Clinical and Diagnostic Services at the Point of Care in Selected Pharmacies Across Greater

Clinical and diagnostic services at the point of care in selected pharmacies across Greater Manchester

Purpose of this memorandum

This memorandum describes an 18 month pilot looking at new ways of providing clinical and diagnostic testing services for delivery at the point of care in community pharmacies in Salford, Stockport, Oldham and Wigan, Ashton, Leigh primary care trusts (PCTs) (the pilot).

It outlines the objectives, the service that is expected to be provided and associated constraints which potential suppliers from these four PCTs need to consider when expressing an interest in participating.

The pilot described by this memorandum involves two procurements, being the procurement of clinical and diagnostic testing services and the procurement of equipment and related consumables in respect of such clinical and diagnostic testing services.

Background

Evidence from capacity planning exercises for laboratory medicine services in Greater Manchester has indicated a 100% increase in GP demand for secondary care blood testing services between 2000-2004, with no sign of any plateauing. Particular increases are noted for tests such as HbA1C (the Diabetes National Service Framework (NSF) recommended test for patient management), cholesterol and INR (the cardiovascular disease NSF- recommended tests for statin and anti-coagulant treatment), tests which could be provided at the point of care.

Recent advances in technology have increased access to point of care blood testing (POCT) for a wide variety of parameters such as glucose and cholesterol. The evidence suggests that demand for such testing is fuelled by rising public interest in health and wellbeing, the ease of use of the technology and, more recently, by opportunities to provide diagnostics in new settings that could reduce the burden on secondary care.

Providing clinical and POCT support services closer to patients to acceptable clinical governance standards may increase their choice of referral, potentially decreases the number of patient journeys, and can reduce hospital admission. Pharmacy has long been recognised as an underutilised resource in health care provision. Over 6 million people a day visit a pharmacy and 85% of pharmacy income comes from the NHS.

The new pharmacy contract, due to be issued in Spring 2005, is expected to allow primary care organisations to commission patient management and diagnostic testing services from pharmacies on the basis of local need. In turn, the new GP (GMS) contract permits service delegation. Such initiatives contribute to the process of moving pharmacy from NHS contracts based on volumes of prescriptions to contracts based on remuneration for services.

To date, clinical & POCT services have been provided in relative isolation. They have rarely been developed as part of integrated care pathways across different health care sectors within large conurbations. Reports of the health and economic benefits of such approaches in terms of clinical, financial and organisational outcomes have not been widely disseminated.

Objectives of the pilot

The objectives are:-

1. On behalf of patients and their GPs, to provide clinical and POCT services in up to 30 pharmacies in selected areas across Greater Manchester for the management of diabetes and cardiovascular disease.
2. To assess whether pharmacies provide a suitable setting to achieve the higher standards of care outlined in NSFs for the management of diabetes and cardiovascular disease.
3. To increase access and choice for patients.

Services to be provided

People with one or more of the following conditions will be considered for invitation to participate in the pilot:

·  People with type 2 diabetes on oral hypoglycaemic and/or insulin drug therapy

·  People with cardiovascular disease on lipid lowering (statin) therapy

·  People on anticoagulant therapy

It is expected that the level of clinical and POCT services to be provided by pharmacies will change as the pilot continues. From the outset, all pharmacies must have the capability to provide POCT services, repeat dispensing and lifestyle advice. Depending on performance and capability, pharmacies may also be expected to provide additional services that include, for example, venepuncture, medication review and dose modification provided that this is agreed by all relevant parties at the time.

POCT & equipment

POCT will include the following:-

·  HbA1C

·  Cholesterol

·  Total

·  HDL-cholesterol

·  INR

·  Blood pressure

POCT will be carried out on equipment selected following a Greater Manchester Strategic Health Authority (GMSHA)-led procurement process brief details of which are described below. It is expected that equipment will be placed free of charge and that GMSHA will remunerate suppliers of equipment on basis of test strip usage for the duration of the contract. Each type of testing equipment is to be provided by a single supplier but this does not preclude any one supplier providing more than one type of testing equipment.

Each supplier of equipment will be expected to provide an infrastructure for training, equipment maintenance, and troubleshooting. Quality assurance standards will be determined by GMSHA with whom remuneration for providing this governance infrastructure will be agreed.

Preparing to deliver the service

It is anticipated that all pharmacies participating in this pilot will require assistance in preparing to deliver the clinical and POCT services. In particular, it is anticipated that they will require assistance in establishing the necessary competences and infrastructure.

Training for pharmacists will be provided in respect of:-

1. Performance of POCT
2. Delivery of care pathways for diabetes and cardiovascular disease
3. Recording, processing and management of data and care records

A grant towards establishing suitable infrastructure will be available. This grant shall be in an amount of up to a maximum of £10,000 depending upon the agreed costs to be incurred in relation to the improvement of infrastructure. As a minimum space for testing equipment, storage of consumables, handling of waste, facilities for hand washing and a consultation area (similar to that expected to be required in the new Pharmacy Contract) will be required.

It is anticipated that a National Programme for Information Technology-compatible solution that allows updating of information to primary and secondary care will be required. Support for this will be provided as part of the infrastructure grant.

This should allow the functionality to deliver:-

·  Electronic patient records

·  Electronic storage of care pathways

·  Interfacing to point of care testing equipment

Remuneration for clinical and POCT services

Remuneration to pharmacies will be based on the provision of clinical and POCT services. Remuneration will be based on an annual agreed cost for patient management rather than payment per episode and it will be paid quarterly in arrears subject to compliance with key obligations.

It is anticipated that participating pharmacies may choose to resource the service in different ways utilising pharmacists, technicians and other healthcare staff. During the procurement process pharmacies will be invited to advise of likely human resource costs that will be incurred for providing services based on their anticipated patient numbers and visits (lasting about 20 minutes); the pharmacist consultation will be one part of this.

Measures of success

Measures of success will include:-

·  Clinical outcomes

·  Financial outcomes, including health economic benefits

·  Organisational outcomes

·  Patient compliance/concordance

·  Participants’ satisfaction

·  Performance and governance measures

Constraints

1. The pilot will expect each pharmacy to participate for a minimum period of 18 months. It is anticipated at least one pharmacy will start providing clinical and POCT services in April 2005 with the remaining pharmacies starting services over subsequent months.
2. Only patients on diabetes and/or cardiovascular disease registers will be considered for referral to pharmacy. Referral will be GP-initiated only. Referral guidelines that include patient inclusion/exclusion criteria and the seeking of patient consent are in the course of being developed as part of the service specification.

1. Care pathways and protocols for the management of diabetes and cardiovascular disease will be provided as part of the service specification and will be deployed across all participating pharmacies.
2. Only equipment and POCT consumables supplied by GMSHA will be used for POCT.
3. POCT services will be delivered to standards set by the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) Point of Care Testing guidelines.
4. Standards for infrastructure in respect of patient consultation facilities are in the course of being developed and will be specified in the service specification.
5. Service contracts are to be established between each pharmacy and their local PCT.
6. Pharmacists will be expected be registered with the RPSGB and to hold suitable personal indemnity insurance.
7. Pharmacists will be required to successfully complete training organised by GMSHA. This will be recognised and accredited by a suitable accrediting body.

Selection criteria

To ensure that bidders meet the necessary standards all bids, whether for the provision of clinical and diagnostic testing services or for the provision of equipment and related consumables, will be judged against consistent selection criteria which will be in three broad groups; financial; capacity; competence.

Financial criteria will be used to judge financial security and value for money.

Capacity criteria will be used to judge whether participants can cope with the anticipated (maximum) level of demand; and that (in relation to clinical and diagnostic testing services) they can establish sufficient throughput to maintain clinical skills.

Competence criteria will be used to judge whether participants will be able to meet relevant clinical and governance standards.

Process

The anticipated procurement timetable and process for the pilot can be summarised as follows:

Steps necessary to both clinical and diagnostic testing services and the provision of equipment and related consumables

Issue of Advert / 15th December 2004
Memorandum of Information - to be despatched to all persons or organisations who have expressed an interest in the Advert (whether in respect of clinical and diagnostic testing services or the provision of equipment and related consumables) as soon as practicable following receipt of such expressions of interest: final date / 31st December, 2004
Pre-qualification questionnaire - to be despatched to all persons or organisations expressing an interest in the Advert / 5th January 2005

Further steps necessary for the provision of clinical and diagnostic testing (pharmacy )services.

Return of responses to the pre-qualification questionnaire / 22nd January 2005
Completion of evaluation of responses to the pre-qualification questionnaires / 10th February 2005
Despatch of the Invitation to Negotiate (ITN) (including a fully worked up legal agreement) to pharmacies who have not been de-selected / 11th February 2005
ITN responses / 04th March 2005
ITN evaluation by (first) PBs selected / 24th March 2005
Start Negotiation for first contract / 28th March 2005
Agree first contract & start first mobilisation / 15th April 2005
Delivery and training on equipment, governance, quality and data reporting / 15th – 29th April 2005
Service Commencement in respect of the first contract – / 29th April 2005
Entry into of other contracts - before / 16th June 2005

Further steps necessary for the provision of equipment and related consumables

Return of responses to the pre-qualification questionnaire / 22nd January 2005
Completion of evaluation of responses to the pre-qualification questionnaires / 10th February 2005
Despatch of the outline specification requirement (including a fully worked up legal agreement) to diagnostics industry suppliers who have not been de-selected / 11th February 2005
Outline specification requirement responses / 28th February 2005
Entry into contracts no later than / 28th March 2005
Delivery and training on equipment, governance, quality and data reporting for a selection of pharmacies / 15th – 29th April 2005
Service Commencement in respect of first pharmacy / 29th April 2005

All of the above dates are subject to amendment by GMSHA.

End note

This memorandum of information describes the pilot as it is defined on the date of issue. It is possible that changes to the pilot as described in this memorandum (whether in relation to the scope of services required or otherwise) could occur as the Pre-qualification questionnaire and the Invitation to negotiate are developed. The ITN will contain the final services contract terms and specification.

Expression of interest

Expressions of interest, whether for the provision of clinical and diagnostic testing services or for the provision of equipment and related consumables, should be sent by e-mail to and three hard copies to the Diagnostics Project Support Manager, Room 720A, Greater Manchester SHA, Gateway House, Piccadilly Approach, Manchester, M60 7LP. They should include the name of organisation, a contact name, address and telephone/fax/e-mail contact details.