ALEX EKWUEME FEDERAL UNIVERSITY NDUFU ALIKE IKWO

P.M.B. 1010, ABAKALIKI, EBONYI STATE

FACULTY OF SCIENCE AND TECHNOLOGY
DEPT. OF BIOLOGY/MICROBIOLOGY/BIOTECHNOLOGY

MCB406

ANALYTICAL MICROBIOLOGY AND QUALITY CONTROL

 1. Microbiological specification and regulations
2. Local and international approaches to obtaining
safe food
3. Management and quality assurance in the
microbiology laboratory

Lecturer: Dr. (Mrs) M. O. Victor-Ekwebelem

Date: October, 2021
 Microbiological specification and regulations

 Microbiological Criteria:
Microbiological criteria are used
at any stage in the food chain to
assess the acceptance of lots of
raw material or finished product.

 They are based on the absence /

presence of certain
microorganisms or quantitative
limits of these microorganisms,
per unit(s) of mass, volume, area
or lot.
 Three types of Microbiological criteria

Mandatory microbiological criteria which

1. Microbiological Standards:
are written into law or government regulations and specified
by government to protect public health

2. Microbiological Guidelines: Microbiological criteria which provide

advice to food manufacturers about acceptable or expected
microbial levels when the food production process is under
control when applying best practices.

3. Microbiological Microbiological criteria established

Specifications:
between buyers and producers that define product quality
and safety attributes required by the buyer.
• a detailed description of requirements

Why do we use microbiological criteria/specifications?

Guidelines for the microbiological examination
1. Sampling
• For regulatory purposes, a minimum of 5 sample units from a lot is generally specified for examination.
• The size of the samples taken should also be adequate to enable appropriate microbiological analyses to be
undertaken.
• A minimum sample size of 100g or ml is commonly required
• The statistical validity of a microbiological examination increases with the number of field
• samples analysed
• lot A lot is defined as a quantity of food or food units produced and handled under uniform conditions. This
may be restricted to a food item produced from a particular production line or piece of equipment within a
certain time period (not exceeding 24 hours).

2. Food examination.

Standard Plate Count

The standard plate count (SPC), also referred to as the aerobic plate count or the total viable count, is one of the
most common tests applied to indicate the microbiological quality of food. The significance of SPCs, however,
varies markedly according to the type of food product and the processing it has received. When SPC testing is
applied on a regular basis it can be a useful means of observing trends by comparing SPC results over time
Three levels of SPC are listed in Table 1 based on food type and the processing/handling the food
has undergone.

Level 1 . applies to ready-to-eat foods in which all components of the food have been cooked in the
manufacturing process/preparation of the final food product and, as such, microbial counts should
be low.
Level 2 . applies to ready-to-eat foods which contain some components that have been cooked and
then further handled (stored, sliced or mixed) prior to preparation of the final food or where no
cooking process has been used.

Level 3 - SPCs not applicable. This applies to foods such as fresh fruits and vegetables (including
salad vegetables), fermented foods and foods incorporating these (such as sandwiches and filled
rolls). It would be expected that these foods would have an inherent high plate count because of
the normal microbial flora present.

Note: An examination of the microbiological quality of a food should not be based on SPCs alone.
The significance of high (unsatisfactory) SPCs cannot truly be made without identifying the
microorganisms that predominate or without other microbiological testing.
Categories of microbiological quality
• Four categories of microbiological quality have been assigned based on standard plate counts,
levels of indicator organisms and the number or presence of pathogens. These are satisfactory,
marginal, unsatisfactory and potentially hazardous.

• Satisfactory . results indicate good microbiological quality. No action required.

• Marginal . results are borderline in that they are within limits of acceptable microbiological
quality but may indicate possible hygiene problems in the preparation of the food.
• Action: Re-sampling may be appropriate. Premises that regularly yield borderline results should
have their food handling controls investigated.
• Unsatisfactory . results are outside of acceptable microbiological limits and are indicative of
poor hygiene or food handling practices.
• Action: Further sampling, including the sampling of other foods from the food premise may be
required and an investigation undertaken to determine whether food handling controls and
hygiene practices are adequate.
• Potentially Hazardous . the levels in this range may cause food borne illness and immediate
remedial action should be initiated.
• Action: Consideration should be given to the withdrawal of any of the food still available for sale
or distribution and, if applicable, recall action may be indicated. An investigation of food
production or handling practices should be instigated to determine the source/cause of the
problem so that remedial actions can commence.
Table 1: Guideline levels for determining the microbiological quality of ready-to eat foods
potential action for each of the categories of microbiological quality is presented in Table 2.

Table 2: Potential action based on the microbiological category of ready-to-eat foods

• Generally, Salmonella and E. coli O157 should
not be present in any ready-to-eat product
 method used to estimate the risk of
foodborne illness
• In many countries, governments rely on disease and food surveillance data in
combination with expert advice on epidemiology, food microbiology and food
technology to evaluate which types and numbers of harmful microorganisms in foods
will cause disease. The level of risk can be expressed in a qualitative way (e.g., high,
medium or low risk), or when possible, as the number of cases of foodborne disease per
number of people per year. Particularly in developing countries, disease surveillance
data are limited or not available at all. In such instances, estimates of the risk level have
to be based on clinical information available (e.g., how many stool samples have been
found to contain salmonellae) in combination with results from microbiological surveys
of foods, evaluations of the types of foods that are produced, how they are produced
and how they are stored, prepared and used. A few countries may use scientific
techniques such as Quantitative Microbiological Risk Assessment (QMRA) to estimate
the risk of illnesses using detailed knowledge of the relationship between the number of
microorganisms in foods and the occurrence of foodborne diseases.
• Whatever method is used to estimate the risk of foodborne illness, the next step is to
decide whether this risk can be tolerated or needs to be reduced. The level of risk a
society is willing to accept is referred to as the “Appropriate Level Of Protection” (ALOP)
 Regulatory agencies and industrial assurance personnel
regularly examine foods or ingredients for microorganisms or
their metabolic products that may indicate
1. The presence of a pathogen or harmful toxin
2. The possibility that faulty practices occurred during
production, processing, storage and distribution
3. The suitability of a food or ingredient for a desired
purpose.
• Setting goals for public health is the right and responsibility
of governments.
• These goals may specify the maximum number of harmful
bacteria that may be present in a food.

• Where possible, the determination of this number should be

based on scientific and societal factors.
• Costs may include industry costs for reformulation and
changes in processing, consumer costs due to increased
prices, or reduced availability of certain products, and
regulatory costs in terms of surveillance.
 An approach to food safety
 Food safety does not happen by accident. To prepare safe food you must follow
 certain steps and procedures throughout the entire food preparation process,
you do this by developing a food safety plan.
 A basic food safety plan uses the hazard analysis critical control points (HACCP)
method.

 is not a complicated process; it just means that you have to first identify the
various steps you must take when you prepare your menu items, then look for
possible sources of contamination, and then find ways to control these sources

 HACCP is an approach to food safety that is systematic and preventive. It is

recommended by the Codex Alimentarius Commission, the United Nations
international standards organization for food safety.

 It goes beyond inspecting finished food products. It helps to find, correct, and
prevent hazards throughout the production process. These include physical,
chemical, and biological hazards.
There are seven universally accepted principles/ approach to food safety. These
principles are:

1. Hazard analysis

2. Identifying critical control points

3. Establishing critical limits for each critical control point.

4. Establishing monitoring procedures for critical control points.

5. Establishing corrective actions.

6. Establishing verification procedures.

7. Record keeping.
 Bodies with roles to play in food safety

(a). The Federal Ministry of Health (FMOH)

 The Federal Ministry of Health is responsible for the
formulation of national policies, guidelines and regulations
on food safety including monitoring and evaluation.

 It is also responsible for the assessment of the nutritive

value of food, environmental sanitation, food environment
and handlers,

 control of food borne disease, quality of public water from

taps, as well as national and international matters relating
to food.
Operational Approaches for Food Safety Guideline by MOH

 Requirements for Programs, Services, and Accountability (Standards) are

published by the Minister of Health and Long-Term Care under the authority
of section 7 of the Health Protection and Promotion Act (HPPA) to specify the
mandatory health programs and services provided by boards of health.
 The Standards identify the minimum expectations for public health programs
and services.

 Boards of health are accountable for implementing the Standards including

the protocols and that are referenced in the Standards.

 Guidelines are program and topic-specific documents which provide direction

on how boards of health shall approach specific requirement(s) identified
within the Standards.

 The purpose of this Guideline is to provide direction on how boards of health

must approach/apply requirements outlined in the Food Safety Standard and
Food Safety Protocol, to achieve consistency for specific program
requirements
The standards and requirements to Food Safety

Requirement 1. The board of health shall:

a) Conduct surveillance of suspected and confirmed food-borne illnesses, food premises, and food
for public consumption;
b) Conduct epidemiological analysis of surveillance data including monitoring of trends over time,
emerging trends, and priority populations; and
c) Respond by adapting programs and services in accordance with the Food Safety Protocol, the
Operational Approaches for Food Safety Guideline, and the Population Health Assessment and
Surveillance Protocol,.

Requirement 2.
The board of health shall ensure food handlers in food premises have access to training in safe food-
handling practices and principles in accordance with the Food Safety Protocol, and the Operational
Approaches for Food Safety Guideline.

Requirement 3.
The board of health shall increase public awareness of food-borne illnesses and safe food-handling
practices and principles in accordance with the Food Safety Protocol, and the Operational Approaches
for Food Safety Guideline, by: a) Adapting and/or supplementing national/provincial food safety
communications strategies where local assessment has identified a need; and/or
b) Developing and implementing regional/local communications strategies where local assessment has
identified a need
Requirement 4.

• The board of health shall provide all the components of the Food Safety Program,

Requirement 5.
The board of health shall ensure 24/7 availability to receive reports of and respond to:

a) Suspected and confirmed food-borne illnesses or outbreaks;

b) Unsafe food-handling practices, food recalls, adulteration, and consumer complaints;

and

c) Food-related issues arising from floods, fires, power outages, or other situations that
may affect food safety in accordance with the Health Protection and Promotion Act;
the Food Safety Protocol, the Infectious Diseases Protocol, and the Operational
Approaches for Food Safety Guideline.
 (b) The National Agency For Food And Drug Administration and Control (NAFDAC)

 NAFDAC is responsible for the regulation and control of the importation, exportation,
manufacture, advertisement, distribution, sale and use of food, drug, cosmetics,
medical devices, chemicals, packaged water and detergent at Federal and State levels
in Nigeria.

 Appropriate tests are conducted and compliance with standard specifications for the
effective control of the quality of food, bottled water and the raw materials as well as
their production processes in factories and other establishments is ensured.

 The Agency undertakes appropriate investigations into production premises and raw
materials for food and establishes relevant quality assurance systems including
certification of the production sites and the regulated products and pronounces on
the quality and safety of food, bottled water and chemicals.

• The role of the Agency also includes the inspection of imported food facilities to
ascertain relevant quality assurance systems necessary for certification of the
imported food product.
 Regulatory strategies USED BY NAFDAC

 The National Agency for Food & Drug Administration

& Control (NAFDAC) is the regulatory authority in
Nigeria with the mandate to regulate and control the
manufacture, importation, exportation,
advertisement, distribution, sale and use of food,
drug, cosmetics, medical devices, chemicals,
detergents and packaged water often referred to as
regulated products.

 NAFDAC is the lead Agency for food safety and quality.

Regulatory strategies
a. Product Registration : The product registration process is one of the
regulatory strategies of NAFDAC.
The Agency uses product registration to establish and monitor the
ownership and/or distributorship of the products it regulates, generally
known as regulated products (i.e. food, drug, cosmetics, medical devices,
chemicals, detergents and packaged water); their safety; quality; labelling;
claims etc.

NAFDAC employs a structured and systematic Regulation and Enforcement

of Legislation on Food Safety in Nigeria at the end of which the product is
assigned a NAFDAC Registration Number which is an attestation to the
safety, quality and appropriateness for its intended use.

The registration process involves:

1. Documentation: Documents are required such as:
 Power of Attorney from the manufacturer authorizing an applicant to
speak for his principal on all matters relating to the latter’s
specialties;

 Certificate of Manufacture and Free Sale which is an evidence that

the product is manufactured and freely sold in the country of origin;

 Certificate of Incorporation of the representative company in Nigeria;

 Evidence of Trade Mark registration; Comprehensive Certificate of

Analysis of the batch of product to be registered.

 The permit to import samples for registration purposes is issued if

documentation is satisfactory.
2. Labelling: Labels should be informative, clear and accurate;
 Indicate the name of product;

 Name and address of the manufacturer, packer, distributor,

importer, exporter, or vendor;

 Make provision for NAFDAC Registration Number; batch

number, manufacturing date and expiry or best before date;
net content,

 Ingredients list in metric weight in case of solids, semi solids

and aerosols and metric volume in case of liquids.
3. Inspection: Good Manufacturing Practice (GMP)
inspection of the production facility is carried out prior to
registration of the product.

4. Product Approval Committee Meetings: A three (3) tier

product approval meeting is held to consider the
documentation, laboratory reports, GMP inspection reports,
product labels etc. of a product prior to its registration.

• Once a product is satisfactory, it is assigned a NAFDAC

Registration Numbers and can be freely sold or marketed
within the country.
b. Consultative Meetings: NAFDAC encourages
sectoral groups, small and medium scale
entrepreneurs etc. to form umbrella
associations. E.G.
• Association of Food, Beverage and Tobacco
Employers (AFBTE);
• National Association of Small Scale
Industrialists (NASSI);
• Association of Table Water Producers
(ATWAP),
• Association of Fast Foods and Confectionaries
c. Public Enlightenment Campaigns:
• The Agency organizes public enlightenment
campaigns on topical and emerging issues using
the electronic media, print media and physical
presence .

• The Agency also uses television advertisements

and radio jingles to inform and educate the
public.
d. Training and Publications
• NAFDAC organizes international, national and in-house capacity building training
programmes consistently for staff , the industry and the general public.
• There are also collaborations and exchange programmes with credible regulatory
authorities and international bodies such as the United States Food and Drug
Administration (USFDA), US Department of Agriculture (USDA), International
Atomic Energy Agency (IAEA), World Health Organization (WHO), Directorate
General for Health and Consumers (DG SANCO) of the European Commission,
African Union/Interafrican Bureau for Animal Resources (AU/IBAR) etc.
• The Agency produces informative news bulletins, pamphlets, magazines etc; such
as the:
• “Consumer Safety” Magazine which not only offers technical information to the
general public but also has a catch-them-young programme for schools through
the Consumer Safety Club where NAFDAC educates members of the club on food
safety issues and
• organizes annual essay competitions on selected food safety topics for member
schools
Standards Organization of Nigeria (SON)
• The Standards Organisation of Nigeria is responsible for the formulation and
enforcement of set standards on the composition of imported and locally
manufactured food.

• responsible for investigating the quality of facilities, materials and products in

Nigeria. They also establish a quality assurance system, including certification of
factories, products and laboratories and to promote consumer confidence and
global competitiveness of Nigerian products and services through standardisation
and quality assurance

• The mandate of the Organisation includes preparation of Standards relating

products, measurements, materials, processes and services amongst others and
their promotion at National, Regional and International levels; certification of
products, assistance in the production of quality goods and services; improvement
of measurement accuracies and circulation of information relating to standards
• The Federal Ministry of Agriculture and Rural
Development (FMA&RD)
• The Federal Ministry of Agriculture and Rural
Development is responsible for formulating
policies on primary agricultural production
and practices which cover plants, animals,
pests and diseases etc.; supervising and
overseeing its departments and parastatals i.e.
research institutes, colleges of agriculture,
colleges of fisheries etc.
Management and quality assurance in the microbiology laboratory

Lecturer: M. O. Victor-Ekwebelem (Mrs)

MCB 406
DEPT. OF BIOLOGY/MICROBIOLOGY/BIOTECHNOLOGY
FEDERAL UNIVERSITY NDUFU ALIKE IKWO. EBONYI STATE
 WHAT IS QUALITY?
QUALITY ASSURANCE?
Quality means meeting the pre-determined requirements of users for a
particular substance or service.

Quality includes the following :

(a) Total Quality Management (TQM)
(b) Continuous Quality Improvement (CQI)
(c) Quality Assurance (QA)

Quality assurance has been defined by WHO as:

“The total process whereby the quality of laboratory reports can be

guaranteed.”

It includes group of activities carried out in order to ensure the validity of

test results
It has been summarized as the: right result, at the right time, on the right
specimen, from the right patient, with the result interpretation based on correct
reference data, and at the right price

Right result

Right price Right time

QUALITY ASSURANCE

Interpretation based
on correct reference Right
data specimen/sample

Right patient/product
Quality Management
 Quality management is defined in ISO 9000: as coordinated activities
to direct and control an organisation with regard to quality.

 Quality management generally includes establishment of a quality

policy with quality objectives, and quality planning, quality control,
quality assurance and quality improvement.

 It describes both management requirements and technical

requirements.

Approach to quality management in microbiology laboratories

A common approach for implementation of a practical QA/QC system is “the 5D’s”.
1. Decide where it is relevant to perform quality management
2. Describe who does what, how and when
3. Do what is decided and described
4. Document what has actually been done
5. Deem whether procedures and practices give the desired results and make
improvement, if necessary
1. Decide

Example of a flowchart describing the steps of a microbial analysis.

2. Describe

 When the steps requiring an operational procedure have

been decided, the procedures should be written as short
and clear as possible without missing any points

 It is suggested that the procedures follow a common

format, which includes at least the following:

1. A unique title
2. The purpose of the procedure
3. The process
4. Responsibilities
5. Name of the author and the approving person
6. Date of approval, date of expiry and edition
3. Do
• This part is quite simple: You just have to do what was decided and
described.

4. Document
• Document what has actually been done. This requirement is included for
at least four reasons:

1. It provides a tool for identifying errors and thereby preventing the same
errors to take place in the future work.

2. It enables the company to perform internal audit to verify that the

actions to be taken were actually taken.
3. It enables audit to be done by an independent third party, if necessary.

4. In case of complaints, or if unusual results have been obtained, the

laboratory can control and prove that the quality of the analysis is
sufficient and the results are reliable.
 Phases of Quality Assurance.
• Quality assurance has been defined by WHO as the total process whereby the
quality of laboratory reports can be guaranteed.

• Laboratory quality assurance: A group of activities carried out in order to ensure the
validity of test results

Quality control (QC)

• The term QC covers that part of QA, which primarily concerns the control of errors in
the performance of tests and verification of test results.

• QC must cover all aspects of every procedure within the department.

• It must be practical, achievable, and affordable.

• All materials equipment and procedures must be adequately controlled.

• Culture media must be tested for sterility and performance ion is increasingly
alarming in some sections of the community,

• In summary, QC is Continual monitoring of working practices, equipment & reagents

• Microbiological investigations are important in the diagnosis,
treatment, and surveillance of infectious diseases and policies
regarding the selection and use of antimicrobial drugs.

• It is, therefore, essential that test reports are relevant, reliable,

timely, and interpreted correctly.

• High cost of culture media and reagents,

• lack of rational approach to the selection and use of

microbiological investigations, and

• A shortage of trained technical staff and microbiologists are

important factors in preventing the establishment of essential
quality control in developing country laboratories
Standard operating procedures (SOPs)
• Each laboratory must have SOPs, sometimes referred to as the local
laboratory bench manual. It is required for the following reasons:

a) to improve and maintain the quality of laboratory services and identify

problems associated with poor work performance.

b) to provide laboratory staff with written instructions on how to perform

tests consistently to an acceptable standard in the laboratory.

c) to help avoid short-cuts being taken when performing tests.

d) to provide written standardized techniques for use in the training of

laboratory personnel.

e) to facilitate the preparation of a list and inventory of essential reagents,

chemicals and equipment.

f) to promote safe laboratory practice.

• The QC/QA program must ensure optimization and result
integrity throughout the 3 stages/phases/processes:

1. Pre-analytical

2. Analytical

3. Post-analytical
1. Pre-analytical
(a) Specimen collection:
• The material must be from the actual site of infection.
• It should be properly collected with minimum chances of contamination.
• It should be in adequate sized sterile container. E.g. Pus should be collected from
the inflamed area near the margins of the abscess and should not be collected from
the centre of the abscess where the dead and necrotic material is likely to be there.

• Optimal time of Collection of sample must be established to provide the best

chance of recovering the causative micro-organism from the specimen. E.g. In
typhoid fever the blood culture is recommended to be done in the first week of
fever.

• The WIDAL test should be done in the end of second week of fever. The specimen
should be collected before the administration of any antibiotic. If the patient is on
antibiotics then the specimen should be collected before the next dose of antibiotic
is administered.
(b) Specimen container
• Appropriate collection devices and specimen containers should be used for the
collection of specimen.

• All containers used for collection of culture specimen should be sterile.

• The handling of the containers, while collection of the specimen, should also be
such that the sterility of the container is maintained at all times.

• Labeling of the specimen should be proper to ensure there is no mixing up of

specimen.

(c) Cultre media

• Proper selection of culture media should be made to ensure that the pathogenic
organisms are isolated from the specimen.

• Fastidious organisms like Streptococci and Meningococci may require blood agar
and chocolate agar to be used for Isolation.
(d) Specimen transportation: The primary objective of the
transport of diagnostic Specimen is to maintain the sample in as
near its original state as possible.
• If prolonged delay is expected before the specimen can be
processed, it is generally preferable to freeze the specimen at -
70°C.
• Freezing at -20°C may be used for many specimens if the period
of storage is brief.

• Transport media: Some transport media’s are available for

microbiology specimen e.g. Stuart’s media, Cary-Blair media.

• Specimen receipt and Preliminary observations: Initial

observation and handling of specimen should be performed
carefully.
• While handling the specimen universal safety precautions should be
observed at all times. Personal protective equipment like gloves and
masks should be worn whenever necessary.

The acceptance of specimens includes the following:-

• Documentation of essential data in a log book
• Visual examination of the specimen for adequacy.
• Samples which do not meet the acceptance criteria should be
rejected.
• For example saliva is rejected when sputum sample is supposed to
be collected.
• A well formed stool is not the proper sample for hanging drop
preparation to look for darting motility of suspected Vibrio cholera
Bacteria.
• Rejection of inappropriate specimen includes:
• Submission of contaminated specimens
• Delay in specimen delivery
• Viral culture without transport media
• Collection of specimens from inappropriate
body sites
• specimen container leaking,
• Specimen in wrong medium, Non-sterile
container for culture
2. Analytical
• Analytical phase includes the following:-
(a) Training and re-training of the staff: The quality system is only as good as
the staff who actually work with it. No matter how good the quality system is on
paper, if the theory cannot be translated into practice, quality cannot be achieved.
• Training of the staff is essential to achieve the goals of the quality system.
• The training must include an understanding of the importance of quality.
• Post training support is also essential to ensure continued competence of the
staff.

(b) Microscopic examination of specimen: The microscopic examination of the

clinical specimen is done to assess the presence of pathogenic bacteria,. It may
also be used to assess the suitability of the specimen for acceptance or rejection.
(c) Processing of specimen: The proper processing of microbiology specimen
includes:
• The proper selection of culture media,
• maintaining the optimal temperature and atmosphere of incubation and
• proper characterization of the isolated pathogen by appropriate biochemical
reactions and antibiotic sensitivity testing.

(d) Monitoring and evaluation: The laboratory management must develop and
implement quality indicators to systematically monitor and evaluate laboratory’s
contribution to the patient care.
• Assessment of quality through audits (Internal or External) is a must.
• The laboratory must participate in an External quality assurance program.
• It is also possible to do inter – laboratory comparisons of test results. Internal
quality is also essential to evaluate the technician competence and the
performance of automated equipment.
• The following should be incorporated in the microbiological SOPs covering the analytical stage:

a) Detailed procedure for examining different specimens.

b) Staining techniques and QC of stains.

c) Aseptic techniques and safe handling of infectious material.

d) Preparation and QC of culture media and preservation of stock strains.

e) Inoculation of liquid and solid media.

f) Reading and interpretation of cultures.

g) Techniques used to identify pathogens.
h) Antimicrobial sensitivity testing and QC of procedures and antibiotic discs.
i)Cleaning and QC of equipment used in microbiology laboratory.
j) Immunologic techniques and QC of antigen and antibody reagents.
k) Safe working practices.
l) Disposal of specimens and cultures.

m) Cleaning of glassware, plastic ware, etc.

n) Sterilization procedures and their control. Control of stains and reagents All stains and reagents
must be clearly labelled, and dated
3. Post - analytical
a) Reporting of results: Reports of microbiology culture results should be
issued as soon as useful information becomes available.
• Each laboratory must establish those results that will be considered
“Urgent” or “critical”.
• In addition some results may be considered as important but not
necessarily urgent.
b) Analysis of results: It is incumbent on the laboratory Head to provide
feedback to the clinician on some parameters of laboratory performance.
• Studies on the Turn around time (TAT) and anti microbial susceptibility
patterns is helpful to the clinicians.

The terminology and format used in reporting should be standardized and

agreed between laboratory personnel and clinicians.
• Any preliminary report must be followed by a full written report.
• All reports must be checked for correctness and clarity and signed by
head of the department.

• Report distribution and delivery systems must be efficient and

urgent reports should be telephoned at all the significant stages

• Appropriate steps must be taken to ensure confidentiality of reports both in

the laboratory and during transfer.

• Those receiving the reports should consult the laboratory when any part of
the report is not clear.
• There must be effective communication between those requesting tests and
laboratory staff.

• Microbiologist should be prepared to give advice on the type of

investigations that might be helpful in the diagnosis and be prepared to
advise on antibiotic
• treatment.
Benefits of Quality assurance programs include the
following

• Production of quality products and reliable services.

• Motivation factor for the staff to work better.

• Creation of good reputation for the laboratory.

• Prevention of legal suits and associated complications