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Audit in the Clinical Laboratory


Quality Control Slide Set

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;-

  1. The audit commission is now responsible for the external audit of NHS activities
  2. Purchaser pressure - purchasers (health authorities, local authorities, fund-holding GPs etc.) will be looking for evidence of high quality cost-effective services
  3. Professional clinical audit by al health care professionals is consistent with the commitment to improve the quality of services to the patient.
  4. Managerial - many aspects of medical audit are of interest to health managers who may use the results for the determination of managerial policies
  5. 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:

  1. what should we do?
  2. what do we do?
  3. Are we doing what we should be doing?
  4. Can we improve what we do?
  5. 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.

  1. 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
  2. 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.
  3. 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.
  4. 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.
  5. Are the test methods being carried out according to standard operating procedures?
  6. 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.
  7. 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.
  8. 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.
  9. Purchasing of equipment, reagents, stationary and other items
  10. Laboratory reports: are they precise and clear?
  11. Storage of reagents and specimens
  12. 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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