The main thrust of the NHS reforms is to provide the best
possible cost-effective service to the patient. The main effect
is to run each part in the NHS like a commercial organization.
Audit is an essential means of achieving such an aim and this is
recognized by the financial resources made available by the
Department of Health for it. A number of factors will ensure that
audit will remain an essential part of the service;-
The audit commission is now responsible for the external
audit of NHS activities
Purchaser pressure - purchasers (health authorities,
local authorities, fund-holding GPs etc.) will be looking
for evidence of high quality cost-effective services
Professional clinical audit by al health care
professionals is consistent with the commitment to
improve the quality of services to the patient.
Managerial - many aspects of medical audit are of
interest to health managers who may use the results for
the determination of managerial policies
Commercial - as laboratories increase their contact with
commercial organizations e.g. by income-generating work,
the customers may want to look for information about the
quality of the service they intend to purchase.
Audit is an essential part of the quality assurance program of
a laboratory. A quality assurance program covers all aspects of
the service provided. It may include policies on the induction
and training of new staff, staff development, laboratory manuals,
safety policies, equipment maintenance etc. Audit is a means of
assessing whether one is achieving one's stated objectives. There
are five key questions in the audit process:
what should we do?
what do we do?
Are we doing what we should be doing?
Can we improve what we do?
Have we improved?
Financial audit and the work of the audit commission are
undertaken by auditors from outside the laboratory. The medical
virologist may have an important role in medical and laboratory
All doctors are required to participate in medical audit which
is defined as the systematic critical analysis of the quality of
medical care. The medical virologists may be involved as part of
the multidisciplinary team which may cover topics such as
infection control, appropriate use of the virology laboratory,
Laboratory audit is concerned primarily with the everyday
aspects of the work of the department and is a means of providing
feedback to both the users of the laboratory and its staff.
Laboratory audit is usually organized internally although the
NEQAS and Clinical Pathology Accreditation schemes can complement
the in-house program of audit. A diagnostic virology may wish to
examine the following areas by audit.
Request forms; are they easy to use? Are all relevant
details provided by the user. For example, date of
contact or onset would be particularly useful in the case
of requests for rubella serology
Specimens; is the right specimen received at the right
time? Are the appropriate investigations selected by the
laboratory staff? It is essential that specimens for
virus isolation should arrive at the laboratory as soon
as possible after collection or else the chance of
isolation will decrease. This is not so important for
serological tests. The laboratory staff would have much
more leeway in selecting tests in the general serology
department than other departments.
Turn-around times for each request. Attempts should be
made to monitor the turn-around time in each department
and see whether improvements can be made. Virology
laboratories generally have the worse reputation for
turn-around times compared to other pathology
Is the range of investigations available appropriate? The
number of requests for a specific test and the positivity
rate should be audited. Those tests for which requests
which are rare and/or have a low positivity rate should
Are the test methods being carried out according to
standard operating procedures?
Usage of the laboratory out of hours. On call laboratory
services are expensive and should only be provided when
necessary. Records should be kept for every individual
Safety policies and procedures. Every laboratory should
have a comprehensive safety policy. Every single accident
in the laboratory should be recorded and improvements
made if necessary. The use of dangerous substances should
Efficient use of staff. Do senior staff perform duties
that should or could be delegated to others. Efficient
use of staff would be a much more important consideration
in a small laboratory than a larger one. The training of
all staff may be audited.
Purchasing of equipment, reagents, stationary and other
Laboratory reports: are they precise and clear?
Storage of reagents and specimens
Complaints and corrective action taken
The audit process begins with the auditor drawing up an audit
checklist compiled from the quality system manual of the part
being audited. The auditor then checks compliance, non-compliance
or possible non-compliance against this checklist and write a
report. Corrective action requests may then be submitted as part
of the report. The quality system itself can be audited by a
non-technical person, whereas technical activities must be
audited by a person with sufficient technical background. In
general, it is better to have a series of small audits rather
than a single large audit. Any faults identified by an audit
should lead to immediate corrective action and appropriate
changes in documentation, which should be discussed in management
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