Activity Details

Course Overview

Medical laboratory services are essential to patient care and therefore must meet the needs of all patients and the clinical personnel responsible for their care.

To help achieve this, ISO 15189:2012 Medical laboratories - Requirements for quality and competence to specify  the needs for quality and competence within medical laboratories.

ISO 15189:2012 can be applied by medical laboratories to develop their quality management systems whilst assessing their own competence. It can also be used for recognizing the proficiency of medical laboratories by customers, regulating authorities and accreditation bodies.

ISO 15189:2012 is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines such as clinical physiology, medical imaging and medical physics may also find it useful. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities.

• ISO 15189 specifies the quality management system requirements particular to medical laboratories
• ISO 15189 standards based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories.
• ISO 15189 advises the users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff.

Expected outputs:

By the end of the course, each participant is expected to be able to:

• Identify their overall approach to the audit, how they will ensure that all areas of the laboratory and the Standard have been adequately addressed.
• Prepare checklists as a tactical tool allowing the auditor to plan the gathering of information.
• Use different questioning techniques, the examination of data and reasoning skills in order to achieve a realistic conclusion Judge effectiveness of corrective action

Course ouatines :

First day (Management requirements)

·         Notions of the policies considerations (Definition and objectives)

·         Notions of the Process (Definition, 5M rules, indicators)

·         Wheel of Deming (PDCA, application for the standard 15189, for audit, supply, …)

·         Management system of the quality (definition, interest)

·         Corrective actions and nonconformities (recording, control)

·         Preventive actions (recording, control)

·         Complaints customers

·         Advisory services (in pre – examination and post examination processes)

·         External services and supplies

·         Review of contracts

·         Management review

·         Documentary system (quality handbook, procedures, instructions, recordings)

Pre – examination processes

·         Information of the patients

·         Methods of taking samples

·         Transport of samples

·         Reception of samples and check of the identity and the state of samples

·         Notion of confidentiality

·         Advisory services

·         Documentary system of this stage

Second day (Technical requirements)

Personnel

·         Recruitment

·         In – service training and evaluation

·         Authorization, competency and evaluation

·         Organization chart

·         Function, post and task

·         Procedure of the human resources

·         Authorized staff in particular tasks

·         Staff referent

Workstation

·         Location of the equipment

·         Environmental conditions (temperature, pressure)

·         Preservation of reagents (temperature of refrigerators and freezers)

·         Hygiene and safety

·         Conformity of the samples

·         Access in nonconformities pre – examinations

·         Preservation of samples (place, temperature, duration)

·         Authorization of the staff, training, schedule

·         Couple automaton – technique (identification, serial number, after - sales services,…)

·         Measures in case of dysfunction

·         Validation of the methods, uncertainty, correlation between two automatons

·         Traceability, lot number, last date of use

·         Method, standard, linearity, limit of detection

Validation of the methods

·         Identification of the method

·         Bibliographical search

·         Search for known specifications, definition of the expected performances

·         Characteristics to be validated: Repeatability, reproducibility, correctness, interval of measure, uncertainty, linearity, contamination, stability of reagents, robustness, interferences, reference interval, comparison of methods, conflicts

·         Control of the risk (HACCP system)

Metrology

·         Temperature

·         Volume

·         Weight

Laboratory information system (LIS)

Third day (Audit)

Definitions (Audit, criteria, Proofs, observation,…), objectives, standard 19011

Interest of the audit: Relationship between the system and

·         The strategic capacities

·         The standard Iso 15189

·         Requirements of the management system of the quality

The bases of the audit: Requirements in a relationship with

·         Procedures, instructions, …

·         Policy of the laboratory

·         The quality management (part 4 of the standard)

·         The technical requirements (part 5 of the standard)

·         The 8 principles to direct our reflection

Exercise of the audit

Laboratory requester mandate

Documentary analysis

Audit plan, general organization,

PDCA

Organize the criteria of audit

Realize the audit

·         Meeting of opening

·         Collection of the proofs

·         Formulation of reports

·         Meeting of close

·         Follow – up of the actions after the audit

Attitude of the auditor

·         Benevolence

·         Neutrality

·         Fairness

 The course will be enriched with examples, workshops and case studies.

Participants:

·         Lead Auditors working with Accreditation Bodies

·         Internal auditors in medical laboratories