Select Committee on Health Minutes of Evidence

Memorandum by Quest Diagnostics Limited (PS55)


  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 Beecham (SB).


  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 1997.

  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 service.

  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 solving.

  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 trends.

  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 above.

  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 Masters degrees.


  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 of Health.

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Prepared 15 May 2002