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.” 21 CFR 864.4020(a).
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.
Batch Fax Inquiries — Contacts made by MML to clients via fax versus telephone.
Calls to Client —Calls made from MML to client. The majority of calls are necessary to resolve discrepant information or specimen integrity issues.
Calls to MML — Incoming calls from the client to MML.
Calls by Reason—Total number of calls for each call reason defined in call monitoring system.
Cancelled Tests— Total number of cancelled tests.
CLIA — Clinical Laboratory Improvement Amendments of 1988 (42 CFR Part 493).
CLSI — Clinical Laboratory Standards Institute—Formerly known as the National Committee for Clinical Laboratory Standards (NCCLS).
CAP — College of American Pathologists.
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).
Defect — A part, product, or service that does not conform to specification or customer expectations.
DPM — Defects Per Million.
DLMP — Department of Laboratory Medicine and Pathology.
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.
Incoming Defects —Information missing or incorrect in the test order/paperwork causing additional work and delay in testing. For example, missing or incorrect urine duration or volume.
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." 21 CFR 809.
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 (42CFR 493.2). A laboratory is a facility designed for collection, processing and/or testing of specimens or procedures (DLMP Enterprise Information Model).
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.
Lost Specimens—Total number of cancelled tests due to lost specimens.
Percentage of Acceptable Proficiency Testing (PT) —Overall percentage of Mayo Department of Laboratory Medicine and Pathology performance in external Proficiency Testing (PT) through various agencies or vendors. The percentage is calculated by dividing the number of successful challenges by the total number of challenges for the month. Any PT event that is less than 100% is thoroughly investigated.
Percentage of Critical Value Results Called Within 60 Minutes—MML policy is to provide all critical results to the client within 60 minutes of resulting. This metric provides the percentage of critical results provided to the client within 60 minutes.
Percentage of Test Results Meeting Turn Around Time —Turn around time target is established from the following fields in the Laboratory Test Catalog:
- Analytic Time
- Days(s) and Time(s) Performed
Turn around time is calculated from the time specimen is received at MML to time of result. This excludes reflex testing, referral testing, test add-ons and revised results.
Pre-analytical Reject Rate —Events or circumstances that alter the concentration of analytes in the specimen before the actual measurement by the testing laboratory which includes patient preparation, the specimen collection process, specimen transport and handling. (i.e. hemolysis, specimen misidentification or quantity not sufficient).
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 (CLSI GP27-A2). 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 (CLSI GP26-A3).
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.
Revised Report Rate —Number of occurrences where information on the patient’s test report must be changed generating a revised report to the client. The rate is calculated by dividing the number of resulted tests by the number of revised tests x 100.
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.
Semi Urgent Result—A result or finding, which can be unexpected or ambiguous, that does not pose an immediate health threat but has near-term severe health consequences if not acknowledged and/or treated.
Six Sigma —A statistical concept that represents the amount of variation present relative to customer requirements or specifications. Sigma (σ) is the measurement used. The term "Sigma" is often used as a scale for levels of 'goodness' or quality. The central idea behind Six Sigma is measuring the number of 'defects' in a process to systematically determine how to eliminate them and get as close to 'zero defects' as possible. To achieve Six Sigma Quality, a process must produce no more than 3.4 defects per million opportunities.
- 6σ = 3.4 defects per million opportunities
- 5σ = 233 defects per million opportunities
- 4σ = 6,210 defects per million opportunities
- 3σ = 66,807 defects per million opportunities
- 2σ = 308,537 defects per million opportunities
- 1σ = 691,462 defects per million opportunities
TLCP - Define, document, and implement a standardized test life cycle process (TLCP) that improves DLMP operations and prepares all Mayo Clinic CLIA laboratories for increased FDA and other regulatory oversight of lab tests, especially Laboratory Developed Tests (LDTs).
Total Test Count — Total count of orderable tests. Count occurs at time of result.