KMLTTB cheat sheet

In Kenya, the laboratory profession is regulated under the Medical Laboratory Technicians and Technologists Act, which establishes the KMLTTB as the licensing and disciplinary body for laboratory practitioners.

Registration categories typically include student/attachee, registered technician (diploma level), registered technologist (degree level), and specialist or postgraduate registration; each carries a defined scope of practice.

Annual practising licence renewal is conditional on evidence of continuing professional development; practising without a valid licence is an offence subject to sanctions.

Scope-of-practice rule: a technician works under defined supervision protocols, while a technologist may independently authorise and interpret results within accredited test menus.

Mandatory notification: laboratories must report notifiable diseases and critical/panic values to the requesting clinician and, where required, to public health authorities within defined timeframes.

Records rule: request forms, worksheets, and reports are retained per national and accreditation requirements (commonly a minimum of five years for clinical records, longer for transfusion and occupational health records).

Only a licensed practitioner may sign out a diagnostic report; delegation of result authorisation requires documented competency assessment and institutional policy.

Disciplinary pathway: complaint or inspection finding, investigation, hearing before the board's disciplinary committee, then outcomes ranging from caution to suspension or removal from the register.

Four core bioethical principles: respect for autonomy, beneficence, non-maleficence, and justice; apply them to consent, test selection, and equitable access decisions.

Confidentiality rule: patient results are disclosed only to the patient, authorised clinicians, or as required by law; minimum-necessary disclosure applies to insurers, employers, and research use.

Informed consent is required before HIV testing, genetic testing, and research use of stored samples; exceptions are limited to statutory public health or court-ordered situations.

Conflict-of-interest rule: disclose any financial interest in a supplier, referral laboratory, or test kit vendor, and recuse from procurement or evaluation decisions involving that party.

Competence boundary rule: decline or refer a test or interpretation outside one's training rather than issue an unverified result; document the referral.

Research ethics: protocols involving human samples require ethics committee approval, and anonymised residual samples still require consent or a documented waiver.

Error disclosure: a known analytical or reporting error affecting patient care must be disclosed promptly to the clinician and documented in the incident system, not concealed.

Anti-fraud rule: never alter a result, backdate a record, or report an unperformed test; such acts constitute professional misconduct and possible criminal fraud.

Quality system essentials span organisation, personnel, equipment, purchasing, process control, documents and records, information management, incident management, assessment, and continual improvement.

Quality control rule: run at least two levels of control (normal and abnormal) per testing day or shift, and accept a run only when controls fall within established limits.

Westgard multirule: 1-3s is a warning; 2-2s, R-4s, 4-1s, and 10x indicate rejection because they signal systematic or random error.

Levey-Jennings charts plot control values against mean and standard deviation; shifts show a sudden mean change, trends show a progressive drift across consecutive runs.

Sigma metric = (TEa − |bias|) / CV; higher sigma means fewer controls are needed, lower sigma demands tighter control rules and more frequent verification.

External quality assessment (proficiency testing) performance is reviewed by the quality manager; an unsatisfactory result triggers root-cause analysis and corrective action, not simply a repeat test.

Corrective action follows root-cause analysis (for example, 5-Why or fishbone); preventive action addresses a potential nonconformity before it occurs.

Document control requires unique identifiers, version numbers, approval signatures, effective dates, and retrieval of obsolete copies from all use points.

Verification vs validation: verification confirms a method performs as the manufacturer claims in your laboratory; validation establishes performance for an in-house or modified method.

Core performance characteristics: precision (repeatability and within-lab), trueness/bias, accuracy, analytical measuring range (linearity), limit of detection, limit of quantification, and analytical specificity including interference.

Acceptance rule: a reagent lot is released for patient testing only after documented verification of precision and, where applicable, comparison with the current lot or a reference method.

Calibration vs verification: calibration assigns values using calibrators; verification checks that the calibrated system meets defined acceptance criteria before reporting patient results.

Equipment qualification sequence: design qualification, installation qualification, operational qualification, and performance qualification; each stage is documented before clinical use.

Method comparison uses at least 20 patient samples spanning the measuring range, analysed by Deming or Passing-Bablok regression; bias is judged against the total allowable error.

Carryover studies alternate high and low samples; carryover percentage must fall below the laboratory-defined limit before the analyser is accepted.

Any reagent or equipment change that could affect results requires documented change control, impact assessment, and re-verification before results are released.

Competency assessment combines direct observation, blinded rechecking of results, problem-solving case review, and record review; a single method is insufficient evidence of competence.

Training records must show objectives, content, trainer qualification, duration, assessment method, outcome, and date, and must be retained for the licence renewal period.

New staff require induction training plus supervised practice with sign-off at defined milestones before independent reporting is authorised.

Continuing professional development points are typically earned through accredited workshops, conferences, journal clubs, e-learning, and published work; documented evidence is required for renewal.

Adult learning principle: training is structured around tasks the learner performs, with feedback and repetition, rather than passive lecture alone.

Trainer competence rule: the trainer must hold verified competence in the topic and be authorised by the laboratory director or training coordinator.

Refresher training is triggered by a change in method or equipment, a prolonged absence from the bench, or an adverse incident linked to a competence gap.

Training effectiveness is evaluated by post-training assessment and by monitoring quality indicators such as error rates in the trained task.

Biosafety levels: BSL-1 for low-risk agents, BSL-2 for clinical diagnostic work with human specimens, BSL-3 for agents transmitted by aerosol with serious consequences.

Standard precautions apply to all specimens regardless of diagnosis; gloves, gown, eye protection, and hand hygiene are determined by anticipated exposure, not by known status.

Sharps rule: never recap a needle by hand, and dispose of sharps immediately at the point of use into a puncture-resistant container filled to no more than three-quarters.

Spill response sequence: alert and evacuate, don personal protective equipment, contain and absorb, disinfect with an appropriate agent such as sodium hypochlorite, then document the incident.

Specimen rejection criteria include unlabelled or mislabelled requests, insufficient volume, wrong container or anticoagulant, gross haemolysis, and prolonged transport beyond stability limits.

Chain of custody is mandatory for forensic, doping, and medico-legal specimens; each transfer records handler identity, date, time, and specimen condition.

Formalin, xylene, and other hazardous chemicals require a current safety data sheet, labelled storage, and documented staff training before handling.

Post-exposure prophylaxis for bloodborne exposure must begin as soon as possible after risk assessment; the incident is logged and the source tested under consent rules.

Critical value rule: a result in the defined panic range is phoned to the responsible clinician within a stated time, and the read-back, recipient name, and time are recorded.

Report elements: patient identifiers, unique specimen number, test name and units, reference interval, method or analyser, authorising practitioner, and interpretation where applicable.

Delta check rule: compare the current result with the patient's previous value; a change exceeding the defined threshold triggers specimen re-check before release.

Laboratory information systems must maintain an audit trail of result entry, amendment, and authorisation; amendments retain the original value and the reason for change.

Turnaround time is monitored from specimen receipt (or collection) to report authorisation, and is tracked as a quality indicator with defined targets.

Reference intervals must be verified for the local population and analyser; published intervals transferred without verification are a common accreditation finding.

Data protection rule: patient identifiable data is accessed on a need-to-know basis, and exports to portable media require encryption and documented authorisation.

ISO 15189 is the international standard for medical laboratories covering quality and competence; accreditation is granted by an authorised national body after assessment.

Internal audit cycle: plan the audit, check against standard and local procedures, record findings with evidence, issue corrective actions, and verify closure at a defined interval.

Nonconformity grading distinguishes critical (patient safety or invalid results) from major and minor findings; critical findings can suspend testing or accreditation.

Management review is held at defined intervals and covers quality indicators, audit results, complaints, EQA performance, resource needs, and improvement actions.

Quality indicators are measurable and trended, for example specimen rejection rate, report error rate, turnaround time compliance, and EQA performance score.

Risk assessment uses likelihood and severity scoring; high-risk processes receive more frequent monitoring and documented contingency plans.

Complaint handling requires logging, investigation, response to the complainant, and analysis of trends feeding into improvement, not just individual resolution.

Contingency planning covers analyser breakdown, power failure, and loss of information systems, with documented backup methods and a defined downtime reporting procedure.