An Expert View On Quality Control In Medical Laboratory- A Brief Study

Abstract

The medical laboratory is a place where blood, body fluids and other biological Specimens are tested, analyzed, or evaluated. The observation may be macroscopic or microscopic. The tests may be performed manually or using specialized instruments. Precise measurements are made and the result are calculated and interpreted. Because of this, laboratory workers must have the skills necessary to perform variety of tasks. Laboratory testing is an integral part of modern medical practice, and laboratory medicine confronts the same challenges of quality, cost, and access as the larger health care system. Quality is paramount in a medical laboratory setting & Safety is a topic that should be foremost in the thoughts and actions of all health care providers, both employees and employers. The goal of medical laboratory health care workers should provide quality patient care in an environment that is safe for both workers and patients.

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AN EXPERT VIEW ON QUALITY CONTROL IN MEDICAL
LABORATORY- A BRIEF STUDY
Dr. Md. Kamal Hussain, PhD

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AN EXPERT VIEW ON QUALITY CONTROL IN MEDICAL
LABORATORY- A BRIEF STUDY
Dr. Md. Kamal Hussain, PhD
Horizon Healthcare
(KINGDOM OF SAUDI ARABIA)
Emails: drkamalhussain@gmail.com
ABSTRACTS
The medical laboratory is a place where blood, body fluids and other biological Specimens are tested, analyzed, or
evaluated. The observation may be macroscopic or microscopic. The tests may be performed manually or using
specialized instruments. Precise measurements are made and the result are calculated and interpreted. Because of
this, laboratory workers must have the skills necessary to perform variety of tasks. Laboratory testing is an integral
part of modern medical practice, and laboratory medicine confronts the same challenges of quality, cost, and access
as the larger health care system. Quality is paramount in a medical laboratory setting & Safety is a topic that should
be foremost in the thoughts and actions of all health care providers, both employees and employers. The goal of
medical laboratory health care workers should provide quality patient care in an environment that is safe for both
workers and patients.
Keywords: Quality Management, Quality Control, Laboratory Quality Assurance, Medical Laboratory Quality
1. INTRODUCTION
Quality assurance in clinical laboratories is such an important issue because laboratory results are used to aid in
diagnosing, prescribing treatment and monitoring the progress of patient. Laboratory result must be reliable and
laboratory quality control procedures and result must be documented. Laboratory workers have the ethical and legal
responsibility to ensure the work performed in the laboratory is of the highest quality. This can be guaranteed by
adherence to a comprehensive quality assurance program. Medical laboratory services are essential in the diagnosis
and assessment of the health of patients. Their services encompass arrangements for requisition, patient
preparation, patient identification, collection of samples, transportation, storage, processing and examination of
clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory
services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other
interested parties. The laboratory’s aim is not only to provide accurate results, but to do on the right patient within a

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meaningful timeframe as regards clinical management, using appropriate laboratory procedures and with a respect
for ethics, confidentiality and the safety of the patient.
2. QUALITY MANAGMENET/ CONTROL IN MEDICAL LABORATORY
Quality management/ control are an essential part of every laboratory daily operations. It is often thought to be
applicable only to testing procedures. A program of quality management or quality assurance should be in place to
ensure quality throughout the total testing process, from ordering the test to entering the result on the patient chart.
Processing the samples in the lab, the test procedures, and procedural control are parts of quality control. Quality
Management is an enabler of quality and a core component of good clinical management; it is patient-focused,
impartial, objective, and operates within a peer review model. It provides many benefits such as those detailed below.
The need to drive up the quality of care for patients, whilst delivering efficiency and productivity, is a key principle for
regulators of healthcare services. Quality Management & Accreditation can be used as a tool to support the
commissioning or specification of medical laboratory services that are technically competent, safe and reliable, and
that continually improve the experience for patients by: a). providing an independent assurance of quality and safety
that supports world-class decisions on how to deliver better care and value for patients; b). providing a mechanism for
measuring quality improvement; c).supporting consistency in the quality of care; and encouraging innovation.
3. QUALITY ASSURANCE ACTIVITIES IN MEDICAL LABORATORY
From the moment a test is ordered, attention to detail becomes an issue critical to the quality of lab results. The strict
quality assurance programs and quality controls procedures that guide the work of the clinical laboratory, from the
first handling of test specimen and paperwork to the reporting of results to your health care provider (Fig.1). To make
it easier to see all the points where quality is monitored and the areas where the quality of inputs is important- we
have divided the tasks into three main phases.
3.1. PRE-ANALYTICAL ACTIVITIES
What will happen when the test is ordered and the sample is collected. This question will be arise, where quality
originates from the moment of test is ordered, quality becomes an issue critical to the outcome. Quality assurance
procedures extend to the following areas: a). Test ordering process b).Specimen collection procedures, c). Transport
to the lab, d).Specimen handling and storage, e).Completeness of patient information. Automated ordering systems
are increasingly used to minimize errors in sample collection and test request. Well-organized computer screens
allow health care provider to quickly input test order themselves, minimizing the chance for misunderstanding and
error. Important: a patient who does not follow preparation instruction or provides insufficient information to the health
care providers undermines the entire quality assurance effort for a specific test.
3.2. ANALYTICAL ACTIVITIES
What happens in the lab where the test is conducted? This question to be seen in this phase. In the lab where the
specimen in analyzed, quality assurance procedures guide and monitor all related activities, including the following:
a). Instrument maintenance and operation b). Test regents, c).Supplies, d) Personnel, e).Actual test performance,
and f).Other aspects of lab activity. Where procedures can be conducted, human error can be minimized. Many test
method use automated analyzers. Most instruments have internal computer systems to detect malfunctions. Also in
some labs, external computer systems bring extremely abnormal result to the operator’s attention.
3.3. POST ANALYTICAL ACTIVITIES
What happens between the time test is run and the result are reported. As test result are made available to the health
care provider, work quality continues to be monitored in areas such as the following: a). Report sent to appropriate
party, b).Timely reporting of data, c).Reference ranges included, d).Immediate notifications. Where procedures can
be automated, errors in reporting can be minimized. Most lab results are collected and managed by a computer
system capable of sending electronic reports to the health care provider.

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Fig.1. Quality assurance activities in medical laboratory
4. THE ROLE OF TESTING: EVALUATING TEST DATA IN A CLINICAL CONTEXT
The health care providers are expected to evaluate all of the relevant finding-test data plus information from other
sources- before setting on a diagnosis and developing a treatment plan. Careful evaluation and consideration of test
finding increases the reliability of a diagnosis and reduces the chance of medical errors. As the diagram shows
(Fig.2), data from medical tests are part of the information set that needs to be considered when a health care
provider makes a diagnosis. A retest or other test to confirm the findings may be appropriate.
Fig.2. Information Sources critical to the Diagnostic Process

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5. ACCREDITATION AND QUALITY MANAGEMENT SYSTEM
Accreditation of health laboratories is the process by which an independent and authorized agency accredits the
quality system and competence of a laboratory on the basis of certain pre-defined standards. Accreditation is done at
regular intervals to ensure maintenance of standards and reliability of results generated to support clinical and public
health activities by the laboratories. The accreditation process requires: a). Identification of an authoritative body b).
Adoption of standards, and c). Institution of a mechanism of assessment of laboratories to certify their compliance
with standards.
5.1. BENEFITS OF A QUALITY MANAGEMENT SYSTEM & ACCREDITATION
a) Facilitates the implementation and maintenance of an effective quality system
b) Gives confidence to users in availing the services
c) Gives confidence to the laboratory for the results generated
d) Provides national/international recognition of technical competence
e) Helps in defending laboratories while dealing with legal disputes pertaining to laboratory results
f) Reduces the operating costs of the laboratories by getting results right the first time and every time
g) Helps private sector laboratories to attract more business
h) Helps in national and international acceptance of results
i) Meets purchase or regulatory specifications
j) Increases competitiveness and market share.
6. QUALITY SYSTEM
A well-defined quality system is a must for ensuring quality. It is a part of overall quality management which aims at
ensuring the consistency, reproducibility, traceability and reliability of the products or services. A quality system is
defined as the organizational structure and resources needed to implement quality requirements. The International
Organization for Standardization (ISO) defines a quality system as the organizational structure, responsibilities,
procedures and resources needed for implementing quality management. A quality system has the following five key
elements: a).Organizational management and structure b).Quality standards, c).Documentation, d).Training, e).
Assessment
6.1. ORGANIZATIONAL MANAGEMENT AND STRUCTURE
The overall responsibility for the design, implementation, maintenance and improvement in the quality system rests
with the laboratory management. Quality is the responsibility of all staff members of the organization.
6.2. QUALITY STANDARDS
Quality standards are an integral part of the quality system. These aim at ensuring safety and consistency. They need
to be followed to meet regulatory requirements as well as to monitor functioning of the laboratory.
6.3. DOCUMENTATION
A document is a record of any information or instructions including policy statements, quality manuals, procedures,
specifications, calibration tables, reports, job description, documents of external origin such as regulations, standards
and examination procedures, etc. Documents may be stored either as hard copy or electronically.
6.4. TRAINING
The quality system is only as good as the staff who actually works with it. No matter how good the quality system
is on paper, if theory cannot be translated into practice, quality cannot be achieved. Training must also include an
understanding of why quality is important. Training should be competency-based and must be followed by post-
training support.

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6.5. ASSESSMENT
The laboratory management shall develop and implement quality indicators to systematically monitor and evaluate
the laboratory’s contribution to patient care. When the programme identifies opportunities for improvement within the
system, the laboratory management shall take appropriate steps to address them. Error management shall be
vigorously implemented.
7. MEDICAL LABORATORY SAFETY
Safety is a topic that should be foremost in the thoughts and actions of all health care providers, both employees and
employers. The goal of health care workers should be provide quality patient care in an environment that is safe for
both workers and patients. Safety has become not just a humanitarian issue, but also a legal necessity.
7.1 PHYSICAL AND CHEMICAL HAZARDS
Physical hazardous are present in ordinary equipment or surrounding. Electrical equipment, open flames, laboratory
instruments. Electricity: one of the major sources of physical hazard. All equipment must be properly grounded, all
electrical cords are plugs must be kept in good repair, with no frayed cords or exposed wires. Extension cords
present several safety hazards and should not be used except in an emergency. Fire is another potential danger in
the workplace. Examples of fire safety signs: a). Extinguishers for different kinds of fires, b). Fire extinguisher locator,
c). Flammable liquids warning, d). fire escape route. Glassware is a routine item in most laboratories, but it can cause
injuries. Only glassware that is free of chips and cracks should be used. Damaged glassware is weakened and may
break, resulting in injury. Broken glass should be cleaned up with a brush and dustpan, not with bare hands.
Wherever possible, Plastic ware should replace glass containers in the laboratory. Chemicals Hazards present a
variety of hazards. Chemical may be flammable, toxic, caustic, corrosive, carcinogenic, or mutagenic. Occasionally,
laboratories procedures use radioisotopes that present that hazard of potential exposure to radioactivity. ”Chemicals
must be labeled with hazard information” Examples of hazard information on chemical labels: corrosive materials,
toxic chemicals, flammable solvents, cancer hazard.
7.1.0. SAFE STORAGE OF CHEMICALS
Flammable liquids, concentrated acids, and concentrated bases should be stored in proper containers in safe places.
Special cabinet are available for safe storage of different types of hazardous chemicals. Personal items, such as
purses, should not be kept in the storage space, as they my cause a container to be overturned. Manufacturers color-
coding of chemical container labels to indicate proper storage makes this task easier.
7.1.1. DISPOSAL OF CHEMICAL WASTES
All chemicals and reagents should be disposed of properly and according to regulations. It is very important that the
laboratory supervisor or instructor provides explicit instructions for disposal.
7.2. BIOLOGICAL HAZARDS
Safety in the clinical lab used to involve avoiding acid splashes onto the skin or into the eyes and avoiding fire
hazards or the breathing of toxic fumes. However, with the appearance of HIV and AIDS, along with the recent
increase in Hepatitis B and Hepatitis C infections, health care workers must be especially cautious of biological
hazards as well.
7.2.1. STANDARDS PRECAUTIONS
Standards Precautions are a set of guidelines for health care workers developed by CDC in 1996 as an extension of
OSHA Blood Borne Pathogens (BBP) standard. The use of Standards Precautions intensifies safety practices
requiring that every patient and every body fluid be regarded as potentially infected with blood borne pathogens.
Standards Precautions for infection control:

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Wash hands (plain soap):- wash after touching blood, body fluids, secretions, excretions, and contaminated
items. Wash immediately after gloves are removed and between patients contacts. Avoid transfer of
microorganisms to other patients or environments.
Wear gloves: - Wear when touching blood, body fluids, secretions, excretions, and contaminated items. Put
on clean gloves just before touching mucous membranes and no intact skin. Change gloves between tasks
and procedures on the same patient after connect with material that ma contain high concentrations of
microorganisms. Remove gloves promptly after use, before touching non contaminated items and
environmental surface, and before going to another patient, and wash hands immediately to avoid transfer of
microorganisms to other patient or environments.
Wear mask and eye protection:- protects mucous membranes of the eyes, nose and mouth during
procedures and patient care activities that are likely to generate splashes or sprays of blood , body fluids,
secretions, or excretions.
Wear gown: - protect skin and prevent soiling of clothing during procedures.
Patient care equipment.
Environmental control: - follow hospital procedures for routine care and disinfection of environmental
surface, beds, bedside equipment and other frequently touched surface.
Never recap used needles using both hands.
Patient placement: - use a private room for patient who contaminated the environment or who does not
assist in maintaining appropriate hygiene or environmental control. Consult infection control if a private room
in not available.
8. QUICK OVERVIEW OF CONTINUOUS LABORATORY QUALITY MANAGEMENT (Fig.3.)
Fig.3. Continuous Laboratory Quality Management

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9. GENERAL LABORATORY RULES DESPITE CERTAIN SAFETY HAZARDS
The clinical laboratory can be safe work environment. Each worker must be responsible, use safe work habits, and
observe and follow all safety rules which is given below:
Refrain from horseplay
Do not eat, drink, chew-gum, or apply cosmetics in the work area.
Wear a laboratory apron, or buttoned laboratory coat, and closed- toe shoes.
Pin long hair up to prevent contact with chemicals, equipment, or flames.
Do not wear chains, bracelets, rings, or other loose jewelry.
Use gloves when handling hazardous chemical and biological specimens.
Clean and disinfect the work area before and after laboratory procedures and at any other time as
appropriate.
Wash hands before and after any lab procedures, after removing gloves, and at any other time as
appropriate.
Wear safety glasses, goggles when working with strong chemicals and whenever splashes are possible.
Wipe up spills promptly, using the appropriate procedure for the type of spill.
Use an appropriate mask or respirator when working with chemicals or other materials that give off dust or
fumes.
Follow manufacturer’s instructions for opening for operating all equipment. Handle all equipment with care
and store properly.
Report any broken or frayed electrical cords, exposed electrical wires, or damage to equipment.
Do not use bare hands to pick up broken glass. Use a broom or brush and a dustpan. Discard into special
containers for broken glass.
Do not allow visitors into the work area of the lab unless they are properly attired and have been instructed
in patient confidentiality issues and safety precautions.
Report any accident immediately to supervisors.
10. CONCLUSION
The influence of laboratory medicine on the quality and cost of health care as a whole is much greater because
laboratory test results influence the majority of patient care decisions. Thus, practices that reduce laboratory-related
error rates or optimize use of laboratory testing can have a substantial effect on patient safety, clinical decision
making about treatments and interventions, health outcomes, and costs. Quality Management can systematically
assess & improve important functions & work process & their outcomes of Medical Laboratory. In the last two
decades, the initiative for quality management & quality improvement in medical laboratory has been recognized
predominantly by the requirement of healthcare providers & public at large. It is really very important to all the
healthcare providers to maintain the basic quality management system within the laboratory as this cost the patient
life & death as well as staff safety & satisfaction. The outcome of good quality management can increase the level of
the patient safety & patient satisfaction as well as the staff safety & satisfaction. Medical Laboratory deals with blood,
body fluids and other biological Specimens & carries various chemical & hazardous waste & risk. It is recommended
to all medical Laboratory services provider to apply the universal precaution to assure the clean & healthy
environment. “Quality is based on patient satisfaction” The principles and the statistics involved in Quality Assurance
can be become quite complicated. However, the terminology and less complicated applications must be understood
and used by all lab workers who perform tests.

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REFRENCES
1. Comprehensive Accreditation Manual for Pathology and Laboratory Services. Okbrook Terrace, Join
Commission on Accreditation of Healthcare Organization; 1998
2. Guidelines on Establishment of Accreditation of Health Laboratories, Dr Panadda Silva; WHO Collaborating
Centre on Strengthening Quality System in Health Laboratories, Department of Medical Sciences,
Ministry of Public Health, Nonthaburi, Thailand ; 2007
3. ISO 10011:1993. Guidelines for auditing quality systems.
4. ILAC G3:1994. Guidelines for training courses for assessors.
5. ISO EN 15189:2003. Medical laboratories – particular requirements for quality and competence.
6. Jansen RT, Blaton V, Burnett D, Huisman W, Queralto JM, Zerah S, et al. (1997) Essential criteria for quality
systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997; 37:121–32
7. Plebani M (2001). Role of inspectors in external review mechanisms: criteria for selection, training and
appraisal. Clin Chim Acta 2001;309:147–54.