Transcript Accreditation of the Clinical Laboratory

Development and Implementation of a
Quality System
The Molecular Diagnostics Research Laboratory
University of Malaya
Yap SF
Department of Pathology
University of Malaya
Backbone of the Accreditation
Process
Standards of Laboratory Practice
Criteria against which all laboratories
are judged
Requirements for Laboratory Accreditation
CAP Checklist 1992






Planned and systemic QAP
QAP in effect at sectional level
Documentation, monitoring, evaluation of QA
indicators in each section at all shifts
Monitoring & evaluation efforts documented,
reported with appropriate actions
Annual internal appraisal of QAP to assess all
elements of the QAP
Laboratory director and all professional staff must
participate in the QA activities
Standards and Guidelines
CPA
A set of 6 standards (A-F)
 Organisation and administration
 Staffing and direction
 Facilities and equipment
 Policies and procedures
 Staff development and education
 Evaluation
Standards and Guidelines
ISO/IEC 17025
“General requirements for competence of testing and
calibration laboratories”
 Released 2/2000
 Replaces ISO/IEC guide 25
 Encompasses :
“Management System Requirements”
“Technical Requirements”
 Internationally recognised basic document for accreditation
of laboratories

Structure of ISO/IEC 17025
Section 1 : Organisation and Management
ISO 9000 like
Quality Management
Section 2 : Technical Requirements
New Elements : Control of non-conforming tests
Measurement of uncertainty
Verification of standard methods
Plan for introduction of analytical
methods
Key Elements of ISO/IEC 17025









Internal QC
Participation in external QAS
Working procedures or Standard Operating
Procedures (SOPs)
Use of traceable standard reference materials
Instrument maintenance and calibration
Validated methods
Report of measurement uncertainty
Qualified personnel
Records and reports
Standards and Guidelines
ISO/DIS 15189





“Quality Management in the Medical Laboratory”
Drafted by technical committee ISO/TC 212
For clinical laboratory testing
Provides requirements relevant to “quality
management” of medical laboratories
Encompasses :
“Management System Requirements”
“Resources and Technical Requirements”
Guideline on Development of a Quality
System
NCCLS doc GP26A

A quality system model for healthcare
 Consistent with requirements of the ISO guide for
quality standards
 Applicable to any service in a healthcare
organisation
 Based on the application of a list of quality system
essentials (QSE) applied to ALL operations in the
workflow path
Quality System Elements
Organisation
Personnel
Equipment
Process Control
Documents and Records
Purchase and Inventory
Internal Assessment
Process Improvement
Occurrence Management
Service and Satisfaction
Quality System Management
Requirements





A Management Policy and System
Standardisation of Procedures
Documentation of :
- Quality Policies
- Management Procedures
- Operational Procedures
Internal Audits
External Assessment
Implementation
The Initial Phase
1. Development of a quality manual (QSE : Organisation)
2. Development of Process Control (QSE : Process
Control)
a) Analysis and validation of processes
b) Development of SOPs
c) Implementation of process control checks
3. Development of a management system for documents
& records (QSE : Document Control)
Development of Processes and
Procedures
1.
2.
3.
4.
Staff training & competence testing (QSE : Personnel)
Equipment management (QSE : Equipment)
Purchase and inventory (QSE : Purchase and inventory)
Control of non-conforming product (QSE : Occurrence
Management)
5. Internal quality indicators and audit (QSE : Internal
Assessment)
6. Process improvement (QSE : Process Improvement)
7. Monitoring of service & customer satisfaction (QSE :
Service and Satisfaction)
Development of Process Controls
1.
2.
3.
4.
Process analysis
Process validation
Preparation of SOPs
Implementation of process controls
QC programme
PT programme
Occurrence log
Development & use of quality indicators
Equipment Management Plan
1. Verification of functional status
2. Determination & documentation of
schedule for service and calibration
3. Preparation of procedure manuals
4. Implementation of instrument logs
5. Prepare inventory
6. Appointment of equipment management
officer
Personnel Orientation, Training and
Education
1. Orientation of new staff
2. Initial instruction & training
Laboratory safety
General laboratory procedures
Quality laboratory practices
3. Continuous education and competence
monitoring
4. Documentation of training and education
People Qualification

Analytical Technique

Instrument Operation

Result Interpretation

Basic Troubleshooting

Regulations and Quality Standard
Requirements
The 10 Step Implementation Plan
Where are we?

Develop & implement quality system
 Develop SOPs
 Develop organisation infrastructure (including roles
and responsibilities)
 Train people
 Validate equipment
 Validate analytical procedures
 Develop program to use certified reference materials
 Develop quality assessment schemes
 Develop internal audit program
 Develop procedures for recording & archiving
What is Quality?
A word widely used and apparently well-understood but
seldom defined
Crosby “ Quality has much in common with sex”
Everyone is for it (Under certain conditions, of course)
Everyone feels they understand it (Even though they
wouldn’t want to explain it)
Everyone thinks execution is only a matter of following
natural inclination (After all, we do get along somehow)
And of course most people feel that all problems in these
areas are caused by other people (If only they would take
time to do things right)
Quality Laboratory Processes (QLP) and
Quality Control (QC)

QLP : Good processes, procedures and people

QC : Control of products and processes

QLP and QC can be grouped into 3 areas :
Pre-analytical
Analytical
Post-analytical
Quality Requirements
The Medical Laboratory Perspective







Staff – qualification, training, experience and
competence
Facilities – adequate and appropriate
Test menu – repertoire, medical usefulness
Support – specimen acquisition, transportation,
processing, storage
Analysis – appropriate analytical quality
Service – fit demand for use, meet needs for TAT
Communication – mechanism effective
A Comprehensive QAP for the Clinical
Laboratory






Design control : facility, staffing, analysis
Raw material control : standards, controls, reagents,
instruments and equipments, samples, personnel
Process control : internal (calibrate and control processes)
& external (monitor proficiency)
Output control : result and medical significance
Reliability control : test utilisation and patient
needs/outcome
Verification control : inspection, accreditation, productivity,
cost analysis
Quality System Elements








(Standard) Operating Procedures
Method validation
Instrument validation, calibration, maintenance
Documentation of tasks and procedures
Personnel qualification
Use of qualified reference material
Internal audits
Records
Accreditation Bodies





College of Pathologists (CAP) LAP, USA
Joint Commission on Accreditation of Hospitals
(JCAHO), USA
Clinical Pathology Accreditation (CPA), UK Ltd
National Association of Testing Authorities
(NATA), Australia
Department of Standards (DSM) Malaysia –
“SAMM”