The Retail Model:Legal and Risk Implications

Speaker: Jonathan NashSolicitor

Community Equipment

Retail Model• Model is not mandatory• No change to legal basis of statutory provision• State service users will continue to be state

assessed • Main changes are delivery, installation,

maintenance and ownership: above and below the line (big kit) and custom equipment and top ups (Direct Payments already available)

• Big and small kit to be state provided for hospital discharge cases (and for palliative care?) – recent purported change to model

NHS Primary Law• NHSA 2006 S.3(1)(e) Services and facilities

for the prevention of illness, the care of persons suffering from illness and the after-care of persons suffering from illness

• To such extent as the Secretary considers necessary to meet all reasonable requirements and for s.3(1)(e) ‘as he considers are appropriate as part of the health service’

• S.1(3) Services must be free of charge except when legislation expressly states otherwise

• Postcode Lottery

LA Assessment

• S.47 NHSCCA 1990• Where it appears to an LA an individual

may be in need of community care services:• It shall carry out an assessment; and• Decide whether to provide services

• S.47 “is central to virtually all social services community care responsibilities”

FACS Eligibility Criteria• Discretionary provision becomes an individual

duty through the application of the FACS policy guidance.

• Critical, substantial, moderate and low bands• LA chooses which bands it can afford to meet.• Just meeting critical is expressly allowed and has

not been overturned by the recent Harrow case.• It is unlawful for a LA to have different FACS

eligibility for different services• Postcode Lottery is unchanged by Retail Model as

the partner authority has ability to choose which products can be locally prescribed

Community Equipment Definitions

• HSC 2001/008; LAC (2001) 13 - NHS responsible for permanent wheelchairs and equipment for home nursing e.g. pressure relief mattresses, commodes and feeding equipment [LAC (2001)18]

• LAs responsible for equipment for daily living e.g. shower chairs and raised toilet seats and hoisting equipment [LAC (90)7]

• It also includes, but is not limited to:• Minor adaptations, such as grab rails, lever taps

and improved domestic lighting• Ancillary equipment for sensory impairments e.g.

liquid level indicators, hearing loops, assistive listening devices and flashing doorbells;

• Communication aids for speech impairment;• Telecare e.g. fall and gas alarms and health state

monitoring for vulnerable people

• Some can be construed as joint NHS/ LA responsibility

LA / HA

• LAC (90)7 -Equipment which can be installed and removed with little or no structural modification to the dwelling should usually be the LA’s responsibility rather than the HA’s

• CSDPA 1970 Home adaptation duty overlaps with the housing authority duty to provide a means-tested Disabled Facilities Grants for adaptations up to £25,000 - Housing Grants, Construction and Regeneration Act 1996

Community Care (Delayed Discharges etc) Act (Qualifying Services) (England) Regulations

2003• Community equipment and• Minor adaptations under £1000 (including

buying and fitting) • Are required to be provided free of charge. • Note the key point that community equipment

does not have to be under £1000 in order to be provided free of charge.

Integrated Community Equipment Services Initiative

• HSC 2001/008; LAC (2001)13

• Integrated Service must:

• Use Health Act 1999 flexibilities to pool budgets

• Have a single operational manager and a board to advise that manager

• Use unified stock

Forerunners of Retail Model:1.NHS Wheelchair Voucher Scheme

• HSG (96)53• The voucher covers the cost of a standard

wheelchair (NHS Option)• Users can purchase from the wheelchair service

which retains ownership and responsibility for maintenance and repair (Partnership Option)

• Or from an independent supplier, with the user owning the wheelchair and responsibility for maintenance and repair (Independent Option)

• In cases 2 and 3 the user can top up.• The voucher has a period of approx 5 years

before the user is expected to need another wheelchair

• A user whose needs or circumstances change may apply to be reassessed at any time.

• NHS Wheelchair Services unable to trace issued covers might be at risk of legal liability – MDA SN9933

2. Direct Payments • HSCA 2001• Payment in lieu of a social service• Obligation where the LA is satisfied the DP can

meet the user’s needs, the user requests a DP and is capable of managing the payment.

• Conditions can be applied e.g. return of equipment when no longer required

• 2003 Guidance: LA must clarify who owns the equipment, and who is responsible for maintenance and ongoing care.

• Must apply equally to top ups under Retail Model

3. Minor Adaptations Without Delay

• The 2002 College of OTs guide states that initial assessment by an OT is generally not required for a range of minor adaptations such as grab and hand rails, threshold ramps, drop kerbs, kitchen and bathroom taps and handles.

Consumer Protection:Medical Devices Regulations 1994

• ‘Medical devices’ broadly defined and should apply to wide range of daily living equipment

• Manufacturers must ensure new or fully refurbished medical devices meet function and safety requirements - CE mark

• Potential criminal liability for non-compliance

Consumer Protection Continued• CPA 1987 - Strict civil liability imposed on

defective products causing harm• Failure by supplier to identify source of defective

equipment causing injury results in strict liability• General Product Safety Regulations 1994 –

criminal and civil liability where unsafe products are supplied commercially

• Lifting Operations and Lifting Equipment Regulations 1998 – 6 monthly examinations of certain lifting equipment by relevant organisation

• Sales of Goods Act 1979 - strict liability for goods of unsatisfactory quality

Negligence• Duty of care• Breach (Omission or comission)• Causation • Forseeable harm• Reasonable or ordinary competence• Recorded and reasoned decisions balancing risk v

benefits • Employer’s vicarious liability or primary liability

for systemic failures• S.2 Unfair Contract Terms Act 1977– Liability

cannot be reduced for negligence resulting in PI or death

Instruction & Information

• The delivery of a collapsible walking aid without professional demonstration and supervision was criticised by a Birmingham coroner in 1998.

• MDA DB9801 makes recommendations on delivery, inspection of equipment, installation of equipment and the instruction of users

Responsibility of users

• Following relevant instruction and information, a user must follow them (McKay v Royal Inland Hospital – hospital bed)

• And can even be contributorily negligent for failing to ask for instructions and increase own safety (Brushett v Cowan - crutches)

Maintenance and Inspection

• Where equipment belongs to the LA or NHS, MDA DB9801 recommends defect reporting by users and professionals; regular inspection of potentially hazardous equipment; identifying particularly vulnerable users

• Ongoing duty of care and duty to re-assess where material change of circumstance or equipment unfitness / deterioration.

Corporate Manslaughter Act 2007

• Where the way an organisation’s activities are managed or organised causes a person’s death and amounts to a gross breach of the relevant duty of care, it will be liable to a fine.

• Extension of the law of negligence • Gross breach = falling far below what can

be reasonably expected

Areas of concern• Delay between prescription and redemption• Private installation• Instruction• Closure of cases and ongoing maintenance /

replacement / reassessment• Repeat prescriptions?• Costs of delivery / maintenance v NHS ‘free’

service• Lack of supplier stock• Top up ownership• Resale / traceability• Carers redeeming prescriptions

• Identification and treatment of self-funders • Data Protection • Change to FACS v prevention• Regulatory body’s legal status?• Retailer’s code of practice? (There is no legal duty

to stock spare parts)• B&Q• NHS Supply Chain has expertise in delivering

items, not installation and instruction• 2007 Comprehensive Spending Review called for

£1bn in savings• Financial Robustness questioned in anonymous

report recently submitted to THIIS