Maria Laura Chiozza

Performance criteria and quality indicators for the pre-analytical phase

Abstract The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

Harmonization of pre-analytical quality indicators

Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.

Nocturnal enuresis in the adolescent: a neglected problem

Objective  To assess the features of adolescent bedwetters, as few data are available on enuresis in this age group.

Towards harmonization of quality indicators in laboratory medicine

Abstract The identification of reliable quality indicators (QIs) in the total testing process (TTP) represents a crucial step in enabling users to quantify the quality of laboratory services, but the current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence showing the multitude of errors that continue to occur in the pre- and post-analytical phases. Although interesting programs on indicators of the extra-analytical phases have been developed in some countries, there is no consensus on the production of joint recommendations for the adoption of universal QIs and the use of common terminology in the total testing process. In view of the different QIs and terminologies currently used, there an urgent need to harmonize proposed QIs, which should comply with three main principles: they must be patient-centered, consistent with the requirements of the International Standard for medical laboratories accreditation, and address all stages of the TTP. A model of quality indicators (MQI), consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), includes 56 QIs related to key processes (34 pre-, 7 intra- and 15 post-analytical phase) and three to support processes. The scope of harmonization in laboratory medicine, more far-reaching than method harmonization, should cover a wider range of topics, namely all steps of the “brain-to-brain loop”. The identification of valuable QIs is a key step in paving the way towards quality and patient safety in laboratory medicine.

Quality indicators in laboratory medicine: A fundamental tool for quality and patient safety

OBJECTIVES The identification of reliable quality indicators (QIs) is a crucial step in enabling users to quantify the quality of laboratory services. The current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence pointing to the multitude of errors that continue to occur in the pre- and post-analytical phases. DESIGN AND METHODS Different QIs and terminologies are currently used and, therefore, there is the need to harmonize proposed QIs. RESULTS A model of quality indicators (MQI) has been consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The model includes 57 QIs related to key processes (35 pre-, 7 intra- and 15 post-analytical phases) and 3 to support processes. CONCLUSIONS The developed MQI and the data collected provide evidence of the feasibility of the project to harmonize currently available QIs, but further efforts should be done to involve more clinical laboratories and to collect a more consistent amount of data.

Clinical Governance: from clinical risk management to continuous quality improvement.

Abstract 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.

Immunohistochemical Distribution of Endothelin in Biopsies of Pediatric Nephrotic Syndrome

In a retrospective, double-blind study, we analyzed, utilizing an immunohistochemical technique, the distribution of Endothelin (Et) in 20 renal biopsies of 17 children with nephrotic syndrome (NS): 9 cases of steroid-responsive and 8 of steroid-resistant minimal-change disease (MCD) and 3 cases of focal segmental glomerulosclerosis (FSGS). Thirteen out of 20 biopsies (9/9 steroid-responsive MCD and 4/8 steroid-resistant MCD) showed a weak positivity of the vascular endothelial cells, as the normal renal tissue samples obtained from tumor nephrectomies. Seven out of 20 biopsies, all steroid-resistant NS, showed a marked positivity of the vascular endothelium and of the tubules and/or interstitial cells. In 4 of these 7 cases (1 MCD, 3 FSGS) a positivity of glomeruli was also revealed. The positivity of vascular endothelium seems to confirm its central role in Et production. The marked immunoreactivity detected in the endothelial cells and other renal components reveals a local increase in Et in some steroid-resistant MCD and, particularly, in FSGS. These preliminary observations suggest that Et may participate (cause or epiphenomenon) in the mechanisms underlying the development of glomerulosclerosis and the progression of renal damage.

A model of quality assurance and quality improvement for post-graduate medical education in Europe

Background: The issue of quality assurance (QA) and quality improvement (QI), being the quality of medical education intimately related to the quality of the health care, is becoming of paramount importance worldwide. Aim: To describe a model of implementing a system for internal QA and QI within a post-graduate paediatric training programme based on the ISO 9001:2000 standard. Methods: For the ISO 9001:2000 standard, the curriculum was managed as a series of interrelated processes and their level of function was monitored by ad hoc elaborated objective indicators. Results: The training programme was fragmented in 19 interlinked processes, 15 related procedures and 24 working instructions. All these materials, along with the quality policy, the mission, the strategies and the values were made publicly available. Based on the measurable indicators developed to monitor some of the processes, areas of weakness of the system were objectively identified and consequently QI actions implemented. The appropriateness of all this allowed the programme to finally achieve an official ISO 9000:2001 certification. Conclusions: The application of the ISO 9001:2000 standard served to develop an internal QA and QI system and to meet most of the standards developed for QA in higher and medical education.

Measurement of melatonin in blood by radioimmunoassay. Analytical considerations and clinical usefulness.

Melatonin assay has proved to be clinically useful for the diagnosis and investigation of several diseases (e.g., Cushings syndrome, depressive disorders). We have evaluated the analytical performance of a radioimmunoassay for the determination of melationin in plasma. The interference of some anticoagulants has been investigated, as well as the preliminary extraction of the hormone using a liquid-liquid and a solid-phase extraction method. The variation coefficients of the assay, within and between runs, were between 3.8% and 9.2% and between 4.1% and 10.5%, respecitively. The well-documented circadian rhythm of melatonin secretion was confirmed in our healthy subjects. Preliminary results appear to confirm the significance of melatonin measurement in neurosurgical patients.

Urinary excretion of glycosaminoglycans in patients with isolated nocturnal enuresis or combined with diurnal incontinence

Objective To determine variations in the amount of glycosaminoglycans (GAGs) excreted by patients with nocturnal enuresis and/or diurnal incontinence.