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Consignment Stock Policy and Procedures

Amendments Date Page(s) Comments Approved by

April All 2015 New Policy

Compiled by: Sylvia Lestrade

In Consultation with: Nicola Hutchison

Ratified by:

Date Ratified:

Date Issued: April 2015

Review Date: 3 years

Target Audience: All procurement and clinical staff involved with Consignment Stock

Impact Assessment Carried Out By:

Policy Owner: Associate Director of Procurement

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ASHFORD & ST. PETER’S HOSPITAL NHS FOUNDATION TRUST

CONSIGNMENT STOCK POLICY AND PROCEDURES

CONTENTS

1. INTRODUCTION

2. SCOPE

3. AIM

4. RESPONSIBILITY FOR CONSIGNMENT STOCKS

5. DEFINITIONS

6. WHEN AND WHEN NOT TO CONSIGN

7. LIABILITY FROM CONSIGNED PRODUCTS

8. INDEMNITY

9. CONSIGNMENT AGREEMENT FORM

10. REPLENISHING THE CONSIGNMENT

11. STORAGE, MANAGEMENT AND STOCKTAKING OF CONSIGNE D PRODUCTS

12. TERMINATION OF CONSIGNED AGREEMENTS

13. EQUALITY AND DIVERSITY

14. MONITORING COMPLIANCE

15. SUMMARY OF OBLIGATIONS OF THE PARTIES

16. PAYMENT TERMS

17. CONSIGNMENT STOCK AND STORAGE

18. TITLE AND RISK AND INSURANCE

19. APPENDICES

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APPENDICES Appendix 1 - EQUALITY IMPACT ASSESSMENT An Equality Impact Assessment must be carried out for every policy document, referenced in the main body of the document and included as an appendix. Appendix 2 – POLICIES, PROCEDURES AND GUIDELINES

REVIEW COMMUNICATION FORM Appendix 3 PROFORMA FOR RATIFICATION OF POLICIES

PROCEDURES AND GUIDELINES BY RATIFYING COMMITTEE

Appendix 4 CONSIGNMENT STOCK AGREEMENT Appendix 5 LIST OF CONSIGNMENT PRODUCTS Appendix 6 CHANGE IN AGREEMENT FORM Appendix 7 LIST OF AMENDED/REPLACED CONSIGNMENT

PRODUCTS Appendix 8 LOG OF USED CONSIGNMENT STOCK Appendix 9 CONSIGNMENT TERMINATION AGREEMENT

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1. Introduction This policy covers the procedures to be followed when products are obtained by the Trust from a Supplier on the basis of a Consignment arrangement. This policy is for the Consignment of Clinical Consumables, Devices and Surgical Instruments from Suppliers and will be circulated to Directorate Managers, line managers who utilise Consignment agreements, and will be disseminated via the Theatre User Group/internal departmental staff inductions, and published on the Trust’s Intranet. In addition to providing information to health care providers to improve patient care, Supplier representatives promote and sell their products. If this is not carried out ethically and contravenes Trust, NHS, or Government policies, representatives may be barred from the Trust site and/or reported to company/commercial/professional organisations if codes of practice are breached. Suppliers must not attempt to influence business decision making by offering hospitality to Trust staff; the frequency and scale of hospitality accepted will be managed openly by the Trust. 2. Scope

When products are obtained by the Trust from a Supplier on the basis of a Consignment arrangement, ownership of the products remains with the Supplier. The Trust is obliged to keep the products in a safe and secure environment, to replace any goods it consumes from the Consignment and to return the Consignment in its entirety when the Consignment arrangement ends. Products typically acquired on a Consignment basis include: surgical implants, surgical instruments, interventional and diagnostic devices and implantable devices, e.g. breast implants, hips and knees replacement, lens and stents, implantable cardiac devices (pacemakers and defibrillators), and electrophysiology consumables. The acquisition of products on a Consignment basis can be sensible, prudent and risk-mitigating when well-managed; and care must be taken to ensure that staff are not ill-advised if Consignment is introduced solely for the benefit of the Supplier; or that the Consignments are poorly managed.

Use of Consignment goods enables the availability of stock that may be rarely used and minimises risks of obsolescence, and would not be financially viable to stock permanently within the Trust. Consignment goods can also avoid associated next-day delivery costs for goods needed in an emergency situation. Goods can be returned to the Supplier free of charge when they are deemed no longer necessary to the Trust. 3. Aim

The aim of this policy is to ensure that for any products consigned to the Trust by Suppliers, such arrangements are put in place only when it’s appropriate, that appropriate records are maintained, that product liability is clearly documented, that the ownership of products is clear and differentiated from conventionally procured Trust-owned products, and that responsibility and accountability for the management of consigned products are defined and understood.

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4. Responsibility for Consignment Stocks The responsibility for entering into any Consignment agreement lies with the Associate Director of Procurement (ADoP). The responsibility for fulfilling the Trust’s obligations arising from such an agreement, for managing the consigned products, and for funding the replenishment of the Consignment resides with the Divisional Directorate. The formal Consignment agreement with the Supplier should be signed on behalf of the Trust by the (ADoP) or nominated deputies (typically senior managers from the Supplies and Procurement department); and the ADoP should ensure that appropriate arrangements are in place to manage the Consignment. The ADoP must approve all Consignment agreements at the earliest opportunity and before final signature between both parties. Responsibility for security and associated audit trail for Consignment goods remains within the department where it is to be used.

5. Definitions

5.1 "Consignment Products" means those products belonging to the Supplier and/or its affiliates specified in the Consignment Stock Agreement (CSA).

5.2 "Consignment Stock" means the stock of the Consignment Products held by the Trust at the Facility on a Consignment basis.

5.3 "Facility" means such storage and/or warehousing facility of the Trust as the Trust shall specify to the Supplier for the receipt and storage of the Consignment Stock. 5.4 “Replenishment” means the process by which the Trust will order and pay for replacements of Consignment Products it has consumed from the Consignment Stock.

6. When and when not to Consign

Reasons to support the Consignment of products include:

6.1 To avoid the risk of obsolescence, for example:

• to ensure the availability of the required single-use sterile products used in a

procedure where a wide range of types and sizes are available for use, but typical usage will be from a narrower “core” range. Consequently, there is a risk that products at the extremes of the type/size range, whilst stocked in case they are needed, may not be used and may then go beyond their use-by date. If the Trust owns such stock, it will assume the risk of obsolescence. If the stock is consigned then the Supplier will assume this risk (subject to the Consignment agreement being clear on this point – see clauses 7 and 9)

• it may be that a particular range of products is used by only one or two

operators; were the stock to be owned by the Trust and these operators leave the Trust, then the risk of obsolescence will be met by the Trust. If the stock is consigned, then it can be returned to the Supplier when no longer required at no risk to the Trust.

6.2 To avoid significant and unnecessary financial investment in stock

and/or instrumentation, for example:

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• where a wide range of types and sizes of single-use sterile consumable

products are required to enable selection of the correct type/size for a particular patient procedure then the necessary financial investment in stock can be disproportionate to the expenditure on products used in such procedures. Taking Consignment stock can mitigate this requirement with the Trust paying only for products actually used.

• where a wide range of types and sizes of non-sterile consumable products are

required to enable selection of the correct type/size for a particular patient procedure, then the necessary financial investment in stock can be disproportionate to the expenditure on products used in such procedures; taking Consignment stock can mitigate this requirement with the Trust paying only for products actually used.

• where, in order to use a particular consumable product, specific associated

instruments are required, again with significant financial investment, Suppliers may agree to consign instrumentation to enable the Trust to use their products.

• where expensive next-day deliveries to support emergency procedures can

be avoided by holding Consignment stock of products and instrumentation.

6.3 Reasons to question the Consignment of products include: 6.3.1 When the benefit arising from the Consignment is more for the Supplier than for the Trust, for example:

• a Supplier’s motive in offering Consignment of products will generally be to ensure that their product is readily available on stockroom shelves and therefore more likely to be used. If the Trust will not benefit reasonably via the supporting reasons outlined above then the Consignment arrangement should not be pursued.

6.3.2 When the cost of replenishing the Consignment is punitive by comparison with replacing Trust-owned stock, for example:

• a Supplier may apply differential pricing for replenishing Consignment stocks by comparison with replacing Trust-owned stock – this might be by not providing a level of discount otherwise offered or by charging higher prices. Where any additional cost outweighs any risk-mitigating and financial benefit to the Trust then the Consignment arrangement should not be pursued.

6.3.3 When the Supplier providing the consigned product is not prepared to provide quantities of products to support the activity levels of the Divisional Directorate, for example:

• a Supplier may wish to restrict the quantities of each product in the consigned

stock to an unacceptable level which will require the Divisional Directorate to supplement the consigned stock of an individual product with Trust-owned stock of the same product. This is highly likely to lead to confusion over ownership of and liability for consigned and Trust-owned product and therefore, in such circumstances the proposed Consignment arrangement should be declined.

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6.4 The decision as to where and when not to consign lies with the Divisional Directorate or their nominated deputy, and will involve a balance between supporting the requirements of the Divisional Directorate and questioning reasons outlined above. If in doubt, advice can be sought from the ADoP and relevant Supplies staff. 7. Liability for Consigned Products

The liabilities in respect of the consigned products are defined in the Trust Consignment Stock Agreement (CSA) (Schedule 4) and key points are as follows:

7.1 The Trust will be liable for any physical loss or damage to products whilst held on their premises, hence the requirement for safe and secure storage. The remedying of any financial loss will be met by the Divisional Directorate’s budget, by means of completing a requisition and sending to the Supplies Department in order that a replacement can be ordered for the loss or damaged product. Any such loss over two and a half thousand pounds (£2,500) (whether separated or amalgamated) should be reported to the Finance Directorate for inclusion in the Trust’s Losses and Compensation Register. 7.2 The Trust will accept responsibility for maintaining the documentation log of Consignment goods both held, and used throughout the agreement period. Raising a purchase order for payment of Consignment goods will occur following implantation/use of Consignment equipment.

7.3 The Trust will be liable for replacing any consigned product it has consumed, maintaining the product types and quantities detailed in the Consignment Stock Register. Replenishment of consumed items should be arranged by way of a requisition and purchase order. If different goods are to be returned to the department upon mutual agreement, a ‘Change in Consignment Agreement Form’ (Appendix 6) must be entered into.

7.4 The Supplier will be liable for any loss arising from products going beyond their “use-by” or “expiry” dates and will replace any such products at no charge to the Trust, maintaining the product types and quantities detailed in the Consignment Stock Register. To enable the Supplier to meet this obligation, the Trust will provide the Supplier with accompanied access to their consigned stock but only by prior arrangement.

7.5 Representatives should respect their position as a visitor to the Trust and comply with the Trust’s security regulations in line with the Trust’s ‘Visitor’ Policy. They may not enter any clinical or non-clinical areas or visit any member of staff without a prior appointment. A representative arriving for an appointment must be met by their host.

Where previous Consignment agreements other than the Trust CSA have been entered into prior to the implementation of this policy, the Divisional Directorate should ensure that the key points detailed above are consistent, particularly with respect to Supplier liabilities. If not, then wherever possible the agreement should be replaced with the Trust CSA. 8. Indemnity

There are two types of supply – one where the sale of goods involves a financial

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transaction between the parties and one where no financial transaction occurs. In the former, the Sale of Goods Act applies, but where no financial transaction is involved, the Sale of Goods Act does not apply and would not therefore provide indemnity for the Trust. In such situations, indemnity can be provided via a Master Indemnity Agreement (MIA) scheme managed by the Department of Health (DH) with which most reputable Suppliers are registered. Before entering in to a Consignment agreement, Directorates should check that the Supplier is registered with the DH MIA Scheme by enquiring via the following link: http://nhsmia.bipsolutions.com/ If the Supplier is not registered with the DH MIA scheme then, as a general rule, the Consignment stock arrangement should not be pursued. In exceptional circumstances, Supplier specific Indemnity Forms can be signed but in such circumstances, advice should be sought from the ADoP. Overall, it is worth remembering that the NHS terms and conditions of contract (August 2014) governs the CSA between both parties. 9. Consignment Agreement Form The Trust CSA, should be used for all Consignment arrangements, effective from the date of this policy. There is also a List of Consignment Products which includes a schedule listing the product types and quantities consigned. Where Consignment arrangements have been established prior to the effective date of this policy, and are based on a Supplier’s Consignment agreement, the Supplier’s agreement must be checked to ensure compliance with the key points identified in Section 7 (Liability for consigned products). If the agreement is not consistent on these key points, particularly in respect of Supplier liabilities, then wherever possible the agreement should be replaced with the Trust CSA. The following procedure should be adopted in relation to the Trust CSA: • The Divisional Director should ensure that appropriate measures are in place to

manage the Consignment. • The ADoP must approve all Consignment agreements. Where agreements are

made with the line manager due to urgency of required Consignment goods, the ADoP must approve all agreements at the department’s earliest opportunity. Where the ADoP does not approve a Consignment agreement continuing, after agreement with the Divisional Directorate, termination of the Consignment must occur before final signature between both parties.

• The formal Consignment agreement with the Supplier should be signed on

behalf of the Trust by one of the following persons: the Director of Finance and Information, ADoP, Divisional Manager, Departmental Manager or nominated deputy, and the Supplier.

• An original signed copy of the agreement and Consignment Register must be

held by the ADoP • An original signed copy of the agreement and schedule should be provided to

the Supplier. • A copy of the agreement and schedule should be sent to the Manager of the

department responsible for the Consignment goods.

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• If products are added to, or removed from the Consignment stock, a Change in Agreement Consignment Form should be completed together with an addendum to the product-listing schedule, and actioned in terms of signature and copying as the original agreement (Appendix 6).

• The receipt from the Supplier once goods are received should only be signed

after goods are examined for quantity, condition, and a storage location has been agreed with the Supplier and appropriate departmental manager.

10. Replenishing the Consignment

A log of used Consignment Goods should be completed as Consignment stock is used in order to track goods and maintain stock. This is located in Appendix 8 It is the Trust’s responsibility to replenish the Consignment when the product has been consumed. This should be effected by the Divisional Directorate raising a non-stock requisition form for the required products and submitting it to the Trust Supplies Department. The requisition content and format should be in all respects the same as for replenishment of Trust-owned product other than the annotating of the requisition “Replenishment of Consignment Stock”. In some circumstances (e.g. for implantable products), Suppliers may require the Trust to inform them of the batch, lot or serial numbers of consumed product(s) and in such circumstances this information should be provided on the requisition form for transcription onto the Trust’s official purchase order. 11. Storage, Management and Stocktaking of Consigne d Products

11.1 Consigned products should be stored in a safe and secure environment – the Trust is liable for any physical loss or damage to products whilst held on Trust premises. 11.2 Storage of Consignment goods should be clearly labelled, in an area that is secure, but separate from Trust-owned stock.

11.3 Whilst the Supplier will be responsible for replacing at no charge any consigned product which goes beyond its expiry date, products should be used in date order with the shortest expiry date product used first.

11.4 Consigned products should be stored in a way which enables them to be clearly differentiated from Trust-owned stock. Unless specifically agreed to by Suppliers, neither the products nor their packaging should be marked in any way to assist this differentiation – marking the product or packaging is likely to make it non-returnable to the Supplier.

11.5 The Supplier should be provided with access to the consigned stock for the

purposes of inspecting and recording quantities, quality and condition of the consigned products. This inspection will be undertaken, (preferably quarterly) and must be by appointment only, The Supplier must be accompanied by an appropriate member of staff. A written record of the inspection must be provided by the Supplier, signed by both parties, and a copy kept by both the Supplier and the Department. Any products beyond their expiry date should be replaced by the Supplier and any shortages, lost, or damaged products should be replaced by the Directorate by way of a requisition and official order. The loss should be recorded

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by the Directorate in the Trust’s Losses and Compensation Register maintained by the Finance Directorate where appropriate/necessary. Any discrepancies - in terms of quantity or condition, has a period of three months in order to be rectified. Any discrepancy (shortages or damage) advised by the Supplier more than 3 months following the inspection will be considered invalid; this point being confirmed in the Trust’s CSA.

11.6 In exceptional circumstances, the Supplier may be permitted to remove

consigned products for urgent supply to other healthcare providers. The line manager must be informed of any request to take Consignment goods and be present at their removal.

11.7 A record of any removal of Consignment goods must be signed by both the Supplier and the appropriate departmental manager (Appendix 6) and kept by the Supplier and Clinical Measurements/Theatres Department. In no circumstances should the Supplier be permitted to remove consigned instrumentation for supply to other healthcare providers.

11.8 When stocktaking, Divisional Directorates should omit consigned products from their stock count and stocktaking return.

12. Termination of Consignment Agreements

When a Consignment arrangement is no longer required and is terminated, it is important that accurate records are maintained confirming the return and removal of the consigned products. The stock should be replenished to the levels detailed in the Consignment Stock Register.

All goods should be set aside, clearly labelled, and in-line with quantities documented in the latest log signed by both the Supplier and the department (or nominated deputy).

A Consignment Termination Form should be completed (Appendix 9) and must be signed by the line manager or nominated deputy and Supplier prior to removal of the consigned product, and prior to being sent to the ADoP for final signatory. The original must be held by the Directorate with copies for the Supplier, Supplies and Procurement Department, and the Department.

The following procedure should be adopted in relation to the Consignment Termination Form:

• The form should be signed by the ADoP or senior managers from the Supplies and Procurement department, and the Supplier.

• An original signed copy of the form should be held by the AD0P. • An original signed copy of the form should be provided to the Supplier. • A copy of the form should be sent to relevant Directorate marked for the

attention of the Directorate Manager.

13. Equality and Diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way

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we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against any individuals or groups on any grounds. This document has been properly assessed. 14. Monitoring Compliance

A Trust wide record of all Consignment stock arrangements, current and terminated, will be held by the Trust Supplies Department by way of copies of all Consignment Agreement Forms and Consignment Termination Forms. Monitoring will be an ongoing activity by the Departmental Managers. Records of Consignment Agreement Forms, Change Forms, Stock Check Forms, and Termination Forms will be kept within the department as evidence.

DISSEMINATION AND IMPLEMENTATION The policy has been written by the Contracts Manager in co-ordination with the Cardiac Investigations Manager and Theatre Manager. It has been agreed by the Supplies and Procurement Department. The policy will be available on TrustNet with local copies within each department utilising Consignment stock for ease of access. All senior staff will be instructed on the importance of initiating and maintaining Consignment Goods during the departmental (local) staff induction. ARCHIVING All associated data will be held by the Clinical Governance Department. The Quality Department will hold current and previous copies of this policy.

Standard/process/ Monitoring and audit issue Method By Committee Frequency CSA All CSAs are ADoP, FD, At initiation of the

approved prior to Divisional agreement signature Managers, Change Control All Change Control Directorate At initiation of the

Requests are initiated Manager required changes approved and recorded by the Directorate Manager

(copied to the Supplier and ADoP)

Termination of CSA The termination Directorate At the termination

of a CSA is initiated, Manager of the agreement

approved and recorded by the ADoP (copied to the Supplier and

Directorate Manager)

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15. Summary of Obligations of the Parties

15.1 The Supplier shall supply the Trust, and the Trust shall hold on Consignment at the Facility those Consignment Products required by the Trust pursuant to the CSA.

15.2 As and when required for use by the Trust, the Trust shall physically pick and remove from the Facility each required Consignment Product. In doing so, the Trust shall draw upon the stock of Consignment Products on a first in/first out basis.

15.3 Within 14 days of the use by the Trust of a Consignment Product, the Trust shall raise a purchase order to replenish the Consignment Stock and the Supplier shall raise and issue to the Trust an invoice for the sale of such Consignment Product to the Trust.

15.4 All purchase orders for Consignment Products to replenish the Consignment Stock issued by the Trust shall at a minimum, include details of product type, product model, product catalogue number, quantity, price and purchase order number. 15.5 All orders for and deliveries of Consignment Products to replenish the Consignment Stock made pursuant to the CSA and each sale of Consignment Product by the Supplier to the Trust hereunder shall (save as superseded by the provisions of the CSA) be made on the NHS Terms and Conditions for the Supply of Goods (August 2014) and at the prices referenced in the Consignment Stock Register.

15.6 All deliveries of Consignment Products to replenish the Consignment Stock shall be made by the Supplier to the Facility and shall be tracked, registered and delivered to the Facility with the Supplier’s transport and documentation clearly stating the purchase order number for such products and referencing that such products are Consignment Products.

15.7 A Supplier representative, a Trust representative from the Supplies department and a representative from the management department holding the Consignment Stock will, by appointment, carry out regular stock checks to establish the following:

(a) that products which are out of date are removed and replaced by the Supplier

(b) that stock levels are adequate to provide for current usage

(c) that stock rotation is occurring (First In First Out)

16. Payment Terms

The Trust shall make payment in full for each purchase of Consignment Products to replenish the Consignment Stock within 30 days from the receipt of a valid invoice issued by Supplier. Payment shall be made by BACS to the Supplier. Suppliers should be aware that the prices offered for Consignment Stock

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replenishment must be similar to, or lower than framework agreement prices. The supplier must agree to transfer the lower price agreement to the Trust.

17. Consignment Stock and Storage

17.1 The Trust shall store the Consignment Products in a secure location at the Facility in accordance with all instructions provided by the Supplier and all storage conditions indicated on the packaging of the Consignment Products.

17.2 Following delivery of the Consignment Products by the Supplier to the Facility, the Consignment Products shall not be moved or removed from the Facility by the Trust other than for use in accordance with the provisions of Clause 2, for return to the Supplier pursuant to Clause 4 or 6.3, or with the prior written consent of the Supplier.

17.3 Following delivery of the Consignment Products by the Supplier to the Facility, the Consignment Products shall not be moved or removed from the Facility by the Supplier other than pursuant to Clause 4 or 6.3, or in exceptional circumstances where Consignment Products are removed by the Supplier for urgent use by another healthcare provider and replaced by the Supplier in due course. In such circumstances, a signed record shall be maintained by the Supplier and the Trust showing the date of removal and return. For the avoidance of doubt, such exceptional circumstances shall not apply to consigned surgical instrumentation.

17.4 The Trust shall handle and store the Consignment Products with all due care and skill so as to maintain them in perfect condition and shall protect the Consignment Products from any loss or damage.

17.5 The Trust will visibly demarcate the Consignment Stock as the property of the Supplier and keep the Consignment Stock separate from other goods kept in stock including other products purchased from the Supplier so that it shall be immediately clear that the Consignment Products are Consignment Stock and are the property of the Supplier.

17.6 The Parties agree that the Supplier and its authorised representatives shall be entitled at an agreed time (and in any event no less than every quarter) on the giving of reasonable notice, to inspect the Facility to audit and verify the contents, quantity, quality and condition of the Consignment Products provided in the Consignment Stock Register, and their conditions of storage. A written record showing Consignment Stock quantities, quality and condition at the time of inspection shall be made by the Supplier, signed by both parties with a copy provided to both parties. Any discrepancy between the quantities of Consignment Products counted and those detailed in the Consignment Stock Register, or in the quality or condition of any Consignment Product should be advised to the Trust by the Supplier immediately. Any discrepancy advised to the Trust by the Supplier more than 3 months following the inspection shall be considered invalid.

17.7 Following the inspection of the Consignment Products by the Parties, any Consignment Products which are no longer within their ‘use-by’ or ‘expiry’ date will be removed and replaced by the Supplier at no cost to the Trust. A record of Consignment Products removed for replacement will be prepared by the Supplier and signed by both Parties prior to removal and a similar record prepared by the Supplier and signed by the parties on receipt of the replacement Consignment Products.

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18. Title and Risk and Insurance 18.1 Title and ownership of the Consignment Stocks shall remain with the Supplier until payment in full for each specific Consignment Product has been received by the Supplier from the Trust, at which point title and ownership shall transfer to the Trust.

18.2 The risk of loss and damage to the Consignment Products shall remain with the Supplier until their delivery to the Facility. The Trust shall be responsible for any loss or damage caused to the Consignment Stocks following their delivery to the Facility.

18.3 The risk of loss to the Consignment Stock arising from Consignment Products exceeding their use-by or expiry dates shall in all circumstances remain with the Supplier.

18.4 The Trust shall insure the Consignment Stocks against loss or damage due to fire, flood, theft and other such risks via the NHS Litigation Authority Risk Pooling Scheme.

18.5 The Supplier will indemnify the Trust in respect of its liabilities in accordance with, and via its participation in the NHS Master Indemnity Agreement (MIA) scheme, see http://nhsmia.bipsolutions.com

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APPENDIX 1

Equality Impact Assessment Summary Name:

Policy/Service: Consignment Stock Policy and Procedures

• BackgroundDescription of the aims of the policy • Context in which the policy operates • Who was involved in the Equality Impact Assessment

Methodology

• A brief account of how the likely effects of the policy was assessed (to include race and ethnic origin, disability, gender, culture, religion or belief, sexual orientation, age)

• The data sources and any other information used • The consultation that was carried out (who, why and how?)

Key Findings

• Describe the results of the assessment

• Identify if there is adverse or a potentially adverse impacts for any equalities groups

Conclusion

• Provide a summary of the overall conclusions Recommendations

• State recommended changes to the proposed policy as a result of the impact assessment

• Where it has not been possible to amend the policy, provide the detail of any actions that have been identified

• Describe the plans for reviewing the assessment Guidance on Equalities Groups

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Race and Ethnic origin (includes gypsies and Religion or belief (include dress, individual travellers) (consider communication, access care needs, family relationships, dietary to information on services and employment, requirements and spiritual needs for and ease of access to services and consideration) employment)

Disability (consider communication issues, Sexual orientation including lesbian, gay and access to employment and services, bisexual people (consider whether the whether individual care needs are being met policy/service promotes a culture of and whether the policy promotes the openness and takes account of individual involvement of disabled people) needs

Gender (consider care needs and Age (consider any barriers to accessing employment issues, identify and remove or services or employment, identify and remove justify terms which are gender specific) or justify terms which could be ageist, for

example, using titles of senior or junior) Culture (consider dietary requirements, Social class (consider ability to access family relationships and individual care services and information, for example, is needs) information provided in plain English?)

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APPENDIX 2 Policies Procedures and Guidelines Review Communication Form

Policy title: Consignment Stock Policy and Procedures

Consultation start date:

Deadline for feedback:

Feedback to be provided to:

‘Before and after’ comparison of key changes:

Existing policy New proposed policy

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APPENDIX 3

PROFORMA FOR RATIFICATION OF POLICIES PROCEDURES and GUIDELINES BY RATIFYING COMMITTEE

Please complete this form electronically Include contact telephone numbers The boxes will expand as required Policy/Guidelines Name:

Name of Person completing form: Date:

Author(s) (Principle contact) Name of author or sponsor to attend ratifying committee when policy/guideline is discussed Date of final draft Has this policy/guideline been thoroughly proof-read to check for errors in spelling,

Yes No typing, grammar and consistency? (delete as necessary) By whom: Is this a new or revised policy/guideline?

New Revised (delete as necessary) Describe the development process used to generate this policy/guideline. Who was involved, which groups met, how often etc.? Who is the policy/guideline primarily for? Is this policy/guideline relevant across the Trust or in limited areas? How will the information be disseminated and how will you ensure that relevant staff are aware of this policy/guideline? Describe the process by which adherence to this policy/guideline will be monitored. (This needs to be explicit and documented for example audit, survey, questionnaire) Is there a NICE or other national guideline relevant to this topic? If so, which one and how does it relate to this policy/guideline?

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Has the policy been checked against minimum requirements for NHS LA Standards (if applicable) What (other) information sources have been used to produce this policy/guideline? Has the policy/guideline been impact assessed with regard to disability, race, gender, age, religion, sexual orientation? Other than the authors, which other groups or individuals have been given a draft for comment?(e.g. staff, unions, human resources, finance dept., external stakeholders and service users) Which groups or individuals submitted written or verbal comments on earlier drafts? Who considered those comments and to what extent have they been incorporated into the final draft? Have financial implications been considered? Proposed review date

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APPENDIX 4

CONSIGNMENT STOCK AGREEMENT The Supply of Consignment Products

TO ASHFORD AND ST PETERS HOSPITALS NHS FOUNDATION TRUST

Foundation Trust Reference:

This Consignment Stock Agreement is entered into

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On

The day of , 20

Between

(1) Ashford and St Peter's Hospitals NHS Foundation Trust (the Trust)

Of

London Road, ASHFORD, Middlesex, TW15 3AA

And also of

Guildford Road, CHERTSEY, Surrey, KT16 0PZ

And

(1) *****(the Supplier)

Of

********************************************

For The Delivery and Acceptance of Consigned Stock as s pecified in the attached schedules WHEREAS The Trust requires the Supplier to supply those products listed in the Consignment Register to the Trust on a Consignment Stock basis and on the terms and conditions set out in the Consignment Stock Agreement and NHS terms and conditions of contract for the supply of services (August 2014). Subsequent purchases relating to the ordering of goods is subject to NHS terms and conditions of contract for the purchase of goods (August 2014). THEREFORE THE PARTIES HEREBY AGREE AS FOLLOWS: 1 Definitions 1.1 "Consignment Products" means those products belonging to the Supplier and/or its affiliates specified in the Consignment Register to be supplied to the Trust pursuant to this Agreement and to be held by the Trust in the Consignment Stock.

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1.2 "Consignment Stock" means the stock of the Consignment Products held by the Trust at the Facility on a Consignment basis. 1.3 "Facility" means such storage and/or warehousing facility of the Trust as the Trust shall specify to Supplier for the receipt and storage of the Consignment Stock. 1.4 “Replenishment” means the process by which the Trust will order and pay for replacements of Consignment Products it has consumed from the Consignment Stock. Nature and Scope.

1. The Trust and the Supplier agrees that the Supplier delivers, and the Trust accepts Consigned Product, as defined herein, under the terms hereof and also in:

(a) Subsequent documented clarifications between the trust and the contractor after delivery of items

2. The contract price for the service is specified in the attached schedules. Payment of the contract price will be made in accordance with the schedules and this Agreement.

3. No variation should be made to the nature of this agreement other than agreed in writing between the parties, and in accordance with this agreement.

4. This Agreement shall begin on the date hereof and shall continue until

terminated. This Agreement may be terminated by either party by giving the other party not less than ninety (90) days’ prior written notice of termination.

5. In the event of termination, this Agreement shall remain in effect to govern the

disposition of any remaining Consigned Product.

6. This Agreement supersedes any previous Supplier Consignment agreement to

ensure compliance with the Trust Consignment Stock Policy

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SCHEDULE 1 - Consignment of Product

1. The Supplier shall deliver to the Trust at the designated locations, the quantities and qualities of products as required and identified (the Consigned Product) and the Trust shall accept such Consigned Product on Consignment according to the terms of this Consignment Agreement.

2. Upon title to Consigned Product, the Trust shall receive, hold and exercise reasonable care for such Consigned Product which shall remain the sole and exclusive property of Supplier. As and when required for use by the Trust, the Trust shall physically pick and remove from the Facility each required Consignment Product. In doing so, the Trust shall draw upon the stock of Consignment Products on a first in/first out basis.

3. Within 14 days of the use by the Trust of a Consignment Product, the Trust shall

raise a purchase order to replenish the Consignment Stock and the Supplier shall raise and issue to the Trust an invoice for the sale of such Consignment Product to the Trust.

4. All purchase orders for Consignment Products to replenish the Consignment

Stock issued by the Trust shall at a minimum include details of product type, product model, product catalogue number, quantity, price and purchase order number.

5. Any costs associated with the care of the Consigned Product, while in the

possession of the Trust, shall be borne by the Supplier.

6. All deliveries of Consignment Products to replenish the Consignment Stock shall

be made by the Supplier to the Facility and shall be tracked, registered and delivered to the Facility with the Supplier’s transport and documentation clearly stating the purchase order number for such products and referencing that such products are Consignment Products.

7. A Supplier representative, a Trust representative from the Supplies department,

and a representative from the department holding the Consignment Stock will by prior appointment carry out quarterly stock checks and inspection to establish the following: (a) that products which are out of date are removed and replaced by the Supplier (b) that stock levels are adequate and suitable to provide for current usage (c) that stock rotation is occurring (First In First Out) Discrepancies advised by the Supplier more than three months following the inspection will be considered invalid.

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8. The Supplier shall keep a record of any Consignment Product removed for replacement and this record will be signed by both parties prior to removal. A similar record will be prepared by the Supplier and also signed by both parties on receipt of the replacement Consignment Product.

9. The Supplier will be liable for any loss arising from products going beyond their “use-by” or “expiry” dates and will replace any such products at no charge to the Trust, maintaining the product types and quantities detailed in the Consignment Stock Register. To enable the Supplier to meet this obligation, the Trust will provide the Supplier with accompanied access to their consigned stock but only by prior arrangement .

10. All legal and equitable rights, title and interest to the Consigned Product shall remain with the Supplier until such Consigned Product are used by the Trust, at which time ownership shall immediately pass to the Trust.

SCHEDULE 2 – Payment for Consigned Product

1. Prices for Consigned Product shall be in accordance with Framework prices or as contractually agreed with the Supplier.

2. The Trust will not pay any additional charges for having the stock as a Consignment

3. The Trust shall release (within 30 days from the receipt of a valid invoice) payment to the Supplier upon release of a valid matched invoice, with the relevant purchase order number for the Consigned Product used by the Trust once an item has been used and replaced.

SCHEDULE 3 – Legal Compliance

1. The Supplier shall cooperate fully to effect compliance with any law, regulations and any departmental instructions governing the Consigned Product.

2. The Supplier shall ensure that its invoicing system reflects that the Consigned

Products are shipped and delivered to the Trust as a Consignment; not as a sale.

SCHEDULE 4 - Risk of Loss; Insurance

1. The risk of accidental loss or destruction of any of the Consigned Product while in the possession of the Trust shall be borne by the Supplier.

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2. The Trust shall have no liability to the Supplier as a bailee or otherwise with respect to the Consigned Products, except where it can be proven that any damage to the Consigned Product may be directly as a result of an act or omission of the Trust through gross negligence; or the Trust’s intentional damage to destroy the Consigned Product.

3. It is the obligation of the Supplier to adequately insure the Consigned Product at

its own expense for the benefit of, and in the name of Supplier.

4. The Trust shall handle and store the Consignment Products in a safe, clean and

secure location with all due care and skill, in accordance with all instructions provided by the Supplier and all storage conditions indicated on the packaging of the Consignment Products. In addition, the Trust will ensure that it will not remove, deface or obscure any identifying mark or packaging on, or relating to the Consignment Stock. Moreover, the Trust will maintain the Consignment Products in perfect condition and shall protect them from any loss or damage.

SCHEDULE 5 – Loan and Movement of Consigned Product s Offsite

1. In the event that it becomes necessary that Consigned Products are removed from the Trust to be loaned elsewhere; the exit and subsequent return of Consigned Products must be evidenced and fully documented.

2. Following delivery of the Consignment Products by the Supplier to the Facility, the Consignment Products shall not be moved or removed from the Facility by the Supplier other than pursuant to Schedule 1 clause 4- 5, or in exceptional circumstances where Consignment Products are removed by the Supplier for urgent use by another healthcare provider and replaced by the Supplier in due course. In such circumstances, a signed record shall be maintained by the Supplier and the Trust showing the date of removal and return.

3. For the avoidance of doubt, such exceptional circumstances shall not apply to consigned surgical instrumentation.

SCHEDULE 6 - Disposition of Consigned Product.

1. In the event that Consigned Products not already covered by a Purchase Order are not used by the Trust upon termination of this Agreement, the Trust, shall arrange the return of these Consigned Products to the Supplier, who in turn will, at its own risk and expense shall remove the Consigned Products at no charge to the Trust.

2. The Trust will not be responsible for any costs associated with the termination of the agreement, or otherwise.

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SCHEDULE 7 – Invoices

Invoices for the Trust, quoting relevant purchase o rder to be sent to:

RTK Payables A185 Shared Business Services Phoenix House Topcliffe Lane WAKEFIELD West Yorkshire WF3 1WE

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SCHEDULE 8 – Authorised Persons

Trust Authorised Person :

Associate Director of Procurement

Name …………………………………….. Signature ……………………………………. Date ……………………………………..

Senior Manager (Supplies and Procurement) Name …………………………………….. Role ……………………………………. Signature ……………………………………. Date ……………………………………… For and on behalf of ASHFORD AND ST PETER'S HOSPITALS NHS FOUNDATION TRU ST

The specific names listed above represent the situation at the time of signing but may be changed by the Trust and the Contractor will be informed of any changes made. Name …………………………………….. Role ……………………………………. Signature ……………………………………. Date ………………………………………

For and on behalf of

The Supplier

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APPENDIX 5

LIST OF CONSIGNMENT PRODUCTS

Product Description

Catalogue Code or Product Reference

Serial Number

Unit of Supply

Quantity Price per unit, £

29

30

Product Description

Catalogue Code or Product Reference

Serial Number

Unit of Supply

Quantity Price per unit, £

31

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APPENDIX 6: CHANGE IN AGREEMENT CONSIGNMENT FORM DATE:

BETWEEN: Ashford & St Peter’s NHS Foundation Trust, and

_____________________________________________________________________

_____________________________________________________________________

______________________________(The Supplier)

The Trust, entered into a Consignment Agreement Form dated _____________________. The Supplier / Trust (please circle as appropriate) wish to amend the initial agreement by changing the quantity / type (please circle as appropriate) of goods on Consignment. The following list of Consignment goods is now the true representation of goods held within the Trust and replaces the Original Consignment Stock Agreement list of products. Terms and conditions of the agreement are still in place.

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WITNESS SIGNATURES

The undersigned agree to the terms and conditions of the Agreement and confirm that the listed products are correct;

Signature of Departmental Staff Member: ______________________________________

Print Name: ___________________________________________________________ Job Title: ___________________________________________________________ Date: ___________________________________________________________________ Signature of Supplier Representative: _______________________________________ Print Name: _____________________________________________________________ Job Title: _____________________________________________________________ Date: ____________________________________________________________________ Signature of Associate Director of Procurement _______________________________ Print Name: ____________________________________________________________ Job Title: ____________________________________________________________ Date: ____________________________________________________________________

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APPENDIX 7 LIST OF AMENDED/REPLACED CONSIGNMENT PRODUCTS

Previous Product

Description

Produce Replacement Description

Catalogue Code

Serial Number Quantity Price per unit, £

35

36

APPENDIX 8 LOG OF USED CONSIGNMENT STOCK (For Departmental Use Only)

Date of Use Product Description

Serial Number

Quantity Name of Physiologist (Print Name)

37

38

APPENDIX 9

CONSIGNMENT TERMINATION AGREEMENT

FOR

The Supply of Consignment Products

TO

ASHFORD AND ST PETERS HOSPITALS NHS

FOUNDATION TRUST Foundation Trust Reference:

39

This Consignment termination Agreement is dated: ********

Between

(2) Ashford and St Peter's Hospitals NHS Foundation Trust (the Trust)

Of

London Road, ASHFORD, Middlesex, TW15 3AA

And also of

Guildford Road, CHERTSEY, Surrey, KT16 0PZ

And

(2) *****************(the Supplier)

Of

********************************************

WHEREAS

The Supplier and the Trust entered into a Consignment Stock Agreement dated [date of original agreement] (copy attached)

************ and the Trust now wish to terminate the Agreement and unanimously confirm the following:

1. All Consignment Products in the Consignment Stock belonging to******** have been inspected by both Parties and can unanimously confirm:

• that the quantities of Consignment Products in the Consignment Stock are consistent with the quantities specified in the List of Consignment Products’ YES/NO* (if no, please specify)

• that the Consignment Products in the Consignment Stock are in an acceptable condition and are not damaged in any way YES/NO* (if no, please specify)

2. The Consignment Products in the Consignment Stock have been removed by ************** (or arrangements made for removal) on ******* (date) YES/NO* (if no, please specify)

*Delete as appropriate. If any response is “NO”, explanatory comments should be added below.

COMMENTS (IF APPLICABLE):

Authorised Persons

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Trust Authorised Persons :

Signature of Departmental Staff Member: ______________________________________ Print Name: ___________________________________________________________ Job Title: ___________________________________________________________ Date: ___________________________________________________________________

Signature of Associate Director of Procurement _______________________________

Print Name ____________________________________________________________

Job Title: ____________________________________________________________

Date: _______________________________________________________________

Signature of Supplier Representative _______________________________________

Print Name _____________________________________________________________

Job Title: _____________________________________________________________

Date: _______________________________________________________________

The specific names listed above represent the situation at the time of signing but may be changed by the Trust and the Contractor will be informed of any changes made. COMMENTS (IF APPLICABLE):