KMLTTB key terms

Planned, documented learning activities that maintain and extend a practitioner's competence after initial qualification, such as workshops, online courses, case reviews, and conference attendance, usually recorded in a portfolio with points or hours.

A structured record in which a practitioner logs learning activities, dates, hours, evidence of attendance, and reflections on how each activity changed practice. Auditors and regulators use it to verify compliance with annual CPD requirements.

A standard measure of participation in approved learning activities, commonly one CEU per ten contact hours. Professional bodies set conversion rules and may accredit providers so that credits count toward licence renewal.

The habit of reviewing what happened in a case or activity, why it happened, and what will change next time. Written reflections turn attendance at training into demonstrable learning and are often required in CPD records.

A structured process of judging whether a staff member can perform defined tasks to the required standard, using direct observation, blind samples, records review, or written tests. Results identify training needs and support authorization to work independently.

A systematic comparison of required competencies against each person's current knowledge and skills, used to design a targeted training plan. It draws on job descriptions, competency gaps, incident findings, and new test introductions.

Orientation given to new or transferred staff covering laboratory policies, safety, quality system, information systems, and supervised practice on assigned methods before independent work is permitted. Completion is documented and signed off.

A trainer watches a trainee perform a complete procedure on a real or simulated sample and scores each step against a checklist. It verifies technique, safety behaviour, and specimen handling that written tests cannot confirm.

Formal written permission for a named staff member to run a specific method independently, granted after documented training and competency verification. It is withdrawn if competence lapses or serious errors occur.

The range of duties a laboratory professional is legally and professionally permitted to perform given their qualification, registration, and workplace authorization. Working outside it may breach regulations and expose patients to risk.

Official entry of a qualified practitioner onto a regulatory register, granting the legal right to practise and use a protected title. Registration is usually time-limited and renewed on evidence of good standing and CPD.

A regulator's judgment that a practitioner has the health, character, competence, and conduct needed to work safely. Concerns may lead to conditions, suspension, or removal from the register after a fair hearing.

The published standards of behaviour expected of registered practitioners, covering honesty, patient confidentiality, competence, and reporting of risks. Breaches can trigger disciplinary action by an employer or regulator.

A situation where a professional's personal, financial, or other interest could improperly influence a work decision, such as accepting gifts from a supplier. It must be declared and managed, often by withdrawal from the decision.

The principle that purchasing of reagents, equipment, and services must follow transparent, pre-defined criteria free from personal gain or vendor influence. It protects test quality and public money and is a common audit focus.

Reporting a genuine concern about unsafe practice, fraud, or harm to patients to a person or body able to act on it, with legal protection against retaliation in many jurisdictions. Internal reporting channels should be tried first where safe.

The duty to keep identifiable patient information private and share it only with those who need it for care, legal, or quality purposes. It governs result reporting, discussions, and use of data in teaching or research.

Agreement to a procedure, test, or use of samples and data given voluntarily by a person who understands the purpose, risks, and alternatives. It must be documented and can be withdrawn.

An independent body that reviews proposed studies involving human participants or their samples and data before they begin, checking consent, risk, and confidentiality. Approval is normally required before any research use of residual specimens.

Legal and procedural safeguards for personal information held by a laboratory, including access limits, secure storage, retention periods, and lawful sharing. Breaches involving patient results can carry regulatory and legal consequences.

The coordinated set of policies, processes, documents, and records by which a laboratory plans and controls its work to consistently meet quality requirements. It forms the basis for accreditation to standards such as ISO 15189.

A top-level document describing the laboratory's quality management system, its scope, structure, and how each standard requirement is met. It references lower-level procedures and is controlled under document management rules.

The system ensuring only current, approved versions of procedures and forms are in use, with unique identifiers, version numbers, approval records, distribution lists, and removal of obsolete copies from all work areas.

A written, approved instruction describing exactly how to perform a routine task, including materials, steps, acceptance criteria, and safety notes. Staff must be trained on it, and changes follow document control.

The defined periods for keeping quality and technical records, such as worksheets, instrument printouts, and personnel files, set by regulation, accreditation, or contract. Records must remain legible and retrievable for the whole period.

A planned, independent review of laboratory activities against the quality system and standard requirements, performed by trained staff not directly responsible for the area audited. Findings are graded and tracked to closure.

Action taken to remove the root cause of a detected nonconformity so it does not recur, following investigation of why it happened. It is distinguished from immediate correction and is verified for effectiveness.

A failure to meet a specified requirement, whether in a process, product, or the quality system itself. It must be recorded, contained, investigated, and resolved, with recurrence prevented where possible.

A structured investigation, using tools such as the five whys or cause-and-effect diagrams, to find the underlying reason a problem occurred rather than blaming an individual. Its output drives corrective action.

Periodic testing of unknown samples supplied by an outside organizer, with results compared against peer laboratories or a reference value. Unsatisfactory performance triggers investigation and corrective action as part of quality monitoring.

A formal scheme in which a laboratory's results on circulated samples are scored against assigned values or peer consensus to demonstrate competence. Some regulators require participation for accreditation or licensing.

Daily testing of control materials of known target values alongside patient samples to monitor precision and detect drift or shift. Results are plotted on charts and judged against defined acceptance rules before patient results are released.

A control chart plotting control results over time against mean and standard deviation lines, making trends, shifts, and outliers visible. It is the usual graphic tool for reviewing internal quality control data.

A set of statistical decision rules, such as 1-3s, 2-2s, R-4s, 4-1s, and 10x, applied to control results to decide whether an analytical run should be accepted or rejected. They balance error detection against false rejection.

A quantified estimate of the range within which the true value of a result is expected to lie, accounting for imprecision, bias, and other sources. It helps clinicians interpret results near decision limits.

The process of confirming by documented evidence that an analytical method meets specified requirements for its intended use, covering accuracy, precision, specificity, linearity, and limits of detection and quantification before routine use.

Confirmation that a method already validated elsewhere performs as claimed in the local laboratory, typically checking precision, bias, and reportable range with a small study. It precedes routine use of a new platform.

Adjusting or checking an instrument against materials of known value so that results trace to a reference standard. It is performed on a defined schedule and after major maintenance or failed quality control.

Testing a newly received batch of reagent or consumable against the current lot or known samples to confirm performance before it enters routine use. It protects against supplier variation and shipping damage.

Assessment of a supplier's ability to consistently provide reagents, equipment, or services meeting requirements, using certificates, audits, performance history, and reference checks. Approved suppliers are reviewed periodically.

The range of results expected in a defined healthy population, usually covering the central 95 percent, established by local or published studies. Results outside it are flagged but do not by themselves prove disease.

The practice of tracking and controlling the shelf life of reagents, controls, and consumables so that expired materials are never used and stock is rotated first-in-first-out. Expired use is a common audit finding.