5S — (Sort, Shine, Set in Order, Standardize, and Sustain) A method of creating a clean and orderly workplace that exposes waste and errors.

ASR — Analyte Specific Reagents — “Antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens”

Assessment — A systematic, independent examination that is performed at defined intervals and at sufficient frequency to determine whether actual activities comply with planned activities, are implemented effectively, and achieve objectives. Assessments usually include comparison of actual results to expected results. Types of assessments include external, internal and quality assessments, self-assessments, and peer review

CLIA — Clinical Laboratory Improvement Amendments of 1988

CLSI — Clinical Laboratory Standards Institute — Formerly known as the National Committee for Clinical Laboratory Standards (NCCLS)

COLA – An independent, non-profit accreditor whose education program and standards enable clinical laboratories and staff to meet U.S. CLIA and other regulatory requirements

Critical Value — A value that represents a pathophysiological state at such variance with normal (expected values) as to be life-threatening unless something is done promptly and for which some corrective action could be taken (Clinical Pathology Working Group, April 2000)

Cytospin and Cell Block – Methods for processing the specimen which ensure the optimal amount of cells on a slide for aiding in diagnosing

Defect — A part, product, or service that does not conform to specification or customer expectations.

Direct Immunoflourescence – Immunofluorescence is the labeling of antibodies or antigens with fluorescent dyes. The direct immunoflourescence technique creates distinctive patterns in patients with connective tissue diseases, bullous disorders and other dermal pathologies

DPM — Defects Per Million.

FMEA — Failure Modes and Effects Analysis — A fault tree method (first developed for systems engineering) that examines potential failures in products or processes. It may be used to evaluate risk management priorities for mitigating known threat-vulnerabilities.

IUO — Investigational Use Only — Investigational use only reagents or test kits.

IVD — In vitro Diagnostic — “In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body”

Immunohistochemical stains – This staining technique can be used to identify specific types of cells within a given sample using specialized antibodies to lock on to the antigens present within the tissue.

Joint Commission, The — Formerly known as Joint Commission on Accreditation of Healthcare Organizations.

KPI — Key Performance Indicators — Measurements that represent the status of an operational area and progress made to reach operational objectives

Laboratory — A facility for the biochemical, microbiological, serological, chemical, immunohematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease, or the impairment of or the assessment of the health of human beings. A laboratory is a facility designed for collection, processing and/or testing of specimens or procedures (DLMP Enterprise Information Model)

Laser Scanning Cytometry – A method of examining tissue and fluids for cutaneous lymphomas

Lean Manufacturing — A management philosophy focusing on reduction of the seven wastes (over-production, waiting time, transportation, processing, inventory, motion and scrap) in manufactured products. By eliminating waste, quality is improved, and production time and cost are reduced. Lean “tools” include constant process analysis, “pull” production, and mistake-proofing

Non-Gynecological Cytology – Cytology is used to study individual cells in a body fluid. Cytology is predominately used when screening for malignancies

Papanicolaou (PAP) stain – A multichromatic stain used to enhance details of a cell

Proficiency Testing — A program in which multiple specimens are periodically sent to a group of laboratories for analysis and/or identification; in which each laboratory’s results are compared with those of other laboratories in the group and/or with an assigned value and reported to the participating laboratory and others. Proficiency testing is an evaluation of the ability of a laboratory to achieve a correct test result when compared with other laboratories using the same methodology. This is accomplished using the laboratory’s materials, personnel, equipment, environmental conditions, and procedures through the analysis of unknown specimens distributed at periodic intervals by an external source

Quality Indicator — A specific measurement of the performance of functions and processes used to make informed decisions regarding whether a process is in control or to identify opportunities for improvement

Quality Management — All activities of the overall management function that determine quality policy, objectives and responsibilities, and implementation by means such as quality planning, quality control, quality assurance, and quality improvement within the quality system

Quality Program — The comprehensive planned, written, and managed system for significantly decreasing errors, lending credibility to test results, and improving product and service safety and quality

RUO — Research Use Only — The FDA considers RUO products to be those in the laboratory research phase of development; that is, either basic research or the initial search for potential clinical utility.

Six Sigma — A statistical concept that represents the amount of variation present relative to customer requirements or specifications

Special stains – These stains are performed to demonstrate characteristics of specific tissues which aid in diagnosing. Light Microscopy: Hematoxylin and Eosin is the most commonly used stain on tissue samples, which the pathologist will then examine and interpret using the
light microscope