This seminar focused on the health and care sector. Including a topical update on four key areas:-
- charity governance
- employment - whistle-blowing, safeguarding, sleep-ins
- regulatory - when the inspector calls, CQC/H&S/controlled medicines
- commissioning - contracts and GDPR.
For further information and training visit our website - https://www.brownejacobson.com/health
7. Principle 1 – Organisational Purpose
The Board is clear about the charity’s aims and ensures that
these are being delivered effectively and sustainably.
— Periodically review aims and external environment
— Leads development of, and agrees, a strategy
— Regularly review sustainability of income sources and business
models
— Consider benefits and risks of partnership working, merger or
dissolution
8. Principle 2 – Leadership
Every charity is headed by an effective board that provides strategic
leadership in line with the charity’s aims and values.
— Take collective responsibility for its decisions
— Chair provides leadership to the Board
— Staff – proper arrangements
— Functions are formally recorded
— Subsidiary – clear rationale, benefits, risks
— All trustees give sufficient time
9. Principle 3 – Integrity
The Board acts with integrity, adopting values and creating a
culture which helps achieve the charity’s purposes.
— Code of Conduct – standards of probity and behaviour
— External perception – operates responsibly and ethically
— Follows the law – considers non-binding rules, codes and
standards
— Identify, deal with and record conflicts of interest/loyalty
10. Principle 4 – Decision-making, risk and
control
Decision-making process are informed, rigorous and timely, and that effective
delegation, control and risk-assessment and management systems are set up and
monitored.
— Regularly review delegated matters and matters reserved to the Board
— Committees – suitable membership and terms of reference
— Regularly review key policies and procedures
— Regularly monitors performance
— Regularly review specific, significant risks
— Appointing auditors and audits
11. Principle 5 – Board Effectiveness
The Board works as an effective team within appropriate balance of
skills, experience, backgrounds and knowledge.
— Meets as often as is needed to be effective
— Chair, with others, plans the Board’s programme of work and its
meetings
— Vice-chair or similar-sounding board and intermediary
— Regularly discusses effectiveness, motivations and behaviours
— Regularly considers the mix of skills, knowledge and experience
needed to govern, lead and deliver
— Size is right – min 5, max 12 – typically considered good practice
12. Principle 5 – Board Development
— An appropriately resourced induction
— Ongoing learning and development of Trustees
— Annual review of Board performance including individual
trustees and the chair
— External evaluation of Board and trustees every 3 years
— Explanation in annual report how the charity reviews or
evaluates the Board
13. Principle 6 – Diversity
The Board’s approach to diversity supports its effectiveness,
leadership and decision-making.
— Encourage inclusive and accessible participation
— Periodically undertakes training and/or reflection
— Positive effort to remove, reduce or prevent obstacles to people
being trustees
— Regular feedback on how meetings could be more accessible and
constructively challenge
— Publishes an annual description re: Board and leadership diversity
14. Principle 7 – Openness and
Accountability
The Board leads the charity in being transparent and accountable –
open, unless good reason not to be.
— Identifies key stakeholders – users, beneficiaries, staff, volunteers,
members, donors, suppliers, local communities and others
— Strategy for regular and effective communication
— Hold the Board to account
— Develop a culture of openness – complaints handling
— Register of interests
— Process for remuneration of staff
15. Status of Code
Apply the recommended practice
or
Explain what you’ve done instead
16. Legal Duties & Responsibilities
— Primary duty
— Skill and care
— Safeguard property
— Investment
— Not to profit personally
— Conflicts of interest
— Act personally
— Statutory duties
17. Standard of Skill of Trustees
The degree of competence which
could reasonably be expected from
someone with your degree of
knowledge and experience
18. Standard of Care of Trustees
The degree of care a reasonable person
would exercise on his own behalf
21. Principles for Good Decision Making
— Acted within charity’s powers, using correct procedures
— Acted in good faith and only in charity’s interests
— Adequately informed yourselves
— Taken into account all relevant factors
— Disregarded any irrelevant factors
— Managed conflicts of interest
— Made decisions that are within the range of decisions
that a reasonable trustee body would make
22. Make Governance Good
— Trustees commit to improving their performance
— Right structure and sufficient time for effective
discussion and decision making
— Right mix of skills and expertise
— Make regular opportunities to re-assess that balance
— Access to the right information and advice in the best
format
— Ask probing, challenging, awkward questions
23. Possible Tips
— Meetings – start, duration, end
— Agenda – for information, discussion, decision
— Minutes – action points, decision log
— Feedback – honest, regular
— Self-reflection
24. Health and social care charities seminar –
employment update
Kerren Daly, Partner
26. Protected disclosure
“it is unlawful for an employer to subject one of its workers to
a detriment (including threats, disciplinary action, loss of work
or pay, or damage to career prospects) or dismissal on the
ground that they have made a protected disclosure”
Section 47B(1), ERA 1996
27. Handling the complexities of a
disclosure
— Complaints under the Dignity at Work Policy
– Can they be a protected disclosures?
– Which policy do you investigate the claims under?
— Grievances
— When do you invoke a disciplinary process?
— Multiple whistleblowers
— Complaints with no merit
— Malicious/vexatious complaints
28. Sector scrutiny
– Francis Freedom to Speak Up review
– National Guardian Office case review
– Charity commission
29. Examples of Good Practice
— Detailed communications plan
— Internal staff webpages
– dedicated to speaking up
– Freedom to Speak Up Guardian
– relevant policies and procedures
– comments from workers
33. Investigations
— Have clear policies in place
— Evidence in support and against the allegation(s)
— Relationships e.g. CQC, police, Local Authority and health agencies
— Disciplinary action
34. Disciplinary action
— Process
— Set out conclusions fully and clearly
— Avoid overstated conclusions, over emphasis and self-
justification
— Referrals to any other body? E.g. regulator?
36. Mencap - ET and EAT decision
— Carer for autistic adults
— Required to work sleep-ins and was paid a flat rate
— No specific duties but expected to assist if it became necessary
overnight
— ET upheld her claim that sleep-in shift hours should be at NMW –
including those when she was asleep
— EAT Upheld
— Mencap stated to pay NMW for every hour of a sleep-in shift
37. Court of Appeal 2018
— Upheld Mencap appeal
— Care workers doing sleep-in shifts are only entitled to the
NMW when they are required, because they need to
undertake a specific activity, to actually be awake
— NMW – only counts time required to be awake for the purpose
of working
— “bright line” approach
38. HMRC and Social Care Compliance
Scheme
— Initial guidance and scheme published post EAT decision
— In July 2018 – following CofA – HMRC advice
— BEIS guidance on calculating minimum wage to be
updated in due course - once issued, those on the SCCS
will receive updated guidance
39. Ongoing uncertainty
— Await Supreme Court decision
— Remember – CofA was clear that each case to be decided on
the facts:
“it must be borne in mind that the decision which side of the
line dividing “actual work” from “availability for work” a given
case falls is factual in character, and in marginal cases different
tribunals might well assess very similar facts differently.”
40. What should providers do?
— Uncertainty
— Still waiting for HMRC guidance
— Already registered? Complete self review but question
remains how to calculate sleep-in pay?
44. CQC Enforcement Update
— Inspections and ratings
– Inspections to be less frequent
– Less announced
– Ratings expanded
— From April 2015, service user health and safety is their remit
— >100% increase in enforcement action 2017/2018 vs.
2015/2016
– Despite similar special measures and improving ratings
— Significant increase in prosecutions including larger providers
45. CQC Prosecution Case Study
– Charitable and ‘medium’ provider
– Fatal accident – fall from shower chair
– Staff training and equipment auditing criticised
– £200k fine and costs
– Very significant mitigation
– Would have been £300k - £1.3m
46. CQC Enforcement Beyond Prosecutions
— Fines may actually be lower than HSE (for now)
— Urgent conditions, suspensions, closures and
cancellations possible
— Direct influence on commissioners
— Reputational harm
— Ongoing enhanced scrutiny
47. CQC - Themes To Be Aware Of
— Delay in CQC prosecutions
— Theme in prosecutions is failure to heed warning – your
action plan can be Exhibit A
— Risk of harm is enough
— CQC at inquests
— Director offences and fit and proper person test
48. 2017 Social Care Inspection Frameworks
— New and “strengthened” themes and KLOEs
— Person-led – staff time and response times
— External cooperation - medicines
— Staff welfare / development and open culture
— Learning from incidents and concerns – Notifications and
duty of candour
— Use of technology – data safety
— End of life care – processes after death
49. 2017 Healthcare Inspection Frameworks
— Staffing levels / mixes vs planned
— Medicines management
— Learning from incidents and concerns – including from
other providers
— 7 day care
— Contribution to public health
— Maintaining care quality between settings
— Choice, least restrictive and community access
50. Other Areas of Increased Focus
— Mental capacity and DoLS
— Physical environment
— Medicines management
— Staffing levels / skill mix
Lack of funding acknowledged but focus is on the end
result
51. Expanding CQC Ratings
— CQC ratings of independent healthcare expanded
– Cosmetic surgery
– Substance misuse
— Further expansion April 2018
– Inclusive approach
– Independent community health services
– Independent doctors including online
52. The Next Phase of CQC Regulation
— Scope of registration changes
– Parent organisations, etc.
– Implications for directors or equivalent
– Wide interpretation beyond mere financial control
— Increased provider information collection
— Greater responsibilities for fit and proper director
complaints
— Accreditation schemes to be awarded
53. Recent CQC Guidance Updates
— Financial viability on registration
– Potential to roll out to existing providers
— Fit and proper person director test
– Serious mismanagement and serious misconduct
— Registration of learning disability services
– Registering the right support’
54. Registering the Right Support
— Revised 2017
— Apparent relaxation on 6 bed limit
— Maintained insistence on community setting
— Application less flexible than hoped
— Centurion Health Care appeal October 2018
– CQC criticised for “one size fits all” approach
– Need for service user choice emphasised
– More attention required to service users’ needs
55. Demonstrating Outstanding Care
— Start preparing now
– CQC box
– Staff engagement
— Preparing for inspection
– Provider Information Return
– Put time aside
– Speak to staff
– Locate and organise
56. Demonstrating Outstanding Care
— During the inspection
– Be available
– Have policies, important records organised
— Informal feedback session
– Be available
– Respond as much as you can to issues raised
– Make a good note of other issues for future response
57. Demonstrating Outstanding Care
— After the inspection
– Be proactive
– Enforcement action may come before draft report
– Draft inspection report sent
– Factual accuracy response within 14 days
– Strict format and deadline proposals
– Final report published
– Ratings published
– Appeal against ratings
58. Fire Safety
— Evacuation
– Alarm response
– PEEPs & training
— Smoking / vaping residents
– Emolients
– Charging
— Escape routes
– Butterfly model
– Mobility scooters
60. This session
1. Background to NHS Contracts
2. Commissioning for Clinical Services
3. Commissioning for Non-Clinical Services
4. GDPR in contracts
5. ACO’s, ICS’, STP’s and all that…….
61. Key NHS standard contracts, terms and conditions
— Clinical services
– 2017-19 NHS Standard Contract
– Shorter Form NHS Standard Contract 2017-19
– NHS Standard Sub-contract for the Provision of Clinical Services (full
length and shorter form)
— Non-clinical services
– NHS Terms and Conditions for the provision of services
62. NHS contracts
— Why are two of the templates SLAs and two contracts?
— Section 9 NHS Act 2006:
“In this Act, an NHS contract is an arrangement under which one
health service body (“the commissioner”) arranges for the provision
to it by another health service body (“the provider”) of goods or
services which it reasonably requires for the purposes of its
functions.”
63. NHS Contracts (cont’d)
“Health service body” now includes the following (length of the list means that
the following is just an extract):
– the Board
– a clinical commissioning group
– an NHS trust
– a Special Health Authority
– the Care Quality Commission
– NICE
– the Health and Social Care Information Centre
– the Secretary of State
– the Department of Health, Social Services and Public Safety
NB – foundation trusts and independent sector providers were never included in
this list
64. NHS Contracts
If you have an “NHS contract”:
“Whether or not an arrangement which constitutes an NHS contract
would apart from this subsection be a contract in law, it must not be
regarded for any purpose as giving rise to contractual rights or
liabilities.” (Section 9(5) NHS Act 2006)
65. NHS Contracts
— Doesn’t mean that NHS contracts should be treated with any less rigour
by the parties, it will just be enforced differently
— Disputes arising out of an NHS contract cannot be enforced through the
courts, but are determined by the Secretary of State. In practice, NHS
contracts have detailed dispute resolution clauses which allow disputes
to be referred to mediation arranged by NHSE and NHSI or CEDR for
non – NHS bodies.
67. Clinical and non-clinical services
— Clinical services: treatment, care, diagnosis of patients - healthcare
services of any kind e.g. acute, ambulance, patient transport,
continuing healthcare services, community-based, high-secure,
mental health and learning disability services
— Non-clinical services: any kind of support services to staff or which
support delivery of patient care e.g. accommodation, estates and
facilities, chaplaincy, finance, HR
69. NHS standard contracts – clinical services
— 2017-19 NHS Standard Contract
— Shorter Form NHS Standard Contract 2017-19
— NHS Standard Sub-contract for the Provision of Clinical Services (full
length)
— NHS Standard Sub-contract for the Provision of Clinical Services
(shorter form)
— All available with supporting materials on NHS England’s Standard
Contract page
70. Use of the NHS Standard Contract
— Must be used by NHS England and CCGs where they are buying clinical
services
— Must be used regardless of the proposed duration or value of a contract
(small-scale short-term pilot or long-term/high-value services). (Although,
see comments about Shorter-Form NHS Standard Contract later)
— Not intended for use by provider organisations when they are buying
services from other provider organisations.
— Structure of NHS Standard Contract is important as other NHS standard
contracts adopt and follow a similar structure
71. Structure of NHS Standard Contract
— Three parts:
– The Particulars (all locally agreed details go in here, for example,
details of the parties, the service specifications and schedules
relating to payment)
– Service Conditions (SCs)
– General Conditions (GCs)
— SCs and GCs may not be amended (although some parts only apply to
some services)
— Particulars must not be used to vary SCs or GCs
72. Completion of the contract
— Traffic-light markings in Appendix 2 of Technical Guidance (relevant for
Particulars) state what can and can’t be amended and also provides
useful step-by-step guide
— Select/tick service categories, which then determine whether some
clauses in the SCs are not applicable
— Use of NHS England’s eContract system for population of Particulars
73. Order of Priority (GC1)
— Clause (GC1)
– General conditions
– Service Conditions
– Particulars
– All trump Commissioner Documents, Documents Relied on and Local
Agreements and Policies
— Docs Relied On for side letters/heads of agreement that cut across the
mandated provisions will not be enforceable!
74. Shorter-Form NHS Standard Contract
— 74 pages (before the local Schedules are completed) vs 210 pages
— No specific financial threshold for use but recommended for lower
annual values/low complexity services –so contracts with small
providers, including care homes etc
— Within limitations on use, for commissioners to determine when they
use it
75. Shorter-Form NHS Standard Contract (cont’d)
— Must not be used for acute, cancer, A&E, minor injuries, 111 or
emergency ambulance services, or any other hospital inpatient
services, including for mental health and learning disabilities
— May be used for non-inpatient mental health and learning disability
services, for any community services, for non-inpatient diagnostic,
screening and pathology services and for patient transport services
76. Structure–Shorter Form NHS Standard Contract
— Based on same model as the full-length version. Same three-part
structure (Particulars, Service Conditions and General Conditions) and
similar approach to completion
— Technical Guidance is relevant to the shorter-form version, but a
separate User Guide for the shorter-form version is also available
— As for full-length version – not designed for use by provider
organisations when buying clinical services
77. NHS Standard Sub-Contract
— Designed for use when sub-contracting clinical services
— In most circumstances when a provider organisation is buying clinical services
from another provider organisation (NHS or independent sector provider) it will
be sub-contracting services it is contracted to provide under NHS Standard
Contract
— Use is not mandatory but recommended because:
– less negotiation as consistent with NHS Standard Contract
– risk reduction as it has been drafted so as to ensure flow-down of terms of the NHS
Standard Contract
— Full-length and shorter-form versions – match with NHS Standard Contract
version used
78. NHS Standard Sub-Contract - Structure
— Similar structure to NHS Standard Contract. Full-length version also
includes the Sub-Contract Principles (contains additional conditions)
— SCs and GCs of NHS Standard Contract part of NHS Standard Sub-
Contract where appropriate and easily identify differences
— Full-length Sub-Contract can be used when multiple commissioners
under 1 head contract and when one or more sub-contractors
80. The NHS Terms and Conditions - Introduction
— Three sets of terms and conditions for use by NHS bodies when buying
goods and services:
– the NHS Terms and Conditions for Supply of Goods;
– the NHS Terms and Conditions for Provision of Services; and
– the combined NHS Terms and Conditions for the Supply of Goods
and the Provision of Services
— Contract, framework, purchase order and managed services versions
of each
81. The NHS Terms and Conditions – Introduction
— Contract versions – used where signed contract is required.
Commercial schedule, specification and tender response document -
bound together with the legal terms and conditions to form the
contract
— Purchase order versions - used when contract incorporating these
terms and conditions formed when purchase order entered into
— Framework versions – call-off terms added as appendix to the
agreement
82. The NHS Terms and Conditions - Overview
— Designed for use by the NHS when buying from commercial
organisations (but could be used as basis for buying services from
another NHS body)
— Aim of the new terms and conditions is to deliver standard approach to
risk for the NHS – especially for the specification, price and payment
provisions, performance management, liability, insurance, intellectual
property, termination, and information governance
83. NHS Terms and Conditions – Overview (cont’d)
— Not mandatory – but aim is that the contracts should be used without
‘deviation’
— Not to be used for clinical services
— All available and supporting guidance at the Department of Health and
Social Care site
84. Order of priority – Contract version
— Front page
— Key Provisions
— Specification and Tender Response
— General Terms and Conditions
— Commercial Schedule
— Information Governance
— Then Definitions, any other schedules (in order they appear) and any
other documents which are part of the contract
85. Factors to consider when contracting
— Take into account the context in which a contract is made - part of
local NHS system?
— Agreeing to use NHS contracts or terms and conditions where
appropriate is sensible - useful counter-offer, represents NHS
position and are regularly updated
— Some circumstances where there is strong argument for having own
bespoke contract
— Consider whether service is clinical/non-clinical and use most
appropriate contract
87. Key points
• Came into effect on 25 May 2018 across Europe
• Data Protection Bill 2018 issued to supplement GDPR in UK
• Main concepts and principles remain the same, but new elements of
GDPR enhance the provisions under the DPA
• Some hefty fines…
88. Enforcement
• Elizabeth Denham, the Information
Commissioner (ICO)
— Supervisory Authorities
– Investigative powers
– Corrective powers
— Penalties
– 2% global turnover or €10m
– 4% global turnover or €20m
— Compensation
89. Personal Data
“means any information relating to an identified or identifiable natural
person (‘data subject’)
An identifiable natural person is one who can be identified, directly or indirectly, in
particular by reference to an identifier such as a name, an identification number, location
data, an online identifier or to one or more factors specific to the physical, physiological,
genetic, mental, economic, cultural or social identity of that natural person;”
This means that an IP address or roll number
can amount to personal data
90. Special Categories
Article 9 now refers to “Special Categories of Personal Data” rather than
Sensitive Personal Data. This category includes personal data revealing:
• racial or ethnic origin
• political opinions
• religious or philosophical beliefs or
• trade union membership and
• the processing of genetic data, biometric data for the purpose of uniquely
identifying a natural person
• data concerning health or
• data concerning a natural person's sex life or sexual orientation
91. Processing
Will mean:
“any operation or set of operations which is
performed on personal data … whether or not by
automated means, such as collection, recording,
organisation, structuring, storage, adaptation or
alteration, retrieval, consultation, use, disclosure by
transmission, dissemination or otherwise making
available, alignment or combination, restriction,
erasure or destruction;”
92. Principles
The GDPR requires:
— Data to be processed lawfully, fairly and in a transparent manner
— Data to be collected for specified, explicit and legitimate purposes and not
further processed in a manner that is incompatible with those purposes;
— Processing of data should be adequate, relevant and limited to what is
necessary in relation to the purposes for which they are processed
— Data to be accurate and, where necessary, kept up to date; inaccurate data
should be erased or rectified without delay
93. Principles (cont.)
— Data to be kept in a form which permits identification of data subjects for no
longer than is necessary for the purposes for which the personal data are
processed
— Data to be processed in a manner that ensures appropriate security of the
personal data, including protection against unauthorised or unlawful processing
and against accidental loss, destruction or damage, using appropriate technical
or organisational measures
The data controller will be responsible for, and must be able to
demonstrate, compliance with these principles as well as accountability
94. What does the Bill do?
• Addresses data processing in law enforcement and the intelligence
services – Law Enforcement Directive
• Addresses permitted derogations from the GDPR
• Attempts to ensure that on leaving the EU the UK has “adequate” data
protection regime in respect of EU requirements
• Formally repeals Data Protection Act 1998
• Addresses necessary amendments to other legislation
95. What does the Bill do? (cont’d)
— Provides exemptions from some of the GDPR’s requirements
– Complex drafting – requires careful consideration
– Largely reflects current position under the Data Protection Act 1998 in
substance
– Incorporates current subject access modification orders relating to
education, health and social care data
96. What does the Bill do? (cont’d)
— Provides additional detail as to the bases of processing of special
categories of personal data
– Processing for the performance of a task carried out in the public interest
or in the exercise of official authority includes processing necessary for the
exercise of a function conferred on a person by an enactment or rule of law
– Employment, health and research conditions – Schedule 1, Part 1
– Substantial public interest conditions – Schedule 1, Part 2
– Appropriate policy documents and safeguards – Schedule 1, Part 4
97. Article 28 GDPR
Processing by a processor must be governed by a
contract that is binding on the processor with
regard to the controller and that sets out the
subject-matter and duration of the processing, the
nature and purpose of the processing, the type of
personal data, categories of individuals whose data
is being processed and the obligations and rights of
the controller.
98. Assess third party relationships
— Assess the status of third parties – are they a data processor or data controller?
— Data Controller
– Third party data controllers are subject to the same GDPR obligations as a public
authority
– Best practice to have data sharing agreements / protocol / memorandum of
understanding
– Consider – do you have a lawful basis for sharing the information?
— Data processor
– Data sharing agreement must be in place under the GDPR
– That agreement must be compliant with specific provisions
99. Data sharing agreements – Article 28
— The below are legally required to be included as part of any data
sharing agreement under Article 28:
– Subject matter and duration of processing
– Nature and purpose of processing
– Type of personal data
– Categories of data subjects
– Obligations and rights of the controller
100. Data sharing agreements cont.
— Article 28 also specifies provisions which must be included in a data
sharing agreement:
— Processing must be in line with the instructions of the data controller
— Commitment to confidentiality
— Requirement to meet all measures under Article 32 (security) (see below)
— Assists the controller where possible, including with investigation of breaches
and audits
— Securely destroy or return personal data to the controller at the end of the
agreement
101. Data sharing agreements cont.
— Consider – are your data sharing agreements compliant?
— If not, contact the data processor and query how they intend to make
the agreement GDPR compliant? Processors are likely to have a
proposal in place as they are likely to work for a substantial number of
controllers
— Seek advice on proposed changes
ROSF2
103. Contracts
—Indemnities
– Consider the new level of fines and the level of indemnity
—Definitions
– GDPR terminology differs from previous data protection law and it is likely
that amendments will be required
NHS contracts
Data Protection Protocol – mandated for use with NHS Standard Contracts
Complies with all the requirements of Article 28