Biomaterial Database

Quality control in coagulation testing. 2008

Mario Plebani, and Maria Colomba Sanzari, and Lorena Zardo

Department of Laboratory Medicine, University-Hospital of Padova, Italy. mario.plebani@unipd.it

The term "QUALITY CONTROL" in laboratory medicine refers to all the procedures commonly used in clinical laboratories to monitor the routine performance of testing processes, to detect possible errors, and to correct problems before test results are reported. In particular, internal quality control (IQC) and external quality assessment (EQA) programs are used to evaluate and improve quality in laboratory medicine. Laboratory testing is necessary for the diagnosis and treatment of patients with hemostatic disorders. However, whereas the benefits of quality control and quality assessment in hemostasis have been demonstrated many times and are well documented, available scientific evidence is significantly less than that in clinical chemistry and in other fields of laboratory medicine. Currently available data on analytical quality in coagulation testing not only demonstrates that quality is often unsatisfactory, but also highlights the need for more objective establishment of performances goals. This should be useful for better addressing both IQC and EQA programs. New challenges to EQA schemes for coagulation testing derive from the introduction of innovative tests, genetic analysis, and the need to assess not only analytical procedures but also all steps included in the total testing process.

UI	MeSH Term	Description	Entries
D007753	Laboratories	Facilities equipped to carry out investigative procedures.	Laboratory
D011785	Quality Assurance, Health Care	Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.	Quality Assessment, Health Care,Health Care Quality Assessment,Health Care Quality Assurance,Healthcare Quality Assessment,Healthcare Quality Assurance,Quality Assessment, Healthcare,Quality Assurance, Healthcare,Assessment, Healthcare Quality,Assessments, Healthcare Quality,Assurance, Healthcare Quality,Assurances, Healthcare Quality,Healthcare Quality Assessments,Healthcare Quality Assurances,Quality Assessments, Healthcare,Quality Assurances, Healthcare
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D001778	Blood Coagulation Disorders	Hemorrhagic and thrombotic disorders that occur as a consequence of abnormalities in blood coagulation due to a variety of factors such as COAGULATION PROTEIN DISORDERS; BLOOD PLATELET DISORDERS; BLOOD PROTEIN DISORDERS or nutritional conditions.	Coagulation Disorders, Blood,Disorders, Blood Coagulation,Blood Coagulation Disorder,Coagulation Disorder, Blood,Disorder, Blood Coagulation
D001780	Blood Coagulation Tests	Laboratory tests for evaluating the individual's clotting mechanism.	Coagulation Tests, Blood,Tests, Blood Coagulation,Blood Coagulation Test,Coagulation Test, Blood,Test, Blood Coagulation
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015588	Observer Variation	The failure by the observer to measure or identify a phenomenon accurately, which results in an error. Sources for this may be due to the observer's missing an abnormality, or to faulty technique resulting in incorrect test measurement, or to misinterpretation of the data. Two varieties are inter-observer variation (the amount observers vary from one another when reporting on the same material) and intra-observer variation (the amount one observer varies between observations when reporting more than once on the same material).	Bias, Observer,Interobserver Variation,Intraobserver Variation,Observer Bias,Inter-Observer Variability,Inter-Observer Variation,Interobserver Variability,Intra-Observer Variability,Intra-Observer Variation,Intraobserver Variability,Inter Observer Variability,Inter Observer Variation,Inter-Observer Variabilities,Inter-Observer Variations,Interobserver Variabilities,Interobserver Variations,Intra Observer Variability,Intra Observer Variation,Intra-Observer Variabilities,Intra-Observer Variations,Intraobserver Variabilities,Intraobserver Variations,Observer Variations,Variabilities, Inter-Observer,Variabilities, Interobserver,Variabilities, Intra-Observer,Variabilities, Intraobserver,Variability, Inter-Observer,Variability, Interobserver,Variability, Intra-Observer,Variability, Intraobserver,Variation, Inter-Observer,Variation, Interobserver,Variation, Intra-Observer,Variation, Intraobserver,Variation, Observer,Variations, Inter-Observer,Variations, Interobserver,Variations, Intra-Observer,Variations, Intraobserver,Variations, Observer