Factitious Biochemical Measurements Resulting From Hematologic Conditions

Dalal, Bakul I.; Brigden, Malcolm L.

doi:10.1309/ajcpy9rp5qytyfwc

Cited by 44 publications

(39 citation statements)

References 78 publications

(116 reference statements)

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“…22,23 Recently collected data on the interference of para-proteins in many laboratory measurements, including glucose, bilirubin, C-reactive protein, creatinine and albumin, demonstrate that the frequency of this type of error is variable and probably underreported. 24 In addition, it has been demonstrated that haemolysis still causes factitiously high biochemical parameter levels, thus stressing the need for more appropriate guidelines for the identification and appropriate treatment of unsuitable specimens. 25 As already stressed, there is no discrepancy between the impressive reduction in analytical errors achieved over the last few decades and current evidence that analytical quality is not satisfactory when evaluated on the sigma scale, the Six Sigma being one of the best available approaches for providing objective estimates and metrics in several industries.…”

Section: Analytical Errorsmentioning

confidence: 99%

The detection and prevention of errors in laboratory medicine

2009

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The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories. Evidence demonstrates that pre-and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. Most errors are identified in pre-pre-analytic and post-post-analytic steps outside of the laboratory. In a patientcentred approach to the delivery of health-care services, there is the need to investigate, in the TTP, any possible defect that may have a negative impact on the patient. In the interests of patients, any direct or indirect negative consequence related to a laboratory test must be considered, irrespective of which step is involved and whether the error depends on a laboratory professional (e.g. calibration/testing error) or non-laboratory operator (e.g. inappropriate test request, error in patient identification and/or blood collection). Patient misidentification and problems communicating results, which affect the delivery of diagnostic services, are recognized as the main goals for quality improvement. International initiatives aim at improving these aspects. Grading laboratory errors on the basis of their seriousness should help identify priorities for quality improvement and encourage a focus on corrective/preventive actions. It is important to consider not only the actual patient harm sustained but also the potential worst-case outcome if such an error were to reoccur. The most important lessons we have learned are that system theory also applies to laboratory testing and that errors and injuries can be prevented by redesigning systems that render it difficult for all health-care professionals to make mistakes.

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Section: Analytical Errorsmentioning

confidence: 99%

The detection and prevention of errors in laboratory medicine

2009

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“…The analytical phase has improved over recent decades owing to increased automation, improved technology, assay standardisation, effective quality assessment schemes, statistical IQC and improved education. However, failure to obtain the required analytical quality is still evident, resulting from analytical interference and bias caused by variation between different reagent lots (Dalal and Bridgen, 2009;Savukoski et al, 2012;Algeciras-Schmnich et al, 2013). IQC, one TTP element, is our focus with the impetus to reduce error in the analytical phase through a standardised approach to IQC practice.…”

Section: Quality Matters In the Ttpmentioning

confidence: 99%

In control? IQC consensus and statutory regulation

Lee

Fitzgibbon

O’Shea

2016

International Journal of Health Care Quality Assurance

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Purpose - Internal quality control (IQC) represents an essential risk management tool within the total testing pathway (TTP) that contributes to the overall objective of assuring the quality of results produced in medical laboratories. Controlling analytical phase quality alone requires significant expertise and input by scientifically trained staff. This effort has escalated exponentially following the publication of the International Organisation for Standardisation (ISO)15189:2012 requirements for quality and competence in medical laboratories. The reported inconsistency and diversity to IQC approaches in diagnostic laboratories is definitive evidence that international guidance in IQC programme design and implementation is long overdue. The paper aims to discuss these issues. Design/methodology/approach - Herein, the authors define, describe and critically examine the essential elements four stages of an IQC programme and suggest a template to inform both design and ease of implementation. For practical application, the authors have stratified the proposed methodology into four stages: staff education and training; IQC material; IQC targets; and IQC procedure, and provide recommendations that meet ISO15189:2012 requirements. Findings - These recommendations are informed by the published literature together with the collective experience working in clinical biochemistry and diagnostic endocrinology laboratories. The authors note that the laboratory staff's effort on IQC is a continuous process, driven by changes within each IQC stage, in response to risk analysis, maximising economic value or through professional leadership and central to IQC programme implementation and delivery. Practical implications - The authors offer a template that laboratories can use to inform the design and implementation of their IQC programme. Originality/value - The proposed IQC programme is user friendly, flexible and pragmatic with the potential to harmonise practice. The authors have provided a template to potentially harmonise IQC practice nationally. Given the central and critical role that IQC practice plays in ensuring the quality of patient results' importance, the authors contend that the time has come for international consensus and statutory regulation regarding the minimally acceptable criteria for its implementation, monitoring and review.

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“…The subsequent decrease in detected absorbance leads to a falsely low measured concentration (3,4 ). Detection of the prozone effect requires dilution of the sample to remove the antigen excess and allow appropriate formation of the antigen-antibody complex, resulting in an accurate measurement (3,5 ). The prozone effect is more often observed when measurements are obtained using an immunoturbidimetric method; modern nephelometers are typically less susceptible to this effect because they employ an automatic dilution step to detect antigen excess (5 ).…”

Section: Immunoglobulin Excess and The Prozone Effectmentioning

confidence: 99%

“…The formation of the complex is pH dependent and uses an acid buffer (3,7 ). The low pH environment of the reaction mixture can lead to precipitation of immunoglobulins and result in increased turbidity and light scattering (5,7 ). Resolution of the interference is obtained by diluting the sample or removing the plasma proteins via various deproteinization methods (5, 7 ).…”

Section: Immunoglobulin Excess Affecting Measurement Of Phosphorousmentioning

confidence: 99%

Unexpected Test Results in a Patient with Multiple Myeloma

Gilbert

Bachmann

2014

Clinical Chemistry

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A 53-year-old male patient with an established diagnosis of IgG multiple myeloma was seen by a hematologistoncologist in consultation from an outside hospital. He had previously received 1 cycle of chemotherapy treatment, but he was found to be intermittently noncompliant with his therapy. The patient reported occasional nosebleeds and fatigue. Except for a slightly cachectic appearance, the physical examination was unremarkable. Laboratory results are shown in Table 1.Serum protein electrophoresis revealed monoclonal paraproteinemia in high abundance marked by an intense band in the ␥ region. Immunofixation electrophoresis was not ordered at that time, but it was previously performed at another institution and was positive for IgG monoclonal protein.The attending pathologist noted the discrepancy between the presence of a monoclonal band by serum protein electrophoresis and the patient's quantitative immunoglobulin measurements. Several additional suspicious test results were also noted. DISCUSSIONMultiple myeloma is a hematologic malignancy characterized by proliferation of a neoplastic plasma cell population that usually leads to abundant production of a monoclonal immunoglobulin, also called paraprotein or M-protein, as well as decreased concentrations of normal polyclonal immunoglobulins. Overwhelming expansion of plasma cells in the bone marrow with concomitant suppression of other normal blood cell lineages often results in thrombocytopenia and anemia, which are classically manifested as symptoms of bleeding and fatigue. Renal insufficiency, as evidenced by increased blood creatinine and blood urea nitrogen concentrations, also may occur and is likely due to filtration of associated monoclonal free light chains, which can cause tubular damage. Serum protein electrophoresis typically yields a discrete band in the ␥ region, and immunofixation demonstrates the presence of IgG monoclonal protein in over 50% of cases (1 ).Overproduction of plasma proteins in concentrations that exceed typical physiologic limits can be an important source of laboratory test interference. Paraproteins can adversely affect various instruments and methodologies. For example, a paraproteinassociated increase in blood viscosity can cause difficulty in sample aspiration by some instruments that results in assessments being performed on smaller-than-expected sample volumes and subsequent falsely decreased laboratory results (2 ). In addition, M-proteins, especially those that are also cryoglobulins, can precipitate and cause erroneous measurements via several methods (1 ). Other interferences such as the prozone effect and the volume displacement effect are discussed below. IMMUNOGLOBULIN EXCESS AND THE PROZONE EFFECTQuantitative immunoglobulin concentrations in this case were suspiciously low considering the marked increases in total protein, the large monoclonal band identified on serum electrophoresis, and the patient's anemia and thrombocytopenia, all of which suggested the presence of active disease.Immunoglobulins IgA, IgM, and ...

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Factitious Biochemical Measurements Resulting From Hematologic Conditions

Cited by 44 publications

References 78 publications

The detection and prevention of errors in laboratory medicine

The detection and prevention of errors in laboratory medicine

In control? IQC consensus and statutory regulation

Unexpected Test Results in a Patient with Multiple Myeloma

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