Notes in Pg 6-10 Definitions

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Status	Last Update	Fields
Published	09/27/2024	Addendum: {{c1::Information}} appended to a final report with {{c1::no changes}} to the original test result(s); original report is {{c2::intact}} and…
Published	10/10/2024	{{c1::Alternative performance assessment}} is a system for determining the reliability of laboratory examinations for which no commercial pr…
Published	09/27/2024	Amended/amendment: Any {{c1::change}} in a previously issued anatomic pathology or cytopathology report intended to {{c1::correct}} an inaccuracy, inc…
Published	09/27/2024	Analytical validation: The process used to confirm with objective evidence that a laboratory-developed or modified FDA-cleared/approved test method or…
Published	09/27/2024	Analytical verification: The process by which a laboratory determines that an unmodified FDA-cleared/approved test performs according to the {{c1::spe…
Published	09/27/2024	Annual: {{c1::Every 12 calendar months}}
Published	09/27/2024	Authority: The power to {{c1::give orders/make decisions}}; the {{c1::power/right}} to direct someone or control a process
Published	09/27/2024	Biennial: {{c1::Every 24 calendar months}}
Published	09/27/2024	Biorepository: An entity that {{c1::collects}}, {{c1::processes}}, {{c1::stores}}, {{c1::manages}}, and {{c1::distributes}} {{c2::biospecimens}} for r…
Published	09/27/2024	Check: Examination to determine the {{c1::accuracy}}, {{c1::quality}}, or {{c1::presence}} of any attribute of a test system
Published	09/27/2024	Clinical validation: The determination of the ability of a test to {{c1::diagnose}} or {{c1::predict}} risk of a particular health condition or predis…
Published	09/27/2024	Commutable: The property of a reference material that yields the same {{c1::numeric result}} as would a patient's specimen containing the {{c1::same q…
Published	09/27/2024	Confirmation: {{c1::Substantiation}} of the correctness of a value or process
Published	09/27/2024	Corrected/correction: A {{c1::change}} in a {{c1::previously issued}} clinical pathology test report intended to correct an inaccuracy, including chan…
Published	09/27/2024	Corrective Action: Action taken to eliminate the {{c1::cause of a detected nonconformity}} or {{c1::other undesirable situation}}
Published	09/27/2024	Correlation: Establishment of agreement between {{c1::two or more measured values}}
Published	09/27/2024	Credentialing: The process of {{c1::obtaining}}, {{c1::verifying}}, and {{c1::assessing}} the qualifications of a practitioner to provide care in a he…
Published	09/27/2024	Device: Any {{c1::reagent, reagent product, kit, instrument, apparatus, equipment or related product}}, whether used alone or in combination, intended…
Published	09/27/2024	Digital image analysis: The computer-assisted software detection or quantification of {{c1::specific features}} in an image following enhancement and …
Published	09/27/2024	Distributive testing: Laboratory testing performed on the {{c1::same specimen, or aliquot}} of it, that requires {{c2::sharing between two or more lab…
Published	09/27/2024	Examination: Refers to the process of {{c1::inspection of tissues and samples}} prior to {{c1::analysis}}. Not an analytical test.
Published	09/27/2024	FDA: 1) For laboratories subject to US regulations - FDA refers to the {{c1::US Food and Drug Administration}}, which is the regulatory body under Hea…
Published	09/27/2024	Function Check: Confirmation that an {{c1::instrument or item of equipment operates}} according to manufacturer's specifications prior to {{c2::initia…
Published	09/27/2024	High complexity: Rating given by the FDA to commercially marketed in vitro diagnostic tests based on t{{c1::heir risks to public health}}.
Published	09/27/2024	Instrument: {{c1::An analytical unit that uses samples to perform chemical or physical assays (e.g. chemistry analyzer, hematology analyzer)}}
Published	09/27/2024	Instrument platform: Any of a series of {{c1::similar or identical analytical methods}} intended by their manufacturer to give identical patient resul…
Published	09/27/2024	Laboratory: Term used to refer to a {{c1::clinical laboratory, biorepository, forensic drug testing laboratory, or reproductive laboratory}} part…
Published	09/27/2024	Laboratory Director: The individual who is responsible for {{c1::the overall operation and administration of the laboratory}}, including provision of …
Published	09/27/2024	Maintenance: Activities that {{c1::prolong the life of an instrument}} or {{c1::minimize breakdowns/mechanical malfunctions}}. Examples include cleani…
Published	09/27/2024	Moderate complexity: Rating given by the FDA to commercially marketed in vitro diagnostic tests based on their {{c1::risks to public health}}
Published	09/27/2024	Modification of manufacturer's instructions: Any {{c1::change}} to the manufacturer's supplied {{c1::ingredients}} or {{c1::modifications}} to the ass…
Published	09/27/2024	Non-conforming event: An occurrence that: 1) {{c1::deviates from the laboratory's policies or procedures}}2) {{c1::does not comply with applicable reg…
Published	09/27/2024	Nonwaived: Tests categorized as either {{c1::moderate}} complexity (including provider-performed microscopy) or {{c1::high}} complexity according to a…
Published	09/27/2024	Performance verification: The set of processes that demonstrate {{c1::an instrument or an item of equipment operates according to expectations prior t…
Published	09/27/2024	Personnel: The collective group of {{c1::employees and contractors employed in the laboratory organization}}. {{c2::Contractors}} may include those in…
Published	09/27/2024	Policy: 1) {{c1::Set of basic principles or guidelines that direct or restrict the facility's plans, actions, and decisions}}2) {{c1::Statement that t…
Published	09/27/2024	Predictive marker testing: {{c1::Immunohistochemical}} and {{c1::in situ hybridization}} tests used to predict responsiveness to a specific treatment …
Published	09/27/2024	Preventive action: Action taken to {{c1::eliminate the cause of a potential nonconformity}} or {{c1::any other undesirable potential situation}}
Published	09/27/2024	Primary source verification report: A {{c1::document}}, usually prepared by a third party agent or company that confirms that a job applicant's {{c1::…
Published	09/27/2024	Primary specimen: The {{c1::body fluid, tissue, or sample}} submitted for examination, study or analysis. It may be within a collection tube, cup, syr…
Published	09/27/2024	Procedure: 1) {{c1::Specified way to carry out an activity of a process}} (also referred to by ISO as "work instructions"2) {{c2::Set of steps perform…
Published	09/27/2024	Process:1) Set of {{c1::interrelated or interacting activities that transforms inputs into outputs}}2) Series of {{c1::events, stages, or phases that …
Published	09/27/2024	Proficiency testing: Evaluation of {{c1::participant (laboratory or individual)}} performance against {{c1::pre-established criteria}} by means o…
Published	09/27/2024	Qualified pathologist: A pathologist who has training in the {{c1::specific functions to be performed}}.
Published	09/27/2024	Reagent: Any {{c1::substance}} in a test system other than a {{c2::solvent}} or {{c2::support material}} that is required for the {{c1::target analyte…
Published	09/27/2024	Reference interval: The {{c1::range of test values}} expected for a designated population of individuals.
Published	09/27/2024	Report errors: A report element  that is either {{c1::incorrect}} or {{c1::incomplete}}
Published	09/27/2024	Responsibility: A {{c1::duty}} or {{c1::task}} that an individual is {{c1::required}} or {{c1::expected to do}}
Published	09/27/2024	Root cause analysis (RCA): A systematic process for identifying the {{c1::causal factor(s) that underlie errors or potential errors in care}}.
Published	09/27/2024	Secondary specimen: Any {{c1::derivative}} of the primary specimen used in subsequent phases of testing. It may be an aliquot, dilution tube, slide, b…
Published	09/27/2024	Section Director: The individual who is responsible for the {{c1::technical}} and/or {{c1::scientific}} oversight of a specialty or section of the lab…
Published	09/27/2024	Semiannual: Every {{c1::6 calendar months}}
Published	09/27/2024	Sentinel event: An {{c1::unexpected}} occurrence that reaches a patient and results in {{c1::death, permanent harm, or severe temporary harm}}, unrela…
Published	09/27/2024	Subject to US Regulations: Laboratories located within the {{c1::United States}} and laboratories located outside of the US that have obtained or appl…
Published	09/27/2024	Telepathology: The practice of pathology and cytology in which {{c1::digitized or analog video, still image(s), or other data files}} are examine…
Published	09/27/2024	Test: A {{c1::qualitative, semiqualitative, quantitative, or semiquantitative}} procedure for detecting the presence of, or measuring of an analyte
Published	09/27/2024	Testing personnel: Individuals responsible for {{c1::performing laboratory assays}} and {{c1::reporting laboratory results}}
Published	09/27/2024	Test system: The process that includes {{c1::pre-analytic, analytic, and post-analytic}} steps used to produce a test result or set of results. A test…
Published	09/27/2024	Visitor: An individual entering the laboratory who is not considered {{c1::personnel}}.
Published	09/27/2024	Waived: A category of tests defined as "{{c1::simple}} laboratory examinations and procedures which have an {{c1::insignificant}} risk of an erroneous…
Status	Last Update	Fields