Memorandum by Quest Diagnostics Limited
Quest Diagnostics is the United States leading
provider of diagnostic testing, information and services with
$3.4 billion in annual revenues. The company's diagnostic testing
yields information that enables health care professionals and
consumers to make better decisions to improve health. Quest Diagnostics
offers patients and physicians the broadest access to diagnostic
testing services through its national network of approximately
30 full-service laboratories, 150 rapid response laboratories
and over 1,300 patient service centres, where specimens are collected.
The company is the leading provider of esoteric testing, including
gene-based testing, and is the leader in routine medical testing,
drugs of abuse testing, and non-hospital-based anatomic pathology
testing. Through partnerships with pharmaceutical, biotechnology
and information technology companies. Quest Diagnostics provides
support to help speed the development of health care insights
and new therapeutics, Quest Diagnostics has 25,000 employees,
processes around 100 million requisitions annually and has laboratory
operations in Mexico, Brazil and the UK. In 1999 Quest Diagnostics
acquired the total Clinical Laboratory business of SmithKline
In 1995 SB began business development in the
UK with a view to entering the UK pathology testing market. With
95 per cent of the market within the NHS, the market testing of
support services in the NHS indicated that this market would become
open to private suppliers.
In the autumn of 1996 West Middlesex Hospital
NHS Trust and SB Clinical Laboratories signed a partnership agreement
for pathology services. This contract is currently being re-tendered.
The partnership was ground breaking in two key
areas. The first was the development of a Consultant Pathologist
led service that was supported by the Royal College of Pathologists.
The second was that the majority of testing was to be performed
at an off site facility.
Subsequent to the partnership agreement 83 employees
transferred from the Trust to SB. A 32,000 sq ft Laboratory facility
was developed at Heston, some five miles from the trust campus,
and most of the operation transferred to the new facility in early
The consultant pathologists remain employees
of the Trust, and are retained by Quest Diagnostics to provide
clinical and quality support for other work performed in the laboratory.
The present configuration of services has a
"rapid response" laboratory on the West Middlesex Hospital
site. The operation is staffed and managed by Quest Diagnostics
and operates 24 by seven. About 65 per cent of the total pathology
test volume are directed to the off site, high volume laboratory.
The two sites are linked by Quest Diagnostics IT system and courier
logistics making the service seamless to the end user. Quest Diagnostics
also provides phlebotomy for the wards, outpatients and some primary
care centres and courier services for sample pick up to GP surgeries.
The high volume main laboratory performs about
1.5 million tests annually. The laboratory also processes tests
from private health care organisations, and pharmaceutical companies
as part of our Global Clinical Trials business. Wherever possible
we run the tests in the same way and on the same platforms to
achieve cost advantages through volume.
The advantages to the Trust are freedom from
capital investment, the risk management connected with a high
profile clinical support service and the freedom from managing
variable demand and associated costs of a demand led pathology
Quest Diagnostics is committed to developing
more Public Private Partnerships with the NHS. The contribution
we make is through continuing quality improvement, customer focused
services, cost effectiveness, improved recruitment and retention,
the ability to manage change, technology and capital investment.
A key part of our ability to deliver these contributions
is through creating an organisational culture that supports the
satisfaction model. That is, satisfied employees delivering services
to satisfied customers will result in satisfied shareholders.
Our aim is to be a "top 100" place to work and attract,
retain and reward the best people in our field.
A raft of company wide initiatives including
two-way communications, diversity, reward, goal sharing and training
support the culture and retention of employees.
As an organisation Quest Diagnostics is leading
the charge to raise the quality of healthcare delivery. We are
the pioneers in applying Six Sigma Quality to healthcare services.
Six Sigma is a rigorous, data-centred approach to process improvement
that delivers "virtual perfection". Motorola first introduced
it in 1979 and companies like General Electric and Allied Signal
use it to dramatically reduce errors by preventing them from happening
in the first place. Quest Diagnostics has set a goal to achieve
Six Sigma Quality throughout the organisation.
The UK operation maintains a quality assurance
(QA) programme to monitor and evaluate the quality of pre-analytical,
analytical and post-analytical phases of the testing process,
to identify and correct problems and provide confidence that the
service meets the needs of its users.
Activities organised at the corporate QA level
include periodic inspections and company-wide surveillance of
external quality assessment performance. There is regular communication
across the network of QA specialists for development of policies
and procedures, exchange of information and to facilitate problem
Within the London Laboratory a QA team (comprising
the Medical Director, Quality Assurance officer and representatives
from operational departments) has the brief of reviewing QA issues
and metrics and of initiating quality improvement programmes.
The objective is to ensure that services for doctors and patients
meet high quality standards and are continually improved. There
is a laboratory-wide process for follow-up and corrective action
for concerns or complaints received from users of the service;
the same mechanism is used for problems identified internally.
Records are kept by the client services department and monitored
by the QA team.
External Quality Assessment (EQA) participation
is maintained to cover the test repertoire. The main source agencies
are UK National External Quality Assessment Schemes (UK NEQAS)
and College of American Pathologists Surveys Program (CAP surveys).
The EQA review procedure requires documentation of report review
by the appropriate specialist pathologist, laboratory team leader
and the QA officer; there is a proforma for noting investigation
and corrective action of unacceptable or discrepant results or
Monitoring of internal quality control and laboratory
records within technical departments is built into a system of
weekly checks, followed up by monthly review, to identify problems
and carry out prompt remedial action. This is supplemented by
secondary review of data and/or QA issues by senior staff including
the pathologist responsible for that discipline. The on-site QA
officer supports this review process and carries out internal
audit activities including the review of all EQA as indicated
Policies and procedures are defined for in-service
training, continuing education and competence assessment for all
laboratory staff. A training plan is developed for each role and
records kept for each member of staff.
Critical documents, including technical procedures,
are produced through a controlled document process managed by
the QA unit and require signed approval, use of a unique number,
version control and issue of identifiable official copies.
Clinical Pathology Accreditation (CPA) is the
external agency for inspecting the quality of clinical laboratories
in the UK. Our UK operation is fully accredited, and following
our inspection last year we were invited to be a pilot site for
the new standards that CPA are introducing. The following is a
quote from the inspector's report
"In summary the inspectors saw this as a
successful partnership between the public and private sector in
offering the West Middlesex Hospital and local health centres,
an excellent analytical and clinical service from a facility at
Heston which is possibly the finest that most of the inspectors
have encountered in the United Kingdom"
The laboratory is accredited by the US College
of American Pathologists (CAP), which is a more empirical audit
process than CPA, and requires biannual audit visits to maintain
accreditation status. CAP accreditation also requires participation
in CAP analytical surveys as a continual monitoring process.
In the year between CAP audits our corporate
QA team subjects us to an internal Quest Diagnostics audit. Continual
analytical quality is surveyed via internal quality control measures
where we are compared in performance against the other laboratories
in out network. Annual improvement targets in this measure are
part of senior management objectives.
The laboratory is accredited through CPSM as
a training site for Biomedical Scientists. Since 1997 we have
had eight trainees achieve state registration, fully trained three
cytology screeners and four Biomedical scientists have gained
As part of the contract with West Middlesex,
Quest Diagnostics assumes liability for the delivery of the service.
This includes transport of samples, blood collection from patients,
analytical testing and reporting data protection, storage and
archiving material. The contract specifies that Quest Diagnostics
maintain employers liability insurance for a minimum of £10
million and public liability insurance of US$15 million.
The laboratory processes work from multiple
clients including the NHS, private hospitals and clinics and as
part of the service to pharmaceutical companies provides testing
to physicians across Europe.
For our business to be successful we clearly
have to meet customer expectations on the time taken for results
to be available.
For the West Middlesex Hospitals we provide
"urgent" testing on site, and that operation is almost
exclusively dedicated to meeting the specific demands of that
customer. Results are typically available within minutes.
The less acute work processed at the main laboratory
is processed from multiple clients. The daily operation runs from
0630 to 2200 hours seven days a week with most routine testing
available the same day. We know that some of our GP customers
have modified the way they work, as the results from the morning
surgery now become available that afternoon.
All samples are allocated a unique numerical
identifier and bar-coded, and are tracked through the analytical
process and into storage. This gives us the ability to "pull"
a sample at any time from the routine process and analyse it urgently.
Quest Diagnostics has drawn upon its UK and
international experience to contribute to discussion on the development
of pathology services and has provided and analysis to the Department