

1 UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST POLICY FOR THE DONATION AND LOAN OF EQUIPMENT Approved By: Policy and Guidelines Committee Date of Approval: 16 th July 2004 Date of Review: 13 th December 2005 (Policy & Guideline Committee) Trust Ref: B19/2004 Originator: Review Date: Mr M Edwards, Assistant Director of Corporate and Legal Affairs Annual MGE/NA/loanofequipmentpolicy-update 1

2 SUMMARY STATEMENT This Policy outlines the procedures to be undertaken when equipment is either (a) loaned to the Trust, (b) loaned by the Trust, (c) donated to the Trust, or (d) donated by the Trust. Staff should familiarize themselves with the general provisions of this Policy and wherever any doubt exists, should seek further advice. Equipment Loaned to the Trust and by the Trust The relevant procedures would generally be undertaken by the Medical Physics Department of the Trust who should be informed of every loan. Where any doubt exists or where Medical Physics are unable to assist, the matter will be referred to the Corporate and Legal Affairs Department. Donations by and to the Trust When equipment may be donated to the Trust or where the Trust is considering donating equipment to others, the provisions of this policy must be adhered to. Revision September 2005 Clause 8.7 extended to include consumables. Clause 9.0 Equipment Loans to Patients where Equipment is owned by Third Parties added and subsequent clauses renumbered. Clause 10.4 added in respect of transportation of equipment in private vehicles. MGE/NA/loanofequipmentpolicy-update 2

3 CONTENTS 1.0 Introduction 2.0 Definition of Equipment 3.0 Staff Responsibilities 4.0 Equipment on Loan to the Trust 5.0 Donations of Equipment to the Trust 6.0 Equipment Loaned by the Trust to other Healthcare Provider Providers 7.0 Equipment Loaned to Patients 8.0 Donations of Equipment by the Trust 9.0 Equipment Loans to Patients Where Equipment is Owned by Third Parties 10.0 Transport of Equipment 11.0 Inspection and Testing of Loan/Donated Equipment 12.0 Amendments to Indemnities and Alternative Indemnities 13.0 Completion of Indemnities 14.0 Training 15.0 Further Advice. MGE/NA/loanofequipmentpolicy-update 3

4 APPENDICES APPENDIX A APPENDIX B APPENDIX C APPENDIX D APPENDIX E APPENDIX F Trust Form of Indemnity A Trust Form of Indemnity B Trust Delivery Note for Use with Trust Form of Indemnity A and B Form of Agreement for the Loan of Equipment to Other Healthcare Providers. Form of Agreement for the Loan of Equipment Beyond the Hospital Premises for the Purposes of Patients Healthcare. Form of Indemnity Agreement for the Donation of Equipment MGE/NA/loanofequipmentpolicy-update 4

5 UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST 1.0 INTRODUCTION The Trust acknowledges its responsibilities and obligations in complying with current legislation (including but not limited to the Health and Safety at Work etc Act 1974 and the Consumer Protection Act). Where equipment is loaned to the Trust or where the Trust loans equipment to a third party it is essential that all liabilities regarding fitness for purpose are clearly identified between the parties. Attention is also drawn to the Medical Devices Agency Safety Notices MDA SN 2002(17) and (18). For existing arrangements at the date of introduction of this Policy, see Clauses 4.12 and Reference should also be made to the Trust s Policy for the Management of Medical Equipment within UHL, wherever applicable Except as provided for in Clause 8 below, this Policy does not cover the sale transfer of ownership and disposal of Trust equipment (including used medical devices) for which specific advice should be sought in each and every instance (see 14.0 further advice). 2.0 DEFINITION OF EQUIPMENT For the purposes of this Policy, equipment means any tangible object which is capable of being touched or felt. It will include not only tools, furniture, and devices, but also, where appropriate, consumables and kits made up of an assembly of different objects. 3.0 STAFF RESPONSIBILITIES Trust Staff have responsibilities to ensure that when equipment is loaned by the Trust, the following procedures are followed to ensure that the Trust discharges its duty of care to the equipment users and patients. When equipment is loaned to the Trust, the loan procedure where applicable must be followed to ensure the Trust is indemnified against any claims for loss or injury resulting from its use. In the event of Trust staff not following these procedures, those agreeing to the loan, bringing in equipment from outside the Trust, or transporting equipment, may find themselves personally responsible for any liabilities arising. MGE/NA/loanofequipmentpolicy-update 5

6 4.0 EQUIPMENT ON LOAN TO THE TRUST 4.1 The NHS Form of Indemnity A (Form A) is to be used for all equipment on loan to the Trust by a supplier (see Appendix A). Only one Form A needs to be executed by a Supplier. 4.2 The Form of Indemnity A may be executed by the NHS Purchasing and Supplies Authority (PASA) on behalf of the Trust. Confirmation of whether or not PASA holds a Form of Indemnity A may be obtained by visiting the PASA website at Where a Form A is not held by PASA, the Trust shall obtain one and hold it locally. 4.3 Form of Indemnity A provides protection to the Trust when the Trust is in receipt of equipment on loan except for damage caused by the Trust or any claims or proceeding made or brought which arise due to the negligence of the Trust. 4.4 Before any loan commences, the Trust shall seek evidence that the Supplier s indemnity insurance is adequate and current. On expiry of the insurance, proof of renewal shall be obtained from the Supplier. 4.5 In the absence of any consideration, Form A is to be executed as a deed to ensure enforceability. Under the terms of the Form, any loan shall be deemed to be a contract for the hire of goods under Section 6 of the Supply of Goods and Services Act A Trust Delivery Note (Appendix C) must be signed for each piece of equipment loaned by the Supplier to the Trust. The reference number of the Form A must be quoted on all delivery notes. 4.7 The Delivery Note must record, wherever applicable, details of model/make serial number, value description, location, and intended purpose of the equipment. The period of loan whether indefinite for a defined period should also be clearly quoted. 4.8 For testing and safety of equipment, please refer to clause In receiving any equipment on loan, staff shall ensure that the integrity of the Trusts purchasing procedures are not compromised. Staffs attention is drawn to the Code of Business Conduct for Trust Staff, Section 3 and specifically to sub-clauses: MGE/NA/loanofequipmentpolicy-update 6

7 i. personal gifts must not be solicited under any circumstances ii. tendering and contract procedures iii. relationship with the Pharmaceutical Industry and other Commercial Interests Before acceptance of loaned equipment, staff shall consider and satisfy themselves of the adequacy of i. instructions for use (and updates) ii. training arrangements iii. service and maintenance responsibilities iv. decontamination Certification (whenever appropriate evidence of decontamination shall occupy the delivery note for further advice, see 14.0) Where equipment is to be loaned for the purpose of a medical trial no action shall be taken until full approval is given by the R&D Department and where appropriate, by the Local Ethics Committee Indemnities in existence prior to the adoption of this Policy including any relevant Master Indemnity Agreements may continue until they expire. When a new piece of equipment is to be supplied, then a new Form A will be required in accordance with the provisions of this Policy Form of Indemnity A will not be required in respect of loans of equipment from other NHS health care bodies In exceptional circumstances, where the advantages to the Trust outweigh any disadvantages, the need for a Form of Indemnity Form A may be waived providing always the express approval of the C&LA Directorate has first been obtained. 5.0 DONATIONS OF EQUIPMENT TO THE TRUST 5.1 For the purposes of this Clause, the word donation shall imply an intention that the legal rights of ownership shall be transferred by the donor to the Trust. 5.2 Before any equipment is accepted by the Trust the receiving department must ensure that the benefits to the Trust outweigh any risks arising from use of the equipment and that any running and maintenance costs can be met. (See also 10.0 Inspection and Testing of Equipment where applicable). MGE/NA/loanofequipmentpolicy-update 7

8 5.3 Wherever possible, especially when dealing with Charities or private donations, staff should seek financial donations rather than equipment to enable the Trust to benefit from VAT exemption advantages and NHS procurement procedures. 5.4 Where the donation is to be made by a commercial enterprise a Trust Form of Indemnity B (Form B) shall be obtained wherever it is reasonable and practicable to do so. (See Appendix B). Only one Form B needs to be executed by a Supplier. When considering whether it is practicable to receive a donation, the Trust shall take in to account the benefits the donated equipment will bring to the Trust in conjunction with any risks for which the Trust would assume liability should Form B not be completed. 5.5 The Form of Indemnity B may be executed by the NHS Purchasing and Supplies Authority (PASA) on behalf of all Trusts. Confirmation of whether or not PASA holds a Form of Indemnity B may be obtained by visiting the PASA Website at Where a Form B is not held by PASA, the Trust shall obtain one and hold it locally. 5.6 Form B provides protection to the Trust when equipment is donated to the Trust excepting any damage caused by the Trust or any claims or proceedings made or brought which arise due to the negligence of the Trust, its employees or agents. 5.7 In the absence of any consideration, Form B is to be executed as a deed to ensure enforceability. 5.8 A Trust Delivery Note (Appendix C) must be signed for each piece of equipment donated to the Trust. The reference number on Form B must be quoted on all delivery notes. 5.9 The Delivery Note must record wherever applicable, details of model/make, serial number, value, description, location, and intended purpose of the equipment When equipment is donated to the Trust by suppliers, staff shall ensure that the integrity of the Trust s purchasing procedures are not compromised. Staffs attention is drawn to the Code of Business Conduct for Trust Staff, Section 3 and specifically to sub-clauses: i. personal gifts must not be solicited under any circumstances ii. tendering and contract procedures iii. relationship with the Pharmaceutical Industry and other Commercial Interests. MGE/NA/loanofequipmentpolicy-update 8

9 5.11 Before the free issue equipment is received, staff should seek evidence of the suppliers indemnity insurance arrangements. On expiry of the insurance, proof of renewal should be sought from the insurer Indemnities in existence prior to the adoption of this Policy including any relevant Master Indemnity Agreement may continue until they expire. When a new piece of equipment is to be supplied, then a new Form B will be required in accordance with the provisions of this Policy. 6.0 EQUIPMENT LOANED BY THE TRUST TO OTHER HEALTHCARE PROVIDERS Trust staff arranging the loan of medical or other equipment to another Trust or other Healthcare Providers must ensure that the Loan of Equipment to Other Healthcare Providers Form (Appendix D) is completed by both parties and retained in loaning department. Also, that the equipment is safe and in full working order before hand over. Records must be kept of any equipment loaned, to whom loaned, dates of loan and return etc. these must be retained for at least five years. Returned equipment must be checked again before use within the Trust. The necessary training needs in the use of the equipment shall be brought to the attention of the borrowing healthcare body who shall thereafter assume all liability in respect of such training needs. The Loan of Equipment Form will not be required where the loan is the subject of a separate Form of Agreement. This will normally only apply where hire charges are levied. (For further advice see Clause 14.0). For equipment loans to patients where title is held by a third party refer to Clause EQUIPMENT LOANED TO PATIENTS 7.1 For equipment loans to patients, an Equipment Loan Agreement should be completed. Before loaning equipment to patients, it must be checked for full operational and electrical safety and a record of such must be retained. Returned equipment shall be checked, cleaned and decontamined before use again within the Trust or use by another patient. An example Indemnity is given at Appendix E, but generally this will need to be tailored for each specific requirement. (See Clause 14.0 further advice). For small items of equipment of minimum value, and in exceptional circumstances, further advice may be sought to determine whether the Equipment Loan Agreement may be waived. MGE/NA/loanofequipmentpolicy-update 9

10 7.2 Trust staff arranging the loan of equipment to a patient shall ensure that the patient is trained to use the equipment and can confirm its correct operation. The patient should be asked to sign a form to say they have been trained, and are confident they can use it competently. Staff should also provide clear written instructions on the use of the device. These would normally be as supplied by the equipment manufacturer. The patient should be instructed to stop using the equipment and arrange for its return to the Hospital if they suspect a malfunction. A contact name and number at UHL must be given in the Loan Agreement. 7.3 Where the patient is unable to sign the Agreement or operate the equipment and these tasks have been delegated to a carer, the carer shall assume the duties of the patient under the terms of this Clause In the event a patient fails to comply with the terms of an indemnity, further advice shall be sought (see Clause 13.0) before any action is contemplated. 8.0 DONATIONS OF EQUIPMENT BY THE TRUST 8.1 For the purposes of this Clause, a donation shall be where title in the goods is transferred to a third party without any charge or fee being levied. 8.2 Section 11 of the National Health and Community Care Act 1990 provides that the trustees of an NHS Trust have the power to accept, hold and administer any property for its own purposes. The Act provides sufficient power for the Trust to undertake the donation of equipment. 8.3 No capital equipment shall be donated where there is a residual value in the equipment as trade-in when purchasing new or replacement equipment or if offered for sale in the market place. No capital equipment shall be declared as having no residual value without first seeking approval and agreement from the Directorate of Finance. 8.4 For all donations, the Trust shall obtain an indemnity (see Appendix F) to exclude liability for the use or condition of the equipment. In compliance with the Unfair Contract Terms Act 1977, and the Consumer Protection Act 1987 the Indemnity does not extend to include death or personal injury. All equipment to be donated shall therefore be inspected to ensure it is in safe working order. Electrical equipment shall be fully tested immediately prior to donation the records of which shall be retained for a minimum of 6 years. MGE/NA/loanofequipmentpolicy-update 10

11 8.5 Whilst the Trust encourages the donation of equipment where appropriate (generally but not exclusively to third world countries) no equipment shall be donated without first being assessed with regard to any potential risk arising from the donation. Specific attention shall be given to electrical equipment directly involved in the healthcare of patients. Generally, electrical equipment shall only be donated following a full and detailed risk assessment and where any failure of the equipment is unlikely to have any adverse healthcare risks for patients. The cost of undertaking such an assessment must be considered and it may be determined that the costs are sufficiently prohibitive as to prevent the donation proceeding. Alternatively, consideration may also be given to seeking reimbursement of the assessment costs from the recipient prior to the donation proceeding. 8.6 The Directorate of Corporate and Legal Affairs shall investigate the credentials and approve the identity of any potential recipients of donated equipment prior to the donation being made. Generally but not exclusively, donations will only be made to registered charities or direct to the end users. Direct donations to private individuals acting as an intermediary should at all times be avoided. 8.7 The provisions of this Clause 8.0 shall not extend to include drugs or drug products which shall not be donated under any circumstances, and nor shall it include consumables except, in the case of consumables, in those circumstances where it can be demonstrated that no deterioration or loss of sterility has occurred. 8.8 All proposals for the donation of equipment shall be submitted to the Assistant Director of Corporate and Legal Affairs (Administration) who shall oversee the management of the proposal to ensure compliance with the provisions of this Clause When donating equipment, all instruction books, maintenance manuals, logbooks and any other relevant information including details of alterations or modifications should be passed to the recipient. 9.0 EQUIPMENT LOANS TO PATIENTS WHERE EQUIPMENT IS OWNED BY THIRD PARTIES The Trust often facilitates the loan of equipment to patients where title in the equipment lies with third parties (eg, Red Cross, British Heart Foundation etc). In these circumstances, the following shall apply:- MGE/NA/loanofequipmentpolicy-update 11

12 9.1 Where the Trust provides storage for the equipment the Trust will assume liability for any loss and/or damage to the equipment unless any agreement or undertaking with the third party provides otherwise. 9.2 Where the Trust assumes liability for equipment held in storage by the Trust it shall be the responsibility of the directorate/department to ensure that safe and secure arrangements are made. 9.3 Where the Trust collects the equipment from the third party for delivery to patients the third party shall be provided with details of the equipment provided, the patients name and address and the period of loan. 9.4 The third party shall assume full liability for the equipment during the period of loan. If the Trust is advised of any loss the third party shall be immediately notified of such loss or damage. 9.5 For long term loans any maintenance of the equipment that may be required from time to time shall be organised between the patient and the third party. The Trust shall advise the patient at the commencement of the loan of the procedures for effecting and carrying out such maintenance. 9.6 Wherever appropriate the Trust shall provide the patient and/or the patient s carer with all necessary training in the use of such equipment. 9.7 It is recognized that staff often undertake to transport such equipment in their own vehicles on behalf of the Trust. In these circumstances, the provisions of Clause 10.4 below shall apply. In all other circumstances, clauses 10.1, 10.2, and 10.3 shall apply TRANSPORT OF EQUIPMENT 10.1 Equipment on loan to the Trust must not be transferred from the Hospital Site which received the equipment to another site within the Trust, without first ensuring (1) it is within the agreement of the Supplier to do so, (2) adequate and suitable means of transport are arranged which meet with the Trusts insurance/indemnity arrangements where applicable Persons arranging the transport of equipment on loan must ensure that there is adequate insurance cover or indemnity arrangements in place for damage to the equipment in transit and any other losses arising from malfunctions caused by the move. Equipment, which has been subjected to abnormal stresses during transport, should be tested by the local Medical Physics relevant local technical services department, or Biomedical Engineering Department before being put into use. MGE/NA/loanofequipmentpolicy-update 12

13 10.3 Details of existing Trust insurance indemnity arrangements cover may be checked with the Directorate of Corporate and Legal Affairs Where a staff member undertakes to transport equipment in a private vehicle on behalf of the Trust, the staff member shall ensure that adequate comprehensive cover is in place and that the staff members insurers have been informed of this extension of the vehicles use. The staff member shall also assume responsibility to ensure that any goods or equipment transported is loaded into their vehicle in a safe and appropriate manner. The staff members shall assist the Trust in pursuing any claims arising in respect of any damage or loss of the equipment whilst being so transported to ensure they are dealt with in an appropriate and timely manner by the staff members insurers INSPECTION AND TESTING OF EQUIPMENT 11.1 Suppliers of equipment on loan (whether for a fee or free issue) must provide evidence that the equipment meets the essential requirements of the relevant EC directives (eg C.E Marking etc). This may be in the form of a standard declaration of conformity. It is recommended that medical equipment entering the Trust on loan is inspected and tested by the local Medical Physics Servicing workshop or relevant local technical department. Technical staff can then ensure that the equipment meets technical requirements, agreements are in place and records kept. The equipment will also be labelled as loan equipment. Prior notice to the local servicing workshop will facilitate this process. IT equipment on loan should be referred to the local Computer Services Department. Other non-medical equipment on loan should be referred to the local Estates Department for inspection and testing Medical and other equipment delivered to the Receipt and Distribution Points of the respective hospitals will be sent to the Medical Physics or Estates Departments automatically. Managers must ensure that items delivered directly to clinical areas are tested by Medical Physics (LRI and GH) Medical Service Centre (LGH),and/or Estates staff before use. Labels will be attached to all items that have been through this process to indicate maintenance arrangements and the inventory number For equipment that generates ionising radiation, it is the duty of the installer to carry out a critical examination of the radiation safety MGE/NA/loanofequipmentpolicy-update 13

14 features of the equipment in accordance with the Ionising Radiation Regulations The Medical Physics Department will carry out acceptance tests on behalf of the Trust. A prior risk assessment must be carried out either by the provider or the Trust before the use of laser or X-Ray equipment. This risk assessment should be authorised and approved by the Radiation Protection Adviser and a manager from the department in which the equipment is to be used. For further advice on radiation safety, users should contact the Radiation Protection Adviser in the Medical Physics Department at LRI Any member of staff, including but not limited to managers, clinicians, medical and nursing staff, who allow the use of medical or other equipment and has not yet followed these procedures may be made personally liable in the event of an accident or untoward event involving that equipment AMENDMENTS TO INDEMNITIES AND ALTERNATIVE INDEMNITIES No indemnities or agreements (see Appendices A to F) shall be amended, waived or replaced without the express agreement of the Directorate of Corporate and Legal Affairs which shall, wherever appropriate, seek further legal advice COMPLETION OF INDEMNITIES Where standard unamended indemnities are offered, these may be signed on behalf of the Trust by senior authorised staff. Proposals for authorised signatories shall be identified by the relevant Directorates/Departments and submitted to the Director of Corporate and Legal Affairs for approval. However, where any amendments to the standard Forms are under consideration, these must be passed back to the Assistant Director of Corporate and Legal Affairs (Admin.) for agreement and execution TRAINING No equipment should be received by the Trust unless staff are adequately trained for its use or unless suitable arrangements are in place to train staff before it is put to use FURTHER ADVICE For further advice, contact the Assistant Directorate of Corporate and Legal Affairs (Administration) on extension Further information may also be obtained from: For Medical Equipment: MGE/NA/loanofequipmentpolicy-update 14

15 LRI: Medical Physics Department, Ext 5607 LGH: Medical Physics Department, Ext 4359 Glenfield: Medical Physics Department, Ext 3511 For IT Equipment: Facilities: All Sites: Assistant Director of IM&T, Ext 3957 LRI: Facilities Helpline, Ext 5343 LGH: Facilities, Helpline, Ext 4990 Glenfield: Facilities, Helpline, Ext 3939 Manual Handling: Manual Handling Co-ordinator Ext 3079 Control of Infection LRI: Ext: 5661 LGH: Ext: 4456 Glenfield: Ext: 3573 MGE/NA/LOANOFEQUIPMENTPOLICY December 2005 MGE/NA/loanofequipmentpolicy-update 15

16 Appendix A NHS Form of Indemnity A Reference Number [ ] Equipment on loan EITHER* NHS Trust/NHS Foundation Trust/Health Authority OR NHS Purchasing and Supply Agency... A DEED made the. day of...200_ BETWEEN EITHER*. ( the Authority ); OR NHS Purchasing and Supply Agency. ( PASA ); and ( the Supplier )... WHEREAS The Supplier is the owner of equipment (the Equipment ) and wishes to make the Equipment available directly to the Authority or through PASA to NHS Trusts, NHS Foundation Trusts, Health Authorities and other users ( Users ) agreed by the parties for a specified period in accordance with the terms of this Deed. The Equipment and the period for which the Equipment will be on loan to the Authority or the relevant User(s) shall be specified in either an NHS delivery note or, where this Deed acts as a master indemnity agreement for all loans made by the Supplier, a Supplier standard delivery note, in each case completed by the Supplier and the Authority or the relevant User(s) at the outset of the loan (a Delivery Note ). For the avoidance of doubt, there shall be no limit on the number of Delivery Notes which may be completed pursuant to this Deed. Equipment shall be deemed to include any part or parts of the Equipment and all replacements and additions supplied by the Supplier during the continuance of this Deed. IT IS HEREBY AGREED that the Supplier shall make the Equipment available to the Authority or the relevant User(s) by way of loan free of charge for the period agreed between the Authority or the relevant User(s) and the Supplier, at the premises ( the Premises ) specified in the relevant Delivery Note on the terms set out in this Deed:- 1.- For the avoidance of doubt, this Deed is not a contract for hire pursuant to the Supply of Goods and Services Act MGE/NA/loanofequipmentpolicy-update 16

17 2.- Title to the Equipment shall remain for all purposes fully vested in the Supplier. 3.- The Equipment (other than Equipment which the Authority or relevant User(s) has taken on loan for the purposes of trial or evaluation at the request of the Supplier) shall at all times after its delivery to the Authority or the relevant User(s) be at the sole risk of the Authority or relevant User(s) as regards damage, loss or destruction. The Authority or the relevant User(s) shall be liable for the repair or replacement of any such Equipment which is damaged, destroyed or lost whilst in its possession or control. 4.- Subject to Clause 5, Equipment which the Authority or relevant User(s) has taken on loan for the purposes of trial or evaluation at the request of the Supplier shall at all times after its delivery to the Authority or the relevant User(s) be at the sole risk of the Supplier as regards damage, loss or destruction and neither the Authority nor the relevant User(s) shall be under any obligation to keep the Equipment insured. For all pieces of Equipment on loan to the Authority at any one time the Supplier shall keep a record of the purpose of the loan and, when requested by the Authority upon reasonable notice, communicate the purpose of the loan to the Authority within a reasonable time. 5.- The Authority or the relevant User(s), as the case may be, shall be liable for the repair of: 5.1 any damage to the Equipment occurring at the Premises (or during transit in the event that the Authority or relevant User collects the Equipment pursuant to Clause 6) and caused by the Authority or the relevant User(s) failing to use or operate such Equipment in accordance with the express instructions of the Supplier; and 5.2 any damage to the Equipment occurring at the Premises (or during transit in the event that the Authority or relevant User collects the Equipment pursuant to Clause 6) and caused by the act or omission of the Authority or the relevant User(s) their employees, agents or contractors or any third party beyond reasonable control of the Supplier. 6.- The Supplier shall use its reasonable endeavours to deliver the Equipment to the Premises on a date agreed between the Supplier and the Authority or the relevant User(s). Except where carried out solely by the Authority or the relevant User(s), delivery shall be effected by the Supplier delivering the Equipment to the Premises or (if otherwise agreed) by the Authority or the relevant User(s) collecting the Equipment from the Supplier s premises or any other premises agreed by the parties. Unless otherwise agreed, the Authority or relevant User(s) shall be responsible for installation of the Equipment at the Premises such that it is in working order for use by the Authority or the relevant User(s). The Authority s responsibility shall also extend to any and all costs and damage caused by or arising out of the failure to correctly install the Equipment, provided always that it is the Authority which has installed the Equipment. For the avoidance of doubt, should the Supplier be responsible for installing the Equipment, the Authority shall have no responsibility to meet any costs and damage caused as a result of the installation. MGE/NA/loanofequipmentpolicy-update 17

18 7.1 Subject to Clauses 7.2 and 7.3 below, the Supplier shall indemnify and hold harmless the Authority, the relevant User(s) and the Secretary of State for Health against all losses suffered by the Authority, the relevant User(s) or the Secretary of State for Health: (i) or in connection with any defect in the design or manufacture of the Equipment; (ii) arising directly as a result of the provision by the Supplier of negligent training or instruction in the use, or preparation for use, of the Equipment to the Authority, the relevant User(s) or the Secretary of State for Health 7.2 The Supplier shall not be liable for any loss suffered by the Authority, the relevant User(s) or the Secretary of State for Health to the extent that such loss was caused by the negligent acts or omissions of or breach of statutory duty by the Authority, the relevant User(s) or the Secretary of State, save where such acts, omissions or breaches were occasioned as a result of following the instructions of the Supplier or the Supplier's agents, employees or contractors. For the avoidance of doubt, but without prejudice to the generality of the foregoing, the following circumstances shall amount to negligent acts: (i) a failure to use or operate the Equipment in accordance with the operating instructions and other relevant information of which the Authority or relevant User(s) has been made expressly aware by the Supplier; including failure to observe requirements for the safe disposal or reprocessing of the Equipment; (ii) a failure by the Authority or relevant User(s) to ensure that the Equipment is operated by persons who have been made aware of the method of operation in accordance with Clause 9; and (iii) use of the Equipment for a use or in a manner for which it was not intended. 7.3 (i) The Supplier shall be liable for physical damage to the Premises resulting from its negligence up to a maximum of five million pounds ( 5,000,000.00) (in respect of any one event or series of connected events). (ii) Nothing in this Deed shall exclude or limit the Supplier's liability for death or personal injury caused by its negligence or any liability the Supplier may have pursuant to the Consumer Protection Act 1987 to a person who has suffered damage caused by defective Equipment. (iii) The Supplier shall not be liable for any loss of profit, income, business, revenue or goodwill or any indirect or consequential losses. (iv) Without prejudice to Clauses 7.3(i) and 7.3(ii) above, the Supplier's maximum aggregate liability arising in connection with (a) any defect in the design or manufacture of the Equipment or (b) the provision of negligent training or instruction in the use of, or preparation for use, of the Equipment, whether arising in contract, tort (including negligence) or otherwise, shall in no circumstances exceed five million pounds ( 5,000,000.00) (in respect of any single event or series of connected events). MGE/NA/loanofequipmentpolicy-update 18

19 7.4 The Supplier does not accept and hereby excludes, any liability for negligence save as provided in this Clause The Supplier shall take out and maintain insurance cover with an insurer reasonably acceptable to the Authority or the relevant User(s) on terms sufficient to cover its liability to the Authority or the relevant User(s) and the Secretary of State for Health under this Deed and in any event with a minimum indemnity cover of 5 million in any year (or such other amount as may be agreed by the Authority or the relevant User(s) in writing). On request the Supplier shall provide documentary evidence of such insurance cover to the Authority or the relevant User(s). If at any time the Supplier shall default in its obligations to insure as aforesaid then the Authority or the relevant User(s) shall hereby be irrevocably appointed by the Supplier as the Supplier s agent to effect such insurance cover as the Supplier would have taken out and maintained and accordingly the Authority or the relevant User(s) shall recharge to the Supplier (who hereby undertakes to make payment to the Authority or the relevant User(s) promptly on demand) the full cost of effecting such insurance cover together with such sum as shall cover all costs reasonable incurred by the Authority or the relevant User(s) in effecting such insurance provided that such sum shall not exceed an amount equivalent to five per cent (5%) of the cost of the policy effected. 9.- The Supplier shall provide to the Authority or the relevant User(s) instructions for use relating to the Equipment and detailed instructional manuals (where available) for the intended purpose stated by the Supplier, including any information and documents required by the Control of Substances Hazardous to Health Regulations The instruction manual shall accompany the Equipment and shall be in the English language and contain appropriate directions as to the operation of the Equipment. The Supplier shall provide a telephone number to the Authority which telephone line shall be manned during normal working hours by those of the Supplier s staff who are trained and qualified to deal properly with any enquiries the Authority or the relevant User(s) may have in relation to the operation of the Equipment. The Authority or the relevant User(s) will notify Supplier promptly of any fault or safety issue arising with or damage to the Equipment and will use its reasonable endeavours to ensure that the Equipment is not used until such fault or damage has been repaired or the safety issue resolved Where appropriate, the Supplier warrants and represents that the Equipment complies with the Essential Requirements of the Medical Devices Directive (93/42) and is CE marked. The Supplier further warrants that the Equipment is fit for the intended purpose for which the Equipment is supplied The Supplier and the Authority or the relevant User(s) shall complete and sign a Delivery Note in relation to each item of Equipment to be covered by this Deed This Deed shall continue in force from the date hereof until it is terminated by either party in accordance with this clause. For the avoidance of doubt, the parties obligations under this Deed shall apply only to Equipment which is in the possession of the Authority or the relevant User(s) from time to time and shall not apply to Equipment which has been returned to the Supplier in accordance with MGE/NA/loanofequipmentpolicy-update 19

20 Clause 16. This Deed will terminate if either party serves on the other party not less than 3 months written notice to expire at any time Upon termination of this Deed for whatever reason the Authority or the relevant User(s) shall forthwith provide the Supplier with written particulars of any contamination or other hazard including any safety hazard that has arisen in respect of the Equipment during the period in which the Equipment was on loan to the Authority or the relevant User(s) sufficient to facilitate compliance by the Supplier with statutory and other reasonable requirements to make safe the Equipment, the contamination and any other hazard so that it may be maintained, repaired, removed, transported or otherwise dealt with by the Supplier as may be appropriate provided that the Authority or the relevant User(s) shall accept no liability whatsoever for any failure by the Supplier to make safe the Equipment or to deal with any contamination or other hazard in accordance with any statutory or other requirements whether or not such failure has arisen out of or is connected with any written particulars provided by the Authority or the relevant User(s) under this condition, except that the Authority or the relevant User(s) shall be responsible for any and all costs where Equipment is returned to the Supplier with insufficient or incorrect information of a hazard or contamination. If such contamination or other hazard has resulted from the failure of the Authority or the relevant User(s), their servants or agents to use the Equipment for the Supplier s intended purpose, the Authority or the relevant User(s) shall bear the reasonable cost of making safe the Equipment, the contamination and any other known hazard The Equipment shall not be modified or repaired by the Authority or the relevant User(s) without the prior written agreement of the Supplier Neither the Authority nor the relevant User(s) shall be liable for any charge for maintenance, repair, consumable materials or accessories required for the operation of the Equipment during the period in which the Equipment is on loan to the Authority or the relevant User(s) or for any carriage or installation charges except as provided in this Deed or by agreement and the issue of an official purchase order by the Authority or the relevant User(s) Upon receipt of a written request at any time from the Authority or the relevant User(s) or at the end of the loan period specified in the relevant Delivery Note, the Supplier shall remove the Equipment from the Premises with all practicable speed, free of charge, and at that time shall provide the Authority or the relevant User(s) with a receipt for the Equipment, and shall have the right to enter onto the Authority s or relevant User(s) premises to exercise such removal The Supplier shall provide the Authority or the relevant User(s) with reasonable written notice of the time at which it intends to remove the Equipment from the Premises in accordance with Clause The Supplier shall be solely responsible for the cost of making good and reinstating the Premises to the reasonable satisfaction of the Authority or the relevant User(s) following the removal of the Equipment provided always that if the Equipment is free-standing and not in any way attached to the fabric of the Premises then there shall be no obligation on the Supplier under this clause. MGE/NA/loanofequipmentpolicy-update 20

21 19.- Nothing in this Deed shall create any obligation on the Authority or the relevant User(s) to purchase or take on paid hire either during the period of this Deed or at any time thereafter any quantity of the Equipment and the Supplier acknowledges that it has not relied on any representation on behalf of the Authority or the relevant User(s) as to any future business between the Supplier and the Authority or the relevant User(s) (except that nothing in this clause shall exclude the Authority s liability for fraudulent misrepresentations) and the Supplier warrants that neither the Authority nor any relevant User(s) is under any obligation to the Supplier in connection with the Equipment (save as expressly set out herein) or future orders therefore Each party, and its employees and agents, shall at all times keep confidential and secret and shall not (without the prior written consent of the disclosing party) disclose to any person any information or other matters acquired by the receiving party in connection with this Deed save where required to comply with the requirements of any regulatory or other competent authority or as otherwise required by law Nothing in this Deed is intended to confer on any person any right to enforce any term of this Deed which that person would not have had but for the Contracts (Rights of Third Parties) Act The parties acknowledge that the provisions of this Clause 21 shall not affect any right or remedy which exists or is available, whether express or implied, apart from the Contracts (Rights of Third Parties) Act EXECUTED AND DELIVERED as a deed by for and on behalf of [ ] NHS TRUST/ ) NHS FOUNDARION TRUST/ ) HEALTH AUTHORITY OR ) NHS Purchasing and Supply Agency * ) acting by: MGE/NA/loanofequipmentpolicy-update 21

22 Director: ) Director/Secretary: ) EXECUTED AND DELIVERED as a DEED by, for and on behalf of [ ] ) acting by: Director: ) Director/Secretary: ) *Delete as appropriate (the form should be executed by the Authority OR by NHS PASA see Guidance Notes) APPENDIX B Form of Indemnity B Reference Number [ ] Free issues EITHER* NHS Trust/Health Authority OR MGE/NA/loanofequipmentpolicy-update 22

23 NHS Purchasing and Supply Agency.. A DEED made the.. day of.. 200_ BETWEEN EITHER * ("the Authority"); OR NHS Purchasing and Supply Agreement.. ('PASA); and ("the Supplier"). WHEREAS The Supplier is the owner of goods (the "Goods") and wishes to transfer the legal and equitable title in the Goods to the Authority or to NHS Trusts, Health Authorities and other users agreed with PASA ('Users) in accordance with the terms of this Deed. The Goods shall be specified in a NHS Delivery Note completed by the parties at the time of the transfer. For the avoidance of doubt, there shall be no limit on the number of NHS Delivery Notes which may be completed by the parties pursuant to this Deed. IT IS HEREBY AGREED that the Supplier shall transfer the legal and equitable title in the Goods to the Authority or the relevant User(s) free of charge on the terms set out below: 1. Sections 12 to 15 of the Sale of Goods Act 1979 (as amended) are to be implied into this Deed. 2. Clause 28 (Indemnity) and Clause 29 (Insurance) of the NHS Conditions of Contract for the Purchase of Goods (June 2002 edition) shall be incorporated into this Deed. EXECUTED AND DELIVERED as a deed by for and on behalf of [ ] NHS TRUST/HEALTH AUTHORITY OR NHS Purchasing and Supply Agency acting by:- ) ) ) ) Director: Director/Secretary: MGE/NA/loanofequipmentpolicy-update 23

24 EXECUTED AND DELIVERED as a deed by for and on behalf of [ ] acting by:- ) ) ) ) Director: Director/Secretary: ) ) * Delete as appropriate (the form should be executed by the Authority OR by NHS PASA see Guidance Notes) Appendix C UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST TRUST DELIVERY NOTE FOR USE WITH TRUST FORMS OF INDEMNITY A (EQUIPMENT ON LOAN) AND B (FREE ISSUE) Date day of Supplier.. MGE/NA/loanofequipmentpolicy-update 24

25 Form of Indemnity Reference Number. Authority ( Premises ). Site:.. Department:. This Trust Delivery Note is supplementary to the Trust Form of Indemnity with the reference number shown above. Model/Make Serial Number Value. Description. Purpose.. Form of Indemnity A The Supplier wishes to make the Equipment detailed above available to the Authority for the following period of time:- Period [ ] years and [ ] months commencing on [ ] day of the [ ] 200 [ ] The trial/testing to be undertaken by the Authority (if any) The Authority acknowledges receipt of the Equipment detailed above on the terms of the Form of Indemnity detailed above and this NHS Delivery Note:- SIGNED on behalf of the Authority.. The Supplier hereby loans the Equipment detailed above to the Authority on the terms of the Form of Indemnity detailed above and this Trust Delivery Note:- SIGNED on behalf of the Supplier. Form of Indemnity B MGE/NA/loanofequipmentpolicy-update 25

26 The Authority hereby receives the Goods detailed above from the Supplier on the terms of the Form of Indemnity detailed above and this Trust Delivery Note:- SIGNED on behalf of the Authority The Supplier hereby transfers the legal and equitable title to the Goods detailed above to the Authority as from the date hereof on the terms of the Form of Indemnity above and this NHS Delivery Note:- SIGNED on behalf of the Supplier.. APPENDIX D UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST MGE/NA/loanofequipmentpolicy-update 26

27 FORM OF AGREEMENT FOR THE LOAN OF EQUIPMENT TO OTHER HEALTH CARE PROVIDERS This agreement made the day of 200 Between University Hospitals of Leicester NHS Trust (the Trust ) and of in respect of (the Borrower) (address) (the equipment ) (give make, model, serial number wherever relevant) IT IS AGREED THAT: 1.0 The Trust who at all times shall retain ownership in the equipment shall loan the equipment to the Borrower free of charge. The Borrower shall be responsible for collection of the equipment from and delivery to the Trusts premises. 2.0 The period of loan shall commence on the date first mentioned above and shall continue until such time as the purpose for which the equipment is loaned ceases, or until such time as the equipment is recalled by the Trust, whichever is the earlier. The Borrower shall indemnify the Trust and be liable for the replacement cost of the equipment if the equipment is not returned within 14 days of any request to do so by the Trust. 3.0 Prior to or at commencement of the period of loan, the Trust shall reasonably satisfy itself that the Borrower is fully conversant with the operation and use of the equipment. 4.0 The Trust shall be liable for and shall indemnify the borrower against all liability arising from any failure of the equipment providing always that this indemnity shall not extend to liability arising or resulting from: negligence by the Borrower, or failure by the Borrower to observe the provisions of this agreement. MGE/NA/loanofequipmentpolicy-update 27

28 5.0 The Borrower shall be liable for and shall indemnity the Trust against all liability arising from any loss or damage to the equipment, howsoever caused, other than damage arising from or attributed to fair wear and tear. 6.0 The Trust shall, at no cost to the Borrower carry out such maintenance as may be required from time to time. The Borrower shall monitor the equipment and advise the Trust whenever maintenance becomes due and return the equipment to the Trust for maintenance purposes in compliance with any request by the Hospital to do so. 7.0 The Borrower shall retain possession of the equipment at all times during the period of loan and shall not permit its use by any third party. 8.0 The Borrower shall not modify or interfere with the equipment in any way without the express agreement of the Trust and shall notify the Trust of any defect or failure immediately such defect or failure becomes apparent by contacting: Department: Tel. No: Signature: (On behalf of the Trust) Name: Signature: (On behalf of the Trust) Name: APPENDIX E UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST MGE/NA/loanofequipmentpolicy-update 28

29 FORM OF AGREEMENT FOR THE LOAN OF EQUIPMENT BEYOND THE HOSPITAL PREMISES FOR THE PURPOSES OF CONTINUING HEALTH CARE This agreement made the day of 20 Between and of in respect of (the Hospital ) (the Patient ) (address) (the equipment ) IT IS AGREED THAT: 1.0 The Hospital who at all times shall retain ownership of the equipment shall loan the equipment to the Patient, without charge to the patient. The Patient shall be responsible for collection of the equipment from and delivery to the Hospital premises; in exceptional circumstances, alternative arrangements may be agreed at the Hospital s discretion. 2.0 The period of loan shall commence on the date of this agreement and shall continue until the patient no longer has a medical need for the equipment or until alternative equipment is available, or until the equipment is recalled by the Hospital, whichever is the earlier. The Patient shall be liable for the replacement cost of the equipment if the equipment is not returned within 14 days of any request to do so by the Hospital. 3.0 Before the loan commences, the Hospital shall fully instruct the Patient (or a third party where Clause 8 of this Agreement applies) in the preparation and use of the equipment. 4.0 The patient will be liable for any costs, including the cost of repairs which may arise from the patients failure to observe the conditions of this agreement, failure to comply with the instructions given by the Hospital on the operation and use of the equipment, or which arises from the Patient s own negligence. 5.0 The patient shall be liable for and shall reimburse the Hospital for any loss or damage to the equipment, other than damage arising from or attributed to fair wear and tear. 6.0 The Hospital shall (at no cost to the Patient) carry out any maintenance that may be required. The patient shall ensure that equipment is returned to the Hospital for maintenance purposes in compliance with any request MGE/NA/loanofequipmentpolicy-update 29