Laboratory Policy and Procedural

Manuals

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 Definitions
A policy is a statement that outlines the
institution's position on an administrative or
operational issue.

A procedure is an instructional document

that provides explanations and step-by-step
directions on how to perform a task, test, or
process.

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 Definitions
 Policy manuals are collections of statements that
outline the position of the institution on a wide range
of administrative and operational issues.
 Procedure manuals, in contrast, provide detailed
information about subjects only alluded to in
memos, performance evaluations, training
sessions, and the day-to-day verbal and written
interchange between lab. personnels and their
clients
 Manuals must be complete, clear in instruction and
explanation.
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Laboratory policy
 should be dynamic documents with up-to-
date, pertinent, and accurate information.
 The primary objective is to ensure
effective communication b/n members of
an organization.
 remove any ambiguities and allow uniform
and consistent application of the lab.
policies and procedures.
 They must be living documents
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 Laboratory policy…
 Laboratory policies, therefore, means those
decisions which are taken in consultation
with medical and nursing staff to enable a
laboratory to operate:
– reliably
– effectively, and in harmony with other
departments of the hospital or health
center.
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 Laboratory policy
 Such policies usually cover:
– Laboratory hours and emergency work
– Range of tests to be performed and referral of
specimens
– Collection of specimens
– Workload capacity of the laboratory
– Delivery of reports
– Reporting of results and record keeping
– Safety measurements

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 Laboratory hours and emergency work
 There should be definite laboratory working hours.
 In peripheral laboratories it is often more difficult to
maintain working hours b/c of;
– large outpatient clinics
– emergency nature of much of the work.
 Outside of normal working hours, each laboratory
should organize a system for testing urgent
specimens.

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 Laboratory hours….
 Only essential tests for the immediate care and
assessment of a patient should be requested
urgently.
 Written details of the emergency laboratory service
should be circulated to all those concerned.
 Are investigations on the normal working hour but
requiring urgent investigations.
 The laboratory staffs that participate in the
emergency service must be able to work efficiently
and reliably without supervision.

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 Range of tests to be performed and
referral of specimens
 In deciding which tests should be undertaken in the
given laboratory the following are important
considerations: -
 What is the clinical value of each investigation &
w/c tests should have priority b/c they are
needed to
Establish a diagnosis
Asses a patient’s condition and prognosis
Judge whether to refer a patient to a center
with more facilities
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Range of tests…
 Prevent and control disease in a community
 Assist health authorities to plan cost-effectively.
 The level of experience and training of the lab staff
 Level of lab equipment and can equipment be
operated reliably and safely?
 What are the costs involved?
 Can specimens be preserved and transported
safely?
 How quickly can the results of referred tests be
known?

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 Collection of specimens
 The correct collection of specimens is essential
 Written instructions regarding the collection of
routine and urgent specimens must be issued by
the lab to all those responsible for the collection of
specimens from inpatients and outpatients.
 There should be an organized system for the
collection of routine specimens from wards.
 Specimens for urgent analysis should be
delivered to the laboratory ASAP.
 A request form must accompany every specimen.

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 Collection of specimens…
 every specimen must be clearly labeled
 Clerical mistakes can have serious
consequences
 there should be specimen rejection criteria.
 a note indicating how to correct the fault
should accompany the returned form
 there should be a SOP for sample collection
in the sample collection area.

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 Workload capacity of a laboratory
 The workload capacity of a lab must match with
– the number of staff
– the level of training
– the size of the laboratory and its facilities
 If the amount of work requested is beyond the capabilities
of a laboratory, this must be communicated to officials.
 When workload is excessive, testing of specimens becomes
unreliable and safety measures tend to be ignored.
 Too little work can also lead to unreliable test results due to
a lack of concentration.
 

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 Delivery of reports
 All results must be checked by experienced technical staff
before released.
 Any unexpected result should be investigated and repeated
if necessary.
 Laboratory workers must understand the clinical
significance and accepted normal range of the tests they
perform.
 panic results should be reported as soon as possible.
 When a result is phoned, it is advisable to request the
person receiving the report to repeat back the name of the
patient and test result
 A written report should follow as soon as possible.

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 Delivery of reports cont…
 There should be an organized system for the delivery
of reports.
 To avoid any loss of reports and to keep the results of
tests confidential all forms should be placed in
marked envelopes or in closed folders.
 Request forms and other laboratory printed stationery
should be prepared.
– A record of all test results must be dated, filled & kept
– Records are also required when preparing work reports
and estimating the workload of the laboratory.

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Standard Operating Procedure

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 Standard operating procedures
 Standard operating procedure (SOPs) is some
times referred to as the local laboratory bench
manual.

 It is defined as approved documents or manuals

that describe how to perform various operations in
the laboratory.

 It is also defined as tools to efficiently implement

preset quality objectives in all functions and
activities of a laboratory.
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 Standard operating procedures
 It contains step-by-step instructions that
laboratory staff should meticulously follow to
produce the
– Right result, at the
– Right time, on the
– Right specimen, from the
– Right patient, with result interpretation based
on
Correct reference data, in a consistent
manner, and safe laboratory practice.
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 Standard operating procedures
SOPs are part of an organization’s Quality
Manual.
This quality manual is a manual that is
talking about
– policies (the “what to do” issues),
– processes (the “how it happens” issue),
and
– procedures (the “how to do it” or SOPs).
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 Standard operating procedures
 The “WHAT TO DO” or Policies are talking about
statements of the organization’s mission, goals and
purpose.
– E.g. establishing Quality Laboratory services to
support disease prevention, diagnosis, treatment
and health research.
 The “HOW IT HAPPENS” or Processes describe
steps involved to carry out quality policies.
 The “HOW TO DO IT” or SOPs present procedures /
work instructions for practical implementation.

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 Standard operating procedures
 SOPs are required for the following reasons : -

– To improve and maintain the quality of laboratory services.

– To provide laboratory staff with written instructions on how

to perform tests consistently to an acceptable standard in
their laboratory
– To serve as a guide for new staff training

– To prevent unwarranted short-cuts being taken when

performing tests

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Standard operating procedures
– To make clinical and epidemiological
interpretation of test results easier by
standardizing specimen collection techniques,
test methods and test reporting.
– Help to assess employee competence and
identify retraining needs
– Facilitate the preparation of a list and
inventory of essential reagents, chemicals and
equipment
– Promote safe laboratory practice

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 Standard operating procedures
 SOPs must be: -
– applicable and achievable in the laboratory in
which they will be used.
– clearly written and easy to understand and
follow.
– kept up to date using appropriate
technologies.
– written and implemented by a qualified
experienced laboratory officer and
– followed by all members of staff.
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 SOP Elements
 The following are among the common elements of SOPs: -
– Title of SOP including number, version date it is
prepared.
– Staff able to perform test
• Unsupervised: list names
• Under supervision: list names
– Cost of test = state the cost of the test on SOP.
– Purpose of test = state the main reasons for
performing the test, i.e. clinical and/or public health
reasons.

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SOP Elements...
– Principle of test = state briefly the
technology used.
– Specimen = state the specimen required
and how to collect it
– Equipment = list the items of equipment
needed to perform the test
– Reagents/stains = list reagents, stains, etc
needed to perform the test

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SOP Elements...
– Controls = list controls and sources to be used in
the test.
– Method of test = describe in a numbered sequence
how to perform the test
– Results documentation and reporting system
should include all required elements:
• Patient’s name, unique identifier, dates and time
of sample collection and result reporting
• Name and address of the laboratory
• All required signatures
• Units, reference ranges, etc.
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SOP Elements...
– Sources of errors = summarize the important
and commonest causes of an incorrect test
result.
– Specimen retention requirements
– Safety concerns including waste and left-over
specimen disposal system
– References = list the main sources of the
information contained in the SOP, e.g. book,
journal, published paper, leaflets etc
– Authors
– Approval signatures
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Standard operating procedures...

 Good SOPs are comprehensive, covering all

aspects of details making analytical processes
error-proof and failsafe.
 They are written clearly and concisely, because
complex procedures are
– Misunderstood
– Quickly forgotten
– User unfriendly
– Ignored and susceptible to short cutting

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 Standard operating procedures cont...

 Good SOPs also

– provide an easy, efficient means to document
complicated techniques
– Communicate what is exactly done in the lab
– Do not use more words than necessary
– Do not require frequent updates and corrections
– Follow standard outline
– Are easily understood by new personnel
– Are periodically reviewed and kept up-to-date
– Accepted by lab director, QA manager and employee

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 Standard operating procedures cont...
 The common problems of SOPs are: -
– Inadequate (not comprehensive, complex, or
difficult to comprehend)
– Lost
– Are not meticulously followed
– SOP deviations as evidenced by QC results are
not documented and discussed
– Old SOP versions are not removed from the
worksite

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Problems of SOPs…
– Absence or weak management support for
compliance programs
– Adherence to SOPs as a job requirement
is not defined or not communicated to lab
staff
– Poor or absent supervision and
documentation of gaps
– Difficulty in dealing with change. “We have
always done it this way” attitude.
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