WHO - 2009 - LQMS Training Toolkit

Laboratory Quality Management System
Training toolkit
Handbook
This document collects the whole set of the toolkit content sheets.
World Health Organization.
Laboratory Quality Management System - Training toolkit.
WHO/HSE/IHR/LYO/2009.1
Published by World Health Organization on behalf of the U.S. Centers for Disease
Control and Prevention; the World Health Organization; the Clinical and Laboratory
Standards Institute®.
© World Health Organization, 2009
The designations employed and the presentation of the material in this publication do not
imply the expression of any opinion whatsoever on the part of the World Health
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are complete and/or error-free. WHO, U.S. Centers for Disease Control and the Clinical
and Laboratory Standards Institute disclaim all responsibility for any use made of the
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Contacts
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oms@lyon.who.int
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Clinical and Laboratory Standards Institute

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customerservice@clsi.org
1. Introduction
Content Sheet 1-1: The Importance of Laboratory Quality
Definition of Laboratory quality can be defined as accuracy, reliability, and timeliness of the
quality reported test results. The laboratory results must be as accurate as possible, all
aspects of the laboratory operations must be reliable, and reporting must be
timely in order to be useful in a clinical or public health setting.
Level of When making

accuracy measurements, there is
required always some level of
inaccuracy. The
challenge is to reduce
the level of inaccuracy
as much as possible,
given the limitations of
our testing systems. An
accuracy level of 99%
may at first glance appear acceptable, but the resulting 1% error can become
quite large in a system where many events occur, such as laboratory testing.
Negative Laboratories produce test results that are widely used in clinical and public
consequences health settings, and health outcomes depend on the accuracy of the testing
of laboratory and reporting. If inaccurate results are provided, the consequences can be
error very significant:
• unnecessary treatment; treatment complications
• failure to provide the proper treatment
• delay in correct diagnosis
• additional and unnecessary diagnostic testing.
These consequences result in increased cost in time, personnel effort, and
often in poor patient outcomes.
Minimizing In order to achieve the highest level of accuracy and reliability, it is essential
laboratory error to perform all processes and procedures in the laboratory in the best possible
way. The laboratory is a complex system, involving many steps of activity
and many people. The complexity of the system requires that many processes
and procedures be performed properly. Therefore, the quality management
system model, which looks at the entire system, is very important for
achieving good laboratory performance.
Introduction ● Overview of the Quality System ● Module 1● Content Sheet 4

Content Sheet 1-2: Overview of the Quality Management System
Definition of A quality management system can be defined as “coordinated activities

quality to direct and control an organization with regard to quality.” This
management definition is used by the International Organization for Standardization
system (ISO), and by the Clinical and Laboratory Standards Institute (CLSI).
Both groups are internationally recognized laboratory standards
organizations, and will be discussed later in the lectures.
In a quality management system, all aspects of the laboratory operation,
including the organizational structure, processes, and procedures, need
to be addressed to assure quality.
Complexity of There are many procedures and processes that are performed in the
laboratory laboratory and each of these must be carried out correctly in order to
processes assure accuracy
and reliability of
testing. An error
in any part of the
cycle can produce
a poor laboratory
result. A method
of detecting errors
at each phase of
testing is needed if
quality is to be
assured.
ISO standards group laboratory processes into pre-examination,

examination, and post-examination categories. Comparable terms in
current laboratory use include: pre-analytic, analytic, and post-analytic
processes; or pre-test, test, and post-test processes.
Path of Workflow The entire set of operations that occur in testing is called the Path of
Workflow. The Path of Workflow begins with the patient and ends in
reporting and results interpretation.
The concept of the Path of Workflow is a key to the quality model or the
quality management system, and must be considered when developing
quality practices. For example, a sample that is damaged or altered as a
result of improper collection or transport cannot provide a reliable
result. A medical report that is delayed or lost, or poorly written, can
negate all the effort of performing the test well.
Quality The complexity of the laboratory system requires that many factors
management must be addressed to assure quality in the laboratory. Some of these
system addresses factors include:
all processes
• the laboratory environment
• quality control procedures
• communications
• record-keeping
• competent and knowledgeable staff
• good quality reagents and equipment.

Content Sheet 1-3: The Quality Management System Model
Overview of the When all of the laboratory procedures

quality and processes are organized into an
management understandable and workable
system model structure, the opportunity to ensure
that all are appropriately managed is
increased. The quality model used
here organizes all of the laboratory
activities into twelve quality system
essentials. These quality system
essentials are a set of coordinated
activities that serve as building
blocks for quality management.
Each must be addressed if overall
laboratory quality improvement is
to be achieved. This quality
management system model was developed by CLSI1, and is fully
compatible with ISO standards.2,3
Assuring accuracy and reliability throughout the Path of Workflow depends
on good management of all of the quality essentials.
Organization In order to have a functioning quality management system, the structure and
management of the laboratory must be organized so that quality policies can
be established and implemented. There must be a strong, supporting
organizational structure—management commitment is crucial; and there must
be a mechanism for implementation and monitoring.
Personnel The most important laboratory resource is a competent, motivated staff. The
quality management system addresses many elements of personnel
management and oversight, and reminds us of the importance of
encouragement and motivation.
Equipment Many kinds of equipment are used in the laboratory, and each piece of
equipment must be functioning properly. Choosing the right equipment,
installing it correctly, assuring that new equipment works properly, and
having a system for maintenance are all part of the equipment management
program in a quality management system.
1
CLSI/NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second
Edition. CLSI/NCCLS document HS1-A2. Wayne, PA: NCCLS; 2004.
2
ISO 15189:2007. Medical laboratories–Particular requirements for quality and competence. Geneva:
International Organization for Standardization.
3
ISO 9001:2000. Quality management systems–requirements. Geneva: International Organization for
Standardization.
Purchasing and The management of reagents and supplies in the laboratory is often a
Inventory challenging task. However, proper management of purchasing and inventory
can produce cost savings in addition to assuring supplies and reagents are
available when needed. The procedures that are a part of management of
purchasing and inventory are designed to assure that all reagents and supplies
are of good quality, and that they are used and stored in a manner that
preserves integrity and reliability.
Process Control Process Control is comprised of several factors that are important in assuring
the quality of the laboratory testing processes. These factors include quality
control for testing, appropriate management of the sample, including
collection and handling, and method verification and validation.
The elements of process control are very familiar to laboratorians; quality

control was one of the first quality practices to be used in the laboratory and
continues to play a vital role in assuring accuracy of testing.
Information The product of the laboratory is information, primarily in the form of test
Management reporting. Information (data) needs to be carefully managed to assure
accuracy and confidentiality, as well as accessibility to the laboratory staff
and to the health care providers. Information may be managed and conveyed
with either paper systems or with computers; both will be discussed in the
section on Information Management.
Documents and Many of the twelve quality system essentials overlap each other. A good
Records example is the close relationship between Documents and Records, and
Information Management. Documents are needed in the laboratory to inform
how to do things, and laboratories always have many documents. Records
must be meticulously maintained, so as to be accurate and accessible.
Occurrence An “occurrence” is an error or an event that should not have happened. A

Management system is needed to detect these problems or occurrences, to handle them
properly, and to learn from mistakes and take action so that they do not
happen again.
Assessment The process of assessment is a tool for examining laboratory performance and
comparing it to standards or benchmarks, or the performance of other
laboratories. Assessment may be internal, or performed within the laboratory
using its own staff, or it may be external, conducted by a group or agency
outside the laboratory.
Laboratory quality standards are an important part of the assessment process,
serving as benchmarks for the laboratory.

Process The primary goal in a quality management system is continuous improvement
Improvement of the laboratory processes, and this must be done in a systematic manner.
There are a number of tools that are useful for process improvement.
Customer The concept of customer service has often been overlooked in laboratory
Service practice. However, it is important to note that the laboratory is a service
organization; therefore, it is essential that clients of the laboratory receive
what they need. The laboratory should understand who the customers are,
and should assess their needs and use customer feedback for making
improvements.
Facilities and Many factors must be a part of the quality management of facilities and
Safety safety. These include:
• Security—which is the process of preventing unwanted risks and hazards
from entering the laboratory space.
• Containment—which seeks to minimize risks and prevent hazards from
leaving the laboratory space and causing harm to the community.
• Safety—which includes policies and procedures to prevent harm to
workers, visitors, and the community.
• Ergonomics—which addresses facility and equipment adaptation to allow
safe and healthy working conditions at the laboratory site.
Quality In the quality management system model all twelve QSEs must be addressed
management to assure accurate,
system model reliable, and timely
laboratory results, and to
have quality throughout
the laboratory
operations. It is
important to note that
the 12 QSEs may be
implemented in the
order that best suits the
laboratory. Approaches
to implementation will
vary with the local situation.
Laboratories not implementing a good quality management system are
guaranteed that there will be many errors and problems occurring that may go
undetected. Implementing such a quality management system may not
guarantee an error-free laboratory, but it does yield a high quality laboratory
that detects errors and prevents them from recurring.

Content Sheet 1- 4: History of Laboratory Quality Management
Definition of ISO 9000 defines quality management as “coordinated activities to direct

quality and control an organization with regard to quality.” This is intimately related
management to the definition of a quality system—“organizational structure, resources,
processes and procedures needed to implement quality management.”
Quality management concepts in use today had their onset in the 20th
century, and are primarily an outgrowth of manufacturing and shop
processes.
Principal One of the earliest concepts of the quality management movement was that
innovators of quality control of the product. Shewhart developed a method for statistical
and their process control in the 1920s, forming the basis for our quality control
contributions procedures in the laboratory. Quality control methods were not applied in the
laboratory until the
1940s. Other critical
thinkers and
innovators, including
Arman Feigenbaum,
Kaoru Ishikawa, and
Genichi Taguchi,
added to the
concepts. The most
recent of importance
to the laboratory is
Galvin’s work on
micro-scale error reduction.
Quality Management is not new.

Content Sheet 1-5: International Laboratory Standards
Need for A part of quality management is assessment, measuring performance against a

international standard or benchmark. The new concept of quality management required that
laboratory standards be set, and again industry has been in the lead.
standards
Important Using a set of standards established by the U.S. military for the manufacture and
laboratory production of equipment, the International Organization for Standardization
standards established standards for industrial manufacturing; we know these standards as ISO.
organizations
The ISO 9000 documents provide guidance for quality in manufacturing and service
industries, and can be broadly applied to many other kinds of organizations. ISO
ISO 9001:2000 addresses general quality management system requirements and apply to
laboratories. There are two ISO standards that are specific to laboratories:
• ISO 15189:2007. Medical laboratories–Particular requirements for quality and
competence. Geneva: International Organization for Standardization.
• ISO/IEC 17025:2005. General requirements for the competence of testing and
calibration laboratories. Geneva: International Organization for Standardization.
CLSI Another important international standards organization for laboratories is the Clinical
and Laboratory Standards Institute, or CLSI, formerly known as the National
Committee for Clinical Laboratory Standards (NCCLS). CLSI uses a consensus
process involving many stakeholders for developing standards. CLSI developed the
quality management system model used in these training materials. This model is
based on twelve quality system essentials (QSE), and is fully compatible with ISO
laboratory standards.
CLSI has two documents that are very important in the clinical laboratory.
• CLSI/NCCLS. A Quality Management System Model for Health Care; Approved
Guideline—Second Edition. CLSI/NCCLS document HS1-A2. Wayne, PA:
NCCLS; 2004.
• CLSI/NCCLS. Application of a Quality Management System Model for Laboratory
Services; Approved Guideline—Third Edition. CLSI/NCCLS document GP26-A3.
Wayne, PA: NCCLS; 2004.
This training toolkit is based on the CLSI quality management system model and the
ISO 15189 standard.
Other There are many other standards organizations, and many examples of laboratory
standards standards. Some countries have established national laboratory quality standards that
apply specifically to laboratories within the country. Some laboratory standards apply
only to specific areas in the laboratory or only to specific tests. The World Health
Organization has established standards for some specific programs and areas.

Content Sheet 1-6: Summary
Quality Quality management is not new; it grew from the good works of innovators who
management defined quality over a span of 80 years. Quality management is as applicable for the
medical laboratory as it is for manufacturing and industry.
Key messages • A laboratory is a complex system and all aspects must function properly to achieve
quality.
• Approaches to implementation will vary with the local situation.
• Start with changes that can be easily accomplished and have the biggest impact.
• Implement in stepwise process but ultimately, all quality essentials must be
addressed.

2. Facilities and Safety
13
Content Sheet 2-1: Facilities and Safety Overview
Role in quality The laboratory work space and facilities

management must be such that its workload can be Organization Personnel Equipment
system performed without compromising the
quality of work and the safety of the
laboratory staff, other health care Purchasing Process Information
personnel, patients, and the community. &
Inventory
Control Management
This module will describe essential

elements for laboratory design and safety
that prevent and control exposure to Documents
&
Occurrence
Management
Assessment
physical, chemical, and biological Records
hazards.
This module addresses pathogens and Process Customer Facilities
Improvement Service &
chemicals of moderate or low level risk Safety
rather than highly dangerous substances.

As a general rule, all diagnostic
laboratories should be designed and
organized for biosafety level 2, or above.
Importance of A laboratory safety program is important in order to protect the lives of employees and
safety patients, to protect laboratory equipment and facilities, and to protect the environment.
Negligence of laboratory safety is very costly. Secondary effects of a laboratory accident are:
• loss of reputation
• loss of customers / loss of income
• negative effect on staff retention
• increased costs–litigation, insurance.
Responsibilities Ensuring quality and safety during laboratory processes is a major concern for
laboratory managers. Often, the laboratories they manage are designed by architects
and/or administrators who have little knowledge of specific laboratory needs, making
the job of the manager more difficult.
As a Laboratory director, it is important to:
• actively participate in the design and planning stages of new laboratory facilities;
• assess all potential risks and apply basic concepts of organization in order to provide a
proper and safe environment for conducting laboratory activities, including services
to patients;
• consider the organization of the laboratory when developing new activities or new
diagnostic techniques in the laboratory.
As a Quality manager (or designated Safety Officer), it is necessary to:

Facilities and Safety ● Module 2 ● Content Sheet 14
• develop a complete and thorough description of basic safety rules and organization
and ensure that personnel are trained in their specific duties when new activities or
techniques are introduced into the laboratory;
• know the basics of safety and biosafety management issues when working with
chemicals and pathogens of moderate or low level of risk;
• know how to perform an extensive risk assessment when developing new activities in
the laboratory;
• conduct laboratory safety audits.
As a Laboratorian it is important to:

• be aware of basic safety rules and processes;
• understand the basics of safety and biosafety management issues when working with
toxic chemicals, biological samples, physical hazards, and when interacting with
patients.
Everyone in the laboratory is responsible for quality and safety.

Content Sheet 2-2: Laboratory Design
Access When designing a laboratory or organizing workflow, ensure that patients and patient
samples do not have common pathways. Circulation paths should be designed in such a
way that contact between the public and biological materials can occur only in the
rooms where patient samples are collected. The reception desk where incoming patients
register should be located as close as possible to the entry door.
Access to rooms where manipulation or analysis of samples takes place or where

hazardous chemicals or other materials are stored must be restricted to authorized
persons, usually laboratory technical staff and maintenance staff.
Restriction of access may be accomplished using signs on doors, locks when
appropriate, and staff identification badges.
Circulation To identify where improvements in laboratory design may be needed in order to prevent
pathways or reduce risks of cross-contamination, follow the path of the sample as it moves
through the laboratory during the pre-examination, examination, and post-examination
phases of testing. Pathways to assess include
• Sample collection areas—A laboratory layout with both the reception and the
sample collection room located at the entrance saves time and energy.
• Sample processing areas—Here, samples are centrifuged, as needed, allocated for
different examinations, and dispersed to the appropriate sections of the laboratory
for analysis. If possible, locate the sample processing area separated from but nearby
the testing areas.
• Circulation pathways of biological samples between different sections of the
laboratory—These pathways should be assessed for the purpose of minimizing
contamination risks. If possible, circulation pathways of clean and dirty laboratory
materials should never cross, and circulation pathways of contaminated waste
should be isolated.
• Post-examination pathways—After the analysis of the samples, the results must be
accurately recorded, properly filed, and delivered on time to the right person.
Communication systems appropriate to the size and complexity of the laboratory
including the efficient and reliable transferring of messages should be part of the
laboratory design.
For the most efficient design, all related services should be located in close
proximity.

Content Sheet 2-3: Geographic or Spatial Organization
Distribution of When organizing laboratory work space, divide the laboratory into areas with different
activities access control in order to separate patients from biological samples. Where samples are
actually processed, plan for spatial organization that ensures the best service.
For optimal organization of the laboratory, consider.

• Delineation of laboratory activities—Care should be taken to either group related
activities in a single room, or to clearly delineate bench space for specific activities.
Measures must be taken to prevent cross-contamination of samples.
• Location of service rooms—Service rooms to accommodate autoclaves, sinks for
cleaning glassware, preparation and sterilization of culture media, and others, should
be located in a central area to minimize distances and facilitate circulation paths of
materials, samples, and goods. A responsible staff member should be designated to
oversee cleaning and maintenance of the service rooms.
• Location of activities with specific requirements, such as:
o molecular biology—needs to be located in a separate space, with at least two
rooms, so that preparation of DNA extracts is not performed in the same room as
where the subsequent steps (preparation of reagent mixes and DNA
amplification) are performed;
o fluorescence microscopy—requires a dark room with proper ventilation; it must
not be used for storage of stock materials and other chemicals;
o UV illumination systems for DNA gel photography—requires a dark room and
appropriate eye protection equipment.
Spatial The Laboratory director and Safety Officer must consider special needs for equipment
provision for when designing laboratory space. Some things to consider are:
equipment
• access to equipment for entry and maintenance—Make sure that there are no
physical restrictions for access such as door and elevator size that could pose a
problem for the delivery and maintenance of new machines and equipment.
• power supply—Consider the need for a stable power supply for sensitive equipment,
and a back-up power supply or emergency generator for times when the laboratory’s
primary power source is down.
• managing disposal of liquids from equipment—Disposal of liquid reagents, by-
products, and wastes from laboratory equipment and procedures is a major concern
for laboratories. When placing equipment in the laboratory, be sure to consider how
liquid wastes will be handled. It is important to be aware of, and comply with, local
and national requirements for liquid waste disposal, in order to prevent
contamination of community sewage systems with pathogens or toxic chemicals.

Content Sheet 2-4: Physical Aspects of Premises and
Rooms
Facilities The laboratory must be designed to ensure proper ventilation throughout, with an active
ventilation system, and adequate space for circulation of persons and laboratory carts
and trolleys.
Rooms should have a high ceiling to ensure proper ventilation, and walls and ceilings
should be painted with washable, glossy paint or coated with a material suitable for
cleaning and disinfection. The floor must also be easy to clean and disinfect, and have
no edges between the walls and floor.
Work benches Laboratory work benches should be constructed of materials that are durable and easy to
disinfect. If the laboratory’s budget allows, ceramic tiles are good materials to use for
benchtops, as they are easy to clean and are resistant to deterioration from harsh
disinfectants and aggressive cleaning products. However, be aware that the grout
between them can sometimes harbor contaminating microorganisms, so must be
disinfected regularly.
Wood should not be used, as it is not easy to clean or to disinfect, and will deteriorate
over time when repeatedly exposed to disinfectants and detergents. Wood also harbors
growth of contaminants when wet or damaged.
The disadvantage of using steel for benchtops is that steel will rust when washed with
chlorine.
It is advisable to organize work benches according to the type of analysis that is
performed, with adequate space for benchtops equipment and enough space to place
SOP while in use and display job aids. In areas where microbiology procedures are
performed, work benches should be separated by the different types of samples or
pathogens that are analyzed in order to minimize risks of cross-contamination.
Cleaning It is very important that all areas of the laboratory be cleaned and maintained on a
regular basis. Examples of areas that need daily attention are:
• benchtops—Clean and disinfect benchtops after completing examinations, and after
any spills of samples or reagents. This responsibility is generally assigned to the
technical staff performing the tests.
• floors—These are usually cleaned by cleaning staff, unless restricted access allows
only technical staff to disinfect the floors at the end of the day.
Other areas of the laboratory should be scheduled for cleaning on a weekly or monthly
basis, depending on laboratory conditions. For example, ceilings and walls may require
cleaning weekly, whereas items such as refrigerators and storage areas might be
scheduled for a monthly cleaning.
Cleaning and disinfection of laboratory areas should be recorded, including the date and
name of the person performing the maintenance.

Content Sheet 2-5: Safety Management Program
Developing a Often, the responsibility for developing a safety program and organizing appropriate
laboratory safety measures for the laboratory is assigned to a laboratory safety officer. In smaller
safety laboratories, the responsibility for laboratory safety may fall to the laboratory manager
program or even to the quality officer. The steps for designing a safety management program
include.
• Developing a manual to provide written procedures for safety and biosafety in the
laboratory.
• Organizing safety / biosafety training and exercises that teach staff to be aware of
potential hazards and how to apply safety practices and techniques. Training should
include information about universal precautions, infection control, chemical and
radiation safety, how to use personal protective equipment (PPE), how to dispose of
hazardous waste, and what to do in case of emergencies.
• Setting up a process to conduct risk assessments. This process should include initial
risk assessments, as well as on-going laboratory safety audits to look for potential
safety problems that can be corrected.
General safety The Safety Officer should be assigned responsibility for ensuring that there is an
equipment adequate supply of appropriate equipment for safety and biosafety, such as:
• personal protective equipment (PPE)
• fire extinguishers and fire blankets
• appropriate storage and cabinets for flammable and toxic chemicals
• eye washers and emergency shower
• waste disposal supplies/equipment
• first aid equipment.
Standard Policies should be put in place that outline the safety practices to be followed in the
safety laboratory. Standard laboratory safety practices include the following.
practices
• Limiting or restricting access to the laboratory.
• Washing hands after handling infectious or hazardous materials and animals, after
removing gloves, and before leaving laboratory.
• Prohibiting eating, drinking, smoking, handling contact lenses, and applying
cosmetics in work areas.
• Prohibiting mouth pipetting.
• Using techniques that minimize aerosol or splash production when performing
procedures. Biosafety cabinets should be used whenever there is a potential for
aerosol/splash creation or when high concentrations/ large volumes of infectious
agents are used.
• Preventing inhalation exposure by using chemical fume hoods or other containment
devices for vapors, gases, aerosols, fumes, dusts, or powders.
• Properly storing chemicals according to recognized compatibilities. Chemicals
posing special hazards or risks should be limited to the minimum quantities
required to meet short-term needs and stored under appropriately safe conditions
(i.e. flammables in flammable storage cabinets). Chemicals should not be stored on
the floor or in chemical fume hoods.
• Securing compressed gas cylinders at all times.
• Decontaminating work surfaces daily.
• Decontaminating all cultures, stocks, and other regulated wastes before disposal via
autoclave, chemical disinfection, incinerator, or other approved method.
• Implementing and maintaining an insect and rodent control program.
• Using PPE such as gloves, masks, goggles, face shields, and laboratory coats when
working in the laboratory.
• Prohibiting sandals and open-toed shoes to be worn while working in the
laboratory.
• Disposing of chemical, biological, and other wastes according to laboratory
policies.
Procedures, Monthly and yearly exercises must be organized for fire drills and laboratory
exercises evacuation procedures. This is an occasion for the Safety Officer to emphasize risks to
laboratory staff and to review with them the specific procedures for evacuation,
handling of incidents, and basic security precautions.
Waste Laboratory waste management is a critical issue. All potentially harmful and
Management dangerous materials (including liquids and radioactive materials) must be treated in a
specific way before disposing. Separate waste containers should be used depending on
the nature of the waste, and must be clearly identified by a color code. Specific
attention should be given to the management of potentially harmful contaminated waste
such as sharps, needles, or broken glassware. Sharps containers must be available on
the work benches so they are conveniently accessible to staff.
Internationally Many labels that give warnings and instructions for safety precautions are
recognized internationally recognized and can be found at the following websites:
labels
http://www.ehs.cornell.edu/lrs/lab_dot_labels/lab_dot_labels.cfm
http://ehs.unc.edu/labels/bio.shtml
http://www.safetylabel.com/safetylabelstandards/iso-ansi-symbols.php

Content Sheet 2-6: Identification of Risks
Laboratories Laboratory workers encounter risks in significant numbers; the risks vary with the types
are hazardous of activities and analyses that are performed.
environments
Risk assessment is compulsory for the laboratory director in order to manage and
reduce risks to laboratory employees. Assistance from a safety officer is needed to
appreciate potential risks and incorporate appropriate preventive measures. It is
important to develop safety procedures that describe what to do in case of accidents,
injuries, or contamination. In addition, it is important to keep a record of staff
exposures to hazards, actions taken when this occurs, and procedures put into place to
prevent future occurrences.
An outcome of a study of
physical risks encountered
by laboratory staff that
was conducted by the
Howard Hughes Medical
Institute, Office of
Laboratory Safety is
shown in the chart. This
study only addressed
physical risks, but
personnel contamination
and infection have been reported in many instances, and recent reports on laboratory-
acquired infection by SARS show that the risks are never reduced to zero, even in high
confinement facilities.
Physical Laboratory equipment is a significant source of potential
hazards injury to laboratory staff, thus making training on specific
safety procedures imperative. Examples of equipment in
which safety training and precautions are important include
autoclaves, centrifuges, compressed gas cylinders, and fume
hoods. Many laboratory instruments pose a danger of
electrical shock, and some equipment can emit dangerous
microwaves or radiation, if not properly used or maintained.
Storage of compressed gases in the laboratory requires
precautions unique to the unusual containers in which these
materials are kept, and the high pressures to which they are
subject. Cylinders are kept chained to the wall so that they
cannot fall over. The safety caps must be secured over the valve of the cylinder
whenever a gas bottle is moved or taken out of service.
Needles and Needles, broken glass, and other sharps need to be handled and disposed of
sharps appropriately to prevent risks of infection to laboratory and housekeeping (custodial)
staff. For proper disposal of sharpsthe following instructions should be followed.
• Needle recapping is not advisable or necessary. If recapping is crucial, the correct
procedure is for the person doing the recapping to keep one hand behind the back,
and using the other hand to scoop the cover onto the needle.
• Put sharps in a puncture-resistant, leak-proof, sharps container. Label the container
with the word, "SHARPS”. If the sharps are not biohazardous, deface any
BIOHAZARD markings or symbols, and then seal the container tightly.
Laboratory glass and plastic ware are not considered to be sharps for disposal purposes.
Laboratory glass (including plastic ware) is any item that could puncture regular waste
bags and therefore endanger waste handlers. Laboratory glass must be placed in sturdy
cardboard boxes for safety during transport through the building. Any cardboard box
may be used, provided it is sturdy and of a size that will not weigh more than
40 pounds when full.
Contaminated laboratory glass must be appropriately decontaminated prior to disposal.
Never use boxes for the disposal of:
• sharps;
• biohazardous materials that have not been autoclaved;
• liquid wastes;
• chemically contaminated laboratory glassware / plastic ware;
• chemical containers that cannot be disposed of as regular solid waste.
Chemical Exposure to toxic chemicals poses a real threat to the health and safety of laboratory
hazards staff. There are three main routes in which chemicals enter the body.
• Inhalation—This is the major route of entry when working with solvents; there is
great rapidity of absorption when fumes are inhaled.
• Absorption through skin—This may produce systemic poisoning; the condition of
the skin determines the rate of absorption. Examples of chemicals with these risks
are organic lead, solvents such as xylene and methylene chloride, organophosphate,
pesticides, and cyanides.
• Ingestion—Accidental ingestion is generally due to poor hygiene practices, such as
eating or smoking in the laboratory.
To prevent or reduce incidents caused by exposure to toxic chemicals, all chemicals,
including solutions and chemicals transferred from their original containers, should be
labeled with their common names, concentrations, and hazards. Additional information
such as the date received, date opened, and date of expiration should also be recorded.
It is crucial that chemicals be stored properly. Store corrosive, toxic, and highly
reactive chemicals in a well-ventilated area, and store chemicals that can ignite at room
temperature in a flammables cabinet.
Radiochemicals require special precautions, and need dedicated benches with specific
bench covers for manipulation of radiolabelled elements. Specific storage areas for
radioactive materials are needed. These must provide appropriate protection
(plexiglass, lead) and specific waste containers, depending on the chemical nature of
waste and radio elements.
Material The Material Safety Data Sheet (MSDS) is a technical bulletin providing detailed
Safety Data hazard and precautionary information. 4 Businesses
Sheet are required to provide to their customers the MSDS
for all chemicals they manufacture or distribute.
Laboratories need to heed precautions listed in the
MSDS in order to ensure the chemicals they use are
handled and stored safely.
The MSDS provides the following information:
• product information
• fire and explosion precautions
• toxicology
• health effects
• personal protective equipment (PPE)
that is recommended
• storage recommendations
• leaks and spills—recommended
actions
• waste disposal recommendations
• first aid.
Material Safety Data Sheets should be:

• available to all employees prior to use of hazardous materials;
• kept close to where the hazardous material is used and located.
Biological Laboratory-acquired infections are not infrequent in medical laboratories. The table
hazards shows the most frequently reported
infections acquired in laboratories in the Disease or Agent No. of
United States from 1979 to 1999. 5 Cases
Mycobacterium tuberculosis 223
Q fever 176

Hantavirus 169
Hepatitis B virus 84
Aerosols are the main sources of Brucella sp. 81
contamination within diagnostic
laboratories; contamination can occur Salmonella sp. 66
over very long distances. This is why the Shigella sp. 56
major target of containment systems is
Hepatitis non-A, non-B 28
the blockage of aerosol diffusion in and
outside the laboratory. Diagnostic Cryptosporidium sp. 27
laboratories of containment level 2, Total 1074
where activities concern only pathogens
of moderate risks, must have appropriate ventilation. Higher containment level
laboratories or working cabinets must ensure a continuous inward air flow as well as an
absolute filtration of exhausted air, to avoid aerosol dissemination outside the working
area and/or the whole laboratory.6
Disease Probable Max Distance Number

Source from Source Infected
Brucellosis Centrifugation Basement to 3rd floor 94
Coccidioidomycosis Culture transfer 2 building floors 13
solid media
Coxsackie Spilled tube of infected mouse 5 feet estimated 2
Virus infection tissue on floor
Murine Typhus Intranasal inoculation of mice 6 feet estimated 6
Tularemia 20 petri plates dropped 70 feet 5
Venezuelan 9 lyophilized 4th floor stairs to 3rd or 24
encephalitis ampoules dropped 5th floor

Content Sheet 2-7: Personal Protective Equipment
(PPE)
Basic The major routes in which laboratory staff acquire work-related infections are:
information
• inhalation of aerosols generated by accident or by work practices;
• percutaneous inoculation;
• contact between mucous membranes and contaminated material;
• accidental ingestion.
To reduce the risk of these occurrences, it is imperative that staff have access to
personal protective equipment (PPE), be trained in how to properly use it, and
habitually use the PPE while working in the laboratory. Approved goggles, face shields,
splatter guards, masks, or other eye and face protection should be worn when handling
infectious or other hazardous materials outside the biosafety cabinet.
Hand Gloves should be worn in all instances, and be available to laboratory staff on a routine
protection basis. Effective use of gloves, however, relies on two simple practices.
1. Remove gloves when leaving the working area to prevent contamination of other
areas such as the telephone, door handles, and pens.
2. Never re-use gloves. Do not attempt to wash or decontaminate gloves — they will
develop microcracks, become more porous, and loose their protective properties.
After use, gloves must be disposed of in the contaminated waste.
Face Goggles—The projection of droplets is a frequent occurrence when opening patient

protection sample containers. Protection of eyes and other mucous membranes is strongly
recommended to prevent contact with these droplets; the use of goggles will protect
eyes and should be systematic for this step.
Another way to protect eyes and other mucous membranes from projection is to
manipulate the specimen tubes behind a screen, glass or plexiglass, or face shield. This
equipment should be compulsory as well, when manipulating dangerous liquids, such as
liquid nitrogen or some solvents.
Contact lenses do not offer protection from splashes. Additional eye protection must be
worn with contact lenses.
Masks—Masks serve as a barrier when splashes or sprays occur.
Body Laboratory coats are compulsory in all instances in the regular level 2 laboratory. Be
protection aware of the composition of fabrics, as some might be highly flammable.
A disposable laboratory coat is compulsory in level 3 laboratories or in specific instances
such as sample collection when highly dangerous pathogens can be involved, such as
suspected cases of H5N1 avian influenza or severe acute respiratory syndrome (SARS).

Content Sheet 2-8: Emergency Management and First
Aid
Emergencies Laboratories need to have procedures in place for how staff should deal with
accidents and emergencies. General written procedures for first aid should be
developed and made available to all staff so they know the first things to do, and
that whom to call or notify in case of minor cuts and bruises, major wounds, or skin
contamination.
Chemical A chemical spill is considered to be minor only if the person who spilled it is
spills familiar with the chemical, knows the associated hazards, and knows how to clean
up the spill safely. The recommended steps for dealing with a minor spill include:
• alert coworkers, then clean up spill;
• follow procedures for disposal of materials used to clean up spill;
• absorb free liquids with an appropriate absorbent, as follows:
o caustic liquids—use polypropylene pads or diatomaceous earth;
o oxidizing acids—use diatomaceous earth;
o mineral acids—use baking soda or polypropylene pads;
o flammable liquids—use polypropylene pads.
• neutralize residues and decontaminate the area.
Anything beyond a minor spill and requiring help from outside of the laboratory
group constitutes a major spill. Steps to deal with major spills include alerting
co-workers, moving to a safe location, and calling authorities to report the situation.
Biological When surfaces are contaminated by biological spills, the appropriate actions to
spills take are:
1. define/isolate the contaminated area;
2. alert co-workers;
3. put on appropriate PPE;
4. remove glass/lumps with forceps or scoop;
5. apply absorbent towel(s) to the spill; remove bulk and reapply if needed;
6. apply disinfectant* to towel surface;
7. allow adequate contact time (20 minutes);
8. remove towel, mop up, and clean the surface with alcohol or soap and water;
9. properly dispose of materials;
10. notify the supervisor, safety officer, and other appropriate authorities.

* Disinfectant:
For most spills, use a 1:100 solution of household bleach (hypochlorite).
For spills containing large amounts of organic material, use a 1:10 solution of
household bleach, or an approved mycobactericidal. Suggested sources of
mycobacteriocidals are registered with the US Environmental Protection Agency
(http://www.epa.gov/oppad001/chemregindex.htm).
Alcohols are not recommended as surface decontaminates because they evaporate
quickly, thus decreasing “contact time”.
If laboratory personnel become contaminated with biological hazards due to

splashes or spills, immediate steps to take include:
1. clean exposed skin or body surface with soap/water, eyewash (for eye
exposures), or saline (for mouth exposures);
2. apply first aid and treat as an emergency;
3. notify supervisor, safety officer, or security desk (after hours);
4. follow appropriate reporting procedures;
5. report to physician for treatment/counseling.
Laboratory Laboratory personnel need to be alert for conditions that might pose a risk for fires.
fires Keep in mind that liquids with low flash points may ignite if they are near heat sources
such as hot plates, steam lines, or equipment that might produce a spark or heat.
A small laboratory fire is considered to be one that is extinguishable within

1-2 minutes. The appropriate action to take is to cover the fire with an inverted
beaker or wet paper towels. If this fails, use a fire extinguisher. For large fires, call
the appropriate local authorities, usually the fire department and the police
department.
Laboratories should have the appropriate class of extinguisher for the fire
hazards in the laboratory. In general, a class BC or class ABC extinguisher is
appropriate. Fire extinguishers must be inspected annually and replaced as
needed. Laboratory personnel should be trained on the various classes of fires
and basic fire extinguisher use in annual Laboratory Safety and Hazardous
Waste Management Training.
All laboratory personnel must learn how to operate a portable fire

extinguisher.

Summary When designing a laboratory or organizing workflow, ensure that patients and patient
samples do not have common pathways. To identify where improvements in laboratory
design may be needed in order to prevent or reduce risks of cross-contamination, follow
the path of the sample as it moves through the laboratory during the pre-examination,
examination, and post-examination phases of testing.
The design of laboratory work areas should ensure proper ventilation, surfaces that can
be cleaned and disinfected.
In establishing a safety management program, it is important to appoint a responsible
supervisor. The laboratory should have a safety manual that establishes policy and
describes standard procedures for handling safety and emergency issues. Personnel need
to be trained in how to apply safety practices and techniques, and to be aware of potential
hazards.
Key message Neglecting laboratory safety is costly. It jeopardizes the lives and health of employees
and patients, and jeopardizes laboratory reputation, equipment and facilities.

3. Equipment
Content Sheet 3-1: Equipment Management Overview
Role in Equipment management is one of

quality the essential elements of a quality
management management system. Proper
system management of the equipment in
the laboratory is necessary to
ensure accurate, reliable, and timely
testing.
The benefits of a good equipment
management program are many:
• helps to maintain a high level

of laboratory performance;
• reduces variation in test
results, and improves the
technologist’s confidence in
the accuracy of testing results;
• lowers repair costs, as fewer
repairs will be needed for a well-maintained instrument;
• lengthens instrument life;
• reduces interruption of services due to breakdowns and failures;
• increases safety for workers;
• produces greater customer satisfaction.
Program A great deal of thought and planning should go into equipment management.
considerations
As the laboratory puts an equipment management program in place the following
elements should be considered:
• Selection and purchasing—When obtaining new equipment what criteria should
be used to select equipment? Should equipment be purchased, or would it be
better to lease?
• Installation—For new equipment, what are the installation requirements, and
who will install the new instrument?
• Calibration and performance evaluation—What is needed to calibrate and
validate that the equipment is operating correctly? How will these important
procedures be conducted for both old and new instruments?
• Maintenance—What maintenance schedule is recommended by the
manufacturer? Will the laboratory need additional preventive maintenance
procedures? Are current maintenance procedures being conducted properly?
Equipment ● Module 3 ● Content Sheet 30

• Troubleshooting—Is there a clear procedure for troubleshooting for each
instrument?
• Service and repair—What is the cost? Can the laboratory obtain the necessary
service and repair in its geographical area?
• Retiring and disposing of equipment—What must be done to dispose of old
equipment when it needs to be replaced?
Oversight It is the responsibility of the laboratory director to:
• oversee all the equipment management systems in the laboratory;
• ensure that all persons who will be using the instruments have been
appropriately trained and understand how to both properly operate the
instrument and perform all necessary routine maintenance procedures.
Equipment management responsibility may be specifically assigned to a

technologist in the laboratory. In many laboratories there is a person who has good
skills with equipment maintenance and troubleshooting. Giving this person the role
of oversight of all equipment is recommended.
Oversight of an equipment management program includes:

• assigning responsibilities for all activities;
• assuring that all personnel are trained on operation and maintenance;
• monitoring the equipment management activities:
o review all equipment records routinely;
o update maintenance procedures as necessary;
o ensure that all procedures are followed.
Note: day-to-day maintenance should be the responsibility of the technical operator.

Everyone who uses the equipment should be trained in calibration and daily
maintenance.

Content Sheet 3-2: Selecting and Acquiring Equipment
Selecting Selecting the best instrument for the laboratory is a very important part
equipment of equipment management. Some criteria to consider when selecting
laboratory equipment are listed below.
• Why and how will the equipment be used? The instrument should be
matched against the service the laboratory provides.
• What are the performance characteristics of the instrument? Is it
sufficiently accurate and reproducible to suit the needs of the testing
to be done?
• What are the facility requirements, including the requirements for
physical space?
• Will the cost of the equipment be within the laboratory’s budget?
• Will reagents be readily available?
• Will reagents be provided free of charge for a limited period of time?
If so, for how long?
• How easy will it be for staff to operate?
• Will instructions be available in a language that is understood?
• Is there a retailer for the equipment in the country, with available
services?
• Does the equipment have a warranty?
• Are there any safety issues to consider?
If the decisions about purchasing are made outside the laboratory, for
example by a central purchasing body, the laboratory manager should
provide information that will support selecting equipment that will best
serve the needs of the laboratory. In areas where there are national
programs for purchasing standard equipment, the laboratories of the
country should have some input to decisions. In addition, in areas where
donors are likely to provide some of the equipment that is used,
laboratory management should have input into choice of equipment. If
this is not possible, management should consider declining equipment, if
inappropriate for laboratory needs.
Acquiring Is it better to purchase, rent or lease equipment? When making this

equipment decision, it is a good idea to factor in repair costs. 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.
The manufacturer should provide all of the necessary information to
operate and maintain equipment.
Before purchasing ask if:

• wiring diagrams, computer software information, a list of parts
needed, and an operator’s manual are provided;
• the manufacturer will install the equipment and
train staff (covering travel expenses as necessary)
as part of the purchase price;
• the warranty includes a trial period to verify that
the instrument performs as expected;
• the manufacturer’s maintenance can be included in the contract and
if so, whether maintenance is provided on a regular basis.
Determine if the laboratory can provide all the necessary physical
requirements, such as electricity, water, and space. There must be
adequate room to move the equipment into the laboratory; consider door
openings and elevator access.
Installing Before equipment is installed, verify that all physical requirements

equipment (electrical, space, doors, ventilation, and water supply) have been met.
Other things to consider are:
• The vendor’s responsibilities for installation should be confirmed in
writing prior to beginning the installation process.
• A checklist of the expected performance specifications should be
developed, so that performance can be quickly verified as soon as
the equipment is installed.
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:
• check that the package contents contain all of the parts;
• make a copy of any software that is part of the system;
• do not allow the equipment to be used before it is completely
installed, performance is verified, and testing personnel are trained.

Content Sheet 3-3: Getting Equipment Ready for Service
After After equipment has been installed, the following details need to be addressed
installation before putting the equipment into service:
• assign responsibility for performing the maintenance and operation
programs;
• develop a system for recording the use of parts and supplies (see
Module 4- Purchasing
and Inventory
Overview);
• implement a written
plan for calibration,
performance
verification, and proper
operation of the
equipment;
• establish a scheduled
maintenance program
that includes daily, weekly, and monthly maintenance tasks;
• provide training for all operators; only personnel who have been
trained specifically to properly use the equipment should be authorized
as operators.
Designate those authorized to use the equipment and when it is to be used.
Equipment Follow the manufacturer’s directions carefully when performing the initial
calibration calibration of the instrument. It is a good idea to calibrate the instrument
with each test run, when first putting it into service. Determine how often
the instrument will need to be recalibrated, based on its stability and on
manufacturer’s recommendation. It may be advantageous to use calibrators
provided by or purchased from the manufacturer.
Performance Prior to testing patient specimens, it is important to evaluate the

evaluation performance of new equipment to ensure it is working correctly with
respect to accuracy and precision.
In addition, test methods using kits or laboratory instruments need to be

evaluated for the ability to detect disease (sensitivity, specificity, positive
and negative predictive value), and to determine normal and reportable
ranges.

Verification of manufacturers’ performance claims—Manufacturers
provide performance evaluations for testing methods using their kits or
instruments, and include the information in the package inserts or
operators’ manuals. However, laboratories need to verify the
manufacturers’ performance claims, and demonstrate they can get the
same results using the kits or equipment in their laboratory, with their
personnel.
Some of the steps that should be followed to verify performance include:

• testing samples with known values and comparing the results to the
expected or
certified value;
• if equipment is
temperature-
controlled,
establishing the
stability and
uniformity of the
temperature.
Validation of new
equipment and
associated
techniques—
If the equipment and/or associated techniques are new, validation

processes will be important. This can be carried out by running samples in
parallel on both previous and new equipment/methods for a period of time
to determine that the expected results can be obtained. These validation
procedures should be completely recorded.
Function In order to verify that equipment is working according to the

checks manufacturer’s specifications, it is necessary to monitor instrument
parameters by performing periodic function checks. This should be done
before using the instrument initially, then with the frequency
recommended by the manufacturer. These function checks should also be
done following any instrument repairs. Some examples of function checks
are daily monitoring of temperatures and checking the accuracy of
wavelength calibration.

Content Sheet 3-4: Implementing an Equipment Maintenance
Program
Preventive Preventive maintenance includes measures such as systematic and

maintenance routine cleaning, adjustment, and replacement of equipment parts at
scheduled intervals. Manufacturers generally recommend a set of
equipment maintenance tasks that should be performed at regular
intervals: daily, weekly, monthly, or yearly. Following these
recommendations will ensure that the equipment performs at maximum
efficiency and will increase the lifespan of the equipment. This will also
help to prevent:
• inaccurate test results due to equipment failure
• delays in reporting results
• lower productivity
• large repair costs.
Maintenance A maintenance plan will include preventive maintenance procedures as

plan well as provision for inventory, troubleshooting, and repair of equipment.
When implementing an equipment maintenance program, some of the
initial steps will include what follows.
• Assign responsibility for providing oversight.
• Develop written policies and procedures for maintaining equipment,
including routine maintenance plans for each piece of equipment.
The plan should specify the frequency with which all maintenance
tasks should be performed.
• Develop the format for records, create logs and forms, and establish
the processes to maintain records.
• Train staff on the use and maintenance of the equipment, and assure
that all staff understand their specific responsibilities.
It is recommended that a label be attached to the instrument indicating

when the next maintenance or service should be performed.
Equipment The laboratory should keep an inventory log of all equipment in the
inventory laboratory. The log should be updated with information on new
equipment, as it is added, and include documentation of when old
equipment is retired.
For each piece of equipment, the equipment inventory log should have a
record of:
• instrument type, make and model number, and serial number of the
instrument, so that any problems can be discussed with the
manufacturer;
• date the equipment was purchased, and whether it was purchased
new, used, or reconditioned;
• manufacturer/vendor contact information;
• presence or absence of documentation, spare parts, and maintenance
contract;
• warranty’s expiration date;
• specific inventory number indicating the year of acquisition; this is
especially useful for larger laboratories. For example, use the style
“YY-number” (04-001, 04-002, etc.) where “YY-number” equals the
last two numbers of the year followed by a number attributed in the
year.
An inventory process must be conducted if the laboratory does not have

an existing inventory system for equipment.
• This could be conveniently organized following a model grid room
by room, for example, reception, sampling, serology, and
parasitology.
• During the inventory, the condition of the equipment should be
documented as:
o functional
o partially functional, or
o non-functional. Equipment that is not functioning needs to be
evaluated as to whether or not it can be repaired. Non-repairable
equipment should be retired, and work should be scheduled for
equipment needing repair.
Inventory of To ensure that the laboratory does not run out of spare parts, an inventory
spare parts record of those used most frequently should be kept for each piece of
equipment. The record should include:
• part name and number;
• average use of the part, and the minimum to keep on hand;
• cost;
• date when the part is placed into storage, and when it is used (in and
out stock log);

• quantity of each part remaining in inventory.

Content Sheet 3-5: Troubleshooting, Service, Repair,
and Retiring Equipment
What is Problems with equipment may present in many ways. The operator may notice
the source subtle changes such as drift in quality control or calibrator values or obvious
of the flaws in equipment function. Sometimes, the equipment fails to operate. It is
problem? important to teach operators to troubleshoot equipment problems in order to
quickly get the equipment functioning and resume testing as rapidly as
possible.
When an operator observes instrument drift, it is important to repeat the
preventive maintenance procedures as a first step to resolve the problem. If this
does not work, proceed with troubleshooting processes.
Trouble- Manufacturers frequently provide a flowchart that can help determine the
shooting source of problems. Some of the questions to consider are listed below.
• Is the problem related to a poor sample? Has the sample been collected and
stored properly? Are factors such as turbidity or coagulation affecting
instrument performance?
• Is there a problem with the reagents? Have they been stored properly, and
are they still in date? Have new lot numbers been introduced without
updating instrument calibration?
• Is there a problem with the water or electrical supply?
• Is there a problem with the equipment?
Make one change at a time based on symptoms. If equipment is the problem,

review the manufacturer’s instructions to verify that all procedures are being
followed correctly.
When If problems cannot be identified and corrected in-house, attempt to find a way
problems to continue testing until the equipment can be repaired. Some ways to achieve
cannot be this are as follows.
corrected
• Arrange to have access to back-up instruments. It is often too costly for the
laboratory to have its own back-up instruments, but sometimes a central stores
agency can maintain back-up instruments to be shared throughout the local
area or country.
• Ask the manufacturer to provide a replacement instrument during repairs.
• Send the samples to a nearby laboratory for testing.
Be sure to notify the appropriate providers that that there are problems and that
there will probably be delays in completing the testing.

Do NOT use faulty equipment! Seek help from the
manufacturer or other technical expert.
Place a note on the equipment so all staff are aware
that it is not in use.
Service Manufacturers may provide service and repair of equipment that is purchased
and repair 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.
Routine service should be scheduled so as not to interrupt the flow of work.
Retiring It is very important to have a policy and

and procedures for retiring older laboratory
disposing equipment. This will usually occur when
of it is clear that the instrument is not
equipment functioning and is not repairable, or
when it is outmoded and should be
replaced with new equipment.
Once a piece of equipment is fully
retired and it has been determined that it
has no further usefulness, it should be
disposed of in an appropriate manner.
This last step is often neglected in laboratories, and old equipment
accumulates, taking up valuable space and sometimes creating a hazard.
When disposing of equipment, salvage any useable parts, particularly if the

equipment is being replaced with another similar one. Then consider any
potential biohazards, and follow all safety disposal procedures.

Content Sheet 3-6: Equipment Maintenance Documentation
Developing Equipment documents and records are an essential part of the quality
documents system. The policies and procedures for maintenance should be defined
and policies in appropriate documents, and keeping good equipment records will
for allow for thorough evaluation of any problems that arise. (Module 16:
recordkeeping Documents and Records)
Each major piece of equipment will have its own equipment
maintenance document. Smaller, commonly used equipment such as
centrifuges and pipettes may be managed with an equipment
maintenance document or manual that deals with all such equipment in
the laboratory.
An equipment maintenance document should include:
• step-by-step instructions for routine maintenance, including
frequency of performance, and how to keep records of performance;
• instructions for carrying out function checks, frequency of
performance, and how to record the results;
• directions for calibrating the instrument;
• guide for troubleshooting;
• any required manufacturer’s service and repair;
• list of any specific items needed for use and maintenance, such as
spare parts.
For major equipment, include identification of the specific instrument,

and perhaps information on its performance.
Recording Each piece of equipment should have a dedicated logbook documenting

maintenance all characteristics and maintenance elements:
information
• preventive maintenance
activities and schedule;
• recording of function
checks and calibration;
• any maintenance performed
by the manufacturer;
• full information on any
problem that the instrument
develops, the subsequent
troubleshooting activity,
and follow-up information regarding resolution of the problem. In
recording problems, be sure to record:
o date problem occurred, and when equipment was removed from
service;
o reason for breakdown or failure;
o corrective action taken; including a note about any service
provided by the manufacturer;
o date returned to use;
o any changes to procedure for maintenance or function checks as
a result of the problem.
Some of the tools that are helpful for keeping records on equipment
management are:
• charts
• logs
• checklists
• graphs
• service reports.
The log book should be available for review during the entire life of the
equipment.

Summary All laboratories should have a well-organized equipment management

program. The program should address equipment selection, preventive
maintenance, and procedures for troubleshooting and repair.
It is essential that good documents and records be maintained. These will
include a complete and accurate inventory of all laboratory equipment,
documents provided by the manufacturer on operation, maintenance, and
troubleshooting, and records of all preventive maintenance and repair
activities.
Key • A good equipment maintenance program results in a high level of

messages performance and greater confidence in the reliability of results.
• A significant benefit to the laboratory will be fewer interruptions in test
performance, lower repair costs, and elimination of premature
replacement of equipment.
• Increased safety for laboratory workers will result from well-maintained
equipment.

4. Purchasing and Inventory
Content Sheet 4-1: Purchasing and Inventory Overview
Role in quality Purchasing and inventory

management management is a critical, or
systems essential, component of the quality
management system.
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.
Benefits Careful management of inventory helps to prevent waste, which can occur if reagents
and supplies are stored improperly, or if reagents become out-dated before they can be
used. Establishing a purchasing and inventory management program will ensure that:
• supplies and reagents are always
available when needed;
• high quality reagents are obtained at
an appropriate cost;
• reagents and supplies are not lost to
improper storage or kept and used
beyond expiration.
Considerations 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 laboratory system for managing the reagents and supplies must take into account
these variables.
Challenges The challenge of inventory management is balancing the availability of supplies and
Purchasing & Inventory ● Module 4 ● Content Sheet 45
reagents in stock with their expiration dates. The life-span 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' and
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.
Key Successful purchasing and inventory management requires that policies and
components procedures be
established for
managing all critical
materials and services.
Some of the key
components to address
are:
• vendor/manufacturer
qualifications;
• purchase agreements;
• receiving, inspecting,
testing, storing, and handling of materials; all purchased material should be
inspected and appropriately tested to ensure that specifications are met. Policies
should be established for storing and handling materials as they are delivered to the
laboratory.
• 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.
• assessing and maintaining inventory;
• controlling expiration periods;
• dispatching supplies to satellite laboratories.

Content Sheet 4-2: Purchasing
Selecting It is very important to set expectations and build and maintain relationships with
vendors providers of materials and services. Laboratories that purchase directly should look
very carefully at vendors’ and manufacturers’ qualifications, examining such things as
specifications and methods of transport. Laboratories that receive reagents and
supplies from a central stores area managed by their government should interact with
those managing the central stores area to accomplish these same objectives.
At the outset, the laboratory should:
• define criteria for supplies or materials to be purchased;
• look for the best price, taking into account the qualifications and credibility of the
supplier;
• consider the advantages and disadvantages of purchasing “brand name” vs.
“generic” products, e.g., is it better to purchase specific pipette tips for a specific
pipette, or is it just as effective to use generic pipette tips that cost less?
It may be useful to seek information from other laboratories when considering quality,
reliability of supply, and cost.
It is equally important to evaluate vendors after purchase. Consider such factors as
whether the vendor delivered the specified goods, or whether the central procurement
body assured that user specifications were met.
Considerations When setting up procedures for

purchasing, there are a number
of considerations:
• understand any local or
national government
requirements that need to be
accommodated in the
contracts;
• negotiate for the best price
without undermining
quality;
• carefully review all contracts to make sure the laboratory’s requirements are being
met;
(Contracts should clearly address payment mechanisms and provisions to assure
reliable availability and delivery of reagents and supplies. Ask if there are penalties
for ending a contract.)
• determine how payments will be made, and how the vendor will assure reliable
availability and delivery of supplies and reagents.

Content Sheet 4-3: Implementing an Inventory Management Program
Implementation In establishing an inventory control program, there are a number of factors to consider. A
steps 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 re-order.
The following are important steps for
implementation:
• assign responsibility–without this,
nothing may get done;
• analyze the needs of the laboratory;
• establish the minimum stock needed
for an appropriate time period;
• develop needed forms and logs;
• establish a system for receiving, inspecting, and storing supplies;
• maintain an inventory system in all storage areas, and for all reagents and supplies
used in the laboratory.
Analyze A laboratory needs a process for analyzing its needs for materials; and for determining
needs 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. The information necessary for
analyzing needs includes:
• a complete description of each item used;

• 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;
• approximate usage per month (quantification), for example, 6 boxes used per month;
• the priority or importance level the item has in doing the work of the laboratory-is it
used every day or only once a month?
• length of time required to receive a delivery-will the order take a day, week, or month
to arrive?
• storage space and conditions-will a bulk order use too much storage space? Does the
item require storage in a refrigerator?

Content Sheet 4-4: Quantification
Quantification How can a laboratory determine how much of any particular item to order?
Why?
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:
• ensure essential supplies will be available when needed;
• prevent overstocking, which can lead to wastage of expensive materials.
Quantification provides information for:
• estimating annual budget requirements;
• allowing for better planning;
• making decisions and monitoring performance of the inventory management
system.
Quantification Quantification is performed when making annual plans for the laboratory and this
When? 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.
Quantification The two frequently used methods are consumption-based quantification and
How? morbidity-based quantification.
Consumption-based quantification
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.

For planning, it is a good idea to consider whether any supplies or reagents have
been out of stock for more that 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.
Morbidity-based quantification
In using the morbidity-based quantification method, 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.
A good morbidity-based quantification method is more accurate than the

quantification by consumption method, but it depends on accurate data.

Content Sheet 4-5: Forms and Logs
Developing Developing an appropriate recordkeeping system is an important step for inventory

forms and logs management. Good tools for managing the stock include:
• standardized forms
• card systems
• log books.
For any system that is used, the following information should be recorded:
• date reagent or set of supplies are received;

• lot numbers for all supplies, reagents, and kits;
• pass or fail acceptance criteria;
• date the lot number or box of supplies was put into service, or if not usable, the date
and method of disposition.
See Annex 4-A: Inventory log form example, Annex 4-B: Supplies request form example.
Logbook The stock logbook or card system will provide a way to keep track of all supplies and
reagents that are on hand at any given time. In addition to information mentioned above,
it is a good idea to record:
• name and signature of the person receiving materials;

• date of receipt;
• expiration date;
• quantity of the material received;
• minimum stock that should be on hand;
• current stock balance.
Additional information to record could include:

• shelf number or name;
• destination, for example, to -20oC freezer, to media room.
It is a good idea to keep the stock logbook in the storage area.

Content Sheet 4-6: Receipt and Storage of Supplies
Receiving and A system should be established so when supplies are received, personnel know what
inspecting is expected. All supplies and reagents should be inspected as they arrive in the
supplies laboratory to be sure that they are in good condition, and to verify that what is
received is what was ordered.
In addition, the person receiving supplies should:
• sign their name verifying receipt of goods;

• date each item received;
• note expiration date;
• store new shipment behind existing shipment;
• create or update logbook records.
Storage Storage of reagents and supplies is a very important part of inventory control. Good
practices to keep in mind are:
• keep the storeroom clean, organized, and locked to protect the inventory;
• make sure storage areas are well-ventilated and protected from direct sunlight;
• storage conditions are in accordance with manufacturer’s instructions, paying
particular attention to any temperature requirements or other specifications such as
safety requirements.
• use good shelving strong enough to support items, and organize items carefully on
the shelves to prevent movement shifts or falls; shelves should be attached firmly
to support walls to prevent tipping.
• items should be easily accessible to staff; sturdy step stools should be available for
reaching higher shelves; heavier items should be stored on lower shelves; laboratory
staff should not be required to lift heavy items.
• when storing, put the new shipment behind existing materials that are already in the
laboratory; organize the reagents and materials so that the older materials get used
first–items with the first expiry dates are the first used.
Organization Labeling shelves is a useful tool for storing inventory and will help to systemize and
of shelves organize storage space.
• Assign a number (or name) to different areas of the shelves;
• Record in the log book what shelves are used for which reagents and supplies.

This system helps to avoid “losing” a
product, and will save staff time that
might be used for hunting through a
number of shelves. Even someone who
is not familiar with the storeroom can
find a product if this system is in place.
It is also useful to number cold rooms,
refrigerators, and freezers for the same
purpose.
Labeling Establishing a system for labeling reagents will be very helpful. It is important to label
reagents reagents with the date they are opened, and to make sure the expiration date is clearly
visible.
This picture shows a label with

important information, and to it
has been added the date the bottle
was first opened.

Content Sheet 4-7: Monitoring Inventory
Continuous Procedures should be developed

monitoring of and put in place for continuous
inventory monitoring of the inventory. To
ensure this is done effectively:
• assign the responsibility for

this task to an appropriate
person or persons; someone
must be in charge;
• be sure that all supplies and
reagents in the laboratory are
covered by the system and
maintain inventory management in all of the storage areas;.
• conduct weekly physical counts of reagents and supplies in order to check the system,
and as a part of the monitoring process;
• make sure that all records relevant to inventory management are updated and
maintained.
Computerized In many laboratories, a simple computerized system can be set up for management of
inventory inventory.
management
There are many advantages to using a computer. A computer will:
Advantages
and drawbacks • keep track of the exact number of supplies and reagents on hand, as it can be updated
daily;
• allow for good management of expiration dates; the system can be set up to alert
when lot numbers are near the expiration date, and therefore use of resources can be
optimized;
• generate statistics that will help when planning and making purchases;
• help manage the process for distributing reagents to satellite laboratories;
• ease the burden of inventory management.
Some drawbacks to setting up a computerized system are:
• an on-site computer is needed, and it could be expensive to purchase;
• staff using the system will need to be trained.
Example Annex 4-C provides an example of a computerized inventory report.

The soft-ware program that developed this inventory report example is free of charge
and is available on the CD. There are other free soft-ware programs available.

Summary A well-managed laboratory will have a system for inventory maintenance and
purchasing. The system will require planning and monitoring to ensure that appropriate
quantities of supplies and reagents are always available, and also to prevent wastage.
In implementing an inventory management system, the laboratory must assign
responsibility for the program, analyze the needs of the laboratory, and establish the
minimum stock needed for an appropriate time period. Appropriate logs and forms will
be needed, as well as a procedure for receiving, inspecting, and storing supplies.
The laboratory will need to maintain an inventory system for all reagents and supplies
used in the laboratory; this system must include all areas where reagents and supplies are
stored.
Key messages Properly managing inventory will:

• increase the efficiency and effectiveness of the laboratory, because it will provide an
uninterrupted flow of needed materials;
• assure products are available when they are needed;
• assure that patient and clinical needs are met.

5. Process control - Sample management
Content Sheet 5-1: Overview of Sample Management
Role in Sample management is a part of process

quality control, one of the essentials of a quality Organization Personnel Equipment
management management system.
system
The quality of the work a laboratory
produces is only as good as the quality
Purchasing Process Information
of the samples it uses for testing. The & Control Management
Inventory
laboratory must be proactive in
ensuring that the samples it receives
meet all of the requirements needed to
Documents Occurrence Assessment
produce accurate test results. & Management
Records
Process Customer Facilities

Safety
Sample vs. ISO and CLSI define a sample as “one or more parts taken from a system and intended to
specimen provide information on the system” (ISO 15189:2007). The term “specimen” is very
commonly used in the laboratory to indicate a sample taken from the human body, but the
terminology used throughout ISO documents is “primary sample”, or just “sample”. In this
workshop, the terms “sample” and “specimen” should be considered interchangeable.
It is useful to note that in some of the existing transport regulations, the term “specimen”
continues to be used.
Importance Proper management of samples is critical to the accuracy and reliability of testing, and,
of good therefore, to the confidence in laboratory diagnosis. Laboratory results influence
management therapeutic decisions and can have significant impact on patient care and outcomes. It is
important to provide accurate laboratory results in order to assure good treatment.
Inaccuracies in testing can impact length of hospital stays, as well as hospital and
laboratory costs. Inaccuracies can also affect laboratory efficiency, leading to repeat
testing with resultant waste of personnel time, supplies, and reagents.
Sample Written policies for sample management must be established and reflected in the
management Laboratory Handbook. Components to be addressed include:
components
• information needed on requisitions or forms
• handling urgent requests
• collection, labeling, preservation and transport
• safety practices (leaking or broken containers, contaminated forms, other biohazards)
• evaluating, processing, and tracking samples
• storage, retention, and disposal.
Sample Management ● Module 5 ● Content Sheet 57

Content Sheet 5-2: The Laboratory Handbook
Purpose and To ensure that all samples are managed properly and that persons collecting
distribution samples have the needed information, the laboratory should develop a
laboratory handbook. This handbook should be made available at all sample
collection areas, including those that are distant from the laboratory.
All laboratory staff should also be familiar with the information in the
handbook, and should be able to answer questions about the information
included.
The laboratory handbook is an important laboratory document. It must be kept
up-to-date and be referenced in the laboratory’s quality manual.
Content Important information that should be included in the laboratory handbook:
• contact names and telephone numbers of key personnel;
• name and address of the laboratory;
• hours of operation of the laboratory;
• list of tests that can be ordered;
• detailed information on sample collection requirements;
• sample transport requirements, if any;
• expected turnaround times (TAT);
• description of how urgent requests are handled; this should include a list of
what kinds of tests are done on an urgent basis, what are the expected
turnaround times, and how to order them.
The laboratory should periodically provide training sessions to health care and
laboratory personnel who are responsible for the collection of samples.

Content Sheet 5-3: Collection and Preservation
The The collection of appropriate and optimum samples is the responsibility of the
laboratory’s laboratory, even though the
responsibilites actual collection process is
often carried out by persons
who are not part of the
laboratory staff. The sample
may be collected at the
bedside by a nurse if the
patient is being managed in
a hospital. The health care
provider may collect a
sample in a clinic setting.
The laboratory can help to assure good samples by providing collection

information to health care personnel at the collection site, making sure that
appropriate containers and collection supplies are available, defining a
good labeling system, and checking all samples carefully when they arrive in
the laboratory.
Test The first step in the process of obtaining the sample is the request for testing.
requisition The laboratory must make available a test request form that specifies all the
information that will be needed
for proper handling and
reporting.
Essential information for the test
request form includes:
• patient identification;
• tests requested;
• time and date of the sample
collection;
• source of the sample, when
appropriate;
• clinical data, when indicated;
• contact information for the
health care provider requesting the test.
Collection of samples in the field for epidemiological studies should be

accompanied by a form that includes the patient’s name, a unique
identification number, demographic information, and the patient’s health
status. The additional information is necessary to assist in identifying the
source of an infection, and finding potential contacts.

Sample Sample collection and preservation will vary, depending on the test and the
collection type of sample to be collected. The laboratory must carefully define a sample
requirements collection process for all tests it performs. The following should be
considered when preparing instructions:
• Patient preparation—Some tests require that the patient be fasting. There

may also be special timing issues for tests such as blood glucose, drug
levels, and hormone tests.
• Patient identification—The person collecting the sample must accurately
identify the patient. This might be done by questioning the patient, by
questioning an accompanying family member, or by the use of an
identifying wrist band or other device.
• Type of sample required—Blood tests might require serum, plasma, or
whole blood. Other tests might require urine or saliva. Microbiology
testing deals with a variety of sample types, so specific information as to
what is required for the test is needed.
• Type of container—The container for the sample is often very important,
as it will affect volume and any needed additives such as anti-coagulants
and preservatives. If the container does not control volume, for example as
with Vacutainer® tubes, this will need to be clearly specified. Some
microbiology samples will require specific transport media to preserve
microorganisms.
• Sample labeling—All requirements for labeling of the sample at the time
of collection will need to be explained in detail in the instructions for
collection.
• Special handling—Some samples may require special handling, such as
immediate refrigeration, protection from light, or prompt delivery to the
laboratory. Any important safety precautions should be explained.
Patient samples are sometimes collected by the patient themselves, for

example, faecal parasitology samples. It is important that the laboratories
have set protocols to ensure that appropriate collection kits with instructions
for collection, safety precautions, and labeling are available for their patients.
It is suggested that instructions for the patients be in the languages for the
community the laboratory is serving or presented as simple easy-to-understand
graphics.
Sample Each sample should be clearly labeled with:

labeling • the patient’s first and last name;
• a unique identification number – this might be a hospital number or a

number assigned by the laboratory;
• the test that has been requested;

• the time and date of collection;
• the initials of the person collecting the sample.
Potential Proper sample collection is an important element for good laboratory practice.
outcomes of Improper collection of samples can lead to poor outcomes, such as:
collection
errors • delays in reporting test results
• unnecessary re-draws/re-tests
• decreased customer satisfaction
• increased costs
• incorrect diagnosis / treatment
• injury
• death.

Content Sheet 5-4: Sample Processing
Verification Once a sample enters the laboratory, there are a number of steps needed prior to
of quality testing. These pre-examination steps include:
• verifying the sample is properly labelled, adequate in quantity, in good
condition, and appropriate for the test requested. The test request must be
complete and include all necessary information;
• recording sample information into a register or log;
• enforcing procedures for handling sub-optimum samples, including sample
rejection, when necessary.
Rejection of The laboratory should establish rejection criteria and follow them closely. It is
samples sometimes difficult to reject a sample, but remember that a poor sample will not
allow for accurate results. It is the responsibility of the laboratory to enforce its
policies on sample rejection so that patient care is not compromised.
Management should regularly review the number of rejected samples and reasons
for rejections, conduct training on sample collection, and revise written procedures
for sample management as needed.
The following are examples of samples that should be rejected:
• unlabeled sample;
• broken or leaking tube/container;
• insufficient patient information;
• sample label and patient name on the test request form do not match;
• hemolyzed sample (depending on test requested);
• non-fasting samples, for tests that require fasting;
• sample collected in wrong tube/container; for example, using the wrong
preservative or non-sterile container;
• inadequate volume for the quantity of preservative;
• insufficient quantity for the test requested;
• prolonged transport time, or other poor handling during transport.
Record the reason for rejection in the log book and include all pertinent
information.

When rejecting a sample, it is important to:
• promptly inform authorized person that the sample is unsuitable for testing;
• request another sample be collected following procedures outlined in the
laboratory handbook;
• retain rejected sample pending a final decision regarding disposition.
In some circumstances and after consultation with the requester, it may be

necessary to proceed with the testing of a sample that is not optimal.
Register or The laboratory should keep a register (log) of all incoming samples. A master
log register may be kept, or each specialty laboratory may keep its own sample
register.
Assign the sample a laboratory identification number – write the number on the
sample and the requisition form. If computers are used for reports, enter the
information into the computer.
The register should include:

• date and time of collection;
• date and time the sample
was received in laboratory;
• sample type;
• patient name and
demographics, as required;
• laboratory assigned
identification (e.g., number
276_01_06_2009);
• tests to be performed.
Tracking The laboratory needs a system to allow for tracking a sample throughout the
system laboratory from the time it is received until results are reported.
This can be done manually by careful keeping of records.
• confirm receipt of samples, include date and time;
• label samples appropriately; keep with the test requisition until laboratory ID is
assigned;
• track aliquots–traceable to the original sample.
If computers are available, maintain a database for tracking. The following

information about each sample should be entered into the database:
• identification number;
• patient information;
• collection date and time;
• type of sample: for example, urine, throat, cerebrospinal fluid for culture;
• tests to be performed;
• name of ordering physician (or other health care provider);
• location of patient, such as ward, clinic, outpatient;
• diagnostic test results;
• time and date results are reported.
Sample
handling

Content Sheet 5-5: Sample Storage, Retention, and
Disposal
Sample Written policies should be developed that include:

storage
• description of what samples should be stored;
• retention time;
• location–consider ease of access;
• conditions for storage, such as atmospheric and temperature requirements;
• system for storage organization, one method being to store samples by day of receipt or
accession number.
Sample Set a laboratory policy for retention of each type of sample. Some samples can be quickly
retention discarded, and others may need to be retained for longer periods. Monitor stored samples,
and do not keep for longer than necessary, as refrigerator and freezer space may be limited.
Sample freeze/thaw cycles must be monitored, as samples may deteriorate with these
conditions.
Planning is required for samples that may need long-term storage. An organized, accessible
system using computer tracking would be useful for these samples. The inventory of stored
samples should be reviewed at specified intervals to determine when they should be
discarded.
Sample When referring samples to other laboratories for testing:

referral
• obtain a laboratory handbook with detailed procedures from each laboratory;
• ensure the sample is labelled correctly, in the correct container, accompanied by a
requisition form that specifies the required test(s), and includes the sending laboratory’s
contact information;
• carefully monitor samples that are referred:
o keep a record of all tests / samples referred, date of referral, name of person
referring the test;
o record and report results received for each referred sample;
o monitor turn around times and record any problems encountered.
Sample The laboratory is responsible for ensuring that disposal of all laboratory waste is handled in
disposal a safe manner. To ensure proper disposal of patient samples:
• develop a policy for sample disposal; apply local, as well as country regulations for
disposal of medical waste;
• establish and follow procedures to disinfect samples prior to disposal.

Content Sheet 5-6: Sample Transport
Need for Frequently, samples are collected outside the laboratory, and must be transported for
transport subsequent processing and testing. Transport may be for a short distance, but sometimes a
distant clinic or collection site requires the use of vehicles or airplanes. In addition, it may
be necessary for the laboratory to ship samples to referral laboratories. In all cases,
transport must be managed carefully in order to maintain integrity of the sample, giving
attention to temperature, preservation needs, special transport containers, and time
limitations. It is also important to ensure the safety of those handling the material before,
during, and after transport.
Safety Laboratories that mail or transport samples by air, sea, rail, and road between local,
requirements regional, and reference laboratories or between laboratories in other countries must adhere
to a number of regulations. These regulations are designed to deal with transportation
accidents and spills, reduce biohazards, and keep samples intact for testing.
Regulations Regulations for transporting samples come from several sources, including:
• national transport regulations;

• International Civil Aviation Organization (ICAO), as conveyed by the International Air
Transport Association (IATA);
• rail and road traffic agencies;
• postal services.
Private courier companies may have their

own requirements.
Compliance with industry standards and
regulations is mandatory. Heavy fines may
be imposed on personnel who violate these
regulations. At risk are: the safety of
courier, carrier, and laboratory personnel, as well as passengers.
The United Nations committee of experts, consisting of voting representatives from over
30 countries and non-voting advisors from various organizations, makes recommendations
for the transport of dangerous goods. Many countries adopt the United Nations regulations
in their entirety to stand as their national dangerous goods regulations. Some countries apply
variations. National authorities should provide details of their own national requirements.
Classification Sample transport requirements are based on the category of samples being transported.
Infectious substances are classified as Category A or Category B. There is no direct
relationship between Risk Groups and Category A and B.

Category A: Infectious substances capable of causing permanent disability or life-
threatening or fatal disease to humans or to humans and animals. These are assigned the
following proper shipping name and UN number:
• Infectious substance, affecting humans, UN 2814
• Infectious substance affecting animals only, UN 2900
Category B: Infectious substances that do not meet the criteria for inclusion in Category
A. They are assigned the following proper shipping name Biological substance, Category
B, and UN number UN 3373
Medical or clinical wastes that contain infectious substances also need to be classified as
Category A or B depending on the infectious material and whether it is present in the
culture.
Exemptions: The UN Model Regulations for the Transport of Infectious Substances

includes a list of exemptions, which are samples that have a minimal likelihood that
pathogens are present. They do not have the same requirements for packaging and
shipping as Categories A and B. See Annex 5-G for more information.
Packaging All three categories of samples have specific packaging instructions and labelling
requirements requirements depending on their classification. All potentially hazardous material requires
triple packaging.
• The primary container is a tube or vial containing the sample; it is made with either
glass, or metal, or plastic. It must have a leak-proof seal; if necessary it can be wrapped
with waterproof tape. The tube or vial must be labelled with a permanent marker.
• The secondary container is a watertight polyethylene box intended to protect the
primary container. It is supplied with cardboard or bubble-wrap or a vial holder in
which several primary containers can be placed in order to protect them. Absorbent
material (gauze, absorbent paper) must be added in a sufficient quantity to absorb the
fluid completely in case of breakage.
• The outer container is a strengthened cardboard box used to protect the secondary
container. Both the secondary and outer containers are reusable as long as they are
intact, but old labels must be removed.
There is specific packaging for samples requiring shipment on dry-ice.
Managing Assure that all regulations and requirements are met when transporting samples; be aware of
sample any national requirements that apply to samples transported by hospital or laboratory vehicles.
transport
All personnel who package or who drive transport vehicles should be trained in the proper
procedures, both for safety and for good maintenance of samples. If ICAO regulations
must be met, staff must have specific training in packaging of dangerous goods.
When transporting locally, whether by ambulance, or by clinic or laboratory staff, it is
important to maintain sample integrity. Assure that temperatures are controlled, using ice
boxes or air conditioning, set an acceptable transport time, and monitor compliance.

Content Sheet 5-7 : Summary
Summary A laboratory handbook describing sample collection and providing testing information
must be available to everyone who needs this information.
It is important to have a system for tracking samples as they move through the laboratory.
Establish and implement a policy for sample storage and sample disposal.
Maintain sample integrity and assure that all regulations and requirements are met.
It may be useful to appoint someone with oversight responsibilities for sample
management.
Key • The laboratory must have good samples in order to ensure accuracy and reliability of
messages testing and confidence in results.
• Sample management directly affects patient care and outcome.

6. Process control - Introduction to
Quality Control
Content Sheet 6-1: Process Control—Introduction to Quality Control
Role in quality Process control is an essential

management element of the quality management Organization Personnel Equipment
system system, and refers to control of the
activities employed in the handling
of samples and examination Purchasing Process Information
processes in order to ensure accurate &
Inventory
Control Management
and reliable testing. Sample

management, discussed in Module 5,
and all quality control processes are Documents
&
Occurrence
Management Assessment
a part of process control. Records
Quality control (QC) monitors

activities related to the examination Process Customer Facilities
(analytic) phase of testing. The goal Safety
of quality control is to detect,

evaluate, and correct errors due to
test system failure, environmental
conditions, or operator performance,
before patient results are reported.
What is QC? Quality control is the part of quality management focused on fulfilling quality
requirements (ISO 9000:2000 [3.2.10]). Simply put, it is examining “control”
materials of known substances along with patient samples to monitor the
accuracy and precision of the complete analytic process. QC is required for
accreditation purposes.
In 1981, WHO used the term ‘Internal Quality Control’ (IQC), which it defined
as “a set of procedures for continuously assessing laboratory work and the
emergent results.” The terms QC and IQC are sometimes used interchangeably;
cultural setting and country may influence preferences for these terms.
In the past few years, the term ‘internal quality control’ has become confusing
in some settings because of the different meanings that have been associated
with the term. Some manufacturers of test kits for qualitative tests have
integrated ‘built-in’ controls into the design of their kits, which they sometimes
refer to as internal controls. Other manufacturers include their own control
materials with the kits they sell, and they refer to these as ‘internal controls,’
meaning that the materials are meant specifically for that manufacturer’s kit.
Finally, some people refer to any quality control materials that are used in
conjunction with test runs as IQC, as in the 1981 WHO definition
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.
QC for varying Quality control processes vary, depending on whether the laboratory
methods examinations use methods that produce quantitative, qualitative, or semi-
quantitative 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 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 “non-reactive”; “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.
Semi-quantitative 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 serological agglutination procedures. In the
case of other serologic testing, the result is often expressed as a titer – again
involving a number but providing an estimate, rather than an exact amount of
the quantity present.
Some microscopic examinations are considered semi-quantitative because

results are reported as estimates of the number of cells seen per low power field
or high power field. For example, a urine microscopic examination might report
0-5 red blood cells seen per high power field.
Because quality control processes differ for these various types of

examinations, the presentations for QC will be divided into two modules.
Module 7 will address QC for quantitative examinations, and Module 8 will
address QC for qualitative and semi-quantitative examinations.
Elements of a Regardless of the type of examination that is performed, steps for implementing
QC program and maintaining a QC program include:
• establishing written policies
and procedures, including
corrective actions;
• training all laboratory staff;
• assuring complete
documentation;
• reviewing quality control
data.
These responsibilities will be
described in more detail in
Modules 7 and 8.
Summary • QC is part of the quality management system, and is used to monitor the
examination (analytic) phase of testing.
• The goal of QC is to detect, evaluate, and correct errors due to test system
failure, environmental conditions, or operator performance, before patient
results are reported.
• Different QC processes are applied to monitor quantitative, qualitative, and
semi-quantitative tests.
7. Process control - Quality Control for
Quantitative Tests
Content Sheet 7-1: Overview of Quality Control for Quantitative
Tests
Role in Quality Control (QC) is a component

quality of process control, and is a major Organization Personnel Equipment
management element of the quality management
system system. It monitors the processes
related to the examination phase of
testing and allows for detecting errors Purchasing Process Information
& Control Management
in the testing system. These errors may Inventory
be due to test system failure, adverse
environmental conditions, or operator
performance. QC gives the laboratory Documents Occurrence
& Management Assessment
confidence that test results are accurate Records
and reliable before patient results are
reported.
This module explains how quality Process
Improvement
Customer
Service
Facilities
&
control methods are applied to Safety
quantitative laboratory examinations.
Overview of Quantitative tests measure the quantity of a substance in a sample, yielding a numeric
the process result. For example, the quantitative test for glucose can give a result of 110 mg/dL.
Since quantitative tests have numeric values, statistical tests can be applied to the results
of quality control material to differentiate between test runs that are “in control” and
“out of control”. This is done by calculating acceptable limits for control material, then
testing the control with the patient’s samples to see if it falls within established limits.
As a part of the quality management system, the laboratory must establish a quality
control program for all quantitative tests. Evaluating each test run in this way allows the
laboratory to determine if patient results are accurate and reliable.
Implementation The steps for implementing a quality control program are:

process • to establish policies and procedures;
• to assign responsibility for monitoring and reviewing;
• to train all staff on how to properly follow policies and procedures;
• to select good quality control material;
• to establish control ranges for the selected material;
• to develop graphs to plot control values; these are called Levey-Jennings charts;
• to establish a system for monitoring control value;
• to take immediate corrective action if needed;
• to maintain records of quality control results and any corrective actions taken.
Quantitative QC ● Module 7 ● Content Sheet 74

Content Sheet 7-2: Control Materials
Defining control Controls are substances that contain an established amount of the substance being
materials 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 to evaluate the operator’s performance and environmental conditions that
might impact results.
Differentiating It is important not to confuse calibrators and control materials.

controls and
calibrators 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 It is critical to select the appropriate control materials. Some important characteristics
of control to consider when making the selection.
materials
• 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.
• 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.
• 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.
Because it is more efficient to have controls that last for some months, it is best to
obtain control materials in large quantity.
Types and Control materials are available in a variety of forms. They may be frozen,
sources of freeze-dried, or chemically
control material preserved. The freeze-
dried or lyophilized
materials must be
reconstituted, requiring
great care in pipetting in
order to assure the correct
concentration of the
analyte.
Control materials may be
purchased, obtained from a
central or reference laboratory, or made in-house by pooling sera from different
patients.
Purchased controls may be either assayed or unassayed.
Assayed controls have a pre-determined target value, established by the
manufacturer. When using assayed controls the laboratory must verify the value
using its own methods. Assayed controls are more expensive to purchase than
unassayed controls.
When using either unassayed or “in-house” or homemade controls, the laboratory
must establish the target value of the analyte.
The use of in-house controls requires resources to perform validation and testing
steps. An advantage is that the laboratory can produce very large volumes with exact
specification.
Remember that quality control materials are usually serum-based. Universal

precautions should be used when handling.
Choosing When choosing controls for a particular method, select values that cover medical
controls decision points, such as one with
a normal value, and one that is
either high or low, but in the
medically significant range.
Controls are usually available in

‘high’, ‘normal’, and ‘low’
ranges.
Shown in the graphic are
normal, abnormal high and low,
and critical high and low ranges.
For some assays, it may be important to include controls with values near the low
end of detection.
Preparing and When preparing and storing quality control materials it is important to carefully
storing control adhere to the manufacturer’s instructions for reconstituting and for storage. If in-
material house control material is used, freeze aliquots and place in the freezer so that a small
amount can be thawed and used daily. Do not thaw and re-freeze control material.
Monitor and maintain freezer temperatures to avoid degradation of the analyte in any
frozen control material.
Use a pipette to deliver the exact amount of required diluent to lyophilized controls
that must be reconstituted.

Content Sheet 7-3: Establishing the Value Range for the
Control Material
Assaying Once the appropriate control

control over materials are purchased or
time prepared, the next step is to
determine the range of acceptable
values for the control material.
This will be used to let the
laboratory know if the test run is
“in control” or if the control
values are not reading properly –
“out of control”.
This is done by assaying the
control material repeatedly over time. At least 20 data points must be collected over a
20 to 30 day period. When collecting this data, be sure to include any procedural
variation that occurs in the daily runs; for example, if different testing personnel
normally do the analysis, all of them should collect part of the data.
Once the data is collected, the laboratory will need to calculate the mean and standard
deviation of the results.
A characteristic of repeated measurements is that there is a degree of variation.
Variation may be due to operator technique, environmental conditions, and the
performance characteristics of an instrument. Some variation is normal, even when all
of the factors listed above are controlled. The standard deviation gives a measure of the
variation.
One of the goals of a quality control program is to differentiate between normal
variation and errors.
Characteristics A few theoretical concepts are important because they are used to establish the normal
of repeated variability of the test system. Quality control materials are run to quantify the variability
measures and establish a normal range, and to decrease the risk of error.
The variability of repeated measurements will be distributed around a central point or

location. This characteristic of repeated measurements is known as central tendency.
The three measures of central tendency are:

• Mode, the number that occurs most frequently.
• Median, the central point of the values when they are arranged in numerical
sequence.
• Mean, the arithmetic average of results. The mean is the most commonly used
measure of central tendency used in laboratory QC.

Statistical Statistical notations are symbols used in mathematical formulas to calculate statistical
notations measures. For this module, the symbols that are important to know are:
∑ the sum of
N number of data points (results or observations)

X1 individual result
X1 -. Xn data point 1- n where n is the last result
X the symbol for the mean.
the square root of the data.
Mean The formula for the mean is:
As an example of how to calculate a mean, consider ELISA testing. The method is to

gather data as ratios, add the values, and divide by the number of measurements.
Before The purpose of obtaining 20 data points by running the quality control sample is to
calculating QC quantify normal variation, and establish ranges for quality control samples. Use the
ranges results of these measurements to establish QC ranges for testing.
If one or two data points appear to be too high or low for the set of data, they should not
be included when calculating QC ranges. They are called “outliers”.
• If there are more than 2 outliers in the 20 data points, there is a problem with the
data and it should not be used.
• Identify and resolve the problem and repeat the data collection.
Normal If many measurements are taken, and the results are plotted on a graph, the values form
distribution a bell-shaped curve as the results vary around the mean. This is called a normal
distribution (also termed Gaussian distribution).
The distribution can be seen if data points are plotted on the x-axis and the frequency
with which they occur on the y-axis.
The normal curve shown (right) is really a

theoretical curve obtained when a large
number of measurements are plotted. It is
assumed that the types of measurements used
for quantitative QC are normally distributed
based on this theory.

Accuracy and If a measurement is repeated many times, the result is a mean that is very close to the
precision true mean.
Accuracy is the closeness of a measurement to its true value.
Precision is the amount of variation in the measurements.

• The less variation a set of measurements has, the more precise it is.
• In more precise measurements, the width of the curve is smaller because the
measurements are all closer to the mean.
Bias is the difference between the expectation of a test result and an accepted reference
method.
The reliability of a method is judged in terms of accuracy and precision.
Target A simple way to portray precision and accuracy is to think of a target with a bull’s eye.
illustration The bull’s eye represents the accepted reference value which is the true, unbiased value.
If a set of data is clustered around the bull’s eye, it is accurate.
The closer together the hits are, the more precise they are. If most of the hits are in the
the bull’s eye, as in the figure on
the left, they are both precise and
accurate.
The values in the middle figure are
precise but not accurate because
they are clustered together but not
at the bull’s eye. The figure on the
right shows a set of hits that are
imprecise.
Measurements can be precise but
not accurate if the values are close together but do not hit the bull’s eye. These values
are said to be biased. The middle figure demonstrates a set of precise but biased
measurements.
The purpose of quality control is to monitor the accuracy and precision of

laboratory assays before releasing patient results.
Measures of The methods used in clinical laboratories may show different variations about the mean;
variability hence, some are more precise than others. To determine the acceptable variation, the
laboratory must compute the standard deviation (SD) of the 20 control values. This is
important because a characteristic of the normal distribution is that, when measurements
are normally distributed:
• 68.3% of the values will fall within -1 SD and +1 SD of the mean
• 95.5% fall within -2 SD and +2 SD
• 99.7% fall between -3 SD and +3 SD of the mean.
Knowing this is true for all normally shaped distributions allows the laboratory to
establish ranges for quality control material.
Once the mean and SD are computed for a set of measurements, a quality control
material that is examined along with patients samples should fall within these ranges.
Standard Standard deviation (SD) is a measurement of variation in a set of results. It is very

deviation useful to the laboratory in analyzing quality control results.
The formula for calculating standard deviation is:
∑ (x 1 − x )
2
SD = n −1
The number of independent data points (values) in a data set are represented by “n”
Calculating the mean reduces the number of independent data points to n – 1. Dividing
by n-1 reduces bias.
To better understand the concept of SD, see the example in Annex A, and Activity
Sheet 7-1.
Calculating The values of the mean, as well as the values of + 1, 2, and 3 SDs are needed to develop
acceptable the chart used to plot the daily control values.
limits for the
control • To calculate 2 SDs, multiply the SD by 2 then add and subtract each result from the
mean.
• To calculate 3 SDs, multiply the SD by 3, then add and subtract each result from
the mean.
The data in Annex 7A has a mean of 190.5 and an SD of 2, therefore:

+ 1 SD is 188.5 - 192.5
+ 2 SD is 186.5 - 194.5, and
+ 3 SD is 184.5 - 196.5.
For any given data point 68.3% of will fall between + 1 SD, 95.5% between + 2D, and
99.7% between + 3 SD of the mean.
Once these ranges are established, they can be used to evaluate a test run. For example,
if you examine a control with your patients’ samples and get a value of 193.5, you know
there is a 95.5% chance that it is within 2 SD of the mean.
When only one control is used, we consider a examination run to be “in control” if a
value is within 2 SD of the mean.

Coefficient of The coefficient of variation (CV) is the standard deviation (SD) expressed as a
variation percentage of the mean.
CV (%) = SD x 100
Mean
The CV is used to monitor precision. When a laboratory changes from one method of
analysis to another, the CV is one of the elements that can be used to compare the
precision of the methods. Ideally, the value of the CV should be less than 5%.

Content Sheet 7-4: Graphically Representing Control
Ranges
Using graphs Once the appropriate range of control values has been established, the
for analysis laboratory will find it very useful to represent the range graphically for the
and purpose of daily monitoring. The common method for this graphing is the use
monitoring of Levey-Jennings charts.
Developing In order to develop Levey-Jennings charts for daily use in the laboratory, the first
data for step is the calculation of the mean and standard deviation of a set of 20 control
Levey- values as explained in Content sheet 7-3.
Jennings
charts
Levey- A Levy-Jennings chart can then be drawn, showing the mean value as well as
Jennings plus/minus ( + ) 1, 2, and 3 standard deviations (SD). The mean is shown by
chart drawing a line horizontally in the middle of the graph and the SD are marked off
at appropriate intervals and lines drawn horizontally on the graph as shown
below.
This Levey-Jennings chart was developed using 20 repeated measurements of the

control value. In order to use the Levey-Jennings chart to record and monitor
daily control values, label the x-axis with days, runs, or other interval used to run
QC. Label the chart with the name of the test and the lot number of the control
being used.

Content Sheet 7-5: Interpreting Quality Control Data
Plotting A quality control sample tested along with patient’s samples can now be used to
control determine if daily runs are “in control”. A control sample must be run with each
values set of patient samples.
Run the control and plot it on the Levey-Jennings chart. If the value is within
plus or minus 2 SD (+ 2 SD), the run can be accepted as “in-control”.
The values on the chart are those run on days 1, 2, and 3 after the chart was made.
In this case, the second value is “out-of-control” because it falls outside of 2 SD.
When using only one quality control sample, if the value is outside 2 SD, that run
is considered “out of control” and the run must be rejected.
Number of If it is possible to use only one control, choose one with a value that lies within
controls used the normal range of the analyte being tested. When evaluating results, accept all
runs where the control lies within + 2 SD. Using this system, the correct value
will be rejected 4.5% of the time.
In order to improve efficiency and accuracy, a system using two or three

controls for each run can be employed. Then, another set of rules can be used
to avoid rejecting runs that may be acceptable. These rules were applied to
laboratory QC by a clinical chemist named James Westgard. This Westgard
Multirule System requires running two controls of different target values for
each set of examinations, developing a Levey-Jennings chart for each, and
applying the rules. The Westgard Multirule System is covered in the optional
material for this module.
The use of three controls with each run gives even higher assurance of accuracy
of the test run. When using three controls, choose a low, a normal, and a high
range value. There are also Westgard rules for a system with three controls.
Detecting Errors that occur in the testing process may be either random or systematic.
error
With random error, there will be a variation in quality control results that show no
pattern. This type of error generally does not reflect a failure in some part of the
testing system, and is therefore not like to reoccur. Random error is only a cause
for rejection of the test run if it exceeds + 2 SD.
Systematic error is not acceptable, as it indicates some failure in the system that
can and should be corrected. Examples of evidence of systematic error include:
• Shift–when the control is on the same side of the mean for five consecutive
runs.
• Trend–when the control is moving in one direction, and appears to be heading
toward an out-of-control value.
Shifts and Even when a control value falls within 2 SD, it can be a cause for concern. Levey-
trends Jennings charts can help distinguish between normal variation and systematic
error.
Shifts in the mean occur when an abrupt change is followed by six or more
consecutive QC results that fall on one side of the mean but typically within 95%
range as if clustered around a new mean. On the sixth occasion this is called a
shift and results are rejected.
Trends occur when values gradually, but continually, move in one direction over
six or more analytical runs. Trends may display values across the mean, or they
may occur only on one side of the mean. On the sixth occasion, this is determined
to be a trend and results are rejected.
The source of the problem must be investigated and corrected before patients’
samples are reported.
Measurement As variation occurs in measurements, uncertainty exists as to the true value.

uncertainty Uncertainty represents a range of values in which the true value is reasonably
expected to lie. In most situations, measurement uncertainty is estimated at “95%
coverage.” For most instances, a range of + 2 SD is accepted as measurement
uncertainty that is explained by random variation.
But the degree of variation also depends on the method used. Methods that are
more precise have less uncertainty because the amount of variation included in
the 95% limits is smaller.
Laboratories should strive to use methods that have a high degree of precision,
and always follow standard operating procedures.

Content Sheet 7-6: Using Quality Control Information
When QC is When the quality control sample that is used in a test run is out of the acceptable
out of range range, the run is considered to be “out of control”. When this happens, there are
several steps that the laboratory must follow.
• The testing process should be stopped, and the technologist must immediately
try to identify and correct problems.
• Once possible sources of error have been identified, and corrections have
been made, the control material should be re-checked. If they read correctly,
then patient samples, along with another quality control specimen, should be
repeated. Do not simply repeat the testing without looking for sources of error
and taking corrective action.
• Patient results must not be reported until the problem is resolved and the
controls indicate proper performance.
Problem When attempting to solve quality control problems, it is useful to have

solving established policies and procedures for remedial action. Often, manufacturers of
either equipment or reagents will provide guidelines that can be helpful. Use any
troubleshooting guides that are available.
Possible problems to consider include:
• degradation of reagents or kits
• control material degradation
• operator error
• failure to follow manufacturer’s instructions
• an outdated procedure manual
• equipment failure
• calibration error.

Summary A quality control program for quantitative tests is essential to assuring accuracy
and reliability of laboratory testing. The laboratory must establish a quality
control program that monitors all quantitative tests. The program will have
written policies and procedures that are followed by all laboratory staff.
The overall responsibility of managing the quality control program is usually
assigned to the quality manager, who monitors and reviews all quality control
data on a regular basis. The recording of the quality control data must be
complete and easy to access.
For quantitative testing, statistical analysis can be used for the monitoring
process, and the use of Levey-Jennings charts provides a very useful visual tool
for this monitoring.
When controls are out of range, corrective action and trouble shooting must be
undertaken; the problem must be fixed before reporting patient results.
Therefore, good protocols for troubleshooting and corrective action are an
important of the quality control process.
Key • A quality control program allows the laboratory to differentiate between

messages normal variation and error.
• The quality control program monitors the accuracy and precision of
laboratory assays.
• The results of patient testing should never be released if the quality control
results for the test run do not meet the laboratory target values.

8. Process control - Quality Control for
Qualitative and Semi-quantitative
Procedures
Content Sheet 8-1: Overview of Quality Control for Qualitative and
Semi-quantitative Procedures
Role in Quality Control (QC) is a component

quality of process control, and is a major Organization Personnel Equipment
management element of the quality management
system system. It monitors the processes
related to the examination phase of
Purchasing Process
testing and allows for detecting errors & Control
Information
Management
Inventory
in the testing system. These errors
may be due to test system failure,
adverse environmental conditions, or Documents Occurrence Assessment
operator performance.QC gives the & Management
Records
laboratory confidence that test results
are accurate and reliable before
patient results are reported. Process Customer Facilities
This module explains how QC Safety
methods are applied to qualitative

and semi-quantitative laboratory
examinations.
Qualitative Qualitative examinations are those that measure the presence

and semi- or absence of a substance, or evaluate cellular characteristics
quantitative such as morphology. The results are not expressed in
examinations numerical terms, but in descriptive or qualitative terms such
as “positive,” “negative,” “reactive,” “non-reactive,”
“normal,” or “abnormal”. Examples of qualitative
examinations include microscopic examinations for cell morphology or presence of
parasitic organisms, serologic procedures for presence or absence of antigens and
antibodies, some microbiological procedures, and some
molecular techniques.
Semi-quantitative examinations are similar to qualitative
examinations; testing does not measure the precise
quantity of a substance. The difference is that results of
these tests are expressed as an estimate of how much of
a measured substance is present. This estimate is
sometimes reported as a number. Therefore, test results
for semi-quantitative tests may be shown as “trace amount”, “1+, 2+, or 3+”, or
positive at 1:160 (titer or dilution). Examples of semi-quantitative examinations are
urine dipsticks, tablet tests for ketones, and serological agglutination procedures.
Some microscopic examinations are considered semi-
quantitative because results are reported as estimates of the
number of cells seen per low power field or high power
field. For example, a urine microscopic examination might
report: 0-5 red blood cells seen per high power field.
QC Qualitative and Semi-quantitative Procedures ● Module 8 ● Content Sheet 88

Important As with quantitative procedures, it is important to verify that results of qualitative
concepts and semi-quantitative examinations are correct prior to reporting them to the
requesting healthcare provider.
Conducting quality control for many of these tests is not as easily accomplished as
with quantitative tests. Therefore, it becomes essential that other processes within
the quality system are carefully conducted, in addition to traditional quality control
methods. Following are some important over-arching concepts for quality that apply
to qualitative and semi-quantitative tests.
• Sample management is important in all laboratory testing. Examinations that are
dependent on a viable organism in the sample may need closer monitoring and
better communication with non-laboratory staff (see Sample Management
Module 5).
• Dedicated, professional staff who understand the principles of QC are key to
quality.
• Incubators, refrigerators, microscopes, autoclaves, and other equipment must be
maintained and monitored carefully(see Equipment Management Module 3).
• Positive and negative controls must be used to monitor the effectiveness of test
procedures that use special stains or reagents, tests with endpoints such as
agglutination, color change, or other non-numeric results.
• Reagents should be stored according to manufacturer’s instructions, labelled
with the date they are opened and put into use, and discarded at the expiration
date (see Purchasing and Inventory Module 4).
• Keeping records of all quality control processes and corrective actions is
necessary for continual improvement of the laboratory quality system (see
Documents and Records Module 16).
• When problems occur, investigate, correct, and repeat patient testing (see
Occurrence Management Module14).
If QC results are not what is expected, do not report patient results.

Content Sheet 8-2: Quality Control Materials
Control Qualitative and semi-quantitative examinations include tests that utilize a variety of
types control materials. These controls may be built-in (on-board, or procedural) controls,
traditional controls that mimic patient samples, or may consist of stock cultures for use
with microbiological examinations.
Built-in Built-in controls are those that are integrated into the design of a test
controls system such as a test kit device. Usually, the device is marked with
designated areas where colored lines, bars, or dots should appear to
indicate success or failure of positive and negative controls, and these
controls are performed automatically with each test. The
manufacturer’s product instructions may also refer to these as
procedural controls, on-board controls, or internal controls.
Most built-in controls monitor only a portion of the examination phase,
and they vary from one test to another as to what is being monitored. For example,
built-in controls for some kits may indicate that all the reagents impregnated into the
device are active and working properly, whereas built-in controls for other kits may only
indicate that a sample was added and solutions flowed through the device correctly. It is
important to carefully read the instructions provided by the manufacturer to understand
what the built-in controls monitor, and to determine whether additional controls may be
needed.
Examples of test kits with built-in controls are rapid tests that detect the presence of
antigens or antibodies, such as those for infectious disease (HIV/AIDS, influenza, Lyme
Disease, streptococcal infection, infectious mononucleosis), drugs of abuse, pregnancy, or
faecal occult blood.
Even though these built-in controls give some degree of confidence, they do not monitor
for all conditions that could affect test results. It is advisable to periodically test traditional
control materials that mimic patient samples, for added confidence in the accuracy and
reliability of test results.
In some settings, these built-in controls are referred to as internal controls.
Traditional Traditional control materials are made to mimic patient samples, and they are tested with
controls the patient samples to evaluate the examination component. Positive controls have known
reactivity and negative controls are non-reactive for the analyte being tested. The controls
should have the same composition, or matrix, as patient samples, including viscosity,
turbidity, and color, in order to properly evaluate the test performance. Control materials
are often lyophilized when received, and need to be carefully reconstituted before use.
Some manufacturers may provide these controls with their test kits, but more frequently,
they need to be purchased separately.
Traditional controls evaluate the testing process more broadly than built-in controls. They
assess the integrity of the entire test system, the suitability of the physical testing
environment (temperature, humidity, level workspace), and whether the person
conducting the test performs it correctly.
Positive and negative controls are recommended for many qualitative and semi-
quantitative tests, including some procedures that use special stains or reagents, and tests
with endpoints such as agglutination or color change. These controls should generally be
used with each test run. Use of controls will also help to validate a new lot number of test
kits or reagents, to check on temperatures of storage and testing areas, and to evaluate the
process when new testing personnel are carrying out the testing.
Things to keep in mind when using traditional controls for qualitative or semi-quantitative
tests are:
• test control materials in the same manner as testing patient samples;
• use a positive and negative control, preferably once each day of testing, or at least as
often as recommended by the manufacturer;
• choose positive controls that are close to the cut-off value of the test, to be sure the test
can detect weak positive reactions;
• for agglutination procedures, include a weak positive control as well as a negative
control and a stronger positive control;
• for tests with an extraction phase, such as some rapid group A streptococcus tests,
choose controls that are capable of detecting errors in the extraction process.
Stock Quality control in microbiology requires use of live control organisms with predictable
cultures reactions to verify that stains, reagents, and media are working correctly. They must be
kept on hand and carefully maintained in the form of stock and working cultures. For each
reaction, organisms with both positive and negative results should be tested.
The following organizations offer reference strains, which are available from local
distributors:
• ATCC─American Type Culture Collection;
• NTCC─National Type Culture Collection (UK);
• CIP─Pasteur Institute Collection (France).
Purchased reference strains are usually lyophilized and kept in the refrigerator. Once they
are reconstituted, plated, and checked for purity, they can be used to make working
cultures for quality control.
Some laboratories may choose to use isolates from their own laboratories for QC. If so,
they should be monitored closely to verify that reactions tested are sustained over time.

Content Sheet 8-3: Quality Control of Stains
Procedures In performing many qualitative and semi-quantitative procedures, stains are needed for
using stains evaluating microscopic morphology of cells, parasites, or microbes, or to determine
their presence or absence. Stains are used for microscopic procedures that provide
information for either preliminary or definitive diagnosis. These are frequent in
haematology, urinalysis, cytology, histology, microbiology, parasitology, and other
laboratory areas.
In microbiology, permanent stains such as acridine orange, trichrome and iron-
hematoxylin for faecal parasites, and Giemsa stain for malaria are frequently used.
Gram stains are used for identification of bacteria and yeast from colonies and samples.
Acid-fast stains are particularly important for preliminary diagnosis, since growth of
mycobacteria takes several weeks. In many sites, Mycobacterium tuberculosis (TB)
cultures are not available and acid-fast smears will provide the final diagnosis for
patients. For wet mounts, iodine solutions are used to detect cysts and eggs in faecal
samples and KOH preparations to detect fungal elements.
Examination of blood smears requires a stain that allows for
clear visualization of red blood cells, white blood cells,
platelets, and inclusions within cells. Differentiation of cells
in blood most frequently employs a Wright stain, and some
haematology procedures use special stains to help
differentiate infection from leukaemia.
Cytology and histology tests require a wide variety of stains that provide valuable
information for diagnosis. Many other stains are available to laboratory staff for special uses.
The common elements for QC are the same: the stains should be prepared and stored
properly, and checked to be sure they perform as expected. Remember that many of the
microscopic examinations that rely on stains are critical in diagnosis of many diseases.
Stain Some stains can be purchased commercially, but others must be prepared by the
management laboratory, following an established procedure. Once stains are made, their bottles
should be labeled with the following information:
• name of the stain
• concentration
• date prepared
• date placed in service
• expiration date/shelf life
• preparer’s initials.
It may be useful to keep a log book for recording information on each stain in use,
including the lot number and date received. The expiration date must be noted on the
label. Some stains deteriorate and lose their ability to produce the correct reactions.
Stains should be stored at the correct temperature at all times and in an appropriate
staining bottle. Some stains must be protected from light. In some cases, working
solutions can be made from stock solutions. If so, storage of working solutions should
be carefully monitored.
Quality Because of their importance, stains should be checked each day of use with positive and
control negative QC materials, to make sure their reagents are active and they provide the
intended results. In most cases, positive and negative controls should be stained with
each batch of patients’ slides. All quality control results must be recorded each time
they are run.
Stains should also be examined to look for precipitation or crystal formation, and to
check for bacterial contamination. Careful maintenance and care of the stock and
working solutions of stains is an essential component in a system to provide good
quality in microscopic examinations.
Be aware that many stains are toxic therefore take appropriate safety precautions
when working with them.

Content Sheet 8-4: QC of Microbiological Media
QC is essential The quality of media used in the microbiology laboratory is crucial to achieving
for media optimal and reliable results. Some media
are essential to isolation of microbes, so
it is imperative that they function as
expected. Quality control procedures
provide the confidence that media has
not been contaminated prior to use, and
that it supports the growth of the
organism with which it was inoculated.
Verifying The performance characteristics of all media used in the laboratory must be verified
performance by the appropriate quality control methods. For media that is prepared in-house, this
evaluation must be conducted for each batch prepared; for all commercially prepared
media, the performance verification will be performed for each new lot number.
In all cases, in-house and purchased media should be carefully checked for:
• sterility—incubate overnight before use;
• appearance—check for turbidity, dryness, evenness of layer, abnormal color;
• pH;
• ability to support growth—using stock organisms;
• ability to yield the appropriate biochemical results—using stock organisms.
Use of control The laboratory must maintain sufficient stock organisms to check all its media and
organisms for test systems. Some examples of important stock organisms, and the media checked,
verification include:
• Escherichia coli (ATCC #25922): MacConkey or eosin methylene blue (EMB),

some antimicrobial susceptibility testing.
• Staphylococcus aureus (ATCC #25923): blood agar, mannitol salt, and some
antimicrobial susceptibility tests.
• Neisseria gonorrhoeae (ATCC# 49226): chocolate agar and Thayer-Martin agar.
For selective media—inoculate a control organism that should be inhibited as well as

one that should grow. Discard any batch of media that does not work as expected.
For differential media—inoculate the media with control organisms that should
demonstrate the required reactions. For example, inoculate both lactose fermenting
and non-lactose fermenting organisms to EMB or MacConkey agar to verify that the
colonies exhibit correct visual appearance.
Note: sheep and horse blood are preferred in preparing media for routine cultures.
Blood agar made from human blood should not be used as it will not demonstrate the
correct haemolysis pattern for identification of certain organisms, and it may contain
inhibitory substances. In addition, human blood can be biohazardous.
In-house media It is important to keep careful records for media that is prepared in the laboratory. A
preparation log book should be maintained that records:
records
• date and preparer's name
• name of the medium, the lot number, and manufacturer
• number of prepared plates, tubes, bottles, or flasks
• assigned lot batch number
• color, consistency, and appearance
• number of plates used for QC
• sterility test results at 24 and 48 hours
• growth test(s)
• pH.

Examinations Qualitative and semi-quantitative examinations are those that give non-numerical results.
with non- Qualitative examinations measure the presence or absence of a substance, or evaluate
numerical cellular characteristics such as morphology. Semi-quantitative examinations provide an
results estimate of how much of the measured substance is present.
Qualitative and semi-quantitative testing must be monitored by quality control processes.

These processes should use controls that mimic patient samples as much as possible.
Quality controls that check kits, reagents, stains, and microbiological media and assure
that they work as expected must be used whenever they are available.
The laboratory must establish a quality control program for all of its qualitative and
semi-quantitative tests. In establishing this program, set policies, train staff and assign
responsibilities, and assure that all resources needed are available. Make sure that
recording of all quality control data is complete, and that appropriate review of the
information is carried out by the quality manager and the laboratory director.
Key • All staff must follow the quality control practices and procedures.
messages
• Always record quality control results and any corrective actions that are taken.
• If QC results are not acceptable, do not report patient results.

9. Assessment-Audits
Content Sheet 9-1: Overview of Assessment
Role in quality Assessment is an important element of

management the 12 quality system essentials
Organization Personnel Equipment
system (QSE). It is the means for determining
the effectiveness of a laboratory’s
quality management system through
internal and external audits, and Purchasing Process Information
& Control
evaluation of performance in an Inventory
Management
external quality assessment (EQA)

program. This module is focused on
descriptions of internal and external Documents Occurrence Assessment
&
audits; EQA will be described in Records
Management
Module 10.

Safety
What is An assessment can be defined as the systematic examination of some part (or
assessment? sometimes all) of the quality management system to demonstrate to all concerned that
the laboratory is meeting regulatory, accreditation, and customer requirements.
Laboratories are generally very familiar with assessment processes, as most will have
had some kind of assessment by an external group.
Accepted standards, whether international, national, local, or standards from
accrediting organizations, form the basis for laboratory assessment. In that respect,
Assessment is inter-related with Norms and Accreditation (Module 11).
In an assessment, someone is asking the following questions.
• What procedures and processes are being followed in the laboratory; what is being
done?
• Do the current procedures and processes comply with written policies and
procedures? And in fact, are there written policies and procedures?
• Do written policies and procedures comply with standards, regulations, and
requirements?
Assessments are performed in a variety of ways, and under a number of different
circumstances.
ISO standards are very specific about assessment requirements, and the term “audit” is
used instead of “assessment”. The terms may be considered interchangeable, and local
usage will determine the actual terminology required. The ISO definition for audit is
“systematic, independent and documented process for obtaining evidence and evaluating
it objectively to determine the extent to which required criteria are fulfilled.”
Assessment-Audits ● Module 9 ● Content Sheet 98

Why perform An assessment, or audit, allows the laboratory to understand how well it is performing
an when compared to a benchmark or standard. Any gaps or nonconformities in
assessment? performance can show if the policies and procedures that the laboratory has set require
revision or are not being followed.
A laboratory needs this information about its performance for:

• planning and implementing the quality system;
• monitoring effectiveness of the quality system;
• correcting any deficiencies that are identified;
• working toward continuous improvement.
External and Assessments conducted by groups or agencies from outside the laboratories are called
internal audits external audits. They can include assessments for the purpose of accreditation,
certification, or licensure.
Another type of assessment that laboratories can utilize is the internal audit, where
staff working in one area of the laboratory conducts assessments on another area of the
same laboratory. This provides information quickly and easily on how the laboratory is
performing, and whether it is in compliance with policy requirements.
Laboratory Audits should include the evaluation of steps in the whole laboratory path of workflow.
path of
workflow They should be able to detect problems throughout the entire process.
The value of a well-designed

audit is that it will reveal
weaknesses in the pre-
examination, examination, and
post-examination phases.
Auditing During audits, information is gathered about:

• processes and operating procedures
• staff competence and training
• equipment

• environment
• handling of samples
• quality control and verification of results
• recording and reporting practices.
The findings are compared with the laboratory’s internal policies and to a standard or
external benchmark. Any breakdown in the system or departure from procedures will
be identified.

Content Sheet 9-2: External Audit
External Assessments conducted by groups or agencies from outside the laboratories are called
auditors external audits. Some examples of external auditors are described below.
• Health authorities may assess laboratories to evaluate the quality of performance, or

compliance with licensing requirements and national regulations. They may also assess
as part of a capacity strengthening plan of action, or for public health program needs.
• Accreditation bodies are organizations that provide accreditation or certification. When

a laboratory seeks accreditation, an initial audit will be required to evaluate compliance
with standards. In order to maintain accredited status, the accreditation bodies will
require periodic audits. (See Module 11 Norms and Accreditation).
• An audit may be requested by major public

health programs, or by agencies that provide
funding for programs. These groups want to
ensure that quality standards are being met
and that quality practices are in place.
International programs such as the WHO
Polio Initiative regularly assess disease-
specific laboratories according to their own
standards with their own checklists: for
example, WHO Polio laboratory accreditation
standard and WHO measles accreditation standard.
Standards In conducting external audits, the assessors will verify that laboratory policies, processes,
and procedures are documented and comply with designated standards. Different standards
can be used for the assessment processes, ranging from international standards to a locally
developed checklist.
Laboratory management must demonstrate to the assessment team that all requirements as
laid down in the standard are being followed.

Preparation When a laboratory undergoes an external audit the laboratory needs to be fully prepared, so
that the assessment experience is as easy as possible for both the assessors and the
laboratory staff, and so the assessment yields the maximum amount of information.
To be ready for the external audit, it is necessary to:
• plan thoroughly and carefully;

• organize everything ahead of time, including documents
and records, to save valuable time during the audit;
• make all staff aware of the audit; arrange schedules so
that all staff needed for the audit will be available.
On occasion, some external audits might occur without prior notification. In this case, the
laboratory would not be able to make special preparation, so the laboratory should always
be sure its system is operating properly.
Audit report After the audit the recommendations of the assessors are often presented as a verbal
and plan of summary to the laboratory management and staff, which are then followed by a thorough
action written report.
After the external audit has been completed the laboratory should:
• review the recommendations of the assessors;

• identify gaps or nonconformities, learning where benchmarks or standards were not
fully met;
• plan to correct the nonconformities; this will result in a plan for all needed corrective
actions to be taken by the laboratory; the corrective action plan should include a time
line, as well as indicate who is responsible for doing the work;
• finally, record all results and actions taken so that the laboratory has a permanent
record of the event; often a written report is useful for preserving all information.

Content Sheet 9-3: Internal Audit
Purpose Most laboratory technologists are relatively familiar with external audits; however, the
idea of conducting internal audits might be new to some people.
An internal audit allows the laboratory to look at its own processes. In contrast to
external audits, the advantages of internal audits are that laboratories can perform them
as frequently as needed, and at very little or no cost. Internal audits should be a part of
every laboratory quality system, and are a requirement of ISO standards.7
The audits should be conducted regularly and when problems are identified that need
to be studied. For example, internal audits should be performed after receiving a poor
performance on a proficiency testing (PT) survey, after an increased number of
unexpected abnormal results for a particular test, or after an increase in expected turn
around time.
Value of an The internal audit is a valuable tool in a quality management system. An internal audit
internal can help the laboratory to:
audit
• prepare for an external audit;
• increase staff awareness of quality system requirements;
• identify the gaps or nonconformities that need to be corrected – the opportunities
for improvement (OFIs);
• understand where preventive or corrective action is needed;
• identify areas where education or training needs to occur;
• determine if the laboratory is meeting its own quality standards.
Internal ISO standards put much emphasis on internal audits, and for those seeking
audit and accreditation under ISO, internal audits are required.
ISO
ISO requirements state that:
• the laboratory must have an audit program;
• the auditors should be independent of the activity;
• audits must be documented and reports retained;
• results must be reported to management for review;
• problems identified in the audits must be promptly addressed and appropriate
actions taken.

Content Sheet 9-4: Internal Audit Program
Responsibilities The laboratory director is responsible for setting overall policies for the internal audit
program. Responsibilities will include assigning authority for the program (usually to
the quality manager) and supporting the corrective action measures that are indicated. It
is essential that the laboratory director be fully informed about the results of all internal
audits.
The quality manager is responsible for organizing and managing the laboratory internal
audit program. This includes setting a timeframe for the audits, choosing and training
the auditors, and coordinating the process. The follow-up activities will also usually be
the responsibility of the quality manager, and these include managing all corrective
action efforts. The quality manager must be sure that laboratory management and the
laboratory staff are fully informed about outcomes of the audit.
The commitment of laboratory management and the quality manager will be key
to successfully establishing a process for internal audits.
Process The quality manager or other designated qualified personnel should organize the
internal audit following these steps:
• develop a formal plan;

• prepare a checklist based on selected guidelines or standards;
• meet with all staff and explain the audit process;
• select staff to serve as auditors;
• collect and analyze information;
• share results with staff;
• prepare a report;
• present the report to management;
• retain the report as a permanent laboratory record.
Select areas In order to facilitate the internal audit process, it is useful to keep it simple. Focus on
for audits defined areas of the laboratory activities, identified by issues such as customer
complaints or quality control problems. Narrowing the audit to the specific
corresponding process will save time and energy. Perform short and frequent audits
rather than initiating an annual comprehensive and overwhelming effort.

Establish a ISO 15189:2007 [4.14.2] states: “The main elements of the quality management system
schedule should normally be subject to internal audit once every twelve months.” This
requirement does not mean that a complete audit needs to be done annually. Rather, it
means that over a period of a year, every part of the laboratory should have at least one
inspection. Doing a number of small bench-specific, or section-specific audits is much
easier than trying to do them all at the same time.
Establish a policy that, at specified intervals, some section of the laboratory or a specific
process will have an internal audit. In general, audit regularly and consider three to six
month intervals between audits. If audits reveal specific problems, it may be necessary
to include more frequent audits.
Checklists and When developing checklists for internal audits:
forms used
• take into account any established national policies and standards; for example, most
countries have standards for HIV/AIDS and tuberculosis testing; laboratories
conducting this testing need to ensure checklists reflect these standards;
• ensure checklists are easy to use and include areas for recording information;
• focus on specific tests or processes; whatever the area of focus, address all areas of
the quality system; if auditing ELISA tests, consider personnel competency or
equipment maintenance, sample handling, and quality control associated with these
tests.
Forms will be needed for recording corrective actions and for making reports.
Select auditors When the laboratory initializes an internal audit program, selection of auditors is one of
the first steps to address. It is very important, and required by ISO standards, that the
auditors are independent of the area audited. Some things to consider are:
• the availability of staffing, and level of technical expertise—depending on the area
for auditing, there might be many kinds of personnel who would be appropriate for
conducting the audit; for example, if the laboratory is looking at safety issues, a
hospital safety expert, or even a housekeeping expert might be appropriate.
• whether to hire a consultant—this could still be conducted as an internal audit: the
audit is planned by the laboratory itself, without any external constraints, but
consultants or peers recruited by the laboratory for this specific audit will help the
laboratory staff to conduct it.
Any knowledgeable person in the laboratory can perform internal audits, not just
the manager or supervisor.

Important skills When deciding the personnel to choose for the audit process, take into account the skills
for auditors that will be needed for a good result. A good auditor will:
• pay attention to details, for example, check expiry dates, open and inspect
refrigerators and storage areas;
• be able to communicate effectively, but also diplomatically; diplomacy is an
important skill, since it is easy to imply criticism during an audit process.
The auditors chosen must have

the technical skills needed to
evaluate the area being audited,
and must have a good
understanding of the
laboratory’s quality
management system. Some
staff may have specialized
expertise in a limited area, such
as sample transport or
housekeeping, but could serve
as auditors in these areas.
Some in-house training on how
to conduct an audit should be provided to those who will serve as auditors.
If auditors are poorly chosen, the audits will be much less effective.

Content Sheet 9-5: Actions as Result of Audit
Audits Audits must lead to actions— this is why

should lead laboratories conduct them, to further the
to actions
process of continual improvement in the
laboratory.
Audits identify opportunities for improvement

(OFI). Both preventive and corrective actions
are steps taken to improve a process or to
correct a problem.
A record of OFIs should be kept, along with actions that are taken. Preventive and
corrective actions should be carried out within an agreed-upon time. Normally the quality
manager is responsible for initiating actions.
Problem Sometimes the cause of the problem is not obvious or easily found; in such cases a
solving problem-solving team may be necessary to:
• look for root causes;
• recommend the appropriate corrective action;
• implement the actions decided
upon;
• check to see if the corrective
actions are effective;
• monitor the procedures over
time.
All actions and findings from the

monitoring should be recorded so the
laboratory can learn from its
activities.
This is one example of a form for

recording OFIs and the corrective
action taken.

Continuous Continuous monitoring is the key element to success in the quality system.
monitoring
It is through this process
that we are able to achieve
the continual improvement
that is our overall goal.

Summary Assessment is important in monitoring the effectiveness of the laboratory quality

management system.
Both external and internal audits yield useful information. It will be used to identify
problems in the laboratory, in order to improve processes and procedures.
An outcome of assessment is finding root causes of problems and taking corrective actions.
Key • All laboratories should establish an internal audit program. Conducted on a regular
messages basis, it will provide information for continual improvement.
• Problems become opportunities for improvement.

10. Assessment- External Quality
Assessment
Content Sheet 10-1: Overview of External Quality Assessment (EQA)
Role in quality Assessment is a critical aspect

management of laboratory quality
system management, and it can be
conducted in several ways. One
of the commonly employed
assessment methods is that of Purchasing Process Information
& Control
external quality assessment. Inventory
Management

& Management
Records

Safety
Definition of The term external quality assessment (EQA) is used to describe a method that
EQA allows for comparison of a laboratory’s testing to a source outside the laboratory.
This comparison can be made to the performance of a peer group of laboratories
or to the performance of a reference laboratory.
The term EQA is sometimes used interchangeably with proficiency testing;
however, EQA can also be carried out using other processes.
EQA is here defined as a system for objectively checking the laboratory’s
performance using an external agency or facility.
Types of EQA Several EQA methods or processes are commonly used. These include:
1. Proficiency testing―external provider sends unknown samples for testing to
a set of laboratories, and the results of all laboratories are analyzed,
compared, and reported to the laboratories.
2. Rechecking or retesting―slides
that have been read are
rechecked by a reference
laboratory; samples that have
been analyzed are retested,
allowing for inter-laboratory
comparison.
External Quality Assessment ● Module 10 ● Content Sheet 111

3. On-site evaluation―usually done when it is difficult to conduct traditional
proficiency testing or to use the rechecking/retesting method.
Another method of inter-laboratory comparison is the exchange of samples

among a set of laboratories, usually reserved for specialized tests for which no
proficiency testing is available. This method is used either by very specialized or
sophisticated laboratories and therefore will not be further discussed in this
module.
EQA Participation in an external quality assessment program provides valuable data

benefits and information which:
• allows comparison of performance and results among different test sites;

• provides early warning for systematic problems associated with kits or
operations;
• provides objective evidence of testing quality;
• indicates areas that need improvement;
• identifies training needs.
EQA helps to assure customers, such as physicians, patients, and health
authorities, that the laboratory can produce reliable results.
Individual laboratories can use EQA to identify problems in laboratory practices,
allowing for appropriate corrective action. EQA participation will help to
evaluate reliability of methods, materials, and equipment, and to evaluate and
monitor training impact.
For laboratories performing public health-related testing, EQA can help to assure
that results from different laboratories during surveillance activities are
comparable.
EQA participation is usually required for accreditation. Also, EQA participation
creates a network for communication, and can be a good tool for enhancing a
national laboratory network. Samples received for EQA testing, as well as the
information shared by the EQA provider, are useful for conducting continuing
education activities.
Principal EQA programs vary but principal characteristics include the following:
characteristics
of an EQA • EQA programs can either be free-of-charge or require a fee. Free EQA
scheme programs include those offered by a manufacturer to ensure equipment is
working correctly and those organized by a regional or national program for
quality improvement.

• Some EQA programs are obligatory, either required by an accrediting body or
by law. Others are voluntary, and the quality manager may choose to
voluntarily participate in an EQA program in order to achieve improvement
in the quality of the laboratory’s performance.
• The EQA program can be organized at different levels: regional, national, or

international.
• Individual laboratory results are kept confidential, and generally are only
known by the participating laboratory and the EQA provider. A summary is
generally provided and allows comparison to the overall group.
• Some EQA schemes may

address a single disease,
for example the EQA
program for tuberculosis.
Others may address many
kinds of laboratory tests,
looking at the overall
testing performance for
microbiology. An example
of this multi-disease or test
program is the national
microbiology EQA in
France, which is
obligatory.
Successful performance in an EQA program reflects the effectiveness of the

laboratory’s quality management, and allows for recognition of laboratory
quality by external groups.
EQA is important for improvement of the laboratory quality management

system, as it is a measure of laboratory performance.

Content Sheet 10-2: Proficiency Testing
Definitions Proficiency testing, or PT, has been in use by laboratories for many years. It is the
most commonly employed type of EQA, as it is able to address many laboratory
methods. Proficiency testing is available for most of the commonly performed
laboratory tests, and covers a range of chemistry, haematology, microbiology, and
immunology testing. Most laboratorians are familiar with the proficiency testing
process, and many laboratories employ some kind of proficiency testing.
Standards organizations recognize the importance of this tool, and the following are
examples of formal definitions that are in use.
• ISO/IEC Guide 43-1:1997: “Proficiency testing schemes (PTS) are
interlaboratory comparisons that are organized regularly to assess the
performance of analytical laboratories and the competence of the analytical
personnel”.
• CLSI: “A program in which multiple samples are periodically sent to members
of a group of laboratories for analysis and/or identification; whereby each
laboratory’s results are compared with those of other laboratories in the group
and/or with an assigned value, and reported to the participating laboratories
and others”.
Proficiency In the proficiency testing process, laboratories receive samples from a proficiency
testing testing provider. This provider may be an organization (non-profit or for-profit)
process formed specifically to provide PT. Other providers of proficiency testing include
central reference laboratories, government health agencies, and manufacturers of
kits or instruments.
In a typical PT program, challenge samples are provided at regular intervals. An
optimal frequency will be 3─4 times yearly. If the program cannot provide challenges
with this frequency, the laboratory may be able to seek additional sources.
The laboratories participating in the program analyze the samples and return their
results to the central organization. Results are evaluated and analyzed, and the
laboratories are provided with information about their performance and how they
compared with other participants. The participating laboratories use the information
regarding their performance to make appropriate changes and improvements.
Roles of To be successful, PT instructions must be followed carefully, all paper work

laboratory completed accurately, and results submission deadlines met. All PT results, as well
as corrective actions, should be recorded and the records maintained for an
appropriate period of time.
PT is a tool to measure laboratory performance. Therefore, there must be no
difference in the treatment of PT samples and the patient’s sample. Proficiency

testing providers make every effort to produce samples that exactly mimic, or closely
resemble, usual samples received from patients. PT samples must be processed by
normal testing method(s) and involve personnel who routinely perform the testing.
When PT is used for any purpose other than internal quality improvement, the
provider or central organization generally prohibits the discussion of results with
other laboratories. Some PT organizers send different samples to different groups
of laboratories to avoid inter-laboratory discussion.
Nothing is gained from PT participation unless the information received is

directed to improvement in the laboratory.
Limitations It is important to remember that PT does have some limitations and it is not
appropriate to use PT as the only means for evaluating the quality of a laboratory.
PT results are affected by variables not related to patient samples, including
preparation of the sample, matrix effects, clerical functions, selection of statistical
methods of evaluation, and peer group definition.
PT will not detect all problems in the laboratory, particularly those that address the
pre- and post-examination procedures.
A single unacceptable result does not necessarily indicate that a problem exists in
the laboratory.

Content Sheet 10-3: Other EQA Methods
Using other In situations where it is difficult to provide appropriate external samples, or

EQA methods sometimes, when normal laboratory quality control methods cannot be
applied, other procedures have been developed and used for EQA. The
primary examples, and their uses, are as follows.
• Rechecking/retesting has been used traditionally for EQA for
microscopic slides for acid-fast bacilli (AFB), and for human
immunodeficiency virus (HIV) rapid testing. It can also be used in other
situations, but is not usually employed if traditional PT is feasible.
• On-site evaluation has proven a useful technique for the same
situations—AFB examination and HIV rapid testing. It allows for an
external evaluation of quality on-site, and can be conducted in
conjunction with proficiency testing or rechecking/retesting.
These procedures can be time-consuming and costly, and so are used only
when there are not good alternatives. It is essential to have a reference
laboratory with the capacity to do the repeat testing; the use of a reference
laboratory gives assurance that the re-examination process will give a
dependable result. The turnaround for the retesting must be accomplished in
a timely manner allowing for immediate corrective actions. In some
settings, transport of samples or slides to the reference laboratory will
present problems.
Retesting This EQA method is used for HIV rapid testing. HIV rapid testing presents
process some special challenges, because it is often performed outside a traditional
laboratory, and by persons who are not trained in laboratory medicine.
Additionally, the kits are single-use, and cannot be subjected to the usual
quality control methods that laboratories employ. Therefore, retesting of
some of the samples using a different process such as enzyme immunoassay
(EIA) or ELISA (enzyme-linked immunosorbent assay) helps to assess the
quality of the original testing.
Characteristically, the retesting is:
• done by a reference laboratory, to ensure quality;

• performed on dried blood spots or serum collected at the time of the
rapid test performance;
• not performed as a blinded process, as this is unnecessary.

The number of samples retested must provide statistically significant data in
order to detect error. This becomes difficult in settings where small numbers
of rapid tests are performed. A full discussion of the statistical issues in
retesting is found in the CDC/WHO reference Guidelines for Assuring the
Accuracy and Reliability of HIV Rapid Testing: Applying a Quality System
Approach.
Rechecking This method is most commonly used for acid-fast smears; the slides that were
process read in the original laboratory are “rechecked” in a central or reference
laboratory. This allows for the accuracy of the original report to be evaluated,
and also allows for the assessment of the quality of the slide preparation and
staining.
The following principles are important when performing recheck procedures.
• The slides for re-examination must be collected randomly. Every effort
should be made to avoid systematic sampling bias.
• Rechecking must be based upon statistical considerations. A common
method is for the central laboratory to recheck 10% of negative and
100% of positive slides.
• When discrepancies occur, there should be procedures in place to resolve
them.
• The outcome of rechecking must be analyzed for effective and timely
feedback.
Advantage of It is usually recommended that rechecking be done in a blinded fashion, so

performing that the laboratorian performing the retest does not know the original results.
blind recheck
In the study described in Annex 10-A (and shown in Presentation 10,
Slide 20), random blinded rechecking provided more accurate estimates of
AFB microscopy results than on the non-randomly selected, non-blinded
smears. This resulted in improved diagnosis and monitoring of treatment
response.
On-site A periodic visit by evaluators for on-site laboratory assessment is a type of

evaluation EQA that has been used when other methods of EQA are not feasible or
effective. Again, this method has most frequently been employed for
assessment of sites performing AFB smears, and those performing HIV rapid
testing.
On-site evaluation can be a valuable tool to:

• obtain a realistic picture of laboratory practices by observing the
laboratory under routine conditions in order to check that it is meeting
quality requirements;

• provide information for internal process improvement;
• measure gaps or deficiencies—learn “where we are”;
• assist the laboratory in collecting information for planning and
implementation of training, monitoring, and corrective actions.
On-site evaluation for the purpose of EQA may be conducted by a central
reference laboratory or other health authorities. On-site evaluation can be
used together with retesting and rechecking schemes to provide more
information about performance.

Content Sheet 10-4: Comparison of EQA Methods
Comparison of Some of the characteristics of proficiency testing and rechecking are compared
some in the table below.
characteristics
Comparison of proficiency testing (PT) and rechecking/retesting (RC)
Method/characteristics PT RC
Interlaboratory comparison Yes Yes
Simulated samples Yes No
Real samples Yes/No Yes
Time and resources needed Less More
Analytes evaluated Many Few
Summary of Proficiency testing:

comparison
• gives a good, objective measure of the laboratory performance;
• can be organized to address most kinds of laboratory testing;
• is cost-effective and can therefore be used frequently.
Retesting / rechecking:
• is useful when it is difficult or impossible to prepare samples to test all of
the testing process;
• is expensive and uses considerable staff time.
On-site evaluation:
• can give a true picture of a laboratory’s overall performance, and offer real-
time guidance for improvements that are needed;
• is probably the most costly, requiring staff time and travel time and
expenses of those performing the evaluation.

Content Sheet 10-5: Managing EQA in the Laboratory
Participation All laboratories should participate in EQA challenges, and this should include
in EQA EQA for all testing procedures performed in the laboratory, if possible. The
benefits of this participation are considerable, and EQA provides the only means
available to a laboratory to ensure that its performance is comparable to that of
other laboratories.
For laboratories that are accredited, or that plan to seek accreditation, EQA
participation is essential. ISO 15189 addresses EQA requirements for laboratories
as follows.
• There is a requirement that the laboratory participate in interlaboratory
comparisons.
• Where an established EQA scheme is not available, an alternate EQA

mechanism will have to be considered for interlaboratory comparison such as
exchange of samples with other laboratories.
• The laboratory management shall monitor the results of EQA and participate in
the implementation of corrective actions.
Management When participating in EQA programs, the laboratory needs to develop a process
process for the management of the process. A primary objective is to assure that all EQA
samples are treated in the same manner as other samples tested.
Procedures should be developed.
• Handling of samples—These will need to be logged, processed properly, and
stored as needed for future use.
• Analyses of samples—Consider whether EQA samples can be tested so that
staff do not recognize them as different from patient samples–blinded testing.
• Appropriate record keeping—Records of all EQA testing reporting should be
maintained over a period of time, so that performance improvement can be
measured.
• Investigation of any deficiencies—For any challenges where performance is
not acceptable.
• Taking corrective action when performance is not acceptable—The purpose of
EQA is to allow for detection of problems in the laboratory, and to, therefore,
provide an opportunity for improvement.
• Communication of outcomes to all laboratory staff and to management.

EQA If the laboratory performs poorly on EQA, the problems may lie anywhere along
performance the path of workflow. All aspects of the process will need to be checked. Some
problems examples of problems that may be identified include the following.
Pre-examination
• The sample may have been compromised during preparation, shipping, or after
receipt in the laboratory by improper storage or handling.
• The sample may have been processed or labeled improperly in the laboratory.
Examination
• The EQA challenge materials may exhibit a matrix effect in the examination
system used by the participating laboratory.
• Possible sources of analytical problems include reagents, instruments, test
methods, calibrations, and calculations. Analytical problems should be
investigated to determine whether error is random or systemic.
• Competency of staff will need to be considered and evaluated.
Post-examination
• The report format can be confusing.
• Interpretation of results can be incorrect.
• Clerical or transcription errors can be sources of error.
Incorrect data captured by the EQA provider is another possible source of error.

Summary EQA is a system for objectively checking the laboratory’s performance using an
external agency or facility.
All laboratories should participate in an EQA process for all tests performed,
whenever possible. Accredited laboratories are required to participate in EQA.
There are several methods for conducting EQA; traditional proficiency testing is
available for many tests, is cost-effective, and provides useful information.
When proficiency testing is not practical or does not provide enough information,
other methods should be employed.
There must be no difference in the treatment of a proficiency testing sample and a

patient sample. The normal testing methods must be followed and the procedure
must involve personnel who routinely perform the testing.
Key • As EQA uses valuable resources, the laboratory should make the best use
messages possible of its participation in EQA.
• EQA should not be punitive. It should be viewed as educational and used as a

tool to help direct improvement efforts in the laboratory.
• EQA is one of the critical elements of a laboratory quality management

system.

11. Assessment - Norms and Accreditation
Content Sheet 11-1: Overview of Norms and Accreditation
Role in Assessment is the means of

quality determining the effectiveness of a
management Organization Personnel Equipment
laboratory’s quality management
system system. Standards, as well as other
normative documents that provide
guidelines, form the basis for Process
Purchasing Information
assessment. They may be developed & Control Management
Inventory
at international, national or local
level.
Organizations that establish norms Documents Occurrence Assessment
or standards, and that provide for & Management
Records
accreditation or certification of
laboratories, play a vital role in the
assessment process.
Safety
Overview of An important way for a laboratory to be recognized as delivering accurate and

the process reproducible results is to go through evaluation or assessment processes conducted by a
credible, qualified organization. Successful completion of this process gives the
laboratory recognition that it is in compliance with the quality standards and norms used
for the assessment.
Responsibilities Laboratory directors need to be aware of the importance of gaining accreditation,

certification and licensure, by implementing international or national standards, in line
with the scope of laboratory activities, and in accordance with national legislation. A
major duty of laboratory managers should be to seek information about appropriate
norms and standards, and about accreditation and certification processes, so that these
can be used to provide better service.
Quality managers must convey to the laboratory staff the need for compliance with
standards, whether international or national. The quality officer will explain the process
for meeting standards, and will organize and prepare the laboratory for assessments.
Laboratorians must be aware of requirements of the chosen standards, contribute to the
development of tasks for meeting standards, be aware of assessment processes, and help
to assure readiness for assessment processes.
Assessment: Norms and Accreditation ● Module 11 ● Content Sheet 124

Content Sheet 11-2: International Standards and
Standardization Bodies
Definitions Normative document—a document that provides rules, guidelines or

characteristics for activities or their results. It covers such documents as
standards, technical specifications, codes of practice and regulations.8
Standard document—a document established by consensus and approved
by a recognized body, that provides for common and repeated use,
guidelines or characteristics for activities or their results, aimed at the
achievement of the optimum degree of order in a given context.9
Regulation—any standard that is mandated by a governmental agency or
authoritative body.
Standards may be developed internationally, nationally, or locally.

Compliance to a standard may be required by government or another
authoritative body, or may be voluntary.
Standards developed internationally may have the broadest consensus or

agreement, but may be less specific. Standards developed locally may have
the highest degree of applicability, but may not be useful for comparison
with other regions or countries.
Standardization Examples of international organizations are giving below.
bodies
• ISO (International Organization for Standardization)
ISO is the world's largest developer and publisher of international
standards, and ISO standards are applicable to many kinds of
organizations including clinical and public health laboratories.
ISO is a network of the national standard institutes of 157 countries, one

member per country, with a Central Secretariat in Geneva, Switzerland
that coordinates the system. It is a non-governmental organization, and
it forms a bridge between the public and private sectors. On the one
hand, many of its member institutes are part of the governmental
structure of their countries or have been mandated by government.
However, many members have roots uniquely in the private sector,
having been set up by national partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet
both the requirements of business and the broader needs of society.
The work of preparing standards is conducted by ISO technical

committees. Each member body has the right to be represented on the
committees. International organizations, both governmental and
non-governmental, also take part in the committee activities. Draft
international standards adopted by the technical committees are

circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member
bodies casting a vote.
• CLSI (Clinical and Laboratory Standards Institute)

CLSI is a global, non-profit, standards-developing organization that
promotes the development and use of voluntary consensus standards and
guidelines within the health care community. CLSI documents are
developed by experts working on subcommittees or working groups
under the direction and supervision of an area committee. Development
of CLSI standards is a dynamic process. Each CLSI area committee is
committed to producing consensus documents related to a specific
discipline, as described in its mission statement.
• CEN (European Committee for Standardization)

CEN was founded in 1961 by the national standards bodies in the
European Economic Community and associated countries. The general
terms include openness and transparency, consensus, and integration.
Formal adoption of European Standards is decided by a weighted

majority vote of the CEN national members and is binding on all of
them. The responsibilities are shared between 30 national members
from each country, 7 associate members, and 2 counselors, as well as
the CEN Management Centre in Brussels.
• WHO (World Health Organization)

WHO has developed several standards for disease-specific diagnostic
laboratories. One example is polio, where accreditation is required in
order for a laboratory to participate in the Polio Network for Eradication
of Poliomyelitis. Seven criteria have been selected, including, among
others, a minimum activity of 150 samples annually, successful
participation in proficiency testing, and accuracy and timeliness of
reports of cases to the network.

Content Sheet 11-3: National Standards and Technical Guidelines
Country- Standards may be developed within a country to apply only to national use. These may
specific be created by governmental organizations, or may also be developed by a recognized
standards body with a specific area or domain for application.
In some instances, national standards have been developed based on an international

standard such as ISO, and adapting this standard to the culture and general condition of
the country.
Guidelines Guidelines are developed in a variety of situations. Usually ISO standards need more
technical guidance for actual implementation in laboratories and in countries. Several
national and international organizations have developed those guidelines.
Another use for guidelines is to address a specific kind of testing, or to provide

guidance for certain parts of the laboratory. For example, there may be guidelines for
performance of HIV rapid testing, or guidelines for obtaining the appropriate biological
safety cabinet for the testing being conducted.
Examples Many national guidelines and standards have been developed. Some examples include
the following.
• GBEA (Guideline for Good Analysis Performance), France

French legislation created these guidelines to assure the quality of the services
offered by the French laboratories in 1994. It was revised in 1999 and 2002. All
clinical laboratories in France are required by law to comply with GBEA.
• BLQS (Bureau of Laboratory Quality Standards), Thailand

The BLQS of the Department of the Medical Sciences has developed national
quality standards for health laboratories based on ISO 17025 and ISO 15189. A
check list with 110 items was developed and a stepwise approach was devised.
Depending on the score obtained when compared to the checklist, laboratories will
be accredited against country-wide national standards, or can apply for the ISO
accreditation process.
• CLIA (Clinical Laboratory Improvement Amendments of 1988), USA

CLIA was mandated by legislation in 1988, and brings all medical laboratory
testing in the United State. under federal regulation. Quality standards are defined
based on the complexity of testing performed. The objective of the CLIA program
is to ensure quality laboratory testing, regardless of where it is performed (e.g.,
physician’s office, hospital laboratory, health clinic, nursing home).

Content Sheet 11-4: Certification and Accreditation
Applying Standards are used when a laboratory seeks recognition of its ability to use quality
standards practices in carrying out its work. Remember that meeting the standards may be a legal
requirement, or may be voluntary. There are three processes that may be used to indicate
that the laboratory is complying with defined standards.
• Certification—The procedure by which an independent body gives written assurance
that a product, process or service conforms to specific requirements.10
In the certification process, a laboratory is visited by representatives from a

certification body. These representatives are looking for evidence of compliance with
standards, policies, procedures, requirements, and regulations. Primarily, the
inspection team checks for physical presence of texts, procedures, and documents.
• Accreditation—The procedure by which an authoritative body gives formal

recognition that a body or person is competent to carry out specific tasks.11
A laboratory is visited by representatives from an accreditation body who are looking

for evidence of compliance with standards, policies, procedures, requirements, and
regulations, and also observe workers to ensure that they perform functions and
duties correctly and competently.
Accreditation provides a higher level of assurance to those using the laboratory that
its testing is reliable and accurate because it includes an evaluation of competency.
• Licensure—The granting of ability to practice, usually provided by a local

governmental agency. Licensure is usually based on demonstrated knowledge,
training and skills.12 Generally, when laboratory licensure is used, it is a legal
requirement for operation.
Elements of The accreditation process requires:

accreditation
• an accreditation body that oversees the assessments and grants accreditation; this
body may also set the standards used in the accreditation process;
• standards with which a laboratory must comply in order to gain accreditation;
• knowledgeable assessors or inspectors who seek to establish compliance with the
standards by conducting the assessment;
• a user laboratory which is required to, or voluntarily seeks to, comply with the
standards by being assessed.
Certification A certification or accreditation body is an organization or agency with the authorized

and right and authority to inspect a facility, and provide written evidence of its compliance
accreditation (certification) and competence (accreditation) with a standard.

bodies
Certification and accreditation bodies have the following common characteristics.
• Approved—Accreditation and certification bodies usually require their own
accreditation status. This accreditation is commonly performed under the authority of
national or international bodies, such as national standards agencies. International
accreditation bodies often are accredited to ISO 17011.13
• Knowledgeable—These bodies must be knowledgeable and skilled in the content and
interpretation of the standards against which they accredit, as well as in the discipline
they accredit. An accreditation body team includes both discipline content experts and
accreditation requirement experts.
• Standards-based—Assessments are always based on established standards.
• Objective—Interpretation of competence and skill is based on evidence rather than
impression. The inspection teams do not write their own rules, but rather measure
compliance with given rules or standards.
• Competent—These organizations ensure that all staff are trained and skilled, and that
auditing teams involve members knowledgeable in both technical and quality
management information. The bodies maintain competency because of professionalism,
and because of the importance of sustaining their own accredited status.
Commonly Standards may be applicable to accreditation or to certification, or they may be

used regulatory. Some important examples of accreditation standards include ISO 17025 and
standards for IS0 15189, both international standards in wide use. ISO 15189 is a preferred standard
accreditation for medical laboratories because it applies to the total laboratory, regardless which tests it
or certification performs, as opposed to ISO 17025, which is designed and intended to be implemented
on an individual test-by-test basis.
ISO 17025 specifies general requirements for competence to carry out tests and/or
calibrations, including sampling.
It is applicable to testing and
calibration laboratories, and can
be used for developing quality,
administrative, and technical
systems that govern operations. It
can be used by laboratory clients,
regulatory authorities, and
accreditation bodies wishing to
confirm or recognize competence
of laboratories. It does not cover
compliance with regulatory and
safety requirements.

ISO 15189 is sector specific, meaning that it is designed and intended for use only by
medical laboratories. ISO 15189 specifies particular requirements for quality and
competence of medical laboratories. It provides guidance for laboratory quality management
and technical processes to ensure quality in medical laboratory examinations. ISO 15189 is
applicable to all currently
recognized disciplines of
medical laboratory
services, and is based on
both ISO 17025 and
ISO 9001. It is for use by
medical laboratories for
developing quality,
administrative, and
technical systems that
govern their operations,
and is also for use by
organizations wishing to
confirm or recognize
competence of medical laboratories.

Content Sheet 11-5: Process of Accreditation
The decision to pursue accreditation is not one to be taken lightly or

without forethought.
Accreditation visits are expensive therefore laboratory directors and quality managers must
prepare well in advance of the visits to ensure resources are not wasted. Accreditation could
begin with one part of the laboratory and then continue with the other sections.
Preparation Seeking accreditation requires the following.

• Commitment—The path towards meeting standards and recognition is rarely
straightforward. When the process becomes difficult, challenging and requires time
and effort, it is not uncommon to quit or postpone the process. Once stopped, it
becomes very difficult to begin again.
• Planning—The path towards accreditation will take time. Laboratories should
organize their staff and time to ensure that the process goes to completion with a
minimum of obstruction.
• Knowledge—Application of standards requires knowledge of the standards and how to
interpret them. If there are not people in the laboratory that have that knowledge, the
laboratory may consider sending staff for special training or hiring a consultant.
• Resources—The process to accreditation may require reorganization, restructuring,
trained staff, or additional equipment. Recognition of potential costs should be
considered in the planning phase at the start of the process.
Interpretation When using standards to prepare for accreditation, keep in mind the following
of terms interpretations of terms commonly used in standards.
• Consensus—Agreement between delegations representing all the stakeholders

concerned-suppliers, users, government regulators and other interest groups.
Consensus is not a numeric or majority determination. Consensus represents
general agreement in the absence of strong and compelling objection.
• Normative Statement—Information within a document that is a required and
essential part of the standard. Includes the word “shall”.
• Informative Statement—Information within a document that is informational only;
often it is in the form of a ‘note’. Information may be explanatory, or cautionary, or
provide an example.
• Compliance—Meets both the text and the spirit of a requirement.
• Non-conformity—Failure to fulfill the requirements of a specified process, structure
or service. May be categorized as major (complete) or minor (partial).
• Verification of conformity—Confirmation by examination of evidence.

Content Sheet 11-6: Benefits of Accreditation
Value of It is through the accreditation of third-party evaluators that the laboratory’s clients can
accreditation have confidence that when something is measured, calibrated, inspected, tested or
certified, the job has been done
competently.
The essential aspect of
accreditation is that it promotes
confidence in results and
services because it is a valid
means of verifying claims about
quality, performance, and
reliability. The use of
internationally-recognized
standards as the reference
criteria for laboratory
accreditation is the key to
building trust across borders and promoting best practices worldwide.
Outcomes The outcomes of accreditation are:
• Measurement of strength and integrity of the quality system ;

• continual monitoring of the quality system;
• recognition for your efforts.
Accredited laboratories tend to perform better on proficiency testing and are more likely
to have a working quality management system.
Accreditation Accreditation is a valuable tool to determine the effectiveness of the quality system.
as a tool However, it is not the ultimate goal. Once accreditation status is obtained, the important
challenge will be to maintain that status.
A well-managed laboratory will know that it is meeting its goals. The laboratory should
look at accreditation as one form of audit that the quality managed laboratory puts into
place to ensure that the system is working properly.
Accreditation status must be renewed regularly and the laboratory challenged each time
to maintain and improve the quality level.

Summary Standards or norms provide guidelines that form the basis for quality practices in the
laboratory. They are developed by organizations, often through a consensus process.
Accreditation and certification are two processes that can allow for recognition that a
laboratory is meeting designated standards.
When a laboratory seeks this recognition, careful planning will be needed to have a
successful outcome. An active quality management program can assure that a laboratory
is in a constant state of "accreditation-readiness".
Key message • Accreditation is an important step in the continual improvement of the quality
management system.
• It is an accomplishment to be accredited; it is an achievement to maintain
accreditation.

12. Personnel
Content Sheet 12-1: Overview of Personnel Management
Role in quality Personnel are the most important

management laboratory resource.
system Organization Personnel Equipment
Critical to the implementation of
the quality management system are
people who possess integrity and
recognize the importance of their &
Process
Control Management
Inventory
work and participate in continuous
improvement.
Laboratorians are important Documents Occurrence
Assessment
& Management
partners in healthcare. Records

Safety
Overview of the Recruiting and retaining qualified staff is essential to laboratory quality. Failure
process to check the education qualifications and references for a new hire can lead to
problems in the future.
As a Laboratory director it is important to:
• Hire an appropriate number of staff to cover workload.
• Verify that items on the job application are correct.
• Develop complete and thorough job descriptions for each employee.
• Train each employee in their specific duties.
• Provide orientation for new employees. Even with a credible background,
differences between laboratories are common, so a manager needs to assure
new employees have adequate orientation and training.
• Conduct and record competency assessments on all personnel. It is management’s
responsibility to verify that trained employees are sufficiently competent to do their
work.
• Provide opportunities for continuing education; new techniques or updates for
existing methods can be introduced using continuing education courses.
• Conduct annual employee performance appraisals.
Personnel ● Module 12 ● Content Sheet 135

As a Quality manager it is necessary to:
• provide employees with orientation and training;
• keep track of employee records and make sure they are confidential;
• include policies relevant to personnel in the Quality Manual.
As a Laboratorian it is important to:

• participate in training and continuing education opportunities;
• request training that may be needed as job responsibilities increase;
• maintain records of personal professional development.
Importance of Success or failure depends on the knowledge and skills of the people in the
motivation laboratory, and their commitment and motivation to do the job to perform tasks as
described in the job description. Motivated employees are more likely
committed to their work.
Elements of motivation vary for different people:
• some respond to concrete rewards such as bonuses and praise;
• some respond best to flexible work schedules that fit their responsibilities to
home and children;
• most respond to recognition, and feeling that they are an integral part of the
healthcare team.
The manager can motivate the team by emphasizing that everyone’s job is
important; whether it is performing testing, collecting specimens, making reagents,
or managing the laboratory.
Retention of Migration and turn-over of staff have been described as major challenges in many
staff countries. Apart from economic factors, the lack of good working environment and
improper management practices can contribute to loss of staff. A good personnel
management program can contribute to the retention of staff.

Content Sheet 12-2: Recruitment and Orientation
Personnel Management must establish appropriate personnel qualifications for all positions in the
qualifications laboratory. These should include requirements for education, skills, knowledge, and
and job experience. When defining qualifications, keep in mind any special skills and knowledge
description that are needed such as language, information technology, and biosafety.
Job descriptions give a clear and accurate picture of responsibilities and authorities for
each staff position. Job descriptions should:
• lay out all activities and tasks that should be performed;
• specify responsibilities for conducting testing and implementing the quality system
(policies and activities);
• reflect the employee’s background and training;
• be kept current and be available for all people working in the laboratory.
Job descriptions should be competency-based and reflect any skills needed. The
requirements for each staff position may vary depending on the size of the laboratory and
complexity of testing services offered. For example, in small laboratories with limited
personnel, staff may have many responsibilities and perform many tasks, whereas in larger
laboratories with more personnel, staff may be more specialized.
Remember, not only are clear job descriptions a guideline, but they can be used to formally
assess personnel competency.
Orientation Orientation is the process of introducing a

new staff member to the new work
environment and to his/her specific tasks
or duties.
Nothing is more frustrating to an
employee than not knowing where to find
the necessary resources.
Orientation is different from training.

Orientation of laboratory personnel should include the following aspects.
• General orientation:
o A tour of the work place and introduction to all management and staff.
o Information about:
how the organization fits into the medical community and/or the public
health system;
key personnel and lines of authority;
the laboratory interaction with both users and customers of the laboratory;
the policies and procedures regarding facilities and safety.
• Personnel policies:
o ethics
o confidentiality
o employee benefits
o work schedules.
• An employee handbook that outlines the policies of the organization and information
about the laboratory quality system. A copy of the employee’s job description and a
detailed review of its contents. Employees should be provided with an overview of
Standard Operating Procedures (SOP).
A checklist that addresses each aspect of the orientation is important. Ask employees to
initial and date the checklist to document discussion of each topic (Annex 12-A).

Content Sheet 12-3: Competency and Competency Assessment
Definitions Competency is defined as the application of knowledge, skills, and behaviors used in
performing specific job tasks (ISO 10015:1999).14
Accurate laboratory test results depend on staff competent in performing a range of
procedures that occur throughout the entire examination process.
Competency assessment is defined as any system for measuring and documenting
personnel competency. The goal of competency assessment is to identify problems with
employee performance and to correct these issues before they affect patient care.
Overview This graphic is an illustration of the relationship between job description, competency
assessment, and training.
An initial competency assessment may reveal the need for specific training of the
employee. Competency assessment
should be conducted at regular
intervals during the employee’s tenure.
Competency assessments conducted

either initially or periodically help to
identify or prevent performance
problems that may be solved through
task-specific training.
Competency Competency assessment methods include the following.

assessment
methods • Direct observation helps identify and prevent any performance problems:
o The employee’s techniques are watched during the examination process, which
allows the observer to see if the employee is following SOP.
o To avoid subjectivity during a competency assessment, the observer uses a
custom-designed checklist (Annex 12-B); checklists are used when there are
specific, observable items, actions, or attributes to be observed.
Observation is the most time-consuming way to assess employee competence, but

this method is advised when assessing the areas that may have a higher impact on
patient care.

• Monitor records, e.g., review worksheets and logs prepared by the employee.
• Review and analyze quality control records and results of proficiency tests performed
by the employee being evaluated.
• Retesting or rechecking results to compare results among personnel; discrepancies

should be resolved.
• Assess knowledge or problem-solving skills using case studies. Employees are asked
to respond orally or in writing to simulated technical problems.
Methods for determining personnel competency may need to be adapted to local
customs and concerns.
Policies Policy writing for competency assessment is a critical quality systems issue and is the
and responsibility of the management. Each policy should be shared with everyone in the
processes laboratory and assessments of all personnel documented.
An example of policy for competency assessment is: “Every employee shall regularly
be assessed for competency for the tasks defined in his/her job description.”
Processes describe how the policy will be enacted. For example, the following questions
should be addressed.
• Who will conduct assessments? Responsibility for conducting the assessment
should be assigned to someone who has previously demonstrated competency in
the area to be assessed. The responsible person must document and evaluate the
results of the assessment.
• What will be assessed? Which job task or tasks and procedure performed in the
pre-examination, examination, and post-examination testing process will be
assessed? Critical competencies for each task should be identified. First-line
supervisors should be involved in this step. Examples of critical competencies
include:
o patient identification
o sample collection
o evaluation of adequacy of samples
o use of equipment
o application of quality control procedures
o interpretation of results.
• When will assessments occur (annually or biannually)? It is important to develop
a timeline for periodic assessment of each employee. A period of training and
then assessment should be implemented for everyone as new procedures and

equipment are introduced into the laboratory.
Policies and processes should be reviewed annually and modified when necessary.
Procedures Procedures describe specifically how each element of the processes will be performed.
An employee competency assessment would follow these procedures, as per examples
given below.
1. The assessor contacts the employee in advance to inform him/her that the
assessment will be done at a pre-arranged time.
2. The assessment is done while the employee is performing tasks using routine
samples.
3. The assessment is done by a specified method previously described (e.g., Annex
12-B) and is recorded in a log book (e.g., Annex 12-C).
4. The results of the assessment are shared with the employee.
5. A remedial action plan is developed defining required retraining. The plan should
be written and the manager must insure that the plan is understood by the
employee. The plan should outline specific steps to be taken to resolve or correct
the problem with related deadlines. Needed resources should be clearly outlined in
the plan. For example, the employee may need an updated version of the SOP.
6. The employee is asked to acknowledge the assessment, related action plan, and re-
assessment.
If more than one person makes the same error even after training has occurred, consider
root cause of error such as equipment malfunction and operating procedures ambiguity.
Competency Standard forms (Annex 12-B) should be generated in advance and used so all
assessment employees are assessed the same way. This will prevent employees from thinking that
documentation the assessments are biased.
All competency assessments must be recorded (Annex 12-C) showing date and results
and should be kept in a place where they remain confidential. These records are part of
a laboratory’s quality documents, and should be periodically reviewed and used for
continuous improvement.

Content Sheet 12-4: Training & Continuing Education
Definitions Training is a process to provide and develop knowledge, skills, and behaviors to meet
requirements. In this context, training is linked to the job description and competency
assessment and addresses identified gaps on specific tasks to be performed by the employee.
Competency should be reassessed after any job-specific training.
Retraining is required when competency assessment reveals the need for
improving an employee’s knowledge and skills.
Cross-training provides an opportunity for staff to acquire skills outside
their own discipline. This allows for flexibility in shifting or reassigning
personnel whenever needed; this may occur in crisis situations or with
absences of staff due to illness or vacation.
Continuing education is an educational program that brings employees up-to-date in a
particular area of knowledge or skills. Since laboratory medicine is constantly changing,
keeping current takes effort on the part of both employee and management.
Rationale Reasons for training and continuing education are to:
• achieve quality practices in the laboratory and produce accurate, reliable, and timely
test results;
• help staff achieve personal career goals;
• improve the organization’s capabilities and achievement of quality objectives.
In laboratory medicine new testing methodologies and instruments are continuously

introduced to the market place that could have implications for laboratory testing and
improved patient care.
Methods When planning a training or continuing education activity, consider:

• identification of training needs
• design of training
• provision of training
• evaluation of training results.
Activities can often be organized at low cost, for example:

• starting a journal club
• starting case study discussion groups
• watching videotapes and CDs

• researching a topic and presenting findings to colleagues
• interactive self-study programs including e-learning freeware or printed courses
• collecting and maintaining a set of teaching slides (e.g., haematology and parasitology).
This picture is from a laboratory with limited resources.

It shows a staff member demonstrating how this
laboratory approaches continuing education. The staff
conducted education sessions once a week in this room.
Resources Local resources—When organizing internal continuing education programs, local

resources available from the healthcare community should be considered. Some of these
resources include:
• quality assurance committee
• clinicians
• nurses
• pathologists
• infection control personnel
• epidemiologists / surveillance officers
• external assessors.
Each of these groups may offer specialized knowledge and experience they can share with
laboratory staff. They can be invited to give lectures, lead discussions, and exchange
information.
External resources—External continuing education programs can also be presented by
topic experts such as those associated with:
• proficiency testing services
• manufacturers
• scientific societies
• World Health Organization
• U.S. Centers for Disease Control and Prevention
• nongovernmental organizations.

Content Sheet 12-5: Employee Performance Appraisal
Periodic Employees should have a periodic formal appraisal of their overall performance. This is
appraisal broader than competency assessment and includes the following elements:
• technical competency
• efficiency
• adherence to policies
• observance of safety rules
• communication skills
• customer service
• punctuality
• professional behavior.
Feedback Appraisal can affect an employee’s morale, motivation, and self-esteem and should be
conducted equitably for all employees. People respond to criticism differently even if
delivered tactfully; therefore, consider unique approaches that match personality when
counseling employees. Positive feedback, as well as suggestions for improvement,
should be provided.
All identified problems should be addressed with the employee when they occur so that
they can correct any issue before the formal evaluation. A periodical appraisal that is
part of the employee’s record should not have items that were not previously discussed
with the employee.
Cause Poor performance may not always be due to technical incompetence. Performance may
of poor be affected by:
performance
• distractions, especially personal issues such as either a sick child or parent, or
financial problems, can make the employee’s concentration difficult;
• excessive workloads that pressure or hurry the employee may cause them to
inadvertently make errors;.
• insufficient initial orientation or training;.
• resistance to change—some people may not want to use new procedures; “we’ve
always done it this way, why change?”
The following factors could also contribute to poor results performance.
• Compromised sample—The laboratorian may or may not know that the sample
arrived in the wrong preservative or was improperly stored.

• Absence of SOPs or failure to update them. Test kits may come with modified
manufacturer’s instructions, and these modifications need to be reflected in the SOPs.
• Poorly written procedures such as omitting certain steps, including the wrong
sequence of steps, or incorrect sample or reagent quantities can cause very serious
errors and should always be suspected when several employees obtain erroneous
results.
• Job descriptions that are not clear may be a source of error—For example, confusion
about who has responsibility for calibrating an instrument could result in the
calibration not being done; therefore, causing erroneous results.

Content Sheet 12-6: Personnel Records
Policy Medical laboratories should maintain employee records that contain information integral to
their laboratory-related work. Keep records of positions held and dates for each of these
positions. This information is important for calculating employee benefits. All terms and
conditions of employment should be a part of the personnel record.
What Personnel information that the laboratory maintains may differ in different regions and
settings. While a complete list of information may include the following, some parts may
not be required in all regions and all settings:
• employment details;
• original application and resume;
• tests the employee is authorized to perform;
• conditions of continued employment;
• job description;
• both original and subsequent competency assessments;
• continuing education programs attended;
• personnel actions–corrective, disciplinary;
• leave records;
• health information including records of work injury or exposure to occupational
hazards, vaccine status, skin tests if any;
• performance appraisals;
• emergency contact information.
Where The personnel files should be kept in a secure site to protect confidentiality. Not all
information needs to be maintained within the laboratory offices. Some institutions
maintain a human resources/personnel department that may be responsible for employee
records. Consider what is essential to be maintained in the laboratory itself such as
emergency contact information or job descriptions.

Important Management of personnel is critical to the success of a quality management program.

principles of Several elements are important in this management process. Job descriptions should
personnel reflect all skills needed and accurately describe tasks, roles, and authorities. The
management competency of personnel will need to be evaluated at the time of hiring and on a
regular, recurring basis. A very important part of the management process is to seek
ways to attract qualified personnel, and to provide motivation and appropriate benefits
and working conditions so as to retain staff.
Key • Personnel are the most important resource in the laboratory.

messages
• Managers must create an environment that will fully support all laboratory personnel in
order to maintain a high quality of laboratory performance.
• Continuing education is vital to personnel competency, but does not need to be
expensive. New testing methodologies and instruments are constantly introduced to the
market place, and employees need to update their knowledge and skills.

13. Customer Service
Content Sheet 13-1: Overview of Customer Service
Role in This module will describe basic

quality elements that are essential for Organization Personnel Equipment
management developing an effective customer
system service program.
Customer satisfaction is a major Purchasing Process Information
& Control
component of a quality management Inventory
Management
system, and a significant focus in the

ISO standards. Ultimately, the
laboratory produces a product – the Documents
&
Occurrence
Management
Assessment
test result–for its customers. If the Records
customer is not well served, the

laboratory is not achieving its
primary function. Improvement Service &
Safety
Overview of the Philip Crosby defined quality practice as meeting the requirements of the
process customer. He applied this practice to business and manufacturing, but it is equally
important for a medical laboratory.
The medical laboratory needs to
know who its clients are and to
understand clients’ needs and
requirements.
Medical laboratories have a range
of customers including patients,
physicians, public health agencies,
and the community.
Laboratory It is the responsibility of the laboratory director to ensure that the customers’
responsibilities needs are met, and that there is customer satisfaction. The quality manager is
responsible for measuring the degree of customer satisfaction, using surveys,
indicators, and audits to take preventive and corrective action.
All laboratory staff must understand the importance of customer satisfaction.

Laboratory personnel must always interact with customers in a way that is
appropriate, providing needed information, and being courteous.
Customer Service ● Module 13 ● Content Sheet 149

Establishing a Seeking customer satisfaction requires the following.
program to
address 1. Commitment―Customer satisfaction is a requirement of several international
customer standards for laboratory quality, but some laboratory staff might consider it
satisfaction secondary to technical competency. Because of the importance of customer
satisfaction in a quality system, all staff must be strongly committed to the
process.
2. Planning―Monitoring takes time and planning to be done properly.
Appropriate monitoring tools need to be developed prior to gathering
information. Poor planning results in inadequate information and often leads
to uninterpretable information.
3. Knowledge―Creation of useful monitoring tools requires specific
knowledge. If there are not people in the laboratory that have that knowledge,
the laboratory may consider sending staff for special training or hiring a
consultant.
4. Resources―The process to monitoring does not have to be heavily resourced,
but does take time. Some of that time can be saved by having access to
calculators, computers, and the internet.

Content Sheet 13-2: The Laboratory Clients — The Customers
The laboratory The laboratory has many clients and the needs of all must be carefully
and its clients addressed. A central figure in the client list is the physician or health care
provider. The initial request for service originates with this person, and the
laboratory staff generally identify the ordering physician as the primary
client. Remember that in a hospital setting, the health care provider will be
assisted by many other people, including nurses, medical assistants,
phlebotomists, and secretaries or clerks. These vital hospital personnel
should also be considered clients of the laboratory, and their needs must be
considered.
Another important client for the laboratory is the patient, usually including
his/her family. Family members may play a very important role in patient
management, and may help with sample collection and transport.
When laboratory testing is being performed to meet a public health need,
public health officials or workers become clients of the laboratory. The
laboratory is a critical partner in surveillance, disease detection and
prevention, and other public health programs. Laboratories need to meet the
needs of the public health workers in addressing problems. They sometimes
need to share information without compromising the confidentiality of the
patient. Specialized laboratories such as food safety or water testing
laboratories would have other customers to consider such as food
producers, manufacturers, or water systems managers.
The community in which a laboratory works also has expectations. The
community needs to be assured that the laboratory will not create a risk for
workers, visitors, or the public.
In many countries, laboratory tests can only be ordered by a licensed health
care provider ─ a physician, or a nurse, or a dentist. In some countries,
laboratory tests can be ordered by the patient directly without referral from
a physician or nurse. Some patients do not have the knowledge or expertise
to order the right test or to interpret results. Laboratory personnel may have
to provide assistance in test selection and interpretation.
Legal identity International standards usually require that any laboratory clearly identify
itself to the public, giving assurance that an identified person is in charge
and accessible. At a minimum, every laboratory must make public a
laboratory name and address, and the name of the director, including
relevant contact information.

Physician/ The health care provider expects to have access to accurate clinically
health care relevant information that can be understood and used in a timely manner.
provider Health care professionals need assurance of laboratory responsibility
requirements throughout the testing process, including preexamination steps, the testing
process itself, and the post-examination process.
In the re-examination phase, physicians will be particularly interested in the
test menu. They benefit from an accurate collection manual, requisition
forms that are complete but user-friendly, and a timely delivery system.
For the testing or examination phase, physicians would like to be sure of

working with competent personnel. They need to know that the test
methods being used have been validated and that testing is done with good
process control and with quality control procedures in place. Appropriate
management of all adverse occurrences or errors will significantly affect
physician laboratory use.
The physician looks to the laboratory to do an excellent job in managing the

post-examination steps, as these are critical to receiving the results of
testing. A solid laboratory information system, a method for results
verification, and for delivering timely and interpretable results to the right
place are all important.
Patient The patient expects to receive personal care, keeping in mind comfort and
requirements privacy. He or she also expects to be assured that the testing has been done
correctly and properly, and provided to the health care provider in a timely
manner.
The laboratory actions needed to meet the patient requirements include:
• providing adequate information, both for collection of a specimen, and
also information about the laboratory;
• providing good collection facilities;
• having available trained and knowledgeable personnel; personnel
should know how to collect a sample properly, and should be trained to
be courteous to all patients.
• giving assurance that the laboratory records are maintained properly so
that they can be easily retrieved, and also giving assurance of protection
of the confidentially of the records.

Public health Public health professionals have the same needs as health care providers,
requirements requiring that all parts of the pre-examination, examination, and post-
examination processes are carried out properly. They may need special
kinds of information in dealing with an outbreak or epidemic, such as
specific collection processes or forms designed for the particular project or
investigation. Public health officials will also be particularly concerned
with safety issues and containment of infectious material.
Food manufacturers and producers and, water plant managers will need
information from the laboratory to help them comply with their specific
quality requirements.
Community The community in which a laboratory does its work expects that dangerous
requirements materials will be kept within the confines of the facility, and that the
laboratory will protect their own workers from risk. The community should
be aware of communicable disease alerts, and surveillance and response
activities.
The laboratory is responsible for assuring safety and security, for
containment of any infectious materials, for dealing appropriately with
waste management, and for following all regulations for the transport of
dangerous goods.
Serving all All clients benefit when a laboratory chooses to put in place a quality
clients well system and to seek recognition that it is accredited to the highest standards.
This provides assurance that the laboratory is following quality practices
and that the results it produces are accurate and reliable.
Good customer service provides:

• valuable information for best patient care;
• valuable information to improve surveillance and other public health
actions;
• a professional image for the laboratory.
Customer service is an integral part of a quality management system.

Content Sheet 13-3: Assessing and Monitoring Customer Satisfaction
Methods for In order to understand whether client needs are being met, the laboratory
assessment will need to employ tools for gaining information. The laboratory needs to
actively seek information from customers, rather than just waiting for
customers to contact the laboratory with a complaint.
Important information on customer satisfaction may be obtained using:
• complaint monitoring
• quality indicators
• internal audit
• management review
• satisfaction surveys
• interviews and focus groups.
The monitoring of customer service/satisfaction is part of the continual
improvement performed by the laboratory.
Using When the laboratory is contacted about a problem, this can provide
assessment important and helpful information. All such complaints should be
methods thoroughly investigated, and remedial and corrective action taken.
However, remember that received complaints may reflect only the “tip of
the iceberg” because many people do not complain. The laboratory
cannot use received complaints as the only means of assessing customer
satisfaction.
Quality indicators are an objective measure of laboratory practices.

Indicators can be developed that look at complaints, timeliness, patient
refusals, lost or delayed laboratory reports, as examples. When these
indicators are being monitored, information about customer needs and
satisfaction will be acquired.
When the laboratory conducts internal audits, some aspects of laboratory

practice that affect patient satisfaction can be examined. Examples might
include turnaround times, always of great concern to physicians or health
care providers.
All findings from these investigations should be very carefully reviewed

by management and followed up with appropriate action.

Content Sheet 13-4: Customer Satisfaction Surveys
Customer In order to actively seek information about how clients view the laboratory’s
surveys service, it will be necessary to conduct surveys (paper-based or electronic)
or to use interviews and focus groups. In this way the laboratory can
address specific questions to areas of concern, and can look at areas not
commonly covered by complaints or internal processes.
ISO standards put a heavy emphasis on the importance of customer
satisfaction; customer surveys are required in ISO 9001 standards for
quality management systems. Any laboratory that implements a quality
management system, whether accredited or not, needs to use some method
for surveying clients in order to understand whether needs are being met.
To be successful, surveys should be carefully planned and organized.
Deciding which clients to ask to participate in a survey is important.
Surveying health care practitioners is often easier than surveying patients.
Laboratory staff can also be asked to participate in surveys and may offer
good suggestions for streamlining operations to improve customer service.
Any survey questionnaire should be pre-tested for clarity. When developing
material, avoid leading and biased questions. Be sure to analyze the results
in a timely manner, and, when possible, provide some feedback to the group
that has been surveyed.
If the survey is to be conducted using interviews, the following tips can be
helpful.
• Write out all questions in advance, so that everyone is asked the same
questions.
• After asking some specific questions about their satisfaction with the
laboratory, ask an open-ended question that allows customers to provide
honest feedback. For example, ask how the laboratory could improve its
service to you.
Employing focus groups can be a very useful technique for gathering
information on customer satisfaction. The process of a group discussion will
often elicit comments and ideas from all the participants that might not
otherwise surface. When conducting focus group discussions, consider the
following:
• assemble small groups of 8-10 people;
• include people with diverse backgrounds and laboratory needs;
• start by asking questions that build trust;
• develop a focus group guide for consistency between groups;
• ask open-ended questions—not “yes or no” questions.

Summarize verbal responses in a written report that can be used by the
laboratory as a tool to improve customer service.
Successful When measuring customer satisfaction, whether by survey, indicators, or

surveys identify audits, much will be learned when the method is successful. This
OFI information and the insights on customer service that it provides can be used
to help the laboratory identify opportunities for improvement (OFI). The
OFI will lead to preventive and corrective actions.
Information gathering must lead to change in a continual improvement
process.

Summary Seeking customer satisfaction requires commitment from the laboratory

management and staff. It is important to remember that technical competency is not
the only goal for the laboratory.
A program for addressing customer satisfaction requires good planning, the

development of appropriate monitoring tools, the knowledge to apply the tools to
gain usable information.
Customers, or clients, of the laboratory include physicians and other health care
providers, hospital and clinic staff, patients and their families, public health
officials, and the general community.
Monitoring customer satisfaction requires some resources, primarily involving staff

time. Managers need to assure that these resources are available.
Key • Meeting customer needs is a primary goal of the laboratory.

messages
• Everyone in the laboratory is responsible for quality, and, therefore, for
customer service.
• An active quality management system ensures laboratories meet all client
requirements.

14. Occurrence Management
Content Sheet 14-1: Overview of Occurrence Management
Role in quality Occurrence management, or dealing

management with laboratory errors, is important in
systems assuring good service from the
laboratory. It is one of the twelve
quality essentials, and must be
addressed in laboratory quality Purchasing Process Information
& Control
management. Inventory
Management
This module will describe and

explain basic elements that are
Documents
essential for developing an effective &
Occurrence
Management
Assessment
occurrence management program. Records

Safety
Overview of the Occurrence management is a central part of continual improvement. It is the process by
process which errors, or near errors (also called near misses) are identified and handled. The
goal of an occurrence management program is to correct the errors in either testing or
communication that result from an event, and to change the process so that the error is
unlikely to happen again.
Well managed laboratories will also review their systems and detect process problems
that could possibly cause error at some time in the future, allowing for prevention of
these errors.
Definition An occurrence is any event that has a negative impact on an organization, including its
personnel, the product of the organization, equipment, or the environment in which it
operates. All such events must be addressed in an occurrence management program.
Occurrence Management ● Module 14 ● Content Sheet 159

Content Sheet 14-2: Sources and Consequences of
Laboratory Error
Causes of Some of the common causes of error in the laboratory are easily identifiable, and are
laboratory error also readily correctable.
For example, some errors may occur because staff are unclear about who is responsible
for carrying out a particular task, so it may remain undone. To prevent these types of
errors, individual responsibilities must be clearly defined and communicated.
Other errors occur when procedures are not written or followed, and staff are not
adequately trained. Written procedures serve as a guide for all staff, and help to assure
that everyone knows what to do. It is essential to ensure that these written procedures
are followed correctly. Staff need to be trained on how to conduct the procedures, and
if this training is neglected errors can result.
There are many other sources of error, in addition to these which are frequently
observed. While they often occur during pre- and post-examination processes, errors
can occur throughout the testing process.
Two useful studies for understanding sources of laboratory errors:

15
Retrospective data collection found Australian pathology laboratories had a
transcription-error rate of up to 39% and an error rate of up to 26% for analytical
results.
16
A report from the College of American Pathologists in collaboration with the CDC
Outcomes Working Group describes error stratification in the working process for
clinical laboratories. In more than 88 000 defects, 41% were observed in the
preexamination phase of testing, 55% in the post-examination phase, and only 4% in
the examination phase.
Pre-examination Some examples of pre-examination errors that are frequently seen include:
errors • collecting the wrong sample;
• mislabeling or failing to label the sample;
• storing the sample incorrectly prior to testing, so that the sample deteriorates;
• transporting the sample under conditions that damage the sample or that endanger
staff and public safety;
• damaging the reagents or test kits by storing them improperly.
Examination A list of common errors that occur during the testing process include:
errors
• failing to follow an established algorithm; as an example, for HIV testing;

• reporting of results when the quality control material tests out of range;
• incorrect measuring of the sample or reagents; usually these are dilution or
pipetting errors;
• using reagents that have been improperly stored, or after their expiration date.
Post- Many of the common laboratory errors occur following the testing of the sample, and
examination some of these may be more difficult to detect. Common examples of these kinds of
errors errors include:
• making a transcription error when preparing the report;

• producing a report that is illegible, usually caused by poor handwriting, but
sometimes by damage to the report form;
• sending the report to the wrong location, which often results in complete loss of
the report;
• failing to send the report.
Consequences The laboratory is a critical partner in all health systems, and it must perform its
of laboratory functions well in order to help ensure good outcomes of health programs and
error interventions. A failure in the laboratory role can have significant effect, producing:
• inadequate or inappropriate patient care;

• inappropriate public health action;
• undetected communicable disease outbreaks;
• wasting of resources;
• death of an individual.

Content Sheet 14-3: Investigation of Occurrences
Occurrence A cycle of events reflects the

cycle includes process of occurrence management.
investigation When occurrences are found, they
must all be investigated to find the
causes of the problem. The
investigation will help to identify
the actions needed to correct the
problem and to ensure that it does
not occur again. All necessary
communication must take place,
including informing any health care
providers whose clients are affected.
Detecting Occurrences are detected through a variety of investigative techniques. Monitoring of

occurrences complaints and satisfaction surveys will yield much information. Once the laboratory
establishes and monitors quality indicators, deficits will be noted. The tools of external
assessment, such as proficiency testing, external quality assessment, accreditation and
certification processes, will be very
useful in occurrence management. A
very valuable tool is the use of the
internal audit, which can be performed
at any time in the laboratory. The
laboratory’s process improvement
efforts will identify opportunities for
improvement.
It is the responsibility of management to
review all the information that results
from use of these tools, to look for underlying patterns and potential causes for
persistent or repeated error.
Investigation involves gathering complete and detailed information about events that
led to a problem, and a thorough analysis to determine all the factors that contributed to
the problem occurrence.
Root cause The most aggressive and complete approach to addressing occurrences is to seek the
analysis root cause of the problem. This is more than just a thorough examination, but is a
planned and organized approach toward finding not only the superficial causes of a
problem, but also the deeper, or core problems. With some occurrences, they are
likely to occur and reoccur until such time as the true root causes are discovered,
and addressed.
The example shown illustrates how root cause analysis was used to determine how a
major blood transfusion reaction could occur.

Content Sheet 14-4: Rectifying and Managing Occurrences
Correction of As a reminder, an occurrence is any event that has a negative impact on an organization,
occurrences which includes personnel, product, equipment, or the environment.
There are several levels of action that may be undertaken to rectify occurrences,
including the following.
• Preventive actions involve a planned and organized evaluation of processes and

procedures to identify potential error points, so action can be taken to prevent the
errors from ever
occurring. Preventive
actions require planning
and team participation.
• Remedial action, or
remediation, is the
fixing of any
consequences that
result from an error.
For example, if an
erroneous result has
been reported, it is
essential to immediately notify all persons concerned about this error, and to
provide the correct result.
• Corrective actions address the cause of the error. If a test was done incorrectly,
resulting in an incorrect result, corrective actions sort out why the test was not
performed properly, and steps are taken so that the error does not happen again. As
an example, a piece of equipment may have been malfunctioning, and the corrective
actions would be to recalibrate, repair, or otherwise address the equipment problem.
Occurrence The management process for dealing with errors or occurrences involves several steps.
management The laboratory should develop a system for prompt investigation of every laboratory
process problem and error.
1. Establish a process to detect all problems, using the tools that are available.
Remember that problems may go undetected unless there is an active system for
looking for them.
2. Keep a log of all problem events that records the error, any investigation activities,
and any actions taken.
3. Investigate the causes of any problem that is detected, and carefully analyze the
information that is available.

4. Take the necessary action—remedial and corrective, and if the problem is detected
before the error actually occurs, preventive action.
5. Monitor and observe for any recurrence of the original problem, keeping in mind
that there may be a systemic problem.
6. Provide information to all those who need it, and to those who are affected by the
error.
Responsibilities The responsibility for monitoring for occurrence belongs to everyone in the laboratory.
It is important, however, that someone be designated as the person responsible for
marshalling the energies and activities of all staff into an effective management
process. In many instances, this is the responsibility of the laboratory director, or
laboratory manager, or the quality manager.

Summary Occurrence management is an integral component of laboratory quality

management. It establishes the methods for finding errors and preventing
them from occurring again, and also seeks to identify potential errors and
prevent them from happening.
The laboratory should employ an active process for occurrence management

and take a positive approach. Make an effort to detect problems as early as
possible, and then take immediate remedial and corrective action. Be
proactive, and see opportunities to identify potential error, thus preventing an
occurrence. And finally, keep good records of all problems, investigations,
and actions taken.
Key messages The difference between a quality-managed laboratory and laboratories with
no system in place is that the quality laboratory detects the problem,
investigates, and takes actions.

15. Process Improvement
Content Sheet 15-1: Continual Improvement Concept
Role in Process improvement, one of the 12

quality quality system essentials (QSE), Organization Personnel Equipment
management establishes a program for helping to
system assure continual improvement in the
laboratory quality over time. This
continual improvement of the Purchasing Process Information
& Control
laboratory processes is essential in a Inventory
Management
quality management system.

& Management
Records

Safety
Historical W. Edwards Deming is one of the originators of the concept of continual

basis improvement, the primary goal of a quality management system.
Beginning in the 1940s, he worked with manufacturing and industrial processes, and
introduced many of the tools used in quality improvement efforts; his ideas and
concepts are used today to produce reliable, quality laboratory results.
Deming outlined 14 points for quality (Annex 15-A), many of which can easily be
applied to the laboratory. For the purposes of this discussion, two of his points are
particularly important.
1. Create constancy of purpose for improvement. The message here is that there
is a need to be constantly working toward making the process better.
2. Improve constantly and forever. This statement points out that continual
improvement will always be a goal. Perfection is never achieved, but we try to get
as close to it as possible. Process improvement is something that is never finished,
but rather continues on “forever”.
Process Improvement ● Module 15 ● Content Sheet 167

Deming’s The Deming PDCA Cycle, standing for Plan-Do-
PDCA Cycle Check-Act, shows how to achieve continual
improvement in any process.
• Plan—Identify the problems, the potential
sources of system weakness or error. Decide on
the steps to be used to gather information. Ask
the question, “how can you best assess the
current situation and analyze root causes of
problem areas?” Using the information that is
gathered through these techniques, develop a plan for improvement.
• Do—Implement whatever plans have been developed–put the plan into action.
• Check—This refers to the monitoring process. It will be important to assess the
effectiveness of the action taken, using focused review and audit processes. If the
system weakness is complex, a pilot study may be needed in order to understand
all the complexities. After “checking”, revise the plan as required to achieve the
improvements needed.
• Act—Take any corrective action that is required, and then re-check to be sure that
the solution has worked. This cycle is a continuous process, so the laboratory will
begin again with a planning process to continue the improvements.
This is the continual improvement process, and, in the laboratory, this process is
applied to all procedures and processes that are a part of the Path of Workflow.
ISO process ISO 15189 [4.12] describes a very similar set of activities for achieving continual
for continual improvement in the laboratory. These are outlined as follows:
improvement
• identify potential sources of any system weakness or error;
• develop plans to implement improvement;
• implement the plan;
• review the effectiveness of the action through the process of focused review and
audit;
• adjust the action plan and modify the system in accordance with the review and
audit results.

Content Sheet 15-2: Tools for Process Improvement
What is A process is a series of actions or operations contributing to an end. In every case, inputs
process (patient samples) are turned into outputs (patient examination results) because some kind
improvement? of work, activity, or function is carried out. Process improvement is a systematic and
periodic approach to improving laboratory quality, and the inputs and outputs that glue
these processes together. It is a way of solving problems. If there is a problem, however hard
to describe, one or more processes needs to be improved.
Conventional Many useful techniques have been developed to use in process improvement, and some
tools for have been discussed in other modules in the training materials. For example, both
improvement internal and external audits will identify system weaknesses and problem areas.
Participation in an external quality assessment, or EQA, is another useful tool; it allows
for comparing laboratory performance to that of other laboratories.
Management review of all information gathered through these activities should be

conducted. In addition, there should be, on a regular basis, management reviews of the
laboratory records, for example, quality control, inventory management, and equipment
maintenance. These reviews will provide useful information about areas for improvement.
Using information from these reviews and from audits, and through the process of
monitoring the organization’s customer complaints, worker complaints, errors, near-errors
or near-misses, opportunities for
improvement (OFI) will be identified.
These OFIs will be the focus for
corrective action.
When conducting audits or evaluating
laboratory records, it is important to
have a goal or standard of performance.
Therefore, quality indicators will be
needed, and will have an important role
to play.
The plan leads to the goals; the
opportunities for improvement (OFI), which are the result from monitoring, lead to the
creation of a new plan, with the process leading to continual improvement.
Newer tools New ideas for tools to use for continual improvement continue to come from the
manufacturing industry. Two of these new tools are now being used in laboratory quality
improvement.
1. Lean is the process of optimizing space, time, and activity in order to improve the
physical paths of workflow. This tool of industry is applicable to laboratories, and
many laboratories are currently engaged in creating a lean system. Lean analysis may

lead to revised processes and changes in laboratory floor plans. This should save time
and financial resources, as well as help to reduce errors in the Path of Workflow (an
example of this tool is in Annex 15-B).
2. Six Sigma is also a concept that has come to us from the manufacturing industry.
This consists of a formal structure for project planning in order to implement change
and improvement. In Six Sigma, the focus is to move toward reducing error to very
low levels. The processes that are described in Six Sigma are define, measure,
analyze, improve, and control. These are similar ideas to those already discussed. The
Six Sigma concept applies a very structured method for achieving these processes.
(This module will not explore Six Sigma in depth; it is included here so that
participants will become familiar with the term. See Module 15 reference list for
sources of Six Sigma information.)

Content Sheet 15-3: Quality Indicators
Reminder: It is often useful to consider a number of definitions in order to make very clear what
What is is meant by a term such as quality. Philip Crosby, in his essays on Quality
quality? Management from the 1960s, defined quality as “conformance to requirements, not as
‘goodness’ or ‘elegance’.”
What is a Established measures used to determine how well an organization meets needs and
quality operational and performance expectations is a good working explanation of a quality
indicator? indicator.
Quality indicators are addressed in ISO 9001 and ISO 15189 documents.
Refer to Annex 15-C.
ISO 9001 [5.4.1] requires that quality objectives should be measurable. Thus, the
objectives or indicators must be quantifiable or otherwise capable of analysis, allowing for
an assessment of the success of the quality system.
ISO 9001 [8.4] more specifically requires collecting and analyzing specific information or
data upon which one can determine effectiveness and continual improvement. Some of the
indicators that are required to be considered include customer satisfaction, conforming to
customer requirements for products, counting the number of preventive actions addressed,
and ensuring that suppliers are providing materials that will not adversely affect your quality.
ISO 15189 [4.12.4] states that the laboratory shall implement quality indicators to
systematically monitor and evaluate the laboratory’s contribution to patient care. When
the program identifies opportunities for improvement, the laboratory management shall
address them regardless of where they occur. Also it is stated that laboratory management
shall ensure that the medical laboratory participates in quality improvement activities that
deal with relevant areas and outcomes of patient care.
Purpose of Quality indicators are information that is measured. The indicators:

quality
indicators • give information about the performance of a process;
• determine quality of services;
• highlight potential quality concerns;
• identify areas that need further study and investigation;
• track changes over time.

Content Sheet 15-4: Selecting Quality Indicators
General In selecting quality indicators for measuring performance, Mark Graham Brown,17 a
guidelines leading expert on performance measurement, suggests the following useful guidelines.
• Fewer are better; that is, do not try to have too many quality indicators, as tracking
becomes difficult. Few laboratories can effectively address more than five or six
indicators at a single time.
• Link the indicators to the factors needed for success. Choose the quality indicators
that relate to areas that need correction in order to achieve good performance; select
those that will be most meaningful to the laboratory.
• Measures (indicators) should be based around customer and stakeholder needs.
• Measures should look at all levels of the laboratory; if possible, include indicators
that will evaluate function at the top management level but also flow down to all
levels of employees.
• Measures should change as the environment and strategy changes. Do not stick with
the same indicators over long periods of time.
• Base the targets and goals for the measures on rational values, rather than values of
convenience. They should be established on the basis of research rather than arbitrary
estimates.
Developing Quality indicators—also called metrics—are the specific targets that are regularly examined
successful using objective methods, in order to determine if the goals of compliance are being met.
indicators When developing quality indicators an organization should ensure the following.
• Objective—The indicators must be measurable, and not dependent on subjective
judgments. It must be possible to have concrete evidence that the event (or indicator)
either occurs or does not, or that the target is clearly met.
• Methodology available—Be sure that the organization has the tools needed to
accomplish the necessary measurements. The laboratory must have the ability to
gather the information. If the data or information collection requires special
equipment, then make sure the special equipment is available before starting.
• Limits—The laboratory will need to know the acceptable value, including the upper
and lower range, before starting measurements. Determine in advance the limits of
acceptability, and at what point a result causes concern. Also consider what action
will be required. For example, how many delayed reports per month would be
considered acceptable? How many would be considered as requiring corrective
actions? How many would require immediate revision of the action plan?
• Interpretation—Decisions must be made as to how indicator information will be
interpreted before beginning measurements. Know in advance how to interpret the
information that has been collected. For example, if you are monitoring completed
requisitions to see if they are correct, you need to know how many samples you have
examined, if they have come from multiple sources or all sources, and whether they

are for only one type of sample or all sample types.
• Limitation—The organization should understand exactly what information is being
provided by the indicator, and be clear on what is not being determined by the
measurement of a particular indicator. For example, if collecting the number of
accidents or errors, do you know if all are being reported?
• Presentation—The organization must decide how to present the information in order
to fully display its value. Some information is best presented in a table, whereas other
information might be best shown by a longitudinal graphic bar or in text.
Presentation of information is important when looking for trends that predict future
outcome.
• Action plan—Before beginning the use of an indicator, the laboratory should have
some idea of what to do if the indicator shows that there is a problem. Also decide
how to collect the information, who will collect it, and how long it will be collected.
• Exit plan—Because making these measurements takes time and resources, there
should be a plan as to when to stop using a particular indicator and replace it with
another. Generally, this is done when the original indicator shows that the operation
is working and stable.
When developing quality indicators, be sure to engage the bench-level staff – those who
do the work have a clear understanding of the tasks and outcomes. The planning process
is best done in groups rather than by the quality manager alone. By engaging the people
who actually do the work, the opportunity for success improves.
Characteristics Good quality indicators (also called metrics) have the following characteristics:
of good quality
indicators • Measurable—The evidence can be
gathered and counted.
• Achievable—The laboratory has the
capability of gathering the evidence it
needs.
• Interpretable—Once it is gathered, the
laboratory can make a conclusion
about the information that is useful to
the laboratory.
• Actionable—If the indicator
information reports a high or unacceptable level of error, it is possible to do
something about the problem identified.
• Balanced—Consider indicators that examine multiple aspects of the total testing cycle.
Look at indicators in the pre-examination, examination, and post-examination phases.
• Engaging—Indicators should examine the work of all staff, not just one group.
• Timed—Consider indicators with both short term and long term implications.
The laboratory produces much information, but all the things that can be measured are
not necessarily informative. As an example, a computer can analyze data in a variety of

ways, but this does not always mean that the information is useful for continual
improvement activities.
Mark Graham Brown warns “Many organizations spend thousands of hours collecting
and interpreting data. However many of these hours are nothing more than wasted time
because they analyze the wrong measurements, leading to inaccurate decision making.”
18
Some All laboratories should consider implementing a process for using a set of indicators
examples of which cover pre-examination, examination, and post-examination issues as well as
quality patient care systems. Examples of quality indicators are listed in Annex 15-D.
indicators
A 2005 study19 of
medical laboratories Most common indicators tracked (%) 2005
carried out in the United
States showed the most Patient ID
commonly monitored
indicators in use at that
Result turn
time were related to around time
proficiency testing,
quality control, Competency
personnel competencies, personnel
turnaround time, and
Quality
patient identification control
and its accuracy.
Proficiency
It is important to note that
testing
ideally, quality indicators
used in health care should 40 60 80 100
be linked to patient
outcomes. However, this is very difficult with laboratory indicators because patient
outcome is dependent upon a complex set of circumstances including age and underlying
illness, stage of illness, stage of diagnosis, and stage of therapy. Therefore, laboratories
often use quality indicators other than health outcomes of patients.

Content Sheet 15-5: Implementing Process Improvement
Essentials for Regardless of the technique used, continual improvement requires action from the
implementation people within the organization. Some of the necessary steps are important management
roles, and others require the entire laboratory staff for success. These essential factors
and steps include what follows.
• Commitment from all levels of the laboratory staff. Improvement requires continual
awareness and activity. This is a full-time task, and requires dedicated staff time .
• Careful planning so that goals can be achieved. Before action plans are implemented,
there is much to consider: root causes of error; risk management; failures, potential
failures and “near misses”; costs, benefits and priorities; and the costs of inaction.
• An organizational structure that supports the improvement activities.
• Leadership—Top management must be engaged and supportive.
• Participation and engagement of the people that normally perform the tasks being
addressed. These are the staff most likely to know and understand what is done on a
regular and daily basis, and without their participation, improvement programs have
little opportunity for lasting success.
Planning for When undertaking and implementing action plans for quality improvement, there are a
quality number of factors to consider.
improvement
• What are the root causes of error? In
order to correct errors it is important to
identify the root causes, or underlying
causes, of the problem.
• How will risk be managed in the
laboratory? Risk management takes into
account the trade-offs between the risk of
a problem, and the costs and effort
involved in fixing it.
• Failures, potential failures, and near-misses are categories into which laboratory
problems fall. Failures are most commonly identified, as a failure in the system will
usually be immediately obvious. Failures need to be addressed as a part of continual
improvement. However, a good process improvement program will try to identify
potential failures, which are not so obvious, as well as near-misses, those situations
where a failure has almost occurred.
• Any process improvement program must take into account the costs of making
changes, the benefits of making the changes, and the priorities for action. These
decisions relate to the concept of risk management.
• Finally, it is important to consider the cost of inaction, or failure to take action. What
will be the cost, in money, time, or adverse effects, of not correcting a problem in the
laboratory quality system?

Role of Early on, Deming observed that quality managers working without the clear, active, and
leadership open participation of top management cannot succeed in implementing continual
improvement. Sustained leadership must come from the top.
Good leadership fosters the culture for improvement.
• Openness—The process must be understood by all and a recognition that all
laboratory staff will have good ideas to help with improvements.
• Commitment—It must be clearly communicated that there is support for the process
and that improvements will occur.
• Opportunity—A good leader will assure that all staff have the opportunity to
participate in the process.
Participation in Always remember that top management, quality managers, and consultants do not
the process know everything that the bench-level staff know, and often are not aware of all of the
staff’s tasks. It is vital to engage all bench-level staff in the process improvement
program, as their knowledge and support are also essential. Furthermore, when staff
know they can make a difference, they will benefit the laboratory by pointing out
potential problems that, when addressed, can be avoided.
Continual improvement requires both leadership and engaged team participation.
Quality The following steps show how to plan quality improvement activities:
improvement
activities • use a timeline, and do not take on more than can be accomplished within a timeframe;
• use a team approach, involving bench-
level staff;
• use appropriate quality improvement
tools;
• implement corrective or preventive
actions;
• report quality improvement activities,
findings, and corrective action progress to management and also to laboratory staff.
If possible, design a study so that results can be statistically measured. Use available
information to select a topic for study, for example:
• customer’s suggestions or complaints;
• identified errors from occurrence management program;
• problems identified in internal audits.
Consider as a guideline to have no more than one project every six months.
Retiring a Use a quality indicator only as long as it provides useful information. Once it is
quality indicating a stable and error-free operation, select a new quality indicator.
indicator

Continual The process for continual improvement includes:

improvement
• identification of the problem;
• analysis of the data and the processes;
• determination of the root cause of the

problem;
• generating of ideas for solutions.
Continual improvement is the core of quality management but it requires commitment,

planning, structure, leadership, participation, and engagement.
Key messages • Quality counts. It is a very important goal for any laboratory.
• Continual improvement is an outcome of an active laboratory quality management
system.

16. Documents and Records
Content Sheet 16-1: Introduction to Documents & Records
Role in The management of documents and

quality records is one of the 12 essential
management elements of the quality system. The
system management system addresses both use
and maintenance of documents and
records. A major goal of keeping Purchasing Process Information
Control
documents and records is to find &
Inventory
Management
information whenever it is needed.

& Management
Records

Safety
Documents Documents provide written information about policies, processes, and procedures.
and records; Characteristics of documents are that they:
what are the
differences? • communicate information to all persons who need it, including laboratory staff, users,
and laboratory management personnel;
• need to be updated or maintained;
• must be changed when a policy, process, or procedure changes;
• establish formats for recording and reporting information by the use of standardized
forms. Once the forms are used to record information, they become records.
Some examples of documents include a quality manual, standard operating procedures
(SOP), and job aids.
Records are the collected information produced by the laboratory in the process of
performing and reporting a laboratory test. Characteristics of records are that they:
• need to be easily retrieved or accessed;
• contain information that is permanent, and does not require updating.
Some examples of records include: completed forms, charts, sample logs, patient records,
quality control information, and patient reports.
Information is the major product of the laboratory, so manage it carefully with a good
system for the laboratory’s documents and records.
Documents and Records ● Module 16 ● Content Sheet 179

Content Sheet 16-2: Overview of Documents
Documents include all the written policies, processes, and procedures of the laboratory.
In order to develop laboratory documents, it is important to understand each of these
elements and how they relate.
What is a A policy is “a documented statement of overall intentions and direction defined by those in
policy? the organization and endorsed by management20.”
Policies give broad and general direction to the quality system. They:
• tell “what to do”, in a broad and general way;
• include a statement of the organizational mission, goals, and purpose;
• serve as the framework for the quality system, and should always be specified in the
quality manual.
Although there are national policies that affect laboratory operations, each laboratory will
develop policies specific to its own operations.
What is a Processes are the steps involved in carrying out quality policies. ISO 9000 [4.3.1] 21
process? defines a process as a “set of interrelated or interacting activities that transform inputs into
outputs.”
Some examples of laboratory inputs include test requests, samples, and requests for
information. Examples of laboratory outputs include laboratory data and reports of results.
Using these examples, one process might be how to transform a test request (input) into a
test result (output).
Another way of thinking about a process is as “how it happens”. Processes can generally
be represented in a flow chart, with a series of steps to indicate how events should occur
over a period of time.
What are Procedures are the specific activities of a process (ISO 9000 [3.4]). Procedures are very
procedures? familiar to laboratorians–a procedure is easily described as the performance of a test.
A procedure tells “how to do it”, and shows the step-by-step instructions that laboratory
staff should meticulously follow for each activity. The term Standard Operating
Procedure (SOP) is often used to indicate these detailed instructions on how to do it.
Job aids, or work instructions, are shortened versions of SOPs that can be posted at the
bench for easy reference on performing a procedure. They are meant to supplement, not
replace, the SOPs.

Document A good way to represent the relationship of policies,
hierarchy processes, and procedures is as a tree. The policies are
represented by the roots, and they form the base for all
the other parts. The processes can be viewed as the
trunk of the tree, representing a series of steps or flow
of actions through the laboratory. The leaves of the
tree can be thought of as the procedures; there will be
many procedures in the laboratory for accomplishing
the activities or the work.
The quality manual is the overall guiding document

that defines the quality system through policies established by the laboratory. Next in the
hierarchy of documents are the processes, the sets of activities. Procedures either flow
from processes, or make up a part of a process; these will generally be described as
standard operating procedures (SOP). Work instructions or job aids are shortened versions
of SOPs. Finally, forms are used to record results; when completed, they become records.
Why are Documents are the essential guidelines for all of the laboratory operations. Some of the
documents important documents that every laboratory should have include:
important?
• Quality Manual—This is the overall guiding document for the quality system and
provides the framework for its design and implementation. A laboratory is required to
have a Quality Manual for ISO accreditation (the quality manual is discussed further in
content sheets 16-3 and 16-4).
• Standard Operating Procedures (SOP)—SOP contain step-by-step written instructions
for each procedure performed in the laboratory. These instructions are essential to
ensure that all procedures are performed consistently by everyone in the laboratory.
• Reference materials—Good reference materials are needed in order to find scientific
and clinical information about diseases, laboratory methods, and procedures.
Sometimes, there are difficult interpretive issues, for which references or textbooks will
be needed. As an example, when examining samples microscopically for parasites,
photographs and descriptive information can be very helpful.
Written documents are required by formal laboratory standards, including those leading to
accreditation. Standards generally require that policies and procedures be written and available.
Most inspection/assessment activities include an examination of the laboratory’s documents.
The documents are an important element on which the laboratory is assessed.
Documents are the communicators of the quality system. All policies, processes, and
procedures must be written, so that everyone will know the proper procedures and can carry
them out. Verbal instructions alone may not be heard, may be misunderstood, are quickly
forgotten, and are difficult to follow. Everyone, both inside and outside the laboratory, must
know exactly what is being done, and what should be done at each step. Therefore, all of
the guidelines must be written so that they are available and accessible to all who need
them.

Documents are a reflection of the laboratory’s organization and its quality management. A
well-managed laboratory will always have a strong set of documents to guide its work.
A good rule to follow is: “Do what you wrote and write what you are doing.”
What makes Documents communicate what is done in the laboratory. Good documents are:
a good
document? • written clearly and concisely; it is better to avoid wordy, unnecessary explanations in
the documents;
• written in a user-friendly style; it might be helpful to use a standard outline so the
general structure will be familiar to staff and easily used by new personnel;
• written so as to be explicit and accurate reflecting all implemented measures,
responsibilities, and programs;
• maintained to ensure that it is always up-to-date.
Accessibility The documents needed in the work process must be accessible to all staff. Persons
managing samples should have the procedures for sample management directly available to
them. Testing personnel will need the SOPs in a convenient place, and perhaps a job aid
posted in clear view of the work space where testing is performed.
The testing personnel need immediate access to quality control charts and trouble-shooting
instructions for equipment. All staff must have access to safety manuals.

Content Sheet 16-3: The Quality Manual
What is a The quality manual is a document that describes the quality management system of an
quality organization (ISO 15189). Its purpose is to:
manual?
• clearly communicate information;
• serve as a framework for meeting quality system requirements;
• convey managerial commitment to the quality system.
As the quality manual is an important guide or roadmap, all persons in the laboratory should
be instructed on its use and application. The manual must be kept up to date, and
responsibility for the updating should be assigned.
Writing a Although ISO 15189 standards require that laboratories have a quality manual, the style and
quality structure are not specified. There is considerable flexibility in how to prepare it, and a
manual laboratory can construct the manual so that it is most useful and suited to the needs of the
laboratory and its customers.
When writing a quality manual, it is a good idea to use a steering committee. Because the
quality manual needs to be tailored to the specific needs of the laboratory, each facility
should carefully consider how to best involve those who are needed. Involve the policy
makers for the laboratory. It is also essential to involve the bench technologists, to take
advantage of their expertise and get their buy-in.
The quality manual should state policies for each of the twelve essentials of the quality
system. Also describe how all the related quality processes occur, and make note of all
versions of procedures (SOP), and where they are located. For example, SOPs are a part of
the overall quality system. Although there are usually too many to include directly in the
quality manual, the manual should specify that SOPs be developed, and indicate that they
be compiled in the SOP manual.
Annex 16-A and Annex 16-B show examples of the table of contents from quality manuals
provided by ISO 15189 and CLSI, respectively. These examples give suggestions for topics
to include when developing a quality manual.
Key Points The key points to remember about the quality manual are:
• there is only ONE official version;
• the quality manual is never finished; it is always being improved;
• it should be read, understood, and accepted by everyone;
• it should be written in clear, easily-understood language;
• the quality manual should be dated and signed by the management.
Developing a quality manual is a very big job, but it is also very rewarding and useful for
the laboratory.

Content Sheet 16-4: Standard Operating Procedures (SOP)
What is an Standard Operating Procedures (SOP) are also documents, and contain written step-by-
SOP? step instructions that laboratory staff should meticulously follow when performing a
procedure. A laboratory will have many SOPs, one for each procedure conducted in the
laboratory.
Written SOPs ensure the following.
• Consistency—Everyone should perform the tests exactly the same so that the same
result can be expected from all staff. Consistency enables people who use laboratory
results to observe changes in a particular patient’s results over time; if different
laboratories use the same SOPs, comparisons of their results can be made; it should
be emphasized that all laboratory staff must follow the SOPs exactly.
• Accuracy—Following written procedures help laboratory staff produce more
accurate results than relying on memory alone because they won’t forget steps in the
process.
• Quality—Together, consistent (reliable) and accurate results are primary goals of the
laboratory, and could be considered as the definition of quality in the laboratory.
A good SOP should be as follows.
• Detailed, clear, and concise, so that staff not normally performing the procedure will
be able to do so by following the SOP. all necessary details, for example, ambient
temperature requirements and precise timing instructions, should be included.
• Easily understood by new personnel or students in training.
• Reviewed and approved by the laboratory management. Approval is indicated by a
signature and a date; this is important to assure that the procedures being used for
testing in the laboratory are those that are up-to-date and appropriate.
• Updated on a regular basis.
Standardized It is a good idea to standardize the formats of SOPs so staff can easily recognize the flow
format of the information.
Headers are a very important part of the format. Below are examples of two different
types of headers that could be used when writing an SOP.
• Complete Standardized Header—Typically the standardized header would appear on
the first page of each SOP. The standardized form makes it easy for staff to quickly
note the pertinent information.

• Reduced Standardized Header—This standardized form includes a smaller version
of the header that would appear on all pages other than the first.
An example of a SOP is provided in Annex 16-C.
Preparing There are a few things to keep in mind when preparing an SOP. Firstly, it is important to
SOPs assess the scientific validity of the procedure. Then, when writing the procedure, include
all steps and details explaining how to properly perform the procedure. The SOP should
refer to any relevant procedures that may be written separately, such as instructions for
sample collection or quality control. Finally, a mechanism should be established for
keeping SOPs updated.
SOPs should include the following information.
• Title—name of test.
• Purpose—include information about the test—why it is important, how it is used,
and whether it is intended for screening, to diagnose, or to follow treatment; and if it
is to be used for public health surveillance.
• Instructions —detailed information for the entire testing process, including pre-
examination, examination and post-examination phases.
Pre-examination instructions should address sample collection and transport to the
laboratory, and conditions needed for proper sample handling. For example,
instructions should indicate whether the sample needs a preservative, whether it
should be refrigerated, frozen, or kept at room temperature. Instructions should also
reflect laboratory policies for sample labelling, such as requirements to verify more
than one type of patient identification, to write the collection date on the sample
label, and to make sure all information needed is included on the test request form.
Examination instructions should address the actual step-by-step laboratory
procedures to follow and the quality control procedures needed to ensure accuracy
and reliability.
Post-examination instructions should provide information on reporting the results,
including the unit of measurement to be used, the normal (reference) range, ranges
that are life-threatening (sometimes called “panic values”), and instructions for how

to deal with an urgent report. They should also include references to the published
sources of the procedures, including published evidence that the procedures are
scientifically valid.
• Name of the person preparing the SOP.
signatures of approving officials and dates of approval—It is necessary to follow the
laboratory’s quality policy and regulatory requirements.
Manufacturer’s The instructions that manufacturers provide in their product inserts tell how to perform
instructions the test, but do not include other important information that is specific to laboratory
policy, such as how to record results, algorithms outlining the sequence of testing, and
safety practices. The manufacturer’s instructions may describe recommended quality
control procedures for the test, but the recommendations may not be as comprehensive as
protocols that a laboratory has put into place. Do not rely solely on manufacturer
product inserts for SOPs. Use information from these inserts, but develop SOPs
specific to your laboratory.
What is a A job aid is a shortened

Job aid? version of an SOP. It is
designed for use directly at
the testing site. It should be
placed in a visible location,
and serves as a reminder of
the steps that need to be
completed. The job aid and
the SOP must include the
same instructions. If a job aid
is distributed to sources
outside the laboratory, ensure
that the information illustrated matches that which is instructed in the SOP. External
laboratory assessors often check to see if job aids and SOPs are in accordance.
Job aids supplement–not replace–the SOP. They do not include all the details that are
provided in the SOP.
An example of a job aid is provided in Annex 16-D.

Content Sheet 16-5: Document Control
Purpose of Documents, by definition, require updating. A system must be established for managing
document them so that current versions are always available. A document control system provides
control procedures for formatting and maintaining documents and should:
• assure that the most current version of any document is the one that is in use;
• ensure the availability and ease of use when a document is needed;
• provide for the appropriate archiving of documents when they need to be replaced.
Elements of A document control system provides a method for formatting documents so that they are
document easily managed, and sets up processes for maintaining the inventory of documents. In this
control system the laboratory will need:
• a uniform format that includes a numbering system, to include a method for identifying
the version (date) of the document;
• a process for formal approval of each new document, a distribution plan or list, and a
procedure for updating and revising laboratory documents;
• a master log or inventory of all documents of the laboratory;
• a process to ensure that the documents are available to all who need them, including
users outside the laboratory;
• a method for archiving documents that become outdated but need to be kept for future
reference.
Controlled All documents that are produced by and/or used in the laboratory must be included in the
documents control system. Some important examples include:
• Standard Operating Procedures (SOP)—It is essential to have all SOPs up-to-date,
showing the procedures that are in current use. Also, when work instructions or job aids
are used, they must exactly match the SOPs for the tasks described.
• texts, articles, and books that are part of the documents referenced in a laboratory;
• documents of external origin, such as instrument service manuals, regulations and
standards, and new references (that may change over time).
Developing While establishing a document control program, the following should be considered.
the
document • System for standardizing the format and/or numbering — It is very useful to have a
control numbering or coding system that applies to all documents created within the
system organization. Because documents are “living” and require updating, the numbering
system should indicate the document version.

One suggestion for a numbering system is to use a letter for the type of document, then
an incremented number for each of the documents of this type. All pages of the
documents would contain the appropriate number. For example, B1, B2, B3, … for
books ; T1, T2, ... for official texts. A location code could be used, and would be
useful for the master log or file. For example, “Book number 2, pages 188-200, on
bookshelf 1” B2, 188-200, BS1.
Establishing a document numbering system can be a difficult and time-consuming
process. If the laboratory already has an effective system in place, there is no need to
change it.
• Approval, distribution, and revision process—Control of documents requires that they
be reviewed on a regular basis, with revision as needed, followed by approval and
distribution to those who need them. The review and approval process is generally
performed by laboratory management, and approval is indicated by signatures with
appropriate dates. Policies for the approval, distribution, and revision of documents
should be clearly established as a part of the Documents and Records policy.
• Master log—This will allow the person responsible for document control to know
exactly what is in circulation, and where copies
can be found. The log should be kept up-to-date
at all times.
• Accessibility—The document control plan must
provide a process for assuring that relevant
versions of documents are available at the point
of use. This may include provision for having
current sample collection information available
outside the laboratory if collection is performed
in other places such as hospital wards or
physician offices.
• System for archiving—Remember that archiving old versions of documents will be very
important. It is frequently necessary to refer to older versions of documents when
researching a problem, or when reviewing quality practices. As a part of the distribution
process, it will be necessary to collect all old versions of the documents for
archiving/destruction.
Implementing When implementing a new document control system, the following steps will be needed.
document
control • Collect, review, and update all existing documents and records—Usually a laboratory
without a document control system will find many outdated documents that will need
to be revised.
• Determine additional needs—Once all documents have been collected, it should be
possible to determine needs for new process or procedure descriptions. If the quality
manual has not yet been developed, this should probably be done at that time as it
serves as the framework for all the efforts.

• Develop or obtain examples of documents, including forms and worksheets, if needed
—Remember that forms of all kinds are documents, but once they have information
added they become records. In order to help with formatting, examples from other
laboratories or from published materials can be used.
• Involve stakeholders—It is useful when creating documents to be used in the laboratory
to involve all staff who will be using them. For documents that will be used outside the
laboratory, such as reports, it is very helpful to seek input from those who will use the
reports.
Common Some of the common problems found in laboratories that do not have document control
problems systems, or that do not manage their document control systems include the following.
• Outdated documents in circulation.
• Distribution problems—If multiple copies of documents are dispersed throughout
different areas of the laboratory, it will be cumbersome to gather all copies when it is
time to update them, and some could be overlooked. For this reason, multiple copies
should be avoided. Documents should not be distributed more widely than needed, and
a record should be kept of where all documents are located.
• Failure to account for documents of external origin—These documents may be
forgotten in the management process, but it is important to remember that they may
also become outdated and need to be updated.

Content Sheet 16-6: Overview of Records
Importance Remember that records are laboratory information, either written by hand or computer-
of records printed. They are permanent, and are not revised or modified. They should be complete,
legible and carefully maintained, as they are used for many purposes, such as:
• continuous monitoring—without access to all the data collected as a part of a quality
system process, continuous monitoring cannot be accomplished;
• tracking of samples—well-kept records allow for tracking of samples throughout the
entire testing process; this is essential for troubleshooting, looking for sources of error
in testing, and investigating identified errors;
• evaluating problems—well-kept equipment records will allow for thorough evaluation
of any problems that arise;
• management—good records serve as a very important management tool.
• etc.
Never change a record. If new information needs to be added to a record, it should be

noted as an addition, with a date, and signature or initials.
Examples of Many kinds of records are produced in a laboratory. Some examples include:
laboratory
records • sample log book, registers;
• laboratory workbooks/sheets;
• instrument printouts –maintenance records
• quality control data
• EQA / PT records
• patient test reports
• personnel records
• results of internal and external audits
• continuous improvement projects
• incident reports
• user surveys and customer feedback
• critical communications: i.e. letters from regulatory agencies, from government, or
maybe from administrative offices within the healthcare system.

A method to record any information that must be kept should be established. The following
type of records could be easily forgotten.
• Information on the management and handling of rejected samples.
• Data needed on any sample referred to another laboratory; to include when the sample
was transported, where it was sent, and when the report was issued. The sample should
be able to be tracked throughout the referral process.
• Information about adverse occurrences or problems. Include all information that is
pertinent, such as the results of any investigation of the problem (see Module 14 -
Occurrence Management).
• Inventory and storage records. These help keep track of reagents and supplies; (see
Module 4 - Purchasing and Inventory).
• Equipment records.
Test report Test reports should be designed so that all information that is needed by the laboratory, the
contents laboratory users, and for any accreditation requirement, is included.
The following is a list of test report contents required by ISO 15189:
• identification of test;
• identification of laboratory;
• unique identification and location of patient, where possible, and destination of the
report;
• name and address of requestor;
• date and time of collection, and time of receipt in laboratory;
• date and time of release of report;
• primary sample type;
• results reported in SI units or units traceable to SI units, where applicable;
• biological reference intervals, where applicable;
• interpretation of results, where appropriate;
• applicable comments relating to quality or adequacy of sample, methodology
limitations, or other issues that affect interpretation;
• identification and signature of the person authorizing release of the report;
• if relevant, notation of original and corrected results.
Many of the items listed above are used by laboratories for their report forms. Some may be
used less often, depending on the test and the context. For some tests, the report form may
also need to include the patient’s gender, as well as the date of birth (or age).

Content Sheet 16-7: Storing Documents and Records
Where to Storage must be given careful consideration, as the main goal of documentation is finding
keep the information when it is needed.
documents
and records
Using a It is important to consider the following when using a paper system for records.
paper
system • Permanence—paper records must last for as long as needed. This should be ensured by
binding pages together, or using a bound book (log register). Pages should be
numbered for easy access, and permanent ink used.
• Accessibility—paper systems should be designed so that information can be easily
retrieved whenever needed.
• Security—documents and records must be kept in a secure place. Security
considerations include maintaining patient confidentiality. Care should be taken to
keep documents safe from any environmental hazards such as spills. Consider how
records can be protected in the event of fires, floods, or other possibilities.
• Traceability—it should be possible to trace a sample throughout all processes in the
laboratory, and later to be able to see who collected the sample, who ran the test, and
what the quality control results were for the test run including issuing of the report.
This is important in the event there are questions or problems about any reported
laboratory result. All records should be signed, dated, and reviewed to ensure that this
traceability throughout the laboratory has been maintained.
Using an Electronic systems have essentially the same requirements as paper systems. However, the
electronic methods for meeting these requirements will be different when using computers. The
system following are factors to consider.
• Permanence—backup systems in case the main system fails are essential. Additionally,
regular maintenance of the computer system will help to reduce system failures and loss of
data.
• Security—it is sometimes more difficult to assure confidentiality with a computer
system, as many people may have access to the data.
• Traceability—electronic record systems should be designed in a way that allows for
tracing the specimen throughout the entire process in the laboratory. Six months after
performing an examination, it should be possible to look at the records and determine
who collected the specimen and who ran the test.

Record Retention times for records should be determined in each laboratory, based on a number of
retention factors:
• the length of time the laboratory will need to have access to its records;
• government requirements or standards that dictate record retention times;
• whether the laboratory is engaged in ongoing research requiring many years of data;
• the time interval between the laboratory’s assessments or audits.

Content Sheet 16- 8: Summary
Summary Documents include written policies, processes, and procedures, and provide a framework
for the quality system. They need to be updated and maintained.
Records include information captured in the process of performing and reporting a
laboratory test. This information is permanent, and does not require updating.
Having a good document control program assures that the most current version of a
document is used, and ensures availability and ease of access when a document is needed.
Key • Information is our product.

messages
• Documents are essential for assuring accuracy and consistency in the laboratory.

17. Information Management
Content Sheet 17-1: Overview of Information Management
Role in quality Information management is a system

management that incorporates all the processes
systems needed for effectively managing Organization Personnel Equipment
data—both incoming and outgoing

patient information. The information
management system may be entirely Purchasing Process Information
paper-based, computer-based, or a Inventory
combination of both.
Whatever technology is employed, Documents Occurrence Assessment
&
information management is another of the Records
Management
vital essentials of a quality system, and is

closely related to Documents and
Records (Module 16). Process
Improvement
Customer
Service
Facilities
&
Safety
Remember that data, and in particular
test results, are the final product of
the laboratory. Laboratory directors
need to ensure that the laboratory has
an effective information management
system in place in order to achieve
accessibility, accuracy, timeliness,
security, confidentiality, and privacy
of patient information.
Important When planning and developing an information management system, whether it is a

elements manual paper-based system or an electronic system, there are some important
elements to consider:
• unique identifiers for patients and samples
• standardized test request forms (requisitions)
• logs and worksheets
• checking processes to assure accuracy of data recording and transmission
• protection against loss of data
• protection of patient confidentiality and privacy
• effective reporting systems
• effective and timely communication.
Information Management ● Module 17 ● Content Sheet 196

Content Sheet 17-2: Elements of Information Management
Unique A unique identifier is an important tool for managing information, and careful
identifiers thought should be given for how best to assign identifiers to patients and samples
within the information management system.
Patient identifiers—Sometimes hospitalized patients are assigned a unique

identifier upon admission, to be used for the duration of the hospital stay.
A patient may get a new number each time he/she is seen or admitted.
In other settings, the unique identifier may be assigned to the patient on a more
permanent basis, to be used each time the patient has any health care.
Sample identifiers—Laboratories need to assign unique identifiers to patient

samples so they can be tracked throughout the laboratory.
The method for generating and assigning unique identifiers within an

information management system will depend on many factors. Some
commercially available computer systems for laboratories have a numbering
system built in to the software. Laboratories using paper-based systems will need
to establish their own system.
An example of a simple system for generating unique identifiers is as follows.
Consider using a number consisting of the year, the month, the day, and a four
digit number: YYMMDDXXXX. At the beginning of each day, the last four
digits start with the number 0001.
For example, the number 0905130047 can be read 04 05 13 0047, and it would
represent: sample #47, received on May 13, 2009.
To avoid confusion or mix-up of samples use the sample’s full identifying

number throughout the laboratory. At a minimum, the unique number will need
to be used on all aliquots of the sample, on the request form, the laboratory
register or log, and the result sheet.
Whatever system a laboratory chooses, unique identifiers should be used to

eliminate confusion and mix-up of samples, and make samples and information
easier to find.

Test request The test request form is where the entire testing process begins, and is important
forms, logs, for both paper and electronic systems. To optimize test requests:
and worksheets
• standardize the test form—the form should indicate all information that
needs to be provided when ordering and submitting a test request, and
sufficient space for recording the information; (ISO 15189 requirements for
the request form are addressed in Module 16, Documents and Records);
• ensure the request form is completed—when the request form is incomplete,
communicate with the requestor to try to secure the needed information. it
may become necessary to refuse non-urgent test examination until the form
is completed.
Logs that allow for recording data at the time of arrival of the sample in the
laboratory are very important, as are worksheets that document which patient
samples are being tested during a given procedure. In a paper-based system, this
will be a written record, usually in a bound book. For an electronic system, logs
and worksheets may be generated from the computer. Thought should be given
as to what information should be recorded.
There are certain points in data handling where it is easy for errors to occur, such
as manual transfer of patient data from requisition forms to logs, keyboard
electronic entry of data into a computerized information system, or transcription
from worksheets to reports. The laboratory should put processes in place to
safeguard against errors at these points. Sometimes, it may be necessary to adopt
formal checking processes to ensure the accuracy of data recording and
transmission of handwritten or keyed information. One example of simple
checking processes is to always have two people review data transcription to
verify its accuracy. Some computerized systems have electronic checks
requiring duplicate entry of data that are built into the system. If these duplicate
entries do not match, an error alert is generated to the person entering the data.
Security It is important to establish a means to protect against loss of data.

For paper-based systems, this will involve using safe materials for recording and
storing the records properly. For computerized systems, scheduled or regular
backup processes become very important.
It is of utmost importance to safeguard a patient’s privacy, and, in this regard,
security measures must be taken to protect the confidentiality of laboratory data.
Laboratory directors are responsible for putting policies and procedures in place
to assure confidentiality of patient information is protected.
Reporting The product of a laboratory is the test result, or the report. Give sufficient
systems attention to the reporting mechanism to ensure that it is timely, accurate, legible,
and easily understood.
The report should provide all information needed by the health care provider or
the public health official using the data, and include any comments that are
appropriate, such as “sample haemolyzed” or “repeat sample.” It should be

verified and signed by the appropriate laboratory staff.
Whether issuing paper-based or computer-based test reports, laboratories must
assure reports arrive on time to the right person. Reports might be delivered by
laboratory staff to the hospital ward, by courier or by mail to an off-site facility, or
through electronic mechanisms using a sophisticated LIMS. A telephone is often
used to give urgent results. A record of the telephone call must be kept and should
include the caller’s signature, date and time, and whenever possible, the recipient’s
name. Telephone results should be followed by a written report.
The test result report reflects the laboratory’s image to the client, the test
requestor, and to others who may use or need it.
Communication When planning for paper-based or computer-based information systems, be sure

considerations to consider the need for a good system for communicating within and external to
the laboratory. This is especially important in larger organizations. It may be
necessary to devise a system for passing along information between staff
covering different shifts or areas of the laboratory to make sure important details
are not overlooked. The laboratory might also need to develop a policy for
communicating with its customers, such as health care providers, central
reference laboratories, and official agencies. The policy should describe what
communication channels need to be followed, and when, and state who has
authority to communicate with the different levels of customers.
Common There are many points where problems can occur when managing laboratory
problems information. The laboratory should carefully consider potential problems and
plan on how to avoid them. Some of the most common problems are:
• incomplete data for test interpretation, or insufficient or illegible
identification. Systems should be designed to minimize this occurrence; for
example, when using electronic systems, it is possible to design fields so that
if information is missing, data entry cannot be completed;
• forms that are inadequately designed to meet laboratory and client needs;
• standardized forms prepared by others may not be suitable for all
laboratories;
• inability to retrieve data due to poor archiving processes or insufficient back-
up of computerized information;
• poor data organization, which may hinder later data analysis efforts to meet
research or other needs;
• incompatibility between computerized information systems and equipment or
other electronic systems, resulting in problems with data transmission.

Content Sheet 17-3: Manual Paper-based Systems
Developing Financial constraints may require that a laboratory use a manual, paper-based system
a manual for all its information management. Careful planning, attention to detail, and
system awareness of problems can allow for the development of a good paper-based system
that will provide satisfactory service.
Registers, Manual registers, logs and worksheets are widely used, and most laboratorians are
logs and very familiar with use of manual systems for managing samples through the
worksheets laboratory. Even laboratories with some computerization will often have partially or
totally handwritten worksheets.
Laboratory registers or sample logs take many

forms, and almost all laboratories will have one
that has been in use. When reviewing
information management needs, consider
whether an existing register is satisfactory, or
whether it should be redesigned.
Registers and logs with good design are:

• practical to use and easy to complete;
• make it easy to find the data;
• make summarizing data and writing reports easier.
The logbook or register can be supplemented by the use of daily logbooks. For
example, a separate logbook might be used to keep track of the numbers of patients
and samples, or a logbook could be developed that is organized by the type of test.
For some specialties such as microbiology or parasitology, a laboratory might decide
to keep a specific logbook showing the total number of tests and the percentage of
positive results.
Registers and logbooks are unique sources of information for preparing statistics and
reports, although they can be more cumbersome to use and less complete than a
computerized information system.

Data entry When using a paper system, it is
important to emphasize to staff that
all data entry must be complete. A
computerized system usually
requires that all “essential fields”
contain data, but in handwritten
records there is no check on this
point.
Legibility Illegible writing may be a problem, but it must be addressed; emphasize to employees
the importance of legibility.
Carefully consider the ease of use, and
legibility of the final report of results—it
is the primary product of the laboratory,
so make sure it is done properly and
professionally.
Hand- When handwritten reports are issued, the laboratory needs a copy for its files or
written archives. Not having an exact copy of the report can lead to later problems, if errors
reports in transcription occur.
It is imperative that the records be kept in a safe place where they can be easily retrieved.
Storing When storing paper-based materials, keep in mind that the goals are to be able to find
paper-based a result, trace a sample throughout its pathway in the entire process, and evaluate a
materials problem or an occurrence to find its source.
Some useful rules to think about are:
• keep everything, but develop a system for when and how to discard (for example,
after the appropriate established retention time, shred records to maintain patient
confidentiality);
• ensure easy access to information by those who need it;
• use a logical system for filing;
• use numbers to help keep things in chronological order.
Paper is fragile, and vulnerable to water, fire, humidity, and vermin (rodents and
insects). Use a storage area that will protect against these elements as much as possible.

Content Sheet 17-4: Computerized Laboratory Information Systems
Developing a A computerized system for laboratory data is often called a laboratory information
computerized management system and is referred to by the acronym LIMS or LIS. The use of a
system computerized system is becoming more common in laboratories around the world. An
appropriately designed and installed LIMS brings accuracy and accessibility to the flow
of samples and data in the clinical laboratory.
There are a number of options available to those interested in developing a computerized
laboratory information system. Some laboratories may elect to develop an in-house
computer network, and use locally developed systems based on commercially available
database software, such as Microsoft Access. Others may choose to purchase fully
developed laboratory systems, which usually includes computers, software, and training.
One source of information that may be helpful for planning and implementing a LIMS is
the Association for Public Health Laboratories Guidebook for Implementation of
Laboratory Information Systems in Resource Poor Settings.22
Choosing a If the decisions about purchasing are made outside the laboratory, for example by the
system information system department, the laboratory director should provide information that
will support selecting equipment that will best serve the needs of the laboratory. The
most up-to-date hardware or software may not add to the functionality of the laboratory
and can wind-up having to increase overhead, e.g., more data handling, in order to use
LIMS systems that have been designed not for the laboratory but for the accounting or
central supplies departments.
A LIMS with flexibility, adaptability, ease of evolution and support, and system speed
will most benefit the laboratory. The speed issue is very critical as laboratorians will not
use something that is slow or awkward, but if it saves time they will quickly "buy into"
the project and aggressively move the process forward.
Advantages of A complete computerized information system will be able to handle all the basic
computerized information management needs. A computer system has the capacity to quickly and
systems easily manage, analyze, and retrieve data. The computerized system offers some definite
advantages over paper-based systems. Some of these advantages are listed below.
• Error reduction—A well planned computer system, with check systems for errors,
will help to alert the user of inconsistencies, and reduce the number of errors. It will
also provide information that is legible.
• Quality control management—It becomes easy to keep good quality control records,
perform analysis on QC data, and generate statistics automatically.
• Provision of options for data searching—A variety of parameters can be used for data
retrieval, e.g. it is usually possible to access data by name, by laboratory or patient
number, and sometimes by test result or analysis performed. This kind of data

searching is almost impossible with paper-based systems.
• Access to patient information—Most computer systems allow access to all recent
laboratory data for a patient. This is very useful in the process of checking the most
recent results against previous data to look for changes, which is a good practice, and
helps to detect errors. Some computer systems give enough information to determine
the admitting diagnosis or access other useful information related to the illness.
• Generate reports—It is easy to generate detailed, legible reports quickly. A LIMS
will provide standardized (or customized) reports.
• Ability to track reports—A computer system makes it much easier to track reports; to
know when work was finished, who performed the work, when the data was
reviewed, and when the report was sent.
• Ability to track and analyze trends—The computer and its data bases provide very
strong search capabilities, and with careful design it will be possible to retrieve and
use large amounts of data effectively to track and analyze trends of various kinds.
• Improved capability for maintaining patient confidentiality—It is often easier to
maintain confidentiality of laboratory data when using a computer than when dealing
with a hand-written report form by establishing computer user codes that control
access to the data.
• Financial management—Some systems will allow for financial management, for
example, patient billing.
• Integration with sites outside the laboratory—A LIMS can be set up so that data
comes into the laboratory system directly from a patient or client registration point.
Data can be transmitted to many sites or interfaces as needed. Results can be
provided directly to computers accessible to the health care provider or public health
official. Computers can handle data entry into a national laboratory data base, and
almost any other data application that is needed.
• Manufacturer-provided training—Purchased laboratory information systems often
include on-site training for staff. To make the full use of the system, it is essential
that either on-site training of all staff or training at the manufacturer’s headquarters is
provided.
Disadvantages It is important to remember that in spite of all of the advantages, computers do have
disadvantages. Some of these are as follows.
• Training—Personnel training is required, and because of the complexity of LIMS,
this training can be time consuming and expensive.
• Time to adapt to a new system—When starting up a computer system it may seem
inconvenient and unwieldy to laboratory staff. Personnel accustomed to manual
systems may be challenged by such tasks as correcting errors and uncertain of how to
proceed when encountering situations where a field must be filled in.
• Cost—Purchase and maintenance are the most expensive parts of a computerized
system, and the costs can be prohibitive in some settings. Additionally, some

settings will not have good maintenance that is locally available. Surprisingly,
computers use lots of paper, and the cost of materials must be planned for, as this can
add up. Also remember that technology changes rapidly, and the life of a computer
may not be more than a few years. This might require repurchase of computer
equipment periodically in order to remain current and compatible with other systems.
• Physical restrictions—Adequate space and dedicated electrical requirements are
necessary, as well as placement of the computer away from heat, humidity, and dust.
• Need for back-up system—All computer information must be carefully backed up.
Loss of data due to a damaged disk or system crash cannot be tolerated, and backup
systems will be critical.

Information Information management is a system that incorporates all the processes needed for
management effectively managing data—both incoming and outgoing patient information. The system
system can be either entirely paper-based, or it can be partly paper-based with some computer
support, or it may be entirely electronic.
For either paper-based or computer systems, unique identifiers for patient samples will be
needed. Standardized test request forms, logs, and worksheets are also important to both
systems. In helping to prevent transcription errors, a checking process is beneficial.
When considering adding a computer-based system to a laboratory, cost is a big factor. In

implementation, careful planning and training will help to ensure good results.
Key A good information management system will:

messages
• ensure that all data— the final product of the laboratory— is well managed;
• consider all the ways laboratory data will be used when planning a system;
• assure the accessibility, accuracy, timeliness, and security of data;
• ensure confidentiality and privacy of patient information.

18. Organization
Content Sheet 18-1: Organizational Requirements for a Quality
Management System
Definition The term organization in the

context of a quality management
model is used to indicate the
management and the supporting
organizational structure of the
laboratory. Process
Inventory
Organization is one of the
essential elements of the
quality system, and is
intimately related to all the & Management
other elements in the model. Records

Safety
Characteristics The principal element for a successful quality management system is managerial
essential to commitment.
success
• Management at all levels must fully support, and actively participate in the
quality system activities.
• Support should be visible to staff so that there is an understanding of the
importance of the effort.
• Without the engagement of management, including the decision-making level
of the organization, it will not be possible to put in place the policies and the
resources needed to support a laboratory quality management system.
A second vital element is that the organizational structure must be designed to

assure that the quality goals of the organization are met.
• The laboratory must be a legally structured entity according to local
requirements.
• All the organizational elements required to assure a properly functioning
quality management system must be in place.
Organization ● Module 18 ● Content Sheet 207

Key The important organizational requirements for achieving a successful
organizational quality system include the following.
components
• Leadership—Laboratory leaders must be fully committed to
implementation of the system, and these leaders also will need vision,
team-building and motivational skills, good communication techniques,
and the ability to use resources responsibly.
• Organizational structure—The structure of the organization should be
clearly defined, and this should be reflected by a functional organizational
chart with clear assignment of responsibility.
• Planning process—Skills for planning are needed, and planning should
address a time frame, responsibility for conducting the activities, the
availability and use of human resources, management of workflow, and
financial resources.
• Implementation—Implementation requires that a number of issues must
be addressed by the management staff. These include management of
projects and activities, directing resources to accomplish plans, and
assuring that timelines are met and goals achieved.
• Monitoring—As components of the quality management system are put
in place, processes for monitoring will be needed to assure that the
system is working, that benchmarks and standards are being met. This
element is essential to the primary goal of a quality system, which is
continuous improvement.

Content Sheet 18-2: Management Role
Providing Leadership can be defined in many ways, but it is an important factor in the
leadership success of any organization’s efforts for improvement.
A good leader will exercise responsible authority.
Important roles for a leader include:

• providing vision;
• giving a direction for goal-setting;
• motivating staff;
• providing encouragement.
A strong leader will help staff understand the importance of the task at hand.
Responsibilities “Laboratory management shall have responsibility for the design,

of managers implementation, maintenance, and improvement of the quality management
system.” ISO 15189 [4.1.5]
A quality management system outlines specific responsibilities of managers.
Management must be responsible for:
• establishing the policies and processes of the quality system;
• assuring all policies, processes, procedures, and instructions are documented;
• making sure that all personnel understand documents, instructions, and their
duties and responsibilities;
• providing personnel with the appropriate authority and resources to carry out
their duties.
Management is charged with providing a quality manual which describes the
quality management system. The quality manual is the means by which the
policies are established and communicated to the staff and the users of the
laboratory.
Laboratory Directors have the principal responsibility for setting up an
organization that can support the quality system model. They are responsible for
developing policies, assigning authority and responsibility to the appropriate
persons, assuring resources, and reviewing the organizational aspects of the
system for optimal functioning of quality processes. Laboratory directors must
ensure that staff follows the quality policies established by the quality manual.
Quality Managers assist in developing policies, planning, and implementing
the quality management system. They are usually responsible for many of the
implementing and monitoring processes, and must communicate all aspects of
the quality management system processes to the laboratory director or head of
the laboratory.

Laboratory Staff (Laboratorians) are responsible for understanding the
organizational structure of the laboratory, including where authority and
responsibility are assigned. The laboratory staff will follow all of the quality
policies in their daily work routine.
Commitment of Most critical in beginning any new program is to seek approval from the top.
management Management needs to be involved at a sufficiently high level to assure success of
the program. When implementing a quality system, determine what the
“sufficiently high level” is; be sure to include those who make decisions as their
approval and support is vital. Finally, it is important that laboratory managers
communicate their commitment to the entire laboratory staff. Managers must
show the way, and encourage and foster the “spirit” of the organization.

Content Sheet 18-3: Organizational Structure
Elements of When considering organizational structure to support a quality management system, a

structure number of elements should be considered:
• The Path of Workflow is the route of a sample through the laboratory, from
collection to reporting of a result. The organizational structure of the laboratory
must support an optimal Path of Workflow, by allowing processes that yield
efficient sample handling while minimizing error. Considerable attention should
be given to the design of this system.
An accurate and complete organizational chart is necessary. Many problems can be

prevented if responsibilities are clearly defined and all members of the laboratory
team understand what each is supposed to do.
• A quality management system must have a quality manager.
• Resource
allocation must be
sufficient to assure
that personnel and
infrastructure
needs are met.

Quality ISO 15189 [4.1.5 i] states that a laboratory must have a quality manager. The quality
Manager manager is the person most directly responsible for assuring that the quality policies
and procedures are carried out.
The quality manager should sit high in the organizational structure; he or she must be
delegated the appropriate responsibility and authority to assure compliance to the
quality system requirements. The quality manager should report directly to the
decision maker(s) in the organization.
A very large laboratory may need several quality managers, perhaps one for each
section. On the other hand, in a small laboratory this may be a part-time job for a
senior technologist, or even a job that is carried out by the laboratory manager.
The quality manager may be assigned many tasks. Some typical responsibilities of
the quality manager will include:
• monitoring all aspects of the quality system;
• assuring staff are following quality policies and procedures;
• reviewing regularly all records, for example, QC and EQA that are part of the
quality system;
• organizing internal audits, and coordinating external audits;
• investigating any deficiencies identified in the audit process;
• informing management on all aspects of the quality system monitoring.

Content Sheet 18-4: Organizational Functions: Planning
Approaches to Once management is committed to instituting a quality system in the laboratory,

planning a planning process is needed. Approaches used will vary depending on many
factors in the local situation.
• What quality practices are already in use in the laboratory?
• What is the level of knowledge of current staff?
• What resources will be available?
All elements of the quality system should be included in the planning process. It is
not necessary (usually not possible) to implement all parts of the plan at once;
a stepwise approach will often be more practical.
In many laboratories, the implementation of a quality system may involve many
changes. It is, therefore, important to keep all staff involved, and to not proceed too
rapidly, as personnel may find it difficult to meet the goals and can get discouraged.
Communicate with staff frequently, clearly, and positively; this will help to keep
morale high.
During planning, priority areas will emerge as the bigger problems are identified.
It will be important to keep objectives realistic and measurable. Inevitably, there
will be some factors that are beyond the control of the laboratory. Recognize
these and move on to other factors that can be addressed. If these factors are vital
to the ultimate success of the quality program, then look for ways to influence those
who can control them. Always advocate for quality.
Establish plan In planning for implementation of a quality system, the first step is to analyze and
understand the current practices. A useful way to accomplish this is the technique
of gap analysis. To conduct a gap analysis:
• use a good quality systems checklist, evaluate the practices in the individual
laboratory;
• identify gaps, or areas where the laboratory is not using the good laboratory
practices required in the quality system.
Using the information provided by the gap analysis, develop a task list of
everything needing to be addressed, and then set priorities. In determining
priorities, consider first addressing problems that can be easily fixed; this will give
some early successes and boost staff morale. Also evaluate what would have the
most impact on laboratory quality and give these factors high priority.

Problems commonly identified in laboratories using a gap analysis include:
• test ordering
• sample management
• incompetent technical staff
• quality control
• analytical process
• recording and reporting results
• reagent and equipment management.
The quality The implementation of a quality system in the laboratory requires a written plan. A
system plan written plan makes clear to all staff and all users of the laboratory how the process
will proceed. The plan should contain the following components:
• objectives and tasks—what should be done;
• responsibilities—who will get the job done, who will be responsible;
• timeline—when will each task be worked on, when will it be completed;
• budget and resource needs—additional staff, training needs, facilities,
equipment, reagents and supplies, quality control materials;
• benchmarks—essential for monitoring progress in implementation.
The written plan should be made available to all laboratory staff, as everyone must
understand the plan and the process of implementation.

Content Sheet 18-5: Organizational Functions: Implementation
Beginning Once a plan has been written and agreed upon, implementation will begin. These
implementation suggestions will help the laboratory in this process.
• Commit from the beginning to complete the project and achieve the established
objectives. Go in with a positive attitude—a “can do” approach.
• Prepare to implement in stages. It is important to prevent staff from getting
discouraged, so choose manageable “bites” at the beginning. Staggering start
dates will also be helpful; use established priorities to determine start dates.
• Determine resource requirements early in the process, and secure the
necessary resources before starting tasks. If working in a highly resource-limited
environment, choose as initial activities those things that can be done with
available funds and staff – there are many such activities, such as improving
documents, records, or developing up-to-date and improved standard operating
procedures or SOPs.
• Engage all staff by communicating effectively. If training is needed to have
personnel understand the quality system and its goals, this training should
probably be done before starting other tasks.
Following the As a part of the planning process, the laboratory will have established a timeline
timeline for tasks to be performed, including a projected completion date. This timeline is
a critical part of the process, as it allows everyone in the laboratory to observe
progress. A Gantt chart (shown below and Annex 18-A [complete 5-page
version]) is a very useful tool for visually representing the proposed time line; it
shows tasks to be done, with times of beginning and completion.

The timeline should be very carefully prepared, so as to allow appropriate times
for completion. Do not let the laboratory staff become overwhelmed with the
tasks that need to be accomplished.
Providing During the planning process, all additional resources that are needed will have
resources been identified. As implementation begins, be sure that these resources are in
place and available. Several kinds of resources need to be considered:
• all financial requirements— establish a budget;
• personnel needs—are additional laboratory staff required, will training be
needed for any of the staff?
• facilities, equipment, supplies, and computer needs.
Monitoring Establishing a system for monitoring quality management is essential in

basics implementing a quality system. It is the monitoring and maintenance part of the
effort that will produce the continuous improvement that is the overall goal of a
good quality system. Monitoring involves being able to check each part of the
system to be sure that the system is working properly.
Establishing There are several steps in setting up a program to monitor compliance to the quality
monitoring system.
program
• Assign responsibility for the process. Usually the quality manager will be the
person who is primarily responsible for the monitoring program.
• Develop indicators or benchmarks using the laboratory quality policy. These
indicators will be monitored over time.
• Develop a system for the monitoring process; establish time or frequency of
checks, decide how the monitoring will be managed.
• Conduct audit, followed by management review; these constitute two important
tools in monitoring compliance.
Internal audits should be conducted at regular intervals. They are valuable for
evaluation, and they are required by ISO 15189.
Management reviews are a particularly valuable component of the monitoring
process. It is the responsibility of management to review all appropriate quality
systems information, and to look for opportunities for improvement.

Content Sheet 18-6: The Laboratory Quality Manual
Definition The quality manual is a document which fully describes the quality management
system of an organization. It is key to the process, serving as a guide for the entire
system. The manual will clearly lay out the quality policies, and will describe the
structure of the other laboratory documents.
In a laboratory that is implementing a quality management system, there must be
a quality manual. However, there is considerable flexibility in how to prepare it,
and a laboratory can construct the manual so that it is most useful and suited to
the local need (see Module 16, Documents and Records, for additional
information).
ISO 15189 [4.2.4] requires that laboratories have a quality manual, although style
and structure are not specified.
Writing a The purpose of a quality manual is to clearly communicate information, and to serve
quality manual as a framework or roadmap for meeting quality system requirements. The manual is
the responsibility of laboratory management, and thus conveys managerial
commitment to quality and to the quality management system.
The manual should contain the following.
• All quality policies of the laboratory—these should address all twelve elements
of the quality system.
• A reference to all processes and procedures— For example, SOPs are a part of
the overall quality system. There are usually too many to include directly in the
quality manual, but the manual should say that all procedures must have an SOP
and that these can be found in the SOP manual.
• A table of contents—ISO 15189 provides a suggested table of contents, and this
includes a description of the laboratory, staff education and training policies, and
all the other elements of a quality management system (e.g., documents and
records).
Maintaining and The quality manual is the framework for the entire quality management system, and,
using the therefore it must always be correct and up-to-date. The laboratory will need to establish
quality manual a process to assure this. The following steps offer suggestions for developing,
maintaining, and using the quality manual.
• When the quality manual is written and prepared, it must be approved by the head of the
laboratory. In some laboratories, approval by another appropriate person, such as the
quality manager, might also be required. This approval should be indicated by having
official signatures and dates of signing recorded in the manual itself.

• A process or system for updating needs to be established. This system should specify
the frequency for reviewing the manual, assign responsibility for updating to
someone (usually the quality manager), and define how changes in the manual will
be incorporated and documented. Changes to the quality manual will need to be
approved; approval should be indicated by having signatures of the person(s) with
authority to make changes, and the date of the change, recorded in the manual.
• Instruction on use of the manual should be provided to all laboratory staff;
laboratory personnel must understand that the policies detailed in the quality manual
are always to be followed.

Steps for As the laboratory moves from intent to action in the development of a quality
organization management system, the major organizational steps will be to assign responsibility
for implementation, allocate resources, develop and distribute a quality manual,
begin implementation, and
monitor compliance with the
quality policy and the quality
management system
requirements.
Successful implementation of a
quality management system
requires planning, management
commitment, an understanding
of the benefits, engaging staff at
all levels, setting realistic time
frames, and looking for ways to
continually improve.
Key messages Remember:

• Quality is not a science; it is a way of thinking.
• Time invested today will help gain quality results, professional and personal
satisfaction, and peer recognition.
• Everyone in the laboratory is responsible for quality performance.
o Laboratory leaders and managers must commit to meeting quality needs.
o Laboratory personnel must follow all quality assurance procedures and
adhere to requirements and standards.

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Laboratory Quality Management System

© World Health Organization, 2009

WHO Lyon Office - International Health Regulations Coordination

Clinical and Laboratory Standards Institute

Level of When making

Introduction ● Overview of the Quality System ● Module 1● Content Sheet 4

Definition of A quality management system can be defined as “coordinated activities

ISO standards group laboratory processes into pre-examination,

Introduction ● Overview of the Quality System ● Module 1● Content Sheet 6

Overview of the When all of the laboratory procedures

The elements of process control are very familiar to laboratorians; quality

Occurrence An “occurrence” is an error or an event that should not have happened. A

Introduction ● Overview of the Quality System ● Module 1● Content Sheet 8

Introduction ● Overview of the Quality System ● Module 1● Content Sheet 9

Definition of ISO 9000 defines quality management as “coordinated activities to direct

Quality Management is not new.

Introduction ● Overview of the Quality System ● Module 1● Content Sheet 10

Need for A part of quality management is assessment, measuring performance against a

Introduction ● Overview of the Quality System ● Module 1● Content Sheet 11

Introduction ● Overview of the Quality System ● Module 1● Content Sheet 12

Role in quality The laboratory work space and facilities

This module will describe essential

physical, chemical, and biological Records

rather than highly dangerous substances.

As a Quality manager (or designated Safety Officer), it is necessary to:

As a Laboratorian it is important to:

Everyone in the laboratory is responsible for quality and safety.

Facilities and Safety ● Module 2 ● Content Sheet 15

Access to rooms where manipulation or analysis of samples takes place or where

Facilities and Safety ● Module 2 ● Content Sheet 16

For optimal organization of the laboratory, consider.

Facilities and Safety ● Module 2 ● Content Sheet 17

Facilities and Safety ● Module 2 ● Content Sheet 18

Facilities and Safety ● Module 2 ● Content Sheet 20

Material Safety Data Sheets should be:

Facilities and Safety ● Module 2 ● Content Sheet 23

Disease Probable Max Distance Number

Facilities and Safety ● Module 2 ● Content Sheet 24

Face Goggles—The projection of droplets is a frequent occurrence when opening patient

Facilities and Safety ● Module 2 ● Content Sheet 25

Facilities and Safety ● Module 2 ● Content Sheet 26

If laboratory personnel become contaminated with biological hazards due to

A small laboratory fire is considered to be one that is extinguishable within

All laboratory personnel must learn how to operate a portable fire

Facilities and Safety ● Module 2 ● Content Sheet 27

Facilities and Safety ● Module 2 ● Content Sheet 28

Role in Equipment management is one of

• helps to maintain a high level

Equipment ● Module 3 ● Content Sheet 30

Oversight It is the responsibility of the laboratory director to:

• oversee all the equipment management systems in the laboratory;

Equipment management responsibility may be specifically assigned to a

Oversight of an equipment management program includes:

Note: day-to-day maintenance should be the responsibility of the technical operator.

Equipment ● Module 3 ● Content Sheet 31

Acquiring Is it better to purchase, rent or lease equipment? When making this

Before purchasing ask if:

Installing Before equipment is installed, verify that all physical requirements

Equipment ● Module 3 ● Content Sheet 33