Malaysia Standard ISO 15189:2014

Technical Requirements for Quality and Competence for Medical Laboratory

1. Personnel

2. Accommodation and Environmental conditions

3. Laboratory Equipment, Reagent, and Consumables

4. Pre-examination Processes

5. Examination Processes

6. Ensuring Quality of Results

7. Post-examination Process

8. Reporting of Results

9. Release of Results

10. Laboratory Information Management

Outlines for Technical Requirements

Organizational Plan

Qualification

Appropriate education, training, experiences, and skills needed.

Job Descriptions – Duties

Orientations

Introduction of organization, department/area, terms and conditions of employment, facilities, health & safety.

5.1 Personnel

Training – Quality assurance and Quality Management

Authorization to perform particular tasks

Pre-analytical

Analytical

Post-analytical

Competence assessment

Personnel for making judgments/opinions/interpretation etc must be appropriately qualified and experienced.

5.1 Personnel

Reviews of Performance – Competence Reassessment

Periodically conducted

Continuing Education – CME

Confidentiality of Patients

Not influenced by internal or external pressures.

Records Everything!!!!!

5.1 Personnel

Laboratory and Office Facilities

Suitable, sufficient and safe.

Not affected for quality works

Efficient communication

Organized effectively for incompatible activities

Protected from recognized hazards.

Sufficient facilities (electricity, water, ventilation, waste disposal….)

5.2 Accommodation and Environment

From: Director

To: Quality Manager

On Friday Evening at 5pm, Haley’s Comet will be visible in this area, an event which occur every 75 years. Please have employees to assemble in the yard and I’ll explain this rare phenomenon to them. In case of rain we will not be able to see anything so assemble them in the training room and I will show them a documentation film of it.

Communication Distortion

From: Quality Manager

To: Operational Manager

By the order of the director on Friday at 5pm Haley’s Comet will appear above the yard. If it rains please assemble employees and proceed to the training room where this rare phenomenon ill take place, something which occurs every 75 years.

Communication Distortion

From: Operational manager

To: LISCOM

By order of the Director at 5pm on Friday the phenomenal Haley’s Comet will appear in the training room. In case of rain in the yard, the Director will give another order, something which occurs every 75 years.

Communication Distortion

From: LISCOM

To: HODs

On Friday at 5pm the Director will appear in the training room with Haley’s Comet, something which happens every 75 years. If it rains the director will order the Comet into the yard.

Communication Distortion

From: HODs

To: All MLTs

When it rains on Friday at 5pm the phenomenal 75 years old Bill Haley, accompanied by the Director, will drive his Comet through the yard to the training room.

Communication Distortion

Storage Facilities – Documents, Consumables, Supplies

Clean and well maintained.

Appropriate storages for dangerous materials

5.2 Accommodation and Environment

Qualified for :

Fitness of purpose

Meeting quality specification

Documented maintenance plan/program/calibration/metrological traceability

Uniquely labeled

Verified upon installation

5.3 Laboratory Equipment

Only operated by authorized personnel

Machine breakdown

Records!!!!

Identity

Contacts

Dates

Operator’s Manual

Performances

5.3 Laboratory Equipment

Information for users or patients

Special preparation for certain tests

Request Form

Unique ID, details, test required, relevant clinical information, date and time of collection……

Specimen collection, storage, transportation

Sample receptions

Acceptance/Rejection criteria

Records!!!!!

5.4 Pre-Examination Processes

Test Methods

Meet the needs

Published/established methods

Verified/validated before use

Method verification vs Method validation

Measurement of Uncertainty

Qualitative results vs Qualitative results

Biological Reference Intervals

5.5 Examination Processes

Records!!!! (Technical Procedures) Principle of Test

Type of acceptable specimens

QC requirement

Calibration

Safety control

Result interpretation

Limitation

Revise annually/as-needed

Common language

Must be controlled

5.5 Examination Processes

Design of IQC plan

“The laboratory shall design QC procedures that verify the attainment of the intended quality of results”

Quality Specification, Medical Decision Levels.

Eliminating mistakes

Materials/Data

5.6 Ensuring the Quality

External Quality Assurance

Alternative approaches

Records!!!!

5.6 Ensuring the Quality

Reviews of Results

IQC, Clinical Information, previous results

Sample storage after analysis

5.7 Post-Examination Processess

Report to be received by appropriate persons

Within the reports :

Accurate, clearly and unambiguously

Clear identification of person who authorizing, checking and releasing

Comments on sample quality, critical results, interpretations.

5.8 Reporting of Results

Documented procedures for releasing the results.

Who can, who to.

Compromised results

Due to primary specimens (type, quality)

5.9 Release of Results

Confidentiality

Authorization

Responsibilities Patient info

Results Enter

Results Amendment

Release results and reports

5.10 Laboratory Information System

Epilogue

Right Sample From the

Right patient At the

Right Time Using the

Right container

Right Result For

Right Test

Right Report Given at

Right Time To

Right Patient