LABORATORY QUALITY

MANAGEMENT SYSTEM
BY
MLS. TIJJANI MUSA MUHAMMAD

ADMLS, N.O.H.D KANO

SEPTEMBER, 2023.
 DEFINITION

• Refers to a set of policies, procedures and practices

implemented in a laboratory to ensure consistent
quality and accuracy in its operations.

• It involves systematic planning, control, and

monitoring of all activities within the laboratory to
comply with regulatory requirements, maintain
reliable results, and enhance customer satisfaction.

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12 ELEMENT OF LABORATORY QUALITY
MANAGEMENT SYSTEM (QMS)

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• The 12 element of laboratory quality management
system are the building blocks for a QMS framework
in medical and clinical laboratories, developed by the
clinical standards institute (CLSI), these quality
elements are integral to laboratory QMS effectiveness.
• Neglecting any of these elements can compromise the
success of the LQMS, and possibly leading to
potential failure in achieving accurate and reliable
laboratory results, maintaining regulatory compliance
and meeting customer expectations.

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PROCESS CONTROL

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 PROCESS CONTROL

• The key factor that determines the success and

performance of a laboratory is its ability to manage
and control all of its processes effectively.
• Process control encompasses Quality control process
for testing, including;
– Collecting / sample collection.
– Handling,
– Method of verification, and
– Process of validation.

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 What is Quality

• Quality is a degree at which a set of inherent

characteristics fulfills requirements.

• The standard of something as measured against other

things of a similar kind.

• The ability of products or services to satisfy stated or

implies needs of a specific customer.

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 Quality of laboratory services

• Quality of laboratory services can be summarized as

fulfilment; that is what is expected from a qualitative
laboratory results.

• Qualitative services must be

– Good or excellent
– Retaining/ maintaining standard
– Satisfactory
– Acceptable
– Accurate
– Reliable
– Timely/ on time.
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• The process control involves the path of workflow as
shown below;

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 SAMPLE MANAGEMENT
• The entire process of managing a sample must be considered;
- The beginning; sample collection.
- The end; reporting and saving results.
- All the process in between.

• The processed involves;

– Pre examination phase;
• Which involves, patient preparation, provision and availability of all sample collection materials,
and all required documentations prior to sample collection
– Examination phase;
All processes involved in sample processing.
– Post examination phase

• The key factor that determines the success and performance of a laboratory is
its ability to manage and control all its processes is effectively.
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• Sample management is essential to process control
within a quality management system in laboratory.
• Effective sample management is crucial for accurate
and reliable testing, leading to confident laboratory
diagnosis.
• Precise laboratory results are essential for making
informed therapeutic decision and ensuring optimal
patient care and outcome.

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• The sample collected must be standardized and represent the actual
condition of the patient. The sample must be stored in recommended storage
conditions to prevent damage as soon as it is collected.

• Sample management policies must include following;

– Information on the sample collection.
– How to handle urgent request.
– Sample collection, labeling, preservation, and transport procedures.
– Safety practices incase of accident.
– Methods of evaluating, processing and tracking sample.
– Storage , retention and disposal procedures.
– It is essential to manage sample documents effectively to avoid any mix-ups or
discrepancies that could lead to incorrect testing outcome .
– Important information such as sample identification, collection date, time, and
required tests should be documented accurately.

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 LABORATORY ERRORS AND ITS
CONSEQUENCES
Improper process control can lead to laboratory error.
• Let look at this scenario and see its consequences;
– An 80 years old man was admitted at hospital with fever,
loss of weight, and cough, and was investigated for
possible tumor. Sputum was reported to be positive with
tuberculosis, positive culture due to In-laboratory
contamination.
– Furthered investigation found 14 additional patients with
false positive TB culture.

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• What problems can be created by this error?
– Delay in correct diagnosis
– Unnecessary treatment
– Treatment complications
– Pattern of other contamination discovered.
– Problem resolution required 6 months of investigations
contacting of more than 200 patients, many requiring culture
and X-Ray re-examination.
– Revision of laboratory procedures to eradicate the problem.
• So: Laboratory error cost time, energy, personnel and
patient outcome.

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• Therefore;

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THANK YOU FOR LISTENING

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