DH/GMSHA sponsored diagnostics pilots

High Street Testing
Full Business Case

Version 1.5

Contents

1Executive Summary

1.1Strategic Case

1.2Background

1.3Commercial/Legal Issues

1.4Value for Money and Affordability

1.5Additional procurements outside the scope of the outline business case

1.5.1Pharmacy-based IM&T system

1.5.2Outcomes assessments/evaluations of the pilot

2Strategic Case

2.1Outline Business Case

3Procurement Process and Outcome

3.1Bidding population and key dates

3.2Bid Evaluations

3.2.1Pharmacies

3.2.2Equipment

4Description of the preferred bids

4.1Pharmacies

4.2Equipment suppliers

5Service overview

5.1Scope of Services

5.2Summary of Procedures/Other Activity Procured

5.2.1Procedures to be carried out by the pharmacy

5.2.2Contribution to GMS targets

5.3Staffing Proposals

5.4Facility Description

5.5Project implementation

5.6Key stakeholder holders

5.6.1Subject matter experts

5.6.2Secondary care clinical experts

5.6.3Secondary care laboratory experts

5.6.4GPs

5.6.5Department of Health

5.6.6PCTs

5.6.7External organisations

5.7Risk Assessment

5.7.1Approach to Risk Assessment

5.7.2Allocation matrix and likely impact of risk

6Additional procurements

6.1IM&T Proposals

6.2Outcomes assessments and evaluations

7Policy and Commercial Assurance

7.1Policy Assurance

7.1.1Programme Policy Objectives

7.1.2Governance

8Value for Money and Affordability

8.1NHS Equivalent Cost as an Indicator of VfM

8.2Price Summary

9Project Management Arrangements

9.1Proposed Project Structure (including lead responsibilities)

9.2Responsibilities of the Contract Management Board

1Executive Summary

1.1Strategic Case

The overarching strategic objectives of the pilot are:

  1. To provide opportunities under the new pharmacy contract for pharmacists to manage patients
  1. Assess whether ‘high street’ pharmacies can provide a suitable setting to deliver care for long-term conditions
  1. Inform Department of Health (DH) as to the likely valuation of the new pharmacy contract
  1. Inform DH as to the contribution of point of care testing (POCT) to the development of primary care facing laboratory medicine services

The benefits are expected to be enhanced clinical, financial and organisational outcomes, increased patient choice, transferable clinical care pathways, electronic patient records in pharmacies, integration of pharmacy into the healthcare community

1.2Background

GMSHA will be providing choice for up to 9500 patients to attend any one of 22 community pharmacies across 4 Greater Manchester PCTs (Salford, Stockport, Oldham and Ashton, Leigh & Wigan) for POCT and clinical consultation for the following:-

  • HbA1C testing for Diabetes (DM)
  • Cholesterol and high density lipoprotein cholesterol (HDL-chol) testing for cardio-vascular disease (CVD)
  • International Normalised Ratio (INR) testing for anticoagulant management

Pharmacists will report findings to the patient and their GP together with recommendations for action suitable to the patient’s condition.

An advertisement (appendix 1) placed in Manchester Evening News on 15 December 2004 (aimed at the pharmacy community) and in Clinica on 17 December 2004 (aimed at POCT equipment suppliers) attracted 65 expressions of interest from pharmacy outlets and 13 from equipment suppliers by 31 December 2004 (closing date). From here on in, procurement processes for pharmacy and equipment suppliers followed individual timetables.

Pharmacies
Pre-qualification questionnaires (PQQs) were issued 5th January 2005. 58 were returned by 24 January 2005 (closing date). A two-stage evaluation process was pursued:

Stage 1 Evaluation of capacity and capability (led by a GMSHA appointed panel)

Stage 2Assessment of ability to contribute to local healthcare delivery strategies (led by heads of medicines management in the 4 PCTs)

Twenty eight pharmacies were issued an invitation to negotiate (ITN) and draft contact on 4 March 2005. Twenty six were returned by 21 April 2005 (closing date) and were evaluated by a GMSHA panel on the following criteria:

  • Fitness for purpose of existing facilities
  • Level of grant required to bring facilities up to required standards
  • Potential size of patient population
  • Level of training required for pharmacists
  • Extent to which the bidder accepted the terms of the contract.

Recommendation to enter into contracts with 22 of these pharmacies (listed section 4.1) was approved on behalf of GMSHA and the Association of Greater Manchester PCTs Diagnostics Board on 10tMay 2005 by, respectively, Mandy Wearne (Director of Performance) and Adrian Mercer (CEO South Manchester PCT, Association diagnostics lead).

POCT equipment suppliers

PQQs were issued on 7 January 2005 and were returned by all 13 suppliers by the 24 January 2005 closing date. A three stage evaluation process was pursued:

Stage 1Contractual experience and technical capacity (led by a GMSHA appointed reference panel drawn from secondary care laboratories adjoining the 4 PCTs)

Stage 2Eligibility to bid (led by Addleshaw Goddard)

Stage 3Financial and economic standing (led by KPMG financial consultants)

Three suppliers failed to pre-qualify, details supplied in section 3.2.2.

Invitations to tender (ITT) were issued to 10 suppliers on 14February 2005. All suppliers returned documentation by 14 March 2005 closing date. Following evaluation of the equipments’ technical specification by the laboratory reference panel on 21 March 2005, clarification on equipment analytical performance was sought from all suppliers on 5 April 2005 and ITTs re-evaluated on 14 April 2005. Three suppliers were able to meet the following criteria:

  • Externally validated analytical performance
  • Ability to analyse capillary blood
  • Supply of CE-marked equipment

Recommendation to enter into contracts with three suppliers (listed below) was approved on behalf of GMSHA and the Association of Greater Manchester PCTs at the latter’s Diagnostics Board meeting on 26 April 2005:-

  • Roche Diagnostics – for supply of INR equipment
  • Point of Care Services – for supply of Chol/HDL-chol equipment
  • Bayer Diagnostics – for supply of HbA1C equipment

1.3Commercial/Legal Issues

Addleshaw Goddard (Department Health National Implmentation team legal advisors) developed two bespoke contracts for the pilot (one for each of the pharmacy procurement (the Pharmacy Contract) and the equipment and service procurement (the Equipment Contract)) and had input into the design of the procurement process at each key stage.

With regard to the pharmacy procurement, consideration was given to the following contractual structures:

  • GMSHA contracting directly with the individual pharmacies – this would provide significant "hands on" control over the pharmacies but could entail lengthy negotiations and raised concerns about how GMSHA would manage 20 individual contracts; or
  • GMSHA contracting with a single, prime contracting body who would manage the pharmacies – this would free up GMSHA from any lengthy negotiations and any management obligations, however the prime contractor would need to have individual contracts which each pharmacy in place in any event.

The former of these options was adopted for the following reasons:

  • because of the contractual certainty and control offered to GMSHA;
  • because of the lack of an appropriate body who could manage the contracts pursuant to the prime contracting option; and
  • because agreements would have to be reached with each pharmacy individually in any event.

Due to the concern about lengthy negotiations and in order to make the Pharmacy Contract more accessible to high street pharmacists it was decided that the standard form Treatment Centre contract was too complex. Consequently, as there was no precedent PoCT contract available, a number of consultations took place between GMSHA, the interested pharmacies and the local pharmaceutical committee and a short-form, bespoke contract was developed to address the specific local needs of the pharmacists, the patients and the pilot as a whole. It is therefore expected that the pharmacies will enter into their individual contracts without the requirement of any significant negotiation of issues or any amendments.

Together with the Equipment Contract, the ITT document also incorporates a technical specification questionnaire. Because of the individual nature of the pilot, and of the technical complexity of the GMSHA's requirements in terms of the specification for the equipment and consumables, it was appropriate for both the technical specification questionnaire and the Equipment Contract to also be designed and tailored on a bespoke basis.

The Equipment Contract is designed to achieve a workable balance between:

  • enabling the contracting authorities to exercise a sufficient degree of control over the activities of the contractor, without retaining unnecessary risk; and
  • delegating to the provider adequate and manageable responsibility for operational matters which it is proper to expect the provider to handle in its role in the pilot.

With this in mind, a balanced drafting approach has been taken, without the Equipment Contract favouring either party unduly and the appointed equipment contractor(s) will be expected to agree to it without any (or any significant) amendment.

Both the Pharmacy Contract and the Equipment Contract have been drafted so as to dovetail back-to-back in all respects, including in relation to cross-termination issues, training of pharmacists and supply of equipment/consumables.

1.4Value for Money and Affordability

Price comparisons between the current methods of monitoring and pharmacy monitoring are not available; one of the objectives of the pilot is to establish such figures.

The planned expenditure is within the allocated budget of £750,000 and is summarised below.

Cost summary / Pharmacy set up costs / Consumables / Pharmacy revenue / Project costs / Total / Allocation / Unallocated contingency
Base assumptions / £200,000 / £71,976 / £144,008 / £281,300 / £697,284 / £750,000 / £52,716

The pilot is due to last for 18 months from commencement of provision of services. If the pilot proves successful there may be demand for the service to continue; if this is the case PCTs may have to utilise existing budgets to fund the services. Annual revenue costs for 20 pharmacies would be approximately as follows:

PCT / AWL / Oldham / Salford / Stockport / Total
Recurring costs / £ 46,320 / £ 28,048 / £ 33,580 / £ 37,145 / £145,095

1.5Additional procurements outside the scope of the outline business case

1.5.1Pharmacy-based IM&T system

The approach balances the need between the pilot’s objectives and providing an appropriate an IM&T solution that meets local requirements for data capture, results reporting and electronic communication with other stakeholders. The intention is to develop a solution in three phases:-

1)Provide a service within a single pharmacy environment that demonstrates the consultation process, and allows patient information to be captured together with the results of the tests.

2)Provide a fully-hosted centralised service with HL7 messaging accessible by 20 pharmacies in order to enable POCT tests and the result of the consultation with the patient to be uploaded to a central application and transmitted to GPs. ‘Live’ patient data capture June 2005.

3)Integration and linking to National systems and solutions will Requirements for this will not be defined in this specification

1.5.2Outcomes assessments/evaluations of the pilot

The intention is to carry out a broad based set of measures that include:-

  • Clinical outcomes
  • Favourable/adverse changes in diagnostic tests
  • Adverse incidents
  • Stakeholder experience/satisfaction
  • Questionnaire based
  • Attrition profiling
  • Choice take-up rate
  • Attendance rate during pilot lifetimes
  • Referral patterns
  • Financial/organisational outcomes
  • Stakeholder resource implications of change in practice

2Strategic Case

2.1Outline Business Case

An Outline Business Case (OBC) was approved as follows:

  1. On behalf of GMSHA by Dr Martin Connor, Associate Directorate of Reform, 3 December 2004
  1. On behalf of DH Access directorate by Keith Smith, Head DH Diagnostics Branch, on 6 December 2004
  1. On behalf of lead PCT by Adrian Mercer (Chief Executive, South Manchester PCT, lead PCT for diagnostics), on 9 December 2004.

Key changes since these dates:

  • DH co-sponsors of pilot changed from Commercial to Access directorate
  • Greater Manchester sponsors of pilot changed from GMSHA/PCT Diagnostics Project Board to Association of Greater Manchester PCTs Diagnostics Board
  • Name of pilot changed from ‘Point of care diagnostics in high street pharmacies’ to ‘High Street Testing’
  • The new Pharmacy Contract received endorsement from pharmacists in January 2005, introduction with effect from 1st April 2005
  • Confirmation that implementation to be carried out in 22 pharmacies, previously up to 30 pharmacies.
  • A revised budget allocation of £750,000, previously £1million
  • A revised for first pharmacy to accept patients from end of April to mid-June 2005, in part driven by co-incidence of general election on 5th May 2005 preventing ministerial participation in any opening ceremony. Subsequent pharmacies to be implemented over Summer 2005
  • Venepuncture services to be included

3Procurement Process and Outcome

3.1Bidding population and key dates

Pharmacy / Number / Date
EOI responses to Advert / 25 chains/outlets / 31st Dec 2004
PQQs issued / 65 / 5th Jan 2005
PQQs received / 58 / 24th Jan 2005
ITNs issued / 28 / 4th March 2005
ITNs received / 26 / 21st April 2005
Preferred bidders selected / 22 / 10th May 2005
Equipment / Number / Date
EOI responses to Advert / 13 / 31st Dec 2004
PQQs issued / 13 / 5th Jan 2005
PQQs received / 13 / 24th Jan 2005
ITTs issued / 10 / 14th Feb 2005
ITNs received / 10 / 14th March 2005
Preferred bidders selected / 3 / 26th April 2005

3.2Bid Evaluations

3.2.1Pharmacies

PQQ evaluation - stage 1:

An objective scoring system determined:

Capability and capacity

Relevant professional development

Support from local GPs

Scoring was carried out by:

  • Mark Collins, North West representative of the Pharmaceutical Services Negotiating Committee (PSNC);
  • William Greenwood, Head of Primary Care, GMSHA;
  • Roger Kirkbride, Pharmacy Consultant, GMSHA;and
  • Rachael Carter, DH National Implementation Team
  • Stage 1 excluded one bidder on grounds of incomplete information and no current pharmacy contract.

PQQ evaluation - stage 2:

Common selection criteria across the 4 PCTs were pre-determined by the respective Heads of Medicines Management (HOMM) who in turn each led a local panel to select pharmacies based on the following criteria:

Local need and current provision

Twenty eight pharmacies were recommended to be taken forwarded to ITN, spread across the PCTs as follows:

Ashton, Leigh and Wigan6

Oldham7

Salford7

Stockport8

The recommended selections were approved on behalf of the GMSHA/PCT Diagnostics project Board on 28th February 2005 by Dr Martin Connor, Associate Director of Reform, GMSHA

ITN and draft contracts

Twenty six ITNs/draft contracts were returned for evaluation by a GMSHA/PCT Diagnostics Board panel on 6th May 2005 using the following criteria:-

the fitness of purpose of the proposed Facilities as advised by the 4 Heads of Medicines Management

the level of Facilities Grant required in order to ensure that the proposed Facilities comply with the requirements of Schedule 2 of the Contract;

the potential size of the Bidder's patient population set against minimum expected patient numbers required to maintain competence

the level of additional pharmacist training required as judged by the level of relevant continuous professional development undertaken by the pharmacist(s)

the extent to which the Bidder has accepted the terms of the Contract in accordance with this ITN.

The panel consisted of:

  • William Greenwood, Head of Primary Care, GMSHA
  • Roger Kirkbride, Pharmacy Consultant, GMSHA
  • Clive Moss-Barclay, Pharmacy Project Lead, Workforce Development
  • Roger Roberts, Head of Medicines Management Stockport PCT
  • Umesh Patel, Head of Medicines Management Ashton, Leigh & Wigan PCT

NB. Conflict of interests were avoided by HOMMs reviewing submissions from PCTs other than their own.

Twenty two pharmacies (described in section 4.1) were recommended for inclusion in the pilot, approved by Adrian Mercer on behalf of Association of Greater Manchester PCTs Diagnostics Board, Mandy Wearne on behalf of GMSHA 16th May 2005

3.2.2Equipment

PQQ evaluation:

PQQs were evaluated by pre-determined scoring criteria in three categories:-

Criterion / Evaluators
Eligibility to bid / Addleshaw Goddard
Economic and financial standing / KPMG financial consultants
Technical capacity / Local laboratories reference panel

Three bidders were recommended not to be taken forward to Invitation to Tender:

Kaetu Management services

  • No POCT equipment supplied to NHS in last five years
  • No declared infrastructure for training, support, quality assurance
  • Financial evaluation failure, KPMG

Unipath

  • No equipment supply history in UK
  • No information on equipment
  • No declared infrastructure for training, support, quality assurance

BHR pharmaceuticals

  • Financial evaluation failure, KPMG

Decision to reject these bids was approved at the Diagnostics Project Board on 8tFebruary 2005

ITT evaluations

10 ITTS were returned by 14 March 2005. Agreement was reached beforehand with all potential suppliers to return ITTs within 30 days as opposed to the 40 days normally offered as part of a closed procurement. Following initial evaluation on 23 March, clarification was sought on 8 April from all suppliers as to the substantiation of data provided for technical performance. ITTs were re-evaluated by the laboratory reference panel on 14 April with the following outcome:
HbA1C analysers

PanelDr David Lloyd, Clinical scientist, Royal Albert Edward Infirmary, Wigan; Mr Steve Scarisbrick, Biomedical scientist, HopeHospital, Salford; Dr Kathryn Brownbill, Clinical scientist, RoyalOldhamHospital

Supplier / Score / Exclusion(s) / High scoring / Low scoring
Provalis / 65 / No validated performance data
?CE-approval / Good IT functionality, full print out except DOB
Stores > 200 sequential results
Can separate QC from patient results
Fix over phone, replace by next day / No indication of technology used.
Interference from heavily lipaemic samples.
No evidence of any EQA performance.
Bayer DCA 2000 / 57.5 / None / Fully CE-compliant
Pool of equipment at back-up labs
Extensive evaluation data
High performer / IT connectivity not strong.
Can be linked to printer for time, date, result but no other ID.
Axis-shield
Affinion / 36.5 / No validated performance data
No mention of CE-approval / 500 results storable, stored by lot no. of QC / Interference at chol>5.8, trigs > 5.6
No imprecision data at high levels
Printer linkable but no ID on any print-outs
IT connectivity to LIMS only, not to a PC
BioStat / 31.5 / No validated performance data
No mention of CE-approval / None / Disposable device, no storage of records unless kit retained
No IT link-up, no link to operator ID
MDA report disputes their quoted imprecision data
No mention of IFCC-DCCT aligned calibration but presumed OK

Cholesterol/HDL-cholesterol analysers

PanelDr David Lloyd, Clinical scientist, Royal Albert Edward Infirmary, Wigan; Mr Steve Scarisbrick, Biomedical scientist, HopeHospital, Salford; Dr Kathryn Brownbill, Clinical scientist, RoyalOldhamHospital

Supplier / Score / Exclusions / High scoring / Low scoring
Point of Care Services – Cholestek / 61 / None / Market leader, good performance data / Can only use Li-Hep anti-coagulated blood.
No storage of IQC data.
No indicated traceability to a known calibrated method.
No EQA data performance supplied.
No patient data storage
Requires 35ul blood, no warning if short sample.
Menarini – Spotchem / 59.5 / Cannot be used for capillary blood
No validated performance data / Stores 50 results
IT links- can download QC and patient results to Mentor data management software package
Can print out results and link to name/ DOB/ time of analysis / No indicated traceability to a known calibrated method.
Limited performance data provided.
No EQA data.
Maintenance labour intensive – can only use Li-Hep blood.
No indication of life expectancy of strips.
High no.potential interferents.

INR analysers