LMGT211: LABORATORY MANAGEMENT

WEEK 14: QA LAB DESIGN AND WORKFLOW

1ST SEMESTER | S.Y 2023-2024
Instructor: PROF. PAMELA SENGSON RMT, MLS, (ASCPI)

strategic planning and team work that will result to on-

QUALITY ASSESSMENT going quality improvement to satisfy the customer needs.
o That philosophy includes not only resolving problems
• Doing the right things right the first time. It is the degree of that need immediate attention, but also seeking
excellence. There is a customer’s satisfaction. * opportunities for improvement where no problems
currently exist.
Quality Control V.S. Quality Assurance o When there is no problem but we want to continuously
• QC improve our organization, it will minimize the cost, waste,
- Relies heavily on quantitative statistical methods that and injuries, while enhancing resource and process
focus on the final product as defined by the standards set management and facilitating customer satisfaction in a
by the producer. preventive anticipatory matter.

- Series of analytical measurements used to assess the quality o A process where in the CQI serves as a systematic total
of analytical data.* management approach that facilitates on-going quality
- “The tools” improvement as evidence by enhanced customer
- The foundation of quality control is descriptive analysis or satisfaction.
also known as descriptive analytics/statistics.
o Descriptive analysis: summarizes the
characteristics of data set 3. Six Sigma
• QA • Process improvement program that is a hands-on process
- Developed out of the limitations of the QC approach and with the single mantra of "improvement": improved
defined quality in health care institutions by the success of performance, improved quality, improved bottom line,
the of the total organization, not just individual improved customer satisfaction, improved
components of the system in achieving the goals of employee satisfaction.
patient care.
• Sigma: It is a Greek alphabet letter used to describe the
- An overall management plan to guarantee the integrity of the variability in a process.
data.* • In the six sigma methodology, the unit used is defects per unit.
- “The system” • The sigma value indicates the frequency of defects occurring
in one process.
Quality Assessment and Improvement o Higher sigma value = lower number of defects
• To ensure that quality laboratory services are provided, every o Lower sigma value = higher number of defects
laboratory should strive to:
o Obtain modern equipment* 4. Lean
o Hire well trained staff* • Ultimately designed to reduce waste (non- valued activities),
o Ensure a well-designed and safe physical environment* which means to reduce cost by identifying daily work
o Create a good management team* activities that do not directly add to the delivery of
• Quality Systems Management ultimately dispels the concept of laboratory services in the most efficient or cost-effective
“good enough” and promotes one of it can always be done ways.
better. • It directly addresses the age-old concept (?) of that’s the way
we always did it.*
Standard Approaches to Quality Leadership and Management • It constantly looks for ways to improve the process. **

1. Total Quality Management (TQM) Major Figures in Quality Management

• Systems approach that focuses on team, processes,
statistics, and delivery of services products that meet A. Philip Crosby
or exceed customer expectations. - Frequently referred to as Evangelist of quality
• Continually look for ways to reduce errors or what we call management because of his book Quality is Free.
the “defect prevention” by empowering employees to - Preach the need for quality practices in the book Quality is
assist in solving problems and getting them to understand Free.
their integral role within the greater system or their - He propounded that;
universal responsibility. * o Quality is free, poor quality is expensive*
o Do things right and first time*
• The organization culture supports the constant patient o Zero defects are the only legitimate goal of a quality
satisfaction through an integrated system of tools, techniques, program*
and trainings.
• It mainly involves the continuous improvement of the B. W. (William) Edwards Deming
organization processes. This results in high quality product and - Source of most of the concepts and methods contained in
services. the TQM model
• A continuous customer centered employee driven - Credited with providing the Japanese with the information
improvement. and training that brought them to their position as the
world's leader in production of quality products

- Walter Shewhart originated the concept of PDCA (Plan Do

2. Continuous Quality Improvement (CQI) Check Act) cycle. He later on introduced that to W. Edwards
• An element of TQM that strives to continually improve Deming. Deming then promoted the idea widely back in1950s.
practices and not just meet established quality standards. And since he is the one who promoted the idea, it later on
became known as the Deming Wheel or Deming Cycle.
- PDCA became known as Deming Wheel or Deming
• A managerial concept that is both an organizational Cycle.
philosophy and also a systematic process. - PDCA: consist of 4 steps/stages which must be gone through
o Philosophy in a sense that the membership of an to get from problem-faced to problem-solved. The repetition of
organization including its leaders. They are committed to these steps forms a cycle of continual improvement where in;
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 o First, we PLAN for changes to bring about the
improvement. After that, we DO the changes on a small • Low accuracy – away from the target
scale first to try them. Then, we CHECK to see if the • High precision – reproducibility/repeatability is not scattered
changes are working and to investigate selected
processes. Lastly, we ACT to get the latest benefit from • High accuracy – almost all of the values are near the true
the change. value/ center
• Low precision – repeatability is scattered

C. Joseph Juran • High accuracy and precision – near the true value/ target and
- Established the concept that quality is a continuous the reproducibility is great since all are focused on the center
improvement process that requires manager’s active pursuit
in reaching and setting goals for improvement.
Data population
- Widely regarded as the founding father of many of the key ➢ Used to describe and define the items that are being
quality management programs used by many organizations studied at a particular time.
today. That is why he is also known as the “father of quality”
- One of Juran’s quality management principle is the Pareto Quality Control Charts
Principle. a. Gaussian Curve
o Also known as the 80/20 rule. It follows the observations o Focuses on the distribution of errors from the analytical
of the economists Vilfredo Pareto wherein his study method. Occurs when the data can be completely
showed that 80% of the land in Italy was owned by 20% described by the SD and mean.*
of the population. From there, Juran realized that the
same 80/20 rule could also be applied to quality issues b. Cumulative Sum Graph (CUSUM)
o Juran coined the phrase, “the vital few + the vital many” o Calculates the difference between QC results and target
as to convey that a small percentage of root causes can means. The most common method is V-mask where in
result to a higher percentage of problems or defects. it requires computer implementation.*
o Also, the principle applies in other context making it a o It gives the earliest indication of systematic errors.
universal principle. Example: (1) 20% of an organization’s o Can be used within the 13s rule*
products may account for 80% of its profits. (2) 20% of
the team members may contribute to 80% of a successful c. Youden/Twin Plot
result in a given project. o Used to compare results obtained on high and low
control serum from different laboratories. *
- In terms of quality control, Pareto analysis can help identify o Displays the result of analysis by plotting the mean
which factors account for the greatest effect in terms of scrap, values for 1 specimen on the ordinate and abscissa.*
repairs, or cost. This information can in turn be used to drive o It demonstrates and compare the performance of a
improvement in the processes. laboratory when they have paired samples coming from
other laboratories.*

D. Dr. James Westgard d. Shewhart Levey-Jennings Chart

- Applied Shewhart's multirule system to the evaluation of o Most commonly used chart.
quality control data in the medical laboratory. o Also referred to as Levey-Jennings chart, S-L/J, dot
- Professor at the University of Wisconsin Medical School and chart
associate director of Clinical Laboratories-Quality assurance o Allows the laboratorian to apply multiple rules without
with the University of Wisconsin Hospital & Clinics in the aid of the computer.**
Madison
- He is an internationally recognized QC expert because he is e. Westgard Control Rules
the originator of the multirule QC, popularly known as o Application of multi-rule wherein a rejection or warning
Westgard rule. ** rule used to identify or indicate if the analytical
processes are out of control.*
Quality Control Statistics
Westgard Multirule System aka Westgard Rules
Accuracy and Precision
• Accuracy – nearness or closeness of a result to the actual RULE DEFINITION DECISION
value of the analyte when performing a test (VALIDITY) 12s rule Refers to the control rule that Warning
• Precision – ability of an analytical method to give repeated is commonly used with a
results/reproduces a value (RELIABILITY/ Levey- Jennings chart when
REPRODUCABILITY) the control limits are set as the
mean plus/minus 2s

*When you see this type of

ruling in your QC system, it is
a warning.

*Recalibrate the machine

13s rule A run is rejected when a single Reject
control measurement exceeds
the mean plus 3s or the mean
minus 3s control limit.
22s rule reject when 2 consecutive Reject
control measurements exceed
the same mean plus 2s or the
Accuracy and precision can be illustrated with the use of bull’s eye same mean minus 2s control
target. * limit.
➢ Closest to the center, it is the true value. R4s rule reject when 1 control Reject
measurement in a group
exceeds the mean plus 2s and
• Low accuracy – data are far from the true value/target another exceeds the mean
• Low precision - repeatability are scattered minus 2s. This rule should only
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 be interpreted within-run, not ➢ 10 consecutive control measurements falling on 1 side of the
between-run. mean.
41s rule reject when 4 consecutive Reject
control measurements exceed
the same mean plus 1s or the • Mean
same mean minus 1s control - Statistical tool used to measure systematic error /
limit. accuracy
10x rule reject when 10 consecutive Reject
control measurements fall on • Standard Deviation
one side of the mean. - Statistical tool used to measure precision/dispersion of
values around the mean
**Examples of the rules stated earlier:
• Coefficient of Variation
- Statistical tool that allows comparison and check on
precision of variability of each method

Variations
1. Random error – may occur by chance at any time and place
within the testing or service process
2. Systematic error – error that influences observations
consistently in one direction.

1. Random error affects the precision of a test (reproducibility). Some

➢ 1 control exceeds the mean + 3s. In this case, minus 3s was things that could cause random errors are:
exceeded. a. bubbles in reagents or reagent lines;
b. instrument instability;
c. temperature variations; and
d. operator variability, such as variation in pipetting.

• Due to unpredictable causes or origin that is not possibly

determined
• It causes one measurement to defer slightly from the next
• Cannot be eliminated from an experiment
• error: 12S,13S, and R4S or increased in precision
• May occur by chance at any time and place within the testing
or service process
➢ 1 consecutive control measurements exceed the same mean
+ 2s or the same mean – 2s control limit
2. Systematic error causes inaccurate results that are consistently
low or high. Some things that could cause systematic errors include:
a. change in reagent lot;
b. change in calibration;
c. assigning the wrong calibrator values;
d. reagents that were improperly prepared or are deteriorating;
e. pipettor maintenance error (not adjusted correctly or
misaligned); and/or
f. a deteriorating photometric light source in the instrument.
➢ Same mean +2s or the same mean -2s control limit.
• Always affects measurement the same amount or by the
• same proportion provided that a reading is taken the same
• way every time
• They are predictable
• Most systematic errors can be reduced or avoided
• error: 22S and 41S

Errors Which Can Be Observed on LJ Chart:

1. Trend – formed by control values that either increase or decrease

➢ Whenever there is a 1 control measurement in a group for six consecutive days
exceeding the mean +2s and another exceeding -2s. Main cause: deTerioration of reagents

➢ 4 consecutive measurement exceeding the same mean +1s

or -1s control limit.
2. Shift – formed by control values that distribute themselves on one
side or either side of the mean for six consecutive days
Main cause: improper calibration of the instrumentS

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 Laboratory Design

Note: Trend - deTerioration, Shift - instrumentS

Workflow and Laboratory Design

Laboratory Workflow
• The guidance and recommendations given as minimum
Three Phases of Testing Process: requirements pertaining to laboratories of all biosafety levels
1. Preanalysis refers to all the all activities before testing are directed at microorganisms in Risk Groups 1-4.
such as test ordering and sample collection. • Diagnostic and health-care laboratories must all be designed
for Biosafety level 2 or above. As no laboratory has
2. Analysis stage consists of the laboratory activities that complete control over specimens it receives, laboratory
actually procedure a result, such as running a sample on workers may be exposed to organisms in higher risk groups
an automated analyzer. than anticipated.

3. Postanalysis comprises patient reporting and result RISK GROUPS

interpretation. Collectively, all of the interrelated
laboratory steps in the testing process describe its workflow. Risk Group 1 (No or Low Individual and Community Risk)
• A microorganism that is unlikely to cause human or
Issues To Consider When Auditing Operations animal disease.
Test ordering Where are orders placed-in the laboratory,
patient unit, or office? Are inpatient orders Risk Group 2 (Moderate Individual Risk, Low Community
handled differently from outpatient ones? Is Risk)
there a paper or electronic requisition? • A pathogen that can cause human or animal disease but
Sample Who collects the samples-laboratory or is unlikely to be a serious hazard to laboratory workers,
collection physician? When are they collected-all hours or the community, livestock, or the environment. Laboratory
just in the AM? Are samples bar coded at the exposures may cause serious infection, but effective
site of collection or in the laboratory? How are treatment and preventive measures are available, and the
the labels generated? Is there a positive patient risk of spread of infection is limited.
ID system? Does the label contain all the
information needed to process the sample? Risk Group 3 (High Individual Risk, Low Community Risk)
Transportation How are samples delivered-by messenger, • o A pathogen that usually causes serious human or
automatic carrier transport, or a combination? animal disease but does not ordinarily spread from one
Do all laboratories participate? Are all patient infected individual to another. Effective treatment and
care areas served? How are stats handled? preventive measures are available.
What is their impact? Is there a separate system
for emergency department and intensive care • Risk Group 4 (High Individual and Community Risk)
units? • A pathogen that usually causes serious human or animal
Sample receipt Is there a central receiving area? How are disease and that can be readily transmitted from one
samples distributed to each laboratory? Does individual to another, directly or indirectly. Effective
physical layout promote efficient sample flow? treatment and preventive measures are not usually
How are stat samples distinguished from available.
routine ones? How are problem samples
handled? Are samples sorted by workstation or Biosafety Level 1
department?
Sample Are samples centrifuged centrally or in Laboratory design and facilities
processing distributed locations? Are stats handled In designing a laboratory and assigning certain types of work to it,
differently? Are samples aliquoted? If so, where? special attention should be paid to conditions that are known to pose
Is a separate sample drawn for each safety problems. These include:
workstation?
1. Formation of aerosols
“floated” 2. Work with large volumes and/or high concentrations of
- the sample is floated to different sections of microorganisms
lab 3. Overcrowding and too much equipment
Testing How many workstations are used? How does 4. Infestation with rodents and arthropods
capacity relate to need? How are samples 5. Unauthorized entrance
stored and retrieved? How long are samples 6. Workflow: use of specific samples and reagents.
kept? When and why are samples repeated? Are
repeat criteria appropriate? • Lowest level of precaution
Reporting How are results reported? Electronically? By • It practices the use of work with agents that pose a minimal
remote printer? How are stat and critical values risk to workers or the environment and do not typically cause
reported, and are criteria appropriate? How disease in healthy individuals
many calls for reports does the laboratory • Examples of agents used: non-pathogenic strains of E. coli
receive, and why? How are point-of-care tests • and B. subtilis
reported? • Still need to have standard microbiological practices
o Hand washing
o Standard personal protective equipment (gloves, lab coat
or gown, and eye protection)
o Biohazard signs
o Controlled access to the facility when infectious agents
are present o Shielding from splashes or aerosols

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 o Decontaminating surfaces and equipment at least daily • BSL-3 labs must follow all of the same practices as BSL-1 and
o Immediate cleanup and decontamination of spills BSL-2 labs.
o Safe handling of sharps • In addition, BSL-3 labs must incorporate stricter measures
o Prohibiting mouth pipetting including:
o Prohibiting food, drink and smoking materials in the lab o Baseline medical testing and ongoing medical
o Decontamination of infectious materials prior to disposal surveillance for all workers with potential exposure to
• Do not need special containment equipment infectious agents
• Work typically takes place on open benchtops, and the facility o Full body PPE such as wraparound gowns, scrub suits or
does not to be isolated from the surrounding facilities coveralls
• Because these labs are relatively safe and easy to maintain, o Respiratory protection may be required
they can be used as teaching spaces for workers and students o All work with infectious agents must be performed in an
with low levels of training, such as high school biology classes appropriate BSC or other physical containment device
o Access is restricted and controlled at all times
o More stringent control of contaminated waste, equipment
and lab clothing
o A set of two separate, self-closing doors, separated from
general building corridors
• BSL-3 facilities must have more advanced containment
methods, including specialized ventilation that directs air from
clean areas towards areas where infectious agents are present,
and does not allow air to recirculate unless it runs through a
HEPA filter first.
• Windows must be sealed so that airborne particles cannot
Biosafety Level 2 escape.

• Moderate biological hazards

• Can be used for work involving agents that are associated with
human diseases (pathogenic or infectious organisms) that pose
a moderate hazard to personnel and the environment, such as
HIV and the bacteria that cause staph infections.
• Work that involves human blood or cell lines
• In addition to standard microbiological practices, BSL-2
laboratories must follow these additional practices:
o Lab personnel are trained to handle pathogenic agents
and are supervised by scientists with advanced training
o Biosafety cabinets or other physical containment for all
procedures that can generate infectious aerosols or Biosafety Level 4
splashes
o Autoclave or other method of decontamination for • Highest level of precautions
proper disposal o Eyewash stations • Practices are used for work with agents that are very easily
o Lockable doors and more controlled facility access transmitted and cause serious or fatal diseases for which there
o Extra care is taken to control routes of exposure, are no vaccines or treatments, such as the ebola virus and the
including advanced techniques for handling virus that causes smallpox.
contaminated sharps • These facilities are rare and are highly regulated.
o Immunizations are provided to lab personnel when • In addition to the precautions used in bsl-1, 2 and 3 facilities,
appropriate BSL-4 labs must use practices such as:
o Additional PPE, such as face shields, may be necessary o A complete clothing change before entering the lab, and
o A lab-specific biosafety manual that outlines the a decontamination shower before exiting
necessary controls and practices for the work performed o Decontamination of all materials before leaving the
in that lab facility
• BSL-2 facilities will need moderate containment methods such o Strictly-controlled access and records
as Class II biosafety cabinets. o An airlock entrances
• All surfaces in the lab must be easy to clean and o Perform all work in a class III biosafety cabinet, or a
decontaminate effectively. combination of a class I or II biosafety cabinet and a
• Carpets and rugs are not allowed, and windows must be fitted positive-pressure full-body suit with an airsupplied
with screens. respirator
• BSL-4 work must typically take place in a dedicated building or
a completely isolated area of the facility with dedicated air of
all persons entering and exiting the facility intake and exhaust,
and dedicated vacuum lines and decontamination systems.
• Air exhaust and used water must pass through HEPA filtration
before leaving the facility.

Biosafety Level 3

• Serious biological hazards

• Appropriate for work involving agents that can cause serious or
potentially fatal disease through inhalation
• Examples of agents commonly used in BSL-3 work include
yellow fever virus, SARS coronavirus, and tuberculosis
bacteria.
• Work is often strictly controlled by government agencies, and
labs may need to be registered.

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 LMGT211: LABORATORY MANAGEMENT

WEEK 14: QA LAB DESIGN AND WORKFLOW

1ST SEMESTER | S.Y 2023-2024
Instructor: PROF. PAMELA SENGSON RMT, MLS, (ASCPI)

Biosafety Level BSL-1 BSL-2 BSL-3 BSL-4

Description No containment Containment High containment Max containment –

Moderate risk Aerosol transmission “exotic,” high risk
Defined organisms Disease of varying Serious/potentially lethal disease agents
Unlikely to cause severity
disease Life threatening disease

Sample organisms E.coli Influenza, HIV, Lyme Tuberculosis Ebola virus

Disease

Pathogen type Agents that present Agents associated with Indigenous or exotic agents, agents Dangerous and exotic
minimal potential human disease and pose that present a potential for aerosol agents that pose a high
hazard to personnel and moderate hazards to transmission, and agents causing risk of aerosol-
the environment personnel and the serious or potentially lethal disease transmitted laboratory
environment infection and life
threatening disease

Autoclave requirements None None Pass-thru autoclave with Bioseal Pass-thru autoclave with
required in laboratory room Bioseal required in
laboratory room

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