Quality and Managerial Issues
Introduction
Clinical and laboratory services do not operate in isolation but are integrated into the clinical and managerial framework of a hospital, and in the UK into a nationwide network (the NHS). This provides a constraint in both managerial and financial terms and also provides a legal framework in which services are delivered. It is essential that no matter where the patient is treated the right diagnosis is reached and the appropriate treatment is given. NHS service providers in the UK are now subject to rigorous central direction by the Department of Health and inspection by the quasi-autonomous Care Quality Commission (CQC), previously known as the Healthcare Commission and before that the Commission for Healthcare Improvement (CHI) (see http://www.cqc.org.uk/). For mainstream therapeutics and procedures, the National Institute for Health and Clinical Excellence (NICE) determines whether therapies (drugs, procedures) should be available on the NHS, supposedly to eliminate postcode prescribing (see http://www.nice.org.uk/).
With devolution the healthcare systems in Wales, Scotland and Northern Ireland have now diverged substantially from the model in operation in England, despite the anachronistic term of a ‘National’ Health Service. This has become more marked with current (2012) changes introduced by the Coalition Government.
Scotland has retained a system of health boards, which manage all services including hospitals and primary care. There is no system where money follows patients. This is less bureaucratic. There has been divergence in service provision, with some services not available in Scotland, and there are different approvals of drugs so that a new drug may be available in England but not in Scotland and vice versa.
Structure of the NHS and the NHS plan
Department of Health
In 2002 the NHS commenced one of the biggest changes in structure since its creation in 1948. The NHS plan was published in July 2000 and outlined a 10-year plan of investment in NHS.
The Department of Health (DoH) is responsible for leading the NHS on social care as well as improving standards of public health.
The Secretary of State for Health currently works with five ministers for health and the Permanent Secretary of the DoH.
The Secretary of State for Health is accountable to Parliament for the functioning of the NHS.
setting overall direction
ensuring national standards are set
securing resources.
It also interferes by attempting to micromanage services directly!
In 2012, a new Health and Social Care Bill was passed in England. This bill:
will allow GP-led commissioning
will enshrine a right to a level playing field (which means that any qualified provider can bid to run services, including private sector, charities, etc.)
will claim to provide a greater voice for patients (very unlikely, as patients’ wishes are always ignored!)
will remove the NHS from the direct control of the Secretary of State (so politicians can’t be blamed when it all goes wrong!)
will essentially privatize the NHS by the back door.
Delegated responsibilities
Previous DoH responsibilities have been now devolved to other organizations, including the following.
Overall regulation and inspection of the NHS is now the responsibility of the Care Quality Commission (CQC) (previously Healthcare Commission and Commission for Healthcare Audit and Inspection (CHAI)!!).
Regional planning and modernization—devolved to the strategic health authorities.
Evaluation of therapies—devolved to NICE.
National Patient Safety Agency (NPSA, Special Health Authority): responsible for identifying and learning from risks to patients.
NHS Litigation Authority (NHSLA, Special Health Authority)—responsible for all litigation against the NHS.
National Clinical Assessment Authority (NCAA)—responsible for dealing with poorly performing doctors.
Strategic health authorities (SHAs)
Below the Secretary of State for Health there were 28 strategic health authorities (replacing the regional health authorities) who managed the NHS locally. Their roles included the following.
Coherency and developing strategies to improve the local health service.
Ensuring high-quality performance of local health service.
Building capacity.
Making sure national priorities are integrated into local health plans.
Implementation of modernization programmes.
In England these are in the process of being abolished and their functions devolved to GP Commissioning Groups, led by Senates. However, in the short term a smaller number of SHAs still operate and have some delegated responsibilities.
Primary care trusts (PCTs)
PCTs received 75% of NHS budget.
They were supposed to be directly managed by GPs, but in practice GPs often had little input into the decision-making process.
They were responsible for:
planning and securing services for the local population’s needs
improving the health of local population
integrating health and local care socially by working with local authorities.
They were required to spend 10% of their budgets on commissioning services from the independent sector, via independent treatment centres. This has proved highly destabilizing to NHS services: with wards being closed and staff laid off.
As well as commissioning services, they also acted as providers of services, which many viewed as a conflict of interest
As part of the health service reforms (2012), PCTs have been abolished. Their provider functions have been transferred to other provider units (often foundation trusts) and their commissioning role has been transferred to GP-led commissioning groups.
Senior staff have been laid off, with loss of key expertise. Some have been re-engaged by the GP commissioning groups.
GP commissioning groups
These have been established (in shadow in 2011-2012) to take on the role of commissioning services from providers.
They are led by a ‘senate’ of GPs.
They are supposed to have consultant input from secondary care (but are finding it difficult to recruit volunteers)
Although they were originally supposed to take on responsibility for approximately 75% of the NHS budget, it is becoming clear that their freedom of action and financial responsibility is gradually being pared down by the NHS Executive, which is concerned about the serious effect of commissioning errors.
Private organizations have become involved in some of these groups.
Specialist commissioning
In England, clinical immunology and allergy are separately commissioned by regional specialist commissioning teams.
In 2013, regional commissioning will be replaced by central specialized commissioning.
A national advisory process has been set in place for 2012-2013.
Services for SCID and other rare diseases or low-volume expensive procedures (e.g. lung transplantation) are already commissioned nationally, with only one or two sites in England. For SCID, these sites (Great Ormond Street Hospital and Great North Childrens’ Hospital, Newcastle) also provide services for Scotland, Wales and Ireland.
NHS trusts
NHS trusts continue to run some hospitals, usually where there have been major financial issues affecting stability.
They must develop working relationships with the PCT and are accountable to the SHA rather than directly to the DoH.
Their budget is derived predominantly from contracts with PCTs.
Trusts also receive funding from medical schools to undertake medical student training—this replaces the old SIFT (service increment for teaching) arrangements, which have now been dismantled.
The Chief Executive is now legally responsible for activities within the trust. He/she can be dismissed by the trust board.
Foundation trusts
Established in April 2004, foundation trusts are free-standing organizations with greater freedom within the NHS, including the freedom to borrow money in commercial markets.
They now comprise the majority of NHS hospitals in England.
They are considered as separate non-profit making organizations.
They are owned by their members who are local people, employees, and other key stakeholders.
A board of governors must be elected by members of the foundation trust, including local people, patients, and employees.
The board of governors works with the management board to ensure that the foundation trust acts in a way that is consistent with its objectives.
The Secretary of State for Health does not have power to direct NHS foundation trusts or appoint board members.
They are accountable to an independent regulator (Monitor), who is responsible for approving their application for foundation status and who may remove that status if they do not manage their affairs satisfactorily.
They are accountable externally though inspection by the Care Quality Commission.
Income is derived through legally enforceable contracts with PCTs. However, in 2012 at number of trusts required financial bail-outs from the DoH.
Franchise hospitals
One hospital in England with long-standing problems has now been handed over in its entirety to the private sector to be run as an NHS franchise.
It is unclear whether this is a model that will be rolled out more widely.
Opted-out services
Current legislation in England allows services to opt out of direct NHS control, while continuing to provide contractual services to NHS patients.
There are a number of financial models for this.
So far this has mainly involved therapy services in the community, but in the future could include clinical services in secondary and tertiary care.
This could include the development of doctors’ chambers.
Clinical Pathology Accreditation (CPA)
CPA is an organization that provides a means to:
accredit clinical pathology services
accredit external quality assessment schemes (EQA).
Laboratories need to provide documentary evidence to meet an extensive set of standards covering personnel, premises, equipment, and pre- and post-analytical phases of the sample.
New standards were introduced in April 2004. Standards are reviewed by a standards advisory group.
CPA has now been formally absorbed into the UK Accreditation Service (UKAS)—the only internationally recognized accrediting body in the UK.
The original CPA structure of shareholding ownership by the professional bodies has been wound up.
For details see http://www.cpa-uk.co.uk/
Process
Once a laboratory applies for enrolment, inspection will automatically follow.
Only 75% of NHS laboratories are currently enrolled!
The laboratory initially applies for accreditation by submitting an application form, which includes the repertoire and a quality manual that gives details of how the laboratory meets the standards and describes its managerial structure.
Once the application and quality manual have been reviewed by the CPA officers, assessors are appointed and a date for inspection arranged.
The CPA will usually send two inspectors, one clinician or scientist and one senior biomedical scientist (BMS).
Where a laboratory has a small repertoire a single inspector may be used.
Failures to meet the standards will be identified by assessors and signed off at the time by the assessors and the applicant laboratory in one of three categories:
critical non-compliances, representing system failure and an unsafe laboratory
non-critical non-compliances which do not affect the safety of the service
observations.
Paid assessors, with expertise in audit and quality systems management, are now employed by the CPA to carry out the horizontal and vertical audits.
The assessors’ report is then reviewed by CPA officers and passed to the relevant member of the Professional Advisory Committee (PAC).
The PAC is a single advisory committee with 21 members.
It is responsible to the board of CPA for the implementation of all matters relating to the laboratory accreditation section of CPA.
Immunology is represented by a consultant and a BMS, who review all reports before they are issued and have the power to override and alter reports from assessors.
The final report is issued to the laboratory some 6-8 weeks later.
This may be as follows.
Full accreditation without conditions.
Conditional approval for a fixed period of time (usually up to a year) subject to specified conditions that must be met within that period. Once the conditions have been met, full accreditation will be granted;
Referral (failure), where the laboratory has critical non-compliances such that it is unsafe. Decisions to refer laboratories are confirmed by the CPA council, to whom the applicant may appeal.
Extended conditional approval is granted at the discretion of PAC where a laboratory has conditions (such as rebuilding) that cannot be met within a short time frame, but where the service is not unsafe.
Re-inspection currently takes place every 4 years.
An interim inspection takes place every 2 years to review the quality management system. This is undertaken by the paid assessors and does not include peer review.
Copies of the report are sent to the chief executive.
Compliance with CPA standards is a requirement for trusts applying for inspection under the Clinical Negligence Scheme for Trusts (CNST) and is also required by the NHSLA.
UKAS is the sole national accreditation body recognized by government to assess, against internationally agreed standards, organizations that provide certification, testing, inspection, and calibration services.
Medicines and Healthcare Products Regulatory Authority (MHRA)
MHRA is responsible for licensing drugs and medical devices, and products made by genetic engineering for clinical use. It also regulates blood transfusion services (with inspections of both production facilities and blood banks that are separate from the CPA).
Licensing drugs is now regulated by Directives of the European Union.
See http://www.mhra.gov.uk/Aboutus/index.htm for more information.
Quality management system (QMS)
QMS defines the process by which a laboratory ensures that all aspects of its function achieve the highest possible quality.
QMS requires documentation of all functions undertaken, both to meet statutory requirements (COSHH) and to provide the framework for staff to function effectively.
QMS must include robust document control, so that only current versions of policies are available to staff.
Quality manual
The quality manual defines how the laboratory meets each standard for CPA.
It includes the management structure and operational procedures for the laboratory.
It will cross-reference trust policies on health and safety, personnel (training, induction), visitors, standing financial instructions, IT, etc.
Laboratory handbook
The laboratory handbook provides essential information on services to users, including repertoire, sample requirements, normal ranges, on-call services, and contact details.
The handbook must be accessible to all users including primary care. Internet and hard copy may be available.
Annual management review
CPA requires laboratories to undertake an annual management review by standards. This must be submitted each year to the CPA at renewal of registration.
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