QUALITY CONTROL IN CLINICAL

LABORATORY

Moderator : Prof.Th.I.Devi
Speaker : Dr.Gomi Basar
Date & Time : 13th September 2013 @ 10.30 am
Department of Biochemistry, RIMS, Imphal
 Overview

Definition of Quality
Introduction to Quality Control
Fundamentals of Quality Management
Total Quality Management
Quality System And Assessment
Quality Control & Implementations
External Quality Control
New Quality Initiatives

2
 Quality ?
sum-total of all the characteristics
of a product/service that has a
bearing upon the utilization of the
product/service to the entire
satisfaction of the consumer

Conformance to the requirements of users

1) Acceptable
or customers and the satisfaction of their 2) Accessible
needs and expectations
3) Affordable
4) Appropriate
3
 Quality is....

invisible when GOOD

impossible to ignore when

BAD

4
 Introduction
The issue of laboratory quality has evolved over more than
4 decades since the 1st recommendation for quality control
were published in 1965

Now, quality control is seen as only one part of a total

laboratory control program

Quality also includes:

a) Total Quality Management (TQM) an activity to
improve pt. care by having the lab monitor, its work to
detect deficiencies & subsequently correct them
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 b) Continuous Quality Improvement (CQI) or
Performance Improvement (PI) to improve the pt. care
by placing the emphasis on not to make mistakes in the
first place

c) Quality Assurance (QA) external activities that

ensure positive pt. outcomes. It measures what a lab can
do to improve reliability

6
 Fundamentals of Quality Management

Principles of Quality management, assurance, and control

have become the foundation by which clinical laboratories
are managed and operated
Total Quality Management of clinical Laboratory
Control of pre-analytical variables
Control of analytical variables
External quality assessment & Proficiency testing
programs
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 Total Quality Management

TQM also referred to as :

total quality control (QC), total quality leadership,
continuous quality improvement, quality management
science or industrial quality management
Quality systems in healthcare organization is evolving
Public & Private pressure to contain costs are now
accompanied by pressure for quality improvement (QI)
TQM provides management philosophy for
organizational development & a management process for
improvement of quality in all aspects of work
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 Concepts of TQM
The Universal principles of TQM are
(1) Customer focus
(2) Management commitment
(3) Training
(4) Process capability & control
(5) Measurement using quality-improvement tools
Costs must be understood in the context of quality
Quality = conformance to requirements
Quality costs =Costs of conformance + Costs of non

conformance 9
 Quality Costs

Costs of Costs of
Conformance Nonconformance

Prevention Appraisal Internal External

Costs Costs failure Costs failure Costs

Examples: Examples: Examples: Examples:

Training Inspection Scrap Complaints
Calibration Quality control Rework Service
Maintenance Repeat runs Repeat request

Understanding of quality & cost leads to a new perspective of relationship b/n

these two concepts:
Improvement in quality lead to reduction in costs
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 Methodology
Quality improvement occurs when problems are eliminated
permanently
Quality problems are primarily management problems
because only management has the power to change work
process
TQM views the organization as a support structure rather
than a command structure
Most immediate processes required for the delivery of
services are those of the frontline employees
Senior managements role is to support the frontline
employees & empower them
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12
 Implementing TQM
QLPs - include analytical processes & the general policies ,
practices, and procedures that define how all aspects of the
work are done
QC- emphasizes statistical control procedures, but also
includes nonstatistical check procedures
QA- concerned primarily with broader measures &
monitors of lab performance (turnaround time, specimen
identification, patient identification, test utility)
QI- a structured problem solving process to help identify
the root cause of a problem & a remedy for that problem
QP- provides the planning steps
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 These five components, which work together in a feedback loop,
illustrate how continuous QI is accomplished and quality assurance is
built into laboratory process

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 Five Q framework also defines how quality is managed
objectively with the scientific method, or the PDCA cycle

QP-provides the planning step, QLP- establishes standard processes, QC & QA provide
measures for checks and QI provides a mechanism through which to act on those
measures
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 TQM is also considered as a quality system that is
implemented to ensure quality
QS- set of key quality elements that must be in place for
an organizations work operations to function in a manner
to meet the organizations stated quality objectives

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 Quality Systems

The main objective of a laboratory is to

provide reliable, timely and accurate test
results. This is only possible through
consistent monitoring and evaluation of the
laboratorys performance
the implementation and follow-up of corrective
actions for non-conformance to procedure

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 Quality Systems

A reputation based on 10,000 good quality results is

damaged by 1 poor quality result
The establishment of robust testing systems is
essential to the success of laboratory services and
the treatment program
The establishment and continuous monitoring of
quality systems in each testing laboratory is required
for reliable and robust testing

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 Quality Systems

Provide the assurance of the quality of the test

results
Ensure that the lab operations are coordinated,
organised and standardised
Are tools to monitor performance

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QUALITY: A DEGREE OF EXCELLENCE

QUALITY CONTROL (INTER.)

+
QUALITY ASSESSMENT (EXTR.)

QUALITY ASSURANCE

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 Quality Procedures

Internal Quality Control (IQC)

includes personnel, instrumentation, document
control, reagent control and corrective action
External Quality Assurance (EQA)
External quality control is important to ensure
the laboratory is performing to an external
standard

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 Assessment of Quality System

Man-driven Material-driven

Audit, On-site Quality Assessment

inspection
Internal
Internal External

External Schematic way:

External Quality
Accrditation Assessment
Scheme (EQAS)

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 QC v/s QA

Quality Control -QC refers to operational

techniques that must be included during each
assay run to verify that the requirements for
Quality are met with
Quality Assurance - QA refers to all those planned
and systematic activities to provide confidence
that the results given out by the laboratory are
correct
The aim of QC is simply to ensure that the results generated by the
test are correct. However quality assurance is concerned with much
more: that the right test is carried out on the right specimen and that
the right result and right interpretation is delivered to the right person
at the right time
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 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

Pre-analytic Analytic Post-analytic

Specimen collection Result accuracy Result reporting

Clerical errors Record keeping for
Specimen transport
Analytical errors
Specimen quality Assay repeat rates patient and QC
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 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

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Quality Control & Implementation
 Quality control

Quality control is a vital part of quality assurance

All labs benefit from quality control in terms of confidence in
and reproducibility of test results
Recording and monitoring test variables such as
temperature, reagents, controls and equipment
function allows one to look objectively and
retrospectively at parameters vital to the accuracy and
precision of the test
Documentation allows one to foresee a potential
problem before the situation requires corrective action
and adversely effects patient results
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Quality in labs is mutual responsibility of..

Laboratory specialists
Clinicians
Public health physicians

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 Objectives of quality in lab

Support provision of high quality health-care

Reduce morbidity
Reduce mortality
Reduce economic loss
Ensure credibility of lab
Generate confidence in lab results

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 Consequences of poor quality
Inappropriate action
Over-investigation
Over-treatment
Mistreatment
Inappropriate inaction
Lack of investigation
No treatment
Delayed action
Loss of credibility of laboratory
Legal action

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 How to implement a QC program?
Establish written policies and procedures

Assign responsibility for monitoring and reviewing

Train staff

Obtain control materials

Collect data

Set target values (mean, SD)

Establish control charts, Eg- Levey-Jennings charts

Routinely plot control data

Establish and implement troubleshooting and corrective action

protocols

Establish and maintain system for documentation

 Hurdles in Quality Control
Accurate & timely test report are the responsibility of the
laboratory
Total testing process must be managed properly in the
preanalytical, analytical, and postanalytical places

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 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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 Factors influencing analytical variables
REAGENTS STABILITY, INTEGRITY AND
EFFICIENCY:
PROFICIENCY OF PERSONNEL: Stable, Efficient, Desired quality,
Continuously available, Validated EQUIPMENT RELIABILITY:
Education, Training, Aptitude, Meet technical needs, Compatible, User
Competence, Commitment, & maintenance friendly, Cost effective,
Adequate number, CME, Validated
Supervision, Motivation

SPECIFICITY & SENSITIVITY

OF SELECTED TEST:
USE OF APPROPRIATE Adequate ST, Sufficient SP,
CONTROLS: cost effective, compatible
Internal: Labs, Calibrated against
ANALYTICAL FACTORS with, available infrastructure
national and expertise, interpretable,
External: Supplied by meets the needs/ objectives,
manufacturer, National, validated
International

Assessment DOCUMENTATION: Procedural

All the written policies, plans, procedures, reliability using
instructions and records, quality control Standard Operating
procedures and recorded test results involved Procedures
in providing a service or the manufacture of a
product 35
 Control of Analytical Variables
Analytical variables must be controlled carefully to ensure
accurate measurements by analytical methods
Reliable analytical methods are obtained through careful
process of :
(1) Selection
(2) Evaluation
(3) Implementation
(4) Maintenance
(5) Control
Clear concepts in relation to Analytical methods-
Calibration, trueness, accuracy, precision, linearity, & limit
of detection 36
 Calibration
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
and the corresponding values realized by measurement
standards
Calibration function may be linear or curved graphically
In automated clinical chemistry instruments , the relation
b/n analyte conc. and signal is often very stable
In traditional chromatography (HPLC), it is customary to
calibrate each analytical run 37
 Trueness

Trueness of measurements- closeness of agreement b/n

the average value obtained from a large series of results of
measurements and a true value
True value- The known, accepted value of a quantifiable
property
Bias- The difference b/n average value & the true value
Measured value- Result of an individuals measurement of
a quantifiable property

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 Accuracy

Accuracy- the closeness of the agreement b/n

the result of a measurement & a true conc. of
the analyte

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 Precision

Precision- closeness of agreement b/n independent

results of measurements obtained under stipulated
conditions
It is the dispersion of replicate measurements
Inter-assay with multiple runs
Intra-assay: within a run

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 Precision
Repeatability (within same run)
Reproducibility or closeness of results to each other
performed under changed conditions of measurement
(time,operator,calibrators, reagent lots)
Measured by the standard deviation or coefficient of
variation
Std. dev ()/mean(X) x 100 = % C.V.

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 Reliability

The ability to maintain both precision and accuracy

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 Linearity
Linearity refers to the relationship between measured &
expected values over the analytical measurement range
May be considered in relation to actual or relative analyte
concentration
Evaluated by plotting measured& expected conc., F-test,
regression analysis of test run
Testing of linearity is related to assessment of trueness over
the analytical measurement range
The presence of linearity is a prerequisite for a high degree
of trueness

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 Limit of Detection & Quantification
Limit of blank (LoB): highest measurement result that is
likely to be observed for a blank sample
Limit of Detection (LoD): lowest concentration of
measurand that can be consistently detected in 95% of
samples tested under routine laboratory conditions and in
a given sample matrix
Limit of Quantification (LoQ): lowest actual amount of
analyte that can be reliably detected and at which the total
error meets the laboratorys requirements for accuracy
The distinction b/n different results interpretations is
dependent on the relationship b/n LoQ, LoD and LoB
detected detected but below LoQ not detected 44
Variables that may cause imprecision

Equipment
Multiple instruments
Pipettes check precision
Sporadic maintenance
Reagents
Different Lots of Reagents lot-to-lot evaluation
Staff
Difference in training, competencies

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 Laboratory Equipment

All equipment in the laboratory

Should have instruction manuals regarding proper
use and maintenance requirements
Should be monitored and recorded for quality
control procedures, function checks, preventative
maintenance and repairs
These should be documented and filed in separate log
books

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 Laboratory Equipment
Before putting new equipment or a new method into
service it must be validated
- This is accomplishment by correlation and/or agreement
studies
- The new method or equipment is validated against old
method and/or equipment
Refrigerators and freezers
- Record serial numbers
- Record temperatures daily
Maintaining correct temperatures is vital to maintaining
the integrity of reagents and should be maintained as
per manufacturers instructions.
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 Instrument Maintenance

CONTROLS and CALIBRATORS

Manufacturers can provide calibrators and internal controls

REGULAR MAINTENANCE
Daily and weekly instrument maintenance
Monthly, six-monthly and annual maintenance as recommended by
supplier

ROUTINE MAINTENANCE
Ensure that instruments are serviced regularly by a specialised
service engineer and that this maintenance is documented

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 Instrument Maintenance

Required for:

Producing reliable test results

Minimizing instrument breakdown
Lowering repair costs
Preventing delays in reporting test results
Maintaining productivity
Lengthening instrument life

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 PIPETTES IMPACT ON QC

Pipette accuracy and precision must checked regularly -

the first time of use and periodically thereafter

If either fails, it is important to follow the manufacturers

instructions for repair and calibration

Improperly calibrated pipettes will affect our assay and

should be checked for precision and accuracy bi-annually

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 PIPETTES IMPACT ON QC

Pipettes not passing accuracy checks should be cleaned

and checked for worn parts, and be sent to and
serviced by reliable vendors

Maintain complete records of pipette calibration function check

Include serial and other identifying numbers of each pipette

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 Reagents in Laboratory
How to store reagents
Always store according to the manufacturers
recommendations
Reagents must be dated and initialed upon receipt
Lot numbers must be recorded in a reagent quality
control record book
After preparation and/or when placed in service,
reagents must be labeled when put in service
according to the manufacturers suggested
recommendations

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 Reagents in Laboratory
Reagent parallel testing
New reagent lots must be checked with old lots using
a normal control before use
The variability for new lots of reagents compared to
the current lot should not be greater than the
variability found for triplicate samples of the current
lot
Variability should be within 5%
Results of reagent checks must be recorded, dated
and initialed
Document all lot to lot procedures with date and
variability results
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 PERSONNEL (Staff)

Restrict all testing procedures to staff with

appropriate technical training
Testing theory
Instruments
Testing procedures
Perform and document periodic performance
assessments on all testing staff

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 PERSONNEL (Staff)
Active participation by everyone working in the
system is required to meet quality standards &
continuously improve performance
It is laboratory director's responsibility to employ
sufficient qualified personnel for the volume and
complexity of the work performed
Continuing education program should be provided
All documentation should maintained in personnel
file
Regular meeting to keep staff informed of changes &
to solicit their suggestion for improving the lab.
service
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 Documentation

If you have not documented it,

you have NOT done it
If you have not documented,
it is a RUMOUR !!!

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 Value of Documentation
Ensures processes and outcomes are traceable

Processes can be audited, thus external

assessments can take place

Tool for training

Reminds what to do next

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 Key Documents
Results archive
File results in an organised and easily accessible manner
Laboratory monitoring
Documentation of temperature monitoring, reagent
control, accuracy/precision assays, corrective actions,
audit reports
Instrumentation
SOPs
Equipment files + Manuals
Service history records of the instrument
Records of daily, weekly and monthly calibrations and
maintenance 58
Standard Operating Procedures (SOP)
comprehensively written
document that describes the
laboratory procedure and all
other related issues
SOP for TFT
Essential for ensuring
uniformity in laboratory
procedures
The SOP should define test performance, tolerance
limits, reagent preparation, required quality control,
result reporting and references
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 The SOPM should be written in CLSI format and
must be reviewed and signed annually by the
Laboratory director
Must contain all test methods performed by the
laboratory
The SOPM should be available in the work area. It is
the definitive laboratory reference and is used often
for questions relating to individual test
Any obsolete procedures should be dated when
removed from SOPM and retained for at least 2 years

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 Outline for a CLSI Procedure
Document
A. Title: intent of the document; concise
B. Purpose or Principle: the process describes.. info.
regarding theory, clinical implications of examination
C. Procedure instruction: how to do a particular steps,
steps involved
D. Related Documents: listing of other procedures used
E. References: reference the source of information
F. Appendixes or attachments: additional information
G. Author(s): author of the document should be
documented
H. Approved Signature: Evidence that the document has
been approved
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 Validation

is about determining whether

something does what it is supposed
to do

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 Importance of validation

Validation - before we introduce something

Re-validation
after we have changed/modified
periodic
Validation is applied to:
SOP
reagents
equipment
software
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 Factors influencing quality:
Post-analytical
Right recording and reporting

Right interpretation
Range of normal values

Right turnaround time

Report to right user

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 Reporting results
Proper procedure includes:
All data entry results should be verified by a section
head or supervisor (when available) and reviewed
by management for final interpretation and release
of results
In the event that a report has already been sent out
and needs correction, a new report is issued with
updated report written on it
The old report remains in the patient file
Verbal result reports should be documented, listing
the time of the receipt of the report
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 Housekeeping

Surface decontamination of instruments, benchtops,

biosafety hoods and general tidiness

Disposal of biohazardous waste

Monitoring of fridge, freezer and incubator

temperatures

66
 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
Reference ranges :
As per IFCC recommendations, reference values are based
on that of a reference individual, it is established in healthy
individuals based on application of statistical methods to
values generated in the lab
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 Reference ranges

What do I do when controls are out of established

reference ranges?
Results of the normal donor control are expected to be
within the established reference range. If results exceed
reference range limits, follow corrective action:
Repeat test using same aliquot
If the results still exceed the limits, do not automatically
invalidate patient results
Due to the 95% confidence interval, 1 in 20 specimens from healthy
individuals drawn at random can be outside reference range limits
due to biological factors

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 Control Materials
Specimens that are analyzed for QC purpose are known as
control materials
Control materials should be available :
-in a stable form
-in aliquots or vials
-for analysis over an extended period of time, at least 1 yr
Minimal vial-to-vial variation should exist
Should have preferably the same matrix as the specimen

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 Types of Control Materials
Assayed
mean calculated by the manufacturer
must verify in the laboratory

Unassayed
less expensive
must perform data analysis

Homemade or In-house
pooled sera collected in the laboratory
characterized
preserved in small quantities for daily use

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 Managing Control Materials

Sufficient material from same lot number or serum pool

for one years testing

May be frozen, freeze-dried, or chemically preserved

according to instructions by the manufacturer

Requires very accurate reconstitution if this step is

necessary

Always store as recommended by manufacturer

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 Calibrators

Has a known concentration of the substance

(analyte) being measured

Used to adjust instrument, kit, test system in order to

standardize the assay

Sometimes called a standard, although usually not a

true standard

This is not a control

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 Control Charts
A common method to compare the values observed for
control materials with their known values is the use of
control charts
Simple graphical displays in which the observed values are
plotted versus the time when the observations are made
Known values are represented by an acceptable range of
values
When plotted points falls within the control limit- method
is performing properly
When points falls outside control limit problem may be
developing 73
 LEVY- JENNINGS GRAPH
L-Js are the process control graphs wherein the daily
Q.C. values for all levels of controls are plotted
(minimum 20 values) and an inference about the run is
drawn , to decide in control or out of control run.

Advantage:
Simple data analysis and display
Easy adaptation and integration into existing control
practices
A low level of false rejection or false alarms
An improved capability for detecting systematic and
random errors
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 LEVEY - JENNINGS GRAPH

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

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LJ CHART PLOTTED : AN EXAMPLE

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 Westgard Rules

(Generally used where 2 levels of control

material are analyzed per run)

12S rule R4S rule

13S rule 41S rule
22S rule 10X rule

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 Westgard 12S Rule

Warning rule

One of two control results falls outside 2SD

Alerts tech to possible problems

Not cause for rejecting a run

Must then evaluate the 13S rule

78
 12S Rule = A warning to trigger careful inspection
of the control data
+3SD

+2SD

+1SD
12S rule
Mean violation
-1SD
-2SD
-3SD

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

79
 Westgard 13S Rule

If either of the two control results falls outside of

3SD, rule is violated

Primarily sensitive to random error

Run must be rejected

If 13S not violated, check 22S

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 13S Rule = Reject the run when a single control
measurement exceeds the +3SD or -3SD control limit
+3SD

+2SD

+1SD

Mean
13S rule
-1SD violation
-2SD
-3SD

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

81
 Westgard 22S Rule

2 consecutive control values for the same level fall

outside of 2SD in the same direction

Sensitive to systematic error

Patient results cannot be reported

Requires corrective action

82
 22S Rule = Reject the run when 2 consecutive control
measurements exceed the same
+2SD or -2SD control limit
+3SD

+2SD

+1SD

Mean
22S rule
-1SD violation
-2SD
-3SD

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

83
 Westgard R4S Rule

One control exceeds the mean by 2SD, and the

other control exceeds the mean by +2SD

The range between the two results will therefore

exceed 4 SD

Random error has occurred, test run must be

rejected

84
 R4S Rule = Reject the run when 1 control
measurement exceed the +2SD and the other
exceeds the -2SD control limit

+3SD

+2SD

+1SD

Mean
R4S rule
-1SD violation
-2SD
-3SD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

85
 Westgard 41S Rule

Requires control data from previous runs

Four consecutive QC results for one level of control

are outside 1SD

Sensitive to systematic error

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 Westgard 10X Rule

Requires control data from previous runs

Ten consecutive QC results for one level of control

are on one side of the mean (above or below, with
no other requirement on the size of deviation)

Sensitive to systematic error

87
 10x Rule = Reject the run when 10 consecutive control
measurements fall on one side of the mean

+3SD

+2SD

+1SD

Mean

-1SD
-2SD
10x rule
-3SD
violation
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

88
 External Quality Assessment
All the control procedures described previously have
focused on monitoring of a single lab
These procedures constitute internal QC, to distinguish
them from procedures used to compare the
performance of different laboratories are known as
external Quality assessment
These two procedures are complimentary
Internal QC- daily monitoring of precision & accuracy
External QA- long term accuracy of analytical methods

89
 External Quality Assessment

EQA results evaluate performance of the laboratory

against other laboratories participating in the same
program
Different programs do this in different ways. Eg, t-test is
used to test the statistical significance of any difference
b/n an individual labs observed mean & the group mean
When the diff. is significant lab. is alerted
Results are instrument and protocol specific
EQA results should be formally documented within the lab
and should be available on request
90
External Quality Assessment in India

In India EQA is done by Govt. / private organizations

- National Accreditation Board for Testing &
Calibration Laboratories (NABL) , Dept. of Science &
Technology,GOI.(http://www.nabl-india.org)

- ACBI-CMC External Quality Assurance Scheme,

Christian Medical College, Dept. of Clinical
Biochemistry, Chennai(http://www.cmcvellore.ac.in)

91
 Proficiency testing
Laboratories should all enroll and satisfactorily participate
in a performance evaluation/assessment program
If conventional proficiency testing is not available, the
laboratory must exercise an alternative performance
assessment system for determining the reliability of
analytic testing (sample splitting for inter-laboratory
testing)

If the lab has more than one method-system for

performing tests for an analyte, it must be checked
against each other at least twice a year for correlation
of patient results
92
 New Quality Initiatives
Several new quality initiatives have been developed &
implemented to ensure that labs incorporate the
principles of Quality Management & QA in daily operation
- Six Sigma process
- Lean Production
- ISO 9000
- Joint Committee for Traceability in Laboratory Medicine
(JCTLM) Guidelines.

93
 SUMMARY
To ensure that a laboratory practices and provides
quality assurance for all phases of testing, the
laboratory should:

Enroll and satisfactorily participate in a performance

evaluation/assessment program
Establish reference ranges for analytes being tested
Document training and competency assessment for
their technicians
Provide review and verification of all results released,
including verbal result reports
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 SUMMARY
Quality control is a part of a total laboratory control
program under Total Quality Management
TQM is responsible for organizational development and
management for improved quality in all aspects
Five Qs- Qlp,QC,QA,QI,QP constitute the TQM
framework
Quality Control is achieved through proper documented
and validated interventions at Preanalytical, analytical
and post analytical stages
Quality Assurance is internal Quality assessment plus
external Quality assessment
X 95
 No matter how good the quality system is on paper,
quality cannot be achieved if the theory cannot be
translated into practice

Quality costs,

but poor quality costs more

96
 References
Teitz Fundamentals of Clinical Chemistry,6th Ed.
Harold Varley 4th Ed.
Bailey & Scotts 12th Ed.
Internet

97
Thank You
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