Problems in Laboratory Testing in Primary Care

Quality management in European screening laboratories in blood establishments: A view of current approaches and trends

“…By itself, ISO 9001 does not guarantee that reported result is the output of a technical evidence-based test. ISO 15189 requires a detailed set of technical requirements, however the screening laboratory staff must select [29][30][31][32][33][34]. A recent study shows that the relative frequency of nonconformities is still close to that observed in 1996 (85% for both pre and post analytical, and 15% for analytical), but with a lesser absolute frequency amount [35].…”

Laboratory errors, adverse events and research methodologies: a systematic review

“…The nine studies were: 1) Problems in laboratory testing in primary care -that examined the frequency and the characteristics of laboratory problems in primary care and their impacts on health care (11) ; 2) Mistakes in a stat laboratory: types and frequency -that evaluated the frequency and the types of errors found in a stat laboratory, by monitoring four departments (internal medicine, nephrology, surgery and intensive care unit) (19) ; 3) Adverse events and deaths associated with laboratory error at a hospital -Pennsylvania -study of the Centers for Disease Control and Prevention (CDC) that presents the results of an investigation of two deaths (5) ; 4) A physician-based voluntary reporting system for adverse events and medical errors -that aimed at the creation of a voluntary reporting method for the identification of real and potential AEs among inpatients (24) ; 5) Classifying laboratory incident reports to identify problems that jeopardize patient safety -that evaluated the errors and AEs of a laboratory incident report classification system (1) ; 6) Clinical impact associated with corrected results in clinical microbiology testing -that describes the strategy used to identify and characterize the clinical impact associated with corrected results of clinical microbiology tests (28) ; 7) Errors in a stat laboratory: types and frequencies 10 years later -that repeated the study design used by Plebani in 1997 (6) ; 8) Characterizing cases associated with corrected reports in hematology and coagulation -that described the strategy to determine if screening criteria could be applied to corrected results of hematology and coagulation testing, to identify association with adverse clinical impacts (10) ; 9) The development of a system for reporting, classification and grading of quality failures in the clinical biochemistry laboratory -that described a system to report, classify and grade the severity of quality failures in actual and potential adverse impacts (12) .…”

“…However, AE is not considered in this group of norms (8) . In Nutting's study (11) , laboratory errors are considered "problems in laboratory tests". Plebani (19) and Carraro (6) referred to laboratory errors defining them as "any defect during the entire testing process, from ordering tests to reporting results, that influenced in any way the quality of the laboratory service".…”

“…Nutting (11) called the consequences of errors "impacts on health care"; Plebani (19) and Carraro (6) referred to "patient outcome". The CDC (5) mentioned EA, and Weingart (24) , as well as Astion (1) , used a definition of AE similar to that by the Harvard study (3) , which is the most frequently used definition in studies on patient safety: AE is "non-intentional harm that results in death, temporary or permanent disability, or prolonged hospital stay".…”

“…The deaths that caused the investigation by CDC (5) corresponded to 0.09% of the investigated incidents. Nutting (11) reported that 27% of the total incidents caused impact on health care. It is necessary to consider that out of 49 incidents that affected health care, just half represents 13.3% of total incidents, which were described in detail.…”