Analysis Quality Assurance

Without a
Laboratory
Quality System -
too many mistakes
can make analysis
costs of analysis
very costly; due to
expenses caused by wrong decisions, or
repeating analysis of samples
investigation of problems
revision of procedures
loss of good reputation
Prevention is Better than
cure!
‘It costs less to prevent a problem
than it does to correct it’
A formal quality system in the
laboratory should prevent
mistakes by means of:

 quality assurance measures

 quality control of the analytical results
 thorough documentation of the system
 efficient maintenance of records
 regular audits of all aspects of the system
 QA and QC systems
Quality Control:
planned activities designed to provide a quality
product.

Quality Assurance:
planned activities designed to ensure that the
quality control activities are being properly
implemented.

(As defined by the Association of Official Analytical Chemists)

 QUALITY ASSURANCE (QA)
• The purpose of QA is the maintenance of the
overall quality of patient results
• All factors that effect the test results from the time
the test

Result accuracy
Clerical errors
Analytical errors
Assay repeat rates
5
The Quality Assurance Cycle

Patient/Client Prep
Sample Collection
Sample Transport
Reporting
•Data and Lab
Management
•Safety
•Customer
Service

Sample Receipt
and Accessioning
Record Keeping

Quality Control Personnel Competency

Testing Test Evaluations

6
 QA Systems

Quality Assurance measures apply to the

laboratory analytical work overall, which
includes;
 identifying the person having the overall
responsibility for quality

 having laboratory equipment calibrated

to recognised standards

 using reference materials

 joining proficiency testing schemes with

other laboratories doing similar tests
• The calibration function is the relation between
instrument signal(y) and conc. of analyte (x)
y=f(x)
or, x=f1(y)
• It is set of operations that establish the relationship
between values of quantities indicated by the
instrument
• Calibration function may be linear or curved graphically
• In automated clinical chemistry instruments , the relation
Between analyst conc. and signal is often very stable.

8
 Statistical Control of Analytical
Methods
• Statistics definitions :
- Mean, Mode, Median, Standard Deviation
- Coefficient of Variation (CV) is the ratio of the SD to the
average. It is a measure of relative precision expressed as
percentage

9
• It should be automatically generated for the
parameters chosen in a QC template

• Should be available for viewing by day, month, and

other fractions of the year

• Use limit criteria either calculated from the data, or

from user defined means and SDs

• Use red for data points that are outliers

10
 Quality systems -
control charts
A control chart is a means of ensuring
that the method remains in ‘control’ -
3.30
% Fat
continues to perform in accordance
with expectations. This usually
3.25 means that results from analysing
standards fall within + 2 standard
deviations of the accepted value
% fat

3.20

(within the blue lines on the chart).

3.15 Any results appearing outside the red
lines (+ 3 standard deviations)
3.10
indicate that the method is not longer
in control and requires investigation.
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date
 Use of QC Samples
Step change

Regular analysis of a single

control sample will identify a Bias
system in or out of control
Target value
conditions

Drift

In control

Daily QC data
 % Fat
3.30

QC systems 3.25

Quality control measures apply to

% fat
3.20

each analytical
test in the laboratory by
3.15

use of: 3.10

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date

Control chart
• reagent blanks;
• verified standard blind samples
solutions; replicate analyses;
• check samples (from and control charts
both within the lab
and from outside);
 Measurement
traceability

In an absolute sense, the ‘true’

value can be defined only as
being that value directly
traceable to the base system of SI
measurement (SI) or their unit
derivatives - ie: to national or Provides Transfers
international standards via an traceability accuracy
unbroken chain of Certified
comparisons reference material

Laboratory
working standard

Analytical method
 Measurement The Sample
traceability (2)
Analysed by
The SI units:
Kg, Metre, Mole Secondary method:
e.g. lab. method

Calibrated by
Primary methods
(often gravimetric)
Calibration Standards
e.g. AOAC, EPA
Method routinely
Certified by checked by
analysis

Certified Reference Materials
(CRMs - expensive, small
amounts, best accuracy, long life)
Secondary RMs
In-house QC materials
Periodically (fairly cheap, larger amounts,
checked
matrix matched, short life)
 Reference materials & check
samples

SAMPLES
SUPPLIED FOR
INTERNAL PROFICIENCY
QC SAMPLES TESTING

Internal QC samples An accredited

are prepared and laboratory has to prove
quantity values of its performance by
target components CERTIFIED REFERENCE routinely analysing
are checked against MATERIALS (CRMs) samples supplied by
CRMs an independent
laboratory
 Control of Preanalytical
Variables
Preanalytical variability is defined as errors which occur
when non-analytical factors change the conc. of analytes
• Test conducted- appropriate test should be requested &
performed
• Patient identification- labeling of specimen may be
improper; corrected by bar coding
• Turnaround time (TAT)-should be kept minimum
• Laboratory logs- entry of patient & test details in lab
registers & computers
• Transcription errors- a substantial risk of transcription
error exists from manual entry of data, even when
results are double checked; computerization reduces this
error
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 Control of Preanalytical
• Variables
Patient preparation- proper patient preparation is essential
to obtain meaningful test result
• Specimen collection- container, anticoagulant, time taken
to send specimen to lab, corrected by using vacutainer
tubes & collection of samples by lab personnel
• Specimen Transport- critical for some tests
• Specimen Separation, aliquoting- monitoring of the
performance of the centrifuge, container used for storage
• Personnel- variation fr person to person. Safety
precautions for all specimens. Throughput time to be
monitored on a weekly or monthly basis
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 Keeping track of the Lab. No. F7-002

samples

 Sample registration gives each

sample a unique lab number. Sample integrity

 The sample register records all

the information about the sample.

 Just like a sample’s passport, you

should not confuse any sample
with any other.

 The history of the sample should

be traceable throughout.
Samples recorded on receipt
Quality
Laboratory Quality System Quality Manual Admin 1.5.1.
Page 1 of 1
Amiable Laboratory
Issue No.

Manual Title of Section

Title Page
Issue Date
Issued by

QUALITY MANUAL
for
Amiable Laboratory
Benevolent Department
Well-intentioned Organisation
Usual Location

This Manual is issued under the authority of

A quality manual
defines the quality Issue Date ............................................................
system under Issue No. 3
which the Copy No. A Person
laboratory operates Holder
Head of Laboratory

Quality Manual - cover page

Quality
Laboratory Quality System - Quality manual Admin 1.5.1.
Index
Amiable Laboratory Page 1 of 2
Benevolent Department

Manual - Well-intentioned Organisation

Title of Section
Issue No. 3
Copy No.
Issue Date
contents (1) Index of Contents Issued by

Section Para. Content

No.

1 QUALITY POLICY

2 QUALITY SYSTEM
2.1 Aims and Form of Quality System
2.2 Quality Manual
2.3 Quality Management
2.4 Documentation

3 ORGANISATION AND MANAGEMENT

3.1 Organisation
3.2 Organisational Chart
3.3 Staff - Qualifications and Training
Quality Section Para. Content

4
No.
QUALITY AUDIT AND QUALITY SYSTEM

Manual - 4.1
4.2
REVIEW
Purpose
Responsibility

contents (2) 4.3 Implementation

5 EQUIPMENT
5.1 Calibration and Testing Equipment
5.2 Operation and Maintenance of Equipment
5.3 Equipment Records

6 MEASUREMENT TRACEABILITY AND

CALIBRATION
6.1 Policy
6.2 Uncertainty of Measurement
6.3 Calibration

- 7 METHODS AND PROCEDURES FOR TESTS

7.1 Policy and Scope
7.3 Documentation of Methods and Procedures
7.4 Integrity of Data
7.5 Uncertainty of Results
 Section Para Content

Quality 8
No.
LABORATORY ACCOMMODATION AND
ENVIRONMENT

Manual - 9
9.1
9.2
HANDLING OF TEST ITEMS
Receipt and Handling of Items
Identification of Items
contents (3) 10 RECORDS
11 TEST REPORTS
11.1 Use of the UKAS Accreditation Mark
11.2 Validity of Reports
12 HANDLING COMPLAINTS AND ANOMALIES
12.1 Policy
12.2 Procedures
13 SUB-CONTRACTING OF TESTS
13.1 Policy
13.2 Register
14 OUTSIDE SUPPORT SERVICES AND
SUPPLIES
14.1 Policy
14.2 Records
15 SITE SECURITY
15.1 Security of Laboratory Premises
 Factors influencing analytical variables
REAGENTS STABILITY, INTEGRITY AND
EFFICIENCY:
Stable, Efficient, Desired
PROFICIENCY OF PERSONNEL: EQUIPMENT RELIABILITY:
quality, Continuously available, Validated
Meet technical needs, Compatible, User
Education, Training, Aptitude, Com & maintenance friendly, Cost effective,
petence, Commitment, Adequate Validated
number, CME, Supervision, Motivati
on
SPECIFICITY & SENSITIVITY
OF SELECTED TEST:
USE OF APPROPRIATE Adequate ST, Sufficient
CONTROLS: SP, cost effective, compatible
• Internal: Labs, Calibrated against ANALYTICAL FACTORS with, available infrastructure
national and
• External: Supplied by manufacturer, expertise, interpretable, meet s
National, Internation al the needs/
objectives, validated

Assessment DOCUMENTATION: Procedural reliability

All the written using Standard
policies, plans, procedures, instructions and records, Operating Procedures
quality control procedures and recorded test results
involved in providing a service or the manufacture of a
product 35