1. Purpose of Guidance

Guidance on the scope and direction of Virology testing is required to:

Ensure that the assessment and accreditation process is applied fairly to all applicant laboratories

Enable CPA officers to assess whether a Virology Assessor is required

Enable applicant laboratories to understand when direction by a *Consultant Virologist (see section 3 below for definitions) will be required to satisfy CPA Standard B1

Enable applicant laboratories to understand how the requirements for CPA Standard B1 should be met

Provide Guidance on expected standards for Assessors

Enable PAC members and CPA Officers to make consistent decisions in relation to Virology examinations carried out by applicant laboratories

2. Background

Clinical and diagnostic virology services are an integral part of any microbiology service. **Consultant Microbiologists must be competent to advise on the diagnosis, management and prevention of common viral infections. In addition, a microbiology laboratory must have documented arrangements for access to specialist virological advice for more complex cases.

In terms of virological testing, microbiology laboratories may refer all or part of their tests to specialist centres depending on availability of expertise locally. Virology centres will be staffed by one or more *Consultant Virologists/Consultant Healthcare Scientists who provide professional direction and specialist advice and sufficient numbers and grades of Biomedical Scientists with appropriate virological training. Microbiology laboratories must have a documented repertoire of all virological tests available to their users, stating whether these are performed in-house or referred onwards.

3. Definitions

*Consultant Virologist – a clinical pathologist or healthcare scientist who has evidence of training or experience in virology as normally exemplified by completion of the MRCPath (or equivalent) examination in Virology and eligibility for inclusion on the specialist register if medically qualified.

**Consultant Microbiologist with an interest in Virology – a clinical pathologist or healthcare scientist who has completed the MRCPath (or equivalent) examination in Medical Microbiology and is eligible for inclusion on the specialist register if medically qualified, but who has in addition undertaken further specialist training in virology and who has maintained these skills by undergoing appropriate continuing professional development. Maintenance of these skills to be reviewed at annual appraisal.

4. Recognised models for provision of virology services

4.1 Virology centres

Provide a comprehensive range of virology testing as well as specialist advice to their local users as well as to other microbiology laboratories. Professionally directed by a *Consultant Virologist with appropriate medical, scientific and technical staff.

The Royal College of Pathologists does not support single-handed clinical practice in any discipline. However, CPA recognises that there may be single-handed *Consultant Virologists and that this situation is likely to change only slowly. The workload of the laboratory will determine whether Standard B2.1 is satisfied. For single-handed consultants, robust arrangements must be made to provide professional advice and direction during periods of leave and sickness. Appropriate nominated consultants must be identified who are able to provide on-site supervision if required. (See Guidelines for Single-Handed Consultant Practice in Medical Laboratories)

4.2 Virology units

Provide an extended range of virology tests to their local users/a local network, but with agreed access to more specialist testing and advice from a virology centre. May be professionally directed by a *Consultant Virologist or by a **Consultant Microbiologist with an interest in Virology.

4.3 Routine Microbiology Laboratories

May provide a limited range of virology tests to their local users/ a local network. A **Consultant Microbiologist will professionally direct these laboratories. There will be agreed access to specialist testing and advice from a Virology Centre.

5 Virology testing that may be undertaken in the absence of a Consultant Virologist

• Antibody screening for common viral infections such as hepatitis A, B & C, varicella zoster, HIV.

• Hepatitis B surface antigen detection

• Antigen detection for respiratory/enteric viruses using kit based methodologies.

Laboratory staff will be appropriately trained in the performance of these investigations.

6 The following tests should normally be referred to a virology unit/ virology centre:

• Antigen detection using immunofluorescence

• Electron microscopy

• Virus isolation using cell culture

• Confirmatory testing for hepatitis A,B &C, varicella zoster and HIV

• Qualitative or quantitative detection of viral DNA or RNA by commercial or in-house methods.

7 CPA assessment requirements

For those laboratories where the listed repertoire indicates that they would be operating at the level of Virology Centre or Virology Unit, specialist Virology CPA assessors will be required during the assessment process.