ISO 15189:2022 Medical Laboratory Standards

ISO 15189:2022

• It's the fourth edition, released in 2022

Scope

• Specifies requirements for quality and competence in medical laboratories
• Applicable for developing management systems, assessing competence, and recognizing competence by various bodies
• Applies to point-of-care testing (POCT)

Normative References

• Documents whose content is essential for implementing the standard
• ISO/IEC Guide 99:2007: Terminology for metrology
• ISO/IEC 17000:2020: Conformity assessment vocabulary
• ISO/IEC 17025:2017: Testing and calibration laboratories competence

Terms and Definitions

• Terms and definitions are per ISO/IEC Guide 99, ISO/IEC 17000, plus the following:
• Bias: Systematic measurement error estimate applicable to quantitative measurements
• Biological Reference Interval: Distribution of values from a biological reference population, typically the central 95%
• Clinical Decision Limit: Examination result indicating higher risk/diagnostic for a specific disease
• Commutability: Agreement closeness between measurement results for a material using two procedures and other materials
• Competence: Demonstrated ability to apply knowledge and skills to achieve intended results
• Complaint: Dissatisfaction expression requiring a response
• Consultant: Professional expert advisor
• Examination: Operations set to determine value/characteristics of a property
• Examination Procedure: Operation set to perform an examination according to a method
• EQA External Quality Assessment: Performance evaluation via interlaboratory comparisons
• Impartiality: Objectivity in medical laboratory tasks
• Interlaboratory Comparison: Measurement/examination organization, performance, and evaluation on similar materials by independent laboratories
• Internal Quality Control (IQC): Monitors testing process, verifying system correctness and results reliability
• IVD Medical Device: Device for in vitro examination of human-derived specimens
• Laboratory Management: Person(s) responsible for and with authority over a laboratory
• Laboratory User: Person/entity requesting medical laboratory services incl. patients, clinicians
• Management Systems: Interrelated elements to establish policies, objectives, and processes
• Measurement Accuracy: Closeness of measured quantity value to true quantity value
• Measurement Uncertainty (MU): Parameter characterizing the values dispersion attributed to a measurements
• Medical Laboratory: Entity for the examination of human-derived materials for healthcare purposes
• Patient: Material source for an examination
• Point-of-Care Testing (POCT): Examination performed near/at patient site
• Post-Examination Processes: Processes after examination incl. results review, reporting, and storage
• Pre-Examination Processes: Processes from user's request to when examination begins
• Primary Sample/Specimen: Body fluid/tissue taken for examination
• Quality Indicator: Measure of meeting requirements
• Referral Laboratory: External laboratory for sample/data submission for examination
• Sample: One or more parts taken from a primary sample
• Trueness: Closeness of agreement between the average of infinite number of replicate measured quantity values and a reference quantity value
• Turnaround Time: Time between two specified points that include pre-examination, examination, and post-examination processes
• Validation: Confirmation of plausibility through objective evidence

General Requirements

Impartiality

• Labs must be managed to safeguard impartiality.
• The laboratory is responsible for the impartiality of its work and shall not allow any pressures to compromise it
• They should monitor any threat to impartiality, and address effect if identified

Confidentiality

• Legal agreements must ensure the proper management of patient information.
• Management includes privacy and confidentiality
• Patient/user must be informed and agree in advance about any information placed in the public domain.
• Employees must keep confidential all information acquired during laboratory activities

Requirements Regarding Patients

• Lab management needs to ensure well-being, rights, and safety of patients.
• The lab must allow the patients to give helpful information for the method and test selection
• A readily available information should be available including prices and waiting times
• Examination reviews must be in place to ensure the examinations are clinically necessary

Structural and Governance Requirements

General

• Labs or their parent organization must be a legally responsible entity for its activities
• Government labs are recognized if it falls under their government status

Laboratory Director

• Must direct the lab with qualifications, delegated authority, and competence to fulfill the document requirements
• Must implement a management system and apply risk management to improve patient care
• Selected duties can be delegated to qualified personnel, but the overall responsibility remains with the lab director

Laboratory Activities

• Activities must be specified and documented, including those outside the main location
• Conformance must align with document requirements, users, regulatory authorities, and recognition organizations
• Appropriate laboratory advice must be available and meet the needs of both user and patient
• Communication arrangement is necessary with the lab users for advising on sample and examination types, limitations, and frequency, also include professional judgements, effective utilisation, and instances of failures

Structure and Authority

• The organization and structure must be defined along with management and all its interrelationships
• The duties, responsibilities and authority must be defined for all relevant parties

Quality Management

• Personnel must have the authority and resources needed to carry out their duties
• Implementation, maintenance and improvement of the management system must be undertaken, along with reporting and identification of fault and deviations

Objectives and Policies

• Must be established and maintained to meet the various organizational needs and commit to professional practice
• Must fulfil the intended use and conform to all documentation
• Policies must be measurable and consistent, aligned at all levels of the lab, and provide the highest integrity

Risk management

• Processes should be established for identifying any harm to patients and improve patient care
• Actions should be developed to address risks and opportunities in a way that is measurable and safe

Resource Requirements

General

• The lab must have the relevant and necessary personnel, equipment, amenities, reagents and consumables to properly perform all activities

Personnel

• Labs must have access to a sufficient number of competent personnel
• All members in the lab should act impartially and in alignment to the ethical principles of the management system
• The lab should share any changes and updates to personnel.
• Each member must know their organization terms, employment conditions, safety requirements, and occupational services

Competence Requirements

• The required competence must be specified for each role in the lab
• Each should have the relevant skills to work in their role
• Labs require a managing for the competence of all personnel, that includes requirements for frequency of assessment
• Documented information is required that demonstrates competence and all competencies of each member

Authorization

• The laboratory ought to approve faculty to perform specific research facility activities that involve choice, modification, validation, and development
• Review, release, and all data reporting
• Laboratory information is used in everything, including data accessing