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Audit
in the Clinical Laboratory
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 audit.
Medical Audit
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, antiviral usage.
Laboratory Audit
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
laboratories.
- 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 be withdrawn.
- 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 call-out.
- 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 be audited.
- 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 items
- 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 reviews.
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