Module7 - Total Quality Management in Clinical

Laboratory
1. Introduction/Overview are called binary discrete
Quality Assurance variants.
o Ex. Blood typing or
The right result, at the Right time, on the Right Microbiologic identification in
specimen, from the Right patient, with result specimen.
interpretation based on Correct reference data, o Results are in the nature of
and at the Right price Positive or Negative; Reactive
or Nonreactive.
Elements of Quality Assurance o Examination shows what
1. Quality Assessment - involves Internal Quality particular characteristics are
Assessment and External Quality Assessment. present or absent in specimen.
2. Quality Control - evaluation and validation of
the test; internal quality control; and 2. SEMI-QUANTITATIVE
Equipment evaluation and validation.
o These are the test in which the
What is Quality Control in Clinical Laboratory? degree of positivity or
A system designed to increase the probability negativity is roughly estimated,
that each result reported by the laboratory usually by visual identification.
is valid and can be used with confidence by the o Example is urine dipsticks,
physician making a diagnostic or therapeutic chemical test such as benedicts
decision. etc.

3. QUANTITATIVE
Purpose of Quality Control
o These are the test in which
The goal of QC is to detect errors some instrument measures the
and correct them before patient’s results are amount of particular
reported. substances, property and the
result is expresses numerically.
1.2. Monitoring the Quality of Laboratory Example is Chemistry and
Measurements. Hematology Tests.
Clinical laboratories perform qualitative, semi-
quantitative and quantitative tests on variety of  Shewhart set the basic principles of
biologic specimens. industrial quality control in 1931.
 Measurements were made of items
produced by a machine or sequence of
1. QUALITATIVE machines and the average value and
range of values of the measurements
o These are tests in which a were determined.
particular characteristic of  Tolerance limits is an acceptable
specimen is determined to be product then were established, and
either present or absent. These product uniformity could be assured by
continual surveillance of their critical
 measurements to detect deterioration final product as defined by standards
of machine performance and by set by the producer.
correction of problems as they become  It refers to specific activities directed
evident. toward monitoring the individual
 Most quantitative analytical procedures elements of care (ex. Instrument and
involved several operations or steps test procedure).
and each operation is subject of some  Example, if the laboratory tests fall
degree of inaccuracy or imprecision to within the acceptable QC ranges
the possibility of mistake. established for the items (QC Model),
 The attainment of these intra- and the technologists are secured that they
inter- laboratory aims require that all are turning out a high-quality result.
laboratory personnel-technologists,  Quality control in Laboratory Medicine
supervisors and directors be has been defined as the study of those
knowledgeable of the causes of errors, which are the responsibility of
analytical inaccuracies and of the the laboratory and the procedures used
techniques that are available for their to recognize and minimize them.
detection, correction and control.  Quality Control Programs have been an
 Knowledge is required of the degree of integral part of the inspection systems
the inaccuracy and imprecision allowed by the Health Facilities and Services
if analytical values are to be clinically Regulatory Bureau (HFSRB),
useful. Department of Health. The supervising
pathologist should insure that the
1.3. Quality Concepts quality is organized for periodic review
or every major portion of the clinical
 Quality is like love, everyone knows laboratories and that the program can
what it is, but no one knows exactly be documented for the inspector.
how to describe or measure it.
 To develop a plan to assess and ensure 2. Quality Assurance (QA)
the quality of the services delivered by
the laboratory, the manager must have
a full understanding of both the history  Overall activities conducted by the
and philosophy of quality as well as institution that are directed toward
knowledge of specific statistical assuring the quality of services
technique and their application to the provided.
laboratory.  Quality assurance focused on the
recipient – the patient. Furthermore,
1. Quality Control (QC) QA focuses on the monitoring of
outcomes or indicators of care.

 Study of errors and focuses on the test 3. Total Quality Management (TQM)
procedures.
 Refers to the standards and techniques
the measure the quality of the product  Quality management program includes
in the isolation from the needs of the each component (customer, producer,
customer or patient. and supplier) in the creation process
 It relies heavily on quantitative from the acquisition of supplies to
statistical methods that focus on the active follow-up after the product or
 service have been received by a 2. Adopt the new philosophy
delighted customer.
 JACHO and ISO – organizations that 3. Cease dependence inspection to achieve
conducts continuous performance quality.
improvement program.
4. End the practice of awarding business solely
on the price tag
4. Quality Assessment and Improvement (QAI)
5. Constantly improve the process of planning,
production and service
 It focuses on the success of the
organization in designing and achieving 6. Institute training on the job
its set of goals and objectives
7. Institute leadership for people and systems
(continuous performance
improvement). JACHO established nine improvement.
dimensions of performance 8. Drive out fear in order to encourage
improvement plan such as: employees to work together.
a. Efficacy f. Continuity
b. Appropriateness g. Safety 9. Breakdown barriers between Departments
c. Availability h. Efficiency and work areas.
d. Timeliness i. Care and
respect 10. Eliminate slogans, exhortations, and
e. Effectiveness producing targets.

11. Eliminate numerical quotas for

1.4. Major Figure in Quality Management
management and the workforce.
1. PHILIP CROSBY
12. Remove barriers to pride of workmanship
 Evangelist of Quality Management by
preaching, “Quality is Free.” He 13. Institute vigorous program of education and
propounded that: self-improvement for everyone in the
a. Quality is Free. Poor Quality is organization.
expensive.
14. Put everyone in the organization to work
b. Do things right the first time
c. Zero defects is the only accomplishing the transformation.
legitimate goal of quality program. 3. JOSEPH DURAN

 He established the concept that

QUALITY is a continuous improvement
2. W. EDWARDS DEMING process that requires manager active
pursuit in reaching and setting goals for
 Proposed the 14 TQM improvement.
points to bring about a  He was the leader in promoting
“delighted customer” PARTICIPATORY management styles. He
pointed out that it was necessary for all
employees to be included in and
committed to the continual process of
1. Create constancy of
designing and producing a quality
purpose toward service
product.
improvement.
 to trigger careful inspection of the control
data by the following rejection rules.
4. JAMES O. WESTGARD

 He propounded the MULTI-

RULE SYSTEM in the evaluation of
the quality control data in the
medical laboratory particularly the
multi-ranged controls used in Clinical
Chemistry (Westgard Rules).

1.5. Westgard Rule

The individual rule are defined below. The
"thumbnail" graphic next to a rule shows an 22s - reject when 2 consecutive control
example of control results that violate that rule. measurements exceed the same mean plus 2s
You can click on a graphic to get a larger picture or the same mean minus 2s control limit.
that more clearly illustrates the application of
each control rule.

13s refers to a control rule that is commonly

used with a Levey-Jennings chart when the
control limits are set as the mean plus 3s and
the mean minus 3s. A run is rejected when a
single control measurement exceeds the
mean plus 3s or the mean minus 3s control
limit.
R4s - reject when 1 control measurement in a
group exceeds the mean plus 2s and another
exceeds the mean minus 2s. This rule should
only be interpreted within-run, not between-
run. The graphic below should really imply
that points 5 and 6 are within the same run.

12srefers to the control rule that is commonly

used with a Levey-Jennings chart when the
control limits are set as the mean plus/minus
2s. In the original Westgard multirule QC
procedure, this rule is used as a warning rule
41s - reject when 4 consecutive control 12x - reject when 12 consecutive control
measurements exceed the same mean plus 1s measurements fall on one side of the mean.
or the same mean minus 1s control limit.

The preceding control rules are usually used

10x - reject when 10 consecutive control with N's of 2or 4, which means they are
measurements fall on one side of the mean. appropriate when two different control
materials are measured 1 or 2 times per
material.

What are other common multirules?

In situations where 3 different control materials
are being analyzed, some other control rules fit
better and are easier to apply, such as:

2of32s - reject when 2 out of 3 control

In addition, you will sometimes see some measurements exceed the same mean plus 2s
modifications of this last rule to make it fit or mean minus 2s control limit;
more easily with Ns of 4:

8x - reject when 8 consecutive control

measurements fall on one side of the mean.

31s - reject when 3 consecutive control

measurements exceed the same mean plus 1s
or mean minus 1s control limit.
 are increasing or decreasing [note: it is
increasingly rare to see this rule in use]:

7T - reject when seven control measurements

trend in the same direction, i.e., get
progressively higher or progressively lower.

6x - reject when 6 consecutive control

measurements fall on one side of the mean.

How do you perform multirule QC?

You collect your control measurements in the
same way as you would for a regular Levey-
Jennings control chart. You establish the means
and standard deviations of the control materials
in the same way. All that's changed are the
control limits and the interpretation of the data,
In addition, you will sometimes see some
so multirule QC is really not that hard to do! For
modification of this last rule to include a larger
manual application, draw lines on the Levey-
number of control measurements that still fit Jennings chart at the mean plus/minus 3s,
with an N of 3: plus/minus 2s, and plus/minus 1s. See QC - The
Levey Jennings chart for more information
9x - reject when 9 consecutive control about preparing control charts.
measurements fall on one side of the mean.
In manual applications, a 12s rule should be used
as a warning to trigger application of the other
rules, thus anytime a single measurement
exceeds a 2s control limit, you respond by
inspecting the control data using the other
rules. It's like a yield or warning sign at the
intersection of two roads. It doesn't mean stop,
it means look carefully before proceeding.

How do you "look carefully"? Use the other

control rules to inspect the control points. Stop
A related control rule that is sometimes used, if a single point exceeds a 3s limit. Stop if two
points in a row exceed the same 2s limit. Stop if
particularly in Europe, looks for a "trend"
one point in the group exceeds a plus 2s limit
where several control measurements in a row
and another exceeds a minus 2s limit. Because
N must be at least 2 to satisfy US CLIA QC
requirements, all these rules can be applied STATISTICS IN QUALITY MANAGEMENT
within a run. Often the 41s and 10x must be used 1. Accuracy – the closeness of the result to the
across runs in order to get the number of true or actual value of an analyte when
control measurements needed to apply the running the test; more commonly called
rules. A 41s violation occurs whenever 4 “hitting the bulls-eye.”
consecutive points exceed the same 1s limit. 2. Precision – how well a procedure reproduces
These 4 may be from one control material or
a value.
they may also be the last 2 points from a high
3. Data Population – a term used in statistics to
level control material and the last 2 points from
a normal level control material, thus the rule describe and define the items that are being
may also be applied across materials. The studies at particular time.
10x rule usually has to be applied across runs 4. Population Sample - part of a population
and often across materials. that is used to analyze the characteristics of
that population.
Computer applications don't need to use the 1. Slovin’s Formula
12swarning rule. You should be able to select 2. Lynch et.al. Formula
the individual rejection rules on a test-by-test 3. Cochran’s Formula / Modified Cochran’s
basis to optimize the performance of the QC Formula
procedure on the basis of the precision and
accuracy observed for each analytical method 5. GAUSSIAN DISTRIBUTION – describes the
and the quality required by the test.1.6. Basic
statistical phenomenon whereby members of
Statistics in Quality Management
the population are usually evenly disbursed
around the population mean.

 Also termed as BELL SHAPE CURVE,

NORMAL DISTRIBUTION FREQUENCY
POLYGON and LEVY JENNINGS CHART.

 Uses the criteria of Westgard rules and

the performance limits of Levey-
Jennings Charts.

 Example: 68.2% are within 1SD of the

mean

 95.4% are within 2SD of the

mean

 99.7% are within 3SD of the

mean
6. MEAN (X) – the arithmetic average of all  METHODS
data contained in a sample population or an
algebraic test. 1. FLOW CHART. Identify and describe
7. STANDARD DEVIATION – a measurement of the exact sequence of work tasks and
precision or the tendency of the values in each checking out was for improvement by
population to cluster center or scatter around modeling alternative work routes.
2. CONTROL CHART. A chart used to lot
the mean.
control measurement against
8. COEFFICIENT OF VARIANCE (CV) – the
standards to identify when a process is
standard deviation expressed as a percentage in or out of control.
of the mean; considered a measurement of 3. PARETO CHART. The term assigned
precision and variability. to a bar chart that is designed to
illustrate the classical pareto principle
GRAPHICAL PREENTATION IN STATISTICS which states that 80% of all problems
can be attributed to 20% of the
1. CIRCLE or PIE CHART – circular figure with possible causes. According to this
areas marked off. Shaded or sketched concept, the problems are matched
according to percentage or each component with their causes and plotted on a bar
compared to whole. graph, the area in which managers
should devote the majority of heir
2. BAR GRAPH – helpful in resenting
attention and energy become readily
comparative interpopulation and
apparent.
intrapopulation factors.
4. CAUSE and EFFECT diagrams.
3. LINE GRAPH – useful for plotting and Graphical display with a “fishbone”
tracking data over period of time. This is very appearance; used to identify the
adaptable for displaying historical data. possible cause of, or contributing
factors to a problem or quality defect.
5. RUN CHART. Line graphs used to
GAUSSIAN DISTRIBUTION DISPLAYS display data over a period of time.
6. SCATTER DIAGRAMS. Used to show
 There are two popular methods of the relationship between one variable
displaying FREQUENCY DISTRIBUTION, and another.
Characteristics of a population. 7. STORY BOARD. A story told in
sequential picture displayed on a flip
1. HISTOGRAM. This uses a bar graph chart or other visual aids.
format to show the relative size or
frequency of each class interval. A class
interval is the statistical term for each LABORATORY DATA EVALUATION
part of the population. For example, METHODS
one bar may be represent the age
group 20-30 in a patient population. 1. LEVEY JENNING CHART – a control
2. FREQUENCY POLYGON. Line graphs chart used to plot quality control
that give the FREQUENCY values against previously set limits to
DISTRIBUTION its descriptive name determine if a procedure is in or out of
“BELL CURVE.” control.
2. YOUDEN PLOT – technique used to
demonstrate and compare the
performance of a laboratory on paired
 samples with other laboratories. unexplained pattern around the control chart.
3. MULTI RULE ANALYSIS – a set of rules 4. SHIFT – a sudden switch of data points to
such as WESTGARD rules that are used another are of the control chart away from
for accepting or rejecting a control run. the previous mean.

CONCEPT OF ERROR
Computation of Population Sample:

1. RANDOM ERROR

o An error that may occur at any

time and place within the
production process.
o Indicates inaccuracy.
o Need only to be closely
monitored for possible
occurrence.

EXAMINATION OF CONTROL CHARTS 2. SYSTEMATIC ERROR

o An error that occur in a

1. SKEWED CURVES – deviations from the constant direction or pattern
symmetrical bell shaped appearance of o Indicate imprecision
frequency control. o Occur in a predictable
2. TREND – a systematic drift in one direction direction.
away from the established mean. o Need immediate remedial
3. DISPERSION – control or sample values that action.
are widely scattered in an unusual and
MISTAKES 5. Reagent and Standard dilutions

o It is sometimes difficult to  Distilled water rather than buffer was

determine whether an used to prepare reagent
erroneous result was due to an  pH meter standardized with wrong
analytical factor or to a buffer.
mistake, but differentiation is  Reagent contamination.
of some importance if the  New reagent used without checking
cause of the problem is to be against old reagent.
identified and corrected.
6. Instrument Problems
SOME TYPES OF LABORATORY MISTAKES
1. Obtaining the specimen from the wrong  Slow clock used for a times reaction.
patient.  Recorder not properly warmed up;
2. Specimen mix up. blank reading unstable
 Broken balance used to weigh out
 Specimens labeled with wrong accession standards.
number
 Sera transferred to mislabeled tubes 7. Miscellaneous
 Improper cup number was recorded when
a specimen was removed from the auto-  Specimens left at room temperature by
analyzer samples wheel to insert an first shift medical technologist to be
emergency specimen and all specimen on analyzed by second shift medical
the wheel assigned false values. technologist; second medical technologist
s not report for work and specimens were
3. Incorrect chart readings not analyzed until the next day.
 Analyst calculated results mentally rather
 Incorrect reading of auto analyzer peak. than drawing a standard curve or
 Incorrect read off from the standard curve. calculating a factor, the results were
 Read off form the standard curve assigned grossly incorrect.
to wrong specimen  Initial computer printout was incorrect,
and subsequent corrected print out was
4. Dilution and calculation errors ignored.

 Analyst forgot to correct results for 1.7. Quality Management Program

dilution. SAMPLES USED IN QUALITY CONTROL
 Samples diluted by first shift medtech
were analyze by a second shift medtech 1. Serum pool
who was not informed of the prior
2. Aqueous solutions of analytes
dilution.
 A newly employed analyst thought a 1 to 2 3. Liquid serum
dilution meant 1 volume of serum and 2
volume of diluents rather than 1 volume 4. Urine
each.
The following are requirements in order for a
quality control program be effective:
1. The samples had to be essentially equivalent be properly aligned if the institution is
one to the other. to achieve its quality performance
goals:
2. The analytes in the sample had to be stable in
storage over a substantial period of time 1. Philosophy or attitude of its people.
3. The material had to available in sufficient 2. The operation system of the enterprise; and,
quantity to be used by many laboratories or by 3. The actual quality assessment and monitoring
single laboratory for a long period of time. program in place.

PROCEDURE IN MANUFACTURING QUALITY The Philosophy of Quality

CONTROL PLASMA
 The attitude of people towards their
1. Blood plasma is collected.
work, themselves, the organization and
2. The fresh plasma is frozen for transport to a their customers is reflected in how they
manufacturing plant. treat each other, view their shared
interests in achieving common goals,
3. Often a batch of control serum is to be and view their professionalism in the
prepared, as much as 2.00 liters of plasma is delivery of their product or service.
thawed, pooled, supplemented with various  The philosophy of caring and
analytes to achieve the desired concentration in commitment to the delivery of a high-
the final product, mixed thoroughly, filter and quality service starts at the very top and
dispensed into vials. Materials are lyophilized permeates every crevice of the
and capped under nitrogen. institution.
 It is directly tied to the priorities placed
on the quality by the organization’s
QUALITY CONTROL in the Laboratory can be leadership and is demonstrated in how
divided into major types: managers spend their time, what
attracts and consumes their attention,
1. Internal QC (Intralaboratory QC) and to whom they issue rewards.
 If the proper philosophy is not present,
2. External QC (Interlaboratory QC) efforts expanded in the remaining two
ingredients –operational and quality
management system –are wasted.
MANAGEMENT OF QUALITY
Operational Systems
 Many entities offer advice and
programs for the management of
 Quality Management begins with how
quality in an organization.
well managers incorporate quality
 These include the promise all, pre-
practices into their management
packaged programs designed by
functions.
extensive consultants and the theory
 Operational systems represent the
based concepts of Management by
actual practices taking place in an
Objectives, Quality Assurance, and Total
organization – not good in intentions,
Quality Management.
wishes or future plans.
 No matter what approach the manager
 The laboratory must have operational
takes, three areas or ingredients must
systems in place that ensure that every
 step flows smoothly and continually  Preventive
toward the final delivery of a high maintenance
quality service. The following model  Policy and Procedure
illustrates the steps in the testing cycle manual writing and
that are part of the operational systems review
and quality of laboratory practices.  Quality control
functions
Quality Management Programs  Staff orientation,
continuing education
 It differ from operational systems. and development
 The former address specific issues and  Participation in
goals and are plans for ensuring proficiency testing
compliance or bringing about change;  Problem solving and
the later represent the final results of trouble shooting
all efforts and are the actual practices  Laboratory inspection,
taking place. accreditation and
 The wide variety of high quality licensure process.
management programs available to
managers includes MBO, quality circles  Philosophy, operational systems and
and the elements of QC/MBO à QA. quality management programs combine
 Quality Management programs also to create the integrity of the quality
include the specialized functions that management plan. Each is crucial to the
are part of the technical operations of success of the laboratory in achieving
the laboratory and so crucial to the its goal of delivering high-quality
delivery of a quality service. services to its patients.
 Ongoing activities that can be defined
directly as part of quality management
programs include: