QUALITY

SYSTEMS IN
CHEMICAL
LABORATORIES
Chapter 8

What Is Quality?
The ability of a product or service to satisfy
stated or implied needs of a specific
customer
Achieved by conforming to established
requirements and standards.

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Definition of A Lab Quality

System

The organizational structure,

responsibilities, processes, procedures,
and resources for implementing quality
management of the laboratory or
testing site.

In other words all activities which

contribute to quality of tests, directly or
indirectly.

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Benefits of a Quality System

Monitors all parts of the testing
system
Detect and reduce errors
Improve consistency between testing
sites
Help contain costs

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The Lab Quality System

Organization

Purchasing &
Inventory

Personnel

Process
Control
Quality Control &
Specimen Management

Equipment

Information
Management

Documents &
Records

Occurrence
Management

Assessment

Process Improvement

Customer Service

Facilities & Safety

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Organization

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Quality policy
& standards

Sufficient
resources

Clearly defined
roles
& accountability

A culture
committed
to quality

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Personnel
Human resource
planning

Training

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Hiring

Retention

Supervision

Performance
management

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Equipment

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Selection

Acquisition

Installation &
initial calibration

Maintenance,
service & repair

Troubleshooting

Disposition

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Purchasing and Inventory

Procurement

Receiving

Inventory
management

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Storage

Record
keeping

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Process Control
Standard
operating
procedures

Specimen
management

Quality
control

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Documents and Records

Standardized
forms

Document
approval

Document
storage/retrieval

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Document
distribution

Document
destruction

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Information Management

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Information
flow

Data collection
& management

Patient privacy &

confidentiality

Computer
skills

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Occurrence Management

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Written
procedures for
addressing errors

Corrective
actions

Occurrence
records

Occurrence
reporting

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Assessment
External
Quality
Assessment

Improvement
measures

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Internal audit
or self
evaluation

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Process Improvement
On-going
data
collection

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Improvement
measures

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Customer Service
Monitoring
Customer
satisfaction

Process
improvement

Rewards

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Facilities and Safety

Testing and
storage
areas

Safety practice

Safety
procedures
& records

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Who Is Responsible for

Quality?
EVERYONE!

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Laboratory
management and
program staff establish
quality assurance
procedures.
Test site personnel
implement the quality
assurance procedures.

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Quality Assurance vs. Quality

Control
Quality
Assurance
Activities to ensure
process are
Definition adequate for a
system to achieve its
objectives
Establish standard
procedures for
sample collection
Examples Define criteria for
acceptable samples

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Quality
Control
Activities to evaluate
a product or work
result
Analyze known QC

sample to
determine if a test
is valid
Decide if a sample
is acceptable for
testing

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 Process or system for monitoring the quality of

laboratory testing, and the accuracy and
precision of results
Routinely collect and analyze data from every
test run or procedure
Allows for immediate corrective action

Designing a QC Program
Establish written policies and procedures
Corrective action procedures

Train all staff

Design forms
Assure complete documentation and
review

Qualitative vs.Quantitative
Quantitative test
measures the amount of a substance present

Qualitative test
determines whether the substance being
tested for is present or absent

The Quality Assurance Cycle

Patient/Client Prep
Sample Collection
Reporting

Personnel Competency
Test Evaluations

Data and Lab

Management
Safety
Customer
Service
Sample Receipt
and Accessioning

Record Keeping
Quality Control

Sample Transport

Testing

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Why Do Errors Occur?

Some causes include:
Individual responsibilities unclear
No written procedures
Written procedures not followed
Training is not done or not completed
Checks not done for transcription errors
Test kits not stored properly
QC, EQA not performed
Equipment not properly maintained
Errors can occur throughout the testing process
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Pre-testing Errors
Examples include:
Specimen mislabeled or unlabeled
Specimen stored inappropriately before
testing
Specimen transported inappropriately
Test kits stored inappropriately

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Preventing and Detecting Errors

Before Testing

Check storage and room temperature

Select an appropriate testing workspace
Check inventory and expiration dates
Review testing procedures
Record pertinent information, and label
test device
Collect appropriate specimen

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Testing Errors
Examples include:
Country algorithm not followed
Incorrect timing of test
Results reported when control results invalid
Improper measurements of specimen or
reagents
Reagents stored inappropriately or used after
expiration date
Dilution and pipetting errors
Incorrect reagents used
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Preventing and Detecting Errors

During Testing
Perform and review Quality Control (QC)
Follow safety precautions
Conduct test according to written
procedures
Correctly interpret test results

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Post-testing Errors
Examples include:
Transcription error in reporting
Report illegible
Report sent to the wrong location
Information system not maintained

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Preventing and Detecting Errors

After testing
Re-check patient/client identifier
Write legibly
Clean up and dispose of contaminated
waste
Package EQA specimens for re-testing, if
needed

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Why is Quality System

Important?
Ensures that quality is the foundation of
everything we do
Sets the standard for level of quality
Meets/exceeds customer expectations
Provides means to prevent, detect and correct
problems
Becomes the core of a monitoring, evaluation, &
improvement system
Reduces costs

Even the simplest Rapid Test is not foolproof

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