Total quality management principles aim to improve patient care through monitoring laboratory work to detect deficiencies and correct them. Errors can occur in preanalytical, analytical, and postanalytical phases, and quality control procedures help control variables and ensure accuracy. Calibration, precision, accuracy, linearity, and detection limits are important analytical concepts, and factors like equipment, reagents, personnel, and documentation must be controlled and monitored to minimize errors and ensure quality.

1. TOTAL QUALITY
MANAGEMENT
Dr Anurag Yadav
Assistant Professor Department of
Biochemistry
Lean Six Sigma Green Belt

2. CONTENT
 Quality Management
 Errors in Lab
 Element of Quality assurance program
 Control of errors in Variables
 Preanalytical
 Analytical
 Using control material
 Using Patient data
 External quality assessment & Proficiency testing

3. FUNDAMENTALS
 Total Quality Management has been introduced in the Industrial
level under the pressure of the Production and satisfying
customer with the Quality.
 The principle of Quality Management, assurance & control have
become foundation for Clinical Laboratories.

4.  Quality is defined as Conformance with the requirement of
users or customers.
 Directly, Quality refers to satisfaction of the needs and
expectations of users or customers.  1) Acceptable
 2) Accessible
 3) Affordable
 4) Appropriate

5.  Who are our customers?
are often nurses, physicians, patients, patient parties or who
pay the bills.

6. • 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
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

7.  Now, Cost has to be even understood in the context of Quality.
WHY
Quality means conformance with requirements, then Quality Cost
be understood as „cost of Conformance‟ & „Cost Of Non-
conformance‟

9.  This understanding of quality and cost leads to a new
perspective on the relationship between them.
 Improvement in Quality can lead to reduction in cost
eg: with better analytical quality, lab would be able to reduce
waste.

10.  Quality improvement occur when problems are eliminated
permanently.
 This can only be done at the management level (85%).
 This emphasis on processes leads to a new view of the
organization as a system of processes.

12.  Primary importance of these processes for accomplishing the
work of the organization, TQM views the organization as a
support structure rather than as a command structure.

13. PROBLEM-SOLVING METHODS
 These methods outline distinct steps for
(1) Carefully defining the problem,
(2) Establishing baseline measures of process performance,
(3) Identifying root causes of the problem,
(4) Identifying a remedy for the problem,
(5) Verifying that the remedy actually works,
(6) “Standardizing” or generalizing the solution for routine implementation of
an improved process, and
(7) Establishing on going measures for monitoring and controlling the process.

14.  Hence making the TQM organization process a flexible rather
than rigid.

15. TOTAL QUALITY MANAGEMENT OF THE CLINICAL
LABORATORY
 The principle and concept of
TQM has been formulated into
a quality management
procedure.
Traditional
framework
QLP
QC
QA

17.  QLP includes analytical processes and the general policies,
practices, and procedures that define how work is done.
 QC emphasizes statistical control procedures but also includes
nonstatistical check procedures, such as linearity checks,
reagent and standard checks, and temperature monitors.

18.  QA, as currently applied, is primarily concerned with broader
measures and monitors of laboratory performance, such as
(1) turnaround time,
(2) specimen identification,
(3) patient identification, and
(4) 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

19.  The “five-Q” framework also
defines how quality is able to
be managed objectively using
the “scientific method”
 PDCA Cycle ( Plan, Do, Check,
Act)
PDCA
Cycle
Plan
Do
Check
Act

20. Plan (QP)
DO (QLP)
Check
(QC & QA)
Act (QI)

21.  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 laboratory‟s
performance
 the implementation and follow-up of corrective actions for
non-conformance to procedure

22. • A reputation based on 10,000 good quality result is damaged
by 1 poor quality result
• The establishment of robust testing systems is essential for 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

23. • 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

24. ELEMENTS OF QUALITY ASSURANCE PROGRAM
 Quality assurance is used to represent practices that are
generally recommended for ensuring that desired quality goals.
 Broad spectrum of plans, policies, procedure.
 These techniques monitor particular source of errors, estimate
magnitude of errors, alert lab personnel when indicator
deteriorated.

25. Commitment
Facilities and Resources
Personnel Competency and Training
Technical Procedures
Problem-Solving Mechanism

26. The Quality Assurance Cycle
•Data and Lab
Management
•Safety
•Customer
Service
Patient/Client Prep
Sample Collection
Sample Receipt
and Accessioning
Sample Transport
Quality Control
Record Keeping
Reporting
Personnel Competency
Test Evaluations
Testing
26

27. LABORATORY ERRORS

28. QUALITY CONTROL IN LABORATORY
• 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

29. Quality in labs is mutual responsibility of…..
• Laboratory specialists
• Clinicians
• Public health physicians
29

30. 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
30

31. 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
31

32. CONTROLS OF PREANALYTICAL VARIABLES
Responsibility for accurate and timely reporting lies with
lab, but many problems arise before and after
analysis.
To monitor such issues, it is necessary to perform
system analysis and identify types of preanalytical
variables

33. TYPES OF PREANALYTICAL VARIABLES
1. Test usage & practice Guidelines: appropriate use of testing
procedure to cut the cost bearing. Test which require in
emergency care.
2. Patient Identification: correct identification of patient and
specimen is a major concern. Highest error occur with the
hand written labels. The single id number should be allotted
for patient. Barcode preferred (reduce significant problems).

34. 3. Turnaround Time: delayed & lost test requisition, specimen &
report have been major problem. Automatic computer
generated document & tracking system flow.
4. Laboratory Log: tubes once arrive, various logging and
monitoring system is required. Computerized specimen
receiving and feed back to data-base.
Specimen should be inspected to confirm adequacy of volume,
problems which would interfere assay.

35. 5. Transcription error : if electronic identification and tracking not
been implemented.
6. Patient Preparation: such as recent intake of food, alcohol,
drugs, smoking, exercise, stress, sleep, posture during
specimen collection. Hence proper patient preparation is
essential

36. 7. Specimen collection: technique used will affect the test; eg:
prolong tourniquet application, IV line, Hemolysis, improper
container/preservatives, identification of person itself is
important.
8. Specimen Transport: stability of specimen during transport,(
ABG, Amm, Lact, HCO3, PTH). Controlling the specimen
transport is essential, authority to reject specimen.

37. 9. Centrifuge performance: the calibration, speed, type of tube,
timer & temperature.
10. Specimen separation and aliquoting:
11. Container monitoring: collection tube, pipettes, stoppers,
aliquot tubes. Interfere like cork stopper for calcium (false
elevation 10-50%).

38. 12. Personnel monitoring: trained and supervised staff. Written
procedure manual available at area of work. Fast-track
mechanism for urgent samples. Throughout time monitoring,
weekly/monthly statistics,
However records are necessary for documenting the daily
operation.

39. QUALITY MANAGEMENT-II
Presenter: Dr Anurag Yadav
Moderator: Dr Malathi M

40. CONTROL OF ANALYTICAL VARIABLES

41. Factors influencing analytical variables
EQUIPMENT RELIABILITY:
Meet technical needs, Compatible, User
& maintenance friendly, Cost effective,
Validated
Procedural
reliability using
Standard Operating
Procedures
REAGENTS STABILITY, INTEGRITY AND
EFFICIENCY:
Stable, Efficient, Desired quality,
Continuously available, Validated
SPECIFICITY & SENSITIVITY
OF SELECTED TEST:
Adequate ST, Sufficient SP,
cost effective, compatible
with, available infrastructure
and expertise, interpretable,
meets the needs/ objectives,
validated
PROFICIENCY OF PERSONNEL:
Education, Training, Aptitude,
Competence, Commitment,
Adequate number, CME,
Supervision, Motivation
USE OF APPROPRIATE
CONTROLS:
• Internal: Labs, Calibrated
• External: Supplied by
manufacturer, National,
International
DOCUMENTATION:
All the written policies, plans, procedures,
instructions and records, quality control
procedures and recorded test results involved
in providing a service or the manufacture of a
product
Assessment
ANALYTICAL FACTORS
41

42.  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
CONTROL OF ANALYTICAL VARIABLES
42

43. 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
43

44. 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
44

45. TRACEABILITY OF CALIBRATOR

47. 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 individual‟s measurement of a
quantifiable property
47

48. Accuracy
• Accuracy- the closeness of the agreement
b/n the result of a measurement & a true
conc. of the analyte
48

49. 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
49

50. 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 (σ)/mean(X) x 100 = % C.V.
50

51. Reliability
• The ability to maintain both precision and accuracy
51

52. 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.,
 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
52

53. LIMIT OF DETECTION
 Limit of Detection (LoD): lowest concentration of measured that
can be consistently detected in ≥ 95% of samples tested under
routine laboratory conditions and in a given sample matrix
53

54. 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
54

55. 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 ￫55

56. 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.
56

57. 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
57

58. 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
58

59. PIPETTE’S 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 manufacturer‟s
instructions for repair and calibration
• Improperly calibrated pipettes will affect our assay and
should be checked for precision and accuracy bi-annually
59

60. Reagents in Laboratory
• How to store reagents
– Always store according to the manufacturer‟s
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
manufacturer‟s suggested recommendations
￫60

61. • 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
Reagents in Laboratory
61

62. • 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
PERSONNEL (Staff)
62

63. 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
63

64. Documentation
• If you have not documented it,
you have NOT done it …
• If you have documented,
it is a RUMOUR !!!
64

65. 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
65

66. Key Documents
• Results archive
– File results of the Quality control, calibration sheets, maintenance log report,
backup of patient sample results., etc, in an organised and easily accessible
manner
• Laboratory monitoring
– Documentation of temperature monitoring, reagent control,
accuracy/precision assays, corrective actions, audit reports
66

67. • Instrumentation
– SOPs
– Equipment files + Manuals
– Service history records of the instrument
– Records of daily, weekly and monthly calibrations and maintenance

68. Standard Operating Procedures (SOP)
• comprehensively written
document that describes the
laboratory procedure and all
other related issues
• Essential for ensuring
uniformity in laboratory
procedures
SOP for TFT
•The SOP should define test performance, tolerance
limits, reagent preparation, required quality control,
result reporting and references
68

69. • 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
69

70. 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
70

71. Validation
 is about determining whether
something does what it is supposed
to do
71

72. Importance of validation
• Validation - before we introduce something
• Re-validation
– after we have changed/modified
– periodic
• Validation is applied to:
– SOP
– reagents
– equipment
– software
72

73. Factors influencing quality:
Post-analytical
• Right recording and reporting
• Right interpretation
– Range of normal values
• Right turnaround time
• Report to right user
73

74. 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 74

75. Housekeeping
• Surface decontamination of instruments,
benchtops, biosafety hoods and general tidiness
• Disposal of biohazardous waste
• Monitoring of fridge, freezer and incubator
temperatures
75

76. 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,
76

77. 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
77

78. 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
78

79. 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
79

80. Managing Control Materials
• Sufficient material from same lot number or serum
pool for one year‟s 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
80

81. 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
81

82. 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 82

83. 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
83

84. LJ CHART PLOTTED : AN EXAMPLE
84

85. Westgard Rules
(Generally used where 2 levels of control
material are analyzed per run)
• 12S rule
• 13S rule
• 22S rule
• R4S rule
• 41S rule
• 10X rule
85

86. 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
86

87. 12S Rule = A warning to trigger careful
inspection of the control data
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
12S rule
violation
87

88. 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
88

89. 13S Rule = Reject the run when a single control
measurement exceeds the +3SD or -3SD control limit
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
13S rule
violation
89

90. 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
90

91. 22S Rule = Reject the run when 2 consecutive
control measurements exceed the same
+2SD or -2SD control limit
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
22S rule
violation
91

92. 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
92

93. R4S Rule = Reject the run when 1 control
measurement exceed the +2SD and the other
exceeds the -2SD control limit
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
R4S rule
violation
93

94. 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
94

95. 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
95

96. 10x Rule = Reject the run when 10 consecutive
control measurements fall on one side of the mean
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
10x rule
violation
96

97. CONTROL OF ANALYTICAL QUALITY USING
PATIENT DATA
 Patient result is the final product of lab
procedures, hence the lab shall have the
monitoring results.
 Clinical correlation
 Correlation with other Lab tests
 Intralaboratory duplicates
 Delta checks with previous test results
 Limit checks

98. 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
98

99. • EQA results evaluate performance of the laboratory against other
laboratories participating in the same program
• Different programs do this in different ways.
• 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
External Quality Assessment
99

100.  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)
External Quality Assessment in India
100

101. 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
101

102. 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.
102

103. 103
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
￫
SUMMARY

104. 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
104

105.  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 …
105

106. REFERENCE
 Tietz- textbook of clinical chemistry and Molecular
Diagnostics.