Harmonized Terminology Database

accreditation

the act of granting recognition to an organization that maintains suitable standards to prove that it meets a general standard of quality

Project: QMS25, QMS01

addendum

information added as an attachment or supplement to a document or record that expands or clarifies the original document or record

Project: MM01, QMS26

NOTE: An addended report does not change the original test result(s) or diagnosis.

adverse event

unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization, or that results in death

agreement

a contract, order, or understanding between 2 or more parties, such as between a laboratory and 1 of its suppliers or customers

alternative assessment

(of laboratory examination performance) system for determining the reliability of tests for which proficiency testing is either not available or not required

Project: QMS24

EXAMPLES: Ungraded and/or educational challenges, split sample analysis with referral or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means.

amended report

change made to add or rephrase information, editorial changes, changes made to improve readability or clarity, or additional information that changes the final diagnosis or clarifies the original final diagnosis or interpretation

Project: QMS26, QMS12

EXAMPLE: Amending a final surgical pathology diagnosis arising from a second review of the material.

assessment

systematic evaluation process of collecting and analyzing data to determine the current, historical, or projected compliance of an organization compared with a standard

Project: QMS01

assessor

representative of the assessment organization who determines whether the laboratory meets the assessment organization’s requirements

Project: QMS17

NOTE: An assessor can also be referred to as an inspector, auditor, surveyor, or investigator.

audit

systematic, independent, and documented process to obtain and evaluate evidence objectively to determine the extent to which specified criteria are fulfilled (modified from ISO 9000)

Project: QMS15, QMS16, QMS21, QMS01, QMS17

benchmark

the process of measuring products, services, and processes against those of organizations known to be leaders in 1 or more aspects of their operations

NOTE: The highest current performance level in an industry, used as a standard to be equaled or exceeded.

benefit

positive effect or desirable outcome on the health of an individual, or a positive effect on patient management or public health

NOTE: Benefits can include positive effect on clinical outcome, the patient's quality of life, outcomes related to diagnosis, positive effect from diagnostic devices on clinical outcomes, or positive effect on public health (ISO 14971).

certification

process by which a qualified third party provides attestation that a system, process, product, or person conforms to specified requirements (modified from ISO 17000)

Project: QMS04, QMS21, QMS25

change control

a systematic, documented approach to evaluating, testing, approving, and implementing modifications to products, process, or systems to ensure that adverse affects are minimized and that resources are used efficiently

change management

systematic approach for defining, planning, coordinating, testing, tracking, and communicating a new or revised process and for preparing personnel for the transition to the future state

checklist

tool for organizing and ensuring that all important steps or actions in a process are considered or acted upon

Project: QMS15, QMS06

committee

a group of people appointed or chosen to perform a function on behalf of a larger group

Project: QMS14

competence

demonstrated ability to apply knowledge and skills to achieve intended results (modified from ISO 9000)

Project: QMS03, QMS13

competence assessment

evaluation of a person’s ability to apply skill, knowledge, and experience to perform assigned laboratory duties correctly

Project: QMS16, POCT04, QMS03

NOTE: This includes all aspects of testing, from specimen collection to results reporting, and it is usually done with specimens containing known amounts of the analyte(s) for which the specimens are being tested.

complaint

written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, or performance of something that has been released from the laboratory's control or related to a service that affects the laboratory's performance (modified from ISO 13485)

EXAMPLES: Quality of testing, unlabeled specimens, unethical practices, confidentiality of patient information, laboratory qualification, and responsibility issues.

compliance

successful fulfillment of a rule, such as a specification, standard, policy, regulation, or law

Project: QMS15

NOTE: For the purposes of QMS15, compliance means complying both with regulatory and accreditation requirements and with the laboratory’s approved policies, processes, and procedures.

confidentiality

in health care, an ethical obligation to preserve authorized restrictions on, access to, and disclosure of sensitive personal information gathered in association with patient care

NOTE: "Confidentiality" is not synonymous with "privacy"; see privacy.

conflict of interest

situation arising when personal interests or relationships cause bias in decision making and affect job performance

conformance

an affirmative indication or judgment that a product or service has met the requirements of a relevant specification, contract, or regulation

Alternate Term: conformity

consumable materials

materials that are used and then disposed, become incorporated into other materials and lose their identity, or cannot be used for their intended purpose without obliterating or transforming their substance

Project: QMS21

EXAMPLES: Disposable pipettes, pipette tips, test tubes, instrument cuvettes; reagents and controls; label stock.

continual improvement

recurring activity to enhance performance (ISO 9000)

Project: QMS19, QMS06, EP23, MM20, QMS11, QMS01

NOTE 1: Also known as “continuous improvement”; NOTE 2: Continual improvement includes the actions taken throughout an organization to increase the effectiveness and efficiency of activities and processes to provide added benefits to the customer and organization; NOTE 3: Includes the actions taken throughout an organization to increase the effectiveness and efficiency of activities and processes to provide added benefits to the customer and organization; NOTE 4: The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews, or other means and generally leads to corrective (or preventive) action.

continuing education

educational experiences that assist in developing or enhancing the knowledge and skills directly related to an individual's professional occupation

NOTE: Training activities for an individual’s current or future job functions, tasks, and responsibilities are not considered continuing education; see professional development.

contractor

a person hired through an agreement or other arrangement to perform a service or to provide goods at a certain price or within a certain period of time

Project: QMS16

NOTE: A consultant is an example of a contractor.

controlled copy

an approved document that bears all appropriate document control markings such as identification and revision status

Project: QMS02

NOTE: Controlled copies are distributed for use within the organization and are accounted for when revisions are made, to ensure that obsolete copies are removed from potential use.

corrected report

a change in a previously issued examination report intended to correct an inaccuracy, including changes in examination results, patient identification, reference intervals, interpretation, or other content

Project: QMS26

corrective action

action(s) to eliminate the cause and to prevent recurrence of a nonconformity or other undesirable situation (ISO 9000)

Project: QMS11, QMS13, QMS17, QMS19, QMS24

NOTE 1: There can be more than 1 cause for a nonconformity or undesirable situation; NOTE 2: Corrective action is taken to reduce or eliminate recurrence whereas preventive action is taken to prevent occurrence (ISO 9000); see preventive action.

critical equipment

a piece of equipment, material, service, or task that directly affects the quality of the laboratory’s results, products, or services

Alternate Term: critical material, critical task, critical service

culture

the set of shared attitudes, values, goals, and practices that characterizes an institution or organization

Project: QMS16

customer

person or organization that could or does receive a product or a service that is intended for or required by this person or organization (ISO 9000)

Project: QMS16, QMS19, QMS21

EXAMPLES: Consumer, client, end user, retailer, receiver of product or service from an internal process, beneficiary, and purchaser (modified from ISO 9000); NOTE 1: A customer can be internal or external to the organization (ISO 9000); NOTE 2: Employees may be regarded as internal customers; NOTE 3: A customer can be internal or external to the organization and can include patients and health care providers, eg, physicians, nurses, laboratory staff; NOTE 4: An internal customer (person or department with the organization) is the recipient of another person or department's output (product, service, or information); NOTE 5: An external customer (person or organization) receives a product, service, or information but is not part of the organization supplying it.

data

facts used as a basis for reasoning, discussion, or calculation

Project: QMS12, QMS26

disaster

event (internal, local, or national) that can adversely affect the laboratory's operations and/or the safety of personnel, patients, and visitors.

document

(verb) the action of creating a record

Project: I/LA33, QMS26

document

(noun) information and the medium on which it is contained (ISO 9000)

Project: GP26, QMS02, QMS16, QMS26, QMS21

NOTE: Documents may be paper based or electronic.

documentation

information required to be controlled and maintained by an organization and the medium on which it is contained (ISO 9000)

EXAMPLES: Policies, processes, procedures, job aids, forms, records, and reports.

draft

a preliminary sketch, outline, or version

education

the act or process of imparting or acquiring knowledge, developing the powers of reasoning and judgment, and generally preparing oneself or others intellectually

Project: QMS16

effectiveness

extent to which planned activities are realized and planned results are achieved (ISO 9000)

Project: GP26, QMS06, QMS14, QMS12

efficiency

relationship between the result achieved and the resources used (ISO 9000)

Project: QMS14, QMS06, QMS12

equipment

single apparatus or set of devices or apparatuses needed to perform a specific task (adapted from IEV 151-11-25)

Project: QMS13

NOTE: For the purposes of CLSI QMS documents, equipment includes general purpose devices, analytical systems, and computer system hardware and software.

equipment master file

paper or electronic file in which records are maintained of a given instrument or piece of equipment from acquisition to decommission

Project: QMS13

establish

define, document (in writing or electronically), and implement

ethics

foundational principles that guide the behavior and decision-making of organizations and individuals to promote trust and fairness in the organization's operations, comply with legal standards, and foster customer trust and long-term success

evaluation

analysis of completed or ongoing activities that determines or supports the accountability, effectiveness, and efficiency of an activity or program

Project: QMS05, QMS16, QMS14, QMS03, QMS06

event

for the purposes of CLSI QMS documents, generic term used to encompass the terms “incident,” “error,” and “accident."

evidence of compliance

documents, records, factual statements, and other verifiable information demonstrating compliance with requirements

Project: QMS17

examination

set of operations having the objective of determining the numerical value, text value, or characteristics of a property (ISO 15189)

Project: QMS02, GP26, PRE04, QMS11, QMS13, EP12, GP33, POCT07, POCT10, PRE01, GP23, QMS25, EP23, QMS22, QMS01, EP35

EXAMPLE: A test procedure or measurement procedure; NOTE 1: An examination may be the total number of activities, observations, or measurements required to determine a value or characteristic (ISO 15189); NOTE 2: In CLSI QMS02, the term “examination” replaces the term “test”; however, for the purposes of this guideline, readers can consider the terms equivalent; NOTE 3: Laboratory examinations that determine a numerical value of a property are called "quantitative examinations"; those that determine the characteristics of a property are called "qualitative examinations" (ISO 15189); NOTE 4: In clinical chemistry, laboratory examinations have been called assays or tests (ISO 18113-1); NOTE 5: Examination has replaced terms such as test, assay, and analysis in CLSI POCT07. Subsequently, the adjectives preexamination and postexamination have replaced the adjectives preanalytical and postanalytical; NOTE 6: Laboratory examinations are also called "assays" or "tests" (ISO 15189); NOTE 7: In CLSI EP35, examinations are also called measurement procedures; NOTE 8: In CLSI EP12, laboratory examinations that determine a value of a property are measurement procedures; those that determine the characteristics of a property are called qualitative examinations.

external assessment

systematic process conducted by an organization external to the laboratory to collect and analyze data to determine compliance with specified requirements

Project: QMS17, QMS01

NOTE 1: External assessment can also be referred to as an audit, inspection, site visit, or survey; NOTE 2: For the purposes of QMS17, proficiency testing is excluded; NOTE 3: The terms “mock inspection” or “self-assessment” can be used when a laboratory assesses itself for compliance using an external assessment organization’s requirements. In this case, the laboratory is doing an “internal” assessment of itself.

failure

in the broadest sense, a case when the system, process, or product does not meet user or customer expectations

Project: PRE06, EP18, POCT07, QMS20, GP47, QMS06

NOTE 1: Failure includes the inability to perform intended functions satisfactorily or within specified performance limits; NOTE 2: Errors of measurement and errors of use are subsets of failures; NOTE 3: In CLSI PRE06, failure could apply to individual components or the performance of the whole system under a defined combination of variables that do not meet the requirements to perform to expected or required levels.

failure modes and effects analysis

systematic review of a system or process that examines how failures can affect performance

Project: QMS06

NOTE 1: Failure modes and effects analysis involves identifying potential failure modes, determining the consequences of each failure, and reviewing the control measures implemented to prevent or detect the failure; NOTE 2: If estimating the risk of the failures and the risk of harm is part of the analysis, the technique is called “failure modes, effects, and criticality analysis.”

flow chart

diagram, often using geometric symbols, that shows the sequence of activities and decisions made in a process

Alternate Term: process map

Project: QMS18, QMS02

NOTE: A flow chart is also commonly referred to as a "process map."

form

a paper or electronic document on which information, data, or results are recorded

Project: GP26, QMS02, QMS26

NOTE: When completed, a form becomes a record.

function checks

activities performed to evaluate critical operating characteristics (eg, stray light, zeroing, electrical levels, optical alignment, background counts, counting efficiency) according to the accepted method of operation for each type of device or instrument

Project: QMS13, QMS23

NOTE: Function checks must be within the manufacturer’s established limits before patient testing is conducted (42 CFR 493).

gap analysis

a process to determine actions to take to move an entity from its current state to a desired future state

Project: QMS19, QMS01

NOTE 1: Also called "need-gap analysis," "needs analysis," and "needs assessment"; NOTE 2: Gap analysis consists of 1) listing of characteristic factors (such as attributes, competencies, performance levels) of the present situation (ie, “what is”), 2) listing factors needed to achieve future objectives (ie, “what should be”), and then 3) highlighting existing gaps that need to be filled.

goal

broad statement describing a desired future condition or achievement without being specific about how much and when

Project: QMS06, QMS16, QMS03, QMS12

NOTE 1: An example of a goal is “improve laboratory service”; NOTE 2: “Goal” is not synonymous with “objective.” See objective.

harm

injury or damage to the health of people, or damage to property or the environment (ISO/IEC Guide 51)

Project: ISO 14971, EP18, ISO 18113-1, EP23, EP27

NOTE: In EP23 and EP27, damage to property or the environment is considered harmful only if that damage directly harms people.

hazard

potential source of harm (ISO 15190)

Project: ISO 15190, M29, HS11, ISO 18113-1, ISO 18113-2, ISO 18113-3, ISO/IEC Guide 51:1999, ISO/DIS 14971, POCT02, EP18, EP23

NOTE: Depending on the measurand and the nature and extent of the measurement error, an incorrect in vitro device examination result could be considered a hazard. See ISO 14971 for guidance.

human factors engineering

application of human factors knowledge to the design and construction of equipment, products, work systems, management systems, and tasks to reduce the potential for human error, improve safety, and enhance overall system performance

NOTE: Human factors engineering addresses multiple aspects of work, including task analysis and design; device evaluation and usability; communication, collaboration, and teamwork; training; and systems resilience, adaptation, and failure.

implementation plan

detailed listing of activities, costs, expected difficulties, and schedules that are required to achieve the objectives of the strategic plan

Project: QMS13

incorrect result

result that does not meet the requirements for its intended medical use

Project: EP18, EP23

NOTE 1: In the case of quantitative test procedures, a result with a failure of measurement that exceeds a limit based on medical utility; NOTE 2: In the case of qualitative test procedures, a result that is contrary to a true value of the measurand.

information

data that have been transformed through analysis and interpretation into a form that is useful for drawing conclusions and making decisions

installation qualification

activities and records that verify that an instrument or unit of equipment (as well as its subsystems and any ancillary systems) has been installed and configured according to the manufacturer's specifications or installation checklist

NOTE: Installation qualification can be performed by the manufacturer’s technical service engineer.

instructions for use

information supplied by the manufacturer of an in vitro diagnostic medical device concerning the safe and proper use of the reagent or the safe and correct operation, maintenance, and basic troubleshooting of the instrument

Alternate Term: directions for use

Project: ISO 15197, ISO 17593, ISO 15198, I/LA33, EP23

NOTE 1: Instructions for use for in vitro diagnostic reagents for self-testing are described in EN 376 and ISO/DIS 18113-4; NOTE 2: Instructions for use for in vitro diagnostic instruments for self-testing are described in EN 592 and ISO/DIS 18113-4; NOTE 3: Instructions for use may take the form of package insert sheets and/or user manuals.

intended use

use for which a product, process, or service is intended, according to the specifications, instructions, and information provided by the manufacturer (ISO 14971)

Alternate Term: intended purpose

Project: POCT18, ISO 14971, EP18, EP14, EP19, POCT17, EP49

NOTE 1: The clinical use for which the test method was originally designed; NOTE 2: The concept includes definition of the measurand, the target condition, and the clinical use of the measurement procedure, which may include screening, diagnosis, prognosis, and/or monitoring of patients; NOTE 3: The intended use of an in vitro diagnostic device is determined by the manufacturer during the device development stage. Typically, the intended use of an in vitro diagnostic device is to identify the disease or condition the device diagnoses, treats, prevents, cures, or mitigates. A description of the patient population for which the device is intended is also included, as well as information on the type of test (eg, quantitative or qualitative), underlying technology (eg, enzymatic, immunochromatographic, nucleic acid based), and the type of specimen that may be used (eg, serum, plasma, nasal swab). Sometimes, the intended use of the device includes the type(s) of setting (eg, over the counter, prescription, point of care) for which the device may be used. The manufacturer performs clinical and analytical validation studies to generate data to support the intended-use claims; NOTE 4: This concept includes definition of the analyte, the target condition, and the clinical use of the measurement procedure, which may include diagnosis or aid in diagnosis, screening, monitoring, predisposition, prognosis, and/or guiding treatment to anticipate treatment benefit or adverse effects.

job aid

information excerpted from an approved procedure that is presented in a more readily viewable format

Project: QMS02

NOTE: Job aids are subject to document control.

job introduction

program to introduce new personnel to the organization, the department, or area in which the person will work, the terms and conditions of employment, facilities, health and safety requirements (including fire and emergency), and occupational health services (modified from ISO 15189)

Project: QMS16, QMS03

NOTE: A job introduction also includes the key components of patient safety and confidentiality of information.

just culture

balance of accountability and learning by creating a safe environment for personnel to report errors, near misses, and hazards without fear of unfair punishment, by shifting focus from individual blame to system flaws

laboratory director

person, or persons however named, with the specified qualifications, competence, delegated authority, responsibility, and resources to fulfill regulatory and accreditation requirements for medical laboratories

Project: ISO 15189, H26, POCT08, EP23, QMS14, POCT15

NOTE 1: The person or persons referred to are designated collectively as the “laboratory director” (ISO 15189); NOTE 2: National, regional, and local regulations may apply with regard to qualifications and training (ISO 15189); NOTE 3: This person has final responsibility for the quality and appropriateness of laboratory testing; NOTE 4: Typically, the laboratory director is a physician or doctoral scientist who can make decisions about the medical and technical aspects of testing.

laboratory management

person(s) with the responsibility for and authority over a laboratory (ISO 15189)

Project: ISO 15189, QMS14

NOTE 1: Laboratory management has the power to delegate authority and provide resources within the laboratory (ISO 15189); NOTE 2: Laboratory management includes the laboratory director(s), delegates, and individuals specifically assigned to ensure the quality of laboratory activities (ISO 15189)

licensure

personnel licensure – process by which a regulatory agency grants an individual to engage in a given occupation when the applicant has obtained the competence necessary to ensure that public health, safety, and welfare will be reasonably protected

facility licensure – process by which a regulatory agency grants authorization to operate a medical laboratory after it has determined that all required standards are met

maintain

to keep in an existing state; to preserve or retain (as of repair, efficiency, or validity); to preserve from failure or decline

maintenance

combination of all technical and management actions intended to retain an item in, or restore it to, a state in which it can perform as required (ISO 14224)

Project: QMS23

management

coordinated activities to direct and control an organization (ISO 9000)

Project: QMS11

NOTE 1: Management can include establishing policies and objectives and the processes to achieve these objectives (ISO 9000); NOTE 2: The word “management” sometimes refers to people, ie, a person or group of people with authority and responsibility for the conduct and control of an organization (ISO 9000).

management review

review of the organization's quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization

Project: QMS01

measurement

process of experimentally obtaining 1 or more quantity values that can reasonably be attributed to a quantity (JCGM 200:2012)

Project: ISO IEC Guide 99, EP18, ISO 18113-1, EP23, C51

NOTE 1: Measurement does not apply to nominal properties (JCGM 200:2012); NOTE 2: Measurement implies comparison of quantities and includes counting of entities (JCGM 200:2012); NOTE 3: Measurement presupposes a description of the quantity commensurate with the intended use of a measurement result, a measurement procedure, and a calibrated measuring system operating according to the specified measurement procedure, including the measurementconditions (JCGM 200:2012); NOTE 4: In chemistry, “analyte”, or the name of a substance or compound, are terms sometimes used for “measurand”. This usage is erroneous because these terms do not refer to quantities (ISO 18113-1); NOTE 5: The operations can be performed automatically (ISO 18113-1).

measurement procedure

detailed description of a measurement according to 1 or more measurement principles and to a given measurement method, based on a measurement model and including any calculation to obtain a measurement result (JCGM 200:2012)

Project: ISO IEC Guide 99, EP12, POCT05, I/LA21, C34, I/LA33, ISO 18113-1, MM06, H59, I/LA28, C58, EP10, C51, MM01, EP27, MM14, EP26, C40, MM22, H60, EP06, EP14, EP15, C57, MM23, POCT06, POCT04, C24, EP34, EP31, EP35

NOTE 1: A measurement procedure is usually documented in sufficient detail to enable an operator to perform a measurement (JCGM 200:2012); NOTE 2: A measurement procedure can include a statement concerning a target measurement uncertainty (JCGM 200:2012); NOTE 3: A measurement procedure is sometimes called a standard operating procedure, abbreviated SOP (JCGM 200:2012); NOTE 4: This term pertains to specific procedures as marketed by specific manufacturers; NOTE 5: In other documents, equivalent terms were method, device, and assay; NOTE 6: A measurement procedure is based on a measurement method; NOTE 7: In CLSI EP05, “assay” is sometimes used as a stylistic variant for “measurement procedure”; NOTE 8: A qualitative measurement procedure reports nominal values, eg, the presence or absence of the analyte without quantification; NOTE 9: A quantitative measurement procedure generates a spectrum of signal responses that are directly proportional to the measurand levels. If the analyte preparations with known concentrations are available for calibration, the actual concentration of the analyte can be determined; NOTE 10: A semiquantitative measurement procedure is essentially a qualitative measurement procedure with an additional option for a response range (degree of positivity, dilution to which positive results are obtained, or comparison to a color chart), and may use an ordinal scale; NOTE 11: For the purposes of CLSI EP19, includes the hardware, software, reagents, calibrators, and any other items needed to obtain a clinically relevant result; NOTE 12: For the purposes of CLSI EP21, measurement procedures provide quantitative results; NOTE 13: Formerly, the term “analytical method” was used in CLSI C24; NOTE 14: Formerly in CLSI C34, the term “analytical method” was used; NOTE 15: For CLSI EP35, “measurement procedure” is intended to include both quantitative and qualitative examinations; NOTE 16: Typically used to describe a quantitative examination; NOTE 17: See assay.

metric

standard used for measurement

Project: QMS12

milestone

action-planning element that delineates by what date a significant event or action is to be accomplished and by what criteria of success that event or action should be measured

Project: QMS06

model

simplified description or graphic containing the essential structure of a more complex system or process

Project: QMS14

nonconformance

nonfulfillment of a specified requirement (ISO 9000)

Alternate Term: nonconformity

Project: ISO 9000, QMS21

NOTE 1: Other terms frequently used include: accident, adverse event, error, event, incident, nonconformity, and occurrence; NOTE 2: This may be defined as deviation from expected outcome; NOTE 3: Different assessment organizations may have their own terminologies (eg, citation, deficiency, finding, noncompliance, or observation).

nonconforming event

occurrence that does not conform to the laboratory’s policies, processes, and/or procedures or with applicable regulatory or accreditation requirements or has the potential to affect (or has affected) patient, donor, or personnel safety

Project: QMS01, PRE06, QMS11

objective

a statement of future expectations with measurable parameters and an indication of when the expectations should be achieved

Project: QMS03, QMS06, QMS12

NOTE 1: “Objective” is not synonymous with “goal.” For example, a goal is “Improve laboratory service.” An objective is, “Reduce turnaround time of stat test results to the emergency department by 30% within 6 months”; NOTE 2: Objectives are derived from goals and clarify what must be accomplished; NOTE 3: Often characterized as specific, measurable, achievable, relevant, timebound (SMART); NOTE 4: Quality objectives are based on the organization's quality policy and quality goals; NOTE 5: Quality objectives should be periodically reviewed to ensure continued appropriateness.

operational qualification

activities and records to determine whether equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges

NOTE: Operational qualification can be performed by the manufacturer’s technical service engineer.

opportunity for improvement

condition that, when improved, should result in significant enhancement of organizational efficiency and effectiveness and/or customer satisfaction

Project: QMS01, QMS06, QMS17

outcome

observed or measurable result of a process, project, or improvement initiative

Project: QMS14, QMS03, QMS06

Pareto analysis

sorted table or graph that lists events in decreasing order of importance

Alternate Term: Pareto chart

Project: EP18, QMS06

NOTE: Pareto analysis uses the idea that a large majority of problems (80%) are produced by a few key causes (20%).

path of workflow

sequential processes that transform an order for an examination into the information contained in the report of results, including preexamination, examination, and postexamination procedures

Project: QMS01, QMS07, QMS25, GP23, QMS16, QMS21, QMS03

NOTE: There are paths of workflow throughout all of health care, eg, manufacture and issue of blood products and provision of diagnostic imaging, pharmacy, and respiratory therapy services.

performance evaluation

formal, periodic process of evaluating an individual's job performance and overall contribution against set goals, providing feedback for growth, development, or promotion, and informing decisions about compensation

Alternate Term: performance appraisal

performance metric

figures and data representative of an organization's actions, abilities, and overall quality

NOTE 1: A metric can be used to assess the efficiency, performance, progress, or quality of a plan, process, or product; NOTE 2: Also referred to as an indicator; see quality indicator.

performance qualification

activities and records to confirm that the equipment or process performs to the organization's own specified needs and intended use, producing acceptable results under normal operating conditions

Project: QMS18, MM17, QMS23, H62

NOTE 1: Performance qualification needs to be performed by laboratory personnel before use in testing and examinations; NOTE 2: Performance qualification should incorporate test cases and protocols to evaluate the full range of intended use; NOTE 3: Performance qualification represents the final qualification of the equipment; NOTE 4: Performance qualification must be performed by the organization’s personnel; NOTE 5: Performance qualification testing confirms that the equipment performs as expected when used at the expected capacity and under usual conditions, eg, while running calibration beads or a validated assay; NOTE 6: Performance qualification needs to be performed by laboratory personnel before use in testing and examinations. Performance qualification testing confirms that the equipment performs as expected when used at the expected capacity and under usual conditions, eg, while running CS and T beads or a validated assay.

personnel

collective group of employees and contractors hired by an organization

Project: QMS16

plan

written account of intended future course of action aimed at achieving a specific goal(s) or objective(s) within a specific time frame that explains in detail what needs to be done, when, how, and by whom

Project: GP26, QMS16, QMS21, QMS14

NOTE: May be referred to as an action plan.

policy

intentions and directions formally expressed within an organization and endorsed by laboratory leadership

Project: QMS02, QMS16, QMS21

postexamination processes

processes following the examination, including review of results; formatting, releasing, reporting, and retention of examination results; retention and storage of clinical material; sample and waste disposal (ISO 15189)

Alternate Term: postanalytical phase

Project: GP26, QMS25, GP23, QMS22, QMS01

preexamination processes

processes that include, in chronological order, the request for examination, provision of preprocedure instructions to the patient as needed, preparation and identification of the patient, collection of the specimen, transportation to and within the laboratory, and preparation of the specimen for examination, and end when the examination begins (modified from ISO 15189)

Alternate Term: preanalytical processes

Project: QMS25, GP48, GP23, QMS22, QMS01

NOTE: For pathologists and cytotechnologists, preexamination activities extend from the time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic interpretation.

preventive action

action to eliminate the cause of a potential nonconformity or other potential undesirable situation (ISO 9000)

Project: GP26, QMS11, QMS13, EP18

NOTE 1: There can be more than 1 cause for a potential nonconformity (ISO 9000); NOTE 2: Preventive action is taken to prevent occurrence whereas corrective action is taken to reduce or eliminate recurrence (modified from ISO 9000).

preventive maintenance

scheduled periodic work performed on a piece of equipment that is intended to avert malfunction or failure

Project: GP26, GP23, QMS23

privacy

protection from unauthorized viewing or disclosure of personal information

procedure

specified way to carry out an activity (modified from ISO 9000)

Project: QMS03, QMS02, QMS07, QMS21, I/LA33, GP26, GP23, C57, QMS16, QMS21, GP48

NOTE 1: Procedures can be documented or not (ISO 9000); NOTE 2: When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used. The document that contains a procedure can be called a “procedure document” (ISO 9000); NOTE 3: For a quality management system, a procedure is a set of instructions that describes the stepwise actions taken to complete activities identified in processes; NOTE 4: A series of tasks usually performed by one person according to instructions.

process

set of interrelated or interacting activities that transforms inputs into outputs (modified from ISO 9000)

Project: GP26, QMS02, POCT05, POCT05, GP23, QMS16, QMS07, QMS08, I/LA33, QMS18, QMS21, QMS03, QMS29

NOTE 1: A process may be documented as a flow chart or table that describes operations in the laboratory’s path of workflow or activities within a quality system essential; NOTE 2: A process is a set of related tasks and activities that accomplishes a work goal; NOTE 3: A process is a naturally occurring or designed sequence of changes in time of properties or attributes of an object or a system. For example, G(t) is the process of glucose fluctuations over a specified period of time; NOTE 4: Whether the intended result of a process is called output, product, or service depends on the context of the reference (ISO 9000); NOTE 5: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes (ISO 9000).

process control

method for ensuring that a process meets specified requirements

process improvement

actions taken to increase the effectiveness or efficiency of a process in meeting specified requirements

process management

systematic approach for designing, developing, validating, implementing, verifying, maintaining, monitoring, and retiring a given process

procurement

processes for obtaining products and services, including activities involved in establishing fundamental requirements, identifying sourcing activities (eg, market research), negotiating contracts, and evaluating suppliers

Project: QMS21

product

result of a process

Project: M52

EXAMPLE: A medical device or system offered by a manufacturer to provide in vitro diagnostic results; NOTE 1: The products discussed in CLSI M52 are microbial identification and antimicrobial susceptibility testing systems; NOTE 2: See medical device; NOTE 3: There are 4 generic product categories: a) services (eg, transport: a laboratory produces services such as diagnostic examinations and consultation); b) software (eg, computer program, dictionary: generally, laboratories do not produce software); c) hardware (eg, engine mechanical parts: generally, laboratories do not produce hardware); d) processed materials (eg, blood products).

professional development

formal lectures, courses, seminars, webinars, or any other similar type of educational program designed to educate an individual and provide new skills and/or knowledge in preparation for advancement or a future position

Project: QMS16

EXAMPLE: A person performing laboratory examinations in microbiology would seek continuing education to stay current in microbiology, whereas the same person would seek professional development to acquire new knowledge and skills (eg, finance, personnel management) to become an effective manager of microbiology operations.

proficiency testing

evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons (ISO/IEC 17043)

Project: GP26, QMS11, MM09, GP23, QMS24, MM17

NOTE 1: For the purposes of ISO 17043, the term “proficiency testing” is taken in its widest sense and includes, but is not limited to: a) quantitative scheme – in which the objective is to quantify one or more measurands of the proficiency test item; b) qualitative scheme – in which the objective is to identify or describe one or more characteristics of the proficiency test item; c) sequential scheme – in which one or more proficiency test items are distributed sequentially for testing or measurement and returned to the proficiency testing provider at intervals; d) simultaneous scheme – in which proficiency test items are distributed for concurrent testing or measurement within a defined time period; e) single occasion exercise – in which proficiency test items are provided on a single occasion. It may be advantageous to pilot the change to evaluate its effectiveness before implementing a full-scale change; f) continuous scheme – in which proficiency test items are provided at regular intervals; g) sampling – in which samples are taken for subsequent analysis; and h) data transformation and interpretation – in which sets of data or other information are furnished and the information is processed to provide an interpretation (or other outcome); NOTE 2: Some providers of proficiency testing in the medical area use the term “external quality assessment” for their proficiency testing schemes, or for their broader programs, or both; NOTE 3: The requirements of ISO 17043 cover only those external quality assessment activities that meet the definition of proficiency testing (ISO 17043); NOTE 4: In some countries, proficiency testing programs for medical laboratories are called “external quality assessment” programs; NOTE 5: Commonly, a program periodically sends multiple specimens or samples to members of a group of laboratories for analysis and/or identification; the program then compares each laboratory’s results with those of other laboratories in the group and/or with an assigned value and reports the results to the participating laboratory and others; NOTE 6: Other forms of proficiency testing include data transformation exercises, single-item testing (in which one item is sent to several laboratories sequentially and returned to the program at intervals), and one-off exercises (in which laboratories are provided with a test item on a single occasion); NOTE 7: Proficiency testing is sometimes referred to as “external quality assessment.”

program

group of interrelated activities to accomplish specific outcomes on a continuing basis

Project: GP26, QMS16

EXAMPLES: Actions and related documents that comprise a safety program, quality control program, or training program; NOTE: A program is directed at accomplishing a clear objective, including detailed activities to take, by whom, when, and what means or resources to use.

quality

degree to which a set of inherent characteristics fulfills requirements (ISO 9000)

Project: GP26, EP23, QMS14, GP23, QMS16, C40

quality assurance

part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000)

Project: GP26, EP23, POCT01, VET03, M23, H42, H43, C34, EP18, POCT09, H26, POCT07, I/LA28, PRE05, MM19, NBS05, POCT10, POCT12, VET01, POCT14, MM22, GP23, H52, POCT13, M52, QMS21, POCT04, QMS24, VET06, GP48, M02, M07, NBS04, M11, M24, NBS09, MM24, NBS10, POCT16, NBS11, NBS12

NOTE 1: In the medical laboratory environment, quality assurance includes monitoring of raw materials, supplies, instruments, and procedures; specimen collection, transport, storage, and processing; recordkeeping; calibration and maintenance of equipment; quality control procedures; proficiency testing; personnel training; and all else involved in the production of the laboratory results report; NOTE 2: These activities include monitoring, evaluating, taking preventive and corrective actions, if necessary, and monitoring the corrective actions for the preexamination, examination, and postexamination phases; NOTE 3: Quality assurance is also described as a planned and systematic set of quality activities including risk assessment; NOTE 4: Quality assurance includes monitoring, evaluating, and taking corrective actions, if necessary, based on evaluations, and monitoring the corrective actions for preexamination, examination, and postexamination activities. These activities include but are not limited to recordkeeping, calibration and maintenance of equipment, quality control, proficiency testing, and training; NOTE 5: Quality assurance may be said to comprise internal quality assurance and external quality assurance and is interrelated with quality control; NOTE 6: A comprehensive set of policies, procedures, and practices used to monitor the laboratory’s entire testing process and ensure that the testing site’s results are reliable; NOTE 7: An integrated system of activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence; NOTE 8: A comprehensive set of policies, procedures, and practices used to monitor the laboratory’s entire testing process and ensure that the testing site’s results are reliable; NOTE 9: See proficiency testing, quality control, and quality control comparison testing.

quality control

the set of procedures designed to monitor the examination and/or test method and the results to ensure appropriate test system performance

Project: QMS07, QMS13, QMS21, QMS23, QMS24

NOTE: Quality control includes testing quality control materials and charting and analyzing the results to identify sources of error and evaluating and recording the action(s) taken.

quality control plan

a document that describes the practices, resources, and sequences of specified activities to control the quality of a particular measuring system or examination process to ensure requirements for its intended purpose are met

quality improvement

part of quality management focused on increasing the ability to fulfill quality requirements (ISO 9000)

Project: QMS14

NOTE 1: Quality improvement is also described as the continuous process of seeking opportunities for system improvement based on the planned processes of monitoring, interpretation, implementation of required action for change, and remonitoring; NOTE 2: This is often described in the terms referred to as the Deming Cycle (plan-do-check-act).

quality indicator

observations, statistics, or data defined by the organization or service that typify the performance of a given work process and provide evidence that the organization or service is meeting its quality intentions

Project: PRE06, QMS12, QMS19, QMS12, GP23, GP26, QMS06

NOTE 1: Also referred to as “key performance indicator” or “quality metric”; NOTE 2: Also referred to as “key performance indicator” or “quality metric” and may be reported in various formats, such as a dashboard or scorecard;  NOTE 3: Quality indicators are established as part of a facility’s quality management system to monitor processes and specific activities for the purpose of determining the state of quality.

quality management

coordinated activities to direct and control an organization with regard to quality (modified from ISO 9000)

Project: QMS14, QMS03

quality management system

a formal system that documents the structure, processes, roles, responsibilities, and procedures required to achieve effective quality management

Project: QMS25, QMS01

quality manager

role assigned to direct and control an organization with regard to quality

quality manual

description of an organization’s quality management system (modified from ISO 9000)

NOTE: Quality manuals can vary in detail and format to suit the size and complexity of an individual organization (ISO 9000).

quality monitoring

ongoing quality assessment process that establishes the most important monitoring targets to ensure the organization’s ability to provide optimal customer satisfaction

quality plan

document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process, or contract (ISO 9000)

Project: QMS14

NOTE 1: These procedures generally include those referring to quality management processes and to product and service realization processes (ISO 9000); NOTE 2: The plan generally includes quality system essentials and path of workflow processes; NOTE 3: A quality plan may also be referred to as a project plan.

quality planning

activity of setting quality goals and objectives and identifying related processes and resources (modified from ISO 9000)

Project: QMS01, QMS14

NOTE: Establishing quality plans can be part of quality planning (ISO 9000).

quality policy

overall intentions and direction of an organization related to quality as formally expressed by organizational leadership

Project: QMS25, QMS01, GP26, QMS16

NOTE 1: Generally, the quality policy is consistent with the overall policies of an organization and provides a framework for setting quality objectives (modified from ISO 9000); NOTE 2: Quality management principles presented in ISO 9000 can form a basis for the establishment of a quality policy.

quality report

report containing data and information compiled periodically that summarize various aspects of a laboratory’s performance for the purpose of management review

Project: QMS14

quality system essentials

the components of a management infrastructure necessary to support any health care organization’s or service’s path of workflow

Project: GP26, QMS25, QMS01, QMS07, GP23, QMS17

recall

actions taken by a firm to remove a product from the market

NOTE: Recalls are actions taken by manufacturers, distributors, importers, or regulatory agencies to carry out their responsibility to protect the public health.

recommendation

comments or suggestions made by a laboratory external assessment organization for improved practice, to which the laboratory is not required to respond or implement

Project: QMS17

NOTE: Some organizations refer to recommendations as “opportunities for improvement.”

record

(noun) evidence of results achieved or activities performed (modified from ISO 9000)

Project: QMS02, QMS17, GP26, QMS16, QMS26, QMS03

EXAMPLES: Proficiency testing results, completed temperature charts, completed forms; NOTE 1: Records are used to demonstrate traceability and provide evidence of verification, preventive action, and corrective action (modified from ISO 9000); NOTE 2: Generally, records need not be under revision control (ISO 9000).

record

(verb) the action of documenting in a recoverable medium the activities performed or results achieved

Project: QMS02, QMS26

reference document

for purposes of external laboratory assessment, any document (eg, book, checklist, regulation, standard) that specifies requirements

Project: QMS17

NOTE: Reference documents can contain suggestions on how to successfully fulfill the requirements as well as mandatory items required by the organization as proof of compliance.

referral laboratory

external laboratory to which a sample is submitted for examination (ISO 15189)

Project: ISO 15189, MM20, GP36, GP47

NOTE 1: A referral laboratory is one to which laboratory management chooses to submit a sample or subsample for examination or data for analysis or interpretation, or when routine examinations cannot be carried out (ISO 15189); NOTE 2: This differs from a laboratory to which submission of samples is required by regulation (eg, a "reference" laboratory such as public health, forensic, tumor registry) or a central or parent facility to which submission of samples is required by structure (ISO 15189).

referring laboratory

laboratory that submits samples for a supplementary or confirmatory examination procedure and receives the report from the referral laboratory

Project: QMS05, GP36

regulation

rule based on and meant to carry out a specific piece of legislation to control, direct, or manage an activity, organization, or system

Project: QMS14, QMS16, QMS17

regulatory organization

authority established by government to specify requirements for competence for specific analytical activities and to designate authority to accreditation organizations

Project: QMS24

requirement

need or expectation that is stated, generally implied, or obligatory (ISO 9000)

Project: QMS16, QMS21

NOTE 1: A specified requirement is one that is stated, for example, in documented information (ISO 9000); NOTE 2: “Generally implied” means that it is custom or common practice for the organization and interested parties that the need or expectation under consideration is implied (ISO 9000); NOTE 3: A qualifier can be used to denote a specific type of requirement, eg, product requirement, quality management requirement, customer requirement, quality requirement (ISO 9000); NOTE 4: Requirements can be generated by different interested parties or by the organization itself (ISO 9000); NOTE 5: It can be necessary for achieving high customer satisfaction to fulfill an expectation of a customer even if it is neither stated nor generally implied or obligatory (ISO 9000).

responsibility

duty or obligation to satisfactorily perform or complete a task (assigned by someone, or created by one’s own promise or circumstances) that one must fulfill and which has a consequent penalty for failure

review

activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives (modified from ISO 9000)

Project: QMS03

risk

combination of the probability of occurrence of harm and the severity of that harm (ISO 14971)

Project: M29, HS11, GP40, EP18, EP23, QMS16, GP47, QMS21, EP31, QMS17

NOTE 1: In CLSI EP18, the combination of frequency of occurrence and severity is also risk; NOTE 2: A potential hazard or quality deficiency associated with a process, product, or service.

risk assessment

overall process comprising a risk analysis and a risk evaluation (ISO 14971)

Project: ISO IEC Guide 51, ISO DIS 14971, EP18, I/LA33, EP23, GP47, M48

NOTE 1: Risk is a measure of the probability and severity of undesired effects. It is often taken as the simple product of probability and consequence; NOTE 2: Risk assessment is a comprehensive evaluation of risk and its associated impact; NOTE 3: In mycobacterial testing, a thorough workplace evaluation performed to identify practices, situations, etc., that may cause harm (eg, Mycobacterium tuberculosis complex infection) to the laboratory worker; NOTE 4: Due to the potential presence of Mycobacterium tuberculosis complex in patient specimens and its ability to form infectious droplet nuclei when aerosolized, laboratories need to ensure appropriate practices are in place to protect their laboratory workers. Because laboratories vary widely in service levels and number of specimens processed, no single set of safety guidelines can be applied to all laboratories. Thus, a risk assessment should be performed by each laboratory. After the risk severity is identified, measures can be implemented to effectively protect or control harm to the laboratory worker in a particular laboratory setting; NOTE 5: The risk of these practices can be stratified into low, medium, and high risk.

risk management

systematic application of management policies, processes, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (modified from ISO 14971)

Project: QMS01, EP18, EP23, PRE06, GP47

root cause

the most basic reason(s) for a problem, which, if corrected, will reduce or eliminate recurrence of that problem

Project: QMS24

root cause analysis

systematic approach for identifying the causal factor(s) underlying a problem or condition

Project: QMS01, GP26, GP33

NOTE: Regulatory organizations may require use of the term “root cause analysis” to ensure confidentiality of root cause analysis documents.

safety

freedom from unacceptable risk (ISO/IEC Guide 63)

Project: ISO Guide 63-2.12, ISO Guide 63-2.12

severity of harm

refers to either the extent of an adverse outcome for a patient or an event that negatively affects the patient’s health and welfare

Project: QMS17

NOTE: Severity can also be associated with extended patient stay or other financial effects on the organization.

specification

a document that states the requirements to which a given product or service must conform

Project: QMS21, EP19

specimen

discrete portion of a body fluid or tissue or other sample associated with the human body taken for examination, study, or analysis of 1 or more quantities or characteristics to determine the character of the whole (ISO 15189)

Alternate Term: primary sample

Project: POCT05, MM09, PRE05, PRE01, PRE04, GP48, QMS24, MM20, ISO 15189, EP34, NBS04, EP07, C63, MM17, QMS22, C34, GP33, NBS09, NBS08, NBS05, POCT15, MM24, EP39, EP14, EP12

EXAMPLE 1: Biological entities can be, for example, laboratory animals, recombinant material generated from DNA, or human subjects; EXAMPLE 2: Examples include whole blood, urine, stool, cerebrospinal fluid, or solid tissues; NOTE 1: In some countries, the term “specimen” is used instead of primary sample (or a subsample of it), which is the sample prepared for sending to, or as received by, the laboratory and which is intended for examination (ISO 15189); NOTE 2: A specimen is a discrete portion of a body fluid or tissue taken for examination, study, or analysis of one or more quantities or characteristics to determine the character of the whole (ISO 18113-1); NOTE 3: For the purposes of EP34, a specimen may be composed of blood drawn into a collection tube; NOTE 4: The term “neat specimen” may be used to emphasize that the specimen is unmodified; for example, spiking or dilution have not been performed on the specimen; NOTE 5: For newborn screening, the dried blood spot specimen is collected; NOTE 6: For the purposes of EP07 and EP12, a specimen is the component taken directly from the body, with or without anticoagulants and preservatives, that has not been physically or chemically changed, except that it may have been centrifuged (ie, blood cells have been separated from the serum or plasma); NOTE 7: See sample; NOTE 8: The substance may still be referred to as a “specimen” if it was processed from the obtained specimen; thus, examples of specimens include whole blood and serum or plasma prepared from whole blood; saliva; cerebrospinal fluid; feces; urine; fingernail clippings; hair clippings; and tissue, even if embedded in a paraffin block; NOTE 9: For the purposes of CLSI C34, a specimen is the component taken directly from the body, with or without anticoagulants and preservatives, that has not been physically or chemically changed, except that it may have been centrifuged (ie, blood cells have been separated from the serum or plasma); NOTE 10: Biological material that is obtained to detect or measure one or more quantities, such as amount or concentration; NOTE 11: EP14 should not be used to measure the difference between specimen types.

stakeholders

people, departments, and organizations that have an investment or interest in the outcome of actions being taken

NOTE: Stakeholders may be external to a process, such as customers or suppliers, or they may be internal, such as project sponsors, managers, teams, or internal customers.

standard

specification against which the outputs of a process are compared and declared acceptable or unacceptable; also, documents that provide requirements, specifications, guidelines, or characteristics that can be used to ensure that materials, products, processes, and services are fit for their purpose

statistical tools

methods, techniques, and software used to generate, analyze, interpret, and present data

Project: GP26, QMS06

strategy

action plan to set the direction for the coordinated use of resources through goals, programs, projects, policies, processes, procedures, and organizational assets to advance future organization interests

Project: QMS16, QMS21, QMS06

stratification

classification of data into categories and subcategories on the basis of 1 or more chosen criteria

EXAMPLES: Separating reference intervals by age and/or sex; separating nonconforming events by department, discipline, or other criteria.

succession planning

identification and development of potential successors for key positions in an organization, through a systematic evaluation process and training

Project: QMS16

supplier

organization or person that provides a product or service (modified from ISO 9000)

EXAMPLES: Producer, distributor, retailer, or vendor of a product, or a provider of a service or information (modified from ISO 9000); NOTE 1: A supplier can be internal or external to the organization (modified from ISO 9000); NOTE 2: In a contractual situation, a supplier is sometimes called a “contractor” (modified from ISO 9000).

sustainability

ability to maintain or support an activity, process, or performance over time without negatively affecting the environment, community, or society as a whole

Project: QMS06

SWOT analysis

a strategic planning tool used to evaluate an organization's competitive position by examining 4 key areas: strengths, weaknesses, opportunities, and threats

system

sum total of all organizational processes and resources that are part of the delivery of care to patients

NOTE: The system includes personnel, funds, information, supplies, transport, communications, and overall guidance and direction.

target

a specified number that management sets for achieving or exceeding a metric (ie, desired performance)

Project: QMS12

EXAMPLE: A quality indicator is a process performance metric with the objective of fulfilling a target value.

task

planning element that delineates the specific “who, how, and when” to accomplish a specific objective

Project: QMS14, QMS16, QMS03

template

predesigned, standardized, reusable layout in an electronic or paper medium with placeholders for adding specific information used to create documents with a similar design, pattern, style, or content

threshold

a tolerance limit for performance

Project: QMS12

traceability

ability to trace the history, application, or location of that which is under consideration (modified from ISO 9000)

Project: GP26, I/LA28

NOTE: When a product or a service is considered, traceability can relate to the origin of materials and parts, the processing history, and the distribution and location of the product after delivery (modified from ISO 9000).

training

process to provide instruction for performing or improving a job function

Project: QMS16, QMS03

troubleshooting

series of tasks designed to systematically investigate, identify, and correct a nonconforming situation, including adjustments made to correct the problem

Project: QMS13

NOTE 1: All necessary adjustments made to correct the problem need documenting; NOTE 2: Includes a record of the investigation and actions taken; EXAMPLES: Malfunctioning equipment, controls or calibrators out of range, etc.

turnaround time

time interval that encompasses a process to determine availability of a defined outcome

Project: QMS05, MM26

NOTE: Turnaround time can be calculated from multiple time points, such as the time from when a health care provider determines the need for a result to when the result is available to act upon; the time the sample is received in the laboratory to when the result is available to the health care provider; or the time from when the sample is submitted to the referral laboratory until results are returned to the referring laboratory.

uncertainty

(of measurement) non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used (JCGM 200:2012)

Alternate Term: uncertainty of measurement; measurement uncertainty

Project: GP26, QMS21, POCT05, POCT05, C43, POCT07, MM06, GP34, EP21, EP24, C51, MM20, C40, H60, EP05, C57, EP19, QMS24, C24, EP34, MM17, EP46, H20

NOTE 1: Measurement uncertainty includes components arising from systematic effects, such as components associated with corrections and the assigned quantity values of measurement standards, as well as the definitional uncertainty. Sometimes estimated systematic effects are not corrected for but instead, associated measurement uncertainty components are incorporated (JCGM 200:2012); NOTE 2: The parameter may be, for example, a standard deviation called standard measurement uncertainty (or a specified multiple of it) or the half-width of an interval, having a stated coverage probability (JCGM 200:2012); NOTE 3: Measurement uncertainty comprises, in general, many components. Some of these may be evaluated by type A evaluation of measurement uncertainty from the statistical distribution of the quantity values from series of measurements and can be characterized by standard deviations. The other components, which may be evaluated by type B evaluation of measurement uncertainty, can also be characterized by standard deviations, evaluated from probability density functions based on experience or other information (JCGM 200:2012); NOTE 4: In general, for a given set of information, it is understood that the measurement uncertainty is associated with a stated quantity value attributed to the measurand. A modification of this value results in a modification of the associated uncertainty (JCGM 200:2012); NOTE 5: The parameter may be, eg, a standard deviation (or a given multiple of it), or the half-width of an interval, having a stated level of confidence (modified from ISO 15195); NOTE 6: Type A evaluation of measurement uncertainty is defined as evaluation of a component of measurement uncertainty by a statistical analysis of measured quantity values obtained under defined measurement conditions; NOTE 7: Type B evaluation of measurement uncertainty is defined as evaluation of a component of measurement uncertainty determined by means other than a type A evaluation. This might include standard deviations obtained from information associated with authoritative published quantity values, associated with quantity values of certified reference materials, obtained from a calibration certificate, or obtained from experience or other means.

uncontrolled copy

copy made from an approved document for use only within a specified time period or for a special use (eg, approved distribution outside the facility to a regulatory or accreditation organization) and that is marked in a manner (eg, "not controlled") to indicate that the copy will not be accounted for when revisions are made or the document is retired

Project: QMS02

validation

confirmation of plausibility for a specific intended use or application through the provision of objective evidence that specified requirements have been fulfilled (ISO 15189)

NOTE 1: Objective evidence can be obtained through observation, measurement, examination, or by other means (ISO 15189); NOTE 2: The word "validated" is used to designate the corresponding status (ISO 15189); NOTE 3: Specified requirements of an examination method include the following performance specifications: trueness; precision; analytical specificity, which includes interfering substances, detection limit, and quantitation limit; measuring interval; clinical relevance; diagnostic specificity; and diagnostic sensitivity (ISO 15189).

verification

confirmation of truthfulness, through the provision of objective evidence that specified requirements have been fulfilled (ISO 15189)

NOTE 1: Process by which the laboratory confirms that the established performance claims of a measuring system can be replicated in the laboratory before human sample examination is performed (ISO 15189); NOTE 2: The word "verified" is used to designate the corresponding status (ISO 15189); NOTE 3: Verification can be sufficient to implement a new in vitro diagnostic device under circumstances in which the examination is performed and used in the manner as directed in the package insert (ISO 15189).

workflow

progression of tasks, events, or interactions that comprise a work process, involve 2 or more persons, and create or add value to the organization’s activities; in a sequential workflow, an activity depends on the activity that precedes it, and in a parallel workflow, 2 activities can take place concurrently

Project: QMS02

NOTE: The laboratory’s path of workflow is sequential.

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