commercial medicines unitmedia.dh.gov.uk/network/121/files/2011/06/01-homecare-service... · the...

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© Crown Copyright 2011 May 2011

Commercial Medicines Unit

Procurement guidance

For

The provision of homecare delivery service of medicines to patients at home

Issue date: May 2011

Review date: Sep 2012

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Contents Page

1. Introduction 3

2. National Homecare Medicines Committee (NHMC) 4

3. Market overview 7

4. Comparison of home delivery methods 11

5. Data collection 14

6. Homecare delivery service providers 17

7. Stakeholders 20

8. Therapy list 21

9. Specification

• Core 26

• Deliver and Service 32

• Product Prescribing and dispensing 36

• Equipment and ancillaries 40

• Training and Education of staff and patients 43

• Nursing services 45

10. Award Criteria 47

11. CMU homecare medicines team 53

Appendix 1 – Glossary of Terms 54

Appendix 2 – Patient registration form 60

Appendix 3 – Change management form 62

Appendix 4 – Data template 79

Appendix 5 – KPI’s 80

Appendix 6 – Patient survey 81

Appendix 7 – Complaints and adverse incidents 84

Appendix 8 – Refrigeration 88

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Introduction

The Commercial Medicines Unit (CMU) in conjunction with the National Homecare Medicines Committee have produced the enclosed guidance and generic specifications to support service users, providers and most importantly patients in the procurement of a homecare delivery service of medications to patient’s homes. The best practice guidance document gives you an insight into the market, homecare delivery service providers, stakeholders and key market information which is pertinent to the homecare delivery service of medicines. Specifications have been produced with wide consultation and are intended to be as generic and reflective as possible of the NHS needs, in order that they can be used as a template for a number of therapy areas. It is intended that to the latter part of 2010 the homecare team in conjunction with NHMC will develop therapy specific guidance to support other market areas such as; Total Parenteral Nutrition (TPN) and Cystic Fibrosis (CF) as it is felt these therapy areas may require specific guidance documents. Specification and guidance documentation cover:

• Core • Deliver and Service • Product Prescribing and Dispensing • Equipment and Ancillaries • Training and Education of staff and patients • Nursing Services • Patient Registration forms • Change Management guidance • Data template • KPI’s • Patient questionnaire • Complaints and adverse incident form • Refrigeration

Other key documentation held on the CMU homecare website cover:

• Audit procedures – as best practice regional QA and pharmacy procurement specialist should review the awarded suppliers audit reports prior to the final contract decision

• Award criteria

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National Homecare Medicines Committee (NHMC) The NHMC was formed as a sub group of National Pharmaceutical Supply Group as it was recognised that this market was expanding and needed to be managed effectively in order to ensure patient safety and clinical effectiveness. The committee consists of representatives of stakeholder professions with experience in the area of homecare medicines delivery and service in primary care, secondary care, specialised commissioning and industry. CMU facilitates and manages this committee. Members of the NHMC, homecare delivery service providers, Secondary care trusts, Primary Care Trust, NPSG, Specialised Commissioning, Hubs and QA have been consulted during the production of this document. The guidance will be reviewed on a six monthly basis, next review date November 2010. Committee members (as at September 2010) Allan Karr (Chair) Pharmacy Business Manager, University College London Hospitals NHS Foundation Trust Tel: 0207 3809730 email:[email protected]

Jim Armstrong Specialist Procurement Pharmacist, South East Coast CPH Tel: 01634 83 8934 email: [email protected]

Alison Ashman Specialist Procurement Pharmacist / Assistant Director, PRO-CURE Collaborative Procurement Hub Tel: 01256 473202 Ext 3766 email:[email protected] Mobile: 07876 591435

Philip Aubrey Medicines Procurement London and East of England LPP Pharmacy & Medicines Management Operational Lead Tel: 07795 841694 email: [email protected] Graham Brack Pharmaceutical Adviser, NHS Cornwall and Isles of Scilly PCT Tel : 07736 553710 email: [email protected] Teresa Brannigan Contracts Officer, Welsh Health Supplies Tel : 02920 315485 email: [email protected] Carol Clark Category Specialist, Homecare, Commercial Medicines Unit (CMU) Tel: 01282 850672 email: [email protected]

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Judi Cross Pharmaceutical Advisor, South East Coast SCG Tel: 01622 713028 email: [email protected]

Phil Deady Pharmacy Procurement Manager, Leeds Teaching Hospitals NHS Trust Tel: 0113 3927012 email: [email protected] Alastair Gibson Director of Pharmacy Blackpool Fylde and Wyre Hospitals Tel: 01253 303790 email: [email protected] Nick Haslem Commissioning Manager, South East Coast Specialised Commissioning Group Tel: 01622 713010 email: [email protected] Sarah Pacey Assistant Chief Pharmacist, Procurement, Therapeutics and Medicines Performance, Nottingham University Hospitals NHS Trust Tel: 0115 9627674 email: [email protected] Liz Payne Category Manager, Homecare, Commercial Medicines Unit (CMU) Tel: 01926 857313 email: [email protected] Dr Nick Payne Chairman, National Clinical Homecare Association (NCHA Limited) Tel : 07970 387992 email: [email protected] Cherryl Perry Customer Supply Chain Manager, Abbott Laboratories, representing ABPI Tel: 07950 162648 email: [email protected] Simon Perkins Category Specialist, Homecare, Commercial Medicines Unit (CMU) Tel: 01928 794631 email: [email protected] Bernadette Porter Nurse Consultant, The National Hospital for Neurology & Neurosurgery, University College London Hospitals NHS Foundation Trust Tel: 0207 767 2083 email: [email protected] Inderjit Singh Associate Director – Commercial Pharmacy Services, University Hospital Birmingham Tel: 0121 623 6812 email: [email protected]










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David Stead Medicines Procurement Lead for South West, United Bristol Hospitals NHS Trust Tel: 07867 527491 email: [email protected]

Dr.Richard Sturgess All Wales Technical and Computer Services Pharmacist Tel: 029 20 748128 email: [email protected] James Warnock Pharmacy Procurement & Homecare Services Manager, NHS Greater Glasgow & Clyde, Pharmacy Distribution Centre, 10 Dava Street, Govan, Glasgow G51 2BQ Tel: 0141 347 8985 email: [email protected] Kevan Wind Medicines Procurement Specialist Pharmacist, London and East of England Tel: 01702 385225 email: [email protected]





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Market overview

A medicine homecare delivery service can be described as one that delivers ongoing medicine supplies and where necessary associated care, initiated by a hospital prescriber, direct to a patient’s home with their consent. The purpose of the homecare delivery service is to improve patient care and choice for their clinical treatments. Patients that are typically on homecare are those with chronic diseases and stable treatment regimens that do not require acute care input. Currently, most homecare delivery service is initiated by hospital trusts, which normally administer medicines to patients within their own hospital environment. However, on some occasions the supply and administration of medicines is better provided directly to the patient in their own home. For example, there are many therapy areas which will cause patients logistic difficulties with the provision of heavy and large volumes containers which are required for their treatment e.g. dialysis solutions, total TPN, Enteral feeds. The use of such medicine homecare delivery services is expanding throughout the UK with an estimated 120,000 plus patients now receive their medicines via the homecare route. The value of medicines being supplied by this route is estimated to be well in excess of £500 million. These figures are expected to increase substantially as clinical services follow the vision for building on the strengths of pharmacy, using that capacity and capability to deliver further improvements in pharmaceutical services over the coming years as part of an overall strategy to ensure safe, effective, fairer and more personalised patient care. ¹ It must be noted that at the beginning of any homecare medicines service whether it is initiated by a hospital trust or pct dialogue must be undertaken with the manufacturers of the medicine at the beginning of the process to ensure product visibility and agreement for distribution. Homecare delivery service can be further sub-divided into low-tech or high tech. Other definitions are also possible. (a) High Tech Homecare This will include all:

• Intravenous therapy • Other injectable therapy where significant support is required e.g. consumables, storage,

monitoring, preparation and administration. • Any oral therapy that requires significant support such as blood level monitoring or special storage

requirements 1. Department of Health, publications – Pharmacy in England: building on strengths – delivery the future

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(b) Low-tech homecare This will include all: Oral medication and external preparations that require no other support than standard concordance monitoring from the homecare delivery service provider. Injectable therapy that is not intravenous and requires little support other than concordance monitoring. What are the benefits of homecare? There are many benefits in using homecare, key among which is that for many patients it would be necessary to make visits to hospital solely to receive periodic treatment or prescriptions. Homecare delivery services avoids this need, thereby also freeing both patient and hospital time. Homecare can also release hospital beds and return patients to their homes earlier. An example of this would be cystic fibrosis homecare services: not only does homecare decrease hospital visits but also decreases the chances of cross-infection in this vulnerable patient group. Where appropriate homecare services can be commissioned with nursing support to ensure seamless delivery of care without creating any burden to community services. Where patients are receiving a range of home medicines, homecare may offer the opportunity of providing all medications through a single provider. Homecare offers the opportunity of providing high quality, cost effective and accessible care to specific patient groups. Medicines homecare delivery services will vary according to the degree of intervention The types of medicine delivery services provided by a homecare delivery service provider can include the delivery process, pharmaceutical dispensing, and sterile preparation of injectable medicines in a ready to use form, phlebotomy services and nurse or patient administration of injectables. This potentially high level of medical and clinical care will require highly trained staff. The staff are currently either employed by the provider trust or perhaps more commonly by a commercial homecare delivery service providers. A considerable amount of attention should be given to ensure that all clinical governance arrangements are formally agreed and adhered to. It is worth clarifying that Shared Care is different from homecare. In shared care prescribing responsibility passes to the GP in agreement with the Consultant and Primary Care Trust (PCT). In the case of medicine homecare the responsibility for the clinical care remains with the hospital prescriber. How do homecare delivery services work? Typically, homecare arrangements began informally with acute trusts arranging a service for discharged patients, with reimbursement of costs by the PCT. Control was often minimal, but the risk to the PCT was low and the number of patients small. It is clear however that more formal arrangements are necessary. In many areas these have now been developed and robust processes with dedicated teams afford much more control and governance, but some trusts may not have yet instituted this level of control.

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Effective clinical governance is fundamental to homecare delivery services due to the shared nature of the service with acute trusts retaining clinical responsibility, care usually being delivered through an independent contractor and in some case a third party being involved where services are directly funded by PCTs. In addition, each prescription causes generation of an order, delivery note and invoice which must be reconciled, and the timely issuing of prescriptions has to be managed. The use of homecare delivery services introduces an additional dimension into the care of patients. It exposes a wide range of issues including communication regarding treatment outcomes, therapeutic intent and adverse reactions. There requires to be absolute clarity regarding what information can be provided and by whom. Clear communication channels regarding concordance and adverse incidents with the responsible consultant will need to be put in place. Homecare delivery services are most effectively provided when purchased through joint working arrangements between acute trusts and PCTs. It is also recommended that pharmacy procurement specialists are involved to harness expertise of collaborative contracting and tender exercises. What is the role of PCT's in homecare? The day to day management should be retained by the organisation that has clinical responsibility of the patient, usually the acute trust. Acute trusts and PCTs should work in conjunction in agreeing and establishing service criteria and also ensuring appropriate contractual and governance arrangements for homecare delivery services. Joint working is recommended in:

• agreed that a homecare delivery service is a suitable route for the provision of a specific clinical service.

• ensuring that the tendering process is appropriately conducted preferably with those with

experience in homecare delivery service contracting, and a formal contract and/or Service Level Agreement is in place.

• ensuring that the service provided by the appointed homecare delivery service provider is

monitored regularly and thoroughly.

• ensuring there is an appropriate, efficient and adequately resourced process to verify the administration of the prescriptions, purchase orders, delivery notes and invoices.

VAT The points below are a summary of discussions with HM Revenue & Customs (HMRC) and are an overview only. The NHMC takes no responsibility for any inaccuracies and NHS trusts are advised to secure their own advice with regard to particular arrangements.

• VAT liability of homecare delivered medicines and associated services.

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o Medicines dispensed to individuals for their personal use, dispensed by a registered pharmacist against a prescription issued by a registered doctor or nurse for administration in their own home (or residential home) are zero-rated.

o Pharmacy dispensing services provided by a registered pharmacist are exempt from VAT

o Delivery services are subject to VAT at the standard rate

o Where two or more of the above elements form part of a composite supply, the

predominant element will determine the VAT liability of the whole.

• Homecare delivery service providers will seek advice from their local HMRC office who will advise on the VAT status of the proposed services

• The homecare delivery service provider is responsible for collecting the VAT where applicable. If the homecare delivery service provider fails to charge the customer VAT and later finds that its interpretation was incorrect, the HMRC will pursue the homecare delivery service provider for payment of the under declared VAT. It may be that, the homecare delivery service provider will approach its customer seeking further payment, whether or not the customer should make further payment is a commercial matter between the two parties and the HMRC would not involve itself in that issue.

• Medicines used while an individual is receiving care or medical or surgical treatment in a hospital or

nursing home - whether as an in-patient, resident, day-patient or outpatient - cannot be zero rated.

The VAT (Drugs, Medicines, and Aids for the Handicapped) Order 1997/2744 which came into effect on 1 January 1998 is outlined in Business Brief 29/97 www.newsrelease-archive.netlcoi/depts/GCE/coi5955d.ok Comparison of Homecare Delivery methods The method of delivery chosen should involve a local risk assessment and give due consideration to the convenience for the patient. The final decision on the delivery route chosen should be documented in the service level agreement and also include the consent by each individual patient. The most frequent delivery method used by homecare delivery service provider is the use of dedicated vans and suitably trained drivers. The vans must be able to demonstrate validated cold chain where this is required and in all cases show that temperature control is within an acceptable range for the storage of medicines. All packages should be tamper evident. It is expected that on making the delivery the driver will put away stock, remove waste packaging, rotate stock and where appropriate monitor fridge temperatures. The homecare delivery service provider must inform the patient as soon as possible if for any reason delivery cannot be made. If it is necessary to arrange delivery through third part couriers then they should adhere to the usual agreed procedures. For certain services or emergency deliveries the use of national parcel carriers or Royal Mail is used. Where such postal services are used, either via the Royal Mail or other carriers, it is advisable to check with the

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homecare delivery service provider on any restrictions that apply. The Post Office has useful information on its website (www.postoffice.co.uk). Consideration should also be given to any advice from the Royal Pharmaceutical Society. All items must be securely wrapped to prevent loss or damage to the contents and also to avoid harm to recipients or postal employees. Any item should be contained in a strong inner container and enclosed in an outer packaging. This should ensure that any spillage is contained within the outer packaging. For liquids, it is recommended that any tins or bottles should be sealed with tape, wrapped in polythene, sealed again and surrounded with an absorbent material to soak up any leakage. Although medicines could be sent by ordinary post when needed, Royal Mail recommends using their 'Special Delivery' service to guarantee next day delivery and obtain the recipient's signature. It is the supplying pharmacists’ responsibility to ensure that the patient receives their medication. In the case of the Royal Mail medicines for medical purposes may be posted provided these are supplied lawfully. This is however subject to their prior written approval, (which may be subject to conditions, including the type of medicines that may be sent, how, when, by whom and to whom), and subject to such items being sent in suitable tamper-proof packaging and only being sent by Royal Mail's Special Delivery or Recorded Delivery services. Although the Royal Mail may request full details of any medicines being posted, registered pharmacies are not normally required to provide this information. The following restrictions for posting medicines apply.

• The only type of Controlled Drugs permitted are those classified as Schedule 4 e.g. Benzodiazepines. All other types of CDs are prohibited. Guidance may be sought from the Home Office 0207 035 4848 or visit www.homeoffice.gov.uk

• Items requiring refrigeration are prohibited unless specialist containers are used which have been validated to demonstrate suitable temperature control.

• Any medicine that uses an aerosol where the volume exceeds 50ml is prohibited. • Any aerosols that use flammable or toxic gases as propellants are also prohibited.

COMPARISON OF DELIVERY METHODS SERVICE TYPE STRENGTHS WEAKNESSES Postal ( including special delivery

• Lowest cost option for small number of deliveries.

• Track & Trace capability. • Insurance cover for loss of

product and delivery failure. • Post office pick-up point if

patient is not at home.

• Loss incidence higher than with dedicated van.

• No facility to check stock within patients’ homes.

• No certainty regarding delivery time (but before 9am service available)

• Certain categories of medicines prohibited.

• Unable to send items requiring refrigeration.

Dedicated van and driver • Deliveries consistently by

the same driver. • Highest cost option. • Backup needed for when

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• Ability to conduct stock checks in patients’ homes.

• May offer a secure key holding service for access when the patient is out.

• Lower losses than post or courier.

• Flexibility – facility to redirect van for urgent needs.

• Weekend deliveries.

the vehicle is off the road and during holidays.

• Driver needs suitable training

• Police check of driver required

Data collection CMU has not captured homecare delivery service information on either the BTT or Pharmex applications. The introductions of homecare services to CMU lead to a requirement for new business processes and applications. The strategic objectives for the collection are:- Understand value of homecare market to inform national procurement strategy.

• Unbundle service and delivery costs from pharmaceutical costs. • Identify where savings can be made. • Quantify volumes, usage and spend for contracting purposes. • Benchmark prices in order to drive best practice. • Identify patient numbers for homecare by trust, therapy, product and service. • Manage risk in homecare market and ensure appropriate level of competition. • Measure trends in growth of the homecare market.

Provide a central resource of data for the NHS on homecare spend.

• Ensure that CMU is able to respond to Department of Health request for information on NHS Homecare spends.

• Enable the DH to make informed policy decisions on homecare services Avoid any duplication of effort on homecare processes within NHS organisations. Collection of data will be consistent with NHS data and coding standards.

• The “to be” strategic vision from the government and the NHS is to have a more “joined up”, “do Once and Share”, “Auto-identification and data capture (AIDC)” health service². CMU is a leading body of this change and is committed to supporting the standards needed to make this change happen.

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2. Coding for Success – Simple technology for safer patient care, Healthcare Quality Directorate, Department of Health CMU data collection project objectives 1. Collect homecare medicine usage and spend data from homecare delivery service providers.

2. Collect homecare service data from homecare delivery service providers.

3. Collect homecare medicine usage and spend data backdated to the beginning of 2008. 4. Ensure that the data collection process does not allow duplication of transaction (spend and usage)

reporting.

5. Where NHS data standards do not exist, document a consistent data specification to support the exchange of medicine and service information between DH MPIG, CMU, NHS trusts and purchasing groups (for example, hubs) and suppliers.

6. Provide homecare delivery service providers with the capability to provide and access homecare data

direct to/from CMU.

7. Provide trusts with the capability to access homecare data direct from CMU.

8. Facilitate more accurate and timely (near real time) homecare reporting capability.

9. Remove homecare delivery service provider reporting medicine usage and spend to individual trusts. Replace with a collective report submitted to CMU.

10. Collect key performance indicators (KPI’s) on homecare delivery service providers to use to make

informed contract adjudication decisions (against award criteria weightings). Appendix 5

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CMU Data collection fields


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Homecare delivery services Overview - Thick vertical dotted line illustrates new Homecare delivery service provider information flow to CMU


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Homecare delivery service providers

The market is growing and new entrants are emerging both SME and multinationals. In the UK the major suppliers are:-

These suppliers are currently providing, or have shown an interest in supplying, a home delivery service This IS NOT an approved list, these suppliers have not been vetted by CMU or the National Homecare Medicines Committee (NHMC)

Homecare Service Providers Address 1 Address 2 Town County

Post Code Contact Position e-mail

Telephone number

Mobile Number Website Comments

Member of the National Clinical

Homecare Association

Air Products 2 Millennium Gate

Westmere Drive Crewe Cheshire

CW1 6AP

Contracts Manager [email protected] 0800 389 0202

07834 259590

www.airproducts.co.uk

Oxygen and Medicines

Baxter Healthcare Limited T/A Willow Healthcare Services

Unit 1 North Orbital Commercial Park

Napsbury Lane St Albans Herts.

AL1 1XB

Mo Rahman Steve Lane

Business Manager Head of Homecare (Baxter)

[email protected] [email protected]

01727 849721 01635 206273

07825 374917 07717 542261

www.willowhs.co.uk

Low & High Tech. Yes

Bupa Home Healthcare Unit 4 Scimitar Park Roydon Road Harlow Essex

CM19 5GU Alton Austin

Commercial Manager

[email protected]

01279 456789 / 456946

07971 499518

www.bupahomehealthcare.com

Low & High Tech complex and continuing care Yes

Calea UK Limited Cestrian Court

Eastgate Way, Manor Park Runcorn Cheshire

WA7 1NT

Christina Willis

Senior Product Manager

[email protected] 01928 533742

07795308124

www.calea.co.uk High Tech Yes

Careology Ltd

Unit 2-4 Fenchurch Court

Bobby Fryer Close Oxford

OX4 6ZN

Dominic Moreland (MD) or Natasha Arif Manging Director

[email protected] [email protected]

01865 770510 - switchboard or direct 01865 334925

07748 936914

www.careology.co.uk

High Tech - Clotting Factors / Genetics / Chemotherapy Yes

Central Homecare Ltd Selbourne House Mill Lane Alton Hampshire

GU34 2QJ

Gaurang Majmudar

Head of Homecare Development gaurang.majmudar@cen

tralhomecare.co.uk 01420 540535 07879 488000

www.centralhomecare.co.uk

Low & High Tech Yes

CHEMISTREE HOMECARE

Unit 7 Curo Park Park Street Frogmore St Albans

AL2 2DD

Gitika Kalra/Sam Bhudheo/Lesley Parrott

Head of Homecare Business Development Manager/Director of Homecare/Senior Homecare supervisor

[email protected] [email protected] [email protected] [email protected] 01727 877954

07545 243796

www.chemistree.co.uk

Low and High tech - incl CF, all IV

Evolution Homecare Services Ltd

Technology House

239 Ampthill Road Bedford Bedfordshire

MK42 9QG

Paul Probert

Contracts & Sales Support Manager


07713 306564

www.evolutionhomecare.co.uk

Low and High tech Yes

Flexible Homecare Services

Westbury House

52 French Laurence Way Chalgrove Oxford

OX44 7YF

Julian Gooddy Managing Director


No Website (checked High Tech


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03/06/08)

Healthcare at Home Ltd Fifth Avenue Centrum 100

Burton upon Trent

Staffordshire

DE14 2WS Mark Smith

Group Commercial Director [email protected] 0870 600 1540

07772 712216

www.hah.co.uk

Low and High Tech - Integrated Homecare Services Yes

Lloyds Pharmacy - sister company of Evolution

Technology House

239 Ampthill Road Bedford Bedfordshire

MK42 9QG

Trevor Jones

UK Contracts Manager


07788 416093

www.evolutionhomecare.co.uk

High tech; HIV / CF

Mawdsleys (Mawdsley -Brooks & Co. Ltd) Number Three

South Langworthy Road

PO Box 18

Salford, Manchester

M50 2PW

Kelly Jacques

Hospital contracts Manager

[email protected] 0161 742 3360

www.mawdsleys.co.uk

Low-tech therapeutic category initially

Medco Health Solutions (UK) Bewer House Caswell Road

Brackmills Industrial Estate Northampton

NN4 7BZ

Alison Davis

Director- Business Development


07850901514

www.medcohealth.co.uk

Low tech-high tec Yes

Nutricia Limited Newmarket Avenue

White Horse Business Park

Trowbridge Wiltshire

BA14 0XQ

Dave Hobdey

Contracts Manager [email protected] 01225 711586 none

uk.nutricia.com

High Tech Feeding; Enteral Feeds, Specialised Feeds

Pharma Service Division & Applied Dispensing (a division of Healthcare at Home)

Polar Speed Unit 8 Chartmoor Road

Leighton Buzzard Bedfordshire

LU7 4WG John Evans

Director - Pharmaceutical Services [email protected] 01525 217666

07970 578364

www.polarspeed.com

Chill Chain (act as distributors for Careology


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Drug Suppliers Offering Homecare These suppliers are drug companies who offer homecare using an in-house provider

Fresenius Medical Care (UK) Nunn Brook Road Huthwaite

Sutton in Ashfield Nottinghamshire

NG17 2HU

Kathryn Miller

Contracts Co-ordinator

[email protected]

01623 445149 www.fmc-ag.com

Hi Tech; Peritoneal Dialysis and Haemodialysis

Gambro Lundia AB (UK & Ireland

Lundia House

Ermine Business Park Huntington Cambridgeshire

PE29 6XX

David Lyons

HND Business Development office

[email protected]

01480 444000

07870 624706 www.gambro.co.uk

Hi Tech; Haemodialysis

Merz Pharma UK Ltd

260 Centennial Park

Elstree Hill South Elstree Hertfordshire

WD6 3SR

Pharmacy2Home

Head of Medical Information

[email protected]

0208 236 3583

www.merzpharma.co.uk

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19

Homecare stakeholder map


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List of products and therapies

The tables below lists therapy areas and conditions which are currently treated through homecare and examples of the drugs involved. The list of medicines (table 1) are catalogued as they first appear in the BNF and the list is in BNF order. They have not been duplicated where they have more than one indication e.g. Methotrexate first appears under Cytotoxic Drugs and is not repeated under Rheumatology. Table (2) is an alphabetical list of products that have been distributed to patients homes by brand name. These are not exhaustive lists. Please contact [email protected] if you are aware of any other products which are being supplied via homecare. Table (1) Therapy areas and conditions which are currently treated through homecare

BNF Section

Therapy area Medicine Specific medicine

Cardiology 2.1.2 2.5.1 2.11

Congestive heart failure Vasodilator antihypertensives Antifibrinolytics

Milrinone Iloprost Epoprostenol Bosentan Sildenafil Sitaxentan Blood Factors V11, V11a, V111, IX

Primacor Ventavis Flolan Tracleer Revatio Thelin Advate, Benefix, Haemate P. Helixate NexGen, Kogenate, Novoseven, ReFacto,

Respiratory 3.1.1.1 3.4.3 3.6 3.7

Selective beta2 agonists Allergic asthma Oxygen Mucolytics

Terbutaline Omalizumab Oxygen Dornase Alfa

Bricanyl Xolair Pulmozyme

CNS 4.2.1 4.9.1

Antipsychotic drugs Parkinsons disease

Clozaril Denzapine Zaponex APO-Go



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BNF Section


Infections 5.1.4 5.1.7 5.1.9 5.3.1 5.3.3 8.2.4 8.2.4 5.3.5

Cystic fibrosis Antitubercolosis HIV Viral Hepatitis Hepatitis C

Tobramycin Colomycin Imipenem & Cilastatin Amikacin Capreomycin Rifabutin Pyrazinamide Rifampacin & isoniazid combinations Antivirals and related medicines Entecavir Interferon Pegylated Interferon Ribavirin

Tobi Colistin Primaxin Amikin Capstat Mycobutin Rifater, Rifinah Baraclude Intron A, Roferon A, Viraferon Pegintron, ViraferonPeg Copegus, Rebetol


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BNF Section


Endocrine 6.5.1 6.5.1 6.6.1 8.2.4

Infertility Bone metabolism & Growth hormone Bone metabolism & Growth hormone Multiple sclerosis

Chorionic Gonadotrophin Choriogonadotropin Alfa Follitropin Alfa Follitropin Beta Human Menopausal Gonadotrophins Lutropin Alfa Somatropin Teriparatide Interferon Beta 1a Interferon beta 1b Glatiramer Natalizumab

Choragon, Pregnyl Ovitrelle Gonal-F Puregon Menogon,Menopur Luveris Saizen Zomacton Genotrope, Humatrope, Norditropin, Nutropin Aq., Saizen, Zomacton Forsteo Avonex, Rebif Betaferon, Copaxone Tysabri

Malignant disease 8.1 8.2 8.3.4

Cytotoxic drugs Immunosuppressants Hormone antagonists

Capecitabine Gemcitabine Methotrexate Erlotinib Imatinib Topotecan Trastuzumab Bortezomib Bevacizumab Mycophenolate Ciclosporin Sirolimus Tacrolimus Lanreotide Octreotide

Xeloda Gemzar Tarceva Glivec Hycamtin Herceptin Velcade Avastin Cellcept, Myfortic Neoral, Sandimmune Rapamune Prograf, Advagraf Somatuline LA and Autogel Sandostatin and LAR


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BNF Section


Nutrition and Blood 9.1.3 9.1.3 9.3 9.8.1 9.8.1 9.8.1 9.8.1

Anaemia Thalassaemia Parenteral nutrition Gauchers disease Fabrys disease MPS VI MPS II

Darbopoetin Epoetin Alfa Epoetin Beta Desferrioxamine Desferasirox Deferipirone TPN Imiglucerase Miglustat Agalsidase beta Agalsidase alfa Galsufase Idursulfase

Aranesp Eprex, Retocrit NeoRecormon Desferal Exjade Ferriprox Cerezyme Zavesca Fabrazyme Replagal Nagalzyme Elaprase

Musculoskeletal 10.1.3 Rheumatic Disease Adalimumab

Etanercept Infliximab Methotrexate Rituximab

Humira Enbrel Remicade Metoject Mabthera

Skin 13.5.3 Psoriasis Efalizumab Raptiva Metabolic Disorders 9.8.1 Mucopolysaccharidosis

Pompe’s Disease

Aldurazyme Alglucosidase Alfa

Laronidase Myozyme

Vaccines and antisera 14.5 (IV Immunoglobulin)

SC IV

Subcuvia Subgam Vivaglobin Flebogamma Gammagard Octagam Sandoglobulin Vigam


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Table (2) Alphabetical list of products that have been distributed to patients homes by brand name.

1 APO-Go 36 Gonal-F 71 Raptiva 2 Advagraf 37 Haemate P 72 Rebetol 3 Advate 38 Helixate 73 Rebif 4 Amikin 39 Herceptin 74 ReFacto 5 Aranesp 40 Humatrope 75 Remicade 6 Avastin 41 Humira 76 Replagel 7 Avonex 42 Hycamtin 77 Retocrit 8 Baraclude 43 Intron A 78 Revatio 9 Benefix 44 Kogenate 79 Rifater 10 Betaferon 45 Laronidase 80 Rifinah 11 Bricanyl 46 Luveris 81 Roferon A 12 Capstat 47 Mabthera 82 Saizen 13 Cellcept 48 Menogon 83 Sandimmune 14 Cerezyme 49 Menopur 84 Sandoglobulin 15 Clozaril 50 Metoject 85 Sandostatin and LAR 16 Colistin 51 Mycobutin 86 Somatuline LA and autogel 17 Copaxone 52 Myfortic 87 Subcuvia 18 Copegus 53 Myozyme 88 Subgam 19 Choragon 54 Nagalzyme 89 Tarceva 20 Denzapine 55 Neoral 90 Thelin 21 Desferal 56 MeoRecormon 91 Tobi 22 Dynepro 57 NexGen 92 Tracleer 23 Elaprase 58 Norditropin 93 Tysabri 24 Enbrel 59 Novoseven 94 Velcade 25 Eprex 60 Nutropin Aq 95 Ventavis 26 Exjade 61 Octagam 96 Vigam 27 Fabrazyme 62 Ovitrelle 97 Viraferon 28 Ferriprox 63 Pegintron 98 ViraferonPeg 29 Flebogamma 64 Pregnyl 99 Vivaglobin 30 Flolan 65 Primacor 100 Xeloda 31 Forsteo 66 Primaxin 101 Xolair 32 Gammagard 67 Prograf 102 Zomacton 33 Gemzar 68 Pulmozyme 103 Zaponex 34 Genotrope 69 Puregon 104 Zavesca 35 Glivec 70 Rapamune


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Specification document for Homecare Medicines – Core

1. Introduction 1.1 This specification outlines the general requirements for any Homecare Medicine service

purchased by the NHS in England. There are further supplementary specifications which outline the specific requirements with regard to:

• Delivery and service • Product (medicines), prescribing and dispensing • Information and training for patients and staff • Nursing services to be provided • Equipment and ancillaries. • Compounding Services.

There may also be some requirements which are therapy specific which should be detailed separately.

These documents have been produced in partnership with Commercial Medicines Unit (CMU) and the National Homecare Medicines Committee, in consultation with NHS and industry.

The guidance should be utilised by all NHS Organisations.

2. Scope 2.1 This Framework agreement is for provision of a homecare medicines service, which may include

the following therapies and medicines.

{insert list here} 2.2 It is anticipated that the scope in terms of numbers of patients and boundaries of provision will

change during the term of this framework but will be limited to the therapies listed and patients being treated by the Purchasing Authorities listed. Provision will be made for implementing these changes in a way that is acceptable to all parties, and taking into account patient choice and significant market changes.

2.3 Further detail of the product and services requirements are provided throughout this specification.

Appendix XX gives further detail on the current provision of these services and an indication of any planned developments and strategic direction.

3. Definitions

Appendix One


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4. Duration of Framework 4.1 Subject to the provision of the Terms and Conditions, this framework shall remain in force for the

period of [Period] months commencing 1 [Month] 20XX. In addition there will be an option to extend the framework for up to a further 24 months.

5. Selection, Registration and Discharge of Patients 5.1 Patient selection will be carried out by the Purchasing Authority. The Purchasing Authority will

confirm the patient’s motivation and suitability for the home delivery scheme. 5.2 Assessment of the patient’s home environment will be the responsibility of the Purchasing

Authority. 5.3 Service will not commence until the Purchasing Authority has gained patient consent and the

Purchasing Authority has evidence as to the suitability for the patient to receive a home delivery service.

5.4 The Purchasing Authority will complete a registration form for each patient, for dispatch to the Contractor. The NHMC recommended standard registration form is included at Appendix Two. On receipt of the registration paperwork, the Contractor will identify the service elements and activate as required.

5.5 The Contractor will adopt and use the Purchasing Authority’s patient unique identifier to identify each patient once the registration forms have been accepted.

5.6 The Contractor will make initial contact with the patient to confirm registration, and explain the

process in line with the requirements of the patient information section of this specification. 5.7 As the home delivery of each patient is transferred to the Contractor, it will be the responsibility of

the Contractor and the Purchasing Authority to ensure a smooth transition from hospital to home-based supply. As the patient's delivery is transferred to the contractor, it will be the responsibility of the Contractor and the Purchasing Authority to ensure a smooth transition to the contractor. Agreement must be made and stated on the original order of when homecare provision needs to commence. It is the responsibility of the Purchasing Authority to communicate this to the patient.

5.8 Following registration the Contractor must receive an official order in addition to a prescription

from the Purchasing Authority to commence a delivery. Failure to receive an official order could result in non payment

5.9 When patients care transfers between contractors, the contractors involved must follow the

NHMC Change Management Policy. See appendix three.

5.10 In the event of a patient no longer requiring the Homecare medicines service due to transfer to

another therapy, admission into hospital or returning to collecting medicines from hospital, the


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Purchasing Authority may request the Contractor to collect all new and un-used stock and dispose of them as necessary or reimburse the Purchasing Authority. Where a patient's care is transferred between contractors, all contractors must follow the NHMC procedure for change management with patient or patient's family consent. All equipment will be collected and returned to the appropriate provider.

5.11 In the event of a patient’s death the process described in 5.10 will be carried out with particular sensitivity at a time convenient to the patient’s family or carer.

6. Quality of Goods

6.1 The Contractor warrants represents and undertakes that any goods held and then supplied by it will:

6.1.1 Pass any tests and trials the Purchasing Authority requires to satisfy itself that the goods

are not injurious to health including without limitation any tests and trials conducted by NIBSC where applicable.

6.1.2 Meet the product specification. In the event of any dispute as to whether the goods have

been supplied in accordance with the relevant specification, the authority shall refer the matter to the regional quality control pharmacist who shall keep a sample of the goods which the regional quality control pharmacist has previously approved as being in accordance with the specification and this sample shall be used as the standard against which all goods shall be measured in order to determine whether they have been supplied in accordance with the relevant specification; and

6.1.3 The Contractor shall operate and maintain a quality control monitoring system which

meets the requirements of the MHRA and NIBSC and is approved by the Purchasing Authority and make available to Purchasing Authority on demand the results of such quality control monitoring.

6.1.4 The Contractor shall adhere to any relevant national quality standards and general guidance recommended by bodies such as the National Pharmaceuticals Supply Group (NPSG), the Pharmaceuticals Market Support Group (PMSG), the National Homecare Medicines Committee (NHMC), Department of Health (DH), National Health Service (NHS), Care Quality Commission (CQC) and National Patient Safety Agency (NPSA).

6.1.5 The reasons for any faulty or spoiled products will be notified by the Contractor to the

Purchasing Authority in writing within 24 hours of the complaint or sooner where deemed appropriate

7. Management Information 7.1 The Contractor must ensure that records of all hospital sales detailing volumes and prices are

kept and given to a nominated Authorised Officer of the Purchasing Authority on a monthly basis in the format given in Appendix four on an agreed date in an electronic format.


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7.2 The Contractor must comply with all requests by the Department of Health, CMU, the National Homecare Medicines Committee (NHCMC) and the Purchasing Authority for management data to be provided in respect of the products supplied under this framework. This information is to be provided within 10 working days for ad hoc requests.

7.3 All reports of usage and expenditure will be coded so that patients’ names are not revealed by using a patient unique identifier. All requirements of the Data Protection Act 1998 and updates must be met in full.

7.4 Particular care must be taken on the security of patient information. Where identifiable patient

personal information must be transmitted this must be by high level encryption, suppliers to be accredited to ISO27001. Level 2 of the Information Governance Toolkit should be adhered to. (Further information can be found on www.connectingforhealth.nhs.uk/systemsandservices/infogov or www.psnc.org.uk/IG)

On occasion there will be a requirement to transmit data via electronic communication (i.e. e-mail) and/or computer disc (CD). When electronic means are used, each party shall ensure as far as reasonably practicable, that data is properly stored, is not accessible to unauthorised persons, is not altered, lost or destroyed and is capable of being retrieved only by properly authorised persons.

Each party may apply special protection to electronic messages by encryption or by other agreed means, and may apply designations to the messages for protective interchange, handling and storage procedures. Unless the parties otherwise agree, the party receiving a message so protected or designated shall use at least the same level of protection and protective procedures for any further transmission of the message and its associated data for all responses to the message and for all other communications by interchange or otherwise to any other person relating to the message.

If either party becomes aware of a security breach or breach of confidence in relation to any message or in relation to its procedures or systems (including, without limitation, unauthorised access to their systems for generation, authentication, authorisation, processing, transmission, storage, protection and file management of messages) then it shall immediately inform the other party of such breach. On being informed or becoming aware of a breach the party concerned shall:

Immediately investigate the cause, effect and extent of such breach; report the results of the investigation to the other party; and use all reasonable endeavours to rectify the cause of such breach.

8. Performance Monitoring

8.1 The Purchasing Authority is responsible for monitoring Key Performance Indicators. Key

Performance Indicators have been developed for the purpose of monitoring the performance of the Contractor and are detailed in Appendix five. The required information will be provided to the authorised officer at the Purchasing Authority at agreed intervals. In addition to this, the Homecare Provider is responsible for informing on any change in performance standards.


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8.2 Contractors are required to provide a named contact responsible for the provision of

management and performance information. The information must: • be in the spreadsheet format prescribed by the Purchasing Authority • contain product and/or service level detail for each NHS site or organisation and other

third parties if appropriate • be provided to the Purchasing Authority within five working days of the end of the

appropriate sales month. 8.3 Framework monitoring meetings will be held with each of the successful Contractors by the

Purchasing Authority at agreed intervals. 8.4 On occasion a questionnaire will be issued by the Purchasing Authority to the patient and/or carer

in order to ascertain the quality of the level of service. This will be required to be included with deliveries that are dispatched by the Contractor. The Questionnaire will be supplied in an appropriate envelope by the Purchasing Authority. The distribution of questionnaires will be provided free of charge by the Contractor and questionnaires will be returned by patients directly to the Purchasing Authority. A standard questionnaire is included in Appendix 6 but this may be subject to change by the Purchasing Authority.

9. Arrangements for the Payment of Invoices 9.1 The Contractor shall issue invoices detailing the unique patient identifier, items supplied, itemised

unit costs and framework references. 9.2 Invoices to include service charges, these charges must be separately stated on the invoice

documentation and indicated by the Contractor even if only consumables and ancillaries. 9.3 The patient endorsed delivery note must be sent with each invoice by the Contractor Agent to the

Purchasing Authorities’ Finance Department or Pharmacy as agreed. Only invoices that are cross-referenced to patient endorsed delivery notes must be authorised for payment by the Purchasing Authority.

10. Confidentiality 10.1 All contractors must comply with Section 34 on confidentiality in the NHS Conditions of Contract

for the Purchase of Goods and Supply of Services. 10.2 Patient and family confidentiality must be respected and preserved at all times. No circulars or

questionnaires should be sent to patients, relatives, carers or GPs without the prior consent and agreement of the Authority. No patient contact will be made, other than that required by the Framework Participant’s staff in the performance of their duties, or unless specifically requested to do so by the Participating Authority clinical team or other authorised personnel


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10.3 All information, including prices, made available to the service Contractor or the service Contractor’s employees under this framework must not be divulged for any purposes to any other party including other companies within the group.

11. Communications 11.1 Key individuals will be designated the point of contact for the homecare service within the

Purchasing Authority and their contact numbers will be made known to the Contractor. These contacts will be for:

• Queries on referrals • Finance/invoice queries • Emergency/out of hours • Performance monitoring • Contractual queries • Management information • Complaints and adverse incidents. • Prescription Queries

The Homecare provider must also provide a list of their designated key contacts for the specific areas listed above. Please complete Appendix XX.

11.2 The Contractor must provide a named individual, deputy, and contact details for the above

categories and ensure this information is kept up-to-date.

11.3 A free phone Help Line will be available 8:00am to 6:00pm (plus answer phone or emergency bleep outside those hours) 365 days a year, for patients and carers to contact the service Contractor by telephone for information on their products and services. All clinical issues or errors and/or incidents must be fed back by the contractor to the purchasing authority within 24 hours or sooner if deemed appropriate.

12. Managing Complaints and Adverse Incidents 12.1 Any complaints regarding the delivery or service, received from patients by the Purchasing

Authority will be forwarded in writing to the Contractor for a written resolution within two weeks, unless requested by the Purchasing Authority to the contrary.

12.2 The Contractor must provide a complaints procedure and an incidents reporting procedure. The

Purchasing Authority will share in advance their incidence policy and serious untoward incident policy with the contractor and the contractor must adhere to these policies.

13. Sub-Contractors 13.1 Where sub-contractors are used for the provision of products and service within this Framework

agreement, all requirements within this specification will be extended to the sub-contractor and individuals involved. It is the responsibility of the Contractor to ensure that all sub-contractors meet these requirements and to inform the Purchasing Authority of any and all intended sub


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contracted parts of the service. No change can be made without the express permission of the Purchasing Authority.

14. Legal 14.1 The requirements detailed in this specification are in addition to and compliment the NHS

Conditions of Contract for the Supply of Service where the medicines and/or products are being sourced separately i.e. through national and/or regional frameworks or local arrangements. If the Contractor is required to source the medicines as well as provide the homecare service both the NHS Conditions of Contract for the Supply of Service and the NHS Conditions of Contract for the Purchase of Goods will apply. Where there is duplication on terms the supply of service will take precedent.


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Specification document for Homecare Medicines – Delivery and Service

1. Delivery scheduling 1.1 The Contractor shall ensure that the goods are delivered safely and securely to the patient’s

nominated address at any time between Monday and Friday, 8:00am and 6:00pm. Normal delivery dates should include Bank Holidays except Christmas day and New Years day. If this necessitates a revised delivery date, this should be immediately prior to the Bank Holiday. The Purchasing Authority will be advised of and agree with such arrangements. Deliveries recorded outside core hours without prior arrangement will result in that delivery charge being credited to the Purchasing Authority.

1.2 The Contractor shall operate an emergency delivery service whereby delivery will be made within

24 hours of the request being made by the Purchasing Authority at the agreed costs per delivery.

1.3 Deliveries should be made available for Saturday, early morning (before 8:00am) evening (after 6:00pm) and Sunday deliveries.

1.4 The Contractor must agree a delivery time with the patient or carer which is convenient to the

patient and/or carer and the delivery must be made within a two hour window (i.e. 10am – 12pm) as agreed with the patient and/or carer. The delivery time should be confirmed with the patient at least 24 hours in advance, and in accordance with any agreed Key Performance Indicators (KPI’s)

1.5 Delivery date will be no more than two working days after date of dispensing. 1.6 If a patient is not available at the agreed delivery time, it is the patient’s responsibility to contact

the Contractor to re-arrange delivery. 1.7 The frequency of deliveries depends on each patient group and stability of product, it is usually

between every 4-12 weeks. 1.8 Under sections 3 and 6 of the Health and Safety at Work Act 1974 there is a duty to protect

people not in a company's employment who may be affected by handling loads they have supplied.

Therefore it is good practice for manufacturers and suppliers to mark weights (and, if relevant, information about the heaviest side) on loads if this can be done easily.

Please see: http://www.hse.gov.uk/msd/loadguidance.htm

1.9 If it is anticipated that there will be failure to achieve the planned delivery time, the patient and/or

carer must be contacted prior to the expected delivery to arrange an alternative delivery time if requested by the patient and/or carer. It is expected that providers will develop innovative communication methods such as text reminders, online tracking.


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2. Refrigeration 2.1 Where applicable, the Contractor must be able to maintain the cold chain, and provide details of

validation, up to the point of delivery required for the medicines. 2.2 The Contractor may be required to provide refrigeration facilities for the product in the patient’s

home. Further detail of this requirement is outlined in Equipment and Ancillaries specification. 3. Delivery location and stock control 3.1 The Contractor will work with the patient, with their consent, to ensure an appropriate stock level

within the patient’s home as agreed by the patient’s prescriber. 3.2 All drivers should deliver all items to the agreed location within the patient’s home, in some

circumstances this may be in the supplied refrigerator, unless directed by the patient and/or carer.

3.3 Where applicable, all stock delivered is unpacked and rotated enabling normal access to the

product on a first-in-first-out basis. 3.4 Stock identified as out of date will be removed from the patient’s home with the patients consent

and replaced by the Contractor upon approval from the Purchasing Authority. 3.5 To ensure against over-provision, the Contractor, as required or requested by the Purchasing

Authority, will at regular intervals not exceeding three months duration, undertake a stock check of items delivered to the patients home with patient consent to ensure stocks are within agreed levels and dates. The information obtained from such stock checks will be presented to the Purchasing Authority. The Purchasing Authority may wish to carry out its own check of stocks at a patient’s home. Any shortage or surplus stock should be reported as an incident (non-compliance).

4. Waste and disposal 4.1 The Contractor will be responsible for the safe disposal of the patient’s clinical waste (in

accordance with legislation ruling at any time during the framework period on the collection, transportation and disposal of hazardous waste) at intervals agreed with the Purchasing Authority and will provide approved sharps disposal boxes and appropriate clinical waste bags or containers.

4.2 All current UK and EU law and regulations on medicines waste must be adhered to by the

Contractor.

4.3 The delivery personnel must remove all delivery packaging.


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5. Staffing and compliance 5.1 The Contractor must ensure that all staff having face to face access to patients, have undergone

Criminal Records Bureau (CRB) clearance. Contractors will bear the cost of carrying out these checks and will indicate how often these are reviewed and how frequently staff are re-checked.

5.2 All delivery staff, own or courier should be trained adequately in all appropriate aspects of their

part of the service and in patient’s confidentiality requirements. 5.3 The service is to be provided in a courteous, helpful and confidential manner. Drivers are to be

flexible and respect patient’s needs. Products must only be delivered and signed for to the agreed location.

5.4 The Contractor will adhere to the conditions of entry into the patient’s home which may be laid down from time to time by the Purchasing Authority or the patients themselves.

5.5 On no account should any agent or servant of the Contractor enter into the patient's home unless

requested by the patient for any reason. The Contractor will issue specific instructions and take all necessary steps to ensure compliance with this.

5.6 The delivery personnel will carry identification, to be shown on arrival and of smart appearance

and fully conversant with the delivery system. Wherever possible, patients should receive deliveries from the same driver. Patients must be informed in advance, if there is to be a permanent change of driver or if the regular driver is on holiday, or if a courier service is to be used.

5.7 The delivery transport must not bear any markings other than those required by law. 6. Receipt of delivery 6.1 The Contractor must have a list of designated signatories (name and example signature) who are

the only persons who can sign on receipt of delivery. The delivery driver must have a copy of these signatories to match with who is signing on delivery.

6.2 The Contractor must give patients the opportunity to provide an alternative and/or additional

delivery address. This information will form part of the Contractor’s welcome pack. 6.3 All deliveries require a signature. If a patient is not contactable, the Purchasing Authority must be

notified immediately unless previously agreed. 6.4 If the Purchasing Authority agrees to a postal delivery service then postal deliveries will be first

class and require a signature. If a patient is not available a card will be left explaining when and from where the parcel may be collected.

6.5 All Contractors should have the facility and procedures for holding keys for patients, if requested.


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6.6 If there is no-one at home at the agreed delivery date and time, the driver will speak to the co-ordinator who will in turn liaise with the Purchasing Authority. If a second delivery has to be organised, a supplementary charge may be levied to the Purchasing Authority. The supplementary charge will not be levied if the patient is absent due to a sudden hospital admission that the Purchasing Authority may be unaware of.

7. Patient support 7.1 The Contractor should monitor usage trends and will inform a designated person of the

Purchasing Authority immediately, with regard to any patient who gives cause for concern. Areas of concern may include evidence of neglect, poor stock control, over or under use of product, deteriorating health. The Purchasing Authority should also be notified if there are any areas of concern, such as poor stock control or under or over usage.

7.2 At the initiation of a service for a new patient, for a first time delivery to a patient, a minimum of

three working days notice must be given by the contractor of the patient's first delivery. 7.3 Where delivery is not made to the patient directly, the Contractor must make contact with the

patient post delivery to ensure that the patient has received the medicines within 24 hours. 7.4 All contact between the Contractor and the patient must be logged by the contractor with a full

audit trail and made available to the Purchasing Authority on request. 8. Compliance with the Appropriate Policies 8.1 The Contractor shall ensure, when in the patient’s home, that its employees and agents shall in

the performance of this framework comply with all relevant health and safety policies and working practices in force within the Purchasing Authority from time to time (including without limitation smoking and alcohol consumption policies).

9. Holiday Service 9.1 The Contractor will be required in exceptional circumstances to provide additional supplies to

cover patient holidays and travel away from home. The supplier should ensure it is clear whether this can be provided free of charge. Where this is not feasible, details of the approximate cost of a holiday service should be identified. The holiday service should be able to deliver and/or arrange all medicines, including third party ancillaries and equipment. A local contact name or number in case of queries should be identified. The Contractor is also required to comply with the NHMC's UK specification on holiday services. All subcontractors must comply with these terms.


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Specification document for Homecare Medicines –

Product Prescribing and Dispensing 1. The dispensing process 1.1 All prescriptions must be signed by a legally authorised prescriber and screened and validated by the

appropriate clinical pharmacist at the Purchasing Authority.

1.2 The product and/or medicine must be dispensed and labelled in accordance with current legislation by the Contractor. The Contractor must supply examples of current labels before the adjudication meeting.

1.3 All prescriptions must be additionally clinically checked by a registered pharmacist at the Contractors

premises and undergo final dispensing accuracy checks by a registered pharmacist or registered technician.

1.4 The Contractor must have documented procedures for batch tracing and to facilitate batch recall. This

must be implemented and maintained in line with MHRA guidance. 1.5 Contractors must supply all products and medicines as agreed. 1.6 The Contractor must supply all dispensed licensed product and/or medicine with a full manufacturer

patient information leaflet 1.7 It is the responsibility of the Contractor to put right any failure to dispense the full supply required within a

timescale that ensures the patient has their required dosage at all times. The Contractor must show evidence of contingency arrangements and processes in the event of a short-fall in supplies.

1.8 All dispensed product and/or medicine supplied to patients by the Contractor must have a shelf life which is appropriate to the duration of treatment.

1.9 The pharmacist employed/engaged by the contractor has the legal responsibility of ensuring that the

patient has adequate information with respect to the dispensed medicine. Patient information can be given by the dispensing pharmacist, purchasing authority or other healthcare worker who has appropriate professional training. The professional responsibilities should be known to all parties.

2. Product and/or medicine manufacture 2.1 For blood products and unlicensed medicinal products, records of supply, including batch number and

expiry date must be kept by the Contractor for all patients, for the statutory period by the Contractor. The Purchasing Authority will share its unlicensed medicines policy which the contractor must comply with.

3. Packaging and labelling requirements 3.1 All product and/or medicine supplied by the contractor against prescription shall be packaged for each

patient and shall be clearly individually labelled with the name or unique patient identifier of the patient, date of dispensing and delivery date.

3.2 The Contractor will comply with the General Pharmaceutical Council (GPhC) Standards for home delivery

of product and/or medicine or machines and will ensure the integrity of the product is maintained throughout the delivery process.


37

3.3 Before dispatch the Contractor should ensure that the weight of any package over 5kg is clearly specified

on the external packaging of the product and/or medicine. 3.4 Contractors must adhere to MHRA and NPSA guidance 'Best Practice Guidance on the Labelling and

Packaging of Medicine or Product’. This guidance is subject to review and is re-issued annually. 3.5 The Contractor must ensure that all product and/or medicine are stored, transported and delivered in a

clean condition in accordance with those specified by the product license holder and manufacturer. The patient reserves the right to return and/or reject goods which, upon inspection, after delivery, are found to be in a damaged condition. The reasons for any faulty or spoiled products will be notified by the Contractor to the Purchasing Authority in writing within 24 hours of the complaint or sooner where deemed appropriate

3.6 The Contractor must ensure that packs are sealed as appropriate. 4. Product and/or medicine recall 4.1 In the event of the goods being recalled, initiated by the manufacturer of the goods, the Secretary of State

for Health or MHRA (or any such similar regulatory body), the Contractor shall, without delay arrange for the collection of such goods and credit the Purchasing Authority for any goods delivered but unused by the patient including part-used product and/or medicine.

4.2 The Contractor must report the outcomes to the Purchasing Authority of all product and/or medicine

recalls that may affect the product and/or medicine included in this framework, whether any faulty batches have been found or not.

4.3 The Contractor should recover any expenses associated from the manufacturer. 4.4 Product and/or medicine within the expiry date which have spoiled as a consequence of the manufacturing

process or poor packaging will be withdrawn. 4.5 Any spoiled product and/or medicine will be uplifted with patient consent, from their home, by the

Contractor by the next working day at no cost to the Purchasing Authority. 5. Quality control, COSHH and issues 5.1 The Contractor shall operate and maintain a quality control monitoring system which meets the

requirements of the MHRA and/or General Pharmaceutical Council (GPhC) and is approved by the Purchasing Authority and make available to Purchasing Authority on demand the results of such quality control monitoring.

5.2 The Contractor shall operate and maintain compliance in relation to quality and/or environmental

standards (ISO 9001, 9002, 14001, QS 9000, ML, PL MHRA guidance note 14). 5.3 The Contractor shall reply within 24 hours in writing to all enquires and complaints by the Purchasing

Authority relating to the quality, performance and availability of the goods notwithstanding that the grounds for such enquiry or complaint may be inherent in the specification.


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6. Product and/or medicine licensing 6.1 Each party’s rights and obligations arising in connection with this order shall be suspended unless and

until the Contractor can demonstrate to the Purchasing Authority’s satisfaction that:

• the Contractor has a valid MHRA wholesaler dealer license and/or is registered with the General Pharmaceutical Council (GPhC);

• the goods have a valid product licence awarded by the MHRA or EMEA applicable to all

categories of the goods; and

• the goods have been supplied in accordance with current legislation and if such goods are medical devices that they are CE marked.

7. Product and/or medicine purchasing by Homecare Contractor 7.1 The Contractor must seek agreement with manufacturers and wholesalers to provide product and/or

medicine at the Purchasing Authority framework prices.

7.2 The Purchasing Authority is responsible for ensuring that the Contractor has updated framework prices throughout the duration of the framework period.

7.3 The Purchasing Authority will inform the Contractor of any and all start dates of new prices if frameworks are re-negotiated with manufacturers. Product and/or medicine provided by manufacturers or wholesalers to the Contractor for the use of patients of the Purchasing Authority under this framework are not for resale by the Contractor to any third party.

7.4 All new product and/or medicine that become available during the framework period are to be offered to the Purchasing Authority at framework price, i.e. the same level of discount as all awarded product and/or medicine on the framework, after prior approval of the Purchasing Authority.

8. Product and/or medicines liability 8.1 The Contractor shall ensure that they comply with the requirements of all relevant legislation, Codes of

Practice and guidance relating to good and correct practice and particularly in relation to product liability at Common Law and under Statute - such as the provisions of the Consumer Protection Act 1987.

8.2 The Contractor will be responsible for the ordering, receipt, control and payment for all product and/or medicine from nominated Contractors and will be responsible for the maintenance of adequate stock levels to satisfactorily meet the requirements of this framework.


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Specification document for Homecare Medicines – Equipment and Ancillaries

1. Provision of equipment and maintenance 1.1 The Contractor must provide and pay for all equipment required for the safe and effective storage

and administration of the medication except where the Purchasing Authority has requested the use of its own equipment.

1.2 Where servicing and maintenance are required by the Purchasing Authority for its own equipment, the maintenance service will be fully comprehensive. The Terms and Conditions applicable to any Maintenance Contracts arising as a result of this purchase are ‘NHS Conditions of Contract for the Maintenance of Equipment’ July 2007. Suppliers should complete the enclosed maintenance schedule detailing the service they intend to offer.

1.3 All equipment provided by the Contractor should come with a complete set of data sheets with

clear instructions for use.

1.4 The Contractor will possess current GMP certification or CE accreditation if equipment is to be supplied in a sterile condition. The Contractor must be registered to ISO 9001:2000.

1.5 The Contractor will be required to take responsibility for servicing, maintenance and emergency

support for all equipment used to provide the treatment. 1.6 Where replacement equipment is required, the Contractor will provide this to the patient in a time

frame agreed with the Purchasing Authority based on the clinical needs of the patient.

1.7 Any modifications to equipment which affects its operation will be accompanied by additional training for staff and patients as appropriate as requested by the Purchasing Authority and provided by the Contractor at no extra cost.

1.8 The Purchasing Authority reserves the right to state which suppliers and supply route the

Contractor will use to obtain equipment and consumables for the treatment of their patients. 1.9 The Contractor will be responsible for providing a complete maintenance service for equipment

used by patients at home. The Contractor will put into place a protocol to ensure that the maintenance provided satisfactorily meets the Purchasing Authority’s and equipment manufacturer's requirements. The equipment supplier may provide the maintenance service directly or may liaise with the Contractor to ensure that maintenance and emergency provision of equipment is efficiently managed.

1.10 Syringe drivers and infusion pumps will be serviced at annual intervals. A loan-equipment

replacement option will be provided for equipment removed from the patients home for repair, testing or periodic servicing.


40

1.11 Repairs will be performed or replacement equipment provided by the Contractor to the patient in a time frame agreed with the Purchasing Authority based on the clinical needs of the patient of a fault being reported to them. Such a loan shall be deemed to be a Contract for the Hire of Goods as defined by section 6 of The Supply of Goods and Services Act 1982.

1.12 The Contractor should provide a manual to include step by step instruction on how to use the

equipment. It should give problem-solving help lines and the name and telephone number of the co-ordinator should be provided. DVD and/or video and/or audio tape to aid training, in the patient’s home are also useful options. Technical literature of equipment is also to be provided if necessary.

1.13 Where appropriate there should be a separate instruction manual for children. 1.14 The Contractor should provide a check list so that an appropriate clinician can assess the patient

as competent to use the equipment and the patient can countersign. A copy of this will be kept in the patients notes.

1.15 All information should be regularly updated in order to reflect any developments and/or

innovations in delivery systems and equipment. 2. Refrigeration 2.1 The Contractor will supply a suitable medicines refrigerator, which has been PAT tested and

should be installed by the Contractor into the patient’s home prior to the first scheduled delivery of medicines. If there is no fridge provided because the volume of refrigerated product is deemed too small by the Purchasing Authority to warrant its own fridge, then the patient must need to have suitable space in their own domestic fridge and be trained on how to store the product and monitor temperatures according to the manufacturer’s instructions by the Contractor. Appendix eight example refrigerator specification.

2.2 A permanent record of the refrigerator temperature must be made available to the Purchasing

Authority and will be noted each time a delivery is made together with any details or action taken or instructions given to maintain the temperature within acceptable limits of any fridge that has been provided. If the temperature of the refrigerator falls outside the range of +2 degrees C to +8 degrees C, the Contractor will be responsible for advising the Purchasing Authority and seeking authorisation on the continued use of the medical product and the refrigerator.

2.3 Where the Contractor has supplied a refrigerator and where the integrity of the product is compromised due to the failure of the Contractor to service and maintain the refrigerator (if supplied), the Contractor will be responsible for stock replenishment at no additional charge to the Purchasing Authority within a timescale that ensures the patient has the required product to continue treatment.

3. Third Party Ancillary Items 3.1 Ancillary items will be determined by the clinical needs of the patient and will reflect the local

clinical practice of the Purchasing Authority.


41

3.2 Ancillary requirement forms will be completed by the Purchasing Authority at the beginning of a

patients home delivery inclusion. These will be sent to the Contractor who will be responsible for checking ancillary product requirements with the patient in the first pre-delivery call. It is the Contractor’s responsibility to check stock levels and replenish the patient’s additional requirements for ancillary products on a regular basis.

3.3 The Contractor will be responsible for the ordering, receipt, control and payment for all ancillary products from agreed suppliers, and as agreed with the Purchasing Authority, and will be responsible for the maintenance of adequate stock levels to satisfactorily meet the requirements of this framework. The Contractor will ensure that adequate shelf-life remains on products delivered to patient’s homes.


42

Specification document for Homecare Medicines –

Training and Education for Staff and Patients 1. Training 1.1 Contractors should supply information on the level of knowledge and expertise on the medicines

and equipment used in the clinical specialities of their staff involved in homecare services provision, including the methods and frequency of training and accreditation used. The Purchasing Authority should check the contractors training manuals and accreditation status to ascertain they are equivalent of the Purchasing Authority. Any gaps indentified need to be addressed.

1.2 Where the Purchasing Authority changes it's provider of medicine or device, the Purchasing

Authority may require the Contractor to provide the retraining of patient's in the use of the new medicines or device. If the change of medicine or device is enforced upon the Purchasing Authority by the manufacturer, of the medicine or device, then the Contractor should seek the re-training costs from the manufacturer.

1.3 Contractors must agree with the Purchasing Authority a training and education plan detailing the

implementation of the new framework. This will include timescales, number of company resource available and a detailed training programme. This should be completed in line with the framework start date.

1.4 Training of patients and/or carers will be agreed by the Purchasing Authority and Contractor and

will be designed according to individual need. In certain circumstances training may be initiated by the Purchasing Authority and continuing education and training devolved to the Contractor.

1.5 Prior to hospital discharge, there should be a facility if requested, whereby the Contractor has

nursing personnel trained to appropriate agreed standards. Such personnel should be available to do patient and/or carer education at ward level or at the patients home throughout the framework period and should be prepared to undertake further training until patient and/or carer are competent. If this level of competence is not attained then self administration should not be considered. There should be signed agreement of training delivered by both parties.

1.6 If a nursing service is required by the Purchasing Authority, training of the Contractors clinical nurse specialist will be undertaken by the Purchasing Authority. This training should include level three clinical knowledge to ensure competence in Trust protocols. All clinical nurse specialists employed by the Contractor must be deemed competent by the specialist nurse within the Purchasing Authority before commencing delivery of hands on patient care.

1.7 The Contractor must provide therapy specific on-going training and education support. This will

include:

• Delivery of training packages to the Contractor's and Purchasing Authority's new staff; • Refresher courses for existing staff; • Provide access to advice and/or support on to patients;


43

• Regular training focusing on Audit and new Developments in the therapy; • Educational materials which support the current use of their products and services.

These would include product data (which is regularly updated), computer generated slides, videos, and interactive learning tools. This should be available free on loan;

• Instruction manuals translated into various languages, in pictorial format, and large print where appropriate;

• Separate instruction manual and training programme for children where appropriate; • Check list so that the patient and/or carer can self-evaluate whether he or she has been

appropriately trained. A copy of this will be placed in patients notes; • Supply of results of regular regional and/or national audits for benchmarking purposes.

2. Patient and carer education and information 2.1 Contractors should provide and demonstrate how they are able to provide communication tools

such as leaflets, brochures, and other media to patients, carers, and staff, samples to be provided.

2.2 Contractors should include how they will ensure patient confidentiality and data protection is

respected in all aspects of the homecare services provided when training is received by their staff.

2.3 Should a patient and/or carer not be fluent in English, information should be provided in their own

language. Contractors should indicate which languages they are able to provide this service for at no extra cost.

2.4 The Contractor will provide each patient with a ‘welcome pack’ that has been agreed with the

Purchasing Authority, detailing useful and helpful information, as a minimum this should include details on:

• Welcome – role of the driver and provider • Therapy information – description of service and items they will receive • Training and support – help cards • Ordering and delivery information – stock management, customer care teams, what to do

if…. driver details • Contacts – out of hours • Holiday and Travel service • Glossary of terms. • Prescription Queries


44

Specification document for Homecare Medicines – Nursing Services

1. Nursing Services 1.1 The standard of nursing care provided will be comparable in every way to the care that a patient would

expect to receive in a hospital setting. 1.1 This guidance gives an outline of the minimum nursing services required to treat a home patient, however

the specific care will be dependant on the therapy and speciality.

1.2 The purchasing authority will identify and authorise the requirement of nursing services as part of the approval process.

1.3 The Contractor must employ suitably qualified nursing staff for adults and children as appropriate, this level of care will be agreed with the Purchasing Authority.

1.4 The Contractor must ensure that the nursing staff they employ have been legally checked specifically:

• The Nurse has a current NMC (Nursing and Midwifery Council) registration. The Nurse has sufficient

experience and skills, and/or has received sufficient training, as applicable, to enable him/her to carry out his/her duties in the delivery of the Services.

• As a registered nurse, the Nurse is subject to the Nursing and Midwifery Council Code.

• The Nurse is subject to a satisfactory Criminal Record Bureau (enhanced disclosure) checks and with

effect from 1 July 2010 the Nurse will be registered with the Independent Safeguarding Authority.

• The Nurse is subject to satisfactory pre-employment medical checks and holds a valid Fitness to Practice certificate issued by an independent occupational health provider.

• The Nurse should have a personal portfolio with a summary of their verified qualifications and Personal Identification Number issued by the NMC as well as, CRB and pre-employment medical screening, generic training and competency assessments/validations available for inspection.

1.5 The contractor must facilitate CPD for all employed nursing staff and must demonstrate for all staff:

• job specifications • orientation and induction • evidence of CPD • individual’s responsibility towards Health and Safety.

1.6 The Contractor must ensure the nursing staff have been assessed as competent in: • phlebotomy • knowledge of phlebotomy in relation to specific medication – blood tests throughout the course of

treatment • cannulation


45

• intravenous therapy in line with RCN and NMC guidelines • anaphylaxis management/ basic life-support • relevant equipment management • aseptic technique • adult and paediatric management which is evidence based in line with NICE guidance • side effect management • disease awareness • specific therapies as prescribed.

1.7 Contractors must ensure nursing staff have knowledge of clinical governance and be committed to clinical supervision, customer care and complaints handling.

1.8 Contractors must ensure that nursing staff are given copies of hospital and PCT policies and comply to work

within them including:

• Medicines Policy • Anaphylaxis Management Guidelines • Infection Control Manual • Policy for consent to examination or treatment • Health and safety • Records Management Policy • Zero tolerance and policy for the withdrawal of care • Lone Worker Policy (incorporating working alone care and chaperoning) • Resuscitation Policy and Guidelines • Confidentiality • Data protection • Acceptance of gifts • Adverse incident reporting policy

1.9 Contractors must ensure that the risk management policy is calculated in collaboration with the Hospital/

PCT Clinical Governance Departments and be deemed to be of an acceptable risk score.

10.1 Example of a Rick Management Tool 10.2

RISK MANAGEMENT TOOL IMPACT LIKELIHOOD

2- MINOR

2- UNLIKELY 4- Acceptable Risk

Potential Risks- Patient safety Anaphylaxis All nursing staff involved in the administration of will be trained in the treatment of

anaphylaxis and will act in accordance with the agreed anaphylaxis policy. Anaphylaxis kits will be replaced yearly.

MRSA Patient will receive either a daily cannula or the peripheral cannula will not stay insitu for greater than 72 hours, which falls within infection controls guidelines.

Intravenous Cannulation

The nurse will remain with the patient for the duration of the infusion. The nurse competent in cannulation and IV administration will observe the cannula forsigns of tissuing regularly. If the nurse suspects tissuing they will remove the cannula immediately. The nurse will not attempt more than 3 unsuccessful cannulations.


46

Training- All nurses must complete a cannulation-training course and be have level of competence assessed.

Infection Control Disposable sterile dressing packs will be used in the home setting to reduce the chance of infection. It is considered best practice to use volumetric pump to regulate the infusion flow rate. This will wiped with 70% alcohol between each patient contact as infection control procedures.

Blood spillages- In the unlikely event that a blood spillage occurs, the nurse must act in accordance with the infection control policy.

Disposal of sharps The nurse will carry a sharps container with them and remove this from the patient’s home following each infusion in accordance with infection control policy.

Cardiac arrest In the unlikely event of cardiac arrest the nurse will carry a mobile phone to call 999. The nurse will then start CPR, using a mouthpiece in accordance with the resuscitation policy. All nurses must attend a yearly mandatory CPR training update.

Potential risks- staff safety Violent patient The nurse must act in accordance with the Zero tolerance and policy for the withdrawal of

care. Buddy system It is considered best practice to ensure that another member of staff knows where the nurse

is at all times. Transportation of drug

The nurse will collect the drug in person store in a secure facility.

Contractors must outline transparent procedures for handling of concerns or complaints with full details on how to contact their Medical Director

Contractors must maintain professional indemnity (medical malpractice) insurance and encourage nursing staff to ensure they are professionally indemnified personally by membership of an appropriate union such as The Royal College of Nursing. Contractors must ensure that nursing staff deliver clinical procedures and services in accordance with written protocols agreed with the hospital/ PCT. Contractors will ensure that the Hospital / PCT designate an appropriate suitably medically qualified Practitioner to be available for the Nurse to contact at all times whilst the Nurse is involved in delivery of the service. The named hospital / PCT Designated Practitioner will obtain in advance any approvals required for delivery of any of the services. They will also ensure that the Nurse is provided with adequate facilities and information for the performance of the services in accordance within agreed protocols and parameters.

Contractors must ensure that Nursing staff are responsible to the Hospitals/ PCT Designated Practitioner, in respect of clinical matters.

The Hospital / PCT must ensure that all patients are informed that their personal information may be shared with other healthcare professionals and may be used to support clinical audit for the purpose of assuring and monitoring the quality of their treatment.


47

Contractors must use its best endeavours to ensure that any services are performed at the times and venues agreed between the parties and shall give as much notice as reasonably practicable if for any reason they are unable to deliver any services at times and venues agreed between the parties.

Contractors must ensure that in accordance with NMC code of conduct the Nurse will keep confidential all patient identifiable data to which the Nurse may have access during the provision of the Services. The Nurse will deal with all confidential information in accordance with any reasonable policy of the Recipient in accordance with clause 11 hereunder and in accordance with the provisions of the Data Protection Act 1998.

Contractors must ensure that the Nurse will not remove any patient identifiable information from the Recipient’s premises at any time other than as set out in the service documentation. The Nurse may report anonymised aggregated data to other parties only if the Nurse has obtained written consent from the patient to the anonymisation of their data and the reporting of anonymised aggregated data in accordance with a consent form. The contractor will ensure that they use only anonymised data so that no individual patient or Trust can be identified by name or other characteristics in publications or in educational and/or promotional materials and that all data will be processed in accordance with the Data Protection Act 1998. Contactors will ensure that the Nurse will obtain informed consent from the patients prior to participation in the service and that the Nurse will ensure that patients are clearly informed that they have the right to refuse such consent and participation.

2. On Call service 2.1 The Contractor will provide an out of hour’s service. Such a service will support the purchasing authority’s

patients where circumstances dictate there are issues that need resolution. Such a service will also make use of a variety of forms of communication technology that will be specified in the out line of the service.

2.2 The hours of contact should be from: • Nursing support 7:00am to 10:00pm, 7 days a week (including bank holidays).

It is important to realise that the service hours of a nurse may extend beyond this in attending to a patients needs.

• Administration support 8:00am to 6:00pm, 5 days a week excluding bank holidays.

3. Nursing support services 3.1 Patient support:

• Nurses will have the duty to advise over the telephone or provide attendance at patients homes.

3.2 Nurses have a responsibility to report to the Purchasing Authority immediately of any errors or adverse events. The Contractor must ensure clear guidelines and procedures are developed and communicated to all nurses to follow if any adverse reactions occur.


48

Award criteria and weightings - details for adjudication purposes

Framework Agreement for a Home Delivery Service -

XXXXXXX

OJEU Reference

Offer Reference Ref Indicators Weight Reference Supplier A Supplier B Supplier C Supplier D Supplier E Supplier F Supplier G

Supplier infrastructure of home delivery company SUP1 Description of service - premises,

structure, company profile, contact names, confidentiality, previous

homecare experience, implementation programme, communication leaflets

[5a_12.1] [5b_4.1] [5b_4.2] [5d_2.3] [5d_2.4] [5d_2.5]

SUP2 Experience of HIV homecare delivery [5e_1.1] [5e_2.1]

SUP3 Training and education of staff - methods and frequency of training and accreditation used, records of training

[5b_4.3] [5b_4.4] [5b_4.5] [5b_4.6] [5b_7.1] [5b_7.2] [5d_1.1] [5d_1.2]


49

[5d_1.3] SUP4 Method of recruiting / registering

patients - patient consent form, registering patients, patient

confidentiality

[5a_5.2] [5a_5.3] [5a_5.4] [5a_5.5] [5a_5.6] [5a_8.3] [5a_10.1] [5d_2.2] SUP5 Adherence to legal and advisory

practices e.g. COSHHProduct licensing and product liability.EU lawHealth &

Safety

[5a_13.1] [5c_5.1] [5b_3.6] [5b_8.1] [5c_7.1] SUP 6 Member of the National clinical

homecare association (NCHA)

Supplier infrastructure Total

Quality Assurance QA1 Performance standards i.e. Quality std,

service performance, complaints, contingency planning, disposal, patient

survey

[5a_6.1]

[5b_1.6]

[5b_3.5]

[5b_6.6]

[5b_7.3]


50

[5c_1.7]

[5c_2.2]

[5c_2.3]

[5c_3.8]

[5c_3.7]

[5c_4.1]

[5c_4.2]

[5c_4.3]

QA2 Prescription process, validation, length, records, errors [5a_9.3]

[5c_1.1]

[5c_1.2]

[5c_1.3]

[5c_2.2]

QA3 Audit i.e. proof del, service reporting, complaints, contingency planning [5b_5.1]

[5b_6.4]

[5b_1.3]

[5b_6.5]

[5b_3.4]

Quality Assurance Total

Storage and Distribution DIST1 Delivery of medicines - post, vehicle,

courier, emergency, failures to deliver, lost medicines, traceability, product

[5a_5.7]

[5a_5.9]


51

recall, cold chain, waste disposal [5b_1.1]

[5b_1.2]

[5b_1.4]

[5b_1.5]

[5b_1.8]

[5b_2.1]

[5b_2.2]

[5b_3.2]

[5b_3.5]

[5b_4.7]

[5b_4.8]

[5b_4.9]

[5b_5.2]

[5b_5.4]

[5b_5.5]

[5b_5.6]

[5b_5.8]

[5c_1.4]

[5c_1.6]

[5c_1.8]

[5c_1.9]

[5c_1.10]

[5c_1.11]

[5c_3.1]

[5c_3.2]

[5c_3.3]


52

[5c_3.5]

[5c_3.6] DIST2 Drug purchasing by Homecare supplier

- agreement from manufacturer, access/updating contract pricing

[5c_6.1]

[5c_6.2]

[5c_6.3]

Storage and Distribution Total

Customer Services CUST1

Provision of Data [5a_8.1]

[5a_8.2]

[5a_8.3]

[5a_8.4] CUST2

Customer services, communication, free phone help lines, response time [5b_6.3]

[5a_11.1]

[5a_11.2]

[5b_6.3]

[5b_6.4]

[5b_6.5]

[5b_7.2]

[5b_1.10]

[5b_5.4]

[5d_2.1]

CUST3

Invoicing and payment - invoice queries, payment method, discounts, e- 5 [5a_9.1]


53

commerce arrangements, emergency delivery [5a_9.2]

[5a_9.3]

[5b_1.2]

[5c_6.4]

[5c_7.2]

Customer Services Total 18

Price Total Score

Offer schedules

Homecare Service Total 100 0 0 0 0 0 0 0


54

Commercial Medicines Unit homecare medicine team. Commercial Medicines Unit Castle View House East Lane Runcorn WA7 2AA Liz Payne Category Manager Tel. 01926 857313 [email protected] Carol Clark Category Specialist Tel. 01282 850672 [email protected] Simon Perkins Category Specialist Tel. 01928 794601 [email protected] Karen Bell Sourcing Specialist Tel. 01928 794615 [email protected]





55 May 2011 © Crown Copyright 2011

Appendix 1 Glossary of Terms Name Acronym Description

Accredited checking Technician

ACT Accredited checking technician jobs are similar to pharmacy technician jobs. While the latter receives the prescription, takes out the drugs from shelves and packs them, the former checks the dispensed prescription for its accuracy. Checking, labelling and packing have all become formal procedures and the accredited checking technician will be trained in all these in a pharmacy context.

Benefits Tracking Tool BTT Benefits Tracking Tool. Integrated date warehouse and reporting tool providing stakeholders with a single point of access for their management information. Manages the performance of CMU framework agreements maximise compliance by NHS trusts to improve future estimates of framework agreement and product volumes and values.

British Pharmacopoeia BP The British Pharmacopoeia (BP) is the authoritative collection of standards for UK medicines

British Standard BS British Standards are produced by BSI British Standards, a division of BSI Group that is incorporated under a Royal Charter and is formally designated as the National Standards Body (NSB) for the UK.

BS 7320 British standard specification for sharps containers

Benefits Tracking Tool BTT BTT is an integrated data warehouse and reporting tool providing our stakeholders with a single point of access for their management information.

Collaborative procurement hubs

CPH’s Collaborative procurement organisations within the NHS, generally referred to as collaborative procurement hubs (CPHs), commercial procurement collaborative (CPCs) or supply management confederations (SMCs), consist of NHS trusts and primary care trusts. These are normally within the same strategic health authority or regional boundary, collaborating to make the most effective procurement and supply chain decisions, in conjunction with CMU and other organisations including Office of Government Commerce (OGC) and Regional Developments Agencies, in order to provide best value for stakeholders within their respective health economies.


Contractor Someone whose business is to supply a

particular service or commodity. Can be referred to as a supplier or an offeror

CE Accreditation Declaration of conformity CE Mark CE marking when applied to any product or

equipment indicates that the manufacturer or its authorised representative has declared that the product or equipment complies with all applicable European Directives. The principal function of the EU directives is to ensure free trade of goods within the European Community

Compliance Compliance (or Adherence) is a medical term that is used to indicate a patient's correct following of medical advice. Most commonly it is a patient taking medication (drug compliance)

Criminal Records Bureau CRB Delivery packaging Is any additional packaging that is not

required by the patient following a treatment. Department of Health DH European Medicines Agency EMEA European agency for the evaluation of

medicinal products

European Pharmacopoeia EP The European Pharmacopoeia (Ph. Eur.) of the Council of Europe is a pharmacopoeia, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe

General Practitioner GP Good Manufacturing Practice GMP Good Manufacturing Practice (GMP) is

defined as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.” The principles and guidelines for GMP are stated in the Directive 2003/94/EC for medicinal products.

Quality risk management ICH Q9 ICHQ9 is a document on quality risk management. The principles can be applied in connection with pharmaceutical development and preparation of the quality part of marketing authorisation dossiers

Pharmaceutical Quality System ICH Q10 ICHQ10 is a document on pharmaceutical quality system and provides an example of a pharmaceutical quality system for the entire


product lifecycle. Internal standards organisation ISO ISO 9001: 2008 - Quality management

system

Key performance indicators KPI’S Key Performance Indicators are quantifiable measurements, agreed to beforehand, that reflect the critical success factors of an organisation

Manufacturers Licence ML Medicinal products manufactured in the UK must be produced on a site that holds an appropriate Manufacturer's Licence (ML).

Medicines and Healthcare Products Regulatory Agency

MHRA An executive agency of the Department of Health. Enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all the work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks

Medicines Pharmacy and Industry Group

MPIG MPIG are responsible for the PPRS and report to DH Board who report to the Secretary of State.

Multi disciplinary team Collaborative efforts of professionals from different disciplines toward a common goal. Can be made up of Consultant's, Clinician's, Nurses, Pharmacists and Healthcare Workers.

National Clinical Homecare Association

NCHA Represents and promotes the interests of industries whose business is substantially to provide medical supplies and/or clinical services directly to patients in the community within an appropriate quality framework. Provide a forum for lobbying on issues that affect homecare. Set and debate policy decisions with the National Homecare Medicine Supply Committee and other relevant government bodies.

National Health Service NHS National Health Service Quality Assurance Staff

NHS QA staff

Commercial Medicines Unit (CMU)

CMU is an executive agency of the Department of Health. CMU work to ensure that the NHS in England makes the most effective use of its resources by getting the best possible value for money when purchasing goods and services. We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust


and fact-based judgements to ensure that the benefits to patients and the public justify the risks

National Homecare Medicines Committee

NHMC Facilitated and managed by Commercial Medicines Unit. NHMC formed to develop appropriate systems, policies and procedures in order to assist service users, service providers and patients.

National Institute for Biological Standards and Control

NIBSC The National Biological Standards Board (NBSB) is a non-departmental public body (NDPB) of the UK government. NIBSC provides independent testing of biological medicines for the UK market

National Pharmaceutical Supply Group

NPSG Provide advice to Chief Executive, CMU, concerning the cost effective purchasing and distribution of pharmaceutical products to the NHS in England. Acts as a focal point for the NHS for pharmaceutical issues of a national nature and provide pharmaceutical advice accordingly. Acts as a link between pharmacists and CMU at national level. Advise the Department of Health and pharmaceutical industry on significant commercial matters.

Portable Appliance Testing PAT There is a legal obligation for many businesses and organisations to take precautions to ensure any electrical equipment is safe, maintained and fit for purpose. It has become common practice for PAT testing to be carried out as part of a regular system of maintenance and inspection.

Purchasing Authority Secondary Care Trusts, Primary Care Trusts, Foundation Trusts, Collaborative Procurement Hubs and Confederations

Pharmaceutical Price Regulation Scheme

PPRS A British mechanism for determining the prices the NHS pays for brand name drugs.

Pharmaceutical market Support Group

PMSG Committee of pharmacists from England, Wales, Northern Ireland and Scotland. A representative from each purchasing group or division makes up the English representation. Provide strategic advice to the pharmaceutical industry and contracting groups. The PMSG use market intelligence including Phate analyses and licence and patent information

Pharmex Pharmex collects and stores medicinal


product transaction usage and spend level details from trusts.

Regional Quality Control Regional QC

Royal Pharmaceutical Society Great Britain

RPSGB The Royal Pharmaceutical Society of Great Britain (RPSGB) is the statutory regulatory and professional body for pharmacists and Pharmacy Technicians in England, Scotland and Wales.

Serious Untoward incidents SUI’s An SUI is in general terms something out of the ordinary or unexpected, with the potential to cause serious harm and/or likely to attract public and media interest that occurs on NHS premises or in the provision of an NHS or a commissioned service

Service Level Agreemen SLA A service level agreement (frequently abbreviated as SLA) is a part of a service contract where the level of service is formally defined. In practice, the term SLA is sometimes used to refer to the contracted delivery time (of the service) or performance.

Sub-contractor A subcontractor is an individual or in many cases a business that signs a contract to perform part or all of the obligations of another's contract. A subcontractor is hired by a general contactor (or prime contractor) to perform a specific takes as part of the overall project.

United States Pharmacopoeia USP The United States Pharmacopoeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States.


Appendix 2

Patient Registration Form


Appendix 3 How to organise changeover of suppliers for existing homecare services 1. Purpose

To describe how to change to a new supplier for an existing homecare service. • Appendix 1 summarises the tasks needed to be undertaken by department. • Appendix 2 is intended to be used as an aide-memoire for the tasks. • Appendix 3 is an example of a suggested agenda for each meeting (part 1 and 2).

2. Scope

All staff involved in the homecare service for an area where there is a change in supplier

3. Responsibility Pharmacy Procurement manager 4. Equipment /resources Contract specification, access to meeting rooms 5. Procedure As part of contract award, a member of the procurement team should be nominated as project manager to facilitate the change process. The project manager can then act as a central point of contact for all involved and can have responsibility for ensuring the actions below are carried out efficiently. 5.1. Initial Planning 5.1.1 After award of contract, a meeting to discuss the change management process should be arranged. Typically, this

will be a two hour meeting. The first hour (part one) will include the trust’s multidisciplinary team and the new suppliers. For the second hour (part two), the group will be joined by the incumbent supplier. Ideally this meeting should be arranged within one month of contract award to ensure a timely and efficient transition of services.

5.1.2 Suggested attendees at the meeting: • Lead pharmacist for the therapy area(s). NB: If homecare service is for adults and paediatrics, both lead

pharmacists should be included. • Clinical Nurse Specialist/clinicians for the therapy area(s). NB: If homecare service is for adults and

paediatrics, both Clinical Nurse specialists should be included. • Pharmacy Procurement team. • Appropriate representation from the new supplier. Typically:

o Business Development Manager o Customer Services Manager o Pharmacy/Dispensary Manager o Logistics Manager o Finance Manager

• Appropriate representation from the incumbent supplier. Typically: o Business Development Manager o Customer Services Manager

5.1.3 Send e-mail to new supplier 3 weeks before meeting to establish what information is required from

Trust/incumbent supplier to ensure smooth transition.

5.1.4 Send e-mail to incumbent suppliers 2 weeks before with a request to provide information from the new supplier, typically the following:

i. All patients names on homecare service (including current, on hold, planned and unscheduled patients) ii. Copies of current prescriptions iii. Summary of prescription status (number of deliveries made against it, number of deliveries left, date of

renewal)


iv. Patient demographics by drug/treatment type (name, address, unit number, date of birth, next of kin) v. Hardware - details of any pumps, refrigerators etc in the patients possession that are currently owned by

the incumbent suppliers. vi. List of current ancillary items in the patient’s home. vii. Future delivery schedules viii. Special delivery instructions by patient e.g. alternative delivery addresses, instructions on how to access

property, any patients who currently use the ‘key holding’ facility, if offered ix. Any consent data x. Inventory of current stock holding

5.1.5 Trust to prepare and make available at the meeting all required data received The above information must not be stored on electronic devices, CDs, memory sticks or similar without suitable encryption. It is suggested that the advice of the trust’s data protection and governance manager is sought. 5.2. Meeting - Part One: Suggested Agenda Items 5.2.1 Introductions and welcome - allow the group to meet and all names and job titles minuted for future reference.

5.2.2 Overview of specification - go through key points of the specification to ensure clarity in the expected service level

from the trust and new supplier. 5.2.3 Patient data required - review list of data required by the new supplier/Trust (as requested 3 weeks before

meeting). Ensure systems and deadlines are in place to help with the smooth transition of this information. 5.2.4 Prescription format/requirements - discussion between the clinical team/new suppliers regarding the style and

format of the prescription and registration documents. It may be helpful to provide the new supplier with a copy of the old prescriptions in advance of the meeting. Thought should be given to any lead times with printing and a contingency plan in place should the bespoke prescriptions not be ready in time (e.g. will new suppliers accept prescriptions on stationery from incumbent supplier in the interim?).

5.2.5 Prescription process -

• How long will the prescription be valid for? • What will be the expected turnaround time for new and existing prescriptions? • How should treatment/prescriptions be cancelled? • Will suppliers send a reminder to the Trust informing of expiry of prescription (prescription

management service) or will this be handled by the clinical team? • Will a buffer stock be required?

5.2.6 Delivery Schedule - clarification and agreement regarding how often treatments will be delivered

and any unusual delivery schedules for specific patients. Discussion will also be held with new supplier regarding how patients who currently use a key holding facility will be recruited to the service.

5.2.7 Ancillary list - Clarify and agree list of ancillaries with new supplier and clinical team. Discuss how

ancillaries will be replaced (set monthly amount delivered or ‘topped up’ as necessary). 5.2.8 Removal of waste - Agreement from new supplier of how they intend to handle removal of waste

(i.e. packaging etc) and clinical waste (i.e. full sharps bins, expired stock etc). 5.2.9 Purchase of hardware - discussion surrounding whether new supplier intends to purchase any

relevant hardware from incumbent supplier or provide patients with new equipment (if requested in specification).

5.2.10 Invoicing requirements - agreement on best process for invoicing trust for homecare services. The

Trust need to consider the following:


o Will an order be raised before the prescription is sent or retrospectively? o Who will receive the invoice? o Will any new drug codes/cost centres need to be set up on the pharmacy computer

system? o Will the Trust require a consolidated monthly invoice or an individual invoice?

What data will the Trust require on the invoice (e.g. cost per case drugs will require some way of identifying the patient name. unit number)

5.2.11 Start dates:

o Of contract - Group to suggest a start date of contract which will be agreed in part two of meeting.

o New patients - typically, new patients would start on or immediately after the contract start date with the new supplier. It may be sensible to delay potential new starters until after the new contract start date, unless this would disrupt the patient’s treatment.

o Existing patients - will all existing patients receive their deliveries from one set date or will there be a phased approach (in cases of large patient numbers)? The main issue surrounding the transfer of existing patients is how to handle the mid prescription patients i.e. they have received half their deliveries against a six month prescription. This can be handled one of three ways:

Process Pros Cons 1) Rewrite all prescriptions with a new six month validity

• Assured accuracy and currency of new prescriptions

• Transcription can take place directly from copies provided by incumbent supplier

• Large workload for clinical team • Prescriptions will all expire at same

time in six months

2) Rewrite the remainder of the prescription i.e. if two months of treatment have been made against a six month prescription, new prescription is written for four months

• Would ensure that prescription expiry is staggered


• May prove to be a complicated task • Would require detailed information and co-

operation from incumbent supplier • Greater possibility of error in delivery times

3) Stagger the changeover of contract. Patients come on to the new service upon expiry of old prescription

• Would reduce bottleneck of workload for all staff


• Would prolong the length of time taken to transfer patients (up to six months)

• Would reduce any savings made on contract.

5.2.12 Contacting patients - key staff from the Trust and new supplier should be given the responsibility of contacting

patients. The patients should be contacted in a three stage approach: i. Letter from the Trust informing patients of change, when change will be effective from, reasons for

change and reassurance that their care will not be affected. ii. Goodbye letter from incumbent supplier informing patient that their deliveries will be made by another

supplier effective from the agreed date. The letter should be agreed by the Trust before being sent to patient.

iii. A welcome letter and welcome pack from new supplier, reassuring patient of seamless care, and informing them of their new contact number and the date from which the change will be effective. This letter should be agreed by the Trust before being sent to patients.

5.2.13 Review and summary of actions. Each agreed action should have a date of completion and a person responsible. 5.3. Meeting - Part Two: Suggested Agenda Items 5.3.1 Introductions and welcome - Introduce the incumbent suppliers to the rest of the group from part one.


5.3.2 Required patient data - review of data provided by incumbent supplier to ensure all required fields of data have been provided. The clinical team will carefully review accuracy of data after the meeting and feedback to incumbent supplier any errors.

5.3.3 Ancillary items - agreement requested from incumbent supplier that ancillary items currently with the patient will

not be removed upon contract termination. 5.3.4 Hardware - person identified from new supplier and incumbent supplier charged with negotiating over the sale of

hardware. Agreement should be reached within one week of date of meeting and fed back to project manager. 5.3.5 Proposed start date of contract - discussion by all on the feasibility of start date. 5.3.6 Existing patients - agreement made between all regarding the most efficient process of managing the transfer of

existing patients. 5.3.7 Contacting patients - incumbent supplier to be informed that patients will require a letter to say goodbye and

wishing them well for the future. The letter shall be sent after initial contact by the Trust has been made. Project manager to agree letter and advise incumbent supplier when to issue.

5.3.8 Review and summary of actions. Each agreed action should have a date of completion and a person responsible. 5.4. Tasks for clinical team following meeting 5.4.1 Arrange letter to inform patients of change and provide telephone number of a Trust contact who they can call if

they have any questions. 5.4.2 Rewrite any prescriptions or registration forms required by the new supplier in advance of first delivery. 5.4.3 Check the list of patient demographics and prescription copies provided by incumbent supplier for accuracy 5.4.4 Review and follow-up any named actions resulting from the meeting 5.4.5 Notify project manager once a task has been completed. 5.5 Tasks for new supplier following meeting 5.5.1 Print new prescriptions and registrations forms in agreement with requirements of clinical team. 5.5.2 Arrange deliveries for existing Trust patients to ensure seamless care. Deliveries should match closely the next

expected delivery date by the incumbent supplier. Patients should not be left without treatment beyond their due date.

5.5.3 Upon notification by Trust, the new supplier will send out welcome packs and letter to patients stating the

following: i. Brief overview of company ii. Reassurance that they will receive seamless care and quality service iii. A named contact at the company along with a direct telephone line, preferably free-phone or

geographical number. iv. A back up contact in case of absence or holiday v. A 24 hour emergency number if appropriate vi. Date of next delivery

5.5.4 Negotiate with incumbent supplier regarding purchase of hardware. Negotiations should be completed within one

week of meeting. If agreement cannot be reached, new supplier will have a contingency plan to replace hardware. 5.5.5 Arrange a key holding service for patients if required as part of contract.


5.6. Tasks for incumbent supplier following meeting 5.6.1 Arrange goodbye letter to patients 5.6.2 Enter into negotiations with new supplier regarding purchase of hardware. If agreement cannot be reached,

incumbent supplier will arrange for removal of hardware from patients home. This will be conducted discreetly and at the patient’s convenience and soon after installation of new equipment by new supplier.

5.6.3 Incumbent supplier will be fully compliant in the transfer of patient data and ensure that such data is transferred

securely. 5.6.4 Patients who have provided a key to the incumbent supplier for access to house during deliveries will have their

key returned to them securely with last delivery or before end of contract date. 5.7. Miscellaneous tasks following meeting 5.7.1 A robust invoicing system set up. Trust may need to add new drug codes and/or cost centres to stock

management system. 5.7.2 Arrange follow up meeting at least one week prior to contract start date to review actions if necessary. Meeting

should include all named contacts including incumbent supplier. 5.8 Tasks following start of contract 5.8.1 Clinical teams to feed back to project manager any initial problems 5.8.2 New supplier’s named contact will also act as trouble-shooter for initial problems 5.8.3 Meeting to be arranged after two months to assess changeover process. 5.8.4 In liaison with Trust, new supplier will conduct a patient survey to assess the effectiveness of the changeover.


Task list for changing contract to new supplier for homecare medicines 1. Pharmacy Procurement Team Tasks After award of contract: 1.1 Identify key staff to attend a change management meeting and assign a ‘project leader’ to manage the changeover of

suppliers. 1.2 Arrange change management meeting between clinical teams, new supplier and incumbent supplier. 1.3 Book room for meeting. 1.4 Notify attendees of time and venue 1.5 Request details from new supplier regarding what information they need for the meeting 1.6 Arrange agenda for meetings 1.7 Send meeting agendas to clinical team and new supplier 1.8 Send relevant section of meeting agenda to the incumbent supplier 1.9 Send list of requirements identified in 1.5 to incumbent supplier along with a request to provide patients demographics

at the meeting 1.10 Print off contract specification for meeting 1.11 Liaise with procurement business manager (if not attending meeting) to assess invoicing requirements Points at meeting (part one): a) Intro and welcome b) Overview of specification c) Patient data required d) Prescription format/requirements e) Prescription process f) Delivery schedule g) List of ancillaries h) Removal of waste i) Purchase of hardware j) Invoicing requirements k) Agreement on start dates l) Process for contacting patients regarding change of contract m) Review and summary of actions including assigning a designated named contact for new supplier and clinical team Points at meeting (part two) a) Intro and welcome b) Patient data required c) Ancillary items d) Hardware e) Proposed start date of contract f) Transfer of existing patients g) Contacting patients h) Review and summary of actions including assignment of a named contact at incumbent supplier Post meeting 1.12 Check with information governance manager that the method of transfer of data is compliant with guidance relating to

the transfer and security of patient identifiable data 1.13 Inform PASA of change of contract (if required) 1.14 Produce Gantt chart for time line of actions and distribute to all involved 1.15 Organise follow up meeting to occur 1 week before agreed start date 1.16 Write letter to inform patients of supplier change. Agree with clinical team prior to distribution 1.17 Send patient letter to new supplier to distribute on behalf of the Trust 1.18 Inform incumbent supplier that they can now send their ‘Goodbye’ letter 1.19 Inform new supplier that they can distribute welcome packs. 1.20 Discuss effect on Trust stock holding with store managers


Post-start tasks 1.21 Arrange patient questionnaire to assess changeover 1.22 Arrange post change meeting with new suppliers/clinical teams 2. Incumbent Supplier tasks After award of contract 2.1 Arrange suitable representation of staff to attend change management meeting at the Trust 2.2 Prepare file of patient demographic data Points at meeting: a) Provide requested data to clinical team b) Provide new supplier with current list of patient’s ancillary requirements c) Provide new supplier with current hardware held in patients home d) Arrange process of negotiation with new supplier for sale/transfer of hardware and ancillaries e) Provide Trust procurement team with details of any stock held by company that may be part of a designated allocation under

the Purchasing and Supplies Agency national framework f) Provide project manager with a designated named contact Post Meeting: 2.3 Send letter to patients informing them of their last delivery and provide reassurance that their next delivery will be from

the new supplier 2.4 Arrange collection of any hardware in patients home that is not included as part of the sale/transfer of hardware items 3. Clinical team tasks After award of contract: 3.1 Provide list of all current, on hold, and planned patients to procurement team Points at meeting: a) Provide a named contact for clinical team b) Agree how to transfer data for existing patients c) Agree start date of new contract d) Agree style and format of prescription e) Agree on prescription process Post meeting 3.2 Check all data provided by incumbent supplier for accuracy and forward checked data to the project manager 3.3 Write new prescriptions and registration forms if necessary and forward to new supplier 3.4 Agree patient letter with procurement team 3.5 Act as information contact for patients regarding the switch Post-start tasks: 3.6 Monitor and record any initial problems with deliveries. Notify project manager and new suppliers named contact of any incidents/occurrences 3.7 Attend meeting to assess efficiency of change management process 4. New Supplier tasks After award of contract 4.1 Arrange suitable representation of attendees for meeting 4.2 Send list of preliminary requirements to procurement team


Points at meeting: a) Present change management plan b) Provide clinical team and project manager with examples of prescription/registration form stationery c) Arrange negotiations with incumbent supplier for possible purchase of hardware d) Provide project manager with a named contact e) Agree start date of contract Post meeting: 4.4 Assist clinical teams in the writing of new prescriptions 4.5 Arrange initial delivery schedules 4.6 Arrange installation of hardware in patient’s homes if not included in the sale/transfer of hardware from the incumbent

supplier 4.7 Distribute ‘welcome packs’ to patients before first scheduled delivery 4.8 Telephone patients to arrange mutually convenient time for first delivery Post-start tasks 4.9 Make first delivery - provide feedback and evidence to project manager and clinical team that these have occurred 4.10 Attend post change review meeting 4.11 Distribute a Trust led questionnaire to assess the patient’s opinion of the switch


1 - Pharmacy Procurement Team Tasks after award of

contract Individual

Responsibility Deadline/ Date Completed

1.1 Identify key staff to attend meeting. Assign a project manager

1.2 Arrange implementation meeting between clinical teams and new homecare supplier

1.3 Book room for meeting

1.4 Notify attendees of time and venue

1.5 Send e-mail to new supplier requesting details of pre-requirements

for meeting

1.6 Arrange agenda for both meetings

1.7 Send agenda to clinical team and new supplier

1.8 Print off contract specification for meeting

1.9 Liaise with procurement business manager (if not attending meeting) to discuss invoicing requirements

Points at meeting: Part 1 a) Intro and welcome

b) Overview of specification

c) Patient data required

d) Prescription format/requirements

e) Prescription process



contract Individual


f) Delivery schedule

g) List of ancillaries

h) Removal of waste

i) Purchase of hardware

j) Invoicing requirements

k) Agreement on start dates

l) contacting patients

m) Review and summary of actions - assignment of

named contact for new supplier and clinical team.

Points at meeting: Part 2 a) Intro and welcome

b) Patient data required

c) Ancillary items

d) Hardware

e) Proposed start date of contract

f) Transfer of existing patients

g) Contacting patients

h) Review and summary of actions including

assignment of a named contact at incumbent supplier



contract Individual


Post meeting: 1.12 Check with Information Governance and Data Protection Manager

that the method of transfer of patient data is secure

1.13 Inform PASA of change of contract (if required)

1.14 Produce Gantt chart of change process and distribute to clinical

teams, existing supplier and new supplier

1.15 Arrange follow up meeting to check progress

1.16 Draft letter to patients for clinical teams approval

1.17 Send letter to new supplier to distribute on behalf of LTH

1.18 Inform incumbent supplier they can now distribute a letter of

goodbye to patients

1.19 Inform new supplier that welcome packs can be sent out to patients immediately after the letter from the Trust

1.20 Discuss with pharmacy supplies on proposed effect (if any) on

stock holding

START DATE 1.22 Plan for questionnaire to assess efficiency of change management

plan

1.23 Arrange post change meeting with new suppliers/clinical teams


2 - Existing Provider Tasks after award of contract Individual Responsibility Deadline Completed

2.1 Arrange suitable representation of staff to attend change management meeting at the Trust

2.2 Prepare file of current patient data and any other data

requested by procurement team

Points at meeting a) Provide requested data to clinical team

b) Provide new supplier with current list of patient's ancillary

requirements

c) Provide new supplier with current hardware held in patients

home

d) Arrange process for negotiating sale/transfer of hardware

items

e) Provide procurement team with details of any stock held

that may be part of a designated allocation under the Purchasing and Supplies Agency national framework

f) Provide project manager with a designated named contact

post meeting: 2.3 Letter to patient informing them of their last delivery and

provide reassurance that their next delivery will be from the new supplier.

2.4 Arrange collection of any hardware in patients home that is not

part of the transfer/sale of hardware items


3 - Clinical Team Tasks after award of contract Individual Responsibility Deadline Completed

3.1 Provide list of all current, on hold and planned patients to procurement team

Points at meeting a) Provide a named contact for clinical team

b) Agree how to transfer data for existing patients

c) Agree start date of new contract

d) Agree style/format of prescription

e) Agree prescription process

3.2 Check all data provided by incumbent supplier for accuracy.

Forward checked data to the project manager

3.3 Write new prescriptions and registration forms, if required, and forward to new supplier

3.4 Agree patient letter of notification with project manager

3.5 Act as an information contact for patients during the

changeover

3.6 Monitor and record any initial problems with deliveries. Notify project manager and new supplier named contact of any incidents/occurrences

3.7 Attend meeting to assess efficiency of change management process


4 - New Supplier Tasks after award of contract Individual Responsibility Deadline Completed

4.1 Arrange suitable representation to attend change management meeting

4.2 Send a list of preliminary requirements to procurement team prior

to change meeting

Points at meeting a) Present company change management plan

b) Provide clinical team/procurement team with examples of

prescription/registration form stationery

c) Negotiate with previous suppliers on transfer/purchase of ancillary items/hardware

d) Provide project manager with a named contact

e) Agree start date of contract

Post meeting 4.3 Assist clinical teams in rewriting any 'part used' prescriptions for

existing patients (if required)

4.4 Arrange initial delivery schedules

4.5 Arrange installation of hardware in patient's homes if not included

in the sale/transfer of hardware from the incumbent supplier

4.6 Distribute 'welcome packs' to patients before first scheduled delivery

4.7 Telephone patients to arrange mutually convenient time for first

delivery

START DATE 4.8 Make first deliveries - provide feedback and evidence to the

clinical teams that these have occurred

4.9 Attend post change review meeting


4 - New Supplier Tasks after award of contract Individual Responsibility Deadline Completed

4.10 Distribute post change questionnaire (provided by Procurement team)

Agenda for part 1 of Change management meeting:

Agenda for part 2 of meeting (including incumbent supplier):

NO TIME AGENDA ITEM PURPOSE OWNER

1. Introductions and welcome 2. Overview of specification 3. Required patient data 4. Prescription format/requirements 5. Prescription process 6. Delivery schedule 7. Ancillary requirements 8. Removal of waste 9. Purchase of hardware 10. Invoicing requirements 11. Agreement on start dates 12. Notifying patients of change 13. Review of actions

NO TIME AGENDA ITEM PURPOSE OWNER

1. Introductions and welcome 2. Patient data required 3. Ancillary items 4. Hardware 5. Proposed start date of contract 6. Transfer of existing patients 7. Notifying patients of change 8. Review and summary of actions


Appendix 4

CMU Data collection fields


Appendix 5 General KPI Summary Trusts are required to amend these specimen KPI's to reflect each therapy areaComplaints Proof of DeliveryType Status ComplaintRef Number of Deliveries returned

Cost of unused products

Patient (Van/Postal/Other) Issued Unique ref to form Deliveries Number of deliveries returned £Trust Investigation underway Deliveries on time & in full WhyManufacturer Resolved Deliveries outside agreed window

Part deliveriesEmergency deliveriesDeliveries outside normal Mon-Fri Deliveries where stock has been damaged from homecare provider to patient

No of Adhoc/Other deliveries (not covered above)Why

Dispensing At Trust level At Delivery locationNumber of Patients Stock check of items Prescriptions dispensed Number of Patients registered homeItems on prescription Unable to be supplied in total/not dispensed VanItems dispensed Reason why not dispensed PostalDispensing errors Out of stock On ServiceDispensed with less than 6 months expiry date Manufacturer unable to supply On Hold

Off ServiceWhy

Clinical Details of untoward clinical incidents/Adverse Drug Reactions (ADRs)12345

InvoicingNumber of £ Total value of Number of £ Total value of

Invoices dispatched Invoices dispatched Invoices paid by trust within 30 days Invoices paid by trust within 30 daysTotal invoice lines Total invoice lines Invoices not paid by trust within 30 days Invoices not paid by trust within 30 daysInvoice queries from trusts Invoice queries from trusts

Monthly performance ratingPlease self-assess your performance this month:


Appendix 6

Date: Name Address Dear

1

2 The XXXXXXXXX Hospital/PCT would like to know what you think of the Home delivery service provided by XXXXXX. Please could you complete the enclosed questionnaire and return it to us in the pre-paid envelope provided. It is only with your opinions can we continue to maintain and improve the service you receive.

Kind Regards,

2.1 [A signed copy of this letter is held on file at XXXXXXXXXXXHospital/PCT] NAME TITLE HOSPITAL/PCT


[This survey has been sent to you with the permission of the XXXXXXXXX teams responsible for your treatment]

Patient Survey

Name:

Name of Treatment: Name of Homecare provider:

Section ONE: How do you currently rate (company name)performance in the following areas:

Please circle ONE score, where 1= POOR and 5= EXCELLENT) Communication Poor Excellent

1 2 3 4 5 Comments: Delivery times Poor Excellent

1 2 3 4 5 Comments: Customer Services Support Poor Excellent

1 2 3 4 5 Comments: Driver assistance/attitude: Poor Excellent

1 2 3 4 5 Comments: Clinical Waste Collection (Sharps bins etc) Poor Excellent

1 2 3 4 5 Comments: Overall Service Poor Excellent

1 2 3 4 5


Comments: Continued overleaf….

Section TWO: How important are each of the following to you

This section is designed to find out which areas of the service mean the most to you, to give us some idea of what you, the patient, consider a priority (Score 1= Not important 5= Very important) Communication Not important Very important

1 2 3 4 5 Comments: Delivery times Not important Very important

1 2 3 4 5 Comments: Customer Services Support Not important Very important

1 2 3 4 5 Comments: Driver assistance/attitude: Not important Very important

1 2 3 4 5 Comments: Clinical Waste Collection (sharps bins etc) Not important Very important

1 2 3 4 5 Comments: Overall Service Not important Very important

1 2 3 4 5 Comments:

Thank You for your time


Appendix 7 Procedure to define the framework for reporting of incidents occurring in the Homecare Medicines Supply Chain. 1. Purpose

To describe the pathway of contact in the occurrence of an ‘incident’ in the Homecare Medicine supply chain.

2. Scope

This procedure covers all events which can be classed as ‘an incident’ or a ‘Serious Untoward incident’, as defined by Trust policies on Incidents and Serious Untoward Incidents. This procedure details the pathway for recording, responding and actioning incidents and is not intended to direct any remedial clinical activity which may be necessary as a result of the incident

3. Responsibility

It is the responsibility of all staff members involved in the Homecare Medicines supply chain (Trust and Homecare provider staff) to be aware of the procedure and aware of the chain of communication in the event of ‘an incident’. All staffed named as key contacts in the Homecare Incident Contact Matrix will, as part of this procedure, read and acknowledge understanding of the procedures for Incident reporting and Serious Untoward Incidents. All Homecare providers will have their own procedure for dealing with incidents which will be made available to the Trust.

4. Procedure

4.1. Upon discovery of an incident, the member of staff discovering the incident will complete the homecare incident report form (see appendix 1).

4.2. Attach this form to an e-mail and send to all the named contacts shown on the incident

contact matrix* (within the Trust and the Homecare Provider).

4.3. For incidents that have a direct effect on the patient’s care, the person discovering the incident will contact and discuss with the Trust’s key contact (as shown on contact matrix) the nature of the incident. That key contact will then assume responsibility for any remedial action that the patient may require. Where an incident has potential to or has caused harm to a patient, a senior Pharmacy Manager must be contacted immediately. Incidents classified as having potential for harm include, but are not limited to, dispensing errors where patients have taken a dose, missed doses, dispensing of expired stock etc.

4.4. The member of staff assuming the responsibility for the incident will advise the other named

contacts for that therapy area (as detailed in the contact matrix) the details of the incident, what action has already been taken and any subsequent actions required. All future communication regarding the incident should be copied to all contacts for information.

4.5. The homecare provider shall assist the Trust lead in providing remedial care. Emergency

deliveries will be made available if necessary without prejudice.


4.6. The Trust lead will complete a Trust incident reporting form (IR1) in accordance with Trust

policy within 48 hours of the incident. The unique IR1 number will then be communicated to the rest of the key contacts (including Homecare provider contacts) by email.

4.7. The key contact at the Homecare provider must initiate the company’s incident reporting

procedure and supply the Trust with the name of an operational lead at the company to assist the clinical team with any remedial action.

4.8. The homecare provider must provide a detailed, chronological report of the incident to the

Trust, from the moment of occurrence to the point of closure. Report must include details of any communication between the Trust, Homecare provider and the patient. The report should where possible include a root cause analysis. The report should be communicated via email to the key contacts within two weeks of discovery of incident. The report must have a unique number and be cross referenced to the Trust’s IR1 number.

4.9. An incident shall be classed as ‘Closed’ when it is agreed by the clinical lead and the

Homecare provider key contact that all actions have been undertaken to remedy the incident, a root cause analysis has been conducted and actions have been undertaken to avoid/reduce the risk of a repeat of the incident. If closure has not been achieved within the 2 week time frame defined in point 4.8, then a second and subsequent report shall be required. Closure of an incident should be achieved within this 2 week time scale unless circumstances make this impossible. The second report should include details as to why closure within 2 weeks was not achieved. The first report will include an action plan together with deadlines for the actions to enable closure to occur.

4.10. The IR1 shall be forwarded to the Trust’s senior Pharmacy Manager for final sign off and risk

evaluation score.

4.11. The Homecare provider will keep a record of all incidents per quarter and present these figures to the by way of a quarterly report showing number of incidents per month and status of incident i.e. ‘Ongoing’ or ‘Closed’. This data will be used as a performance management tool in future service reviews for purpose of learning.

4.12. The Homecare provider will communicate any key staff changes which may affect the

reporting framework. This should ideally be done before any of the key contact staff at the homecare provider leave or, if not possible, as soon as possible after.

4.13. The key contact matrix shall be maintained by the Trust.


Section A: Please Complete All Fields* Before Submitting This Report (Fields marked * are mandatory)

Hospital Name*: IR1 Number*: (to be completed by Trust only)

Issue Raised by*:

Position and Department*:

Date Issue Raised*: Date Issue Reported to Homecare Provider*:

2.2 Patient Information:

Patient Initials*: Date of Birth*:

Hospital Number: (optional)

Therapy Area/Contract Name*:

Details of Issue*

Does the patient require a written response *?

Yes No (please select )

Name of First Contact for Completed Report (including email address)


Section B: To be completed by Homecare Provider Personnel Only: Investigation and Immediate Corrective Actions Taken:

Details of Preventative Actions and Conclusion:

3 Completed by

Date Completed (including written response to patient where appropriate):

Homecare Provider unique Reference:

Date Issued to Trust:


Appendix 8

Refrigeration

• Temperature range 2-8°c • Temperature distribution – maintain the required range across its entire load area • Capacity – at least one third greater than required to allow for circulation of cooled air • Lockable for child safety • Suitable indicator/visual alarm to alert if temperature exceeds parameters (for length of time) or

door left open • Fridge with fan preferred • Easy to read temperature measurement shown on outside of fridge, calibrated to proven standard

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