Recommendations for the detection and management of unsuitable samples in clinical laboratories

A large body of evidence supports that quality improvement efforts tailored to the analytical phase only, are less likely to generate further clinical and economical progresses. Actually, most diagnostic errors made within the laboratory diagnostics emerge in the extra-analytical domains of testing, especially within the preanalytical phase. It is now clear that the underlying causes are most frequently due to system errors or to the implementation of poorly standardized procedures for collection, handling, transportation, preparation and storage of biospecimens. Some of these problems could generate a number of issues related to the quality of clinical samples, ending up with the reception by the laboratory of unsuitable samples. The identification and the management of unsuitable samples represent thus unavoidable practices in clinical laboratories to guarantee the quality of test results throughout the total testing process. Due to the ongoing evolution of the in vitro diagnostic market and the availability of new evidence, this paper provides a revision of the national recommendations issued by the Italian Society of Clinical Biochemistry and Clinical Molecular Biology in 2007 for detection and practical management of unsuitable specimens in clinical laboratories

Blood collection systems in clinical laboratories: local adaptation of the EFLM guidelines

The importance of the process of purchasing or changing blood collection devices is often overlooked. This is likely attributable to many factors such as the limited knowledge that policymakers, healthcare administrators and also laboratory managers have on the significance of preanalytical quality, but also to the lack of validated criteria for analyzing the quality of blood collection devices. Since a gap remains to be filled between companies\u2019 and laboratory\u2019s validation, the EFLM Working Group on Preanalytical Phase (WG-PRE) has published a comprehensive document, which contains essential prerequisites and technical issues (e.g., physical imperfections, defects of functioning, safety deficiencies) to support local clinical laboratories for the development of tenders for blood tubes and for the validation of new materials ahead of local routine use. This consensus document is a national adaptation of these guidelines

Recommendations for the detection and management of critical results in clinical laboratories

Critical results, (also known as panic or alarm results) identify a laboratory test result associated with a serious risk for the patient\u2019s health, requiring immediate communication to the physician to establish appropriate therapeutic interventions. The adoption of an efficient procedure for the communication of critical values/results is crucial for clinical, ethical, organizational reasons, because it is a requirement for laboratory accreditiation and because of potential legal consequences related to the lack of notification of harmful laboratory results. In 2008, the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) published its first consensus-based recommendation for the detection and management of critical values in clinical laboratories, with the aim to improve the implementation of standardized and universally accepted procedures, promoting an essential policy toward rational and efficient solutions to this issue. These new recommendations represent a complete review of the first document. Using the same consensus conference method between experts of scientific societies, the main aspects of clinical risk, patient safety and legal liability of health care workers were re-considered. The SIBioC and the Italian Society of Laboratory Medicine (SIPMeL), Intersociety Study Group on Standardization of extra-analytical variability of laboratory results, together with the Italian Society of Ergonomics and Human Factors (SIE) collaboration, issued the present join document