3.  All management systems are focused on
getting the job done.
 More efficient and effective management
guarantees the job to be done in the
proper way.
Larger profit Better serviceVs

4. STAGE ACTIVITIES PERFORMED
1. TOTAL QUALITY MANAGEMENT Management approach centered around
“Customer Satisfaction”
2. QUALITY MANAGEMENT All of the below plus the economic
aspects of “Cost of Quality”
3. QUALITY SYSTEM “Comprehensive and Coordinated”
efforts to meet quality objectives
4. QUALITY ASSURANCE Systematic activities to provide
“Confidence” that the organization
meets requirements for quality
5. QUALITY CONTROL Operational techniques applied to
“Specific Tasks” for quality and
regulatory compliance.

6.  Quality : degree to which a set of inherent characteristics
fulfills requirements
 Quality control: part of quality management focused on
fulfilling quality requirements
 Quality assurance: part of quality management focused
on providing confidence that quality requirements will be
fulfilled
 Quality management: coordinated activities to direct and
control an organization with regard to quality

7. 1942-521942-52 US Military develop requirements for contractors for shell, aircraft, missileUS Military develop requirements for contractors for shell, aircraft, missile
supplierssuppliers (Quality without 100% inspection)(Quality without 100% inspection)
19471947 International Organization for Standardization (ISO)International Organization for Standardization (ISO) created to adopt industrialcreated to adopt industrial
standardsstandards
19591959 US Department of Defense establishedUS Department of Defense established MIL-Q-9858MIL-Q-9858 quality managementquality management
19631963 MIL-Q-9858 is internationalized as anMIL-Q-9858 is internationalized as an ABCAABCA standardstandard
19681968 NATO adopts MIL-Q-9858A as Allied Quality Assurance Publication 1 (NATO adopts MIL-Q-9858A as Allied Quality Assurance Publication 1 (AQAP-1AQAP-1))
19791979 British Standards Institute (BSI) developed AQAP-1 for civilian useBritish Standards Institute (BSI) developed AQAP-1 for civilian use BS 5750BS 5750

8.  Calibration: the process of testing and
adjustment of an instrument, kit, or test system to
provide a known relationship between the
measurement response and the value of the
substance measured by the test procedure
 Effectiveness: the extent to which planned
activities are realized and planned results
achieved
 Efficiency: the relationship between the results
achieved and the resources used

9.  Non-QMS processes – processes that are not
contained in either the QSEs or in the laboratory’s
path of workflow, such as those within the finance,
sales, or marketing functions.
 Path of workflow: the sequential processes in a
laboratory’s activities that transform a request for
examination into the laboratory information that is
captured in the report of results.
 Plan: written account of intended future course of
actions aimed at achieving specific goal(s) or
objective(s) within a specific timeframe and explains in
detail what needs to be done, when, how, and by
whom.

11.
Organization
Customer Focus
Facilities and Safety
Personnel
Purchasing and Inventory
Equipment
Process Management
Pre-examination
Examination
Post-examination
Documents and Records
Information Management
Nonconforming Event Management
Assessments
Continual Improvement
Pree-xamination
Examination
Post-examination
Information Management
 Quality System Essentials -
those elements which must
be applied to all operations
in the service’s path of
workflow
 Path of Workflow - as it
relates to the processes
involved in the pre-, during and
post- phases of delivery of
services with the laboratory as
an example

16. ! Internal Quality Control (IQC)
Procedures
! External Quality Assessment
(EQA)
! Quality Management

17. Internal Quality Control

18. ⇒ Done during daily routine work
⇒ Provides an immediate control
⇒ Errors are corrected immediately
⇒ Routinely collect and analyze data from
every test run or procedure
Why do we need Internal Quality Control?
! Ensure that test results are reliable
(trustable)
! Ensure that test results are reproducible
(Closeness of the results of assays of the
same test carried under changed conditions)
! Control quality of daily routine work

19. Monitoring quality of laboratory testing,
accuracy and precision of laboratory results

20.  Precise and
Inaccurate
 Precise and Accurate

21.  Imprecise and
Inaccurate
 Imprecise and ??
Accurate

22.  It ensures continual check that the laboratory’s work does not
fluctuate and that reports are validated before they are
released.
 It is based on monitoring the procedures which are actually
used for the tests in the laboratory. It includes:
· Control charts with tests on control materials
· Duplicate tests on all specimens or on a proportion of the
specimens
· Delta check, comparing current test results with previous
results
· Consistency of mean values of patient data

23.  Use 2-3 levels of controls covering the
medical decision points
 At least 20 control values over a period of
20-30 days for each level of control
 Perform statistical analysis
 Develop Levey-Jenning chart
 Run -regularly- with patient samples
 Monitor control values on chart using
Westgard rules
 Take immediate corrective action, if needed
 Record actions taken (if any)

24.  QC material must be available in large
quantities stored in small aliquots (Ideally
should last for at least 1 year)
 Always consider as Biohazardous
 Requires very accurate reconstitution if
needed
 Always deal with and store as recommended
by manufacturer

25.  Need data set of at least 20 points obtained
over 20-30 days better by different operators
in different times of day
 Calculate mean, standard deviation,
Coefficient of variation and determine target
ranges
 Develop Levey-Jenning charts
 Plot –on the chart- control values each run/
day
 Make decisions regarding acceptability of run
using Westgard rules
 Monitor over time and at defined intervals

26. 1. 192 mg/dL
2. 194 mg/dL
3. 196 mg/dL
4. 196 mg/dL
5. 160 mg/dL
6. 196 mg/dL
7. 200 mg/dL
8. 200 mg/dL
9. 202 mg/dL
10. 255 mg/dL
11. 204 mg/dL
12. 208 mg/dL
13. 212 mg/dL

27. 80
85
90
95
100
105
110
115
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
Mean
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD

28. 80
85
90
95
100
105
110
115
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
Mean
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD

30.  Ideally should have control values clustered around
the mean (+/-2 SD) with little variation in the upward
or downward direction
 Imprecision = large amount of scatter around the
mean. Usually caused by errors in technique
 Inaccuracy = may see as a trend or a shift, usually
caused by change in the testing process
 Random error = no pattern. Usually poor technique,
malfunctioning equipment

31. Random Error (RE):
Imprecision
 Causes:
1. Pipetting error
2. Temperature error
3. Mixing defect
4. Machine need
troubleshooting
 Systematic Error
(SE): Inaccuracy
 Causes:
1. Deterioration of
control material
2. Deterioration of
calibrator
3. Deterioration of
reagents

32.  Allows determination of whether an analytical
run/s (in control) or (out of control)

46. October 1, 2008

47. October 1, 2008

49.  When you're running 2 or 4 control levels, use
the rules:
13s/22s/R4s/41s/10x
 When you're running 3 control levels, use a set
that works for multiples of threes:
13s/2of32s/R4s/ 31s/12x

50.  Rejection rule = Out of control=
1. Stop testing
2. Identify and correct problem
3. Repeat testing on pt samples and control
4. Don’t report pt results until problem is
solved and controls indicate proper
performance

51.  Change one variable at a time to troubleshoot an out of control
test.
 The variables are usually common to all instruments or
procedure systems and include the following:
 1. Try a fresh vial of QC
 2. Try a new reagent (same lot)
 3. Try a new consumable (water, part, solution, tubing) if
applicable.
 4. Try a new reagent (new lot)
 5. Recalibrate (current calibrator)
 6. Recalibrate (new lot calibrator)
 If a system cannot be brought into control, notify
senior staff. Do not process patient samples for the
test affected.

52. When changing to a new lot number of control material,
ideally there should be an overlap period while the new
material is being analyzed to establish the new control
limits.
In cases where the overlap period is not sufficient, it is
possible to establish the mean value for the new control
material in a short time, over say a five-day period, or to
start with the manufacturer’s values.
Then apply the previous estimate of SD to establish the
control limits.
These control limits should be temporary, until sufficient
data is collected to provide good estimates of both the
mean and SD of the new material.

53.  New lots of a quality control material should be
analyzed for each analyte in parallel with the lot of
control material in current use.
 Ideally, a minimum of at least 20 measurements should
be made on separate days when the measurement
system is known to be stable, based on QC results
from existing lots.
 If the desired 20 data points from 20 days are not
available, provisional values may have to be
established from data collected over fewer than 20
days.
 Possible approaches include making no more than four
control measurements per day for five different days

54.  Retained patients samples
◦ Original samples must be assayed in the lab under accepted control run
conditions
◦ Stored aliquited immediately after finishing 1st
analysis
◦ Storage conditions must meet the requirements for analytes to be
measured
◦ Avoid repeated warming/ thawing
◦ Stability of the measurand must be carefully respected
◦ Better to be alternating with QC material
◦ Result of the 1st
assay is used as the base for comparison and calculation
(as if gold value)
◦ Allowable analytical imprecision is used for judgment of acceptance or
rejection
◦ Data calculated from biological variations/ CLIA limits are used for the
issue

55.  Result comparison with an in-control method/
instrument/ procedure for the measurand
◦ The in-control instrument/ method is considered the
reference one
◦ Not more than one hour time gap between the parallel
assays
◦ Principles of assays must be considered if different
◦ Inaccuracy limits is used for comparison
◦ Data calculated from biological variations/ CLIA limits
are used for the issue

56.  Individual Patient Results:
◦ Clinical Correlations
◦ Correlation with other laboratory tests
◦ Intralaboratory duplicates
◦ Delta check with previous test results
◦ Limit Check
 Multiple Patients:
◦ Test distribution statistics
◦ Monitoring patients means

57. QUESTIONS

58. External Quality Control

59. Inter-laboratory comparisons and other
performance evaluations that may extend
throughout all phases of the testing cycle,
including interpretation of results; determination
of individual and collective laboratory
performance characteristics of examination
procedures by means of interlaboratory
comparison

60. A program in which multiple samples are
periodically sent to members of a group of
laboratories for analysis and/or identification, in
which each laboratory’s results are compared with
those of other laboratories in the group and/or with
an assigned value, and reported to the
participating laboratory and others

61.  Introduced into laboratory medicine more than 60
years ago to address that results for aliquots of the
same sample were different when measured by
different laboratories.
 PT/EQA programs are now an essential component of
a laboratory’s quality management system.
 PT/EQA is a component of laboratory accreditation
requirements

64.  Ideal samples for a PT/EQA program would fulfill a range of
criteria:
◦ Stable for the conditions under which they will be transported and
stored
◦ Homogeneous across all the aliquots produced
◦ Have analyte concentrations that include the expected clinical range
◦ Include appropriate sample types (e.g., urine, whole blood, serum)
◦ Available in sufficient volume
◦ Inexpensive enough for cost not to be an impediment
◦ Behave in clinical laboratory measurement procedures in
◦ the same manner as patient samples
◦ Samples from a single donor or pooled samples from multiple donors
can be used

65.  Samples have traceable reference values (when
reference values are used)
 Behave like patient samples (commutability)
 The laboratory may also consider cost
 Similarity of PT samples to patient samples
 Method compatibility with peer groups
 Size of peer groups
 Frequency of challenges
 Timeliness and usefulness of reports
 Educational content
 Customer service

67.  category 1 programs are limited because of:
• Technical aspects such as a lack of reference measurement
procedures, absence of certified reference materials, inability to prepare
commutable samples;
• Practical considerations such as the difficulty of preparing samples
covering the full measuring interval and the complicated logistics of
preparation and distribution of fresh or frozen samples;
• Psychological limitations such as lack of awareness of the quality
factors important in PT/EQA or unwillingness to adopt these;
• Economic concerns because distributing commutable samples in
sufficient quantity and providing target values with reference
measurement procedures is expensive

68.  PT samples should be tested in the same manner as
patient samples, to the extent possible
 Some laboratories may improperly test PT samples
differently from patient samples, by repeat testing of PT
samples when patient samples are tested only once, or by
having a specific analyst test PT samples rather than
rotating PT testing among all the personnel who perform
patient testing.
 There should be no attempt to produce “best” results by
replicate analysis or testing immediately following internal
QC or recalibration

69.  The core content of the result report should
resemble as closely as possible the content of a
routine clinical result report
 If the usual report is deemed inappropriate for a
PT report, it may equally be inappropriate for a
clinical report
 A copy of all PT reports should be retained within
the laboratory in order to verify the information
handling by the PT provider.

70.  Sending a set of samples from an organizing body to a group of
participating laboratories for measurement of 1 or more analytes present in
the samples
 Samples are intended to simulate the clinical samples usually measured
 Laboratories are not informed of the analyte concentration or activity in a
particular sample
 Timely schedules for running and reporting results are included
 Laboratory perform measurements in the same manner as for patient
samples
 Results for the samples are returned to the PT/EQA organizer for
evaluation of conformance to the expected results

71.  The organizer prepares a report that includes:
◦ the results reported by a laboratory
◦ the method used for the measurements
◦ the target values expected for each analyte
◦ evaluation of whether the individual laboratory’s results met the
performance requirements
◦ Reports may also include evaluation of the performance of the
various measurement procedures used by the participants
 The laboratory evaluates its performance according to
the provider report

72.  Limits or quality standards around the target value are established against
which performance can be assessed by:
◦ Regulatory: wider like US CLIA, German Rili-BAeK
◦ Statistical: ± 2-3 SD
◦ Clinically-based: on a difference that may affect clinical decisions or on biological
variation
 Total error limits including bias, imprecision, and analytical nonspecificity
can contribute to the variation in a single result
 Have different limits to separately assess bias and imprecision when replicate
samples are included
 PT/EQA limits are set as a minimum standard to identify results that indicate
poor performance. Thus, meeting these standards may not indicate that
performance is optimal nor that performance meets all clinical needs

73.  Determines the accuracy by comparing PT/EQA results to those
from a reference measurement procedure or from a designated
comparison method or to an all-participant (or all-method) mean/
median. This arrangement is now referred to as accuracy-based
evaluation
 Assess agreement with other measurement procedures and
imprecision among all methods as well as within a method group
 Peer group evaluation provides valuable information to assess
quality, verifying that a laboratory is using a measurement
procedure in conformance to the manufacturer’s specifications
and to other laboratories using the same technology

84.  PT/EQA result represents 1 point in time and will
occasionally be a random error
 Repeat the measurement using a stored aliquot of the
PT/EQA sample (assuming the measurand was stable
on storage) to confirm if the problem has persisted or
to conclude that the problem no longer exists and the
original unacceptable result was a random event, and
therefore no corrective action is indicated. If the
repeated result is still unacceptable, the laboratory
conducts further investigation to identify the root
cause, and then initiates corrective action

85. • Gather data related to the testing event to include
records of calibration, reagent use, QC results, and
maintenance procedures;
• Obtain other data on assay performance, e.g.,
previous PT/EQA results and relevant patient data;
• Identify the root cause of the error;
• Take corrective action and preventive action if
indicated;
• Monitor the success of the corrective action;
• Document the investigation and the corrective action.

86. • Was the testing material received in satisfactory condition?
• Was the appropriate sample tested?
• Were procedures for sample preparation followed?
• Was the appropriate method used for analysis?
• Was the method performed according to documented
procedures?
• Were appropriate reagents and controls used?
• Was equipment operated according to documented
procedures?

87. • Was equipment appropriately maintained?
• Was QC acceptable at the time of testing PT samples?
• Were results interpreted appropriately?
• Has this problem occurred previously with PT samples?
Are data consistent with previous PT distributions? Is
there a trend leading to failure or is the current set
completely unexpected?
• Did repeat testing on the properly stored residual sample
produce similar results?
• Were patient results acceptable at the time of PT testing?

88. 1. Clerical error;
2. Methodologic problem;
3. Equipment problem;
4. Technical problem;
5. Problem with proficiency testing materials;
6. Problem with evaluation of results; and
7. No explanation after investigation: An investigation fails
to reveal an explanation for an unacceptable PT result 19 to 24% of the
time

93.  Split-Sample With Another Laboratory
 Internal Split-Sample Procedures
 Audit-Sample Procedure
 Analysis of Manufacturer’s Product Calibrator or
Trueness Control Material
 Analysis of Interlaboratory Quality Control Data
 Averages of Patient Data

94.  Reference Intervals
 Reevaluation of Interpreted Results
 Direct Observation of Technique-Dependent Tests
 Clinical Correlation Studies
 Government and University Interlaboratory Comparison
Programs
 Analysis of Data From Qualitative Alternative
Assessment Procedures

95. YOUR VALUABLE QUESTIONS