Volume 44, Issue 6

There is no large literature on evidence-based policy-making. We do know that one of the most difficult decisions is about the dependability of evidence we use to make policy. Unless the evidence can fulfil the criteria of quality, validity, and size, then it has the potential to mislead us, whatever study designs or methods have been used. The best examples of evidence-based policy-making come from development of care pathways, in which multidisciplinary groups merge best-available evidence with what is possible in local circumstances. These care pathways almost always have the ability to deliver better care for patients, with less fuss for professionals and at lower cost to the community. They may be the single best way of improving healthcare.

Although Clinical Governance now has a strong structural base in the National Health Service (NHS), its actual application in terms of service delivery is more inconsistent. Cross-agency and boundary working are still underdeveloped and true patient involvement remains the province of a minority of enthusiasts. Despite this, there have been some significant moves forward, in that quality is now intrinsically linked to service delivery, and managers and clinicians are more explicitly accountable for the care they provide. This article examines the introduction of Clinical Governance to the NHS and discusses what practical applications have been made. Case studies drawn from those who are working at the frontline are used to illustrate the impact that Clinical Governance components have had on service delivery and patient experience.

To be effective, Clinical Governance should reach all levels of a healthcare organisation. It requires structures and processes that integrate financial control, service performance, and clinical quality in ways that will engage clinicians and generate service improvements. The Clinical Governance arrangements of many Trusts, however, present several flaws. In particular, the “silos” organisational structure of Clinical Governance is based on generic issues such as risk management, clinical audit, clinical effectiveness and staff development, and it tends to treat clinical work as an undifferentiated aggregate. An alternative model focused on clinical pathways and on a balance between professional autonomy and accountability (responsible autonomy) should be promoted to make Clinical Governance work.

The purpose of this paper is to accurately identify the future governance arrangements the NHS will follow, a close examination of the roles of Directors in implementing such a policy, and the National Policy documents that are required to put this in place.

Reducing medical errors has become an international concern. Population-based studies from a number of nations around the world have consistently demonstrated unacceptably high rates of medical injury and preventable deaths. The introduction of effective reporting systems is a cornerstone of safe practice within hospitals and other healthcare organisations. Reporting can help to identify hazards and risks. However, reporting in itself does not improve safety. It is the response to reports that leads to change. Clinical teams must feel empowered to change the way in which they deliver their services, promoting effective clinical risk management. Process analysis, implementation of evidence-based practices, and a clear accountability system are effective tools not only for decreasing error rates, but also for improving effectiveness. Clinical Governance represents the context in which effective clinical risk management should be promoted and continuously improved. It should not be regarded as a separate activity, but should form part of the everyday practice of all healthcare professionals. It requires good multidisciplinary working and a willingness to reflect on and learn from errors to achieve a patient-centred and safer system.

Clinical Governance is a framework through which the National Health Service (NHS) organisations in the UK are accountable for continuously improving the quality of their services and safeguarding high standards by creating an environment in which excellence in clinical care will flourish. The NHS has moved on from being an organisation that simply delivered services to people, to being a service that is totally patient-led and responds to their needs and wishes. There are numerous national drivers and initiatives for patient involvement, including the NHS Plan 2000 , Involving Patients and public in healthcare 2001 and, more recently, Creating a patient-led NHS 2005 and Patient choice 2005 . There is also an independent public body funded by the Department of Health, the Commission for Patient and Public Involvement in Health (CPPIH), which supports and enables patient involvement in local decisions about delivery of healthcare. At Luton & Dunstable Hospital NHS Trust, patients and carers are seen as a valuable resource and there are formal mechanisms for recruiting patient representatives to sit on hospital committees and to be involved in service provision, including Clinical Governance arrangements.

Continuing Professional Development (CPD) is a key factor for effective implementation of Clinical Governance. The development of a quality system is, in fact, strictly related to the development of competencies of healthcare professionals. Lifelong learning has emerged as a new paradigm that underlines the need to maintain and continuously improve knowledge, competencies and attitudes in the changing scenario of healthcare systems. CPD accreditation is another fundamental issue and a variety of voluntary and compulsory approaches can be recognised at an international level. The experience of the University Hospital of Padova may be useful to demonstrate that CPD can be addressed to implement a Clinical Governance project.

Currently the increased healthcare needs of the population call for strategic planning that provides tools to balance the costs of the system with the quality of services offered. The first requirement for this end is reliable, timely and comparable data. Therefore, a New Health Information System (NSIS) is needed that will contribute to achieving this goal.

This review attempts to address the question: is the Electronic Medical Record (EMR) our best friend or sworn enemy in the context of Clinical Governance and Laboratory Medicine? It provides a brief overview of the history and development of Clinical Governance before going on to define an EMR. It considers how EMRs could assist in delivering quality care in laboratory medicine. A number of outstanding issues regarding EMRs and electronic health records (EHRs) are identified and discussed briefly before the author provides a brief outlook on the future of clinical governance and EMRs in laboratory medicine.

A body of evidence has been accumulated to demonstrate that current practice is not sufficiently safe for several stages of central laboratory testing. In particular, while analytical and perianalytical steps that take place within the laboratory are subjected to quality control procedures, this is not the case for several pre- and post-analytical steps. The ubiquitous application of auto-identification technology seems to represent a valuable tool for reducing error rates. A series of projects in Oxford has attempted to improve processes which support several areas of laboratory medicine, including point-of-care testing, blood transfusion, delivery and interpretation of reports, and support of decision-making by clinicians. The key tools are auto-identification, Internet communication technology, process re-engineering, and knowledge management.

Background: Clinical Governance is described as “a framework through which the NHS organisations are accountable to continue to improve the quality of the service and safeguarding high standards of care by creating an environment in which excellence in clinical care would flourish”; it is aimed to ensure continuous improvement in the overall standard of clinical care, ensuring that clinical decisions are based on the most up-to-date evidence in terms of effectiveness. Methods: If Clinical Governance is a framework through which NHS organisations are accountable to continuously improve the quality of their services and safeguarding high standards of care, Clinical Effectiveness is a vital part of Clinical Governance. Clinical Effectiveness is a term that refers to measuring and monitoring the quality of care, and comprises various activities, including: Evidence-Based Practice, Research and Development, Clinical Audit, Clinical Guidelines, Integrated Care Pathways, and Total Quality Management. Results: The application of evidence-based medicine (EBM) in laboratory medicine or evidence-based laboratory medicine (EBLM) aims to advance clinical diagnosis by researching and spreading new knowledge, combining methods from clinical epidemiology, statistics and social science with the traditional pathophysiological molecular approach. EBLM, by evaluating the role of diagnostic investigations in the clinical decision-making process, can help in translating the results of good quality research into everyday practice. Conclusions: If Clinical Governance is a framework through which organisations are accountable to improve the quality of care, health professionals should identify high quality standards, and systematically and rigorously monitor against them the process and outcomes that represent the diagnostic process. Within such a policy framework, practice guidelines are expected to play a major role, providing the basis to access the quality of care and guidance where clinical practice is found not in line with professional standards.

The requirements of ISO 15189:2003 are discussed in the context of a process- and outcome-based quality management model in which the user's needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organisation and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Examples are provided from the areas of resource management, and pre-examination, examination and post-examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.

The implementation of Clinical Governance will require a redefinition of duties and accountability as a prerequisite to develop and achieve an overall improvement in clinical care through a culture of assessment and monitoring of quality. External Quality Assessment Schemes (EQAS) are the main tool enabling laboratories to measure the quality of their results; they must carefully assess and monitor all elements contributing to the formulation of laboratory information (results, reference ranges/decisional levels, interpretative comments and diagnostic algorithms). There are different ways to design and manage a Scheme and EQAS coordinators are mainly responsible for its effectiveness. The present paper reports, as an example, some experiences of the Centre of Biomedical Research (CRB), which manages EQAS according to high quality specifications and laboratories' needs, that can reflect the Clinical Governance philosophy. Our findings show that EQAS are able to control all the above aspects and, if organisers are committed to fulfilling the responsibility and accountability principles, they will be of great value in quality assessment and in developing an External Quality Assurance Program (EQAP). This is an inter-laboratory comparison designed and conducted to assure the following: evaluation of participants' performance (by evaluating not only analytical performance, but also test interpretation, and advice for clinicians on laboratory requests and diagnosis); evaluation of method performance; and continuous education, training and help. The main aim of the activities of an EQAP in Laboratory Medicine is to sustain improvements in the quality of services provided by participating laboratories for the benefit of patients.

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46–68.2% of total errors), while a high error rate (18.5–47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called “laboratory errors”, although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term “laboratory error” and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes in pre- and post-examination steps must be minimized to guarantee the total quality of laboratory services.

Within the activities of the Risk Management Unit of the Bari Polyclinic Hospital Corporation, an anomalous trend was found, with excessive requests for urgent laboratory tests being made in the time period between 05:00 and 07:45h. In addition to slowing down laboratory operations, this anomaly suggested the possibility of inappropriate testing, at least in terms of the request mode, if not in absolute terms. An audit was implemented within the facility to check the grounds of this suspicion and to identify any errors and/or critical points. The results gathered are extremely interesting, as they show deficiencies at both the organizational and clinical level. The final objective of the investigation is to draft a common corporate procedure.

Clinical Governance is a quality framework encompassing risk management, clinical and cost effectiveness, and patient outcomes. These principles apply to point-of-care testing (POCT), which is becoming widely used within hospitals and the community. Formal regulation of POCT is variable throughout the world, but it is vital that the principles of clinical governance are followed in the implementation and management of POCT and laboratory professionals have a responsibility to advise users of POCT accordingly.

The aim of this study was to identify patients with myocardial necrosis in pre-hospital phase during transport by ambulance, without ST-segment elevation (NSTE) on the ambulance ECG. The analytical performance of the i-STAT ® troponin I (cTnI) method was assessed. A total of 53 NSTE ambulance ECG patients admitted to hospital were followed. The ambulance had experimental software able to receive data from the i-STAT device and transmit it to a protected address and server. cTnI mean values from 2.0 to 34μg/L showed a total CV of 3.0–5.6%. The detection limit was 0.016μg/L. A mean cTnI concentration of 0.09μg/L was associated with a CV of 8.0% (decision limit). The i-STAT cTnI method was linear for concentrations from 0 to 35μg/L. There was no effect (p<0.05) of interfering substances. For point-of-care testing (POCT), cTnI was >0.09μg/L in 20 AMI patients (91%). The median ambulance turnaround time (TAT) was 12min and median hospital TAT was 40min, a difference of 28min. The high sensitivity of the i-STAT cTnI method integrated with tele-medicine procedures could play an important role in the management of acute coronary syndrome patients related to the pre-hospital phase (early diagnosis and treatment in the ambulance). These approaches may allow improvements in patient outcomes and continuous monitoring of the POCT network in the central laboratory, thus meeting quality requirements.