Risk Management in NHS Laboratories – Quality Management System (Part 2)

FILL_IN_THE_BLANK flashcards covering key definitions, processes, roles, standards, quality control methods, auditing, incident management and performance monitoring within the laboratory Quality Management System.

Quality in the laboratory is defined as the __, reliability and timeliness of reported test results.

accuracy

A Quality Management System (QMS) is the set of __ activities to direct and control an organisation with regard to quality.

coordinated

Roughly __ % of all clinical diagnoses are influenced by laboratory data.

70

Ineffective quality management can lead to misdiagnosis, treatment delays, incorrect treatment, and __ testing.

additional

Quality Assurance is the part of the QMS that provides __ that all requirements are met.

confidence

Quality Control refers to the operational activities and __ used to fulfil the requirements for quality.

techniques

Within the laboratory, overall responsibility for quality rests with the __ Director / Clinical Services Manager.

Laboratory

The person who chairs Quality Team meetings and coordinates quality across departments is the __ Manager.

Quality

Pre-analytical, examination and __ phases make up the total testing process.

post-examination

ISO __:2022 is the international standard for medical laboratories.

15189

UKAS accreditation is the process by which laboratories demonstrate compliance with __ 15189.

ISO

Blood Safety and Quality Regulations (BSQR) 2005 are legally enforced in __ Banks.

Blood

The regulatory body that inspects Blood Banks for BSQR compliance is the __.

MHRA

Standard Operating Procedures, policies and risk assessments must all be controlled under the laboratory’s __ management system.

document

The electronic system widely used for document control and CAPA recording is called __.

Q-Pulse

Instrument records must include acceptance testing criteria and the date the equipment __ service.

entered

Internal Quality Control (IQC) uses third-party material containing a __ concentration of the analyte.

known

An IQC result is generally acceptable if it is within __ standard deviations of the target mean.

2

The statistical decision rules applied to IQC results in the lab are the __ Rules.

Westgard

Accuracy relates to closeness to the true value, whereas __ refers to reproducibility of results.

precision

Bubbles in reagents, damaged probes or poorly mixed IQC material are potential causes of __.

imprecision

External Quality Assurance (EQA) compares a laboratory’s results with a reference value and with other labs, providing retrospective assessment of accuracy, bias and __ of bias.

consistency

The ISO definition of an __ is ‘a systematic, independent and documented process for obtaining evidence and evaluating objectively the extent to which criteria are fulfilled’.

audit

An audit performed by laboratory staff on their own processes is called an __ audit.

internal

Following one sample through every stage of the testing process is known as a __ audit.

vertical

A __ audit focuses on a single aspect of the QMS, such as reagent management or competency records.

horizontal

Incidents and policy breaches are collectively termed __.

non-conformances

Non-conformances are logged in Q-Pulse within the __ (Corrective Action Preventive Action) module.

CAPA

Immediate response to an incident is recorded as the __ action.

remedial

The Swiss Cheese Model illustrates that major incidents occur when multiple __ align or fail.

defences

Laboratory contingency planning may involve sending samples to another laboratory when essential services such as __ supply fail.

water

Key Performance Indicators (KPIs) are measurable targets such as turnaround times, error rates and timely completion of __ and audits.

CAPAs