Below is a glossary of terms used in the blood bank, laboratory and transfusion service.
- Analyte—A substance or constituent for which the laboratory performs testing.
- Accuracy—State of quality of being accurate; closeness of test results to the true value and implies freedom from error; also referred to as bias.
- Calibration—Process by which the readings obtained from an instrument or other measuring device in an analytical process are related to known concentrations.
- Calibrator—A material, solution, or lyophilized preparation designed to be used in calibration. The values or concentrations of the analytes of interest in the calibration material are known within limits ascertained during its preparation and determined by the use of an analytical method of stated reliability.
- Change control—A well-known cGMP concept that focuses on managing change to prevent unintended consequences. Change control within quality management systems and information technology systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.
- Change management—The disparate set of processes, tools, techniques,
methods and approaches to achieve our desired end state through change. - CLIA—The Clinical Laboratory Improvement Amendments of 1988; the federal regulatory program governing all laboratory testing.
- Control—Essentially identical specimens of stable materials, usually similar in composition and physical properties to natural specimens, subjected to the same analytical process for surveillance control (monitoring) to estimate the performance characteristics (accuracy, precision) of the analytical process. Control materials are designed to be used in the quality control process and are not used for calibration purposes. Concentration of the analytes of interest in the control material is known within limits ascertained during its preparation and confirmed in use.
- DMAIC—This fix-it tool is used to define what’s broken, measure how broken it is, analyze why it’s broken, improve the process to eliminate root causes and control the process to sustain gains.
- Fishbone diagram—This root-cause analysis tool is used to diagram the team’s collective cause-and-effect knowledge—the head is the incident, the bones possible causes (manpower, methods, materials and machines).
- HLA testing—Testing for the human leukocyte antigen (HLA)
- Kit—All components of a testing system (or unit) that are packaged together.
- Laboratory—A facility for the biological, microbiological, serological, chemical, immunohematological, hematological, 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 impairment of, or of the assessment of the health of human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting and/or preparing or only serving as a mailing service and not performing testing are not considered laboratories.
- Mean—A number that represents an entire set of numbers, determined for the set in any number of ways; average.
- Performance characteristic—A property of a test that is used to describe the quality, e.g., accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range, etc.
- Performance specification—A value or range of values for a performance characteristic established or verified by the laboratory that is used to describe the quality of patient results.
- Precision—State or quality of being precise; freedom from inconsistency or random error; closeness with which repeated determinations agree with each other and implies freedom from variation; also referred to as reproducibility.
- Preventive maintenance—A program of scheduled inspections of laboratory instruments and equipment resulting in minor adjustments or repairs for the purpose of delaying or avoiding major repairs and emergency or premature replacements.
- Proficiency survey—A program in which specimens of quality control material are periodically sent to members of a group of laboratories for analysis and comparison of each laboratory’s results with those of other laboratories in the group through some central organization. Participation in a proficiency survey does not replace the day-to-day quality control process of an individual laboratory.
- Quality management—Sum of all those activities in which the laboratory is engaged to ensure that information generated by the laboratory is correct. Quality management is not restricted to the development and retention of quality control charts but rather includes all aspects of laboratory activities that affect the results produced, from the choices of methods, to the monitoring of instruments, to the education of personnel, to the handling of specimens, and to the reporting of results. Quality management activities are designed to determine how accurate the results emanating from the laboratory are, and to allow those managing the laboratory to determine whether or not the lab is fulfilling its function satisfactorily.
- Quality control—Procedures performed to measure and maintain the quality of performance in the analytical laboratory through measurement of the variability against pre-established criteria specifications, correction as indicated, and documentation. The major purpose of these programs is to establish analytical goals and to assist in their achievement.
- Reportable range—The range of test values expected for a designated population of individuals.
- Root cause analysis—A structured method of problemsolving that allows for effective solutions, RCA is used to determine the root cause of an event, incident, deviation or error. Conducted in a just culture, RCA can be used to identify multiple roots and multiple solutions that lead to long-term, broad-based improvement.
- Sample—In proficiency testing, means the material contained in a vial, on a slide, or other unit that contains material to be tested by proficiency testing program participants. When possible, samples are of human origin.
- The Six S Process—Sort (eliminate all unnecessary items), set (in order), shine (sweep everything clean), standardize (be consistent in the way you work), sustain and safety.
- Standard deviation—The most common measure of statistics, measuring how widely spread the values in a data set are dispersed.
- Target value—For quantitative tests, means either the mean of all participant responses after the removal of outliers (those responses greater than three (3) standard deviations from the mean) or the mean established by definitive or reference methods acceptable for use by the National Reference System for the Clinical Laboratory (NRSCL) by the National Committee for Clinical Laboratory Standards (NCCLS).
- Theory of Constraints—Use this toolset to identify the most important constraint or limiting factor in a process; systematically improve that factor until it no longer constrains; reorganize the process around remaining constraints; and use buffers to avoid gaps and maximize flow. TOC tools include: 5 focusing steps, thinking processes, throughput accounting and drum-buffer-rope.
- TRALI—Transfusion-related acute lung injury (TRALI) is a rare but potentially fatal complication of blood product transfusion.
Sources: AABB, Alabama County Health Department Laboratory Systems Policies and Procedures Manual, FDA, Wikipedia, etc.
