Lab Man Module 3 Midterms

MLS 324
Laboratory Management
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MLS 324
Second Sem A.Y. 2020-2021
COURSE LEARNING OUTCOMES

At the end of the term, the Medical Laboratory Scientist pupils are expected to:
1. Integrate knowledge of physical, social, natural, chemical, humanities, and health

sciences in the practice of Medical Laboratory Science.
2. Communicate effectively orally and in writing using English and Filipino with cultural
sensitivity when interacting with peers, students, patients and other health care
professionals.
3. Demonstrate technical competence (safe, appropriate, and accurate testing) in
the performance of laboratory tests to aid in the diagnosis, treatment, and
management of diseases. Engage in medical laboratory science related researches
and projects that would help the community.
4. Practice analytical and critical thinking skills in making sound judgment in dealing
with implausible laboratory results and take appropriate actions.
5. Manifest dedication and commitment as well as management skills in the laboratory
operation to deliver quality laboratory services.
6. Engage in lifelong learning for professional advancement to be globally and
technologically competent.
7. Work effectively and independently in multi-disciplinary and multi-cultural teams
while preserving and promoting Filipino historical cultural heritage.
8. Demonstrate professional, social and ethical responsibility for the protection and
preservation of the environment through the practice of proper biosafety and waste
management.
9. Practice the principles of social accountability (relevance, equity, quality, and cost
effectiveness) in the delivery of health care to patients, families, and communities.
10. Apply the latest developments in Medical Laboratory Science ethically to all
patients in general.
Laboratory Management
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COURSE INTRODUCTION:
Dear future Medical Technologists,
Laboratory Management plays an important role in healthcare system. Achieving,

maintaining, and improving its day-to-day operational language requires significant
understanding to its purpose and its services provided. It is very important that
laboratory staff working within the laboratory should learn its language of healthcare in
general.
To successfully achieve its goal, one should be expected to understand and perform
numerous mandates from various regulatory agencies, managing human resources,
patient care testing, addressing quality performance issues, and overall accountability
to the facility administration.
We must not forget the purpose of the laboratory, these include improving accuracy,
timeliness, and reliability of all all its operations that sometimes these determinants
serves as a major challenge in its operations.
This module is intended to provide an avenue for students to be introduced to the basic
functions of management, and its essential quality-based services. Each topic is
discussed in a separate units.
By the end of the course, the student should be able to describe the basic concepts of
management as applied in administrative aspects of laboratory operations.
Specifically, it deals with planning, organizing, leading/directing, controlling/evaluating
the human, physical and financial resources of the clinical laboratory. Emphasis is also
given on quality systems and safety.
***
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MODULE 3 - MATERIAL MANAGEMENT AND QUALITY ASSURANCE
This module shall focus on different criteria particularly in the selection of numerous
products in the laboratory, starting from selection, acquisition, installation, and after
sales services.
Furthermore, it shall also emphasize on the processes of purchasing and inventory

together with an overview of financial management related processes. This shall also
cover various quality-based programs.
MODULE SELF MONITORING FORM

To help you keep track of your tasks for this module, you are provided in the below with
a self-monitoring form. Take the time to tick on the “Yes” box for each activity that you
finish and be reminded about pending activities that you are yet to do. Remember that
your success in achieving the module objectives depends entirely on how
conscientious you are of your own progress.
Completed
Schedule Activities Remarks
Yes No
Unit 1 : Material Management
- Engage 📑⇤
Week 1 - Explore
- Explain
- Evaluate 📄⇥
Unit 2 : Quality Assurance
- Explore 📑⇤
Week 2 - Explain
- Elaborate
- Evaluate 📄⇥
📑 ⇤ : For Submission
📄 ⇥ : Quiz
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MODULE CONTENTS
Contents
Course Introduction 03
Module Self Monitoring Form 04
Module Contents 05
Module and Unit Objectives 06
UNIT 1 : Material Management

Engage: Product Research and Product Specialization 07
Explore: Selection of Instrument and Installation of Instruments 08
Explain: Purchasing and Inventory 12
Evaluate: Module 3—Unit 1 Quiz 19
UNIT 2 : Quality Assurance

Explore: Background on Concepts of Quality 21
Explain: Basic Quality Concepts 22
Elaborate: Management of Quality and Proficiency Testing 25
Evaluate: Module 3—Unit 2 Quiz 28
References 29
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MODULE OBJECTIVES
After you are done reading and doing the tasks in this module, you are expected to be
able to:
1. Describe major determinants of material management.

2. Identify the different considerations in product research and its specifications,
Ordering and Inventory of laboratory supplies, financial controls and budget
projections.
3. Define the concepts of quality assurance in a clinical laboratory together with the
different quality system essentials.
4. Identify various measures in proficiency testing.
This module is divided into two (2) lecture units including:

Lecture Unit 1 — Material Management
Unit Objectives:
1. Explain the process of material management and inventory control.
2. Perform simple calculations involving supply ordering, inventory control
and budget projection.
3. Rationalize the contribution of material management and inventory
control in the protection of the environment.
Lecture Unit 2 — Quality Assurance

1. Define the concept of quality formal laboratory perspective.
2. Perform analytical measures to identify weakness in laboratory operations
and decide interventions.
3. Describe a quality management program for a clinical laboratory.
4. Prepare a sample of a quality plan for the clinical laboratory.
5. Explain the standard protocol in proficiency testing.
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UNIT 1: MATERIAL MANAGEMENT
ENGAGE Product Research and Product Specification
LECTURE ACTIVITY 1.1 Acquisition and Selection of new equipment

(15 points)
Product research and specification describes the selection and installation of

equipment, equipment maintenance and calibration, documentation of equipment-
related problems, and record maintenance to ensure that equipment performs as
expected for its intended use.
The acquisition of new equipment and/or diagnostic procedures is an important factor

in this constant quest for quality improvement. The primary driver for the acquisition of
new equipment and/ or implementation of new procedures is this ever-present need to
offer the best possible quality of patient care. The constant demand to improve quality
patient care is, however, often combined with limited available resources and pressure
to reduce testing costs.
Is it better to purchase or lease equipment? When making this decision, it is a good

idea to factor in repair costs. The manufacturer should provide all of the necessary
information to operate and maintain equipment. The initial cost of an instrument may
seem reasonable, but it may be expensive to repair. Also consider savings that could
be negotiated if the laboratory needs more than one piece of equipment.
Proper management of the equipment in the laboratory is necessary to ensure

accurate, reliable and timely testing. From the table below, list down five (5) benefits of
a good equipment management program. Consequently provide at least one (1)
example of documented instruction (eg., standard operating procedures, program,
activity, etc.) that could compensate the listed benefits.
Bene ts Documented Instructions (eg., activities, etc.)
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EXPLORE Selection of instrument and Installation of Instruments
LECTURE ACTIVITY 1.2 Choice of Proper Instrument
The selection of new laboratory equipment or procedures is complex and time-
consuming. Faced with changing clinical needs and limited financial resources,
laboratorians must make difficult choices about which new equipment, technology,
procedures and assays, or combinations of these to acquire and implement and how
to incorporate them into their diagnostic laboratories.
Selection qualification (SQ) process basically consists of the following four parts.
I. Identification of the necessary functional specifications and facility, environmental
and engineering requirements for each piece fo equipment the laboratory desires
to acquire.
II. Comparison of needs to supplier’s functional specifications, capabilities, and
requirements offerings.
III. Process for assessing and comparing acquisition alternatives, such as purchase,
lease, and rent.
IV. Recording specifications, requirements, comparisons, decisions made, justification
for the ultimate selection, and follow-up actions taken.
Selecting the best instrument for the laboratory is a very important part of equipment
management. Some criteria to consider when selecting laboratory equipment are
listed below.
1. Why and how will the equipment be used? The instrument should be matched
against the service the laboratory provides.
2. What are the performance characteristics of the instrument? Is it sufficiently
accurate and reproducible to suit the needs of the testing to be done?
3. What are the facility requirements, including the requirements for physical
space?
4. Will the cost of the equipment be within the laboratory’s budget?
5. Will reagents be readily available?
6. Will reagents be provided free of charge for a limited period of time? If so, for
how long?
7. How easy will it be for staff to operate?
8. Will instructions be available in a language that is understood?
9. Is there a retailer for the equipment in the country, with available services?
10. Does the equipment have a warranty?
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LECTURE ACTIVITY 1.3 Installation of Instruments
Verification, Validation and Calibration
On acquisition of equipment and/or implementation of new procedures, laboratories
are required to establish policies and procedures to maintain or improve the reliability,
efficiency, and clinical utility of the testing systems.
Two critical analyses performed in the laboratory are method verification and
validation. These processes provide critical objective evidence that the chosen system
is fit for purpose, meaning that the particular requirements for a specific intended use
are fulfilled.
Before equipment is installed, verify that all physical requirements (electrical, space,
doors, ventilation and water supply) have been met.
Other things to consider are:
1. The vendor’s responsibilities for installation should be confirmed in writing

prior to beginning the installation process.
2. A checklist of the expected performance specifications should be developed, so
that performance can be quickly verified as soon as the equipment is installed.
Verification According to the Cumulative Techniques and Procedures in Clinical

Microbiology (Cumitech), verification is the one-time process performed
to determine or to confirm a test’s expected performance prior to
implementation in the clinical laboratory. Verification requires
determination of performance characteristics that include sensitivity,
specificity, predictive values, precision, and accuracy of the test. In
contrast, validation is an ongoing process of monitoring a test, procedure,
or method to ensure that it continuously performs as expected.
Validation According to the Clinical Laboratory Improvement Amendments (CLIA)

validation is an integral part of a laboratory’s quality assurance programs,
and it requires personnel competency assessment, quality control, internal
and external proficiency testing, and correlation with clinical findings.
Whenever possible, it is best to have the manufacturer install laboratory equipment; this
will likely improve the conditions of the warranty, and also may ensure that the
installation is done properly and quickly.
If equipment is installed by the laboratory:
1. Check that the package contents contain all of the parts;

2. Make a copy of any software that is part of the system;
3. Do not allow the equipment to be used before it is completely installed,
performance is verified and testing personnel are trained.
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After equipment has been installed, the following details need to be addressed before
putting the equipment into service.
1. Assign responsibility for performing the maintenance and operation programs.

2. Develop a system for recording the use of parts and supplies
3. Implement a written plan for calibration, performance verification, and proper
operation of the equipment.
4. Establish a scheduled maintenance program that includes daily, weekly and
monthly maintenance tasks.
5. Provide training for all operators; only personnel who have been trained
specifically to properly use the equipment should be authorized as operators.
Calibration Program
The laboratory needs to develop calibration plans for instruments and equipment that
involve measurements. The calibration plans need to include the following:
1. Schedule for calibrations and calibration verification, following the manufacturer’s

recommendations or other requirements for frequency
2. Assignment of scheduled responsibility
3. Traceability of calibration standards
4. Performing and recording calibrations and calibration verifications
5. Analysis of the results of calibrations and calibration verifications
6. Recording actions taken when calibration or calibration verifications fail to meet
predetermined criteria
7. Posting of calibration status and date due
8. Posting of any needed adjustments or tolerances
After any calibrations, adjustments, and before resuming use, the laboratory needs to
verify that the equipment functions as expected
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LECTURE ACTIVITY 1.4 Maintenance and Repair
Inventory record
Calibration Veri cation Operation
Maintenance Program
Operator’s Training
The laboratory needs to develop maintenance plans for instruments and equipment
that include the following:
1. Schedules that specify frequency of performing maintenance activities per the

manufacturer’s recommendations or other requirements for frequency
2. Assignment of scheduled responsibilities
3. Performing and recording maintenance activities
4. Process for recording routine service performed
5. Process for recording non routine service and repairs
The maintenance program should include evaluation of any electrical safety and
emergency stop features so that the equipment is kept in safe working condition.
Maintenance plans need to be consistent with the operator’s manual; where

discrepancies occur, records need to support the discrepancy. If maintenance is
performed by a centralized biomedical engineering department, the manufacturer, or
a contract bioengineering company, the laboratory needs to approve the
maintenance plan, and review and follow up on the results.
Manufacturers may provide service and repair of equipment that is purchased from
them. Be sure to set up a procedure for scheduling service that must be periodically
performed by the manufacturer. When instruments need repair, remember that some
warranties require that repairs be handled only by the manufacturer. Large facilities
sometimes have biomedical service technicians in- house who perform equipment
maintenance and repair.
After the repairs, adjustments, or significant maintenance, and before resuming use, the
laboratory needs to verify that the equipment functions as expected.
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EXPLAIN Purchasing and Inventory
LECTURE ACTIVITY 1.5 Supply Ordering Process
Purchasing and inventory management is a critical and essential component of the

quality management system. This particularly describes agreements that the laboratory
has with entities to which it provides services and entities from which it obtains products
and services to ensure that specified requirements for critical supplies and services are
consistently met.
Efficient and cost-effective laboratory operations need the uninterrupted availability of

reagents, supplies and services. Inability to test, even for a short time, is very disruptive
to clinical care, prevention activities and public health programs.
Careful management of inventory helps to prevent waste, which can occur if reagents
and supplies are stored improperly, or if reagents become outdated before they can
be used. Establishing a purchasing and inventory management program will ensure
that:
1. Supplies and reagents are always available when needed;

2. High-quality reagents are obtained at an appropriate cost;
3. Reagents and supplies are not lost due to improper storage, or kept and used
beyond expiration.
Methods for obtaining reagents and supplies vary considerably between laboratories.
Some laboratories may purchase directly but, in many countries, a national
procurement system is in place with a central stores area that distributes directly to the
laboratories. Also, in many places, donors have a major role in the procurement of
supplies and reagents.
The challenge of inventory management is balancing the availability of supplies and

reagents in stock with their expiration dates. The lifespan of reagents can vary from a
few weeks to a number of years. It is important to continuously monitor the expiration
dates to make sure needed reagents are always on hand and have not expired.
However, it is too costly and wasteful to overstock.
Equipment and supplies received or accepted from donors must meet the clients’
needs and the operational needs of the laboratory. Managers may sometimes need to
refuse donations, but this should be done in a diplomatic way to ensure future offers are
not discouraged.
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Key Components
Successful purchasing and inventory management requires that policies and

procedures be established for managing all critical materials and services. Some of the
key components to address are:
1. vendor/manufacturer qualifications;
2. purchase agreements;
3. receiving, inspecting, testing, storing, and handling of materials—all purchased
material should be inspected and appropriately tested to ensure that specifications
are met, and policies should be established for storing and handling materials as
they are delivered to the laboratory;
4. tracking materials to individual patients—the management system must allow for
tracking materials to individual patients; that is, the laboratory should be able to
identify specific test materials used for performing tests on any given day, so that if
there is a problem with a patient result, the laboratory will know what reagents were
used;
5. assessing and maintaining inventory;
6. controlling expiration periods;
7. dispatching supplies to satellite laboratories.
PURCHASE OF MATERIAL AND SERVICES
I. Agreement — The laboratory needs formal agreements and suppliers, contractors,

and consultants that specify the laboratory’s needs and responsibilities and the
supplier’s responsibilities. The approval of such agreements should be documented
to protect the interest of both the laboratory and the supplier.
II. Agreement Review and Amendment — Agreements to obtain critical suppliers,

materials, referral, and other necessary services need review to ensure that each
party’s expectations are defined. Any amendments or other changes also need
review and approval by both parties. Amendments and agreements also need
documentation and approval. Review of agreements are subject to document
control.
III. Purchasing — The laboratory needs to clearly understand its roles and responsibilities
regarding purchasing. Therefore, the laboratory should work with the organization’s
materials management service to develop and document which service performs
which activities in the process of purchasing equipment, materials, and services
used in the laboratory.
IV. Approved Supplier List — The laboratory needs to maintain a listing of suppliers,
contractors, and consultants that were approved through the qualification process
and from which purchases can be made. The laboratory may need to work with the
organization’s materials management service to obtain equipment, materials, or
services when a supplier is not on the approved list. The approved supplier list is
subject to document control.
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V. Purchasing and Use of Referral Laboratory Services — The laboratory needs to
establish a process for evaluating and selecting referral laboratories. The
expectations of the referring laboratory’s customers need consideration when
selecting and monitoring the quality and competence of the referral laboratory and
any consultants used.
Agreements with referral laboratories and consultants need periodic review for the
following, with documentation of the reviews:
1. Requirements of both parties are defined, documented and understood.

2. The referral laboratory or consultant can meet the requirements.
3. There are no conflicts of interest.
4. Examination selections are appropriate for their intended use.
5. Respective responsibilities for the interpretation of the examination results are clearly
defined.
The referring laboratory needs to maintain a listing of all referral laboratories and
consultants it uses, a log of all samples sent to each referral laboratory, and a record of
examinations for each sample.
The referring laboratory needs a process to provide the referral laboratory results and
findings to the person making the original requests. The report needs to include:
1. The name and address of the referral laboratory

2. A copy of the referral laboratory’s report
3. When the referring laboratory creates its own report, all essential elements from the
referral laboratory report without alternations that could affect clinical interpretation
The referring laboratory needs a means to ensure that the performance of any referral
laboratory or consultant it uses meets all required regulations and standards.
Storage and Handling of Materials
The laboratory needs designated storage areas for supplies and reagents to protect
them from damage or deterioration. Storage and handling of these materials need to
be in accordance with the manufacturer’s recommendations and any applicable
safety requirements. Examples include refrigerators and freezers— possible at different
temperatures (eg, blood components vs reagents, -20ºC vs -80ºC freezers); ambient
temperature (ie, room temperature); explosion-proof cabinets; gas cylinder carts; and
so on.
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LECTURE ACTIVITY 1.6 Inventory Management
In establishing an inventory control program there are a number of factors to consider.

A system should be designed so that the laboratory can closely monitor the condition
of all supplies and reagents, know what quantities are available and be alerted when
there is a need to reorder.
The following are important steps for implementation.
1. Assign responsibility—without this, nothing may get done.

2. Analyze the needs of the laboratory.
3. Establish the minimum stock needed for an appropriate time period.
4. Develop needed forms and logs.
5. Establish a system for receiving, inspecting and storing supplies.
6. Maintain an inventory system in all storage areas, and for all reagents and supplies
used in the laboratory.
Furthermore, the laboratory needs processes to maintain adequate amounts of in-date

supplies on-hand. For identified critical materials, records of the following are needed:
1. Date received
2. Lot number
3. Whether or not acceptance criteria were met and any follow-up
4. Date material is placed in service or disposition if not used.
The laboratory should develop an inventory management system that considers the
costs of managing inventory while maintaining adequate accessibility to all materials
and supplies necessary for laboratory operations. The waste reduction principles of
Lean manufacturing are known to greatly improve the laboratory’s ability to maintain a
ready supply of critical materials while reducing outdating and overstock.
Implementing an Inventory Management Program
A laboratory needs a process for analyzing its needs for materials and for determining
how many kits for a particular test should be on hand.
The laboratory should make a list of all the tests it performs and identify all the supplies
and reagents that are needed for each test. It is wise to use all available information to
help estimate the usage of supplies and reagents for the period of time between
ordering new materials.
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The information necessary for analyzing needs includes:
1. A complete description of each item used

2. The package count or number of units in which the item is supplied (e.g. a kit
can include 12 tests or 100 tests, and pipette tips can be packaged as 100 per
box or 1000 per box)
3. Approximate usage per month (quantification, e.g. 6 boxes used per month);
4. The priority or importance level the item has in doing the work of the laboratory
(e.g. used every day or only once a month?)
5. Length of time required to receive a delivery (will the order take a day, week or
month to arrive?)
6. Storage space and conditions (will a bulk order use too much storage space?
Does the item require storage in a refrigerator?).
How can a laboratory determine how much of any particular item to order?
Quantification is a very important process that can help calculate how much is required
of any particular item for a given period of time, and it is an essential part of a
successful inventory management program.
Accurate quantification will:
1. Ensure essential supplies will be available when needed

2. Prevent overstocking, which can lead to wastage of expensive materials.
Quantification provides information for:

1. Estimating annual budget requirements;
2. Allowing for better planning;
3. Making decisions and monitoring performance of the inventory management
system.
Quantification is performed when making annual plans for the laboratory and this
planning will take into account the usual usage of supplies and reagents.
There are times when it is important to consider how new demands on the laboratory
will create a need for greater testing volume. This often occurs when new health
programs are being implemented, and in preparation for epidemics, either identified or
potential.
The two frequently used methods are consumption-based quantification and morbidity-
based quantification:
1. Consumption-based Quantification
2. Morbidity-based Quantification
Consumption-based Quantification
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Laboratories most frequently use the consumption-based method, drawing on their
experience over time. This method is based on actual consumption, so there are a
number of factors to consider. For example, to determine the actual usage, it is
important to also estimate how much wastage has occurred and how many expired or
spoiled reagents and supplies have been discarded. An example of this type of
monitoring is shown in figure 1.6.1.
For planning, it is a good idea to consider whether any supplies or reagents have been
out of stock for more than 15 days during any time of the year. This may mean that
supplies are not ordered in sufficient quantities, or that the wastage or expiry is higher
than predicted.
Figure 1.6.1
Morbidity-based Quantification
In using the morbidity-based quantification method (shown below), the laboratory must
take into account the actual number of episodes, illnesses and health problems that
require laboratory testing. In other words, the laboratory needs to estimate an
expected frequency of the disease in question—how many cases will occur per unit of
population (per 1000, per 10 000, etc.)? Then, considering how many people the
laboratory serves, it can estimate the total number of cases the community might
reasonably expect to observe. Using standard guidelines for diagnosis and treatment,
and considering how well health care providers adhere to these guidelines, can help to
estimate how many laboratory tests will be performed.
Figure 1.6.2
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LECTURE ACTIVITY 1.7 Projection of Budget Supply Cost
It is through budgeting that an organization turns its strategic plans into daily operations.
A budget expresses planned revenues and expenses, as well as the volumes of services
and amounts of resources required to realize them.
Through the budget process the organization establishes priorities for its plans, allocates
its resources, and controls its costs. It authorizes new programs and services and sets
performance standards for existing ones. A budget thus serves as a tool and a
benchmark for monitoring the performance of the organization throughout its fiscal
year. In addition, it is a mechanism for imposing discipline on the organization.
Types of Budgets
Three separate budgets are developed during the budgeting process.

The first, and the one with which you are probably most familiar, is the operating
budget. This is prepared at the level of the cost center, usually by those managers who
have direct responsibility for managing the cost center and who can affect its
operations. The operating budget can be broken down into three components:
1. Statistical budget, or volume budget, which is the fore- cast of activity for the unit
2. Revenue budget, which determines the gross charges that will be generated by
the forecasted volume
3. Expense budget, which projects the amounts of resources that will be required
to produce the forecasted volumes
The capital budget is the second type of budget. Its development can occur
simultaneously with the operating budget. It is usually prepared at the organization level
and includes new or replacement property, physical plant, and equipment needs of
the organization for the coming year.
Most organizations have a system in place to collect information on these needs from
departments across the organization and then arrange the priorities centrally with
respect to acuity of need, organizational goals, and available funding. Capital
budgeting is separated from the operating budget because the impact of capital
purchases is predominantly on cash, with only the depreciation expense affecting the
operating budget
With the operating and capital budgets prepared, an organization can develop the
third type, the cash budget. This is usually prepared by the organization’s finance
department and predicts the cash flows in and out of the organization and the
resultant cash availability.
While obscure to most, it is the most critical of the three budgets. To remain solvent and
thus stay in business, the organization must carefully plan its cash reserves, timing of
cash disbursements, and any borrowing and investing activities.
— End of Unit 1 —
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EVALUATE MODULE 3 UNIT 1 — QUIZ
For OBL Students: Wait for the instructions of the class instructor.
For CBL Students: Refer to the set of questions below:
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UNIT 2: QUALITY ASSURANCE
EXPLORE Background on Concepts of Quality
LECTURE ACTIVITY 2.1 Historical Perspective (30 points)
The earliest definition of quality occurs in early times. Referring to your external
references, Quality has been practiced even from the age of craftsmanship and
guilds. Later it was developed and improved particularly during the first industrial
revolution. Currently, we are living in the 4th industrial revolution (Forbes), where smart
technologies are all over the place, without much scrutiny and the like, these
technology will not function as what is expected. Simply, quality can be defined as
doing it right the first time.
Given the time line below, briefly (Not more than three lines) describe the relevant
events pertaining to quality improvement in each of the dates (9).
Ref. American Society for Quality
Dates (Header) Relevant Events
Craftsmanship and Guilds
First Industrial Revolution
The Taylor System
Quality Processes and SQC
Sampling and Standards
American Society for Quality Control
Company-Worldwide QC in Japan
TQM in the U.S.
Quality 4.0
SQC : Statistical Quality Control ; TQM : Total Quality Management
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EXPLAIN BASIC QUALITY CONCEPTS
LECTURE ACTIVITY 2.2 Quality, Background
The definition of quality varies depending on the perception of a customer of the value
provided by a product or a service (in this case, laboratory service). Thus, quality relies
on customer satisfaction. The definition of quality as consensually agrees by 2005 (ISO
9000) is “The degree to which a set of inherent characteristics fulfills requirement” — (ISO
900 [3.1.1])
Quality can be used with adjectives such as poor, good, excellent and so on.
“Inherent”, as opposed to assigned, means existing in something, especially as a
permanent characteristic. “Requirement” is a need or expectation that is stated,
generally implied or obligatory. Stated means usually explicitly in a document.
Generally implied means that it is custom or common practice for the organization, its
customers and other interested parties. Requirement is the expression in the content of
a document conveying criteria to be fulfilled if compliance with the document is to be
claimed and from which no deviation is permitted.
Types of Quality Control
Quality Control (QC) is a process or a system for monitoring the quality of laboratory
testing. It measures accuracy and precision results. QC results in the laboratory are used
to validate or confirm whether the system (eg, instruments, reagents, calibrators, etc.) is
operating within pre-defined specifications. If QC results are good, it is safe to conclude
that patient test result is reliable
I. Internal QC — refers to the QC practice and performance in an individual

laboratory using known concentrations. Examples of samples with known
concentrations include in-kit controls (ie, manufacturer’s controls) or third party
controls.
II. External QC — measures a laboratory’s ability to obtain the correct result on an

unknown specimen. The specimens are obtained through quality assurance
programs of private, professional, or public organizations or through various
governmental agencies responsible for laboratory licensure. It is useful both for
quality control purposes and for accreditation. Examples include Proficiency Testing
(PT) programs of the different National Reference Laboratories (NRLs), External
Quality Assessment Scheme (EQAS).
Figure 2.2.1
IQC Program
Daily QC (IQC)
Patient Samples Analysis Patient Results
Periodic QC (EQC)
Diagnosis
EQAP Treatment
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Laboratory Practices on Quality Control
It is significantly important to check and perform both internal QC and external QC in

the laboratory due to the following considerations:
1. Laboratory tests are important and essential in the diagnosis

2. Clinician believe that laboratory reports are reliable
3. Mandated by regulatory agencies (licensing)
4. Assurance and evidence that the laboratory is reporting valid test results
5. It is the moral and ethical thing to do
Purpose of Quality Control
1. Detect instrument or calibration error(s)

2. Checks on-going stability of processes
3. Assess daily performance of different concentrations of analytes (ie, high, low,
normal)
4. Indicates if valid to report patient results
To avoid confusion, the term "quality control" will be used here to mean use of control
materials to monitor the accuracy and precision of all the processes associated with
the examination (analytic) phase of testing.
Quality control processes vary, depending on whether the laboratory examinations use
methods that produce quantitative, qualitative or semiquantitative results. These
examinations differ in the following ways.
Quantitative examinations measure the quantity of an analyte present in the sample,

and measurements need to be accurate and precise. The measurement produces a
numeric value as an end-point, expressed in a particular unit of measurement. For
example, the result of a blood glucose test might be reported as 5 mg/dL.
Qualitative examinations are those that measure the presence or absence of a

substance, or evaluate cellular characteristics such as morphology. The results are not
expressed in numerical terms, but in qualitative terms such as “positive” or “negative”;
“reactive” or “nonreactive”; “normal” or “abnormal”; and “growth” or “no growth”.
Examples of qualitative examinations include microscopic examinations, serologic
procedures for presence or absence of antigens and antibodies, and many
microbiological procedures.
Semiquantitative examinations are similar to qualitative examinations, in that the results

are not expressed in quantitative terms. The difference is that results of these tests are
expressed as an estimate of how much of the measured substance is present. Results
might be expressed in terms such as “trace amount”, “moderate amount”, or “1+, 2+,
or 3+”. Examples are urine dipsticks, tablet tests for ketones and some serologic
agglutination procedures. In the case of other serologic testing, the result is often
expressed as a titr—again involving a number but providing an estimate, rather than an
exact amount of the quantity present.
Page 23 of 29
Control Materials
Controls are substances that contain an established amount of the substance being
tested—the analyte. Controls are tested at the same time and in the same way as
patient samples. The purpose of the control is to validate the reliability of the test system
and evaluate the operator’s performance and environmental conditions that might
impact results.
It is important not to confuse calibrators and control materials. Calibrators are solutions
with a specified defined concentration that are used to set or calibrate an instrument,
kit, or system before testing is begun. Calibrators are often provided by the
manufacturer of an instrument. They should not be used as controls since they are used
to set the instrument. Calibrators are sometimes called standards, but the term
calibrator is preferred. They usually do not have the same consistency as patients’
samples.
Characteristics of Control Materials
1. Controls must be appropriate for the targeted diagnostic test—the substance

being measured in the test must be present in the control in a measurable form.
2. The amount of the analyte present in the controls should be close to the medical
decision points of the test; this means that controls should check both
low values and high values.
3. Controls should have the same matrix as patient samples; this usually means
that the controls are serum based, but they may also be based on plasma, urine or
other materials.
Quality Monitoring and Assessment Tools
Assessment is an important element of the 12 quality system essentials. It is the means for
determining the effectiveness of a laboratory’s quality management system through
internal and external audits, and evaluation of performance in an external quality
assessment (EQA) program.
An assessment can be defined as the systematic examination of some part (or

sometimes all) of the quality management system to demonstrate to all concerned that
the laboratory is meeting regulatory, accreditation and customer requirements.
Central-level laboratories are generally familiar with assessment processes, as most will
have had some kind of assessment by an external group. However, intermediate or
peripheral-level laboratories may not be assessed very often in resource-limited
countries.
Page 24 of 29
ELABORATE MANAGEMENT OF QUALITY AND PROFICIENCY TESTING
LECTURE ACTIVITY 2.3 Management of Quality
Management of Quality
Many entities offer advice and programs for the management of quality in an
organization. These include the promise-all, prepackaged programs designed by
expensive consultants and the theory-based concepts of Management by Objectives
(MBO), Quality Assurance (QA), Total Quality Management (TQM), Continuous Process
Improvement (CPI)etc. No matter what approach the manager takes, three areas, or
ingredients, must be properly aligned ion the institution is to achieve its quality
performance goals including:
1. Philosophy or attitude of its people

2. Operational system of the enterprise
3. Actual quality assessment and monitoring program in place
The Philosophy of Quality
The attitude of the people toward their work, themselves, the organization, and their
customers is reflected how they treat each other, view their shared interest in achieving
common goals, and view their professionalism in the delivery of their product or service
The philosophy of caring and commitment to the delivery of high-quality service starts
at the very top and permeates every crevice of the institution. It is directly tied to the
priorities placed on quality by the organization’s leadership and is demonstrated in how
managers spend their time, what attracts and consumes their attention, and to whom
they issue rewards. If the proper philosophy is not present, efforts expended on the
remaining two ingredients— operational and quality management systems— are
wasted. Tokenism and symbolism are not character traits of quality.
Operational System
Quality management begins with how well managers incorporate quality practices into
their management functions. Operational systems represent the actual practices taking
place in an organization— not good intentions, wishes, or future plans.
Several authors, most notably Lundberg (1976) and Bozzo (1991), point out that the
laboratory’s testing cycle begins with the doctor’s request for laboratory services and
continues when the information is received by the physician and new requests are
issued.
The laboratory may have operational systems in place that ensure that every step
follows smoothly and continually to ward the final delivery of a high-quality service. The
following model illustrates the steps in the testing cycle that are part of the operational
systems and quality practices of the laboratory.
Page 25 of 29
Figure 2.3.1 From patient needs to patient needs
Service Assessment Physician Utilization Service Requisition
Specimen Collection Specimen Process Analytical Process
Results Assessment Information Report Service Assessment
Quality Management Programs
Quality management programs differ from operational system. The former address
specific issues and goals and are plans for ensuring compliance or bringing about
change; the latter represent the final results of all efforts and are the actual practices
taking place. The wide variety of high-quality management programs available to
managers include MBO, quality circles, and, of course, the elements of:
QC(MBO) → QA → TQM(CQI) → QA(CPI) → QC (MBO)
Quality management programs also include the specialized functions that are part of
the technical operations of the laboratory and so crucial to the delivery of a high-
quality service. Ongoing activities that can be defined directly as part of quality
management programs include:
1. Preventive Maintenance
2. Policy and procurement manual writing and review
3. Quality control functions
4. Staff orientation, continuing education, and development
5. Participation in proficiency testing
6. Problem solving and troubleshooting
7. Laboratory inspection, accreditation, and licensure process
Philosophy, operational systems, and quality management programs combine to
create the integrity of the quality management plan. Each is crucial to the success of
the laboratory in achieving its goal of delivering high-quality services to its patients.
Proficiency Testing (PT)
Proficiency testing— evaluation of participant performance against pre-established

criteria by means of inter laboratory comparisons (ISO 17043). For the purposes of ISO
Page 26 of 29
17043, the term proficiency testing is taken in its widest sense and includes, but is not
limited to:
1. Quantitative scheme — in which the objective is to quantify one or more

measurands of the proficiency test item;
2. Qualitative scheme — in which the objective is to quantify or describe one or more
characteristics of the proficiency test item;
3. Sequential scheme — in which one or more proficiency test items are distributed
sequentially for testing or measurement and returned to the PT provider at intervals;
4. Simultaneous scheme — in which proficiency test items are distributed for
concurrent testing or measurement within a defined time period;
5. Single occasion exercise — in which proficiency test items are provided on a single
occasion. It may be advantageous to pilot the change to evaluate its effectiveness
before implementing a full-scale change;
6. Continuous scheme — in which proficiency test items are provided at regular
intervals;
7. Sampling — in which samples are taken for subsequent analysis; and
8. Data transformation and interpretation — in which sets of data or other information
are furnished and the information is processed to provide interpretation (or other
outcome).
Some providers of PT in the medical area use the term External Quality Assessment
(EQA) for their PT schemes, or for their broader programs, or both.
— End of Unit 2 —
Page 27 of 29
EVALUATE MODULE 3 UNIT 2 — QUIZ
For OBL Students: Wait for the instructions of the class instructor.
For CBL Students: Refer to the set of questions below:
Page 28 of 29
REFERENCES:
1. McPherson, R.A. & Pincus, M. R. (2011). Henry’s Clinical Diagnosis and Management
by laboratory methods, 22nd edition. P.A. United States: Saunders Elsevier
2. Garcia, L.S. (2014). Clinical Laboratory Management, second edition. Washington

DC, United States: American Society for Microbiology
3. World Health Organization (2011). Laboratory Quality Management System. France.

(WHO)
4. CLSI. Quality Management System: A model for Laboratory Services; Approved

Guideline— Fourth Edition. CLSI document QMS01-A4. Wayne, PA: Clinical
Laboratory Standards Institute; 2011
Page 29 of 29

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MLS 324

COURSE LEARNING OUTCOMES

1. Integrate knowledge of physical, social, natural, chemical, humanities, and health

Dear future Medical Technologists,

Laboratory Management plays an important role in healthcare system. Achieving,

Furthermore, it shall also emphasize on the processes of purchasing and inventory

MODULE SELF MONITORING FORM

Unit 2 : Quality Assurance

UNIT 1 : Material Management

UNIT 2 : Quality Assurance

1. Describe major determinants of material management.

This module is divided into two (2) lecture units including:

Lecture Unit 2 — Quality Assurance

LECTURE ACTIVITY 1.1 Acquisition and Selection of new equipment

Product research and specification describes the selection and installation of

The acquisition of new equipment and/or diagnostic procedures is an important factor

Is it better to purchase or lease equipment? When making this decision, it is a good

Proper management of the equipment in the laboratory is necessary to ensure

Bene ts Documented Instructions (eg., activities, etc.)

Other things to consider are:

1. The vendor’s responsibilities for installation should be confirmed in writing

Verification According to the Cumulative Techniques and Procedures in Clinical

Validation According to the Clinical Laboratory Improvement Amendments (CLIA)

If equipment is installed by the laboratory:

1. Check that the package contents contain all of the parts;

1. Assign responsibility for performing the maintenance and operation programs.

1. Schedule for calibrations and calibration verification, following the manufacturer’s

Calibration Veri cation Operation

1. Schedules that specify frequency of performing maintenance activities per the

Maintenance plans need to be consistent with the operator’s manual; where

Purchasing and inventory management is a critical and essential component of the

Efficient and cost-effective laboratory operations need the uninterrupted availability of

1. Supplies and reagents are always available when needed;

The challenge of inventory management is balancing the availability of supplies and

Successful purchasing and inventory management requires that policies and

PURCHASE OF MATERIAL AND SERVICES

I. Agreement — The laboratory needs formal agreements and suppliers, contractors,

II. Agreement Review and Amendment — Agreements to obtain critical suppliers,

1. Requirements of both parties are defined, documented and understood.

1. The name and address of the referral laboratory

Storage and Handling of Materials

In establishing an inventory control program there are a number of factors to consider.

The following are important steps for implementation.

1. Assign responsibility—without this, nothing may get done.

Furthermore, the laboratory needs processes to maintain adequate amounts of in-date

Implementing an Inventory Management Program

1. A complete description of each item used

1. Ensure essential supplies will be available when needed

Quantification provides information for:

Three separate budgets are developed during the budgeting process.

LECTURE ACTIVITY 2.1 Historical Perspective (30 points)

Ref. American Society for Quality

Dates (Header) Relevant Events

Craftsmanship and Guilds

First Industrial Revolution

The Taylor System

Quality Processes and SQC

Sampling and Standards

American Society for Quality Control

TQM in the U.S.

Types of Quality Control

I. Internal QC — refers to the QC practice and performance in an individual

II. External QC — measures a laboratory’s ability to obtain the correct result on an