International Organization for Standardization (ISO) 15189.
01 Sep 2017-Korean Journal of Laboratory Medicine (Korean Society for Laboratory Medicine)-Vol. 37, Iss: 5, pp 365-370
TL;DR: The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories.
Abstract: The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.
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TL;DR: Existing DNA methylation cancer biomarkers used in clinical practice are summarized, technical factors such as the analytical performance and product-market fit, factors that contribute to successful downstream investment, including geography, and how this impacts intellectual property, regulatory hurdles, and the future of the marketplace and healthcare system are discussed.
Abstract: Carcinogenesis is accompanied by widespread DNA methylation changes within the cell. These changes are characterized by a globally hypomethylated genome with focal hypermethylation of numerous 5'-cytosine-phosphate-guanine-3' (CpG) islands, often spanning gene promoters and first exons. Many of these epigenetic changes occur early in tumorigenesis and are highly pervasive across a tumor type. This allows DNA methylation cancer biomarkers to be suitable for early detection and also to have utility across a range of areas relevant to cancer detection and treatment. Such tests are also simple in construction, as only one or a few loci need to be targeted for good test coverage. These properties make cancer-associated DNA methylation changes very attractive for development of cancer biomarker tests with substantive clinical utility. Across the patient journey from initial detection, to treatment and then monitoring, there are several points where DNA methylation assays can inform clinical practice. Assays on surgically removed tumor tissue are useful to determine indicators of treatment resistance, prognostication of outcome, or to molecularly characterize, classify, and determine the tissue of origin of a tumor. Cancer-associated DNA methylation changes can also be detected with accuracy in the cell-free DNA present in blood, stool, urine, and other biosamples. Such tests hold great promise for the development of simple, economical, and highly specific cancer detection tests suitable for population-wide screening, with several successfully translated examples already. The ability of circulating tumor DNA liquid biopsy assays to monitor cancer in situ also allows for the ability to monitor response to therapy, to detect minimal residual disease and as an early biomarker for cancer recurrence. This review will summarize existing DNA methylation cancer biomarkers used in clinical practice across the application domains above, discuss what makes a suitable DNA methylation cancer biomarker, and identify barriers to translation. We discuss technical factors such as the analytical performance and product-market fit, factors that contribute to successful downstream investment, including geography, and how this impacts intellectual property, regulatory hurdles, and the future of the marketplace and healthcare system.
240 citations
Cites background from "International Organization for Stan..."
...For CRC, a three-protein ELISA panel has been developed that has higher sensitivity and specificity for early stage I-II disease than the FOBT (Fung et al., 2015)....
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...For example, many countries have adopted the prostate specific antigen (PSA) test as a population screen for prostate cancer; and the fecal occult blood test (FOBT) or improved fecal immunochemical test (FIT) for population screening of CRC....
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...…might be more readily detected via the blood than stool (Ahlquist et al., 2012) and there is some evidence that people perceive a DNA-based stool test as preferable over FOBT (Schroy and Heeren, 2005) and a blood-based ctDNA test over a stool based test (Osborne et al., 2012; Adler et al., 2014)....
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...Conversely, late stage cancers might be more readily detected via the blood than stool (Ahlquist et al., 2012) and there is some evidence that people perceive a DNA-based stool test as preferable over FOBT (Schroy and Heeren, 2005) and a blood-based ctDNA test over a stool based test (Osborne et al., 2012; Adler et al., 2014)....
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...In the instance of CRC, an early stage tumor that sheds little ctDNA into the bloodstream may cause bleeding into the bowel and the FOBT or FIT will detect the hemoglobin resulting from this bleeding (Symonds et al., 2016)....
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TL;DR: This guideline provides parameters required for the validation of quantitative determination of small molecule drugs in DBS using chromatographic methods, and to provide advice on how these can be assessed, to contribute to high-quality micro sampling methods used in clinical practice.
Abstract: Dried blood spot (DBS) analysis has been introduced more and more into clinical practice to facilitate Therapeutic Drug Monitoring (TDM). To assure the quality of bioanalytical methods, the design, development and validation needs to fit the intended use. Current validation requirements, described in guidelines for traditional matrices (blood, plasma, serum), do not cover all necessary aspects of method development, analytical- and clinical validation of DBS assays for TDM. Therefore, this guideline provides parameters required for the validation of quantitative determination of small molecule drugs in DBS using chromatographic methods, and to provide advice on how these can be assessed. In addition, guidance is given on the application of validated methods in a routine context. First, considerations for the method development stage are described covering sample collection procedure, type of filter paper and punch size, sample volume, drying and storage, internal standard incorporation, type of blood used, sample preparation and prevalidation. Second, common parameters regarding analytical validation are described in context of DBS analysis with the addition of DBS-specific parameters, such as volume-, volcano- and hematocrit effects. Third, clinical validation studies are described, including number of clinical samples and patients, comparison of DBS with venous blood, statistical methods and interpretation, spot quality, sampling procedure, duplicates, outliers, automated analysis methods and quality control programs. Lastly, cross-validation is discussed, covering changes made to existing sampling- and analysis methods. This guideline of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology on the development, validation and evaluation of DBS-based methods for the purpose of TDM aims to contribute to high-quality micro sampling methods used in clinical practice.
171 citations
Centers for Disease Control and Prevention1, Linköping University2, Mayo Clinic3, Affymetrix4, European Bioinformatics Institute5, St. Jude Children's Research Hospital6, Newcastle University7, Food and Drug Administration8, Indiana University9, University of Missouri10, National Institutes of Health11, University of Utah12, University of Basel13, Bosch14, Coriell Institute For Medical Research15, University of Toronto16, Erasmus University Rotterdam17, University of Illinois at Urbana–Champaign18
TL;DR: This article provides nomenclature recommendations developed by an international workgroup to increase transparency and standardization of pharmacogenetic (PGx) result reporting.
Abstract: This article provides nomenclature recommendations developed by an international workgroup to increase transparency and standardization of pharmacogenetic (PGx) result reporting. Presently, sequence variants identified by PGx tests are described using different nomenclature systems. In addition, PGx analysis may detect different sets of variants for each gene, which can affect interpretation of results. This practice has caused confusion and may thereby impede the adoption of clinical PGx testing. Standardization is critical to move PGx forward.
143 citations
TL;DR: This work proposes an innovative approach for supplementing an IFC exchange file with semantically useful concepts inferred from the explicit and implicit information contained in the building model, and demonstrates semantic enrichment with precast concrete building models.
Abstract: Significant difficulties remain in exchanging information between building information modeling BIM tools. The industry foundation classes IFC exchange schema is too generic to capture the full semantic meaning needed for direct use by different construction project stakeholders' BIM tools. Although BIM standards that prescribe model view definitions MVD for domain-specific exchanges are under development, insufficient semantic definition of exchanges prevents achievement of the full potential of BIM through seamless interoperability. We propose an innovative approach for supplementing an IFC exchange file with semantically useful concepts inferred from the explicit and implicit information contained in the building model. A prototype software was implemented to test the applicability of the approach. It consists of a rule-processing engine and allows composition of inference rule-sets that can be tailored for different domains. The tests demonstrate semantic enrichment with precast concrete building models, adding inferred joint, slab aggregation and connection concepts.
132 citations
TL;DR: To deliver solutions and ensure equitable access to essential services in LMICs, a PALM package focused on these countries is proposed, integrated within a nationally tiered laboratory system, as part of an overarching national laboratory strategic plan.
128 citations
References
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130 citations
Book•
10 Mar 2009
54 citations
"International Organization for Stan..." refers background in this paper
...RCA also provides an opportunity to engage staff in the process of quality improvement....
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...In an ISO 15189 QMS, an RCA is a component of corrective action that serves to redesign and “mistake-proof” a process, implement those process changes, and assure through effectiveness checks that the changes actually solved the problem....
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...RCA is often thought of as one step in the investigation of a major, potentially life-threatening, patient safety event....
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...The central theme of occurrence management in an ISO 15189 QMS is root cause analysis (RCA) [4]....
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...RCA in the context of ISO 15189 has a very different connotation....
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TL;DR: It is demonstrated that actual costs can be reduced by designing "quality at the source" into the processes by suggesting ways to identify opportunities to reduce cost by improving quality in laboratories and pathology practices through the use of Lean, Six Sigma, and industrial engineering.
Abstract: In today's environment, many laboratories and pathology practices are challenged to maintain or increase their quality while simultaneously lowering their overall costs. The cost of improving specimen processes is related to quality, and we demonstrate that actual costs can be reduced by designing "quality at the source" into the processes. Various costs are hidden along the total testing process, and we suggest ways to identify opportunities to reduce cost by improving quality in laboratories and pathology practices through the use of Lean, Six Sigma, and industrial engineering.
31 citations
"International Organization for Stan..." refers background in this paper
...Although the literature of moneysavings in an ISO 15189 system is sparse, cost-of-quality models have demonstrated potential cost savings [6-8]....
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Journal Article•
TL;DR: The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.
Abstract: Background: The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. Methods: The quality management intervention based on ISO 15189 was conceded through three phases; pre – intervention phase, Intervention phase and Post-intervention phase. Results: In pre- intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre- intervention phase and (0.99) in post – intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in postintervention phase. Conclusion: The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.
5 citations