PATH OF WORKFLOW IN THE

MEDICAL MICROBIOLOGY
LABORATORY; QUALITY
MANAGEMENT
DR. ENYINNAYA STELLA O.
OUTLINE

 INTRODUCTION
 FUNCTION OF MEDICAL MICROBIOLOGY
LABORATORY
 GENERAL LABORATORY LAYOUT
 PATH OF WORKFLOW
 LABORATORY FORMS
 QUALITY MANAGEMENT SYSTEM
OBJECTIVE
At the end of the lecture, you should understand :
 Function of Medical Microbiology Laboratory
 The layout of a Laboratory
 How workflows in the Laboratory
 How to fill a Medical Microbiology Laboratory form well
 Explain the importance of a quality management system;
 List the quality management system essential
INTRODUCTION

 Why is the path of workflow essential to consider in health

laboratories?
The entire process of managing a sample must be considered:
• The beginning: Sample collection
• The end: reporting and saving of results
• All processes in between
An error in any part of the cycle can produce a poor
laboratory result.
INTRODUCTION
The Path of workflow is essential to consider because:
 A sample that is damaged or altered as a result of improper collection or
without consideration of the effects of transportation will always result in
an inaccurate result.
 A medical report that is delayed or lost or sent to the wrong clinician or
written in a method that result is misinterpreted negates all the time, energy
and finances spent collecting, transporting and performing the examination
properly.
Functions of Medical Microbiology Lab
 Process patient samples for Diagnosis
 Public health services
 Epidemiological services
 Research
 Training center
General Laboratory layout
 Cloakroom
 Laboratory area
 Work area
 writing area
 Storage
 Common room
 Offices
 Fire Exit
Layout
 The laboratory should not
 be a thoroughfare
 be close to eating areas.
 be freely accessible to patients and visitors.
 Have fans whether ceiling, wall, table or standing. They are an unacceptable health
hazard.

 Should be
 Clean
 Clutter free
 well ventilated preferably with air conditioners
 Comfortable environment
 Create temp for growth of some organisms such as fungi.
The Cloakroom/ Changing room

 Bags and personal effects are not allowed in the Laboratory area
 There must be a Designated room with lockers
 staff to store their belongings safely till the end of office hours.
 Located before entering the Laboratory area
 There should be two rooms
one for men and another for women
lockers on one side
should have adjacent to it toilets (preferably two) and wash
hand basin.
The common room

 Must be away from laboratory area

 For staff to take a break and eat.
 Food and drinks are not allowed in the laboratory and
neither are visitors.
 must have easy chairs and a sink.
 only place that may be carpeted if it is so desired
The Laboratory area.
 This should be a minimum of 100m2 excluding corridors circulation space and
reception areas.
 There should be about 2-3m of bench space per person. Benchtops should be non
porous covering, easy to clean, resistant to chemicals and disinfectant, no wood , no
steel.
 About 10m2 of floor space should be available per person. Floor should be easy to
clean and disinfect.
 DIVIDED INTO Various sections
 Work area
 Writing area
 Storage area
 Laboratory area
Work area
 Media room
 The reception:
 Autoclave room
 Main laboratory
 Store
 Urine bench
 Stool bench
 Swab bench
 Blood culture
 Culture bench
 Semen analysis
 Malaria parasite bench
 Serology
 Csf
WORK FLOW
Path of workflow
1. Pre examination (pre analytic)
• Test ordering and filling of Lab. Forms
• Sample collection (At the reception or at home)
• Transportation
2. Examination (Analytic)
• Processing of samples in the Laboratory
3. Post Examination (post analytic)
• Generating a result/ report creation
• Recording and documentation in the lab form, books or computer system(work
not documented is not done)
• Interpreting of result to the patient
Pre examination: reception:

 area with the most patient interaction.

 should have a table beneath a window through which patients submit their
specimens.
 Samples must be labeled and accompanied by a laboratory form
 should be accomplished without the patients having access into the
laboratory area.
 must have a sink for hand washing just inside the door that leads into a
corridor in the laboratory area
 May be away from laboratory area
Transportation
 Transportation could be through
 Transport media: The primary objective of the use of the transport medium is to
maintain/preserve the specimen as near its original state as possible and to minimize
organism overgrowth from the time of collection to the processing of the specimen.
Examples: cary blair medium for Salmonella, Shigella, Vibrio or Campylobacter,
Amines medium for fastidious organism(campylobacter, mycoplasma), Stuarts
medium for transporting throat, wound and skin swabs suspected of fastidious org.
like gonococci, viral transport medium
 Road, air or sea : samples can be transport alone or with a transport
medium to the lab by road, air or sea.
Examination: Laboratory

Sample is processed in the main Laboratory by

qualified staff using personal protective
equipment(gloves, lab coats, googles)
 Main laboratory
• Urine bench
• Stool bench
• Swab bench
• Blood culture
• Culture bench
• Semin analysis
• Malaria parasite bench
• Serology
• Csf
Post Examination

 Generating a result/ report creation

 Recording and documentation in the lab form, books or
computer system
 Interpreting of result to the patient
What is Quality?

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What is Quality?
 The degree to which a set of inherent characteristics fulfills requirements –
ISO 9000 (International Organization for Standardization)

 The degree to which a service meets or exceeds established professional

standards and user expectations.

 The degree to which the laboratory efficiently and consistently delivers a

level of performance that health care professionals expect and patients need.

 Performing the correct examination on the correct patient sample at the

correct time with the correct results … each and every time.
Achieving a 99% level of quality

means

accepting a 1%
1% error rate

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 In France a 1% error rate
would mean everyday
• 3 bad landings at Orly Paris airport
• 22 new-borns falling from
midwives’ hands
• 600,000 lunches contaminated
by bacteria
• 50,000 parcels lost by postal services
• 14 minutes without water or electricity

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Essential to all aspects of health care are laboratory results that are
accurate,
reliable, and
timely

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.

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Who is Responsible for Quality?

EVERYONE!
QUALITY MANAGEMENT SYSTEM (QMS)

 The goal of an efficient and effective diagnostic laboratory, is to provide

consistently accurate results in a timely manner with the utmost judicious
use of resources.

 All aspects of the laboratory operation need to be addressed to assure

quality; this constitutes a quality management system.

 Quality Management System (QMS)- a systematic approach that

describes, documents, implements, measures and monitors the
effectiveness of the laboratory.
Quality System Essentials

Organization Personnel Equipment

Purchasing Process Information

& Management. Management
Inventory

?
How do we achieve
excellent performance in Documents Non conforming
Assessment
the laboratory &
Records
Events
Management

QMS can be achieved using the

12 Quality System Essentials. Continual
Improvement
Customer
Focus
Facilities
&
Safety
Twelve Quality System Essentials

Organization Personnel Equipment

Set of coordinated
activities that Purchasing
&
Inventory
Process
Management.
Information
Management

function as
building blocks for Documents
&
Non conforming
Events Management Assessment
Records

quality
management Continual Improvement Customer Focus Facilities
&
Safety

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Quality System Essentials
 Organization
• There must be a strong, supporting organizational structure—management commitment is crucial.
Management responsibility.
 Personnel
• The most important laboratory resource is a competent, motivated staff. Training and competency
assessment.
 Equipment
• right equipment, proper installation, and maintenance, calibration

 Purchasing and inventory

• saves cost, ensuring supplies and reagents are available when needed.
• quality reagents & supplies and they used and stored to preserve integrity and reliability
 Process control
• validation, quality control, proficiency testing, specimen management
 Information management
• Manual or electronic. In the form of test reporting. Ensure accuracy and confidentiality.
Quality System Essentials
 Documents and records
• Documents to inform how to do things. Records must be accurate and accessible
 Non-conforming event Management (Occurrence Management)
• document and take corrective action
 Assessment
• Internal or external
 Continual (Process) improvement
• The best way to improve organizational output is to continually improve performance.
• Revise process based on information gathered
 Customer focus (Service)
• Customer group identification, Customer needs, Customer feedback
 Facilities and Safety
• Design for proper flow and ergonomics
• Safety of staff, others, environment
 Implementing
Quality Management
does not
guarantee But it detects errors
an that may occur and
ERROR-FREE prevents them from
Laboratory recurring

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